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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 commercial influence.

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 Service (APHIS).

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 their viewpoints.

References

57. STATES DISTRICT COURT FOR THE DISTRICT OF HAWAII CENTER FOR FOOD SAFETY;

KAHEA; FRIENDS OF THE EARTH,INC., and PESTICIDE ACTION NETWORK NORTH AMERICA, Plaintiffs,vs.

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

http://www.centerforfoodsafety.org/pubs/ORDER%208-10-06.pdf

58. Mendelson,J.

Federal Court Orders for the First Time a Halt to New Field Trials of Genetically Engineered Crops 2007

http://www.centerforfoodsafety.org/GTBC_DecisionPR_2_7_07.cfm

59. Rostov,W.

FEDERAL COURT FINDS USDA ERRED IN APPROVING GENETICALLY ENGINEERED ALFALFA WITHOUT FULL ENVIRONMENTAL REVIEW 2007

http://www.centerforfoodsafety.org/Alfalfa_DecisionPR2_14_07.cfm

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