[Code of Federal Regulations]

[Title 40, Volume 23]

[Revised as of July 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 40CFR158.45]



[Page 84]

 

                   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.

    (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]