The 7th Session of the Codex Task Force on Foods Derived from Biotechnology was highly successful. Work was completed on all three substantive documents under consideration by the Task Force. Specifically, the following three documents were advanced to Steps 5/8 of the Codex accelerated procedure.

• Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Animals.
  
  
• Food Safety Assessment of Foods Derived from Recombinant-DNA Plants Modified for Nutritional or Health Benefits as an Annex to the Codex Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants.
  
  
• Food Safety Assessment in Situations of Low-Level Presence of Recombinant-DNA Plant Material in Food as an Annex to the Codex Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants.
  
  

The Seventh Session of the Codex ad hoc Intergovernmental Task Force on Foods Derived from Biotechnology was held in Chiba, Japan, September 24–28, 2007. The Session was hosted by the Government of Japan and presided over by Dr. Hiroshi Yoshikura, Adviser, Department of Food Safety, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labor and Welfare. 196 delegates, representing 52 members of the Commission and 4 international intergovernmental and 13 non-governmental observer organizations attended the Session. Representing the United States were U.S. Delegate, Dr. Eric Flamm, FDA, 13 government advisors and 5 non-government advisors.

The full report of the 7th Session can be found in ALINORM 08/31/34 on the Codex Web site.

The following summarizes the issues of particular interest to the U.S. Delegation.

Proposed Draft Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Animals
The 6th (2006) Session of the Task Force had a thorough discussion on the Guidelines and reached consensus on all provisions with the exception of two sections dealing with: 1) the use of antibiotic marker genes; and 2) non-heritable constructs. The 7th Session Task Force agreed to focus discussion on these two sections. The 6th Session of the Task Force also requested FAO/WHO to hold a Joint Expert Consultation on these two issues; the Consultation was held February 26–March 2, 2007.

Regarding antibiotic resistance marker genes, several delegations, including the United States, expressed the view that the report of the FAO/WHO expert consultation did not yield any new scientific evidence to warrant further modification or addition to the provisions on the section on antibiotic resistance marker gene, compared to the corresponding section in the Codex Plant Guideline. Based on the findings of the FAO/WHO expert consultation, the Task Force agreed to leave the current text in this section unchanged.

Regarding non-heritable constructs, the discussion focused on the use of r-DNA vaccines and whether food safety issues could arise with respect to their use. The Delegation of the European Community pointed out that the FAO/WHO expert consultation addressed the issues on non-heritable constructs in detail and provided a series of conclusions and recommendations regarding, among others, potential hazards in relation to non-heritable constructs. The Delegation of the European Community noted that the draft proposed guideline did not address non-heritable constructs and proposed two amendments to reflect this fact in the text. Some delegations supported the Delegation of the European Community, noting that the expert consultation's recommendations recognized there might be a need to develop additional guidelines on non-heritable constructs in the future. Several delegations, including the United States, questioned whether non-heritable constructs were beyond the scope of this draft guideline. After some discussion, the Task Force agreed to both include a footnote to paragraph 1 to clarify that the draft proposed guideline had been developed primarily for animals bearing heritable recombinant DNA constructs and add a footnote to indicate the possible need for additional specific consideration for the food safety assessment of non-heritable constructs.

The Task Force agreed to forward the proposed draft guideline, with the aforementioned amendments, for adoption at Steps 5/8 by the 31st Session of the Commission, with the recommendation to omit Steps 6 and 7.

Proposed Draft Annex to the Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants: Food Safety Assessment of Foods Derived from Recombinant-DNA Plants Modified for Nutritional or Health Benefits
At the Sixth Session, the Task Force agreed to a physical Working Group to be led by Canada, co-chaired by Argentina and New Zealand and open to all the members and observers. The Working Group agreed to return the proposed Draft Annex to Step 2 for redrafting by a physical working group. The Working Group also agreed to exclude from the scope of the proposed draft annex, risk management measures and assessment of benefits.

The Task Force undertook a paragraph-by-paragraph discussion of the draft Annex and agreed to the following changes:

• The Task Force added the words "introduction of new nutrient(s) or related substance(s)" to the scope section of the Annex's introduction to clarify that the Annex covers nutrients or related substances newly introduced through r-DNA techniques.
  
  
• The Task Force agreed not to develop additional definitions to terms referred to in the Annex, including those relevant to nutritional risk assessment. The Task Force agreed to both insert text noting that the definitions of key nutritional concepts could be found and/or later be developed in relevant Codex text, in particular, text elaborated by the CCNFSDU and invite the 29th Session of CCNFSDU to review the document and provide comments, where necessary.
  
  
• Regarding the issue of upper levels, the Task Force noted that there were limitations to the available dose-response and clinical data in identifying risk association with nutrients at high levels of intake. The Task Force agreed to add new text, suggested by the United States, on the need to consider the basis for deriving upper levels in assessing the public health implication of exceeding intake levels of nutrients.
  
  
• The Task Force deleted the reference to Acceptable Daily Intake (ADI), recognizing that in Codex standards-setting and in JECFA risk assessments, the concept of ADI was typically used for the assessment of chemicals such as food additives and residues of veterinary drugs in food and would not necessarily be applicable to the safety assessment of nutrition.
  
