[Code of Federal Regulations]
[Title 40, Volume 23]
[Revised as of July 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 40CFR158.45]

[Page 92-93]
 
                   TITLE 40--PROTECTION OF ENVIRONMENT
 
         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
 
PART 158_DATA REQUIREMENTS FOR REGISTRATION--Table of Contents
 
                      Subpart A_General Provisions
 
Sec. 158.45  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.

[[Page 93]]

    (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.

[49 FR 42881, Oct. 24, 1984, as amended at 69 FR 39864, July 1, 2004; 71 
FR 35545, June 21, 2006]