UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460 December 13, 1991 PR NOTICE 91-6 NOTICE TO MANUFACTURERS, FORMULATORS, PRODUCERS AND REGISTRANTS OF PESTICIDE PRODUCTS ATTENTION: Persons Responsible for Registration of Pesticide Products SUBJECT: EPA Policy Regarding Requests to Withdraw Authorization to Cite Data This Notice sets forth EPA's policy for treating requests from registrants or other persons owning rights in originally submitted data ("original data submitters") to withdraw authorization for other registrants or applicants for registration to rely on such data to meet the data submission requirements imposed by FIFRA. As explained more fully in Section II below, EPA will honor the terms and conditions of an original letter of authorization to cite data and will not honor a letter withdrawing that authorization unless both the person owning rights in originally submitted data and the registrant(s) relying on the authorization to cite data agree that such authorization has been withdrawn. By announcing this policy, the Agency is not altering the rights to the use of data or in data compensation granted by FIFRA Sections 3(c)(1)(D), 3(c)(2)(B), and 4(h). Persons owning rights in originally submitted data possess an adequate remedy to protect those rights: they may petition the Agency to cancel or deny the registration of any person who has breached either an agreement with the original data submitter regarding compensation for data or an arbitration decision. I. BACKGROUND AND RATIONALE Both FIFRA and the implementing regulations permit applicants and registrants to fulfill specific data requirements of FIFRA by submitting to EPA the written authorization of an original data submitter that permits the applicant or registrant to rely on the original data submitter's data -- provided, of course, that the data submitted by the original data submitter also fulfills a data requirement for the applicant's or registrant's product. (See FIFRA Section 3(c)(1)(D); 40 C.F.R. Section 152.93(b)(1)1. If the original data submitter's data is entitled to exclusive use protection, an applicant or registrant wishing to rely on such data in support of a data requirement must obtain the written permission of the original data submitter. (See FIFRA Section 3(c)(1)(D); 40 C.F.R. Section 152.93(b)(1)1. Neither FIFRA nor the implementing regulations address, however, whether an authorization to cite data, once given, can be withdrawn, and if so, the circumstances under which such authorization may be withdrawn. Although there exists no clear statutory or regulatory guidance on this issue, the Agency's position, as further explained below, is guided by two concerns central to the administration of the pesticide program: (1) the Agency's need for certainty in administering an efficient pesticide program; and (2) the protection of rights in data compensation. In administering the data collection efforts involved in the pesticide program, the Agency endeavors to ensure that each of the many thousands of registrations subject to data submission requirements is in compliance with those requirements' The Agency has promulgated regulations pursuant to FIFRA which create a streamlined and effective means for registrants to demonstrate compliance with the data submission requirements of FIFRA. 40 C.F.R. Section 152 Subpart E. The process established by these regulations would be undermined if an original data submitter could, unilaterally, alter the status of any registration relying on the original data submitter's data by simply informing the Agency that authorization to cite data had been withdrawn. At the same time, the Agency also acknowledges the substantial interest of original data submitters in protecting their rights to data compensation. The Agency believes, however, that adequate procedures already exist for the protection of these rights. Under 40 C.F.R. Section 152.99 original data submitters may petition the Agency to deny or cancel the registration of an applicant or registrant who has failed to comply with a data compensation agreement or an arbitration decision. Thus, to the extent a desire to withdraw authorization to cite data arises from the breach of a compensation agreement or an arbitration decision, an original data submitter may use the procedures set forth in Section 152.99. Absent such a showing, the Agency does not believe it has an obligation to honor the request of an original data submitter to withdraw authorization to cite data. To do so would make the Agency the arbiter of disputes between registrants that are wholly unrelated to data compensation agreements. II. POLICY EPA will honor the terms and conditions of an original letter of authorization to cite data and will not accept a letter withdrawing that authorization unless both the original data submitter and the registrant(s) or applicant(s) relying on the data submitter's data agree that such authorization has been withdrawn. EPA will, however, entertain a petition to cancel from an original data submitter, pursuant to 40 C.F.R. 152.99, where the original submitter alleges that the registrant or applicant relying on the authorization has violated the terms of a compensation agreement or an arbitration decision. Where such an agreement or decision exists, and one party alleges that the agreement or decision has been violated, the statute and the regulations contemplate that EPA will entertain a petition to cancel. When, however, a petition to cancel is filed pursuant to 152.99(a)(2)(vi) (the applicant has submitted or cited a study originally submitted by the petitioner without the required authorization . . .), EPA will not cancel the registration relying on an original data submitter's authorization based simply on the data submitter's assertion that it has withdrawn its authorization. Rather, as noted in the preceding paragraph, the original data submitter must demonstrate that a compensation agreement or arbitration decision has been breached, or that authorization has never been granted. III. EFFECTIVE DATE This policy is effective immediately. IV. FURTHER INFORMATION If you have questions regarding this policy you may contact Mark Dyner, Office of General Counsel (202-382-5473). Anne E. Lindsay, Director Registration Division ----------------------- CERIS-Net Posting Date: 04.01.92 DISCLAIMER: PR Notices prior to 1992 were received from Ken Olds, US Army, Environmental Hygiene Unit, Aberdeen Proving Grounds, Maryland. 1992 PR Notices are sent to CERIS/NPIRS by the U.S. EPA Documents Center in WordPerfect document format. CERIS/NPIRS converts files to ASCII text, with editing to facilitate file transfer, before posting on the CERIS-Net system. This information is available by anonymous FTP from ceris.purdue.edu in the pub/info/prnotice directory. Contact Ed Ramsey of CERIS at 317/494-0442 for access information.