Intellectual Property Rights, Bioethics, Biosafety and Entrepreneurship in Biotechnology 9789390455478

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TM

Sibi G.

Sibi G.

978-93-90455-47-8

Distributed by: 9 789390 455478

Intellectual Property Rights, Bioethics, Biosafety and

Entrepreneurship in Biotechnology

Intellectual Property Rights, Bioethics, Biosafety and

Entrepreneurship in Biotechnology

Sibi G.

Ph.D.

Head of the Department Department of Biotechnology Indian Academy Degree College-Autonomous Bangalore

Intellectual Property Rights, Bioethics Authors: Sibi G. Published by I.K. International Pvt. Ltd. 4435, 36/7, Ansari Rd, Daryaganj, New Delhi, Delhi 110002 ISBN: 978-93-90455-47-8 EISBN: 978-93-90455-48-5 ©Copyright 2020 I.K. International Pvt. Ltd., New Delhi-110002. This book may not be duplicated in any way without the express written consent of the publisher, except in the form of brief excerpts or quotations for the purposes of review. The information contained herein is for the personal use of the reader and may not be incorporated in any commercial programs, other books, databases, or any kind of software without written consent of the publisher. Making copies of this book or any portion for any purpose other than your own is a violation of copyright laws. Limits of Liability/disclaimer of Warranty: The author and publisher have used their best efforts in preparing this book. The author make no representation or warranties with respect to the accuracy or completeness of the contents of this book, and specifically disclaim any implied warranties of merchantability or fitness of any particular purpose. There are no warranties which extend beyond the descriptions contained in this paragraph. No warranty may be created or extended by sales representatives or written sales materials. The accuracy and completeness of the information provided herein and the opinions stated herein are not guaranteed or warranted to produce any particulars results, and the advice and strategies contained herein may not be suitable for every individual. Neither Dreamtech Press nor author shall be liable for any loss of profit or any other commercial damages, including but not limited to special, incidental, consequential, or other damages. Trademarks: All brand names and product names used in this book are trademarks, registered trademarks, or trade names of their respective holders. Dreamtech Press is not associated with any product or vendor mentioned in this book. Edition: 2020 Printed at: Rekha Printers

Preface In our technology-driven world, intellectual property (IP) represents the major asset of most business enterprises. Intellectual property law is a subject of increasing economic importance and the focus of a great deal of legislative activity at an international and regional level. As a result, laws of copyright, patent, and trademarks have undergone important changes in recent decades. The law of intellectual property not only touches more people than ever before but touches them in new and different ways. Intellectual property issues have become an integral part of the world trading system. One of the features of IPR laws is that IPRs applied to inventions, including biological inventions, have a monopoly right that is limited in time, typically 20 years. The farmers’ rights being debated are more like copyright and trademark IPRs, which generally are not time limited. Biotechnology is the world of business and investment. It is all to do with making and selling products in a highly competitive world. The event of modern biotechnology has given rise to a plethora of regulatory challenges. Those faced with responsibilities to regulate biotechnology would do well to investigate if lessons can be learned from previous experience. The application of intellectual property law to biotechnology has changed the way that scientists exchange materials and ideas and FRQWLQXHVWRKDYHDQLQFUHDVLQJLPSDFWRQWKHZD\WKDWVFLHQWL¿FUHVHDUFKLV performed. This impact, coupled with global agricultural research, has led to substantial need for education and training of scientists worldwide in the basic fundamentals of intellectual property. This handy reference book contains useful tips and practical insight on obtaining and maintaining property. It also highlights the use, sale protection, and transfer of ,QWHOOHFWXDO 3URSHUW\ IRU WKRVH ZKR KDYH LGHQWL¿HG RU KDYH SHQGLQJ patents, marks, copyrights, and trade secrets 7KH ¿UVW SDUW RI WKLV ERRN ZLOO EH GHYRWHG WR LVVXHV RI LQWHOOHFWXDO property rights (IPRs). It is intended as a primer for those who are involved or associated with understanding the needs for improving the LQWHJULW\ RI VFLHQWL¿F documentation. The lack of biosafety capacity in

vi

Preface

developing countries is a major constraint to the transfer of biotechnology products public and private sector research organizations await a clear regulatory environment through which to bring their products to the grower and consumer. The second part of the volume addresses the technical aspects of Biosafety in research. The third part of the book is oriented to Bioethics. It considers what are held to be the advantages of biotechnology, namely, in its actual and potential contributions to medicine, pharmacy, agriculture, the food industry and the preservation of our natural environment. One path of enquiry is to assess risks and costs of the various practices. It also locates emerging legal, social and policy issues pertaining to biotechnology and intellectual property laws and suggests some meaningful solutions to them. The bio-entrepreneur is often a scientist/researcher-turned-entrepreneur who wishes to see his/her research successes put into practice through commercialization. Part four of the book is directed towards entrepreneurship DFWLYLWLHV LQ ELRWHFKQRORJ\ ,W DOVR RXWOLQHV WKH RSSRUWXQLWLHV LQ WKH ¿HOG RI biotechnology ethical considerations, key issues and practical matters for biotechnology entrepreneurs. Despite the complex nature of the topic, the book approaches the issues pertaining to the topic in a clear, integrated and meaningful way. This book will not make the reader an expert, but it does provide enough information to understand the system without a great deal of confusion and toil. It is aimed at providing basic and comprehensive knowledge pertaining to the topic to a wide range of audience comprising legal practitioners, law students, researchers and scholars interested in interdisciplinary research, policymakers and others interested in biotechnology and intellectual property rights. Sibi G.

Acknowledgements I most sincerely convey my deep sense of gratitude to Dr. T. Somasekhar, for his remarkable support during my work. He has always encouraged me to produce quality work with his scholarly inputs. I owe special thanks to Mr. Kiran Kumar Nandi and Ms. Saritha M. for their encouragement to write this book. The understanding and support of my family, though sometimes taken for granted, was absolutely critical to the successful completion of this book. Sibi G.

Contents Preface ........................................................................................................... v Acknowledgements vii

PART I 1. Intellectual Property................................................................ 3 1.1 1.2 1.3 1.4

Introduction Forms of Intellectual Property Examples of Intellectual Property Intellectual Property in the Life Sciences

3 4 7 8

2. Patents .................................................................................... 11 2.1 2.2  2.4 2.5 2.6 2.7 2.8 2.9 2.10 2.11 2.12 2.13 2.14 2.15

What can be Protected by a Patent? Required Elements for Patent Grant +RZGR,QYHQWRUV%HQH¿WE\+ROGLQJD3DWHQW" Kinds of Patents What can be Protected under Patent Law? Exclusions from Patent Protection What is the Procedure for Applying for a Patent? Examination of the Patent Application Patent Infringement What Information is Presented in a Patent Document? Patent Searching, Patent Applications, Duration, and Transfers 3DWHQW&ODVVL¿FDWLRQ&RGHV The Utility Patent Application Process Reissued Patents Patent Marking

11 11  14 15 18 20 21 22 24 24  31 37 37

x

Contents

2.16 2.17 2.18 2.19

Patent Duration and Maintenance Design and Plant Patents Applications Patent Transfers and Licences Obtaining an International Patent

37 38 38 40

3. Copyright................................................................................ 42



3.1 3.2 3.3 3.4 3.5 3.6  3.8 3.9

What can be Protected by Copyright? Creation of Copyright Who Owns a Copyright? What cannot be Copyrighted? Rights for Copyright Copyright Infringement %HQH¿WVRI&RS\ULJKW5HJLVWUDWLRQ Rights of the Copyright Holder Fair Use

43 43 44 44 47 48  53 57

4. Trademarks ............................................................................ 60



4.1 4.2 4.3 4.4 4.5 4.6 4.7 4.8 4.9 4.10  4.12 4.13

Examples of Trademarks Trade Dress Trademark Law How is Trademark Ownership Determined? Registration of a Mark Categories of Trademark Attributes of a Trademark What can be Protected under Trademark Law? Criteria for Registrability Applying for a Trademark 3URFHHGLQJVLQWKH7UDGHPDUNV2I¿FH Infringement of Owner’s Rights International Trademarks—Madrid Protocol

60 61 61 64 64 66 67 68 70 72  75 77

5. Trade Secret ........................................................................... 81 5.1 5.2 5.3 5.4 5.5

How are Trade Secrets Lost or Stolen? Requirements for Protection Trade Secret Protection Methods Trade Secrets and IPRs How to Deal with Trade Secret Misappropriation Accusations?

82 83 84 86 87

Contents

xi

6. Industrial Designs .................................................................. 89 

 6.2 6.3 6.4 6.5 6.6

%HQH¿WVRf Design Registration Requirements for Registration Design Searching Design Search Databases Routes to Design Protection What Kind of Protection do Designs Confer?

89 90 90 92 93 94

7. Plant Variety Protection (PVP) ............................................ 95





7.1 Introduction 7.2 International Union for the Protection of New Varieties of Plants (UPOV) 7.3 Conditions for Protection of Plants 7.4 Examination 7.5 Right of Priority 7.6 How Applications are Processed?  ,VVXDQFHRI393&HUWL¿FDWHV 7.8 Analysis of PVP Productivity 7.9 Rights Granted 7.10 Protection of Plant Varieties 7.11 Plant Variety Protection Compared with Patent Protection 7.12 Plant Protection Mechanisms Provided by Different Countries 7.13 Other Ways of Plant Variety Protection 7.14 Licensing Agreements 7.15 Biotechnology and PVP  &RQÀLFWVLQ,QWHOOHFWXDO3URSHUW\5LJKWVRI$JULFXOWXUDO Biotechnology 7.17 The TRIPS Agreement 7.18 Implications of the TRIPS Agreement

95 96 98 98 99 99  100 101 101 103 104 106 109 110 110 111 112

8. Geographical Indication (GI) ............................................. 118 8.1 8.2 8.3 8.4

Different Kinds of Protected Geographical Names Why Protect GIs? What Kind of Protection do GIs Confer? Routes to GI Protection

119 120 121 121

xii

Contents

9. Domain Name....................................................................... 123 9.1 9.2 9.3 9.4 9.5 9.6 9.7

Domain Name Levels How are Domain Names Protected? Requirements for Domain Name Registration What Kind of Protection do Domain Names Confer? Registration Process Cybersquatting Domain Name Dispute Resolution Procedures

123 124 124 125 125 126 127

10. Ownership, Inventorship and Authorship ........................ 131 10.1 The Relevance of Inventorship 10.2 The Relevance of Ownership 10.3 The Relevance of Authorship

131 133 135

11. Knowledge Transfer ............................................................ 136 11.1 11.2 11.3 11.4 11.5

How to Transfer Knowledge? Supplementary Agreements Exploitation of Intellectual Property Research and Development Collaborations Main Issues to Consider When Performing Knowledge Transfer

137 137 138 139 140

12. Publishing vs Patenting ....................................................... 143 12.1 Traditional Distinction

143

12.2 12.3 12.4 12.5 12.6 12.7 12.8

144 144 145 145 146 146 148

Publishing Assignment Licence Patenting Knowledge Dissemination Alternative Dissemination Routes Secrecy

13. Traditional Knowledge ........................................................ 149 13.1 Why Protect Traditional Knowledge? 149 13.2 Traditional Knowledge and the Intellectual Property System 149

Contents

xiii

14. International Treaties and Conventions on Intellectual Property ................................................................................ 153 14.1 The Paris Convention for the Protection of Industrial Property 14.2 Patent Cooperation Treaty (PCT) 14.3 Trade Related Aspects of Intellectual Property Rights (TRIPS) Agreement 14.4 The Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure 14.5 The Madrid Agreement Concerning the International Registration of Marks and the Protocol Relating to that Agreement 14.6 The Hague Agreement Concerning the International Deposit of Industrial Designs

153 160 168

171

173 180

15. Biotechnology Patents ......................................................... 186 15.1 15.2 15.3 15.4 15.5 15.6 15.7 15.8 15.9 15.10 15.11



Introduction Importance of IP to Biotechnology The Intersection of Genetics and Patent Policy What is a Biotechnological Invention? Different Forms of Intellectual Property in Biotechnology Patents on Biotechnological Inventions What is Patentable and What is Not? How to Patent a Biotechnological Invention? How to Use Biotechnology Patent Indicators? How to Find Biotechnology Patents? How to Get Innovation Indicators from Biotechnology Patents? 15.12 Potential Downsides to Biotech Patents  &RQÀLFWVDQG&RQWURYHUVLHV

186 188 189 191 192 193 194 196 200 200 201 204 205

16. Transferring Intellectual Properties .................................. 215 16.1 Free, Public Distribution of the Intellectual Property 16.2 Sale of Intellectual Property 16.3 Licensing the Intellectual Property

215 216 217

xiv

Contents

PART II 17. Biosafety ............................................................................... 229 17.1 The Cartagena Protocol on Biosafety 17.2 Timeline of the Cartagena Protocol on Biosafety 17.3 Text of the Cartagena Protocol on Biosafety

229 230 232

18. Bioprocessing ....................................................................... 234 18.1 18.2 18.3 18.4 18.5 18.6 18.7 18.8 18.9 18.10

Hazards of Bioprocessing Equipment Fermentation Centrifugation Cell Disruption Filtration Product Handling Containment of Unit Processes Unit Processes in Biotechnology Categories of Containment Safety Cabinets

234 234 234 235 235 235 235 236 236 238

19. Uncontrolled Release of Materials in Biotechnology Operations ............................................................................ 241 19.1 19.2 19.3 19.4 19.5 19.6

The Generation of Aerosols Persistence of Aerosols in a Closed Space Persistence of Aerosols in the Atmosphere Airborne Allergens Health Hazards Toxic Reactions to Products or By-products

242 243 244 245 246 250

20. Animal Models ..................................................................... 253 20.1 20.2 20.3 20.4 20.5

Animals and Biosafety Risk Assessment, Risk Groups, and Biosafety Levels Transgenic Animal Models Regulatory Reporting Select Agents and Toxins

254 255 263 265 266

21. GM Plants............................................................................. 268 21.1 What is Crop Biosecurity?

268

Contents

21.2 21.3 21.4 21.5 21.6 21.7

Prevention, Protection, and Accountability Plant Disease Response Human Pathogens on Plants Crop Development and Plant-based Research Risk Assessment for GMOs Risks, Challenges and Opportunities in Institutional Oversight 21.8 Potential Direct and Indirect Effects of GM Crops on the Environment 21.9 Concerns and Potential Risks of GM Crops to the Environment

xv

269 270 272 272 274 277 287 288

  *HQHWLFDOO\0RGL¿HG2UJDQLVPV ........................................ 293



22.1 22.2 22.3 22.4 22.5  22.7 22.8 22.9

Introduction Risk Assessments Based on Information on Recipients Environmental Performance and Containment Horizontal Gene Transfer Risks of Using Transgenic Microalgae *HQHWLF0RGL¿FDWLRQRI$OJDH Risks Related to Production Systems of GM-Algae Environmental Risks of Bioremediation Microbial-based Cleaning Products

293 295 297 298 300  300 304 306

23. Biosafety Considerations for Large-Scale Production of Microorganisms ........................................... 310 23.1 23.2 23.3 23.4 23.5 23.6 23.7 23.8 23.9

Risk Assessment 311 General Biosafety Recommendations for Large-Scale Work 312 Primary Containment 313 Secondary Containment 317 Biosafety Guidelines 323 The Impact of Agricultural Biotechnology Research 338 Economic Impact Evaluation 339 Biotechnology Research in Selected Commodities 340 Economic, Social and Environmental Impacts of Biotechnology Research Products 343

xvi

Contents

23.10 23.11 23.12 23.13

Genetic Technology Negative Impacts Environmental Damage Labelling

349 350 351 352

PART III 24. Bioethics................................................................................ 359 24.1 Introduction

359

25. Cloning of Animals .............................................................. 364 25.1 25.2 25.3 25.4

How Animal Cloning is Done? Why Clone an Animal? Ethical Questions About Animal Research Ethical Uses for Cloning Animals

367 369 371 374

26. Human Cloning.................................................................... 377 26.1 26.2 26.3 26.4 26.5

Methods for Cloning Humans Reproductive versus Therapeutic Cloning of Humans Why is Human Cloning Controversial? Arguments Against Cloning Arguments for Cloning

378 379 380 381 385

27. Human Genome Diversity Project ..................................... 388 

 27.2 27.3 27.4

6FLHQWL¿F%DFNJURXnd HGDP Forms, 1991 to 1993 HGDP Stalls, 1994 to 1999 Ethical, Legal, and Social Issues Raised by HGDP

388 390 391 391

28. Stem Cell Research .............................................................. 395 28.1 What are Stem Cells? 28.2 Potential Applications and Current Successes Using Embryonic Stem Cells 28.3 Ethical Issues About Using Embryonic Stem Cells 28.4 Arguments for and Against Using Embryonic Stem Cells for Research

395 396 398 398

Contents

xvii

29. Xenotransplantation ............................................................ 403 29.1 29.2 29.3 29.4 29.5 29.6

Regulatory Policy FDA Draft Guidelines on Xenotransplantation Selection of Animal Sources for Xenotransplantation Hurdles to Xenotransplantation Immune Responses to Xenotransplantation Ethical Issues in Xenotransplantation

404 406 410 411 411 413

30. GM Foods ............................................................................. 417 30.1 Uses of GM Technology 30.2 Ethical Questions Concerning GMO

417 420

31. Issues in Food, Agricultural and Animal Biotechnology ...... 431 31.1 31.2 31.3 31.4

Biotechnology and Food Agricultural Biotechnology Animal Biotechnology FDA Regulation of Animal Drugs

431 439 445 447

PART IV 32. Entrepreneurship in Biotechnology ................................... 451



32.1 Biotechnology Entrepreneurship versus General Entrepreneurship 32.2 Technology and Opportunity in Biotechnology  3UR¿OLQJWKH%LRHQWUHSUHQHXU 32.4 Four Backgrounds of Biotechnology Entrepreneurs 32.5 Being the Entrepreneur for a Season 32.6 Driving Forces Behind a Biotech Entrepreneur’s Decisions 32.7 Learning from “Failure” 32.8 Successful Biotechnology Leaders 32.9 Success and Failure 32.10 Requirements for Achieving Success 32.11 Six Factors for Success 32.12 Ethical Considerations for Biotechnology Entrepreneurs 32.13 Key Issues and Practical Matters for Biotechnology Entrepreneurs

Index

453 457  460 461 463 465 466 468 469 472 476 477 481

Part-I

1

Intellectual Property

CHAPTER

1.1

INTRODUCTION

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4പIntellectual Property Rights, Bioethics, Biosafety and Entrepreneurship in Biotechnology

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1.2

FORMS OF INTELLECTUAL PROPERTY

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1.2.1

Copyright

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6പIntellectual Property Rights, Bioethics, Biosafety and Entrepreneurship in Biotechnology

1.2.2

Patents

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1.2.3

Trademarks

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Intellectual Propertyപ7

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1.3

EXAMPLES OF INTELLECTUAL PROPERTY

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1.4

INTELLECTUAL PROPERTY IN THE LIFE SCIENCES

Intellectual SURSHUW\ LV YHU\ LPSRUWDQW IRU LQGXVWULHV WKDW GHYHORS SURGXFWV GHULYHGIURPELRJHQHWLFUHVRXUFHV)RUWKHSKDUPDFHXWLFDOLQGXVWU\SDWHQWV DUH HVVHQWLDO IRU FRPSDQLHV WR UHFRXS WKHLU 5 ' H[SHQVHV ZKLFK DUH ZHOO NQRZQ DV EHLQJ YHU\ KLJK )RU SODQW EUHHGLQJ EXVLQHVVHV SODQW YDULHW\ SURWHFWLRQ393 LVDOVRLPSRUWDQW

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Intellectual Propertyപ9

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Design Rights Database Rights Trademarks

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Trade Secret

Patents

10പIntellectual Property Rights, Bioethics, Biosafety and Entrepreneurship in Biotechnology

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How intellectual property rights promote innovation and create economic and societal value?

Creative concepts & research: Creative concepts & Research: llCopyright in in lablab notebooks Copyright notebooks l Know-how and trade secrets protection l Existing inventions as patents l Confidentiality security

Benefits: l Economic returns l Tex revenues l Employment l Better products IP in the Innovation Cycle

Commercialisation: l Packaging as designs, trademarks and copyright l Licensing agreements l Patent claims on new products l Copyright in product data and patients information l Patent terms l Extension is also possible

Development: l Parental seeds lines, plant breeding books, field trial data as trade secrets l Plant varieties protection l Laboratory, clinical trial testing results confidential as a trade secret l Devices for drugs as patents, designs and copyright

Regulatory approval: l Regulatory data protected

through data protection rules and as trade secrets

2

Patents

CHAPTER

A patent is the right granted by the government of a country to the patent owner allowing him to exclude others from commercially exploiting an invention within that country.

2.1

WHAT CAN BE PROTECTED BY A PATENT?

