Comments to APHIS on Draft Environmental Impact Statement

Secretary Mike Johanns

Docket No. APHIS-2006-0112

U.S. Department of Agriculture's Animal and Plant Health Inspection Service

Regulatory Analysis and Development, PPD

APHIS, Station 3A-03.8

4700 River Road, Unit 118

Riverdale, Md. 20737-1238

Re: Comments on the Programmatic Environmental Impact Statement Docket No. APHIS-2006-0112 on Introduction of Organisms and Products Altered or Produced Through Genetic Engineering

The Sierra Club is submitting comments on the USDA Draft Environmental Impact Statement (DEIS) due to concerns about serious scientific gaps and regulatory flaws in the proposal. The Sierra Club represent 750,000 members nationwide and has a vital public interest in the future releases of new genetically engineering organisms into the environment and the exceptionally poor scientific basis and weak regulatory oversight that the Department of Agriculture persists in pursuing a fast pace in approving and deregulating genetically engineered crops. The agency, for example, is heavily responsible for its regulatory role in the numerous cases of genetic contamination by new genetically engineering organisms impacting American agriculture since the 1990s and continuing to occur in 2007.

The Biotechnology Regulatory Services (BRS), a program within the U.S. Department of Agriculture's (USDA) Animal and Plant Health Inspection Service (APHIS), is responsible for regulating the introduction-meaning the importation, interstate movement, and environmental release-of genetically engineered (GE) organisms. Finally APHIS has made available a draft environmental impact statement (EIS) that evaluates potential revisions to existing regulations regarding the importation, interstate movement and environmental release of genetically engineered (GE) organisms. During the past 15 years, APHIS has been reviewing and revising its biotechnology regulations in attempting to ensure what APHIS views as being "grounded in the latest science and are robust enough to keep pace with the demands of technology", but the unfortunate reality is that APHIS has failed to apply the best available science in its review of new GE crops.

In January 2004, APHIS publicly announced it was beginning a review of its regulations and published a notice of intent to prepare an EIS. The notice identified potential issues and alternatives to be studied in the EIS and requested public comment to further shape the scope of the issues and alternatives. The draft EIS outlines several key areas APHIS is evaluating and seeking public comments on, including expanding APHIS' regulatory scope through additional provisions in the Plant Protection Act (PPA) of 2000, utilizing a tiered permitting system based on potential environmental risk and implementing a process for continued oversight of crops that do not meet the criteria for deregulation. Input received regarding these areas and all aspects of the draft EIS will enable APHIS to make an informed decision regarding any possible future changes to the regulations.

While APHIS publicly claims it is committed to an open and transparent regulatory process that takes all comments into consideration and reflects the latest science, while continuing to protect America's agricultural and natural resources, the opposite seems to be the case since the best available genetic science is not been considered by APHIS and due to the increasing numbers of cases of genetic contamination continue to plague agriculture in the US. APHIS is primarily responsible for the growing genetic contamination mess facing more and more American organic and conventional farmers facing economic chaos and financial ruin when their crops have been contaminated by GE crops. APHIS's actions and inactions are resulting in hundreds of American farmers being economically devastated and ruined by the deregulation disaster that APHIS has spawned. At this time, it appears that APHIS it bent on continuing the deregulation disaster and genetic contamination debacle that will cripple more and more American farmers, especially based on the draft EIS.

Although APHIS' broad biotechnology regulatory authority falls under the scope of the PPA, which has combined and modernized the various authorities and under which APHIS is in theory supposed to safeguards domestic plant resources and regulated GE organisms, including the Federal Plant Pest Act and the Plant Quarantine Act, the Sierra Club is seriously concerned that APHIS is failing miserably to protect American organic and conventional crops from genetic contamination.

