Title: Risk/Safety Assessment: Activities of the OECD Phil Macdonald Biotechnology Environmental Release Assessment Unit Canadian Food Inspection Agency
1Risk/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
3What 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
4Why Have Regulatory Harmonization?Goal increas
es 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 Groups
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 Protocols 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