A patent may be granted for any invention (which may be a device, substance, PHWKRG RU SURFHVV  ZKLFK VDWLV¿HV YDULRXV UHTXLUHPHQWV 7KH LQYHQWLRQ does not need to be ‘pioneering’ – an improvement or variation over what already exists may be patentable. It is sometimes said that only a ‘scintilla’ RILQYHQWLYHQHVVLVUHTXLUHG A patent may be granted for methods of treating human beings, including second indication uses of known compounds.

2.2

REQUIRED ELEMENTS FOR PATENT GRANT ‡ 0DQQHURI0DQXIDFWXUH ‡ 1RYHOW\ ‡ ,QYHQWLYH,QQRYDWLYH6WHS ‡ 8VHIXOQHVV ‡ 1R3ULRU6HFUHW8VH

2.2.1

Manner of Manufacture

7R EH SDWHQWDEOH DQ LQYHQWLRQ PXVW EH D µPDQQHU RI PDQXIDFWXUH¶ 3DWHQW law largely leaves the determination of patentable subject matter to the courts. As a general rule, an invention resulting from human activity (i.e., not naturally occurring) and which has commercial potential will typically be considered to be a manner of manufacture. On the other hand,

12പIntellectual Property Rights, Bioethics, Biosafety and Entrepreneurship in Biotechnology

discovery of a natural phenomenon (e.g., the law of gravity) will not satisfy WKLVUHTXLUHPHQWRISDWHQWDELOLW\ 6LPLODUO\ D PDWKHPDWLFDO IRUPXOD GHVFULELQJ D QDWXUDO SKHQRPHQRQ LV not a manner of manufacture, but a device utilising the mathematical formula, or an algorithm encoding the phenomenon that produces a useful result is likely to be considered a manner of manufacture.

2.2.2

Novelty

7REHSatentable, an invention must be ‘novel’ or new; that is, the invention must not have been publicly disclosed in any form, anywhere in the world DVDWWKHGDWHRIWKH¿UVW¿OHGSDWHQWDSSOLFDWLRQUHIHUUHGWRDVWKHµSULRULW\ date’). Disclosure includes any form of public release of the invention HJSXEOLVKLQJGHWDLOVRIWKHLQYHQWLRQLQDVFLHQWL¿FMRXUQDOXSORDGLQJD description of the invention on the internet, or selling or publicly using the invention) and any statements describing the invention in a public forum (e.g., presenting the invention at a trade fair or academic conference).

2.2.3

Inventiveness or Innovativeness

7REHJUanted a standard patent, an invention must involve an ‘inventive VWHS¶7KLVPHDQVWKDWWKHLQYHQWLRQPXVWEHPRUHWKDQDQµREYLRXV¶H[WHQVLRQ variation or combination of prior public knowledge which could be brought DERXWE\DQRQLQYHQWLYHSHUVRQVNLOOHGLQWKH¿HOGRIWKHLQYHQWLRQ An ‘obvious’ invention is one which could have been arrived at by the inventor as a matter of course (e.g., thought to be worth a try with an expectation that it might provide a useful result) in light of the common JHQHUDONQRZOHGJHLQWKHUHOHYDQW¿HOGHLWKHUWDNHQRUFRQVLGHUHGDOVRZLWK existing technical information publicly available before the priority date, known as ‘prior art information’. 6LPLODUO\WREHJUDQWHGDQinnovation patent, an invention must involve DQ µLQQRYDWLYH VWHS¶ 7KLV PHDQV DQ\ YDULDWLRQ EHWZHHQ WKH LQYHQWLRQ DQG what is currently known about that technology must make a ‘substantial contribution’ to the working of the invention.

2.2.4

Usefulness

A patentable invention must be useful, i.e., the invention should achieve what \RXVD\LWZLOO7KLVµXWLOLW\¶UHTXLUHPHQWLVDQDORJRXVWRDQLQYHQWLRQEHLQJ industrially applicable. If an invention is not useful, an inventor is unlikely to expend the time and expense necessary to obtain a patent.

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2.2.5

No Prior Secret Use

7REHSDWHQWDEOHWKHLQYHQWLRQPXVWQRWKDYHEHHQVHFUHWO\XVHGLQ$XVWUDOLD before the date of the application. Case law suggests that a “secret use” which LQYDOLGDWHVDSDWHQWLVDXVHZKLFKKDVD³WDLQWRIFRPPHUFLDOLW\´7KHUHDUH H[FHSWLRQVWRZKDWFRQVWLWXWHVD³VHFUHWXVH´7KHVHLQFOXGH    

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2.3

HOW DO INVENTORS BENEFIT BY HOLDING A PATENT?

0RVWLQYHQWRUVGRQRWWKHPVHOYHVGHYHORSWKHLQYHQWLRQFRYHUHGE\DSDWHQW Rather, they make arrangements with an existing company to do this for WKHP7\SLFDOO\WKHDUUDQJHPHQWWDNHVWKHIRUPRIDOLFHQFHFRQWUDFW XQGHU which the developer is authorized to commercially exploit the invention in exchange for paying the patent owner royalties for each invention sold. A licence may be exclusive (only one manufacturer is licensed to develop the invention) or nonexclusive (a number of manufacturers are licensed to GHYHORSLW 7KHOLFHQFHPD\EHIRUWKHGXUDWLRQRIWKHSDWHQWRUIRUDVKRUWHU SHULRG RI WLPH 6RPHWLPHV WKH SDWHQW LV VROG RXWULJKW WR WKH GHYHORSHU IRU D OXPS VXP XS IURQW 7KH GHYHORSHU LWVHOI PD\ OLFHQVH RWKHU FRPSDQLHV WR PDUNHW RU GLVWULEXWH WKH LQYHQWLRQ 7KH H[WHQW WR ZKLFK WKH LQYHQWRU ZLOO EHQH¿W IURP WKHVH VXEOLFHQFHV GHSHQGV RQ WKH WHUPV RI WKH DJUHHPHQW between the inventor and the developer. Especially when inventions result from work done in the course of employment, the employer-business usually ends up owning the patent rights and receives all or most of the royalties EDVHGRQVXEVHTXHQWOLFHQVLQJDFWLYLW\7KHVHGLVWULEXWLRQOLFHQVHVDUHRIWHQ limited by geography (for instance, different licenses for different countries or for different parts of one country) and by use. In many cases, the developer will trade licenses with other companies—called crosslicensing— so that FRPSDQLHVLQYROYHGLQWKHWUDGHZLOOEHQH¿WIURPHDFKRWKHU¶VWHFKQRORJ\

2.3.1

Other Application Requirements

7KHUH DUH RWKHU LPSRUWDQW DSSOLFDWLRQ UHTXLUHPHQWV RI ZKLFK RQH PXVW EH aware when applying for grant of a patent. Failure to comply with these

14പIntellectual Property Rights, Bioethics, Biosafety and Entrepreneurship in Biotechnology

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2.4 2.4.1

KINDS OF PATENTS Utility Patents

8VHIXOLQYHQWLRQVPD\TXDOLI\IRUDXWLOLW\SDWHQWLIWKH\¿WLQWRDWOHDVWRQH RIWKHVH¿YHFDWHJRULHVDSURFHVVDPDFKLQHDPDQXIDFWXUHDFRPSRVLWLRQ of matter, or an improvement of an existing idea that falls into one of WKHVH FDWHJRULHV 2IWHQ DQ LQYHQWLRQ WKDW TXDOL¿HV IRU D SDWHQW EHFDXVH RI its usefulness will fall into more than one of the categories. For instance, computer software can usually be described both as a process (the steps that it takes to make the computer do something) and as a machine (a device that takes information from an input device and moves it to an output device). Regardless of the number of categories an invention falls under, only one utility patent may be issued on it. Computer software, for example, in some instances is patented as a set of instructions to an electrical component, WKHUHE\ SXWWLQJ WKH SDWHQW LQWR WKH HOHFWULFDO FDWHJRU\ 3KDUPDFHXWLFDOV DUH SODFHGLQWKHFKHPLFDOFDWHJRU\*HQHVSOLFLQJWHFKQLTXHVDQGWKHSDWHQWHG +DUYDUG 0RXVH D VWUDLQ RI ODERUDWRU\ PRXVH WKDW KDV EHHQ JHQHWLFDOO\ manipulated to contract cancer readily, fall into the chemical category.

2.4.2

Design Patents

7RTXDOLI\IRUDSDWHQWXQGHUWKHGHVLJQWHVWDGHVLJQPXVWEHQHZDQGRULJLQDO and it must ornament a manufactured article. For example, a new shape for a FDUIHQGHUERWWOHRUÀDVKOLJKWWKDWGRHVQ¶WLPSURYHLWVIXQFWLRQDOLW\ZRXOG TXDOLI\$QRWKHUH[DPSOHLQPDNLQJDFKDLUZLWKDSHGHVWDOLQVWHDGRIIRXU legs, an inventor does not reinvent the chair, but only changes its appearance. 7KHGHVLJQFDQEHSURWHFWHGEXWQRWWKHFRQFHSWRIWKHFKDLULWVHOI

2.4.3

Plant Patents

3DWHQWVPD\EHLVVXHGIRUDQ\DVH[XDOO\RUVH[XDOO\UHSURGXFLEOHSODQWVVXFK DVÀRZHUV WKDWDUHERWKQRYHODQGQRQREYLRXV3ODQWSDWHQWVDUHJUDQWHGRQ bushes, trees, roses, and so forth, that are reproduced asexually with human intervention; that is, they do not occur naturally and are not propagated by tubers. A patent rose, for example, is a particular type or colour of rose that is protected from duplication by other horticulturalists. Interestingly, because a patented part of a plant is its colour, these patents are issued in colour booklets rather than in the standard black and white patent document.

Patentsപ15

2.5

WHAT CAN BE PROTECTED UNDER PATENT LAW?

7KUHHEURDGFDWHJRULHVRILQYHQWLRQVFDQEHSURWHFWHGE\SDWHQWVLQYHQWLRQV for useful items are protected as utility patents, inventions for designs are protected as design patents, and new varieties of asexually produced plants are protected as plant patents. Utility Patents 8WLOLW\SDWHQWs are by far the most common type of patent and cover what we generally think of as inventions, such as the cotton gin, the DXWRPRELOHWKHDLUSODQHDQGWKHFRPSXWHU7KHFDWHJRU\RIXWLOLW\SDWHQWVLV TXLWHEURDGKRZHYHUDQGDOVRFRYHUVDQ\QHZDQGXVHIXOSURFHVVPDFKLQH manufacture, composition of matter, or any new and useful improvement WKHUHRI 7KHVH FODVVHV WDNHQ WRJHWKHU LQFOXGH SUDFWLFDOO\ HYHU\WKLQJ WKDW LV PDGHE\KXPDQVDVZHOODVWKHSURFHVVHVIRUPDNLQJWKHSURGXFWV7KXVJROI EDOOVFDPHUDVJHQHVHTXHQFHVJHQHWLFDOO\DOWHUHGPLFHDQGSKDUPDFHXWLFDO drugs can all be patented, as can the processes for making such items. 7KHUHDUHWKUHHEDVLFUHTXLUHPHQWVIRUXWLOLW\SDWHQWVWKHLQYHQWLRQPXVW EHXVHIXOLWPXVWEHQRYHOLQUHODWLRQWRWKHSULRUDUWLQWKH¿HOGDQGLWPXVW QRWEHREYLRXVWRDSHUVRQRIRUGLQDU\VNLOOLQWKH¿HOG 7KH WHUP µXVHIXO¶ PHDQV WKDW WKH VXEMHFW PDWWHU RI WKH LQYHQWLRQ PXVW KDYHDXVHIXOSXUSRVH7KXVDPDFKLQHWKDWFRQWUDGLFWVVFLHQWL¿FSULQFLSOHV such as a perpetual motion machine, is not useful and cannot be patented. 8WLOLW\ LV DOVR IRXQG ODFNLQJ LI WKH LQYHQWLRQ¶V VROH SXUSRVH LV LOOHJDO RU immoral, as was the case in 1990 when a patent was refused for a process of making a cheap cigar wrapper from tobacco leaf that resembled superior products. 7KH QRYHOW\ UHTXLUHPHQW PHDQV WKDW DQ LQYHQWLRQ FDQQRW EH SDWHQWHG LI HLWKHURIWKHIROORZLQJH[LVWV 



‡ 7KHLQYHQWLRQZDVNQRZQRUXVHGE\RWKHUVLQWKLVFRXQWU\RUSDWHQWHG or described in a printed publication before the applicant invented it. 7KLVUHTXLUHPHQWUHIHUVWRWKHDFWVRIRWKHUVDQGHQVXUHVWKDWDSDWHQW LVJUDQWHGRQO\WRWKH¿UVWWRLQYHQW,IDQRWKHUSHUVRQKDVGHVFULEHG the invention, used it, or patented it, it cannot be novel. ‡ 7KH LQYHQWLRQ ZDV SDWHQWHG LQ DQ\ FRXQWU\ GHVFULEHG LQ D SULQWHG publication anywhere in the world, or in public use or on sale in this country more than one year before the application for patent in the 8QLWHG6WDWHV7KLVUHTXLUHPHQWUHIHUVWRWKHDFWVRIWKHLQYHQWRUDQG DOORZVWKHLQYHQWRUDRQH\HDUJUDFHSHULRGWR¿OHDSDWHQWDSSOLFDWLRQ after patenting the invention in another country, describing the invention in a printed publication, or using or offering the invention for sale in WKH8QLWHG6WDWHV

16പIntellectual Property Rights, Bioethics, Biosafety and Entrepreneurship in Biotechnology



‡ 7KHSULQWHGSXEOLFDWLRQPD\EHDVFLHQWL¿FMRXUQDORUHYHQDFRQIHUHQFH SDSHU7KXV LI WKH LQYHQWRU JLYHV D SUHVHQWDWLRQ DW D FRQIHUHQFH DQG describes the invention in materials distributed at the conference, the LQYHQWRU KDV RQO\ RQH \HDU WKHUHDIWHU WR ¿OH D SDWHQW DSSOLFDWLRQ LQ WKH8QLWHG6WDWHV6LPLODUO\LIWKHLQYHQWRUEHJLQVSXEOLFO\XVLQJWKH LQYHQWLRQLQWKH8QLWHG6WDWHVKHRUVKHKDVRQH\HDUWKHUHDIWHUWR¿OH a patent application. If the inventor’s use is for experimental or testing purposes, the one-year grace period does not begin to run until actual public use has commenced.  ‡ )LQDOO\ LI WKH LQYHQWRU VHOOV RU RIIHUV WR VHOO WKH LQYHQWLRQ LQ WKH 8QLWHG6WDWHVKHRUVKHKDVDRQH\HDUJUDFHSHULRGFDOOHGWKHRQVDOH EDU WR¿OHDSDWHQWDSSOLFDWLRQ,IWKHLQYHQWRUGRHVQRW¿OHDSDWHQW application within one year after any of these events, any right to a patent is lost. 7KH UHTXLUHPHQW RI QRQREYLRXVQHVV PHDQV WKDW QRW DOO QHZ DQG XVHIXO LQYHQWLRQV FDQ EH SDWHQWHG7KH VXEMHFW PDWWHU VRXJKW WR EH SDWHQWHG PXVW EHVXI¿FLHQWO\GLIIHUHQWIURPZKDWKDVEHHQXVHGRUGHVFULEHGEHIRUHFDOOHG the prior art, that it is nonobvious to a person having ordinary skill in the DUHDRIWHFKQRORJ\UHODWHGWRWKHLQYHQWLRQ7KXVVXEVWLWXWLQJRQHPDWHULDO for another or making mere changes in size ordinarily does not result in a patentable invention. 'HWHUPLQLQJ QRQREYLRXVQHVV LV GLI¿FXOW DQG FRXUWV KDYH VWUXJJOHG WR develop guidelines. In general, courts consider the following factors in determining whether an invention is nonobvious. Prior art Courts exaPLQHWKHSULRUDUWLQWKHSHUWLQHQW¿HOGWRGHWHUPLQH whether an invention is nonobvious. Journals, publications, previously issued patents, and other sources of public knowledge are examined.

Differences between prior art and the invention  ‡ ,IWKHLQYHQWLRQLVVXSHULRUWRSULRUDUWDQGSHUIRUPVEHWWHUWKDQRWKHU similar inventions, it tends to show nonobviousness.  ‡ /HYHO RI RUGLQDU\ VNLOO LQ WKH SULRU DUW ,I WKH LQYHQWLRQ ZRXOG EH obvious to one possessing ordinary skill in the technology to which the invention relates, the invention cannot be patented. Courts also consider whether the invention is a commercial success (reasoning that inventions that are commercially successful tend to be nonREYLRXV  DQG ZKHWKHU WKH LQYHQWLRQ KDV VDWLV¿HG D ORQJIHOW FRPPHUFLDO need (reasoning that if there has long been a need for the invention that was XQVDWLV¿HGWKHLQYHQWLRQPXVWKDYHEHHQQRQREYLRXVRWKHUZLVHQXPHURXV other people would have been able to meet the need by inventing the item).

Patentsപ17

As mentioned earlier, utility patents remain in force for twenty years from WKHGDWHRQZKLFKDSDWHQWDSSOLFDWLRQLV¿OHGLQWKH8QLWHG6WDWHV3UHYLRXVO\ the term was seventeen years from the date the patent was granted. In 1995, the law was changed to motivate inventors to move their applications WKURXJKWKH863DWHQWDQG7UDGHPDUN2I¿FH372 DVTXLFNO\DVSRVVLEOHWR REWDLQWKHPD[LPXPEHQH¿WRIWKHSDWHQWWHUP8QWLOWKHFKDQJHLQWKHODZ many inventors delayed the process while they gathered funds, conducted PDUNHWLQJDQGVRIRUWKOHDGLQJWRDEDFNORJLQWKH3723DWHQWWHUPVDUH extended under certain circumstances, such as for pharmaceuticals when there is a delay in granting the patent because of the time taken for approval by the Food and Drug Administration. 1 1 1 Fees to maintain utility patents are due 3 , 7 and 11 years after the 2 2 2 original grant for all utility patents. After the patent expires, anyone may make, use, or sell the invention without liability. Design Patents A design patent is granted to any person who has invented any new and nonobvious ornamental design for an article of manufacture. In general, a utility patent protects the way an invention is used and works, whereas a design patent protects the way an article looks. Both design and utility patents may be obtained on an article if there is inventiveness in both LWVXWLOLW\DQGLWVRUQDPHQWDODSSHDUDQFH7KXVDFDPHUDWULSRGRUDFRPSXWHU PRXVH PD\ EH HOLJLEOH IRU ERWK D XWLOLW\ SDWHQW DQG D GHVLJQ SDWHQW 7KH design patent protects only the appearance of an article, not its structural or functional features. Design patents can be obtained for containers such as trash receptacles, jewellery, furniture, clothing, embossed eating utensils, EXULDOXUQVDQGPDQ\RWKHULWHPV7KHGHVLJQPXVWEHRUQDPHQWDOUDWKHUWKDQ primarily functional. Although trash receptacles and eating utensils clearly serve a useful purpose, if there are numerous ways in which an item could be designed and still remain functional, then any one design for it probably LVRUQDPHQWDOUDWKHUWKDQIXQFWLRQDO7KXVEHFDXVHDFKDLUFDQEHGHVLJQHG in a variety of ways (with or without rolled arms, a high back, curved legs, DQG VR IRUWK  D GHVLJQ IRU D FKDLU TXDOL¿HV IRU GHVLJQ SDWHQW SURWHFWLRQ ,I there is only one way in which the article could be designed, it is primarily IXQFWLRQDODQGGRHVQRWTXDOLI\IRUGHVLJQSDWHQWSURWHFWLRQ /LNH XWLOLW\ SDWHQWV GHVLJQ SDWHQWV PXVW EH QRYHO DQG QRQREYLRXV WR D designer of ordinary skill who designs articles of the type applied for in a GHVLJQSDWHQWDSSOLFDWLRQ7KHUHTXLUHPHQWVIRUQRYHOW\DQGQRQREYLRXVQHVV DSSO\HTXDOO\WRGHVLJQSDWHQWV'HVLJQSDWHQWVKDYHDWHUPRIIRXUWHHQ\HDUV from the date of their grant, and no maintenance fees are charged to maintain a design patent in force.

