LIST OF APPENDICES

Appendix I: List of Participants
Appendix II: Proposed Draft Principles for the Risk Analysis of Foods Derived from Modern Biotechnology
Appendix III: Proposed Draft Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant - DNA Plants
Appendix IV: Answers by the 2000 FAO/WHO Expert Consultation on Foods Derived from Biotechnology to the Questions from the Codex ad hoc Intergovernmental Task Force
Appendix V: Preliminary Report of the Ad Hoc Intergovernmental Task Force on Foods Derived from Biotechnology

Appendix I: List of Participants

LISTE DES PARTICIPANTS
LISTA DE PARTICIPANTES

CHAIRPERSON/PRESIDENT/PRESIDENTE

Dr. Hiroshi Yoshikura
Inspection and Safety Division
Department of Food Sanitation
Pharmaceutical and Medical Service Bureau
Ministry of Health, Labor and Welfare
1-2-2 Kasumigaseki, Chiyoda-ku
Tokyo 100-8916, Japan
Phone: +81 3 3595 2252
Fax: +81 3 3595 2251
Email: [email protected]

ARGENTINA/ARGENTINE

Mr. Marcelo Cesa
Secretary of the Argentine Embassy
2-14-14, Moto-Azabu, Minato-ku, Tokyo
106-0046, Japan
Phone: +81 3 3473 7171
Fax: +81 3 3473 7173
E-mail: [email protected]

AUSTRALIA/AUSTRALIE

Dr. Marion Healy
Chief Scientist
Australian New Zealand Food Authority
PO Box 7186, Canberra MC ACT 2601, Australia
Phone: +61 2 6271 2215
Fax: +61 2 6271 2278
E-Mail: [email protected]

Ms. Lois Ransom
Counsellor (Agriculture)
Australian Embassy
2-2-14 Mita, Minato-ku, Tokyo 108-8361, Japan
Phone: +81 3 5232 4027
Fax: +81 3 5232 4029
E-Mail: [email protected]

Dr. Christopher Branson
Senior Adviser
Biotechnology, Science & Technology Policy
Department of Agriculture, Fisheries and Forestry
Edmund Barton Building, Barton ACT
GPO Box 858 Canberra ACT 2601
Phone: +61 2 6272 5634
Fax: +61 2 6272 5926
E-Mail: [email protected]

BANGLADESH

Mr. Hussain Ahmed
Commercial Counsellor
Embassy of Bangladesh in Japan
4-15-15, Meguro, Meguro-ku, Tokyo 153-0063,
Japan
Phone: +81 3 5704 0216
Fax: +81 3 5704 1696

BELGIUM/BELGIQUE/BÉLGICA

Dr. Sebastien Goux
Food Inspection Officer
Belgian Ministry of Health
Phone: +32 2 210 48 46
Fax: +32 2 210 48 16
E-Mail: [email protected]

Ms. Sylvie Mestdagh
Engineer
Ministry of Agriculture
WTC (DG4), bvd Simon Bolivar 30, 1000
Brussels, Belgium
Phone: +32 2 208 38 57
Fax: +32 2 208 38 66
E-Mail: [email protected]

Ms. Ellen Van Haver
Expert
Belgian Biosafety Advisory Council
Phone: +32 2 642 52 93
Fax: +32 2 642 52 92
E-Mail: [email protected]

BRAZIL/BRÉSIL/BRASIL

Dr. Ricardo Oliva
Director of Foods and Toxicology
Brazilian Sanitary Control Agency/Ministry of Health
Sepn 515 Bloco B Ed. Ômega 30 Andar
70770-502-Brasilia, DF, BRASIL
Phone: +55 61 4481102
Fax: +55 61 4481224
E-Mail: [email protected]

Ms. Marilia Regini Nutti
Director
Embrapa Food Technology
Ministry of Agriculture and Supply
Au das Américas 29501
23020-470 Rio de Faneiro
Phone: +55 21 4101350
Fax: +55 21 4101090
E-Mail: [email protected]

Ms. Ana Lucia Delgado Assad
Biotechnology Cordenation
Ministry of Science and Technology
Esplanada dos Ministérios, Bloco E 2⁶ Andar Sala
262 70.067-900 Brasilia IDF-Brasil
Phone: +55 61 3178008
Fax: +55 61 2260834
E-Mail: [email protected]

CANADA/CANADÁ

Mr. Paul Mayers
Director of Food Policy Integration
Health Canada
2012 Health Protection Building, Tunney’s
Pasture, P.L.:0702A4, Ottawa, Ontario K1A 0K9,
Canada
Phone: +613 946 4591
Fax: +613 946 4590
E-Mail: [email protected]

Ms. Elizabeth Vavasour
Toxicologist
Health Canada
Sir Frederick Banting Building, P.L. 2204D1,
Tunney’s Pasture, Ottawa, Ontario K1A 0L2,
Canada
Phone: +1 613 957 1680
Fax: +1 613 957 1688
E-Mail: [email protected]

Mr. Allan McCarville
Senior Advisor, Codex
Health Canada
HPB Building, Room 2394, Postal Locator
0702C1, Tunney’s Pasture, Otawa, Ontario
K1A 0L2, Canada
Phone: +1 613 957 0189
Fax: +1 613 941 3537
E-Mail: [email protected]

Dr. Anne Mackenzie
Associate Vice President, Science Evaluation
Chair, CCFL
Canadian Food Inspection Agency
59 Camelot Drive, Room 203W, Nepean,
Ontario
K1A 0V9, Canada
Phone: +1 613 225 2342 (ext:4188)
Fax: +1 613 228 6638
E-Mail: [email protected]

Mr. Bart Bilmer
Director, Office of Biotechnology
CFIA
3^rd Floor, 59 Camelot Drive, Room 203W,
Nepean, Ontario KIY 3K1, Canada
Phone: +1 613 225 2342 (ext:4185)
Fax: +1 613 228 6604
E-Mail: [email protected]

CHINA/CHINE

Dr. Xuegui Kan
Counsel
Department of Health Legislation and Inspection
Ministry of Health
No.1 Xizhimenwai Nan-Lu
Beijing 100044, China
Phone: +86 10 68792384
Fax: +86 10 68792387
E-Mail: [email protected]

Prof. Xiaoguang Yang M.D. & Ph.D.
Director
Institute of Nutrition and Food Hygiene,
Chinese Academy of Preventive Medicine
29 Nan Wei Road, Beijing 100050,
China
Phone: +86 10 63171734
Fax: +86 10 63011875
E-Mail: [email protected]

Prof. Yufa Peng
Director
Centre for Biosafety Research
Institute of Plant Protection,
Chinese Academy of Agricultural Sciences
Beijing 100094
Phone: +86 10 62815947
Fax: +86 10 62896114
E-Mail: [email protected]

Dr. Xu Haibin M.D. & Ph.D.
Associate Professor
Vice-Director of Dept. of Toxicology
Institute of Food Safety Control and Inspection,
Ministry of Health, China
Phone: +86 10 87780694
Fax: +86 10 67711813
E-Mail: [email protected]

Dr. Qihuai Wang
Assistant Professor
Development center of Science & Technology
Ministry of Agriculture P.R. China
No.18 Maizidian Street, Chaoyang District,
Beijing 100026
Phone: +86 10 64191432
Fax: +86 10 64191432
E-Mail: [email protected]

Mr. Yue Ning
Deputy Director
State Administration for Entry-Exit Inspection
and Quarantine. P.R.China
Phone: +86 10 6599 3859
Fax: +86 10 6599 3847
E-Mail:[email protected]

Mr. Cai Xian Feng
Department for Supervision on Health
State Administration for Entry-Exit Inspection
and Quarantine. P.R. China
Phone: +86 10 65994540
Fax: +86 10 65994497
E-Mail: [email protected]

Dr. Mabel Yeung
Senior Medical Officer
Food incidents Response & Management Section
Food and Environmental Hygiene Department
43/F Queensway Government Offices
Queensway
Hong Kong S.A.R, China
E-Mail: [email protected]

Dr. Dan Dan Ho
Chemist
Government Laboratory of Hong Kong
Special Administrative Region
88, Chung Hau Street
Ho Man Tin Government Offices
Kowloon, Hong Kong
Phone: +852 2762 3853
Fax: +852 2714 4083
E-Mail: [email protected]

DENMARK/DANEMARK/DINAMARCA

Dr. Jan Pedersen
Senior Scientist
Head of delegation
Mørkhøj Bygade 19 Dk-2860 Søborg
Denmark
Phone: +46 3395 6000
Fax: +46 3395 6001
E-Mail: [email protected]

Ms. Anne Christine Duer
Scientific Adviser
Danish Veterinary and Food Administration
Moerkhoej Bygade 19, DK-2860 Soeborg,
Denmark
Phone: +45 33 95 60 00
Fax: +45 33 95 60 01
E-Mail: [email protected]

Mr. Bruno Sander Nielsen
Agricultural Council of Denmark
Phone: +45 33 14 56 72
Fax: +45 33 14 95 74
E-Mail: [email protected]

FINLAND/FINLANDE/FINLANDIA

Ms. Leena Mannonen
Senior Scientific Officer
National Food Agency
P.O. Box 28, FIN-00581 Helsinki, Finland
Phone: +358 9 3931 543
Fax: +358 9 3931 592
E-Mail: [email protected]

FRANCE/FRANCIA

Mr. Olivier Letode
Ministère de l’Agriculture et de la Pêche DGAL
251, rue de Vaugirard 75732 PARIS CEDEX 15
France
Phone: +33 1 4955 8413
Fax: +33 1 4955 5948
E-Mail: [email protected]

Mr. Patrice Dauchet
Ministère de l’Economie, des Finances et de l’Industrie DGCCRF
59, boulevard Vincent Auriol, 75713 PARIS
CEDEX 13 France
Phone: +33 1 4497 2965
Fax: +33 1 4497 3037
E-Mail: [email protected]

Dr. François Hervieu
Ministère l’Agriculture et de la Pêche, DGAL
251, rue de Vaugirard, 75732 PARIS CEDEX 15
France
Phone: +33 1 4955 5912
Fax: +33 1 4955 5948
E-Mail: [email protected]

Ms. Roseline Lecourt
Ministère de l’Economie, des Finances et de l’Industrie, DGCCRF
59, boulevard Vincent Auriol, 75713 PARIS
CEDEX 13 (France)
Phone: +33 1 4497 34 70
Fax: +33 1 4497 3037
E-Mail: [email protected]

Mr. Olivier Ruetsch
Ambassade de France,
Chargé de mission agroalimentaire, Biotechnologies
4-11-44, Minami-Azabu Minato-ku, Tokyo
106-8514, Japan
Phone: +81 3 5420 8887
Fax: +81 3 5420 8920
E-Mail: [email protected]

GERMANY/ALLEMAGNE/ALEMANIA

Dr. Michael Winter
Regierungsdirektor
Federal ministry of Consumer protection, nutrition and agriculture
Rochusstraße 1
Phone: +49 228 941 4121
Fax: +49 228 941 4965
E-Mail: [email protected]

Ms. Bärbel Vogel-Middeldorf
Ministerialrätin (Head of Division)
Federal Ministry of Economics and Technology
Villemombler Straße 76 D-53123 Bonn
Phone: +49 228 615 4246
Fax: +49 228 615 2766
E-Mail: [email protected]

Dr. Marianna Schauzu
Head of Center of Novel Foods and Genetic Engineering
BgVV Federal Institute for Health Protection of Consumers
Thielalee 88-92 D-14195 Berlin
Phone: +49 30 8412 3758
Fax: +49 30 8412 3635
E-Mail: [email protected]

Mr. Herrmann Brol
BgVV Federal Institute for Health Protection of Consumers
Thielalee 88-92 D-14195 Berlin
Phone: +49 30 8412 3539
Fax: +49 30 8412 3635
E-Mail: [email protected]

HUNGARY/HONGRIE/HUNGRÍA

Dr. Diána Bánáti
General Director
Central Food Research Institute
Herman Otlo ut 15 H-1022 Budapest, Hungary
Phone: +36 1 355 8991
Fax: +36 1 212 9853
E-Mail: [email protected]

INDIA/INDE

Mrs. Shoba Koshy
Director, Department of Health
Ministry of Health & Family Welfare
Nirman Bhavan
New Delhi-110011
Phone: +91 3019317
Fax: +91 3019317
E-Mail: [email protected]

Dr. Surendra Singh
Assistant Director (consultancy)
Department of Food Processing Industries
Ministry of Agriculture
Panchsheel Bhawan, August Kranti Marg
New Delhi-110049
Phone: +91 6493227/6492216
Fax: +91 649 3228

INDONESIA/INDONÉSIE

Dr. Joni Munarso
Senior Researcher
Agriculture Research & Development Agency
J1.Ragunan no.29 Pasar Minqqu Jakarta 12540,
INDONESIA
Phone: +62 21 7806202
Fax: +62 260 520158

Ir. Isaka Mustamin
Agriculture Attaché
Indonesian Embassy in Japan
2-9, Higashi-Gotanda, 5-chome, Shinagawa-ku,
Tokyo, 141-0022
Phone: +81 (0)3 -3447-6364
Fax: +81 (0)3 -3447-6364
E-Mail: [email protected]

IRELAND/IRELANDE/IRLANDA

Dr. Patrick J. O’Mahony
Chief Specialist in Biotechnology
Food Safety Authority of Ireland, Abbey Court,
Lower Abbey Street, Dublin 1, Ireland

ITALY/ITALIE/ITALIA

Dr. Paola Picotto
Dirigente Veterinario
Ministero Della Sanita’
Piazza, Marconi, 25 00144 Rome
Phone: +39 6 59943752
Fax: +39 6 59943676
E-Mail: [email protected]

Dr. Marina Miraglia
Senior Researcher, Head of Cereal Unit
Laboratorio Alimenti Instituto Superiore di Sanita’
Viale Regina Elena, 299 00161 Rome
Phone: +39 6 49902367
Fax: +39 6 49902377
E-Mail: [email protected]

