Documents on Harmonisation of Regulatory Oversight in Biotechnology

These consensus documents  comprise technical information for use during the regulatory assessment of products of biotechnology and are intended to be mutually recognised among OECD Member countries. These documents focus on the biology of organisms (such as plants, trees or micro&organisms) or introduced novel traits.

Other Documents

Guidance Document on the Use of Taxonomy in Risk Assessment of Micro-organisms: Bacteria
No. 29, 2003, ENV/JM/MONO(2003)13

Output on the Questionnaire on National Approaches to Monitoring/ Detection/ Identification of Transgenic Products
No. 26, 2003, ENV/JM/MONO(2003)8

OECD Guidance for the Designation of a Unique Identifier for Transgenic Plants
No. 23, 2002, ENV/JM/MONO(2002)7

Report of the Workshop on the Environmental Considerations of Genetically Modified Trees
No. 19, 2001, ENV/JM/MONO(2001)14

Report of the OECD Workshop on Unique Identification Systems for Transgenic Plants, Charmey, Switzerland, 2-4 October 2000
No. 17, 2001, ENV/JM/MONO(2001)5

Industrial Products of Modern Biotechnology Intended for Release to the Environment: The Proceedings of the Fribourg Workshop
No. 4, 1996, OCDE/GD(96)37

Report of the OECD Workshop on the Commercialisation of Agricultural Products Derived through Modern Biotechnology
No. 3, 1995, OCDE/GD(95)72

Commercialisation of Agricultural Products Derived through Modern Biotechnology: Survey Results
No. 1 , 1995,

Analysis of Information Elements Used in the Assessment of Certain Products of Modern Biotechnology
No. 2, 1995, OCDE/GD(95)11

Monographs No. 90 and 91 are companion documents:

• Compendium of Methods for Monitoring Organisms in the Environment
  No. 91, 1994, OCDE/GD(94)41
• Ottawa '92: The OECD Workshop on Methods for Monitoring Organisms in the Environment
  No. 90, 1994, OCDE/GD(94)41

Report of the OECD Workshop on Monitoring of Organisms Introduced into the Environment
No. 52, 1992, OCDE/GD(92)71

International Survey on Biotechnology Use and Regulations
No. 39, 1990

Reports to G8 

Report of the Working Group for the Harmonisation of Regulatory Oversight in Biotechnology (2000)
C(2000)86ADD2

Report of the Task Force for the Safety of Novel Food and Feeds (2000)
C(2000)86/ADD1

Publications on Harmonisation of Regulatory Oversight in Biotechnology

Recombinant DNA Safety Considerations, 1986
Also available: Considérations de sécurité relatives à l'ADN recombiné, pdf (French)

Safety Considerations for Biotechnology: Scale&Up of Crop Plants, 1993
Also available: Considérations de sécurite: Passage à l'échelle, pdf (French)

Safety Considerations for Biotechnology: Scale&Up of Microorganisms as Biofertilizers, 1995
Also available: Questions relative à la securité en biotechnologie - Passage à l'échelle supérieure des mico-organismes utilisés comme biofertilisants
Biofertilisantssecurite, pdf (French)
Biofertilisants pp39-77, pdf (French)

Traditional Crop Breeding Practices: A Historical Review to Serve as a Baseline for Assessing the Role of Modern Biotechnology, 1993, pages 1-84, pdf (English)
TradCropeng 85-146, pdf (English)
TradCropeng147-190, pdf (English)
TradCropeng191-215, pdf (English)
Tradcropengglossary, pdf (English)
Methodtradfr1-51, pdf (French)
Methodtradfr52-132, pdf (French)
Methodtradfr133-186, pdf (French)
Methodtradfr187-245, pdf (French)

Aquatic Biotechnology and Food Safety , 1994

Environmental Impacts of Aquatic Biotechnology , 1995

Safety Evaluation of Foods Derived by Modern Biotechnology, 1993
Also available: Evaluation de la sécurité des denrées alimentaires issues de la biotechnologie moderne : Concepts et principes, pdf (French)

Food Safety Evaluation , 1996

Safety Considerations for Biotechnology: 1992

Documents on the Safety of Novel Foods and Feeds