Law and modern biotechnology: selected issues of relevance to food and agriculture
Gespeichert in:
| 1. Verfasser: | |
|---|---|
| Format: | Buch |
| Sprache: | English |
| Veröffentlicht: |
Rome
Food and Agriculture Organization of the United Nations
2003
|
| Schriftenreihe: | Legislative study
78 |
| Online-Zugang: | Inhaltsverzeichnis |
| Beschreibung: | XVII, 172 Seiten |
| ISBN: | 9251049726 9789251049723 |
Internformat
MARC
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| 245 | 1 | 0 | |a Law and modern biotechnology |b selected issues of relevance to food and agriculture |c Lyle Glowka for the FAO Legal Office |
| 264 | 1 | |a Rome |b Food and Agriculture Organization of the United Nations |c 2003 | |
| 300 | |a XVII, 172 Seiten | ||
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| 338 | |b nc |2 rdacarrier | ||
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Datensatz im Suchindex
| _version_ | 1804135203486040064 |
|---|---|
| adam_text | Contents
FOREWORD ........................................................................ üi
Ust of abbreviations...............................................................xi
Executive summary ............................................................ xiii
INTRODUCTION .......................................................................1
I. BASIS FOR THE STUDY............................................................1
1.1. Methodology of the study and format ...........................................1
II. THE NATURE OF INSTRUMENTS ADDRESSING BIOTECHNOLOGY.............................3
2.1 Regulatory trigger: process versus product.....................................6
III. PUBLIC PARTICIPATION IN POLICY-MAKING AND REGULATORY
DECISION-MAKING...............................................................8
3.1 Access and information.........................................................8
3.1.1. International treatment of access to information..................... 8
3.1.2. National level treatment of access to information ..................... 12
3.2 Labelling.................................................................. 17
3.2.1. Food labelling at the international and national levels................ 18
3.2.2. Labelling related to biosafety at international and national levels.... 24
3.3. Public participation in policy and decision-making........................... 25
3.3.1. Public participation in policy-making................................ 26
3.3.2. Public participation in decision-making.............................. 28
IY. OVERSIGHT MECHANISMS ........................................................ 31
«
4.1. Designating existing or establishing new institutions ....................... 31
4.2. Safety assessment.............................................................35
4.2.1. Risk assessment...................................................... 35
4.2.2. Risk management ..................................................... 39
4.2.2.1. Post approval monitoring and other responsibilities ......... 42
4.2.2.2. Labelling.................................................... 44
4.2.2.3. Traceability................................................. 44
4.3. Decision-making.............................................................. 46
4.3.1. Decision-making considerations other than environment and human health. 46
4.3.2. Mechanisms to ensure greater accountability in decision-making......... 48
4.3.2.1. Criteria for decision-making................................. 48
4.3.2.2. Publicly available rationale................................. 49
43.23. Access to judicial or administrative review....................... 50
V. GENERAL CONCLUSIONS ON GAPS AND TRENDS AND AREAS FOR
POSSIBLE FUTURE WORK........................................................... 51
5.1. General conclusions on gaps and trends and areas for possible future work with regard to
public participation........................................................... 51
5.2. General conclusions on gaps and trends and areas for possible future work with regard to
oversight mechanisms........................................................... 53
INTERNATIONAL INSTRUMENTS RELATED TO MODERN BIOTECHNOLOGY
Biotechnology Industry Organization (United States of America) ........................ 55
Statement of Principles (1999)................................................... 55
Food and Agriculture Organization of the United Nations and World Health Organization
Codex Alimentarius................................................................... 55
Codex Alimentarius Proposed Draft Guidelines for the Labelling of Foods Obtained through
Certain Techniques of Genetic Mod./Genetic Engineering............................... 57