Dr. Brunella Lo Turco
Segretario Generale
Comitato Nazionale Codex Ministero delle
Politiche Agricole
Via Sallustiana 10
00187 Rome Italy
Phone: +39 6 466 56509
Fax: +39 6 488 0273
E-Mail: [email protected]

JAPAN/JAPON/JAPÓN

Ministry of Foreign Affairs

Mr. Hideki MAKINO
Official, Developing Economies Division,
Economic Affairs Bureau
Ministry of Foreign Affairs
2-2-1, Kasumigaseki Chiyoda-ku, Tokyo
100-8950
Phone: +81 3 3580 3311
Fax: +81 3 3592 0504

Mr. Seiichi URAUCHI
Second International Organizations Division,
Economics Affairs Bureau
Ministry of Foreign Affairs
2-2-1, Kasumigaseki, Chiyodaku, Tokyo
Phone: +81 3 3580 3311
Fax: +81 3 3581 9470

Ministry of Finance, National Tax Agency

Mr. Takao MOTOMIYA
Deputy Director, Liquor Tax and Industry
Division, Taxation Department, National Tax Agency
Ministry of Finance
3-1-1, Kasumigaseki, Chiyoda-ku, Tokyo, 100-8978
Phone: +81 3 3581 4161 (ext:3737)
Fax: +81 3 3593 0406
E-Mail: [email protected]

Mr. Osamu SATO
Chief, Liquor Tax and Industry Division, Taxation
Department, National Tax Agency
Ministry of Finance
3-1-1, Kasumigaseki, Chiyoda-ku, Tokyo, 100-8978
Phone: +81 3 3581 4161 (ext:3567)
Fax: +81 3 3593 0406
E-Mail: [email protected]

Mr. Masahiro KAMIYA
Deputy Director, Office of Analysis and Brewing Technology

Mr. Takashi SUZUKI
Technical Officer, Office of Analysis and Brewing
Technology, Taxation Department, National Tax
Agency, Ministry of Finance
3-1-1, Kasumigaseki, Chiyoda-ku, Tokyo,
100-8978
Phone: +81 3 3581 4161 (ext:3639)
Fax: +81 3 3581 4747
E-Mail: [email protected]

Ministry of Education, Culture, Sports, Science and Technology

Mr. Shoichi NAGAYAMA
Deputy Director, Office of Resources, Policy
Division, Science and Technology Policy Bureau
3-2-2, Kasumigaseki, Chiyoda-ku, Tokyo
100-8959
Phone: +81 3 3581 4211
Fax: +81 3 3581 4420
E-Mail: [email protected]

Ministry of Health, Labour and Welfare

Dr. Shimpei OZAKI
Director-General
Department of Food Sanitation,
Pharmaceutical and Medical Safety Bureau

Mr. Soutaro YOSHIOKA
Director
Policy Planning Division
Department of Food Sanitation,
Pharmaceutical and Medical Safety Bureau

Dr. Satoshi TAKAYA
Director
Inspection and Safety Division
Department of Food Sanitation,
Pharmaceutical and Medical Safety Bureau
E-Mail: [email protected]

Dr. Kouichi ISHII
Director
Standards Division
Department of Food Sanitation,
Pharmaceutical and Medical Safety Bureau
E-Mail: [email protected]

Dr. Tomoaki IMAMURA
Deputy Director
Policy Planning Division
Department of Food Sanitation,
Pharmaceutical and Medical Safety Bureau

Dr. Masami SAKOI
Deputy Director
International Affair Division
Minister’s Secretariat

Dr. Shoji MIYAGAWA
Deputy Director
Inspection and Safety Division
Department of Food Sanitation,
Pharmaceutical and Medical Safety Bureau

Mr. Teruyoshi EHARA
Deputy Director
Standards Division
Department of Food Sanitation,
Pharmaceutical and Medical Safety Bureau

Dr. Akira MIKI
Assistant Director
Inspection and Safety Division
Department of Food Sanitation,
Pharmaceutical and Medical Safety Bureau
Phone: +81 3 3595 2252
Fax: +81 3 3595 2251
E-Mail: [email protected]

Dr. Kazuko FUKUSHIMA
Inspection and Safety Division
Department of Food Sanitation,
Pharmaceutical and Medical Safety Bureau
Phone: +81 3 3595 2252
Fax: +81 3 3595 2251
E-Mail: [email protected]

Ministry of Agriculture, Forestry and Fisheries

Mr. Hiroshi HASEGAWA
Director, Innovative Technology Division,
Agriculture, Forestry and Fisheries Research Council

Mr. Seiichirou OHYAMA
Director for International Standardization,
Standards and Labelling Division,
General Food Policy Bureau

Mr. Kazuo YUJI
Deputy Director,
Standards and Labelling Division,
General Food Policy Bureau

Mr. Kiyoshi OHSHIMA
Deputy Director,
Innovative Technology Division, Agriculture
Forestry and Fisheries Research Council

Dr. Kenji ISSHIKI
Associate Director for Research
National Food Research Institute

Dr. Yukiko YAMADA
Associate Director for Research
National Food Research Institute

Dr. Akihiro HINO
Head of Molecular Engineering Lab.
National Food Research Institute

Ministry of Economy, Trade and Industry

Mr. Nobuyuki FUKUSHIMA
Administrative official, Biochemical Industry
Division, Manufacturing Industries Bureau
1-3-1 Kasumigaseki, Chiyoda-ku, Tokyo
100-8901
Phone: +81 3 3501 8625
Fax: +81 3 3501 0197
E-Mail: [email protected]

Mr. Koichi YAMAMOTO
Administrative official, Biochemical Industry
Division, Manufacturing Industries Bureau
1-3-1 Kasumigaseki, Chiyoda-ku, Tokyo
100-8901
Phone: +81 3 3501 8625
Fax: +81 3 3501 0197
E-Mail: [email protected]

Mr. Yuji NEAGARI
Technical official, Biochemical Industry Division,
Manufacturing Industries Bureau
1-3-1 Kasumigaseki, Chiyoda-ku, Tokyo
100-8901
Phone: +81 3 3501 8625
Fax: +81 3 3501 0197
E-Mail: [email protected]

Technical Advisers

Dr. Masatake TOYODA
Director
Division of Foods
National Institute of Health Sciences

Dr. Shigeaki SATO
Professor
Kobe University School of Medicine

Dr. Hiroshi KAMADA
Professor
Institute of Biological Science
Director, Gene Experiment Center, University of Tsukuba

Dr. Atsuo URISU
Associate Professor
Department of Pediatrics
Fujita Health University
The Second Teaching Hospital

Dr. Yukihiro GODA
Section Chief
Division of Foods
National Institute of Health Sciences

Dr. Kazuaki MIYAGISHIMA
Associate Professor
Graduate School of Medicine
Kyoto University
Yoshidakonoe-cho, Sakyo-ku, Kyoto 606-8501, Japan
Phone: +81 75 753 4464
Fax: +81 75 753 4466
E-Mail: [email protected]

Dr. Katsunori OHSHITA
Japan Food Industry Center (JAFIC)

Dr. Kouichi TAMURA
Japan Food Industry Center (JAFIC)

Mr. Teruo NAKAKUKI
Japan Food Industry Center (JAFIC)

Mr. Kensuke WATANABE
Japan Food Industry Center (JAFIC)

Mr. Hiroshi WATANABE
Japan Food Industry Center (JAFIC)

Mr. Touru TAKAMI
Japan Food Industry Center (JAFIC)

Mr. Hiromi OHTA
Japan Food Industry Center (JAFIC)

Mr. Toyokuni ISHITANI
Japan Food Industry Center (JAFIC)

Ms. Yasue ITOH
Japan Food Industry Center (JAFIC)

Ms. Masae WADA
Codex Communication Council of Japan
15 Rokuban-cho, Chiyoda-ku
Tokyo, 102-8085
Phone: +81 (0)3 3265 8121
Fax: +81 (0)3 3221 7864

Dr. Seizo SUMIDA
(Technical Adviser) Managing Director
Japan Bioindustry Association
Grande Bldg. 8F, 2-26-9 Hatchobori, Chuo-ku,
Tokyo 104-0032
Phone: +81 3 5541 2731
Fax: +81 3 5541 2737
E-Mail: [email protected]

Ms. Yoshiko SASSA
Assistant Manager
Japan Bioindustry Association
Grande Bldg. 8F, 2-26-9 Hatchobori, Chuo-ku,
Tokyo 104-0032
Phone: +81 3 5541 2731
Fax: +81 3 5541 2737
E-Mail: [email protected]

KOREA, REPUBLIC OF
CORÉE, RÉPUBLIQUE DE
COREA, REPÚBLICA DE

Mr. Jaeam Lim
GMO Task Force Director
GMO Task Force, Ministry of Agriculture and Forestry
1 Jungang-dong, Kwacheon-city, Kyunggido,
427-719, Republic of Korea
Phone: +82 2 504 9429
Fax: +82 2 503 7798
E-Mail: [email protected]

Dr. Mungi Sohn
Deputy Director
Food Safety Bureau, Korea Food & Drug Administration
5 Nokbun-dong, Eunpyung-Gu, Seoul, 122-704,
Republic of Korea
Phone: +82 2 380 1726
Fax: +82 2 388 6396
E-Mail: [email protected]

Dr. Taesan Kim
Senior Research Scientist
National Institute of Agricultural Science and
Technology, Rural Development Administration,
Ministry of Agriculture and Forestry
250, Seodundong, Suwon, Kyungido, 441-707,
Republic of Korea
Phone: +82 31 290 0372
Fax: +82 31 290 0391
E-Mail: [email protected]

Dr. Sunhee Park
Senior Researcher
Dept. of Food Evaluation, Korea Food & Drug Administration
5 Nokbun-dong, Eunpyung-Gu, Seoul, 122-704,
Republic of Korea
Phone: +82 2 380 1682
Fax: +82 2 382 4892
E-Mail: [email protected]

Dr. Meeah Park
Researcher
Food Sanitation Council, Ministry of Health and Welfare
5 Nokbun-dong, Eunpyung-Gu, Seoul, 122-704,
Republic of Korea
Phone: +82 2 380 1559
Fax: +82 2 383 8321
E-Mail: [email protected]/[email protected]

Dr. Youngchan Kim
Head Researcher
Dept. of Food Industry, Korea Health Industry
Development Institute
57-1, Norangjin-Dong, Dongjak-Gu, Seoul,
156-800, Republic of Korea
Phone: +82 2 2194 7432
Fax: +82 2 824 1764
E-Mail: [email protected]

Mr. Sangkeun Lee
Research Scientist
National Agricultural Products Quality
Management Service, Ministry of Agriculture and Forestry
560, 3-Ga, Dangsan-dong, Youngdeungpo-Gu,
Seoul, 150-804, Republic of Korea
Phone: +82 2 2632 4861
Fax: +82 2 2632 0881
E-Mail: [email protected]

MALAYSIA/MALAISIE/MALASIA

Ms. Nik Shabnam Nik Mohd. Salleh
Principal Assistant Director,
Food Quality Control Division
Ministry of Health Malaysia
4th Floor, Block E, Offices Complex Jalan
Dungun, Bukit Damansara 50490 Kuala Lumpur,
Malaysia
Phone: +60 3 255 5943
Fax: +60 3 253 7804
E-Mail: [email protected]

Dr. Halim Hamat
Biological & Genetics Laboratory Sdn Bhd
Wisma KAM, No.87C-91C Jalan SS25/2 Taman
Bukit Emas 47301 Petaling Jaya, Selangor, Malaysia
Phone: +60 3 5032 7278
Fax: +60 3 5032 7279
E-Mail: [email protected]

MEXICO/MEXIQUE/MÉXICO

Dr. Agustin López Herrera
Cibiogem
Universidad Autonoma Chapingo
Phone: +52 15 95 488 79
Fax: +52 15 95 488 79
E-Mail: [email protected]

M. en B. Elvira Espinosa Gutierrez
Directora de Normalizacion Sanitaria
Health Ministry Mexico, Direccion General de
Calidad Sanitaria de Bienes y Servicios
Donceles 39, Centro C. P. 06010, Mexico, D. F.
Phone: +52 518 36 96/5510 1075(ext:206)
Fax: +52 512 96 28
E-Mail: [email protected]

Dr. José Louis Solleiro Rebolledo
Director General
Georgia 114-701 Col. Nápoles
C.P. 03810 México, D.F.
Phone: +52 5669 0878/5543 6260/5687 8431
Fax: +52 5669 0878/5543 6260/5687 8431
E-Mail: [email protected]/
[email protected]

NETHERLANDS/PAYS-BAS/PAÍSES BAJOS

Dr. L. F. Hagedoorn
Head of Delegation
Ministry of Agriculture, Nature Management and Fisheries
PO Box 20401, 2500 EK DEN HAAG, The Netherlands
Phone: +31 70 378 5788
Fax: +31 70 378 6141
E-Mail: [email protected]

Dr. H. de Sitter
Ministry of Health, Inspectorate for Health Protection
Commodities and Veterinary Public Health
PO Box 16108, 2500 BC DEN HAAG, The Netherlands
Phone: +31 70 340 6959
Fax: +31 70 340 5435
E-Mail: [email protected]

Dr. Otto Cornelius Knottnerus
Central Product Board for Arable Products
PO BOX 29739,2502 LS The Hague
Phone: +31 70 3708343
Fax: +31 70 3708444
E-Mail: [email protected]

NEW ZEALAND
NOUVELLE-ZÉLANDE
NUEVA ZELANDIA

Mr. S. Rajasekar
Manager WTO/SPS & Codex Contact Point for New Zealand
MAF Policy
PO Box 2526, Wellington, New Zealand
Phone: +64 4 474 4216
Fax: +64 4 473 0118
E-Mail: [email protected]

Dr. Graeme King
Senior Scientist
MAF Policy
PO Box 2526, Wellington, New Zealand
Phone: +64 4 474 4209
Fax: +64 4 474 4163
E-Mail: [email protected]

Dr. Paul Dansted
Analyst-Science (Food Standards)
Food, Public Health Directorate, Ministry of Health
PO Box 5013, Wellington, New Zealand
Phone: +64 4 496 2113
Fax: +64 4 496 2340
E-Mail: [email protected]

