The Intersection of International Law, Agricultural Biotechnology, and Infectious Disease [1 ed.] 9789047431329, 9781571053732

Citation preview

The Intersection of International Law, Agricultural Biotechnology, and Infectious Disease

Meredith T. Mariani

M a r t i n u s N i j h o f f P u bl i s h e r s Leiden / Boston

Library of Congress Cataloging-in-Publication Data CIP on file with publisher. ISBN: 1 5710 5373 5 ISBN13: 978 1 5710 5373 2

Copyright © 2007 Koninklijke Brill NV, Leiden, The Netherlands. Koninklijke Brill NV incorporates the imprints Brill, Hotei Publishers, IDC Publishers, Martinus Nijhoff Publishers, and VSP. All rights reserved. No part of this public may be reproduced, translated, stored in a retrieval system, or transmitted in any form or by any means, electronic, mechanical, photocopying, recording or otherwise, without prior written permission from the publisher. Authorization to photocopy items for internal or personal use is granted by Brill provided that the appropriate fees are paid directly to the Copyright Clearance Center, 222 Rosewood Drive, Suite 910, Danvers, MA 01923, USA. Fees are subject to change. Manufactured in the United States of America

TABLE OF CONTENTS About the Author. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . v List of Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vii Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xi

Chapter 1: The Science Behind GMOs . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 A.

B.

Arguments in Favor of Solutions Provided by GMOs. . . . . . . . . . 3 1. Economic Benefits Provided by GMOs . . . . . . . . . . . . . . . . 4 2. Scientific and Environmental Benefits Provided by GMOs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Arguments Against Solutions Provided by GMOs . . . . . . . . . . . . 7 1. Economic Concerns Related to GMOs. . . . . . . . . . . . . . . . . 8 2. Scientific and Environmental Concerns Related to GMOs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Chapter 2: General Environmental Frameworks Addressing GMOs. . . . . . . 15 A. B. C.

Deliberate Release Techniques . . . . . . . . . . . . . . . . . . . . . . . . . . 15 U.N. Convention on Biological Diversity . . . . . . . . . . . . . . . . . . 17 Cartagena Protocol on Biosafety . . . . . . . . . . . . . . . . . . . . . . . . . 18

Chapter 3: Public Health Legislation . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29 A. B.

International Health Regulations . . . . . . . . . . . . . . . . . . . . . . . . . 31 Framework Convention on Global Infectious Disease Prevention and Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

Chapter 4: GMOs, Food Safety, and Foodborne Disease . . . . . . . . . . . . . . 51 A. B. C. D. E.

World Health Organization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52 Food and Agriculture Organization . . . . . . . . . . . . . . . . . . . . . . . 54 Codex Alimentarius . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62 Organization for Economic Cooperation and Development . . . . 73 Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76

iii

iv • International Law, Agricultural Biotechnology, and Infectious Disease

Chapter 5: International Trade Legislation . . . . . . . . . . . . . . . . . . . . . . . . 79 A. B. C. D. E. F.

General Agreement on Tariffs and Trade. . . . . . . . . . . . . . . . . . . 79 Technical Barriers to Trade Agreement . . . . . . . . . . . . . . . . . . . . 84 Sanitary and Phytosanitary Agreement . . . . . . . . . . . . . . . . . . . . 98 WTO Jurisprudence on GMOs: Biotech Products . . . . . . . . . . 116 Office International des Epizooties . . . . . . . . . . . . . . . . . . . . . . 124 International Plant Protection Convention. . . . . . . . . . . . . . . . . 127

Chapter 6: Regional Regulatory Regimes for GMOs . . . . . . . . . . . . . . . . 141 A. B. C. D. E. F.

United States . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 141 European Union . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 166 African Union . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 192 Association of Southeast Asian Nations . . . . . . . . . . . . . . . . . . 202 North American Free Trade Agreement Documentation Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 205 Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 207

Chapter 7: Critique and Proposals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 209 Index. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 225

ABOUT THE AUTHOR

Meredith Mariani obtained a J.D. from the University of Notre Dame Law School and an LL.M. in International and Comparative Law from the George Washington University Law School. She completed her undergraduate work at Mount Holyoke College, with a double major in Biology and Anthropology. She wrote articles and memoranda on stem cell legislation, published by the University of Notre Dame Journal of Legislation and the International Center for Technology Assessment. She currently is an independent consultant focusing on biotechnology law and policy.

v

LIST OF ABBREVIATIONS

AIA APHIS ASEAN ASF AU BPPD BRS BSE Bt CBD CBPP CDC CFSAN CGFRA CJD COAG CPM DNA EC EFSA EMPRES EPA EU FAO FDA FFDCA FIRFA FOS FQPA FSIS

advance information agreement Animal and Plant Health Inspection Service Association of Southeast Asian Nations African Swine Fever African Union Biopesticides and Pollution Prevention Division Biotechnology Regulatory Service Bovine Spongiform Encephalopathy Bacillus thuringienesis U.N. Convention on Biological Diversity Contagious Bovine Pleuropneumonia Center for Disease Control and Prevention Center for Food Safety and Applied Nutrition Commission on Genetic Resources for Food and Agriculture Creutzfeldt-Jakob Disease FAO Committee on Agriculture Commission on Phytosanitary Measures deoxyribonucleic acid European Community(ies) European Food Safety Authority Emergency Prevention System for Transboundary Animal and Plant Pests and Diseases Environmental Protection Agency European Union Food and Agriculture Organization Food and Drug Administration Federal Food, Drug, and Cosmetic Act Federal Insecticide, Fungicide, and Rodenticide Act Department of Food Safety, Zoonoses and Foodborne Diseases Food Quality and Protection Act of 1996 Food Safety Inspection Service vii

viii • International Law, Agricultural Biotechnology, and Infectious Disease

GATT GIEWS GM GMO GRAS GREP HHS IDWGB IHR INFOSAN IPFSAPH IPPC ITWG-AnGR ITWG-PGR JECFA LMO MCAN MFN MRL NAFTA NAGM NIH NPPO OAU OECD OIE OPP OPPT OPPTS PAIA PIP

General Agreement on Tarrifs and Trade Global Information and Early Warning System on Food and Agriculture genetically modified genetically modified organism generally recognized as safe Global Rinderpest Eradication Programme Department of Health and Human Services FAO Inter-Departmental Working Group on Biotechnology International Health Regulations WHO International Food Safety Authorities Network International Portal on Food Safety, Animal and Plant Health International Plant Protection Convention Intergovernmental Technical Working Group on Animal Genetic Resources Intergovernmental Technical Working Group on Plant Genetic Resources Joint FAO/WHO Expert Committee on Food Additives living modified organism Microbial Commercial Activity Notice most-favored nation maximum residue limits North American Free Trade Agreement National Authority on Genetic Modification National Institutes of Health national plant protection organization Organization of African Unity Organization for Economic Cooperation and Development Office International des Epizooties Office of Pesticide Programs Office of Pollution Prevention and Toxics Office of Prevention, Pesticides and Toxic Substances priority areas for interdisciplinary action plant-incorporated pesticide

List of Abbreviations • ix

PPA PRA RPPO RVF SARS SARS-CoV SPS Agreement TBT Agreement TSCA TSE UNEP USDA vCJD WHA WHO

Plant Protection Act pest risk analysis regional plant protection organization Rift Valley Fever Severe Acute Respiratory Syndrome SARS-associated coronavirus Sanitary and Phytosanitary Agreement Technical Barriers to Trade Agreement Toxic Substances Control Act Transmissible Spongiform Encephalopathy U.N. Environmental Program U.S. Department of Agriculture variant Creutzfeldt-Jakob Disease World Health Assembly World Health Organization

INTRODUCTION

Biotechnology possesses the potential to revolutionize genetics, agriculture, public health mechanisms, and environmental management and conservation. The applications of biotechnology are multi-faceted and innovative, exceeding previously conceived boundaries of science. We now have the ability to refashion both animals and plants, resulting in novel manifestations previously unknown to the scientific community in agricultural production, pharmaceutical applications, and biomedical innovations. Biotechnology is also responsible for significant advances in human genetics, genomics, stem cell research, and cloning.1 Agricultural applications provide the most practical uses of current advances in biotechnology, which have the potential for significant impact if agricultural producers worldwide begin using biotechnology techniques. Genetically modified organisms (GMOs) offer significant benefits to global society in the areas of agricultural improvements, environmental management facilitation, biodiversity conservation, sustainable development promotion, and increased human health protection. These new technologies, while groundbreaking and galvanizing, leave unanswered questions in their wake. The most significant and controversial concerns relate to the possible negative scientific, environmental, and social effects from incorporating GMOs into global commerce. Much of the concern stems from a lack of scientific certainty associated with biotechnology, which is most notable for GMOs and their impacts on humans and the surrounding environment. These gaps in scientific knowledge bring oscillation and confusion as to the appropriate means for regulating GMOs. Serious concerns about GMOs are treated as separate and distinct from other disciplines, although GMOs significantly affect a wide range of fields. If GMOs are to be successfully regulated within the global 1 Mapping of the human genome has been the most well-known benefit of progress in biotechnology. Genomics, which is the study of the genetic control of body functions in health and disease, has also seen significant gains in recent years due to advances in biotechnology, as have stem cell research and cloning. Ethics and Uses of Genetic Engineering in Industry, at 71, IBC Proceedings of the Fifth Session, (Dec. 1998).

xi

xii • International Law, Agricultural Biotechnology, and Infectious Disease

community, these discussions must incorporate input from other fields, most notably, public health, food safety, international trade, and environmental regulation. Currently, global debate and regulation of GMOs do not include any discussion of public health concerns, particularly those related to infectious disease. Integration of GMOs into the environment and global commerce could lead to the development of new pathogens, as well as exacerbate the spread of existing infectious diseases. All pathogens possess the ability to bypass borders, but some are more dangerous than others when they do so.2 These more dangerous infectious diseases are special, for their pathological profiles “mesh seamlessly with the processes of globalization, especially the movement of people, goods, and animal and insect vectors through the channels of global commerce, travel, and migration.”3 Developments in public health practices and technologies ameliorated the devastating effect of these pathogens; as germs went global, success in fighting them required that public health technologies and practices go global as well.4 Recently, infectious disease outbreaks involving Avian Influenza,5 Severe Acute Respiratory DAVID P. FIDLER, SARS, GOVERNANCE AND THE GLOBALIZATION OF DISEASE 14 (2004). 2

3

Id.

4

Id.

Avian Influenza is a highly species-specific, contagious disease caused by a virus that usually only infects birds and, occasionally, pigs. Infection with Avian Influenza viruses in domestic poultry has two manifestations, which consist of two levels of virulence. The low pathogenic form results in mild symptoms and can easily go undetected whereas the highly pathogenic form spreads very quickly, causes disease affecting multiple internal organs, with a high and rapid mortality. Sub-types H5 and H7 are introduced in their low pathogenic form and mutate into the highly pathogen form after circulating within poultry populations. The H5 and H7 sub-types of influenza virus are carried naturally by wild waterfowl but usually in its low pathogenic form. Current evidence suggests that migratory birds are able to introduce low pathogenic H5 and H7 sub-types to domestic poultry populations, where it mutates to the highly pathogenic form. The H5N1 virus sub-type is now spreading throughout wild poultry populations as highly pathogenic rather than in its low pathogenic form. World Health Organization (WHO), Avian influenza, frequently asked questions, at http://www.who.int/csr/disease/avian_influenza/avian_faqs/en/print.html (last updated Dec. 5, 2005) [hereinafter Avian Influenza FAQs]. The H5N1 strain of Avian Influenza is very virulent, for it kills, 5

Introduction • xiii

Syndrome (SARS),6 and Bovine Spongiform Encephalopathy (BSE)7 are examples of these more dangerous pathogens, with the ability to jeopardize diplomatic relations, frighten the public, cause massive economic losses, and disrupt global commerce.8 within 48 hours of infection, 100 percent of infected chickens. This strain continued to mutate rapidly, jumping between wild and domestic poultry, until January 2003, when the “z” virus emerged and proved to be more resilient, resistant to anti-flu drugs, and more able to withstand a wider array of environmental challenges than its predecessors. In 2004, this particular strain of H5N1 became even more virulent and able to kill a wide range of species, including rodents and humans. This virus has also proved incredibly difficult to contain, in addition to having a high mortality rate. Laurie Garrett, The Next Pandemic?, FOREIGN AFFAIRS, July/Aug. 2005, at 12–3. 6 Severe Acute Respiratory Syndrome (SARS), first reported in Asia in February 2003, is a viral respiratory illness caused by a novel coronavirus called SARS-associated coronavirus (SARS-CoV). SARS-CoV, over the next few months, spread to more than 24 countries before the outbreak was contained. Centers for Disease Control and Prevention (CDC), Basic Information about SARS, at http://www. cdc.gov/ncidod/sars/factsheet.htm (last visited Jan. 9, 2007) [hereinafter SARS Basic Information]. SARS-CoV also represented the “first severe infectious disease to emerge into the highly globalized world society of the twenty-first century . . . and demonstrated dramatically the global havoc that can be wrecked by a newly emerging infectious disease.” SARS represented one of the most dangerous new pathogens to emerge in the last three decades, due to its human-to-human transmission, high fatality rate, and the inadequacy of current diagnostic technologies and treatments. FIDLER, supra note 2, at 6, 15–16. 7 Transmissible Spongiform Encephalopathies (TSEs) are “diseases characterized by spongy degeneration of the brain with severe and fatal neurological signs and symptoms.” TSEs are found in a variety of animal species; BSE primarily affects cattle and is caused by an agent whose nature is the subject of some debate. TSEs are also found in humans, with Creutzfeldt-Jakob Disease (CJD) being the prototype human TSE. Transmission of CJD occurs either through hereditary predisposition or a more common, sporadic form. A new form of CJD, called variant CJD (vCJD) appeared in 1996 with a different manifestation of symptoms than the classical forms of CJD, which seemed strongly tied to exposure to BSE. There are similarities between the strains of agents responsible for vCJD and BSE, which furthers the hypothesis, put forth by WHO, that the cluster of vCJD is due to the same agent causing BSE in cattle. WHO, Bovine spongiform encephalopathy fact sheet, at http://www who.int/mediacentre/factsheets/fs113/en/print.html (last updated Nov. 2002) [hereinafter WHO BSE fact sheet].

William B. Karesh & Robert A. Cook, The Human-Animal Link, FOREIGN AFFAIR, July/Aug. 2005, at 38. 8

xiv • International Law, Agricultural Biotechnology, and Infectious Disease

Another dimension to the recent spate of infectious disease outbreaks concerns the uncertain nature and origins of the pathogens responsible for Avian Influenza, SARS, and BSE. All three of these diseases present situations in which the causative agent is either unknown or strays from previous patterns of disease expression.9 One argument put forth the possibility, especially in relation to SARS, that these pathogens could be the result of biotechnological techniques. There is no concrete scientific evidence that the pathogens responsible for BSE, Avian Influenza, or SARS are direct or indirect products of biotechnological techniques. But this question raises concerns as to how prepared global regulatory and legislative regimes addressing infectious disease and GMOs are to address the possibility of these developments. Thus far, the legislative and regulatory responses to GMOs have been piecemeal at best, focused mainly on how GMOs interact with one area, like international trade or biological diversity. The intersection between GMOs and infectious disease, which seems to be another narrow focus, showcases how a neglected area of convergence really touches on numerous other fields, including international trade, the environment, food safety, and public health. Further legislative and regulatory efforts involving GMOs and infectious disease require a more integrated response, which is crucial for effective regulation in these areas. This book examThe SARS outbreak constituted the first time that the SARS-CoV was identified in human populations, and more detailed analysis illustrated that the SARS-CoV is not a closely related, mutated, or recombinant variant from existing coronaviruses. FIDLER, supra note 2, at 5. No virus of the H5 sub-type, including H5N1, has significantly circulated among human populations, which indicates a high level of human vulnerability to the spread of such a virus. Human cases of H5N1 were previously attributable to some kind of contact with chickens or domestic poultry, but now human cases are occurring without exposure to H5N1 through dead or diseased birds. There has been one instance of human-to-human transmission of the “z” strain of the H5N1 virus, with many more suspected but unconfirmed. The WHO states “there is no scientific explanation for the unusual disease pattern.” Garrett, supra note 5, at 11–12, 14. Some argue that the BSE agent is composed primarily of a self-replicating protein called a prion. Others argue that the BSE agent is more virus-like, containing nucleic acids carrying genetic material. Significant evidence collected over the past decade indicates that the BSE agent is more likely to be virus-like in nature. But this evidence is not conclusive and illustrates the uncertainty surrounding the nature of transmission for BSE. WHO BSE fact sheet, supra note 7. 9

Introduction • xv

ines the current global and regional legal frameworks and perspectives for infectious disease and GMOs and outlines possible options for future efforts at regulation. Issues related to infectious disease and GMOs must be examined within a more expansive framework, incorporating all possible influences and connections.

CHAPTER 1

THE SCIENCE BEHIND GMOS Understanding global legislative efforts at regulating GMOs requires a basic examination of the science behind biotechnology and its development into innovative techniques that are currently transforming agriculture, environmental applications, public health, food safety, and international trade. The primary objective of these techniques is to apply knowledge of biological functions in order to provide benefits to human health and the environment, which includes a “continuum of technologies ranging from long-established and widely used classical technologies through more advanced, modern technologies.”1 The collection of technologies falls into two general categories: classical and modern biotechnology. “Classical biotechnology” generally refers to traditional plant breeding techniques that strive to improve both quality and quantity of products by selecting and emphasizing random mutations conferring a competitive advantage.2 As early as the 1960s, prokaryotic organisms3 were designed and developed for industrial and agricultural applications, such as frost control, nitrogen fixation improvement, biodegradation and waste treatment, and mineral processing.4 “Modern biotechnology” strives to improve yields and quality improvements, like classical biotechnology, by using more advanced methods such as recombinant DNA techniques, cell and tissue culture, cell fusion, and new bioprocessing methods. However, modern biotechnological techniques, otherwise called “genetic engineering,” allow for a level of specificity unattainable through traditional methods of gene selection.5 These 1 BIOTECHNOLOGY AND BIOSAFETY 8, 44 (Ismail Serageldin & Wanda Collins eds., 1999).

Id. at 8. See also 1 ENCYCLOPEDIA OF ETHICAL, LEGAL, AND POLICY ISSUES IN BIOTECHNOLOGY 27 (Thomas H. Murray & Maxwell J. Mehlman eds., 2000). 2

A prokaryotic organism is a cellular organism that does not have a distinct nucleus, such as a bacterium. 3

4 2 ENCYCLOPEDIA OF ETHICAL, LEGAL, AND POLICY ISSUES IN BIOTECHNOLOGY 1092 (Thomas H. Murray & Maxwell J. Mehlman eds., 2000). 5 1 ENCYCLOPEDIA OF ETHICAL, LEGAL, AND POLICY ISSUES IN BIOTECHNOLOGY 27 (Thomas H. Murray & Maxwell J. Mehlman eds., 2000).

1

2 • International Law, Agricultural Biotechnology, and Infectious Disease

techniques employ living organisms (or parts of organisms) to “make or modify products, improve plants or animals, or develop microorganisms for specific uses.”6 More specifically, genetic engineering allows for the genetic alteration of organisms by isolating and transferring specific sections of DNA genes from one organism to another, which permits faster and more accurate introduction of desired traits and allows for discriminating avoidance of undesirable traits.7 “Genetically modified organism” (GMO) is a term used widely in relation to modern biotechnology products and commonly refers to whole foods8 from plants or animals whose germplasm9 has been modified using recombinant DNA technology.10 Transgenic plants, a sub-set of GMOs, are crops or plants genetically engineered to express traits not found naturally in the altered plants or crops.11 Genetically modified (GM) foods, related to GMOs and transgenic plants, are broader in scope, usually including processed foods with ingredients from GMOs.12 Agricultural, medical, and industrial applications are including varieties of GM plants, animals, and microorganisms with increasing frequency, with promises of improved agricultural practices and yields, enhanced human health, and better environmental management and conservation. 6 2 ENCYCLOPEDIA OF ETHICAL, LEGAL, AND POLICY ISSUES IN BIOTECHNOLOGY 1089 (Thomas H. Murray & Maxwell J. Mehlman eds., 2000).

1 ENCYCLOPEDIA OF ETHICAL, LEGAL, AND POLICY ISSUES IN BIOTECHNOLOGY 27 (Thomas H. Murray & Maxwell J. Mehlman eds., 2000). 7

Whole foods are foods that have not been combined or adulterated; other foods are processed foods. Adulterates are “impurities that have been intentionally introduced generally to enhance the bulk or appearance of a commodity. Id. at 18. 8

Germplasm is the hereditary material of germ cells. A germ cell is a gamete (as an egg or sperm cell) or one of the antecedent cells. MERRIAM-WEBSTER’S COLLEGIATE DICTIONARY 488 (10th ed. 2000). 9

10 Recombinant DNA refers to genetically engineered DNA prepared in vitro by cutting up DNA molecules and splicing together specific DNA fragments usually from more than one species of organism. Id. at 974.

1 ENCYCLOPEDIA OF ETHICAL, LEGAL, AND POLICY ISSUES IN BIOTECHNOLOGY 18 (Thomas H. Murray & Maxwell J. Mehlman eds., 2000). 11

These processed foods involve the consumption of GMOs as an ingredient but processing methods will most likely significantly alter the chemical properties of the GMO. 1 ENCYCLOPEDIA OF ETHICAL, LEGAL, AND POLICY ISSUES IN BIOTECHNOLOGY 18 (Thomas H. Murray & Maxwell J. Mehlman eds., 2000). 12

Science Behind GMOs • 3

GMOs and their products also offer potential benefits and solutions to current agricultural challenges and human health problems. Proponents of genetic engineering claim that GMOs and their products can make a significant contribution towards improving health care, enhancing food quality and security through sustainable agricultural practices, and increasing support for more sustainable methods of environmental conservation and restoration.13 Agricultural practices and problems slated to significantly benefit from the use of GMOs and their products include land and water shortages, widespread herbicide and pesticide use, and increased monoculture agriculture. Public health could also potentially benefit from GMOs and their products, both in terms of controlling infectious diseases, as well as in respect to other therapies directly associated with human health improvements, such as stem cells, cloning, gene therapy, and genomics. A.

ARGUMENTS IN FAVOR OF SOLUTIONS PROVIDED BY GMOS

Proponents of GMOs claim that these products improve agricultural production and overall safety of food, increase the economic vibrancy and vitality of communities, and foster sustainable development.14 GMOs also present more specific benefits, such as more substantial and effective disease resistance, enhanced stress tolerance and nutrient levels, and allergen removal.15 The development of pest-protected plants and natural fertilizers is another potential application of GMOs, which aims to conserve natural resources, soil erosion, and environmental quality.16 The potential benefits brought by GMOs to agricultural and human health applications bolster these techniques as both a highly useful set of tools and an opportunity for increased profits.17 Arguments in favor of GMOs fall into three general categories, focusing primarily on economic, scientific, environmental, and Agenda 21, Chapter 16, Environmentally Sound Management of Biotechnology, available at http://www.unep.org. 13

Louise O. Fresco, Genetically Modified Crops, at http://www.fao.org/ag/magazine/0111sp.htm (last updated Mar. 2005). 14

15 Louise O. Fresco, Genetically Modified Crops, at http://www.fao.org/ag/magazine/0111sp.htm (last updated Mar. 2005). 16 The development of pest-protected plants and natural fertilizers. BILL LAMBERT, DINNER AT THE NEW GENE CAFÉ 299 (2001).

Louise O. Fresco, Genetically Modified Crops, at http://www.fao.org/ag/magazine/0111sp.htm (last updated Mar. 2005). 17

4 • International Law, Agricultural Biotechnology, and Infectious Disease

social advantages presented by these products; the emphasis here will center on economic, scientific, and environmental benefits of GMOs. 1.

Economic Benefits Provided by GMOs

Genetic modifications involving agricultural products aim to maximize crop resistance to disease and inclement conditions, permitting higher yields and hardier crops, and also allow the production of more food on the same or smaller amounts of land.18 Higher yields for primary food staples, such as rice or soy, are a significant boon for developing countries, as are genetic alterations that bolster the nutritional content of agricultural foodstuffs, which advance efforts at combating malnutrition and hunger worldwide. The utilization of GM crops may also reduce postharvest loss of food, as well as improve the quality of fresh and processed foods.19 This move towards more environmentally sustainable agricultural practices also stimulates economic growth focused on providing “more benefit with less throughput and harm.”20 This combination of higher nutritional content with herbicide, pesticide, or viral resistance provides a very attractive agricultural package in the global market. Both developed and developing countries reap rewards from the higher yields and better nutritional value provided by GM crops like rice or soybeans. These potential commercial agricultural applications thrust consistent attention onto GMOs and are the testing ground for potential long-term viability of GMOs and their products for uses beyond agriculture. Many biotech companies are plunging forward with GM crops and releasing these crops into the environment, stating that GMOs are revolutionizing agriculture. The positive possibilities presented by GMOs cannot be discounted, and it is these claims of “better, stronger” plants that have provided a relatively strong market for GM crops. Many of these economic benefits hinge on scientific improvements and the reduction of environmental impacts provided by GM crops, with little negative impact on human health and the environment. 18 BIOTECHNOLOGY AND BIOSAFETY 25 (Ismail Serageldin & Wanda Collins eds., 1999). 19

Id.

20

Id.

Science Behind GMOs • 5

2.

Scientific and Environmental Benefits Provided by GMOs

A primary reason behind the development of GM crops involves the creation of pesticide-producing, herbicide-resistant, and virus resistant crop varieties, with the goal to increase crop yields and reduce ancillary environmental effects stemming from pest control utilizing high levels of pesticides and herbicides. The most promising genetic modification, pest resistance, reduces reliance by food producers on pesticides and herbicides, fostering more sustainable agricultural practices that lessen negative environmental impacts. GM crops that produce pesticides allow for a less toxic, target-specific alternative to traditional chemical pesticides.21 Pesticides manufactured in GM crops also appear in relatively small quantities, which reduce possible exposure to non-target organisms.22 Since pesticides created within GM crops are both less toxic and genetically tailored for a specific target, non-target organisms, including humans, are less likely to be adversely affected.23 Traditional chemical pesticides tend to have a higher level and wider scope of toxicity, resulting in broader adverse impacts to non-target organisms.24 Pesticide-producing GM crops offer the potential of lower risk to humans and the environment. Herbicide-resistant GM crops also offer environmental and human health benefits similar to pesticide-producing GM crops. These varieties of GM crops are developed to possess resistance to a specific herbicide, thus permitting eradication of pests using only one kind of herbicide instead of an herbicide cocktail.25 Herbicide-resistant GM crops lessen The most common form of pest resistance involves the transfer of a bacterial gene, from Bacillus thuringiensis (Bt), which results in the production of a protein fatal to pests. Bt is a naturally occurring soil organism used by gardeners and organic farmers for its insecticidal properties, which removes the need for chemicals. BILL LAMBRECHT, DINNER AT THE NEW GENE CAFÉ 7, 43 (2001). 21

The reduction in risk results from a higher level of specificity to the target pest than other chemical pesticides, a lower level of toxicity, and limited persistence in the environment. 1 ENCYCLOPEDIA OF ETHICAL, LEGAL, AND POLICY ISSUES IN BIOTECHNOLOGY 27, 29 (Thomas H. Murray & Maxwell J. Mehlman eds., 2000). 22

23

Id. at 29.

24

Id.

BIOTECHNOLOGY AND BIOSAFETY 32 (Ismail Serageldin & Wanda Collins eds., 1999). 25

6 • International Law, Agricultural Biotechnology, and Infectious Disease

overall herbicide use by reducing herbicide application to “post-emergence situations using a single, broad-spectrum herbicide” that degrade quickly in the soil.26 Theoretically, less herbicide will be required to destroy pests, since multiple applications of various herbicides will be unnecessary. Agricultural crops are also being genetically modified to express viral resistance to particular pathogens through the insertion of genes from viruses into the plant’s genetic material.27 GM crops, such as squash plants genetically altered to contain viral genes, are able to manufacture viral coat proteins that confer viral resistance and allow these crops to resist infection by specific viruses.28 One traditional means of eradicating viral threats consists of using chemical pesticides to destroy viral vectors, such as insects, responsible for the spread of viruses.29 The use of viral coat protein-mediated resistance could remove, or at least reduce, the need for traditional chemical pesticides. GM crops and microorganisms could also aid in lessening or even removing resource and energy-intensive inputs, such as fuel, fertilizers, or pesticides, which would reduce indirect effects on the environment, such as contamination of surface and groundwater.30 Maintaining current agricultural land use or reducing the amount needed to produce foodstuffs allows for the protection and support of biodiversity, for the need to expand into wilderness will be minimized.31 GM crops, regardless of their specific modifications, present numerous agricultural opportunities with benefits indirectly improving environmental sustainability and human health. But these opportunities do not come without concerns, most of which focus on whether GM crops are

26

Id.

27

Id. at 34.

1 ENCYCLOPEDIA OF ETHICAL, LEGAL, AND POLICY ISSUES IN BIOTECHNOLOGY 28–29 (Thomas H. Murray & Maxwell J. Mehlman eds., 2000). 28

29

Id. at 30.

30

Id.

31 BIOTECHNOLOGY AND BIOSAFETY 25 (Ismail Serageldin & Wanda Collins eds., 1999).

Science Behind GMOs • 7

suitable for release into agricultural areas or the environment at large. Proponents of GMOs claim that concerns about the effects of GM crops on human health and the environment will unnecessarily hinder the potential of GMOs and prevent their release into the environment or use in food production. But advantages promised by GM crops of better, healthier food and a cleaner environment are still indirect and may take generations to manifest, which also leads to significant doubt as to whether GM crops are actually “better” than traditional varieties or provide solutions to agricultural, environmental, or human health problems. B.

ARGUMENTS AGAINST SOLUTIONS PROVIDED BY GMOS

The most significant concerns attached to all GMOs and their products relate to the unknown nature of the risks. Risks associated with GM crops are not purely agricultural in nature; environmental issues related to genetic stability of wild relatives of GM crops, long-term decline of biodiversity, and human health concerns also garner significant notice in the global community. There are also some concerns about the overall viability of GMOs, as well as more specific risks related to each type of genetic alteration bestowed on GM crops. A concern related to all GMOs, regardless of application, relates to the fundamental viability of these products. Minute genetic alterations, from traditional cross-breeding to techniques involving genetic modification, impact how an organism, whether GM or traditional, interacts and flourishes within an environment.32 Not all combinations resulting from genetic modification are successful, and some genetic alterations may disrupt the “functional harmony of a cell to a degree that the cell may lose its viability or may not be able to yield the expected product in useful quantities.”33 Even though some GMOs are viable, such as GM corn and soy crops, there is still significant trial and error involved in establishing which alterations produce a viable product. While most concerns center on what may occur after the introduction of GM crops into the environment or agricultural applications, there is 32 1 ENCYCLOPEDIA OF ETHICAL, LEGAL, AND POLICY ISSUES IN BIOTECHNOLOGY 29 (Thomas H. Murray & Maxwell J. Mehlman eds., 2000). 33 BIOTECHNOLOGY AND BIOSAFETY 8 (Ismail Serageldin & Wanda Collins eds., 1999).

8 • International Law, Agricultural Biotechnology, and Infectious Disease

some question about the fundamental viability of GMOs prior to their use in agricultural situations.34 Whether GMOs will survive and multiply outside the laboratory is crucial to determining the level of risk posed by such products and effects to ecosystems surrounding the point of release, including their effect on non-target organisms.35 Issues related to general viability of GMOs fall into two categories: the transfer of genetic material to other organisms and what conditions would encourage the transfer and subsequent maintenance of newly acquired genes; and the expression and expected effects of the transferred genetic material. These general concerns provide a rough outline of the risks commonly associated with GMOs and illustrate possible reasons why solutions based on genetic modification to current agricultural practices or human health problems may not be the best option. Apprehension and concern about genetic transfer of GM traits exists for all manifestations of GM crops, each with specific potential risk issues attuned to each variety of expressed traits. 1.

Economic Concerns Related to GMOs

The push for GM crops into global agriculture indicates that their rapid introduction may be motivated by economic reasons rooted in market and profit acquisition, prompting agricultural and biotech companies to release GM crops without deliberating on the long-term impacts on human health and the environment.36 This apparent focus on economic gain rather than human health and environmental impacts exacerbates the burgeoning gap between proponents and critics of GMOs, which decreases the likelihood of reaching a compromise for their use. Some critics of GM crops also express concern that even though genetic modification possesses the potential to create more varieties of commercial plants, the agricultural industry seems reluctant to do so.37 Instead, broad international markets for one particular product are being

34

Id. at 45.

35

Id.

36

Id. at 31–32.

37

Id. at 32.

Science Behind GMOs • 9

developed, which contributes to genetic uniformity in rural areas.38 A large area planted with one variety of crops makes that crop very vulnerable to new and matching strains of pathogens or pests.39 This vulnerability echoes concerns about the development of new pathogens or pests resistant to pesticides and herbicides resulting from the use of GM crops in lieu of traditional (i.e., non-GMO) varieties. These unintended GM pests could decimate crop yields, because the pest or virus obtained its viral or resistance-conferring genes from the GM crop, and the properties of pesticide or viral resistance transferred to the crops are thus useless. Many of the economic issues associated with both GMOs and, more specifically, GM crops, also bear a strong connection to scientific and environmental risks. These risks relate more to the actual behavior of GM crops, as well as other varieties of GMOs, beyond the laboratory and how such manifestations possibly affect the organisms and landscapes around them. While retaining biodiversity and preventing the development of new, enhanced pests are primarily environmental issues, such concerns resonate economically as well. Currently, scientific and environmental risks and uncertainties attached to GM crops are the most compelling reasons behind apprehension of the products’ placement in the environment and global food supply. 2.

Scientific and Environmental Concerns Related to GMOs

The risks associated with the introduction of GMOs into agricultural situations and the environment fall into three general categories: gene flow, gene expression, and long-term decline of biodiversity. Gene flow, both vertical and horizontal,40 addresses the movement of foreign genes from GM crops to other plants and organisms.41 Gene expression refers to the materialization of genetic information encoded in a gene and then 38

Id.

39

Id.

40 Vertical gene flow refers to the movement of foreign genes between generations of one species while horizontal gene flow addresses the movement of genes between species. Royal Society of Edinburgh, GM gene flow: scale and consequences for agriculture and the environment 1, at http://www.gmsciencedebate.org.uk/meetings/ pdf/270103-report.pdf. 41

Id.

10 • International Law, Agricultural Biotechnology, and Infectious Disease

expressed in proteins or other external manifestations in an organism, GM or traditional. Gene flow is one of the main consumer concerns related to GM crops, and determining where and how genes from GMOs manifest in the environment is crucial in assessing their impact.42 The most likely environmental effect related to the release of GM crops involves vertical gene flow between GM crops and traditional varieties, as well as horizontal gene flow with related species resulting in a new pest or weed.43 The spread of the genetic material responsible for pesticide production in GM crops results in the integration of these pesticides into agricultural and natural ecosystems.44 This possible exchange of genetic material proves problematic, for crops are generally grown near sexually compatible wild relatives or wild species possessing “some degree of cross compatibility.”45 GM crops that can crossbreed with other plants in the immediate environment also present a higher potential for exposure and impact on non-target organisms; GM crops unable to transfer genetic material, due to lack of wild relatives in the surrounding environs or restricted geographical viability, pose a lesser risk of exposure.46 42

BILL LAMBRECHT, DINNER AT THE NEW GENE CAFÉ 88 (2001).

43 The possibility of genetic transfer between transgenic crops and surrounding plant species also raises concerns similar to those connected to the introduction of non-native species into an ecosystem. This comparison between a more traditional situation of a non-native species and transgenic varieties is an apt one; transgenic crops, despite their intrinsic similarity to traditional varieties of the same, are essentially invasive species in a particular ecosystem. Non-native species, when introduced into ecosystems, tend to displace native species, and it is usually very difficult to predict how this infiltration affects native species. Generally, the effects of non-native species permeating an ecosystem are highly disruptive and very unpredictable, which corresponds to the possible effects resulting from the spread of transgenic crops into the surrounding environment. 1 ENCYCLOPEDIA OF ETHICAL, LEGAL, AND POLICY ISSUES IN BIOTECHNOLOGY 29 (Thomas H. Murray & Maxwell J. Mehlman eds., 2000). 44

Id. at 28.

BIOTECHNOLOGY AND BIOSAFETY 33 (Ismail Serageldin & Wanda Collins eds., 1999). 45

Successful cross breeding requires the close proximity of transgenic crops to wild relatives; this is not very likely in the United States but could be a more common occurrence elsewhere. Domestic crops, such as soybeans, corn, and wheat, no longer contain the ability to compete with wild relatives in the environment, which lessens 46

Science Behind GMOs • 11

Concerns related to gene flow are closely tied to concerns that GM crops altered to produce pesticides will crossbreed with wild relatives and produce “superweeds” resistant to applied herbicides and pesticides.47 These superweeds will then require higher and more varied levels of the toxins in order to achieve efficient eradication of pests and rendering the benefit of pesticide and herbicide resistance provided by GM crops obsolete. The risk of GMOs disrupting ecosystems or creating superweeds is small, but the resulting consequences are disastrous, potentially irreversible, and very difficult, if not impossible, to control.48 Pests could also develop resistance to crops containing a genetically inserted toxin and render the pesticide properties of the GM crop irrelevant, resulting in negative impacts in both non-target organisms and the immediate ecosystem as a whole.49 Similar to transference of herbicide and pesticide resistance to unintended recipients, viral resistance in GM crops could lead to the development and proliferation of new pathogens with unknown etiologies and virulence. A novel risk presented by the release of viral resistant GM crops into the environment is the possible recombination between the genetic material of an external virus and the viral genes present within the GM crop, resulting in the production of a new pathogen.50 Recombination does occur under certain conditions in GM crops and can produce a “new viral strain with an altered host range.”51 Combined with possible transference of herbicide and pesticide resistant genes and the development of pest resistance to GM crops, virus resistant genes compound the risks presented by these varieties of GM crops.

the possibility of these crops transferring genes to wild relatives. 1 ENCYCLOPEDIA OF ETHICAL, LEGAL, AND POLICY ISSUES IN BIOTECHNOLOGY 28–29 (Thomas H. Murray & Maxwell J. Mehlman eds., 2000). 47

Id. at 29.

48

Id.

49 BIOTECHNOLOGY AND BIOSAFETY 31 (Ismail Serageldin & Wanda Collins eds., 1999). 50

Id. at 34–35.

51

Id. at 35.

12 • International Law, Agricultural Biotechnology, and Infectious Disease

Production of environmental toxins produced by GM crops also presents possible risks as such toxins move through the food chain, affect invertebrates and ecological processes, as well as collect in the soil or water.52 Risks posed by environmental toxins are similar to those posed by microbiological, chemical, and physical hazards primarily responsible for illnesses caused by foodborne diseases.53 Foodborne diseases, triggered by chemical hazards and toxins, possess the potential to impact immune, endocrine, and developing nervous systems, even though effects are hard to attach to a certain food or food product due to limited information about the toxicology of the contaminants.54 GM microbial organisms, acting as pesticides, also present unique risks, because microbial pesticides are living organisms and possess the ability to replicate and spread unaided throughout the environment.55 All of these risks illustrate the potential complexities associated with determining the actual risks presented by GM crops and how these risks might manifest in the environment. The arguments against the use of GMOs in food and food products center on similar variants of the same catalogue of risks attached to GM crops. The main distinctions stem from different emphasis within the timeline of production to consumption of agricultural products and additional considerations related to consumer misgivings about GMOs in food or used in food production. Food safety concerns dwell more on what happens to the GM food and feed after it has left the production stage and is available to consumers. Risks attached to GM foods and feed relate specifically to food toxicity and allergenicity triggered by the presence of new proteins, nutritional alterations, and unexpected changes in food composition resulting from genetic modification coupled with consumer con52

Id. at 36.

53 Significant increases over the past few decades in the incidence of diseases caused by microorganisms in food, including pathogens such as Salmonella, Campylobacter jejuni, and enterohaemorrhagic Escherichia coli, and parasites, such as cryptosporidium, cryptospora, and trematodes. World Health Organization [WHO], WHO Global Strategy for Food Safety: safer food for better health 7 (2002), available at http://www.who.int/foodsafety/publications/general/en/strategy_en.pdf [hereinafter WHO Global Strategy]. 54

Id. at 8.

1 ENCYCLOPEDIA OF ETHICAL, LEGAL, AND POLICY ISSUES IN BIOTECHNOLOGY 27–28 (Thomas H. Murray & Maxwell J. Mehlman eds., 2000). 55

Science Behind GMOs • 13

cerns about the impact of these risks on human health.56 GM crops developed to produce pesticides can affect human health by causing allergic reactions to products or crops not previously possessing allergenic properties.57 For example, pesticide-producing genes originating in peanuts are then genetically transferred to corn, without informing consumers allergic to peanuts that corn products could also trigger an allergic response. Allergenic concerns are unique to GM crops and GMOs in food, because no other current technology collects so many proteins from unrelated sources and combines them into one GMO.58 Allergenic risks, like gene flow, and their manifestations in GM products will also be very difficult to predict and will further complicate efforts to ensure the safety of these products from a human health perspective. No matter what kind of GM traits are at risk for being transferred into surrounding indigenous genomes, environmental risks are common to all varieties. Environmental risks relate more to the overall utilization of GM crops, rather than individual application of one strain exhibiting a specific trait, such as herbicide resistance, or when a GM crop or food is available to consumers. These environmental risks have the potential to manifest with all GM crops and add another layer to the more specialized risks for agricultural application. The spread of GM crops throughout various agricultural settings threatens crop genetic diversity by promoting a simpler cropping system and facilitating genetic erosion.59 The use of GM crops not only affects localized crop genetic diversity but can also promote long-term decline in biodiversity and impact long-term genetic stability. Decreases in biodiversity lead to less robust ecosystems, which allows the exposure, development, and proliferation of previously unknown (both “natural” and GM) pathogens. Issues of biodiversity conservation are nebulous, furthering the challenge of determining the real damage posed by GM crops in both human health and the environment. Fiona Macmillan & Michael Blakeney, Genetically Modified Organisms and the World Trade Organization, 3 TUL. J. TECH. & INTELL. PROP. 93, 94 (2001). 56

57

BILL LAMBRECHT, DINNER AT THE NEW GENE CAFÉ 87 (2001).

58

Id.

BIOTECHNOLOGY AND BIOSAFETY 31 (Ismail Serageldin & Wanda Collins eds., 1999). 59

14 • International Law, Agricultural Biotechnology, and Infectious Disease

Precision as to the nature and magnitude of the risks posed by GMOs in food is very difficult to achieve, due to the wide-ranging breadth of variety of GMOs, their reproductive capacities, the complex nature of the ecosystem viability, and the complete lack of information about their longterm effects.60 Some find the possible risks presented by GMOs too great and strongly advocate for their restriction or prohibition in agricultural or environmental applications. Uncertainty as to the effects of risks related to GMOs, coupled with the challenge of regulating agriculture on a global level, fosters a wide disparity of perspectives as to the appropriate place for these products. Many arenas, both international and domestic, are tackling the challenge posed by GMOs and their impacts on human health and the environment, with a range of effectiveness and success.

1 ENCYCLOPEDIA OF ETHICAL, LEGAL, AND POLICY ISSUES IN BIOTECHNOLOGY 29 (Thomas H. Murray & Maxwell J. Mehlman eds., 2000). 60

CHAPTER 2

INTERNATIONAL LEGAL FRAMEWORKS ADDRESSING GMOS Many legislative and regulatory efforts, domestic and international, attempt to address the human health and environmental concerns posed by the increasing presence of GMOs in global commerce. The primary focus will be on international regulatory efforts in areas affected by GMOs, while recognizing the necessity and importance of domestic regimes currently in place or being developed to address GMOs. Most of these conventions and international instruments do not directly regulate GMOs but are the legislative schemes that will bear the most relevance to regulations involving GMOs; those conventions that explicitly address GMOs illustrate what concepts garner emphasis at the global level. In addition to legislative and regulatory efforts, there are a collection of concepts and techniques that could also provide an alternative means of control and oversight of GMOs. Techniques such as deliberate release, which is a form of active risk assessment, and concepts such as the precautionary principle,1 can flesh out current international legislative efforts by supplying a broader, more interdisciplinary perspective for GMO regulation. A.

DELIBERATE RELEASE TECHNIQUES

Due to the limited amount of knowledge of the risks associated with GMOs, members of the global community call for the development of regulations to guide the testing and release of GMOs. Part of the challenge of incorporating GMOs into global agriculture stems from the difficulty of assessing the nature and impact of the risks. “Deliberate release” is one method for attempting to ascertain potential risks of GMOs outside the laboratory. Deliberate release, advocated as a living risk assessment, consists of releasing certain GMOs into a target environment for a specific period of The precautionary principle has been incorporated into various regional and international instruments and conventions addressing harm related to GMOs and will be discussed within the context of those agreements. 1

15

16 • International Law, Agricultural Biotechnology, and Infectious Disease

time and monitoring the resulting interactions of GMOs with the environment.2 It is generally equivalent to releasing a GMO into the environment, but with observation and oversight. Theoretically, deliberate release allows the opportunity to gather information on possible harms created by GMOs. Numerous issues revolve around using deliberate release as a means of determining environmental and health impacts prior to general release, with questions ranging from the overall vitality of GMOs to possible effects on the environment and other species. Deliberate release procedures also contain significant drawbacks, in addition to general viability concerns, that lessen the possible effectiveness as an evidence-gathering tool. While deliberate release provides an opportunity to examine, under controlled settings, the potential problems with a specific GMO once released into the environment, it carries the same potential risks described for GMOs integrated into unmonitored agricultural environments. Critics argue that the restrictions placed on deliberate release procedures, in order to provide some measure of control and prevent transference beyond the testing areas, do not allow for an accurate assessment of the risks posed.3 Deliberate release techniques prevent continued environmental exposure and integration, in some situations, by instituting restrictive means of oversight. Many of the risks mentioned in relation to GMOs will take more than one generation to manifest, especially those based on transfer of genetic material. Restricting deliberate release to one generation prohibits an accurate assessment of interaction, and risks will be dismissed without proper investigation. Using deliberate release, especially in the context of transferred viral genetic information, and leaving GMOs to interact with the environment for an extended period of time is roughly equivalent to releasing the products without any previous risk assessment. A better alternative is to structure the deliberate release over a longer period of time, with conditions that mirror actual environmental conditions while simultaneously providing moderately restrictive oversight. 2 Judy Kim, Out of the Lab and into the Field: Harmonization of Deliberate Release Regulations for Genetically Modified Organisms, 16 FORDHAM INT’L L.J. 1160 (1993). 3

Id. at 1166–68.

International Legal Frameworks Addressing GMOs • 17

Deliberate release, despite its imperfections, provides a potential means to collect much-needed scientific data on the risks of GM crops. It also illustrates the inherent difficulties in developing a useful and accurate means of assessing risk for GMOs. While not a prudent technique for use with infectious pathogens, deliberate release can possibly provide data in gene flow situations involving GMOs that could result in new pathogenic developments. Most importantly, deliberate release procedures comprise the only current means available to ascertain risks related to GMOs outside the laboratory, and they should be explored as a component of regulatory efforts for both GMOs and infectious disease control. B.

U.N. CONVENTION ON BIOLOGICAL DIVERSITY

Utilization and control of GMOs and infectious diseases present environmental challenges beyond discussions of public health, especially regarding biodiversity and sustainable development. Such biodiversity issues find expression, in the global forum, within the U.N. Convention on Biological Diversity (CBD). The CBD, signed by 150 states at the 1992 Rio Earth Summit, strives to promote sustainable development and is considered a practical means for promoting the principles of Agenda 21.4 The CBD takes the more common perception of biological diversity, with its emphasis on plants, animals, microorganisms, and their ecosystems, and broadens it to include issues, such as the need for food security, medicines, fresh air and water, and a healthy environment.5 The CBD sets forth obligations, upheld by member states, for maintaining global ecological health while pursuing economic development projects.6 To achieve this, the CBD provides three main goals, focusing on the “conservation of biological diversity, the sustainable use of its components, and the fair and equitable sharing of the benefits from the use of genetic resources.”7 The success of the CBD, as well as its protocols, relies U.N. Environmental Program (UNEP), About the CBD, at http://biodiv.org/convention/default.shtml (last visited Jan. 8, 2007) [hereinafter About the CBD]. 4

5

Id.

6

Id.

“The objectives of this convention, to be pursued in accordance with its relevant provisions, are the conservation of biological diversity, the sustainable use of its components, and the fair and equitable sharing of the benefits arising out of the uti7

18 • International Law, Agricultural Biotechnology, and Infectious Disease

on individual countries’ informed self-interest, peer pressure from other countries, and public opinion.8 To facilitate communication and implementation of the CBD, governments, non-governmental organizations, academics, members of the private sector, and other interested groups or individuals congregate in meetings fashioned as a global forum to share ideas and strategies for applying the CBD.9 The growing influence and incorporation of GMOs in agriculture captured the attention of the global community but was beyond the original scope of the CBD. The CBD does not directly address questions related to GMOs but allows for the development of protocols to further develop guidance and direction in certain areas related to, but beyond the primary scope of, the CBD.10 C.

CARTAGENA PROTOCOL ON BIOSAFETY

Current applications of GMOs in the agricultural field and risks posed by GMOs connected to biological diversity, including cross-border trade and accidental releases, prompted the development of the Cartagena Protocol on Biosafety (Biosafety Protocol), adopted in January 2000 under the auspices of the CBD.11 The Biosafety Protocol is the first legally binding global regime governing the transnational transfer and use of GMOs. With the exception of some national legislative schemes, the Biosafety Protocol provides the only legislative resource specifically for GMOs at the international level.

lization of genetic resources, including by appropriate access to genetic resources and by appropriate transfer of relevant technologies, taking into account all rights over those resources and to technologies, and by appropriate funding.” UNEP, The U.N. Convention on Biological Diversity art. 1, available at http://biodiv.org/convention/ convention.shtml (last visited Jan. 8, 2007) [hereinafter CBD]. 8

About the CBD, supra note 4.

9

Id.

“1) The Contracting Parties shall cooperate in the formulation and adoption of protocols to this Convention; 2) Protocols shall be adopted at a meeting of the Conference of the Parties; 3) The text of any proposed protocol shall be communicated to the Contracting Parties by the Secretariat at least six months before such a meeting.” CBD, supra note 7, at art. 28. 10

11 UNEP, The Cartagena Protocol on Biosafety (2000), available at http://www. biodiv.org/doc/legal/cartagena-protocol-en.pdf [hereinafter Biosafety Protocol].

International Legal Frameworks Addressing GMOs • 19

The Preamble sets out the overall aims of the Biosafety Protocol, focusing primarily on the “transboundary movement of any living modified organism (LMO) resulting from modern biotechnology that may have adverse effect on the conservation and sustainable use of biological diversity.”12 The Biosafety Protocol also reaffirms the precautionary principle enumerated in Principle 15 of the Rio Declaration, which has become a theoretical mainstay in international environmental legislation, as well as providing guidance in national regulatory efforts for GMOs.13 No clear definition exists in international discourse for the precautionary principle; it is more a bundle of concepts expressing a common idea that allows those charged with regulating environmental or health issues the ability to make decisions in situations lacking scientific certainty about potential hazards or risks.14 Lack of scientific certainty as to the effects of environment and health hazards pose significant challenges for regulators, who then must choose between immediate protective actions or waiting until more evidence on the hazards is gathered.15 The precautionary principle allows for positive action, with the aim to protect the environment or health prior to the determination of the existence or nature of a particular hazard or risk.16 The Biosafety Protocol is very important, from a health and environment perspective, because it is the first convention to include the precautionary principle.17 Coupled with the Biosafety Protocol’s focus 12 “Recalling also decision II/5 of 17 November 1995 of the Conference of the Parties to the Convention to develop a Protocol on biosafety, specifically focusing on transboundary movement of any living modified organism resulting from modern biotechnology that may have adverse effect on the conservation and sustainable use of biological diversity, setting out for consideration, in particular, appropriate procedures for advance informed agreement[.]” Id. at pmbl. 13 The precautionary principle was first enumerated, in 1992, in the Rio Declaration on Environment and Development. Principle 15 of the Rio Declaration sets forth the general definition utilized in both international and domestic regulatory efforts for issues related to the environment, as well as modern biotechnology. Jonathan Adler, More Sorry than Safe: Assessing the Precautionary Principle and the Proposed International Biosafety Protocol, 35 TEX. INT’L L.J. 173, 195–96 (2000).

Jan Bohanes, Risk Regulation in WTO Law: A Procedure-Based Approach to the Precautionary Principle, 40 COLUM. J. TRANSNAT’L L. 323, 331 (2002). 14

15

Id.

16

Id.

17

UNEP, Ninth International Conference on Health and Environment: Solutions

20 • International Law, Agricultural Biotechnology, and Infectious Disease

on GMOs, inclusion of the precautionary principle brings over concepts mainly used in environmental legislation and broadens the possible cache of legislative and regulatory responses for GMOs. The Preamble furthers this interconnection between environmental concerns and GMOs. While the primary emphasis of the Biosafety Protocol is the “conservation and sustainable use of biological diversity,” the Preamble also acknowledges the interplay between the rapid growth and expansion of GMOs, growing public concern over potential negative impacts on biological diversity, and risks to human health.18 Under the backdrop of biological diversity, the Biosafety Protocol also expands its purview by tying together biological diversity, GMOs, and human health, illustrating that connectivity between these three areas is crucial for the successful development and implementation of the Biosafety Protocol. The Preamble also recognizes the great possibilities for human health presented by GMOs by arguing for development of adequate safety measures for environment and human health, not a removal of these technologies from the public forum.19 The Biosafety Protocol provides some important definitions of key terms and is meant to inform their usage within the Biosafety Protocol but can also provide guidance as to how these terms could be understood outside the Biosafety Protocol. Included in the definitions in Article 3 is the most crucial one for regulation in this area: living modified organism for the Millennium 2, available at http://www.nyo.unep.org. Other international environmental treaties incorporate precautionary statements echoing concepts similar to the precautionary principle, such as the Vienna Convention for the Protection of the Ozone Layer, the U.N. Framework Convention on Climate Change, the Convention on Biological Diversity, the Helsinki Convention on the Protection of the Marine Environment of the Baltic Sea Area, the Helsinki Convention on the Protection and Use of Transboundary Watercourses and Lakes, the Maastricht Treaty on European Union, and the Paris Convention for the Protection of the Marine Environment of the Northeast Atlantic. Adler, supra note 13, at 195. “Aware of the rapid expansion of modern biotechnology and the growing public concern over its potential adverse effects on biological diversity, taking also into account risks to human health;” Biosafety Protocol, supra note 11, at pmbl. 18

“Recognizing that modern biotechnology has great potential for human wellbeing if developed and used with adequate safety measures for the environment and human health.” Id. 19

International Legal Frameworks Addressing GMOs • 21

(LMO).20 The Biosafety Protocol defines LMOs as “any living organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology.”21 In order to provide some specificity, Article 3(h) further defines a “living organism,” as “any biological entity capable of transferring or replicating genetic material, including sterile organisms, viruses, and viroids.”22 The main focus of the Biosafety Protocol centers on transboundary movement of LMOs and most of its provisions, while having broad application, are directed primarily towards transboundary transfer and use of LMOs. One of the fundamental proposals of the Biosafety Protocol is the advance information agreement (AIA), which requires informed assent from an importing country prior to transnational transfers of LMOs.23 The LMO is not substantially different than GMO and will only be used in relation to the Biosafety Protocol. 20

21 “‘Living modified organism’ means any living organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology . . . ‘Modern biotechnology’ means the application of: (a) In vitro nucleic acid techniques, including recombinant deoxyribonucleic acid (DNA) and direct injection of nucleic acid into cells or organelles, or (b) Fusion of cells beyond the taxonomic family, that overcome natural physiological reproductive or recombination barriers and that are not techniques used in traditional breeding and selection[.]” Id. at art. 3(g) and (j). 22 “‘Living organism’ means any biological entity capable of transferring or replicating genetic material, including sterile organisms, viruses and viroids[.]” Id. at art. 3(h).

“1) Decisions taken by the Party of import shall be in accordance with Article 15; 2) The Party of import shall, within the period of time referred to in Article 9, inform the notifier, in writing, whether the intentional transboundary movement may proceed: (a): Only after the Party of import has given its written consent; or (b) After no less than ninety days without a subsequent written consent; 3) Within two hundred and seventy days of the date of receipt of notification, the Party of import shall communicate, in writing, to the notifier and to the Biosafety Clearing-House the decision referred to in paragraph 2(a) above: (a) Approving the import, with or without conditions, including how the decision will apply to subsequent imports of the same living modified organism; (b) Prohibiting the import; (c) Requesting additional relevant information in accordance with its domestic regulatory framework or Annex I; in calculating the time within which the Party of import is to respond, the number of days it has to wait for additional relevant information shall not be taken into account; or (d) Informing the notifier that the period specified in this paragraph is extended by a 23

22 • International Law, Agricultural Biotechnology, and Infectious Disease

AIA process must be applied to the “first intentional transboundary movement of living modified organisms for the intentional introduction” into the environment of the importing party.24 Articles 8 through 10 set out the various procedures related to the appropriate application of the AIA, which include notification requirements and initial procedures for approval of transboundary transportation of the LMO in question.25 A collection of provisions in Article 10 provides specific directions to the importing party to facilitate the decision-making process regarding transboundary movement of LMOs.26 Provision 6 of Article 10 gives direction for importing parties regarding insufficient scientific evidence or certainty about potential adverse effects presented by LMOs.27 Insufficient scientific information about the risks posed by LMOs on the “conservation and defined period of time; 4) Except in a case in which consent is unconditional, a decision under paragraph 3 above, shall set out the reasons on which it is based; 5) A failure by the Party of import to communicate its decision within two hundred and seventy days of the date of receipt of the notification shall not imply its consent to an intentional transboundary movement.” Id. at art. 10. “Subject to Articles 5 and 6, the advance informed agreement procedure in Articles 8 to 10 and 12 shall apply prior to the first intentional transboundary movement of living modified organisms for intentional introduction into the environment of the Party of import.” Id. at art. 7(1). 24

25 Article 8 deals specifically with notification, requiring that the exporting party notify, in writing, the “competent national authority of the party of import prior to the intentional transboundary movement of a living modified organism” as defined in Article 7. Id. at art. 8. The written notification to the importing party must contain those requirements enumerated in Annex I. Article 9 allows for the importing party to acknowledge the receipt of notification from the exporting party by providing a time frame of 90 days and specific format requirements for the notification. Id. at art. 9. Article 10 directs the importing party to move beyond receipt of notification towards a decision whether to allow the international transboundary movement requested by the exporting party. Id. at art. 10. 26

Id. at art. 10.

