Risk/Safety Assessment: Activities of the OECD Phil Macdonald Biotechnology Environmental Release Assessment Unit Canadi

1. Risk/Safety Assessment: Activities of the OECDPhil MacdonaldBiotechnology Environmental Release Assessment UnitCanadian Food Inspection Agency

2. Current activities at the OECD concerning risk/safety assessments for the environmental release of products of biotechnology are conducted within the Working Group on Harmonisation of Regulatory Oversight in BiotechnologyThe Working Group was established to promote international harmonisation in biotechnology product regulation among member countries

3. What is regulatory harmonization?Regulatory harmonisation is the attempt to ensure that the information used in risk/safety assessments, as well as the methods used to collect such information, are as similar as possible

4. Why Have Regulatory Harmonization?Goal:• increases mutual understanding of risk/safety assessment approaches among member countries, • shares knowledge • uses resources effectively • can provide a more efficient risk/safety assessment Consequence: improved biosafety decision making, while reducing unnecessary barriers to trade

5. Key characteristics of the Working Group: Works towards harmonization of the risk assessment and regulatory approaches for the evaluation of products of modern biotechnology Focuses on environmental health and safety Complements the work of the sister organization – the Task Force for the Safety of Novel Foods and Feeds Collaborates with UNIDO, UNEP and the CBD (re. Cartagena Protocol on Biosafety) Encourages participation of non-member countries Convenes regular meetings (every 9 months), with occasional inter-sessional projects and meetings

6. Key characteristics of the Working Group (cont): Large focus to date on the regulatory oversight and risk assessment of transgenic crop plants and specific traits Similar work carried out by the Sub-Working Group on Micro-organisms More recent activities concerning Atlantic salmon Work continues within three general project areas: Consensus documents Information dissemination Facilitating harmonization: Emerging issues

7. Consensus documents: • A significant component of the Working Group’s activities has been the preparation of consensus documents on: • the biology of crop plants • micro-organisms • traits associated with transgenic organisms • 23 consensus documents have been published and another ~15 are under development • These documents reflect our current understanding of the biology of plants and micro-organisms, and the traits that have been introduced into them

8. Consensus documents (cont): • These documents include: • current uses of the plants or micro-organisms • for plants includes: • basic biology, taxonomy and cultivation areas and practices • Potential interactions with other species (e.g. disease and pest organisms) • key physiological characteristics • the uses of the key traits so far introduced into transgenic organisms and how they were introduced • All this information serves as an important base-line with which to compare the behaviour of transgenic forms of the organisms to un-modified forms

9. Consensus documents (cont): Examples: • The Biology of Brassica napus L. (Oilseed Rape/Canola)- currently being revised • The Biology of Oryza sativa (Rice) • The Biology of Pinus strobus L. (Eastern White Pine) • Information used in the Assessment of Environmental Applications involving Pseudomonas • General Information Concerning the Genes and Their Enzymes that Confer Tolerance to Glyphosate Herbicide

10. Consensus documents (cont): The Working Group has recently developed a “Points to Consider” document that facilitates: • Formatting and maintaining a consistent content of a typical consensus document • Prioritizing of future documents, i.e. which organism species is a priority for member countries • Updating existing documents, some of which are approaching ten years old • Addressing the needs of non-member countries for organism species specific to them and of importance globally

11. Consensus documents (cont): The Working Group has also developed guidance documents, including: • Guidance Document on Methods for Detection of Micro-organisms Introduced into the Environment • OECD Guidance for the Designation of a Unique Identifier for Transgenic Plants • adopted as a model by the Cartagena Protocol on Biosafety for the Protocol’s Biosafety Clearing House

12. Facilitating harmonization: Information Dissemination • The Working Group has developed and continues to maintain a database, Biotrack, that includes: • Information on products that have been approved for commercial use, including unique identifiers • Information related to regulatory developments in OECD Member countries • Information on field trials of transgenic organisms • Documents produced by the Working Group and the Task Force, such as the consensus documents • Through an MOU with the CBD, elements of Biotrack interoperate with the BCH to assist with the development and implementation of the Cartagena Protocol

13. Facilitating harmonization: New Intiatives • The Working Group has recently initiated a project on environmental risk/safety criteria with the goal of: • defining principles and criteria that underlie environmental risk/safety assessments for transgenic • A discussion document was prepared compiling information elements for an environmental risk assessment common to OECD member countries, plus highlighting requirements unique to specific members, where appropriate • including concrete examples to assist to illustrate parameters • creating a document that encompasses the above to complement and round out existing consensus documents that focus on transgenic plants • a meeting of the countries involved in the development of this document is planned in Ottawa, Canada in December to continue the development of this document

14. Facilitating harmonization: New Intiatives (cont) • In addition, the Working Group, in collaboration with the Task Force, has begun drafting a document that describes the elements necessary for the molecular characterization of a transgenic plant. The document will include information on: • Modification methods • Inserted DNA, expressed RNA, expressed protein, post-translational modification • Inheritance and genetic stability • This molecular characterization document is to complement existing documents, and documents under development, of the Working Group and Task Force and can be applied to a food feed or environmental assessment

15. Facilitating harmonization: New Intiatives (cont) • The Working Group has recently initiated work to address environmental risk/safety issues associated with animal species, specifically the Atlantic salmon • Expert workshop on the biology of Atlantic salmon • Identification and review of the kinds of, and availability of, baseline information of a specific species of transgenic fish • Determination of information that is relevant to risk/safety assessment and might be needed for the development of an Atlantic salmon consensus document • Additional projects related to transgenic animals are anticipated in the future

16. How can the products of the Working Group be used? Consensus documents, guidelines and Biotrack can be used by: Risk assessor in competent authorities Developers of products of biotechnology, as a source of information for applications to regulators Regulatory agencies and regulatory officials Regulatory policy makers Non-member countries, for consideration towards enhancing or establishing regulatory regimes

17. Conclusion the Working Group is geared to towards harmonizing regulatory and risk assessment approaches for products of modern biotechnology Over its history, the Working Group has produced useful scientific documents for developers, risk assessors and government policy makers the working is building on its past successes by producing documents that provide further guidance on the risk assessment of products of modern biotechnology