PRN 94-9: Announcing the Formation of Two Industry-Wide Task Forces: Agricultural Reentry Task Force and Outdoor Residential Exposure Task Force

December 9, 1994

Notice To: Manufacturers, Producers, Formulators, and Registrants of Pesticide Products

Attention: Persons Responsible for Federal Registrations and Reregistrations of Pesticides

Subject: Announcing the Formation of Two Industry-Wide Task Forces: Agricultural Reentry Task Force and Outdoor Residential Exposure Task Force

1. Introduction
2. Summary
3. Joining A Task Force To Satisfy Data Requirements
4. Task Forces
5. For Further Information

1. Introduction

   This PR Notice announces two industry-wide Task Forces being formed in response to generic exposure data requirements. This PR Notice contains the EPA's policy with regard to a registrant's options for, and responsibilities when joining either Task Force as a means to satisfy relevant data requirements. This PR Notice also contains an EPA contact and contacts for each Task Force for persons wanting further information.

2. Summary

   Two reentry Task Forces are being organized pursuant to the provisions of FIFRA 3(c)(2)(B)(ii) to share in the cost of developing generic exposure data. An Agricultural Reentry Task Force has been organized to develop a generic agricultural reentry exposure data base intended to address agricultural post application/reentry data requirements for dermal passive dosimetry monitoring (guideline study 133- 3) and inhalation exposure monitoring (guideline study 133-4). An Outdoor Residential Exposure Task Force has also been organized to develop exposure data on both professionals and non-professionals (residents) who mix, load, and apply pesticides to residential grass, lawn, or turf (guideline studies 231 and 232) and exposure data on non-professionals who reenter residential sites (residential grass, lawn, or turf) which have been treated (guideline studies 133-3 and 133-4). Data generated by these Task Forces may be acceptable for many pesticide product reregistrations in the United States and California. The data bases are expected to also satisfy Canadian requirements. In the future, the data generated by the Task Forces may satisfy certain new product registration data requirements in these areas as well. Because of the wide cross section of pesticide registrants who could potentially benefit from this endeavor, the U.S. Environmental Protection Agency (the Agency) takes this unusual step to inform all pesticide registrants of the existence of these Task Forces. This approach to fulfilling data requirements has the potential to result in considerable financial savings for pesticide registrants, while at the same time providing the Agency with a more complete and scientifically more sound basis for evaluating exposure at agricultural use sites or at residential grass, lawn, or turf sites.

3. Joining A Task Force To Satisfy Data Requirements

   Pesticide registrants who have received a Data Call-In(s) after March 1, 1993 requiring guideline study 231, 232, 133-3, or 133-4 for their product(s) registered for use on residential grass, lawn, or turf, have the option of fulfilling these data requirements through participation in the Outdoor Residential Exposure Task Force. Similarly, pesticide registrants who have received a Data Call-In(s) after March 1, 1993, requiring post application/reentry data requirements (guideline study 133- 3, or 133-4) for their pesticide product(s) have the option of fulfilling these data requirements through participation in the Agricultural Reentry Exposure Task Force. If the registrant elects to participate in a Task Force to satisfy an appropriate data requirement(s), then the registrant must inform the Agency of its election of this option and of its membership in the respective Task Force.

   Registrants, responsible for any of the above data requirements under a Data Call-In Notice(s) received prior to March 1, 1993, may also participate in a Task Force since the Task Forces have indicated their intent to review available data and may purchase acceptable quality studies for inclusion in the development of the appropriate data base. However, no time extensions of deadlines will be considered for, or granted to such registrants merely due to their participation in either Task Force.

   For those registrants who have not yet received a Data Call-In Notice for any of the data requirements listed above, the Agency intends to issue two separate generic Data Call-In Notices during FY-95. One Data Call-In Notice will require exposure data on (1) professionals and nonprofessionals (residents) who mix/load and apply pesticide products to residential grass, lawn, or turf and (2) non-professionals who reenter residential areas (grass, lawn, or turf) which has been treated with a pesticide product. A second Data Call-In Notice will require data on exposure to individuals who reenter agricultural areas that have been treated with a pesticide product. Registrants subject to either, or both, of these Data Call-In Notices will have the option of fulfilling the data requirements through participation in the appropriate Task Force. If a registrant chooses this option, the registrant must inform the Agency of its election of this option and of its membership(s) in the respective Task Force(s).

   Acceptability of Task Force participation with respect to meeting Canadian and California pesticide data requirements must be worked out separately with the corresponding Canadian and California government agencies.

4. Task Forces

   These Task Force(s) are organized pursuant to a FIFRA joint data development agreement with costs to be shared equally by all participants. Each participating company will appoint representatives to respective Administrative and Technical Committees. The Agency is not a participant in either of the Task Forces but will be available as the Agency deems appropriate to provide regulatory and technical guidance and assistance relating to the development of these data. Those desiring further information on either Task Force may contact the following persons:

   Dr. Timothy Pastoor, Administrative Chairman for both Task Forces, (302) 886-5578;

   Harold Himmelman, Counsel for both Task Forces, (202) 789-6012.

   Dr. Edgar Day, Technical Chairman for Agricultural Reentry Task Force, (317) 337-3667.

   Dr. Monty Eberhart, Technical Chairman for the Outdoor Residential Exposure Task Force, (816) 242-2654.

   Data already available from submissions to the Agency, published research, and other sources within industry, government, and academia will be considered in assembling a data base that should facilitate accurate calculations of exposure to pesticides from either reentry at agricultural use sites, or from mixing/loading/applying or reentering at residential sites.

   Any such studies that are compensable under FIFRA 3(c)(1)(F) can only be used with the consent of the owners of the data or through the procedures established in Section 3(c)(1)(F). The Task Forces and its members will retain ownership of the data that they generate and submit to the Agency for purposes of supporting pesticide registrations and retain full rights to data compensation by non-participants wishing to cite their data under the provisions of FIFRA 3(c)(1)(F) for a period of 15 years following submission of the Task Force-generated data. In the case of any data developed for the initial registration of a new pesticide, such data may only be used by another registrant during the 10 year period following registration of the new pesticide with the permission of the original data submitter.

   The Agricultural Reentry Task Force plans to prioritize the sites and reentry activities to be covered by the data it produces. Similarly, the Outdoor Residential Exposure Task Force plans to identify the reentry activities to be covered by the data it produces. It is possible that certain atypical use patterns, uncommon formulations, or other situations for which EPA might require separate reentry studies would not be included in the data generated by either Task Force. Early participation in the respective Task Force should give each registrant a voice in establishing the priorities of that Task Force.

   Participants, in either of the respective Task Forces, individually and separately assume the responsibility of complying with the data requirements for their various products containing active ingredients from reregistration lists A, B, C, and D by the deadlines set by the Agency and must understand and accept the risk involved in the possible failure of either of the Task Forces to meet those deadlines, or to provide satisfactory data to address applicable requirements. Any deadline extensions and waivers for any of the relevant data requirements must be requested from the Agency individually by registrants on a case-by-case basis.

   This PR Notice is issued by the Agency for the sole purpose of informing pesticide registrants of the formation of the Agricultural Reentry Task Force and the Outdoor Residential Exposure Task Force. It is not intended to define or restrict the terms of or subsequent amendments to the joint data development and its operation.

5. For Further Information

   For questions or further information regarding the formation of these two task forces, please contact the Registration Division.

   Daniel M. Barolo, Director
   Office of Pesticide Programs