The Biotechnology Regulatory Services (BRS), a program within the U.S. Department of Agriculture's (USDA) Animal and Plant Health Inspection Service (APHIS), is responsible for regulating the introduction-meaning the importation, interstate movement, and environmental release-of genetically engineered (GE) organisms. Finally APHIS has made available a draft environmental impact statement (EIS) that evaluates potential revisions to existing regulations regarding the importation, interstate movement and environmental release of genetically engineered (GE) organisms. During the past 15 years, APHIS has been reviewing and revising its biotechnology regulations in attempting to ensure what APHIS views as being "grounded in the latest science and are robust enough to keep pace with the demands of technology", but the unfortunate reality is that APHIS has failed to apply the best available science in its review of new GE crops.

In January 2004, APHIS publicly announced it was beginning a review of its regulations and published a notice of intent to prepare an EIS. The notice identified potential issues and alternatives to be studied in the EIS and requested public comment to further shape the scope of the issues and alternatives. The draft EIS outlines several key areas APHIS is evaluating and seeking public comments on, including expanding APHIS' regulatory scope through additional provisions in the Plant Protection Act (PPA) of 2000, utilizing a tiered permitting system based on potential environmental risk and implementing a process for continued oversight of crops that do not meet the criteria for deregulation. Input received regarding these areas and all aspects of the draft EIS will enable APHIS to make an informed decision regarding any possible future changes to the regulations.

While APHIS publicly claims it is committed to an open and transparent regulatory process that takes all comments into consideration and reflects the latest science, while continuing to protect America's agricultural and natural resources, the opposite seems to be the case since the best available genetic science is not been considered by APHIS and due to the increasing numbers of cases of genetic contamination continue to plague agriculture in the US. APHIS is primarily responsible for the growing genetic contamination mess facing more and more American organic and conventional farmers facing economic chaos and financial ruin when their crops have been contaminated by GE crops. APHIS's actions and inactions are resulting in hundreds of American farmers being economically devastated and ruined by the deregulation disaster that APHIS has spawned. At this time, it appears that APHIS it bent on continuing the deregulation disaster and genetic contamination debacle that will cripple more and more American farmers, especially based on the draft EIS.

Although APHIS' broad biotechnology regulatory authority falls under the scope of the PPA, which has combined and modernized the various authorities and under which APHIS is in theory supposed to safeguards domestic plant resources and regulated GE organisms, including the Federal Plant Pest Act and the Plant Quarantine Act, the Sierra Club is seriously concerned that APHIS is failing miserably to protect American organic and conventional crops from genetic contamination.

DEIS Issue 1 and 5: Scope of the Program

The federal review of the relatively weak regulation and oversight of genetically engineered organisms is certainly overdue considering the numerous problems facing American organic and conventional farmers and the genetic contamination mess spreading nationwide. We strongly urge APHIS to classify and recognize as "noxious weeds" under its regulations the genetically engineered crops (biopharm crops) that are designed for producing substances such as insecticides, pharmaceutical products and industrial chemicals. The dilemma is that if genetic contamination occurs from the new biopharmaceutical and bio-industrial crops, the American food supply and export markets will be placed at risk and more American farmers will be confronted with economic devastation and ruin, which APHIS has essentially ignored to this point. Farmers facing genetic contamination can no longer sell their crops and have to turn to the courts for relief which is very difficult to do considering the high legal costs and burden of winning such cases in the state and federal court systems. Many farmers will more likely be driven into economic ruin and bankruptcy before they see any relief from the state and federal court systems. Yet more and more scientists report field observations and laboratory evidence in the form of contaminated DNA that genetically engineered plants present a hazard to other farm crops, and most importantly, pose a serious threat to the health of humans, animals, insects and other wildlife as well as ecological systems. Synthetic pharmaceutical agents and toxic industrial chemicals produce powerful physiological effects. If APHIS allows the planting of GE crops that produce synthetic pharmaceutical agents and toxic industrial chemicals, new biopharm and bio-industrial genetic contamination is not a matter of if it will occur but when it will occur. APHIS has seriously failed to adequately assess the American food supply and economic disaster it will create if it approves the growing of GE crops producing synthetic pharmaceutical agents and toxic industrial chemicals.