“Lack of scientific certainty due to insufficient relevant scientific information and knowledge regarding the extent of the potential adverse effects of a living modified organism on the conservation and sustainable use of biological diversity in the Party of import, taking also into account risks to human health, shall not prevent that Party from taking a decision, as appropriate, with regard to the import of the living modified organism in question as referred to in paragraph 3 above, in order to avoid or minimize such potential adverse effects.” Id. at art. 10(6). 27

International Legal Frameworks Addressing GMOs • 23

sustainable use of biological diversity in the party of import, taking into account risks to human health, shall not prevent that party from taking a decision . . . with regard to the import of the living modified organism.”28 A decision regarding the import of a LMO needs to be made regardless of available scientific information or evidence, even if the reason for a lack of decisive action on the part of the importing party is to “avoid or minimize such potential adverse effects.”29 This section of Article 10 echoes some of the other concerns discussed regarding the appropriate course of action for LMOs due to lack of scientific evidence or information. Even though this approach is limited to deciding whether or not a LMO is permitted within an importing country, it is in accordance with other international instruments that require action of some kind, regardless of the existence or availability of scientific information. The inclusion of such a provision also echoes a more fundamental conundrum connected with conversations about LMOs. Lack of available scientific evidence as to the impacts of LMOs once released into the environment complicates, and in some cases, completely stonewalls attempts to effectively regulate these products. The procedures specifically enumerated for the effective functioning of the AIA process do not apply to all instances of LMO movement.30 The 28

Id.

29

Id.

“1) Notwithstanding Article 4 and without prejudice to any right of a Party of transit to regulate the transport of living modified organisms through its territory and make available to the Biosafety Clearing-House, any decision of that Party, subject to Article 2, paragraph 3, regarding the transit through its territory of a specific living modified organism, the provisions of this Protocol with respect to the advance informed agreement procedure shall not apply to living modified organisms in transit; 2) Notwithstanding Article 4 and without prejudice to any right of a Party to subject all living modified organisms to risk assessment prior to decisions on import and to set standards for contained use within its jurisdiction, the provisions of this Protocol with respect to the advance informed agreement procedure shall not apply to the transboundary movement of living modified organisms destined for contained use undertaken in accordance with the standards of the Party of import.” Id. at art. 6. “‘Intentional introduction into the environment’ in paragraph 1 above, does not refer to living modified organisms intended to direct use as food or feed, of for processing.” Id. at art. 7(2). 30

24 • International Law, Agricultural Biotechnology, and Infectious Disease

AIA does not pertain to LMOs whose intentional transboundary movement, as determined by the parties to the conference, is not likely to have “adverse effects on the conservation and sustainable use of biological diversity” while taking into account human health.31 Risk assessments are the main vehicle, governed by Article 1532 and Annex III under the Biosafety Protocol, for determining potential adverse effects of LMOs, with a primary focus on the conservation and sustainable use of biological diversity.33 These assessments need to be carried out in a “scientifically sound and transparent manner” and may refer to expert advice or guidelines developed by other international organizations.34 Lack of scientific evidence or consensus also does not, in this context, indicate any particular level of risk; risks connected with LMOs also should be compared to those risks posed by non-modified varieties in the environment receiving the LMO.35 The Biosafety Protocol also requires that risk assessments be “The advance informed agreement procedure shall not apply to the intentional transboundary movement of living modified organisms identified in a decision of the Conference of the Parties serving as the meeting of the Parties to this Protocol as being not likely to have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health.” Id. at art. 7(4). 31

“(1): Risk assessments undertaken pursuant to this Protocol shall be carried out in a scientifically sound manner, in accordance with Annex III and taking into account recognized risk assessment techniques. Such risk assessments shall be based, at a minimum, on information provided in accordance with Article 8 and other available scientific evidence in order to identify and evaluate the possible adverse effects of living modified organisms on the conservation and sustainable use of biological diversity, taking also into account risks to human health. (2): The Party of import shall ensure that risk assessments are carried out for decisions taken under Article 10. It may require the exporter to carry out the risk assessment. (3): The cost of risk assessment shall be borne by the notifier if the Party of import so requires.” Id. at art. 15. 32

33 “The objective of risk assessment, under this Protocol, is to identify and evaluate the potential adverse effects of living modified organisms on the conservation and sustainable use of biological diversity in the likely potential receiving environment, taking also into account risks to human health.” Id. at Annex III(1).

“Risk assessment should be carried out in a scientifically sound and transparent manner, and can take into account expert advice of, and guidelines developed by, relevant international organizations.” Id. at Annex III(3). 34

“(4) Lack of scientific knowledge or scientific consensus should not necessarily be interpreted as indicating a particular level of risk, an absence of risk, or an acceptable risk;” “(5) Risks associated with living modified organisms or products 35

International Legal Frameworks Addressing GMOs • 25

carried out on a case-by-case basis, which echoes many other approaches to risk assessments involving GMOs.36 The Biosafety Protocol sets out a specific methodology for proceeding with risk assessments addressing LMOs, focusing on identification of novel characteristics, evaluations of adverse effects and their subsequent consequences, and an estimation of the overall risk posed by the LMOs.37 Uncertainty as to the level of risk presented by LMOs may be addressed by requesting information on specific issues, implementing appropriate risk management procedures, and monitoring the LMO in the environment.38 Article 16(1) directs parties to the Biosafety Protocol to provide the appropriate mechanisms needed to regulate and control the risks identified by the assessment procedures provided by Annex III.39 These risk management measures must only be thereof, namely, processed materials that are of living modified organism origin, containing detectable novel combinations of replicable genetic material obtained through the use of modern biotechnology, should be considered in the context of the risks posed by the non-modified recipients or parental organisms in the likely potential receiving environment.” Id. at Annex III(4), (5). “Risk assessment should be carried out on a case-by-case basis. The required information may vary in nature and level of detail from case to case, depending on the living modified organism concerned, its intended use and the likely potential receiving environment.” Id. at Annex III(6). 36

37 “To fulfill its objective, risk assessment entails, as appropriate, the following steps: (a) An identification of any novel genotypic and phenotypic characteristics associated with the living modified organism that may have adverse effects on biological diversity in the likely potential receiving environment, taking also into account risks to human health; (b) An evaluation of the likelihood of these adverse effects being realized, taking into account the level and kind of exposure of the likely potential receiving environment to the living modified organism; (c) An evaluation of the consequences should these adverse effects be realized; (d) An estimation of the overall risk posed by the living modified organism based on the evaluation of the likelihood and consequences of the identified adverse effects being realized; (e) A recommendation as to whether or not the risks are acceptable or manageable, including, where necessary, identification of strategies to manage these risks.” Id. at Annex III(8). 38 “Where there is uncertainty regarding the level of risk, it may be addressed by requesting further information on the specific issues of concern of by implementing appropriate risk management strategies and/or monitoring the living modified organism in the receiving environment.” Id. at Annex III(8)(f).

“(1): The Parties shall, taking into account Article 8(g) of the Convention, establish and maintain appropriate mechanisms, measures and strategies to regulate, 39

26 • International Law, Agricultural Biotechnology, and Infectious Disease

imposed to the extent necessary to prevent adverse effects while taking measures to prevent unintended transboundary movements of LMOs, such as requiring risk assessments prior to initial releases of LMOs.40 These specifically delineated risk assessment and management procedures, while connected with the Biosafety Protocol, provide a possible template for other situations involving GMOs, as well as infectious diseases. The lack of scientific information is one of the most challenging aspects in regulating GMOs. International and domestic instruments and schemes addressing GMOs must currently operate based on very limited scientific information. This is also the case for newly developing infectious diseases, as well as distinct varieties of previously identified pathogens, like Avian Influenza, SARS, and BSE. The Biosafety Protocol creates, in Article 20, a Biosafety ClearingHouse, with the goal of fostering and facilitating the exchange of scientific, technical, environmental, and legal information on LMOs.41 The manage and control risks identified in the risk assessment provisions of this Protocol associated with the use, handling and transboundary movement of living modified organisms.” Id. at art. 16(1). 40 “(2): Measures based on risk assessment shall be imposed to the extent necessary to prevent adverse effects of the living modified organisms on the conservation and sustainable use of biological diversity, taking also into account risks to human health, within the territory of the Party of import[.]” Id. at art. 16(2). “(3): Each party shall take appropriate measures to prevent unintentional transboundary movements of living modified organisms, including such measures as requiring a risk assessment to be carried out prior to the first release of a living modified organism.” Id. at art. 16(3).

“(1) A Biosafety Clearing-House is hereby established as part of the clearinghouse mechanism under Article 18, paragraph 3, of the Convention, in order to: (a) Facilitate the exchange of scientific, technical, environmental and legal information on, and experience with, living modified organisms[.]” Id. at art. 20(3). “Without prejudice to the protection of confidential information, each Party shall make available to the Biosafety Clearing-House any information required to be made available to the Biosafety Clearing-House under this Protocol, and: (a) Any existing laws, regulations, and guidelines for implementation of the Protocol, as well as information required by the Parties for the advance informed agreement procedure; (b) Any bilateral, regional and multilateral agreements and arrangements; (c) Summaries of its risk assessments or environmental reviews of living modified organisms generated by its regulatory process, and carried out in accordance with Article 15, including, where appropriate, relevant information regarding products thereof, namely, processed materials that are 41

International Legal Frameworks Addressing GMOs • 27

Biosafety Clearing-House functions as an accessible repository for scientific, technical, environmental, and legal information relevant to the implementation of the Biosafety Protocol, as well as providing access to other international biosafety information exchange mechanisms.42 Creating the Biosafety Clearing-House makes available crucial information as to the scientific composition, risk assessments, and legal instruments related to GMOs. Such a collection will enable more informed approaches to regulation involving GMOs in areas outside the Biosafety Protocol. Since lack of adequate information on GMOs, especially scientific, severely hinders legislative and regulatory efforts for GMOs, a repository aimed at collecting current information will aid in promoting such efforts by making information easier to access and utilize. Provisions of the CBD and the Biosafety Protocol present possible mechanisms for regulation of GMOs from a primarily environmental perspective. This collection of provisions, such as the AIA, the Biosafety Clearing-House, and the risk assessment and management procedures, combined with deliberate release techniques and the precautionary principle, provide significant contributions towards finding a legislative and regulatory approach that tackles numerous issues. But these two conventions come from an environmental starting point, and GMOs have an impact on areas other than environmental issues, such as public health, food safety, or international trade. Examination of other current legislative efforts in these areas is crucial to cultivating a more integrated and multifaceted approach to GMOs.

of living modified organism origin, containing detectable novel combinations of replicable genetic material obtained through the use of modern biotechnology; (d) Its final decision regarding the importation or release of living modified organisms; and (e) Reports submitted by it pursuant to Article 33, including those on implementation of the advance informed agreement procedure.” Id. at art. 20(3). “2) A Biosafety Clearing-House shall serve as a means through which information is made available for the purposes of paragraph 1 above. It shall provide access to information made available by the parties relevant to the implementation of the Protocol. It shall also provide access, where possible, to other international Biosafety information exchange mechanisms.” Id. at art. 20(2). 42

CHAPTER 3

PUBLIC HEALTH LEGISLATION Public health and infectious disease control have always been strongly linked, yet public health consists of more than control and eradication of infectious disease.1 David Fidler, in his book International Law and Public Health, defines public health as “what we, as a society, do collectively to ensure the conditions in which people can be healthy.”2 The World Health Organization (WHO) defines health as a “state of complete physical, mental, and social well-being and not merely the absence of disease or infirmity.”3 Both of these definitions are broad in scope and encompass numerous areas that affect and influence physical, social, and mental wellbeing, such as access to medical services, as well as physical, biological, and social environments.4 Public health deals directly with society as whole, seeking to promote the health of the community, as well as the individual.5 The definitions of public health offered by Fidler and the WHO illustrate why a more integrated approach is needed to facilitate the development of a health-oriented global society. Most approaches to public health issues are technical, environmental, or engineering solutions because of the complicated and unpredictable 1 Historically, eradication of smallpox, the progress made against numerous diseases, and developments of modern hygiene influenced the current connection of public health with infectious disease. DAVID P. FIDLER, INTERNATIONAL LAW AND PUBLIC HEALTH 3 (2000). 2 Fidler suggests three levels of prevention for promoting health: The primary level focuses on preventing the occurrence of health problems by “enabling people to increase control over, and improve their health.” The secondary level of prevention centers on prompt detection, successful management, and treatment of a health condition before actual damage to health is incurred. Id. at 3–4. The tertiary level is broader in scope and attempts to limit the specific impairment while increasing quality and length of life. Id. at 6.

World Health Organization (WHO), About WHO, at http://www.who.int/ about/en/ (last visited Dec. 26, 2006). 3

4

FIDLER, supra note 1, at 4.

5

Id. at 3. 29

30 • International Law, Agricultural Biotechnology, and Infectious Disease

nature of the human behavior element in public health problems.6 Successful development of public health improvements and solutions also requires examination of societal concerns, such as human rights and local, regional, and global politics and economics.7 This collection of factors makes efforts to improve or maintain public health infrastructures difficult to achieve. The forces of globalization8 also provide a vital catalyst to the changing nature of public health by increasing the integration of the global community. Globalization enables the rapid spread of pathogens across countries and continents, blurring the lines between domestic and international public health systems, and challenges the ability of states to control and protect against infectious disease.9 States and regions can no longer effectively offer adequate public health protection for their constituents without international cooperation and coordination in infectious disease control.10 Changes in international trade mechanisms also emphasize the effects of globalization on infectious disease and stress the need for international cooperation.11 The increased scope of international trade and travel disrupt domestic public health strategies and regimes; international trade is such a pervasive part of global society that it is virtually impossible to screen all agricultural imports for known pathogens, as well as new pathogenic threats.12 The removal of trade barriers, both physical and regulatory, has increased the speed and efficiency of commodity movement to the point where pathogens move faster than detection methods are able to locate them.

6

Id.

7

Id. at 3, 6.

The term globalization possesses many meanings, depending on the perspective generated by the context of its use. Fidler defines globalization as “processes or phenomena that undermine the ability of the sovereign state to control what occurs within their territory.” Id. at 16. 8

9

Id.

10

Id. at 17.

11

Id.

12

Id. at 21.

Public Health Legislation • 31

Plants and animals, as well as humans, can be infected with pathogenic microbes or disease-carrying agents. Currently, infectious diseases originating from animals, called zoonoses—such as SARS, Avian Influenza, and BSE—pose more of a concern than plant diseases, mainly because these diseases from animals have already crossed into and infected human populations.13 Zoonoses can also affect human food supplies when they occur in food-producing animals.14 Infectious diseases originating in plants may indirectly affect human health because of the damage to food supplies, such as ruined or decreased yields, and to animal and plant nutrition sources.15 The potential damage inflicted by infected food supplies illustrates the interplay between food safety, international trade, and public health. While the mechanisms facilitating international trade influence the development of international institutions and structures to deal with the increasing need for international connectivity, the same cannot be said for public health. The deterioration and, in some instances, non-existence, of public health capabilities and the decreased effectiveness of microbial drugs also contribute to the increased inability of states and regions to respond to infectious disease issues.16 Yet public health, structurally as well as conceptually, remains a domestically focused endeavor, with little international cooperation or connectivity. A.

INTERNATIONAL HEALTH REGULATIONS

International law is the primary mechanism for addressing the questions raised by the possible spread of animal and plant infectious diseases in human populations.17 There are three primary international legislative efforts that attend to the spread and control of animal and plant infectious

Infectious diseases, such as Measles, Tuberculosis, Smallpox, and Influenza, are all thought to have originated in animal hosts; Mad Cow Disease (Bovine Spongiform Encephalopathy) infects humans by means of a new variant of Creutzfeld-Jakob’s Disease. Id. at 145. 13

14

Id.

15

Id.

16

Id. at 22.

17

DAVID P. FIDLER, INTERNATIONAL LAW AND INFECTIOUS DISEASE 145 (1999).

32 • International Law, Agricultural Biotechnology, and Infectious Disease

diseases. The Office International des Epizooties (OIE) and International Plant Protection Convention (IPPC) address, respectively, the global spread of zoonoses and the introduction and spread of plant pests. The WHO, under the purview of the United Nations, is the primary agency addressing the health governance on the international level.18 The WHO’s broad mandate covers numerous areas of health governance, including the facilitation of collaboration and coordination of international health work in order to promote the eradication of epidemic, endemic, and other diseases.19 The WHO developed the International Health Regulations (IHR), which are a crucial component in the WHO’s fight against the global spread of infectious disease.20 The IHR constitute both the only international health agreement binding on WHO member states21 and the primary instrument in the current international repertoire for global infectious disease concerns. The original version of the IHR, passed in 1969 (IHR 1969), aimed to provide “maximum security against the international spread of diseases with a minimum interference with world traffic.”22 IHR 1969 did not specifically define the phrase “maximum security against international spread of diseases” but did provide maximum protection against the trans-

The primary objective of the WHO, established in 1948, is the “attainment by all peoples of the highest possible level of health.” WHO, About WHO, supra note 3. The WHO’s activities are governed by 193 member states through the World Health Assembly (WHA), which is composed of representatives from each member state. Id. The WHA is charged with determining the WHO budget and program, including major policy initiatives. Id. The WHO also performs work on food safety; those mechanisms are discussed in Chapter 4. Id. 18

Constitution of the World Health Organization, art. 2, July 22, 1946, 62 Stat. 2679, 14 U.N.T.S. 185, available at http://www.who.int/governance/eb/who_constitution_en.pdf. 19

20 The IHR were originally adopted in 1969 and revised in 2005; these revisions will enter into force in June 2007, replacing the original IHR. WHO, International Health Regulations (IHR), at http://www.who.int/csr/ihr/en/ (last visited Jan. 1, 2007). 21

FIDLER, supra note 17, at 95.

WHO, International Health Regulations, foreword (1969) (3d ann. ed. 1983) available at http://www.who.int/csr/ihr/ihr1969.pdf [hereinafter IHR 1969]. 22

Public Health Legislation • 33

boundary movement and importation of infectious disease.23 Surveillance was one of the main foundational pillars in IHR 1969 for curtailing and preventing the transboundary movement of infectious disease. The IHR 1969 provisions required WHO member states to report only on three specific diseases: yellow fever, plague, and cholera.24 Member states were also required to develop and maintain specific types of health resources, programs, and organizations.25 IHR 1969, instead of specifically delineating the meaning of “minimum interference,” set out the most restrictive health measures that member states were permitted to take and provided limits on the kinds of procedures available under IHR 1969.26 Provisions related to minimum interference also restricted government interference with diseases not subject to IHR 1969.27 Generally, IHR 1969 failed to provide maximum security with minimum interference and was not considered a success.28 The primary reasons for the breakdown of the IHR 1969 scheme related to its limited disease scope, lack of adequate surveillance, and ultra-restrictive measures applied by WHO member states.29 The early 1990s saw the resurgence of cholera epidemics in parts of South America, plague in India, and the emergence of new infectious diseases, all of which prompted the World Health Assembly (WHA) to call 23

FIDLER, supra note 17, at 61.

24 “‘Disease subject to the Regulations’ (quarantinable diseases) means cholera, including cholera due to eltor vibrio, plague, and yellow fever[.]” IHR 1969, supra note 22, at art. 1. 25

FIDLER, supra note 17, at 62.

“The health measures permitted by these Regulations are the maximum measures applicable to international traffic, which a State may require for the protection of its territory against the diseases subject to the Regulations.” IHR 1969, supra note 22, at art. 23. 26

27 “Except in case of an emergency constituting a grave danger to public health, a ship or an aircraft, which is not infected or suspected of being infected with a disease subject to the Regulations, shall not on account of any other epidemic disease be refused free pratique by the health authority for a port or an airport; in particular it shall not be prevented from discharging or loading cargo or stores, or taking on fuel or water.” Id. at art. 28. 28

FIDLER, supra note 17, at 65.

29

Id. at 67.

34 • International Law, Agricultural Biotechnology, and Infectious Disease

for revisions of IHR 1969.30 The WHA, in 2001, adopted Resolution 54.14, which provided member states with support in identifying, verifying, and responding to international public health emergencies.31 Two years later, an intergovernmental working group open to all member states was convened to revise IHR 1969.32 IHR 1969 was updated in 2005 to address these limitations, as well as issues related to SARS, global public health response to release or use of biological and chemical agents or radionuclear material, and overall global health security concerns.33 The marked development and expansion of cross-border travel, international trade, and communication technology

The WHA developed a resolution at the 48th World Health Assembly in 1995 that called for the revision of the 1969 IHR. WHO, Frequently asked questions about the International Health Regulations, at http://www.who.int/csr/ihr/howtheywork/ faq/en/ (last visited Dec. 26, 2006) [hereinafter WHO, Frequently asked questions]; Revision and Updating of the International Health Regulations, WHA Res. 48.7, World Health Assembly, 48th Ass., 12th plen. mtg. (May 12, 1995) [hereinafter WHA 48.7]. 30

31 WHO, Frequently asked questions, supra note 30; Global Health Security: Epidemic Alert and Response, WHA Res. 54.14, World Health Assembly, 54th Ass., 9th plen. mtg (May 21, 2001), available at http://ftp.who.int/gb/pdf_files/WHA54/ ea54r14.pdf [hereinafter WHA 54.14]. 32

WHO, Frequently asked questions, supra note 30.

The WHA adopted Resolution 58.3 as the final text of the revisions to IHR 1969. Id. For full text of the resolution and the revised IHR, see Revision of the International Health Regulations, WHA Res. 58.3, World Health Assembly, 58th Ass. (May 23, 2005), available at http://www.who.int/gb/ebwha/pdf_files/WHA58/ WHA58_3-en.pdf [hereinafter IHR 2005]. For previous WHA resolutions that informed Resolution 58.3’s revision of IHR 1969, see Severe Acute Respiratory Syndrome (SARS), WHA Res. 56.29, World Health Assembly, 56th Ass., 10th plen. mtg. (May 28, 2003), available at http://www.who.int/gb/ebwha/pdf_files/WHA56/ ea56r29.pdf; Revision of the International Health Regulations, WHA Res. 56.28, World Health Assembly, 56th Ass., 10th plen. mtg. (May 28, 2003), available at http://www.who.int/gb/ebwha/pdf_files/WHA56/ea56r28.pdf; Global Public Health Response to Natural Occurrence, Accidental Release or Deliberate Use of Biological and Chemical Agents or Radionuclear Material That Affect Health, WHA Res. 55.16, World Health Assembly, 55th Ass., 9th plen. mtg. (May 18, 2002), available at http://www.who.int/gb/ebwha/pdf_files/WHA55/ewha5516.pdf; WHA 54.14, supra note 31; WHA 48.7, supra note 30. 33

Public Health Legislation • 35

have brought new challenges to infectious disease control.34 Simply focusing on three diseases, as in IHR 1969, does not account for the increasing variety of current public health risks; misguided and unnecessary trade and travel restrictions also have dampened national reporting responses for infectious disease outbreaks and other events.35 The primary purpose of International Health Regulations 2005 (IHR 2005) focuses on providing public health responses to the international spread of disease that are restricted to public health risks and avoid unnecessary interference with international trade and traffic.36 IHR 2005, drawing from practical experience, significantly broadens the scope of IHR 1969 by covering “existing, new and re-emerging diseases, including emergencies caused by non-infectious disease agents.”37 IHR 2005 establishes a legal framework that allows for rapid information gathering, international assistance, and determination of events constituting public health emergencies of international concern.38 The primary revisions of IHR 1969 focus on enlarging of core capacities, enhancing notification measures, establishing national and WHO IHR focal and contact points, and developing external advice procedures.39 Article 2 provides a broader mandate for IHR 2005, aiming to “prevent, protect against, control and provide a public health response to the international spread of disease” that is limited to public health risks and does not unnecessarily interfere with international traffic and trade.40 IHR 2005 is not limited to specific diseases but now covers any “public 34

WHO, Frequently asked questions, supra note 30.

35

Id.

IHR 2005 also establish a single code of procedures and practices for routine public health measures at international airports, ports, and ground crossings. Id. 36

37

Id.

38

Id.

39

Id.

“The purpose and scope of these Regulations are to prevent, protect against, control and provide a public health response to the international spread of disease in ways that are commensurate with and restricted to public health risks, and which avoid unnecessary interference with international traffic and trade.” IHR 2005, supra note 33, at art. 2. 40

36 • International Law, Agricultural Biotechnology, and Infectious Disease

health emergency of international concern,” which means any extraordinary public health event requiring an international response, because it constitutes a public health risk to other member states.41 In addition to broadening the scope of IHR 1969, this definition also requires examination of both the causal agent and the context in which an event occurs. 42 The actual occurrence of a disease event is not sufficient to assess its risk of international spread; factors, such as the geographical setting, time, size of an outbreak, closeness to an international border or airport, speed of spread, and mode of transmission, are all crucial in determining the potentiality of an event being an international health risk.43 Annex 2 of IHR 2005 provides a decision instrument for member states to use when assessing the potential international magnitude of a public health event.44 Certain events detected by domestic surveillance mechanisms must be communicated to the WHO, such as any event of potential international public health concern or cases of specific diseases that always trigger examination, because they are unexpected, unusual, or are particularly virulent and able to spread rapidly.45 A member state must notify the WHO if the event has a serious public health impact, is unusual “‘Public health emergency of international concern’ means an extraordinary event which is determined, as provided in these Regulations: (i) to constitute a public health risk to other States through the international spread of disease and (ii) to potentially require a coordinated international response[.]”Id. at art. 1. 41

42

WHO, Frequently asked questions, supra note 30.

43

Id.

44

IHR 2005, supra note 33, at Annex 2.

The specified scope of such events is as follows: “A case of the following diseases is unusual or unexpected and may have serious public health impact, and thus shall be notified: Smallpox; Poliomyelitis due to wild-type poliovirus; Human influenza caused by a new subtype; Severe acute respiratory syndrome (SARS). . . . [A]n event involving the following diseases shall always lead to utilization of the algorithm, because they have demonstrated the ability to cause serious public health impact and to spread rapidly internationally: Cholera; Pneumonic plague; Yellow fever; Viral haemorrhagic fevers (Ebola, Lassa, Marburg); West Nile fever; Other diseases that are of special national or regional concern, e.g. dengue fever, Rift Valley fever, and meningococcal disease. . . . Any event of potential international public health concern, including those of unknown causes or sources and those involving other events or diseases than those listed.” Id. (footnotes omitted). 45

Public Health Legislation • 37

or unexpected, or presents a significant risk of international spread and trade and travel restrictions.46 Coordinated risk assessments, combined with transparent and timely notifications and risk communication, increase international confidence and decrease the likelihood of unilaterally imposed travel and trade restrictions.47 These new provisions do not restrict the kinds of information considered by the WHO during public health emergencies. National focal and WHO contact points enable the collection and dissemination of member state notifications, information sources, and risk communications. To facilitate the implementation of IHR 2005, Article 4 establishes National Focal Points for effective communication between member states and the WHO.48 These National Focal Points disseminate information between member states, implement IHR 2005, and maintain communications accessibility with the WHO.49 The WHO must develop IHR Contact Points as a counterpoint to the National IHR Focal Points to ensure open channels of communication between member states and the WHO.50

46

Id.

47

WHO, Frequently asked questions, supra note 30.

48 “Each State Party shall designate or establish a National IHR Focal Point and the authorities responsible within its respective jurisdiction for the implementation of health measures under these Regulations.” IHR 2005, supra note 33, at art. 4(1).

“National IHR Focal Points shall be accessible at all times for communications with the WHO IHR Contact Points provided for in paragraph 3 of this Article. The functions of National IHR Focal Points shall include: (a) sending to WHO IHR Contact Points, on behalf of the State Party concerned, urgent communications concerning the implementation of these Regulations, in particular under Articles 6 to 12; and (b) disseminating information to, and consolidating input from, relevant sectors of the administration of the State Party concerned, including those responsible for surveillance and reporting, points of entry, public health services, clinics and hospitals and other government departments.” Id. at art. 4(2) 49

“WHO shall designate IHR Contact Points, which shall be accessible at all times for communications with National IHR Focal Points. WHO IHR Contact Points shall send urgent communications concerning the implementation of these Regulations, in particular under Articles 6 to 12, to the National IHR Focal Point of the State Parties concerned. WHO IHR Contact Points may be designated by WHO at the headquarters or at the regional level of the Organization.” Id. at art. 4(3). 50

38 • International Law, Agricultural Biotechnology, and Infectious Disease

Member states must develop and sustain surveillance and reporting mechanisms; the WHO uses the resulting information to determine potential disease spread and international traffic interference.51 Based on information collected through surveillance activities, member states must inform the WHO of possible international public health emergencies within its territory and the health measures developed as a response.52 After initial notification, member states must maintain channels of communication with the WHO detailing possible risks, conditions affecting the spread of disease, and challenges attached to responding to this kind of public health emergency.53 Provisions of Article 6 also apply to unexpected or unusual public health events with the potential of manifesting into an international public health emergency.54 When providing guidance

51 “1. Each State Party shall develop, strengthen and maintain, as soon as possible but no later than five years from the entry into force of these Regulations for that State Party, the capacity to detect, assess, notify and report events in accordance with these Regulations, as specified in Annex 1 . . . 4. WHO shall collect information regarding events through its surveillance activities and assess their potential to cause international diseases spread and possible interference with international traffic. Information received by WHO under this paragraph shall be handled in accordance with Articles 11 and 45 where appropriate.” Id. at arts. 5(1), (4). 52 “Each State Party shall assess events occurring within its territory by using the decision instrument in Annex 2. Each State Party shall notify WHO, by the most efficient means of communication available, by way of the National IHR Focal Point, and within 24 hours of assessment of public health information, of all events which may constitute a public health emergency of international concern within its territory in accordance with the decision instrument, as well as any health measure implemented in response to those events.” Id. at art. 6(1).

“Following a notification, a State Party shall continue to communicate to WHO timely, accurate and sufficiently detailed public health information available to it on the notified event, where possible including case definitions, laboratory results, source and type of the risk, number of cases and deaths, conditions affecting the spread of the disease and the health measures employed; and report, when necessary, the difficulties faced and support needed in responding to the potential public health emergency of international concern.” Id. at art. 6(2). 53

“If a State Party has evidence of an unexpected or unusual public health event within its territory, irrespective of origin or source, which may constitute a public health emergency of international concern, it shall provide to WHO all relevant public health information. In such a case, the provisions of Article 6 shall apply in full.” Id. at art. 7. 54

Public Health Legislation • 39

to member states, the WHO also considers information from sources other than notifications and consultations.55 These reporting procedures and guidelines expedite the flow of accurate and timely information to the WHO on potential international public health events.56 Due to its neutral status, the WHO can provide an extensive communication network, as well as assess information, recommend action, and provide tailored technical assistance.57 The WHO can also offer, under Article 10, collaboration and assistance to member states in assessing and managing potential international public health emergencies.58 Member states are responsible for developing mechanisms that permit prompt and efficient responses to international public health risks and emergencies.59 The WHO must publish “WHO may take into account reports from sources other than notifications or consultations and shall assess these reports according to established epidemiological principles and then communicate information on the event to the State Party in whose territory the event is allegedly occurring. Before taking any action based on such reports, WHO shall consult with and attempt to obtain verification from the State Party in whose territory the event is allegedly occurring in accordance with the procedure set forth in Article 10. To this end, WHO shall make the information received available to the States Parties and only where it is duly justified may WHO maintain the confidentiality of the source. This information will be used in accordance with the procedure set forth in Article 11.” Id. at art. 9(1). 55

56

WHO, Frequently asked questions, supra note 30.

57

Id.

58 “When WHO receives information of an event that may constitute a public health emergency of international concern, it shall offer to collaborate with the State Party concerned in assessing the potential for international disease spread, possible interference with international traffic and the adequacy of control measures. Such activities may include collaboration with other standard-setting organizations and the offer to mobilize international assistance in order to support the national authorities in conducting and coordinating on-site assessments. When requested by the State Party, WHO shall provide information supporting such an offer.” IHR 2005, supra note 33, at art. 10(3).

“Each State Party shall develop, strengthen and maintain, as soon as possible but no later than five years from the entry into force of these Regulations for that State Party, the capacity to respond promptly and effectively to public health risks and public health emergencies of international concern as set out in Annex 1. WHO shall publish, in consultation with member States, guidelines to support States Parties in the development of public health response capacities.” Id. at art. 13(1). 59

40 • International Law, Agricultural Biotechnology, and Infectious Disease

guidelines facilitating the development of these mechanisms and provide to member states general and technical guidance, assistance, and assessments on international risk severity and control measure adequacy.60 Determination of a “public health emergency of international concern” permits the Director-General to issue temporary recommendations, which may be modified or extended depending on the circumstances of the public health emergency.61 Temporary measures are health measures implemented by member states involved in the public health emergency that reduce the international spread of disease and “avoid unnecessary interference with international traffic.”62 These recommendations address transboundary movement mechanisms, ranging from persons to various 60 Id. “At the request of a State Party, WHO shall collaborate in the response to public health risks and other events by providing technical guidance and assistance and by assessing the effectiveness of the control measures in place, including the mobilization of international teams of experts for on-site assistance, when necessary.” Id. at art. 13(3). “If WHO, in consultation with the State Parties concerned as provided in Article 12, determines that a public health emergency of international concern is occurring, it may offer, in addition to the support indicated in paragraph 3 of this Article, further assistance to the State Party, including an assessment of the severity of the international risk and the adequacy of control measures. Such collaboration may include the offer to mobilize international assistance in order to support the national authorities in conducting and coordinating on-site assessments. When requested by the State Party, WHO shall provide information supporting such an offer.” Id. at art. 13(4). “When requested, WHO shall provide appropriate guidance and assistance to other States Parties affected or threatened by the public health emergency of international concern.” Id. at art. 13(6). 61 “If it has been determined in accordance with Article 12 that a public health emergency of international concern is occurring, the Director-General shall issue temporary recommendations in accordance with the procedure set out in Article 49. Such temporary recommendations may be modified or extended as appropriate, including after it has been determined that a public health emergency of international concern has ended, at which time other temporary recommendations may be issued as necessary for the purpose of preventing or promptly detecting its recurrence.” Id. at art. 15(1).

“Temporary recommendations may include health measures to be implemented by the State Party experiencing the public health emergency of international concern, or by other States Parties, regarding persons, baggage, cargo, containers, conveyances, goods and/or postal parcels to prevent or reduce the international spread of disease and avoid unnecessary interference with international traffic.” Id. at art. 15(2). 62

Public Health Legislation • 41

means of commercial transport, such as cargo and postal parcels.63 Article 16 permits the application of standing recommendations, on a routine or periodic basis, to address ongoing, specific public health risks, with similar objectives as in Article 15; these recommendations can also be modified or terminated by the WHO.64 Article 17 delineates the criteria required for issuing, modifying, or terminating recommendations, incorporating scientific principles, health measures based on risk assessments, international standards, and activities of intergovernmental organizations and bodies.65 Article 18 provides advice that directs the development of recommendations for persons and means of transport.66 Recommendations for the movement of persons include entry specifications, travel history reviews, medical examination and vaccination requirements, quarantine and isolation procedures, and exit screenings and restrictions.67 WHO 63

Id.

“WHO may make standing recommendations of appropriate health measures in accordance with Article 53 for routine or periodic application. Such measures may be applied by States Parties regarding persons, baggage, cargo, containers, conveyances, goods and/or postal parcels for specific, ongoing public health risks in order to prevent or reduce the international spread of disease and avoid unnecessary interference with international traffic. WHO may, in accordance with Article 53, modify or terminate such recommendations, as appropriate.” Id. at art. 16. 64

65 “When issuing, modifying or terminating temporary or standing recommendations, the Director-General shall consider: (a) the views of the States Parties directly concerned; (b) the advice of the Emergency Committee or the Review Committee, as the case may be; (c) scientific principles as well as available scientific evidence and information; (d) health measures that, on the basis of a risk assessment appropriate to the circumstances, are not more restrictive of international traffic and trade and are not more intrusive to persons than reasonably available alternatives that would achieve the appropriate level of health protection; (e) relevant international standards and instruments; (f) activities undertaken by other relevant intergovernmental organizations and international bodies; and (g) other appropriate and specific information relevant to the event. With respect to temporary recommendations, the consideration by the Director-General of subparagraphs (e) and (f) of this Article may be subject to limitations imposed by urgent circumstances.” Id. at art. 17. 66

Id. at art. 18.

“Recommendations issued by WHO to States Parties with respect to persons may include the following advice: no specific health measures are advised; review travel history in affected areas; review proof of medical examination and any laboratory analysis; require medical examinations; review proof of vaccination or other pro67

42 • International Law, Agricultural Biotechnology, and Infectious Disease

guidelines for recommendations on goods and articles used to transport goods comprise the second half of Article 18, which include inspections, manifest and routing reviews, treatment, isolation or quarantine measures, departure or entry refusals, and seizure and destruction procedures.68 The new IHR 2005 presents numerous new developments in international law and public health. The most important feature of IHR 2005 is the establishment of a global surveillance system for international public health threats.69 The IHR 2005 revisions illustrate a significant departure from IHR 1969 and represent a historic development in international public health law.70 The revisions strengthen WHO authority, expand the scope of the IHR, present more demanding surveillance and response requirements, and apply principles of human rights to public health interventions.71 The surveillance system in IHR 2005 is a significant alteration and extends far beyond the provisions provided in IHR 1969.72 phylaxis; require vaccination or other prophylaxis; place suspect persons under public health observation; implement quarantine or other health measures for suspect persons; implement isolation and treatment where necessary of affected persons; implement tracing of contacts of suspect or affected persons; refuse entry of suspect and affected persons; refuse entry of unaffected persons to affected areas; and implement exit screening and/or restrictions on persons from affected areas.” Id. at art. 18(1). “Recommendations issued by WHO to States Parties with respect to baggage, cargo, containers, conveyances, goods and postal parcels may include the following advice: no specific health measures are advised; review manifest and routing; implement inspections; review proof of measures taken on departure or in transit to eliminate infection or contamination; implement treatment of the baggage, cargo, containers, conveyances, goods, postal parcels or human remains to remove infection or contamination, including vectors and reservoirs; the use of specific health measures to ensure the safe handling and transport of human remains; implement isolation or quarantine; seizure and destruction of infected or contaminated or suspect baggage, cargo, containers, conveyances, goods or postal parcels under controlled conditions if no available treatment or process will otherwise be successful; and refuse departure or entry.” Id. at art. 18(2). 68

Michael G. Baker & David P. Fidler, Global Public Health Surveillance under the New International Health Regulations, 12 EMERGING INFECTIOUS DISEASES 1058, 1058 (2006). 69

70

Id.

71

Id.

72

Id.

Public Health Legislation • 43

Implementing the IHR 2005 surveillance system will require substantial resources, both technical and financial, from member states; Articles 5.1 and 5.2 direct member states to assess their ability to meet the core surveillance requirements and develop compliance plans for these obligations.73 The WHO must assist member states with their obligations for the surveillance system but do not earmark any funds for this purpose.74 IHR 2005 requires member states to collaborate on financial resource mobilization and technical cooperation and logistical support for surveillance capabilities.75 IHR 2005 provides a stronger public health surveillance system that exceeds the mechanisms provided in IHR 1969.76 But the development of a useful, timely, and stable public health surveillance system presents numerous challenges involving technical, resource, legal, governance, and political concerns that could complicate implementation of the IHR 2005 provisions.77 New or previously undetected pathogens will present technical issues, even for the most advanced member states, so surveillance systems will need to be sensitive enough to detect pathogens or infectious agents that have not resulted in a significant amount of diagnosed cases.78 Some member states may not be able to meet the financial and technical burdens required for the development of adequately sensitive surveillance systems. The WHO could work with both the United Nations and the World Bank to develop a global strategy to provide support for surveillance capacity development and maintenance.79 In addition to financial and technical concerns, governance issues, such as managerial and administrative limitations, could slow or block implementation of surveillance systems.80 Few member states know the gaps and weaknesses in their public health surveillance system infra73

Id. at 1060.

74

Id.

75

Id.

76

Id. at 1062.

77

Id.

78

Id. at 1063.

79

Id.

80

Id.

44 • International Law, Agricultural Biotechnology, and Infectious Disease

structure or how to repair them.81 Legal complications, such as possible conflicts with domestic legislation, may arise during the development of public health surveillance systems under IHR 2005.82 Member countries’ political commitment to the incorporation of IHR 2005 could vary, for member countries did not consistently report notifiable diseases under IHR 1969, and there is no indication that this trend would change under IHR 2005.83 All of these concerns bring up important considerations for the viability of the IHR 2005 revisions. Mechanisms for international public health issues will encounter domestic roadblocks, such financial and technical restraints, legislative and governance conflicts, and political apathy. But successful containment and eradication of infectious diseases requires a certain level of burdensome activity. The emergence of new or re-emerging pathogens, such as Avian Influenza, BSE, and SARS, illustrate the need for international public health surveillance programs that are flexible, responsive, and efficient. The success of the new IHR 2005 provisions remains to be seen, but the more comprehensive surveillance and notification procedures may foster more efficient and successful solutions to international public health emergencies. B.

FRAMEWORK CONVENTION ON GLOBAL INFECTIOUS DISEASE PREVENTION AND CONTROL

IHR 2005 offers one possible legislative approach to providing adequate protection against the spread of infectious disease. David Fidler, in International Law and Infectious Disease, presents a legislative alternative to IHR 2005 called the Framework Convention on Global Infectious Disease Prevention and Control (the Framework Convention), which aims to “establish a global legal framework on infectious disease prevention and control, to support and strengthen scientific, medical, and public health efforts to fight infectious diseases undertaken by states, international organizations, and non-governmental organizations.”84 Article 2 delineates the overall objectives of Fidler’s Framework Convention, focusing on: estab81

Id.

82

Id.

83

Id. at 1064.

84

FIDLER, supra note 17, at 318.

Public Health Legislation • 45

lishing international principles for guidance on international infectious disease prevention and control, creating institutions and procedures to implement these guidelines, providing financial and technical assistance to developing countries for infectious disease prevention and control, allowing for convention development through amendments and protocols, and establishing monitoring institutions and procedures.85 Article 3 sets out the general obligations for member states under the Framework Convention. Article 3(1) connects the Framework Convention with preexisting protocols and regulations, positing that “appropriate public health and legal measures” adopted “in accordance with the provisions of this convention” must adhere to other related protocols and regulations already in force.86 In addition to adopting measures adhering to previous regulations for infectious disease control, Article 3(3) provides more specific obligations for member states to the Framework Convention, including cooperation in surveillance and information exchange, improvement of public health infrastructures at all levels, and sharing of scientific and public health research and development.87 85 “Article 2 Objectives: The objectives of the Convention are to: (1) establish general international legal principles and obligations to guide national and international infectious disease prevention and control efforts; (2) create the necessary institutions and procedures to allow the Parties to implement the general international legal principles and obligations nationally, co-ordinate activities with other international organizations and non-governmental organizations, and to enable the Parties to provide financial and technical assistance to developing country Parties on infectious disease prevention and control; (3) provide procedures to allow Parties to develop the Convention through amendments, protocols, and through the incorporation of regulations adopted by the World Health Assembly under Article 21 of the Organization’s Constitution (Regulations); and (4) establish institutions and procedures to monitor Parties’ compliance with the general international legal principles and obligations provided for in the Convention.” Id.

“Article 3(1): The Parties shall adopt appropriate public health and legal measures in accordance with the provisions of this Convention and of those Protocols and Regulations in force to which they are a party to protect human health against infectious diseases, whether of human or animal origin.” Id. 86

“Article 3(3): The Parties shall: (a) Co-operate with other Parties and the Organization in the surveillance of infectious diseases and in the exchange of information and research on improving the local, national, and global surveillance of infectious diseases; (b) Co-operate with other Parties and the Organization in the implementation of public health strategies to prevent and control infectious diseases 87

46 • International Law, Agricultural Biotechnology, and Infectious Disease

Articles 4 and 5 describe the role science plays in the development and guidance of infectious disease policies in the Framework Convention. Article 4 recognizes the importance of scientific development in infectious disease control and states that all infectious disease policies must be based on “relevant scientific information available about the prevention and control of infectious disease.”88 Article 5 states that scientific guidance on infectious disease prevention and control come from WHO recommendations, guidelines, standards, and other relevant information sources.89 Article 7 addresses situations where the WHO does not provide scientific direction and requires member states to report to the Secretariat the nature and use of scientific information for infectious disease policies.90 The Framework Convention developed by Fidler illustrates the possibility of alternative options to IHR 2005 for infectious disease control.

at their source and after they have spread to other regions or populations; (c) Co-operate with other Parties and the Organization in the improvement of public health infrastructure locally, nationally, and internationally; (d) Co-operate with other parties and the Organization in conducting scientific and public health research and development on infectious disease prevention and control and in applying the fruits of such research and development at the local, national, and international levels.” Id. at 318–19. 88 “Article 4 Scientific Basis for Infectious Disease Policies and Measures: The Parties recognize the critical role science and scientific developments play in the human struggle against infectious diseases and shall base all infectious disease policies and measures and their application on the relevant scientific information available about the prevention and control of infectious diseases.” Id. at 319. 89 “Article 5 Scientific Information and Guidance of the Organization: The Parties shall use scientific information and guidance on infectious disease prevention and control provided by the Organization in its recommendations, guidelines, standards, and other relevant information sources. Subject to Articles 6 and 7, this obligation does not prevent a Party from using other scientific information and guidance from other national, international, or non-governmental sources in establishing infectious disease prevention and control policies and measures.” Id. at 319.

“Article 7 Lack of Scientific Information and Guidance from the Organization: In situations in which the Organization has not published or otherwise provided scientific information and guidance in connection with a particular infectious disease prevention and control problem, then Parties shall report to the Secretariat in a timely fashion the nature of the scientific information and guidance used to establish or modify infectious disease prevention and control policies or measures and how the Parties used such information and guidance.” Id. at 320. 90

Public Health Legislation • 47

Even though the Framework Convention is not a real convention negotiated by a collection of member states, and instead is of Fidler’s own devising, it shows that a convention can be conceived with a global perspective for infectious disease control. The Framework Convention also places science at the heart of its provisions and allows for the use of other scientific information other than that which is provided through the WHO. The WHO may not immediately detect new pathogens developing from GMOs; detection and information on their origin and genetic backgrounds may come from sources other than the WHO. Allowing member states to use other sources of scientific information fosters more effective and comprehensive regulations. Article 9 addresses the precautionary principle, which provides guidance when available scientific information is unavailable or uncertain. Article 9 provides that when “available scientific information and guidance is inadequate or uncertain,” member states should confer with the WHO to determine whether precautionary infectious disease prevention and control policies exhibit “general public health and scientific principles and standards and conform to the provisions of this Convention and of international law.”91 SARS, BSE, and Avian Influenza illustrate how challenging curtailing an infectious disease outbreak can be without scientific information for a pathogen’s origin and etiology.92 Article 16 of the Framework Convention discusses the sovereign right to protect health, requiring that each member state have the right to restrict trade flows in and out of their territories for the protection of their populations from infectious disease threats.93 This exercise of trade restriction 91 “Article 9 Precautionary Principle: In situations in which the nature of the available scientific information and guidance is inadequate or uncertain, Parties shall consult with the Organization in adopting or modifying infectious disease prevention and control policies or measures to ensure that precautionary steps reflect general public health and scientific principles and standards and conform to the provisions of this Convention and of international law.” Id. at 320.

DAVID P. FIDLER, SARS, GOVERNANCE AND THE GLOBALIZATION OF DISEASE 87 (2004). 92

“Article 16 Sovereign Right to Protect Health: The Parties recognize that they each have the sovereign right to restrict trade flows into and out of their territories to protect their populations from threats of infectious diseases, and to regulate the immi93

48 • International Law, Agricultural Biotechnology, and Infectious Disease

by member states must be done in accordance with the other provisions of the Framework Convention, preexisting international agreements, and international law.94 The Framework Convention also contains sections on human rights, international humanitarian law, environmental protection, labor, and transportation, but does not include a section on GMOs.95 Both IHR 2005 and the Framework Convention offer possible legislative schemes for infectious disease control but neglect to incorporate issues on GMOs, thus failing to promote a connection between these two areas. As GMOs become more prevalent in agricultural and human health applications, international conventions and instruments will need to incorporate provisions for GMOs into international instruments. Microorganisms adapt quickly, which permits the rapid emergence of new pathogens; SARS is a powerful example of how emerging new infectious diseases can carry significant impacts on human health and economic health and prosperity.96 This increasing rise of infectious diseases needs to be staunched, in both developed and developing countries, if goals like sustainable development and global economic growth are to be achieved.97 Modern biotechnology, genomics, and informatics provide numerous potential techniques and approaches that could aid in preventing, detecting, monitoring, diagnosing, and treating both emerging and reemerging infectious diseases.98 The integration of GMOs into the global food supply adds another dimension to the impacts of modern biotechnology on infectious disease. While GMOs may permit the development of new preventative techniques or treatments, they can also affect the safety of the food supply in ways currently unknown. gration and emigration of individuals that pose a significant infectious disease threat to public health. The Parties shall exercise this sovereign right in accordance with the provisions of the Convention, other international agreements in force to which they are parties, and international law.” FIDLER, supra note 17, at 322. 94

Id.

95

Id. at 323–27.

96 Organization for Economic Cooperation and Development (OECD), Biotechnology and Sustainability; The Fight Against Infectious Disease 1, 5 (2002), available at http://www.oecd.org/dataoecd/23/23/2508407.pdf. 97

Id. at 7.

98

Id. at 8.

Public Health Legislation • 49

Genetic modification techniques or informatics applications could provide more accurate and timely detection methods for infectious disease outbreaks.99 Microbial drug resistance is another salient issue regarding effective treatment of infectious disease outbreaks; modern molecular biological methods, such as genetic fingerprinting, could be used for both strain identification and drug resistance monitoring.100 Vaccines are also another area of infectious disease prevention and treatment that is garnering attention regarding applications of GMOs.101 The ability of scientists to obtain the entire genomic sequence of a human pathogen opens a new field based on the development of novel vaccines and anti-microbial drugs.102 These applications of genetic modification techniques and GMOs provide numerous opportunities to revolutionize infectious disease control. They also illustrate how public health issues can benefit from synthesizing previously unassociated technologies into eradication and control techniques. Using genetic modification techniques and GMOs in infectious disease control fosters more integrated solutions, leading to further instances of connection between GMOs and infectious disease in areas like food safety. Public health, as a concept, is slowly shifting to a more integrated whole, which offers potential for weaving together threads of previously separate disciplines, such as infectious disease control and GMOs. A more holistic and multi-faceted conception of public health is required for successful regulation and control, which is promoted by examining infectious diseases and GMOs as related regulatory areas.

99

Id. at 12.

100

Id. at 14.

101

Id. at 18.

102

Id.

CHAPTER 4

GMOS, FOOD SAFETY, AND FOODBORNE DISEASE Recent developments in global food production, processing, distribution, and preparation are catalyzing research in food safety and foodborne disease to provide a safer global food supply.1 The integration and merging of agricultural and food industries combined with the globalization of the food trade are altering patterns of food production and distribution while providing consumers with a wider variety of safe, accessible, and affordable foodstuffs.2 Food safety and foodborne disease issues tie together all stages of the global food chain and require a finely balanced interplay between regional and international needs. Requirements for effective protection and management of global food supplies and human health become more complicated and multi-faceted challenge for those charged with the safe and productive integration of GMOs into global commerce. Inclusion of GMOs in regulatory and policy initiatives safeguarding food supplies and minimizing effects from foodborne disease is necessary, for GMOs bring numerous potential agricultural benefits affecting food quality and human health. No current international instruments exist that restrict or ban the use or movement of GMOs in global commerce. The Biosafety Protocol addresses transboundary movement of GMOs but does not prohibit the use of these products in food development and production. A collection of international organizations, such as The World Health Organization (WHO), the Food and Agriculture Organization (FAO), Codex Alimentarius (Codex), and the Organization for Economic Cooperation and Development (OECD), are addressing international aspects of food safety and foodborne disease and provide a patchwork of advisory perspectives for regulation.

1 World Health Organization, WHO Global Strategy for Food Safety: Safer Food for Better Health 6 (2002), available at http://www.who.int/foodsafety/publications/general/en/strategy_en.pdf [hereinafter WHO Global Strategy]. 2

Id. at 6. 51

52 • International Law, Agricultural Biotechnology, and Infectious Disease

The WHO, the public heath arm of the United Nations, and the FAO, the food and agriculture division of the United Nations, both address food safety and foodborne disease concerns but from slightly divergent vantage points. Both the WHO and FAO promote a holistic and all-inclusive evaluation of GMOs that encompass food security, social and ethical aspects, and access and capacity-building, which will be used to form a more systematic, coordinated, multi-organizational and international evaluation for GMOs.3 A science-based evaluation system also should be implemented to objectively determine the benefits and risks of each GMO on a case-bycase basis, examining potential effects on biodiversity, the environment, and food safety.4 Domestic experience in regulating GMOs should also be incorporated into the evaluation process.5 To facilitate a more coordinated, multi-organizational approach, the WHO and FAO foster initiatives organizing a series of expert scientific consultations providing member states with technical and scientific advice.6 The WHO and FAO also provide technical assistance, information, socio-economic and environmental analyses to member states and contribute to the Secretariat of Codex’s Commission.7 A.

WORLD HEALTH ORGANIZATION

The WHO recognizes food safety as an “essential public health function” and argues that the “availability of safe food improves the health of people and is a basic human right.”8 Achieving this objective requires 3 WHO, 20 Questions on Genetically Modified (GM) Foods, at http://www. who.int/foodsafety/publications/biotech/20 questions/en/index.html (last visited Jan. 1, 2007) [hereinafter WHO Frequently asked questions].

Food and Agriculture Organization of the United Nations, FAO Statement on Biotechnology, at http://www.fao.org/biotech/state.asp (last visited Jan. 1, 2007) [hereinafter FAO Statement on Biotechnology]. 4

5

Id.

6 Reports and assessments include safety assessments of foods derived from GM animals, microorganisms, plants, and examination of allergenicity of GM foods. WHO, FAO/WHO Expert Consultations on GM Foods, at http://www.who.int/foodsafety/biotech/consult/en/index.html (last visited Jan. 1, 2007). 7

FAO Statement on Biotechnology, supra note 4.

“Safe food contributes to health and productivity and provides an effective platform for development and poverty alleviation.” DAVID P. FIDLER, INTERNATIONAL LAW 8

GMOs, Food Safety, and Foodborne Disease • 53

technical cooperation while striving for a healthy environment and sustainable development by facilitating the involvement of WHO and its member states in a variety of “multisectoral and multidisciplinary actions” on local, national, and international levels.9 WHO’s mandate for “highest possible level of health” for all people translates to food safety as minimizing “the burden of foodborne illness by advising and assisting member states to reduce exposure to unacceptable levels of chemicals or microorganisms in food.”10 The achievement of this mandate requires broadening WHO’s responsibilities in food safety, maximizing resource usage to promote food safety as an essential public health function, and devising interventions for improvements related to global food safety for the development of a food supply “that is adequate in quantity, quality, accessibility, and safety.”11 WHO’s efforts in food safety and GM foods focus on four primary areas: the establishment of scientific safety assessment frameworks,12 the standardization of safety assessment methods for nutritional aspects of GM food,13 the connection of risk assessment to risk management and communication,14 and the creation of a broader perspective of health and AND PUBLIC HEALTH 9 (2000). See also Convention on the Rights of the Child, art. 24, available at http://www.ohchr.org/english/law/crc.htm. 9

FIDLER, supra note 8, at 7.

10

Id. at 6.

11

Id. at 7.

12 “There is a need to facilitate the establishment of sound safety and risk assessment frameworks for foods derived from modern biotechnology. In addition to providing input to the Codex Intergovernmental Task Force on foods Derived from Biotechnology, WHO will develop the principles and guidelines for addressing emerging issues based on sound science.” WHO, General information about biotechnology (GM foods), at http://www.who.int/foodsafety/biotech/general/en/index.html (last visited Jan. 1, 2007) [hereinafter General Information about biotechnology].

“There is a need for increased focus on nutritional assessments of new foods derived from biotechnology and in fact from novel foods in general with specific nutritional traits. These types of considerations are already part of the FAO/WHO Expert Consultation on food derived from biotechnology, but a strengthened effort is needed, This effort should be coordinated with efforts in other intergovernmental for a, such as the OECD Task Force on Novel Foods.” Id. 13

14

“Effective mechanisms and approaches are urgently needed both at national and

54 • International Law, Agricultural Biotechnology, and Infectious Disease

development policy.15 Subsequent evaluations by the WHO of GM foods will assess its potential public health benefits, such as more efficient food production, increased nutrient content, decreased allergenicity, and possible negative impacts on human health related to consumption of these products.16 B.