18പIntellectual Property Rights, Bioethics, Biosafety and Entrepreneurship in Biotechnology

7KHUHLVVRPHRYHUODSEHtween copyright and design patents. For example, jewellery can be protected under copyright or patent law. In many instances, matters of cost and strategy dictate the method of protection sought. For example, copyright applications are inexpensive ($30) and easily obtained, whereas patents are expensive (generally several thousand dollars) and can WDNHXSWRWZR\HDUVWRLVVXH0RUHRYHUFRS\ULJKWSURWHFWLRQJHQHUDOO\ODVWV for the life of the author plus seventy years, whereas design patent protection lasts only fourteen years from the date of grant. Because an item of jewellery may go out of style after a season or two, the designer may well elect to protect the item under copyright law rather than seek a patent for it. On the other hand, patent law protects against the unauthorized making, using, or selling of a patented invention and would thus prohibit a later infringing use even if it were independently created. However, copyright law would allow a later independently created work. Plant Patents 6ince 1930, federal law has allowed for the granting of a patent to anyone who has invented or discovered and asexually reproduced any distinct and new variety of plant or cultivated non-tuberous plant. Asexually reproduced plants are those reproduced by means other than from VHHGVVXFKDVE\JUDIWLQJRUWKHURRWLQJRIFXWWLQJV7KHQHZYDULHW\FDQEH different from previous plants in its resistance to disease or drought, colour, VFHQWÀDYRXURUSURGXFWLYLW\7KXVDQHZFRORXURIURVHGURXJKWUHVLVWDQW FRUQDQGGLVHDVHLPPXQHRUDQJHWUHHVDUHDOODYDLODEOHIRUSURWHFWLRQ7KH on-sale bar applies to plant patents such that if the inventor has used or sold DSODQWYDULHW\LQWKH8QLWHG6WDWHVKHRUVKHKDVRQO\RQH\HDUWKHUHDIWHUWR VHHNDSDWHQWIRULW7KHWHUPRIDSODQWSDWHQWLVLGHQWLFDOWRWKDWIRUXWLOLW\ SDWHQWVWZHQW\\HDUVIURPWKHGDWHRQZKLFKWKHDSSOLFDWLRQIRUWKHSDWHQW LV¿OHGZLWKWKH3728QOLNHXWLOLW\SDWHQWVQRIHHVDUHFKDUJHGGXULQJWKH term of the plant patent to maintain it in force.

2.6

EXCLUSIONS FROM PATENT PROTECTION

8QGHUIHGHUDOODZWKHUHDUHDQXPEHURIH[FOXVLRQVIURPSDWHQWSURWHFWLRQ LQFOXGLQJWKHIROORZLQJ 

‡ ,QYHQWLRQVXVHIXOVROHO\LQWKHXVHRIVSHFLDOQXFOHDUPDWHULDORUDWRPLF energy for atomic weapons.



‡ 1DWXUDO 3KHQRPHQD 6FLHQWL¿F 3ULQFLSOHV $EVWUDFW 7KHRUHPV ± $ newly discovered natural law or phenomenon would include a new plant or animal found in the wild, a new mineral in the earth, or any RWKHU³SURGXFWRIQDWXUH´2WKHU³GLVFRYHULHV´DUHHTXDOO\XQSDWHQWDEOH

Patentsപ19

VXFKDV³PHUHVFLHQWL¿FSULQFLSOHRUDEVWUDFWWKHRUHP´RURWKHUSXUHO\ mental operations. 

‡ 6FKHPHV 3ODQV %XVLQHVV 0HWKRGV ± 0DQ\ ³VXUH¿UH´ VFKHPHV IRU winning money on lotteries or the racetrack have been invented, but QRQHDUHSDWHQWDEOH0HWKRGVIRUDLUFUDIWSLORWVWRKDQGOHWKHFRQWUROV so as to reduce engine noise on take-off are unpatentable.



‡ &RPSXWHU 3URJUDPV ± 0DQ\ FRXQWULHV DUH UHOXFWDQW WR JUDQW SDWHQWV for computer programs, fearing that technological progress in this YRODWLOHLQGXVWU\ZRXOGEHLPSHGHG3URJUDPVDUHHIIHFWLYHO\WUHDWHG as algorithms — “a set of rules or processes for solving a problem in D¿QLWHQXPEHURIVWHSV´²DQGVRIDOOXQGHUWKHSURKLELWLRQDJDLQVW patenting abstract theorems.



‡ 0HGLFDORU6XUJLFDO7UHDWPHQWV±'HYLFHVRUGUXJVIRUWUHDWLQJKXPDQ RU DQLPDO LOOQHVVHV DUH SDWHQWDEOH 6R DUH PHWKRGV RI WHVWLQJ QRW relating to any step of actual treatment or vital function of the body. But methods of treating living humans or animals by surgery or therapy DUH XQSDWHQWDEOH 7KLV LV DOVR WUXH RI PHWKRGV RI XVLQJ PHGLFLQH RU similar substances to diagnose, prevent, or cure ailments in humans or DQLPDOV0HGLFDOWUHDWPHQWVKRXOGLQFOXGHDQ\PRGL¿FDWLRQRIRUJDQLF IXQFWLRQLQKXPDQVRUDQLPDOVPHWKRGVWRERQGFXWVDQGZRXQGVDQG to reduce the urge to smoke have been ruled unpatentable. Although purely cosmetic treatments, such as strengthening hair or nails, may HVFDSH WKH SURKLELWLRQ WKRVH ZLWK DQ DFFRPSDQ\LQJ PHGLFDO EHQH¿W — for example, cleaning teeth to make them both more attractive and also bacteria-free — remain unpatentable.



‡ 0DWHULDO XQGHU 2WKHU ,QWHOOHFWXDO 3URSHUW\ /DZV ± $UFKLWHFWXUDO RU engineering plans and instructions for speech therapy and written directions for use — all protected by copyright are unpatentable. But printed material serving a mechanical end may be patentable, for example, a method of printing a language to indicate stress and LQÀHFWLRQ IRU VFDQQLQJ DQG HQFRGLQJ LQWR D GHYLFH IRU PHFKDQLFDO aural reproduction.

For 200 years, the conventional wisdom has been that business methods were not patentable. In 1998, the Federal Circuit Court issued an opinion allowing a patent for a business method, holding that business methods, mathematical algorithms, and software are patentable as long as they produce XVHIXO WDQJLEOH DQG FRQFUHWH UHVXOWV ,Q WKH ZDNH RI WKLV FDVH WKH 372 reported an increase of approximately 700 per cent in the number of patent DSSOLFDWLRQV FRQWDLQLQJ FODLPV IRU EXVLQHVV PHWKRGV 3DWHQWV KDYH EHHQ

20പIntellectual Property Rights, Bioethics, Biosafety and Entrepreneurship in Biotechnology

issued for amazon.com’s one-click shopping method and priceline.com’s method for letting prospective customers propose a price for a product or VHUYLFH OHDGLQJ H[SHUWV WR TXHVWLRQ ZKHWKHU WKH LVVXDQFH RI VXFK EURDG SDWHQWVXOWLPDWHO\ZLOOVWLÀHLQQRYDWLRQDQGFRPSHWLWLRQLQWKHPDUNHWSODFH 6XI¿FLHQF\RI 7KHGHVFULSWLRQRIWKHLQYHQWLRQLQWKHSDWHQWVSHFL¿FDWLRQ 'HVFULSWLRQ PXVW EH VXI¿FLHQWO\ GHWDLOHG IRU D SHUVRQ VNLOOHG LQ WKH ¿HOGWREHDEOHWRPDNHDQGXVHWKHLQYHQWLRQ Fair Basis

7KH LQYHQWLRQ DV FODLPHG PXVW EH VXSSRUWHG E\ RU EH consistent with the detailed description provided in the VSHFL¿FDWLRQ

Clarity of Claims

A claim must be clear and unambiguous so that its scope FDQEHDVFHUWDLQHG7KLVUHTXLUHPHQWLVRQHRIODQJXDJH

Inventorship

7KHFRUUHFWLQYHQWRUVPXVWEHQDPHGLQWKHDSSOLFDWLRQ

2.7

WHAT IS THE PROCEDURE FOR APPLYING FOR A PATENT?

7KHUHLVQRVXFKWKLQJDVDQDXWRPDWLFSDWHQWWKURXJKFUHDWLRQRUXVDJHRI DQLQYHQWLRQWKHLQYHQWRUPXVW¿OHDQDSSOLFDWLRQDQGSD\D¿OLQJIHH DQG be issued a patent. )RUWKHSXUSRVHRIREWDLQLQJDQHDUO\¿OLQJGDWHWKHLQYHQWRUPD\¿OHZKDW LVNQRZQDVD3URYLVLRQDO3DWHQW$SSOLFDWLRQ33$ 7KHRQO\UHTXLUHPHQWIRU D33$LVWKDWLWPXVWDGHTXDWHO\GHVFULEHWKHLQYHQWLRQ+RZHYHUWRREWDLQD SDWHQWWKHLQYHQWRUPXVW¿OHDIRUPDOSDWHQWDSSOLFDWLRQZLWKLQRQH\HDURI WKH33$GDWHLIRQHLV¿OHG WKDWIROORZVWHFKQLFDOFRQYHQWLRQVDQGFRQWDLQV ZRUGVDQGGUDZLQJVWRFOHDUO\   

‡ WHDFKKRZWRPDNHDQGXVHWKHEDVLFLQYHQWLRQ ‡ H[SODLQ ZK\ WKH LQYHQWLRQ LV GLIIHUHQW IURP DOO SUHYLRXV DQG VLPLODU developments (known as the prior art), and ‡ SUHFLVHO\GHVFULEHZKDWDVSHFWVRIWKHLQYHQWLRQGHVHUYHWKHSDWHQWWKH patent claims).

7KLVSDWHQWDSSOLFDWLRQZLOOEHWKHVXEMHFWRIPXFKSXVKDQGSXOOEHWZHHQ WKHDSSOLFDQWDQGWKHSDWHQWH[DPLQHUHPSOR\HGE\WKH372WRVFUHHQLW

Patentsപ21

2.7.1

Types of Patent Applications

2.7.1.1 Provisional Application $ SURYLVLRQDO DSSOLFDWLRQ GRHV QRW QHHG WR LQFOXGH FODLPV GH¿QLQJ WKH invention but usually will do so. A provisional application generally is used to secure a priority date for the invention, and affords up to 12 months to decide whether to continue with the patenting process elsewhere. A provisional application will lapse after 12 months, and so if patent SURWHFWLRQLVWREHSXUVXHGDFRPSOHWHDSSOLFDWLRQFODLPLQJWKHEHQH¿WRIWKH SURYLVLRQDODSSOLFDWLRQPXVWEH¿OHGZLWKLQWKLVSHULRG 2.7.1.2 Complete Application A complete application can be for either a standard or an innovation SDWHQW DQG PXVW EH DFFRPSDQLHG E\ D FRPSOHWH VSHFL¿FDWLRQ FRQWDLQLQJ DW OHDVWRQHFODLPGH¿QLQJWKHLQYHQWLRQ$FRPSOHWHDSSOLFDWLRQLVH[DPLQHG E\WKHSDWHQWRI¿FHWRGHWHUPLQHLILWVDWLV¿HVWKHUHTXLUHPHQWVIRUJUDQWDQG if so, usually leads to the grant of patent rights. 2.7.1.3 Patent Cooperative Treaty Application $ 3DWHQW &RRSHUDWLRQ 7UHDW\ 3&7  DSSOLFDWLRQ DOVR NQRZQ DV DQ ‘international patent application’) allows applying for patent protection in a number of different countries through one international agency, provided WKDWWKHFRXQWULHVDUHVLJQDWRULHVWRWKH3DWHQW&RRSHUDWLRQ7UHDW\ 7KH3&7DSSOLFDWLRQZLOOQHHGWREHµQDWLRQDOLVHG¶WRWKHGLIIHUHQWFRXQWULHV of interest before a relevant deadline so that the process of local examination DQGJUDQWPD\SURFHHG6HSDUDWHDSSOLFDWLRQVDUHQHFHVVDU\LQWKRVHFRXQWULHV RILQWHUHVWQRWVLJQDWRULHVWRWKH3DWHQW&RRSHUDWLRQ7UHDW\

2.8

EXAMINATION OF THE PATENT APPLICATION

If the patent examiner discovers that another pending application involves WKHVDPHLQYHQWLRQDQGWKDWERWKLQYHQWLRQVDSSHDUWRTXDOLI\IRUDSDWHQW WKHSDWHQWH[DPLQHUZLOOGHFODUHWKDWDFRQÀLFWFDOOHGDQLQWHUIHUHQFH H[LVWV between the two applications. In that event, a hearing is held to determine ZKR LV HQWLWOHG WR WKH SDWHQW$I¿GDYLWV RU GHFODUDWLRQV DUH VXEPLWWHG DQG often live testimony is taken. :KRPD\EHDZDUGHGWKHSDWHQWGHSHQGVRQVXFKYDULDEOHVDVZKR¿UVW FRQFHLYHG RI WKH LQYHQWLRQ DQG ZRUNHG RQ LW GLOLJHQWO\ ZKR ¿UVW DFWXDOO\ EXLOWDQGWHVWHGWKHLQYHQWLRQDQGZKR¿OHGWKH¿UVWSURYLVLRQDORUUHJXODU patent application.

22പIntellectual Property Rights, Bioethics, Biosafety and Entrepreneurship in Biotechnology

Characteristics of a Standard Patent and an Innovation Patent Standard Patent

Innovation Patent

0D[LPXPWHUPRISURWHFWLRQLV 0D[LPXPWHUPRISURWHFWLRQLV years (with a possible extension of up years, provided renewal fees are paid. to 5 years for certain patents), provided RI¿FLDOUHQHZDOIHHVDUHSDLG An unlimited number of claims may be 8SWRFODLPVPD\EHLQFOXGHGLQWKH application. included in the application, although VLJQL¿FDQWDGGLWLRQDORI¿FLDOIHHVDUH incurred where there are more than 20 claims. Examination of the substantive validity Only an administrative formalities of the application is compulsory before check is compulsory. Examination of the substantive validity of the grant. innovation patent is optional. 1HHGWRSDVVWKHµKLJKHU¶LQYHQWLYH step threshold.

1HHGWRSDVVWKHµORZHU¶LQQRYDWLYH step threshold.

7KLUGSDUWLHVPD\LQLWLDWHSUHJUDQW opposition.

7KLUGSDUWLHVPD\LQLWLDWHSRVW FHUWL¿FDWLRQRSSRVLWLRQ

1RIXUWKHUH[DPLQDWLRQLVUHTXLUHG after grant before enforcing the patent.

7KHVXEVWDQWLYHYDOLGLW\RIWKHSDWHQW PXVWEHH[DPLQHGLHFHUWL¿HG  before the patent can be enforced.

Animals and plants and methods for their generation are potentially patentable subject matter.

Animals and plants and methods for their generation are not patentable subject matter.

2.8.1

Exclusive Rights Received for a Patent

2QFH D SDWHQW LV UHJLVWHUHG WKH 3DWHQWV$FW JUDQWV H[FOXVLYH ULJKWV WR WKH patent owner to prevent others from stockpiling, using, selling, manufacturing or importing the patented invention or offering or authorising another to do any of these things. Anyone else will only be able to legally exploit the invention if they have authorisation from the patent owner. It is the patent owner’s responsibility to enforce these rights.

2.9

PATENT INFRINGEMENT

:KHWKHU D SDWHQW KDV EHHQ LQIULQJHG LV D TXHVWLRQ RI IDFW ,W PXVW EH proved that the alleged infringer has done an act which involves each and

Patentsപ23

every featXUH RI DW OHDVW RQH FODLP RI WKH SDWHQW 7KH LQIULQJLQJ DFW PXVW have occurred after the date of publication of the patent application and enforcement proceedings must commence within 3 years from the day on which the relevant patent was granted; or within 6 years from the day on which the infringing act was done. $SDWHQWPD\DOVREHLQGLUHFWO\LQIULQJHG7KLVPD\RFFXUZKHUHDSURGXFW has knowingly been supplied to a third party who will use it in a way that will infringe the patent. In this scenario, the supply of the product would constitute indirect or ‘contributory’ infringement.

Exemptions to Patent Infringement 7Kere are exemptions to patent infringement under certain restricted FLUFXPVWDQFHV7KHVHLQFOXGHIRUH[DPSOHZKHUHDSDUW\KDVEHHQVHFUHWO\ XVLQJDQLQYHQWLRQSULRUWRWKH¿OLQJRIDSDWHQWDSSOLFDWLRQE\DQRWKHUIRU the invention, or where a third party exploits a patented pharmaceutical substance for purposes solely connected with obtaining regulatory authority approval in Australia or overseas for the pharmaceutical substance.

When does a patent expire or otherwise come to an end? 7KHPRst common reason for a patent to come to an end is that the statutory period during which it is in force expires. For utility and plant patents, the statutory period is 20 years after the application date. For design patents, the statutory period is 14 years from date of issuance. Another common reason why patents expire is that the patent owner fails WR SD\ UHTXLUHG PDLQWHQDQFH IHHV 8VXDOO\ WKLV RFFXUV EHFDXVH DWWHPSWV WR commercially exploit the underlying invention have failed and the patent owner chooses not to throw good money after bad. A patent may also be declared invalid (and no longer in force) if it is ODWHU VKRZQ WKDW WKH SDWHQW DSSOLFDWLRQ ZDV LQVXI¿FLHQW WKDW WKH DSSOLFDQW FRPPLWWHGIUDXGRQWKH863DWHQWDQG7UDGHPDUN2I¿FHXVXDOO\E\O\LQJ about or failing to disclose the applicant’s knowledge about prior art that would legally preclude issuance of the patent), or that the inventor engaged in illegal conduct when using the patent— such as conspiring with a patent licensee to exclude other companies from competing with them. Once a patent has expired for any reason, the invention described by the patent falls into the public domain. It can be used by anyone without permission, and the patent owner has no more rights to the invention than any member of the public.

24പIntellectual Property Rights, Bioethics, Biosafety and Entrepreneurship in Biotechnology

2.10

WHAT INFORMATION IS PRESENTED IN A PATENT DOCUMENT?

3DWHQWGRFXPHQWVDUHVWUXFWXUHGLQWKUHHSDUWV 7KH¿UVWIURQW SDJHSUHVHQWVJHQHUDOLQIRUPDWLRQDERXWWKHSDWHQW         

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7HFKQLFDO GHVFULSWLRQ It begins on the second page of the document. It presents a description that can cover more than one page, which includes the technical problem which the invention solves, the state of the art, as well as a technical description of the invention. Third part includes the drawings, the claims (that provide a clear description of what is legally protected) and possibly a search report.

2.11

PATENT SEARCHING, PATENT APPLICATIONS, DURATION, AND TRANSFERS

Because obtaining a utility patent depends on an invention being novel and nonobvious, conducting a search before applying for a patent is critical. A VHDUFKRIWKHSULRUDUWDQG863DWHQWDQG7UDGHPDUN2I¿FH372 UHFRUGVZLOO GLVFORVHZKHWKHUWKHLQYHQWLRQLVVXI¿FLHQWO\QRYHODQGQRQREYLRXVWRTXDOLI\ for patent protection. Once the search has been conducted, an application for WKHSDWHQWLV¿OHGGLVFORVLQJWKHPHWKRGRIPDNLQJDQGXVLQJWKHLQYHQWLRQ /LNHWKHWUDGHPDUNSURFHVVSDWHQWSURVHFXWLRQLQYROYHVH[DPLQDWLRQE\WKH 372DQGUHVSRQVHVE\WKHDSSOLFDQWWRDQ\372REMHFWLRQVXQWLOWKHDSSOLFDWLRQ LV¿QDOO\DSSURYHGRUUHMHFWHG2QFHDXWLOLW\SDWHQWLVLVVXHGLWUHPDLQVLQ IRUFHIRUWZHQW\\HDUVIURPWKHGDWHWKHDSSOLFDWLRQZDV¿OHGDVORQJDVDOO fees are paid during the term of the patent to maintain its existence. As items of personal property, patents can be sold or licensed to others and can be EHTXHDWKHGE\ZLOO$Q\DVVLJQPHQWRUWUDQVIHURIDQDSSOLFDWLRQIRUDSDWHQWRU

Patentsപ25

an issued patent must be in writing. An inventor who wants patent protection LQ RWKHU FRXQWULHV PXVW FRPSO\ ZLWK WKH ODZV DQG UHTXLUHPHQWV RI WKRVH countries.

