General Principles for Risk Analysis of Foods Derived From Biotechnology

• Document is at Step 1 of the Codex procedure.
• Japan is the lead country for the development of this document. The U.S. is a member of the Drafting Group.
• FDA has the lead for the U.S. Jim Maryanski provides the technical lead.
• Rationale for work: Provides an over arching set of principles for the safety assessment of foods derived from biotechnology.
• Expected FDA work activities for 2000. Participate in two Drafting Group meetings to consider initial draft, redraft of principles. Prepare draft U.S. position on document. Present U.S. position at 2^nd Session of Task Force in March, 2001.
  

Guidelines for Risk Assessment of Foods Derived From Biotechnology

• Document is at Step 1 of the Codex procedure.
• Japan is the lead country for the development of this document. The U.S. is a member of the Drafting Group.
• FDA has the lead for the U.S. Jim Maryanski provides the technical lead.
• Rationale for work: Provides a detailed set of guidelines for the safety assessment of foods derived from biotechnology.
• Expected FDA work activities for 2000. Assist Japan with the initial development of the draft guidelines. Participate in two Drafting Group meetings to consider initial draft, redraft of principles. Participate in the detailed redrafting of the Guidelines. Prepare draft U.S. position on document. Present U.S. position at 2^nd Session of Task Force in March, 2001.
  

Listing of Available Analytical Methods for the Detection or Identification of Foods or Food Ingredients Derived from Biotechnology

• Document is at Step 1 of the Codex procedure.
• Germany is the lead country for the development of this document. The U.S. is a member of the Drafting Group.
• FDA has the lead for the U.S.
• Rationale for work: Provides a listing of available methods for the detection or identification of foods derived from biotechnology.
• Expected FDA work activities for 2000. Participate in the Drafting Group activity to prepare the listing of analytical methods. Prepare draft U.S. position on document. Present U.S. position at 2^nd Session of Task Force in March, 2001.

Developing of a Working Paper on Traceability

• Document not in the Codex Step Process.
• France is the lead country for the development of this document.
• FDA has the lead for the U.S.
• Rationale for work: Provide a basis for discussion of the concept of traceability as it relates to foods derived from biotechnology.
• Expected FDA work activities for 2000. Review the Working Paper prepared by France and provide comments for/input into its revision. Prepare draft U.S. position on document. Present U.S. position at 2^nd Session of Task Force in March, 2001.
  

Information Paper on Familiarity

• Document not in the Codex Step Procedure.
• OECD, ASSINSEL are the lead organizations for the development of this document.
• FDA has the lead for the U.S.
• Rationale for work: Provide a basis for discussion of the concept of familiarity as it relates to foods derived from biotechnology.
• Expected FDA work activities for 2000. Review the Information Paper prepared by OECD/ASSINEL when prepared. Prepare draft U.S. position on document. Present U.S. position at 2^nd Session of Task Force in March, 2001.