USDA Proposes Further De-regulation of GMOs / Take action! (9/9/2007)

1.Take Action on GE Crops!
2.USDA Proposes Further De-regulation of GMOs


1.Take Action on GE Crops!

The U.S. Department of Agriculture (USDA) is considering the adoption of new regulations for genetically engineered organisms. There are several key provisions under consideration by the agency, including a ban on the open-air production of crops that produce drugs and industrial compounds, and the controversial proposal to allow "low level" contamination of conventional crops by unapproved GE varieties. USDA has released a Draft Environmental Impact Statement for public comment.

The proposed changes to the lax federal GE regulatory system provide us with a unique and important opportunity to make our voices heard. Public comments are due by Tuesday, September 11th, 2007!

Pharma and Industrial Crops (Issue 4): Pharma and industrial crops have been genetically engineered as "biofactories" for production of experimental drugs or industrial compounds. USDA currently allows these crops to be field tested with no meaningful assessment of potential harm to human health or the environment. USDA has proposed five alternatives for new regulation of pharming. Alternative 3 prohibits outdoor cultivation of any pharma or industrial crop, food or non-food, while Alternative 4 prohibits only food or feed crops engineered to produce drugs or industrial compounds. The Center for Food Safety supports the more stringent Alternative 3. While prohibition of pharmaceutical-producing food and feed crops would be an important step towards protecting human health, it would still allow untested drugs and industrial compounds to be produced in non-food plants like tobacco, posing potential risks to wildlife and the environment. Therefore, we are calling on USDA to implement a ban on the outdoor production of any crops engineered for production of pharmaceuticals or industrial compounds (Alternative 3 for Issue 4).

Contamination of Food Supply with Unapproved GE Crops (Issue 7): USDA has also proposed changes to the way the agency deals with contamination of the commercial food and seed supply with unapproved GE crops grown in field trials for experimental purposes. USDA refers to such contamination as "low-level" or "adventitious" presence. USDA’s current standards for the field testing of most unapproved GE crops are too lax to prevent such contamination. Previous contamination events have substantially impacted the country’s ability to export certain food crops, like corn and rice, and the failure to contain genetically engineered material from crops has sparked concerns over human exposure to novel allergens and proteins designed for pharmaceutical or industrial uses. Allowing the presence of unapproved GE varieties in the food supply will do nothing to protect American farmers and food companies from lost exports, to say nothing of potential threats to human health and the environment. No unapproved GE varieties should be allowed to contaminate other crops. Instead of sanctioning "low-level" presence, USDA should work to better confine and regulate field trials to protect the public and the environment. Therefore, CFS supports Alternative 4 for Issue 7. Alternative 4 requires stricter confinement standards and would maintain USDA’s authority to take action when contamination does occur. As USDA admits, "This alternative would result in the lowest potential for the presence of regulated materials from domestic field tests in commercial commodities and seeds, short of not allowing any field tests at all."

Send your comments to USDA today!

2.USDA Proposes Further De-regulation of GMOs
The proposed changes make the regulatory regime even more permissive.
Prof. Joe Cummins and Dr. Mae-Wan Ho
ISIS Press Release 08/09/07

This article was submitted to the USDA on behalf of ISIS . Please circulate widely to your policy-makers

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:

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.

Additional Comment

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, ISIS 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.


1.Ho MW. GM contamination at 21 km and farther, no co-existence possible. Science in Society 35, 30-31, 2007.

2.Cummins J and Ho MW. GM food animals coming. Science in Society 32, 24-29, 2006.

3.Cummins J and Ho MW. GM crops and microbes for health or public health hazards? Science in Society 32, 30-33, 2006.

4.Ho MW and Cummins J. Is FDA promoting or regulating cloned met and milk? Science in Society 33, 24-27, 2007.

5.Cummins J. Pharm crops in US market. Science in Society 23, 28-29, 2004.

6.Cummins J and Ho MW. Ban plant-based transgenic pharmaceuticals. Science in Society 23, 29. 2004.

7.Ho MW. No biosecurity without biosafety. Biodefence research endangers the public. Science in Society 26, 44-47, 2005.

8.Yoshimura Y, Beckie HJ, Matsuo K. Transgenic oilseed rape along transportation routes and port of Vancouver in western Canada Environ Biosafety Res. 2006 5(2), 67-75.

9.Saji H, Nakajima N, Aono M, Tamaoki M, Kubo A, Wakiyama S, Hatase Y, Nagatsu M. Monitoring the escape of transgenic oilseed rape around Japanese ports and roadsides Environ Biosafety Res. 2005, 4(4), 217-22.

10. Cummins J and Ho MW. Approval of GM crops illegal, US federal courts rule. Science in Society 34, 24, 2007.

11. Cummins J and Ho MW. Transgenic plum gets USDA non-regulated status based on false claims of safety. Science in Society 35, 35-36, 2007.

12. Ho MW, Cummins J and Saunders PT. GM nightmare unfolding in the regulatory sham. Microbial Ecology in Health and Disease 2007, 19, 66-77.


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