2.11.1

The Need for a Patent Search

%HFDXVH RI WKH H[SHQVH DQG WLPH LQYROYHG LQ SUHSDULQJ DQG ¿OLQJ D SDWHQW DSSOLFDWLRQ LQYHQWRUV VKRXOG QRW ULVN ¿OLQJ DQ DSSOLFDWLRQ RQO\ WR KDYH LW UHMHFWHGIRUODFNRIQRYHOW\RUIRUREYLRXVQHVV7KXVH[DPLQLQJWKHSULRUDUW LVFULWLFDOEHIRUH¿OLQJDQDSSOLFDWLRQIRUDSDWHQW)LOLQJDSDWHQWDSSOLFDWLRQ without conducting a search of the prior art is like leaving home for a long road trip without a set of directions. Additionally, searching patent records provides an overview of the competition and usually provides meaningful guidance on preparing the patent application so it meets with the fewest SRVVLEOHREMHFWLRQVIURPWKH372 $OWKRXJK WKH 372 SURYLGHV D SXEOLF VHDUFK URRP IRU SDWHQW VHDUFKLQJ searching prior art takes a great deal of experience, expertise, and familiarity LQWKH¿HOGWRZKLFKWKHLQYHQWLRQUHODWHVVRVHDUFKHVJHQHUDOO\DUHFRQGXFWHG E\ H[SHUWV 1HYHUWKHOHVV VXJJHVWLRQV IRU VHDUFKLQJ DUH SURYLGHG RQ WKH 372¶V ZHEVLWH DW ZZZXVSWRJRY DQG WKH VLWH DIIRUGV DFFHVV WR WKH 372¶V own collection of more than 6,500,000 patents issued since 1790, which can EHVHDUFKHGE\LQYHQWRU¶VQDPHSDWHQWQXPEHURUWRSLF¿HOG$GGLWLRQDOO\ WKH 372 PDLQWDLQV 3DWHQW DQG 7UDGHPDUN 'HSRVLWRU\ /LEUDULHV WKURXJKRXW WKH 8QLWHG 6WDWHV ZKLFK LQFOXGH FROOHFWLRQV RI LVVXHG SDWHQWV 7KH 372 website provides addresses for these approximately eighty libraries. Free sources for searching issued patents are provided at www.delphion.com and ZZZOLEXWH[DVHGX &RYHUDJH LQFOXGHV DOO 86 SDWHQWV VLQFH  8VHUV can search by keywords describing the invention, inventor’s name, or patent registration number. Although searching these databases will disclose issued and expired patents, it will not disclose references to inventions in publications such DVMRXUQDOVDQGFRQIHUHQFHSDSHUV7KXVPRVWLQYHQWRUVUHWDLQWKHVHUYLFHV RIDODZ¿UPRUSURIHVVLRQDOVHDUFK¿UPWRUHYLHZQRWRQO\SDWHQWUHFRUGV but also publications that may bear novelty and nonobviousness. Engaging legal counsel affords additional advantages because not only are the DFWXDO UHVXOWV RI WKH VHDUFK SURYLGHG WR DQ LQYHQWRU EXW WKH ODZ\HU RU ¿UP issues a written availability opinion discussing the chances of obtaining a patent for the invention. ,Q DGGLWLRQ WR WKH QRYHOW\ VHDUFK PDQ\ LQYHQWRUV UHTXHVW WKDW DQ infringement search be conducted. An infringement search is more involved than a novelty search, and the results detail whether the invention might infringe that of another party. A formal written opinion discussing both

26പIntellectual Property Rights, Bioethics, Biosafety and Entrepreneurship in Biotechnology

novelty and infringement often costs between $1,000 and $5,000 but may well be worth the cost, particularly because obtaining advice of competent counsel may protect an inventor from having to pay punitive damages in a later infringement action because it shows that the inventor acted with due GLOLJHQFHUDWKHUWKDQZLOIXOO\DQGUHFNOHVVO\3URIHVVLRQDOSDWHQWVHDUFKHUVFDQ EHIRXQGE\XVLQJWHOHSKRQHGLUHFWRULHV0RVWDUHORFDWHGLQWKH:DVKLQJWRQ '& DQG QRUWKHUQ 9LUJLQLD EHFDXVH RI WKH JUHDWHU DFFHVVLELOLW\ RI 372 UHFRUGVDQGSXEOLFDWLRQVPDLQWDLQHGDWWKH/LEUDU\RI&RQJUHVV 6RPH LQYHQWRUV DGRSW D PLGGOH FRXUVH VHDUFKLQJ WKH IUHH 372 RU ,%0 databases as much as they can. If their preliminary search shows that the LQYHQWLRQPD\TXDOLI\IRUSDWHQWSURWHFWLRQWKH\WKHQUHWDLQWKHVHUYLFHVRI DODZ¿UPWREURDGHQWKHVHDUFKDQGSURYLGHDQDYDLODELOLW\DQGLQIULQJHPHQW opinion.

2.11.2

Where to Search for Patent Information?

7KH HDVLHVW ZD\ WR UHWULHYH SDWHQW UHODWHG LQIRUPDWLRQ LV WR XVH RQOLQH databases. 7KH LQIRUPDWLRQ SUHVHQWHG LQ GDWDEDVHV FDQ WDNH GLIIHUHQW IRUPV 2QH FDQ ¿QG GDWDEDVHV LQFOXGLQJ WKH IXOO WH[W RI SDWHQW GRFXPHQWV EXW DOVR GDWDEDVHV SUHVHQWLQJ D ³VXPPDU\´ RI WKHP 7KH ODWWHU JHQHUDOO\ SUHVHQW WKHLQIRUPDWLRQFRQWDLQHGRQWKHSDWHQWV¶¿UVWSDJHSRVVLEO\HQULFKHGZLWK additional information), called the bibliographic reference. 7KRVH GDWDEDVHV DUH UHVSHFWLYHO\ FDOOHG IXOOWH[W GDWDEDVHV DQG bibliographic databases. Original published document (article, technical study, patent, standard, market study) Summarised

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Patentsപ27

databases including information related to the legal status of the patent, the payment of fees and owners and representatives, are also available. 7KH PRVW FRPPRQ ZD\ WR UHWULHYH SDWHQW UHODWHG LQIRUPDWLRQ LV WKH XVH RI ELEOLRJUDSKLF GDWDEDVHV 6XFK LQIRUPDWLRQ VRXUFHV DUH FHUWDLQO\ ZHOO VWUXFWXUHGDQGDOORZRQHWRSHUIRUPHI¿FLHQWVHDUFKHV A bibliographic reference is a textual document (usually, including an LPDJH VXPPDULVLQJWKHRULJLQDOGRFXPHQW6XFKUHIHUHQFHVJLYHLQIRUPDWLRQ DERXW SDWHQWV DQG KHOS WKH LQYHQWLRQ WR EH LGHQWL¿HG HDVLO\ %LEOLRJUDSKLF references refer to publications. For easy retrieval, producers of databases generally add information such as internal codes or keywords describing the subject treated in the original document. *HQHUDOO\DSDWHQWELEOLRJUDSKLFUHIHUHQFHLQFOXGHV       

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However, a number of differences can be found, according to the producer of the reference and the kind of information, which the original document includes. Information in bibliographic databases is typically structured in what is FDOOHG ³LQIRUPDWLRQDO ¿HOGV´ 7KLV PHDQV WKDW WKH VDPH W\SH RI FRQWHQW LV DOZD\V SODFHG LQWR WKH VDPH LQIRUPDWLRQDO ¿HOG WKH LQIRUPDWLRQ UHODWHG WR WKHWLWOHLVSRVLWLRQHGLQWKHWLWOH¿HOGWKHLQIRUPDWLRQUHODWHGWRWKHQDPHRI WKHLQYHQWRUVLVDOZD\VSUHVHQWHGLQWKHLQYHQWRU¿HOGHWF

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28പIntellectual Property Rights, Bioethics, Biosafety and Entrepreneurship in Biotechnology

One should then regroup all the terms related to each concept, and DVVRFLDWH WHUPV DV ZHOO DV FRQFHSWV XVLQJ %RROHDQ RSHUDWRUV $1' 25 127 WRFRQVWUXFWDTXHU\

2.11.3

How to Run a Search in the Worldwide Database?

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PATENT CLASSIFICATION CODES

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because of the agents involved, liquids or steam can be used as the OXEULFDQW EHWZHHQ WKH VHDOV 7KH OXEULFDQW ÀRZ FDQ EH VHQW WR D ELRZDVWH kill system. The location of the drive is another issue, i.e., bottom-mounted versus top-mounted. Although the bottom-mounted systems facilitate maintenance of the units, top-driven units provide better containment of the processor and should be the choice for BSL-2LS and BSL-3LS operations. It is not generally feasible to operate a fermentor or bioprocessor under negative pressure due to the obvious problems of foaming and product FRQWDPLQDWLRQ )RU SURFHVVHV ZKHUH HVFDSH IURP WKH V\VWHP PXVW EH prevented, the unit should be equipped with devices that monitor the pressure in the chamber and sound an alarm if the set level is exceeded. Pressure vessels must be equipped with a pressure relief system (PRS), ZKLFKFRQVLVWVRIDUXSWXUHGLVNDQGRUSUHVVXUHUHOLHIYDOYH,QGHDOLQJZLWK risk group 2 or 3 agents, it is desirable to have the PRS located so that it releases away from the work area. Depending on the agent in use, some type of shrouding should be considered or the PRS should be vented to a kill tank or some other contained system. A better option might be to use a pressure sensor that will shut off the air supply when the unit exceeds the normal operating range. Sampling devices should maintain the integrity of the culture as well DV PHHW WKH FRQWDLQPHQW UHTXLUHPHQWV )RU */63 DQG %6/O/6 RQH FDQ use a needle and septum or a steamable sampling valve, since the aim is minimizing release. The use of the needle needs to be evaluated for each agent in use to ensure that it does not create employee exposure problems. )RUZRUNZLWKSDWKRJHQVZKHUHSUHYHQWLQJUHOHDVHLVWKHJRDODVDPSOLQJ device that provides containment should be used. In some cases, secondary containment of the sampling device may be needed. All connections to the vessels are to be secured to prevent leakage or release. Depending on the DJHQWDQGRUYHVVHOVL]HKDUGSLSLQJPD\EHLQGLFDWHG$OOFRQQHFWLRQVPXVW EHGHVLJQHGWRIDFLOLWDWHFOHDQLQJDQGGHFRQWDPLQDWLRQHJÀXVKPRXQWHGRU VWHDPDEOH,IWKHIHUPHQWRUGRHVQRWKDYHDVXI¿FLHQWGHJUHHRIFRQWDLQPHQW built into the unit for certain higher-risk materials, the entire unit may need to be placed in a containment device.

23.3.4

Recovery and Purification

In the downstream processing of the culture material, containment of the material is usually required to protect the product. If the organisms are inactivated in the culture system and there are no toxic, allergenic, or biologically active products (as is the case with GLSP processes), additional containment measures should not be needed. If the cultures are not killed before processing, BSL-1LS requires that the equipment being used for

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processing viable organisms be designed “to reduce the potential for the escape of viable organisms”. At the higher containment levels, the equipment needs to be designed to “prevent release”. The risk assessment of the organism, which includes an analysis of any harmful characteristics of the organism, is the most important consideration in the choice of the containment features of the equipment. Downstream processing can be divided into three basic categories, although some of the equipment can be used for more than one purpose: FHOO VHSDUDWLRQ FHOO GLVUXSWLRQ DQG SXUL¿FDWLRQ 6RPH RI WKH HTXLSPHQW include the following:   

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At BSL-lLS, the containment objective is to reduce the potential for release of viable organisms to minimize release. In more practical terms, that means that the equipment used should be designed to prevent spraying, splashing, RUVLJQL¿FDQWUHOHDVHRIPDWHULDO,IQRWGHVLJQHGLQWRWKHHTXLSPHQWLWVHOI this level of containment may be achieved by shielding or putting barriers around the equipment or points where the release can occur. If the equipment generates aerosols, the use of shielding with an exhaust vent placed near the point of aerosol generation could be adequate to minimize release to the work area. At the higher biosafety levels, the requirement is to prevent release of aerosols. However, the rationale for doing that is different for respiratory transmissible agents (typically risk group 3) versus agents transmitted through contaminated fomites, e.g., surfaces or equipment (typically risk group 2). In the latter case, if the employees can be vaccinated and the agent is not transmissible by the aerosol route, the use of venting, shielding, or barriers may be adequate to prevent employee exposure. If prevention of aerosol escape is required, either because of the agent or the nature of the product, more rigorous containment measures must be used. One method is to place the entire piece of equipment in a containment GHYLFHRUURRP)RUH[DPSOHÀRZWKURXJKFHQWULIXJHVDUHNQRZQWRJHQHUDWH aerosols, and where containment is needed, the unit can be placed in a separate room or containment device. Plastic isolators may be considered, but they are designed to be positive-pressure systems. Depending on the DJHQWRUSURGXFWEHLQJSURFHVVHGWKHLVRODWRUVPLJKWEHXVHGLI¿WWHGZLWK a sensing device to detect leakage. Biological safety cabinets (BSCs) can be used for smaller equipment that does not generate much turbulence. In some

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instances, BSC manufacturers, or other specialty equipment fabricators, can PDNHVSHFLDOL]HGFRQWDLQPHQWGHYLFHVIRUVSHFL¿FHTXLSPHQW$FRQWDLQPHQW device may consist of plastic shrouding or can be a cabinet with HEPA supply and exhaust to dissipate the heat load. The device needs to provide accessibility to the equipment for operation, routine maintenance and servicing, materials loading and removal, and cleaning. This may necessitate the use of access panels, portholes, and gloves. Obviously, all of these issues need to be addressed in the design of the device so that it can be used in the manner intended. )RU GUXJ DQG GHYLFH DSSOLFDWLRQV DOO DLU FRPLQJ LQWR FRQWDFW ZLWK RSHQ product must be class 100, which usually requires the unit to have a HEPA ¿OWHU GLUHFWO\ RYHU WKH ZRUN VXUIDFH 7KH XVH RI KRUL]RQWDO ODPLQDUÀRZ FOHDQDLUVWDWLRQVVKRXOGEHOLPLWHGWRPHGLXPSUHSDUDWLRQ)RUDSSOLFDWLRQV where a BSC cannot be used but class 100 conditions are required, a vertical ODPLQDUÀRZXQLWPD\EHXVHGSURYLGHGWKDWDGGLWLRQDOVKLHOGLQJFXUWDLQV low-level returns, etc., are used to reduce employee exposure.

Mechanisms for Cleaning and Disinfecting Equipment All equipment is required to be cleaned and “sterilized” to prevent product contamination between runs, where the “sterilization” cycle has been validated to kill the organism being manipulated. A more appropriate term is “decontaminate”, since one does not always need to eliminate all viable organisms. Some facilities may use a clean-in-place (CIP) system that utilizes detergent and an extreme pH. In some cases, that treatment may be adequate to kill the organism in use, but that has to be validated. If the agent is not NLOOHGE\WKH&,3SURFHVVDOOHIÀXHQWVPXVWEHSLSHGWRDWDQNIRUWUHDWPHQW DQGGLVSRVDO)RUVRPHHTXLSPHQWVWHDPLQJRUWUHDWPHQWZLWKFKORULQHRWKHU disinfectants, or acidic or caustic solution may be used for decontamination. )RU SURFHVVHV UHTXLULQJ FRQWDLQPHQW DERYH WKH */63 OHYHO WKH HTXLSPHQW must be decontaminated before being opened or cleaned.

23.4

SECONDARY CONTAINMENT

The facility design and construction provide the secondary containment that protects people outside the immediate work area, both in other parts of the facility and in the community at large. The process, agent, and environmental-issue determinations, as outlined previously, will dictate many of the design parameters. It is important to keep the basic facility design criteria in mind throughout the process: 

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‡ %6/O/6 IDFLOLW\ GHVLJQHG WR FRQWDLQ ODUJH VSLOOV RU UHOHDVHV RI organisms.  ‡ %6//6IDFLOLW\GHVLJQHGWRFRQWDLQDOOVSLOOVRUUHOHDVHVRIRUJDQLVPV  ‡ %6//6IDFLOLW\GHVLJQHGWRFRQWDLQDOOVSLOOVRUUHOHDVHVRIRUJDQLVPV including aerosols. 2QHRIWKHPRVWVLJQL¿FDQWLVVXHVLVZKHWKHUWKHIDFLOLW\ZLOOEHXVHGIRU WKHPDQXIDFWXUHRIDQ)'$DSSURYHGGUXJRUGHYLFH Because there are a number of ways to achieve containment, various approaches to design issues are provided. These containment concepts are generally not applicable to GLSP facilities, but certain features may be usable, e.g., waste treatment.

23.4.1

Construction and Finishes

All surfaces within the facility should be designed to withstand regular cleaning and decontamination. Decontamination usually is by application of a disinfectant solution, but BSL-3LS facilities generally must withstand IXPLJDWLRQ 7KH ÀRRUV VKRXOG SURYLGH D GXUDEOH VOLSUHVLVWDQW VDQLWDU\ VXUIDFH ,I ODUJH HTXLSPHQW DUH WR EH PRYHG DERXW FRQFUHWH ÀRRUV ZLWK polyacrylate topping or an architectural epoxy can be used. Sheet vinyl ÀRRULQJ ZLWK ZHOGHG VHDPV RU VRPH RWKHU PRQROLWKLF V\VWHP VKRXOG EH considered where environmental release of pathogenic agents is a major concern or to meet good manufacturing practice (GMP) requirements. The facility must be capable of containing releases from fermentors or bioreactors in case of a large spill. If the equipment is not movable, it can be surrounded by a diked area. If the propagation vessel is movable, containment can be achieved by placing the vessel in a diked area with a ramp or in an area with VXQNHQ RU VORSHG ÀRRUV 7KH GLNH RU GHSUHVVHG DUHD PXVW EH RI VXI¿FLHQW YROXPHWRDFFRPPRGDWHWKHFRQWHQWVRIWKHWDQNDQGVXI¿FLHQWGLVLQIHFWDQW to decontaminate the material if there is no liquid biowaste treatment tank. Similarly, drains in the containment area should be capped or raised unless connected to a biowaste treatment system. :DOOV DQG FHLOLQJV VKRXOG EH VPRRWK QRQSRURXV DQG FDSDEOH RI ZLWKVWDQGLQJFOHDQLQJDQGGLVLQIHFWLRQ:DOOVPD\QHHGDGGLWLRQDOVKLHOGLQJ to prevent damage if large equipment is moved around the area. Ceilings can be epoxy-painted hard plaster or inverted T-bar construction. Rigid, walkable ceiling panels provide enhanced containment for BSL-3 facilities. 3HQHWUDWLRQV LQWR WKH ÀRRU ZDOOV DQG FHLOLQJV VKRXOG EH PLQLPL]HG WR IDFLOLWDWH FOHDQLQJ DQG SUHYHQW OHDNDJH WKURXJK WKH ÀRRU $OO SHQHWUDWLRQV into a BSL-3 facility must be sealed to prevent escape of aerosols and to allow fumigation of the facility. Some utilities, e.g., conduits, should be VHDOHG LQWHUQDOO\:RUN VXUIDFHV PXVW EH LPSHUYLRXV WR ZDWHU DQG UHVLVWDQW

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WR FKHPLFDOV SDUWLFXODUO\ WKRVH XVHG IRU GHFRQWDPLQDWLRQ :RUN VXUIDFHV VKRXOGEH¿QLVKHGZLWKVPRRWKHGJHVWRPLQLPL]HLQMXULHVWRWKHHPSOR\HHV )XUQLWXUHXVHGLQWKHIDFLOLW\PXVWEHVWXUG\DQGFDSDEOHRIEHLQJFOHDQHG and decontaminated and should be positioned to facilitate cleaning of the area. 'RRUV VKRXOG EH ÀXVK GHVLJQ RI VPRRWK QRQSRURXV PDWHULDO WKDW FDQ withstand repeated cleaning and treatment with disinfectants. Doors should EH VHOIFORVLQJ DQG VZLQJ LQWR WKH PRUH KD]DUGRXV URRP:LQGRZV VKRXOG be sealed to the frame. Sloping sills help promote cleanability.

23.4.2

Heating, Ventilation and Air Conditioning

'LUHFWLRQDODLUÀRZFUHDWHGE\QHJDWLYHSUHVVXUHGLIIHUHQWLDOVLVXVHGWRFUHDWH an air barrier between production and adjoining areas. Although that is VXI¿FLHQWIRU%6/O/6ZRUNZLWKSDWKRJHQVUHTXLUHVDGGLWLRQDOFRQWDLQPHQW which can be achieved in a number of ways. Two basic designs are most commonly used. In the envelope system, the internal production areas are maintained at positive pressure and are completely surrounded by a negativepressure corridor to prevent migration of the agent or product from the facility. This design may be preferable for operations that are more vulnerable WRFRQWDPLQDWLRQIRUSUHYHQWLQJSURGXFWFURVVFRQWDPLQDWLRQDQGRUWRPHHW VWULQJHQW)'$UHJXODWLRQV,QPRVWFDVHVVDPHJRDOVFDQEHDFFRPSOLVKHG by using negative pressure gradients in the production area and “buffering” DLU ORFNV LH URRPV WKDW FRQWDLQ ERWK DLU VXSSO\ DQG VXI¿FLHQW H[KDXVW WR ÀXVKFRQWDPLQDQWVIURPWKHURRP7KLVPD[LPL]HVWKHFRQWDLQPHQWIRUWKH production area yet minimizes the ingress of environmental contaminants. )RUIDFLOLWLHVZLWKPXOWLSOHURRPVWKHURRPSUHVVXUHVKRXOGEHPRVWQHJDWLYH in the area of highest hazard, which is usually the fermentor or bioreactor. Depending on the techniques or processes involved, culture starter areas may require a similar level of containment. 7KH QXPEHU RI DLU FKDQJHV SHU KRXU $&+  VLJQL¿FDQWO\ DIIHFWV WKH quality of the air. In facilities that must meet class 100,000 conditions, 20 $&+LVQRWXQFRPPRQ)RUIDFLOLWLHVDERYH%6/O/6WR$&+VKRXOG be targeted. The ventilation in the rooms should be designed to maximize WKH DLU H[FKDQJH LQ WKH URRP JHQHUDOO\ ZLWK WKH DLUÀRZ GLUHFWHG IURP WKH entryway towards the interior wall of the room. The heating, ventilation and air conditioning (HVAC) systems should be sized to dissipate the heat load generated by the equipment and provide a comfortable atmosphere for employees wearing personal protective equipment.

