[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: 40CFR158.30]



[Page 79-80]

 

                   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.  158.30  Timing of the imposition of data requirements.



    This part establishes requirements for the types of data which are 

necessary to support the unconditional registration of a pesticide 

product under section 3(c)(5) of the Act. While every registered 

pesticide product must eventually be supported by the data required by 

part 158, when an applicant or registrant must initially satisfy these 

data requirements depends on the factors listed below in this section.

    (a) Existing Registrations. A registrant of a currently registered 

pesticide product is not obligated to satisfy any data requirement in 

part 158 with respect to that product until he receives a notice under 

section 3(c)(2)(B) of the Act that additional data are required to 

support the continued registration of the product, until he applies for 

an amendment to the registration, or until the product is subject to 

reregistration.

    (b) Applications. The amount of data required by the Agency to 

evaluate an application for initial or amended registration depends on 

whether the product is being reviewed under section 3(c)(5) of the Act 

(unconditional registration) or section 3(c)(7) of the Act (conditional 

registration). Refer to Sec.  152.111 of this chapter or consult with 

the appropriate EPA Product Manager to determine under which section of 

the Act the application will be reviewed. The following paragraphs 

identify, for each different type of application, the minimum amount of 

data that must be available for EPA review to permit EPA to make the 

statutory risk-benefit determinations required by section 3(c)(5) or 

3(c)(7) of the Act. In addition to satisfying these minimum data 

requirements, applicants may be required to submit or cite additional 

data, either to permit EPA to assess the safety or efficacy of the 

product (refer to Sec.  158.75) or to comply with the statutory 

requirements of section 3(c)(1)(D) of the Act, or both.

    (1) Applications for unconditional registration under section 

3(c)(5) of the Act. EPA will not approve an application for 

unconditional registration unless all data required by this part which



[[Page 80]]



have not been waived are available for EPA to review.

    (2) Applications for conditional registration of a new chemical 

under section 3(c)(7)(C) of the Act. EPA will not approve an application 

for conditional registration of a pesticide containing an active 

ingredient not contained in any currently registered product unless data 

required by this part are available for EPA to review except for:

    (i) Those data for which the requirement has been waived.

    (ii) Those data for which the requirement was imposed so recently 

that the applicant has not had sufficient time to produce the data.

    (3) Applications for conditional registration of products which are 

identical or substantially similar to currently registered products 

under section 3(c)(7)(A) of the Act. EPA will not approve an application 

for conditional registration of a pecticide product which is identical 

or substantially similar to a currently registered pesticide unless the 

following data are available for EPA to review:

    (i) Product chemistry data, as required by subpart C of this part.

    (ii) Product performance data, to the extent required by Sec.  

158.160.

    (4) Applications for conditional registration of new uses of 

currently registered products under section 3(c)(7)(B) of the Act. EPA 

will not approve an application for registration of a pesticide for a 

new use of a currently registered pesticide product unless the following 

data are available for EPA to review:

    (i) Product chemistry data, as required by subpart C of this part.

    (ii) Product performance data, to the extent required by Sec.  

158.160.

    (iii) Other data pertaining solely to the new use. The applicant may 

generally determine which data pertain solely to the new use by 

comparing the data requirements for all existing uses of all currently 

registered products containing the same active ingredient(s) with those 

for all uses including the new use. Any differences are attributable to 

the new use and must be submitted with the application.



[49 FR 42881, Oct. 24, 1984, as amended at 53 FR 15999, May 4, 1988; 58 

FR 34203, June 23, 1993]