Pharmaceutical crops pose safety threats

January 22, 2008
U.S. Department of Agriculture
1400 Independence Ave., S.W.
Washington, DC 20250

Dear USDA,

As concerned citizens, and organizations representing scientists, medical and public health professionals, the faith community, consumers and taxpayers, advocates of children and families, farmers and food producers, grocery manufacturers and retailers, and food service professionals, we are deeply concerned that the nation’s food supply and the American public are not adequately protected from accidental contamination and exposure to potentially hazardous compounds in genetically engineered pharmaceutical and industrial crops.

We call on the U.S. Department of Agriculture (USDA) for immediate regulatory action under the Plant Protection Act to prohibit the outdoor cultivation of genetically engineered food crops for the purpose of producing pharmaceutical and industrial chemicals.

WHEREAS food and feed crops including corn, rice, soybeans, and peas are being genetically engineered to produce pharmaceutical drugs, hormones, and vaccines; industrial chemicals such as detergent enzymes, biofuels and plastics, and research chemicals; and specialty foods such as food additives, dietary supplements, and so-called medical foods;[1]

WHEREAS biotechnology companies and land-grant universities are growing these plants, referred to as “pharma/industrial crops,” in areas where food and feed versions of the same crops are grown;[2],[3]

WHEREAS food and feed crop production systems are vulnerable at many points, including during seed production, planting, growing, harvest, storage, and transport, to contamination by pharma/industrial genes via cross-pollination and physical mixing;[4]

WHEREAS a previous incident of food contamination with genetically engineered crops that were unapproved for food use-the StarLink corn incident in 2000-disrupted the U.S. food supply, threatened consumer safety and cost farmers, food processors, and taxpayers tens of millions of dollars to mitigate;[5]

WHEREAS pharma/industrial crops produce compounds that are generally not intended for consumption by the general population, may be biologically active at low concentrations, and may be harmful to people and animals that accidentally ingest them in contaminated food and feed;[6]

WHEREAS food contamination by a pharma/industrial crop has already been narrowly averted in the ProdiGene soybean incident in 2002;[7]

WHEREAS undetected contamination by pharma crop genes is likely to cause even greater disruption of the U.S. food supply chain and the international grain trade, leading to recall of products from the market; loss of farmers’ domestic and export markets; increased costs of retrieving contaminated grain, cleaning grain elevators and processing plants, and testing for contaminants; potential liability claims against farmers, retail food companies, and food processors; and reduced domestic and foreign consumer confidence in the safety of the U.S. food supply;[8]

WHEREAS the benefits of pharma/industrial crops are thus far speculative and may not materialize, and whereas biotechnology and drug companies, not farmers, rural communities, and consumers, are the most likely major recipients of economic benefits if there are any;[9]

WHEREAS the USDA’s Office of Inspector General has found the department’s regulation and oversight of genetically engineered crops in general and pharma/industrial crops in particular to be weak and ineffective,[10] and whereas internal compliance documents recently obtained from the USDA bear out this finding;[11]

WHEREAS preventing contamination of the food supply by pharma/industrial food crops, if it is possible at all, would require substantial changes in the USDA’s oversight of these crops,[12],[13] whereas the USDA is unlikely to successfully establish, monitor, and ensure compliance with a complicated, comprehensive new regulatory system designed to fully protect the food supply, and whereas contamination of the food supply may already have occurred;

THEREFORE, we call on the USDA to protect public health and the American food supply by eliminating the serious food safety threat posed by pharma/industrial food crops. At a minimum, we urge the department to act immediately to:

1. Promulgate regulations prohibiting the outdoor production of food and feed crops genetically engineered to produce pharmaceuticals, industrial compounds, and specialty foods not intended for the general population.
2. Strengthen regulations and oversight of outdoor production of non-food and feed crops genetically engineered for these purposes to completely protect the food supply from contamination and to minimize harm to the environment.
3. In cooperation with the Food and Drug Administration, encourage and fund the development of alternative technologies for safely producing needed drugs, industrial chemicals, and specialty foods in contained systems that do not threaten the food supply and the environment.

Sincerely,

Union of Concerned Scientists

PCC Natural Markets

References:

1. Union of Concerned Scientists (UCS). 2003. Pharm and industrial crops, the next wave of agricultural biotechnology. Cambridge, MA.
2. Union of Concerned Scientists (UCS). Pharma crop database. Accessed online on October 25, 2006.
3. Virginia Polytechnic Institute and State University. Field test releases in the U.S. Information Systems for Biotechnology (ISB) database.
4. Andow, D., H. Daniell, P. Gepts, K. Lamkey, E. Nafziger, and D. Strayer. 2005. A growing concern: Protecting the food supply in an era of pharmaceutical and industrial crops. Cambridge, MA: Union of Concerned Scientists.
5. Taylor, M.R. and J.S. Tick. 2003. Post-market oversight of biotech foods: Is the system prepared? Washington, DC: Pew Initiative on Food and Biotechnology (Pew) and Resources for the Future.
6. Bratspies, R. 2004. Consuming (f)ears of corn: Public health and biopharming. American Journal of Law and Medicine, Vol. 30.
7. Fabi, R. 2002. US foodmakers urge ban on food crops for medicine. Reuters Securities News, November 15.
8. Wisner, R. 2005. The economics of pharmaceutical crops: Potential benefits and risks for farmers and rural communities [and references therein]. Cambridge, MA: Union of Concerned Scientists.
9. Wisner, R. 2005. The economics of pharmaceutical crops [and references therein].
10. Office of Inspector General (OIG), Southwest Region. 2005. Audit report: Animal and Plant Health Inspection Service controls over issuance of genetically engineered organism release permits. Audit 50601-8-Te. Washington, DC: U.S. Department of Agriculture.
11. For more information, including documents released to the Union of Concerned Scientists by the USDA, see: Union of Concerned Scientists (UCS). UCS uncovers lax USDA oversight of pharma crops. Accessed online on October 25, 2006.
12. National Research Council (NRC), Committee on Biological Confinement of Genetically Engineered Organisms. 2004. Biological confinement of genetically engineered organisms. Washington, DC: National Academies Press.
13. Andow, D. et al. A growing concern.