BIO Letter to FDA Commissioner Dr. Henney

September 25, 2000

Dr. Jane E. Henney
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20852

Dear Dr. Henney:

As you are aware, over the past week there have been many news stories about Kraft¡¦s announcement to voluntarily recall its Taco Bell shells from U.S. supermarkets. We believe that consumer confidence in the safety of all food products must be our first and only priority. To that end, BIO strongly supports and is committed to:

1. Ensuring that no grain products improved through biotechnology are brought to the domestic commercial commodity market without full U.S. regulatory approval for both human and animal consumption;

2. Ensuring validated test methods for grain are in place and accessible for use by the grain and food industry;

3. Ensuring appropriate, comprehensive, mandatory regulation by the U.S. Food and Drug Administration (FDA), Environmental Protection Agency (EPA) and U.S. Department of Agriculture (USDA);

4. Ensuring the integrity of environmental stewardship for all products of biotechnology.

We also think it important to keep in mind two facts: First, with Starlink corn not yet having the required regulatory approval for human food use, we do have a serious issue of regulatory compliance in this case; second, there is no evidence of any human health risk involved, and we do expect Aventis will receive human food approval.

In addition, we fully support FDA¡¦s May 3 announcement that calls for a proposed rule to mandate developers of bioengineered foods and animal feeds to notify the agency when they intend to market such products. We are also supportive of consumers having access to product information, as FDA has recommended. BIO is fully in favor of FDA¡¦s proposed plan that submitted company information and the agency¡¦s conclusions be made available to the public, consistent with applicable disclosure laws, by posting them on the FDA web site for easy viewing.

With regard to labeling, BIO completely supports FDA¡¦s plans to draft labeling guidance to assist food manufacturers who wish to voluntarily place claims on their label that their foods are made with or without the use of ingredients derived through biotechnology. The guidelines will help ensure that labels for these products are truthful and not misleading.

We recognize that biotechnology is a dynamic science. Regulations in place have adequately addressed the scientific developments of the first generation of biotech products. As the science develops, refinements to the regulatory process may be necessary and desirable to keep pace with the science and to continue to provide for the safety of the food supply. We look forward to working with you to ensure consumer confidence in the safety of these food products.


Carl B. Feldbaum
Biotechnology Industry Organization
Washington, D.C.