The following articles are excerpts from the newsletter:

Pesticide Data Rights, Michael R. Neilson, Esquire, Bergeson & Campbell, P.C., Washington, D.C. and Kenneth W. Weinstein, Esquire, Latham & Watkins, Washington, D.C.

Update on FQPA Litigation, Douglas T. Nelson, Esquire, Mark L. Goldberg, Esquire, The American Crop Protection Association

 

PESTICIDE DATA RIGHTS

Michael R. Neilson, Esquire
Bergeson & Campbell, P.C.
Washington, D.C.

Kenneth W. Weinstein, Esquire
Latham & Watkins
Washington, D.C.

This column reports on recent Pesticides, Chemical Regulation, and Right-to-Know Committee (Committee) activities relating to pesticide data rights issues. In 1999, numerous pesticide registrants expressed to Marcia Mulkey (Director, Office of Pesticide Programs, United States Environmental Protection Agency) their concerns regarding several important issues affecting their rights in pesticide registration data submitted to EPA. Ms. Mulkey suggested that the Committee may be able to assist EPA in addressing the following issues: (1) data citation, compensation, and cost sharing requirements for data submitted to EPA without a formal EPA Data Call-In (DCI); (2) improvements in the process by which EPA considers and acts upon petitions to deny applications for registrations and petitions to cancel registrations; and (3) the proper interpretation of Section 408(i) of the Federal Food, Drug and Cosmetic Act (FFDCA), which provides that data and information that are, or have been, submitted to EPA in support of a tolerance or an exemption from tolerance shall be subject to exclusive use and data compensation to the same extent as under Section 3 of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). On January 19, 2000, EPA subsequently announced the availability for comment of a paper discussing three possible interpretations as options for EPA to implement Section 408(i) of the FFDCA (65 Fed. Reg. 2947).

In September 1999, the Committee formed a working group of practitioners interested in these issues to develop potential proposals that the Committee may consider for submission to EPA. The working group has focused initially on issues relating to data citation, compensation, and cost sharing for those studies submitted to EPA for which the Agency has not issued a DCI. On January 6, 2000, the working group presented a paper at a Pesticide Law meeting of the Committee. The paper summarizes potential proposals for addressing issues related to data citation, compensation, and cost sharing. In addition, the working group’s paper highlights those issues on which a range of views were expressed in the working group’s discussions. The Executive Summary of this paper is reprinted below.

Several trade associations, representing the interests of various pesticide registrants that both generate and cite pesticide registration data, are still evaluating the working group’s paper. The Committee has invited the American Crop Protection Association, Chemical Manufacturers Association, Chemical Producers and Distributors Association, and Chemical Specialties Manufacturers Association to present their views at the next Pesticide Law meeting of the Committee scheduled for March 21, 2000. For a copy of the working group’s paper, please contact Michael Neilson (202-962-8583) or Kenneth Weinstein (202-637-2166). Comments on the working group paper are welcome from all interested parties.

 

American Bar Association Special Committee on Pesticides, Chemical Regulation, and Right-to-Know
Discussion Draft for January 6, 2000 Meeting

REFORMS REQUIRED TO DOCUMENT EPA DATA REQUIREMENTS

Executive Summary

Pesticide registrants have been generating, and are continuing to generate, many kinds of data responding to the information needs of the United States Environmental Protection Agency (EPA) for assessing the risks posed by pesticide products. EPA requires the data for various purposes that are essential to maintaining pesticide registrations in effect, or to issuing new registrations, including to reassess pesticide tolerances, to assess whether products meet the standards for registration, to determine whether new uses can be registered or existing uses maintained, and to determine the appropriate labeling, warnings, and instructions for the use of pesticide products. These data are essential for EPA to address advances in science and the expansion of EPA’s obligations for assessing pesticide registrations, under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and tolerances, under the Food Quality Protection Act’s (FQPA) amendments to the Federal Food, Drug, and Cosmetic Act (FFDCA).

EPA’s data needs have rapidly grown and evolved, in some cases outpacing the Agency's documentation of its data requirements through its regulations and in Data Call-Ins (DCIs) issued to registrants. As a result of these changes, registrants can be impeded in making financial arrangements to develop the data that EPA requires and face uncertainty concerning their obligation to cite, and offer to compensate or to share in the cost of, such studies. This paper proposes to address the problem of identifying data requirements and issuing DCIs for data needs through two mechanisms:

(1) We propose that EPA adopt a DCI procedure whereby a registrant can petition EPA, with notice to other registrants, applicants for registration, and other interested parties, to identify and document additional data that are considered to be "required data." This would be done pursuant to a more streamlined procedure than EPA-initiated DCIs, under the authority of FIFRA 3(c)(2)(B);

(2) We propose that at the time of EPA’s reassessment of any tolerance, EPA take a formal "registration action," similar to reregistration. In this registration action, EPA would identify the data relied upon by the Agency in reassessing each tolerance and to maintain the registrations associated with such tolerance. Registrants would be obligated to cite such data pursuant to FIFRA 3(c)(1)(F) and/or 3(c)(2)(B), as applicable.

Through the petition procedure, registrants would carry for EPA much of the burden of documenting the basis for requiring data. Thus, this procedure would assist EPA in meeting, with its limited resources, EPA’s statutory obligations to document the requirements for data that it imposes.