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BSL-1LS facilities do not require any specialized supply or exhaust features. Most of the following features are critical for BSL-3LS facilities and may be considered for BSL-2LS.  

     





‡ 'HGLFDWHG DLU VXSSO\ LV GHVLUDEOH WR IDFLOLWDWH V\VWHP FRQWURO DQG balancing. ‡ ,IWKHVXSSO\LVVKDUHGZLWKRWKHUDUHDV+(3$¿OWHUVDWWKHURRPVXSSO\ vent or airtight dampers should be used to prevent contamination of the supply system. ‡ 6XSSO\DLUVKRXOGEH+(3$¿OWHUHGLIUHFLUFXODWHGLQWKHIDFLOLW\ ‡ ,I +(3$ ¿OWHUV DUH XVHG VXLWDEOH SUH¿OWHUV VKRXOG EH XVHG WR H[WHQG the life of the HEPA. ‡ 3RUWV VKRXOG EH SURYLGHG LQ WKH ¿OWHU KRXVLQJ WR DOORZ IRU SHULRGLF WHVWLQJRIWKH¿OWHUV ‡ +(3$¿OWUDWLRQRIH[KDXVWDLUVKRXOGEHFRQVLGHUHGGHSHQGLQJRQWKH agent and environmental concerns. ‡ 3URYLVLRQ IRU WHVWLQJ DQG GHFRQWDPLQDWLQJ +(3$ ¿OWHUV RU XVH RI EDJLQEDJRXWDVVHPEOLHVVKRXOGEHPDGH ‡ ([KDXVWDLUIURP%6/VDQGRWKHUFRQWDLQPHQWGHYLFHVVKRXOGEH+(3$ ¿OWHUHGSULRUWRGLVFKDUJHSUHIHUDEO\WRRXWVLGHWKHIDFLOLW\([KDXVWLQJ these devices through the room exhaust system can create problems in air balance. Placing them on a separate exhaust system allows them WREHXVHGWRPDLQWDLQQHJDWLYHDLUÀRZLQWKHIDFLOLW\VKRXOGWKHURRP exhaust system fail. ‡ ,W LV SUHIHUDEOH WKDW +(3$ ¿OWHUV WKH DLU EHIRUH LW OHDYHV WKH URRP WR SUHYHQW FRQWDPLQDWLRQ RI WKH H[KDXVW GXFWZRUN :KHQ WKDW LV not feasible, consideration should be given to the use of redundant IDQV DQGRU DQ HPHUJHQF\ SRZHU VXSSO\ IRU WKH H[KDXVW V\VWHP WR maintain the duct work at negative pressure or, alternatively, to seal RU ZHOG WKH GXFWV XS WR WKH SRLQW RI WKH +(3$ ¿OWHU WR SUHYHQW contaminants from escaping the ductwork. ‡ 7KHH[KDXVWDQGVXSSO\V\VWHPVVKRXOGEHLQWHUORFNHGWRSUHYHQWWKH facility from being pressurized.

23.4.3

Utilities and Maintenance Issues

6XI¿FLHQWOLJKWLQJVKRXOGEHSURYLGHGIRUDOODFWLYLWLHVZLWKHIIRUWVPDGHWR PLQLPL]H UHÀHFWLRQV DQG JODUH /LJKWV VKRXOG EH FRYHUHG ZLWK D FOHDQDEOH surface and sealed for BSL-3LS facilities. Liquid and gas utility services, if not dedicated to the facility, should be protected with backflow preventers or other devices to prevent

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contamination, e.g., a bump tank for steamable distilled water systems, a OLTXLG GLVLQIHFWDQW WUDS DQG D +(3$ RU HTXLYDOHQW¿OWHUDWSRLQW RI XVH IRU vacuum systems.

23.4.4

Facility Layout and Support Systems

'HVLJQDWLQJWKHÀRZRIPDWHULDOVIURP³FOHDQ´WR³GLUW\´FDQEHDPELYDOHQW when referring to large-scale facilities, since there are different meanings from a biosafety standpoint versus GMP requirements. One needs to VSHFLI\ZKHWKHUWKHFRQWH[WLVELRVDIHW\ZKHUH³GLUW\´VLJQL¿HVWKHKLJKHVW FRQFHQWUDWLRQ RI RUJDQLVPV RU WKH *03 VHQVH ZKHUH ³GLUW\´ VLJQL¿HV WKH crudest form of the product, i.e., raw materials. As long as the material and SHUVRQQHOÀRZLVXQLGLUHFWLRQDOPRVWRIWKHELRVDIHW\DQG*03FULWHULDFDQ EHPHW)DFLOLWLHVWKDWDUHXVHGWRPDQXIDFWXUHPXOWLSOHDJHQWVDWWKHVDPH time need additional features to prevent cross-contamination. One way to accomplish this is to use an entry-exit corridor system, with each of the various rooms or suites having entrance and exit airlocks. Considerations need to be made for change rooms, storage areas for raw materials, equipment supplies, janitor’s closet for housekeeping supplies, equipment cleanup and decontamination, toilets and showers, freezer and refrigerator space, gas supplies and servicing, etc. In general, large-scale facilities utilize special garbing, so the entry airlock is typically designed DVDFKDQJHURRP2I¿FHDUHDVVKRXOGEHORFDWHGRXWVLGHRIWKHODUJHVFDOH facility or, at a minimum, in the “cleanest” area of the facility. It is understood that paperwork areas and computer terminals are necessary in the large-scale DUHDEXWRI¿FHDUHDVVKRXOGEHVHSDUDWHIURPSURGXFWLRQDUHDVE\IXOOKHLJKW walls and doors. /DUJHVFDOH IDFLOLWLHV VKRXOG EH DZD\ IURP KLJKWUDI¿F DUHDV WR KHOS restrict access and to promote cleanliness. A controlled access system should be considered for all facilities above the GLSP level to protect the product and at higher levels to protect personnel from inadvertent exposures. These devices can range from an electronic card entry system to a combination lock or a key system. Each facility needs to contain all of the required safety equipment. Handwashing facilities, eyewash stations, and emergency showers must be provided. Sinks should generally be automatic or capable of being operated by foot, knee, or elbow. Larger facilities may also have a handwash sink in the change room. The sinks can be discharged to the sanitary sewer provided that they are not used for discharging viable materials. Provisions should be made to equip the area with telephones, computer terminals, fax machines, etc., to facilitate information and data transfer outside the facility and to minimize the need for personnel and paperwork

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to leave the area. If required, data packets can be autoclaved for removal from areas where pathogens are used. All critical equipment and systems supporting the facility should be placed on a preventive maintenance programme. Control panels and items that require regular maintenance should be positioned to allow repair and adjustments to be performed outside of the facility, where possible. An insect and rodent control programme should be developed for the facility. All critical systems and equipment should have alarms. These alarms should be apparent from outside of the facility so that people will not enter the facility unprepared if the containment has been breached. After completion, the facility must be commissioned or validated. These terms signify the same thing; however, commissioning is used by the military and validation is used by industry. The points that need to be covered are +9$&V\VWHPVZDVWHWUHDWPHQWV\VWHPV¿OWHULQWHJULW\DODUPIXQFWLRQDQG failure mode testing.

23.4.5

Waste Treatment

8QOHVV VSHFL¿HG E\ ORFDO RUGLQDQFH WKHUH LV QR QHHG WR GHFRQWDPLQDWH discharges of viable organisms from GLSP facilities, although state and local regulations may require that stock cultures be decontaminated. There may be ORFDOUHJXODWLRQVJRYHUQLQJVSHFL¿FZDVWHSDUDPHWHUVHJELRORJLFDOR[\JHQ demand level of solids, that may require further processing before disposal. )RU ODUJHVFDOH ZRUN ZLWK SDWKRJHQV DQ DXWRFODYH RU RWKHU PHWKRG IRU decontamination should be available to process waste within the facility. The material generally poses a higher risk because of the concentration and volumes involved. A double-door autoclave with access from inside and outside the facility is preferred. A decontamination tank or system may be needed to inactivate any viable organisms from the process, if that cannot be carried out in the fermentor or bioprocessor. The decontamination method typically involves the application of heat or chemicals to the material. Generally, some type of stirring or spraying system needs to be used in the tank to provide better heat or FKHPLFDO GLVWULEXWLRQ DQG UHGXFH WUHDWPHQW WLPH:DVWH WDQNV PD\ EH XVHG for equipment cleaning solutions and rinses, material from spills, etc. All of these factors should be considered in sizing these tanks. Large-scale processes have the potential for increased risk of exposure because of the volume and concentration of the agents used. However, appropriate practices, equipment, and facility design can reduce the risks VLJQL¿FDQWO\)LQDOO\LWVKRXOGEHQRWHGWKDWWKHUHLVQRVLQJOHFRUUHFWZD\ to achieve an acceptable level of containment. Depending on the agent and the process, a number of techniques can be used.

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Biosafety guidelines for work with small volumes of infectious agents, i.e., those amounts typically used for diagnosis, characterization, or basic UHVHDUFKKDYHEHHQHVWDEOLVKHGE\WKH&'&DQGWKH1,+WKH:RUOG+HDOWK Organization. ,WLVXQGHUVWRRGWKDWWKHRUJDQLVPTXDQWLW\DQGSURFHVVKDYHDVLJQL¿FDQW impact on the choice of an appropriate biosafety level for the work to be FRQGXFWHG 7KHUH LV QR VSHFL¿F YROXPH WKDW FRQVWLWXWHV ³ODUJHVFDOH´ IRU microbial agents. Certain CDC-NIH guidance documents have referred to ODUJHVFDOH DV YROXPHV W\SLFDOO\ LQ H[FHVV RI WKRVH XVHG IRU LGHQWL¿FDWLRQ typing, assay performance, or testing. The risk analysis must include an assessment of the infectivity of the agent, the routes of transmission, the severity of infection, the availability of prophylaxis, the level of containment afforded by the process and equipment used, etc., not just the volume RI PDWHULDO EHLQJ KDQGOHG 6LPLODUO\ WKHUH LV OLWWOH VFLHQWL¿F HYLGHQFH WR support the premise that only volumes greater than 10 litres merit large-scale requirements. Certainly, that is not true for BSL-2 and BSL-3 organisms. The CDC-NIH guidelines recommend raising the biosafety level for culturing and purifying many BSL-2 organisms; however, that was only done in an HIIRUWWRSURYLGHFRQVLGHUDWLRQVIRUWKHELRVDIHW\RI¿FHUDQGVFLHQWLVWVLQWKH establishment of the appropriate level of protection. The NIH recombinant DNA guidelines provide guidance for the large-scale use of recombinant organisms to protect the environment but do not adequately address the level of containment necessary to protect the personnel working with infectious agents. These guidelines serve as an effort to collect best practices for maximizing safety for large-scale work and can be used by an institutional ELRVDIHW\ FRPPLWWHH DQGRU D ELRORJLFDO VDIHW\ RI¿FHU %62  WR GHYHORS biosafety procedures for the work to be done. The guidelines cover four different levels for large-scale work: GLSP, BSL-lLS, BSL-2LS, and BSL-3LS. 7KHVH JXLGHOLQHV GR QRW VSHFL¿FDOO\ DGGUHVV DQLPDO RU SODQW SDWKRJHQV however, the containment principles and practices may be useful for some of those agents. All institutions that engage in large-scale research or production with microorganisms should appoint a BSO to oversee the procedures, facilities, and equipment used. A BSO is critical at BSL-2LS and above, where knowledge and experience with handling pathogenic organisms, biosafety practices, and containment design criteria are required.

23.5 23.5.1

BIOSAFETY GUIDELINES Good Large-Scale Practices (GLSPs)

The GLSP level is recommended for certain risk group 1 organisms that are not known to cause disease in healthy adults, are non-toxigenic, are

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ZHOO FKDUDFWHUL]HG DQGRU KDYH DQ H[WHQGHG KLVWRU\ RI VDIH ODUJHVFDOH work. These organisms should not be able to transfer antibiotic resistance to other organisms. Examples of such organisms are Saccharomyces cerevisiae and Escherichia coli K-12. These organisms should have limited survival DQGRUQRDGYHUVHFRQVHTXHQFHVLIUHOHDVHGLQWRWKHHQYLURQPHQW

Standard Microbiological Practices 1. Individuals wash their hands after handling viable material. Antiseptic hand cleanser may be used as an interim measure if a sink is not readily accessible. 2. Eating, drinking, smoking, handling contact lenses, and applying cosmetics are not allowed in the work area. 3. Mouth pipetting is prohibited.   :RUNVXUIDFHVDUHFDSDEOHRIEHLQJFOHDQHGDQGGLVLQIHFWHG   ,QVHFWDQGURGHQWFRQWUROSURJUDPPHVDUHLQHIIHFW

Special Practices 1. Institutions that engage in large-scale work should have a health and safety programme for their employees.   :ULWWHQLQVWUXFWLRQVDQGWUDLQLQJDUHSURYLGHGIRUSHUVRQQHOZKRZRUN in GLSP conditions. 3. Processing, sampling, transfer, handling, etc., of viable organisms are done in a manner that does not adversely affect the health and safety of the employees. 4. Discharges of viable organisms are disposed of in accordance with applicable local, state, and federal requirements.   7KHIDFLOLW\VKRXOGKDYHDQHPHUJHQF\UHVSRQVHSODQWKDWLQFOXGHVWKH handling of spills.

Safety Equipment 1. Protective clothing, e.g., uniforms and laboratory coats, is provided to minimize the soiling of personal clothing. 2. Safety glasses are worn in the facility.

Facilities Each facility contains a sink for hand washing or has an antiseptic waterless hand cleanser available. If present, the sink should be located near the exit doorway. An eyewash station and emergency shower are provided in the work area or easily accessible to it.

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23.5.2

Biosafety Level-1 Large-Scale

BSL-1LS is recommended for the large-scale growth of risk group 1 organisms that are not known to consistently cause disease in healthy adult humans and pose minimal hazard to personnel and the environment but otherwise do not qualify for GLSP level.

Standard Microbiological Practices 1. Access to the work area may be restricted at the discretion of the project manager when work is ongoing. A warning sign should be placed on the door that lists the agent(s) being used, the names and telephone numbers of persons knowledgeable about and responsible for the facility, and entry requirements, if any. 2. Persons wash or clean their hands after they handle viable organisms, after removing gloves, and on leaving the work area. Antiseptic hand cleanser may be used as an interim measure if a sink is not readily accessible. 3. Eating, drinking, smoking, handling contact lenses, and applying cosmetics are not permitted in the work area.   )RRG LV VWRUHG RXWVLGH WKH ZRUN DUHD LQ FDELQHWV RU UHIULJHUDWRUV designated and used for this purpose only.   0RXWKSLSHWWLQJLVSURKLELWHG2QO\PHFKDQLFDOSLSHWWLQJGHYLFHVDUH used.   :RUN VXUIDFHV DUH GHFRQWDPLQDWHG RQ D URXWLQH EDVLV DQG DIWHU DQ\ spill of viable organisms. 7. Procedures are performed carefully in a manner that minimizes aerosol generation. 8. Policies for the safe handling of sharps are instituted. The use of sharps should be minimized. 9. All discharges of the viable organisms are disposed of in accordance with applicable local, state, and federal regulations. 10. Insect and rodent control programmes are in effect.

Special Practices 1. Institutions that engage in large-scale work have a health and safety programme for their employees.   :ULWWHQ SURFHGXUHV DQG WUDLQLQJ LQ EDVLF PLFURELRORJLFDO SUDFWLFHV are provided and documented.

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3. Medical evaluation, surveillance, and treatment are provided when indicated, e.g., to determine functional status or competency of employees’ immune systems when working with opportunistic pathogens. 4. Spills and accidents that result in overt exposure to viable organisms are reported to the facility supervisor or manager. Medical evaluation, surveillance, and treatment are provided as appropriate, and written records are maintained.   (PHUJHQF\SODQVLQFOXGHPHWKRGVDQGSURFHGXUHVIRUKDQGOLQJVSLOOV and employee exposures. 6. Cultures of viable organisms are handled in a closed system or other primary containment equipment that is designed to reduce the potential for the escape of viable organisms. 7. Sample collection and material addition to a closed system and transfer of culture materials from one closed system to another are conducted in a manner that minimizes employee exposure, the release of viable material, and the generation of aerosols. 8. Cultures of viable organisms should be inactivated by a validated process before removal from the closed system or primary containment system, except as allowed in item 7 in this list or when the viable organism or viral vector is the desired product. In the latter case, the viable organisms should be removed from the closed system or other primary containment system in a manner that minimizes employee exposure, the release of viable material, and the generation of aerosols. 9. Exhaust gases removed from a closed system or other primary containment system minimize the release of viable organisms to the HQYLURQPHQWE\WKHXVHRIDSSURSULDWH¿OWHUVRUSURFHGXUHV 10. A closed system or other primary containment equipment that has contained viable organisms is not to be opened for maintenance or other purposes until it has been decontaminated.

Safety Equipment 1. Protective clothing, e.g., uniforms, laboratory coats, etc., is provided to prevent the contamination or soiling of personal clothing. 2. Safety glasses must be worn. 3. Gloves are worn if the skin on the hands is broken, irritated, or otherwise not intact.

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Facilities

    

1. Each facility contains a sink for handwashing or has an antiseptic waterless hand cleanser available. If present, the sink should be located near the exit doorway. An eyewash station and emergency shower should be provided in the work area or easily accessible to it. 2. The work area has a door that can be closed when large-scale work is ongoing. 3. The work area is designed to be easily cleaned.  )ORRUVDUHDEOHWREHFOHDQHGDQGGLVLQIHFWHGLQFDVHRIVSLOOVRIYLDEOH organisms. Rugs are not allowed.  :RUN VXUIDFHV DUH LPSHUYLRXV WR ZDWHU DQG UHVLVWDQW WR DFLGV DONDOL organic solvents, disinfectants, and moderate heat.  )XUQLWXUH LQ WKH ZRUN DUHD LV VWXUG\ DQG SODFHG VR WKDW DOO DUHDV DUH accessible for cleaning.  ,IWKHZRUNDUHDKDVZLQGRZVWKDWRSHQWKH\DUH¿WWHGZLWKÀ\VFUHHQV  )DFLOLWLHV DUH GHVLJQHG WR FRQWDLQ ODUJH VSLOOV RI YLDEOH PDWHULDOV within the facility until appropriately decontaminated. This can be DFFRPSOLVKHGE\XWLOL]LQJDGLNHRUVORSLQJRUORZHULQJWKHÀRRUZKHUH the process vessels are located. The design should minimize the release of viable organisms directly to the sewer.

23.5.3

Biosafety Level-2 Large-Scale

BSL-2LS is recommended for the propagation and cultivation of risk group 2 infectious organisms and other organisms, such as attenuated strains from a higher risk group, that would be handled at BSL-2 in laboratory scale. The following guidelines have been developed for facilities that handle large volumes of these materials.

Standard Microbiological Practices 1. Access to the work area is restricted to personnel who meet the entry requirements. 2. Persons wash their hands after they handle viable organisms, after removing gloves, and before leaving the work area. 3. Eating, drinking, smoking, handling contact lenses, and applying cosmetics are not permitted in the facility.   )RRG LV VWRUHG RXWVLGH WKH IDFLOLW\ LQ FDELQHWV RU UHIULJHUDWRUV designated and used for this purpose only.

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  0RXWK SLSHWWLQJ LV SURKLELWHG 2QO\ PHFKDQLFDO SLSHWWLQJ GHYLFHV are used.   :RUN VXUIDFHV DUH GHFRQWDPLQDWHG RQ D URXWLQH EDVLV DQG DIWHU DQ\ spill of viable organisms. 7. Procedures are performed carefully in a manner that prevents aerosol generation. 8. All contaminated wastes are decontaminated by an approved method before disposal in accordance with local, state, and federal regulations. :DVWHV WKDW QHHG WR EH WUDQVSRUWHG WR D GLIIHUHQW DUHD RU IDFLOLW\ DUH closed and placed in a durable, leak-proof container for transfer. Material to be transferred off site for decontamination is packaged and labelled in accordance with the applicable regulations. 9. All discharges of viable organisms are inactivated by a validated process, i.e., one that has been demonstrated to be effective with the organism in question or with an indicator organism that is known to be more resistant to the physical or chemical methods used, e.g., Bacillus stearothermophilus for steam heat. 10. Insect and rodent control programmes are in effect.