FOOD AND AGRICULTURE ORGANIZATION

The FAO, like the WHO, provides advice and direction, from a food and agriculture perspective, that establishes priorities for GMOs within current agricultural research needs and policies.17 The FAO’s primary strategy for GMOs is to promote a balanced perspective by bolstering existing domestic research agendas rather than supporting the development of new programs, since numerous disciplines and program areas use GMOs.18 To achieve this, the FAO provides assistance for identification, guidance, and dialogue promotion between public and private sectors for possible research and development opportunities.19 The FAO Committee at international level to bridge the outcomes of risk assessments into risk management and risk communication efforts. New thinking towards involving consumers and other interested parties already at the planning stages of risk communication efforts need to be developed. And the experience gained in this area could be used in other aspects of food safety.” Id. “The development of new foods through modern biotechnology is not always been perceived to be a “public good.” New products with potential health or production benefits in developing countries could change this. Such products will need a more holistic assessment, looking into all aspects of such production changes (health benefit, nutrition, safety, development and socio-economic issues, etc. in preparation of this work there is a need for WHO to strengthen its collaboration with inter-sectoral partners. Such efforts would entail technical issues related to such areas as production efficiency and safety assessments but also more general issues of how foods derived from modern biotechnology could be made useful in addressing the needs of developing countries. Id. 15

16

WHO Frequently asked questions, supra note 3.

17 FAO, Biotechnology in Food and Agriculture Policy Advice, at http://www. fao.org/biotech/act1.asp (last visited Jan. 1, 2007) [hereinafter FAO Policy Advice]. 18

Id.

The FAO may also provide assistance in preparing modern biotechnologyrelated proposals for donor funding and facilitating dialogue as to the various phases of research, development and commercialization of products of modern biotechnol19

GMOs, Food Safety, and Foodborne Disease • 55

on Agriculture (COAG) is responsible for reviewing and dispensing advice on food and agriculture issues, focusing on promoting information exchange and providing technical and legal advice.20 COAG also reviews the development and implementation of FAO agricultural, food, and nutrition work programs, with an emphasis on integration of all social, technical, economic, institutional, and structural aspects in promoting agricultural and rural development.21 Technical assistance for implementation of FAO programs and initiatives is provided through FAO’s technical divisions, which give assistance directly to member states through biotechnology networks and partnerships with international agricultural research institutions.22 These efforts focus on increasing and sustaining agricultural production, including marginal conditions, natural resources that include biodiversity and genetic conservation, biosafety and risk analysis.23 Legal and regulatory advice is also one of FAO’s primary objectives, which aims to establish regulatory frameworks for biosafety,24 food safety, and intellectual property rights.25 Policy decisions addressing biosafety ogy. Research and development promotion will focus on developing initiatives and programs for appropriate biotechnology, “orphan crops and commodities, indigenous and minor livestock breeds, wild forest trees and plants which are important in the ecosystems, agriculture, traditional culture and nutrition of local and tribal communities” that lack major national or regional initiatives. Id. 20 FAO, Status of Research and Application of Crop Biotechnologies in Developing Countries 1 (2005), available at ftp://ftp.fao.org/docrep/fao/008/y5800e/ y5800e00.pdf.

FAO, FAO Governing Bodies Committee on Agriculture, at http://www.fao. org/unfao/govbodies/Agrifinal_en.asp (last visited Jan. 1, 2007). 21

FAO, Biotechnology in Food and Agriculture Technical Assistance, at http:// www.fao.org/biotech/act3.asp (last visited Jan. 1, 2007) [hereinafter FAO Technical Assistance]. 22

23

Id.

24 The FAO defines biosafety as “assessing, monitoring and managing the potential risks associated with GMOs from possible gene flow, competitiveness and other impacts on the health of ecosystems, plants, animals, and humans.” FAO, Biotechnology in Food and Agriculture Regulatory aspects: legal and technical advice on regulatory issues, at http://www.fao.org/biotech/act4.asp (last visited Jan. 1, 2007) [hereinafter FAO Regulatory Aspects). 25

Id.

56 • International Law, Agricultural Biotechnology, and Infectious Disease

issues present long-term implications for agricultural sustainability and food security; international efforts in this area include the Biosafety Protocol and the International Plant Protection Convention (IPPC).26 Codex spearheads efforts on legal and regulatory advice for food safety standards, with specific emphasis on the work of the Ad Hoc Intergovernmental Task Force on Foods Derived from Biotechnology (the Task Force).27 To facilitate advisory, technical, and regulatory program and initiative development, the FAO establishes a collection of priority areas for interdisciplinary action (PAIAs) within FAO, which includes issues on GMOs.28 The primary role of the Biotechnology PAIA is to provide “factual, comprehensive, and updated information about agricultural biotechnology.”29 The FAO Inter-Departmental Working Group on Biotechnology (IDWGB), developed in 1999, facilitates the goals of the PAIA and coordinates the various elements of the FAO’s efforts regarding GMOs.30 Representatives from all FAO departments participate in the IDWGB, including the FAO Commission on Genetic Resources for Food and Agriculture (CGRFA), working on issues related to GMOs, and creates task forces charged with developing an “integrated strategy for mainstreaming ongoing biotechnology-related activities for food and agriculture.”31 CGRFA is a permanent FAO forum that allows member states to discuss and negotiate issues related to genetic resources for food and agriculture, with the goal of reaching consensus through negotiations.32 The 26

Id.

27

Id.

FAO, Results of the FAO Biotechnology PAIA Stakeholder Survey 1 (2006), available at http://www.fao.org/biotech/docs/surveyfaopaia.pdf. 28

This is done through the FAO Biotechnology Web site, an e-mail newsletter FAO-Biotech News, and a series of moderated email conferences hosted by the FAO Biotechnology Forum. Id. 29

30

FAO Statement on Biotechnology, supra note 4.

31 FAO, Inter-Departmental Working Group on Biotechnology, at http://www.fao. org/biotech/cont.asp (last visited Jan. 1, 2007).

The Commission was originally established in 1983 as the Commission on Plant Genetic Resources to deal with plant genetic resources. In 1995, its mandate was broadened to cover all components of ago-biodiversity of relevance to food and agri32

GMOs, Food Safety, and Foodborne Disease • 57

main priorities of CGFRA are to “ensure the conservation and sustainable utilization of genetic resources for food and agriculture, as well as the fair and equitable sharing of benefits derived from their use.”33 Other duties of CGFRA include facilitating and overseeing cooperation between the FAO and other intergovernmental and non-governmental bodies, such as the conference of parties to the Convention on Biological Diversity, the International Plant Genetic Resources Institute, and the U.N. Commission on Sustainable Development.34 One of the main accomplishments of the CGFRA is the International Treaty on Plant Genetic Resources for Food and Agriculture, which provides a framework for the conservation, sustainable use, and equitable benefit-sharing of plant genetic resources for food and agriculture for sustainable agriculture and food security.35 Another mechanism provided by the FAO for information dissemination and guidance is the International Portal on Food Safety, Animal and Plant Health (IPFSAPH), which facilitates international trade in food and agriculture products and assists the implementation of the Sanitary and Phytosanitary (SPS) Agreement through a single access point for domestic and international information in food safety and animal and plant health.36 IPFSAPH takes an interdisciplinary approach to food safety, animal, and plant health by assessing the effects of increasing economic interdependence, novel production and processing techniques, and inter-

culture and was then renamed the Commission on Genetic Resources for Food and Agriculture. The CGFRA is comprised of two subsidiary bodies: the Intergovernmental Technical Working Group on Animal Genetic Resources (ITWGAnGR) and the Intergovernmental Technical Working Group on Plant Genetic Resources (ITWG-PGR). FAO, Commission on Genetic Resources for Food and Agriculture, at http://www.fao.org/ag/cgrfa/default.htm (last visited Jan. 1, 2007) [hereinafter Commission on Genetic Resources]. 33

Id.

34

Id.

35 FAO Commission on Genetic Resources for Food and Agriculture, The International Treaty on Plant Genetic Resources for Food and Agriculture, at http://www.fao.org/ag/cgrfa/itpgr.htm (last visited Jan. 1, 2007).

FAO, International Portal on Food Safety, Animal & Plant Health, at http://www.ipfsaph.org/En/default.jsp (last visited Jan. 1, 2007) [hereinafter IPFSAPH]. 36

58 • International Law, Agricultural Biotechnology, and Infectious Disease

national trade and travel on SPS measures.37 By providing more streamlined access to official information regarding SPS measures, IPFSAPH fosters increased transparency in SPS measures and improved domestic laws and regulations, which further facilitates international trade.38 The complementary approaches on food safety and GMOs taken by the WHO and FAO provide a wealth of advisory guidance for member states to examine when developing domestic, regional, and international regulations. Both the WHO and FAO cover a wide range of relevant areas and illustrate that both intergovernmental organizations are crucial in dissemination and assessment efforts by the global community directed at adequately assessing and regulating GMOs. Foodborne disease is another area examined by the WHO and FAO related to the incorporation of GMOs into agriculture and food and adds another dimension to regulations for GMOs. Agricultural pest and disease migration can cause significant damage, lead to famine, and trigger trade restrictions. Surveillance and control of foodborne diseases are also important food safety issues and are a crucial area of attention for the WHO and FAO. Rapid advancements within current food production, distribution, and management mechanisms permit quick and wide-ranging movement of contaminated food and food products.39 Effective strategy development and control of foodborne diseases consist of managing information about food hazards and current foodborne disease levels in member states while improving food safety.40 WHO’s approach to foodborne diseases include monitoring hazards affecting the entire food production chain instead of only hazards in food, which is the objective of many current food safety regimes.41 WHO’s activities in this area include encouraging the commitment, coordination, 37

Id.

38

Id.

39

WHO Global Strategy, supra note 1.

40 WHO, General information related to foodborne disease, at http://www. who.int/foodsafety/foodborne_disease/general/en/index.html (last visited Jan. 1, 2007) [hereinafter WHO Foodborne Disease]. 41

WHO Global Strategy, supra note 1, at 9.

GMOs, Food Safety, and Foodborne Disease • 59

and improvement of member states’ efforts in foodborne disease surveillance, and food monitoring programs.42 The Department of Food Safety, Zoonoses and Foodborne Diseases (FOS), within the WHO, aims to reduce the negative worldwide impacts of foodborne diseases by addressing food safety issues along the entire food production chain and fostering collaboration on the domestic and international level.43 Effective control of foodborne diseases, like infectious disease control, requires surveillance based on informative resources addressing both incidence of and hazards presented by foodborne diseases.44 WHO sets forth a three-pronged approach for global issues related to foodborne disease. This plan of action relies on developing science-based measures along the entire food production chain, managing risks and communicating information related to foodborne disease, and supporting integrated food safety systems based on risks.45 An interdisciplinary approach, including all areas dealing with foodborne diseases and food safety, provides the best vehicle for the successful development of international surveillance methods.46 WHO can also act as facilitator for the coordination and strengthening of international surveillance methods by guiding the collection of laboratory and epidemiological findings and linkages related to monitoring food contamination.47 The next step in creating “risk-based, sustainable, integrated food safety systems” revolves around adequate risk assessments.48 Both WHO and FAO will jointly collaborate to gather information on the connections between microorganisms and chemicals in food and foodborne diseases.49 These risk assessments can later supply the 42

WHO Foodborne Disease, supra note 40.

43 FOS works specifically with other WHO departments, Regional Offices and WHO collaborating centers as well as other international and national agencies. WHO, Food Safety, at http://www.who.int/foodsafety/en/ (last visited Jan. 1, 2007) [hereinafter WHO Food Safety]. 44

WHO Global Strategy, supra note 1, at 2.

45

Id. at 13.

46

Id.

47

Id.

48

Id. at 15.

49

Id.

60 • International Law, Agricultural Biotechnology, and Infectious Disease

structural basis for creating international guidelines and standards, domestic food regulations, and other measures addressing foodborne diseases.50 WHO’s International Food Safety Authorities Network (INFOSAN) also promotes cooperation by establishing a global network of food safety authorities charged with assisting member states during natural, accidental, and intentional international food safety emergencies.51 INFOSAN’s primary objective is to prevent the international spread of contaminated food by facilitating the dissemination of important global food safety information and improving domestic and international collaborations on food safety issues.52 The FAO developed The Emergency Prevention System for Transboundary Animal and Plant Pests and Diseases (EMPRES) to minimize the risks related to agricultural pest and disease migration.53 EMPRES focuses on “normative and operational activities on the containment and progressive control” of a variety of serious transboundary diseases.54 Four primary elements comprise EMPRES and address issues such as early warning, early reaction, coordination, and research promotion.55 Early warning procedures encompass all disease initiatives based on epidemiological surveillance, aiming to improve awareness and knowledge of disease and infection distribution.56 Early reaction responses are all actions 50

Id.

51 WHO, The International Food Safety Authorities Network (INFOSAN) 2 (2006), available at http://www.who.int/foodsafety/fs_management/flyer_info_eng. pdf. 52

Id.

FAO, Emergency Prevention System for Transboundary Animal and Plant Pests and Diseases (EMPRES), at http://www.fao.org/EMPRES/default.htm (last visited Jan. 1, 2007). 53

54 Examples include the Global Rinderpest Eradication Programme (GREP), the Desert Locust, and efforts directed at transboundary animal disease such as African Swine Fever (ASF), Avian Influenza, Contagious Bovine Pleuropneumonia (CBPP), Foot-and-Mouth Disease, Haemorrhagic Septicaemia, and Rift Valley Fever (RVF). Id. 55 FAO, EMPRES Key Elements, at http://www.fao.org/ag/againfo/programmes/ en/empres/k_elements.html (last visited Jan. 1, 2007). 56

“Early Warning: identified as all disease initiatives based predominately on epi-

GMOs, Food Safety, and Foodborne Disease • 61

aimed at rapid and effective containment and eventual elimination of disease outbreaks, including contingency planning and emergency preparedness.57 EMPRES also focuses on coordination of global and regional eradication initiatives for transboundary diseases.58 Early warning, reaction, and coordination efforts all require significant investments in research, with an emphasis on encouraging collaboration between FAO and other scientific centers of excellence.59 FAO also developed an early warning system for food and agriculture, with the goal of providing continuous monitoring of the global food supply.60 Additional duties include issuing reports on the global food situation and providing early warnings of impending food crises to individual countries.61 INFOSAN and EMPRES comprise the core of surveillance and containment efforts for foodborne disease. INFOSAN, by developing a global network of food safety authorities, allows the integration of food safety information during food safety emergencies, which includes foodborne disease outbreaks. EMPRES also strives to reduce agricultural pest and disease migration, which bolsters INFOSAN’s efforts at curtailing food safety emergencies. Both of these networks connect food safety and fooddemiological surveillance, which would lead to improved awareness and knowledge of the distribution of disease or infection and which permit forecasting the further evolution of an outbreak.” Id. “Early Reaction: identified as all actions that would be targeted at rapid and effective containment of, and leading to, the elimination of a disease outbreak, thus preventing it from turning into a serious epidemic. This includes contingency planning and emergency preparedness.” Id. 57

“Coordination: involves either coordination of global eradication of an identified animal diseases such as rinderpest e.g. through the Global Rinderpest Eradication Programme, or encouraging regional initiatives for eradication of a given transboundary disease.” Id. 58

59 “Enabling Research: identified as prime element of EMPRES to emphasize the collaboration between FAO and scientific centers of excellence in directing research efforts towards problem solving.” Id.

GIEWS was established in the early 1970s, in the wake of the global food crisis, and remains the leading source of information on global food production and food security. FAO, GIEWS The Global Information and Early Warning System on Food and Agriculture 3, available at http://www.fao.org/giews/english/giews_en.pdf. 60

61

Id.

62 • International Law, Agricultural Biotechnology, and Infectious Disease

borne disease issues and facilitate information dissemination in both areas. Such efforts provide a foundation for domestic, regional, and international regulatory instruments and standards, which facilitates the development of various food standards by Codex. C.

CODEX ALIMENTARIUS

Food regulators, consumers, exporters, and importers began looking to the FAO and WHO for guidance in unraveling food regulations operating as trade barriers and providing inadequate protection for consumers.62 The increased use of chemicals, in the early 1950s, in foods presented new public health concerns and prompted requests for research by the WHO and FAO.63 This call for research prompted the development of the first joint FAO/WHO Conference on Food Additives in 1955, which led to the creation of the Joint FOA/WHO Expert Committee on Food Additives (JECFA).64 JEFCA continues to be a significant part of the work done on standards and guidelines for food additives, contaminants, and residues of veterinary drugs in foods.65 Simultaneously, numerous committees, developed by international NGOs, began addressing standards for food commodities and were eventually associated or integrated with appropriate Codex Commodity Committees or became Codex Committees.66 Codex, created in 1963 by the FAO and WHO, develops food standards, guidelines, and codes of practice for protecting consumer health, ensuring fair trade practices, and promoting coordination of international food standards work.67 Codex has become the “global reference point for 62 FAO/WHO, Understanding The Codex Alimentarius 8 (2005), available at ftp://ftp.fao.org/docrep/fao/008/y7867e/y7867e00.pdf [hereinafter Understanding Codex]. 63

Id.

64

Id. at 9.

65

Id.

66

Id.

“Article 1: The Codex Alimentarius Commission shall . . . be responsible for making proposals to, and shall be consulted by, the Directors-General of the Food and Agriculture Organization (FAO) and the World Health Organization (WHO) on all matters pertaining to the implementation of the Joint FOA/WHO Food Standards Programme, the purpose of which is: (a) protecting the health of consumers and 67

GMOs, Food Safety, and Foodborne Disease • 63

consumers, food producers and processors, national food control agencies and the international food trade” and provides an international forum for the development, harmonization, and implementation of food standards.68 The food standards developed by Codex are also used as benchmarks to evaluate domestic food measures under the WTO agreements.69 Codex standards are considered a crucial component in the development of food control systems aimed at safeguarding consumer health.70 Codex and its subsidiary bodies are committed to keeping all Codex materials relevant and consistent with current scientific knowledge and the needs of member states.71 Codex standards relate to product characteristics that are commodityappropriate, such as maximum residue limits (MRLs) for pesticide residues or veterinary drugs in food.72 General standards address food additives, contaminants, and toxins in food, analysis methods, and sampling, which contain general and commodity-specific provisions.73 Commodity standards comprise the largest group of specific standards in Codex and address products, such as cereals, fish, fruits and vegetables, and meat and meat products.74 Codex also develops codes of practice and guidance ensuring fair trade practices in the food trade; (b) promoting coordination of all food standards work undertaken by international governmental and non-governmental organizations; (c) determining priorities and initiating and guiding the preparation of draft standards through and with the aid of appropriate organizations; finalizing standards elaborated under (c) above and, after acceptance by governments, publishing them in Codex Alimentarius either as regional or worldwide standards, together with international standards already finalized by other bodies under (b) above, wherever this is practicable; (e) amending published standards, after appropriate survey in the light of developments.” Id. at 14. 68

Id. at v.

69

Id.

70

Id. at 4.

71

Id. at 16.

72

Id. at 10.

73

Id. at 10–11.

“The major commodities included in the Codex are: cereals, pulses (legumes) and derived products including vegetable proteins; fats and oils and related products; fish and fishery products; fresh fruits and vegetables; processed and quick-frozen 74

64 • International Law, Agricultural Biotechnology, and Infectious Disease

documents for food production, processing, manufacturing, transport, and storage practices, aiming to ensure safety and suitability of food for consumption; guidance documents set out policy directives and interpretive guidelines for Codex general standards.75 Relevant policy areas include food additives, food import and export certifications and inspections, development of microbiological criteria and risk assessments for foods, and risk analyses of foods derived from modern biotechnology.76 Two kinds of subsidiary committees are responsible for the bulk of the work performed by Codex. Codex Committees prepare draft standards for submission and Coordinating Committees regionally coordinate food standard activities.77 General Subject Committees are relevant to all Commodity Committees and provide broad concepts and principles that apply generally to all foods, endorse or review provisions in commodity standards, and develop recommendations as to consumer’s health and safety.78 Five of the General Subject Committees must ensure commodity standards provisions are in conformity with Codex’s main general standards; these committees address areas, such as food additives, hygiene, labeling, methods of analysis and sampling, and nutrition issues for special dietary uses.79 Three other relevant committees to issues of food safety and foodborne disease are the Committee on Pesticide Residues, the fruits and vegetables; fruit juices; meat and meat products, soups and broths; milk and milk products; sugars, cocoa products and chocolate and other miscellaneous products.” Commodity standards tend to follow a fixed form and consist of the following categories of information, such as scope, description, essential composition, food additives, contaminants, hygiene, weights, labeling, and methods of analysis and sampling.” Id. at 11–12. 75

Id. at 11.

76

Id.

77

Id. at 16.

78

These recommendations are based on the advice of expert scientific bodies. Id.

at 17. “Five of the General Subject Committees have the responsibility of ensuring that specific provisions in Codex commodity standards are in conformity with the Commission’s main general standards and guidelines in their particular areas of competence. They are: Committee on Food Additives and Contaminants, Committee on Food Hygiene, Committee on Food Labeling, Committee on Methods of Analysis and Sampling, Committee on Nutrition and Foods for Special Dietary Uses.” Id. 79

GMOs, Food Safety, and Foodborne Disease • 65

Committee on Residues of Veterinary Drugs in Foods,80 and the Committee on Food Import and Export Inspection and Certification Systems (the Food Import and Export Committee).81 The Food Import and Export Committee develop guidelines for the application of standards addressing foods moving in international commerce. These guidelines examine governmental regulatory measures for food and food production systems and ensure that they protect consumers against foodborne hazards and deceptive marketing practices.82 A crucial area of advice in these guidelines addresses food safety emergency response mechanisms, including utilization of channels of communication through the INFOSAN emergency information system.83 To permit more flexibility within the committee structure, Codex developed a third subsidiary body called a Codex Ad Hoc Intergovernmental Task Force, which has very limited terms of reference and is established for a fixed period of time.84 The Task Force on Foods Derived from Biotechnology (Biotechnology Task Force) develops standards and guidelines while coordinating with other Codex committees and accounting for existing work by national authorities, FAO, WHO, and other international organizations on foods derived from biotechnology.85 The Codex Principles for the Risk Analysis of Foods Derived from Modern Biotechnology (Biotechnology Principles) were created using a pre-market safety evaluation of GM foods on a case-by-case basis.86 The Biotechnology Principles establish post-market monitoring of possible consumer health and nutritional effects; two sets of guidelines for safety assessments, addressing GMOs and microorganisms, discuss intended 80 This Committee is responsible for developing MRLs for categories of chemicals used in agricultural production. MRLs are “based on scientific advice regarding the safety of the residues that remain after the substances are used in accordance with defined good agricultural or veterinary practices.” Id. at 18. 81

Id. at 17–18.

82

Id. at 18.

83

Id.

84

Id.

85

Id. at 19.

86

Id. at 27.

66 • International Law, Agricultural Biotechnology, and Infectious Disease

and unintended effects of genetic modification and possible instances of allergenicity.87 The report of the Fifth Session of the Biotechnology Task Force, in 2005, presents some of the current work engaged in by Codex on issues of food safety and standard development in relation to GMOs.88 Codex principles and guidelines are considered to be, by the members of the Biotechnology Task Force, the “appropriate international basis for food safety risk assessment.”89 With this backdrop, the Biotechnology Task Force examined GM animals, plants altered for nutritional or health benefits, GM plants with stacked genes, adventitious presence of unauthorized materials from GM plants, and plants producing pharmaceutical or bioactive substances.90 The Biotechnology Task Force report illustrates the broad scope of Codex’s work in this area as well as its primary objective as a forum for discussion and collaboration on issues of food safety.91 The primary document addressing issues related to GMOs in Codex is the Principles for the Risk Analysis of Foods Derived from Modern Biotechnology (the Principles).92 The Principles set forth the fundamental concepts for subsequent Codex efforts at developing and harmonizing food standards for GMOs. The primary purpose of these Principles is to “provide a framework for undertaking risk analysis on the safety and nutritional aspects of foods derived from modern biotechnology”93 but does not include environmental, ethical, moral, and socio87

Id. at 28.

88 Codex Alimentarius Commission, Report of the Fifth Session of the Codex Ad Hoc Intergovernmental Task Force on Foods Derived from Biotechnology, ALINORM 06/29/34 1 (2005), available at http://www.codexalimentarius.net/web/archives. jsp?year=06 (last visited Jan. 1, 2007) [hereinafter Biotechnology 5th Session Report]. 89

Id. at 3.

90

Id. at 3–9.

91

Biotechnology 5th Session Report, supra note 88.

92 Codex Alimentarius Commission, Principles for the Risk Analysis of Foods Derived from Modern Biotechnology, CAC/GL 44–2003 1 (2003), available at http://www.codexalimentarius.net/web/publications.jsp?lang=en (last visited Jan. 1, 2007) [hereinafter Risk Analysis Principles]. 93

Codex defines modern biotechnology as “the application of: i) In vitro nucleic

GMOs, Food Safety, and Foodborne Disease • 67

economic aspects connected to GM foods.94 The risk analysis process enumerated in the Principles consists of three aspects discussed in other efforts at risk analysis, which are risk assessment, risk management, and risk communication.95 According to the Principles, risk assessment applies to all aspects of GM foods and includes safety assessments and science-based multi-disciplinary data and information obtained from all relevant sources.96 Safety assessments require an examination of a whole food or its components relative to its conventional counterpart97 that scrutinizes both intended and unintended health effects, identifies new or altered hazards, and identifies

acid techniques, including recombinant deoxyribonucleic acid (DNA) and direct injection of nucleic acid into cells or organelles, or ii) fusion of cells beyond the taxonomic family, that overcome natural physiological reproductive or recombinant barriers and that are not techniques used in traditional breeding and selection.” Id. 94

Id.

95

Id. at 2–3.

“10. Risk assessment includes a safety assessment, which is designed to identify whether a hazards, nutritional or other safety concern is present, and if present, to gather information on its nature and severity. The safety assessment should include a comparison between the food derived from modern biotechnology and its conventional counterpart focusing on determination of similarities and differences. If a new or altered hazard nutritional or other safety concern is identified by the safety assessment, the risk associated with it should be characterized to determine its relevance to human health . . . 12. A pre-market safety assessment should be undertaken following a structured and integrated approach and be performed on a case-by-case basis. The data and information, based on sound science, obtained using appropriate methods and analyzed using appropriate statistical techniques, should be of a quality and, as appropriate, of quantity that would withstand scientific peer review. 13. Risk assessment should apply to all relevant aspects of foods derived from modern biotechnology. The risk assessment approach for these foods is based on a consideration of science-based multidisciplinary data and information taking into account the factors mentioned in the accompanying Guidelines . . . 15. Risk assessment should take into account all available scientific data and information derived from different testing procedures, provided that the procedures are scientifically sound and the parameters being measures are comparable.” Id. at 2. 96

“‘Conventional Counterpart’—means a related organism/variety, its components and/or products for which there is experience of establishing safety based on common use as food.” Id. at 1. 97

68 • International Law, Agricultural Biotechnology, and Infectious Disease

changes in key nutrients relevant to human health.98 Scientific data used for risk assessments can be gleaned from a variety of sources, such as the product developer, scientific literature, regulatory agencies, international bodies, and other interested parties.99 Risk management procedures for GMOs should be proportional to the risk and take into account uncertainties present in risk assessments.100 Risk management measures that employ different approaches to achieving the same level of protection for risks associated with nutritional and safety impacts of human health will be considered equivalent.101 Post-market monitoring and food labeling are both possible risk management measures, but the utility of such measures should be determined on a case-bycase basis.102 Certain tools, such as reference materials and analytical “11. A safety assessment is characterized by an assessment of a whole food or a component thereof relative to the appropriate conventional counterpart: A) taking into account both intended and unintended effects; B) identifying new or altered hazards; C) identifying changes, relevant to human health, in key nutrients.” Id. at 2. 98

“14. Scientific data for risk assessment are generally obtained from a variety of sources, such as the developer of the product, scientific literature, general technical information, independent scientists, regulatory agencies, international bodies, and other interested parties. Date should be assessed using appropriate science-based risk assessment methods.” Id. 99

100 “16. Risk management measures for foods derived from modern biotechnology should be proportional to the risk, based on the outcome of the risk assessment and, where relevant, taking into account other legitimate factors in accordance with the general decisions of the Codex Alimentarius Commission as well as the Codex Working Principles for Risk Analysis . . . 18. Risk managers should take into account the uncertainties identified in the risk assessment and implement appropriate measures to manage these uncertainties.” Id. 101 “17. It should be recognized that different risk management measures may be capable of achieving the same level of protection with regard to the management of risks associated with safety and nutritional impacts on human health, and therefore would be equivalent.” Id.

“19. Risk management measures may include, as appropriate, food labeling conditions for marketing approvals and post-market monitoring. 20. Post-market monitoring may be an appropriate risk management measure in specific circumstances. Its need and utility should be considered, on a case-by-case basis, during risk assessment and its practicability should be considered during risk management. Post-market monitoring may be undertaken for the purpose of: A) verifying conclusions about the 102

GMOs, Food Safety, and Foodborne Disease • 69

methods, may be used to facilitate the implementation and enforcement of risk management measures.103 Risk communication entails an interactive approach that includes transparent safety assessment and risk management decision-making processes that are fully documented and open to the public.104 All of these provisions are subject to review, when necessary, to take into account the rapid pace of GMO development.105 Codex also provides guidance for specific GMOs, such as GM plants. Guidelines for the Conduct of Food Safety Assessment of Foods Derived From Recombinant-DNA Plants (Recombinant Plants Food Safety Assessment guidelines) address “safety and nutritional aspects of foods absence or the possible occurrence, impact and significance of potential consumer health effects; and B) monitoring changes in nutrient intake levels, associated with the introduction of foods likely to significantly alter nutritional status, to determine their human health impact.” Id. at 2–3. 103 “21. Specific tools may be needed to facilitate the implementation and enforcement of risk management measures. These may include appropriate analytical methods; reference materials; and, the tracing of products for the purpose of facilitating withdrawal from the market when a risk to human health has been identified or to support post-market monitoring in circumstances as indicated in paragraph 20.” Id. at 3. 104 “Risk Communication: 22. Effective risk communication is essential at all phases of risk assessment and management. It is an interactive process involving all interested parties, including government, industry, academia, media and consumers. 23. Risk Communication should include transparent safety assessment and risk management decision-making processes. These processes should be fully documented at all stages and open to public scrutiny, whilst respecting legitimate concerns to safeguard the confidentiality of commercial and industrial information. In particular, reports prepared on the safety assessments and other aspects of the decision-making process should be made available to all interested parties. 24. Effective risk communication should include responsive consultation processes. Consultation processes should be interactive. The views of all interested parties should be sought and relevant food safety and nutritional issues that are raised during consultation should be addressed during the risk analysis process.” Id.

“30. Recognizing the rapid pace of development in the field of biotechnology, the approach the safety assessments of foods derived from modern biotechnology should be reviewed when necessary to ensure that emerging scientific information in incorporated into the risk analysis. When new scientific information is relevant to a risk assessment becomes available the assessment should be reviewed to incorporate that information and, if necessary, risk management measures adapted accordingly.” Id. 105

70 • International Law, Agricultural Biotechnology, and Infectious Disease

consisting of, or derived from, plants that have a history of safe use as sources of food, and that have been modified by modern biotechnology to exhibit new or altered expression of traits.”106 Risk assessment for GM plants involves the examination of the GM plant in relation to its conventional counterpart that has a history of safe use, aiming to determine new or altered hazards relative to the conventional counterpart.107 Due to the relative inadequacy of traditional toxicological testing and risk assessment procedures for whole foods, a multi-disciplinary approach is applied, including the concept of substantial equivalence,108 to assess safety of GM plants.109 Risk assessments of food derived from GM plants consist of methods aimed at detecting unintended effects from genetic modification 106 Codex Alimentarius Commission, Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants, CAC/GL 45–2003 1 (2003), available at http://www.codexalimentarius.net/download/standards/10021/ CXG_045e.pdf (last visited Jan. 1, 2007) [hereinafter Food Safety Assessment GM Plants Guidelines]. 107 “4. This approach is based on the principle that the safety of foods derived from new plant varieties, including recombinant-DNA plants, is assesses relative to the conventional counterpart having a history of safe use, taking into account both intended and unintended effects. Rather than trying to identify every hazard associated with a particular food, the intention is to identify new or altered hazards relative to the conventional counterpart.” Id.

“13. The concept of substantial equivalence is a key step in the safety assessment process. However, it is not a safety assessment in itself; rather it represents the starting point which is used to structure the safety assessment of a new food relative to its conventional counterpart. This concept is used to identify similarities and differences between the new food and its conventional counterpart. It aids in identification of potential safety and nutritional issues and is considered the most appropriate strategy to date for safety assessment of foods derived from recombinant-DNA plants. The safety assessment carried out in this way does not imply absolute safety of the new product; rather, it focuses on assessing the safety of any identified differences so that the safety of the new product can be considered relative to its conventional counterpart.” Id. at 2. 108

“12. Due to the difficulties of applying traditional toxicological testing and risk assessment procedures to whole foods, a more focused approach is required for the safety assessment of foods derived from food plants, including recombinant-DNA plants. Thus has been addressed by the development of a multidisciplinary approach for assessing safety which takes into account both intended and unintended changes that may occur in the plant or in the foods derived from it, using the concept of substantial equivalence.” Id. 109

GMOs, Food Safety, and Foodborne Disease • 71

and evaluating their possible relevance and impact on food safety.110 A variety of data and information, gleaned from numerous tests and procedures, is used to provide assurances that food developed from GM plants will not have an adverse effect on human health.111 Each safety assessment aims to define the GMO so that risk managers can determine the necessity and appropriateness of possible risk management measures by using the best available scientific knowledge.112 These safety assessments must include descriptions of the GM plant, the host plant, and its use as a food, the donor organism(s), the genetic modification(s), and a compilation of safety information addressing expressed substances other than nucleic acid substances, compositional analyses of key components, metabolite evaluation, food processing, and nutritional modification.113

“17. The safety assessment of foods derived from recombinant-DNA plants involves methods to identify and detect such unintended effects and procedures to evaluate their biological relevance and potential impact on food safety.” Id. 110

111 “A variety of data and information are necessary to assess unintended effects because no individual test can detect all possible unintended effects, or identify, with certainty, those relevant to human health. These data and information, when considered in total, provide assurance that the food is unlikely to have an adverse effect on human health. The assessment for unintended effects takes into account the agronomic/phenotypic characteristics of the plant that are typically observed by breeders in selecting new varieties for commercialization. These observations by breeders provide a first screen for plants that exhibit unintended traits. New varieties that pass this screen are subjected to safety assessment as described in Section 4 and 5.” Id. at 2–3. 112 “21. The goal of each safety assessment is to provide assurance in the light of the best available scientific knowledge, that the food does not cause harm when prepared, used and/or eaten according to its intended use. The expected endpoint of such an assessment will be a conclusion regarding whether the new food is as safe as the conventional counterpart taking into account dietary impact of any changes in nutritional content or value. In essence, therefore, the outcome of the safety assessment process is to define the product under the circumstances in such a way as to enable risk managers to determine whether any measures are needed and if so to make wellinformed and appropriate decisions.” Id. at 3.

“18. The safety assessment of a food derived from a recombinant-DNA plant follows a stepwise process of addressing relevant factors that include: A) Description of the recombinant-DNA plant; B) Description of the host plant and its use as food; C) Description of the donor organism(s); D) Description of the genetic modification(s); E) Characterization of the genetic modification(s); Safety assessment: a) expressed substances (non-nucleic acid substances); b) compositional analyses of key 113

72 • International Law, Agricultural Biotechnology, and Infectious Disease

Included in the Biotechnology Task Force report is a project document titled Food Safety Assessment of Foods Derived from Recombinant-DNA Plants Modified for Nutritional or Health Benefits (Nutritional and Health Benefits Assessment).114 The overall objective of this document is to provide guidance, as an annex to the Recombinant Plants Food Safety Assessment Guidelines, for additional nutritional and safety issues related to foods from nutritionally enhanced GM plants.115 Nutritional and safety considerations include bioavailability and physiological function of intended modifications, with special focus on staple crops of interest to developing countries.116 Codex has also developed guidelines for safety and nutritional aspects of food produced through GM microorganisms. The Guidelines for the Conduct of Food Safety Assessment of Foods Produced Using Recombinant-DNA Microorganisms (Microorganism Guidelines) address foods created using GM microorganisms.117 Food containing both viable and non-viable GM microorganisms falls under the scope of the Microorganism Guidelines.118 These guidelines contain aspects and procedures similar to the Recombinant Plants Food Safety Assessment Guidelines, such as assessing safety relative to conventional counterparts and examining intended and unintended effects GM microorganisms.119 Safety assessments for GM microorganisms also consist of elements similar to those involved in the assessment of GM plants

components; c) evaluation of metabolites; d) food processing; e) nutritional modification; and G) other considerations.” Id. 114

Biotechnology 5th Session Report, supra note 88, at 35–37.

115

Id. at 35.

116

Id.

117 The strains of microorganisms used to manufacture GM microorganisms either must have a history of safe use or their safety must be established. Codex Alimentarius Commission, Guideline for the Conduct of Food Safety Assessment of Foods Produced Using Recombinant-DNA Microorganisms, CAC/GL 46–2003 1 (2003), available at http://www.codexalimentarius.net/download/standards/10025/ CXG_046e.pdf (last visited Jan. 1, 2007) [hereinafter Food Safety Assessment GM Microorganisms Guidelines]. 118

Id.

119

Id. at 2, 4.

GMOs, Food Safety, and Foodborne Disease • 73

but also include aspects related specifically to GM microorganisms.120 Codex adds another layer of informative instruction by formulating information resources into standards, guidelines, and codes of practice that are used to facilitate regulations on GMOs, food safety, and foodborne disease. D.

ORGANIZATION FOR ECONOMIC COOPERATION AND DEVELOPMENT

In addition to the guidance provided by U.N.-based organizations, such as the WHO and FAO, as well as their joint standards work in Codex, other intergovernmental organizations are also tackling food safety issues at the global level. The Organization for Economic Cooperation and Development (OECD), a forum comprised of the governments of 30 market democracies, focuses on the economic, social, and governance challenges and opportunities presented by globalization.121 This forum provides a setting where governments can compare policy experiences, develop answers to common issues, coordinate both domestic and international policy, and identify good practices.122 The OECD also facilitates an environment where peer pressure acts as a catalyzing incentive towards improving policy and developing multilateral instruments, decisions, and

120 “22. The safety assessment of a food produced using a recombinant-DNA microorganism is based on determining the safety of using the microorganism, which follows a stepwise process of addressing relevant factors that include: A) Description of the recombinant-DNA microorganism; B) Description of the recipient microorganism and its use in food production; C) Description of the donor organism(s); D) Description of the genetic modification(s) including vector and construct; E) Characterization of the genetic modification(s); F) Safety assessment: a) expressed substances: assessment of potential toxicity and other traits relating to pathogenicity; b) compositional analyses of key components; c) evaluation of metabolites; d) effects of food processing; e) assessment of immunological effects; f) assessment of viability and residence of microorganisms in the human gastrointestinal tract; g) antibiotic resistance and gene transfer; and h) nutritional modification.” Id. at 4. 121 Membership is limited only by a commitment, by member states, to a market economy and a pluralistic democracy; non-members are invites to subscribe to all OECD agreements and treaties, with an aim to share viewpoints and expertise worldwide. Organization for Economic Co-operation and Development (OECD), The OECD: What is it?, at http://www.oecd.org/document/18/0,2340,en_2649_ 201185_2068050_1_1_1_1,00.html#what (last visited Jan. 1, 2007). 122

Id.

74 • International Law, Agricultural Biotechnology, and Infectious Disease

recommendations in areas requiring international consensus in a globalized economy.123 The primary objective of the OECD is to “foster prosperity and fight poverty through economic growth, financial stability, trade and investment, technology, innovation, entrepreneurship and development cooperation,” as well as incorporating environmental implications of social and economic development.124 Another goal of the OECD involves researching evolving social changes and patterns in trade, agriculture, the environment, technology, health, and many other areas relevant to globalization.125 International trade issues are also a significant focus of the work done by the OECD, with a specific focus on intellectual property rights, patenting, management of biological resources, and new issues stemming from the entry of GMOs entering the marketplace.126 OECD’s involvement in issues related to GMOs consists of three primary areas: human health, agriculture, and environmental and industrial applications, including bioremediation.127 A variety of subsections within OECD address GMOs, which streamline and harmonize GMO notification and registration procedures and information used in safety and risk assessments.128 The OECD also assesses the safety of these applications involving GMOs and GM microorganisms.129 Many of the OECD’s priorities for GMOs mirror those enumerated in the Biosafety Protocol and a strong cooperative relationship exists between OECD and the U.N. Environmental Program (UNEP).130 123

Id.

124

Id.

125

Id.

OECD, Modern Biotechnology and the OECD 1, 7 (1999), available at http://www.oecd.org/dataoecd/29/40/1890904.pdf [hereinafter OECD Modern Biotechnology]. 126

Bioremediation, which is the application of biotechnology to environmental protection has shown technical success and is being integrated into industrial applications. Id. at 6. 127

128

Id. at 5–6.

129

Id. at 6.

130

Id. at 5.

GMOs, Food Safety, and Foodborne Disease • 75

Three OECD Directorates, the Directorate for Science, Technology, and Industry,131 the Agriculture Directorate,132 and the Environment Directorate,133 focus on science, agricultural trade, technology, and GMO regulatory and labeling issues and are spearheaded by the Internal Coordination Group for Biotechnology (the Coordination Group).134 Science and technology policy efforts center mainly on providing support to member states, especially in areas such as public health, sustainable industrial development, and biological resource centers.135 Directorates and Working Groups allow for more specialized attention on the connections between GMOs and trade, safety and risk assessments, and regulatory harmonization. The Working Group on Harmonization of Regulatory Oversight (The Harmonization Working Group), within the Environment Directorate, promotes trade, fosters harmonization of regulations, and produces sciencebased consensus documents addressing environmental risk assessment of GMOs.136 Similar approaches to risk and safety assessment are required for harmonization to be possible; such assessments, based on previous OECD work, need to be based on the characteristics of the organism, the introduced trait, the receiving environment, the intended application, and the interactions between all of these factors.137 OECD collects scientific The Directorate for Science, Technology, and Industry addresses socio-economic concerns and policy issues related to science and technology. Id. at 6. 131

The Agriculture Directorate supports research and analytical work on GMO regulatory and labeling efforts. Id. at 7. 132

133 The Environment Directorate’s responsibilities include regulatory harmonization, with specific attention given to agriculture and trade issues. Id. at 6. 134

Id.

These biological resource centers include culture collections, databanks, and bioinformatics. Id. 135

These consensus documents examine three aspects of GMOs: the biological characteristics of the crop species, the introduced trait, and the potential impact on human health and the environment. The last factor requires the most work towards achieving harmonization, for the first two factors are generally the same from country to country. Id. at 7. 136

137 OECD, Preserving Biodiversity and Promoting Biosafety 1, 6 (2005), available at http://www.oecd.org/dataoecd/4/4/34932656.pdf [hereinafter OECD Biodiversity Biosafety].

76 • International Law, Agricultural Biotechnology, and Infectious Disease

evidence and information for environmental safety assessments but makes no judgment regarding the environmental safety of GMOs or the processes used to develop them.138 Consolidating environmental safety information on GMOs facilitates a more streamlined and cost-effective approach to risk assessment for regulatory authorities.139 In addition to fostering harmonization of risk and safety assessments and procedures, OECD establishes information exchange mechanisms and databases to support the sharing of information and experiences related to risk and safety assessment.140 Biosafety-Biotrack (BioTrack) consolidates information for the regulatory oversight of GMOs, focusing on environmental and food safety.141 BioTrack provides publicly available documents, an online database, and links to regulatory contact and related Web sites, working as a resource collection point, for both member and nonmember states, for food and environmental safety issues.142 BioTrack is one of the best information sources of regulatory developments, field trials, and commercial product approvals for OECD countries and has been linked with the Biosafety Protocol’s Biosafety Clearing-House.143 The OECD contributes another information source and helps direct international regulatory efforts for GMOs by providing access to a myriad of documents and guidance on environmental and food safety issues. E.

CONCLUSION

The WHO, FAO, Codex, and OECD provide a comprehensive collection of tools for the development of domestic, regional, and international legislation for food safety and foodborne disease. As GMOs are further integrated into global food and agricultural industries, perspectives con138

OECD Modern Biotechnology, supra note 126, at 7.

Harmonization of safety and risk assessment information leads to a reduction in duplicitous efforts and promotes mutual acceptance, understanding, efficiency, and information sharing. Id. at 7. 139

140

OECD Biodiversity Biosafety, supra note 137, at 6.

141 OECD, About Biosafety-BioTrack, at http://www.oecd.org/about/0,2337, en_2649_34385_1_1_1_1_37437,00.html (last visited Jan. 1, 2007). 142

Id.

143

OECD Biodiversity Biosafety, supra note 137, at 7.

GMOs, Food Safety, and Foodborne Disease • 77

necting the need for a safe food supply and the containment of foodborne disease with GMOs becomes increasingly crucial. The current international and domestic legislative scheme for food safety and foodborne disease is scattered and minimally connected, without a common theoretical foundation. GMOs are currently treated, at the international level, more as trade disputes rather than a public health concern. While GMOs may provide significant boons to trade and human health, food safety and foodborne disease issues consist of more than impacts on international trade. The risks associated with the use of GMOs could provide footholds for new or re-emerging pathogens and other threats to the environment and human health. Diseases, such as BSE and avian influenza, which are spread through contact with domesticated or agricultural animals, illustrate why food safety, foodborne diseases, and GMOs must be linked in areas beyond trade. These four intergovernmental organizations are beginning to weave food safety, foodborne disease, infectious disease, and GMOs together but a more integrated approach is needed to successfully regulate these areas.

CHAPTER 5

INTERNATIONAL TRADE LEGISLATION A.

GENERAL AGREEMENT ON TARIFFS AND TRADE

Potential international trade impacts from GMOs garner considerable attention in discussions on possible domestic and regulatory efforts for these products. The recent outbreaks of SARS, Avian Influenza, and BSE are also bringing infectious disease concerns to the forefront of international trade policy. Regulation in both areas affects international trade significantly, since trade is the main mechanism for the spread of infectious disease and GMOs throughout the global community. The World Trade Organization (WTO) currently addresses trade issues at the international level, including those involving public health and the integration of GMOs into global commerce. The Agreement Establishing the World Trade Organization creates a single institutional framework encompassing the General Agreement on Tariffs and Trade 1994 (GATT),1 all concluded agreements and arrangements, and the complete results of the Uruguay Round.2 The Uruguay Round negotiations, which took place from 1986 to 1994, transformed the GATT into the World Trade Organization. Twenty agreements, such as the Agreement on Sanitary and Phytosanitary Measures and the Agreement on Technical Barriers to Trade, were also signed into effect after the Uruguay Round in 1994. The WTO provides a rule-based forum for member states to discuss trade concerns, bolstered by negotiated mechanisms and rules that permit trade liberalization and the possible development of trade barriers aimed at protecting consumers or preventing the spread of disease.3 The overall goal of the WTO is to allow General Agreement on Tariffs and Trade, Oct. 30, 1947, 61 Stat. A-11, 55 U.N.T.S. 194. The GATT was incorporated into the Marrakesh Agreement establishing the World Trade Organization and is still the primary treaty for trade in goods. Marrakesh Agreement Establishing the World Trade Organization, Apr. 15, 1994, 33 I.L.M. 1144 [hereinafter GATT]. 1

2 Agreement Establishing the Multilateral Trade Organization (World Trade Organization), Dec. 15, 1993, 33 I.L.M. 13 (1994) [hereinafter The WTO Agreement]. 3 The World Trade Organization (WTO, Understanding the WTO 1, 6 (2005), available at http://www.wto.org/english/thewto_e/whatis_e/tif_e/understanding_e.pdf.

79

80 • International Law, Agricultural Biotechnology, and Infectious Disease

the free flow of trade, with the fewest undesirable side effects, which is achieved by removing obstacles, as well as providing rules that are transparent and predictable.4 The foundational pillars of the GATT are trade without discrimination, national treatment, promoting fair competition and predictability, and encouraging development and economic reform.5 Lowering trade barriers, such as customs duties, import bans, or quotas restricting quantities selectively, is a primary objective of the GATT, which is facilitated by applying concepts such as most-favored nation (MFN) treatment and national treatment.6 Member states cannot, under the WTO Agreements, discriminate between trading partners; this principle is known as most-favored nation (MFN) treatment, enumerated in Article I of the GATT.7 MFN treatment requires that each time a member state lowers trade barriers or opens a market, it must do so for equivalent goods and services from all of its trading partners.8 There are some permitted exceptions, available under strict conditions, to MFN treatment, such as developing a free trade agreement between member states discriminating against goods from outside the group, giving developing countries special access to markets, or raising trade barriers against products being traded unfairly from specific member states.9 National treatment is another concept aimed at preventing discrimination between WTO member states and builds on the MFN provisions in Article 1 of the GATT.10 Both imported and locally produced goods, services, trademarks, and copyrights should be treated equally once these products, services, or intellectual property items have entered the market.11 Other rules focus on securing fair conditions of trade by developing dumping and subsidies provisions.12 Article XX of the GATT is the 4

Id. at 10.

5

Id.

6

Id.

7

Id.

8

Id. at 10–11.

9

Id. at 11.

10

Id.

11

Id.

12

Id. at 12.

International Trade Legislation • 81

most relevant article to specific trade issues presented by GMOs and infectious disease control and provides generalized exceptions to all of the trade obligations under the GATT, such as MFN treatment, national treatment, tariffs, and non-tariff barriers.13 Article XX permits the development and implementation of measures by WTO member states providing exceptions to trade obligations so far as these measures are not applied in an unjustifiably or arbitrarily discriminatory manner or constitute a disguised restriction on international trade.14

RAJ BHALA, INTERNATIONAL TRADE LAW: THEORY AND PRACTICE 1608 (2d ed. 2000). 13

“Subject to the requirement that such measures are not applied in a manner which would constitute a means of arbitrary or unjustifiable discrimination between countries where the same conditions prevail, or a disguised restriction on international trade, nothing in this Agreement shall be construed to prevent the adoption or enforcement by any contracting party of measures: a) necessary to protect public morals; (b) necessary to protect human, animal or plant life or health; (c) relating to the importation or exportation of gold or silver; (d) necessary to secure compliance with laws or regulations which are not inconsistent with the provisions of this Agreement, including those relating to customs enforcement, the enforcement of monopolies operated under paragraph 4 of Article II and Article XVII, the protection of patents, trade marks and copyrights, and the prevention of deceptive practices; (e) relating to the products of prison labor; (f) imposed for the protection of national treasures of artistic, historic or archaeological value; (g) relating to the conservation of exhaustible natural resources if such measures are made effective in conjunction with restrictions on domestic production and consumption; (h) undertaken in pursuance of obligations under any intergovernmental commodity agreement which conforms to criteria submitted to the contracting parties and not disapproved by them or which is itself so submitted and not so disapproved; (i) involving restrictions on exports of domestic materials necessary to ensure essential quantities of such materials to a domestic processing industry during periods when the domestic price of such materials is held below the world price as part of a government stabilization plan; provided that such restrictions shall not operate to increase the exports of or the protection afforded to such domestic industry, and shall not depart from the provisions of this Agreement relating to non-discrimination; (j) essential to the acquisition or distribution of products in general or local short supply; provided that any such measures shall be consistent with the principle that all contracting parties are entitled to an equitable share of the international supply of such products, and that any such measures, which are consistent with other provisions of this Agreement shall be discontinued as soon as the conditions giving rise to them have ceased to exist.” GATT, supra note 1, at art. XX. 14

82 • International Law, Agricultural Biotechnology, and Infectious Disease

The nature of Article XX requires the establishment of an equilibrium between rights and duties; member states must strike a balance between “the right of a member to invoke an exception under Article XX and the duty of that same member to respect the treaty rights of other members.”15 The objective is to ensure that competing rights under Article XX and other substantive provisions of the GATT will not cancel each other out and result in the distortion, nullification, or impairment of the balance struck by member states in these agreements.16 But this equilibrium is not static and constantly evolves based on the kind of measures and the factual nature of each specific case.17 Article XX provides a list of measures encompassing a variety of issues allowed as exceptions to the primary requirements of the GATT.18 This list of measures in Article XX represents appropriate exceptions to substantive obligations of the GATT, for “domestic policies embodied in such measures have been recognized as important and legitimate in character.”19 The Appellate Body of the WTO held that measures requiring exporting member states to comply with certain policies, covered by one or more of the exceptions present in Article XX, do not make measures “incapable of justification under Article XX.”20 Interpreting Article XX to require otherwise would render the Article XX exceptions useless, for these exceptions permit member states to develop measures that may restrict trade in order to safeguard certain domestic concerns, such as public morals, conservation of exhaustible natural resources, and human health or the environment. The most relevant measure in Article XX for issues presented by GMOs and infectious disease is Article XX(b), which permits member states to develop measures restricting trade if such measures are “necessary to protect human, animal, or plant life or health.”21 15 Appellate Body Report, United States—Import Prohibitions of Certain Shrimp and Shrimp Products, ¶¶ 156, 159, WT/DS58/AB/R (Oct. 12, 1998) [hereinafter USShrimp Products]. 16

Id.

17

Id.

18

See supra note 14 and accompanying text.

19

US-Shrimp Products, supra note 15, at ¶ 121.

20

Id.

21

See supra note 14 and accompanying text.

International Trade Legislation • 83

This right, enumerated in Article XX(b), to exclude products that pose a threat to a member state’s health is balanced by the overall requirement in Article XX that this right not be misapplied for discriminatory or protectionist purposes.22 These measures can be at whatever level the member state deems appropriate, so long as they are applied equally to all products and are the least restrictive to international trade; this grants the member state a significant level of autonomy in developing these measures.23 The only limitation on this autonomy is the requirement to respect the obligations set forth in the GATT and other agreements.24 This prerogative built into Article XX does not only apply to safeguarding human, animal, or plant life or health but to all measures produced under the exceptions in Article XX(b).25 The broad scope and applicability of Article XX(b) allows for flexibility but gives little guidance as to the appropriate content of these measures. The Panel, in United States—Standards for Reformulated and Conventional Gasoline (US-Gasoline), sets forth a three-pronged test for Article XX(b), requiring that the member state invoking the Article XX(b) exception has to show that the policy objective in the provision falls “within the range of policies designed to protect human, animal, or plant life or health, that the inconsistent measures for which the exception was being invoked were necessary to fulfill the policy objective, and that the measures were applied in conformity with the requirements of the introductory clause of Article XX.”26 The Panel also addressed, in US-Gasoline, what aspects of measures falling under Article XX(b) must be justified as “necessary.”27 The Panel stated that the necessity of the policy goal was not the objective of examination but whether the means used to achieve the policy goal

22

See US-Shrimp Products, supra note 15, at 121.

Appellate Body Report, United States—Standards for Reformulated and Conventional Gasoline, ¶¶ 30, 31, WT/DS4/AB/R (Apr. 22, 1996) [hereinafter USGasoline Appellate Body Report]. 23

24

Id.

25

Id.

26 Panel Report, United States—Standards for Reformulated and Conventional Gasoline, ¶ 6.20, WT/DS2/R (Jan. 29, 1996) [hereinafter US-Gasoline Panel Report]. 27

US-Gasoline Appellate Body Report, supra note 23, at ¶ 16.

84 • International Law, Agricultural Biotechnology, and Infectious Disease

were necessary.28 While this test provides more direction for determining the soundness of measures developed under Article XX(b) will be evaluated, the scope of this test is still very broad and permits a wide range of potential regulatory possibilities for member states. Article XX(b) may provide a spread of regulatory options, but any measures developed under Article XX(b) still must be substantiated. Determination of the validity of these measures requires certain evidentiary submissions to prove the applicable and tailored nature of these measures to protecting human, animal, and plant life or health. The Panel, when evaluating scientific data and risk assessments presented for Article XX(b) measures, enjoys a certain “margin of discretion” when determining the value and weight attributed to relevant evidence.29 This “margin of discretion” permits the Panel to accord more weight to certain evidentiary elements than others, whose value will not be reassessed by the Appellate Body.30 The expansive nature of the three-pronged Article XX(b) test and the discretionary nature of evidence examination does not contribute much to the clarification regarding the appropriate content of these measures. Numerous areas, such as GMOs and infectious disease, require more specificity than provided in the GATT provisions, to ensure the efficacy and appropriateness of regulatory efforts under Article XX(b). The need for more direction under Article XX(b) catalyzed the development of the Technical Barriers to Trade Agreement (TBT Agreement; see Section B) and the Sanitary and Phytosanitary Agreement (SPS Agreement; see Section C). B.

TECHNICAL BARRIERS TO TRADE AGREEMENT

The WTO Agreement on Technical Barriers to Trade (the TBT Agreement) establishes rules and procedures for the development, adoption, and application of voluntary and mandatory product standards and procedures.31 These rules determine whether a standard or procedure, otherwise 28

Id.

29 Appellate Body Report, European Communities—Measures Affecting Asbestos and Asbestos-Containing Products, ¶ 161, WT/DS135/AB/R (Mar. 12, 2001) [hereinafter EC-Asbestos Appellate Body Report]. 30

Id.

31

Agreement on Technical Barriers to Trade, Apr. 15, 1994, Marrakesh Agree-

International Trade Legislation • 85

legitimate, is actually a protectionist measure aimed at safeguarding domestic industry.32 The provisions of the TBT Agreement attempt to strike a balance between the need for action by member states and guarding against the protectionist application of product standards.33 In addition to providing guidance for the implementation and use of product standards, the TBT Agreement also facilitates the harmonization of product standards and procedures among member states.34 Harmonization efforts focus on maintaining the level of safety and protection set forth in the relevant product procedures and standards of human, animal, or plant life or health, the environment, or consumers.35 The TBT Agreement, as stated in Article 1.3, applies to all products, including industrial and agricultural products, but does not include sanitary and phytosanitary measures and government procurement procedures, as stated in Articles 1.4 and 1.5.36 Three types of measures fall under the scope of the TBT Agreement—standards, technical regulations, and conformity assessment procedures.37 The TBT Agreement also generally distinguishes between central government measures, local government measures, and non-governmental measures and sets out different rules for all three types of measures.38 The TBT Agreement does not prescribe specific standards, ment Establishing the World Trade Organization, Annex 1A Multilateral Agreements on Trade in Goods, 33 I.L.M 1125 (1994) [hereinafter TBT Agreement]. 32

BHALA, supra note 13, at 570.