Dr. Joan Wright
Counsel-Regulatory and Special Projects
New Zealand Dairy Board
PO Box 417 Wellington, NEW ZEALAND
Phone: +64 4 471 8553
Fax: +64 4 471 8539
E-Mail: [email protected]

Dr. Rob Lake
Food Scientist
ESR (Institute of Environmental Science & Research Limited)
PO Box 29-181 Christchurch, NEW ZEALAND
Phone: +64 3 351 6019
Fax: +64 3 351 6010
E-Mail: [email protected]

NIGERIA/NIGÉRIA

Dr. O. A Oloko
Federal Ministry of Agriculture and Rural
Development, Area11 Garki Abuja PMB 135 Garki
Abuja
Phone: +23 49 314 4141
Fax: +23 49 314 4142
E-Mail: [email protected]

M. I. Ejemba
Federal Ministry of Agriculture and Rural Development
Area11 Garki Abuja
PMB 135 Garki Abuja
Phone: +23 4 314 0984
E-Mail: [email protected]

Dr. Wilson Okpeke
Federal Ministry of Agriculture and Rural Development
Area11 Garki Abuja
PMB 135 Garki Abuja

NORWAY/NORVÈGE/NORUEGA

Mrs. Åse Fulke
Head of Section
General Affairs & Labelling Food
Norwegian Food Control Authority
P.O. Box 8187 DEP N-0034 Oslo Norway
Phone: +47 22 24 67 29
Fax: +47 22 24 66 99
E-Mail: [email protected]

Mrs. Solbjørg Hogstad
Adviser,
Norwegian Food Control Authority
General Affairs & Labelling,
Ullevålsveien 76, P.O. Box 8187 Dep, N-0034 Oslo,
Norway
Phone: +47 22 24 66 50
Fax: +47 22 24 66 99
E-Mail: [email protected]

Mrs. Hilde Margrethe Helgesen
Food Policy Officer
Consumer Council of Norway
P.O. Box 123 N-1325 Lysaker Norway
Phone: +47 67 59 97 31
Fax: +47 67 53 60 10

OMAN, SULTANATE OF,
SUTANAT D’OMAN,
SULTANATO DE OMÁN

Mr. Juma Said Al.obeidani
Sultanate of Oman

PHILIPPINES/FILIPINAS

Dr. Oscar Giron Gutierrez
Bureau of Food and Drugs

PORTUGAL

Mrs. Maria de Lourdes Camilo
Engineer
Agriculture Ministry
Av. Conde Valbom, 98, 1050 Lisboa, Portugal
Phone: +351 21 7983823
Fax: +351 21 7983834
E-Mail: [email protected]

Mrs. Ana Paula Bico
Engineer
Agriculture Ministry
Av. Conde Valbom, 98
1050 Lisbon Portugal
Phone: +351 21 7983823
Fax: +351 21 7983834
E-Mail: [email protected]

ROMANIA/ROUMANIE/RUMANIA

Mrs. Carmen Fratita
Expert
Ministry of Foreign Affairs, Department for
Foreign Trade and Economic Promotion,
Directorate for Multi Commercial Negotiations
Romania, Bucharest, 152-153, Calea Victoriei Street
Phone: +40 1 3150247
Fax: +40 1 315 0449
E-Mail: [email protected]/
[email protected]

SINGAPORE/SINGAPOUR/SINGAPUR

Ms. Seah Huay Leng
Head, Food Control Department
Ministry of the Environment
40 Scotts Rd, The Environment Building 19th
Storey, Singapore (228231)
Phone: +65 731 9819
Fax: +65 731 9843/731 9844
E-Mail: [email protected]

Dr. Chew Siang Thai
Deputy Director, Veterinary Public Health & Food
Supply Division and
Head, Veterinary Public Health Laboratory Branch
Agri-Food & Veterinary Authority
51 Jalan Buroh Singapore (619495)
Phone: +65 267 0826
Fax: +65 265 0784
E-Mail: [email protected]

Mr. Phua Teck Heng Leslie
Head, Microbiology Section, Veterinary Public
Health Laboratory Branch
Agri-Food & Veterinary Authority
51 Jalan Buroh Singapore (619495)
Phone: +65 267 0823
Fax: +65 265 0784
E-Mail: [email protected]

SOUTH AFRICA/AFRIQUE DU SUD/SUDÁFRICA

Ms. Wilna Jansen van Rijssen
Deputy Director, Food Control
National Department of Health
Private Bag X828, Pretoria, 0001, South Africa
Phone: +27 12 3120154
Fax: +27 12 3264374
E-Mail: [email protected]

SWEDEN/SUÈDE/SUECIA

Ms. Monika Schere
Senior Administrative Officer
Ministry of Agriculture
SE-103 33 Stockholm Sweden
Phone: +46 8 405 13 15
Fax: +46 8 20 64 96
E-Mail: [email protected]

Mr. Christer Andersson
Associated Professor
National Food Administration
Box 622 SE-751 26 Uppsala Sweden
Phone: +46 18 17 57 64
Fax: +46 18 10 58 48
E-Mail: [email protected]

Mr. Martin Frid
Food and Trade Policy Officer
Swedish Consumer Coalition
Box 88 SE-577 22 Hultsfred Sweden
Phone: +46 479 10 713
E-Mail: [email protected]

SWITZERLAND/SUISSE/SUIZA

Dr. Martin Schrott
Head of Delegation, Staff Scientist
Swiss Federal Office of Public Health, Division Food Science
CH-3003 Berne
Phone: +41 31 322 69 89
Fax: +41 31 322 95 74
E-Mail: [email protected]

THAILAND/THAÏLANDE/TAILANDIA

Prof. Pakdee Pothisiri
Head of Delegation
Director General
Department of Medical Sciences Ministry of Public Health
88/7 Moo 4 Soi Bamrasnaradura Hospital, Tarad
Khwan, Amphoe Muang, Nonthaburi 11000
Phone: +66 2 5899862
Fax: +66 2 9511459
E-Mail: [email protected]

Dr. Saipin Maneepun
Director of the Institute of food research and product development
Kasetsart University
Ministry of University Affairs
P.O. Box 1043, Chatuchak, Bangkok 10400 Thailand
Phone: +66 2 9428620
Fax: +66 2 5611970
E-Mail: [email protected]

Mrs. Darunee Edwards
Deputy Director
National Center for Genetic Engineering and
Biotechnology, National Science and Technology
Development Agency
Gypsum Metropolitan Tower, 15th Floor,
539/2 Sri-Ayudhya Rd., Rajdhevee, Bangkok 10400
Phone: +66 2 6425322-31
Fax: +66 2 2488304
E-Mail: [email protected]

Mrs. Oratai Silapanapaporn
Chief, Food Standards Group 1
Office of the National Codex Alimentarius
Committee, Thai Industrial Standards Institute
Ministry of Industry
Rama VI Rd., Ratchathewi, Bangkok 10400 Thailand
Phone: +66 2 2023444
Fax: +66 2 2487987
E-Mail: [email protected]

Ms. Pimpun Pitanpitayarat
Food Specialist
Food and Drug Administration, Ministry of Public Health
Thanon Tiwanond, Amphoe Muang, Nonthaburi
11000
Phone: +66 2 5907178
Fax: +66 2 5907177
E-Mail: [email protected]

TURKEY/TURQUIE/TURQUÍA

Mr. Sinan Yanaz
Foreign Trade Expert
The Undersecretariat for Foreign Trade
Phone: +90 312 212 8800
Fax: +90 312 212 8765
E-Mail: [email protected]

UNITED KINGDOM
ROYAUME-UNI
REINO UNIDO

Mr. Nick Tomlinson
Head of Novel Foods Division
Food Standards Agency
Aviation House, 125 Kingsway, London, W2B
6NH, U.K.
Phone: +44 20 7276 8562
Fax: +44 20 7276 8563
E-Mail: [email protected]

Dr. Clair Baynton
Food Standards Agency
Aviation House, 125 Kingsway, London, W2B
6NH, U.K.
Phone: +44 20 7276 8566
Fax: +44 20 7276 8564
E-Mail: [email protected]

UNITED STATES OF AMERICA
ETATS-UNIS D’AMÉRIQUE
ESTADOS UNIDOS DE AMÉRICA

Dr. L. Robert Lake
Director, Office of Regulations and Policy
Center for Food Safety and Applied
Nutrition (HFS-4) Food and Drug Administration
200 C Street, SW Washington, DC 20204
Phone: +1 202 205 4160
Fax: +1 202 401 7739
E-Mail: [email protected]

Dr. Sally L. Mc Cammon
Science Advisor
Animal and Plant Health Inspection Service U.S.
U.S. Department of Agriculture
4700 River Road (Unit98), Riverdale, MD 20737
Phone: +1 301 734 5761
Fax: +1 301 734 5992
E-Mail: [email protected]

Dr. Janet L. Andersen
U.S. Environmental Protection Agency
Office of Pesticide Programs (7511C)
1200 Pennsylvania Avenue, NW
Washington, DC 20460
Phone: +1 703 308 8712
Fax: +1 703 308 7026
E-Mail: [email protected]

Amb. Marc Baas
U.S. Department of State
EB/TPP/ATT
Room 3526 Washington, DC 20520
Phone: +1 202 647 3090
Fax: +1 202 647 2302
E-Mail: [email protected]

Mr. Patrick Clerkin
Associate U.S. Manager for Codex
U.S. Codex Office
U.S. Department of Agriculture
Room 4861-South Building 1400 Independence
Avenue, SW Washington, DC 20250
Phone: +1 202 205 7760
Fax: +1 202 720 3157
E-Mail: [email protected]

Ms. Mary Frances Lowe
U.S. Environmental Protection Agency (7506C)
1200 Pennsylvania Avenue NW
Ariel Rios Building,
Washington, DC 20460
Phone: +1 703 305 5689
Fax: +1 703 308 1850
E-Mail: [email protected]

Dr. James Maryanski
Biotechnology Coordinator
Center for Food safety & Applied Nutrition Food and Drug Administration
200 C Street, SW-HF-13 Washington, DC 20204
Phone: +1 202 205 4359
Fax: +1 202 401 7739
E-Mail: [email protected]

Mr. John Pitchford
U.S. Department of Agriculture
1400 Independence Avenue, SW Room 1627-South
Building Washington, DC 20250
Phone: +1 202 720 0226
Fax: +1 202 720 1015
E-Mail: [email protected]

Dr. Terri Dunahay
Foreign Agriculture Service
U.S. Department of Agriculture
1400 Independence Avenue, SW
Room 5548-South
Building Washington, DC 20250
Phone: +1 202 690 1642
Fax: +1 202 690 0677
E-Mail: [email protected]

Dr. H. Michael Wehr
Food and Drug Administration
200 C Street, SW, (HFS-550) Washington, DC
20250
Phone: +1 202 260 2786
Fax: +1 202 205 4773
E-Mail: [email protected]

Dr. Jeffrey Barach
National Food Processors Association
1350 I Street, NW Washington, DC 20005
Phone: +1 202 639 5955
Fax: +1 202 639 5991
E-Mail: [email protected]

Mr. David Hegwood
O’Mara & Associates
1200 19th Street, Suite 201 Washington, DC 20036
Phone: +1 202 822 1630
Fax: +1 202 822 1636
E-Mail: [email protected]

Mr. W. Kirk Miller
Director of International Programs and Regulatory Affairs
North American Export Grain Association
1300 L Street, NW Suite 900 Washington, DC
20005
Phone: +1 202 682 4030
Fax: +1 202 682 4033
E-Mail: [email protected]

Dr. Barbara Petersen
President
Novigen Sciences, Inc.;IFT
1730 Rhode Island Ave, NW Suite 1100
Washington, DC 20036
Phone: +1 202 293 5374
Fax: +1 202 293 5374
E-Mail: [email protected]

Mr. Michael Douglas Woolsey
Senior Agricultural Attaché
U.S Embassy
10-5, Akasaka 1-Chome Minato-ku, Tokyo 107-8420
Phone: +81 3 3224 5106
Fax: +81 3 3589 0793
E-Mail: [email protected]

Ms. Suzanne Hale

INTERNATIONAL GOVERNMENTAL ORGANIZATIONS

European Community (EC)

Mr. Patrick Deboyser
Head of ‘Food Law & Biotechnology’
European Commission
Rue de la Loi, 200 1049 Brussels, Belgium
Phone: +32 2 295 1529
Fax: +32 2 295 1735
E-Mail: [email protected]

Council of Ministers of the European Union (EU)

Mr. Kari Töllikkö
Administrator
European Union, Council Secretariat
175 Rue de la Loi, 1048 Brussels, Belgium
Phone: +32 2 285 7841
Fax: +32 2 285 6198
E-Mail: [email protected]

Office international des epizooties (OIE)

Dr. Yoshihiro Ozawa
Office International des Epizooties (OIE)

Organisation for Economic Co-operation and Development (OECD)

Dr. Peter Kearns
Principal Administrator
Environment, Health and Safety Division
OECD
2 rue André-Pascal
75775 Paris, Codex16, France
Phone: +33 1 45 24 16 77
Fax: +33 1 45 24 16 75
E-Mail: [email protected]

Mr. Tetsuya Maekawa
Administrator
Environment, Health and Safety Division
OECD
2 rue André-Pascal
75775 Paris, Codex16, France
Phone: +33 1 45 24 76 19
Fax: +33 1 45 24 16 75
E-Mail: [email protected]

Food and Agriculture Organization of the United Nations (FAO)/
Organisation des Nations Unies pour l’Alimentation et l’Agriculture/
Organization de las Naciones Unidas para la Agricultura y la Alimentación

Dr. Ezzeddine Boutrif
Officer-in-Charge
Food Quality and Standards Service
Phone: +39 06 5705 6156
Fax: +39 06 5705 4593
E-Mail: [email protected]

