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[SANET-MG] comments on the Ventria application for a large "field test" of humaized rice
The information below is my comment on the Ventria EA on their humanized
rice trial. USDA appears to presume that "mere legalities" may be
ignored by a large government department. They should stop granting
field trials and allowing GM crops to be deemed to be unregulated until
the approval procedures are thoroughly reviewed , preferably from
outside USDA. The relatively short period allowed for public input
related to environmental releases of pharm crops recently , suggests
that the department may be taking on a Hitler Bunker outlook rather than
honestly reviewing their procedures and practices.
30 March 2007
Professor Joe Cummins
The Institute of Science in Society
Comments on Field Tests of Rice Modified with Human genes
Ventria Bioscience; Availability of an Environmental Assessment for
Field Tests of Rice Genetically Engineered To Express Lactoferrin,
Lysozyme, or Serum Albumin DEPARTMENT OF AGRICULTURE Animal and Plant
Health Inspection Service [Docket No. APHIS-2007-0006]
The Court Cases described below indicate that USDA/APHIS had flouted the
law in approving field trials and petitions for genetically modified
crops. Until the court cases are finally resolved or USDA/APHIS
undertakes a system of truly independent assessments the there should be
a moratorium on new approvals until these vital issues are resolved. The
current application is not adequate to protect the environment ,
particularly, wild animals and the health of humans exposed to the
humanized rice. USDA/APHIS should stand down until they have insured
monitoring and approval are full, truthful and truly independent of
US Court Cases Recognize That GM crop Field Testing and Releases are Illegal
Three court cases recently addressed the open field testing and the
approval of genetically modified crops. United States district courts
examined the procedures used by USDA to evaluate the impact of the
release of genetically modified GM crops on the environment and
endangered species. In all three cases the USDA evaluations of the GM
crops were found to be defective rendering the original releases illegal.
The first case was heard in US District Court in Hawaii. The plaintiffs
were the Center for Food Safety, KAHEA: The Hawaiian-Environmental
Alliance, Friends of the Earth and the Pesticide Action Network, North
America. The defendants were the US Secretary of Agriculture and
administrators of the USDA.
From 2001 to 2003, four companies ProdiGene, Monsanto, Hawaii
Agriculture Research Center (HARC), and Garst Seed -- planted corn and
sugarcane that had been genetically modified to produce experimental
pharmaceutical products. The companies modified the genetic structure of
the corn or sugarcane so that, when harvested, the plants would contain
hormones, vaccines, or proteins that could be used to treat human
illnesses. For example, one company engineered corn to produce
experimental vaccines for the Human Immunodeficiency Virus and the
Hepatitis B virus, while another company engineered corn and sugarcane
to produce cancer-fighting agents. These techniques are still
experimental, and from 2001 to 2003 these four companies conducted field
tests of these genetically engineered pharmaceutical producing plant
varieties on Kauai, Maui, Molokai, and Oahu. ProdiGene, Monsanto, HARC,
and Garst Seed received permits to plant these crops from the United
States Department of Agriculture, Animal and Plant Health Inspection
The Plaintiffs argue that USDA/ APHIS broke the law in issuing these
permits. Because these crops produce experimental pharmaceutical
products, the Plaintiffs argue, their effect on Hawaii’s ecosystem
(especially Hawaii’s 329 endangered and threatened species) is unclear.
The Plaintiffs contend that these experimental crops could
cross-pollinate with existing food crops, thus contaminating the food
supply. The Plaintiffs also argue that animals that feed on corn (as
well as animals further up the food chain that feed on corn-eating
animals) would become unwitting carriers of experimental pharmaceutical
products, causing even more widespread dissemination of these
experimental vaccines, hormones, and proteins. According to the
Plaintiffs, APHIS was required to evaluate the environmental impact of
these genetically engineered crops before issuing the permits. In
failing to do so, the Plaintiffs argue, APHIS violated both the National
Environmental Policy Act (“NEPA”) and the Endangered Species Act (“ESA”).
Based on the administrative record, the court concludes that APHIS’s
issuance of the four permits -- without an EA, an EIS, or an explanation
as to why neither an EA nor an EIS was required -- was arbitrary and
capricious. Furthermore, as explained in the following section, APHIS’s
issuance of the four permits without considering the exceptions to the
applicable categorical exclusion was also arbitrary and capricious and
an unequivocal violation of a clear congressional mandate. (57).
The second decision was filed in Federal Court in Washington DC The
federal lawsuit was filed by the Center for Food Safety,
Klamath-Siskiyou Wildlands Center and other individuals and
organizations in 2003. In 2007 the court ruled a halt top field trials
of genetically modified crops. The decision required more rigorous
environmental reviews of such trials. Past trials of GM creeping bent
grass led to widespread dispersal of pollen from the GM grass USDAs
approval of bent grass trials was ruled illegal (58).
A third decision , filed in the Northern California US District Court,
by the Center for Food safety along with environment activists, seed
producers and farmers found that GM alfalfa had been approved for
commercial release illegally because there had been no full
environmental review of the GM alfalfa prior to its commercial release.
The court found that concerns that the GM alfalfa will contaminate
normal and organic alfalfa were valid and that USDA’s counter claims
were not convincing and do not demonstrate the hard look required by
federal environmental laws. The court required a full environmental
review prior to release of the GM alfalfa (59).
In the court cases described *above USDA flouted the law and
disregarded* human and environmental of their approvals of the GM crops.
Generally it is safe to say that approval of GM crops in USA and in
Canada has been haphazard and has lead to extensive pollution of non-GM
and organic crops. Court actions may help to insure that rigorous
environmental reviews precede field tests and commercial releases of GM
crops.. However, the failure to identify the location and the exact
nature of GM crops being tested must be addressed along with the
frivolous use of Confidential l Business Information designations to
avoid disclosing information essential for safety evaluation.
Finally, a fundamental problem that must be addressed is the bias of
regulators towards dispersal of the GM crops. The regulatory regimes
draw from a pool of scientists and technicians who are blindly
uncritical of the technology behind GM crops and full prepared to flout
the law to further the commercial spread of GM crops. There should be a
clean sweep of the regulatory regimes and the imposition of balanced
review panels. Currently, public input provides a form of balance, but
the public input is , for the most part, ignored during the review
process. Regulators simply ignore the input on any but those supporting
57. STATES DISTRICT COURT FOR THE DISTRICT OF HAWAII CENTER FOR FOOD SAFETY;
KAHEA; FRIENDS OF THE EARTH,INC., and PESTICIDE ACTION NETWORK NORTH
MIKE JOHANNS, Secretary, U.S.Department of Agriculture; WILLIAM
T. HAWKS, Under Secretary of Agriculture for Marketing and
Regulatory Programs; BOBBY R.ACORD, Deputy Administrator, U.S.
Department of Agriculture, Animal and Plant Health Inspection Service
and CINDY SMITH, Deputy Administrator, U.S. Department of
Agriculture, Animal and Plant Health Inspection Service, Biotechnology
Regulatory Services Program, Defendants.
Case 1:03-cv-00621-JMS-BMK Document 247 Filed 08/10/2006
Federal Court Orders for the First Time a Halt to New Field Trials of
Genetically Engineered Crops 2007
FEDERAL COURT FINDS USDA ERRED IN APPROVING GENETICALLY ENGINEERED
ALFALFA WITHOUT FULL ENVIRONMENTAL REVIEW 2007
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