Our decision to follow genetic engineering policy began with a New York Times Op-Ed Sophia shared with us. The piece, “Not Grass Fed, but at Least Pain-Free,” advocated the genetic engineering of livestock to inhibit unpleasant feelings in relation to pain. Frustrated by the postulation of such genetic engineering as a solution to the ills of factory farming, I sought to determine what legislation governed genetically engineered food animals. Upon further research, I discovered that there was, in fact, very little legislation on the subject.
The following article discusses the guidelines for regulation of genetically engineered animals established by the Food and Drug Administration (FDA) on January 15, 2009 (the same as those discussed in Sophia’s 3/25 response): http://www.reuters.com/article/idUSTRE50E6VQ20090115. The FDA will regulate genetically engineered animals under the Federal Food, Drug and Cosmetic Act. The measure defines a drug as “anything that changes the ‘structure or any function’ of a person or animal. The framework requires producers to describe the DNA inserted into the animals, how it behaves in the animal, and its impact on the animal’s health. The product must also be demonstrated not to differ from traditional foods. This framework would require labeling only for significant changes in the food. Consumer groups, in particular, are outraged by the lack of labeling.
The guidelines were subject to a sixty-day period of public comment, which seems to have been well publicized as I found several news articles covering the opening for public comment. In response to some of the 28,000 comments, FDA officials said the new guidelines “would provide a ‘rigorous and predictable science-based framework’ to review genetically engineered animals in a timely and transparent manner.” The new guidelines will exempt some genetically engineered animals (those used for research, not those designed for consumption) from the regulation process, but oblige the FDA to make public any intentions of exemption.
The article frames the legislation as “[bringing] the decades-old technology of genetic engineering for animals one step closer to the dinner table.” Such phrasing emphasizes the topic’s place at the center of the general public’s private lives. The dinner table, after all, serves as the ideological center of the American family, the place where families gather to share in nourishment and stories. Regardless of how the dinner table actually plays out in individual households, its invocation calls upon family values and encourages the public to become involved in the debate.
Much of the fear surrounding genetic engineering arises from the mysterious nature of both the science and the regulation. Although FDA officials claim increased transparency, their public discussions have not covered the process undergone by producers of genetically engineered animals. A news release on the FDA’s website does not cover the specifics of the process, nor the standards that must be met (see http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2009/ucm109066.htm). Instead, the press release focuses on defining genetically engineered animals and suggesting potential benefits. The actual guidelines are not very accessible to the general public either, as the document (meant for producers rather than consumers) is somewhat lengthy and not particularly readable (http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM113903.pdf).
What seems to be missing from both the Reuters article and the FDA press release is a discussion of what the term “guidelines” means in the first place. To quote the FDA’s official document, “Guidance for Industry: Regulation of Genetically Engineered Animals Containing Heritable Recombinant DNA Constructs”: “This guidance represents the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public” (2). The non-binding nature of these guidelines worries me. As with the EPA and other governmental institutions, each president nominates certain individuals to head the FDA. As we have seen with regard to the Endangered Species Act (ESA), these nominations can have far-reaching consequences: President George W. Bush’s nomination for Assistant Secretary of the Interior for Fish, Wildlife and Parks, Julie MacDonald, doctored scientific reports to convey less dire need for the protection of certain species. During Bush’s time in office, species awaiting review were left to sit for much longer than the maximum allotted time. The ESA is federal legislation, yet has been interpreted and implemented (or not) very differently in different administrations. The new FDA guidelines on genetically engineered animals do not even carry the weight of law, but simply reflect the “current thinking” of the administration. “Current thinking” is, inherently, subject to change; what is “current” now may not have been accepted ten years ago and may not be accepted ten years from now. What is to stop the FDA from completely disregarding these guidelines (which imply flexibility in their very name) on genetically engineered animals if federal legislation (which is much more difficult to change and requires certain actions to be taken) is not even properly followed?
(Written by Julia Munson)
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