Codex Alimentarius Guidelines for the Production Processing Labelling and Marketing of
Organically Produced Foods (1999) ................................................... 58
Codex Alimentarius Proposed Draft Principles for the Risk Analysis of Foods Derived from
Modern Biotechnology................................................-................ 60
Codex Alimentarius Proposed Draft Guideline for the Conduct of Food Safety Assessment
of Foods Derived from Recombinant DNA Plants......................................... 61
Codex Alimentarius Proposed Revised Code of Ethics for International Trade in Food..... 62
Codex Alimentarius Proposed Draft Code of Practice on Good Animal Feeding.............. 63
Food and Agriculture Organization of the United Nations
International Treaty on Plant Genetic Resources for Food And Agriculture (2001) ....... 64
International Plant Protection Convention (1997) ...................................... 65
Code of Conduct for the Import and Release of Exotic Biological Control Agents (1996).. 67
Code of Conduct for Responsible Fisheries (1995) ...................................... 68
International Code of Conduct on Plant Biotechnology as it Affects the Conservation and
utilization of Plant Genetic Resources (1992) (Preliminary Draft) ................... 69
Organization for Economic Co-operation and Development
Safety Considerations for Biotechnology (1992) ........................................ 72
United Nations Commission on Economic Co-operation in Europe
Convention on Access to Information, Public Participation in Decision-Making and Access to
Justice in Environmental Matters (1998) ............................................. 74
United Nations Commission on Sustainable Development
Agenda 21, Chapter 16, Environmentally Sound Management of Biotechnology (1992) ....... 76
United Nations Environment Programme
Convention on Biological Diversity (1992) ....................................... 77
Cartagena Protocol on Biosafety to the Convention on Biological Diversity (2000) .. 78
UNEP Technical Guidelines on Biosafety (1995) ..................................... 82
United Nations General Assembly
United Nations Convention on the Law of the Sea (1982)............................. 83
UN Guidelines for Consumer Protection (1985) ...................................... 84
United Nations Industrial Development Organization
Voluntary Code of Conduct for the Release of Organisms into the Environment (1991). 85
World Conservation Union
IUCN position statement on Translocation of Living Organisms (1987)................ 86
World Trade Organization (WTO)
Agreement on the Application of Sanitary and Phytosanitary Measures (1994) ....... 87
Agreement on Technical Barriers to Trade (1994) ................................... 88
SELECTED NATIONAL AND REGIONAL INSTRUMENTS RELATED TO
MODERN BIOTECHNOLOGY
AFRICA
Africa Union
OAU Draft Model National Legislation On Safety In Biotechnology (Revised) (2001)... 90
South Africa
Genetically Modified Organisms Act (1997) ......................................... 92
Tunisia
Draft Law on the Contained Use, Voluntary Release and Commercialization of GMOs ... 93
Draft Law Concerning the Import and Transfer of GMOs .............................. 95
NEAR EAST
Egypt
Biosafety Regulation and Guidelines (1994) ........................................ 96
NORTH AMERICA
Canada
Plant Protection Act (1990) and Regulations (1995)................................. 99
Seed Act (1985) and Regulations (1996) ............................................ 100
Feeds Act and Regulations (1938)................................................... 101
Food and Drugs Act (1985) and Regulations.......................................... 102
National Standard for Voluntary Claims about Foods that are And are Not Products Of Gene
Technology (July 2001 Draft)......................................................... 103
LATIN AMERICA
Andean Community
Biodiversity Regional Strategy for Andean Tropic Countries....................... 104
Brazil
Law No. 8974 of 5 January 1995 .................................................. 106
Decree No. 1752 of 20 December 1995 ............................................. 107
Decree No. 3.871 of 18 July 2001 ................................................ 107
Costa Rica
Law 778 on Biodiversity.......................................................... 108
Plant Protection Law No. 7664 ................................................... 109
Cuba
Decree No. 190-Biological Safety {Official Gazette 1999)......................... 110
Resolution No. 76/2000 — General Rules of Biological Safety for the Facilities where Biological
Agents and their Products, Organisms and Fragments with Genetic Information are Used. Ill
Mexico