33

Id.

34

Id.

35

Id.

36 “1.3) All products, including industrial and agricultural products, shall be subject to the provisions of this Agreement.” TBT Agreement, supra note 31, at art. 1.3. “1.4) Purchasing specifications prepared by governmental bodies for production or consumption requirements of governmental bodies are not subject to the provisions of this Agreement but are addressed in the Agreement on Government Procurement, according to its coverage.” Id. at art. 1.4. “1.5) The provisions of this Agreement do not apply to sanitary and phytosanitary measures as defined in Annex A of the Agreement on the Application of Sanitary and Phytosanitary Measures.” Id. at art. 1.5. 37

TBT Agreement, supra note 31.

“6) Central government body: Central government, its ministries and departments or any body subject to the control of the central government in respect of the activity in question.” Id. at Annex 1(6); “7) Local government body: Government 38

86 • International Law, Agricultural Biotechnology, and Infectious Disease

technical regulations, or conformity assessment procedures; it provides general procedural and other requirements to be observed when adopting and maintaining these kinds of measures.39 Product standards developed, in accordance with the TBT Agreement, may be either voluntary or mandatory; voluntary standards are measures that address fluctuating issues, such as market demands, whereas mandatory measures are generally those required by domestic governments, like nutritional labeling requirements.40 Annex I of the TBT Agreement defines standards as documents, approved by a recognized body, which set forth “rules, guidelines, or characteristics for products or related processes and production methods.”41 Standards may also include documents that focus exclusively on “terminology, symbols, packaging, marking, or labeling requirements as they apply to a products, process, or production method.”42 These documents are then integrated into voluntary product standards, which may be established by either a government or private body.43 Article 2 delineates the rules regarding preparation, adoption, and application of technical regulations by central government bodies.44 Technical regulations are mandatory product standards developed at the

other than a central government (e.g. states, provinces, Lander, cantons, municipalities, etc.), its ministries or departments or any body subject to the control of such a government in respect of the activity in question.” Id. at Annex 1(7); “8) Non-governmental body: Body other than a central government body or a local government body, including a non-government body which has legal power to enforce a technical regulation.” Id. at Annex 1(8). 39

BHALA, supra note 13, at 570.

40

Id. at 571.

41 “Document approved by a recognized body, that provides, for common and repeated use, rules, guidelines or characteristics for products or related processes and production methods, with which compliance is not mandatory. It may also include or deal exclusively with terminology, symbols, packaging, marking or labeling requirements as they apply to a product, process or production method.” TBT Agreement, supra note 31, at Annex 1(2). 42

Id.

43

BHALA, supra note 13, at 572.

44

TBT Agreement, supra note 31, at art. 2.

International Trade Legislation • 87

central government level, for only governmental agencies have the authority to mandate product standards.45 The TBT Agreement defines technical regulations as documents that delineate product characteristics or their related processes and production methods.46 Like the documentation required for standards, technical regulations can also focus specifically on terminology, symbols, packaging, marking, or labeling requirements applicable to a product, process or production method.47 The Appellate Body, in European Communities—Measures Affecting Asbestos and AsbestosContaining Products (EC-Asbestos), clarified the meaning of “technical regulation” and stated that a technical regulation must “regulate the characteristics of products in a binding or compulsory fashion.”48 Product characteristics examples in the definition of “technical regulation,” presented in Annex I of the TBT Agreement, illustrate that “product characteristics” include both features and qualities intrinsic to the product, as well as related characteristics, “such as the means of identification, the presentation and the appearance of a product.”49 Product characteristics may be established in a positive or negative manner as either possessing or not possessing certain characteristics.50 Technical regulations also need to identify the products they cover but do not need to specifically enumerate products in the regulations.51 Not 45

BHALA, supra note 13, at 572.

“Document which lays down product characteristics or their related processes and production methods, including the applicable administrative provisions, with which compliance is mandatory. It may also include or deal exclusively with terminology, symbols, packaging, marking or labeling requirements as they apply to a product, process or production method.” TBT Agreement, supra note 31, at Annex 1(1). 46

47

Id.

48 Documents, for technical regulations, must stipulate or provide product characteristics, which include “any objectively definable features, qualities, attributes or other distinguishing mark of a product.” These kinds of characteristics may refer to “a product’s composition, size, shape, color, texture, hardness, tensile strength, flammability, conductivity, density, or viscosity.” EC-Asbestos Appellate Body Report, supra note 29, at ¶¶ 67–69. 49

Id.

In both cases, the legal effect is the same by requiring that documents set out binding product characteristics affirmatively or by negative implication. Id. 50

51

EC-Asbestos Appellate Body Report, supra note 29, at ¶ 70.

88 • International Law, Agricultural Biotechnology, and Infectious Disease

expressly naming products in technical regulations also permits a more flexible application of these regulations, by allowing the outlined characteristics to determine the scope of the technical regulations rather than a pre-determined list of included products.52 The Appellate Body, in European Communities—Trade Description of Sardines (EC-Sardines), sets forth three required criteria that a document must meet to fall within the meaning of “technical regulation.”53 First, documents “must apply to an identifiable product or groups of products,” but these products or groups of products do not need to be specifically identified in the document.54 Second, documents have to identify at least one product characteristic, which may be intrinsic, related to the product, or applied in either a positive or negative form.55 Third, mandatory compliance with the product characteristics is required.56 Technical regulations must not be more trade restrictive than necessary to fulfill a legitimate objective while taking into account risks attached to non-fulfillment.57 Article 2.2 provides a list as to what constitutes a “legitimate objective,” but this list is open-ended, not exhaustive, and includes protection of human health or safety, animal or plant life or health, or the environment.58 When examining risks for non-fulfillment of a legitimate 52

Id.

53 Appellate Body Report, European Communities—Trade Description of Sardines, ¶ 176, WT/DS231/AB/R (Sept. 26, 2002) [hereinafter EC-Sardines Appellate Body Report]. 54

Id.

55

Id.

56

Id.

57 “2.2 Members shall ensure that technical regulations are not prepared, adopted or applied with a view to or with the effect of creating unnecessary obstacles to international trade. For this purpose, technical regulations shall not be more trade-restrictive than necessary to fulfill a legitimate objective, taking account of the risks non-fulfillment would create. Such legitimate objective are: inter alia: national security requirements; the prevention of deceptive practices; protection of human health or safety, animal or plant life or health, or the environment. In assessing such risks, relevant elements of consideration are, inter alia: available scientific and technical information, related processing technology or intended end-uses of products.” TBT Agreement, supra note 31, at art. 2.2. 58

Id.

International Trade Legislation • 89

objective, member states examine elements, such as available scientific and technical information, related processing technology, or the intended end uses of a product.59 For technical regulations to be found more trade restrictive than necessary, member states need to illustrate that there is another measure reasonably available that fulfills the member state’s legitimate objectives and is significantly less restrictive to international trade.60 Article 2.3 does not permit the maintenance of technical regulations when the circumstances or objectives behind the original regulations no longer exist or have changed so that a less trade-restrictive option is available.61 This provision requires the periodic review of technical regulations, similar to Article 5.7 of the SPS Agreement (see Section C), which mandates the reexamination of provisional sanitary and phytosanitary measures due to changing circumstances or new scientific evidence.62 Article 2.4 requires that member states utilize relevant international standards as a basis for developing technical regulations, except when such standards would be ineffective or inappropriate for a member state’s legitimate objectives.63 The WTO adjudicative bodies expounded on the meanings of “basis” and “ineffective” in Article 2.4, providing further guidance for the implementation of this article. “Basis” is defined, for technical regulations, as “the principle constituent or fundamental principle for the purpose of enacting the technical regulation.”64 The Appellate Body further developed the meaning of “basis” by stating that “there must be a very strong and very close relationship between two things in order

59

Id.

60

BHALA, supra note 13, at 573.

61

Id. at 574.

62

Id.

“2.4 Where technical regulations are required and relevant international standards exist or their completion is imminent, Members shall use them, or the relevant parts of them, as a basis for their technical regulations except when such international standards or relevant parts would be an ineffective or inappropriate means for the fulfillment of the legitimate objectives pursued, for instance because of fundamental climatic or geographical factors or fundamental technological problems.” TBT Agreement, supra note 31, at art. 2.4. 63

64

EC-Sardines Appellate Body Report, supra note 53, at ¶¶ 240–245.

90 • International Law, Agricultural Biotechnology, and Infectious Disease

to be able to say that one is the ‘the basis for’ the other.”65 The European Commission argued, in EC-Sardines, that a rational relationship between an international standard and a technical regulation was adequate to illustrate that the technical regulation was based on the international standard.66 The Appellate Body disagreed and did not find it necessary to define the required foundational association between international standards and technical regulations; their primary objective was to determine if the measure fulfills this obligation of a connective association.67 An international standard cannot be a basis for a technical regulation if that standard contradicts the technical regulation.68 In the context of Article 2.4, “ineffective” refers to means that do not possess the “function of accomplishing the legitimate objective,” whereas inappropriate means is one not “specially suitable for the fulfillment of the legitimate objective.”69 A measure can be inappropriate but still effective in fulfilling its objective; effectiveness “bears upon the results of the means employed, whereas the question of appropriateness relates more to the nature of the means employed.”70 Legitimate objectives, as stated in Article 2.4, include those explicitly mentioned in Article 2.2, as well as other objectives outside the enumerated list, which will require an “examination and a determination on the legitimacy of the objectives of the measures.”71 Member states, when developing or applying technical regulations that may have significant impacts on the international trade of other member states, must provide information on the regulations, as stipulated in paragraphs 2 through 4 of Article 2.72 Article 2.5 also provides a rebuttable presumption for techni65

Id. at ¶ 245.

66

Id. at ¶¶ 257–248.

67

Id.

68

Id.

Panel Report, European Communities—Trade Description of Sardines, ¶ 7.116, WT/DS231/R (May 29, 2002) [hereinafter EC-Sardines Panel Report]. 69

70

Id.

71

Id. at ¶ 7.122.

“2.5 A Member preparing, adopting or applying a technical regulation which may have a significant effect on trade of other Members shall, upon the request of 72

International Trade Legislation • 91

cal regulations drafted in accordance with relevant international standards and addressing one of the legitimate objectives stated in Article 2.2; technical regulations developed in this manner are presumed “not to create an unnecessary obstacle to international trade.”73 Article 2.6 promotes harmonization of technical standards by encouraging member states to participate in the development of international standards by international standardizing bodies for products subject to technical regulations.74 Under Article 2.7, member states must give positive consideration “to accepting as equivalent technical regulations” of other member states, even if these regulations differ.75 Member states, in order to consider technical regulations equivalent, need to be satisfied that other member states’ technical regulations “adequately fulfill the objectives of their own regulations.”76 Both Article 2.6 and 2.7 streamline technical regulations between member states by fostering participation in international standard setting and horizontal acceptance of technical standards from other member states. As more member states contribute to the development of international standards, it is more likely that the resulting international standards will represent a wider consensus for technical regulations, which will facilitate the mutual acceptance of equivalent technical regulations between member states. another Member, explain the justification for that technical regulation in terms of the provisions of paragraphs 2 to 4. Whenever a technical regulation is prepared, adopted or applied for one of the legitimate objectives explicitly mentioned in paragraph 2, and is in accordance with relevant international standards, it shall be rebuttably presumed not to create an unnecessary obstacle to international trade.” TBT Agreement, supra note 31, at art. 2.5. 73

Id.

74 “2.6 With a view to harmonizing technical regulations on as wide a basis as possible, Members shall play a full part, within the limits of their resources, in the preparation by appropriate international standardizing bodies of international standards for products for which they either have adopted, or expect to adopt, technical regulations.” Id. at art. 2.6.

“2.7 Members shall give positive consideration to accepting as equivalent technical regulations of other Members, even if these regulations differ from their own, provided they are satisfied that these regulations adequately fulfill the objectives of their own regulations.” Id. at art. 2.7. 75

76

Id.

92 • International Law, Agricultural Biotechnology, and Infectious Disease

Harmonization of technical regulations also requires a similar starting point for content development of these measures. Article 2.8 mandates that all technical regulations need to be based on product requirements for performance rather than design or descriptive characteristics. 77 Descriptive characteristics or design can change easily, whereas performance-dependent product requirements are not altered unless such changes increase product performance. Product requirements for performance can be developed more readily at the international level, for they are likely to be more uniform than design or descriptive characteristics. Even though Article 2.6, 2.7, and 2.8 encourage harmonization of technical standards, these articles do not require it. Member states are permitted to draft technical regulations that are not based on international standards. Article 2.9 sets forth procedural requirements for technical regulations that are not based on relevant international standards and may have a significant impact on the trade of other member states.78 Article 2.10 adds other substantive procedural safeguards for situations involving “urgent problems of safety, health, environmental protection or national security.”79 Article 3 provides direction for the application of technical reg77 “2.8 Wherever appropriate, Members shall specify technical regulations based on product requirements in terms of performance rather than design or descriptive characteristics.” Id. at art. 2.8. 78 “2.9 Whenever a relevant international standard does not exist or the technical content of a proposed technical regulation is not in accordance with the technical content of relevant international standards, and if the technical regulation may have a significant effect on trade of other Members, Members shall: 2.9.1 publish a notice in a publication at an early appropriate stage, in such a manner as to enable interested parties in other Members to become acquainted with it, that they propose to introduce a particular technical regulation; 2.9.2 notify other Members through the Secretariat of the products to be covered by the proposed technical regulation, together with a brief indication of its objective and rationale. Such notifications shall take place at an early appropriate stage, when amendments can still be introduced and comments taken into account; 2.9.3 upon request, provide to other Members particulars or copies of the proposed technical regulation and, whenever possible, identify the parts which in substances deviate from relevant international standards; 2.9.4 without discrimination, allow reasonable time for other Members to make comments in writing, discuss these comments upon request, and take these written comments and the results of these discussions into account.” Id. at art. 2.9. 79

“Subject to the provisions in the lead-in to paragraph 9, where urgent problems

International Trade Legislation • 93

ulations by local government bodies and non-governmental bodies.80 These guidelines require that member states ensure that the technical regulations of local governments and non-governmental bodies comply with the provisions set forth in Article 2.81 Member states also cannot develop measures that allow or encourage local government and non-governmental bodies to act inconsistently with Article 2.82 Articles 5 and 6 of the TBT Agreement expand provisions for conformity assessment procedures and central government recognition of conformity assessment procedures implemented in other WTO member states.83 Conformity assessment procedures cannot be more favorable to domestic suppliers of like products than that accorded to suppliers from other member states and must not develop or implement conformity assessment procedures that create unnecessary obstacles to international trade.84 Article 5.2 delineates guidelines for conformity assessment proof safety, health, environmental protection or national security arise or threaten to arise for a Member, that Member may omit such of the steps enumerated in paragraph 9 as it finds necessary, provided that the Member, upon adoption of a technical regulation, shall: 2.10.1 notify immediately other Members through the Secretariat of the particular technical regulation and the products covered, with a brief indication of the objective and the rationale of the technical regulation, including the nature of the urgent problems; 2.10.2 upon request, provide other Members with copies of the technical regulation; 2.10.3 without discrimination, allow other Members to present their comments in writing, discuss these comments upon request, and take these written comments and the results of these discussions into account.” Id. at art. 2.10. 80

Id. at art. 3.

81

Id. at art. 3.1.

82 “3.1 Members shall take such reasonable measures as may be available to them to ensure compliance by such bodies with the provisions of Article 2, with the exception of the obligation to notify as referred to in paragraphs 9.2 and 10.1 of Article 2.” Id. at art. 3.4. 83

Id. at arts. 5, 6.

“Members shall ensure that, in cases where a positive assurance of conformity with technical regulations or standards is required, their central government bodies apply the following provisions to products originating in the territories of other Members: 5.1.1 conformity assessment procedures are prepared, adopted and applied so as to grant access for suppliers of like products originating in the territories of other Members under conditions no less favorable than those accorded to suppliers of like products of national origin or originating in any other country, in a comparable situa84

94 • International Law, Agricultural Biotechnology, and Infectious Disease

cedures, guaranteeing that these measures do not present unnecessary obstacles to international trade or discriminates against imported products.85 Member states also need to ensure that their central government tion; access entails suppliers’ right to an assessment of conformity under the rules of the procedure, including, when foreseen by this procedure, the possibility to have conformity assessment activities undertaken at the site of facilities and to receive the mark of the system; 5.1.2 conformity assessment procedures are not prepared, adopted or applied with a view to or with the effect of creating unnecessary obstacles to international trade. This means, inter alia, that conformity assessment procedures shall not be more strict or be applied more strictly than is necessary to give the importing Member adequate confidence that products conform with the applicable technical regulations or standards, taking account of the risks non-conformity would create.” Id. at art. 5.1. “5.2 When implementing the provisions of paragraph 1, Members shall ensure that: 5.2.1 conformity assessment procedures are undertaken and completed as expeditiously as possible and in a no less favorable order for products originated in the territories of other Members than for like domestic products; 5.2.2 that standard processing period of each conformity assessment procedure is published or that the anticipated processing period is communicated to the applicant upon request; when receiving an application, the competent body promptly examines the completeness of the documentation and informs the applicant in a precise and complete manner of all deficiencies; the competent body transmits as soon as possible the results of the assessment in a precise and complete manner to the applicant so that corrective action may be taken if necessary; even when the application has deficiencies, the competent body proceeds as far as practicable with the conformity assessment if the applicant so requests; and that, upon request, the applicant is informed of the stage of the procedure with any delay being explained; 5.2.3 information requirements are limited to what is necessary to assess conformity and determine fees; 5.2.4 the confidentiality of information about products originating in the territories of other Members arising from or supplied in connection with such conformity assessment procedures is respected in the same way as for domestic products and in such a manner that legitimate commercial interests are protected; 5.2.5 any fees imposed for assessing the conformity of products originating in the territories of other Members are equitable in relation to any fees chargeable for assessing the conformity of like products of national origin or originating in any other country, taking into account communication, transportation and other costs arising from differences between location of facilities of the applicant and the conformity assessment body; 5.2.6 the sitting of facilities used in conformity assessment and the selection of samples are not such as to cause unnecessary inconvenience to applicants or their agents; 5.2.7 whenever specifications of a product are changed subsequent to the determination of its conformity to the applicable technical regulations or standards, the conformity assessment procedure for the modified product is limited to what is necessary to determine whether ade85

International Trade Legislation • 95

bodies use guidelines and recommendations from international standardizing bodies as the basis for conformity assessment procedures.86 Guidelines and recommendations from international standardizing bodies are not required as a foundation for conformity assessment procedures if they are inappropriate for reasons, such as national security requirements, the prevention of deceptive practices, protection of human health or safety, animal or plant life or health, or the environment, and fundamental technological and infrastructural problems.87 Once conformity assessment procedures are developed, member states must accept the procedures from other member states, even when these procedures differ.88 Even though Article 6 requires acceptance of conformity assessment procedures between member states, domestic governments must be satisfied that procedures from other member states provide a level of conformity equivalent to that present in member states’ own procedures.89 Article 6 also promotes mutual recognition of conformity quate confidence exists that the product still meets the technical regulations or standards concerned; 5.2.8 a procedure exists to review complaints concerning the operation of a conformity assessment procedure and to take corrective action when a compliant is justified.” Id. at art. 5.2. “In cases where a positive assurance is required that products conform with technical regulations or standards, and relevant guides or recommendations issued by international standardizing bodies exist or their completion is imminent, Members shall ensure that central government bodies use them, or the relevant parts of them, as a basis for their conformity assessment procedures, except where, as duly explained upon request, such guides or recommendations or relevant parts are inappropriate for the Members concerned, for, inter alia, such reasons as: national security requirements, the prevention of deceptive practices; protection of human health or safety, animal or plant life or health, or the environment; fundamental climatic or other geographical factors; fundamental technological or infrastructural problems.” Id. at art. 5.4. 86

87

Id.

88

Id. at art. 6.

“With respect to their central government bodies: 6.1 Without prejudice to the provisions of paragraphs 3 and 4, members shall ensure, whenever possible, that results of conformity assessment procedures in other Members are accepted, even when those procedures differ from their own, provided they are satisfied that those procedures offer an assurance of conformity with applicable technical regulations or standards equivalent to their own procedures. It is recognized that prior consultations 89

96 • International Law, Agricultural Biotechnology, and Infectious Disease

assessment procedures results, as well as direct participation of member states’ conformity assessment bodies in the development of these procedures.90 Articles 7 and 8 set out procedures for assessment of conformity for both local government and non-governmental bodies, pursuant to the requirements enumerated in Articles 5 and 6.91 Article 9 guides the formay be necessary in order to arrive at a mutually satisfactory understanding regarding, in particular: 6.1.1 adequate and enduring technical competence of the relevant conformity assessment bodies in the exporting Member, so that confidence in the continued reliability of their conformity assessment results can exist; in this regard, verified compliance, for instance through accreditation, with relevant guides or recommendations issued by international standardizing bodies shall be taken into account as an indication of adequate technical competence; 6.1.2 limitation of the acceptance of conformity assessment results to those produced by designated bodies in the exporting Member.” Id. at art. 6.1. 90 “6.3 Members are encouraged, at the request of other Members, to be willing to enter into negotiations for the conclusion of agreements for the mutual recognition of results of each other’s conformity assessment procedures. Members may require that such agreements fulfill the criteria of paragraph 1 and give mutual satisfaction regarding their potential for facilitating trade in the products concerned. 6.4 Members are encouraged to permit participation of conformity assessment bodies located in their territories of other Members in their conformity assessment procedures under conditions no less favorable that those accorded to bodied located within their territory or the territory of any other country.” Id. at arts. 6.3, 6.4.

“With respect to their local government bodies within their territories: 7.1 members shall take such reasonable measures as may be available to them to ensure compliance by such bodies with the provisions of Articles 5 and 6, with the exception of the obligation to notify as referred to in paragraphs 6.2 and 7.1 of Article 5. 7.2 Members shall ensure that the conformity assessment procedures of local governments on the level directly below that of the central government in members are notified in accordance with the provisions of paragraphs 6.2 and 7.1 of Article 5. Noting that notifications shall not be required for conformity assessment procedures the technical content of which is substantially the same as that of previously notified conformity assessment procedures of central government bodies of the Members concerned. 7.3 Members may require contact with other Members, including the notifications, provision of information, comments and discussions referred to in paragraphs 6 and 7 of Article 5, to take place through the central government. 7.4 Members shall not take measures which require or encourage local government bodies within their territories to act in a manner inconsistent with the provisions of Articles 5 and 6. 7.5 Members are fully responsible under this Agreement for the observance of all provisions of Articles 5 and 6. Members shall formulate and implement positive measures and mechanisms in support of the observance of the provisions of Articles 5 and 6 by 91

International Trade Legislation • 97

mation of international systems for conformity assessment to facilitate conformity assurances for technical regulations.92 Member states, under these articles, bear full responsibility for ensuring that local and state governments adhere to the requirements of the TBT Agreement.93 This responsibility would include facilitating the understanding of the TBT Agreement by developing “positive measures and mechanisms in support of observance of the TBT Agreement.”94 Even though domestic governments are required to ensure adherence by local and state governments to these provisions, there are no explicit provisions that require local or state compliance with the rules enumerated in the TBT Agreement.95 Local and state governments are not precluded from developing measures with a higher level of protection than the level preother central government bodies.” Id. at art. 7. “8.1 Members shall take such reasonable measures as may be available to them to ensure that non-governmental bodies within their territories which operate conformity assessment procedures comply with the provisions of Articles 5 and 6, with the exception of the obligation to notify proposed conformity assessment procedures. In addition, Members shall not take measures which have the effect of, directly or indirectly, requiring or encouraging such bodies to act in a manner inconsistent with the provisions of Articles 5 and 6. 8.2 Members shall ensure that their central government bodied rely on conformity assessment procedures operated by non-governmental bodies only if these latter bodies comply with the provisions of Articles 5 and 6, with the exception of the obligation to notify proposed conformity assessment procedures.” Id. at art. 8. “Where a positive assurance of conformity with a technical regulation or standard is required, Members shall, wherever practicable, formulate and adopt international systems for conformity assessment and become members thereof or participate therein. 9.2 Members shall take such reasonable measures as may be available to them to ensure that international and regional systems for conformity assessment in which relevant bodies within their territories are members or participants comply with the provisions of Articles 5 and 6. In addition, Members shall not take any measures which have the effect of, directly or indirectly, requiring or encouraging such systems to act in a manner inconsistent with any of the provisions of Articles 5 and 6. 9.3 Members shall ensure that their central government bodies rely on international or regional conformity assessment systems only to the extent that these systems comply with the provisions of Articles 5 and 6, as applicable.” Id. at art. 9. 92

93

BHALA, supra note 13, at 577.

94

Id.

95

Id.

98 • International Law, Agricultural Biotechnology, and Infectious Disease

sent at the domestic level or from maintaining measures that promote safety or protect human, animal, or plant life or health, the environment, or consumers.96 The TBT Agreement sets out guidelines for member states developing protective measures for numerous situations, while the SPS Agreement (see Section C) focuses solely on sanitary and phytosanitary measures. Attention given to GMOs in international trade focuses on the SPS Agreement, even though the TBT Agreement may be more practically useful for effective trade regulation of GMOs, given its broader scope. A discussion as to which of these two agreements will provide better coverage for GMOs requires an examination of the SPS Agreement. C.

SANITARY AND PHYTOSANITARY AGREEMENT

The SPS Agreement delineates the basic rules for food safety and animal and plant health standards in international trade.97 These kinds of standards were previously governed by GATT rules, such as Article I and Article III, as well as the exception provided in Article XX(b).98 Member states were concerned about trade restrictions and protectionism resulting from the application of sanitary and phytosanitary measures and requested clear rules for their use.99 The SPS Agreement provides more distinct requirements and procedures as guidance for the development and harmonization of sanitary and phytosanitary measures.100 Article 1.1 defines the scope of the SPS Agreement as covering only sanitary and phytosanitary measures developed by member states that affect international trade.101 Sanitary and phytosanitary measures, as 96

Id.

Agreement on Sanitary and Phytosanitary Measures, Apr. 15, 1994, Marrakesh Agreement Establishing the World Trade Organization, Multilateral Agreements on Trade in Goods, 33 I.L.M 1125 (1994) [hereinafter SPS Agreement]. 97

98 WTO, Understanding the WTO Agreement on Sanitary and Phytosanitary Measures, at http://www.wto.org/english/tratop_e/sps_e/spsund_e.htm (last visited Jan. 2, 2007). 99

Id.

100

BHALA, supra note 13, at 1665–6.

101

“This Agreement applies to all sanitary and phytosanitary measures which may,

International Trade Legislation • 99

defined in Annex A of the SPS Agreement, protect human, animal, and plant life and health from risks presented by pests, disease, additives, contaminants, toxins, or disease-causing organisms in food, food products, and feed.102 The definitions for sanitary and phytosanitary measures, focusing on pests, diseases, additives, contaminants, and toxins, set out in Annex A are broad and could apply to most, if not all, protective measures for GMOs and infectious disease.103 Member states can develop their own sanitary and phytosanitary measures but must not use these measures as disguised trade barriers or safeguards for domestic industry.104 These general objectives and definitions provide the foundation for the more specific guidelines presented in the provisions of the SPS Agreement and creates an instrument based on science while allowing flexibility in maintaining and promoting trade interests. Article 2 sets forth the basic rights and obligations of member states under the SPS Agreement. Article 2.1 provides that member states have the right to “take sanitary and phytosanitary measures necessary for the protection of human, animal, or plant life or health” so long as such measures are not inconsistent with other provisions of the SPS Agreement.105 directly or indirectly, affect international trade. Such measures shall be developed and applied in accordance with the provisions of this Agreement.” SPS Agreement, supra note 97, at art. 1.1. 102 “Sanitary and phytosanitary measure-Any measure applied: (a) to protect animal or plant life or health within the territory of the Member from risks arising from the entry, establishment or spread of pests, diseases, disease-carrying organisms or diseases-causing organisms; (b) to protect human or animal life or health within the territory of the Member from risks arising from additives, contaminants, toxins or disease-causing organisms in foods, beverages or feedstuffs; (c) to protect human life or health within the territory of the Member from risks arising from diseases carried by animals, plants or products thereof, or from the entry, establishment or spread of pests; or (d) to prevent or limit other damage within the territory of the Member from the entry, establishment or spread of pests.” Id. at Annex A(1). 103 Fiona Macmillan & Michael Blakeney, Genetically Modified Organisms and the World Trade Organization, 3 TUL. J. TECH. & INTELL. PROP. 93, 95–6 (2001).

“Members have the right to take sanitary and phytosanitary measures necessary for the protection of human, animal, or plant life or health, provided that such measures are not inconsistent with the provisions of the Agreement.” SPS Agreement, supra note 97, at art. 2.1. 104

105

Id.

100 • International Law, Agricultural Biotechnology, and Infectious Disease

A fundamental provision of the SPS Agreement, delineated in Article 2.2, requires that provisions developed to protect human, animal, or plant life or health must be “applied only to the extent necessary,” be based on scientific principles, and cannot be maintained “without sufficient scientific evidence.”106 In European Communities Concerning Meat and Meat Products (Hormones) (EC-Hormones), the Appellate Body stated that “sufficient scientific evidence” is an integral part of the carefully negotiated balance in the SPS Agreement between the interests of promoting international trade and safeguarding human health.107 Article 2.2 requires, expressed by the Appellate Body in Japan—Measures Affecting Agricultural Products (Japan Agricultural Products II), a rational or objective relationship between the sanitary and phytosanitary measure and the scientific evidence.108 Such a relationship must be determined on a caseby-case basis and is contingent upon the quality and quantity of the scientific evidence and the characteristics of the measure.109 By mandating that these measures be based on a rational relationship between “sufficient” scientific evidence and the sanitary and phytosanitary measures, Article 2.2 acknowledges that the “best science” and scientific certainty are rare occurrences. Determining a rational relationship on a case-by-case basis allows for situations in which available scientific information is limited, such as those involving GMOs. An important consideration when determining the sufficiency of scientific evidence is that member states generally act from “perspectives of prudence and precaution where risks are irreversible.”110 Sanitary and phytosanitary measures require choices made between dissimilar scientific perspectives, and the SPS Agreement “Members shall ensure that any sanitary or phytosanitary measure is applied only to the extent necessary to protect human, animal, or plant life or health, is based on scientific principles and is not maintained without sufficient scientific evidence, except as provided for in paragraph 7 of Article 5.” Id. at art. 2.2. 106

Appellate Body Report, European Communities Concerning Meat and Meat Products (Hormones), ¶ 177, WT/DS26/AB/R (Jan. 16, 1998) [hereinafter ECHormones Appellate Body Report]. 107

108 Appellate Body Report, Japan—Measures Affecting Agricultural Products, ¶ 84, WT/DS76/AB/R (Feb 22, 1999), [hereinafter Japan-Agricultural Products II Appellate Body Report]. 109

Id.

110

EC-Hormones Appellate Body Report, supra note 107, at ¶ 124.

International Trade Legislation • 101

permits member states to make such decisions.111 Article 2.2 sets the tone for all subsequent articles of the SPS Agreement by establishing a foundation of scientific evidence and risk assessments for sanitary and phytosanitary measures. Article 2.3 echoes GATT Article XX by requiring that any measures developed under the SPS Agreement cannot “unjustifiably discriminate between members where identical or similar conditions prevail” and also must be applied so as to not constitute a disguised restriction on international trade.”112 A violation of Article 2.3 must show arbitrary or unjustifiable discrimination between member states not imposing the measure or between the member state imposing the measure and another member state when identical or similar conditions prevail between the two involved member states.113 Sanitary and phytosanitary measures conforming to the provisions of the SPS Agreement benefit from a presumption of validity as to their consistency with Article XX(b).114 The SPS Agreement also harmonizes sanitary and phytosanitary measures between member states.115 Article 3 fosters the harmonization of sanitary and phytosanitary measures as broadly as possible while recognizing the right of member states to protect the life and health of their pop-

111

BHALA, supra note 13, at 1665.

“Members shall ensure that their sanitary and phytosanitary measures do not arbitrarily or unjustifiably discriminate between Members where identical or similar conditions prevail, including between their own territory and that of other Members. Sanitary and phytosanitary measures shall not be applied in a manner which would constitute a disguised restriction on international trade.” SPS Agreement, supra note 97, at art. 2.3. 112

113 Panel Report, Australia—Measures Affecting Importation of Salmon—Recourse to Article 21.5 by Canada, ¶ 7.111, WT/DS18/RW (Feb. 18, 2000) [hereinafter Australia Salmon Panel Report]. 114 “Sanitary or phytosanitary measures which conform to the relevant provisions of the Agreement shall be presumed to be in accordance with the obligations of the Members under the provisions of the GATT 1994 which relate to the use of sanitary or phytosanitary measures, in particular the provisions of Article XX(b).” SPS Agreement, supra note 97, at art. 2.4. 115

Id. at art. 3.

102 • International Law, Agricultural Biotechnology, and Infectious Disease

ulations.116 Harmonization also prevents the application of sanitary and phytosanitary measures in an arbitrary or unjustly discriminatory manner or as a disguised restriction on international trade while permitting member states to maintain domestically appropriate levels of sanitary and phytosanitary protection.117 Article 3.1, by requiring member states to base sanitary and phytosanitary measures on existing international standards, guidelines, or recommendations, fosters a backdrop of common scientific standards to guide the development of sanitary and phytosanitary measures.118 The Appellate Body, in EC-Hormones, stated that basing these measures on international standards does not mean that sanitary and phytosanitary measures must conform to international standards.119 The use of the phrase “based on” implies a less stringent threshold for sanitary and phytosanitary measures and requires that these measures are built upon or supported by current international standards; measures based on international standards may not conform to those standards, for not all of the elements of the international standard are necessarily present in the sanitary or phytosanitary measure.120 Member states are only obligated to base their sanitary and phytosanitary measures on existing international standards; examination of protection levels and types of recommended sanitary and phytosanitary measures suggested by these standards or if they were developed is not necessary.121 These provisions are similar to the articles of the TBT Agreement directing technical regulations and conformity assessment procedures to be based on international standards. 116

EC-Hormones Appellate Body Report, supra note 107, at ¶ 177.

117

Id.

“To harmonize sanitary and phytosanitary measures on as wide a basis as possible, Members shall base their sanitary and phytosanitary measures on international standards, guidelines, and recommendations, where they exist, except as otherwise provided for in this Agreement, and in particular paragraph 3.” SPS Agreement, supra note 97, at art. 3. 118

119 Panel Report, European Communities Concerning Meat and Meat Products (Hormones)—Complaint by the United States, ¶ 8.72, WT/DS26/R/USA (Aug. 18, 1997) [hereinafter EC-Hormones Panel Report US]. 120

EC-Hormones Appellate Body Report, supra note 107, at ¶ 163.

121

Id.

International Trade Legislation • 103

Article 3.2 provides a presumption of validity, similar to Article 2.4, for measures that conform to international standards, guidelines, or recommendations.122 This presumption acts as an incentive for member states to conform their sanitary and phytosanitary measures with existing international standards.123 But the decision, by a member state, to not conform their sanitary and phytosanitary measures to international standards does not permit the imposition of a burden of proof on a member state that may be a penalty.124 Member states may choose to create sanitary and phytosanitary measures that do not conform to international standards by developing measures with a higher level of protection than that present in existing international standards. Member states may, under Article 3.3, develop sanitary and phytosanitary measures with a higher level of protection than provided by current international standards if there is a scientific justification or as a consequence of the determined level of protection established in accordance with Article 5.125 Article 3.3 also states that all sanitary and phytosanitary measures resulting in a different level of protection than international standards will not be considered inconsistent with the SPS Agreement.126 The Appellate Body, in EC-Hormones, declared the right of member states to develop their own level of sanitary and phytosanitary “Sanitary or phytosanitary measures which conform to international standards, guidelines or recommendations shall be deemed to be necessary to protect human, animal or plant life or health, and presumed to be consistent with the relevant provisions of this Agreement and of GATT 1994.” SPS Agreement, supra note 97, at art. 3.2. 122

123

EC-Hormones Appellate Body Report, supra note 107, at ¶ 102.

124

Id.

125 “Members may introduce or maintain sanitary or phytosanitary measures which result in a higher level of sanitary of phytosanitary protection than would be achieved by measures based on the relevant international standards, guidelines or recommendations, if there is scientific justification, or as a consequence of the level of sanitary or phytosanitary protection a Member determines to be appropriate in accordance with the relevant provisions of paragraphs 1 through 8 of Article 5. Notwithstanding the above, all measures which result in a level of sanitary or phytosanitary protection different from that which would be achieved by measures based on international standards, guidelines or recommendations shall not be inconsistent with any other provisions of this Agreement.” SPS Agreement, supra note 97, at art. 3.3. 126

Id.

104 • International Law, Agricultural Biotechnology, and Infectious Disease

protection is an autonomous right and not an exception from the obligations present in Article 3.1.127 Scientific justification is defined as an “examination and evaluation of available scientific information in conformity with relevant provisions” of the SPS Agreement and echoes the risk assessment provisions in Article 5.1.128 A rational relationship also must exist between the sanitary and phytosanitary measures at issue and the available scientific information, which echoes the provisions of Article 2.2.129 Article 3 provides three options for developing sanitary and phytosanitary measures in accordance with current international standards. A member state may opt to establish a measure based on an international standard that includes some, but maybe not all, aspects of the international standard; a member state does not benefit from the presumption of consistency available in Article 3.2.130 If a member state decides that the sanitary and phytosanitary measure will embody, in its entirety, the international standard and essentially convert it into a domestic standard, then these measures enjoy a presumption of consistency, as stated in the second part of Article 3.2.131 A member state may also choose to promulgate a level of protection different from that provided in the international standard, which can be higher than the level in the international standard.132 The objective behind Article 3 is to emulate previously existing international standards but not exceed them, for sanitary and phytosanitary measures in excess of existing standards could be perceived as a restriction on international trade.133 This does not mean those measures providing a higher level of protection than the SPS Agreement will be invalid; measures offering higher levels of protection will not benefit from the presumption of validity provided by Article 3. The creation and development 127

EC-Hormones Appellate Body Report, supra note 107, at ¶ 172.

128

Id. at ¶¶ 173, 175–176.

129

Japan-Agricultural Products II Appellate Body Report, supra note 108, at ¶ 79.

130

EC-Hormones Appellate Body Report, supra note 107, at ¶¶ 170–172.

131

Id.

132

Id.

133

Macmillan & Blakeney, supra note 103, at 97.

International Trade Legislation • 105

of sanitary and phytosanitary measures, as governed by Article 3 of the SPS Agreement, require both current international standards as well as scientific information. Member states obtain and cultivate scientific information through the performance of risk assessments, which are addressed in Article 5 of the SPS Agreement. The backbone of the SPS Agreement, as enumerated in Article 2.2, relies on scientific principles and risk assessments to direct the development of sanitary and phytosanitary measures. Risk assessment and risk management issues are continuing sources of discussion and contention, especially for GMOs and infectious disease. One of the most complicated issues for GMOs is how to determine not only what perceived risks actually constitute risks but how to manage risks based on speculative or extremely limited scientific information. Article 5 presents a possible approach within the SPS Agreement and provides guidelines for future risk assessment efforts. Article 5.1 requires that member states base their sanitary and phytosanitary measures on risk assessments addressing risks to human, animal, or plant life or health, while consulting risk assessment techniques employed by relevant international organizations.134 Article 5 should be read in conjunction with Article 2.2, for Article 5.1 is the specific application of the basic obligations regarding scientific justification and evidence present in Article 2.2.135 The risk assessment requirements in Article 5.1 are presented as a countervailing factor for the right of member states to set their own levels of protection.136 Risk assessments, as stated in Annex A, contain two separate but related definitions; the first definition focuses on the evaluation of the likelihood of entry, establishment, or spread of a pest or disease and the possible economic and biological consequences.137 The second defi“Members shall ensure that their sanitary and phytosanitary measures are based on an assessment, as appropriate to the circumstances, of the risks to human, animal. Or plant life or health, taking into account risk assessment techniques developed by the relevant international organizations.” SPS Agreement, supra note 97, at art. 5.1. 134

135

BHALA, supra note 13, at 1687.

136

EC-Hormones Appellate Body Report, supra note 107, at ¶ 177.

“Risk assessment—The evaluation of the likelihood of entry, establishment or spread of a pest or disease within the territory of an importing member according to 137

106 • International Law, Agricultural Biotechnology, and Infectious Disease

nition addresses possible adverse effects on human and animal health resulting from additives, contaminants, toxins, or disease-causing organisms in food, beverages, and feedstuffs.138 Both definitions apply to GMOs and infectious disease agents and can be used as bases for risk assessments in developing sanitary and phytosanitary measures. The Appellate Body, in Australia—Measures Affecting Importation of Salmon (Australia Salmon), set out three distinct elements required to evaluate the likelihood of entry, establishment, or spread of a pest or disease and its economic and biological effects.139 The first element identifies the relevant diseases or pests and the biological and economic consequences connected to the entry, establishment, and spread of these diseases or pests.140 The second element evaluates the biological and economic consequences of the likelihood of entry, establishment, or spread of these diseases.141 The third element examines the likelihood of entry, establishment, or spread in the second element, but in the context of applying sanitary and phytosanitary measures.142 A risk assessment should

the sanitary or phytosanitary measures which might be applied, and of the associated potential biological and economic consequences; or the evaluation of the potential for adverse effects on human or animal health arising from the presence of additives, contaminants, toxins or disease-causing organisms in food, beverages or feedstuffs.” SPS Agreement, supra note 97, at Annex A(4). 138

Id.

139 Appellate Body Report, Australia—Measures Affecting Importation of Salmon, ¶ 121, WT/DS18/AB/R (Oct. 20, 1998) [hereinafter Australia Salmon Appellate Body Report]. 140 “On the basis of [the] definition [prescribed in the first part of paragraph 4 of Annex A] we consider that, in this case, a risk assessment within the meaning of Article 5.1 must: (1) identify the diseases whose entry, establishment or spread a Member wants to prevent within its territory, as well as the potential biological and economic consequences associated with the entry, establishment or spread of these diseases; (2) evaluate the likelihood of entry, establishment or spread of these diseases, as well as the associated potential biological and economic consequences; and evaluate the likelihood of entry, establishment or spread of these diseases according to the SPS measures which might be applied.” Id. 141

Id.

142

Id.

International Trade Legislation • 107

also identify the adverse effects on human health and the potential occurrence of these effects.143 Article 5.1 does not require that the member state developing the sanitary and phytosanitary measures carry out its own risk assessment; a member state may use, as objective justification for its measure, a risk assessment performed by another member state or international organization, as long as the applied risk assessment is appropriate for the circumstances.144 These risk assessments, under Article 5.1, do not need to represent one specific or prevailing viewpoint of scientific opinion.145 Member states can develop sanitary and phytosanitary measures based on either mainstream or minority scientific opinions; risk assessments based on a minority viewpoint do not indicate a lack of a reasonable relationship between the risk assessment and the sanitary and phytosanitary measure.146 A determination as to the absence of that relationship can be performed on a case-by-case basis by examining all the considerations attached to potential adverse health effects.147 But risk assessments do need to address the specific risk at issue and cannot be presentations of generalized risk.148 Article 5.2 sets out what factors must be taken into account when compiling risk assessments for sanitary and phytosanitary measures. These measures must be based on available scientific evidence, relevant processes and production methods, relevant inspection, sampling, and testing methods, prevalence of specific diseases or pests, existence of pest- or disease-free areas, relevant ecological and environmental conditions, and quarantine or other treatment.149 These factors are primarily scientific in 143

EC-Hormones Panel Report US, supra note 119, at ¶ 8.98.

144

Australia Salmon Panel Report, supra note 113, at ¶ 8.71.

145

EC-Hormones Appellate Body Report, supra note 107, at ¶¶ 193–194.

146

Id.

147

Id.

148

Id. at ¶ 200.

“In the assessment of risks, Members shall take into account available scientific evidence, relevant processes and production methods; relevant inspection, sampling and testing methods; prevalence of specific diseases or pests; existence of 149

108 • International Law, Agricultural Biotechnology, and Infectious Disease

nature and do not take into account social or economic needs relevant to a comprehensive risk assessment, which comports with the emphasis on scientific evidence as the foundation behind sanitary and phytosanitary measures. But there is no indication that this list is exhaustive; risk assessments under Article 5.1 take into account risks ascertainable from controlled laboratory environments, as well as the actual potential for adverse effects on human health.150 Risk assessments, used as a basis for import prohibitions, also cannot be developed using the concept of “zero risk,” for there is always a possibility of adverse effects associated with most, if not all, imports.151 But risks addressed in risk assessments need to be ascertainable risks, not theoretical risks or uncertainties.152 This requirement for ascertainable risks as the basis of risk assessments does not preclude a member state from deciding that “zero risk” will be its own level of risk protection.153 Uncertainty as to certain elements in a risk assessment does not permit deviation from the requirements set out in Article 5.1, 5.2, 5.3, and paragraph 4 of Annex A.154 Article 5.3 presents a limited list of economic considerations that must be included in risk assessments for sanitary and phytosanitary measures. These factors are potential damage to production or sales, establishment or spread of disease, costs of pest or disease eradication and control in the territory of an importing member state, and cost effectiveness of alternative approaches to risk limitation.155 This provision is important for sani-

pest-or disease-free areas; relevant ecological and environmental conditions; and quarantine or other treatment.” SPS Agreement, supra note 97, at art. 5(2). 150

EC-Hormones Appellate Body Report, supra note 107, at ¶ 187.

151

Australia Salmon Panel Report, supra note 113, at ¶ 8.81.

152

Australia Salmon Appellate Body Report, supra note 139, at ¶ 125.

153

Id.

154

Id. at ¶ 130.

“In assessing the risk to animal or plant life or health and determining the measure to be applied for achieving the appropriate level of sanitary or phytosanitary protection from such risk, Members shall take into account as relevant economic factors: the potential damage in terms of loss of production or sales in the event of the entry, establishment or spread of a pest or disease; the costs of control or eradication in the 155

International Trade Legislation • 109

tary and phytosanitary measures for infectious disease or GMOs, due to their potential societal and economic impacts. Beyond the very limited list presented in Article 5.3, socio-economic concerns, such as those related to ecological impacts or human health, are not explicitly considered for risk assessments.156 However, the SPS Agreement cannot realistically provide comprehensive coverage for all areas related to sanitary and phytosanitary measures, because it is primarily a trade instrument. Irrespective of additional considerations, member states are bound by the SPS Agreement, even though safeguarding international trade may not be the only motivating factor behind the development of sanitary and phytosanitary measures. Inclusion requirements for risk assessments under the SPS Agreement matter, because sanitary and phytosanitary measures for GMOs and infectious disease will be based on these risk assessments. If the risk assessments are incomplete or do not account for all the various aspects of sanitary and phytosanitary measures, the resulting product will not be as effective in protecting human, animal, or plant life and health. While the SPS Agreement directs the validity of risk assessments, the list enumerated by Article 5.3 of the SPS Agreement may not be comprehensive enough to provide thorough and complete risk assessments. These directives for risk assessments fail to fully appreciate the complex and multitudinous array of factors that comprise effective risk assessments for infectious disease and GMOs, for these areas generate risks in other areas besides science and trade, such as the environment or public health. Assessing other concerns besides trade is essential for comprehensive and instructive risk assessments, especially for GMOs and infectious disease. These impacts will adversely affect human health and the environment, if these risks related to GMOS and infectious disease are actually realized. Including socio-economic or ethical issues is not just a means to placate minority approaches to GMO regulation; in this area, it is necessary to capture all of the attenuated circumstances related to the introduction of GMOs into trade channels. Similar concerns are relevant territory of the importing Member; and the relative cost-effectiveness of alternative approaches to limiting risks.” SPS Agreement, supra note 97, at art. 5(3). 156

Id.

110 • International Law, Agricultural Biotechnology, and Infectious Disease

for infectious disease control, for understanding the complete array of mechanisms available for the spread of pathogens on an international scale is crucial for their detection, control, and eradication. Other international organizations are tackling risk assessment issues related to GMOs and infectious disease from vantage points other than trade, which allows for the potential expansion of risk assessment techniques for these areas and other instances of sanitary and phytosanitary protection. Article 5.1 allows for risk assessment techniques “developed by the relevant international organizations” to be incorporated into risk assessments for sanitary and phytosanitary measures. Given the uncertain nature of risks associated with infectious diseases, especially new pathogens, and GMOs, divergent discussions foster dynamic development of comprehensive and effective risk assessment and management. Numerous perspectives could lead to contradictory approaches to risk assessment and risk management for GMOs and infectious disease but can also the different areas affected by these issues. Infectious disease and GMOs present a variety of possible risks and require different approaches until GMOs are better understood from a scientific perspective. As research and development continues on GMOs, an increasing amount of commonality grows between infectious disease and GMOs, whose connections originally seem convoluted or indirect. This increased commonality leads to more connectivity between GMOs and infectious disease and can result in more integrated risk assessment and management applications, which offset the singular focus on trade in the provisions of the SPS Agreement. The dismissal of other influences, especially in risk assessment issues, could further the development of sanitary and phytosanitary measures that do not express all of the interests affected by GMOs and infectious disease. But the SPS Agreement is still, fundamentally, a trade agreement, and Article 5.4 reaffirms trade as the primary motivation behind the SPS Agreement by advising that member states, when determining the appropriate level of sanitary and phytosanitary protection, promote the minimization of trade effects.157 The Panel, in EC-Hormones, echoes the “Members should, when determining the appropriate level of sanitary and phytosanitary protection, take into account the objective of minimizing negative trade effects.” SPS Agreement, supra note 97, at art. 5.4. 157

International Trade Legislation • 111

hortatory statement of Article 5.4 and states that this objective of minimizing trade effects needs to be taken into account when interpreting other provisions of the SPS Agreement.158 Article 5.5 promotes consistency in the application of sanitary and phytosanitary measures by directing member states to avoid “arbitrary or unjustifiable distinctions” in the level of protection if such distinctions lead to “discrimination or a disguised restriction” on trade.159 To achieve this consistency, Article 5.5 provides suggestions to member states, such as cooperating to develop guidelines facilitating the implementation of Article 5.5 and recognizing all relevant factors, including the dimension added when people voluntarily expose themselves to human health risks.160 In EC-Hormones, the Appellate Body examined three elements in Article 5.5, which are cumulative in nature.161 The first element requires that member states establish their own level of sanitary and phytosanitary protection to protect against risks to human life or health in various risk scenarios.162 The second element states that the levels of protection in sanitary and phytosanitary measures must express arbitrary or unjustifiable differences in their treatment of different situations.163 Finally, these arbitrary or unjustifiable restrictions, as embodied in the relevant sanitary and phytosanitary measures, must result in the discrimination or a disguised restriction of international trade.164 All three of these elements must be established to 158

EC-Hormones Panel Report US, supra note 119, at ¶ 8.166.

159 “With the objective of achieving consistency in the application of the concept of appropriate level of sanitary or phytosanitary protection against risks to human life or health, or to animal and plant life or health, each Member shall avoid arbitrary or unjustifiable distinctions in the levels it considers to be appropriate in different situations, if such distinctions result in discrimination or a disguised restriction on international trade. Members shall cooperate in the Committee, in accordance with paragraphs 1,2 and 3 of Article 12, to develop guidelines to further the practical implementation of this provision. In developing the guidelines, the Committee shall take into account all relevant factors, including the exceptional character of human health risks to which people voluntarily expose themselves.” SPS Agreement, supra note 97, at art. 5.5. 160

Id.

161

EC-Hormones Appellate Body Report, supra note 107, at ¶¶ 214–215.

162

Id.

163

Id.

164

Id.

112 • International Law, Agricultural Biotechnology, and Infectious Disease

find a violation of Article 5.5, especially the second and third elements.165 Finding aspects of levels of protection arbitrary or unjustifiable can indicate the presence of a discriminating or restrictive measure.166 The goal of consistency behind the provisions of Article 5.5 “does not establish a legal obligation of consistency of appropriate levels of protection,” for member states develop protection levels over time in response to changing risk factors.167 Avoiding protection levels that pose arbitrary or unjustifiable inconsistencies is the main objective of Article 5.5.168 Situations presenting differing levels of protection must possess some common elements, such as the establishment and spread of similar diseases or the risk of the same biological or economic consequences.169 The extent of the discrepancy in levels of protection is only one factor in determining the existence of discrimination or a disguised restriction on trade; such a finding must be done on a case-by-case basis.170 To further the understanding of Article 5.5, the SPS Committee adopted The Guidelines to Further the Practical Implementation of Article 5.5 (the Guidelines) in June 2000.171 The Guidelines provide direction for the two elements of Article 5.5: “(1) the objective of achieving consistency in the application of the concept of the appropriate level of protection and (2) the obligation to avoid arbitrary or unjustifiable distinctions in levels considered appropriate if such distinctions result in discrimination or a disguised restriction on international trade.”172 Member states should delineate appropriate levels of protection in a “sufficiently clear manner” and con165

Id.

166

Id.

167

Id. at ¶ 213.

168

Id.

169

Australia Salmon Appellate Body Report, supra note 139, at ¶ 146.

170

EC-Hormones Appellate Body Report, supra note 107, at ¶ 240.

171 WTO, Committee on Sanitary and Phytosanitary Measures Guidelines to Further the Practical Implementation of Article 5.5, G/SPS/15, (2000), available at http://www.wto.org/english/res_e/booksp_e/analytic_index_e/sps_02_e.htm#fnt124 [hereinafter The Guidelines]. 172

Id.

International Trade Legislation • 113

sider varying levels of protection in different situations, whether these differences are arbitrary or unjustifiable, and whether such differences may result in discrimination or a disguised restriction on international trade.173 No specific definition of “discrimination or disguised restriction on international trade” exists, but certain factors, taken cumulatively, could indicate the existence of discrimination or disguised restrictions on trade.174 These factors include substantial, arbitrary, or unjustifiable differences in protection levels considered to be appropriate in different situations and the absence of scientific justification or risk assessments for a sanitary or phytosanitary measure purported to achieve the appropriate level of protection.175 To further prevent arbitrary or unjustifiable differences in protection levels, member states should assess proposed sanitary and phytosanitary measures with previously considered ones containing sufficiently common elements.176 Article 5.6 reaffirms trade as the primary motivation behind the SPS Agreement by requiring that sanitary and phytosanitary measures are not “more trade-restrictive than required to achieve the appropriate level of sanitary and phytosanitary protection.”177 To limit trade restrictions within sanitary and phytosanitary measures, member states must also take into account technical and economic feasibility.178 A violation of Article 5.6

173 “A Member should, when determining an appropriate level of protection, either as an overall policy objective or for a specific situation, consider: whether there is a difference between the level of protection under consideration and levels already determined by the Member in different situations and, if so, whether these differences are arbitrary or unjustifiable, and, if so, whether they may result in discrimination or in a disguised restriction on international trade.” Id. at 2. 174

Id. at 3.

175

Id.

176

Id.

177 “Without prejudice to paragraph 2 of Article 3, when establishing or maintaining sanitary or phytosanitary measures to achieve the appropriate level of sanitary or phytosanitary protection, Members shall ensure that such measures are not more trade-restrictive than required to achieve their appropriate level of sanitary or phytosanitary protection, taking into account technical and economic feasibility.” SPS Agreement, supra note 97, at art. 5.6. 178

Id.

114 • International Law, Agricultural Biotechnology, and Infectious Disease

requires establishment of all three elements and are cumulative in nature.179 It is also important to maintain that appropriate levels of protection, and the sanitary and phytosanitary measure are not the same; an appropriate level of protection is an objective preceding the development of a sanitary and phytosanitary measure, and the measure is a means used to achieve that objective.180 Determining the practical meaning of the word “required” in Article 5.6 presents a difficult task for those charged with balancing trade restriction and sanitary and phytosanitary protection. What is considered “required” for adequate sanitary and phytosanitary protection varies for each situation, and a singular definition may not completely capture the nuance of each particular set of circumstances, such as different types of GMOs, specific infectious diseases, or a GM pathogen. The ambiguity of the meaning of “required” in Article 5.6 also recalls previous concerns regarding the possible exclusion of GMO-focused sanitary and phytosanitary measures from the scope of the SPS Agreement, as well as the difficulty in obtaining comprehensive risk assessments for GMOs and infectious disease control. The SPS Agreement also does not provide significant guidance for member states beyond what is provided in its provisions. While this lack of specific direction affords a certain amount of flexibility for member states when devising sanitary and phytosanitary measures, it also leaves room for confusion and permits the development of inefficient or misguided sanitary and phytosanitary measures. GMOs and infectious disease control issues further compound the challenge of creating workable sanitary and phytosanitary measures, due to the limited and constantly changing amount of available scientific information in theses areas. A recurring concern in discussions about infectious disease control and GMOs centers on the lack of scientific evidence on risks associated with GMOs and possible interactions with areas like infectious disease control. Article 5.7 addresses the difficulty posed by inadequate scientific evidence in the development of sanitary and phytosanitary measures and 179

Australia Salmon Appellate Body Report, supra note 139, at ¶ 194.

180

Id. at ¶¶ 200–201, 203.

International Trade Legislation • 115

allows for the adoption, by member states, of provisional sanitary and phytosanitary measures based on available and pertinent scientific information.181 In the meantime, member states must obtain additional information required for a “more objective assessment of risk.”182 In addition to acquiring more information, the provisional measures must be reviewed, in light of the new information, within a reasonable time.183 All four of these requirements are cumulative in nature and are equally crucial in establishing consistency with this provision.184 Article 5.7 is the only provision in the SPS Agreement that permits a qualified exemption to the requirement to base sanitary and phytosanitary measures on a risk assessment present in Article 2.2.185 The development and maintenance of provisional sanitary and phytosanitary measures provides a mechanism for regulation in areas, such as GMOs and infectious disease, which lack adequate and current scientific information. The Appellate Body, in Japan-Agricultural Products II, held that a “reasonable period of time” must be established on a case-by-case basis.186 Defining what constitutes a “reasonable time” could prove to be problematic, for what is a reasonable time to gather more scientific information for one area may not be sufficient in another set of circumstances. Also, a “reasonable time” may be subject more to the trade concerns of the member states affected by the sanitary and phytosanitary measures in question rather than the need for more comprehensive scientific information. The emphasis on trade concerns over the more appropriate scientific course of action will complicate efforts to develop sanitary and phytosan181 “In cases where relevant scientific evidence is insufficient, a Member may provisionally adopt sanitary or phytosanitary measures on the basis of available pertinent information, including that from the relevant international organizations as well as from sanitary or phytosanitary measures applied by other Members. In such circumstances, Members shall seek to obtain the additional information necessary for a more objective assessment of risk and review the sanitary or phytosanitary measure accordingly within a reasonable period of time.” SPS Agreement, supra note 97, at art. 5.7. 182

Id.

