June 6, 2001

Bernard Schwetz, Ph.D. DVM
Acting Commissioner
Food and Drug Administration
5600 Fishers Lane
Rockville, Maryland 20857

Dear Acting Commissioner Schwetz:

I have been following the Food and Drug Administration's investigation of the StarLink affair with great interest ever since the first report of contamination was aired in September of last year. Of particular concern to me is the joint FDA/CDC investigation of allergic complaints allegedly linked to StarLink corn. With continuing reports of the spread of StarLink contamination throughout the food and grain supply, I am sure we agree that protection of public health must be our paramount concern, and that this demands the most rigorous and comprehensive investigation possible into the allergenic risk (if any) posed by StarLink corn.

The Scientific Advisory Panel (SAP) that met on November 28^th, 2000 to consider this question and was dissatisfied with the quality of the information provided to that point. Asked to prioritize the types of information that would be required to better assess the "potential allergenic risk of the Cry9C protein," the SAP's top two demands were:

1) Data on the presence of specific antibodies in individuals who either claim to have experienced adverse effects after consuming food that might have been made from StarLink corn or who have significant occupational exposure to StarLink corn or corn products; and

2) Monitoring of reports from the medical community for individuals who claim to have experienced adverse effects either after consuming food that might have been made from StarLink corn or from occupational exposure to StarLink corn.

To the best of my knowledge, only about 50 people who called the FDA and filed consumer injury reports from late September through late October or November of 2000 have been included in the allergy investigation. This is an extremely small number of reports, and cannot possibly be representative of the exposed population, which probably numbers in the millions. Because this handful of cases is not representative of the exposed population, the results may do little to settle the question of the allergenic risk of Cry9C in the food supply. This is certainly one reason the SAP called for additional monitoring, to "supplement the cases currently under investigation and ... provide additional support for proving or refuting the allergenicity of Cry9C." The SAP also recommended that the medical community be informed of the investigation because corn is rarely allergenic, and so is seldom suspected by most doctors as the potential cause of an allergic reaction.

Yet the FDA already knows of at least 210 people who called various food companies with complaints about allergic reactions to yellow corn products that may have contained StarLink. The true number is almost certainly much higher. This evidence came to light in two submissions to the FDA from the National Food Processors Association (NFPA) and the Grocery Manufacturers of America (GMA). Although both NFPA and GMA claim that there was no increase in allergic complaints received after 9/18/00, a careful examination of the data shows this to be untrue. In fact, the frequency of allergic reports linked to yellow corn reported in the NFPA submission increased 90-fold in the eight weeks following the first report of StarLink contamination on 9/18/00. An analysis of these submissions is attached for your information. These reports should be the starting point for a much fuller and more comprehensive investigation of StarLink's potential allergenic risk that involves at least the following measures:

1) Obtain full records of all allergic complaint reports received by food companies (as reported in the GMA and NFPA submissions) that are related to yellow corn products, and include these people in the ongoing investigation.

2) Ensure that reports of all yellow-corn related complaints registered by food companies since the GMA/NFPA submissions are likewise investigated.

3) Include all allergic complaints possibly related to StarLink that have been received by the FDA since the cutoff date (late November 2000) in the ongoing investigation (see appendix to attached summary).

4) Conduct appropriate outreach to the medical and allergy communities, alerting physicians and food allergy groups (e.g. Food Allergy and Anaphylaxis Network) to the presence of a possibly allergenic corn in the food supply.

5) Given the possibility of inhalational and/or dermal sensitization to StarLink, conduct an investigation into occupational exposure to StarLink corn among seed company and grain mill workers, as recommended by the Scientific Advisory Panel. This investigation should involve sera testing of those workers who complain of allergic reactions that might be linked to StarLink.

6) Set up a monitoring system to route all future yellow-corn related complaints received by food companies, the medical and allergy communities, and occupational health groups to the FDA.

These six measures are all fully compatible with the Scientific Advisory Panel's recommendations cited above.

In addition, we request that you provide answers to the attached list of questions. A matter of such great public interest and import deserves a full public airing. Only in this way can we arrive at the truth and ensure that the public is protected from the presence of potentially dangerous substances in the food supply.

Thank you in advance for your attention to this matter. I look forward to a timely response to my requests. I do believe that a complete response to the concerns raised in this letter and adequate answers to the attached questions should be made before either the FDA or EPA draw any conclusions.

Sincerely,

Congressman Dennis Kucinich