9th ISBGMO, Jeju Island Korea
Risk/Safety Assessment: Activities of the OECD
Phil Macdonald
Biotechnology Environmental Release Assessment Unit
Canadian Food Inspection Agency
9th ISBGMO, Jeju Island Korea
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 Biotechnology
The Working Group was established to promote
international harmonisation in biotechnology product
regulation among member countries
9th ISBGMO, Jeju Island Korea
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
9th ISBGMO, Jeju Island Korea
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
9th ISBGMO, Jeju Island Korea
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
9th ISBGMO, Jeju Island Korea
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
9th ISBGMO, Jeju Island Korea
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
9th ISBGMO, Jeju Island Korea
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
9th ISBGMO, Jeju Island Korea
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
9th ISBGMO, Jeju Island Korea
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
9th ISBGMO, Jeju Island Korea
Consensus documents (cont):
The Working Group has also developed guidance
documents, including:
• Guidance Document on Methods for Detection of Microorganisms 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
9th ISBGMO, Jeju Island Korea
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
9th ISBGMO, Jeju Island Korea
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
9th ISBGMO, Jeju Island Korea
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, posttranslational 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
9th ISBGMO, Jeju Island Korea
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
9th ISBGMO, Jeju Island Korea
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
9th ISBGMO, Jeju Island Korea
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