183

Id.

184

Japan-Agricultural Products II Appellate Body Report, supra note 108, at ¶ 89.

185

Id. at ¶ 80.

186

Id. at ¶ 93.

116 • International Law, Agricultural Biotechnology, and Infectious Disease

itary measures in areas like infectious disease control and GMOs. Not all sanitary and phytosanitary measures developed by member states to address concerns of human, animal, and plant life or health contain direct relations to trade. Redrafting these measures to reflect a focus on international trade instead of human health or the environment reduces their effectiveness in combating these, as well as other, issues. Measures for infectious disease control and GMOs, while inextricably tied to international trade concerns, are primarily health related and need to maintain that focus if they are to be effective. Too much emphasis on what is beneficial for trade interests alters the overall goal of preserving human, animal, and plant health, which is the objective both the SPS Agreement and GATT Article XX claim to promote. D.

WTO JURISPRUDENCE ON GMOS: BIOTECH PRODUCTS

Until recently, the WTO dispute settlement bodies had not directly discussed GMOs, and WTO member countries looked to other adjudicated cases for guidance. The majority of these cases primarily address environmental issues but prove to be instructive as to the proper interpretation of the relevant provisions of the GATT (Section A), SPS (Section C), and TBT (Section B) Agreements in relation to GMOs. The recent ruling on the European Communities—Measures Affecting the Approval and Marketing of Biotech Products (Biotech Products) case addresses the complex and contentious international trade situation for GMOs between the United States and the European Union. The dispute between the United States, as well as Canada and Argentina, and the European Union focuses on the application of the EU’s approval regime for GM food and GMOs, which also includes specific measures developed and maintained by EU member states prohibiting or restricting marketing for GM food and GMOs.187 The primary objective of the EU regime is to safeguard human health and the environment and the relevant legislation requires case-by-case evaluations of possible risks posed by GM food and GMOs.188 These evaluations then determine whether or not marketing of 187 Panel Report, European Communities—Measures Affecting the Approval and Marketing of Biotech Products, ¶ 2.19, WT/DS291/R, WT/DS292/R, WT/DS293/R (Sept. 20, 2006) [hereinafter Biotech Products Panel Report]. 188

Id. at ¶ 2.21.

International Trade Legislation • 117

a GM food or GMO is approved or denied.189 The relevant directives and regulations permit EU member states to adopt safeguard measures for GM food and GMOs approved for EU-wide marketing.190 Member states may prohibit or provisionally restrict the use or sale of an approved GM food or GMO within their territory if there exists additional information or scientific knowledge that a GM food or GMO poses a human health or environmental risk.191 The United States, Canada, and Argentina (the Complaining Parties), in May 2003, requested consultations with the EU regarding measures, developed by the EU and its member states, affecting U.S., Canadian, and Argentinean food and agricultural imports.192 Measures created at the EU level regulating the approval of GM food and GMOs resulted, as asserted by the United States, Canada, and Argentina, in restrictions on U.S., Canadian, and Argentinean agricultural and food imports.193 EU member states also developed measures that contain domestic marketing and import bans on GM food and GMOs, despite approval from the European Union for import and marketing.194 All three countries argued that both the European Union and EU member state measures violated Articles 2, 5, 7, 8, and Annexes B and C of the SPS Agreement,195 Articles 2 and 5 189

Id. at ¶ 2.22.

190

Id. at ¶ 2.23.

191

Id.

WTO, European Communities—Measures Affecting the Approval and Marketing of Biotech Products Summary of the Dispute, at http://www.wto.org/english/tratop_e/dispu_e/cases_e/ds293_e.htm (last updated Oct. 9, 2006) [hereinafter WTO Summary of Dispute]. 192

193

Id.

194

Id.

The United States held that the European Union violated Articles 2.2, 2.3, 5.1, 5.2, 5.5, 5.6, 7 and 8, and Annexes B(1), B(2), B(5), C(1)(a), C(1)(b), and C(1)(c) of the SPS Agreement. Canada held that the European Union violated Articles 2.2, 2.3, 5.1, 5.5, 5.6, 7, and 8, and paragraphs 1, 2 and 5 of Annex B, and paragraphs 1(a), 1(b), 1(c), and 1(e) of Annex C of the SPS Agreement, and Argentina held that the European Union violated Articles 2.2, 2.3, 5.1, 5.2, 5.5, 5.6, 7, 8, and 10.1, and Annexes B(1) and (5) and C(1)(a), (b), (c), (d) and (e) of the SPS Agreement. Biotech Products Panel Report, supra note 187, at ¶¶ 3.25(a), 3.27(a), 3.29(a). 195

118 • International Law, Agricultural Biotechnology, and Infectious Disease

of the TBT Agreement,196 and Articles I, III, X, and XI of the GATT.197 The Panel issued its decision in September 2006 and found that the European Union, between June 1999 and August 2003, applied a de facto moratorium on the approval of GM food and GMOs.198 This de facto moratorium resulted in the violation of the EU’s obligations under Annex C(1)(a) and Article 8 of the SPS Agreement, due to the undue delay, caused by the de facto moratorium, in completion of EU approval procedures for these products.199 The Panel did not find that the European Union acted inconsistently with its obligations under Articles 2.2, 2.3, 5.1, 5.5, or 5.6 of the SPS Agreement.200 The product-specific EU measures, for approval procedures addressing 24 out of 27 GM food and GMOs, were found to violate the first clause of Annex C(1)(a) and Article 8 of the SPS Agreement because of the undue delay caused in the completion of the product-specific approval procedures, but they did not violate their obligations set forth in Articles 2.2, 2.3, 5.1, 5.5, and 5.6 of the SPS Agreement.201 The safeguard measures employed by EU member states were inconsistent with Articles 5.1 and 2.2 of the SPS Agreement, because risk assessments did not form the basis of these measures, in accordance with the requirements in the SPS Agreement, and could not be maintained without sufficient scientific evidence.202 196 The United States held that the European Union violated Articles 2.1, 2.2, 2.8, 2.9, 2.11, 2.12, 5.1.1, 5.1.2, 5.2.1, 5.2.2, 5.6 and 5.8 of the TBT Agreement. Canada held that the European Union violated Articles 2.1, 2.2, 2.8, 2.9, 5.1, 5.2.2, 5.2.3, 5.6, and 5.8 of the TBT Agreement, and Argentina held the European Union violated Articles 2.1, 2.2, 2.8, 2.9, 2.11, 5.1, 5.2.1, 5.2.2, 5.2.3, 5.2.4, 5.6, 5.8, and 12 of the TBT Agreement. Id. at ¶¶ 3.25(d), 3.27(b), 3.29(d). 197 The United States held that the European Union violated Articles I:1, III:4, X:1, and XI:1 of the GATT. Canada held that the European Union violated Articles I:1, III:4, X:1, and XI:1 of the GATT, and Argentina held that the European Union violated Articles I:1, III:4, X:1, X:3(a) and XI:1 of the GATT. Id. at ¶¶ 3.25(b), 3.27(c), 3.29(c). 198

WTO Summary of Dispute, supra note 192.

199

Biotech Products Panel Report, supra note 187, at ¶ 8.14(a).

200

Id. at ¶¶ 8.14(b)–(g).

201

Id. at ¶¶ 8.18(a)–(g).

202

Id. at ¶¶ 8.21–8.30.

International Trade Legislation • 119

The Panel found that a de facto moratorium203 did exist between June 1999 and August 2003 and was generally applicable to all applications slated for approval of GM food and GMOs under Directives 90/220, 2001/18 and Regulation 258/97.204 During the relevant time period, both the European Union and its member states “had the ability and opportunity to prevent or delay the approval of applications in the manner identified” by the Complaining Parties.205 A declaration, submitted by the Complaining Parties, illustrated intent on behalf of five EU member countries to exercise their powers within the European Union in such a way as to prevent the approval of further applications for GM food and GMOs.206 Due to this declaration of intent, the European Union had a reason to believe that these five countries would constitute a blocking minority, preventing the attainment of a qualified majority support required for application approval of these products.207 No applications for GM food and GMOs were approved between October 1998 and August 2003, whereas ten were approved prior to 1998 and three were approved after 2003, which suggests, in addition to the documentary evidence submitted, that actions were taken, or not taken, by the European Union and some member states to prevent approvals for a specific time period.208 The decision to delay final approval was procedural in nature, since it related to the application or operation of existing EU approval procedures.209 The decision to apply the de facto moratorium also did not impose an effective marketing ban; it merely was a procedural decision used to delay final substantive approval decisions.210 The Panel also found that the de facto moratorium did not itself constitute a sanitary and phytosanitary measure, since it did not satisfy all of “De facto” means that there was no adoption of the moratorium through a formal EU rule or decision-making process. Id. at ¶ 7.1272. 203

204

Id.

205

Id. at ¶ 7.1271(a).

206

Id. at ¶ 7.478.

207

Id. at ¶ 7.467.

208

Id. at ¶ 7.127(c).

209

Id. at ¶ 7.1378.

210

Id. at ¶ 7.1379.

120 • International Law, Agricultural Biotechnology, and Infectious Disease

the constitutive elements required in Annex A(1).211 The de facto moratorium was not a measure intended to achieve the EU’s “appropriate level of sanitary or phytosanitary protection,” which means the measure cannot be considered a sanitary and phytosanitary measure pursuant to Article 5.1.212 For a measure to violate both Article 5.5 and 5.6, it must first be a sanitary and phytosanitary measure applied to achieve a specific level of sanitary or phytosanitary protection.213 The Panel’s determination that the de facto moratorium was not a sanitary and phytosanitary measure removes Article 5.5 and 5.6, in addition to Article 5.1, from consideration in this dispute.214 Since the European Union, in applying the de facto moratorium, did not act inconsistently with Article 5.1, there is no claim under Article 2.2, since an inconsistency with Article 2.2 is implied from a demonstrated inconsistency with Article 5.1.215 The Complaining Parties also argue that the European Union, in addition to imposing the de facto moratorium, also failed to consider productspecific applications for approval.216 The product-specific measures and the de facto moratorium are distinct but closely related measures, for the product-specific measures result from specified acts or omissions that are “the direct consequence of the moratorium as applied to individual applications.”217 The Panel held that the European Union breached its obligations under the first clause of Annex C(1)(a) and Article 8 of the SPS Agreement with respect to 21 product-specific measures challenged by the United States and four product-specific measures challenged by Canada.218 The European Union did not violate, by means of these product-specific measures, Articles 5.1, 5.5, 2.2, or 2.3 of the SPS Agreement.219 The Panel did 211

Id. at ¶¶ 7.1379–1383.

212

Id. at ¶ 7.1392.

213

Id. at ¶¶ 7.1404–7.1405, 7.1415–7.1416.

214

Id. at ¶ 7.1416.

215

Id. at ¶ 7.1437.

216

Id. at ¶¶ 7.1629–7.1631.

217

Id. at ¶ 7.1630.

218

Id. at ¶¶ 8.18(a), 8.38(a).

219

Id. at ¶¶ 8.18(c)–(f), 8.38(b)–(f).

International Trade Legislation • 121

not find that failure to consider a final approval application imposed a new marketing ban on the specific GM food and GMOs.220 The practical effect of failing to examine these approval applications is to extend the time period during which the GM food or GMO would be subject to the provisional marketing ban stemming from the pre-marketing approval requirement.221 The EU’s failure to consider a specific application or approval is not a sanitary and phytosanitary measure within the meaning of Article 5.1.222 Since the claim of the Complaining Parties with respect to Article 2.2 hinges on a breach of Article 5.1 and no violation of Article 5.1 was found, the claim against Article 2.1 is also not viable.223 The same concerns hold for claims brought against the European Union for productspecific measures under Articles 5.5 and 5.6.224 Only sanitary and phytosanitary measures are subject to the provisions of Article 5.5 and 5.6, which removes consideration of the EU’s failure to consider individual approval applications from the scope of these two articles.225 .

The Complaining Parties also put forth a series of claims addressing measures developed by EU member states that prohibit the import, use of, or marketing of specific GM food or GMOs.226 Once a GM food or GMO has been approved for marketing within the European Union, member states may not prohibit or restrict trade in or use of that particular product within their territories if the conditions for marketing approval are being met.227 Member states may adopt provisional safeguard measures that pro-

220

Id. at ¶ 7.1693.

221

Id. at ¶ 7.1698.

222

Id. at ¶ 7.1700.

223

Id. at ¶ 7.1757.

224

Id. at ¶¶ 7.1721–7.1722, 7.1727–7.1728, 7.1740–7.1743, 7.1748–7.1749.

225 Id. Canada also claimed the European Union breached its obligations under Article 2.3, since a violation of Article 5.5 implicates a violation of Article 2.3. Since the Panel found that Article 5.5 did not apply to the product-specific measures, Article 2.3 does not apply either and no breach was found. Id. at ¶ 7.1765. 226

Id. at ¶ 7.2529.

GM food or agricultural products are approved under Directives 90/220 or 2000/18 or Regulation 258//97. Id. at ¶ 7.2530. 227

122 • International Law, Agricultural Biotechnology, and Infectious Disease

hibit or restrict trade in EU-wide approved GM food or GMOs.228 Provisional safeguard measures are appropriate when there are “justifiable reasons to consider that a product which has been properly notified and has received written consent . . . constitutes a risk to human health or the environment.”229 The Panel determined that all of the measures challenged by the Complaining Parties were sanitary and phytosanitary measures and then proceeded to examine whether the safeguard measures must be based on a risk assessment, as required under Article 5.1.230 The European Union disagreed with this approach and argued that the safeguard measures, due to their provisional nature, should be examined under Article 5.7.231 The Panel determined that the provisional nature of the safeguard measures does not preclude application of Article 5.7 to the exclusion of Article 5.1.232 In order to assess the relationship between Articles 5.1 and 5.7, an examination of the interplay between Articles 2.2 and 5.7 is necessary, for Article 2.2 is a crucial component of the context of Article 5.1.233 The Panel held that Article 2.2 excludes from its scope the types of situations covered in Article 5.7 and characterized Article 5.7 as a right rather than an exception.234 Article 5.7 does not provide a qualified exemption to the first and second requirements of Article 2.2, which are the obligations to ensure that sanitary and phytosanitary measures are applied only to the extent necessary to protect human, animal, or plant life or health and to ensure they are based on scientific measures.235 The Panel characterizes Article 5.7 as a qualified right rather than an exception; a challenged sanitary and phytosanitary measure, adopted and maintained in accordance with the four cumulative requirements of Article 5.7, does not require sufficient scientific evidence for their maintenance, as speci-

228

Id.

229

Id. at ¶ 7.2531.

230

Id. at ¶ 7.2923.

231

Id.

232

Id. at ¶ 7.2948.

233

Id. at ¶ 7.2961.

234

Id. at ¶ 7.2969.

235

Id. at ¶ 7.2970.

International Trade Legislation • 123

fied in Article 2.2.236 It follows that if the sanitary and phytosanitary measure in question does not comport with the four requirements of Article 5.7, then the obligations present under Article 2.2 must be applied. 237 The qualified exemption status of Article 5.7 confirms the right of member states to develop measures necessary for the protection of human, animal, or plant life or health in situations where the available scientific evidence is insufficient.238 Article 5.7 also acts as a “qualified exemption from the obligation under Article 5.1 to base sanitary and phytosanitary measures on a risk assessment.”239 The Panel found that none of the safeguard measures, as challenged by the United States, met the provisions of Article 5.1 or 5.7, and each of the safeguard measures taken and applied by EU member states failed to meet the EU’s obligations under the SPS Agreement.240 Biotech Products addressed the specific legislative situation in the European Union and its external effect on the United States, Argentina, and Canada. But the Panel did not, by its own admission, examine any of the salient issues on GMOs in current international discourse. The Panel did not discuss whether GMOs were safe or are like their conventional counterparts or whether the EU has the right to require pre-market approval of GMOs or if the EU requirements for a product-by-product scientific risk assessment violated their obligations under the WTO Agreements.241 All of these concerns still direct the discussions on GMOs, and Biotech Products does little to provide any further direction for member states as to the appropriate regulation for GMOs in the WTO. However, the disputes in Biotech Products did not directly address safety of GMOs or the fundamental obligations of member states for approval of GMOs, which legitimately keeps these issues outside the purview of the Panel’s consideration. The Biotech Products opinion does put member states on notice that this is just the beginning of adjudication for GMOs and international trade. 236

Id. at ¶ 7.2974.

237

Id.

238

Id. at ¶ 7.2983.

239

Id. at ¶ 7.2997.

240

Id. at ¶¶ 8.9–8.10.

241

Id. at ¶ 8.3.

124 • International Law, Agricultural Biotechnology, and Infectious Disease

Biotech Products illustrates the concurrent application of the TBT Agreement and the SPS Agreement to trade issues related to GMOs. Most of the regulatory attention for GMOs and trade has been on the SPS Agreement, due to its mandate to protect human, animal, or plant life or health. But as Biotech Products shows, some legislative provisions for GMOs may involve technical regulations or conformity assessment procedures. Given the broader mandate and lack of scientific evidence requirement, the TBT Agreement may be an alternative for measures addressing GMOs while scientific evidence is compiled for these products. The scientific requirements of the SPS Agreement, while not stringent, do place a scientific threshold for measures and risk assessments that may not be workable for sanitary and phytosanitary measures on GMOs. Article 5.7 of the SPS Agreement permits provisional sanitary and phytosanitary measures in situations with scarce scientific information, but the provisional requirements may not be provisional enough, especially with the emergence or re-emergence of pathogens like BSE, SARS, and Avian Influenza. The unknown etiology and causes of these pathogens and their connections to GMOs illustrate that even scientific research cannot always keep pace with the movement of new pathogens and organisms. Currently, international instruments like the SPS and TBT Agreements cannot accommodate these sorts of issues, for their existence was not contemplated at the drafting of these instruments; their flexibility can only go so far. Both the SPS and the TBT Agreements permit the use of international standards when developing their respective measures; some international organizations are looking beyond trade and beginning to examine connections between GMOs and infectious diseases that may provide useful templates for future regulatory action at the international trade level. E.

OFFICE INTERNATIONAL DES EPIZOOTIES

Two other organizations and conventions relevant to GMOs and infectious disease are the Office International des Epizooties (OIE), and the International Plant Protection Convention (IPPC; see Section F). Both the OIE and the IPPC aim to harmonize domestic sanitary and phytosanitary measures based “on international standards grounded in the best available science,” as well as “seek to facilitate flows of information about outbreaks of infectious disease in order to provide international surveillance data.”242 242

DAVID P. FIDLER, INTERNATIONAL LAW AND INFECTIOUS DISEASE 146 (1999).

International Trade Legislation • 125

OIE is an intergovernmental organization with the mission to ensure transparency in the global animal disease situation.243 Each member state must report animal diseases detected within its borders so that such information can be disseminated to other countries, facilitating preventative action.244 These reporting duties apply to both naturally occurring and deliberately caused instances of infectious disease outbreaks.245 The OIE also fosters the collection and utilization of veterinary scientific information by focusing on providing the latest scientific information on animal disease control for improving “methods used to control and eradicate these diseases.”246 In addition to providing information on animal diseases and promoting accessibility to member states, the OIE also strives to “provide expertise and encourage international solidarity in the control of animal diseases.”247 Such expertise comes in the form of technical support to member states, with a special emphasis on addressing the needs of poor countries regarding animal disease control.248 OIE discusses a variety of potential applications of GMOs, such as use of GM animals for disease control, food, and for the production of pharmaceutical and industrial products, which could also involve issues of infectious disease control.249 Livestock production and animal welfare, two primary focal points of the OIE’s work, are strongly affected by infectious disease outbreaks, which also involves human health concerns and envi-

243 The OIE was created pursuant to an international agreement negotiated on January 25, 1924. Office International des Epizooties (OIE), The OIE at a Glance at http://www.oie.int/eng/OIE/en_oie.htm?e1d1 (last updated Sept. 22, 2004). 244

Id.

245

Id.

246

Id.

247

Id.

248 This objective is very important, for poorer countries rely heavily on the health of their livestock to sustain their populations and usually do not possess adequate public health infrastructure to control the spread of animal diseases within their territory and outside their borders. Id.

OIE, Public perceptions of transgenic animals 150 (2005), at http://www.oie.int/ eng/publicat/rt/2401/24-1%20pdfs/14-einseiedel149-158.pdf [hereinafter OIE transgenic animals]. 249

126 • International Law, Agricultural Biotechnology, and Infectious Disease

ronmental impacts.250 GM animals provide valuable tools to complement preexisting disease-combating techniques and present innovative avenues of disease intervention and control.251 GMOs also present advantages for disease control and eradication programs through the development of vaccines, rapid diagnostic tests, and other related products.252 Recent advances in genetic modification, including gene transfer techniques and information provided by new genomic technologies, are permitting a deeper understanding of the host-pathogen relationship, which will allow for more tailored and effective disease control.253 While the majority of these technologies are still in their infancy, the prospect of integrating infectious disease control strategies with tools developed through genetic modification opens new possibilities for collaboration and benefit.254 The OIE devotes time and resources to delving into ways to control the movement of animals and animal products in international trade, food safety, and bioterrorism, but does little to incorporate GMOs into their efforts for protecting against the movement of animal diseases. The Director-General of the OIE, in a 2003 editorial, recognizes the increasing concerns held by the global community as to the “natural occurrence or deliberate misuse of pathogenic biological agents that could affect public health, food and animal production.”255 In response, disease prevention methods are being updated and expanded to improve the ability of member states to address natural, accidental, or deliberate introductions of animal diseases.256 Yet, distinct and substantial differences exist, at the 250 OIE, Disease-resistant genetically modified animals, 275 (2005), at http:// www.oie.int/eng/publicat/rt/2401/24-1%20pdfs/24-whitelaw275-284.pdf [hereinafter OIE GM animals]. 251

Id. at 276–77.

OIE, Biotechnology applications in animal health and production, at http://www.oie.int/eng/publicat/rt/2401/a_r240102.htm, (last updated Mar. 2, 2005). 252

253

OIE GM animals, supra note 250, at 277.

254

Id. at 280.

255 “Many countries share a common concern about the natural occurrence or deliberate misuse of pathogenic biological agents that could affect public health, food and animal production.” OIE, Biosafety, Biosecurity and Prevention of Diseases, at http://www.oie.int/eng/Edito/en_edito_jun03.htm (last updated June 2003). 256

Id.

International Trade Legislation • 127

domestic level, as to the perceptions of the threats posed by the “deliberate use of pathogenic agents.”257 This variance of threat perception is also an issue for GMOs and hinders the development of domestic legislative regimes, international guidelines, and legislative responses that account for the risks posed by GMOs and their introduction into the food supply and environment. The OIE highlights some of the benefits provided by GMOs for the control of animal disease outbreaks, such as innovative approaches to animal disease control and a more comprehensive understanding of the hostpathogen relationship. The recent outbreaks of Avian Influenza, SARS, and BSE illustrate how linkages between GMOs and animal diseases are becoming more salient. The uncertain nature of the origins of these pathogens showcase that issues regarding GMOs must be incorporated into analyses of animal pathogens and human infectious disease outbreaks. Work done by OIE is beginning to assess these connections, but more needs to be done to adequately account for emerging impacts of GMOs. F.

INTERNATIONAL PLANT PROTECTION CONVENTION

While the overall objective of the OIE (see Section E) is the control and eradication of animal diseases, the IPPC has a broader focus and addresses all plants and plant products. The goal of IPPC is to “secure action to prevent the spread and introduction of pests of plants and plant products, and to promote appropriate measures for their control.”258 International trade issues play a significant role in the IPPC, which recognizes the importance of developing technically justified, transparent, and non-discriminatory or arbitrary phytosanitary measures.259 The IPPC 257

Id.

258 “With the purpose of securing common and effective action to prevent the spread and introduction of pests of plants and plant products, and to promote appropriate measures for their control, the contracting parties undertake to adopt the legislative, technical and administrative measures specified in this Convention and in supplementary agreements pursuant to Article XVI.” The Revised International Plant Protection Convention (IPPC), art. 1(1), Oct. 2, 2005, available at https://www. ippc.int/IPP/En/default.jsp (last updated 2004).

“Recognizing that phytosanitary measures should be technically justified, transparent and should not be applied in such a way as to constitute either a means of arbi259

128 • International Law, Agricultural Biotechnology, and Infectious Disease

also promotes international cooperation in preventing the spread of plant and plant product pests, furthering the harmonization of phytosanitary measures, and incorporating international principles addressing the protection of plant, human, and animal health, and the environment.260 The IPPC applies to cultivated plants and natural flora and includes direct damage and indirect damage from plant pests.261 Like the OIE, the IPPC contributes significantly to the development of international standards in addition to fundamental elements of national plant protection.262 Article 10 on the IPPC governs the development of international standards and directs member states to utilize other international standards when pursuing activities related to the IPPC.263 To facilitate the development of international standards, Article 8 provides guidelines for fostering cooperation between contracting parties.264 trary or unjustified discrimination or a disguised restriction, particularly on international trade[.]” Id. at pmbl. “Recognizing the necessity for international cooperation in controlling pests of plants and plant products and in preventing their international spread, and especially their introduction into endangered areas; . . . desiring to provide a framework for the development and application of harmonized phytosanitary measures and the elaboration of international standards to that effect; . . . taking into account internationally approved principles governing the protection of plant, human and animal health, and the environment[.]” Id. 260

261

Id.

262

Id. at art. 10.

263 “1. The contracting parties agree to cooperate on the development of international standards in accordance with the procedures adopted by the Commission. 2. International standards shall be adopted by the Commission. 3. Regional standards should be consistent with the principles of this Convention; such standards may be deposited with the Commission for consideration as candidates for international standards for phytosanitary measures if more broadly applicable. 4. Contracting parties should take into account, as appropriate, international standards when undertaking activities related to this Convention.” Id.

“1. The contracting parties shall cooperate with one another to the fullest practicable extent in achieving the aims of this Convention, and shall in particular: a) cooperate in the exchange of information on plant pests, particularly the reporting of the occurrence, outbreak or spread of pests that may be of immediate or potential danger, in accordance with such procedures as may be established by the Commission; b) participate, in so far as is practicable, in any special campaigns for combating pests 264

International Trade Legislation • 129

Article 2 of the IPPC defines terms used for developing phytosanitary measures aimed at controlling pests of plants and plant products.265 Pest, as defined in Article 2, refers to “any species, strain or biotype of plant, animal or pathogenic agent injurious to plants or plant products.”266 This is a very broad definition and encompasses traditional pests and those derived from genetic modification. The definition provided for “plant products” maintains this scope and includes “unmanufactured material of plant origin (including grain) and those manufactured products that, by their nature or that of their processing, may create a risk for the introduction and spread of pests.”267 Article 2 also contains terms on issues, such as quarantine, risk analysis, and regulatory responses to the prevention of pest establishment and movement. Quarantine pests are pests of “potential economic importance” to the area in question but either are not present there or present in small amounts and officially controlled.268 This could be a relevant term for GMOs accidentally or intentionally released into the environment, either from deliberate release situations or pollen drift from GM crops. The decision whether or not to regulate a specific pest is based on “pest risk analysis,” which determines regulatory action based on evaluative consideration of biological, other scientific, and economic evidence.269 Pests are not the only articles subject to regulation under the IPPC; the definition of “regulated article” under Article 2 includes plants, plant products, a variety of storage and transportation materials, and any other organism, object, or material able to contain or that may seriously threaten crop production and need international action to meet the emergencies; and c) cooperate, to the extent practicable, in providing technical and biological information necessary for pest risk analysis. 2. Each contracting party shall designate a contact point for the exchange of information connected with the implementation of this Convention.” Id. at art. 8. 265

Id. at art. 2.

266

Id. at art. 2.1.

267

Id.

268 “‘Quarantine pest’—a pest of potential economic importance to the area endangered thereby and not yet present there, or present but not widely distributed and being officially controlled;” id.

“‘Pest risk analysis’—the process of evaluating biological or other scientific and economic evidence to determine whether a pest should be regulated and the strength of any phytosanitary measures to be taken against it[.]” Id. 269

130 • International Law, Agricultural Biotechnology, and Infectious Disease

spread pests or require phytosanitary measures.270 These definitions provide a wide swath of coverage for the IPPC and include regulatory applications on GMOs. The Commission on Phytosanitary Measures (CPM) governs the implementation of the IPPC and is responsible for assessing and addressing the overall status, on a global level, of plant protection, with a primary focus on developing and adopting international standards for phytosanitary measures.271 The IPPC also provides mechanisms for cooperation and collaboration, on the domestic and regional level, aimed at addressing the overall goals of the IPPC. Article 4(1) requires that each member state develop a national plant protection organization (NPPO) to facilitate the achievement of the goals set forth in Article 1(1) of the IPPC.272 NPPOs are responsible for a variety of tasks, such as growing plant surveillance, inspection of plant and plant products consignments moving in international traffic, disinfestations and disinfection of plants, plant products, and

270 “‘Regulated article’—any plant, plant product, storage place, packaging, conveyance, container, soil and any other organism, object or material capable of harboring or spreading pests, deemed to require phytosanitary measures, particularly where international transportation is involved[.]” Id. 271 “1. Contracting parties agree to establish the Commission on Phytosanitary Measures within the framework of the Food and Agriculture Organization of the United Nations (FAO).” Id. at art. 11.1. “2. The functions of the Commission shall be to promote the full implementation of the objectives of the Convention and, in particular, to: a) review the state of plant protection in the world and the need for action to control the international spread of pests and their introduction into endangered areas; b) establish and keep under review the necessary institutional arrangements and procedures for the development and adoption of international standards, and to adopt international standards; c) establish rules and procedures for the resolution of disputes in accordance with Article XIII; d) establish such subsidiary bodies of the Commission as may be necessary for the proper implementation of its functions; e) adopt guidelines regarding the recognition of regional plant protection organizations; f) establish cooperation with other relevant international organizations on matters covered by this Convention; g) adopt such recommendations for the implementation of the Convention as necessary; and h) perform such other functions as may be necessary to the fulfillment of the objectives of this Convention.” Id. at art. 11.2.

“Each contracting party shall make provision, to the best of its ability, for an official national plant protection organization with the main responsibilities set out in this Article.” Id. at art. 4. 272

International Trade Legislation • 131

other regulated articles, protection of endangered areas and maintenance of pest-free and low-pest prevalence areas, the development of pest risk analyses, and the assurance of phytosanitary security of consignments after certification.273 In addition to creating NPPOs, member states must conduct investigations and research focused on plant protection, disseminate information about regulated pests and appropriate means of control and prevention, and issue phytosanitary regulations.274 The IPPC also mandates the establishment of regional plant protection organizations (RPPOs) between member states, whose primary objectives are coordination between member states and cooperation with the IPPC Secretary and the CPM on the development of international standards.275 273 “2. The responsibilities of an official national plant protection organization shall include the following: (a) the issuance of certificates relating to the phytosanitary regulations of the importing contracting party for consignments of plants, plant products and other regulated articles; (b) the surveillance of growing plants, including both areas under cultivation (inter alia fields, plantations, nurseries, gardens, greenhouses, and laboratories) and wild flora, and of plants and plant products in storage or in transportation, particularly with the object of reporting the occurrence, outbreak and spread of pests, and of controlling those pests, including the reporting referred to under Article VIII paragraph 1(a); (c) the inspection of consignments of plants and plant products moving in international traffic and, where appropriate, the inspection of other regulated articles, particularly with the object of preventing the introduction and/or spread of pests; (d) the disinfestations or disinfection of consignments of plants, plant products and other regulated articles moving in international traffic, to meet phytosanitary requirements; (e) the protection of endangered areas and the designation, maintenance and surveillance of pest free areas and areas of low pest prevalence; (f) the conduct of pest risk analyses; (g) to ensure through appropriate procedures that the phytosanitary security of consignments after certification regarding composition, substitution and reinfestation is maintained prior to export; and (h) training and development of staff.” Id. at art. 4.2. 274 “3. Each contracting party shall make provision, to the best of its ability, for the following: a) the distribution of information within the territory of the contracting party regarding regulated pests and the means of their prevention and control; b) research and investigation in the field of plant protection; c) the issuance of phytosanitary regulations; and d) the performance of such other functions as may be required for the implementation of this Convention.” Id. at art. 4.3.

“1. The contracting parties undertake to cooperate with one another in establishing regional plant protection organizations in appropriate areas. 2. The regional plant protection organizations shall function as the coordinating bodies in the areas covered, shall participate in various activities to achieve the objectives of this 275

132 • International Law, Agricultural Biotechnology, and Infectious Disease

The mandate of the IPPC, which is to protect plant health, also includes plant pest issues presented by GMOs.276 The CPM Exploratory Open-Ended Working Group on Phytosanitary Aspects of GMOs, Biosafety, and Invasive Species (the Working Group) notes that the risk analysis and management procedures provided by the IPPC were appropriate for addressing both the “direct or indirect risks of pests to cultivated and wild flora and plant products” and issues of plant health presented by GMOs.277 The Working Group also suggests that a supplementary standard be developed to address plant pest risks posed by GMOs.278 In the interest of developing connectivity and cohesion between the IPPC and related international instruments addressing GMOs and biosafety, the Working Group recommends that the IPPC Secretariat share information with the Convention on Biological Diversity Secretariat and submit the appropriate information to meetings on the Biosafety Protocol.279 In response to the need for international standards dealing with GMOs, the CPM developed an international standard, ISPM No. 11, which addresses pest risk analysis for quarantine, including analyses of environmental risks and GMOs.280 ISPM No. 11 provides “details for the Convention and, where appropriate, shall gather and disseminate information. 3. The regional plant protection organizations shall cooperate with the Secretary in achieving the objectives of the Convention and, where appropriate, cooperate with the Secretary and the Commission in developing international standards. 4. The Secretary will convene regular Technical Consultations of representatives of regional plant protection organizations to: a) promote the development and use of relevant international standards for phytosanitary measures; and b) encourage inter-regional cooperation in promoting harmonized phytosanitary measures for controlling pests and in preventing their spread and/or introduction.” Id. at art. 9. Commission on Phytosanitary Measures (CPM), Third Interim Commission on Phytosanitary Measures 3 (2001), available at https://www.ippc.int (follow “CPM/ICPM reports” hyperlink; then follow “ICPM 3, Report of the Third Session of the ICPM (2001)” hyperlink) (last visited Jan. 3, 2007). 276

277

Id. at 4.

278

Id.

279

Id.

Secretariat of the IPPC, International Standards for Phytosanitary Measures, ISPM No. 11, Pest Risk Analysis for Quarantine Pests including Analysis of Environmental Risks and Living Modified Organisms 1 (2004), available at 280

International Trade Legislation • 133

conduct of pest risk analysis (PRA) to determine if pests are quarantine pests” and includes processes and options for risk assessment and management.281 The standard also sets forth details on the risks, presented by plant pests, to the environment and biological diversity and provides guidance for ascertaining phytosanitary risks posed by GMOs.282 Pest risk analysis, or PRA, for quarantine pests follows a three-stage process, which consists of identifying the relevant pests and pathways, categorizing pests, and evaluating possibility of entry, spread, and economic consequences, and determining potential management options.283 Stage 1, or the initiation process, identifies pests and pathways related to quarantine and which ones should be considered for risk analysis.284 Identification of a pathway or pest as a potential hazard or possible subject of phytosanitary measures,285 as well as reviews of phytosanitary polihttp://www.ippc.int (follow “Standards (ISPMs)” hyperlink; the follow “ISPM No. 11 (2004) Pest risk analysis for quarantine pests including analysis of environmental risks and living modified organisms” hyperlink) (last updated May 3, 2006). “The standard provides details for the conduct of pest risk analysis (PRA) to determine if pests are quarantine pests. It describes the integrated processes to be used for risk assessment as well as the selection of risk management options.” Id. at 117. 281

“It also includes details regarding the analysis of risks of plant pests to the environment and biological diversity, including those risks affecting uncultivated/unmanaged plants, wild flora, habitats and ecosystems contained in the PRA area. . . . It includes guidance on evaluating potential phytosanitary risks to plants and plant products posed by living modified organisms (LMOs). This guidance does not alter the scope of ISPM No. 11 but is intended to clarify issues related to the PRA for LMOs.” Id. 282

283 “Stage 1 (initiating the process) involves identifying the pest(s) and pathways that are of quarantine concern and should be considered for risk analysis in relation to the identified PRA area. Stage 2 (risk assessment) begins with the categorization of individual pests to determine whether the criteria for a quarantine pest are satisfied. Risk assessment continues with an evaluation of the probability of pest entry, establishment, and spread of their potential economic consequences (including environmental consequences). Stage 3 (risk management) involves identifying management options for reducing the risks identified at stage 2. These are evaluated for efficacy, feasibility and impact in order to select those that are appropriate.” Id. at 118. 284

Id. at 119.

“A requirement for a new or revised PRA on a specific pest may arise in the following situations: an emergency arises on discovery of an established infestation 285

134 • International Law, Agricultural Biotechnology, and Infectious Disease

cies and priorities, is sufficient to jumpstart the PRA process. 286 GMOs do not necessarily warrant a PRA unless the GMO in question presents a phytosanitary risk beyond that posed by related non-GMOs; the overall objective of the initiation phase of the PRA is to identify which GMOs possess the characteristics of a potential pest and require further assessment.287 Parent plants of GMOs are not considered pests, but further assessment is required to determine if the genetic modification results in traits that could manifest as a plant pest risk.288 ISPM No. 11 identifies types of GMOs subject to phytosanitary risk assessment, such as agricultural crops (used for both food and feed), plants used for bioremediation or industrial purposes, plants developed for pharmaceutical production, biological control agents, and pests with altered pathogenic characteristics.289 Pest characterization requires that a GMO be “injurious or potentially injurious to plants or plant products.”290 Information gathering comprises the foundational element of the PRA; ISPM No. 11 enumerates specific informational requirements for GMOs, such as details related to the transformation process, including genotypic and phenotypic characteristics, intended use and containment, risk management measures, and the expected quantity of the imported

or an outbreak of a new pest within a PRA area . . . a new pest risk is identified by scientific research . . . an organism is identified as a vector for other pests . . . an organism is genetically altered in a way which clearly identifies its potential as a plant pest.” Id. at 120. 286

Id. at 119.

287

Id.

288

Id.

289 “The types of LMOs that an NPPO may be asked to assess for phytosanitary risk include: plants for use (a) as agricultural crops, for food and feed, ornamental plants or managed forests; (b) in bioremediation (as an organism that cleans up contamination); (c) for industrial purposes (e.g. production of enzymes or bioplastics); (d) as therapeutic agents (e.g. pharmaceutical production); biological control agents modified to improve their performance in that role; pests modified to alter their pathogenic characteristics and thereby make them useful for biological control . . . organisms genetically modified to improve their characteristics such as biofertilizer or other influences on soil, bioremediation or industrial uses.” Id. 290

Id.

International Trade Legislation • 135

GMO.291 At the cessation of Stage 1, an NPPO will determine whether or not a GMO is a potential pest and requires further analysis under Stage 2.292 ISPM No. 11 sets out three overlapping steps, in Stage 2, for pest risk assessment, including characterization and assessment of possible spread and potential economic impacts.293 PRAs are only as complex as warranted by the technical elements of the circumstances, which permits a PRA to “be judged against the principles of necessity, minimal impact, transparency, equivalence, risk analysis, managed risk and non-discrimination.”294 The crucial aspects of a PRA include pest categorization, pest identification, regulatory status, potential pest entry and introduction, spread and establishment, and possible economic consequences.295 Pest categorization focuses on the processes used to determine whether the criteria in the quarantine pest definition are satisfied.296 Pest 291 “For LMOs, information required for a full risk analysis may include: name, identity, and taxonomic status of the LMO (including any relevant identifying codes) and the risk management measures applied to the LMO in the country of export; toxemic status, common name, point of collection or acquisition, and characteristics of the donor organism; description of the nucleic acid or the modification introduced (including genetic construct) and the resulting genotypic and phenotypic characteristics of the LMO; details of the transformation process; appropriate detection and identification methods and their specificity, sensitivity and reliability; intended use including intended containment, quantity or volume of the LMO to be imported.” Id. at 120.

A PRA under the IPPC may only constitute a portion of the required overall risk assessment for an LMO, for Stage 1 may showcase other risks that do not fall under the scope of the IPPC. When a NPPO finds potential non-phytosanitary risks, it may be appropriate to inform the relevant authorities in order to provide a complete risk assessment for LMOs and their related products. Id. at 121. 292

“The process for pest risk assessment can be broadly divided into three interrelated steps: pest characterization, assessment of the probability of introduction and spread, assessment of potential economic consequences (including environmental impacts).” Id. 293

294

Id.

295

Id. at 121–23.

“At the outset, it may not be clear which pest(s) identified in Stage 1 require a PRA. The categorization process examines for each pest whether the criteria in the 296

136 • International Law, Agricultural Biotechnology, and Infectious Disease

identification, in the case of GMOs, must be clearly defined and requires “characteristics of the recipient or parent organism, the donor organism, the genetic construct, the gene or transgene vector and the nature of the genetic modification.”297 Pest introduction issues include incidents of entry and establishment and, in the case of assessing GMO introduction probability, require analysis of intentional and unintentional pathways of introduction and intended use.298 Annex 3 of ISPM No. 11 delineates phydefinition for a quarantine pest are satisfied. In the evaluation of a pathway associated with a commodity, a number of individual PRAs may be necessary for the various pests potentially associated with the pathway. The opportunity to eliminate an organism or organisms from consideration before an in-depth examination is undertaken is a valuable characteristic of the categorization process. An advantage of pest characterization is that is can be done with relatively little information, however information should be sufficient to adequately carry out the categorization. The categorization of a pest as a quarantine pest includes the following primary elements: identity of the pest; presence or absence in the PRA area; regulatory status; potential for establishment and spread in PRA area; potential for economic consequences (including environmental consequences) in the PRA area.” Id. at 121. 297 “The identity of the pest should be clearly defined to ensure that the assessment is being performed on a distinct organism, and that biological and other information used in the assessment is relevant to the organism in question. If this is not possible because the causal agent of particular symptoms has not yet been fully identified, then it should have been shown to produce consistent and to be transmissible. The taxonomic unit for the pest is generally species. The use of a higher or lower taxonomic level should be supported by scientifically sound rationale. In the case of levels below the species, this should include evidence demonstrating that factors such as differences in virulence, host range or vector relationships are significant enough to affect phytosanitary status. In cases where a vector is involved, the vector may also be considered a pest to the extent that it is associated with the causal organism and is required for transmission of the pest. In the case of LMOs, identification requires information regarding characteristics of the recipient or parent organism, the donor organism, the genetic construct, the gene or transgene vector and the nature of the genetic modification.” Id.

“Pest introduction is comprised of both entry and establishment. Assessing the probability of introduction requires an analysis of each of the pathways with which a pest may be associated from its origin to its establishment in the PRA area . . . the assessment of probability of spread is based primarily on biological considerations similar to those for entry and establishment . . . with respect to a plant being assessed as a pest with indirect effects, wherever a reference is made to a host or a host range, this should be understood to refer instead to a suitable habitat (that is a place where the plant can grow) in the PRA area . . . imported plants not intended to be planted may be used for different purposes . . . the risk arises because of the probability that the plant may 298

International Trade Legislation • 137

tosanitary risks for GMOs, such as changes in adaptive characteristics,299 adverse effects of gene flow or gene transfer,300 averse effects on non-target organisms,301 genotypic and phenotypic instability,302 and other injurious effects.303 ISPM No. 11 also requires “clear indicators” that the pest in question is likely to have unacceptable economic consequences, which also includes environmental impacts.304 Economic impacts must relate to the actual pest nature of the GMO and not potential economic or environment impacts generally connected with GMOs.305 escape or be diverted from the intended use to an unintended habitat and stay there. Assessing the probability of introduction of an LMO requires an analysis of both intentional or unintentional pathways of introduction and intended use.” Id. at 123. 299 “Changes in adaptive characteristics which may increase the potential for introduction or spread, for example alterations in: tolerance to adverse environmental conditions (e.g. drought, freezing, salinity, etc.); reproductive biology; dispersal ability of pests; growth rate or vigor; host range; pest resistance; pesticide (including herbicide) resistance or tolerance.” Id. at 137. 300 “Adverse effects of gene flow or gene transfer including, for example: transfer of pesticide or pest resistance genes to compatible species; the potential to overcome existing reproductive and recombination barriers resulting in pest risks; potential for hybridization with existing organisms or pathogens to result in pathogenicity or increased pathogenicity.” Id.

“Adverse effects on non-target organisms including, for example: changes in host range of the LMO, including the cases where it is intended for use as a biological control agent or organism otherwise claimed to be beneficial; effects on other organisms, such as biological control agents, beneficial organisms, or soil fauna and microflora, nitrogen-fixing bacteria, that result in a phytosanitary impact (indirect effects); capacity to vector other pests; negative direct or indirect effects of plant-produced pesticides on non-target organisms beneficial to plants.” Id. 301

“Genotypic and phenotypic instability including, for example: reversion of an organism intended as a biocontrol agent to a virulent form.” Id. 302

303 “Other injurious effects including, for example: phytosanitary risks presented by new traits in organisms that not normally pose phytosanitary risk; novel or enhanced capacity for virus recombination, trans-encapsidation and synergy events related to the presence of virus sequences; phytosanitary risks resulting from nucleic acid sequences (markers, promoters, terminators, etc) present in the insert.” Id. 304 “”There should be clear indications that the pest is likely to have an unacceptable economic impact (including environmental impact) in the PRA area.” Id. at 122.

“In the case of LMOs, the economic impact (including environmental impact) should relate to the pest nature (injurious to plants and plant products) of the LMO.” Id. 305

138 • International Law, Agricultural Biotechnology, and Infectious Disease

Pest risk management, or Stage 3 of ISPM No. 11, centers on means to react to perceived risks, evaluate the efficacy of proposed actions, and identify the best available options, based on information collected and assessed in Stage 2.306 Phytosanitary measures are meant to account for uncertainty in environmental risk assessment and should be developed in proportion to the risk.307 Member countries should determine their acceptable level of risk for GMOs, which can be expressed through comparison to the risk levels associated with related organisms.308 Overall risk is determined by examining the assessments of introduction probability and economic impact; if the risk is unacceptable, the first step is to identify phytosanitary measures that could reduce the risk to or below an acceptable level.309 Measures can also be applied to prevent or reduce crop infestations by GMOs posing a phytosanitary risk, such as management systems, trait expression management, control of reproductive ability, and control of alternative hosts.310 These mechanisms provide options to control the spread of GMOs that pose a phytosanitary risk in a variety of situations. Risk analysis is one of the most contentious areas in GMO regulation, but little direction exists for assessing and managing these risks. Since the IPPC is used as a potential information source for phytosanitary measures, the standards developed under the IPPC provide guidance for other organizations when creating measures and standards for GMOs. The SPS Agreement (see Section C) further increases the relevance of the OIE (see Section E) and IPPC by referring to them as “international standard-setting organizations” that member states should refer to when developing sanitary and phytosanitary measures. The OIE includes in its 306

Id. at 130.

307

Id.

308 “The acceptable level of risk may be expressed in a number of ways, such as: reference to existing phytosanitary requirements, indexed to estimated economic losses, expressed on a scale of risk tolerance, compared with the level of risk accepted by other countries. For LMOs, the acceptable level of risk may also be expressed by comparison to the level of risk associated with similar or related organisms, based on their characteristics and behavior in a similar environment to the PRA areas.” Id. 309

Id.

310

Id. at 132.

International Trade Legislation • 139

mandate a specific reference to its role in the development of sanitary and phytosanitary measures under the SPS Agreement. The OIE pledges to “safeguard world trade by publishing health standards for international trade in animals and animal products.”311 WTO dispute settlement panels use both the OIE and the IPPC for scientific guidance and expertise. The OIE and the IPPC have the potential to provide guidance in efforts addressing GMOs and infectious disease control. Coupled with the Codex Alimentarius (see Chapter 4, Section C), these treaties provide an invaluable resource for the development of sanitary and phytosanitary measures addressing animal diseases, plant products, and international trade. Despite the guidance provided by the international standards put forth by the OIE, more attention needs to be paid to possible connections between GMOs and animal diseases, due to the strong connection between pathogens of animal origins and human infectious disease. The IPPC, with its focus on protection from plant pests, could be more influential regarding GMOs and infectious disease, for most GMOs in the food supply are GM crops or products derived from GM plants. The increased prevalence of GM plants in agricultural applications, rather than GM animals or animal products, may account for the higher level of attention paid to GMOs in the IPPC than the OIE. Due to its position as a conveyor of international standards, the IPPC, by incorporating GMOs into its repertoire, can influence and direct the inclusion of GMOs in phytosanitary measures created under the SPS Agreement. Combined with the original goal of the IPPC, phytosanitary measures drafted by member states using the IPPC as a guideline may develop a stronger sense of connectivity between GMOs and infectious diseases. One highly significant and contested area for GMOs and infectious disease centers on international trade impacts and how measures for infectious disease and GMOs may violate the GATT (see Section A). The OIE and the IPPC provides some guidance as to animal disease and plant harm that could be used to guide measures on infectious disease and GMOs so that sanitary and phytosanitary standards do not violate the SPS Agreement. Even if the work of the OIE and the IPPC are not directly applicable, they offer a starting point for what constitutes valid sanitary and 311

See supra note 243.

140 • International Law, Agricultural Biotechnology, and Infectious Disease

phytosanitary measures and gives elementary guidance when developing measures for infectious disease and GMOs. Since the goals of the OIE and IPPC overlap with concerns related to infectious disease and GMOs, these conventions can be revised to reflect growing challenges related to devising international standards for GMOs and infectious disease, both separately and as a combined issue.

CHAPTER 6

REGIONAL REGULATORY REGIMES FOR GMOS Currently, there are no international instruments that restrict or ban the use or movement of GMOs in global commerce. The Biosafety Protocol regulates the transboundary movement of GMOs but does not prohibit the use of these products in food development and production. There are regional and domestic efforts to regulate the use of GMOs in local agricultural applications, ranging from prohibition and strict regulation to minimal or non-existent regulatory schemes. The United States and the European Union present diametrically opposed perspectives as to the appropriate means to regulate GMOs, which have polarized international and domestic regulatory efforts for GMOs. Other regional organizations and agreements, such as the African Union, Association of Southeast Asian Nations (ASEAN), and the North American Free Trade Agreement (NAFTA), are addressing various aspects of GMO regulation, such as general provisions on biosafety, risk assessment guidelines, and documentation provisions for GMOs in food and feed. A.

UNITED STATES

Over the past decade, the United States has been incorporating GMOs into its primary agricultural commodities, such as corn, soybeans, cotton, and canola.1 American farmers readily adopted these new varieties, which aimed to increase productivity, profitability, and improve environmental management by reducing pesticide use and expanding conservation tillage.2 In 2005, “52% of corn, 87% of soybeans, and 79% of cotton planted in the U.S. are genetically engineered” and fully integrated into preexisting agricultural commodity markets.3 The integration of GMOs United States Department of Agriculture (USDA) Advisory Committee on Biotechnology, Opportunities and Challenges in Agricultural Biotechnology: The Decade Ahead 3 (2006), at http://www.usda.gov/documents/final_main_reportv6.pdf?class= [hereinafter USDA Advisory Committee Report]. 1

2

Id.

3

Id. 141

142 • International Law, Agricultural Biotechnology, and Infectious Disease

into U.S. agricultural industries prompts the inquiry into whether the current U.S. regulatory framework for traditional agricultural products is sufficient to address GMOs.4 Using existing health and safety laws permits immediate regulatory coverage for GMOs; the creation of a new, more comprehensive approach did not seem feasible, because three separate federal agencies have regulatory jurisdiction over GMOs.5 This basic network of existing federal statutes creates an umbrella of agency jurisdiction over GMOs consisting of the U.S. Department of Agriculture (USDA), the Food and Drug Administration (FDA), and the Environmental Protection Agency (EPA).6 The foundation for the current U.S. coordinated, risk-based regulatory framework is the 1986 Coordinated Framework for the Regulation of Biotechnology (the Coordinated Framework), which mandates that federal agencies responsible for the regulatory oversight of particular product categories or uses are also responsible for evaluating similar GMOs.7 The Coordinated Framework concluded that GMOs were not fundamentally different from their conventional counterparts; regulatory focus should center on the products rather than the processes used to develop them.8 The Coordinated Framework also provides guidelines for research, which update the Guidelines for Research with Genetically Engineered Organisms.9 The

4 Coordinated Framework for Regulation of Biotechnology, 51 Fed. Reg. 23302 (June 26, 1986) [hereinafter Coordinated Framework]. 5

Id. at 23303.

6

Id.

7 The National Biological Information Infrastructure (NBII), United States Regulatory Agencies Unified Biotechnology Website Frequently Asked Questions, at http://usbiotechreg.nbii.gov/FAQRecord.asp?qryGUID=2 (last visited Jan. 4, 2007). 8 The Environmental Protection Agency (EPA), Introduction to Biotechnology Regulation for Pesticides, at http://www.epa.gov/pesticides/biopesticides/regtools/ biotech-reg-prod.htm (last updated May 2, 2006).

The National Institutes of Health (NIH) in the Department of Health and Human Services (HHS) developed the Guidelines for Research with Genetically Engineered Organisms in 1986. These guidelines described how research on GMOs should be conducted by prescribing the conditions required for experiments performed by institutions receiving NIH funding. Coordinated Framework, supra note 4, at 23304. 9

Regional Regulatory Regimes for GMOs • 143

USDA, EPA, and FDA, under the Coordinated Framework, operate in an integrated, coordinated, and sometimes overlapping manner while providing coverage for all GMOs in the United States. The FDA regulates foods, food additives, human drugs, biologics and devices, and animal drugs, whereas food products prepared from livestock and poultry fall under the jurisdiction of the Food Safety Inspection Service (FSIS) under the USDA.10 FDA agency officials and scientists also evaluate applications for “new human drugs and biologics, complex medical devices, food and color additives, infant formulas, and animal drugs.”11 Additional duties include monitoring the manufacture, import, transport, storage, and sale of a variety of products, and inspecting facilities throughout the United States.12 The primary objective of the FDA is to protect consumers against “impure, unsafe, and fraudulently labeled food” in areas not covered by the FSIS of the USDA.13 The FDA is also responsible for “ensuring the safety and proper labeling of all plantderived foods and feeds,” including GMOs.14 All foods and feeds must meet the same rigorous safety standards, whether imported or domestic, or derived from conventional breeding techniques. The FDA, with state and local authorities following its lead, aims to market safe and wholesome foods through a transparent, enforceable, accessible, and science-based regulatory process, which imposes liability

Food and Drug Administration (FDA), What the FDA regulates, at http://www.fda.gov/comments/regs.html (last visited Jan. 4, 2007). See also FDA, What the FDA does not regulate, at http://www.fda.gov/comments/noregs.html (last visited Jan. 4, 2007). 10

FDA, History of the FDA, at http://www.fda.gov/oc/history/historyoffda. default.htm (last visited Jan. 4, 2007). 11

12

Id.

13 FSIS is responsible for ensuring the safety, wholesomeness, and accurate labeling of meat, poultry, and egg products. FDA/USDA, United States Food Safety System, at http://www.foodsafety.gov/~fsg/fssyst2.html (last updated May 10, 2000) [hereinafter U.S. Food Safety System].

The National Biological Information Infrastructure (NBII), United States Regulatory Agencies Unified Biotechnology Website Role of U.S. Agencies, at http://usbiotechreg.nbii.gov/roles.asp (last visited Jan. 4, 2007). 14

144 • International Law, Agricultural Biotechnology, and Infectious Disease

for non-compliance by food industry members.15 Generally, federal statutes for food safety issues have a broad mandate that permits flexibility, within preexisting legislation, for the incorporation of new health risks, technology, or products.16 Statutory authority for regulation of food and cosmetics comes from a variety of sources, with the most relevant being the Federal Food, Drug, and Cosmetic Act (FFDCA). The FDA does not have any specific legislative provisions for GMOs and plans to evaluate GMOs on a case-by-case basis, utilizing preexisting administrative procedures and requirements with no plan to develop a separate administrative track for GMOs.17 In 1992, the FDA published its Statement of Policy for Foods Derived from New Plant Varieties (the Policy), which delineates the FDA’s interpretation of the FFDCA regarding application of GMOs to food production.18 The regulatory status of a GM food under the FDA depends on objective characteristics and intended use of the foods, not the method in which it is created.19 The process used to develop GM foods will be useful in understanding safety or nutritional characteristics of the final product, but the characteristics of the final food product should be the primary instructive factor for safety and regulatory concerns.20 Substances in food, as a result of genetic modification of plants, are considered food additives if the substance has been altered so that the substance is not generally recognized as safe (GRAS).21 The FDA expects, as stated in the Policy, that substances found in food from a GM plant will “be the same or substantially similar to substances commonly found in food, such a proteins, fats and oils, and carbohydrates.”22

15

U.S. Food Safety System, supra note 13.

16

Id.

17

Coordinated Framework, supra note 4, at 23303.

Statement of Policy for Foods Derived From New Plant Varieties, 57 Fed. Reg. 22984, (May 29, 1992) [hereinafter the Policy for New Plant Varieties]. 18

19

Id.

20

Id.

21

Id. at 22985.

22

Id.