Official Mexican Standard NOM-056-FITO-1995 to Establish the Phytosanitary Requirements
for Interstate Movement, Importation and Conduct of Field Trials with Regard to Organisms
Manipulated by the Application of Genetic Engineering (1995) .................... 112
Law on Sustainable Rural Development............................................. 114
The Geneal Law on Health......................................................... 115
Peru
Law No. 27104 on the Prevention of Risks Derived from Biotechnology (Diario Official 1999) .... 116
Decree No. 102-2001-PCM - National Strategy on Biological Diversity.............. 117
ASIA
Asean
ASEAN Guidelines on Risk Assessment of Agriculture-Related Genetically Modified
Organisms (1999)..................................................................... 118
China
Safety Administration Regulation on Genetic Engineering of 24 December 1993 ..... 119
Safety Administration Implementation Regulation on Agricultural Biological Genetic
Engineering of 10 July 1996 ......................................................... 120
Indonesia
Ministerial Decree on the Provision on Biosafety of Genetically Engineered Agricultural
Biotechnology Products (1997) ...................................................... 121
Food Act (1996)......................................................................... 122
Consumer Protection Act (1999) ......................................................... 124
Food Labels and Advertising (Reg. 69/1999) ............................................. 124
Philippines
Executive Order Constituting the National Committee on Biosafety (No. 430,1990)......... 125
Philippine Biosafety Guidelines (1991) ................................................. 125
Thailand
Biosafety Guidelines in Genetic Engineering and Biotechnology (1992).................... 127
Plant Variety Protection Act (1999)..................................................... 129
EUROPE
European Union
Directive 2001/18/EC (Deliberate Release of Gmos into the Environment) ................. 129
Regulation 258/97/EC (Concerning Novel Foods and Novel Food Ingredients)................ 133
Regulation 1139/98/EC (Labelling of Certain Foodstuffs Produced from Gmos)
as Amended ..................... ....................................................... 135
Regulation 50/2000/EC (Labelling of Foodstuffs and Food Ingredients Containg
GM Additives and Flavourings ........................................................... 136
Proposed Regulation on Genetically Modified Food and Feed............................... 137
France
Law 92-654 (Control of GNO Use and Spread) (1992) ...................................... 142
Decree 93-1177 (Application of Law 92-654 to GM Plants, Seeds and Seedlings) (1993) .... 143
*
Decree 94-359 (Control of Phyto-Pharmaceutical Products) (1994)......................... 144
Decree 95-487 (Applications for GM Animals) (1995) ..................................... 144
Decree 97-685 (Animal Feed Stuff) (1997)................................................ 145
Decree 98-318 (Control of Fertilizers and Cultivation Supporting Substances Wholly or
Partially Containing Gmos) (1998)....................................................... 145
United Kingdom
Environmental Protection Act (1990) as Amended ..............................;.......... 146
The Gmos (Deliberate Release) Regulation (1992) as Amended.............................. 148
Novel Foods and Novel Food Ingredients Regulations (1997) as Amended ................... 149
Food Standards Act (1999) .............................................................. 150
South West Pacific
Australia
Gene Technology Act (2000)......................................... 151
Joint Australia New Zealand Food Standards Code, Standard 1.5.2. (Food Produced Using
Gene Technology) (2000).......................................... 154
INTERNATIONAL INSTRUMENTS RELATED TO MODERN BIOTECHNOLOGY
SYNOPTIC TABLES ................................................... 155
REFERENCES ........................................................ 169
|
| adam_txt |
Contents
FOREWORD . üi
Ust of abbreviations.xi
Executive summary . xiii
INTRODUCTION .1
I. BASIS FOR THE STUDY.1
1.1. Methodology of the study and format .1
II. THE NATURE OF INSTRUMENTS ADDRESSING BIOTECHNOLOGY.3
2.1 Regulatory trigger: process versus product.6
III. PUBLIC PARTICIPATION IN POLICY-MAKING AND REGULATORY
DECISION-MAKING.8
3.1 Access and information.8
3.1.1. International treatment of access to information. 8
3.1.2. National level treatment of access to information . 12
3.2 Labelling. 17
3.2.1. Food labelling at the international and national levels. 18
3.2.2. Labelling related to biosafety at international and national levels. 24
3.3. Public participation in policy and decision-making. 25
