U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
June 26, 2001

Steve Johnson
Assistant Administrator
Environmental Protection Agency
(MC-7101)
1200 Pennsylvania Avenue, N.W.
Washington, DC  20460

Dear Mr. Johnson:

On June 13, 2001, FDA provided you with several documents reporting on FDA's and CDC's collaborative investigation into the public health significance of consumer complaints of alleged allergic reactions to food that may have contained StarLink^TM corn. At the time the reports and data were submitted to you, one consumer complaint food sample, No. 124952, was still being analyzed. We now have the results of testing this sample for cry9c DNA using the polymerase chain reaction (PCR) method and of testing for Cry9C protein using the EnviroLogix ELISA test kit. An updated table of results is enclosed.

You should note that the reported adverse event associated with sample #124952 occurred outside the time period specified in CDC's case definition (July 1, 2000 through November 30, 2000, as noted in the CDC Report to FDA, Investigation of Human Health Effects Associated with Potential Exposure to Genetically Modified Corn, June 11, 2001, forwarded to EPA on June 13, 2001). Consequently, this consumer complaint report was not included in CDC's field epidemiological investigation.

The addition of the test results for sample No. 124952 completes the report of test results on consumer complaint samples that were collected as of June 12, 2001. I hope this information will help EPA in its efforts to resolve questions about Cry9C.  

Enclosure

cc:
Bill Jordan U. S. Environmental Protection Agency 1200 Pennsylvania Avenue, N.W. Washington, DC  20460

Janet Anderson U. S. Environmental Protection Agency 1200 Pennsylvania Avenue, N.W. Washington, DC  20460

Carol Rubin, D.V.M., MPH Chief, Health Studies Branch Division of Environmental Hazards and Health Effects Centers for Disease Control and Prevention 1600 Clifton Road, N.E., Mail Stop E-23 Atlanta, GA  30333

Michael McGeehin, Ph.D. Director, Division of Environmental Hazards and Health Effects National Center for Environmental Health Centers for Disease Control and Prevention 1600 Clifton Road, N.E., Mail Stop E-23 Atlanta, GA  30333

Karen Deasy, CDC Liaison to FDA, HFS-22

Cliff Gabriel, OSTP

Bernard A. Schwetz, D.V.M., Ph.D., HF-1

Ellen Morrison, HFC-130

Janice F. Oliver, HFS-3

L. Robert Lake, HFS-4

Robert L. Buchanan, HFS-6

James Maryanski, Ph.D., HFS-13

Terry Troxell, Ph.D., HFS-300

Richard Raybourne, Ph.D., HFS-326

Joseph R. Baca, HFS-600

Karl C. Klontz, M.D., FDA, HFS-728

Table 1 Consumer Samples of Processed Food Analyzed for StarLink^TM Corn (June 22, 2001 Update)

FDA Complaint Number	FDA Sample Number	Product	Product Lot Number	PCR Test Result	EnviroLogix ELISA Test Result
Consumer Complaint Reported Adverse Event Occurring Within CDC's Case Definition Time Period a
BLT-5197	65819	Kelloggs Corn Flakes (consumer)	--	Not detected	Not detected
BLT-5197	67988	Kelloggs Corn Flakes (store)	KLC 001	Not detected	Not detected
746	103311	Kraft Taco Bell Brand Taco Shells	07DEC002XSB7	Not detected	Not detected
SAN-2578	103968	La Cumplidora Corn Tortilla, non-consumed home made chicken enchilada	--	Not detected	Not detected
136	104671	Don Pancho Authentic Mexican Foods Corn Tortillas	Consumer removed lot code	Not detected	NT b
275	105055	Santitas White Corn Tortilla Chips	Dec51.7913229055	Not detected	Not detected
SEA-7552	107254	Kraft Taco Bell Brand Home Style Originals	09NOV001XSB7	Not detected	Inconclusive c
480	110194	Doritos Nacho Cheese Flavored Tortilla Chips	56525214/DORI-0014C**2379	Not detected	Not detected
765	110939	Tyson Mexican Original Enchilada Style Corn Tortilla	Use by Nov 02 00 506	Not detected	Not detected
291	117019	Kelloggs Crispix Cereal	2001 KLC 007 Exp. 7/31/01	Not detected	Not detected
Consumer Complaint Reported Adverse Event Occurring Outside CDC's Case Definition Time Period
3228	124952	KASH N' KARRY White Corn Tortilla (Chips) from Grocery Store d	May2301HAS	Detected	Not detected
CDC's case definition time period is July 1, 2000 through November 30, 2000. NT: Not tested using the EnviroLogix ELISA kit because no sample remained. Inconclusive: Close to the estimated level of detection. The inter-laboratory validation study did not address this specific region. Consumer's product was not available to FDA. FDA collected the same product with a different lot number from a grocery store.

Hypertext updated by dav/dms/ear 2001-NOV-26