Regional Regulatory Regimes for GMOs • 145

The FFDCA is the primary legislative instrument for the regulation of GM food. No specific section of the FFDCA directly applies to GM food, but some provisions, developed to regulate other aspects of foods and cosmetics, may be applicable. The FFDCA prohibits a collection of acts in Section 301, which result in penalties ranging from injunctive action, seizure, debarment, approval denials, and suspensions to criminal and civil penalties.23 Misbranded or adulterated food, devices, drugs, or cosmetics cannot be introduced, delivered for introduction, manufactured, received, or delivered for pay through channels of interstate commerce.24 Any action facilitating the destruction, alteration, or removal of a label, resulting in the misbranding of a food, device, drug, or cosmetic, is also prohibited by Section 301(k).25 Submissions of reports or recommendations that are “false or misleading in any material respect” or the disclosure of a trade secret without express written consent can also lead to a violation of Section 301.26 Chapter 4 of the FFDCA provides definitions and standards for food that address food additives, adulterated and misbranded food, and tolerances in foods for poisonous ingredients and pesticide chemical residues.27 Section 401 delineates the scope of Chapter 4 and permits the Secretary28 to develop regulations that establish reasonable definitions and standards of identity for food while promoting “honesty and fair dealing in the interest of consumers.”29 Adulterated and misbranded30 foods are the two most 23 The Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 (2004) [hereinafter FFDCA]. 24

Id.

“(k) The alteration, mutilation, destruction, obliteration, or removal of the whole or any part of the labeling of, or the doing of any other act with respect to, a food, drug, device, or cosmetic, if such act is done while such article is held for sale (whether or not the first sale) after shipment in interstate commerce and results in such article being adulterated or misbranded.” Id. at § 301(k). 25

26

Id. at § 301.

27

Id. at ch. 4.

28 “Secretary” refers to the Secretary of Health and Human Services. Id. at § 201(d). 29

Id. at § 401.

Section 403 defines misbranded food as food in which the labeling is false or misleading on any aspect. Id. at § 403(a)(1). 30

146 • International Law, Agricultural Biotechnology, and Infectious Disease

applicable categories, under the FFDCA, in issues related to GMOs. Section 402 defines adulterated food as food that “bears or contains any poisonous or deleterious substance which may render it injurious to health;” adulterated food is considered unsafe within the meaning of Sections 406, 408(a), and 409.31 Substances in food increased by human action or not inherently present are “added” substances under the FFDCA.32 A food is not adulterated if the quantity of the particular substance does not render the food injurious to health.33 A GM food “injurious to health” means that the GM food contains a higher level of a particular substance than its conventional counterpart, which triggers regulation under Section 402(a)(1).34 The presence of an added substance must result in a reasonable possibility that consumption of the food will be injurious to health for the food to be considered adulterated.35 Section 402 also imposes a legal duty on producers and manufacturers of any food or food product, including GM food, to ensure that the food satisfies relevant safety standards.36 Section 406 in Chapter 4 of the FFDCA delineates tolerances for poisonous ingredients in foods and may be relevant in regulatory issues for GM food. Uncertainty as to health effects of GM foods could increase the 31 “A food shall be deemed to be adulterated (a)(1) if it bears or contains any poisonous or deleterious substance which may render it injurious to health; but in case the substance is not an added substance such food shall not be considered adulterated under this clause if the quantity of such substance in such food does not ordinarily render it injurious to health[.]” Id. at § 402(a)(1). “(2)(A) if it bears or contains any added poisonous or added deleterious substance (other than a substance that is a pesticide chemical residue in or on a raw agricultural commodity or processed food, a food additive, a color additive, or a new animal drug) that is unsafe within the meaning of section 406[.]” Id. at § 402(a)(2)(A). “(B) if it bears or contains a pesticide chemical residue that is unsafe within the meaning of section 408(a)[.]” Id. at § 402(a)(2)(B). “or (C) if it is so if it bears or contains (i) any food additive that is unsafe within the meaning of section 409[.]” Id. at §402(a)(C)(i).

Statement of Policy for Regulating Biotechnology Products, 51 Fed. Reg 23312, (Jun. 26, 1986) [hereinafter Policy for Biotechnology Products]. 32

33

Id.

34

Id.

35 Statement of Policy: Foods Derived from New Plant Varieties, 57 Fed. Reg. 22984, 22988, (May 29. 1992) [hereinafter Policy for New Plant Varieties]. 36

Id.

Regional Regulatory Regimes for GMOs • 147

applicability of Section 406 to GM foods. Any substance added to food that is poisonous or deleterious will be considered unsafe unless the substance is required in production or cannot be avoided by good manufacturing practices.37 In that case, regulations must limit the quantity of these substances in food as necessary for public health, taking into account other ways, besides those mentioned above, that may affect the consumer.38 These foods will also not be considered adulterated within the meaning of clause (1) of Section 402(a).39 Another potential provision bearing on regulation of GMOs and GM food addresses tolerance and exemptions for pesticide chemical residues.40 The FFDCA, in Section 201(q)(1)(A), defines “pesticide chemical” as any substance defined as such in the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).41 “A pesticide chemical residue” is a residue, in or on a raw agricultural commodity or processed food, of a pesticide “Any poisonous or deleterious substances added to any food, except where such substance is required in the production thereof or cannot be avoided by good manufacturing practice shall be deemed to be unsafe for purposes of the application of clause (2)(A) of section 402(a); but when such substance is so required or cannot be so avoided, the Secretary shall promulgate regulations limiting the quantity therein or thereon to such extent as he finds necessary for the protection of public health, and any quantity exceeding the limits so fixed shall also be deemed to be unsafe for purposes of the application of clause (2)(A) of section 402(a). While such a regulation is in effect limiting the quantity of any such substance in the case of any food, such food shall not, by reason of bearing or containing any added amount of such substance, be considered to be adulterated within the meaning of clause (1) of section 402(a). In determining the quantity of such added substances to be tolerated in or on different articles of food the Secretary shall take into account the extent to which the use of such substance is required or cannot be avoided in the production of each such article, and the other ways in which the consumer may be affected by the same or other poisonous or deleterious substances.” FFDCA supra note 23, at § 406. 37

38

Id.

39

Id.

40

Id. at § 408.

“(q)(1)(A) Except as provided in clause (B), the term “pesticide chemical” means any substance that is a pesticide within the meaning of the Federal Insecticide, Fungicide, and Rodenticide Act, including all active and inert ingredients of such pesticide. Notwithstanding any other provision of law, the term ‘pesticide’ within such meaning included ethylene oxide and propylene oxide when such substances are applied on food.” Id. at § 201(q)(1)(A). 41

148 • International Law, Agricultural Biotechnology, and Infectious Disease

chemical or another substance resulting from metabolism or degradation of a pesticide chemical.42 Pesticide chemical residues in or on a food will be considered unsafe unless exemption or tolerance limits exist for the specific residue.43 A food containing pesticide chemical residues subject to an exemption or tolerance will not be considered adulterated under Section 402.44 Certain GMOs developed to produce pesticides or herbicides may fall under the scope of Section 402 if degradation results in residues in GM foods for which no tolerance limit exists. GMOs and GM food may also be possibly regulated as food additives. The Center for Food Safety and Applied Nutrition (CFSAN), one of six product-oriented centers under FDA jurisdiction, develops policies and regulations for labeling, international food standards, food additive safety, and health risks connected to foodborne chemical and biological contaminants.45 CFSAN also works with international bodies, such as the WHO, the FAO, and Codex to foster understanding of U.S. requirements and facilitate the development and harmonization of international food standards.46 The FFDCA provides provisions for food additives and defines “food additive,” in Section 201(s), as any substance whose intended use may be expected to affect food characteristics and has not been demonstrated to be safe for its intended use.47 Food additives do not include pesticide “(2) The term ‘pesticide chemical residue’ means a residue in or on raw agricultural commodity or processed food of (A) a pesticide chemical; or (B) any other added substance that is present on or in the commodity or food primarily as a result of the metabolism or other degradation of a pesticide chemical.” Id. at § 201(q)(2). 42

“(1) GENERAL RULE—Except as provided in paragraph (2) or (3), any pesticide chemical residue in or on a food shall be deemed unsafe for the purpose of section 402(a)(2)(B) unless—(A) a tolerance for such pesticide chemical residue in or on such food is in effect under this section and the quantity of the residue is within the limits of the tolerance; or (B) an exemption from the requirement of a tolerance is in effect under this section for the pesticide chemical residue.” Id. at § 408(1). 43

44

Id.

45 FDA, Center for Food Safety and Applied Nutrition (CFSAN) Overview, at http://www.cfsan.fda.gov/~lrd/cfsan4.html (last updated Jan. 23, 2005). 46

Id.

47

“The term ‘food additive’ means any substance the intended use of which

Regional Regulatory Regimes for GMOs • 149

chemical residues in raw agricultural products, pesticide chemicals, color additives, or new animal drugs.48 A food additive will be considered unsafe unless an exemption or regulation exists delineating the conditions of its safe use.49 If the substance in question is GRAS for a certain food use, then that product is not a food additive.50 Section 409 of the FFDCA results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food (including any substance intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food; and including any source of radiation intended for any such use), if such substance is not generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures (or, in the case of a substance used in food prior to January 1, 1958, through either scientific procedures or experience based on common use in food) to be safe under the conditions of its intended use; except that such term does not include (1) a pesticide chemical residue in or on a raw agricultural commodity or processed food; or (2) a pesticide chemical; or (3) a color additive; or (4) any substance used in accordance with a sanction or approval granted prior to the enactment of this paragraph pursuant to this Act, the Poultry Products Inspection Act (21 U.S.C. 451 and the following) or the Meat Inspection Act of march 4, 1907 (34 Stat. 1260), as amended and extended (21 U.S.C. 71 and the following); (5) a new animal drug; or (6) an ingredient described in paragraph (ff) in, or intended for use in, a dietary supplement.” FFDCA, supra note 23, at § 201(s). 48

Id.

“(a) a food additive shall, with respect to any particular use or intended use of such additives, be deemed to be unsafe for the purposes of the application of clause (2)(C) of section 402(a), unless (1) it and its use or intended use conform to the terms of an exemption which is in effect pursuant to subsection (j) of this section; (2) there is in effect, and it and its use or intended use are in conformity with, a regulation issued under this section prescribing the conditions under which such additive may be safely used; or (3) in the case of a food additive as defined in this Act that is a food contact substance, there is (A) in effect, and such substance and the use of such substance are in conformity with, a regulation issued under this section prescribing the conditions under which such additive may be safely used; or (B) a notification submitted under subsection (h) that is effective. While such a regulation relating to a food additive, or such a notification under subsection (h)(1) relating to a food additive that is a food contact substance, is in effect, and has not been revoked pursuant to subsection (i), a food shall not, by reason of bearing or containing such a food additive in accordance with the regulation or notification, be considered adulterated under section 402(a)(1).” Id. at § 409. 49

50

Policy for Biotechnology Products, supra note 32, at 23313.

150 • International Law, Agricultural Biotechnology, and Infectious Disease

requires that food additives, in order to be used in food, must be a subject of a food additive regulation based on an food additive petition, which will not be approved unless certain evidentiary criteria are met.51 The most important criterion involves showing that the food additive is safe under the conditions of its proposed use by demonstrating “to a reasonable certainty that the additive will not adversely affect the health of consumers.”52 The comprehensiveness of testing for GM foods depends on a variety of factors, including the novelty of the substances used to produce the organism, the purity of the resulting product, and the product’s potential consumption patterns.53 Provisions of the FFDCA for adulterated food, poisonous ingredient tolerances, food additives, and pesticide chemical residues provide possible avenues of regulation for GMOs in food, especially as new GMO varieties are developed and their possible effects on food are unknown. The USDA addresses agricultural applications of GMOs before these products are developed into food and food products. The Animal and Plant Health Inspection Service (APHIS), as part of the USDA, is responsible for regulating animal biologics, plants, seeds, plant pests, animal pathogens, and regulated articles, performing wildlife management activities, and administering relevant legislative responses.54 Within APHIS, the Biotechnology Regulatory Service (BRS), created in 2002, regulates the “field testing, interstate movement, and importation” of GMOs that are known to be, or could be, plant pests.55 BRS achieves this objective by assessing the agricultural and environmental safety of GMOs, developing permit and notification procedures, and coordinating domes51

Id.

52

Id.

53

Id.

54 Regulated article is defined as “certain genetically engineered organisms containing genetic material from a plant pest.” USDA, Frequently Asked Questions about Biotechnology, at http://www.usda.gov/wps/portal/usdahome (last updated Oct. 6, 2005), (follow “Agriculture” hyperlink; then follow “Biotechnology” hyperlink; then follow “Frequently Asked Questions about Biotechnology” hyperlink).

USDA, About Biotechnology Regulatory Service (BRS), at http://www. aphis.usda.gov/brs/about_brs.html (last visited Jan. 4, 2007). 55

Regional Regulatory Regimes for GMOs • 151

tic regulation and policy for GMOs among U.S. agencies.56 BRS is also responsible for promoting the safe development and use of GMOs through international activities, such as “agreements, organizations, workshops, bilateral and multilateral negotiations and regulatory capacity building.”57 The USDA passed, in 2000, the Plant Protection Act (PPA), which consolidates and extends USDA authority to regulate plant health.58 The PPA’s main objective is the “detection, control, eradication, suppression, prevention, or retardation of the spread of plant pests or noxious weeds,” with the goal of limiting or removing the risk presented to United States agriculture, environment, and economy.59 APHIS also regulates, through the PPA, both GMOs that “are known or suspected to be plant pests or pose a plant pest risk” and their traditional counterparts.60 The PPA controls the “import, handling, interstate movement, and release into the environment of regulated organisms;” GMOs are considered “regulated articles” under the PPA.61 General or specific permits are required, under the PPA, for the introduction and movement of plant pests within the United States.62 Plant pests are defined as any living stage of protozoa, non-human animals, parasitic plants, bacteria, fungi, viruses or viroids, and infectious agents or other pathogens.63 Movement of all organisms and products subject to the 56

Id.

57

USDA, BRS, at http://www.aphis.usda.gov/brs/ (last visited Jan. 4, 2007).

58 The Plant Protection Act is part of the Agricultural Risk Protection Act of 2000. Plant Protection Act, Pub. L. No. 106-224, § 402, 114 Stat. 438 (2000) (codified as amended in scattered sections of 7 U.S.C.) [hereinafter PPA]. 59

Id.

60

See supra note 14.

61

Id.

62 “Except as provided in subsection (c), no person shall import, enter, export, or move in interstate commerce any plant pest, unless the importation, entry, exportation, or movement is authorized under general or specific permit and is in accordance with such regulations as the Secretary may issue to prevent the introduction of plant pests into the United States or the dissemination of plant pests within the United States.” PPA, supra note 58, at § 411(a). 63

“(14) PLANT PEST—The term “plant pest” means any living stage of any of

152 • International Law, Agricultural Biotechnology, and Infectious Disease

PPA, such as plants, plant products, biological control organisms, noxious weeds, articles, or means of conveyance, can be prohibited or restricted if such action is necessary to prevent the dissemination of plant pests or noxious weeds.64 Remedial measures, such as seizure or quarantine, may be employed to prevent the dissemination of new or not widely prevalent plant pests or noxious weeds, by destroying or disposing of any plant, plant pests, noxious weeds, biological control organisms, plant products, articles, or means of conveyance moving through interstate commerce and thought to contain or be a plant pest or noxious weed.65 The PPA also provides emergency provisions resulting from the presence of a new or not widely distributed plant pest or noxious weed that threatens plants or plant products.66 Civil and criminal penalties are also available for violations of the following that can directly or indirectly injure, cause damage to, or cause disease in any plant or plant product: (A) a protozoan; (B) a nonhuman animal; (C) a parasitic plant; (D) a bacterium; (E) a fungus; (F) a virus or viroid; (G) an infectious agent or other pathogen; (H) any article similar to or allied with any of the articles specified in the preceding subparagraphs.” Id. at § 403(14). 64 “The term ‘noxious weed’ means any plant or plant product that can directly or indirectly injure or cause damage to crops (including nursery stock or plant products), livestock, poultry, or other interests of agriculture, irrigation, navigation, the natural resources of the United States, the public health, or the environment.” Id. at § 403(10).

“(a) AUTHORITY TO HOLD, TREAT, OR DESTROY ITEMS: If the Secretary considers it necessary in order to prevent the dissemination of a plant pest of noxious weed that is new or not known to be widely prevalent or distributed within and throughout the United States, the Secretary may hold, seize, quarantine, treat, apply other remedial measures to, destroy, or otherwise dispose of any plant, plant pest, noxious weed, biological control organism, plant product, article, or means of conveyance that (1) is moving into or through the United States or interstate, or has moved into or through the United States or interstate, and—(A) the Secretary has reason to believe is a plant pest or noxious weed or is infested with a plant pest or noxious weed at the time of the movement;” Id. at § 414(a). 65

“(a) AUTHORITY TO DECLARE—If the Secretary determines that an extraordinary emergency exists because of the presence of a plant pest or noxious weed that is new to or not known to be widely prevalent in or distributed within and throughout the United States and that the presence of the plant pest or noxious weed threatens plants or plant products of the United States, the Secretary may (1) hold, seize, quarantine, treat, apply other remedial measures to, destroy, or otherwise dispose of, any plant, biological control organism, plant product, article, or means of conveyance that the Secretary has reason to believe is infested with the plant pest or noxious weed; (2) quarantine, treat, or apply other remedial measures to any premises, 66

Regional Regulatory Regimes for GMOs • 153

the PPA; warrantless seizures and inspections are also permitted if there is probable cause to believe that a person or means of conveyance is transporting a plant, plant product, biological control organism, article, plant pest, or noxious weed.67 including any plants, biological control organisms, plant products, articles, or means of conveyance on the premises, that the Secretary has reason to believe is infested with the plant pest or noxious weed; (3) quarantine any State or portion of a State in which a Secretary finds the plant pest or noxious weed or any plant, biological control organism, plant product, article, or means of conveyance that the Secretary has reason to believe is infested with the plant pest or noxious weed; and (4) prohibit or restrict the movement within a State of any plant, biological control organism, plant product, article, or means of conveyance when the Secretary determines that the prohibition or restriction is necessary to prevent the dissemination of the plant pest or noxious weed or to eradicate the plant pest or noxious weed. (b) REQUIRED FINDING OF EMERGENCY—The Secretary may take action under this section only upon finding, after review and consultation with the Governor or other appropriate official of the State affected, that the measures being taken by the State are inadequate to eradicate the plant pest or noxious weed. (c) NOTIFICATION PROCEDURES (1) In general—Except as provided in paragraph (2), before any action is taken in any State under this section, the Secretary shall notify the Governor or other appropriate official of the State affected, issue a public announcement and file for publication in the Federal Register a statement of (A) the Secretary’s findings; (B) the action the Secretary intends to take; (C) the reasons for the intended action; and (D) where practicable, an estimate of the anticipated duration of the extraordinary emergency. (2) Time sensitive actions—if it is not possible to file for publication in the Federal Register prior to taking action, the filing shall be made within a reasonable time, not to exceed 10 business days, after commencement of the action. (d) APPLICATION OF LEAST DRASTIC ACTION—No plant, biological control organism, plant product, plant pest, noxious weed, article, means of conveyance shall be destroyed, exported, or returned to the shipping point of origin under this section unless, in the opinion of the Secretary, there is no less drastic action that is feasible and that would be adequate to prevent the dissemination of any plant pest or noxious weed new to or not known to be widely prevalent or distributed within and throughout the United States. (e) PAYMENT OF COMPENSATION—The Secretary may pay compensation to any person for economic losses incurred by the person as a result of action taken by the Secretary under this section. The determination by the Secretary of the amount of any compensation to be paid under this subsection shall be final and shall not be subject to judicial review.” Id. at § 415. “(a) ROLE OF ATTORNEY GENERAL—The activities authorized by this section shall be carried out consistent with guidelines approved by the Attorney General. (b) WARRANTLESS INSPECTIONS—The Secretary may stop and inspect, without a warrant, any person or means of conveyance moving (1) into the United States to 67

154 • International Law, Agricultural Biotechnology, and Infectious Disease

The USDA also developed more specific regulations for the introduction of GMOs. Title 7 of the Code of Federal Regulations Section 340 sets forth restrictions on the introduction of regulated articles, which are defined as any organisms that have been altered or produced through genetic modification and where the donor organism, recipient organism, or vector is a plant pest, unclassified, or a plant pest developed through genetic modification.68 These restrictions include notification procedures for regulated articles, lists of organisms constituting plant pests, and permit and labeling requirements.69 Section 340 has a similar scope to the PPA by referring primarily to GMOs that are, developed from, or could be plant pests. Both the PPA and Section 340 provide permit requirements restricting or prohibiting the introduction and movement of GMOs. These regulations refer only to GMOs that are or could be plant pests and do not include GMOs used in food and food products or those developed as pesticides. The EPA minimizes risks to human health and safeguards ecological integrity through regulation development and enforcement, determine whether a person or means of conveyance is carrying any plant, plant product, biological control organism, plant pest, noxious weed, or article subject to this title; (2) in interstate commerce, upon probable cause to believe that the person or means of conveyance is carrying any plant, plant product, biological control organism, plant pest, noxious weed, or article subject to this title; and (3) in intrastate commerce from or within any State, portion of a State, or premises quarantined as part of an extraordinary emergency declared under section 415 upon probable cause to believe that the person or means of conveyance is carrying any plant, plant product, biological control organism, plant pest, noxious weed, or article regulated under that section or is moving subject to that section. (c) INSPECTIONS WITH A WARRANT—(1) GENERAL AUTHORITY—The Secretary may enter, with a warrant, any premises in the United States for the purpose of conducting investigations or making inspections and seizures under this title. (2) APPLICATION AND ISSUANCE OF A WARRANT—Upon proper oath or affirmation showing probably cause to believe that there is on certain premises any plant, plant product, biological control organism, plant pest, noxious weed, article, facility, or means of conveyance regulated under this title, a United States judge, a judge of a court of record in the United States, or a United States magistrate judge may, within the judge’s or magistrate’s jurisdiction, issue a warrant for the entry upon the premises to conduct any investigation or make any inspection or seizure under this title. The warrant may be applied for and executed by the Secretary or any United States Marshal.” Id. at § 421. 68

Restriction on the Introduction of Regulated Articles, 7 C.F.R. § 340 (2006).

69

Id.

Regional Regulatory Regimes for GMOs • 155

financial assistance, environmental research and education initiatives, and voluntary partnerships and programs.70 The EPA also regulates several GM products, which includes pesticides produced by plants or microorganisms and non-pesticidal substances, such as industrial enzymes, biosensors, and bioremediation agents produced using microorganisms.71 The Office of Prevention, Pesticides and Toxic Substances (OPPTS) is responsible for developing domestic strategies for toxic substance control, pollution prevention, and informational resources about chemical risks.72 Within OPPTS, the Office of Pesticide Programs (OPP) regulates all pesticide uses and establishes maximum levels for pesticide residues, including GM pesticides.73 The Office of Pollution Prevention and Toxics (OPPT), within OPPTS, control the use of industrial chemicals and GM microorganisms used in the manufacture of specialty chemicals and bioremediation agents.74 All plants have substances with protective chemical and structural mechanisms that repel pests and eradicate pathogens.75 Substances that plants produce for protection, conventional or GM, are pesticides, as mentioned above, if humans intend to use these substances for pesticidal purposes.76 Types of pesticides regulated by the EPA are chemical pesticides, 70 EPA, About the EPA, at http://www.epa.gov/epahome/aboutepa.htm (last updated on Dec. 20, 2006).

Discussions continue as to whether the EPA should include, within its scope of regulation, insects that produce pesticidal substances and plants and animals that produce non-pesticidal substances. None of these products are currently under review by the EPA. EPA, Biotechnology Research Program 1 (2005), at http://www.epa. gov/nheerl/publications/files/biotechnology_research_program_4_8_05.pdf [hereinafter EPA Biotech Research Program]. 71

EPA, Prevention, Pesticides and Toxic Substances, at http://www.epa.gov/oppts (last updated Dec. 28, 2006). 72

73

EPA Biotech Research Program, supra note 71, at 2.

74 OPPT is also interested in GM plants for uses such as phytoremediation and enhanced wood production. Id. at 3.

EPA, Introduction to Biotechnology Regulation for Pesticides, at http://www. epa.gov/pesticides/biopesticides/regtools/biotech-reg-prod.htm (last updated May 2, 2006) [hereinafter Biotech Regulation for Pesticides]. 75

76

Id.

156 • International Law, Agricultural Biotechnology, and Infectious Disease

biopesticides, anti-microbials, pest control devices, and those derived from a common source or production method.77 The OPPTS regulates three main categories of biopesticides,78 which consist of biochemical pesticides,79 microbial pesticides,80 and plant-incorporated pesticides (PIPs).81 Regulation of conventional and GM microbial pesticides, PIPs, and biochemical pesticides falls to the Biopesticides and Pollution Prevention Division (BPPD), within the OPP.82 The EPA regulates pesticides in the United States under two federal statutes: the FIFRA and the FFDCA.83 Under FIFRA, the EPA registers pesticides for domestic use and delineates labeling and other regulatory requirements for the prevention of unreasonable adverse effects on human health and the environment.84 The EPA, through provisions in the FFDCA, establishes tolerances for pesticide residues in food.85 The USDA’s Office of Pest Management Policy enforces these tolerances, while the FDA enforces tolerances for most foods, and the USDA/FSIS enforces tolerEPA, Types of Pesticides, at http://www.epa.gov/pesticides/about/types.htm (last updated Sept. 21, 2006). 77

“Biopesticides are certain types of pesticides derived from natural materials as animals, plants, bacteria, and certain minerals.” Id. 78

79 Biochemical pesticides are naturally occurring substances that control pests by non-toxic mechanisms and include substances, such as insect sex pheromones and scented plant extracts, used to lure insect pests to traps. Id. 80 Microbial pesticides consist of a microorganism, such as a bacterium, fungus, virus, or protozoan, as the active ingredient and can control many different kinds of pests. The most widely used microbial pesticides are subspecies and strains of Bacillus thuringiensis (Bt). Id.

Plant-Incorporated Pesticides (PIPs) are pesticidal substances that plants produce from genetic material that has been added to the plant. An example of this is the insertion of the Bt pesticidal protein gene into a plant’s genetic material. The plant subsequently produces the Bt bacterium, which manufactures the pest-destroying substance. Biotech Regulation for Pesticides, supra note 75. 81

82

Id.

83

Id.

84 EPA, The Food Quality Protection Act (FQPA) Background, at http://www. epa.gov/pesticides/regulating/laws/fqpa/backgrnd.htm (last updated Sept. 7, 2006). 85

Id.

Regional Regulatory Regimes for GMOs • 157

ances for meat, poultry, and some egg products.86 The Food Quality and Protection Act of 1996 (FQPA) amends both FIFRA and FFDCA to establish a more consistent, protective, and science-based regulatory framework by mandating a single, health-based standard for all pesticides in food87 and requiring periodic re-evaluations of pesticide registrations and tolerances.88 The main objectives of FIFRA are to regulate and control pesticide distribution, sale, and use, examine the consequences of pesticide use, and require user registration when purchasing pesticides.89 Section 136 of FIFRA provides key definitions for terms potentially relevant to GMOs and GM products.90 A pesticide refers to any substance or combination of substances, with the purpose of “preventing, destroying, repelling, or mitigating any pest.”91 A pest is classified as any insect, rodent, nematode, 86

Id.

The FQPA Amendments for FFDCA provide a strong, health-based safety standard for pesticide residues in all foods and uses a “reasonable certainty of no harm” as the general safety standard. EPA, Highlights of the Food Quality Protection Act of 1996, at http://www.epa.gov/pesticides/regulating/laws/fqpa/fqpahigh.htm (last updated Aug. 2, 2006). 87

The FQPA amendments for FIFRA include pesticide reregistration and renewal programs, registration for safer pesticides, and requirements for minor use and antimicrobial pesticides. Id. 88

89 EPA, Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), at http://www.epa.gov/region5/defs/html/fifra.htm (last updated Dec. 11, 2006). 90

FIFRA, 7 U.S.C.A. § 136 (Jan. 20, 2004).

“The term ‘pesticide’ means (1) any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pest, (2) any substance or mixture of substances intended for use as a plant regulator, defoliant, or desiccant, and (3) any nitrogen stabilizer that is a ‘new animal drug’ within the meaning of section 321(w) of title 21, that has been determined by the Secretary of Health and Human Services not to be a new animal drug by a regulation establishing conditions of use for the article, or that is an animal feed within the meaning of section 321(x) of title 21 bearing or containing a new animal drug. The term ‘pesticide’ does not include liquid chemical sterilant products (including any sterilant or subordinate disinfectant claims on such products) for use on a critical or semi-critical device, as defined in Section 321 of title 21. For purposes of the preceding sentence, the term ‘critical device’ includes any device which is introduced directly into the human body, either into or in contact with the bloodstream or normally sterile areas of the body and the term ‘semi-critical device’ includes any device which contacts intact mucous mem91

158 • International Law, Agricultural Biotechnology, and Infectious Disease

fungus, weed, or other form of terrestrial or aquatic plant, animal, virus, bacteria, or microorganism.92 GMOs could easily be incorporated into these broad definitions in FIFRA of both pest and pesticide. An adulterated pesticide includes any pesticide whose strength or purity falls below a certain standard expressed in its labeling or has had a substance or component substituted or removed.93 If a pesticide is labeled in a false or misleading manner or the label lacks key information as to the use, containment, or registration status, it is considered misbranded within FIFRA, which is similar to the definition provided in the FFDCA for misbranded foods.94 branes but which does not ordinarily penetrate the blood barrier or otherwise enter normally sterile areas of the body.” Id. at § 136(u). 92 “The term ‘pest’ means (1) any insect, rodent, nematode, fungus, weed or (2) any other form of terrestrial or aquatic plant or animal life or virus, bacteria, or other microorganism (except viruses, bacteria, or other microorganisms on or in living man or other living animals) which the Administrator declares to be a pest under section 136w(c)(1).” Id. at § 136(t).

“The term ‘adulterated’ applies to any pesticide if (1) its strength or purity falls below the professed standard of quality as expressed on its labeling under which it is sold; (2) any substance has been substituted wholly or in part for the pesticide; or (3) any valuable constituent of the pesticide has been wholly or in part abstracted.” Id. at § 136(c). 93

“(1) a pesticide is misbranded if (A) its labeling bears any statement, design, or graphic representation relative thereto or to its ingredients which is false or misleading in any particular; (B) it is contained in a package or other container or wrapping which does not conform to the standards established by the Administrator pursuant to section 136w(c)(3) of this title; (C) it is an imitation of, or is offered for sale under the name of, another pesticide; (D) its label does not bear the registration number assigned under section 136e of this title to each establishment in which it was produced; (E) any word, statement, or other information required by or under authority of this subchapter to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or graphic matter in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use; (F) the labeling accompanying it does not contain directions for use which are necessary for effecting with purpose for which the product is intended and if complied with, together with any requirements imposed under section 136a(d) of this title, are adequate to protect health and the environment; (G) the label does not contain a warning or caution statement which may be necessary for effecting the purpose for which the product is intended and if complied with, together with any requirements imposed under section 136a(d) of this title, are adequate to protect health and the envi94

Regional Regulatory Regimes for GMOs • 159

Some pesticides are implemented for public health purposes, such as vector95 control or mitigation of microorganisms that pose threats to public health.96 FIFRA utilizes the phrase “protect health and the environ-

ronment; (H) in the case of a pesticide not registered in accordance with section 136a of this title and intended for export, the label does not contain, in words prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or graphic matter in the labeling) as to render it likely to be noted by the ordinary individual under customary conditions of purchase and use, the following: ‘Not Registered for Use in the United States of America.’ (2) A pesticide is misbranded if (A) the label does not bear an ingredient statement on that part of the immediate container (and on the outside container or wrapper of the retail package, if there be one, through which the ingredient statement on the immediate container cannot be clearly read) which is presented or displayed under customary conditions or purchase, except that a pesticide is not misbranded under this subparagraph if (i) the size or form of the immediate container, or the outside container or wrapper of the retail package, makes it impracticable to place the ingredient statement on the part which is presented or displayed under customary conditions of purchase; and (ii) the ingredient statement appears prominently on another part of the immediate container, or outside container or wrapper, permitted by the Administrator; (B) the labeling does not contain a statement of the use classification under which the product is registered; (C) there is not affixed to its container, and to the outside container or wrapper of the retail package, if there be one, through which the required information on the immediate container cannot be clearly read, a label bearing (i) the name and address of the producer, registrant, or person for whom produced; (ii) the name, brand, or trademark under which the pesticide is sold; (iii) the net weight or measure of the content, except that the Administrator may permit reasonable variations; (iv) when required by regulation of the Administrator to effectuate the purposes of this subchapter, the registration number assigned to the pesticide under this subchapter, and the use classification; and (D) the pesticide contains any substance or substances in quantities highly toxic to man, unless the label shall bear, in addition to any other matter required by this subchapter (i) the skull and crossbones; (ii) the word ‘poison’ prominently in red on a background of distinctly contrasting color; and (iii) a statement of a practical treatment (first aid or otherwise) in case of poisoning by the pesticide.” Id. at § 136(q). 95 “The term ‘vector’ means any organism capable of transmitting the causative agent of human disease or capable of producing human discomfort or injury, including mosquitoes, flies, fleas, cockroaches, or other insects and ticks, mites, or rats.” Id. at § 136(oo).

“The term ‘public health pesticide’ means any minor use pesticide product registered for use and used predominately in public health programs for vector control or for other recognized health protection uses, including the prevention or mitigation of viruses, bacteria, or other microorganisms (other than viruses, bacteria, or other 96

160 • International Law, Agricultural Biotechnology, and Infectious Disease

ment,” which is defined as protecting against any unreasonable adverse effects on the environment; Section 136(bb) defines “unreasonable adverse effects on the environment” as unreasonable risks to humans or the environment, while accounting for economic, social, and environmental costs and benefits stemming from pesticide use, or human dietary risks resulting from pesticide residues in food.97 Pesticides cannot be distributed or sold within the United States without registration, as provided in Section 136(a) of FIFRA.98 Unregistered pesticides may be transferred if they are subjects of an experimental use permit or if the transfer is between establishments under the same producer for packaging purposes.99 An application for registration must include both basic informative statements and relevant data supporting registration, illustrating that the product “will not cause unreasonable adverse effects to humans or the environment.”100 Approval of registration microorganisms on or in living man or other living animal) that pose a threat to public health.” Id. at § 136(nn). “The terms ‘protect health and the environment’ and ‘protection of health and the environment’ mean protection against any unreasonable adverse effects on the environment.” Id. at § 136(x). “The term ‘unreasonable adverse effects on the environment’ means (1) any unreasonable risk to man or the environment, taking into account the economic, social, and environmental costs and benefits of the use of any pesticide, or (2) a human dietary risk from residues that result from a use of a pesticide in or on any food inconsistent with the standard under section 346a of title 21. The Administrator shall consider the risks and benefits of other pesticides. In weighing any regulatory action concerning a public health pesticide under this subchapter, the Administrator shall weigh any risks of the pesticide against the health risks such as the diseases transmitted by the vector to be controlled by the pesticide.” Id. at § 136(bb). 97

98

Id. at § 136a.

99

Id.

“The Administrator shall publish guidelines specifying the kinds of information which will be required to support the registration of a pesticide and shall revise such guidelines from time to time. If thereafter the Administrator requires any additional kind of information under subparagraph (B) of this paragraph, the Administrator shall permit sufficient time for applicants to obtain such additional information. The Administrator, in establishing standards for data requirements for the registration of pesticides with respect to minor uses, shall make such standards commensurate with the anticipated extent of use, pattern of use, the public health and agricultural need for 100

Regional Regulatory Regimes for GMOs • 161

will delineate classification, scope of use, and labeling requirements for the pesticide.101 Section 136(j) sets forth specific acts that are prohibited by FIFRA and subject to penalties, as covered in Sections 136(k) and 136(l).102 Actions resulting in unregistered pesticides, pesticides with canceled or suspended registrations, adulterated or misbranded pesticides, pesticides with altered compositions following registration, and pesticides with destroyed or altered labels all fall under Section 136(j), as do failures to maintain appropriate records and permit inspections.103 A pesticide or device, if found to be in violation of any provisions of FIFRA, may not be used or sold and can possibly be seized or destroyed by the EPA.104 Criminal and civil penalties are also available, under Section 136(l), for such violations of FIFRA.105 Regulation of chemicals not used as pesticides fall under the scope of the Toxic Substances Control Act (TSCA).106 The TSCA allows the EPA to track and screen all industrial chemicals currently produced or imported such minor use, and the level and degree of potential beneficial or adverse effects on man and the environment. The Administrator shall not require a person to submit, in relation to a registration or reregistration of a pesticide for minor agricultural use under this subchapter, any field residue data from a geographic area where the pesticide will not be registered for such use. In the development of these standards, the Administrator shall consider the economic factors of potential national volume of use, extent of distribution, and the impact of the cost of meeting the requirements on the incentives for any potential registrant to undertake the development of the required data. Except as provided by section 136h of this title, within 30 days after the Administrator registers a pesticide under this subchapter the Administrator shall make available to the public the data called for in the registration statement together with such other scientific information as the Administrator deems relevant to the Administrator’s decision.” Id. at § 136a(c)(2)(A). 101

Id. at § 136(a).

102

Id. at § 136(j).

103

Id.

104

Id. at § 136(k).

105

Id. at § 136(l).

EPA, Toxic Substances Control Act (TSCA), at http://www.epa.gov/region5/ defs/html/tsca.htm (last updated Dec. 11, 2006). 106

162 • International Law, Agricultural Biotechnology, and Infectious Disease

into the United States.107 The EPA can also require testing or reporting of chemicals that pose an environmental or human health risk; the manufacture and import of chemicals posing an unreasonable risk can be banned under the TSCA.108 Provisions provided in TSCA also permit the tracking and control of new industrial chemicals with unknown or dangerous characteristics, irrespective of their effect on the environment or human health.109 Violations of TSCA consist of not complying with rules developed for testing, manufacturing, or processing chemical substances, or regulations developed for hazardous chemical substances.110 Using chemical substances for commercial purposes, without adhering to regulations required for manufacturing or hazardous chemical substances, also violates the TSCA, as does failing to maintain adequate records.111 Penalties for violation of TSCA include seizure of any chemical substance found in violation of TSCA and both civil and criminal penalties.112 The TSCA permits the EPA to review new chemicals prior to their introduction into commerce. Intergeneric113 microorganisms are considered new chemicals and the EPA has developed a separate final rule for GM microbial products. This rule addresses GM microorganisms commercially developed as industrial enzymes, specialty chemicals, and biofertilizers and develops procedures for pre-manufacture review of these microorganisms comparable to traditional chemical substances.114

107

Id.

108

Id.

109

Id.

110

TSCA § 2615, 15 U.S.C.A § 2601 (1976).

111

Id.

112

Id. at §§ 2615, 2616.

113 Intergeneric, a term used primarily in U.S. legislation, means, in this case, microorganisms (or other GM organisms) created to contain genetic material from organisms in more than one taxonomic genera. EPA, Microbial Products of Biotechnology: Final Rule (62 Fed. Reg. 17910), at http://www.epa.gov/ biotech_rule/pubs/biorule.htm (last updated Mar. 31, 2006). 114 EPA, Microbial Products of Biotechnology: Final Regulations under the TSCA Summary (Fact Sheet), at http://www.epa.gov/biotech_rule/pubs/fs-001.htm (last updated Mar. 31, 2006).

Regional Regulatory Regimes for GMOs • 163

The rule establishes a reporting mechanism designed for microorganisms called the Microbial Commercial Activity Notice (MCAN) and sets out application and reporting requirements for intergeneric microorganisms.115 Some of these microorganisms, usually industrial enzymes, would be exempt from submitting a MCAN if certain conditions are met, such as identifying eligible microorganisms and possible specified uses.116 Other microorganisms also exempt from reporting requirements are those used in contained facilities for research and development purposes and certain field testing.117 None of the statutes implemented by the EPA include specific provisions for GMOs or GM products, but GM plants developed to combat plant pests are defined as pesticides under FIFRA.118 GM microorganisms developed to “degrade toxic pollutants, leach minerals, enhance oil recovery, produce industrial chemicals, and act as pesticides” also fall under the scope of FIFRA and will be evaluated for potential health and environmental risks.119 This illustrates that FIFRA, as well as TSCA and FFDCA, may be able to incorporate, in their current form, GMOs and GM products. Concepts of precaution and science-based risk analysis, which include risk assessment, management, and communication, are crucial for effective GMO regulation in the United States.120 FDA risk assessments include three primary components: hazard identification, hazard characterization, and exposure assessment.121 Food safety hazards, in the United States, are either determined by statute or drawn from previous experience.122 For 115

Id.

116

Id.

117

Id.

118

Biotech Regulation for Pesticides, supra note 75.

These risks include potential adverse effects to non-target organisms, environmental fate of the microorganism, and the potential pathogenicity and infectivity of the microorganism to humans. EPA Proposed Policy Regarding Certain Microbial Products, 49 Fed. Reg. 50880, 50884 (Dec. 31, 1984) [hereinafter EPA Policy for Microbial Products]. 119

120

U.S. Food Safety System, supra note 13.

121

Id.

122

Id.

164 • International Law, Agricultural Biotechnology, and Infectious Disease

products currently in the food supply, hazards, like emerging pathogens, may be detected due to previous experience with similar pathogens.123 Regulations for new food ingredients or pesticides require the disclosure of possible hazards prior to incorporation into the food supply.124 Hazard characterization depends on data from different exposure levels and modes, with the goal of providing the most relevant and accurate information.125 Assessments of potential exposure must “differentiate between short term exposure for acute hazards and long term exposure for chronic hazards.”126 The type of hazard directs the kind of assessment used to determine its possible effects; an acute hazard, like a pathogen, would require more focused, short-term analyses on vulnerable populations, whereas chronic hazards, like chemicals or pesticides that possibly cause long-term damage, would require studies on lifetime exposure.127 Assessments for GMOs need to include short-term and long-term analyses, due to their ability to present both acute and chronic hazards. Risk management principles aim to reduce risk to the “lowest practical, or achievable, level.”128 Safe uses of pesticides, food additives, and animal drugs must be ascertained prior to marketing, which involves the use of experts able to make “scientifically defensible decisions in the interest of public health” based on varying levels of available information.129 Communication of risk fosters transparency, which is a primary goal of the American food safety regulatory regime.130 In addition to communication of risk assessment and management strategies, U.S. law permits public comment on the factual bases for regulations.131 Since GMOs may be used as pesticides and may be considered food additives, safe uses 123

Id.

124

Id.

125

Id.

126

Id.

127

Id.

128

Id.

129

Id.

130

Id.

131

Id.

Regional Regulatory Regimes for GMOs • 165

of GMOs must be determined before marketing. Experts must be able to make “scientifically defensible” decisions on the safety of GMOs based on inadequate scientific information. Providing public comment on regulations for GMOs allows dialogue between the public, and regulators contribute to determinations on which GMO safety issues are salient and require more scientific information prior to public approval and marketing of GMOs. The United States integrates elements of precaution into its food safety regulatory framework, such as pre-market approval requirements for food additives, animal drugs, and pesticides. 132 Pre-market approval procedures do not allow these products on the market until or unless producers can show them to be safe, as determined by the appropriate regulatory authorities.133 In the U.S. regulatory framework, the EPA, USDA, and FDA are the agencies responsible for determining the safety of GMOs in the food supply. The EPA’s comprehensive regulatory strategy for pesticides, industrial chemicals, and pesticide tolerances in food complements and overlaps efforts provided by the FDA and USDA. The EPA regulates microbial pesticides, as well as any other pesticide, with APHIS collaboration when the pesticide is a plant pest, animal pathogen, or regulated article.134 The EPA and the USDA both address issues of safety for microbial products and are working towards integrating and streamlining their respective regulatory strategies and procedures.135 The EPA regulates herbicides used on herbicide tolerant plants but the actual regulation of those kinds of plants falls to the USDA and the FDA.136 The collaboration required between the FDA, USDA, and the EPA shows that this division of labor is complicated for conventional products, nonetheless for GMOs and GM products. And such a division is workable only so long as GMOs can be considered substantially similar to their conventional counterparts. Further research and

132

Id.

133

Id.

134

Coordinated Framework, supra note 4, at 23304.

135

EPA Policy for Microbial Products, supra note 119, at 50881.

136

Biotech Regulation for Pesticides, supra note 75.

166 • International Law, Agricultural Biotechnology, and Infectious Disease

development may prove that such an assumption is not accurate, or dividing regulation for GMOs among three different regulatory bodies may not provide adequate coverage. B.

EUROPEAN UNION

The European Union fosters an integrated approach to food safety, with the overall goal of providing a high level of food safety, animal health and welfare, and plant health throughout the European Union.137 The European Union achieves this through “farm-to-table” measures and sufficient monitoring, while promoting the functioning of the internal market.138 Food safety and public health objectives took on a higher level of urgency after a series of crises revolving around human food and animal feed exposed weaknesses and gaps in the application of EU food legislation.139 Improvements to EU food safety legislation involve the establishment of the European Food Safety Authority (EFSA), more transparency and communication with consumers, and an improved legislative framework with greater harmonization for EU member state control systems.140 The Committee on the Environment, Public Health and Food Safety (the Committee) oversees the EFSA. The primary objective of the EFSA is to become the scientific point of reference for the EU food safety regime by responding to issues and crises in an independent, transparent manner.141 EFSA also performs scientific risk assessments for GMOs within the European Union and assists in harmonizing EU legislation for the authorization, labeling, and traceability procedures for GMOs.142 Since 137 European Commission, Food Safety—From the Farm to the Fork, at http:// ec.europa.eu/food/intro_en.htm (last visited Jan. 4, 2007). 138

Id.

Commission White Paper on Food Safety, at 4, COM (1999) 719 final (Jan. 12, 2000). 139

140 The general principles that form the basis for European Union food safety policy are: a comprehensive, integrated approach throughout the food chain; a clear definition of the roles of all stakeholders in the food chain; traceability of feed and food and their ingredients; a coherent, effective and dynamic food policy; risk analysis; scientific advice to the highest standards of independence, excellence, and transparency; application of the precautionary principle in risk management. Id. at 8–9. 141

Id. at 16.

142

EUROPA, General principles of food law—European Food Safety Authority—

Regional Regulatory Regimes for GMOs • 167

2003, all food and food products that are, contain, or are derived from GMOs must be labeled as GMOs.143 The linchpin of EU regulatory policy for GMOs is the precautionary principle, which adds another layer to regulatory frameworks for food safety and public health. The precautionary principle is incorporated when the “potentially dangerous effects of a phenomenon, product, or process have been identified by a scientific and objective evaluation” and risk cannot be determined with sufficient certainty.144 Questions of risk analysis and management benefit the most from the precautionary principle, which can only be applied to potential risks and cannot be a justification for arbitrary decisions.145 Three conditions must be met prior to the incorporation of the precautionary principle: recognition of potentially adverse effects, evaluation of available scientific data, and the extent of scientific uncertainty.146 Implementation of the precautionary principle should be based on the fullest possible scientific and risk evaluations, which will determine the extent of scientific uncertainty, and examination of the potential consequences of inaction.147 Regulation (EC) 178/2002 sets forth general principles and requirements of food law in the European Union, with the primary objective of establishing the EFSA.148 Free movement of safe and wholesome food coupled with a high level of protection for human life, health, and the environment is the foundational strategy behind EU food law.149 Variant legislative food law regimes within EU member states requires the develProcedures for food safety, at http://europa.eu/scadplus/leg/en/lvb/f80501.htm (last updated May, 15, 2006). 143 EUROPA, Introduction: genetically modified organisms (GMOs), at http:// europa.eu/scadplus/leg/en/lvb/l21171.htm (last updated June 6, 2006) [hereinafter EU GMOs]. 144 EUROPA, The precautionary principle, at http://europa.eu/scadplus/leg/en/lvb/ l32042.htm (last updated Nov. 2, 2005). 145

Id.

146

Id.

147

Id.

148

Regulation 178/2002, pmbl., 2002 O.J. (L 31) 1 (EC).

149

Id.

168 • International Law, Agricultural Biotechnology, and Infectious Disease

opment of a common basis, at the EU level, in order to prevent restrictions on the free movement of food, unequal conditions of competition, and impairment in the functioning of the internal market.150 The incorporation of the precautionary principle can foster a common foundation for health protection in the European Union, but it must be applied in a uniform manner, due to its potential to create barriers to the free movement of food or feed.151 The integration of evolving scientific and technical issues connected to food and feed safety into policy objectives, like the precautionary principle, is crucial to the development of a successful food law regime.152 The creation of the ESFA will facilitate the further evolution of EU food law by reinforcing scientific and technical support and being an independent scientific source for risk assessment, risk management, and risk communication.153 The primary goal of Regulation 178/2002 is to establish a foundation for a high level of protection for human health and consumer interest while accounting for diversity in the food supply and ensuring the effective functioning of the internal market.154 Regulation 178/2002 provides definitions for many terms used throughout EU food legislation, such as food, risk assessment, risk management, risk communication, hazard, and traceability.155 Article 5 sets out the general principles for EU food law,

150

Id.

151

Id.

152

Id.

153

Id.

154 “This Regulation provides the basis for the assurance of a high level of protection of human health and consumers’ interest in relation to food, taking into account in particular the diversity in the supply of food including traditional products, whilst ensuring the effective functioning of the internal market. It establishes common principles and responsibilities, the means to provide a strong science base, efficient organizational arrangements and procedures to underpin decision-making in matters of food and feed safety.” Id. at art. 1(1).

“For the purposes of this Regulation, ‘food’ (or ‘foodstuff ’) means any substance or product, whether processed, partially processed or unprocessed, intended to be, or reasonably expected to be ingested by humans ‘Food’ includes drink, chewing gum and any substances, including water, intentionally incorporated into the food during its manufacture, preparation or treatment. It includes water after the point of com155

Regional Regulatory Regimes for GMOs • 169

which focus on free movement of food and feed within the European Union, levels of protection for human, animal, and plant life and health, environmental protection, fair practices in food trade, and the incorporation of relevant international standards.156 The precautionary principle, as enumerated in Article 7, permits the development of provisional risk managepliance as defined in Article 6 of Directive 98/83/EC and without prejudice to the requirements of Directives 80/778/EEC and 98/83/EC. ‘Food’ shall not include: (a) feed; (b) live animals unless they are prepared for placing on the market for human consumption; (c) plants prior to harvesting; (d) medicinal products within the meaning of Council Directives 65/65/EEC and 92/73/EEC; (e) cosmetics within the meaning of Council Directive 76/768/EEC; (f) tobacco and tobacco products within the meaning Council Directive 89/622/EEC; (g) narcotic or psychotropic substances within the meaning of the United Nations Single Convention on Narcotic Drugs, 1961, and the United Nations Convention on Psychotropic Substances, 1971; (h) residues and contaminants.” Id. at art. 2. “‘[R]isk assessment’ means a scientifically based process consisting of four steps: hazard identification, hazard characterization; exposure assessment and risk characterization[.]” Id. at art. 3(11). “‘[R]isk management’ means the process, distinct from risk assessment, of weighing policy alternatives in consultation with interested parties, considering risk assessment and other legitimate factors, and, if need be, selecting appropriate prevention and control options[.]” Id. at art. 3(12). “‘[R]isk communication’ means the interactive exchange of information and opinions throughout the risk analysis process as regards hazards and risks, risk-related factors and risk perceptions, among risk assessors, risk managers, consumers, feed and food businesses, the academic community and other risk assessment findings and the basis of risk management decisions[.]” Id. at art. 3(13). “‘[H]azard’ means a biological, chemical or physical agent in, or condition of, food or feed with the potential to cause an adverse health effect[.]” Id. at art. 3(14). “‘[T]raceability’ means the ability to trace and follow a food, feed, food-producing animal or substance intended to be, or expected to be incorporated into a food or feed, through all stages of production, processing and distribution.” Id. at art. 3(15). “1. Food law shall pursue one or more of the general objectives of a high level of protection of human life and health and the protection of consumers’ interests, including fair practices in food trade, taking account of, where appropriate, the protection of animal health and welfare, plant health and the environment. 2. Food law shall aim to achieve the free movement in the Community of food and feed manufactured or marketed according to the general principles and requirements in this Chapter. 3. Where international standards exist or their completion is imminent, they shall be taken into consideration in the development or adaptation of food law, except where such standards or relevant parts would be an ineffective or inappropriate means for the fulfillment of the legitimate objectives of food law or where there is a scientific justification, or where they would result in a different level of protection from the one determined as appropriate in the Community.” Id. at art. 5. 156

170 • International Law, Agricultural Biotechnology, and Infectious Disease

ment measures to address assessment situations where scientific uncertainty as to adverse health effects complicates risk management.157 Provisional risk management measures must be proportionate and not more trade restrictive than necessary to provide the high level of protection required in the European Union; these measures must also be reviewed within a reasonable period of time, taking into account the kind of scientific information required and the nature of the risks to human health.158 Consumer interest and transparency are also important goals of Regulation 178/2002, focusing on facilitating consumer choice by providing risk information and opportunities for public consultation.159 Contribution to the development of inter“1. In specific circumstances where, following an assessment of available information, the possibility of harmful effects on health is identified but scientific uncertainty persists, provisional risk management measures necessary to ensure the high level of health protection chosen in the Community may be adopted, pending further scientific information for a more comprehensive risk assessment.” Id. at art. 7(1). 157

“2. Measures adopted on the basis of paragraph 1 shall be proportionate and no more restrictive of trade than is required to achieve the high level of health protection chosen in the Community, regard being had to technical and economic feasibility and other factors regarded as legitimate in the matter under consideration. The measures shall be reviewed within a reasonable period of time, depending on the nature of the risk to life or health identified and the type of scientific information needed to clarify the scientific uncertainty and to conduct a more comprehensive risk assessment.” Id. at art. 7(2). 158

“1. Food law shall aim at the protection of the interests of consumers and shall provide a basis for consumers to make informed choices in relation to the foods they consume. It shall aim at the prevention of: (a) fraudulent or deceptive practices; (b) the adulteration of food; and (c) any other practices which may mislead the consumer.” Id. at art. 8. “There shall be open and transparent public consultation, directly or through representative bodies, during the preparation, evaluation and revision of food law, except where the urgency of the matter does not allow it.” Id. at art. 9. “Without prejudice to the applicable provisions of Community and national law on access to documents, where there are reasonable grounds to suspect that a food or feed may present a risk for human or animal health, then, depending on the nature, seriousness and extent of that risk, public authorities shall take appropriate steps to inform the general public of the nature of the risk to health, identifying to the fullest extent possible the food or feed, or type of food or feed, the risk that it may present, and the measures which are taken or about to be taken to prevent, reduce or eliminate that risk.” Id. at art. 9. “1. The traceability of food, feed, food-producing animals and any other substance intended to be, or expected to be, incorporated into a food or feed shall be established at all stages of production, processing and distribution. 2. Food and feed business operators shall be able to identify any person from whom they have 159

Regional Regulatory Regimes for GMOs • 171

national standards is also a focus, while trying to maintain the high level of protection present in the European Union.160 Food and feed law in the European Union, as stated in Regulation 178/2002, must ensure that food placed on the market is safe, which is determined by assessing both long- and short-term effects on human health, including subsequent generations, possible cumulative toxic effects, specific health sensitivities in certain consumer groups, and reasons behind lack of fitness for human consumption.161 Chapter III of Regulation 178/2002 been supplied with a food, a feed, a food-producing animal, or any substances intended to be, or expected to be, incorporated into a food or feed. To this end, such operators shall have in place systems and procedures which allow for this information to be made available to the competent authorities on demand. 3. Food and feed business operators shall have in place systems and procedures to identify the other businesses to which their products have been supplied. This information shall be made available to the competent authorities on demand. 4. Food or feed which is placed on the market or is likely to be placed on the market in the Community shall be adequately labeled or identified to facilitate its traceability, through relevant documentation or information in accordance with the relevant requirements of more specific provisions. 5. Provisions for the purpose of applying the requirements of this Article in respect of specific sectors may be adopted in accordance with the procedures laid down in Article 58(2).” Id. at art. 18. “Without prejudice to their rights and obligations, the Community and the Member States shall: (a) contribute to the development of international technical standards for food and feed and sanitary and phytosanitary standards; (b) promote the coordination of work on food and feed standards undertaken by international governmental and non-governmental organizations; (c) contribute, where relevant and appropriate, to the development of agreements on recognition of the equivalence of specific food and feed-related measures; (d) give particular attention to the special development, financial and trade needs of developing countries, with a view to ensuring that international standards do not create unnecessary obstacles to exports from developing countries; (e) promote consistency between international technical standards and food law while ensuring that the high level of protection adopted in the Community is not reduced.” Id. at art. 13. 160

“1. Food shall not be placed on the market if it is unsafe. 2. Food shall be deemed to be unsafe if it is considered to be: (a) injurious to health; (b) unfit for human consumption. 3. In determining whether any food is unsafe, regard shall be had: (a) to the normal conditions of use of the food by the consumer and at each stage of production, processing and distribution, and (b) to the information provided to the consumer, including information provided to the consumer, including information on the label, or other information generally available to the consumer concerning the 161

172 • International Law, Agricultural Biotechnology, and Infectious Disease

establishes the EFSA, which will provide scientific advice and technical support for food and feed legislation, as well as promoting a high level of avoidance of specific adverse health effects from a particular food or category of foods. 4. In determining whether any food is injurious to health, regard shall be had: (a) not only to the probable immediate and/or short-term and/or long-term effects of that food on the health of a person consuming it, but also on subsequent generations; (b) to the probable cumulative toxic effects; (c) to the particular health sensitivities of a specific category of consumers where the food is intended for that category of consumers. 5. In determining whether any food is unfit for human consumption, regard shall be had to whether the food is unacceptable for human consumption according to its intended use, for reasons of contamination, whether by extraneous matter of otherwise, or through putrefaction, deterioration or decay. 6. Where any food which is unsafe is part of a batch, lot or consignment of food of the same class or description, it shall be presumed that all the food in that batch, lot or consignment is also unsafe, unless following a detailed assessment there is no evidence that the rest of the batch, lot, or consignment is unsafe. 7. Food that complies with specific Community provisions governing food safety shall be deemed to be safe insofar as the aspects covered by the specific Community provisions are concerned. 8. Conformity of a food with specific provisions applicable to that food shall not bar the competent authorities from taking appropriate measures to impose restrictions on it being placed on the market or to require its withdrawal from the market where there are reasons to suspect that, despite such conformity, the food is unsafe. 9. Where there are no specific Community provisions, food shall be deemed to be safe when it conforms to the specific provisions of national food law of the Member State in whose territory the food is marketed, such provisions being drawn up and applied without prejudice to the Treaty, in particular Articles 28 and 30 thereof.” Id. at art. 14. “1. Feed shall not be placed on the market or fed to any food-producing animal if it is unsafe. 2. Feed shall be deemed to be unsafe for its intended use if it is considered to: have an adverse effect on human or animal health; make the food derived from food-producing animals unsafe for human consumption. 3. Where a feed which has been identified as not satisfying the feed safety requirements is part of a batch, lot or consignment of feed of the same class or description, it shall be presumed that all of the feed in that batch, lot or consignment is so affected, unless following a detailed assessment there is no evidence that the rest of the batch, lot or consignment fails to satisfy the feed safety requirement. 4. Feed that complies with specific Community provisions governing feed safety shall be deemed to be safe insofar as the aspects covered by the specific Community provisions are concerned. 5. Conformity of a feed with specific provisions applicable to that feed shall not bar the competent authorities from taking appropriate measures to impose restrictions on it being placed on the market or to require its withdrawal from the market where there are reasons to suspect that, despite such conformity, the feed is unsafe. 6. Where there are no specific Community provisions, feed shall be deemed to be safe when it conforms to the specific provisions of national law governing feed safety of the Member State in whose territory the feed

Regional Regulatory Regimes for GMOs • 173

protection for human life and health.162 EFSA will also be responsible for scientific opinions on GMOs other than food and feed animal and plant health and welfare issues.163 Tasks associated with EFSA include coordination of risk assessment methodologies and identification of emerging risks.164 Regulation 178/2002 provides the basic framework to ensure the is in circulation, such provisions being drawn up and applied without prejudice to the Treaty, in particular Articles 28 and 30 thereof.” Id. at art. 15. 162 “1. A European Food Safety Authority, hereinafter referred to as the ‘Authority,’ is hereby established. 2. The Authority shall provide scientific and technical support for the Community’s legislation and policies in all fields which have a direct or indirect impact on food and feed safety. It shall provide independent information on all matters within these fields and communicate on risks. 3. The Authority shall contribute to a high level of protection of human life and health, and in this respect take account of animal health and welfare, plant health and the environment, in the context of the operation of the internal market. 4. The Authority shall collect and analyze data to allow the characterization and monitoring of risks which have a direct or indirect impact on food and feed safety. 5. The mission of the Authority shall also include the provision of: (a) scientific advice and scientific and technical support on human nutrition in relation to Community legislation and, at the request of the Commission, assistance concerning communication on nutritional issues within the framework of the Community health program; (b) scientific opinions on other matters relating to animal health and welfare and plant health; (c) scientific opinions on products other than food and feed relating to genetically modified organisms as defined by Directive 2001/18/EC and without prejudice to the procedures established therein. 6. The Authority shall provide scientific opinions which will serve as the scientific basis for the drafting and adoption of Community measures in the field falling within its mission. 7. The Authority shall carry out its tasks in conditions which enable it to serve as a point of reference by virtue of its independence, the scientific and technical quality of the opinions it issues and the information it disseminates, the transparency of its procedures and methods of operation, and its diligence in performing the tasks assigned to it. It shall act in close cooperation with the competent bodies in the Member States carrying out similar tasks to these of the Authority. 8. The Authority, Commission and Member States shall cooperate to promote the effective coherence between risk assessment, risk management and risk communication functions. 9. The Member States shall cooperate with the Authority to ensure to accomplishment of its mission.” Id. at art. 22. 163

Id.

