Risk/Safety Assessment: Activities of the OECD Phil Macdonald Biotechnology Environmental Release Assessment Unit Canadian Food Inspection Agency

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Risk/Safety Assessment Activities of the
OECDPhil MacdonaldBiotechnology
Environmental Release Assessment UnitCanadian
Food Inspection Agency
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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
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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
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Why 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
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• 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

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• 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

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• 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

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• 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

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• 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

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• 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

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• 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

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• 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

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• 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

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• 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

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• 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

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• 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

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• 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