Comments to USDA’s Animal and Plant Health Inspection Service Regarding the Agency’s Draft Programmatic Environmental Impact Sta
Comments of the Competitive Enterprise Institute<?xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" />
to USDA’s Animal and Plant Health Inspection Service
Regarding the Agency’s Draft Programmatic Environmental Impact Statement regarding the Introduction of Organisms and Products Altered or Produced Through Genetic Engineering
Docket No. APHIS–2006–0112
72 FR 40,111 (July 23, 2007)
I appreciate the opportunity, on behalf of the Competitive Enterprise Institute (CEI), to submit these comments regarding the USDA/APHIS draft Programmatic Environmental Impact Statement regarding the Introduction of Organisms and Products Altered or Produced Through Genetic Engineering.
CEI is a non-profit research and advocacy organization, and for over two decades it has been extensively involved in issues of plant and animal biotechnology and other issues of public health and environmental protection. For the past ten years, my own research at CEI has been focused extensively on issues related to recombinant DNA technology and the safety of products developed with it. I was therefore encouraged to find that USDA/APHIS has set a goal of developing a “science-based system” (p. 17) for the regulation of genetically engineered plants. Unfortunately, the proposals set forth in the draft PEIS would not accomplish that goal.
During the past three decades, numerous scientific bodies – including the U.S. National Academies of Science, the American Medical Association, the World Health Organization, and dozens of others – have studied the potential risks of recombinant DNA-modified (or genetically-engineered) plants and have concluded that:
- The risks associated with the introduction of recombinant DNA-modified organisms are the same in kind as those associated with the introduction of unmodified organisms and organisms modified by other methods;
- Recombinant DNA-modified plants typically present both a high degree of “familiarity” and a greater degree of certainty about genetic changes than do plants bred with more conventional techniques; and
- Assessment of the risks of introducing recombinant DNA-modified organisms into the environment should be based on the nature of the organism and of the environment into which the organism is to be introduced, and independent of the breeding methods used.
All types of plant breeding – including traditional techniques as well as recombinant DNA methods – routinely introduce new DNA, proteins, and other substances into food crops. The very purpose of plant breeding is to alter the genotype and phenotype of plants. Yet, countless scientific societies agree that the risks associated with plant breeding typically are minimal and can be managed effectively, whether or not rDNA techniques were used. This is not to suggest that plant breeding is risk-free. What matters, though, is not how a new plant variety was developed, but what characteristics the plant variety expresses. As the U.S. National Research Council concluded in its 2004 report, Safety of Genetically Engineered Foods, “assess[ing] products based exclusively on their method of breeding is scientifically unjustified.” (p. 180).
Despite this long-standing consensus of the scientific community that risk is a function of a plant’s characteristics, and not how the plant was bred, USDA/APHIS has since 1987 maintained a scientifically indefensible regulatory apparatus under its “plant pest” authority in which heightened regulatory scrutiny is triggered solely on the basis of whether or not a new plant variety was bred using rDNA techniques. It is therefore disappointing to see that the draft Programmatic Environmental Impact Statement would not rectify this unjustifiable focus on rDNA techniques. Instead, the document would entrench and expand the existing scheme by proposing to regulate genetically engineered plants and non-viable materials under USDA’s “noxious weed” authority.
In some ways, it is encouraging that USDA/APHIS will consider excluding from its regulations “specific classes of highly familiar organisms and highly domesticated, nonweedy crop plants,” (p. 25) as well as establishing “a tiered permitting system” that applies lesser scrutiny to products expected to pose lower risk. Perhaps this is a tacit recognition that basing regulatory oversight on the use or non-use of rDNA is inappropriate and to carve out small classes for more rational treatment? Still, as long as USDA/APHIS maintains a regulatory apparatus in which use of recombinant DNA techniques serves as a trigger for heightened regulatory oversight, it will fail to have a science-based regulatory system; it will inappropriately allocate public resources to the examination of products posing negligible risk; and it will needlessly raise the cost of research and development while failing to advance consumer or environmental safety.
Instead, regulatory efforts should be redirected to focus oversight on new organisms that express characteristics likely to pose significant risk, regardless of the methods used in their development, while leaving relatively low-risk traits of both classical and molecular genetic modification unburdened by costly regulation. This would re-focus limited public resources on those products that are most likely to pose a genuine risk. Such a regulatory approach would also free many negligible risk products from unnecessarily strict oversight and allow them to be placed on the market sooner, where they can begin to benefit consumers and the environment. Focusing only on recombinant DNA techniques, and treating all gene-spliced products as though they are uniquely risky, is counterproductive and does more harm than good.
Competitive Enterprise Institute
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September 11, 2007