[Code of Federal Regulations]
[Title 40, Volume 20]
[Revised as of July 1, 2002]
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]