Letter sent to USDA demands an end to open-air cultivation of biopharm crops

Ann M. Veneman
Secretary, U.S. Department of Agriculture
1400 Independence Avenue SW
Washington DC 20250

Re: Avoiding Food Contamination and Environmental Harm by Crops Engineered with Biopharmaceuticals and Biochemicals

Dear Secretary Veneman:

In the Fall of 2000, the discovery of genetically engineered StarLink corn in the American food supply found the Food and Drug Administration unprepared to test for contamination by engineered crop varieties found unacceptable for human consumption. This led Kraft Foods on September 22, 2000 and the Grocery Manufacturers Association on May 3, 2001 to request that the FDA develop the means to test for the presence of all engineered varieties before they are approved for entry into the market.

Food processors also called for an end to the practice of "split approvals" -that is, authorization to cultivate and market crops that are approved only for animal consumption, but not human consumption -- as a precaution against contamination of the human food supply with potentially unsafe ingredients. Yet today, dozens of crops engineered with biopharma-ceuticals and biochemicals not approved for human consumption are being grown nationwide.

On February 21, 2002, the Committee on Environmental Impacts Associated with Commercialization of Transgenic Plants of the National Academy of Sciences (NAS) wrote in a review of the USDA¹s Animal and Plant Health Inspection Service that:

"The production of non-edible and potentially harmful compounds in crops such as cereals and legumes that have traditionally been used as food creates serious regulatory issues. With few exceptions, the environmental risks that will accompany future novel plants cannot be predicted."

and,

"Likewise, it is possible that crops transformed to produce pharmaceutical or other industrial compounds might mate with plantations grown for human consumption, with the unanticipated result of novel chemicals in the human food supply."

The NAS Committee also criticized the USDA¹s failure to adequately evaluate and supervise biopharmaceutical plant field trials, which raises the possibility that past or current test plantings have already resulted in undetected contamination of food crops and the environment with biopharmaceuticals. We agree with the food processing industry¹s requests and share the concern expressed by the National Academy¹s expert committee. Therefore, we recommend that the USDA take the following additional steps to protect the American food supply and environment:

1) Stop granting permits for open-air cultivation of all crops genetically engineered with biopharmaceuticals (such as vaccines), industrial chemicals, or other substances with potential human health impacts. Crops engineered with industrial biochemicals are not approved for human consumption. Crops engineered with drugs are, at best, approved for consumption only by people with a doctor¹s prescription.

2) Allow, at most, the genetic engineering of chemicals or biopharmaceuticals into those non-food crops that do not pose the risk of food contamination. The USDA has issued "split approval" permits allowing cultivation of ten food crops engineered to produce biopharmaceuticals or chemicals that are not approved for general human consumption in more than 300 field trials conducted across the country from Hawaii, to Iowa, to Florida. The USDA should end this practice to ensure that these substances never enter the human food supply.

3) Require non-food crops engineered with chemicals or biopharmaceuticals to be cultivated indoors and establish a tracking system governing the handling and disposal of byproducts to prevent environmental contamination. As there has been virtually no study of the environmental toxicity and persistence of biopharmaceuticals and chemicals engineered into plants, it is irresponsible to permit their open-air cultivation.

4) Explore contained alternatives to open-air biopharming for production of biopharmaceuticals. In addition to currently used techniques such as bacterial, yeast and mammalian cell cultures, plant cell cultures and rhizosecretion (secretion of biopharmaceuticals from plant roots) show much promise. Unlike biopharming, these methods are conducted in controlled production facilities, and so do not present the risk of contamination.

We request that the USDA act promptly on these recommendations and reply in writing with a description of how the agency plans to respond.

Sincerely,

Larry Bohlen
Director, Health and Environment Programs
Friends of the Earth

Ronnie Cummins
National Director
Organic Consumers Association

Ellen Hickey
Director of Research and Communications
Pesticide Action Network (PAN) North America

Joseph Mendelson, III
Legal Director
The Center for Food Safety

Matt Rand
Campaign Manager for Biotechnology
National Environmental Trust

Mark Ritchie
President
Institute for Agriculture and Trade Policy

Wendy Wendlandt
National Political Director
The State PIRGs

cc: Craig A. Reed, Administrator, Animal and Plant Health Inspection Service, USDA

William T. Hawks, Undersecretary for Marketing and Regulatory Programs, USDA

Bernard A. Schwetz, Acting Principal Deputy Commissioner, FDA

Joseph A. Levitt, Director, Center for Food Safety and Applied Nutrition, FDA

Lloyd R. Lake, Director, Office of Regulations and Policy, Center for Food Safety and Applied Nutrition, FDA

Christine Todd Whitman, EPA Administrator

Stephen L. Johnson, Assistant Administrator for Prevention, Pesticides and Toxic Substances, EPA