Mr. Teiji Takahashi
Director
FAO, Liaison office in Japan
6F Yokohama International Organization Center,
Pacifico-Yokohama 1-1-1, Minato Mirai,
Nishi-ku, Yokohama 220-0012
Phone: +81 45 222 1101
Fax: +81 45 222 1103
E-Mail: [email protected]

World Health Organization (WHO)
Organisation Mondiale de la Santé (OMS)
Organizacion Mundial de la Salud (OMS)

Dr. Jørgen Schlundt
Coordinator, Food Safety Programme
PHE/SDE
Phone: +41 22 791 3445
Fax: +41 22 791 480
E-Mail: [email protected]

Dr. Hajime Toyofuku
Technical Officer
Food Safety Programme Department of Protection of
the Human Environment Cluster Sustainable
Development and Health Environments
20, Avenue Appia CH-1211 Geneva 27
Switzerland
Phone: +41 22 791 3556/+41 22 791 2111
Fax: +41 22 791 4807
E-Mail: [email protected]

Dr. Harry A. Kuiper
WHO Temporary Advisor Rikilt
Postbus 230 6700 AE Wageningen
Bezoecadres Gabouwnr, 123
Bornsesteeg 45, Wageningen
Phone: 317 47 5463
Fax: 317 41 7717
E-Mail: [email protected]

Dr. Genaro Garcia
Regional Advisor
Veterinary Public Health Program
Pan American Health Organization
World Health Organization
525 23rd Street, N.W. Washington D.C.
20037-2895
Phone: 202 974 3193
Fax: 202 974 3643
E-Mail: [email protected]

World Trade Organization (WTO/OMC)

Mrs. Gretchen Heimpel Stanton
Senior Counsellor
World Trade Organization (WTO)
GWR, 154 rue de Lausanne, 1211, Genève 21,
Switzerland
Phone: +41 22 739 50 86
Fax: +41 22 739 57 60
E-Mail: [email protected]

INTERNATIONAL NON-GOVERNMENTAL ORGANIZATIONS

Association des amidonneries de cereales de l’UE (AAC)

Ms. Catherine Vigreux
Association des Amidonneries de Céréales de I’U.E.
43, av.des Arts, B-1040 Brussels,
Belgium
Phone: +32 2 289 67 60/63
Fax: +32 2 513 55 92
E-Mail: [email protected]

Association internationale des selectionneurs pour la
protection des obtentions vegetales (ASSINSEL)

Mr. Tatsuo Uehara
Director
Japan Seed Trade Association (JASTA)
26-11 Hongo 2 Chome Bunkyo-Ku Tokyo 113
Phone: +81 33 811 2654
Fax: +81 33 818 6039
E-Mail:[email protected]

Ms. Marsha A. Stanton
Seed Regulatory Policy Monsanto
C2SB 800 N. Lindbergh St. Louis, MO 3167,U.S.A
Phone: +1 314 694 4020
Fax: +1 314 694 4928
E-Mail: [email protected]

Dr. Mieko Kasai
Manager, Biotechnology, Agricultural Products
Du Pont Kabushiki Kaisha
Arco Tower, 8-1, Shimomeguro 1-chome
Meguro-ku, Tokyo 153-0064
Phone: +81 3 5434 6349
Fax: +81 3 5434 6187
E-Mail: [email protected]

Confederation mondiale de l’industrie de la santé animale (COMISA)

Dr. Warren M. Strauss
Director, Global Organizations
COMISA
Monsanto Company, 600 13th Street, NW, Suite 660,
Washington, DC 20005, U.S.A.
Phone: +1 202 383 2845
Fax: +1 202 783 0382
E-Mail: [email protected]

Consumers International (CI)

Ms. Jean Halloran
Director
Consumer Policy Institute-Consumers’ Union
101 Truman Avenue, Yonkers, New York
10703-1057, U.S.A.
Phone: +1 914 378 2457
Fax: +1 914 378 2928
E-Mail: [email protected]

Ms. Nobuko Hiwasa
Secretary General
National Liaison Committee of Consumer Organizations
Plaza F, 15 Rokubancho, Chiyoda-ku, Tokyo
102-0085, Japan
Phone: +81 3 5216 6024
Fax: +81 3 5216 6036

Dr. Koa Tasaka
Consumers’ Union of Japan
Asaga Building 2F, 1-10-16 Megurohon-cho,
Meguro-ku, Tokyo, Japan
Phone: +81 3 3711 7766
Fax: +81 3 3715 9378
E-Mail: [email protected]

Mr. Samuel Ochieng
Chief Executive Officer
Consumer Information Network
Solai Plaza, Off Kamunde Road, Kariobangi, 2nd
Floor, Room 211, PO Box 7569, Nairobi, Kenya
Phone: +254 2 781131
Fax: +254 2 797944
E-Mail: [email protected]

Mr. Mukoni Ratshitanga
National Consumer Forum
P.O BOX 4487 Halfway House 1685
Republic of South Africa
Phone: +27 11 313 3237/3329
Fax: +27 11 313 3086
E-Mail: [email protected]

Ms. Saree Aougsomwang
Foundation for Consumers
211-2 soi Ngamwongwon 31, Ngamwongwan Rd,
Mnang District, Nonthaburi Thailand
Phone: +662 952 5060?2
Fax: +662 952 5060
E-Mail: [email protected]

Council for Responsible Nutrition (CRN)

Mr. Eddie Kimbrell
Kimbrell and Associates
13209 Moss Ranch Lane Fairfax, VA 22033
Phone: +1 703 631 9187
Fax: +1 703 631 3866
E-Mail:[email protected]

Global Crop Protection Federation (GCPF)

Mrs. Susanne Maise
Manager, Int. Scientific & Regulatory Affairs
Global Crop Protection Federation (GCPF)
Avenue Louise 143, 1050 Brussels, Belgium
Phone: +32 2 5420410
Fax: +32 2 5420419
E-Mail:[email protected]

Dr. Dirk Klonus
Registration Manager
Global Crop Protection Federation (GCPF)
Avenue Louise 143, 1050 Brussels, Belgium
Phone: +32 2 5420410
Fax: +32 2 5420419
E-Mail: [email protected]

International Association of Consumer Food Organizations (IACFO)

Ms. Michiko Kamiyama
Japan Offspring Fund, 2-5-2 Kojimachi,
Chiyoda-ku, Tokyo 102-0083, Japan
Phone: +81 3 5276 0256
Fax: +81 3 5276 0259
E-Mail: [email protected]

Mr. Junichi Kowaka
Japan Offspring Fund, 2-5-2 Kojimachi,
Chiyoda-ku, Tokyo 102-0083, Japan
Phone: +81 3 5276 0256
Fax: +81 3 5276 0259
E-Mail: [email protected]

Ms. Natsuko Kumasawa
Japan Offspring Fund, 2-5-2 Kojimachi,
Chiyoda-ku, Tokyo 102-0083, Japan
Phone: +81 3 5276 0256
Fax: +81 3 5276 0259
E-Mail: [email protected]

Ms. Satoko Endo
Japan Offspring Fund, 2-5-2 Kojimachi,
Chiyoda-ku, Tokyo 102-0083, Japan
Phone: +81 3 5276 0256
Fax: +81 3 5276 0259
E-Mail: [email protected]

Ms. Kwan Mo Chung
Japan Offspring Fund, 2-5-2 Kojimachi,
Chiyoda-ku, Tokyo 102-0083, Japan
Phone: +81 3 5276 0256
Fax: +81 3 5276 0259
E-Mail: [email protected]

Ms. Hyan Ki Lee
Japan Offspring Fund, 2-5-2 Kojimachi,
Chiyoda-ku, Tokyo 102-0083, Japan
Phone: +81 3 5276 0256
Fax: +81 3 5276 0259
E-Mail:j [email protected]

Ms. Seiko Miyake
Japan Offspring Fund, 2-5-2 Kojimachi,
Chiyoda-ku, Tokyo 102-0083, Japan
Phone: +81 3 5276 0256
Fax: +81 3 5276 0259
E-Mail: [email protected]

Ms. Mami Niida
Japan Offspring Fund, 2-5-2 Kojimachi,
Chiyoda-ku, Tokyo 102-0083, Japan
Phone: +81 3 5276 0256
Fax: +81 3 5276 0259
E-Mail: [email protected]

Ms. Kaori Takise
Japan Offspring Fund, 2-5-2 Kojimachi,
Chiyoda-ku, Tokyo 102-0083, Japan
Phone: +81 3 5276 0256
Fax: +81 3 5276 0259
E-Mail: [email protected]

Mr. Takenori Ueda
Japan Offspring Fund, 2-5-2 Kojimachi,
Chiyoda-ku, Tokyo 102-0083, Japan
Phone: +81 3 5276 0256
Fax: +81 3 5276 0259
E-Mail: [email protected]

Ms. Yumiko Hayasaka
Japan Offspring Fund, 2-5-2 Kojimachi,
Chiyoda-ku, Tokyo 102-0083, Japan
Phone: +81 3 5276 0256
Fax: +81 3 5276 0259
E-Mail: [email protected]

Mr. Yasuhisa Sekimoto
Japan Offspring Fund, 2-5-2 Kojimachi,
Chiyoda-ku, Tokyo 102-0083, Japan
Phone: +81 3 5276 0256
Fax: +81 3 5276 0259
E-Mail: [email protected]

International Biotechnology Forum (IBF)

Dr. Michael Phillips
Executive Director for Food and Agriculture
International Biotechnology Forum
1625 K st., NW, Suite 1100, Washington, D.C.
20006, U.S.A.
Phone: +1 202 857 0244
Fax: +1 202 857 0237
E-Mail: [email protected]

International Cooperative Alliance (ICA)

Ms. Toshiko Suzuki
Consumers Co-operative Tokyo
4-1-3 Shakuji-machi, Nerima-Ku, Tokyo
177-8511, Japan
Phone: +81 3 3904 1352
Fax: +81 3 5393 5619
E-Mail: [email protected]

Ms. Yumiko Kawasaki
Consumers Co-operative Tokyo
166-3 Sakanoshita, Tokorozawa-shi,
Saitama-pre,358-0012, Japan
Phone: +81 42 944 1136
Fax: +81 42 945 2213
E-Mail: [email protected]

Mr. Tatsuhito Kasamatsu
Consumers Co-operative Kobe
1-3-23, Okamoto, Higashinada-ku, Kobe,
Hyogo-pre 668-0072, Japan
Phone: +81 78 453 0116
Fax: +81 78 453 0185
E-Mail: [email protected]

Ms. Ryoko Shimizu
Deputy Director, Oranization for the Policy
Making by Citizen’s Sector
4-1-5 Akazutsumi, Setagaya-ku, Tokyo, Japan
Phone: +81 3 3325 7861
Fax: +81 3 3325 7955
E-Mail: [email protected]

Mr. Nobuhiro Yagishita
Planning Coordination Division, Seikatsu Club
Consumers’ Co-operative Kanagawa
Paleana Building 5F, 2-2-15 Shin-Yokohama,
Kouhoku-ku, Yokohama, Kanagawa-pre
Phone: +81 45 474 0985
Fax: +81 45 472 0999
E-Mail: [email protected]

Dr. Kiyoshi Fukushima
Japanese Consumers’ Co-operative Union
CO-OP PLAZA, 3-29-8, Shibuya, Shibuya-ku,
Tokyo 150-8913, Japan
Phone: +81 3 5778 8109
Fax: +81 3 5778 8008

Dr. Kazuyuki Akiyama
Japanese Consumers’ Co-operative Union
1-17-18, Nishiki-cho, Warabi-shi, Saitama-pre
335-0005, Japan
Phone: +81 48 433 8300
Fax: +81 48 433 8309

Mrs. Tamami Sasaki
Laboratory Manager
Japanese Consumers’ Co-operative Union Laboratory
1-17-18, Nishiki-cho, Warabi-shi, Saitama
335-0005, Japan
Phone: +81 48 433 8300
Fax: +81 48 433 8309
E-Mail: [email protected]

Mr. Shuuichi Watanabe
Japanese Consumers’ Co-operative Union
CO-OP PLAZA, 3-29-8, Shibuya, Shibuya-ku,
Tokyo 150-8913, Japan
Phone: +81 3 5778 8109
Fax: +81 3 5778 8008
E-Mail: [email protected]

Mr. Isao Nakano
Japanese Consumers’ Co-operative Union
CO-OP PLAZA, 3-29-8, Shibuya, Shibuya-ku,
Tokyo 150-8913, Japan
Phone: +81 3 5778 8124
Fax: +81 3 5778 8125
E-Mail: [email protected]

Mr. Hiroshi Suzuki
Japanese Consumers’ Co-operative Union
CO-OP PLAZA,3 -29-8, Shibuya, Shibuya-ku,
Tokyo 150-8913, Japan
Phone: +81 3 5778 8109
Fax: +81 3 5778 8008
E-Mail: [email protected]

International Council of Grocery Manufacturers Associations (ICGMA)

Dr. Sue DVM Ferenc
Vice President, Scientific and Regulatory Policy
The Grocery Manufacturers of America
1010 Wisconsin Ave., NW, Suite 900,
Washington, DC 20007, U.S.A.
Phone: +1 202 337 9400
Fax: +1 202 337 4508
E-Mail: [email protected]

International Food Additives Council (IFAC)

Dr. Rodney J. H. Gray
Director, Regulatory Affairs
IFAC
Hercules Incorporated 11333 Hercules Plaza
Wilmington DE 19894 U.S.A
Phone: +1 302 594 5621
Fax: +1 302 594 6689
E-Mail: [email protected]

International Federation of Organic Agriculture Movements (IFOAM)

Mr. Katsushige Murayama
World Board Member
IFOAM (International Federation of Organic Agriculture Movements)
509 Chinonomiya, Makioka, Higashi-Yamanashi,
Yamanashi Pref. 404-0016, Japan
Phone: +81 553 35 4628
Fax: +81 553 35 4629
E-Mail: [email protected]

International Life Sciences Institute (ILSI)

Mr. Fumitake Fukutomi
ILSI Japan
Kojimachi R-K Bldg 2-6-7, Kojimachi,
Chiyoda-ku, Tokyo 102-0083, Japan
Phone: +81 3 5215 3535
Fax: +81 3 5215 3537
E-Mail: [email protected]