3.3.1. Public participation in policy-making. 26
3.3.2. Public participation in decision-making. 28
IY. OVERSIGHT MECHANISMS . 31
«
4.1. Designating existing or establishing new institutions . 31
4.2. Safety assessment.35
4.2.1. Risk assessment. 35
4.2.2. Risk management . 39
4.2.2.1. Post approval monitoring and other responsibilities . 42
4.2.2.2. Labelling. 44
4.2.2.3. Traceability. 44
4.3. Decision-making. 46
4.3.1. Decision-making considerations other than environment and human health. 46
4.3.2. Mechanisms to ensure greater accountability in decision-making. 48
4.3.2.1. Criteria for decision-making. 48
4.3.2.2. Publicly available rationale. 49
43.23. Access to judicial or administrative review. 50
V. GENERAL CONCLUSIONS ON GAPS AND TRENDS AND AREAS FOR
POSSIBLE FUTURE WORK. 51
5.1. General conclusions on gaps and trends and areas for possible future work with regard to
public participation. 51
5.2. General conclusions on gaps and trends and areas for possible future work with regard to
oversight mechanisms. 53
INTERNATIONAL INSTRUMENTS RELATED TO MODERN BIOTECHNOLOGY
Biotechnology Industry Organization (United States of America) . 55
Statement of Principles (1999). 55
Food and Agriculture Organization of the United Nations and World Health Organization
Codex Alimentarius. 55
Codex Alimentarius Proposed Draft Guidelines for the Labelling of Foods Obtained through
Certain Techniques of Genetic Mod./Genetic Engineering. 57
Codex Alimentarius Guidelines for the Production Processing Labelling and Marketing of
Organically Produced Foods (1999) . 58
Codex Alimentarius Proposed Draft Principles for the Risk Analysis of Foods Derived from
Modern Biotechnology.-. 60
Codex Alimentarius Proposed Draft Guideline for the Conduct of Food Safety Assessment
of Foods Derived from Recombinant DNA Plants. 61
Codex Alimentarius Proposed Revised Code of Ethics for International Trade in Food. 62
Codex Alimentarius Proposed Draft Code of Practice on Good Animal Feeding. 63
Food and Agriculture Organization of the United Nations
International Treaty on Plant Genetic Resources for Food And Agriculture (2001) . 64
International Plant Protection Convention (1997) . 65
Code of Conduct for the Import and Release of Exotic Biological Control Agents (1996). 67
Code of Conduct for Responsible Fisheries (1995) . 68
International Code of Conduct on Plant Biotechnology as it Affects the Conservation and
utilization of Plant Genetic Resources (1992) (Preliminary Draft) . 69
Organization for Economic Co-operation and Development
Safety Considerations for Biotechnology (1992) . 72
United Nations Commission on Economic Co-operation in Europe
Convention on Access to Information, Public Participation in Decision-Making and Access to
Justice in Environmental Matters (1998) . 74
United Nations Commission on Sustainable Development
Agenda 21, Chapter 16, Environmentally Sound Management of Biotechnology (1992) . 76
United Nations Environment Programme
Convention on Biological Diversity (1992) . 77
Cartagena Protocol on Biosafety to the Convention on Biological Diversity (2000) . 78
UNEP Technical Guidelines on Biosafety (1995) . 82
United Nations General Assembly
United Nations Convention on the Law of the Sea (1982). 83
UN Guidelines for Consumer Protection (1985) . 84
United Nations Industrial Development Organization
Voluntary Code of Conduct for the Release of Organisms into the Environment (1991). 85
World Conservation Union
IUCN position statement on Translocation of Living Organisms (1987). 86
World Trade Organization (WTO)
Agreement on the Application of Sanitary and Phytosanitary Measures (1994) . 87
Agreement on Technical Barriers to Trade (1994) . 88
SELECTED NATIONAL AND REGIONAL INSTRUMENTS RELATED TO
MODERN BIOTECHNOLOGY
AFRICA
Africa Union
OAU Draft Model National Legislation On Safety In Biotechnology (Revised) (2001). 90
South Africa
Genetically Modified Organisms Act (1997) . 92
Tunisia
Draft Law on the Contained Use, Voluntary Release and Commercialization of GMOs . 93
Draft Law Concerning the Import and Transfer of GMOs . 95
NEAR EAST
Egypt
Biosafety Regulation and Guidelines (1994) . 96
NORTH AMERICA
Canada
Plant Protection Act (1990) and Regulations (1995). 99
Seed Act (1985) and Regulations (1996) . 100
Feeds Act and Regulations (1938). 101
Food and Drugs Act (1985) and Regulations. 102
National Standard for Voluntary Claims about Foods that are And are Not Products Of Gene
Technology (July 2001 Draft). 103
LATIN AMERICA
Andean Community
Biodiversity Regional Strategy for Andean Tropic Countries. 104
Brazil
Law No. 8974 of 5 January 1995 . 106
Decree No. 1752 of 20 December 1995 . 107
Decree No. 3.871 of 18 July 2001 . 107
Costa Rica
Law 778 on Biodiversity. 108
Plant Protection Law No. 7664 . 109
Cuba
