To whom it may concern:  

On behalf of the Union of Concerned Scientists (UCS), we are pleased to have the opportunity to comment on EPA's proposed Pesticide Registration (PR) Notice entitled "Draft Guidelines for Expedited Review of Conventional Pesticides under the Reduced-Risk Initiative and for Biological Pesticides," as announced in a June 18, 1997, Federal Register notice (62 Fed Reg. 33078).  

In the notice, issued to comply with the Food Quality Protection Act, the Agency proposes the criteria under which conventional and biological pesticides would be considered to pose reduced risk for purposes of receiving expedited review. In general, we believe that the Agency should offer expedited review only to those pesticides with a high degree of certainty of safety and that the Agency should make decisions about those pesticides in six months or less.  

UCS disagrees with the apparent presumption in the draft that all applications to register a genetically engineered plant pesticide would receive a fast-track review as reduced-risk products. Not all plant pesticides qualify as reduced-risk products. UCS urges the Agency to establish criteria for fast-track review that confer reduced-risk status only on engineered plant pesticides which: i) enhance a crop's natural defense system, including chemical and structural defenses; or ii) reduce, in a non-toxic manner, a pest's ability to damage a crop (e.g., through behavioral changes, altered physiology or reproduction); and iii) are highly compatible with biologically based integrated pest management approaches, and iv) possesses a low potential for evolution of pest resistance.  

Under the criteria that we propose, Bt crops, engineered to produce insecticidal toxins from Bacillus thuringiensis (Bt), would not merit expedited reviews because of the toxic mode of action of Bt proteins and potential to elicit resistance. Scientists agree that widespread use of Bt crops threatens the loss of Bt insecticidal sprays due to resistance.  

We note that EPA's proposed plant-pesticide policy (59 Fed. Reg. 60496) would subject very few plant pesticides to oversight under the Federal Insecticide, Fungicide, and Rodenticide Act and the Federal Food, Drug, and Cosmetic Act. The policy has a narrow scope—focussing mainly on crops engineered to produce new pesticides with a toxic mode of action. As we interpret the proposed rule, it would not cover either herbicide-tolerant crops or transgenic plant pesticides that alter a plant's natural defense mechanisms. We disagree with this narrow scope and have urged the Agency to broaden it to cover all plant pesticides that are products of genetic engineering.  

In the event that EPA decides in the future to regulate transgenic herbicide-resistant crops as plant pesticides, the Agency should not expedite their review. Because they are designed to perpetuate rather than reduce farmers' reliance on chemical herbicides, they are inherently inconsistent with the long-term goals of reduced-risk technologies.  

Finally, the Agency should commit to periodically revisit and progressively tighten the criteria that determine reduced-risk status. Increasingly stringent criteria will preserve safer pesticides as an attractive commercial incentive and ensure progress towards the ultimate goal of a safer food supply and a healthier environment.  

Sincerely,  

 Jane Rissler, Ph.D.
Senior Staff Scientist

Margaret Mellon, Ph.D., J.D.
Director, Agriculture and Biotechnology Program