Mr. Shoei Hashimoto
Suntory Ltd.
1-2-3,Moto-Akasaka, Minato-Ku, Tokyo
107-8430, Japan
Phone: +81 3 3470 1137
Fax: +81 3 5770 0965
E-Mail: [email protected]

Dr. Shogo Kurasawa
Ajinomoto Inc.
1-15-1,Kyobashi, Chuo-Ku Tokyo 104-8315, Japan
Phone: +81 3 5250 8289
Fax: +81 3 5250 8403
E-Mail: [email protected]

Ms. Lucyna Kurtyka
ILSI
1126 Sixteenth Street, NW Washington, D.C.
20036-4810, USA
Phone: +1 202 659 0074
Fax: +1 202 659 3859
E-Mail: [email protected]

Mr. Clint Navales
Procter & Gamble Far East Inc.
Kobe Technical Center
17, Koyo-Cho, Naka 1 Chome Higashinada-Ku,
Kobe 658-0032, Japan
Phone: +81 78 845 6076
Fax: +81 78 845 6950
E-Mail: [email protected]

Dr. Toshifumi Ogawara
Kikkoman Corp.
399, Noda, Noda-shi, Chiba-Prefecture,
278-0037, Japan
Phone: +81 471 23 5500
Fax: +81 471 23 5550
E-Mail: [email protected]

Ms. Atsuko Sakiyama
Danisco Cultor Japan Co. Ltd.
Park West 9F 6-12-1, Nishi-shinjuku, Shinjuku-Ku,
Tokyo 160-0023, Japan
Phone: +81 3 5381 3920
Fax: +81 3 5381 3951
E-Mail: [email protected]

Mr. Yukio Suzuki
San-Ei Gen F.F.I.
1-1-11, Sanwa-Cho, Toyonaka-Shi, Osaka
561-8588, Japan
Phone: +81 6 6333 0521
Fax: +81 6 6333 3631
E-Mail: [email protected]

International Soft Drink Council (ISDC)

Dr. Shuji Iwata
Chairman of Japan Soft Drinks Association
Technical Committee
International Soft Drink Council
Phone: +81 3 3270 7300
Fax: +81 3 3270 7306
E-Mail: [email protected]

International Union of Biological Sciences (IUBS)

Prof. Darryl R. J. Macer
Bioethics Program (IUBS)
International Union of Biological Sciences (IUBS)
Institute of Biological Sciences, University of
Tsukuba, Tsukuba Science City, Ibaragi 305-8572,
Japan
Phone: +81 298 53 4662
Fax: +81 298 53 6614
E-Mail: [email protected]

Ms. Makina Kato
Bioethics Program (IUBS)
International Union of Biological Sciences (IUBS)
Institute of Biological Sciences, University of
Tsukuba, Tsukuba Science City, Ibaragi 305-8572,
Japan
Phone: +81 298 53 4662
Fax: +81 298 53 6614
E-Mail: [email protected]

Ms. Minakshi Bhardwaj
Bioethics Program (IUBS)
International Union of Biological Sciences (IUBS)
Institute of Biological Sciences, University of Tsukuba,
Tsukuba Science City, Ibaragi 305-8572,
Japan
Phone: +81 298 53 4662
Fax: +81 298 53 6614
E-Mail: [email protected]

World Veterinary Association (WVA)

Dr. Susumu Kumagai
University of Tokyo, Graduate School of
Agricultural and Life Sciences, Yayoi 1-1-1,
Bunkyo-ku, Tokyo 113-8657, Japan
E-Mail:[email protected]

The 49th Parallel Biotechnology Consortium

Dr. Philip L. Bereano
Professor
Department of Technical Communication
College of Engineering
Box 352195 University of Washington Seattle,
Wash, 98195, U.S.A.
Phone: +1 206 543 9037
Fax: +1 206 543 8858
E-Mail: [email protected]

Greenpeace International

Mr. Bruno Heinzer
GE Campaigner
Greenpeace International
Postfach, CH-8031, Zurich, Switzerland
Phone: +41 1 447 41 41
Fax: +41 1 447 41 99
E-Mail: [email protected]

SECRETARIAT

Joint FAO/WHO Secretariat

Dr. Alan W. Randell
Senior Officer
Joint FAO/WHO Food Standards Programme
Food and Nutrition Division
Food and Agriculture Organization of the United Nations
Viale delle Terme di Caracalla 00100 Rome, Italy
Phone: +39 6 570 54390
Fax: +39 6 57054593
E-Mail: [email protected]

Mr. Makoto Tabata
Food Standards Officer Joint FAO/WHO Food
Standards Programme
Food and Nutrition Division
Food and Agriculture Oranization of the United Nations
Viale delle Terme di Caracalla 00100 Rome, Italy
Phone: +39 6 570 54796
Fax: +39 6 570 54593
E-Mail: [email protected]

Japanese Secretariat

Dr. Mitsuhiro USHIO
Director for International Food Safety Planning
Department of Food Sanitation
Pharmaceutical and Medical Safety Bureau
Ministry of Health, Labour and Welfare

Mr. Fumio SAKAMOTO
Deputy Director
Policy Planning Division
Department of Food Sanitation
Pharmaceutical and Medical Safety Bureau
Ministry of Health, Labour and Welfare

Mr. Hideki YAMADA
Deputy Director
Policy Planning Division
Department of Food Sanitation
Pharmaceutical and Medical Safety Bureau
Ministry of Health, Labour and Welfare

Mr. Jun SAKAMOTO
Deputy Director
Standards Division
Department of Food Sanitation
Pharmaceutical and Medical Safety Bureau
Ministry of Health, Labour and Welfare

Dr. Yasuhisa NAKAMURA
Deputy Director
Standards Division
Department of Food Sanitation
Pharmaceutical and Medical Safety Bureau
Ministry of Health, Labour and Welfare

Dr. Hiroaki HARUSHIMA
Plan Coordinating Officer
Tokyo Quarantine Station

Mr. Fumio OKADA
Deputy Director
Inspection and Safety Division
Department of Food Sanitation
Pharmaceutical and Medical Safety Bureau
Ministry of Health, Labour and Welfare

Dr. Hideshi MICHINO
Deputy Director
Inspection and Safety Division
Department of Food Sanitation
Pharmaceutical and Medical Safety Bureau
Ministry of Health, Labour and Welfare

Dr. Yoshiko SAITO
Assistant Director
Inspection and Safety Division
Department of Food Sanitation
Pharmaceutical and Medical Safety Bureau
Ministry of Health, Labour and Welfare

Dr. Masayuki TASAI
Deputy Director
International Affairs Division
Minister’s Secretariat

Dr. Hiroshi UMEDA
Assistant Director
Office of Port Health Administration
Policy Planning Division
Department of Food Sanitation
Pharmaceutical and Medical Safety Bureau
Ministry of Health, Labour and Welfare

Dr. Tsuyoshi MORITA
Assistant Director
Office of Health Policy on Newly Developed
Foods Policy Planning Division
Department of Food Sanitation
Pharmaceutical and Medical Safety Bureau
Ministry of Health, Labour and Welfare

Mr. Toshihiro MASADA
Section Chief
Policy Planning Division
Department of Food Sanitation
Pharmaceutical and Medical Safety Bureau
Ministry of Health, Labour and Welfare

Mr. Takeshi YAMAGISHI
Section Chief
Inspection and Safety Division
Department of Food Sanitation
Pharmaceutical and Medical Safety Bureau
Ministry of Health, Labour and Welfare

Mr. Ietarou MARUYAMA
Section Chief
Inspection and Safety Division
Department of Food Sanitation
Pharmaceutical and Medical Safety Bureau
Ministry of Health, Labour and Welfare

Mr. Naoki IKUTA
Section Chief
Policy Planning Division
Department of Food Sanitation
Pharmaceutical and Medical Safety Bureau
Ministry of Health, Labour and Welfare

Dr. Aki NAKAI
Section Chief
Standards Division
Department of Food Sanitation
Pharmaceutical and Medical Safety Bureau
Ministry of Health, Labour and Welfare

Ms. Kumiko TSURUMAKI
Inspection and Safety Division
Department of Food Sanitation
Pharmaceutical and Medical Safety Bureau
Ministry of Health, Labour and Welfare

Ms. Keiko MISHIMA
Inspection and Safety Division
Department of Food Sanitation
Pharmaceutical and Medical Safety Bureau
Ministry of Health, Labour and Welfare

Mr. Shinichirou TANAKA
Policy Planning Division
Department of Food Sanitation
Pharmaceutical and Medical Safety Bureau

Ms. Akiko ZUSHIDEN
Inspection and Safety Division
Department of Food Sanitation
Pharmaceutical and Medical Safety Bureau

Ms. Nobumi NAKAYAMA
Inspection and Safety Division
Department of Food Sanitation
Pharmaceutical and Medical Safety Bureau
Ministry of Health, Labour and Welfare

Mr. Masanori NONO
Chemistry Division
Center for Imported Food Inspection and Port
Health Control Yokohama Quarantine Station

Dr. Shunsaku MINAMI
Director
Center for Imported Food Inspection and Port
Health Control Yokohama Quarantine Station

Mr. Kazuhiko KAWAMURA
Deputy Director, Food Labelling Office, General Food Policy Bureau,
Ministry of Agriculture, Forestry and Fisheries

Dr. Takami KOSAKO
Assistant Director, Food Division, Livestock
Industry Department, Agricultural Production Bureau,
Ministry of Agriculture, Forestry and Fisheries

Mr. Hiroyuki KOKUBU
Section Chief, Food Division, Livestock Industry
Department, Agricultural Production Bureau,
Ministry of Agriculture, Forestry and Fisheries

Dr. Toshiaki KAYANO
Deputy Director, Innovative Technology Division,
Agriculture, Forestry and Fisheries Research Council
Ministry of Agriculture, Forestry and Fisheries

Mr. Junichi TAKEUCHI
Research Coordinator, Innovative Technology
Division, Agriculture, Forestry and Fisheries Research Council,
Ministry of Agriculture, Forestry and Fisheries

Mr. Naoki TAKIZAWA
Section Chief, Innovative Technology Division,
Agriculture, Forestry and Fisheries Research Council,
Ministry of Agriculture, Forestry and Fisheries

Mr. Makoto ENDO
Tokyo Center for Quality Control and Consumer Service,
Ministry of Agriculture, Forestry and Fisheries

Mr. Toshifumi FUJITA
Section Chief, Tokyo Center for Quality Control and Consumer Service,
Ministry of Agriculture, Forestry and Fisheries

Mr. Yoshihide ENDO
Deputy Director, Food Industry Promotion
Division, General Policy Bureau
Ministry of Agriculture, Forestry and Fisheries

Appendix II: Proposed Draft Principles for the Risk Analysis of Foods Derived from Modern Biotechnology

(At Step 5 of the Elaboration Procedure)

SECTION 1 - INTRODUCTION

1. For many foods, the level of food safety generally accepted by the society reflects the history of their safe consumption by humans. It is recognised that in many cases the knowledge required to manage the risks associated with foods has been acquired in the course of their long history of use. Foods are generally considered safe, provided that care is taken during development, primary production, processing, storage, handling and preparation.

2. The hazards associated with foods are subjected to the risk analysis process of the Codex Alimentarius Commission to assess potential risks and, if necessary, to develop approaches to manage these risks. The conduct of risk analysis is guided by general decisions[18] of the Codex Alimentarius Commission (CAC) as well as the Codex Working Principles for Risk Analysis[19].

3. While risk analysis has been used over a long period of time to address chemical hazards (e.g. residues of pesticides, contaminants, food additives and processing aids), and it is being increasingly used to address microbiological hazards and nutritional factors, the principles were not elaborated specifically for whole foods.

4. The risk analysis approach can, in general terms, be applied to foods including foods derived from modern biotechnology. However, it is recognised that this approach must be modified when applied to a whole food rather than to a discrete hazard that may be present in food.

5. The principles presented in this document should be read in conjunction with the Codex Working Principles for Risk Analysis to which these principles are supplemental.

6. Where appropriate, the results of a risk assessment undertaken by other regulatory authorities may be used to assist in the risk analysis and avoid duplication of work.

SECTION 2 - SCOPE AND DEFINITIONS

7. The purpose of these Principles is to provide a framework for undertaking risk analysis on the safety and nutritional aspects of foods derived from modern biotechnology. This document does not address environmental, other ethical, moral and socio-economic aspects of the research, development, production and marketing of these foods[20].

8. The definitions below apply to these Principles:

-“Modern Biotechnology” means the application of:

(i). In vitro nucleic acid techniques, including recombinant deoxyribonucleic acid (DNA) and direct injection of nucleic acid into cells or organelles, or

(ii). Fusion of cells beyond the taxonomic family,

that overcome natural physiological reproductive or recombinant barriers and that are not techniques used in traditional breeding and selection[21].

- “Conventional Counterpart “ means a related organism/variety, its components and/or products for which there is experience of establishing safety based on common use as food[22].

SECTION 3 - PRINCIPLES

9. The risk analysis process for foods derived from modern biotechnology should be consistent with the Codex Working Principles for Risk Analysis[23].

RISK ASSESSMENT

10. Risk assessment includes a safety assessment, which is designed to identify whether a hazard, nutritional or other safety concern is present, and if present, to gather information on its nature and severity. The safety assessment should include a comparison between the food derived from modern biotechnology and its conventional counterpart focusing on determination of similarities and differences. If a new or altered hazard, nutritional or other safety concern is identified by the safety assessment, the risk associated with it should be characterized to determine its relevance to human health.

11. A safety assessment is characterized by an assessment of a whole food or a component thereof relative to the appropriate conventional counterpart:

a) taking into account both intended and unintended effects;
b) identifying new or altered hazards;
c) identifying changes, relevant to human health, in key nutrients.

13. Risk assessment should apply to all relevant aspects of foods derived from modern biotechnology. The risk assessment approach for these foods is based on a consideration of science-based multidisciplinary data and information taking into account the factors mentioned in the accompanying Guidelines[24].

