NGFA Supports FDA on Biotech Rules

May 8, 2001

The National Grain and Feed Association has said it generally supports the Food and Drug Administration's proposed rules that would formalize its procedures for reviewing and approving plant-derived biotech foods and feed intended for use in humans or animals.

The NGFA supported the FDA's proposal to require that technology providers formally submit data and information concerning new plant-derived biotech commodities at least 120 days prior to the scheduled "commercial distribution" of such products. Presently, such a procedure is voluntary, although FDA and the biotech industry say that all foods or feeds containing biotech ingredients have undergone a voluntary consultation process with FDA prior to entering the market.

But the NGFA urged the agency to amend its proposed rule to clarify that the production and distribution of biotech seed would not be permitted until FDA has officially approved the commodity so as to prevent the premature release of such seed. In its proposed rule, FDA had defined commercial distribution to apply to commodities that are intended for sale or exchange for consumption in any form by humans or animals, which the NGFA said could be misinterpreted as not applying to seed because it is not in a form that is consumable.

The NGFA supported FDA's proposed conditions under which the agency would require pre-market notification by biotech providers. Specifically, FDA proposed that such prenotification be required for any bioengineered food or feed, including those derived from a new plant variety modified to contain a pesticidal substance (such as Bt) unless each of the following conditions had been met:

1) The bioengineered food or feed is derived from a plant line that represents a biotech transformation event that already has been approved as part of a previous pre-market notification;

2) The use or application of the bioengineered food or feed has been addressed in a previous notification;

3) FDA has sent the biotech provider a letter stating that the agency has evaluated the use or application of the bioengineered food or feed, and has no questions about it. Foods and feeds containing biotech ingredients that already have been introduced into the market would not be subjected to the new pre-market notification requirement, according to the FDA proposal, so long as they have been addressed satisfactorily under the existing voluntary consultation process.

The NGFA also supported FDA's proposal to give itself the option to extend its evaluation period by another 120 days, which would amount to a maximum 240-day review period. But the NGFA urged the agency to clarify that the bioengineered food/feed would not be allowed to be released or marketed during the entirety of the review process, which would culminate with the issuance of an official letter of approval from FDA. In its proposed rule, FDA said only that it would "expect" that biotech foods or feed would not be marketed during the review period.

NGFA also urged FDA to amend its final rule to:

· deny future approval to biotech events for commercial release unless they are approved for both food and feed use. This would prevent the so-called "split" registration that occurred for Aventis CropScience USA's StarLink* corn, which was approved for use in feed and industrial products, but not for human food; and

· require biotech commodities developed for non-food or feed uses (such as industrial-use products or those with medicinal properties) to undergo the same mandatory pre-market clearance process because of concerns over cross-pollination and the inability of biotech companies to ensure strict segregation of such crops, as occurred with StarLink. The NGFA said such a policy is necessary to avoid future market disruptions and preserve U.S. access to the broadest array of world consumers.

The NGFA also urged that FDA require that providers of future biotech events not approved for use in food or feed prove that they have implemented a rigorous identity-preservation system that ensures strict segregation of the products to keep them separate from the commodity stream.

In addition, the NGFA took the opportunity to encourage FDA to work with the Environmental Protection Agency and U.S. Department of Agriculture to require that there be a commercially available test capable of detecting the biotech event(s) in a quick, accurate, affordable and repeatable manner before the commodity intended for use in bioengineered food or feed is approved for commercial release.