In addition, when synthetic pharmaceutical agents and toxic industrial chemicals are accidentally eaten by consumers once genetic contamination occurs, a range of significant adverse health effects can be anticipated and deaths and permanent injuries will occur if APHIS moves ahead in deregulation of biopharm and bio-industrial crops that are also being used for food crops. Without a doubt, all of our food crops must never be allowed to produce synthetic pharmaceutical agents and toxic industrial chemicals. APHIS should not even authorize field testing of these biopharm and bio-industrial crops.

APHIS has failed to assess the economic harm to organic and conventional farmers when their crops and fields become contaminated by pollen, seeds and vegetative material capable of propagating a new plant. These kinds of economic harm to American farmers needs to be fully considered and evaluated by APHIS.

APHIS has also failed to properly and fully assess the harm to American consumers when organic and conventional foods are contaminated. APHIS needs to get its act together and seriously consider harm to American consumers who are growing more suspicious of GE crops as a whole and who are turning more increasingly to organically grown foods for their families and pets.

EIS's needed for non-food biopharm and bio-industrial crops to consider threats to public drinking water supplies and other environmental and health impacts.

APHIS also needs to conduct environmental impacts of every single non-food biopharma and bio-industrial crop to determine if other environmental impacts may be likely to occur. Public water supplies today are finding more and more traces of pharmaceutical compounds, and the potential exists to contaminate public and private drinking water supplies if synthetic pharmaceutical agents and toxic industrial chemicals escaped into the environment.

Plant Species with Genetically Compatible Native Relatives should not be used for Biopharm and Bio-industrial Chemical Production

APHIS also needs to carefully assess potential contamination of native plant species if their relatives are used for producing synthetic pharmaceutical agents and toxic industrial chemicals. Genetic contamination of native plants is unacceptable since once released into the environment, the genes and organisms cannot be recalled. Sierra Club opposes the use of plant species with wild relatives in the U.S. for producing synthetic pharmaceutical agents and toxic industrial chemicals.

Annuals vs perennials used for Biopharm and Bio-industrial Chemical Production

Annual plant species present enough environmental hazards if they escape into ecosystems and become weedy organisms, but fertile perennial plant species may present even greater environmental threats due to their long-lived biology and capability to produce thousands of fertile seeds over time. APHIS needs to require EIS's for all new GE crop varieties intended for producing synthetic pharmaceutical agents and toxic industrial chemicals because these novel organisms have significant potential to cause environmental impacts. Containment systems are not feasible unless they are grown in well-controlled, large greenhouses. So far, little interest has been expressed in growing biopharm and bio-industrial crops in large greenhouses.

Ethanol production vs Food production vs Drugs/Chemical production

The American food supply may also be threatened in other ways such as by diverting large acreage's to ethanol production and drugs and industrial chemicals. Yet APHIS has not comprehensively evaluated the economic and environmental impacts if large farm acreage is lost to food production. APHIS needs to thoroughly assess these impacts.

Sierra Club opposes the growing of GE crops for biopharmaceutical drugs and bio-industrial chemicals and cannot support commercialization through permitting. These crops are extremely hazardous and should not be grown at all since contamination is inevitable.

Genetic contamination at any level is totally unacceptable and APHIS must not approve even low-level genetic contamination since this is bad science not based on any scientific evidence but on purely political and vested economic interests seeking to profit from these non-food GE crops. Yet GE food crops are causing enough chaos for organic and conventional farmers and consumers.

The one gene-one protein theory from molecular biology is no longer applicable since modern genetics shows that cellular biochemical regulation is far more sophisticated and complicated via alternative splicing and epigenetics. Unfortunately, APHIS regulations seem to be based on outdated scientific models and not the best available science from epigenetics, alternative splicing and other discoveries in recent decades.

Sincerely,

Neil Carman, Ph.D.

Sierra Club Genetic Engineering Committee