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

15. Risk assessment may be based on the data and information derived from different testing procedures, provided that the procedures are scientifically sound and the parameters being measured are comparable.

RISK MANAGEMENT

16. Risk management measures for foods derived from modern biotechnology should be proportional to the risk, based on the outcome of the risk assessment and, where relevant, taking into account other legitimate factors[25] in accordance with the general decisions of the Codex Alimentarius Commission (CAC) as well as the Codex Working Principles for Risk Analysis[26].

17. It should be recognised that different risk management measures may be capable of meeting the same objective with regard to the management of risks associated with safety and nutritional impacts on human health, and therefore would be equivalent.

18. Risk managers should take into account the uncertainties identified in the risk assessment and implement appropriate measures to manage these uncertainties.

19. Risk management measures may include, as appropriate, food labelling,[27] conditions for marketing approvals, post-market monitoring and development of analytical methods for the detection or identification of foods derived from modern biotechnology.

20. Post-market monitoring may be an appropriate risk management measure in specific circumstances. Its need and utility should be considered, on a case-by-case basis, during risk assessment and practicability in addition during risk management. Post-market monitoring may be undertaken for the purpose of:

A) verifying conclusions about the absence or the possible occurrence, impact and significance of potential consumer health effects; and

B) monitoring changes in nutrient intake levels, associated with the introduction of foods likely to significantly alter nutritional status, to determine their human health impact.

RISK COMMUNICATION

22. Effective risk communication is essential at all phases of risk assessment and risk management. It is an interactive process involving all interested parties, including government, industry, academia, media and consumers.

23. Risk communication should include transparent safety assessment and management decision-making processes. These processes should be fully documented at all stages and open to public scrutiny, whilst respecting legitimate concerns to safeguard the confidentiality of commercial and industrial information. In particular, reports prepared on the safety assessments and other aspects of the decision-making process should be made available to all interested parties.

24. Effective risk communication should include responsive consultation processes. Consultation processes should be interactive and may include consultation with existing bodies. The views of all interested parties should be sought and relevant food safety and nutritional issues that are raised during consultation should be addressed during the risk analysis process.

CONSISTENCY

25. A consistent approach should be adopted to characterise and manage safety and nutritional risks associated with foods derived from modern biotechnology. The acceptable level of risk for these foods should be consistent with that for similar foods already on the market.

26. A transparent and well-defined regulatory framework should be provided in characterising and managing the risks associated with foods derived from modern biotechnology. This should include consistency of data requirements, assessment frameworks, acceptable level of risk, communication and consultation mechanisms and timely decision processes.

CAPACITY BUILDING AND INFORMATION EXCHANGE

27. Efforts should be made to improve the capability of regulatory authorities, particularly those of developing countries, to assess and manage risks, including enforcement, associated with foods derived from modern biotechnology or to interpret assessments undertaken by other authorities or recognised expert bodies, including access to analytical technology.

28. Regulatory authorities, international organisations and expert bodies and industry should facilitate through appropriate contact points including but not limited to Codex Contact Points and other appropriate means, the exchange of information including the information on analytical methods.

REVIEW PROCESSES

29. Risk analysis methodology and its application should be consistent with new scientific knowledge and other information relevant to risk analysis.

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

Appendix III: Proposed Draft Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant - DNA Plants

(At Step 5 of the Elaboration Procedure)

SECTION 1 - SCOPE

1. This Guideline supports the Principles for the Risk Analysis of Foods Derived from Modern Biotechnology and addresses safety and nutritional aspects of foods derived from plants that have a history of safe use as sources of food and that have been modified to exhibit new traits.

2. This document does not address animal feed or animals fed the feed. This document also does not address environmental risks.

3. The Codex principles of risk analysis, particularly those for risk assessment, are primarily intended to apply to discrete chemical entities such as food additives and pesticide residues, or a specific chemical or microbial contaminant that have identifiable hazards and risks; they are not intended to apply to whole foods as such. Indeed, few foods have been assessed scientifically in a manner that would fully characterise all risks associated with the food. Further, many foods contain substances that would likely be found harmful if subjected to conventional approaches to safety testing. Thus, a more focused approach is required where the safety of a whole food is being considered.

4. This approach is based on the principle that the safety of foods derived from new plant varieties, including recombinant-DNA plants, is assessed relative to the conventional counterpart having a history of safe use, taking into account both intended and unintended effects. Rather than trying to identify every hazard associated with a particular food, the intention is to identify new or altered hazards relative to the conventional counterpart.

5. This safety assessment approach falls within the risk assessment framework as discussed in Section 3 of the Principles for the Risk Analysis of Foods Derived from Modern Biotechnology. If a new or altered hazard, nutritional or other food safety concern is identified by the safety assessment, the risk associated with it would first be assessed to determine its relevance to human health. Following the safety assessment and if necessary further risk assessment, the food would be subjected to risk management considerations in accordance with the Principles for the Risk Analysis of Foods Derived from Modern Biotechnology before it is considered for commercial distribution.

6. The Guideline describes the recommended approach to making safety assessments of foods derived from recombinant-DNA plants where a conventional counterpart exists, and identifies the data and information that are generally applicable to making such assessments. While this Guideline is designed for foods derived from recombinant-DNA plants, the approach described could, in general, be applied to foods derived from plants that have been altered by other techniques.

SECTION 2 - DEFINITIONS

7. The definitions below apply to this Guideline:

“- Recombinant-DNA Plant” - means a plant in which the genetic material has been changed through in vitro nucleic acid techniques, including recombinant deoxyribonucleic acid (DNA) and direct injection of nucleic acid into cells or organelles.

- “Conventional Counterpart” - means a related plant variety, its components and/or products for which there is experience of establishing safety based on common use as food[29].

SECTION 3 - INTRODUCTION TO FOOD SAFETY ASSESSMENT

8. Traditionally, new varieties of food plants have not been systematically subjected to extensive chemical, toxicological, or nutritional evaluation prior to marketing, with the exception of foods for specific groups, such as infants, where the food may constitute a substantial portion of the diet. Thus, new varieties of corn, soya, potatoes and other common food plants are evaluated by breeders for agronomic and phenotypic characteristics, but generally, foods derived from such new plant varieties are not subjected to the rigorous and extensive food safety testing procedures, including studies in animals, that are typical of chemicals such as food additives or pesticide residues that may be present in food.

9. The use of animal models for assessing toxicological endpoints is a major element in the risk assessment of many compounds such as pesticides. In most cases, however, the substance to be tested is well characterised, of known purity, of no particular nutritional value, and, human exposure to it is generally low. It is therefore relatively straightforward to feed such compounds to animals at a range of doses some several orders of magnitude greater than the expected human exposure levels, in order to identify any potential adverse health effects of importance to humans. In this way, it is possible, in most cases, to estimate levels of exposure at which adverse effects are not observed and to set safe upper limits by the application of appropriate safety factors.

10. Animal studies cannot readily be applied to testing the risks associated with whole foods, which are complex mixtures of compounds, often characterised by a wide variation in composition and nutritional value. Due to their bulk and effect on satiety, they can usually only be fed to animals at low multiples of the amounts that might be present in the human diet. In addition, a key factor to consider in conducting animal studies on foods is the nutritional value and balance of the diets used, in order to avoid the induction of adverse effects which are not related directly to the material itself. Detecting any potential adverse effects and relating these conclusively to an individual characteristic of the food can therefore be extremely difficult. Another consideration in deciding the need for animal studies is whether it is appropriate to subject experimental animals to such a study if it is unlikely to give rise to meaningful information.

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

12. The concept of substantial equivalence is a key step in the safety assessment process. However, it is not a safety assessment in itself; rather it represents the starting point which is used to structure the safety assessment of a new food relative to its conventional counterpart. This concept is used to identify similarities and differences between the new food and its conventional counterpart[30]. It aids in the identification of potential safety and nutritional issues and is considered the most appropriate strategy to date for safety assessment of foods derived from recombinant-DNA plants. The safety assessment carried out in this way does not imply absolute safety of the new product; rather, it focuses on assessing the safety of any identified differences so that the safety of the new product can be considered relative to its comparator.

UNINTENDED EFFECTS

13. In achieving the objective of conferring a specific target trait (intended effect) to a plant by the insertion of defined DNA sequences, additional traits could, in some cases, be acquired or existing traits could be lost or modified (unintended effects). The potential occurrence of unintended effects is not restricted to the use of in vitro nucleic acid techniques. Rather, it is an inherent and general phenomenon that can also occur in conventional breeding. Unintended effects may be deleterious, beneficial, or neutral with respect to the health of the plant or the safety of foods derived from the plant. Unintended effects in recombinant-DNA plants may also arise through the insertion of DNA sequences and/or they may arise through subsequent conventional breeding of the recombinant-DNA plant. Safety assessment should include data and information to reduce the possibility that a food derived from a recombinant-DNA plant would have an unexpected, adverse effect on human health.

14. Unintended effects can result from the random insertion of DNA sequences into the plant genome which may cause disruption or silencing of existing genes, activation of silent genes, or modifications in the expression of existing genes. Unintended effects may also result in the formation of new or changed patterns of metabolites. For example, the expression of enzymes at high levels may give rise to secondary biochemical effects or changes in the regulation of metabolic pathways and/or altered levels of metabolites.

15. Unintended effects due to genetic modification may be subdivided into two groups: those that are “predictable” and those that are “unexpected”. Many unintended effects are largely predictable based on knowledge of the inserted trait and its metabolic connections or of the site of insertion. Due to the expanding information on plant genome and the increased specificity in terms of genetic materials introduced through recombinant-DNA techniques compared with other forms of plant breeding, it may become easier to predict unintended effects of a particular modification. Molecular biological and biochemical techniques can also be used to analyse potential changes at the level of gene transcription and message translation that could lead to unintended effects.

16. The safety assessment of foods derived from recombinant-DNA plants involves methods to identify and detect such unintended effects and procedures to evaluate their biological relevance and potential impact on food safety. A variety of data and information are necessary to assess unintended effects because no individual test can detect all possible unintended effects or identify, with certainty, those relevant to health. These data and information, when considered in total, provide assurance that the food is unlikely to have an adverse effect on human health. The assessment for unintended effects takes into account the agronomic/phenotypic characteristics of the plant that are typically observed by breeders in selecting new varieties for commercialization. These observations by breeders provide a first screen for plants that exhibit unintended traits. New varieties that pass this screen are subjected to safety assessment as described in Sections 4 and 5.

FRAMEWORK OF FOOD SAFETY ASSESSMENT

17. The safety assessment of a food derived from a recombinant-DNA plant follows a stepwise process of addressing relevant factors that include:

A) Description of the new variety;

B) Description of the host plant and its use as food;

C) Description of the donor organism(s);

D) Description of the genetic modification(s);

E) Characterization of the genetic modification(s);

F) Safety assessment:

a) expressed substances (non-nucleic acid substances);
b) compositional analyses of key components;
c) evaluation of metabolites;
d) food processing;
e) nutritional modification; and

G) Other considerations.

19. Experiments intended to develop data for safety assessments should be designed and conducted in accordance with sound scientific concepts and principles, as well as, where appropriate, Good Laboratory Practice. Primary data should be made available to regulatory authorities at request. Data should be obtained using sound scientific methods and analysed using appropriate statistical techniques. The sensitivity of all analytical methods should be documented.

20. The goal of each safety assessment is to provide assurance, in the light of the best available scientific knowledge, that the food does not cause harm when prepared, used and/or eaten according to its intended use. The expected endpoint of such an assessment will be a conclusion regarding whether or not the new food is as safe and nutritious as the conventional counterpart against which it has been compared and for which there exists a history of safe use. In essence, therefore, the outcome of the safety assessment process is to define the product under consideration in such a way as to enable risk managers to determine whether any measures are needed and if so to make well-informed and appropriate decisions.

SECTION 4 - GENERAL CONSIDERATIONS

DESCRIPTION OF THE NEW VARIETY

21. A description of the new plant variety being presented for safety assessment should be provided. This description should identify the crop, the transformation event(s) to be reviewed and the type and purpose of the modification. This description should be sufficient to aid in understanding the nature of the food being submitted for safety assessment.

DESCRIPTION OF THE HOST PLANT AND ITS USE AS FOOD

22. A comprehensive description of the host plant should be provided. The necessary data and information should include, but need not be restricted to:

A) common or usual name; scientific name; and, taxonomic classification;

B) history of cultivation and development through breeding, in particular identifying traits that may adversely impact on human health;

C) information on the host plant’s genotype and phenotype relevant to its safety, including any known toxicity or allergenicity; and

D) history of safe use for consumption as food.

24. The history of use may include information on how the plant is typically cultivated, transported and stored, whether special processing is required to make the plant safe to eat, and the plant’s normal role in the diet (e.g. which part of the plant is used as a food source, whether its consumption is important in particular subgroups of the population, what important macro- or micro-nutrients it contributes to the diet).

DESCRIPTION OF THE DONOR ORGANISM(S)

25. Information should be provided on the donor organism(s) and, when appropriate, on other members of the corresponding genus. It is particularly important to determine if the donor organism(s) or other closely related members of the family naturally exhibit characteristics of pathogenicity or toxin production, or have other traits that affect human health (e.g. presence of antinutrients). The description of the donor organism(s) should include:

A) its usual or common name;

B) scientific name;

C) taxonomic classification;

D) information about the natural history as concerns food safety;

E) information on naturally occurring toxins, anti-nutrients and allergens; for microorganisms, additional information on pathogenicity and the relationship to known pathogens; and

F) information on the past and present use, if any, in the food supply and exposure route(s) other than intended food use (e.g. possible presence as contaminants).

26. Sufficient information should be provided on the genetic modification to allow for the identification of all genetic material potentially delivered to the host plant and to provide the necessary information for the analysis of the data supporting the characterization of the DNA inserted in the plant.