Decree No. 190-Biological Safety {Official Gazette 1999). 110
Resolution No. 76/2000 — General Rules of Biological Safety for the Facilities where Biological
Agents and their Products, Organisms and Fragments with Genetic Information are Used. Ill
Mexico
Official Mexican Standard NOM-056-FITO-1995 to Establish the Phytosanitary Requirements
for Interstate Movement, Importation and Conduct of Field Trials with Regard to Organisms
Manipulated by the Application of Genetic Engineering (1995) . 112
Law on Sustainable Rural Development. 114
The Geneal Law on Health. 115
Peru
Law No. 27104 on the Prevention of Risks Derived from Biotechnology (Diario Official 1999) . 116
Decree No. 102-2001-PCM - National Strategy on Biological Diversity. 117
ASIA \
Asean
ASEAN Guidelines on Risk Assessment of Agriculture-Related Genetically Modified
Organisms (1999). 118
China
Safety Administration Regulation on Genetic Engineering of 24 December 1993 . 119
Safety Administration Implementation Regulation on Agricultural Biological Genetic
Engineering of 10 July 1996 . 120
Indonesia
Ministerial Decree on the Provision on Biosafety of Genetically Engineered Agricultural
Biotechnology Products (1997) . 121
Food Act (1996). 122
Consumer Protection Act (1999) . 124
Food Labels and Advertising (Reg. 69/1999) . 124
Philippines
Executive Order Constituting the National Committee on Biosafety (No. 430,1990). 125
Philippine Biosafety Guidelines (1991) . 125
Thailand
Biosafety Guidelines in Genetic Engineering and Biotechnology (1992). 127
Plant Variety Protection Act (1999). 129
EUROPE
European Union
Directive 2001/18/EC (Deliberate Release of Gmos into the Environment) . 129
Regulation 258/97/EC (Concerning Novel Foods and Novel Food Ingredients). 133
Regulation 1139/98/EC (Labelling of Certain Foodstuffs Produced from Gmos)
as Amended .'. 135
Regulation 50/2000/EC (Labelling of Foodstuffs and Food Ingredients Containg
GM Additives and Flavourings . 136
Proposed Regulation on Genetically Modified Food and Feed. 137
France
Law 92-654 (Control of GNO Use and Spread) (1992) . 142
Decree 93-1177 (Application of Law 92-654 to GM Plants, Seeds and Seedlings) (1993) . 143
*
Decree 94-359 (Control of Phyto-Pharmaceutical Products) (1994). 144
Decree 95-487 (Applications for GM Animals) (1995) . 144
Decree 97-685 (Animal Feed Stuff) (1997). 145
Decree 98-318 (Control of Fertilizers and Cultivation Supporting Substances Wholly or
Partially Containing Gmos) (1998). 145
United Kingdom
Environmental Protection Act (1990) as Amended .;. 146
The Gmos (Deliberate Release) Regulation (1992) as Amended. 148
Novel Foods and Novel Food Ingredients Regulations (1997) as Amended . 149
Food Standards Act (1999) . 150
South West Pacific
Australia
Gene Technology Act (2000). 151
Joint Australia New Zealand Food Standards Code, Standard 1.5.2. (Food Produced Using
Gene Technology) (2000). 154
INTERNATIONAL INSTRUMENTS RELATED TO MODERN BIOTECHNOLOGY
SYNOPTIC TABLES . 155
REFERENCES . 169
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| spelling | Glowka, Lyle Verfasser aut Law and modern biotechnology selected issues of relevance to food and agriculture Lyle Glowka for the FAO Legal Office Rome Food and Agriculture Organization of the United Nations 2003 XVII, 172 Seiten txt rdacontent n rdamedia nc rdacarrier FAO legislative study 78 Legislative study 78 (DE-604)BV005630125 78 Digitalisierung UB Passau - ADAM Catalogue Enrichment application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=014696736&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Glowka, Lyle Law and modern biotechnology selected issues of relevance to food and agriculture Legislative study |
| title | Law and modern biotechnology selected issues of relevance to food and agriculture |
| title_auth | Law and modern biotechnology selected issues of relevance to food and agriculture |
| title_exact_search | Law and modern biotechnology selected issues of relevance to food and agriculture |
| title_exact_search_txtP | Law and modern biotechnology selected issues of relevance to food and agriculture |
| title_full | Law and modern biotechnology selected issues of relevance to food and agriculture Lyle Glowka for the FAO Legal Office |
| title_fullStr | Law and modern biotechnology selected issues of relevance to food and agriculture Lyle Glowka for the FAO Legal Office |
| title_full_unstemmed | Law and modern biotechnology selected issues of relevance to food and agriculture Lyle Glowka for the FAO Legal Office |
| title_short | Law and modern biotechnology |
| title_sort | law and modern biotechnology selected issues of relevance to food and agriculture |
| title_sub | selected issues of relevance to food and agriculture |
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