USDA Considers Pharma/Industrial Crop Oversight Changes
Through lax regulations, weak enforcement, and a total lack of public accountability, the U.S. Department of Agriculture (USDA) has exhibited a miserable track record in regulating genetically engineered (GE) crops—including food crops like corn and safflower that are engineered to produce drugs and industrial chemicals (pharma/industrial crops). UCS analysis has demonstrated that these crops are likely to end up in our food supply without stronger regulations. Now, the USDA is considering changes to its weak regulations.
In a draft programmatic environmental impact statement (EIS) published in the Federal Register on July 17, 2007, the USDA outlined 10 areas of its agricultural biotechnology regulatory program in which it is contemplating rule changes. Oversight of pharma/industrial crops is perhaps the most important of these areas from a food safety perspective.
With the release of the draft EIS, the USDA has kicked off a multi-step process that will end with the promulgation of new regulations for GE organisms used in U.S. agriculture for the foreseeable future. The USDA is considering the public comments it received in response to the July 2007 EIS. UCS joined food companies and others in advocating for an end to outdoor production of pharma/industrial substances in food crops. The department will next prepare a final EIS and propose new rules based on the alternatives it has selected. Those rules will be available for a new round of public comment, after which the agency will issue final rules. It appears as though the agency is aiming to complete the rule-making process by the end of 2008.
Summary and analysis of USDA question and options regarding pharma/industrial crops
QUESTION [Issue 4 in draft EIS]: Are there changes that should be considered relative to environmental review of, and permit conditions for, genetically engineered plants that produce pharmaceutical and industrial compounds?
The USDA's discussion under this question makes clear that the department considers its current oversight both appropriate and successful in ensuring the safety of outdoor releases of pharma/industrial crops (Draft EIS, pp. 31-32). Despite its conviction that the current process is adequate, the USDA notes that "it has been suggested that plants engineered to produce substances not intended for food use, as handled under [its] current regulatory system, pose unacceptable risks to human health, the environment, and to trade" (Draft EIS, p. 32).
Apparently responding to outside pressure, the draft EIS offers four alternatives more stringent than the current approach.
Alternative 1: No Action - Continue to allow food and feed crops to be used for the production of pharmaceutical and industrial compounds and to allow field testing under very stringent conditions.
The current program, or Alternative 1, requires companies to go through a permitting process before they are allowed to grow pharma/industrial crops outdoors. Under the process, the USDA may or may not evaluate the risks of outdoor production in an environmental assessment (EA) that it releases for public comment. Whether or not it prepares an EA, the agency then approves the outdoor production and grants a permit laying out conditions that developers must meet before, during, and after production.
UCS has concluded that the current oversight is woefully inadequate to prevent contamination. Recent incidents involving unapproved (non-pharma) varieties of GE rice in particular reveal that the USDA's status quo is insufficient to prevent contamination of the food supply.
Alternative 2: Continue to allow food and feed crops to be used for the production of pharmaceutical and industrial compounds. The agency would impose confinement requirements, as appropriate, based on the risk posed by the organism and would consider food safety in setting conditions.
This alternative is a variation on the existing regulatory scheme, and it is the USDA's preferred option. UCS rejects Alternative 2 because we believe this slight tweaking of the USDA's current program is unlikely to prevent contamination.
Alternative 3: Do not allow crops producing substances not intended for food uses to be field tested, that is, these crops could be grown only in contained facilities.
Alternative 3 is a significant departure from the current program, and would ban the outdoor production of all GE pharma/industrial crops. As such, it is the most stringent of the five proposed options. UCS believes that Alternative 3 could protect the food supply from contamination by pharma/industrial food crops, but we advocate a ban with a somewhat narrower scope for reasons outlined below.
Alternative 4: Allow field testing only if the crop has no food or feed uses.
Alternative 4 is a ban on the outdoor production of food and feed crops for pharmaceutical and industrial purposes. It is less stringent than Alternative 3, as it would allow the outdoor production of pharma/industrial compounds in crops that are not used for food or animal feed, such as tobacco and jojoba.
UCS strongly recommends that the USDA adopt this approach, as we believe a ban is the only way to achieve complete protection of the food supply from contamination by drugs and industrial chemicals. Though less stringent than the ban in Alternative 3, this approach would focus a highly effective solution on the crops that pose the risks of greatest concern to the most stakeholders. Moreover, if the claims of pharma/industrial crop companies that their products will eventually provide societal and consumer benefits is true, permitting outdoor production of non-food crops would allow pursuit of those benefits. Many other stakeholders—the food industry, consumer groups, and the public—have voiced their opposition to the outdoor use of pharma/industrial food crops.
Alternative 5: Allow field testing of food/feed crops producing substances not intended for food uses only if food safety has been addressed.
The USDA's description of Alternative 5 is vague, and it is unclear from the draft EIS exactly how food safety would be addressed, and by what agency. Would the USDA itself conduct food safety assessments, or would it ask the Food and Drug Administration (FDA) to do this? Although the FDA has an existing procedure for early food safety assessment of GE crops, UCS believes this procedure is weak, and we therefore reject this alternative as inadequate to ensure food safety.
