ISIS Press Release 08/09/07
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
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: 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.
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.
References
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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