Special Practices 1. Institutions that engage in large-scale work have a health and safety programme for their employees. 2. Doors to the work area are kept closed when work is ongoing. 3. Access to the work area is restricted to personnel whose presence is required and who meet entry requirements, i.e., immunization, if any. Individuals who cannot take or do not respond to the vaccine, who cannot take the recommended prophylaxis in the event of an exposure incident, who are at increased risk of infection, or for whom infection may prove unusually hazardous are not allowed in the work area until their situation has been reviewed by appropriate medical personnel. The individuals are informed of the potential risks and sign an acknowledgment, consent form, or similar document, which indicates that they understand and accept the potential risk.   :ULWWHQ SURFHGXUHV DQG SROLFLHV IRU KDQGOLQJ LQIHFWLRXV RUJDQLVPV are provided.   3HUVRQQHO DUH DEOH WR GHPRQVWUDWH SURILFLHQF\ LQ VWDQGDUG microbiological practices and procedures and the handling of human pathogens at biosafety level 2. This can consist of previous experience DQGRUWUDLQLQJ7UDLQLQJLQWKHKD]DUGVDVVRFLDWHGZLWKWKHRUJDQLVPV

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LQYROYHG DQG WKH SUDFWLFHV DQG RSHUDWLRQV VSHFL¿F WR WKH ODUJHVFDOH work area is provided and documented. Appropriate immunization, medical evaluation surveillance, and treatment are provided when indicated, i.e., immunization, survey of immune status, etc. A hazard warning sign, incorporating the universal biohazard symbol, identifying the infectious agents, listing the names and telephone numbers of the persons knowledgeable about and responsible for the work area, along with any special requirements for entering the work area, is posted at the entry to the work area. :KHQ DSSURSULDWH EDVHOLQH VHUXP VDPSOHV RU RWKHU VXUYHLOODQFH samples are collected and stored for all personnel working in or supporting the work area. A biosafety manual is available that details required safety practices and procedures, spill cleanup, handling of accidents, and other appropriate safety information. The use of sharps is avoided. If required, additional safety devices or personal protective equipment is used to prevent accidental exposure. Plastic laboratoryware is substituted for glassware whenever possible. If glassware is used, it is coated or shielded to minimize the potential for breakage. Viable organisms are placed in a container that prevents leakage during collection, handling, processing, and transport. Viable organisms are handled in a closed system or other primary containment equipment that prevents their release into the environment. Sample collection, material addition to a closed system, and transfers of culture materials from one closed system to another are conducted in a manner that prevents employee exposure and the release of viable material from the closed system. &XOWXUH ÀXLGV DUH QRW UHPRYHG IURP D FORVHG V\VWHP H[FHSW DV allowed in item 13 in this list) unless the viable organisms have been inactivated by a validated procedure. In cases where the viable organism or viral vector is the desired product, the materials should be removed and processed in equipment that prevents employee exposure and release of viable material. ([KDXVW JDVHV UHPRYHG IURP D FORVHG V\VWHP RU RWKHU SULPDU\ FRQWDLQPHQW V\VWHPV DUH ¿OWHUHG RU RWKHUZLVH WUHDWHG WR SUHYHQW WKH release of viable organisms to the environment. A closed system that has contained viable organisms will not be opened for maintenance or other purposes unless it has been decontaminated.

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17. Rotating seals and other mechanical devices directly associated with the closed system used for the propagation of viable organisms are designed to prevent leakage or are fully enclosed in ventilated housings WKDW DUH H[KDXVWHG WKURXJK ¿OWHUV RU RWKHUZLVH WUHDWHG WR SUHYHQW WKH release of viable organisms to the environment. 18. Closed systems, used for the propagation of viable organisms, and other primary containment equipment are tested for the integrity of the containment features before use and following any changes RU PRGL¿FDWLRQV WR WKH V\VWHP WKDW FRXOG DIIHFW WKH FRQWDLQPHQW characteristics of the equipment. These systems are equipped with a sensing device that monitors the integrity of the containment while in XVH&RQWDLQPHQWHTXLSPHQWIRUZKLFKWKHLQWHJULW\FDQQRWEHYHUL¿HG or monitored during use is enclosed in ventilated housings that are H[KDXVWHGWKURXJK¿OWHUVRURWKHUZLVHWUHDWHGWRSUHYHQWWKHUHOHDVHRI viable organisms. 19. Closed systems that are used for propagation of viable organisms or RWKHUSULPDU\FRQWDLQPHQWHTXLSPHQWLVSHUPDQHQWO\LGHQWL¿HG7KLV LGHQWL¿HULVXVHGRQDOOUHFRUGVUHJDUGLQJYDOLGDWLRQWHVWLQJRSHUDWLRQ and maintenance. 20. Contaminated equipment and work surfaces are decontaminated with a suitable disinfectant on a routine basis, after spill cleanup, etc. Contaminated equipment is decontaminated before servicing or transport. Absorbent toweling and coverings used on work surfaces to collect droplets and minimize aerosols are discarded and decontaminated after use. 21. Individuals seek medical attention immediately after an exposure incident. Spills and accidents that result in overt exposure to infectious materials are immediately reported to the facility supervisor or manager and the BSO. Appropriate medical treatment, medical evaluation, and surveillance are provided, and written records are maintained. 22. Emergency procedures include provisions for decontamination and cleanup of all spills or releases of viable material, including proper use of personal protective equipment. 23. Animals not involved in the work being performed are not permitted in the work area.

Safety Equipment 1. Protective clothing, e.g., laboratory coats, protective coveralls, etc., is worn to prevent contamination of personal clothing. If the organism can be transmitted through the skin, the protective clothing is

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waterproof with solid-front, wraparound, or back- or side-tie coats. Protective clothing is removed when leaving the work area. 3URWHFWLYHH\HZHDULVZRUQDWDOOWLPHVLQWKHZRUNDUHD)DFHSURWHFWLRQ i.e., face shield or goggles and face mask or respirator, is worn for any procedures that may involve splashing or spraying. Respirators are worn if the agents involved are transmissible via the respiratory route. Impervious gloves are worn at all times in the work area when work is ongoing. Double gloving is considered if personnel are working for extended periods or with processes that may require direct contact with the infectious material. Gloves are discarded upon leaving the work area. The selection of a respirator or face mask is based on the transmissibility of the agent. If the agent is transmitted through the respiratory URXWH D UHVSLUDWRU ZLWK D ¿OWUDWLRQ HI¿FLHQF\ FDSDEOH RI SURWHFWLQJ the individual from the organism is used, e.g., HEPA for viruses RU 1 IRU Mycobacterium tuberculosis. If the agent is transmitted through mucous membrane contact, a face mask that prevents droplet penetration, e.g., plastic moulded, is preferred. Personnel are trained in the use of respirators and face masks for procedures that may involve aerosol generation and for emergency situations that involve the release of viable organisms in the work area. %6&VRURWKHUYHQWLODWHGFRQWDLQPHQWGHYLFHVFDQEHXVHGWRFRQWDLQ aerosol-generating processes or to prevent contamination of viable organisms when removed from a closed system. Only centrifuge units with sealed rotor heads or safety cups that can be opened in a BSC are used, or the centrifuge is placed in a containment device.

Facilities 1. Each facility contains a sink for handwashing, an eyewash station, and an emergency shower. The sink is foot, elbow, or knee operated, automatic, or otherwise not hand operated and is located near the door of each room in the work area. 2. The work area has a door that is closed when large-scale work is ongoing. 3. The work area is designed to be easily cleaned and disinfected. )XUQLWXUHDQGVWDWLRQDU\HTXLSPHQWDUHVHDOHGWRWKHÀRRURUUDLVHGWR allow for cleaning and disinfection of the facility.

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  )ORRUVZDOOVDQGFHLOLQJVDUHPDGHRIPDWHULDOVWKDWDOORZIRUFOHDQLQJ DQG GLVLQIHFWLRQ RI DOO VXUIDFHV /LJKW ¿[WXUHV DUH FRYHUHG ZLWK D cleanable surface.   :RUN VXUIDFHV DUH LPSHUYLRXV WR ZDWHU DQG UHVLVWDQW WR DFLGV DONDOL organic solvents, disinfectants, and moderate heat.   :LQGRZV WR WKH IDFLOLW\ DUH NHSW FORVHG DQG VHDOHG ZKLOH ZRUN LV ongoing. 7. General laboratory-type work areas are designed to have a minimum of $&+)RUODUJHVFDOHIDFLOLWLHVWKHQXPEHURI$&+ZLOOGHSHQGRQ the size of the area, the chemicals and agents handled, the procedures and equipment utilized, and the microbial or particulate requirements for the area. 8. Ventilation in the work area is designed to maximize the air exchange in the area, i.e., the supply and exhaust are placed at opposite ends of the room, ceiling supply with low-level exhaust, etc. 9. The work areas in the facility where the infectious organisms are handled are at negative pressure to the surrounding areas. 10. Provisions are made to contain large spills of viable organisms within the facility until appropriately decontaminated. This can be accomplished by placing the equipment in a diked area or sloping or ORZHULQJWKHÀRRUVLQWKRVHDUHDVWRDOORZVXI¿FLHQWFDSDFLW\WRFRQWDLQ the viable material and disinfectant. 11. Drainage from the facility is designed to prevent the release of large YROXPHVRIYLDEOHPDWHULDOGLUHFWO\WRWKHVHZHUHJÀRRUGUDLQVDUH FDSSHGUDLVHGRU¿WWHGZLWKOLTXLGWLJKWJDVNHWVWRSUHYHQWUHOHDVHRI untreated organisms to the sewer.

23.5.4

Biosafety Level-3 Large-Scale

BSL-3LS is recommended for propagation and cultivation of infectious RUJDQLVPV FODVVL¿HG DV ULVN JURXS  ZKLFK DUH KDQGOHG DW %6/ DW laboratory scale. The following guidelines have been developed for facilities that handle large volumes of these materials.

Standard Microbiological Practices 1. Access to the facility is restricted to personnel who meet the entry requirements. Individuals who have not been trained in the operating and emergency procedures of the facility are accompanied by trained personnel at all times while in the facility. 2. Persons wash their hands after they handle viable materials, after removing gloves, and before leaving the work area.

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3. Eating, drinking, smoking, handling contact lenses, and applying cosmetics are not permitted in the work area.   )RRG LV VWRUHG RXWVLGH WKH ZRUN DUHD LQ FDELQHWV RU UHIULJHUDWRUV designated and used for this purpose only.   0RXWKSLSHWWLQJLVSURKLELWHG2QO\PHFKDQLFDOSLSHWWLQJGHYLFHVDUH used.   :RUNVXUIDFHVDUHGHFRQWDPLQDWHGRQDURXWLQHEDVLVDQGDIWHUDQ\VSLOO of viable material. 7. Procedures are performed carefully in a manner that prevents aerosol generation. 8. All contaminated wastes are decontaminated by an approved method before disposal in accordance with local, state, and federal regulations. :DVWHV WKDW QHHG WR EH WUDQVSRUWHG WR D GLIIHUHQW DUHD RU IDFLOLW\ DUH closed and placed in a durable, leakproof container for transfer. Material to be transferred off site for decontamination is packaged and labelled in accordance with the applicable regulations. 9. All discharges of the viable materials are inactivated by a validated process, i.e., one that has been demonstrated to be effective with the organism in question or with an indicator organism that is known to be more resistant to the physical or chemical methods used, e.g., B. stearothermophilus for steam heat. 10. Insect and rodent control programmes are in effect.

Special Practices 1. Institutions that engage in large-scale work must have a health and safety programme for their employees. 2. Doors to the facility are kept closed except for entry and egress. 3. Access to the facility is restricted to personnel whose presence is required and who meet entry requirements, i.e., immunization, if any, and comply with all entry and exit procedures. Individuals who cannot take or do not respond to the vaccine, who cannot take the recommended prophylaxis in the event of an exposure incident, who are at increased risk of infection, or for whom infection may prove unusually hazardous are not allowed in the work area until their situation has been reviewed by appropriate medical personnel. The individuals are informed of the potential risks and sign an acknowledgment, consent form, or similar document, which indicates that they understand and accept the potential risk.

334പ/ŶƚĞůůĞĐƚƵĂůWƌŽƉĞƌƚLJZŝŐŚƚƐ͕ŝŽĞƚŚŝĐƐ͕ŝŽƐĂĨĞƚLJĂŶĚŶƚƌĞƉƌĞŶĞƵƌƐŚŝƉŝŶŝŽƚĞĐŚŶŽůŽŐLJ

  :ULWWHQSURFHGXUHVDQGSROLFLHVIRUKDQGOLQJLQIHFWLRXVPDWHULDOVDUH provided.   $OO SHUVRQQHO ZRUNLQJ DW D %6//6 IDFLOLW\ PXVW GHPRQVWUDWH SUR¿FLHQF\LQVWDQGDUGPLFURELRORJLFDOSUDFWLFHVDQGWHFKQLTXHVDQG in handling human pathogens at BSL-3. This can consist of previous H[SHULHQFH DQGRU D WUDLQLQJ SURJUDPPH 7UDLQLQJ LQ WKH KD]DUGV associated with the materials involved and the practices and operations VSHFL¿FWRWKHIDFLOLW\LVSURYLGHGDQGGRFXPHQWHG 6. Appropriate immunization, medical evaluation surveillance, and treatment are provided where indicated, e.g., immunization and survey of immune status. 7. A hazard warning sign, incorporating the universal biohazard symbol, identifying the infectious agents, listing the names and telephone numbers of the persons knowledgeable about and responsible for the facility, along with any special requirements for entering the work area, is posted at the entry to the facility. 8. Baseline serum samples or other appropriate specimens are collected and stored for all personnel working in or supporting the facility. Additional specimens may be collected periodically depending on the agents handled. 9. A biosafety manual is available that details required safety practices and procedures, spill cleanup, handling of accidents, and other appropriate safety information. 10. The use of sharps is avoided. If required, additional safety devices or personal protective equipment is used to prevent accidental exposure. Plastic laboratoryware is substituted for glassware whenever possible. If glassware is used, it is coated or shielded to minimize the potential for breakage. 11. Viable organisms are placed in a container that prevents leakage during collection, handling, processing, and transport. 12. Viable organisms are handled in a closed system or other primary containment equipment that prevents their release into the environment. 13. Sample collection, material addition to a closed system, and transfer of culture materials from one closed system to another are conducted in a manner that prevents employee exposure and the release of viable material from the closed system.   &XOWXUHÀXLGVDUHQRWUHPRYHGIURPDFORVHGV\VWHPH[FHSWDVDOORZHG in item 13 in this list) unless the viable organisms have been inactivated by a validated procedure. In cases where the viable organism or viral vector is the desired product, the materials should be removed and

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processed in equipment that prevents employee exposure and release of viable material. ([KDXVW JDVHV UHPRYHG IURP D FORVHG V\VWHP RU RWKHU SULPDU\ FRQWDLQPHQW V\VWHPV DUH ¿OWHUHG RU RWKHUZLVH WUHDWHG WR SUHYHQW WKH release of viable organisms to the environment. A closed system that has contained viable organisms will not be opened for maintenance or other purposes unless it has been decontaminated. Rotating seals and other mechanical devices directly associated with a closed system used for propagating viable organisms are designed to prevent leakage or are fully enclosed in ventilated housings that are H[KDXVWHGWKURXJK¿OWHUVRURWKHUZLVHWUHDWHGWRSUHYHQWWKHUHOHDVHRI viable organisms. Closed systems used for the propagation of viable organisms and other primary containment equipment are tested for the integrity of the containment features before use and following any changes RU PRGL¿FDWLRQV WR WKH V\VWHP WKDW FRXOG DIIHFW WKH FRQWDLQPHQW characteristics of the equipment. These systems are equipped with a sensing device that monitors the integrity of the containment while in XVH&RQWDLQPHQWHTXLSPHQWIRUZKLFKWKHLQWHJULW\FDQQRWEHYHUL¿HG or monitored during use is enclosed in ventilated housings that are H[KDXVWHGWKURXJK¿OWHUVRURWKHUZLVHWUHDWHGWRSUHYHQWWKHUHOHDVHRI viable organisms. Closed systems that are used for propagation of viable organisms or RWKHUSULPDU\FRQWDLQPHQWHTXLSPHQWLVSHUPDQHQWO\LGHQWL¿HG7KLV LGHQWL¿HULVXVHGRQDOOUHFRUGVUHJDUGLQJYDOLGDWLRQWHVWLQJRSHUDWLRQ and maintenance. Contaminated equipment and work surfaces are decontaminated with a suitable disinfectant on a routine basis, after spill cleanup, etc. Contaminated equipment is decontaminated before servicing or transport. Absorbent toweling and coverings used on work surfaces to collect droplets and minimize aerosols should be discarded and decontaminated after use. Individuals seek medical attention immediately after an exposure incident. Spills and accidents that result in overt exposure to infectious materials are immediately reported to the facility supervisor or manager and the BSO. Appropriate medical treatment, medical evaluation, and surveillance are provided, and written records are maintained. Emergency procedures include provisions for decontamination and cleanup of all spills or releases of viable material, including proper use of personal protective equipment.

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23. Animals not involved in the work being performed are not permitted in the work area.

Safety Equipment 1. Persons entering the facility will change or completely cover their clothing with garments such as solid-front or wraparound gowns or coveralls. If the organism can be transmitted through the skin, the protective clothing must be waterproof. Head and shoe covers or dedicated shoes are provided. Protective clothing is to be removed when leaving the facility and decontaminated before disposal or laundering.   3URWHFWLYHH\HZHDULVZRUQDWDOOWLPHVLQWKHZRUNDUHD)DFHSURWHFWLRQ i.e., face shield or goggles and face mask or respirator, is worn for any procedures that may involve splashing or spraying. Respirators are worn if the agents involved are aerosol transmissible. 3. Impervious gloves are worn at all times in the work area when work is ongoing. Double gloving is considered if personnel are working for extended periods or with processes that may require direct contact with the infectious material. Gloves are discarded upon leaving the work area. 4. The selection of a respirator or face mask is based on the transmissibility of the agent. If the agent is transmitted through the UHVSLUDWRU\ URXWH D UHVSLUDWRU ZLWK D ¿OWUDWLRQ HI¿FLHQF\ FDSDEOH of protecting the individual from the organism is used, e.g., HEPA for viruses or N9Ss for M. tuberculosis. If the agent is transmitted through mucous membrane contact, a face mask that prevents droplet penetration, e.g., plastic molded, is preferred. Personnel are trained in the use of respirators or face masks for procedures that may involve aerosol generation and for emergency situations that involve the release of viable organisms in the work area.   &ODVV,,RU,,,%6&VRURWKHUYHQWLODWHGFRQWDLQPHQWGHYLFHVDUHXVHGWR contain processes of viable materials if removed from a closed system. 6. Only centrifuge units with sealed rotor heads or safety cups that can be opened in a BSC are used, or the centrifuge is placed in a containment device.   &RQWLQXRXVÀRZFHQWULIXJHVRURWKHUDHURVROJHQHUDWLQJHTXLSPHQWLV FRQWDLQHG LQ GHYLFHV WKDW DUH H[KDXVWHG WKURXJK ¿OWHUV RU RWKHUZLVH treated to prevent the release of viable organisms. 8. Vacuum lines are protected with liquid disinfection traps and HEPA ¿OWHUV RU HTXLYDOHQW ZKLFK DUH URXWLQHO\ PDLQWDLQHG DQG UHSODFHG DV needed.

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Facilities   7KHIDFLOLW\LVVHSDUDWHGIURPDUHDVWKDWDUHRSHQWRXQUHVWULFWHGWUDI¿F ÀRZ ZLWKLQ WKH EXLOGLQJ 7KH IDFLOLW\ KDV D GRXEOHGRRU HQWU\ DUHD such as an airlock or pass-through. 2. Each major work area contains a sink for handwashing that is not hand operated, e.g., automatic or foot, knee, or elbow operated. 3. An eyewash station and emergency shower are available in the facility.   7KHIDFLOLW\LVGHVLJQHGWREHHDVLO\FOHDQHGDQGGLVLQIHFWHG)XUQLWXUH DQGVWDWLRQDU\HTXLSPHQWDUHVHDOHGWRWKHÀRRUUDLVHGRUSODFHGRQ wheels to allow for cleaning and disinfecting of the facility.   :RUN VXUIDFHV DUH LPSHUYLRXV WR ZDWHU DQG UHVLVWDQW WR DFLGV DONDOL organic solvents, disinfectants, and moderate heat.   )ORRUVZDOOVDQGFHLOLQJVDUHPDGHRIPDWHULDOVWKDWDOORZIRUFOHDQLQJ DQG GLVLQIHFWLRQ RI DOO VXUIDFHV /LJKW ¿[WXUHV DUH VHDOHG RU UHFHVVHG and covered with a cleanable surface. 7. Penetrations into the containment facility are kept to a minimum and sealed to maintain the integrity of the facility.   :LQGRZVWRWKHIDFLOLW\DUHNHSWFORVHGDQGVHDOHG   /LTXLG DQG JDV VHUYLFHV WR WKH IDFLOLW\ DUH SURWHFWHG IURP EDFNÀRZ XQOHVV WKH\ DUH GHGLFDWHG WR WKH IDFLOLW\ )LUH SURWHFWLRQ VSULQNOHU V\VWHPVGRQRWUHTXLUHEDFNÀRZSUHYHQWLRQGHYLFHV 10. Ventilation system for the facility is designed to control air movement. 11. The position of the supply and exhaust vents is designed to maximize the air exchange in the area, i.e., the supply and exhaust are placed at opposite ends of the room, ceiling supply with low-level exhaust, etc. 12. General laboratory type work areas are designed to have a minimum of $&+)RUODUJHVFDOHIDFLOLWLHVWKHQXPEHURI$&+ZLOOGHSHQGRQ the size of the area, the chemicals and agents handled, the procedures and equipment utilized, and the microbial and particulate requirements for the area. 13. The facility is at negative air pressure to the surrounding areas or FRUULGRUV7KH V\VWHP FUHDWHV GLUHFWLRQDO DLUÀRZ WKDW GUDZV DLU IURP the “clean” areas of the facility into the “contaminated” areas. If there are multiple contaminated areas, the area of the highest potential contamination is the most negative. 14. The exhaust air from the facility is not recirculated to any other area LQWKHIDFLOLW\DQGLVGLVFKDUJHGWRWKHRXWVLGHWKURXJK+(3$¿OWHUVRU other treatments that prevent the release of viable microorganisms.