“The tasks of the Authority shall be the following: (a) to provide the Community institutions and the Member States with the best possible scientific opinions in all cases provided for by Community legislation and on any questions within its mission; (b) to promote and coordinate the development of uniform risk assess164

174 • International Law, Agricultural Biotechnology, and Infectious Disease

safety of food placed on the market in the European Union. Regulation (EC) 1829/2003 builds on the framework provided in Regulation 178/2002 by providing an authorization procedure for GMOs introduced into the EU internal market. All food and feed containing GMOs is subject to a single authorization procedure under Regulation (EC) 1829/2003.165 Regulation 1829/ 2003 governs approval and placement of GMOs in the internal market, while simultaneously maintaining the functioning of the internal market and providing a high level of protection for human life and health, animal health and welfare, the environment, and consumer interest.166 Article 3 delineates the scope for the authorization and supervision provisions of Regulation 1829/2003, which includes GMOs used for food, food containing or consisting of GMOs, and food produced from or containing ingredients produced from GMOs.167 Food outlined in Article 3(1) cannot ment methodologies in the fields falling within its mission; (c) to provide scientific and technical support to the Commission in the areas within its mission and, when so requested, in the interpretation and consideration of risk assessment opinions; (d) to commission scientific studies necessary for the accomplishment of its mission; (e) to search for, collect, collate, analyze, and summarize scientific and technical data in the fields within its mission; (f) to undertake action to identify and characterize emerging risks, in the fields within its mission; (g) to establish a system of networks or organizations operating in the fields within its mission and be responsible for their operation; (h) to provide scientific and technical assistance, when requested to do so by the Commission, in the crisis management procedures implemented by the Commission with regard to the safety of food and feed; (i) to provide scientific and technical assistance, when ‘requested’ to do so by the Commission, with a view to improving cooperation between the Community, applicant countries, international organizations and third countries, in the fields within its mission; (j) to ensure that the public and interested parties receive rapid, reliable, objective and comprehensible information in the fields within its mission; (k) to express independently its own conclusions and orientations on matters within its mission; (j) to undertake any other task assigned to it by the Commission within its mission.” Id. at art. 23. 165

EU GMOs, supra note 143.

166 Regulation (EC) 1829/2003 amends Regulation (EC) No 258/97 and Regulation (EC) No 1139/98 and repeals Directive 79/112/EEC and Regulation (EC) No 50/200. Id.

“Section 1 Authorization and supervision Article 3 Scope: 1. This Section shall apply to: (a) GMOs for food use; (b) food containing or consisting of GMOs; (c) food produced from or containing ingredients produced from GMOs.” Regulation 1829/2003, art. 3(1), 2003 O.J. (L 2681) 1 (EC). 167

Regional Regulatory Regimes for GMOs • 175

have adverse effects on human health, animal health, or the environment, mislead the consumer, or differ significantly from the food it replaced so that its consumption would be nutritionally disadvantageous for the consumer.168 Regulation 1829/2003 also provides, in Chapter III, similar requirements for GM feed.169 Food cannot be placed in the internal market unless covered by an authorization, which must satisfy the requirements of Article 4(1).170 An authorization under Regulation 1829/2003 must contain information regarding the transformation events, studies illustrating the food complies with the requirements set out in Article 4(1), conclusions from the performed risk assessments, a monitoring plan for possible environmental effects, and various other requirements.171 The EFSA, in Article 6, has the 168 “Article 4 Requirements: 1. Food referred to in Article 3(1) must not: (a) have adverse effects on human health, animal health, or the environment; (b) mislead the consumer; (c) differ from food which it is intended to replace to such an extent that its normal consumption would be nutritionally disadvantageous for the consumer.” Id. at art. 4. 169

Id. at ch. III.

“2. No person shall place on the market a GMO for food use or food referred to in Article 3(1) unless it is covered by an authorization granted in accordance with this Section and the relevant conditions of the authorization are satisfied.” Id. at art. 4(2). “3. No GMO for food use or food referred to in Article 3(1) shall be authorized unless the applicant for such authorization has adequately and sufficiently demonstrated that it satisfies the requirements of paragraph 1 of this Article.” Id. at art. 4(3). 170

171 “The application shall be accompanied by the following: (a) the name and the address of the applicant; (b) the designation of the food, and its specification, including the transformation event(s) used; (c) where applicable, the information to be provided for the purpose of complying with Annex II to the Cartagena Protocol on biosafety to the Convention on Biological Diversity (hereinafter referred to as the Cartagena Protocol); (d) where applicable, a detailed description of the method of production and manufacturing; (e) a copy of the studies, including, where available, independent, peer-reviewed studies, which have been carried out and any other material which is available to demonstrate that the food complies with the criteria referred to in Article 4(1); (f) either an analysis, supported by appropriate information and data, showing that the characteristics of the food are not different from those of its conventional counterpart, having regard to the accepted limits of natural variations for such characteristics and to the criteria specified in Article 13(2)(a), or a proposal for labeling the food in accordance with Article 13(2)(a) and (3); (g) either a reasoned statement that the food does not give rise to ethical or religious concerns, or a proposal for labeling it in accordance with Article 13(2)(b); (h) where appropriate, the

176 • International Law, Agricultural Biotechnology, and Infectious Disease

option of requesting the performance of safety and risk assessments to facilitate their decision granting authorization of GM foods.172 Once authorization is granted, it is valid for ten years and can be renewed in accordance with Article 11.173 Section 2 addresses labeling provisions for GM food. These requirements will not apply to foods that contain, consist of, or are produced conditions for placing on the market the foods or foods produced from it, including specific conditions for use and handling; (i) methods for detection, sampling (including references to existing officials or standardized sampling methods) and identification of the transformation even and, where applicable, for the detection and identification of the transformation even in the food and/or in food produced from it; (j) samples of the food and their control samples, and information as to the place where the reference material can be accessed; (k) where appropriate, a proposal for post-market monitoring regarding use of the food for human consumption; (l) a summary of the dossier in a standardized form.” Id. at art. 5(3). “4. In the case of an application relating to a GMO for food use, references to ‘food’ in paragraph 3 shall be interpreted as referring to food containing, consisting of or produced from the GMO in respect of which an application is made.” Id. at art. 5(4). 172 “3. In order to prepare its opinion the Authority: (a) shall verify that the particulars and documents submitted by the applicant are in accordance with the criteria referred to in Article 4(1); (b) may ask the appropriate food assessment body of a Member State to carry out a safety assessment of the food in accordance with Article 36 of Regulation (EC) No 178/2002; (c) may ask a competent authority designated in accordance with Article 4 of Directive 2001/18/EC to carry out an environmental risk assessment; however, if the application concerns GMOs to be used as seeds or other plant-propagating material, the Authority shall ask a national competent authority to carry out the environmental risk assessment; (d) shall forward to the Community reference laboratory referred to in Article 32 the particulars referred to in Article 5(3)(i) and (j). The Community reference laboratory shall test and validate the method of detection and identification proposed by the applicant; (e) shall, in verifying the application of Article 13(2)(a), examine the information and data submitted by the applicant to show that the characteristics of the food are not different from those of its conventional counterpart, having regard to the accepted limits of natural variations for such characteristics.” Id. at art. 6(3).

“The authorization granted in accordance with the procedure referred to in this regulation shall be valid throughout the Community for 10 years and shall be renewable in accordance with Article 11. The authorized food shall be entered in the Register referred to in Article 28. Each entry in the Register shall mention the date of authorization and shall include the particulars referred to in paragraph 2.” Id. at art. 7(5). 173

Regional Regulatory Regimes for GMOs • 177

from GMOs in a proportion no higher than 0.9 percent, either assessed from the food ingredients considered individually or as a whole, whose presence must be adventitious or technically unavoidable.174 These requirements also hold for labeling of GM feed.175 Products used for both food and feed can be submitted on a single application, which will result in one opinion and decision from the European Union.176 Permitting a single application process for products used as both food and feed promotes further harmonization of legislation addressing GM food. Article 47 provides transitional measures for the adventitious or technically unavoidable presence of GM material in food or feed.177 If the food “1. This Section shall apply to foods which are to be delivered as such to the final consumer or mass caterers in the Community and which: (a) contain or consist of GMOs; or (b) are produced from or contain ingredients produced from GMOs.” Id. at art. 12(1). “2. This Section shall not apply to foods containing material which contains, consists of or is produced from GMOs in a proportion no higher than 0.9 per cent of the food ingredients considered individually or food consisting of a single ingredient, provided that this presence is adventitious or technically unavoidable.” Id. at art. 12(2). 174

175 “1. This Section shall apply to feed referred to in Article 15(1). 2. This Section shall not apply to feed containing material which contains, consists of or is produced from GMOs in a proportion no higher than 0.9 per cent of the feed and of each feed of which it is composed, provided that this presence is adventitious or technically unavoidable. 3. In order to establish that the presence of this material is adventitious or technically unavoidable, operators must be in a position to supply evidence to satisfy the competent authorities that they have taken appropriate steps to avoid the presence of such materials. 4. Appropriate lower thresholds may be established in accordance with the procedure referred to in Article 35(2), in particular in respect of feed containing or consisting of GMOs, or in order to take into account advances in science and technology.” Id. at art. 24. 176 “1. Where a product is likely to be used as both food and feed, a single application under Articles 5 and 17 shall be submitted and shall give rise to a single opinion from the Authority and a single Community decision. 2. The Authority shall consider whether the application for authorization should be submitted both as food and feed.” Id. at art. 27.

“1. The presence in food or feed of material which contains, consists of or is produced from GMOs in a proportion no higher than 0.5% shall not be considered to be in breach of Article 4(2) or Article 16(2), provided that: (a) this presence is adventitious or technically unavoidable; (b) the genetically modified material has benefited from a favorable opinion from the Community Scientific Committee(s) or the 177

178 • International Law, Agricultural Biotechnology, and Infectious Disease

or feed received a positive risk evaluation, the presence of an adventitious or technically unavoidable level no higher than 0.5 percent will not violate Article 4(2) or 16(2).178 But certain factors must be present to prevent a breach, such as the presence of the material must be adventitious or technically unavoidable, the GM material received a positive opinion from the ESFA, the authorization application has not been rejected, and detection methods for detecting adventitious or technically avoidable levels are publicly available.179 These requirements are very strict and place a high burden on countries attempting to export GMOs to the European Union that do not maintain the same level of acceptable adventitious material in their products or did not obtain a risk assessment from EFSA. These authorization procedures, delineated in Regulation 1829/2003, provide streamlined process for GMOs and facilitates the development of a comprehensive, accountable, and strict framework for GMOs and GM material in the European Union. Regulation (EC) 258/97 still applies to two GM organisms but only in a transitional capacity, after which Regulation 1829/2003 will apply.180 Regulation 258/97 addresses novel foods and feed ingredients and sets out assessment and labeling procedures for these products.181 Article 1(2) delineates the scope of Regulation 258/97, which covers food and food

Authority before the date of application of this Regulation; (c) the application for its authorization has not been rejected in accordance with the relevant Community legislation; and (d) detection methods are publicly available. 2. In order to establish that the presence of this material is adventitious or technically unavoidable, operators must be in a position to demonstrate to the competent authorities that they have taken appropriate steps to avoid the presence of such materials. 3. The thresholds referred to in paragraph 1 may be lowered in accordance with the procedures referred to in Article 35(2), in particular for GMOs sold directly to the final consumer. 4. Detailed rules for implementing this Article shall be adopted in accordance with the procedures referred to in Article 35(2). 5. This Article shall remain applicable for a period of three years after the date of application of this Regulation.” Id. at art. 47. 178

Id.

179

Id.

180

EU GMOs, supra note 143.

EUROPA, Novel foods and novel food ingredients, at http://europa.eu/scadplus/leg/en/lvb/l21119.htm (July 26, 2006). 181

Regional Regulatory Regimes for GMOs • 179

ingredients consisting of, produced from, or containing GMOs.182 Also included within the purview of Regulation 258/97 are food and feed ingredients isolated from microorganisms, fungi, or algae, those with new or intentionally modified molecular structures, those with from plants and animals not obtained through traditional breeding with a history of safe use, or those resulting from production processes that significantly affect nutritional value, metabolism, or level of undesirable substances.183 Article 3 require that the food and feed ingredients covered in Article 1 not present a danger to or mislead the consumer or differ from their conventional counterparts so that their consumption would be nutritionally disadvantageous.184 Food or feed ingredients produced from GMOs, but not containing them, are not subject to the request for admittance, notification, assessment, and labeling provisions required by Articles 4, 6, 7, and 8.185 “This Regulation shall apply to the placing on the market within the Community of foods and food ingredients which have not hitherto been used for human consumption to a significant degree within the Community and which fall under the following categories: (a) foods and food ingredients containing or consisting of genetically modified organisms within the meaning of Directive 90/220/EEC; (b) foods and food ingredients produced from, but not containing, genetically modified organisms; (c) foods and food ingredients with new or intentionally modified primary molecular structure; (d) foods and food ingredients consisting of or isolated from micro-organisms, fungi or algae; (e) foods and food ingredients consisting of or isolated from plants and food ingredients isolated from animals, except for foods and food ingredients obtained by traditional propagating or breeding practices and having a history of safe food use; (f) foods and food ingredients to which has been applied a production process not currently used, where that process gives rise to significant changes in the composition or structure of the foods or food ingredients which affect their nutritional value, metabolism or level of undesirable substances.” Regulation 258/97, art. 1(2), 1997 O.J. (L 043) 1 (EC). 182

183

Id.

“1. Foods and food ingredients falling within the scope of this Regulation must not: present a danger for the consumer, mislead the consumer, differ from foods or food ingredients which they are intended to replace to such an extent that their normal consumption would be nutritionally disadvantageous for the consumer.” Id. at art. 3(1). 184

“3. Paragraph 2 shall not apply to the foods and food ingredients referred to in Article 1(2)(b) where the genetically modified organism used in the production of the food or food ingredient has been placed on the market in accordance with this Regulation.” Id. at art. 3(3). “1. The person responsible for placing on the Community market (hereinafter ‘the applicant’) shall submit a request to the Member States in 185

180 • International Law, Agricultural Biotechnology, and Infectious Disease

The notification procedures in Article 5 are required for food and feed ingredients produced from GMOs, isolated from microorganisms, fungi, and algae and obtained from animals and plants without a history of safe use, if these products are substantially equivalent to existing food and feed ingredients in composition, nutritional value, metabolism, intended use, which the product is to be placed on the market for the first time. At the same time, he shall forward a copy of the request to the Commission. 2. An initial assessment as provided for in Article 6 shall be carried out. Following the procedure referred to in Article 6(4), the Member State referred to in paragraph 1 shall inform the applicant without delay; that he may place the food or food ingredient on the market, where the additional assessment referred to in Article 6(3) is not required, and that no reasoned objection has been presented in accordance with Article 6(4), or that in accordance with Article 7, an authorization decision is required. 3. Each Member State shall notify to the Commission the name and address of the food assessment bodies responsible in its territory for preparing the initial assessment reports referred to in Article 6(2). 4. Before the date of entry into force of this regulation, the Commission shall publish recommendations concerning the scientific aspects of: the information necessary to support an application and the presentation of such information, the preparation of the initial assessment reports provided for in Article 6. 5. Any detailed rules for implementing this Article shall be adopted in accordance with the procedure laid down in Article 13.” Id. at art. 4. “1. The request referred to in Article 4(1) shall contain the necessary information, including a copy of the studies which have been carried out and any other material which is available to demonstrate that the food or food ingredient complies with the criteria laid down in Article 3(1), as well as an appropriate proposal for the presentation and labeling, in accordance with the requirements of Article 8, of the food or food ingredient. In addition, the request shall be accompanied by a summary of the dossier. 2. Upon receipt of the request, the Member State referred to in Article 4(1) shall ensure that an initial assessment is carried out. To that end, it shall notify the Commission of the name of the competent food assessment body responsible for preparing the initial assessment report, or ask the Commission to arrange with another Member State for one of the competent food assessment bodies referred to in Article 4(3) to prepare such a report. The Commission shall forward to the Member States without delay a copy of the summary provided by the applicant and the name of the competent body responsible for carrying out the initial assessment. 3. The initial assessment report shall be drawn up within a period of three months from receipt of a request meeting the conditions laid down in paragraph 1, in accordance with the recommendations referred to in Article 4(4), and shall decide whether or not the food or food ingredient requires additional assessment in accordance with Article 7. 4. The Member State concerned shall without delay forward the report of the competent food assessment body to the Commission, which shall forward it to other Member States. Within a period of 60 days from the date of circulation of the report by the Commission, a Member State or the Commission may make

Regional Regulatory Regimes for GMOs • 181

and level of undesirable substances.186 Article 9 delineates the information comments or present a reasoned objective to the marketing of the food or food ingredient concerned. The comments or objections may also concern the presentation or labeling of the food or food ingredient. Comments or objections shall be forwarded to the Commission, which shall circulate them to Member States within the period of 60 days referred to in the first subparagraph. The applicant shall, where a Member State so requests, provide a copy of any pertinent information appearing in the request.” Id. at art. 6. “1. Where an additional assessment is required in accordance with Article 6(3) or an objection is raised in accordance with Article 6(4), an authorization decision shall be taken in accordance with the procedure laid down in Article 13. 2. The decision shall define the scope of the authorization and shall establish, where appropriate: the conditions of use of the food or food ingredient, the designation of the food or food ingredient, and its specification, specific labeling requirements as referred to in Article 8. 3. The Commission shall without delay inform the applicant of the decision taken. Decisions shall be published in the Official Journal of the European Communities.” Id. at art. 7. “1. Without prejudice to the other requirements of Community law concerning the labeling of foodstuffs, the following additional specific labeling requirements shall apply to foodstuffs in order to ensure that the final consumer is informed of: (a) any characteristic or food property such as: composition, nutritional value or nutritional value or nutritional effects, intended use of the food, which renders a novel food or food ingredient no longer equivalent to an existing food or food ingredient. A novel food or food ingredient shall be deemed to be no longer equivalent for the purpose of this Article if scientific assessment, based upon an appropriate analysis of existing data, can demonstrate that the characteristics assessed are different in comparison with a conventional food or food ingredient, having regard to the accepted limits of natural variations for such characteristics. In this case, the labeling must indicate the characteristics or properties modified, together with the method by which that characteristic or property was obtained; (b) the presence in the novel food or food ingredient of material which is not present in an existing equivalent foodstuff and which may have implications for the health of certain sections of the population; (c) the presence in the novel food or food ingredient of material which is not present in an existing equivalent foodstuff and which gives rise to ethical concerns; (d) the presence of an organism genetically modified by techniques of genetic modification, the non-exhaustive list of which is laid down in Annex IA, Part 1 of Directive 90/220/EEC. 2. In the absence of an existing equivalent food or food ingredient, appropriate provisions shall be adopted where necessary in order to ensure that consumers are adequately informed of the nature of the food or food ingredient. 3. Any detailed rules for implementing this Article shall be adopted in accordance with the procedure laid down in Article 13.” Id. at art. 8. “By way of derogation from paragraph 2, the procedure laid down in Article 5 shall apply to foods or food ingredients referred to in Article 1(2)(b), (d) and (e) which, on the basis of the scientific evidence available and generally recognized or on 186

182 • International Law, Agricultural Biotechnology, and Infectious Disease

required for market placement of a food or feed ingredient containing or consisting of a GMO.187 All kinds of GMOs have the potential of being accidentally or intentionally released into the environment. The single authorization procedure set forth in Regulation 1829/2003 facilitates the tracking of GMOs within the European Union, but separate procedures are required to manage the potential release of GMOs into the environment. Directive 2001/18, which replaced Directive 90/220/EEC, permits the deliberate release into the environment of some GMOs after adherence to risk assessment procedures.188 This directive develops both harmonized procedures and criteria and a common methodology for risk evaluation of deliberate release

the basis of an opinion delivered by one of the competent bodies referred to in Article 4(3), are substantially equivalent to existing foods or food ingredients as regards their composition, nutritional value, metabolism, intended use and the level of undesirable substances contained therein.” Id. at art. 3(4). “1. Where a food or food ingredient falling within the scope of this regulation contains or consists of a genetically modified organism within the meaning of Article 2(1) and (2) of Directive 90/220/EEC, the information required in the request for placing on the market referred to in Article 6(1) shall be accompanied by: a copy of the written consent, if any, from the competent authority, to the deliberate release of the genetically modified organisms for research and development purposes provided for in Article 6(4) of Directive 90/220/EEC, together with the results of the release(s) with respect to any risk to human health and the environment; the complete technical dossier supplying the relevant information requested in Article 11 of Directive 90/220/EEC and the environmental risk assessment based on this information, the results of any studies carried out for the purposes of research and development or, where appropriate, the decision authorizing the placing on the market provided for in part C of Directive 90/220/EEC. Articles 11 to 18 of Directive 90/220/EEC shall not apply to foods and food ingredients which contain or consist of genetically modified organisms. 2. In the case of foods or food ingredients falling within the scope of this Regulation containing or consisting of genetically modified organisms, the decision referred to in Article 7 shall respect the environmental safety requirements laid down by Directive 90/220/EEC to ensure that all appropriate measures are taken to prevent the adverse effects on human health and the environment which might arise from the deliberate release of genetically modified organisms. During evaluation of requests for the placing on the market of products containing or consisting of genetically modified organism, the necessary consultations shall be held by the Commission or the Member States with the bodies set up by the Community or the Member States in accordance with Directive 90/220/EEC.” Id. at art. 9. 187

Regional Regulatory Regimes for GMOs • 183

procedures.189 The intentional introduction of GMOs into the environment should proceed according to the “step by step” principle, which consists of reducing GMO containment and gradually increasing release if the evaluation, addressing issues of risk to human health and the environment, of previous steps permits such action.190 Deliberate release refers to the “intentional introduction into the environment of a GMO or a combination of GMOs for which no specific containment measures are used to limit their contact” with the environment.191 EU member states are required, under Article 4(1), to ensure that all measures are performed to avoid adverse effects on human health and the environment.192 This includes providing both environmental risk assessments and inspection and control measures and examining possible adverse effects on a case-by-case basis.193 Directive 2001/18 also sets 188

EU GMOs, supra note 143.

189

Directive 2001/18, pmbl., 2001 O.J. (L 106) 1 (EC).

190

Id.

191 “For the purposes of this Directive: . . . (3) ‘deliberate release’ means any intentional introduction into the environment of a GMO or a combination of GMOs for which no specific containment measures are used to limit their contact with and to provide a high level of safety for the general population and the environment[.]” Id. at art. 2(3).

“Member States shall, in accordance with the precautionary principle, ensure that all appropriate measures are taken to avoid adverse effects on human health and the environment which might arise from the deliberate release of the placing on the market of GMOs. GMOs may only be deliberately released or placed on the market in conformity with part B or part C respectively.” Id. at art. 4(1). 192

“Any person shall, before submitting a notification under part B or part C, carry out an environmental risk assessment. The information which may be necessary to carry out the environmental risk assessment is laid down in Annex III. Member States and the Commission shall ensure that GMOs which contain genes expressing resistance to antibiotics in use for medical or veterinary treatment are taken into particular consideration when carrying out an environmental risk assessment, with a view to identifying and phasing out antibiotic resistance markers in GMOs which may have adverse effects on human health and the environment. This phasing out shall take place by the 31 December 2004 in the case of GMOs placed on the market according to part C and by 32 December 2008 in the case GMOs authorized under part B.” Id. at art. 4(2). “Member States and where appropriate the Commission shall ensure that potential adverse effects on human health and the environment, which may occur 193

184 • International Law, Agricultural Biotechnology, and Infectious Disease

forth detailed provisions for situations involving release into the market and release for other purposes unrelated to GMO market placement.194 Each section contains measures addressing notification, new information attainment and provision modification, and tiered authorization procedures.195 The annexes of Directive 2001/18 provide information on genetic modification techniques, environmental risk assessment principles, and notification requirements for release of GMOs.196 Directive 2001/18 allows for a controlled introduction of GMOs into the environment, with numerous checkpoints throughout the process. Regulatory efforts for the introduction of GMOs would be incomplete without legislation addressing the subsequent movement of such products. Regulation (EC) 1946/2003 governs the transboundary movement of GMOs within and beyond the borders of the European Union.197 Its primary goal is to implement the provisions of the Biosafety Protocol, which aims to ensure an “adequate level of protection for the transfer, handling and use of GMOs that may have adverse effects on the environment and human health.”198 Labeling issues and concerns had not been fully addressed legislatively until Regulation (EC) 1830/2003.199 Council Regulation (EC) directly or indirectly through gene transfer from GMOs to other organisms, are accurately assessed on a case-by-case basis. This assessment shall be conducted in accordance with Annex II taking into account the environmental impact according to the nature of the organism introduced and the receiving environment.” Id. at art. 4(3). “Member States shall ensure that the competent authority organizes inspections and other control measures appropriate, to ensure compliance with this Directive. In the event of a release of GMO(s) or placing on the market as or in products for which no authorization was given, the Member State concerned shall ensure that necessary measures are taken to terminate the release or placing on the market, to initiate remedial action if necessary, and to inform its public, the Commission and other Member States.” Id. at art. 4(5). 194

Id. at part B.

195

Id.

196

Id. at ann. IA, II, III.

197

EU GMOs, supra note 143.

EUROPA, Transboundary movement of genetically modified organisms, at http://europa.eu/scadplus/leg/en/lvb/l28119.htm (last updated Jan. 28, 2004). 198

199

EU GMOs, supra note 143.

Regional Regulatory Regimes for GMOs • 185

1139/98 governed labeling concerns in the European Union, prior to Regulation 1830/2003, for GMOs and, later amended by Commission Regulation (EC) 49/2000, harmonized labeling requirements for GM maize or soya.200 Regulation 1139/98 specified the exact language required for labels on foods and food ingredients produced whole, or in part, from GM maize or soya.201 Regulation 49/2000, in January 2000, amends Regulation 1139/98 and provides a de minimis level for adventitious content of DNA or proteins resulting from GM food.202 Food contaminated with GM soya or maize does not have to be labeled pursuant to Regulation 1129/98 if the adventitious presence of DNA or protein is not higher than 1 percent of the relevant food ingredients.203 Regulation 1830/2003 amends Directive 2001/18 by harmonizing the EU framework for labeling and traceability of GMOs, thus promoting the effective functioning of the internal market.204 Regulation 1830/2003 ensures traceability and labeling for GMOs at all stages of the food chain while providing a high level of protection for the environment and health.205 Regulation 1830/2003 presents two primary objectives, which use this compulsory labeling framework to inform consumers and develop a “safety net” based on traceability through all stages of production.206 200 This regulation referred to genetically modified soya with increased tolerance to the herbicide glyphosate and genetically modified maize with combined modification for insecticidal properties conferred by the Bt-endotoxin gene and increased tolerance to the herbicide glufosinate ammonium. These products are covered by Decision 96/281/EC and Decision 97/98/EC, respectively. Council Regulation 1139/98, 1998 O.J. (L 159) 1 (EC).

“This Regulation shall apply to food and food ingredients which are to be delivered as such to the final consumer (hereinafter referred to as the ‘specified foodstuffs’) produced, in whole or in part, from: genetically modified soya beans covered by Decision 96/281/EC, genetically modified maize covered by Decision 97/98/EC.” Id. at art. 1(1). 201

202

Commission Regulation 49/2000, 2000 O.J. (L 6) 13 (EC).

203 EUROPA, Labeling of foods containing genetically modified maize and soya, at http://europa.eu/scadplus/leg/en/lvb/l21233.htm (last visited Jan. 4, 2007). 204

Regulation 1830/2003, 2003 O.J. (L 268) 24 (EC).

This regulation harmonizes the traceability measures set forth in Directive 2001/18/EC, which addresses deliberate release of genetically modified/engineered/GMOs into the environment. It also repeals Council Directive 90/220/EEC. Id. 205

206

Id.

186 • International Law, Agricultural Biotechnology, and Infectious Disease

Traceability is defined, in Regulation 1830/2003, as the ability to “trace GMOs and products from GMOs at all stages of their placing on the market through the production and distribution chains.”207 These traceability measures facilitate the withdrawal of GMOs that pose “unforeseen adverse effects on human health, animal health or the environment” and promote the implementation of risk management provisions based on the precautionary principle.208 Regulation 1830/2003 applies, from production to market integration, to all products consisting of, or containing GMOs and GM food and feed.209 Before a product consisting of or containing GMOs can be placed on the market, the operator receiving the product must obtain written confirmation that the product contains or consists of GMOs.210 Labels developed for these products must contain the specific phrases enumerated in Article 4 of Regulation 1830/2003.211 These traceability and labeling provisions do not apply to products, either used as is or intended for direct use in food, feed, or processing, containing trace levels of GMOs in levels no “3. ‘Traceability’ means the ability to trace GMOs and products produced from GMOs at all stages of their placing on the market through the production and distribution chains;” Id. at art. 3(3). 207

208

Id.

209 “1. This Regulation shall apply, at all stages of the placing on the market, to: (a) products consisting of, or containing, GMOs placed on the market on accordance with Community legislation; (b) food produced from GMOs, placed on the market on accordance with Community legislation; (c) feed produced from GMOs, placed on the market in accordance with Community legislation. 2. This regulation shall not apply to medicinal products for human and veterinary use authorized under Regulation (EEC) No 2309/93.” Id. at art. 2. 210 “1. At the first stage of the placing on the market of a product consisting of or containing GMOs, including bulk quantities, operators shall ensure that the following information is transmitted in writing to the operator receiving the product: (a) that it contains or consists of GMOs; (b) the unique identifier(s) assigned to those GMOs in accordance with Article 8.” Id. at art. 4A(1).

“6. For products consisting of or containing GMOs, operators shall ensure that: (a) for pre-packaged products consisting of, or containing GMOs, the words ‘This product contains genetically modified organisms’ or ‘This product contains genetically modified [name of organism(s)]’ shall appear on, or in connection with, the display of the product. This paragraph shall be without prejudice to other specific requirements in Community legislation.” Id. at art. 4B(6). 211

Regional Regulatory Regimes for GMOs • 187

higher than those specified in other EU legislation, if these traces of GMOs are adventitious or technically unavoidable.212 Article 5 also sets forth more specific traceability and labeling provisions for products for food and feed produced from GMOs.213 Regulation 1830/2003 allows for the development of “unique identifiers,” which are numeric or alphanumeric codes that identify a GMO based on its transformation event and can be used for obtaining specific information on a GMO.214 This regulation allows for a consistent, harmonized approach to labeling and trace212 “7. Paragraphs 1 to 6 shall not apply to traces of GMOs in products in a proportion no higher than the thresholds established in accordance with Article 21(2) or (3) of Directive 2001/18/EC and in other specific Community legislation, provided that these traces of GMOs are adventitious or technically unavoidable.” Id. at art. 4C(7). “Paragraphs 1 to 6 shall not apply to traces of GMOs in products intended for direct use as food, feed or for processing in a proportion no higher than the thresholds established for those GMOs in accordance with Articles 12, 24 or 47 of Regulation (EC) No 1829/2003, provided that these traces of GMOs are adventitious or technically unavoidable.” Id. at art. 4C(8). 213 “1. When placing products produced from GMOs on the market, operators shall ensure that the following information is transmitted in writing to the operator receiving the product: (a) an indication of each of the food ingredients which is produced from GMOs; (b) an indication of each of the feed materials or additives which is produced from GMOs; (c) in the case of products for which no list of ingredients exists, an indication that the product is produced from GMOs. 2. Without prejudice to Article 6, operators shall have in place systems and standardized procedures to allow the holding of the information specific in paragraph 1 and the identification, for a period of five years from each transaction, of the operator by whom and to whom the products referred to in paragraph 1 have been made available. 3. Paragraphs 1 and 2 shall be without prejudice to other specific requirements in Community legislation. 4. Paragraphs 1, 2, and 3 shall not apply to traces of GMOs in products for food and feed produced from GMOs in a proportion no higher than the thresholds established for those GMOs in accordance with Articles 12, 24, or 47 of Regulation (EC) No 1829/2003, provided that these traces of GMOs are adventitious or technically unavoidable.” Id. at art. 5.

“4. ‘Unique identifier’ means a simple numeric or alphanumeric code which serves to identify a GMO on the basis of the authorized transformation event from which it was developed and providing the means to retrieve specific information pertinent to that GMO[.]” Id. at art. 3(4). “In accordance with the procedure referred to in Article 10(2), the Commission shall: (a) prior to the application of Articles 1 to 7 establish a system for development and assignment to unique identifiers to GMOs; (b) adapt the system provided for in point (a), as appropriate. In so doing, account shall be taken of developments in international fora.” Id. at art. 8. 214

188 • International Law, Agricultural Biotechnology, and Infectious Disease

ability for all products containing a certain level of GMOs or GM ingredients. By tracking and identifying all products containing GMOs or GM products, the European Union is able to monitor more easily possible impacts presented by GMOs. Directive (EEC) 219/90 promotes human health by ensuring the containment and limiting the spread of GM microorganisms into the environment.215 GM microorganisms are classified into two separate groups, depending on characteristics of both the vector and the recipient organism.216 Article 2(b) defines “genetically modified microorganism” as a microorganism whose genetic material has been altered using one of the techniques specified in Annex I of Directive 219/90.217 Facilitating the safe utilization of genetic modification techniques in the European Union requires the development of common measures that limit the potential adverse effects related to the contained use of GM microorganisms.218 These measures include risk assessment, consent, and notification requirements, containment specifications for every operation stage, and plans for emergency situations.219 Directive 98/81/EC, passed in 1998, amends Directive 219/90 to account for technical progress and provide a list of GM microorganisms safe for human health and the environment.220 GM microorganisms also affect public health in the European Union, which is governed by a collection of decisions and directives aimed at creating a more responsive health protection strategy. The EU public health framework has similar goals to the food safety regime set forth by the EFSA. In response to the expanding European Union, pressure on health systems, and the emergence of new illnesses, the European Union developed a new framework promoting a more inte215

EU GMOs, supra note 143.

216

Council Directive 90/219/EEC, Annex II, 1990 O.J. (L 117) 1 (EC).

“For the purposes of this Directive: . . . (b) ‘genetically modified microorganism’ shall mean a microorganism in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination.” Id. at art. 2(b), Annex I. 217

218

Id. at pmbl.

219

Id.

220

Council Directive 98/81, 1998 O.J. (L 330) 13 (EC).

Regional Regulatory Regimes for GMOs • 189

grated health strategy with a focus on a high level of health protection.221 Decision 1786/2002/EC sets out this framework consisting of three main objectives, which focus on improving the availability of health information, developing rapid response mechanisms for major health threats, and assessing health determinants, such as harmful factors related to lifestyle.222 Monitoring and rapid response systems will consist of networking activities fostering shared public health information and monitoring, activities geared at responding to unforeseen health threats, and preparatory efforts related to integrating health networks, monitoring, and rapid reaction systems.223 Within these objectives, the public health framework includes other legislative measures, such as an international network of epidemiological surveillance and veterinary and phytosanitary measures.224 The phytosanitary measures will be closely connected to the policies developed for food safety in the European Union.225 To foster coherence in the EU’s global health strategy, new mechanisms and instruments for health protection are being integrated into other policy areas, such as the internal market, consumer protection, and the environment.226 Decision 2004/210/EC sets up Scientific Committees within the European Union to address issues of consumer safety, public health, and the environment and work in conjunction with the EFSA.227 Relevant committees under Decision 2004/210/EC to GMOs and infectious disease are the Scientific Committees on Health and Environmental Risks (Health and Environmental Risks Committee) and Emerging and Newly Identified 221 EUROPA, New European Community health strategy, at http://europa.eu/scadplus/leg/en/cha/c11563.htm (last updated Mar. 17, 2005) [hereinafter EU Health Strategy]. 222

Id.

223

Decision 1786/2002, art. 3(2)(a), 2002 O.J. (L 271) 1 (EC).

224

EU Health Strategy, supra note 221.

225

Id.

226

Id.

EUROPA, Scientific Committees for consumer safety, public health and the environment, at http://europa.eu/scadplus/leg/en/lvb/l28153.htm (last updated May 18, 2005). 227

190 • International Law, Agricultural Biotechnology, and Infectious Disease

Health Risks (Health Risks Committee).228 The Health and Environmental Risks Committee is responsible for providing opinions on the “toxicity and ecotoxicity of chemical, biochemical, and biological compounds, particularly new and existing chemicals,” as well as environmental contaminants.229 The Health Risks Committee is responsible for addressing questions on multi-disciplinary issues requiring “a comprehensive assessment of risks to consumer safety or public health.”230 Relevant areas include “potential risks associated with interaction of risk factors, synergistic effects, cumulative effects, antimicrobial resistance,” new technologies, and methodologies for assessing new risks.231 The European Center for Disease Prevention and Control (the Center), as established by Regulation (EC) 851/2004, is charged with identifying, assessing, and communicating threats to human health related to both current and emerging communicable diseases in the European Union.232 Its main tasks consist of epidemiological surveillance, early warning and response systems, scientific opinions, technical assistance, and developing measures to prepare for new health threats.233 The Center will harmonize surveillance methods, encourage and monitor cooperation between laboratory networks, and provide independent scientific opinions on infectious disease agents that may threaten public health.234 Operation and coordination of the early warning and response system also falls under the purview of the Center, in addition to identifying emerging health threats.235 Decision 2119/98/EC establishes the network for the epidemiological surveillance and control of communicable diseases in the European

228

Id.

229

Id.

230

Id.

231

Id.

EUROPA, European Center for Disease Prevention and Control, at http:// europa.eu/scadplus/leg/en/cha/c11541.htm (last updated July 27, 2006). 232

233

Id.

234

Id.

235

Id.

Regional Regulatory Regimes for GMOs • 191

Union.236 This network will be utilized for both the epidemiological surveillance and an early warning and response system for the prevention and control of communicable diseases.237 Decisions 2000/96/EC and 2002/253/EC list and define the communicable diseases subject to the surveillance network, with foodborne and waterborne diseases comprising one focus area under Decision 2000/96/EC.238 An early warning system, provided by Decision 2000/57/EC, facilitates the exchange of information between member states and the European Commission.239 Certain events involving communicable diseases must be reported under Decision 2000/57/EC, such as outbreaks of communicable diseases extending to more than one member state or the appearance of a communicable disease or pathogen that may require coordinated action within the European Union.240 Increasing anti-microbial resistance is prompting the European Union to develop an overall approach to bolster existing EU legislation addressing anti-microbial substances.241 The strategy for dealing with anti-microbial resistance comprises four main areas, such as surveillance, prevention, research and development, and international cooperation.242 Priorities for surveillance focus primarily on intra-EU mechanisms and participation, with an aim to expand and improve data collection regarding consumption of anti-microbial agents in all sectors of the European Union.243 Resistance to anti-microbial agents is not the only goal of surveillance; EUROPA, Network for the surveillance and control of communicable diseases, at http://europa.eu/scadplus/leg/en/cha/c11548b.htm (last updated Sept. 7, 2005). 236

237

Id.

238 Both of these Decisions were amended by Commission Decision 2003/534/EC. Commission Decision 2000/96, 2000 O.J. (L 28) 50 (EC); Commission Decision 2002/253, 2002 O.J. (L 86) 44 (EC).

EUROPA, Early warning and response system for the prevention and control of communicable diseases, at http://europa.eu/scadplus/leg/en/cha/c11548c.htm (last updated Nov. 30, 2005). 239

240

Id.

241 EUROPA, Community strategy against antimicrobial resistance, at http://europa.eu/scadplus/leg/en/cha/c11568.htm (last updated May 26, 2005). 242

Id.

243

Id.

192 • International Law, Agricultural Biotechnology, and Infectious Disease

trends of communicable diseases and infections can also illustrate possible resistance to anti-microbial agents.244 Prevention mechanisms include emphasis on information dissemination, infection prevention programs, a reinforced food monitoring system, and removal of anti-microbial agents as growth promoters in feed.245 Special attention needs to be given to GMOs that contain antibiotic-resistant genes utilized for medical or veterinary purposes, so that such organisms and genes can be monitored for potential adverse effects on human health and the environment.246 Research and product development will focus on the development of new microbial agents, alternative treatments and vaccines, and rapid and reliable diagnostic tests.247 International cooperation is also crucial for successful efforts at curtailing the spread of anti-microbial resistance, due to the ease in which anti-microbial agents move across national and international borders.248 This collection of legislation illustrates a move towards a public health regime focused on detection and surveillance of anti-microbial and communicable disease threats. The integration of health protection into other areas, such as food safety, the internal market, and environmental protection, facilitates the development of a more cohesive EU health and food safety strategy. This integrated regulatory approach to public health and food safety issues provides a solid legislative backdrop for GMOs and infectious disease, which increases the consideration of these two areas in future regulatory efforts. C.

AFRICAN UNION

The African Union,249 in 2001, developed the OAU Draft Model National Legislation on Safety in Biotechnology (African Model Law) to 244

Id.

245

Id.

246

Id.

247

Id.

248

Id.

The African Union, created September 9, 1999 by the Heads of State and Government on the Organization of African Unity (OAU), issued a declaration establishing the African Union, with the goal of “accelerating the process of integration in 249

Regional Regulatory Regimes for GMOs • 193

harness the promise of GMOs for Africa while ensuring the safety of human health and the environment.250 The Preamble of the African Model Law also refers to the precautionary principle as being the fundamental linchpin for regulatory efforts for GMOs.251 The African Model Law applies, as delineated in Article 2, to the import, export, transit, contained use, release, or placing on the market of any GMO intended for environmental release, pharmaceutical applications, and for food, feed, or processing.252 GMOs are defined, in Article 1, as any biological entity capable of genetic material transfer or replication whose genetic material has been altered through techniques of modern biotechnology.253 Products of

the continent to enable it play its rightful role in the global economy while addressing multifaceted social, economic and political problems compounded as they are by certain negative aspects of globalization.” African Union (AU), African Union in a Nutshell, at http://www.africa-union.org/ (last visited Jan. 3, 2007). AU, African Model Law on Safety in Biotechnology preamble (2001), available at http://www.africa-union.org/root/au/AUC/Departments/HRST/biosafety/AU_ Biosafety.htm (last visited Jan. 3, 2007) [hereinafter African Model Law]. 250

251 “Whereas with the potential risks posed by genetic modification it is consistent with the precautionary principle to regulate any undertaking for the import, contained use, release or placing on the market of genetically modified organisms and products of genetically modified organisms.” Id. 252 “This law shall apply to the import, export, transit, contained use, release or placing on the market of any genetically modified organism whether intended for release into the environment, for use as a pharmaceutical, for food, feed or processing or a product of a genetically modified organism.” Id. at art. 2.

“Genetically modified organism (GMO) means any biological entity, capable of replication or transferring genetic material and includes plants, animals, microorganisms (viruses, bacteria, plasmids), cell cultures and other vector systems in which the genetic material has been altered through modern biotechnology.” Id. at art. 1. “‘Modern biotechnology’ includes the following techniques: i) recombinant nucleic acid techniques involving the formation of new combinations of genetic material by the insertion of nucleic acid molecules produced by whatever means outside an organism into a virus, bacterium, plasmid or other vector, and their incorporation into host organisms in which they do not naturally occur but in which they are capable of continued propagation; ii) techniques involving the direct introduction into an organism of heritable material prepared outside the organism including micro-injection, macroinjection and micro-encapsulation; and iii) cell fusion (including protoplast fusion) or hybridization techniques where live cells with new combinations of heritable genetic material are formed through the fusion of two or more cells.” Id. 253

194 • International Law, Agricultural Biotechnology, and Infectious Disease

GMOs consist of any material obtained through processing from any GMO and their products.254 To facilitate the implementation of the African Model Law, state governments must develop national focal points that liaise with the Biosafety Clearing-House of the Biosafety Protocol.255 In addition to national focal points, state governments also must provide a competent authority to supervise the implementation of the African Model Law.256 The Competent Authority is responsible for prescribing standards and policy recommendations, performing risk assessments257 and inspections, developing legal measures, both domestic and international, to address issues of human health and environmental risks, and maintaining a public database for GMOs.258 The Competent Authority also liaises with the Biosafety “Product of a genetically modified organism means any material derived by processing, or howsoever otherwise, from any genetically modified organism or from a product of a genetically modified organism.” Id. 254

255 “National Focal Point: The government shall designate or establish a National Focal Point to be responsible on its own behalf for liaison with the Secretariat of the Protocol and Clearing-House and facilitate the exchange of information among the relevant bodies and authorities.” Id. at art. 3. 256 “The Government shall designate or establish a Competent Authority to follow up, supervise and control the implementation of this law.” Id. at art. 3(2).

“Risk assessment means the evaluation of the direct and indirect, short, medium and long term risk to the environment, biological diversity or human health, including socio-economic conditions or to ethical values arising from the contained use, release or placing on the market of a genetically modified organism or of a product of a genetically modified organism.” Id. at art. 1. 257

“The powers and duties of the Competent Authority shall include the following: a) to prescribe criteria, standards, guidelines and regulations as may be necessary for the fulfillment of the objective of this law[.]” Id. at art. 3(2)(a). “b) to take into account the policy recommendations and other guidelines of the National Biosafety Committee in making decisions on the import, transit, contained use, release or placing on the market of a genetically modified organism[.]” Id. at art. 3(2)(b). “c) to cause the establishment of Institutional Biosafety Committees at relevant institutions or nominate independent panels or any other body of experts, as appropriate, as technical and scientific advisors on issues of biosafety[.]” Id. at art. 3(2)(c). “d) to keep genetically modified organisms globally under constant review and when any one of them is suspected of posing a serious risk to human health or to the environment, to ban its transiting through the country’s territories and notify the Clearing-House, the customs and trade officials accordingly[.]” Id. at art. 3(2)(d). “f) to maintain and make 258

Regional Regulatory Regimes for GMOs • 195

Clearing-House by providing information regarding importation requirements for GMOs.259 Governmental and non-governmental institutions and representatives of the private sector also must establish national and institutional biosafety committees to provide policy recommendations to the Competent Authority and implement safety mechanisms and approval procedures at the institutional level.260

available to the public on request, a database on genetically modified organisms and products of genetically modified organisms intended for direct use as food or feed, or for processing[.]” Id. at art. 3(2)(f). “h) to review, make or have made risk assessments of genetically modified organisms or products of genetically modified organisms. When the genetically modified organism is to be imported, the cost will be borne by the exporter[.]” Id. at art. 3(2)(h). “i) to take legal measures nationally or internationally to protect human health and the environment from risks that may be posed by genetically modified organisms or of their products, inter alia, through enforcing this law and the Cartagena Protocol on Biosafety[.]” Id. at art. 3(2)(i). “j) to designate inspectors and undertake inspection as well as other control measures to ensure compliance with this law[.]” Id. at art. 3(2)(j). “k) any other functions as may be specified by the government.” Id. at art. 3(2)(k). “e) To inform the Secretariat of the Cartagena Protocol, if appropriate, that it has no access to the Clearing-House[.]” Id. at art. 3(e). “g) to declare through Biosafety Clearing-House that: i) a genetically modified organism or a product of a genetically modified organisms intended as food or feed or for processing may be imported only after it has been subjected to a full risk assessment according to this law, and ii) it is an application to import that will trigger the risk assessment and that it shall not automatically happen every time a new genetically modified organism is posted in the Clearing-House[.]” Id. at art. 3(2)(g). 259

“3) National Biosafety Committee: a) a national biosafety committee comprising representatives of governmental and non-governmental organizations, and the private sector that are relevant to the issues of biotechnology and biosafety shall be established by the government to provide, as appropriate, policy recommendations and guidelines to the Competent Authority. b) The national Biosafety Committee shall further develop based on its general responsibility specified in 2(a) of this Article, its terms of reference and may draw up its own rules of procedure. c) A member of a National Biosafety Committee who finds a conflict of interest in the case at hand shall so declare it and withdraw from the Committee insofar as that case of conflict of interest is concerned.” Id. at art. 3(3). “4) Institutional Biosafety Committee: institutions that are involved in the import, export, handling, contained use, release or placing on the market of genetically modified organisms or products of genetically modified organisms shall establish Institutional Biosafety Committees to institute and control safety mechanisms and approval procedures at the institution level.” Id. at art. 3(4). 260

196 • International Law, Agricultural Biotechnology, and Infectious Disease

An advanced informed agreement261 or written approval, issued in response to a written application, is required, under Article 4, for the importation, transit, placement on the market, or the contained use or release of GMOs.262 The application must include information on previous releases or uses of the relevant GMO, as well as risk assessment reports addressing effects of release on the environment, biological diversity, and human health and possible consequences of unintentional release.263 Article 6 delineates the procedures employed for approval or denial of GMOs, stating that approval cannot be granted unless there is sufficient evidence that the GMO does not pose any risk to the environment, biological diversity, or human health.264 GMO approvals are not permitted unless the approval benefits the country without significant risk, contributes to sustainable development, does not present adverse socio-economic impacts or undermine community knowledge and technologies, and adheres to community ethical values.265 Lack of scientific evidence with “Advance informed agreement means consent obtained based upon full disclosure of all relevant information and the taking of full responsibility by the supplier of the information for its accuracy and completeness before any activity is undertaken.” Id. at art. 1. 261

“1) No person shall import, transit, carry out the contained use of or a release of, or place on the market a genetically modified organism or a product of a genetically modified organism without an advance informed agreement or the explicit written approval of the Competent Authority, whichever is appropriate.” Id. at art. 4(1). “2) Any person who wishes to carry out any import, or deliberate release, or contained use of, or place on the market, a genetically modified organism or a product of a genetically modified organism shall submit an application in writing to the Competent Authority.” Id. at art. 4(2). 262

263 “b) assessment report on risks that may be posed by the genetically modified organism or product of a genetically modified organism upon the environment, biological diversity or human health, including the consequences of unintentional release.” Id. at art. 4(3)(b). “c) information from previous or current release of the genetically modified organism or product of a genetically modified organism by any other country[.]” Id. at art. 4(3)(c).

“No approval shall be given unless there is a firm and sufficient evidence that the genetically modified organism or the product of the genetically modified organism poses no risks/significant risks to human health, biological diversity and in general the environment.” Id. at art. 6(7). 264

265

“No approval shall be given unless it is considered and duly determined by the

Regional Regulatory Regimes for GMOs • 197

respect to significant risk of damage must not hinder the development of preventative measures.266 This provision echoes other domestic, regional, and international instruments that allow development of measures without sufficient scientific evidence, such as the Biosafety Protocol and Article 5.7 of the SPS Agreement. Article 8 sets forth the stipulations for risk assessments performed as required for applications concerning GMOs for contained use applications, importation, release, or market placement.267 Risk assessments must include examination of socio-economic conditions, cultural norms, and risks to the environment, biological diversity, and human health.268 If the assessment illustrates that risks cannot be avoided, approval for the application must be denied.269 Article 9 addresses risk management issues and require the development of an accident containment strategy and other measures to avoid adverse effects resulting from the use of GMOs.270 Such Competent Authority that the import, contained use, release or placing on the market of the genetically modified organism or the product of a genetically modified organism will: a) benefit the country without causing any significant risk to the environment, biological diversity or human health; b) contribute to sustainable development; c) not have adverse socio-economic impacts, and d) accord with ethical values and concerns of communities and does not undermine community knowledge and technologies.” Id. at art. 6(9). “In any event, where there is reason to suspect threats of serious damage, lack of scientific evidence shall not be used as a basis for not taking preventative measures.” Id. at art. 6(8) 266

267

Id. at art. 8.

268 “No decision on any application to import, make contained use of, release or place on the market a genetically modified organism or a product of a genetically modified organism may be made by the Competent Authority without the assessment of risks to the environment, biological diversity and human health, including socioeconomic conditions and cultural norms.” Id. at art. 8(2). 269 “In case where the evaluation of the assessment shows that risks cannot be avoided, the Competent Authority shall refuse approval for the import, contained use of, release or placing on the market the genetically modified organism or product of a genetically modified organism.” Id. at art. 8(5).

“1) The Competent Authority shall develop, maintain and use as the need arises, an accident containment strategy to [protect] human health, biological diversity and, in general, the environment from accidents in genetic engineering, the use of genetically modified organisms, and their products.” Id. at art. 9(1). “2) The Competent 270

198 • International Law, Agricultural Biotechnology, and Infectious Disease

actions include observation period requirements, prohibitions conditioned on the expression of unacceptable risks, and measures created for imminent and serious danger to the environment, biological diversity, and human health.271 The Competent Authority, pursuant to Article 10, develops and implements emergency plans for the unintentional release of GMOs.272 Article 11 imposes generalized labeling requirements, which Authority shall impose such measures, as may be necessary to implement Annex IV and to avoid adverse effects on the environment, biological diversity and human health, including on socio-economic conditions arising from a genetically modified organism or a product of a genetically modified organism.” Id. at art. 9(2). 271 “3) Without limiting the generality of paragraphs 9(1) and 9(2), the Competent Authority may: a) require any genetically modified organisms to undergo a period of observation commensurate with its life-cycle or generation time, at the cost of the applicant, before and after its it put to its intended use[.]” Id. at art. 9(3)(a). “b) prohibit the import, contained use, release or placing on the market of any genetically modified organism or the product of a genetically modified organism, if it contains characteristics or specific traits which pose unacceptable risks to the environment, biological diversity, human health, socio-economic conditions or cultural norms[.]” Id. at art. 9(3)(b). “g) take measures, as necessary, in the case of imminent and serious danger to the environment, biological diversity, human health, socio-economic conditions, or ordre public caused by a genetically modified organism or a product of a genetically modified organism, at the coast of the person responsible for causing such danger[.]” Id. at art. 9(3)(g).

