July 10, 2002
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 biopharmaceuticals 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 USDA’s 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.”1
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.”2
The NAS Committee also criticized the USDA’s failure to adequately evaluate and supervise
biopharmaceutical plant field trials, which raises the possibility that past or current test plantings
“Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation,”
Feb. 21, 2002, National Academies' National Research Council, Exec. Summary, p 15.
2
Ibid, p 68.
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have already resulted in undetected contamination of food crops and the environment with
biopharmaceuticals. We agree with the food processing industry’s requests and share the concern
expressed by the National Academy’s 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 doctor’s 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
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Mark Ritchie
President
Institute for Agriculture and Trade Policy
Wendy Wendlandt
National Political Director
cc:
The State PIRGs
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
About the Genetically Engineered Food Alert Coalition:
Genetically Engineered Food Alert advocates that genetically engineered food ingredients or
crops should not be allowed on the market unless: independent safety testing demonstrates
they have no harmful effects on human health or the environment; they are labeled to ensure
the consumer's right-to-know; and the biotechnology corporations that manufacture them are
held responsible for any harm. The campaign is endorsed by more than 250 scientists,
religious leaders, doctors, chefs, environmental and health leaders, and farm groups.
Genetically Engineered Food Alert founding members include: Center for Food Safety,
Friends of the Earth, Institute for Agriculture and Trade Policy, National Environmental
Trust, Organic Consumers Association, Pesticide Action Network North America, and the
State Public Interest Research Groups.
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