  
• The Task Force considered how to take into account the occurrence of more than one form of a chemical nutrient. The Task Force agreed not to use the terms "multiple" and "analogues" and instead use the phrase "more than one chemical form". The Task Force also discussed bioavailability regarding chemical forms of a nutrient and agreed to add a new sentence stating that "if more than one chemical form of the nutrients or related substances is present, their combined bioavailability should be established, where appropriate" in the paragraph relating to bioavailability.
  
  
• Regarding the need for further guidance on the use of animal studies, the Task Force agreed to add a new sentence which states that "in-vivo studies in animals are of limited value in assessing nutritional value or nutrient bioavailability for humans and would require careful design in order to be relevant."
  
  
• After discussion on the issue of evaluating exposure to r-DNA plants with nutritional modification, particularly with respect to evaluating nutritional or health benefits as part of the safety assessment, the Task Force agreed to add a new sentence as follows: "When evaluating the exposure, it is appropriate to consider information on whether consumption of the modified food could lead to adverse nutritional effects as compared to consumption of the food that it is intended to replace."
  
  
• The Task Force also agreed to delete reference to FAO diet data and the FAO Food Balance Sheets since these two items, as pointed out by the Joint FAO/WHO Joint Expert Consultation on nutritional risk assessment, provide limited information for quantitative exposure estimation. The Task Force agreed however to include a footnote noting that "data on staple food products may also be supplemented by information from FAO Balance sheets."

The Task Force agreed to forward the Annex to the Commission for adoption at Steps 5/8 of the Accelerated Procedure. The Task Force, recognizing that the Annex contained references to certain concepts related to nutrition, agreed to invite CCNFSDU to review the document and provide comments where necessary.

Proposed Draft Annex to the Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants on Low-Level Presence of Recombinant-DNA Plant Material
The Task Force, at its 6th (2006) Session, recommended development of an Annex to the Plant Guideline on "Food Safety Assessment in Situations of Low-Level Presence of Recombinant-DNA Plant Material in Food." The United States chaired (along with Germany and Thailand as co-chairs) a Working Group to develop the document. The document contains two basic sections, one on food safety assessment and a second on information sharing that focuses on a new database to be developed by FAO as a component part of FAO's International Portal on Food Safety, Animal and Plant Health (IPFSAPH).

The Task Force considered two formats for the food safety component, a short version which essentially referenced only those changes to the Plant Guideline and a longer version which repeated the Plant Guideline modified for use in low-level situations. The Task Force agreed to the short form as the preferred form for the Annex.

The Task Force made no substantive changes to the food safety assessment portion of the Annex.

Regarding the draft guidance on data and information sharing, the European Community proposed several modifications, which were discussed at length by the Task Force and further modified by the Task Force.

• The European Community Delegation proposed to include in the database specific references to Cartagena Protocol and/or OECD BioTrack Product Database in the notifications. Some Delegations expressed the view that specific references to the Cartagena Protocol and OECD BioTrack in the Database could be construed as an endorsement of these organizations to which not all Delegates were Members of and questioned the relevance and necessity of referring to these resources in the database. The Task Force ultimately agreed to refer in the database "links to the information on the same product in other databases maintained by relevant international organizations, as appropriate."
  
  
• The Delegation of the European Community also proposed that the summary of the safety assessment should follow the structure of the headings of the Codex Plant Guidelines. Several Delegations noted that revising the food safety summary to adhere exactly with the structure of the headings of the Codex Plant Guidelines could pose a burden for those countries whose national legislation requires a different format for such summaries. After extensive discussion, the Task Force agreed to modify the European Community's proposed language to state that the summary of the safety assessment should be consistent with the framework of the food safety assessment of the Codex Plant Guideline.
  
  
• The Delegation of the European Community also proposed that the summary of the safety assessment should focus on the areas of specific relevance and interest of the risk assessor and include either a validated protocol for an event specific detection method suitable for low-level situations and appropriate (either viable or non-viable reference material) or information on where these can be secured. The Delegation of the European Community expressed the view that such information was crucial to facilitating the management of low-level presence circumstances and for the rapid assessment of the actual presence of the recombinant-DNA plant materials in commodities. Some Delegations expressed the view that information such as specific detection method protocols and certain reference materials may not be obtainable for reasons such as confidentially concerns. After further discussion, The Task Force ultimately agreed to a new database element: "where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situations may be obtained" with a footnote reading "This information may be provided by the product applicant or in some cases by Codex members".

The Task Force agreed to advance the document to Steps 5/8 for adoption by the Commission at the CAC's 2008 Session. The Task Force agreed to request FAO to provide an update on the database at the 2008 Session of the Commission.

Other Business and Future Work
The Observer from the OIE informed the Task Force that as a follow-up to the FAO/WHO Expert Consultation on the Safety Assessment of Foods Derived from Recombinant-DNA Animals (26 February–2 March 2007), the OIE may consider convening an expert meeting, jointly with FAO and WHO in 2008, to consider the issues related to the animals with non-heritable recombinant-DNA constructs including recombinant-DNA vaccines.

Date and Place of Next Session
Given that the three proposed draft documents were advanced to Steps 5/8, no further session of the Task Force was foreseen. Should the need for another session of the Task Force arise following the consideration of these proposed drafts by the 31st Session of the Commission in July 2008, the host government would make the necessary arrangements in consultation with the Codex Secretariat.