[Notes: (3) The working group has discussed various mechanisms for providing notice of such petitions to any other parties. These potential mechanisms include: (a) publication of notices of petitions in the Federal Register; (b) posting petitions on EPA’s web site; and/or (c) placing petitions in a public docket. There was a widely held view, although perhaps not unanimous, that any notice procedure should not be cumbersome or time consuming, which may preclude publication of Federal Register notices.

(4) The members of the working group expressed a range of views concerning the data which would be eligible to be made "required" data through this petition process, including: (a) all data which have been submitted within the 15-year compensable period prior to the date of submitting a petition; (b) data generated since enactment of the FQPA; or (c) only data submitted prospectively following EPA’s adoption of a petition procedure.

(5) In working group discussions, it has been observed that some registrants would consider EPA’s adoption of mechanism 2 alone, without any action on a process to require data that is now being generated and submitted, to constitute a failure on the part of EPA to address the problem of undocumented data requirements.]

 

UPDATE ON FQPA LITIGATION

Douglas T. Nelson, Esquire
Mark L. Goldberg, Esquire
The American Crop Protection Association

The American Crop Protection Association (ACPA), the American Farm Bureau Federation, and seven other agricultural industry groups filed a lawsuit on June 2, 1999, in the U.S. District Court for the District of Columbia requesting that EPA issue regulations governing the issuance of Section 18 exemptions. On June 3, EPA published in the Federal Register proposed Section 18 regulations. On June 7, ACPA and the co-plaintiffs, with eight additional co-plaintiffs, amended the lawsuit to request that EPA follow its statutory requirements in assessing and reassessing crop protection products under the Food Quality Protection Act (FQPA). The amended lawsuit asked EPA to update its regulations specifying the information the Agency needs; utilize data call-in procedures rather than rely on defaults, theoretical models, and assumptions; publish a revised schedule for tolerance reassessment; and implement notice and comment rulemaking, rather than informal and draft policies in choosing a percentile of acute dietary exposure (99.9%) and determining an appropriate FQPA safety factor (10x). Judge Ellen Segal Huvelle has been assigned the case.

On July 29, the industry lawsuit was amended to add the names of seven additional co-plaintiffs. The complete list of co-plaintiffs is as follows: ACPA, American Farm Bureau Federation, Agricultural Retailers Association, American Agri-Women, California Citrus Mutual, Chemical Producers & Distributors Association, Georgia Peanut Producers Association, International Sanitary Supply Association, Kansas Fertilizer and Chemical Association, Michigan Agri-Business Association, Mid-America Crop Protection Association, National Association of Wheat Growers, National Grain Sorghum Producers, Southern Crop Protection Association, United Fresh Fruit & Vegetable Association, Western Crop Protection Association, Western Growers Association, Chemical Manufacturers Association, Michigan Bean Commission, National Agricultural Aviation Association, National Pest Control Association, Oregonians for Food and Shelter, Women Involved in Farm Economics, and Wyoming Ag Business Association.

On August 3, the Natural Resources Defense Council (NRDC) and six environmental organization co-plaintiffs filed suit in the United States District Court for the Northern District of California, alleging that EPA has failed to reassess, as mandated by FQPA, the riskiest one-third of all tolerances and failed to implement an endocrine screening program by August 3, 1999. Specifically, NRDC seeks an injunction ordering EPA to assess the riskiest pesticides, including all organophosphates, as expeditiously as possible. NRDC also seeks an injunction ordering EPA to expeditiously implement the endocrine screening program proposed in the August 1998 Endocrine Disruptor Screening and Testing Advisory Committee Final Report. EPA moved to dismiss NRDC’s "one-third" count and requested an extension of time to respond to the endocrine screening count.

ACPA amended its lawsuit on August 19 alleging that EPA’s tolerance reassessment schedule must take into consideration all of the Agency’s responsibilities under the Federal Food, Drug, and Cosmetic Act (FFDCA) pertaining to tolerance reassessment. ACPA argues final EPA action reassessing tolerances also must comply, for example, with EPA’s duty to consider the cumulative effects of exposure to compounds with a common mechanism of toxicity under FFDCA Section 408(b)(2)(D), and EPA’s duty to obtain data that are required to support the continuation of tolerances under FFDCA Section 408(f)(1). ACPA’s amendment also requests that when EPA implements its endocrine screening program, it must take into account appropriate validated test systems and other scientifically relevant information. ACPA argues it would be unlawful for EPA to implement a screening program that does not provide for use of appropriate validated test systems and other scientifically relevant information.

EPA’s answer to ACPA’s amended complaint was filed September 8 and contained a motion to dismiss all claims except the Section 18 cause of action. The motion to dismiss alleges that ACPA’s claims are not ripe and that no final agency action or harm has occurred. ACPA responded October 22; EPA has responded to ACPA. ACPA is currently in the process of writing a surrebuttal.

Also, in response to a similar petition filed by NRDC, ACPA petitioned the United States Ninth Circuit Court of Appeals with regard to EPA’s failure to reassess one-third of all tolerances and implement an endocrine screening program by August 3, 1999. This case will first determine whether jurisdiction for these issues belongs in the Court of Appeals or District Court. ACPA’s and NRDC’s petitions have been consolidated and opening briefs were due February 8, 2000.