[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: 40CFR152.113]

[Page 27-28]
 
                   TITLE 40--PROTECTION OF ENVIRONMENT
 
         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
 
PART 152--PESTICIDE REGISTRATION AND CLASSIFICATION PROCEDURES--Table of Contents
 
                Subpart F--Agency Review of Applications
 
Sec. 152.113  Approval of registration under FIFRA sec. 3(c)(7)--Products that do not contain a new active ingredient.

    (a) Except as provided in paragraph (b) of this section, the Agency 
may approve an application for registration or amended registration of a 
pesticide product, each of whose active ingredients is contained in one 
or more other registered peticide products, only if the Agency has 
determined that:
    (1) It possesses all data necessary to make the determinations 
required by FIFRA sec. 3(c)(7)(A) or (B) with respect to the pesticide 
product which is the subject of the application (including, at a 
minimum, data needed to characterize any incremental risk that would 
result from approval of the application);
    (2) Approval of the application would not significantly increase the 
risk of any unreasonable adverse effect on the environment; and

[[Page 28]]

    (3) The criteria of Sec. 152.112(a), (d), and (f) through (h) have 
been satisfied.
    (b) Notwithstanding the provisions of paragraph (a) of this section, 
the Agency will not approve the conditional registration of any 
pesticide under FIFRA sec. 3(c)(7)(A) unless the Agency has determined 
that the applicant's product and its proposed use are identical or 
substantially similar to a currently registered pesticide and use, or 
that the pesticide and its proposed use differ only in ways that would 
not significantly increase the risk of unreasonable adverse effects on 
the environment.
    (c) Notwithstanding the provisions of paragraph (a) of this section, 
the Agency will not approve the conditional registration of any 
pesticide product for a new use under FIFRA sec. 3(c)(7)(B) if:
    (1) The pesticide is the subject of a special review, based on a use 
of the product that results in human dietary exposure; and
    (2) The proposed new use involves use on a major food or feed crop, 
or involves use on a minor food or feed crop for which there is 
available an effective alternative registered pesticide which does not 
meet the risk criteria associated with human dietary exposure. The 
determination of available and effective alternatives shall be made with 
the concurrence of the Secretary of Agriculture.