161.45—Waivers.
(a) Rationale and policy.
(1)
The data requirements specified in this part as applicable to a category of products will not always be appropriate for every product in that category. Some products may have unusual physical, chemical, or biological properties or atypical use patterns which would make particular data requirements inappropriate, either because it would not be possible to generate the required data or because the data would not be useful in the Agency's evaluation of the risks or benefits of the product. The Agency will waive data requirements it finds are inappropriate, but will ensure that sufficient data are available to make the determinations required by the applicable statutory standards.
(2)
The Agency will waive data requirements on a case-by-case basis in response to specific written requests by applicants. Because of the wide variety of types and use patterns of pesticides, it is impossible to spell out all of the circumstances which might serve as a basis for waiving data requirements. The Agency, however, will take into account, as appropriate, the factors enumerated in sections 3(c)(2)(A) and 25(a)(1) of FIFRA.
(b) Procedure for requesting waiver.
(1)
An applicant should discuss his plans to request a waiver with the EPA Product Manager responsible for his product before developing and submitting extensive support information for the request.
(2)
To request a waiver, an applicant must submit a written request to the appropriate Product Manager. The request must specifically identify the data requirement for which a waiver is requested, explain why he thinks data requirement(s) should be waived, describe any unsuccessful attempts to generate the required data, furnish any other information which he believes would support the request, and when appropriate, suggest alternative means of obtaining data to address the concern which underlies the data requirement.
(c) Notification of waiver decision.
The Agency will review each waiver request and inform the applicant in writing of its decision. In addition, for decisions that could apply to more than a specific product, the Agency may choose to send a notice to all registrants or to publish a notice in the Federal Register announcing its decision. An Agency decision denying a written request to waive a data requirement shall constitute final Agency action for purposes of FIFRA section 16(a).
(d) Availability of waiver decisions.
Agency decisions under this section granting waiver requests will be available to the public at the OPP Regulatory Public Docket located as set forth in 40 CFR 150.17(c). Any person may obtain a copy of any waiver decision by written request in the manner set forth in 40 CFR part 2.