“1. In order to manage the unintentional release and/or emergency arising from an accident with a genetically modified organism or a product of a genetically modified organism, the Competent Authority shall, as necessary, ensure, that: (a) an emergency plan is drawn up for the protection of human health, biological diversity and in general the environment outside the area of release or contained use in the event of an accident and the appropriate emergency services are aware of the hazards and are informed in writing; and (b) information on safety measures and procedures to adopt in the case of an accident is made available by the applicant to persons likely to be affected by the accident. The information shall be updated and made available periodically. It shall also be made available to the general public. 2. The applicant shall inform the Competent Authority immediately of any accident and provide the following information: (a) the circumstances of the accident; (b) the identity and quantity of the genetically modified organism or products of genetically modified organism released unintentionally; (c) any measure necessary to assess the effects of the accident on human health, biological diversity and in general the environment; and (d) the emergency measures taken or to be taken. 3. Upon receipt of the information under paragraph 10(2), the Competent Authority shall: (a) ensure that all measures possible have been taken to neutralize risks to human health, biological diversity and 272

Regional Regulatory Regimes for GMOs • 199

must specify the product’s GM status, relevant traits and characteristics, and potential risks and allergenicity concerns.273 Exportation of a GMO requires a written advance informed agreement from the importing country, as required by Article 13.274 The African Model Law provides liability and redress provisions, which require any person who imports, utilizes contained use, releases, or places on the market GMOs or their products strictly liable for any harm cased by the GMO.275 Liability is joint and several and applies to all developers, producers, and suppliers involved in the manufacture and marketing for GMOs.276 Compensation for harm to biological diversity or the in general the environment; and (b) inform relevant government and non-governmental organizations in countries likely to be affected, and the Biosafety ClearingHouse.” Id. at art. 10. 273 “1. Any genetically modified organism or product of a genetically modified organism shall be clearly identified and labeled as such, and the identification shall specify the relevant traits and characteristics given in sufficient detail for purposes of traceability. 2. Any genetically modified organism or any product of a genetically modified organism shall be clearly labeled and packaged using the words given in Annex II, part C, and shall comply with such further requirements, if any, imposed by the Competent Authority, to indicate that it is, or has been derived from, a genetically modified organism, and, where applicable, whether it may cause allergies or pose other risks.” Id. at art. 11. 274 “1. Any person who intends to export a genetically modified organism or a product of a genetically modified organism shall provide to the Competent Authority a written advance informed agreement of the Competent Authority of the importing country. 2. The presentation of the advance informed agreement by an exporter shall in no way absolve the exporter from complying with any other laws governing foreign trade. 3. The submission of the advance informed agreement shall not preclude the country of the exporter from taking into account other considerations in deciding whether or not to approve the export. 4. There shall be no authorization for the reexport of a genetically modified organism that has been banned by the laws of the exporting country.” Id. at art. 13.

“1. A person who imports, arranges transit, makes contained use of, releases or places on the market a genetically modified organism or a product of a genetically modified organism shall be strictly liable for any harm caused by such a genetically modified organism. The harm shall be fully compensated.” Id. at art. 14(1). 275

“2. Liability shall attach to the person responsible for the activity which results in the damage, injury, or loss as well as to the provider, supplier or developer of the genetically modified organism or of the product of a genetically modified organism.” 276

200 • International Law, Agricultural Biotechnology, and Infectious Disease

environment consists of reinstatement costs and rehabilitation, clean up, and prevention measures.277 Economic harm and damage to social and cultural conditions, and livelihood of indigenous community knowledge systems or technologies are also potential areas of liability.278 Article 14 minimally limits the viable time frame to bring a cause of action regarding harm caused by a GMO.279 Any person, group of persons, private or state organization has standing to bring an action for breach of “any provision relating to damage to the environment, to biological diversity, to human health or to socio-economic conditions.”280 Article 15 states that Id. at art. 14(2). “3. If there is more than one person responsible for the damage, injury or loss, then the liability shall be joint and several.” Id. at art. 14(3). 277 “4. In the case of harm to the environment or biological diversity, compensation shall include the costs of reinstatement, rehabilitation or clean-up measures which actually are being incurred and, where applicable, the costs of preventative measures.” Id. at art. 14(4).

“5. In the case of harm to human health, compensation shall include: a) all costs and expenses incurred in seeking and obtaining the necessary and appropriate medical treatment; b) compensation for any disability suffered, for diminished quality of life, and for all costs and expenses incurred in reinstating, as far as possible, the quality of life enjoyed by the person before the harm was suffered; c) compensation for loss of life and all costs and expenses incurred for funeral and other related expenses[.]” Id. at art. 14(5). 278

“Liability shall also extend to harm or damage caused directly or indirectly by the genetically modified organism or product of the genetically modified organism to economic, social or cultural conditions; including negative impacts on the livelihood or indigenous knowledge systems or technologies of a community or communities, or damage or destruction arising from incidence of public disorder triggered by the genetically modified organism or the product of a genetically modified organism, disruption or damage to production or agricultural systems, reduction in yields, soil contamination, damages to the biological diversity, damage to the economy of an area or community, and any other consequential damage.” Id. at art. 14(6). 279

“7. The right to bring any civil action in respect of harm caused by a genetically modified organism or a product of a genetically modified organism shall, having due regard to the laws on limitations of rights commence from the date on which the affected person(s) or the community, or communities could reasonably be expected to have learned of the harm, taking due account of: (a) the time the harm make take to manifest itself; and (b) the time that it may reasonably take to correlate the harm with the genetically modified organism or the product of a genetically modified organism, taking into consideration the situation or circumstance of the person(s) or community or communities affected.” Id. at art. 14(7). 280

Regional Regulatory Regimes for GMOs • 201

any natural or legal person, if in violation of the African Model Law, can be subject to criminal and civil penalties.281 This instrument echoes many of the provisions with those of the Biosafety Protocol, such as the advanced informed agreement procedures, the national focal points responsible for liaising with the Biosafety ClearingHouse, and the incorporation of the precautionary principle as a foundational aspect of the African Model Law. While the provisions of the African Model Law are arguably more protective than those of the Biosafety Protocol, this instrument still provides a regulatory mechanism that allows for a more unified approach to GMO regulation throughout Africa. “1. Any natural or legal person who (a) imports, releases, places on the market or makes contained use of any genetically modified organism or products of a genetically modified organism without the written approval of the Competent Authority; (b) violates any conditions attached to the grant of approval under this law; (c) fails to furnish any information as required by the provisions of this law; (d) withholds information that has become available to her/him/it after the approval of her/his/its application, and that could change the evaluation of the risk posed by her/his/its project; (e) provides false, misleading or deceptive information under Article 4.3 in order to secure an approval; (f) does not label, package or identify any genetically modified organism or a product of a genetically modified organism in accordance with this law or with any conditions imposed under this law; (g) labels, packages or identifies any genetically modified organism or a product of a genetically modified organism in a manner that is false, misleading or deceptive or in contravention of a any regulation made under this law; (h) exports a genetically modified organism or a product of a genetically modified organism without the advance informed agreement of the importing country; (i) participates in any proceeding related to decision taking in respect of a subject matter covered by this law in which she/he/it has any direct or indirect interest of any kind; (j) violates any other provision of this law or any condition or requirement imposed under this law; (k) fails to declare any conflict of interest arising in a National or Institutional Biosafety Committee of which s/he is a member, or in the evaluation of a risk assessment in which s/he is involved, and fails to withdraw from its activities in relation to that case; (l) uses a genetically modified organism or a product of a genetically modified organism for hostile purposes; (m) obstructs or fails to assist the Competent Authority or other authorized officers in the performance of their duties under this law; (n) fails to inform the Competent Authority of an accident or emergency involving a genetically modified organism or a product of a genetically modified organism commits an offense and is liable on conviction to imprisonment for a term not exceeding . . . years or to a fine or both. 2. Any person shall upon conviction of any offense under this law shall be prohibited from engaging in any activity in relation to genetically modified organisms 281

202 • International Law, Agricultural Biotechnology, and Infectious Disease

D.

ASSOCIATION OF SOUTHEAST ASIAN NATIONS

The Association of Southeast Asian Nations (ASEAN), established in 1967, aims to accelerate regional economic growth, social progress, and cultural development and fosters regional peace and stability by promoting justice and the rule of law between member countries.282 ASEAN member countries pursue these objectives through a collection of fundamental principles, which are mutual respect for sovereignty and national identity, cooperation, and the peaceful settlement of disputes.283 Other primary goals of ASEAN are the development of a “stable, prosperous and highly competitive ASEAN economic region” and an integrated socio-cultural community, which includes infectious disease and agricultural issues.284 ASEAN Ministers for Agriculture and Forestry, in 1999, developed the ASEAN Guidelines on Risk Assessment of Agriculture-Related Genetically Modified Organisms (The ASEAN Guidelines).285 The ASEAN Guidelines are not legally binding and will not usurp domestic legislation on risk assessment associated with transboundary movement of or products of genetically modified organisms. 3. Where the offense is committed by a corporation, and where the court feels that a custodial sentence ought to be imposed, the executive officer in charge at the time the offense is committed, shall be liable to imprisonment.” Id. at art. 15. The original ASEAN member countries were Indonesia, Malaysia, Philippines, Singapore, and Thailand. ASEAN now includes Brunei Darussalam, Vietnam, LAO PDR, Myanmar, and Cambodia. The Association of Southeast Asian Nations (ASEAN), Overview ASEAN, at http://www.aseansec.org/147.htm (last visited Jan. 3, 2007). 282

283 “ASEAN Member Countries have adopted the following fundamental principles in their relations with one another, as contained in the Treaty of Amity and Cooperation in Southeast Asia (TAC): mutual respect for the independence, sovereignty, equality, territorial integrity, and national identity of all nations; the right of every State to lead its national existence free from external interference, subversion or coercion; non-interference in the internal affairs of one another; settlement of differences or disputes by peaceful manner; renunciation of the threat or use of force; and effective cooperation among themselves.” Id. 284

Id.

ASEAN, ASEAN Guidelines on Risk Assessment of Agriculture-Related Genetically Modified Organisms, at http://www.aseansec.org/6226.htm (last visited Jan. 3, 2007). 285

Regional Regulatory Regimes for GMOs • 203

GMOs.286 The primary objective of the ASEAN Guidelines is to provide a common, science-based risk assessment framework for the release of GMOs, which are defined as organisms whose genetic material “has been altered in a way that is unlikely to occur naturally by mating or natural recombination.”287 The ASEAN Guidelines do not address issues, such as “compensation and liability, labeling, socio-economic and religious factors.”288 Each ASEAN country is responsible for developing a National Authority on Genetic Modification (NAGM), whose responsibilities include reviewing proposals for release of GMOs, ensuring adherence and harmonization for domestic guidelines, and developing information exchange mechanisms.289 All GMOs brought into ASEAN member countries for release must comport with preexisting domestic and international regula-

“i. The Guidelines would be legally non-binding, and would not take precedence over national legislation.” Id. at pmbl. 286

287 “1.2 These Guidelines provide a common framework for: a) assessment of risks or agriculture-related GMOs to human health and the environment; and b) scientific basis for decisions relating to the release of agriculture-related GMOs in ASEAN Member Countries . . . Scope of Guidelines: Covers release of agriculture-related organisms genetic material that has been altered in a way that is unlikely to occur naturally by mating or natural recombination.” Id. at art. 1.2. 288 “iii. Issues such as compensation and liability, labeling, socio-economic and religious factors would not be covered under the Guidelines.” Id. at pmbl.

“4.1 Each country shall establish its own NAGM which will consist of representatives from national agencies involved in agriculture, trade, economics, environment, health, science and technology and/or any other agencies and sectors the respective NAGMs deem appropriate. 4.2 The NAGM’s roles and responsibilities are to: a) review and approve proposals related to the release of agriculture-related GMOs in the respective countries, it may establish more than one-subcommittee of experts for specific areas to assess risks involved, as deemed necessary for specific projects. b) ensure that national guidelines are complied with by the Proponent in the release of agriculture-related GMOs in their respective countries. c) provide advice on matters related to release of agriculture-related GMOs; d) provide access to the public information on planned release(s); e) ensure guidelines are harmonized with regional and international practices; g) update the ASEAN Secretariat on any changes in composition of their respective NAGM members, and h) inform ASEAN Secretariat of all approvals in the registration of agriculture-related GMOs in their respective countries.” Id. at art. 4.1. 289

204 • International Law, Agricultural Biotechnology, and Infectious Disease

tions and be proposed to the relevant NAGM.290 Risk assessment procedures rely on the concept of substantial equivalence for evaluation, which states “if a new food or food component is found to be substantially equivalent to an existing food or food component, it can be treated in the same manner with respect to safety.”291 Release of GMOs will be determined on a case-by-case basis, with four basic outcomes, which are approval, approval under specified conditions, prohibition of release, or a request for further information.292 The Proponent293 is also responsible, following approval of release for the GMO, for collecting information and performing post-release monitoring activities; if new information regarding envi-

“5.1 All agriculture-related GMOs brought into any ASEAN member country by the Proponent for release should comply with existing national and international regulations.” Id. at art. 5.1. “5.2 Before the release of any agriculture-related GMOs in any ASEAN member country, the Proponent is required to submit a proposal to the NAGM within whose territory the release is to take place. The Proponent should consult the respective NAGM of ASEAN member countries to determine the appropriate approval process for the agriculture-related GMOs and the specific information necessary for an assessment.” Id. at art. 5.2. 290

291 “3.1 ‘Substantial equivalence’ embodies the concept that if a new food or food component is found to be substantially equivalent to an existing food or food component, it can be treated in the same manner with respect to safety (i.e. the food or food component can be concluded to be as safe as the conventional food or food component.” Id. at art. 3.1. “The NAGM will appoint a panel of scientific experts to evaluate the proposal. The composition of the panel will comprise of members with expertise relevant to the proposed release. The panel of experts will review and assess the level of risk associated with each stage of the release using the questionnaire and risk assessment criteria as attached as Appendices 2 and 3 and submit their recommendations to NAGM preferably within 90 days. The concept of substantial equivalence will be used in the evaluation.” Id. at art. 6.1.

“The NAGM will decide on the release on a case-by-case basis. The NAGM will either: i) grant approval for the release of the agriculture-related GMOS; ii) grant approval for the release of the agriculture-related GMOs under specified conditions; iii) prohibit release of the agriculture-related GMOs with reasons for the prohibitions given in writing, or iv) require the Proponent to submit additional information which the NAGM deems necessary to complete the assessment, followed by decision (i), (ii), or (iii).” Id. at art. 6.4. 292

“ ‘Proponent’ refers to any person, firm, company, institution or organization planning to release agriculture-related GMOs into any ASEAN member country.” Id. at art. 3.1. 293

Regional Regulatory Regimes for GMOs • 205

ronmental or human health risks is discovered, the Proponent must notify the relevant NAGM immediately.294 The ASEAN Guidelines, while not legally binding, facilitate the development of common science-based risk assessment frameworks throughout ASEAN member countries. The use of substantial equivalence bears some similarity to the U.S. approach to GMO regulation by focusing on the relation between a GMO and its conventional counterpart rather than the GMO as a separate product. ASEAN promotes an integrated approach to risk assessment in the region by providing a mechanism for harmonizing risk assessment procedures. These guidelines may also catalyze the development of subsequent agreements addressing other areas relevant to GMO regulation, including issues related to infectious disease. E.

NORTH AMERICAN FREE TRADE AGREEMENT DOCUMENTATION REQUIREMENTS

The United States, Canada, and Mexico (the Participants), within NAFTA, developed Documentation Requirements for Living Modified Organisms for Food or Feed or for Processing (The Documentation Requirements), to clarify and facilitate the documentation requirements of the Biosafety Protocol.295 The United States and Canada are not parties to the Biosafety Protocol, whereas Mexico is, and transboundary movements between parties and non-parties must be consistent with the objectives of the Biosafety Protocol.296 Parties and non-parties to the Biosafety Protocol 294 “The Proponent shall continually collect information and perform post-release monitoring relating to the agriculture-related GMOs and their application(s). The Proponent shall report to the NAGM immediately if new information regarding risks to environment or human health is found. The NAGM reserves the right to recall any agriculture-related GMOs approved for release in its respective country based on its assessment of new information.” Id. at art. 10.4. 295 Documentation Requirements for Living Modified Organisms for Food or Feed, or for Processing, at http://www.agr.gc.ca/itpd-dpci/english/topics/bsp_trilateral.htm (last visited Jan. 3, 2007) [hereinafter Documentation Requirements for LMOs].

“1) Transboundary movements of living modified organisms between Parties and non-Parties shall be consistent with the objective of this Protocol. The Parties may enter into bilateral, regional and multilateral agreements and arrangements with nonParties regarding such transboundary movements.” United Nations Environmental Program (UNEP), The Cartagena Protocol on Biosafety art. 24(1) (2000), available 296

206 • International Law, Agricultural Biotechnology, and Infectious Disease

may enter into arrangements regarding transboundary movement of LMOs.297 Article 18.2(a) of the Biosafety Protocol delineates documentation requirements for LMOs intended for direct use as food, feed or for processing, which require clear identification that such products “may contain” LMOs and are not intended for intentional introduction into the environment.298 The Participants determined that the language “may contain,” referenced in Article 18(2)(a) of the Biosafety Protocol, must appear on the commercial invoice provided by the exporter.299 This documentation will be utilized for all transboundary movements of food, feed, or processing commodities where a LMO of that commodity species is authorized or sold from an exporting country.300 Certain situations do not require this documentation, such as shipments from exporting countries that have not developed commodities containing LMOs of that species, shipments containing a contractually defined meaning of “non LMO shipment,” and at http://www.biodiv.org/doc/legal/cartagena-protocol-en.pdf Biosafety Protocol]. 297

[hereinafter

the

Id.

298 “2. Each party shall take measures to require that documentation accompanying: (a) Living modified organisms that are intended for direct use as food or feed, or for processing, clearly identifies that they ‘may contain’ living modified organisms and are not intended for intentional introduction into the environment, as well as a contact point for further information. The Conference of the Parties serving as the meeting of the Parties to this Protocol shall take a decision on the detailed requirements for this purpose, including specification of their identity and any unique identification, no later than two years after the date of entry into force of this Protocol[.]” Id. at art. 18(2)(a). 299 “1. The ‘may contain’ language, when included as per section 4 below. Should appear on the commercial invoice as provided by the exporter. The importer is responsible for receiving the invoice and maintaining it after entry. 2. The ‘may contain’ language, when included, should state: ‘Cartagena Biosafety Protocol Provision: The shipment may contain living modified organisms intended for direct use as food or feed, or for processing, that are not intended for intentional introduction into the environment.’ ” Documentation Requirements for LMOs, supra note 295.

“4(a) The ‘may contain’ documentation will be used for all transboundary movements of commodities intended for food or feed, or for processing, where an LMO of that commodity species is authorized in, or sold from, a country of export, except[.]” Id. 300

Regional Regulatory Regimes for GMOs • 207

adventitious presence of LMOs in a non-LMO shipment.301 The Participants also aim to maintain open channels of communication regarding scientific information and pledge to cooperate on agricultural biotechnology issues affecting all three countries.302 The Documentation Requirements promote harmonization with the Biosafety Protocol’s provisions from a trade perspective, but with limited results. F.

CONCLUSION

The widely disparate legislative responses to GMO regulation provided by the United States and European Union result in fundamentally opposed schemes that have affected the success of international efforts to address GMOs. Most domestic, regional, and international regulatory efforts incorporate elements from either one of these approaches, as illustrated by the ASEAN Guidelines. The African Model Law and the Documentation Guidelines use the Biosafety Protocol as a foundation, which loosely correlates with the precaution-based EU regulatory regime. The conflicts between the European Union and United States also illustrate the challenge in achieving consensus on the appropriate way to address GMOs and how easy it is to end up with completely divergent domestic and regional regulatory results for the same products. None of these instruments and guidelines mentions infectious disease or public health concerns, except for the EU regulations developing an EU global public health strategy. The U.S. legislative regime, spread out between three federal agencies, addresses domestic public health concerns in another agency—the Centers for Disease Control and Prevention (CDC). If infectious disease issues were examined alongside GMOs, a fourth federal agency would have to be incorporated into the piecemeal and overlapping U.S. regulatory framework, further complicating GMO regulation “(i) Shipments for which the exporting country does not have in commerce any LMO of that species; or (ii) when the exporter and importer have contractually defined a ‘non-LMO shipment;’ provided, that such a shipment achieves a minimum of 95 percent non-LMO content, and that such definition does not conflict with regulations on the importing country. B) Adventitious presence of LMOs in a non-LMO shipment should not be considered a trigger for the ‘may contain’ documentation.” Id. 301

“The Participants hereby intend to maintain a continuous exchange of scientific information and to address issues on agricultural biotechnology that may arise among the three nations utilizing the expertise of scientific personnel. The Participants will elaborate on the subjects and mechanisms for information exchange.” Id. 302

208 • International Law, Agricultural Biotechnology, and Infectious Disease

and infectious disease control. The more streamlined EU regime makes incorporation of infectious disease concerns into GMO regulation smoother, but food safety and public health regulation still remain separate within the European Union. The African Model Law, the ASEAN Guidelines, and the Documentation Requirements all focus on a specific element of GMO regulation and leave little room for further development. For Africa and Southeast Asia, these documents represent the beginnings of a regional dialogue, which allows for future expansion, especially given recent events related to Avian Influenza and SARS.

CHAPTER 7

CRITIQUE AND PROPOSALS Current international and domestic regulatory efforts for GMOs and infectious disease illustrate the lack of connectivity between these two disciplines. However, association between GMOs and infectious disease has not been proposed, because the links have seemed insubstantial and not crucial to devising responsive legislative schemes for GMOs and infectious disease. As a result, international conventions and regulations, such as the Biosafety Protocol, the IHR, domestic and regional food safety regimes, the TBT and SPS Agreements, the IPPC, and the OIE focus only on narrow areas of influence. Some are only loosely stretched to tackle GMOs, with very limited coverage and even less connection and integration. The Biosafety Protocol and the IHR may seem to be exceptions, because these two instruments specifically address GMOs and infectious disease, but both documents still suffer from the same drawbacks as other international conventions. The Biosafety Protocol, while the main international instrument on transboundary movement of GMOs, does not address human health issues in any depth and thus is unable to communicate an effective and comprehensive regulatory scheme for GMOs. The IHR suffers from a similarly myopic perspective, and its recent revisions do not incorporate GMOs and how they relate to infectious disease. But all of these instruments, regardless of their source, showcase the numerous areas affected by GMOs and infectious disease. There are also other influences on GMOs and infectious disease that are more diffuse and conceptual, such as human choice and globalization, which complicates efforts to control the spread of infectious disease and the use of GMOs in agricultural applications. Controlling or anticipating the element of human choice is incredibly difficult to regulate in issues of public health, food safety, and consumer choice and is an aspect generally ignored in discussions involving GMOs and infectious disease. Article 5.5 of the SPS Agreement briefly mentions voluntary exposure to human health risks and how such exposure should be considered when determining if the application of a sanitary or phytosanitary measure is arbitrary or unjustifiable. The SPS Agreement gives 209

210 • International Law, Agricultural Biotechnology, and Infectious Disease

no further guidance as to how voluntary exposure to human health risks should be examined or how much influence human action should have on the invalidation of sanitary and phytosanitary measures. Add to this ambiguity some critics’ arguments advocating the rights of consumers to know whether their food or food products contain GMOs, and a significant gap addressing human action, GMOs, and infectious disease becomes obvious. While regulating human action with respect to GMOs may be very difficult, it is an integral component of successful regulation for public health issues. People must make informed decisions as to the level of risk considered acceptable in their lives; domestic governments play the primary role in curtailing these outbreaks but can only do so much when it comes to directing individual choice. It seems improbable that individuals or populations would willingly consent to expose themselves to a pathogen, but the case for voluntary exposure to GMOs is more complicated. Most of the arguments for labeling and traceability stem from consumer needs to be informed regarding the presence of GMOs in the food supply, for decisions about voluntary exposure to GMOs cannot be made without this information. Due to the speed in which GMOs are being incorporated into global agriculture, GM products are not always identified as GMO; most labeling regimes are developed after the introduction of GMOs into domestic and international food supplies. The introduction and spread of GMOs, coupled with the possible development of a GM pathogen, shows how exposure to a GMO, which is thought to be less harmful than exposure to a pathogen, may actually foster the rapid proliferation of an unknown pathogen through introduction channels for GMOs. Due to the inherent boundary-defying nature of GMOs, transfer across domestic boundaries is a significant concern in the development of a viable regulatory plan for these products. GMOs and pathogens do not respect political or economic boundaries and traverse them without difficulty. Domestic means for controlling infectious disease and GMOs proves to be ineffective, for the regulations imposed by one country or region do nothing to curtail the spread of these pathogens or GMOs over domestic borders. Unless other states or regions maintain the same kind of provisions, domestic efforts at regulation, short of blanket prohibition of products (either carriers of infectious disease or GMOs), do little to prevent the spread of infectious disease and curtail the risks associated with GMOs.

Critique and Proposals • 211

A possible response would involve states or regions prohibiting GMOs and all possible carriers of infectious diseases. Due to the volatile political climate related to GMO regulation, a prohibitive response might inflame tempers on one side while stoking protective tendencies on the other. Such a response also removes the potential boon to agricultural applications touted for GMOs by the scientific community and the agriculture industry. A more viable position involves strict regulation of transmission vectors for infectious disease, since infectious disease does not present benefits like those connected with GMOs. Local, domestic, and regional governments generally show more willingness to regulate infectious disease, and devising more coordinated plans for action is likely to be more fruitful than for GMOs. Market globalization exacerbates the difficulty inherent in maintaining control over markets and hinders domestic responses to public health needs, as well as social, economic, and environmental concerns.1 The stress globalization places on other domestic infrastructures, like local and domestic economies, directly affects a nation or region’s ability to deal with the complexities GMOs present to their markets, as well as to their agricultural industries and economies. Developing countries have the greatest difficulty balancing market globalization and managing social, environmental, and economic issues. As a result of these challenges, the developing world remains a hotbed for threats from infectious disease and constantly struggles to “reduce social, economic, and environmental problems that continue to benefit pathogenic microbes.”2 Developing countries are also one of the main recipients of GMOs. Many of the agricultural improvements provided by GMOs, such as increased hardiness, enhanced vitamin content, and herbicide and pesticide resistance, are aimed at making crops easier to grow in difficult conditions, provide more nutritional value, and lessen overall cost, which directly benefit developing countries. Critics of the widespread use of GMOs in developing countries argue that the benefits provided by GMOs will not materialize in developing countries, and GMOs are merely a means to create revenue for agriculture and biotech industries in developed countries. Moreover, developing coun1

DAVID P. FIDLER, INTERNATIONAL LAW AND PUBLIC HEALTH 23 (2000).

2

Id. at 22.

212 • International Law, Agricultural Biotechnology, and Infectious Disease

tries may not possess the requisite infrastructure to address the spread of pathogens or deal with the possible risks of releasing GMOs into their environment. This lack of infrastructure combined with globalization prevents developing countries from alleviating social, economic, and environment conditions that foster the spread of all varieties of pathogens, including new threats developing out of GMOs. These kinds of risks threaten the developing world the most and could have a significant, wideranging impact. Effective regulation of GMOs relies on the detection, containment, and control mechanisms provided by public health systems. Because of this, risk assessments for GMOs need to assess the adequacy of public health systems to detect and contain GMOs posing potential human health risks. If GMOs overwhelm agricultural markets, then human health risks posed by GMOs may not receive the attention they deserve, especially from those within the public health infrastructure. Infectious disease is the traditional realm of emphasis in public health, but GMOs are bringing new concerns that require attention from those involved in public health discourse. In many instances, public health facilities provide a means of first response. Without such infrastructures in place, new pathogens resulting from genetic transfer between GM crops and wild relatives will be more difficult to monitor or detect. Also, if GM crops affect non-target animal, human, or plant life in the area of release (and such effects could resemble outbreaks of some kind of infectious disease), detection of the subsequent effects will be difficult without preexisting public health infrastructures. Beyond initial detection concerns, lack of public health infrastructure makes future containment, control, and prevention challenging if not impossible to accomplish and leaves developing countries vulnerable to importation and proliferation of infectious disease.3 GM pathogens will pose even greater problems than more “conventional” infectious diseases. There will be little science-based information as to the genetic alterations and combinations that gave rise to the new GM pathogen. Curtailing the spread and mitigating the effects of an outbreak of a GM pathogen will be very difficult, for research will be required so that appropriate response efforts can be developed. There will be an 3

Id.

Critique and Proposals • 213

inevitable lag between discovery of the outbreak and effective containment and amelioration of its effects. Moreover, this assumes that the outbreak resulting from a GM pathogen is detected. More likely, an unknown etiology and origin will make it difficult to determine the occurrence of an outbreak and effective containment measures. Current legislative efforts in public health discourse, such as the IHR, do not provide an adequate foundation for regulation addressing new issues related to nascent intersections between GMOs and infectious disease. Concerns about public health impacts resulting from the incorporation of GMOs into global commerce, such as the possible development of GM pathogens and the struggles of the developing world to weather the changes wrought by globalization, press for the creation of new public health regulation. Ignorance of the complex interactions and rising levels of integration between human choice, infectious disease, forces of globalization, and GMOs exacerbate conceptual connections and regulatory efforts in these areas. This finding reaffirms the need for connectivity when tackling problems, such as infectious disease or GMOs. Both fields draw on sources of innovation and application than span many disciplines; if one aspect, or many, are ignored for the sake of simplicity or uncertainty, then the entire effort for managing these kinds of complex issues fall short. Public health is not the only area affected by GMOs becoming more of a commercial reality. The movement of GMOs into global commerce also brings significant changes to international trade mechanisms. Agricultural applications of GMOs resonate strongly in international trade discourse, and domestic regulations addressing GMOs are the subject of the WTO dispute resolution bodies. Lack of an international consensus as to the appropriate regulatory response to the risks of GMOs allows countries to develop their own legislative responses to these products. Labeling and traceability schemes developed in the European Union, the United States, and other regions are attracting attention as possible restrictions on trade and are creating a level of animosity and impasse for international trade and GMOs. The SPS and the TBT Agreements are problematic, for they do not specifically address GMOs or infectious disease but are the primary international legislative instruments applicable to GMOs in global commerce.

214 • International Law, Agricultural Biotechnology, and Infectious Disease

While both the TBT and the SPS Agreements are expansive regarding what constitutes measures falling under their scope, they are still trade agreements. Their primary goals are to facilitate trade in the global marketplace and cannot adequately address or properly protect the interests affected by GMOs and infectious disease. The best choices for trade concerns may not the best course for dealing with the intersection of GMOs and infectious disease. Yet international trade channels are the main means of transfer of GMOs and infectious disease across national borders. Regulation of international trade and its relation to GMOs and infectious disease is crucial in the upcoming efforts to deal with the challenges both fields pose; it cannot, however, be the only or most important perspective. The first steps in cultivating connectivity require recognition that associations between GMOs, infectious disease, and other disciplines are necessary for effective regulation in these areas. Regulations addressing GMOs and infectious disease could be more chilling than necessary on GMOs in order to achieve the goals related to infectious disease control and prevention. This level of complexity and challenge should not prevent regulatory development, for like any intersection of science, law, and health, this depth is not uncommon. Due to the multi-faceted nature of questions on GMOs and infectious disease, it is important to determine starting points for regulatory efforts tackling these two areas. During the early period of GMO research and development, discussions about future regulation of GMOs focused primarily on the distinctions between the end products and the processes used to create them. Despite lack of consensus on the potential effects of GMOs on human health and the environment, end products were determined to be the focus of risk assessments and regulations, rather than the processes used to develop GMOs.4 This distinction is important, because it distinguishes between basing regulations on how something is done versus what it is. Merely because something is created by genetic modification does not mean it is inherently harmful and should be strictly regulated or prohibited. However, GMOs should perhaps be treated in a different manner than their conventional counterparts, for the process is what fundamentally changes the nature of the end product.

4 BIOTECHNOLOGY AND BIOSAFETY 45 (Ismail Serageldin & Wanda Collins eds., 1999).

Critique and Proposals • 215

Understanding how genetic modification creates products like GM crops will instruct regulation, for better understanding of the integrated whole provides useful information in developing legislation for the end products. But the process alone cannot be the determining factor for whether a product makes it past the gate. Restricting the use of GMOs, based on the technology used to create them, imposes a negative value on the technology itself instead of the impacts of the specific products, redirecting the focus onto the process rather than the effects. There is nothing wrong with utilizing beneficial technology whose risks are well documented and do not pose significant threat to the environment or human health. Understanding the difference between the genetic modification processes used to create GMOs and the actual GMOs provides context for future regulatory efforts addressing the possible negative impacts of GMOs. It is important to conceptualize how these risks could interact with each other, on an international level, and then regulate accordingly without removing the potential benefit of such technologies. Food safety and foodborne disease is the most prolific area, both domestically and internationally, dealing with GMOs and their place in the global marketplace.5 Food safety, in the wake of BSE, is an area where GMOs and infectious disease intersect beyond more common infectious disease outbreak scenarios. Add concerns of previously unknown pathogens from GMOs engineered for viral resistance and food safety becomes an intersection for numerous disciplines. This intersection of food safety, infectious disease, and GMOs garners little substantive attention on either the domestic or international stage. Despite the lack of attention given to the connections between infectious disease, food safety, and GMOs, infectious diseases and GMOs possess fundamental regulatory similarities. Pathogens, regardless of origin, do not recognize or respect political, geographic, or economic boundaries. The potency of their virulence lies in their ability to spread and adapt, or mutate, across the artificial borders of the global community. GMOs share this same disregard for borders and can appear in areas never intended for their presence. This connection may begin to attract more attention as infectious diseases continue to regain the global spotlight. 5 Concerns regarding GMOs and food safety range from food production through to consumer choice and consumption. There is also a less visible issue regarding virus infiltration into the food supply, from both a biowarfare as well as an infectious disease outbreak perspective.

216 • International Law, Agricultural Biotechnology, and Infectious Disease

The HIV/AIDS pandemic demonstrates how pervasive and challenging it is to rein in a virus. The SARS epidemic, while nowhere near the scope and devastation of HIV/AIDS, still illustrates how quickly a pathogen of unknown origin and etiology can create a public health crisis. When determining the etiology of the SARS virus, a suggestion surfaced that the virus responsible for the outbreak could be genetically engineered. Whether or not this claim came to fruition is somewhat irrelevant, for the suggestion it posits is more important. GM viruses or pathogens are already part of the present, and very few mechanisms exist to prevent the accidental release of GM viruses into the environment. The ease of transboundary movement, combined with the unknown origins and effects of new pathogens and GMOs, exponentially complicates the ability to detect, understand, and manage these previously unconnected issues and emphasizes the importance of regulative connectivity. GMOs and infectious disease controls intersect in other areas besides food safety. Environmental concerns, both those directly associated with GMOs and more diffuse ones connected to long-term effects of GM crops, also affect the creation, virulence, and spread of infectious disease. GM crops altered with viral genes pose a double risk comprised of the risks generally associated with GM crops plus the potential development of new pathogens. International trade also provides a significant area of overlap, especially with respect to reducing restrictive trade impacts while minimizing negative impacts of GM crops and the spread of new and unknown pathogens. Yet, current regulatory efforts for GMOs and infectious disease in these areas focus on one particular area of concern and develop guidelines for that specific discipline. In addition to this lack of affiliation linking GMOs and infectious disease, the nature of risks presented by GM crops are, at best, under researched, and, at worst, completely unknown and misunderstood. The concern in some countries regarding GM crops increases the preexisting predisposition to excessively regulate, or, in some cases, prohibit, these products while strictly regulating against infectious disease outbreaks. Preventing or strictly controlling an infectious disease outbreak is not an endeavor that should be restricted; but caution should be exercised when regulating infectious disease outbreaks related to a GM pathogen. A distinction should be made between the pathogen and the processes involved

Critique and Proposals • 217

in its manifestation, preventing overtly restrictive measures for GMOs that provide agricultural, economic, and environmental benefits. GM crops provide agricultural benefits, whereas infectious diseases do not provide any benefit to human health, environmental sustainability, or agricultural production. Even though there is concern about the general safety of GM crops, recent work indicates that benefits associated with GM crops will manifest outside the laboratory. Not utilizing GM crops will remove these potential benefits, such as increased crop yields and resistance to pesticides, herbicides, and viruses. Regulations that strictly curtail or outright prohibit GMOs (while most likely running afoul of the SPS Agreement) could have a detrimental impact on food production and quality improvement. These public perceptions regarding GMOs and infectious diseases could lead to the prohibition or strict curtailment GMOs, which could severely restrict or remove the potential for positive agricultural, human health, or environmental applications of GMOs. A middle ground needs to be the objective of regulatory efforts, no matter the underlying perspective, while striving to find a balance between safeguarding human and environmental health. This will allow for scientific innovation and development, and maintaining international trade opportunities. One approach cannot possess more influence than another, for regulatory success relies on the synergistic confluence of these differing vantage points. Achieving this regulatory synergy between GMOs and infectious disease proves challenging and requires a substantial shift in both perspective and approach. A fundamental requirement for effective regulation addressing GMOs requires foundation in scientific principles and evidence in order to be viable. Measures, such as those showing how a certain product or occurrence interacts and alters the environment, present evidentiary challenges regarding proof of viability and must contain a certain amount of substantiation. Scientific research and analysis is the most appropriate method for determining how human health or the environment responds to new stimuli and provides foundational information for subsequent regulations for infectious disease and GMOs. Deliberate release techniques could prove very useful here, despite the lack of international harmonization, for this is the only current means for actually assessing how a GMO may interact within a specific setting or environment. Even

218 • International Law, Agricultural Biotechnology, and Infectious Disease

though there is disagreement as to its inherent safety and applicability, deliberate release could be used towards gathering adequate scientific information that may bridge the perceptional gaps accompanying regulatory efforts for GMOs, as well as go far in justifying the imposition of restrictive measures in these two areas. The effectiveness of measures seeking to impose restrictions of any kind relies on reaffirmation and implementation by the global community. If those responsible for doing so find that measures for GMOs and infectious disease do not possess any scientific basis, then such measures may be considered arbitrary, hastening their invalidation by the international community. This concern of arbitrariness or bias is crucial in measures or restrictions involving trade, for scientific foundations provide an objective starting point and make it more likely that these measures will be applied. Scientific information as to effects of GMOs is limited, for GM techniques are still developing, albeit at a rapid rate. Despite the lack of reliable and comprehensive information on the effects of GMOs on human health and the environment, agricultural companies, laboratories, and domestic governments are still incorporating GMOs into international commerce. Provisions like Article 5.7 of the SPS Agreement, Article 10 in the Biosafety Protocol, and Article 9 in Fidler’s Framework Convention reflect the reality that GMOs are being released and utilized without adequate scientific information cataloguing their effects outside the confines of the laboratory. Some sort of mechanism needs to be in place to simultaneously address the presence of GMOs in the environment and the need for scientific information to develop appropriate regulation for GMOs. A variety of risk assessment procedures pepper international legislation for the areas affected by GMOs and infectious diseases; these means of ascertaining risk are useful and provide possible avenues of action. The same criticism applies, for these risk assessments are geared towards one specific discipline, and each approach takes a different set of factors into account from varying perspectives. The results of the risk assessments will vary significantly for the same GM products and instruct disparate regulatory responses. These concerns regarding risk assessments combined with the lack of adequate scientific information as to the positive or negative impacts of GM crops increases the complexity of regulating these disciplines. Regulations for GMOs and infectious disease need to navigate this quagmire of complex and conflicting objectives, which is challenging but not impossible.

Critique and Proposals • 219

One possible means of cultivating connectivity between GMOs and infectious disease involves the development of an “epistemic community” charged with fostering communication and exchanges of information, with the goal of promoting more integrated legislative responses to modern biotechnology and infectious diseases. Sean Murphy, in his article Biotechnology and International Law, discusses the establishment of an “epistemic community” focused on dealing with modern biotechnology and how these scientific innovations interact with international law. The primary goal of an epistemic community is to foster an “informal, nonbinding regime in order to create shared understandings among knowledgeable actors about the substance and process of the desired binding regime.”6 The epistemic community functions as the backdrop to an internationally created binding regime for modern biotechnology; through this forum, knowledge can be exchanged and built upon as a means to facilitate and maintain a more formalized biotechnology-based treaty system.7 The concept of an epistemic community is primarily a means to create of a binding international regime, which could have broader uses within the field of biotechnology.8 An epistemic community, by providing information as to the “substance and process” of a binding international regime for biotechnology, can also bridge the gap between science and law by providing collaborative advice and insight without a legislative purpose in mind. While Murphy’s goal is to use the epistemic community as a foundation for developing an international regulatory regime for modern biotechnology, such a community could also be implemented on a smaller scale, within the larger community, and utilized to strive for a similar goal for GMOs and infectious disease. The goals of the epistemic community would be two-fold; development of an international, binding regime would take primary focus while fostering a deeper and more expansive understanding of modern biotechnology issues, regardless of the focus of the planned binding regime. By encouraging the exchange of ideas, the epistemic community also serves the purpose of pulling together related but previously unconnected issues that are currently becoming more relevant to each other, such as GMOs Sean Murphy, Biotechnology and International Law, 42 HARV. INT’L L.J. 47, 120 (2001). 6

7

Id.

8

Id.

220 • International Law, Agricultural Biotechnology, and Infectious Disease

and infectious disease. In addition to broadening the general discussions about modern biotechnology, the understandings cultivated by the epistemic community will also establish what kind of language to use for defining the relevant interests at stake.9 Current efforts, according to Murphy, are not successful, because these efforts are not “positioned to draw upon an epistemic community of relevant actors.”10 The very nature of modern biotechnology lends itself to applications that have significant international effects. In our increasingly globalized world, it is easy to remark that it is the case now with most things, but various far-reaching applications for GMOs make it an area that requires a global response. Certain areas do not require such an approach, for regulation can be achieved primarily at the domestic level with some regulation tying together those aspects that do have international implications. But successful regulation of GMOs, like infectious disease, depends on the validity and efficacy of both domestic and international regimes. An epistemic community focused on issues of modern biotechnology needs to draw perspective and contribution from a variety of different sectors.11 A convergence of different sectors promotes repetitive interaction between these sectors over time, allowing for “cooperative behavior and bargaining of interests.”12 Drawing from a variety of perspectives allows for more multi-faceted solutions and prevents the capture of the epistemic community by a single interest or constituency.13 These multi-faceted solutions ideally lead to solutions with a broader appeal and potentially “remove fragmentation of different treaty regimes.”14 This fragmentation of different treaty regimes is the current state of affairs for GMOs and infectious disease, and a more multi-faceted approach, as suggested in connection with the epistemic community, could work to alleviate this and move towards a more integrated result. 9

Id. at 121.

10

Id.

11

Id. at 122.

12

Id. at 122–23.

13

Id. at 123.

14

Id.

Critique and Proposals • 221

The main aim behind an epistemic community focused on modern biotechnology is to provide an “ongoing dialogue for resolving problems by cooperatively inclined actors, whose positions can be redefined over time as the prospects and problems of biotechnology unfold.”15 This objective is well suited to the mercurial nature of scientific innovation; one of the main reasons why law and science do not intersect well is that wheels of scientific research are moving ever forward at a pace that the law has extreme difficulty matching. Creating and maintaining open avenues of dialogue will be crucial in assessing the benefits and risks inherent in GMOs, as well as fashioning an appropriate and functional global legislative regime based on these benefits and risks. The “safe and beneficial” application of modern biotechnology needs to be the primary goal of a transnational forum.16 Through striving to achieve this goal, a transnational forum on modern biotechnology provides those involved from different sectors a means to air concerns and discuss information.17 This exchange of information and ideas could lead to a more “consensus-driven outcome on a wide range of issues” and foster a more connective perspective globally.18 The value of creating an epistemic community in modern biotechnology also applies to infectious disease. Since adequate regulation of both areas requires a significant amount of collaboration and cooperation on a global level, this idea of a epistemic community supplies a solid starting point for cultivating connectivity between GMOs, infectious disease, and other areas of intersection between science and public health. The lack of attention paid to the connections between infectious disease and GMOs could be ameliorated through an epistemic community, resulting in the incorporation of this connectivity into treaty regimes and domestic legislative agendas. This kind of transnational forum can, as Murphy mentioned, work against the singular influence of one interest and work towards a broader base of opinion and perspective. Recognizing the complex and multi-faceted nature of GMOs and infectious disease, this poten-

15

Id.

16

Id. at 132.

17

Id.

18

Id. at 132–33.

222 • International Law, Agricultural Biotechnology, and Infectious Disease

tial benefit is perhaps the most important. Efforts to regulate GMOs or infectious disease tend to come from one or a few related perspectives or viewpoints, which result in a one-sided effort that does not reflect all the aspects that influence discussions on GMOs and infectious disease. Creating an epistemic community focused on the interrelations of GMOs and public health, most notably infectious disease, will provide a means to collect this vast array of divergent perspectives and concerns. The most significant issue when devising any sort of regulatory regime for GMOs, at any level, is the scattered nature of the legislative efforts and conceptual underpinnings comprising the current regulatory situation for GMOs. As a result, there is no connectivity between areas that need to be examined together, such as GMOs and infectious disease. An epistemic community will permit the exchange of existing legislative solutions to certain concerns related to GMOs, like providing a means to collate scientific information in one place or harmonizing risk assessment procedures for GMOs released into the environment. Assembling and examining mechanisms like the AIA, the Biosafety Clearing-House, deliberate release techniques, as well as public health infrastructures used for infectious disease surveillance, will foster more integrated regulatory efforts as different approaches from various disciplines are considered collectively. External influences, like effects of globalization that create situational factors enabling both the incorporation of GMOs and the spread of infectious diseases can also be dissected and incorporated into the more specialized aspects of regulation. An international legislative response for modern biotechnology, as suggested by Murphy, may be a long time coming, but the groundwork can be laid for effective regulation of modern biotechnology by cultivating connectivity between infectious disease control and GMOs. The connection between GMOs and infectious disease may be limited and hinge primarily on the unknown nature of the shared risk of new pathogens resulting from the release of GM crops into the environment. On its own, this may not present a particularly compelling reason for increased attention to the risk of new pathogens and other food safety concerns, especially when the existing science behind GMOs seems to indicate that such an occurrence is unlikely. But when GMOs and infectious diseases are examined within a broader context, taking into account all of the disci-

Critique and Proposals • 223

plines affected by the integration of GMOs into global commerce, their similarities are placed in sharper relief, and their connections as concepts become more salient. It is this commonality, in both origins and effects, which suggests the idea that GMOs and infectious disease should not be sundered from one another, either in theoretical or practical discourse. The epistemic community serves as a stepping stone towards developing an international response incorporating science, agriculture, biological diversity, international trade, the environment, public health, and economics. Cultivating connectivity between GMOs and infectious disease is only the first step.

INDEX

1992 Rio Earth Summit, 17 Ad Hoc Intergovernmental Task Force on Foods Derived from Biotechnology (the Task Force), 56. 65 Adulterates, 2 Advance informed agreement (AIA), 19, 21–4, 26–7, 196, 199, 222 African Swine Fever (ASF), 60 African Union, 141, 192–3 OAU Draft Model National Legislation on Safety in Biotechnology (African Model Law), 192–201 Agenda 21, 3, 17 Agreement on Technical Barriers to Trade (TBT Agreement), 79, 84–98, 102, 118, 124, 213 Association of Southeast Asian Nations (ASEAN), 141, 202 ASEAN Guidelines on Risk Assessment of Agriculture-Related Genetically Modified Organisms (the ASEAN Guidelines), 202–5, 207–8 National Authority on Genetic Modification (NAGM), 203–5 Australia-Measures Affecting Importation of Salmon-Recourse to Article 21.5 by Canada Panel Report, 101, 107–8 Appellate Body Report, 106, 108, 112, 114 Avian influenza, xii, xiv, 26, 31, 44, 47, 60, 77, 79, 124, 127, 208 Bacillis thuringienesis (Bt), 5, 156 Biodiversity, 9, 13, 17, 55 Decline of, 9, 13 Biochemical pesticides, 156 Biopesticides, 156 Biopesticides and Pollution Prevention Division (BPPD), 156

Biosafety Clearing-House, 21, 23, 26–7, 76, 222 Biotechnology Regulatory Service (BRS), 150–1 Bovine Spongiform Encephalopathy (BSE), xiii–xiv, 26, 31, 44, 47, 77, 79, 124, 127, 215 Cartagena Protocol on Biosafety (Biosafety Protocol), 18–27, 51, 56, 74, 76, 132, 141, 184, 194, 197, 201, 205–207, 209, 218 Center for Food Safety and Applied Nutrition (CFSAN), 148 Classical biotechnology, 1 Cloning, xi, 3 Codex Alimentarius (Codex), 51, 52, 53, 56, 62–73 Codex Ad Hoc Intergovernmental Task Force, 65, 66 Codex Principles for the Risk Analysis of Foods Derived from Modern Biotechnology (Biotechnology Principles), 65 Fifth Session of the Biotechnology Task Force, 66 Food Safety Assessment of Foods Derived from Recombinant-DNA Plants Modified for Nutritional or Health Benefits (Nutritional and Health Benefits Assessment), 72 Guidelines for the Conduct of Food Safety Assessment of Foods produced Using Recombinant-DNA Microorganisms (Microorganism Guidelines), 72 Guidelines for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants (Recombinant Plants Food Safety Assessment Guidelines), 69–72

225

226 • International Law, Agricultural Biotechnology, and Infectious Disease Codex Alimentarius (continued) Principles for the Risk Analysis of Foods Derived from Modern Biotechnology (the Principles), 66–9 Task Force on Foods Derived from Biotechnology (Biotechnology Task Force), 65 Commission on Genetic Resources for Food and Agriculture (CGFRA), 56–7 Commission on Phytosanitary Measures (CPM), 130–2 Committee on Agriculture (COAG), 55–6 CPM Exploratory Open-Ended Working Group on Phytosanitary Aspects of GMOs, Biosafety, and Invasive Species (the Working Group), 132 Creutzfeldt-Jakob Disease (CJD), xiii, 31 Deliberate release, 15–17, 27, 129, 182–3, 185, 196, 217–8 Department of Food Safety, Zoonoses, and Foodborne Disease (FOS), 59 Emergency Prevention System for Transboundary Animal and Plant Pests and Diseases (EMPRES), 60–1 Environmental Protection Agency (EPA), 142–3 154–65 Office of Pesticide Programs (OPP), 155–6 Office of Pollution Prevention and Toxics (OPPT), 155 Office of Prevention, Pesticides and Toxic Substances (OPPTS), 155–6 Epistemic community, 219–223 European Communities Concerning Meat and Meat Products (Hormones) Appellate Body Report, 100, 102–5, 107, 108, 111–2 Panel Report, 102, 107, 111–2 European Communities—Measures Affecting Asbestos and AsbestosContaining Products, 84, 87 European Communities—Measures Affecting the Approval and Marketing of Biotech Products, 116–24

European Communities—Trade Description of Sardines Appellate Body Report, 88–90 Panel Report, 90 European Union (EU), 116–23, 141, 166–92, 207–8, 213 Commission White Paper on Food Safety, 166 Council Directive 90/219/EEC, 188 Council Directive 98/81, 188 Decision 1786/2002/EC, 189 Decision 2000/57/EC, 191 Decision 2000/96/EC, 191 Decision 2002/253/EC, 191 Decision 2004/210/EC, 189 Decision 2119/98/EC, 190–1 European Food Safety Authority (EFSA), 166–8, 172–3, 175, 178, 188–9 Regulation 49/2000, 185 Regulation 178/2002, 167–74 Regulation 258/97, 178–182 Regulation 851/2004, 190 Regulation 1139/98, 185 Regulation 1829/2003, 174–178 Regulation 1830/2003, 185–8 Regulation 2001/18, 182–4 Federal Food, Drug, and Cosmetic Act (FFDCA), 144–50, 156–8, 163 Federal Insecticide, Fungicide, and Rodenticide Act (FIRFA), 147, 156–61, 163 Food and Agriculture Organization (FAO), 51–62, 65, 73, 76, 148 Food and Drug Administration (FDA), 142–4, 148, 156, 163–5 Food Quality and Protection Act of 1996 (FQPA), 156–7 Food safety, 12–3, 51–77, 98, 143–4, 148, 163–5, 166, 188, 192, 208, 209, 215–6, 222 Food Safety Inspection Service (FSIS), 143, 156 Foodborne disease, 12, 51–2, 58–61, 64, 73, 76–7, 215 Framework Convention on Global Infectious Disease Prevention and Control, 44–48

Index • 227 Gene expression, 9 Gene flow, 9–11, 17, 55, 137 Horizontal, 9–10 Vertical, 9–10 General Agreement on Tariffs and Trade 1994 (GATT), 79–84, 98, 101, 116, 118, 139 Article XX, 80–4, 98, 101, 116 Genetic engineering, 1–3 Genetically engineered, 2, 141, 150, 216 Genetically modified (GM) crops, 4–14, 17, 129, 139, 212, 216–8, 222 Arguments against, 7–14 Arguments in favor, 3–7 Environmental toxins and, 12 Herbicide-resistant, 5–7 Pesticide-producing, 5 Risks, 7–8 Virus resistant, 5–7, 11 Genetically modified (GM) food, 2, 12, 52–4, 65, 67, 116–22, 144–50, 176–7, 185–6 Allergenicity, 12–13, 52, 54, 66, 199 Food toxicity, 12 Risks, 12 Genetically modified (GM) microorganisms, 72–4, 162–3, 188 Genetically modified organisms (GMOs), xi–ii, xiv–v, 1–14, 15–20, 26–7, 47–9 51–2, 54, 58, 68, 74–7, 79, 98, 109–10, 114, 116–24, 125–7, 129, 132–40, 141–4, 148, 150–1, 154, 163–7, 174, 177–89, 193–201, 203–5, 206–7, 209–23 Generally recognized as safe (GRAS), 144, 149 Genomics, xi, 3, 48 Germplasm, 2 Global Information and Early Warning System on Food and Agriculture (GIEWS), 61 Global Rinderpest Eradication Program (GREP), 60, 61 Globalization, 30, 73, 209, 211–13, 222 Crop genetic diversity, 13 Guidelines to Further the Practical Implementation of Article 5.5 (the Guidelines), 112–3

Human genetics, xi Human genome, xi Infectious disease, xii, xiii, xiv, xv, 17, 29–49, 79, 106, 109–10, 114–6, 125, 127, 139–40, 192, 207, 209–223 Inter-Departmental Working Group on Biotechnology (IDWGB), 56 International Food Safety Authorities Network (INFOSAN), 60–1, 65 International Health Regulations (IHR) 31–2 IHR 1969 32–36, 42–3 IHR 2005 34–44, 46, 48, 209, 213 International Plant Genetic Resources Institute, 57 International Plant Protection Convention (IPPC), 32, 56, 124, 127–40, 209 International Portal on Food Safety, Animal and Plant Health (IPFSAPH), 57–8 International trade, 30–1, 57–8, 74, 79–140, 213–4, 216–7 International Treaty on Plant Genetic Resources for Food and Agriculture, 57–8 ISPM No. 11, 132–8 Japan-Measures Affecting Agricultural Products, 100, 104, 115 Joint FAO/WHO Expert Committee on Food Additives (JECFA), 62 Living modified organism (LMO), 19–27, 132–3, 205–6 Maximum residue limits (MRL), 63, 65 Microbial Commercial Activity Notice (MCAN), 163 Microbial drug resistance, 49 Microbial pesticide, 156 Modern biotechnology, 1,2, 19–20, 54, 66–70, 219–222 Most-favored nation (MFN) treatment, 80–1 National Authority on Genetic Modification (NAGM), 203–5

228 • International Law, Agricultural Biotechnology, and Infectious Disease National plant protection organization (NPPO), 130–1, 134–5 National treatment, 80 North American Free Trade Agreement (NAFTA), 205 Documentation Requirements for Living Modified Organisms for Food or Feed or for Processing (The Documentation Requirements), 205–7 Office International des Epizooties (OIE), 32, 124–8, 138–40, 209 Organization for Economic Cooperation and Development (OECD), 51, 73–6 Agriculture Directorate, 75 Biosafety-Biotrack (BioTrack), 76 Directorate for Science, Technology, and Industry, 75 Environment Directorate, 75 Internal Coordination Group for Biotechnology (the Coordination Group), 75 Working Group on Harmonization of Regulatory Oversight (the Harmonization Working Group), 75 Organization of African Unity (OAU), 192 Plant-incorporated pesticide (PIP), 156 Plant Protection Act (PPA), 151–4 Pest risk analysis (PRA), 133–5 Precautionary principle 15, 19–20, 47, 166–9, 183, 193, 201 Priority areas for interdisciplinary action (PAIA), 56 Public health, 29–49 Recombinant DNA, 1–2 Regional plant protection organization (RPPO), 131 Rift Valley Fever (RVF), 54 Sanitary and Phytosanitary Agreement (SPS Agreement), 57, 89, 98–124, 138–9, 197, 209, 214, 216, 217 SARS-associated coronavirus (SARSCoV), xiii–xiv

Severe Acute Respiratory Syndrome (SARS), xii–xiv, 26, 31, 34, 36, 44, 47–8, 79, 124, 127, 208, 216 Stem cell research, xi “Superweeds,” 11 Toxic Substances Control Act (TSCA), 161–3 Transgenic crops, 5, 9–10, 13 Transgenic plants, 2 Transmissible Spongiform Encephalopathy (TSE), xiii U.N. Convention on Biological Diversity (CBD) 17–18, 27, 57, 132, 175 United States, 10, 116–20, 123, 141–166, 205–7 1986 Coordinated Framework for the Regulation of Biotechnology (the Coordinated Framework), 142, 144, 165 Plant Protection Act (PPA), 151 Restriction on the Introduction of Regulated Articles, 154 Statement of Policy for Foods Derived from New Plant Varieties (the Policy), 144, 146 Statement of Policy for Regulating Biotechnology Products (Policy for Biotechnology Products), 146, 149 United States Department of Agriculture (USDA), 141–3, 150–1, 154–6, 165 Animal and Plant Health Inspection Service (APHIS), 151 United States—Import Prohibitions of Certain Shrimp and Shrimp Products, 82–3 United States—Standards for Reformulated and Conventional Gasoline Appellate Body Report, 83 Panel Report, 83 Variant Creutzfeldt-Jakob Disease (vCJD), xiii Whole foods, 2, 70 World Health Assembly (WHA), 32–4

Index • 229 World Health Organization (WHO), 29, 32–3, 35–9, 41–3, 46–7, 51–4, 58–60, 62, 65, 73, 76, 148 World Trade Organization (WTO), 79–80, 123, 139, 213 Zoonoses 31–2, 59