27. The description of the transformation process should include:

A) information on the specific method used for the transformation (e.g. Agrobacterium-mediated transformation);

B) information, if applicable, on the DNA used to modify the plant (e.g. helper plasmids), including the source (e.g. plant, microbial, viral, synthetic), identity and expected function in the plant; and

C) intermediate host organisms including the organisms (e.g. bacteria) used to produce or process DNA for transformation of the host organism;

A) the characterization of all the genetic components including marker genes, regulatory and other elements affecting the function of the DNA;

B) the size and identity;

C) the location and orientation of the sequence in the final vector/construct; and

D) the function.

29. In order to provide clear understanding of the impact on the composition and safety of foods derived from recombinant-DNA plants, a comprehensive molecular and biochemical characterization of the genetic modification should be carried out.

30. Information should be provided on the DNA insertions into the plant genome; this should include:

A) the characterization and description of the inserted genetic materials;

B) the number of insertion sites;

C) the organisation of the inserted genetic material at each insertion site including copy number and sequence data of the inserted material and, where appropriate, of surrounding region; and

D) identification of any open reading frames within the inserted DNA or created by the insertions with contiguous plant genomic DNA including those that could result in fusion proteins.

A) the gene product (e.g. a protein or an untranslated RNA);

B) the gene product’s function;

C) the phenotypic description of the new trait(s);

D) the level and site of expression in the plant of the expressed gene product(s), and the levels of its metabolites in the plant, particularly in the edible portions; and

E) the amount of the target gene product(s) if the function of the expressed sequence(s)/gene(s) is to alter the accumulation of a specific endogenous mRNA or protein.

A) to demonstrate whether the arrangement of the genetic material used for insertion has been conserved or whether significant rearrangements have occurred upon integration;

B) to demonstrate whether deliberate modifications made to the amino acid sequence of the expressed protein result in changes in its post-translational modification or affect sites critical for its structure or function;

C) to demonstrate that the intended effect of the modification has been achieved and that all expressed traits are expressed and inherited in a manner that is stable through several generations consistent with laws of inheritance. It may be necessary to examine the inheritance of the DNA insert itself or the expression of the corresponding RNA if the phenotypic characteristics cannot be measured directly;

D) to demonstrate that the newly expressed trait(s) are expressed as expected in the appropriate tissues in a manner and at levels that are consistent with the associated regulatory sequences driving the expression of the corresponding gene;

E) to indicate whether there is any evidence to suggest that one or several genes in the host plant has been affected by the transformation process; and

F) to confirm the identity and expression pattern of any new fusion proteins.

Assessment of possible toxicity

33. In vitro nucleic acid techniques enable the introduction of DNA which can result in the synthesis of new substances in plants. These can be conventional components of plant foods such as proteins, fats, carbohydrates, vitamins which are novel in context of that recombinant-DNA plant. Conventional toxicology studies are not considered necessary where the substance or a closely related substance has been consumed safely in food, taking into account its exposure, for the reasons described in Section 3.

34. In other cases, the use of conventional toxicology studies on the new substance will be necessary. This may require the isolation of the new substance from the recombinant-DNA plant, or the synthesis or production of the substance from an alternative source, in which case the material should be shown to be structurally, functionally and biochemically equivalent to that produced in the recombinant-DNA plant.

35. The safety assessment of the expressed substance should identify the concentration of the substance in the edible parts of the recombinant-DNA plant, including, as appropriate, variations and mean values. Current dietary exposure and possible effects on population sub-groups should also be considered. In the case of proteins, the assessment of potential toxicity should focus on amino acid sequence similarity between the protein and known protein toxins and anti-nutrients (e.g. protease inhibitors, lectins) as well as stability to heat or processing and to degradation in appropriate representative gastric and intestinal model systems. Appropriate oral toxicity studies[31] may be carried out in cases where the protein is present in the food, is not similar to proteins that have been safely consumed in food, and has not previously been consumed safely in food.

36. The expressed trait should be shown to be unrelated to any characteristics of donor organisms that could be harmful to human health. Information should be provided to ensure that genes coding for known toxins or anti-nutrients present in the donor organisms are not transferred to recombinant-DNA plants that do not normally express those toxic or anti-nutritious characteristics. This assurance is particularly important in cases where a recombinant-DNA plant is processed differently from a donor plant, since conventional processing techniques associated with the donor organisms may deactivate anti-nutrients or toxicants.

37. Additional in vivo or in vitro studies may be needed on a case-by-case basis to assess the toxicity of expressed substances. The types of studies depend on the original source of the expressed substances and their function. Such studies may include assays of metabolism, toxicokinetics, chronic toxicity/carcinogenicity, impact on reproductive function, and teratogenicity.

38. The safety assessment should take into account the potential accumulation of any substances, toxic metabolites, contaminants, or pest control agents on plants that might result from genetic modification.

Assessment of possible allergenicity (proteins)

39. When the protein(s) resulting from the inserted gene is present in the food, it should be assessed for potential allergenicity in all cases. A detailed presentation of issues to be considered can be found in annex[32].

40. A decision-tree strategy[33] should be applied in the assessment of the potential allergenicity of the newly-expressed protein(s). The decision-tree approach should rely upon various criteria used in combination (since no single criterion is sufficiently predictive). As noted in Paragraph 19, the data should be obtained using sound scientific methods.

41. The newly expressed proteins in foods derived from recombinant-DNA plants should be evaluated for any possible role in the elicitation of gluten-sensitive enteropathy, if the introduced genetic material is obtained from wheat, rye, barley, oats, or related cereal grains.

42. The transfer of genes from commonly allergenic foods and from foods known to elicit gluten-sensitive enteropathy in sensitive individuals should be avoided unless it is documented that the transferred gene does not code for an allergen or for a protein involved in gluten-sensitive enteropathy.

COMPOSITIONAL ANALYSES OF KEY COMPONENTS

43. Analyses of concentrations of key components[34] of the recombinant-DNA plant and, especially those typical of the food, should be compared with an equivalent analysis of a conventional counterpart grown and harvested under the same conditions. In some cases, a further comparison with the recombinant-DNA plant grown under its expected agronomic conditions may need to be considered (e.g. application of an herbicide). The statistical significance of any observed differences should be assessed in the context of the range of natural variations for that parameter to determine its biological significance. The comparator(s) used in this assessment should ideally be the near isogenic parental line. In practice, this may not be feasible at all times, in which case a line as close as possible should be chosen. The purpose of this comparison, in conjunction with an exposure assessment as necessary, is to establish that substances that are nutritionally important or that can affect the safety of the food have not been altered in a manner that would have an adverse impact on human health.

44. The location of trial sites should be representative of the range of environmental conditions under which the plant varieties would be expected to be grown. The number of trial sites should be sufficient to allow accurate assessment of compositional characteristics over this range. Similarly, trials should be conducted over a sufficient number of generations to allow adequate exposure to the variety of conditions met in nature. To minimise environmental effects, and to reduce any effect from naturally occurring genotypic variation within a crop variety, each trial site should be replicated. An adequate number of plants should be sampled and the methods of analysis should be sufficiently sensitive and specific to detect variations in key components.

EVALUATION OF METABOLITES

45. Some recombinant-DNA plants may have been modified in a manner that could result in new or altered levels of various metabolites in the food. Consideration should be given to the potential for the accumulation of metabolites in the food that would adversely affect human health. Safety assessment of such plants requires investigation of residue and metabolite levels in the food and assessment of any alterations in nutrient profile. Where altered residue or metabolite levels are identified in foods, consideration should be given to the potential impacts on human health using conventional procedures for establishing the safety of such metabolites (e.g. procedures for assessing the human safety of chemicals in foods).

FOOD PROCESSING

46. The potential effects of food processing, including home preparation, on foods derived from recombinant-DNA plants should also be considered. For example, alterations could occur in the heat stability of an endogenous toxicant or the bioavailability of an important nutrient after processing. Information should therefore be provided describing the processing conditions used in the production of a food ingredient from the plant. For example, in the case of vegetable oil, information should be provided on the extraction process and any subsequent refining steps.

NUTRITIONAL MODIFICATION

47. The assessment of possible compositional changes to key nutrients, which should be conducted for all recombinant-DNA plants, has already been addressed under ‘Compositional analyses of key components’. However, foods derived from recombinant-DNA plants that have undergone modification to intentionally alter nutritional quality or functionality should be subjected to additional nutritional assessment to assess the consequences of the changes and whether the nutrient intakes are likely to be altered by the introduction of such foods into the food supply.

48. Information about the known patterns of use and consumption of a food, and its derivatives should be used to estimate the likely intake of the food derived from the recombinant-DNA plant. The expected intake of the food should be used to assess the nutritional implications of the altered nutrient profile both at customary and maximal levels of consumption. Basing the estimate on the highest likely consumption provides assurance that the potential for any undesirable nutritional effects will be detected. Attention should be paid to the particular physiological characteristics and metabolic requirements of specific population groups such as infants, children, pregnant and lactating women, the elderly and those with chronic diseases or compromised immune systems. Based on the analysis of nutritional impacts and the dietary needs of specific population subgroups, additional nutritional assessments may be necessary. It is also important to ascertain to what extent the modified nutrient is bioavailable and remains stable with time, processing and storage.

49. The use of plant breeding, including in vitro nucleic acid techniques, to change nutrient levels in crops can result in broad changes to the nutrient profile in two ways. The intended modification in plant constituents could change the overall nutrient profile of the plant product and this change could affect the nutritional status of individuals consuming the food. Unexpected alterations in nutrients could have the same effect. Although the recombinant-DNA plant components may be individually assessed as safe, the impact of the change on the overall nutrient profile should be determined.

50. When the modification results in a food product with a composition that is significantly different from its conventional counterpart, it may be appropriate to use alternative conventional foods (i.e. foods whose nutritional composition is closer to that of the food derived from recombinant-DNA plant) as appropriate comparators to assess the nutritional impact of the food.

51. Because of geographical and cultural variation in food consumption patterns, nutritional changes to a specific food may have a greater impact in some geographical areas or in some cultural population than in others. Some food plants serve as the major source of a particular nutrient in some populations. The nutrient and the populations affected should be identified.

52. Some foods may require additional testing. For example, animal feeding studies may be warranted for foods derived from recombinant-DNA plants if changes in the bioavailability of nutrients are expected or if the composition is not comparable to conventional foods. Also, foods designed for health benefits may require specific nutritional, toxicological or other appropriate studies. If the characterization of the food indicates that the available data are insufficient for a thorough safety assessment, properly designed animal studies could be requested on the whole foods.

SECTION 5 - OTHER CONSIDERATIONS

USE OF ANTIBIOTIC RESISTANCE MARKER GENES

53. Alternative transformation technologies that do not result in antibiotic resistance marker genes in foods should be used in the future development of recombinant-DNA plants, where such technologies are available and demonstrated to be safe.

54. Gene transfer from plants and their food products to gut microorganisms or human cells is considered a rare possibility because of the many complex and unlikely events that would need to occur consecutively. Nevertheless, the possibility of such events cannot be completely discounted[35].

55. In assessing safety of foods containing antibiotic resistance marker genes, the following factors should be considered:

A) the clinical and veterinary use and importance of the antibiotic in question;

(Certain antibiotics are the only drug available to treat some clinical conditions (e.g. vancomycin for use in treating certain staphylococcal infections). Marker genes encoding resistance to such antibiotics should not be used in recombinant-DNA plants.)

B) whether the presence in food of the enzyme or protein encoded by the antibiotic resistance marker gene would compromise the therapeutic efficacy of the orally administered antibiotic; and

(This assessment should provide an estimate of the amount of orally ingested antibiotic that could be degraded by the presence of the enzyme in food, taking into account factors such as dosage of the antibiotic, amount of enzyme likely to remain in food following exposure to digestive conditions, including neutral or alkaline stomach conditions and the need for enzyme cofactors (e.g. ATP) for enzymatic activity and estimated concentration of such factors in food.)

C) safety of the gene product, as would be the case for any other expressed gene product.

REVIEW OF SAFETY ASSESSMENTS

57. The goal of the safety assessment is a conclusion as to whether the new food is as safe as and no less nutritious than the conventional counterpart against which it was compared. Nevertheless, the safety assessment should be reviewed in the light of new scientific information that calls into question the conclusions of the original safety assessment.

1. ANNEX

ASSESSMENT OF POSSIBLE ALLERGENICITY

[still to be developed by the Working Group on Allergenicity]

Appendix IV: Answers by the 2000 FAO/WHO Expert Consultation on Foods Derived from Biotechnology to the Questions from the Codex ad hoc Intergovernmental Task Force[36]

1) WHAT OVERARCHING SCIENTIFIC PRINCIPLES SHOULD BE APPLIED TO THE SAFETY AND NUTRITIONAL ASSESSMENT?

Experience throughout the world has led to the identification of a number of common scientific principles currently used in safety and nutritional assessment.

The existing food supply has a long history of safe use, even though some foods are not safe for some individuals and many foods contain substances that would present health concerns if they were present above accepted levels. Most foods derived using recombinant-DNA techniques are obtained from traditional crops that have usually been modified to exhibit one or a few well-defined traits. The knowledge and experience gained in the use of traditional crops is an important component in the safety assessment of foods derived from such plants.

Safety assessment of whole foods and many complex food ingredients requires use of an approach that differs from the strategy used to assess safety of single, well-defined chemicals, such as food additives, pesticides and contaminants. The approach for whole foods is case-by-case, based on an evaluation of multi-disciplinary data and information, that is derived from, as appropriate, but is not limited to, agronomic, genetic, molecular biological, nutritional, toxicological and chemical properties. Toxicology testing in animals is not routinely employed, but when necessary based on an assessment of available data and information, tests should be designed to address specific issues.

The following issues are some of the main points considered in the evaluation: the new gene, the new protein and other food components, taking into account both intended and unintended changes in the food and steps to reduce the likelihood of adverse, unexpected effects. In specific cases, additional effects (such as antibiotic resistance) may be evaluated.

Genetically modified foods and conventional foods have many characteristics in common, and in many cases, the new food or food ingredient will be nutritionally equivalent to its conventional counterpart.

Analytical methods traditionally applied in the evaluation of food constituents such as total protein, fat, ash, fibre and micronutrients may need to be augmented with additional analyses using profiling methods to identify unexpected effects and modified nutrient profiles which may impact dietary intake and health.

