“Proposed Draft Guideline” Satisfactory Given Its Reduced Scope
but Nonetheless An Insufficient Response:
Comments of the Organic Trade Association on the Codex Alimentarius Commission’s
Request for comments on the Proposed Draft Guideline for the Conduct of Food Safety Assessment of Recombinant-DNA Microorganisms in Food and “Proposed Draft Guideline for the Conduct of Food Safety Assessment of Foods Produced Using Recombinant-DNA Microorganisms”
Submitted by Tom Hutcheson,
Associate Policy Director
January 9, 2002
First, the Organic Trade Association (OTA) can give only qualified support to the proposal of the Open-Ended Working Group of the Codex Ad-Hoc Intergovernmental Task Force on Foods Derived from Biotechnology to change the title of “Proposed Draft Guideline for the Conduct of Food Safety Assessment of Recombinant-DNA Microorganisms in Food” to “Proposed Draft Guideline for the Conduct of Food Safety Assessment of Foods Produced Using Recombinant-DNA Microorganisms”.
This paper is necessary—and well-done—but insufficient. It was the intent of the Task Force to address the problem of the food safety assessment of recombinant-DNA microorganisms. That work has been postponed but must still be performed. If it is necessary for that work to proceed independently, as noted under “Section 1—Scope: 2” then that work should be the primary task of the Working Group—not “other bodies”—and these papers of narrower scope must be delegated to subordinate bodies. If another body is necessary, it should be identified; if one cannot be identified, then the mandate of the Working Group should be the highest goal with which it has been charged—the conduct of food safety assessment of recombinant-DNA microorganisms in food. The Working Group cannot decrease its responsibility by altering the title of this document.
The topic of the assessment of the food safety of recombinant-DNA microorganisms in food is next to paramount, only less important than the development of a comprehensive protocol for the food safety assessment of recombinant-DNA in food. The problem of genetic instability and the apparent need for on-going testing is especially vexing and must be addressed before public confidence can be firmly established in recombinant-DNA food.
On the other hand, the narrowed scope has, while demonstrating the scale of need for further policy work, brought considerable clarity to one topic. While not all the implications of the issues have been addressed, such as the apparent need for on-going testing regarding gene instability, the most important issues have been addressed to various degrees.
OTA especially applauds the serious consideration given to unintended effects, and the delineation of the scope of the effects. The consideration of the description and characterization of the recombinant-DNA, recipient microorganism, donor organism, and genetic modification will provide the basis for a workable protocol.
Under item 35, OTA is pleased to see the recognition of the need for information regarding the conservation of the arrangement of the modified genetic material; the recognition of the possibility that genetic modification may change an amino acid sequence’s expression, including the possibility that such modification may affect other sites necessary for that sequence’s anticipated function; the need to test for genetic stability; and especially the recognition that various genes in the recipient may be affected by genetic modification or exchange.
Regarding the safety assessment, OTA is pleased that the various parameters discussed have been identified but cautions against treating the items listed this document as the final enumeration of relevant subjects.