The proposed changes make the regulatory regime even more permissive. Prof. Joe Cummins and Dr. Mae-Wan Ho
The United States Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) has proposed changes to regulations on Introduction of Organisms and Products Altered or Produced Through Genetic Engineering, available for public comment before 11 September 2007 at: http://www.regulations.gov/fdmspublic/component/main.
APHIS is seeking public comment on its draft environmental impact statement (DEIS) presenting alternatives in a series of questions. The questions and our answers are given below.
Question 1: Should APHIS continue to regulate GE [genetically engineered] organisms solely on the basis of potential risks as plant pests, or should they also be regulated based on other potential risks such as those for noxious weeds and biological control organisms?
Answer: APHIS should more realistically take into account the risk of transgenic contamination of crops and weedy relatives of the crops. The detrimental economic impact of transgenic contamination as well as the toxic potential, especially of pharmaceutical products or transgenic biopolymers, must be evaluated. Crops modified with genes to enhance energy production may genetically contaminate food crops. Finally, transgenic contamination should be treated as any other environmental pollution. APHIS should take into account the strong evidence that transgenic contamination is unavoidable [1] (GM Contamination At 21 km and Farther. No Co-Existence Possible, SiS 35)
Question 2: Should a new system of risk-based permit categories be designed to deal with new products and new concerns?
Answer: It is imperative that crops such as food crops modified to produce pharmaceutical proteins or crops destined for energy production should be evaluated by criteria that are different from those of food crops in recognition that the transgenes pose unique dangers to health. The same applies to transgenic/cloned animals or genetically engineered bacteria modified for food/pharmaceutical purposes [2-4] (GM Food Animals Coming, GM Crops and Microbes for Health or Public Health Hazards? , SiS 32; Is FDA Promoting or Regulating Cloned Meat and Milk? SiS 33). In the case of transgenic and cloned animals, animal health and welfare must be included as part of the risk assessment. In the case of GM bacteria, the risks of horizontal gene transfer are the greatest.
Question 3: Should APHIS continue to accommodate commercialization but in some cases grant conditional approvals when additional information is needed about particular regulated articles proposed for deregulation?
Answer: Definitely not. Conditional approval of transgenic crops is a terrible idea. The current system of field test releases include very large test areas, and even allows for commercial production of high value products such as pharmaceutical proteins produced on the test site [5] (Pharm Crop Products In US Market, SiS 23) . This needs to be brought under stricter regulation rather than the relaxed scheme proposed.
Question 4: Should APHIS modify its rules for regulating and confining plants producing pharmaceutical and industrial compounds?
Answer: APHIS should stop approving any open releases of such plants [6] (Ban Plant-based Transgenic Pharmaceuticals, SiS 23) as transgene contamination is unavoidable [1].
Question 5: Should APHIS regulate nonviable plant material derived from regulated plants?
Answer: There is in a sense no nonviable plant material in the case of GE plants, as the GE DNA survives the plant and can be transferred horizontally to practically all species, in dust and debris from transgenic crops and the processed products of transgenic crops.
Question 6: Should there be a new mechanism to provide oversight for pharmaceutical plants?
Answer: Here to fore plants modified to produce pharmaceutical proteins have not yet been approved for commercial production in NorthAmerica nor in Europe . Commercial production of crops such as rice or safflower modified to produce pharmaceutical proteins has been permitted in South America . These plants must not be released into the open environment, but should be strictly contained in sealed greenhouses with pollen traps, to prevent transgene contamination of air, water and soil [6].
Question 7: Should low-level occurrence of a regulated article be exempted from regulation?
Answer: Definitely not. Low-level contamination with regulated articles should not be permitted, as unlike chemical contamination, transgene contamination has the potential to grow. The articles regulated must remain so at any detectable level.
Question 8: Should low-risk organisms intended for importation for a nonpropagative use be exempted from regulatory review or be subject to expedited review?
Answer: The presumption of ‘low-risk’ is highly questionable. Lethal pathogens have been created ‘accidentally’ on that presumption, and importation for contained use in research laboratories have a habit of leaking out [7] ( No Biosecurity without Biosafety SiS 26). What may be at issue here are genetically modified crops imported from other countries for food, feed or processing. Japanese researchers found that modified canola imported for oil extraction were spilled along the transport corridors from dock to processing plant and took root in the soil of Japan [8, 9]. They further found that the transport corridors from the production area to the dock in Canada were similarly polluted with modified canola. The Japanese report should be taken seriously and point out that imported transgenic material is bound to genetically pollute the country importing the crops. The low risk organisms fantasized by APHIS simply do not exist.
Question 9: Should interstate movement of GE Arabidopsis or other GE organisms be exempted from movement restrictions?
Answer: No, they should not be exempted, for reasons given in answer to Question 8.
Question 10: Should APHIS consider relieving other regulatory requirements when the environmental risk is low?
Answer: APHIS’ criteria on regulation are so low that they cannot go any lower. One should be reminded that USDA has lost multiple lawsuits to civil society within the past year over its regulation of GM crops [10], which has been deemed inadequate (Approval of GM Crops Illegal, US Federal Courts Rule, SiS 34).
Question 11: Should APHIS switch from prescriptive packaging-container requirements to performance-based ones?
Answer: Packaging was discussed in the APHIS document but there was little specific information provided regarding the actual; packages. APHIS raises the spectre that packaging would be deregulated except for special cases, that proposal is premature and a threat to the environment.
APHIS has not dealt with an important conflict of interest in their regulation of transgenic crops. That conflict of interest flows from the fact that USDA both financially benefits from its patents on modified crops and promotes modified crops. For example, APHIS granted the petition for deregulation of transgenic plums, even though an overwhelming majority of the public comments submitted went against the petition and there were outstanding safety concerns against deregulation [11] (Transgenic Plum Gets USDA Non-regulated Status Based on False Claims of Safety, SiS 35).
This is the time for APHIS to put its house in order or hand the regulatory duty to an independent and unbiased agency, one incorporating representatives of the public including critics of transgenic crops as well as those creating and promoting them.
Since 1999, I-SIS has submitted close to 40 detailed objections to US regulatory agencies, mostly addressed to the USDA/APHIS. We are extremely concerned over the regulatory regime on both sides of the Atlantic, where the precautionary principle is routinely ignored, science is manipulated and corrupted, and the law sidestepped in efforts to promote genetically modified organisms (GMOs) in the face of massive public opposition and damning evidence piling up against the safety of GM food and feed. We have summarized these concerns in a recent scientific publication [12] GM Food Nightmare Unfolding in the Regulatory Sham (Ho MW, Cummuns J and Saunders PT, Microbial Ecology in Health and Disease 2007, 19, 66-77), which is enclosed with this submission.
Article first published 08/09/07
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