Because of the potential for broad changes in nutrient levels and interactions with other nutrients as well as unexpected effects, it may be necessary in certain instances to undertake feeding tests in animals to determine outcomes that result from changes in nutrient profiles and nutrient bioavailability. Nutritional modifications which are within normal ranges of nutrient variation might require a less extensive evaluation than those outside normal ranges.

The data and information should be of a quality and quantity that would withstand scientific peer review. Safety assessment is designed to identify information on the nature and the severity of any hazards that may be present, allowing appropriate management methods to be defined.

In conclusion, safety assessment of food and food ingredients obtained using recombinant-DNA techniques does not require new scientific principles or methodology. Similar principles for the assessment of the safety and wholesomeness of genetically modified foods should be applied as practised for conventional foods. Depending on the characteristics of the genetic modifications, specific safety and nutritional aspects are assessed.

2) WHAT IS THE ROLE, AND WHAT ARE THE LIMITATIONS, OF SUBSTANTIAL EQUIVALENCE IN THE SAFETY AND NUTRITIONAL ASSESSMENT? ARE THERE ALTERNATIVE STRATEGIES TO SUBSTANTIAL EQUIVALENCE THAT SHOULD BE USED FOR THE SAFETY AND NUTRITIONAL ASSESSMENT?

The concept of substantial equivalence is well established as an important component in safety assessment, and has been elaborated in several international reports. It is based on the idea that an existing organism (plant) used as food, or as a source of food, can serve as the basis for comparison when assessing the safety for human consumption of a food or a food component that has been modified or is new. There is a broad consensus that substantial equivalence is of value in safety assessment.

Application of the concept of substantial equivalence may lead to the identification of similarities and defined differences in the food and food ingredients. Further safety assessment will be focused on establishing the safety of the differences in the new product such that safety of the food or food ingredient can be established, relative to its comparator. The safety assessment carried out in this way does not provide an absolute safety warrant for the new product.

Another aspect of the concept of substantial equivalence is that it can only be applied where there is a suitable comparator. This requires that sufficient data is available or can be generated for the comparator. Where there is no comparator, substantial equivalence cannot be used to assess safety. In such cases, safety testing will be required based on the properties of the food concerned.

Current strategies for assessing the safety of foods derived from genetically modified plants are considered appropriate. There are presently no alternative strategies that would provide a better assurance of safety for genetically modified foods than the appropriate use of the concept of substantial equivalence. However, some aspects of the steps in safety assessment process could be refined to keep abreast of developments in genetic modification technology. Methodologies, such as profiling techniques, offer a means of providing a more detailed analytical comparison. However, much more developmental work would be necessary before such methods could be validated.

3) WHAT SCIENTIFIC APPROACH CAN BE USED TO MONITOR AND ASSESS POSSIBLE LONG-TERM HEALTH EFFECTS OR UNINTENDED/UNEXPECTED ADVERSE EFFECTS?

The Consultation considered that the methodologies for safety evaluation elaborated in the report are adequate to detect and evaluate any possible long-term effects of genetically modified foods.

The Consultation considered the issue of long-term effects from the consumption of genetically modified foods and noted that very little is known about the potential long-term effects of any foods. In many cases, this is further confounded by wide genetic variability in the population, such that some individuals may have a greater predisposition to food-related effects.

Against this background, the Consultation acknowledged that for genetically modified foods, the pre-marketing safety assessment already gives assurance that the food is as safe as its conventional counterpart. Accordingly it was considered that the possibility of long-term effects being specifically attributable to genetically modified foods would be highly unlikely.

An important aspect of the safety assessment is a consideration of the nature of the introduced gene product. Where there is no history of consumption of the introduced gene product or of the food, a 90-day study will probably be indicated. If such studies show evidence suggesting possible long-term effects, e.g. evidence of cell proliferation, further long-term studies would need to be considered if the development of the product was to continue.

The Consultation was of the view that monitoring to establish links between diet and disease is desirable. However, many chronic health effects are multifactorial and it was recognised that observational epidemiological studies would be unlikely to identify any such effects against a background of undesirable effects of conventional foods. Experimental studies, such as randomised controlled trials (RCTs), if properly designed and conducted, could be used to investigate the medium/long term effects of any foods, including genetically modified foods. Such studies could provide additional evidence for human safety, but would be difficult to conduct. In this respect, it is also important to recognise the wide variation in diets from day to day and year to year.

The same problems apply to the detection of potential long-term beneficial health effects. Nevertheless, it was recognised that genetically modified foods intended to produce nutritional effects are under development for use in developed and developing countries. In such cases, a change in nutrient levels in a particular crop plant may impact overall dietary intake and it would be important to monitor changes in nutrient levels in such foods and evaluate their potential effect on nutritional and health status.

The potential occurrence of unintended effects is not specific for the application of recombinant-DNA techniques, rather it is an inherent and general phenomenon in conventional breeding. One of the approaches to cope with this problem is to select and discard plants with unusual and undesired phenotypic and agronomic parameters already at an early stage. The practice of consecutive back-crossing is also a major procedure used to eliminate unintended effects. Only in rare cases are these approaches accompanied by analytical screening of defined constituents.

Unintended effects due to genetic modification may be subdivided into two groups: those which are “predictable” based on metabolic connections to the intended effect or knowledge of the site of insertion and those which are “unexpected”. Due to the increased precision of genetic modification compared to conventional breeding, it may become easier to predict pathways likely to be influenced by unintended effects.

The comparator used to detect unintended effects should ideally be the near isogenic parental line grown under identical conditions. In practice, this may not be feasible at all times, in which case a line as close as possible should be chosen. The resulting natural variation should be taken into account in assessing the statistical significance of the unintended effect.

Where statistically significant unintended differences are observed, their biological significance should be assessed. This may be assisted by knowledge of the mechanisms leading to the changes. In order to assess the biological and safety relevance of an unintended effect, data on the genetically modified plant should be compared to data on other conventional varieties and literature data. If the differences exceed natural variations in traditional food crops, further assessment is required.

Present approaches to assess possible unintended effects are based, in part, on the analysis of specific components (targeted approach). In order to increase the probability of detecting unintended effects, profiling techniques are considered as useful alternatives (non-targeted approach). Profiling techniques are used at different level e.g. genomics, proteomics and metabolomics.

In the future, genetic modifications of plants are likely to be more complex perhaps involving multiple between-species transfers and this may lead to an increased chance of unintended effects. In such cases, profiling techniques may contribute to the detection of differences in a more extensive way than targeted chemical analysis but they are not yet fully developed and have certain limitations. Having detected differences using profiling techniques, their safety implications of such difficulties will still need to be considered.

4) WHAT SCIENTIFIC APPROACH CAN BE USED TO ASSESS THE POTENTIAL ALLERGENICITY?

An assessment of the potential allergenicity should be made for all genetically modified foods. In the assessment, the novel proteins resulting from the inserted gene should be the focus of the investigation in most cases.

An assessment of the potential allergenicity of the genetically modified food should be conducted in all cases. Possible enhancement of the inherent allergenicity of the host plant food should also be included in the assessment only when the intended effect of the genetic modification involves a significant alteration of the protein content of the food product derived from the host plant.

A decision-tree strategy should be applied in the assessment of the potential allergenicity of the novel protein(s). When the transferred gene is obtained from a source with a known history of allergenicity, the assessment should focus initially upon the immunochemical reactivity of the newly introduced protein with IgE from the blood serum of individuals with known allergies to the source of the transferred genetic material. Where necessary (in cases where no evidence of immunochemical reactivity is obtained), skin tests with extracts of the novel protein and blinded oral food challenges with the genetically modified food should be conducted on individuals with known allergies to the source of the transferred genetic material to provide confirmation that the novel protein is not allergenic. This series of tests provides adequate evidence regarding the allergenicity (or lack thereof) of novel proteins expressed by genes obtained from known allergenic sources.

The decision-tree approach should rely upon various criteria used in combination (since no single criterion is sufficiently predictive). The current criteria include the sequence homology of the newly introduced protein to known allergens, the immunochemical reactivity of the newly introduced protein with IgE from blood serum of appropriate, allergic individuals when sequence homology is found, and the stability of the novel protein to digestion in gastric and intestinal model systems. This Consultation suggests that the incorporation of two additional criteria to the decision-tree approach when the genetic material is not known to be allergenic might be useful. The level and site of expression of the novel protein and the functional properties of the novel protein should be considered for addition to the list. These criteria taken together offer reasonable evidence that the novel protein is not allergenic, is not cross-reactive with known allergens, and has limited potential to become a food allergen. However, the development of additional criteria could offer additional confidence in the decision-tree approach. In particular, this Consultation advocated continued research on the development of a well-validated animal models for the assessment of the potential allergenicity of novel proteins from genetically modified foods. The Consultation also advocated additional research to identify allergenic proteins in food and to determine their protein sequences.

5) WHAT SCIENTIFIC APPROACH CAN BE USED TO ASSESS THE POSSIBLE RISKS ARISING FROM THE USE OF ANTIBIOTIC RESISTANCE MARKER GENES IN PLANTS AND MICROORGANISMS?

In genetically modified plants, the product of an antibiotic resistance gene must be subjected to standard safety assessments as would be performed on any other introduced gene product. Thus the product of the antibiotic resistance gene must be assessed for toxicity and potential allergenicity.

Where antibiotic resistance marker genes are present in plants or microorganisms, the possibility of transfer of the genes to pathogenic microorganisms and possible clinical implications must be considered. Horizontal gene transfer from plants and plant products consumed as food to gut microorganisms or human cells is considered as a rare possibility, but cannot be completely discounted. The most important consideration with respect to horizontal gene transfer is the consequence of a gene being transferred and expressed in transformed cells. An important example is the transfer of antimicrobial resistance genes, if it were to occur, from genetically modified foods to gut microorganisms. Important considerations for the assessment of the consequences of the transfer and expression of this gene in transformed cells would be the clinical and veterinary importance of the antibiotic in question, the levels of natural resistance and the availability of effective alternative therapies. In general, antibiotic resistance genes used in food production that encode resistance to clinically important antibiotics should not be present in widely disseminated genetically modified organism or foods and food ingredients.

Appendix V: Preliminary Report of the Ad Hoc Intergovernmental Task Force on Foods Derived from Biotechnology

TO BE PRESENTED TO THE 24^TH SESSION OF THE CODEX ALIMENTARIUS COMMISSION

INTRODUCTION

1. The 23^rd Session of the Codex Alimentarius Commission, held in June/July 1999 in Rome, decided to establish the Ad Hoc Intergovernmental Task Force on Foods Derived from Biotechnology (hereinafter referred to as the Task Force) to develop standards, guidelines or recommendations, as appropriate, for foods derived from biotechnology or traits introduced into foods by biotechnology. The Government of Japan was designated as host Government of the Task Force.

2. According to the time frame set out in its terms of reference, the Task Force shall complete its work within four years, and shall first submit a preliminary report to the Codex Alimentarius Commission in 2001, a mid-term report, where appropriate, to the Executive Committee in 2002, and a full report in 2003.

SESSIONS OF THE TASK FORCE

3. The Task Force held two Sessions in Chiba (Japan), the first being from 14-17 March 2000 and the second from 25 to 29 March 2001.

4. The First Session agreed to an overall work programme as follows[37]:

• General principle for risk analysis of foods derived from biotechnology (precise title still to be determined);
• Specific guidance on the risk assessment of foods derived from biotechnology (precise title still to be determined);
• List of available analytical methods including those for the detection or identification of foods or food ingredients derived from biotechnology.

5. Two ad hoc open-ended Working Groups were established. A Working Group chaired by the Government of Japan was entrusted to elaborate draft texts of the General Principles and the Specific Guidance for Risk Assessment while a Working Group chaired by the Government of Germany prepared a list of available analytical methods.

6. The first of these Working Groups met twice in Tokyo, Japan, from 5-7 July and from 30 October to 1 November 2000 and the second Working Group held a half-day meeting on the afternoon of 23 March 2001 in Tokyo after working primarily by correspondence.

7. At its Second Session, the Task Force considered the Proposed Draft General Principles and the Proposed Draft Guideline, a report of the Working Group for Analytical Methods, and a discussion paper on the concept of traceability and an information paper on familiarity.

PROGRESS OF THE WORK OF THE TASK FORCE

• General principle for risk analysis of foods derived from biotechnology: “Proposed Draft Principles for the Risk Analysis of Foods Derived from Modern Biotechnology” have been completed for submission to the 24th Session of the Codex Alimentarius Commission for consideration at Step 5;
• Specific guidance on the risk assessment of foods derived from biotechnology: “Proposed Draft Guideline for the Conduct of Safety Assessment of Foods Derived from Recombinant-DNA Plants” has been completed for submission to the 24^th Session of the Codex Alimentarius Commission for consideration at Step 5. An annex on the assessment of allergenicity is under preparation;
• List of available analytical methods including those for the detection or identification of foods or food ingredients derived from biotechnology: A first “List of methods validated by inter-laboratory studies” was prepared and will be complemented by the Working Group for Analytical Methods.

JOINT FAO/WHO EXPERT CONSULTATIONS ON FOODS DERIVED FROM BIOTECHNOLOGY

8. Two Joint FAO/WHO Expert Consultations were convened in June/July 2000 (Geneva) and in January 2001 (Rome). The 2000 Consultation addressed overall aspects of safety assessment of genetically modified foods of plant origin and responded to five specific questions presented by the First Session of the Task Force. The answers, noted with satisfaction by the Second Session of the Task Force are attached to this report[38]. The Task Force notes however that the responses represent the current state of scientific opinion and are subject to further development as more scientific information becomes available. The 2001 Consultation specifically addressed the allergenicity of foods derived from biotechnology.

9. The outcome of both Consultations was well taken into account during the drafting of the General Principles and the Guideline.

STATUS OF THE PRELIMINARY REPORT

10. This report was adopted by the Task Force in Chiba on 29 March 2001. The responses of the Expert Consultation to the five questions and the texts of the Proposed Draft Principles and Guidelines form an integral part of this preliminary report.