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  7KH IDFLOLW\ KDV D GHGLFDWHG DLU VXSSO\ V\VWHP IRU WKH IDFLOLW\ ,I WKH VXSSO\V\VWHPLVQRWGHGLFDWHGWRWKHIDFLOLW\LWFRQWDLQV+(3$¿OWHUV or appropriate dampers which can protect the system from potential EDFNÀRZLQWKHHYHQWRIDV\VWHPIDLOXUH 16. The supply and exhaust systems for the facility are interlocked to prevent the room from being pressurized in the event of power or equipment failure. The system is alarmed to indicate system failures RUFKDQJHVLQGHVLUHGDLUÀRZ   $ YLVXDO PRQLWRULQJ GHYLFH WKDW LQGLFDWHV DQG FRQ¿UPV GLUHFWLRQDO DLUÀRZLVSURYLGHGDWWKHHQWU\WRWKHIDFLOLW\ 18. Visible or audible alarms are available to notify personnel of any HVAC system failure. 19. A method for decontaminating all wastes is available in the facility, i.e., autoclave, chemical disinfection, incineration, or other approved method. 20. Provisions are made to contain large spills of viable organisms within the facility until appropriately decontaminated. This can be accomplished by placing the equipment in a diked area or sloping or ORZHULQJ WKH ÀRRUV LQ WKRVH DUHDV WR DOORZ IRU VXI¿FLHQW FDSDFLW\ WR contain the viable organisms and disinfectant. 21. Drainage from the facility is designed to prevent the release of YLDEOH RUJDQLVPV GLUHFWO\ WR WKH VHZHU HJ ÀRRU GUDLQV DUH FDSSHG UDLVHG RU ¿WWHG ZLWK OLTXLG WLJKW JDVNHWV WR SUHYHQW UHOHDVH RI untreated organisms to the sewer.

23.6

THE IMPACT OF AGRICULTURAL BIOTECHNOLOGY RESEARCH

The expected role of biotechnology in sustainable agriculture is to contribute to the development of new varieties, presenting mainly resistance to diseases, environmental stresses, contribution to recuperation and protection of the environment, decreasing the need for agricultural supplies and producing important metabolites of fundamental importance in the human diet. Biotechnology research offers a wide range of possibilities to crop improvement. In the short term its most important contribution is the LQFUHDVHRIWKHTXDQWLW\DQGTXDOLW\RIJOREDOIRRGIHHGDQG¿EUHSURGXFWLRQ

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Plant biotechnology can already produce transgenic seeds that contribute to increased productivity and to sustainable cropping systems that are an essential ingredient for improving responsible use of natural resources and to safeguard the environment. $ FRPSOH[ OLVW RI GHVLUDEOH EHQH¿WV H[SHFWHG IURP ELRWHFKQRORJLFDO research and its productive use are important parameters that should be carefully analysed as research results come to light and production reaches the market. Impact evaluation is the intellectual tool that should respond to the need of the situation. Presently, transgenic products are heavily criticized because it is not clear ZKDW EHQH¿WV WKH\ ZLOO RIIHU WR VRFLHW\$OWKRXJK RQH FDQ HDVLO\ VHH VRPH advantages for the producers (reduction in production costs, increase in productivity), the groups against these products are posing other questions, especially in terms of impacts at the consumer level or in the environmental area.

23.7

ECONOMIC IMPACT EVALUATION

To evaluate the economic impact of agricultural research, the most popular methods are the economic surplus or input account method, the production function or productivity model and the decomposition method. The concept of economic surplus is the most used method to analyse the economic impact generated by the agricultural research. Elasticities of the demand and supply curves of the product under evaluation, the shift of the supply curve, price changes and the production values of the product area are used. The supply curve would be located to the left hand side if there ZDV QR WHFKQRORJLFDO LQQRYDWLRQ JHQHUDWHG E\ DJULFXOWXUDO UHVHDUFK :KHQ WHFKQRORJLFDO LQQRYDWLRQ RFFXUV WKH FRQVXPHUV EHQH¿W ZLWK DQ LQFUHDVH LQ WKH VXSSO\ RI SURGXFWV DQG WKH SURGXFHUV EHQH¿W ZLWK D UHGXFWLRQ LQ production costs. In order to calculate this surplus, it is necessary to determine the rate of supply shift due to the new technology. This rate is calculated by comparing the traditional technology to the new technology (traditional variety vs. improved variety, for example). This rate of shift as a result of agricultural research is computed, in general, using yield increases due to new varieties compared with the traditional varieties and the rate of adoption of new varieties is estimated as a percentage of the cultivated area. In the case of production or productivity function studies, the relationship EHWZHHQ UHVHDUFK LQSXWV DQG SURGXFWLYLW\ FKDQJH LV LGHQWL¿HG E\ ¿WWLQJ DQ aggregate production function model (i.e., research, extension and education variables characterize changes in technology). Other explanatory variables can be used according to the production function to be estimated, as for

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23.8

BIOTECHNOLOGY RESEARCH IN SELECTED COMMODITIES

Papaya Papaya is a host of several pathogens, where viruses and fungi are the most important constraints for the economic exploitation of this product. Among the viral infections in papaya, the most important is caused by the papaya ringspot virus (PRSV), generating a greater negative impact in this crop. Because of this virus, the producing regions of papaya have changed over time and become itinerant. The absence of natural resistance in the germplasm of this species, the disappointing results obtained from research efforts to transfer a natural gene present in some wild species of Papaya carica to the commercial papaya, and the palliative character of other control forms (roguing and cross protection) utilized to combat the disease put genetic engineering as a possible solution. The use of genetic resistance derived from the pathogen (PDR) could have a great potential for controlling the disease. The development of transgenic papaya expressing the gene pc (‘protein cover’) in isolates of PRSV is presented as a way of controlling this disease, with a large potential for it to be effective and with a chance to remain so for a long period. Soybean The soybean research emphasizes the development of a novel system to obtain fertile transgenic soybean plants at a high frequency and the integration of the human growth hormone and insulin genes in soybean genome. There is a worldwide interest in the utilization of the recombinant DNA technology to introduce new traits in soybean, which in turn, should allow FRVW UHGXFWLRQ DQG SURGXFWLYLW\ WR LQFUHDVH DPRQJ RWKHU EHQH¿WV 7KH protocols so far published have failed to achieve reproducibility, simplicity LQFRQGXFWLQJWKHH[SHULPHQWVKLJKHI¿FLHQF\DQGYDULHW\LQGHSHQGHQFH7KH combination of: (i) genes which codify herbicide-active polypeptides, capable of translocating systemically and concentrating in the apical meristematic region of the plant, and (ii) a short multiple-shooting induction protocol, have allowed the development of a simple and routine system to obtain transgenic soybean plants at a high frequency and variety independence. The apical meristematic region of mature soybean embryonic axes was excised, and bombarded with the plasmid DNA. Then, the bombarded embryonic axes were transferred to the culture medium containing MS basal

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salts, suFURVHF\WRNLQLQDQGWKHVHOHFWLYHDJHQW$IWHU±ZHHNVLQFXOWXUH putative transgenic shoots were excised and transferred to the greenhouse for further development. The plants were allowed to set seeds and progeny analyses were performed. )RXU HOLWH FRPPHUFLDO VR\EHDQ YDULHWLHV 'RNR 5& %5 &HOHVWH DQG Conquista) were transformed. The frequency of transformation (number RI WUDQVJHQLF SODQWVQXPEHU RI ERPEDUGHG HPEU\RQLF D[HV  YDULHG IURP ±GHSHQGLQJRQWKHFXOWLYDU9LUWXDOO\QRFKLPHUDVZHUHREVHUYHG7KH development of technologies for the introduction and expression of foreign genes in plants has allowed studies of gene function, and has resulted in great advances towards plant genetic engineering with enhanced input traits.

Beans The ‘golden mosaic’ geminivirus is one of the main diseases affecting the cultivation of beans in Latin America. This disease is caused by a geminivirus WKDWLVWUDQVPLWWHGE\WKHZKLWHÀ\Bemisia tabaci Gennadius). The cultivated areas of beans, in several Brazilian states have been strongly affected by the golden mosaic. This is attributed to the expansion of soybean cultivation in the country, host of this insect. In some regions, due to the high incidence of this disease, the producers have to abandon this crop as the only option. 7KH ORVVHV DUH DURXQG ± RI WKH ¿QDO SURGXFWLRQ DQG FDQ UHDFK WRWDO loss, depending on the variety, the stage of the plants when infected and the type of isolated virus. A more effective method to control viral diseases has been with the introduction of resistance of the host. Studies with the objective of controlling the golden mosaic geminivirus through the introduction of variety resistance have been carried out in Brazil since the 1970s. Despite the extensive efforts of the bean national research programme, no resistant JHUPSODVP KDV EHHQ IRXQG7KH YHUL¿HG ORZ QDWXUDO UHVLVWDQFH WR90') BR in species of Phaseolus has oriented to develop research using genetic HQJLQHHULQJ WR ¿QG WKLV UHVLVWDQFH XVLQJ µSDWKRJHQGHULYHG UHVLVWDQFH¶ WR virus PDR. Potatoes As far as potatoes are concerned, the emphasis is on the study of mechanisms of resistance derived from the pathogen potato leafroll virus (PLRV) and introduction of the gene that gives resistance to the potato virus Y (PVY). This virus belongs to the Potyvirus genus. PVY infects potato (Solanum tuberosum) causing necrosis, mottling or yellowing vein clearing RI OHDÀHWV OHDI GURSSLQJ DQG SUHPDWXUH GHDWK ,Q ¿HOGV HVWDEOLVKHG ZLWK infected tuber seeds, yield reduction is dramatic. To avoid it, growers are

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compelled to renew frequently tuber seed stocks, with lasting effects on SURGXFWLRQ FRVWV JURZHUV¶ LQFRPH DQG ¿QDO SRWDWR SULFHV IRU FRQVXPHUV Strategies to reduce losses by viral infection are based in the use of virus-free seed potatoes and special cultural practices. Usually, these procedures do not offer permanent solutions to PVY infection. Development of resistant cultivars in potato can be a more effective strategy but, due to the tetraploid nature of its genome, potato breeding is NQRZQ WR EH H[WUHPHO\ GLI¿FXOW +RZHYHU WKH DELOLW\ WR WUDQVIRUP SODQWV using Agrobacterium tumefaciens Ti plasmids has made it possible to produce plants with new traits without severe changes in the genetic background of the cultivar. Coat protein (CP)-mediated protection has been used in several crops to obtain transgenic plants resistant or tolerant to viral infection.

Cotton One line of the research on cotton aims to obtain transgenic cotton plants with variety independence and a high frequency, and to develop systems for the introduction and expression of genes of economic interest in elite cotton cultivars. Due to the economic importance of cotton worldwide, there is considerable interest in utilizing the recombinant DNA technology for the introduction of useful genes. Several laboratories have been involved in the development of a protocol capable of obtaining transgenic cotton. The combination of genes which codify herbicide-active polypeptides, capable of translocating systemically and concentrating in the apical meristematic region of the plant and a short multiple-shooting induction protocol, have allowed the development of a simple and routine system to obtain transgenic cotton plants at a high frequency and variety independence. Another line of the research on cotton aims to develop cotton seed resistant to herbicides. Herbicides are an important segment in the area of crop protection. As there is this demand in the cotton market, it is necessary to generate elite cultivars of cotton resistant to herbicide to be introduced in the breeding programme for release in the market. The development of this project is important to the partnership with the Cotton National Research Center, and the gene that will be used is derived from the imidazolinones. This herbicide acts as an enzymatic system present only in the plants and absent in animals and humans. It has advanced characteristics for environmental safety.

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23.9

ECONOMIC, SOCIAL AND ENVIRONMENTAL IMPACTS OF BIOTECHNOLOGY RESEARCH PRODUCTS

Papaya

Economic Impacts The release of new varieties with resistance to PRSV will permit a substantial increase in the Brazilian production of papaya due to expansion of the cultivated area to regions abandoned in the past and due to an increase in the productivity. This increase in the production, and the reduction in the production costs, will allow the generation of more revenue for the papaya producers. Economic impacts will also be important on the government side because of the increase in the volume of tax collected at the producer level and specially in the processing and distribution segments. An economic surplus on the exports sector will also be expected due to the increase in production, and consequently there will be a surplus to be sold in the international market. Also, the abolition of the use of fungicides to control PRSV can represent a reduction in the imports of agricultural inputs or the possibility of exporting more of these inputs no longer used in the papaya production system.

Social and Environmental Impacts Effects on the Producers The introduction of transgenic seeds for the development of papaya trees that are resistant to PRSV will provide important social impacts at the producer level, depending on the farm size (large or small). )RU ODUJH SURGXFHUV LW ZLOO SHUPLW VXVWDLQDEOH SURGXFWLRQ LQ WKH VDPH area by re-establishing the expected triennial rotation of the trees instead RI D VKRUWHU URWDWLRQ ± \HDUV  WKDW LV FDXVHG E\ WKH GLVHDVH 'LVHDVH FRQWURO ZLOO WKHQ EH FDUULHG RXW E\ LGHQWL¿FDWLRQ DQG H[WHUPLQDWLRQ RI affected trees. This will eliminate the occupation of ‘mosaiqueiro’ (hunter of infected trees) that presently produces such a defensive treatment. Manpower will be concentrated on directly productive aspects of the production process. )RU ODUJH SURGXFHUV LW DOVR ZLOO GLPLQLVK WKH PDQDJHULDO EXUGHQ RI maintaining the quality of the productive process and liberate time and energy for other tasks. It will create a certain dependency on the producer, vis-à-vis the furnisher of GM seeds, and his technical assistance.

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The impact of the release of resistant cultivars to PRSV among small producers will be very important, given the concentration of the papaya production on the hands of small producers and family agriculture that have W\SLFDOO\ KDG OLPLWHG UHVRXUFHV 7KH XVH RI ELRWHFKQRORJLFDOO\ PRGL¿HG LPSURYHG VHHGV ZLOO KDYH D GLUHFW LQÀXHQFH RQ WKH TXDOLW\ RI OLIH RI WKHVH groups as a result of the income increase. It will result in more jobs because of the possibilities for expansion of the productive area. The use of diseaseresistant cultivars, which do not require the application of chemicals as control, represents a direct contribution to the wellbeing of human health and VRZLOOEHQH¿WPLOOLRQVRISDSD\DFRQVXPHUV,WZLOOSHUPLWWKHFRQWLQXRXV use of papaya fruits as an important nutritional component for their families, WHQGLQJ WR EHQH¿W VPDOO IDUPHUV IRU ORQJHU SHULRGV RU HYHQ LQ D GH¿QLWLYH way in the areas of small production. It will make possible the participation of small papaya producers in the market as it will more frequently generate VRPHFRQVXPSWLRQVXUSOXV)LQDOO\LWZLOOLQWURGXFHDUHODWLRQVKLSSUHVHQWO\ not existing between the distributor of transgenic seeds and the small papaya producers.

Effects on the Processing and Distribution Segments The effects on these components of the papaya productive chain will also be important given the improvement of quality and the increase in production. The possibility of expansion in the production to new areas also will affect the industries involved in the processing and distribution of papaya in the market.

Impacts on Consumers As a result of the introduction of these new varieties the production will increase and it will force prices down, quality up and increase further diffusion of the consumption. Among the new consumers, more and more people of the lower social segments shall be included. The visible split of opinions between consumers who accept GM food products and those who are against them can ensure deep disagreement between them and make the DGRSWLRQRIWUDQVJHQLFSDSD\DVHHGVOHVVWKDQSDFL¿F2QHFDQH[SHFWWKDWWKH political overtones of the discussion about transgenics will be long-lasting and with no unequivocal winners. Other Effects Expected The complexity of seed production technology and quality control will GHPDQGKLJKO\TXDOL¿HGPDQSRZHURIPHGLXPVXSHULRUDQGGRFWRUDOOHYHOV DV ZHOO DV HI¿FLHQW FRPPXQLFDWRUV WR FRQGXFW WKH UHODWLRQVKLS EHWZHHQ JHQHWLFDOO\ PRGL¿HG VHHG SURGXFHUV DQG IUXLW SURGXFHUV $V D UHVXOW WKH

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use of specialized and general education will intensify and the search for technical information will grow larger.

Soybean

Economic Impacts According to the estimates made through interviews and personal contacts, the new varieties of soybeans with resistance to herbicides will reduce WKH SURGXFWLRQ FRVWV E\ ± $ UHSRUW SUHSDUHG E\ WKH 8QLYHUVLW\ RI Illinois about the economics of GMOs in agriculture has indicated that DQ DGGLWLRQDO EHQH¿W IRU VR\EHDQ SURGXFHUV ZDV D UHGXFWLRQ LQ WKH SULFHV of other herbicides. This shows that even the farmers electing not to use *5 JO\SKRVDWHUHVLVWDQW  VR\EHDQV KDYH EHQH¿WHG IURP LWV LQWURGXFWLRQ LQ the USA. These new varieties will also allow an increase in the national production due to the cleaning of the cultivated area that makes the new varieties more productive. $QRWKHUEHQH¿WZLOOJRWRWKHJRYHUQPHQWPRUHWD[ZLOOEHFROOHFWHGDV a consequence of the increase in the revenues of the soybeans producers. An important contribution in the generation of surplus as a result of the increase in soybean exports is also expected.

Social and Environmental Impacts Effects on the Producers Herbicide-resistant soybean varieties will increase the gains of the producers, and consequently their quality of life. At the same time, it will make them more dependent on the furnishers of GM seeds and the related WHFKQLFDO DVVLVWDQFH 7KLV FUHDWHV D VLWXDWLRQ RI FRQÀLFWLQJ LQWHUHVWV WKDW may characterize the long-term relationship between these two links of the productive chain. The occupational roles will change little, but a few jobs will disappear as the new technology is labour-saving. There will be additional income to the producers and technology property owners. The potential commercial utilization of soybean plants to produce human growth hormone and insulin will create a new and important social organization of the soybean market by adding to it a specialization on pharmaceuticals. The productive chain will probably be organized with the central participation of highly sophisticated small producers that will be able to produce and maintain the quality of the product.

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Effects on Processing and Distribution No important impact of herbicide-resistant soybean varieties is expected in the present pattern of processing and distribution, except those originating from lower production prices and higher productivity. Impacts on Consumers The consumHUVLQJHQHUDOZLOOEHQH¿WIURPORZHUSULFHVDQGQHZSURGXFWV Those that depend on the use of previously expensive health products will be greatly helped by the diffusion and adoption of the research results. The socially relevant, politically emotional disagreement about transgenics will affect soybean seed adoption as much as it will papaya and any other transgenic product. The discussion about possible environmental LPSDFWV ZLOO KDYH D GDPDJLQJ LQÀXHQFH RQ DGRSWLRQ RI KHUELFLGHUHVLVWDQW soybean varieties as well as on the adoption of transgenic medical products, irrespective of what evidence is already available. This will press scientists, including health and medical specialists, to produce new, more convincing empirical arguments on them. Other effects expected: quality and quantity of manpower use, and the increasing value of education for the production of high-tech products will be about the same as in the case of papaya already discussed above. Legal and pharmaceutical professionals will have a previously unsuspected role in the soybean productive chain. Beans

Economic Impacts The new transgenic varieties with resistance to golden mosaic virus leads to increase in production and the reduction in the cost of production.

Social and Environmental Impacts Effects on the Producers The small producers are the main growers of beans in Brazil both for self-consumption and for market. The positive results of the research will permit the production of a second yield in the same area at the dry season. It will re-open to the producers the alternative of returning to bean production in areas where the culture was uprooted because of the presence RI ZKLWHÀ\ 7KHVH HIIHFWV ZLOO LQFUHDVH WKH RFFXSDWLRQ RI WKH H[LVWLQJ manpower.

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Effects on Processing and Distribution It is expected that more production will result in more participation of the small bean growers on the national market and will increase the local consumption of goods and services. As it was pointed out about other commodities, the bean producers will be more dependent on seed producers because they will have to renew the seed periodically.

