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The Issue

EPA's Plans under the Government Performance and Results Act ("GPRA') may be jeopardized by "me-too" conditional pesticide/herbicide registrations under FIFRA.

EPA's GPRA Plans Seek to Replace Higher-Risk Pesticides/Herbicides with New Products Posing Less Risk

EPA's Annual Performance Plan and Congressional Justification for FY 2001 contains a Strategic Goal of "Safe Food, including an "Objective" to "Reduce Agricultural Pesticides Risk." (EPA Performance Plan, p. III-1.) EPA's Plan further explains, "Progressively replacing older, higher-risk pesticides is one of the most effective methods for curtailing adverse impact on health and the ecosystem while preserving food production rates." (EPA Performance Plan, p. 111-3.) The term "pesticides" encompasses herbicides. (EPA Performance Plan, p. 111-2.) In compliance with the statute, EPA's Performance Plan was submitted to Congress under GPRA, 31 U.S.C. 1115.

EPA's 2000 GPRA Strategic Plan states similar goals, objectives, and strategies. For example, EPA's Safe Food Goal states that the risk from agricultural use of pesticides/herbicides will be reduced "from pre-Food Quality Protection Act (FQPA) levels (pre- 1996)." EPA intends to achieve this risk reduction in part by "facilitat(ing] a reasonable transition from the higher-nisk pesticides for the agricultural community." One of EPA's "priorities" is "encourage lower-risk means of pest control." (EPA Strategic Plan, pp. 25-26).

Conditional "Me-Too" FIFRA Registrations for Higher-Risk Pesticides/Herbicides Would Jeopardize EPA's GPRA Plans By Unreasonably Increasing Risk

CRE understands that a number of companies are considering replacing their currently registered "higher-risk" pesticides/herbicides with new, more environmentally friendly and equally effective products. CRE further understands that some companies have already agreed to such replacements pursuant to EPA's Reduced Risk Initiative. CRE strongly supports these efforts.

Other less scrupulous companies may try to take advantage of these good corporate citizens by filing me-too FIFRA registration applications for the "higher-risk" applications. Under a me-too registration, a company can rely on data supporting another registrant's product, as long as the original registrant does not have exclusive use rights to the data under FIFRA. If the original registrant has exclusive use rights to some but not all of his product data, then the me-too applicant may ask for a conditional registration under FIFRA. In other words, the me-too applicant may ask that his registration be granted on the condition that at some specified date he fill in the gaps caused by the original registrant's exclusive use rights to some of the missing data. A me-too conditional registrant can then make and sell the "higher-risk" pesticide/herbicide pending his providing EPA with the missing data.

Granting conditional registration to a me-too applicant under these circumstances would severely impede EPA's implementation and achievement of its GPRA Strategic Plan and Annual Performance Plan. Granting conditional registration to this type of me-too applicant would increase pesticide risk, rather than reduce it. This type of conditional registration would put back in the environment and on food "higher-risk" pesticides/herbicides that the original registrant is replacing with new, equally effective products that pose less risk.

Denying conditional registration under these circumstances would be consistent with and may be required by FIFRA. EPA cannot grant any conditional registration unless it first:

determines that (i) the pesticide and proposed use are identical or substantially similar to any currently registered pesticide and use thereof, or differ only in ways that would not significantly increase the risk of unreasonable adverse effects on the environment, and (ii) approving the registration ... would not significantly increase the risk of any unreasonable adverse impact on the environment."

7 U.S.C. 136a(c)(7)(A) (emphasis added),

When the original registrant has voluntarily canceled his registration for a "higher-risk" pesticide/herbicide and replaced it with a new, equally effective, less risky product, granting conditional registration for the old product to a me-too registrant would "significantly increase the risk of unreasonable adverse effects on the environment." The original registrant has decreased the risk by replacing the old pesticide/herbicide with a new one posing less risk. The "adverse impact" caused by allowing a me-too applicant to put the old product back into the environment and back on food would, under these circumstances, be "unreasonable."

Recommendations and Conclusions

EPA should deny me-too pesticide/herbicide applicants conditional registration when the original registrant has canceled, or has agreed to cancel, the product and to replace it with an equally effective new product posing less risk. Granting conditional registration under these circumstances would be inconsistent with FIFRA, EPA's GPRA Plans, and the Agency's goal of reducing pesticide/herbicide exposure, especially with regard to children.