March 20, 1997

Janet L. Andersen
Director, Biopesticides and Pollution Prevention Division
Public Response and Program Resources Branch
Field Operations Division (7506C)
Office of Pesticide Programs

Environmental Protection Agency
401 M Street, SW
Washington, DC 20460
REF: Docket No. OPP-00470

Dear Ms. Andersen or to whom it may concern:

On behalf of the Institute for Agriculture and Trade Policy (IATP), we are writing to provide our comments and recommendations on plans for genetically engineered plant pesticide use and the adequacy of existing pest resistance management policies. For your information enclosed is information on IATP.

As you know, the bacterium Bacillus thuringiensis (Bt) is critically important to the organic, sustainable agriculture, and integrated pest management communities. The rapid deployment of transgenic plants containing the Bt gene indicates that EPA may not be appropriately regulating such releases in the public interest and with adequate concern for consumer protection and economic welfare.

EPA's Current Pest Management Resistance Policy is Inadequate

EPA currently is not taking adequate steps to protect Bt. Resistance management plans should be mandatory, not voluntary. The recent genetically altered Bt crop failures evidence that voluntary approaches to resistance management are not likely to work. And this failure has likely accelerated the rate at which the pests are building their resistance. The new Bt crops threaten to encourage new strains of pests that will be resistant to Bt and thus render it useless as a topical pesticide. Farmers, especially organic farmers, have long used Bt because it breaks down quickly, is highly effective, and has few negative effects on humans and soil. Without Bt, these farmers and the public at large will be negatively affected, both economically and with respect to consumer safety, as the use of synthetic pesticides will necessarily increase.

Testing Prior to the Release of Transgenic Crops is Inadequate

More scientific data is needed to evaluate resistance management plans. Public meetings held by EPA and the U.S. Department of Agriculture and many papers published in the last few years have laid out the kinds of information needed to develop and evaluate resistance management plans, including data on pest biology and behavior, models of resistance management strategies, data on the genetics of resistance, and assays and strategies for resistance monitoring. Much more research is needed before resistance management plans can rest on a sound scientific footing. The Union of Concerned Scientists (UCS) has said repeatedly that these data should have been amassed and analyzed before approval of commercial plantings of transgenic crops like the Bt cotton.

IATP urges the EPA to heed the call of the UCS and mandate pest resistance management plans prior to any approval for release of a genetically engineered plant pesticide such as Bt, and that such plans be sufficiently broad and deep to ensure that regulators can determine the safety and efficacy of such releases.

EPA has a Responsibility to Regulate Preserve Public goods.

Bt is a public good - it occurs naturally in the soil. The privatization of this public good through the patenting of Bt plants is contrary to concepts of public utility. The economic benefit of a public good should not accrue exclusively to a private party. Regulation is necessary to ensure an appropriate balance of costs and benefits while encouraging innovation in the biotechnology industry. Insufficient attention to either side of this delicate public policy balance can produce enormous, long term loss of public goods and have secondary effects on the social and economic conditions of society as a whole. A more aggressive regulatory policy is needed to share benefits from the development of genetically engineered organisms such as plant pesticides with the public - local farmers, and others in the agricultural sector as well as society in general. At present, the costs of the genetically altered Bt crop failures of last season are being borne by the individual farmers while a private company has used its patent protection to immunize itself from sharing in the risks and resulting financial losses. The EPA must establish a more balanced regulatory strategy for protecting the public interest.

Recommendations.

IATP recommends that EPA take immediate and effective action to save Bt as a public good. EPA must forego further commercial approvals and suspend current registrations of Bt crops until workable resistance management plans are available. Finally, EPA should convene a meeting of the Scientific Advisory Panel to evaluate the resistance management plans.

Thank you for your attention to our comments and recommendations. We look forward to continuing to participate in this important public policy debate.

Sincerely,

Eyvette R. Flynn, Senior Policy Analyst
Kristin Dawkins, Research Director and Senior Fellow