Impacts on Consumers The consumers will have access to the goods at lower prices and the supply will be more regular, i.e., there will be more food security and less need for import. Other Effects Expected Controversy about the use of transgenic food will probably continue and VRPHVKRUWWHUPSDQLFDVLQWKHFDVHRIWKH¿UVWµPDGFRZ¶PD\KDSSHQLI any disaster, true or false, is believed to occur.

Potatoes

Economic Impacts The new varieties with resistance to PVY will permit a reduction in production cost. The reduction will generate an increase in the revenues RI WKH SRWDWR SURGXFHUV DQG DOVR PRUH WD[ IRU WKH JRYHUQPHQW )RU the consumers, this cost reduction should represent a reduction in the price of this commodity. The abolition of the use of fungicides for PVY control can also represent an economy in the imports of agricultural inputs or the possibility of exporting more of these inputs no longer used in the potato production system.

Social and Environmental Impacts Effects on the Producers The virus-resistant potato will no longer compel growers to frequently renew tuber seed stocks and will revert the dramatic yield reduction caused by the disease. The harvest forecast will grow in precision and gains in production costs will be offered resulting in growers’ higher income levels and a consequent increase in quality of life.

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Effects on Processing and Distribution The need for frequent renewal of tuber seed stocks will decrease, perhaps almost completely disappearing and make the producer less susceptible to sudden variations. A better quality product will come to the market. Impacts on Consumers Part of the gains resulting from more favourable conditions of production will go to the consumers, who will have a product of high quality and a more constant supply. The reduction in the use of chemical inputs may result in health quality improvement for consumers and for all those that deal with the product. Other Effects Expected 7KH JHQH WKDW FRGL¿HV WKH SURtein cover is a part of the virus. It is not supposed to be harmful to human beings and animals, as many licensed and largely commercialized GM products have the gene NPT II already. Research abounds and no harm was detected. This can become a good defence argument against any opposition to this transgenic product in particular, and to the class of transgenic products in general. Cotton

Economic Impacts The use of the new cotton varieties with resistance to herbicides will permit the increase of the production of cotton. The main impact will be in the production costs, which are considerably reduced with the introduction of genes resistant to herbicides. This cost reduction is estimated WR EH ± ZKLFK ZLOO SHUPLW D VXEVWDQWLDO LQFUHDVH LQ WKH UHYHQXH SHU hectare for cotton producers. 7KLV LQFUHDVH LQ UHYHQXHV PHDQV PRUH SUR¿WDELOLW\ IRU WKH SURGXFHUV in this activity that permits an expansion in the cultivated area or investments in technology in the same area, making the culture more productive. )LQDOO\ WKH LPSDFW RQ SURGXFWLYLW\ PXVW EH VLJQL¿FDQW GXH WR WKH cultivation of these cultivars resistant to herbicides. The increase in the productivity will be a consequence of the utilization of a clean cultivated area (without weeds) to cultivate cotton and consequently better conditions to increase the productivity comparatively to a situation where the cotton is cultivated with traditional varieties.

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Social and Environmental Impacts Effects on the Producers Herbicide-resistant cotton varieties will positively affect the gains of the producers and also the quality of life. However, as was observed on soybean seeds with this type of resistance, they will become more dependent on the VHHG IXUQLVKHU DQG RQ WHFKQLFDO DVVLVWDQFH &RQÀLFWLQJ LQWHUHVWV PD\ characterize the long-term relationship between them and affect the behaviour of the productive chain by making internal relations more unstable and FRQÀLFWLYH$ IHZ MREV ZLOO GLVDSSHDU VLQFH WKH QHZ WHFKQRORJ\ LV ODERXU VDYLQJ 7KH SUR¿WV ZLOO LQFUHDVH DQG WKHLU GLVWULEXWLRQ ZLOO IDYRXU WKH producers and the technology owners at the expense of labour. The gene to be utilized for producing herbicide-resistant cotton seeds is a derivation of a new class of herbicide, which behaves as an enzymatic system that is present only in plants, neither in animals nor in humans. This corresponds to a very advanced characteristic that favours environmental security.

Effects on Processing and Distribution An expansion of the area cultivated with cotton may have an impact on the country’s share of the international market and reverse the present position of importer to exporter. This may compensate for the lower job intensity of production by creating new jobs in new productive areas. Impacts on Consumers The reduction in the production cost will lower cotton prices, and will GLUHFWO\EHQH¿WWKHFRQVXPHUVDQGFRQVHTXHQWO\WKHLUTXDOLW\RIOLIH Other Effects Expected Relations between the national cotton productive chain and the transnational research laboratories on transgenics will grow closer because of the use of international patent as a basis of the developed technology.

23.10

GENETIC TECHNOLOGY

Many people believe food security will be achieved only by supplementing modern agricultural techniques with genetic engineering. This technology, it is claimed, will increase plant yields, animal produce and the nutritional value of food, whilst decreasing the amount of land needed and minimising damage to the environment. By means of GM techniques we should be able, relatively quickly, to produce strains of plants that will be resistant to pests,

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diseases and drought. This will immediately increase yields in a world in which as much as half the global crop can be lost to these three evils. It will also reduce our carbon footprint and avoid environmental damage because we will be able to reduce our use of fertilisers, pesticides and water, and where use of such products is unavoidable, use more environment-friendly versions. GM technology also holds out the promise of increasing the nutritional value of food. Perhaps one day, for example, it will be possible to deliver the day’s nutrients in a single meal. This technology would have obvious applications in the developing world. *ROGHQ ULFH IRU H[DPSOH ZDV ¿UVW SURGXFHG LQ  E\ PHDQV RI WKH insertion of daffodil and bacterial genes coding for an enzyme involved in the synthesis of beta-carotene (a precursor of vitamin A) into the rice genome. This ‘poster child’ of GM foods promises to provide the recommended daily allowance of vitamin A in the daily 100–200 gm of rice eaten by children in countries like India, Vietnam or Bangladesh. :HUHJROGHQULFHWREHPDGHDYDLODEOHLQWKHFRXQWULHVRIWKHZRUOGLQ ZKLFKWKHUHLVDYLWDPLQ$GH¿FLHQF\LWPLJKWVDYHXSWRFKLOGUHQ each year from losing their sight. Given that half of these children die within 6 months of going blind, the use of golden rice would also save many lives. But the technology also has application in the west. In the UK, for H[DPSOH  RI WKH SRSXODWLRQ GRHV QRW HDW WKH RLO\ ¿VK WKDW ZRXOG JLYH them the recommended daily amount of omega three fatty acids needed for KHDOWK7KLVFRXOGEHUHPHGLHGLIFURSVZHUHPRGL¿HGZLWKJHQHVIURPWKH DOJDH WKDW LV WKH VRXUFH RI WKH RPHJD WKUHH FRQWHQW RI ¿VK DQG RI DQLPDOV IHGRQ¿VKPHDO

23.11

NEGATIVE IMPACTS

,Q  'U ,ULQD (UPDNRYD D OHDGLng scientist at the Institute of Higher Nervous Activity and Neurophysiology of the Russian Academy of Sciences IHGIHPDOHUDWVIRRGWRZKLFKÀRXUIURPVR\EHDQVPRGL¿HGWREHUHVLVWDQW to the pesticide Roundup™ had been added. The rats were then allowed to become pregnant. During their pregnancy, the feeding regime continued. A WRWDORIRIWKHRIIVSULQJRIWKHVHUDWVGLHGZLWKLQZHHNVDQG ZHUH VLJQL¿FDQWO\ VWXQWHG ± ZHLJKLQJ OHVV WKDQ  JP DIWHU  ZHHNV ,Q FRQWUDVWRQO\RIWKHRIIVSULQJRIUDWVIHGRQQRQ*0VR\GLHGDQG were stunted. In another study, researchers at Australia’s CSIRO took the gene for a protein capable of killing pea weevil pests from the common bean and

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transferred it into the pea. Some mice were given injections of the protein, whilst others had the protein put into their airways. The injected mice showed a hypersensitive skin response, while the airway-exposed mice GHYHORSHGDLUZD\LQÀDPPDWLRQDQGPLOGOXQJGDPDJH

23.12

ENVIRONMENTAL DAMAGE

Another problem is that geQHWLFDOO\ PRGL¿HG RUJDQLVPV PLJKW GDPDJH WKH environment. One concern that has been expressed is that herbicide-tolerant crops might encourage even greater use of herbicides than so far used. Other worries involve the fear that such crops will ‘escape’ into the wild by pollinating related species, and that selective pressures will result in weeds that are themselves tolerant to herbicides, mandating the use of different, and possibly more damaging, herbicides. In the United States in 2006, for example, a herbicide-resistant grass designed to improve golf courses and domestic lawns was found three miles outside its test site in Oregon. Some had grown from seeds produced by GM plants, others had hybridized as a result of the pollination of a non-GM plant by the GM strain. The grass, Agrostis stolonifera or creeping bentgrass, is a perennial grass with many relatives in the wild (making pollination easier). Its escape was blamed on human error. The advent of glyphosate-resistant crops, furthermore, has led to a dramatic increase in the use of glyphosate as a weed killer. This has, in turn, led to many common weeds – ragweed, waterhemp, goosegrass – evolving a resistance to glyphosate. Another study in Missouri, which tested waterhemp from 144 locations DFURVVWKHVWDWHIRXQGRIWKHSRSXODWLRQVZHUHUHVLVWDQWWRJO\SKRVDWH The glyphosate-resistant giant ragweed has also been found to have at least moderate resistance to other herbicides. &URSVJHQHWLFDOO\PRGL¿HGWREHUHVLVWDQWWRLQVHFWSHVWVJHQHUDWHVLPLODU worries regarding insecticides and resistance. There are also, however, additional worries. The use of this technology means that there is less food available for birds and other forms of wildlife that rely on insects for their survival. It is also possible that such GM plants could have an adverse effect RQEHQH¿FLDOLQVHFWVWKDWSUH\RQWKHLQVHFWVWRZKLFKWKHFURSVDUHUHVLVWDQW )RU H[DPSOH D WUDQVJHQLF SRWDWR H[SUHVVLQJ WKH VQRZGURS OHFWLQ JHQH for aphid resistance caused an adverse effect on ladybirds, which prey on aphids. )LQDOO\ JHQHWLFDOO\ HQJLQHHULQJ SODQWV WR UHVLVW YLUXVHV RIWHQ WDNHV WKH form of introducing a form of the virus into the plants as a sort of vaccine. If such plants were to pollinate near relatives, there is always the possibility of a hybrid virus that could cause more damage than the original virus.

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23.13

LABELLING

Labelling has become a key issue for gene-splicing applied to food production. Labels that warn of gene spliced ingredients in food are fundamentally different from the labels currently on food—that list calories, fat content, and so on—because these represent a modest, one-time expense for food producers. By contrast, gene-spliced fruits, vegetables, and grains would have to be continually segregated through all phases of production— planting, harvesting, processing, and distribution—adding costs and compromising economies of scale. The need to segregate gene-spliced foods, especially the thousands of processed foods that contain small amounts of derivatives of corn or soybeans, would raise production costs and pose a particular disadvantage to productVLQWKLVFRPSHWLWLYHPDUNHWZLWKORZSUR¿W margins. )'$¶V ORQJVWDQGLQJ FRmmonsense approach to food labelling has been WKDW ODEHO LQIRUPDWLRQ PXVW EH ERWK DFFXUDWH DQG µµPDWHULDO¶¶ )'$ GRHV not require a ‘‘product of biotechnology’’ or ‘‘genetically engineered’’ label for foods from plants or animals that have been improved with rDNA WHFKQLTXHV ,Q WKH  IRRG SROLF\ VWDWHPHQW WKH )'$ VDLG WKDW ODEHOOLQJ is required ‘‘if a food derived from a new plant variety differs from its traditional counterpart such that the common or usual name no longer applies to the new food, or if a safety or usage issue exists to which consumers must be alerted’’. The statement of policy also emphasized that, as for other foods derived from new plant varieties, no premarket review or approval is required unless the characteristics of the new biotechnology products raise explicit safety issues. It noted that these safety issues could be raised by food from new plant varieties however they were created. The safety issues include the introduction of a substance that is new to the food supply (and, hence, lacks a history of safe use), increased levels of a natural toxicant, changes in the levels of a major dietary nutrient, and transfer RI DQ DOOHUJHQ WR D PLOLHX ZKHUH D FRQVXPHU ZRXOG QRW H[SHFW WR ¿QG LW (e.g., a peanut protein transferred to a potato). )'$FODUL¿HGWKDWLIDQHZIRRGUDLVHVDQ\RIWKHVHVDIHW\LVVXHVLWFRXOG EH VXEMHFW WR )'$ UHJXODWLRQV IRU SUHPDUNHW WHVWLQJ SURGXFW ODEHOOLQJ RU UHPRYDO IURP WKH PDUNHWSODFH )'$ FLWHG WKH H[DPSOH RI QHZ DOOHUJHQV in a food as a possible material fact whose omission could make a label misleading. The agency reiterated that the genetic method used in the development of a new plant variety is not considered to be material information because there is no evidence that new biotech foods are GLIIHUHQW IURP RWKHU IRRGV LQ ZD\V UHODWHG WR VDIHW\ 7KHUHIRUH )'$ VDLG that product labelling will not be required to include the method of development of a new plant variety.

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7KH DSSURDFK WDNHQ E\ )'$ LQ LWV  SROLF\ VWDWHPHQW LV FRQVLVWHQW ZLWKVFLHQWL¿FFRQVHQVXVWKDWWKHULVNVDVVRFLDWHGZLWKQHZELRWHFKQRORJ\ derived products are fundamentally the same as for other products. Dozens RI QHZ SODQW YDULHWLHV PRGL¿HG ZLWK WUDGLWLRQDO JHQHWLF WHFKQLTXHV HJ hybridization and mutagenesis) enter the marketplace every year without premarketing regulatory review or special labelling. As discussed above, many of these products are from ‘‘wide crosses’’ in which genes have been moved across natural breeding barriers (without rDNA techniques). None of these plants exist in nature. None requires or gets a premarket review by a government agency. (Safety tests by plant breeders are primarily taste and appearance and, in the case of plants with high levels of known intrinsic toxicants—e.g., tomato and potato—levels of certain alkaloids.) Nonetheless, they have become an integral, familiar, and safe part of our diet: wheat, corn, rice, oats, black currants, pumpkins, tomatoes, and potatoes. )'$OLVWVQLQHFDWHJRULHVRIREOLJDWRU\LQIRUPDWLRQRQELRWHFKIRRG 1. Name of the bioengineered food and the crop from which it was derived. 2. Description of the various intended uses of the bioengineered food, including animal feed uses. 3. Information concerning the sources and functions of introduced genetic material. 4. Information on the purpose or intended technical effects of the modification, and its expected effects on the composition or characteristics of the food or feed.   ,QIRUPDWLRQ DERXW WKH LGHQWLW\ DQG IXQFWLRQ RI WKH QHZO\ LQWURGXFHG genetic material and new gene expression products, including an estimate of the concentration of any expression product in the bioengineered crop and the food derived from it. 6. Comparison of the composition and characteristics of the bioengineered food with the food derived from the parental variety or other commonly consumed varieties. 7. Information about the identity and levels of toxicants that occur naturally in the food. 8. Discussion of the available information concerning the potential for altered allergenicity (ability to elicit an allergic reaction) in the bioengineered food. 9. Any other information relevant to the safety and nutritional assessment of the bioengineered food.

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The Paris based Organization for Economic Cooperation and Development 2(&'  KDV HQGRUVHG D SROLF\ IRU ELRWHFK IRRGV VLPLODU WR )'$¶V  DSSURDFK ,Q LWV  SXEOLFDWLRQ 6DIHW\ (YDOXDWLRQ RI )RRGV 'HULYHG by Modern Biotechnology, OECD invoked the concept of ‘‘substantial equivalence’’, the crux of which is that new foods that are ‘‘substantially equivalent’’ to other varieties should be regulated ‘‘in the same manner as their analogous conventional counterparts”. A demonstration of substantial equivalence takes into consideration a number of factors, such as:  



‡ NQRZOHGJH RI WKH FRPSRVLWLRQ DQG FKDUDFWHULVWLFV RI WKH WUDGLWLRQDO or parental product or organism; ‡ NQRZOHGJH RI WKH FKDUDFWHULVWLFV RI WKH QHZ FRPSRQHQWV  RU trait(s) derived, as appropriate, from information concerning: the component(s) or traits(s) as expressed in the precursor(s) or parental organism(s); transformation techniques (as related to understanding the characteristics of the product) including the vector(s) and any PDUNHUJHQHVXVHGSRVVLEOHVHFRQGDU\HIIHFWVRIWKHPRGL¿FDWLRQDQG the characterization of the component(s) or trait(s) as expressed in the new organism; and ‡ NQRZOHGJH RI WKH QHZ SURGXFWRUJDQLVP ZLWK WKH QHZ FRPSRQHQWV or trait(s), including the characteristics and composition [i.e., the amount of the component(s) or the range(s) of expression(s) of the new trait(s)] as compared with the conventional counterpart(s) (i.e., the existing food or food component). The OECD document elaborated ‘‘principles for the application of substantial equivalence to the assessment of organisms developed by the application of biotechnology’’:



‡ ,I WKH QHZ RU PRGL¿HG IRRG RU IRRG FRPSRQHQW LV GHWHUPLQHG WR EH substantially equivalent to an existing food, then further safety or QXWULWLRQDOFRQFHUQVDUHH[SHFWHGWREHLQVLJQL¿FDQW



‡ 6XFK IRRGV RQFH VXEVWDQWLDO HTXLYDOHQFH KDV EHHQ HVWDEOLVKHG DUH treated in the same manner as their analogous conventional counterparts.



‡ :KHUHQHZIRRGVRUFODVVHVRIQHZIRRGVRUIRRGFRPSRQHQWVDUHOHVV ZHOONQRZQWKHFRQFHSWRIVXEVWDQWLDOHTXLYDOHQFHLVPRUHGLI¿FXOWWR apply; such new foods or food components are evaluated taking into account the experience gained in the evaluation of similar materials (for example, whole foods or food components such as proteins, fats or carbohydrates).

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‡ :KHUHDSURGXFWLVGHWHUPLQHGQRWWREHVXEVWDQWLDOO\HTXLYDOHQWWKH LGHQWL¿HGGLIIHUHQFHVVKRXOGEHWKHIRFXVRIIXUWKHUHYDOXDWLRQV



‡ :KHUH WKHUH LV QR EDVLV IRU FRPSDULVRQ RI D QHZ IRRG RU IRRG component, that is, where no counterpart or similar materials have been previously consumed as food, then the new food or food component should be evaluated on the basis of its own composition and properties.

The European Union The European Union (EU) announced controversial rules for the labelling and sale of new biotechnology derived foods in December 1996. The nowPDQGDWRU\ODEHOVZLOODGGVLJQL¿FDQWO\WRWKHFRVWVRISURFHVVHGIRRGVPDGH from fresh fruits and vegetables. The precise costs will vary according to the product. But a company using a gene-spliced, higher-solids, lesswatery tomato (more favourable for processing), for example, must bear the additional costs of segregating the product at all levels of planting, harvesting, shipping, processing and distribution. Labels must appear on minestrone soup, indicating the presence of gene-spliced tomato, potato or other products (at least any amount above an arbitrary one per cent threshold). The added production costs are a particular disadvantage to products in WKLVFRPSHWLWLYHORZSUR¿WPDUJLQPDUNHWVHJPHQWDQGDWEHVWZLOOOLNHO\ relegate many gene spliced products to the status of expensive ‘‘boutique’’ IRRGVRXWRIWKHUHDFKRIOHVVDIÀXHQt consumers.

Part-III

24

Bioethics

CHAPTER

24.1

INTRODUCTION

In the 1950s and 1960s, physicians and theologians came together to discuss GLI¿FXOW TXHVWLRQV DULVLQJ IURP PHGLFDO DGYDQFHV RI WKH WLPH 6RPH RI WKHVH TXHVWLRQV ZHUH DERXW XVLQJ KXPDQ VXEMHFWV LQ UHVHDUFK VRPH ZHUH DERXWWKHXVHRIQHZPHGLFDOWHFKQRORJLHVDQGVRPHZHUHDERXWSURWHFWLQJ WKH SXEOLF IURP KDUPIXO PHGLFDWLRQV 7KH RXWFRPH ZDV WKH EHJLQQLQJ RI PRGHUQELRHWKLFV7KHWHUPELRHWKLFVZDV¿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¶V ELRHWKLFDO GHEDWHV DV DUH YLUWXDOO\ DQ\ GLVFXVVLRQV UHODWHG WR DFFHSWDEOHXVDJHVRIELRWHFKQRORJ\7KHGLVFXVVLRQRIELRHWKLFVLQWKLVERRN KRZHYHU ZLOO EH OLPLWHG WR RQO\ D IHZ RI WKH PDQ\ UHPDUNDEOH VFLHQWL¿F EUHDNWKURXJKVRIWKHSDVWGHFDGH

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