[Code of Federal Regulations]
[Title 40, Volume 21]
[Revised as of July 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 40CFR154.35]

[Page 52]
 
                   TITLE 40--PROTECTION OF ENVIRONMENT
 
         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
 
PART 154--SPECIAL REVIEW PROCEDURES--Table of Contents
 
                          Subpart B--Procedures
 
Sec. 154.35  Finality of determinations.

    (a) The Administrator will not approve an application for 
registration or amended registration of a pesticide product except by 
use of the procedures specified in paragraph (c) of this section, if:
    (1) The application proposes registration of a product for a use 
which earlier had been the subject of a notice under Sec. 154.21(a);
    (2) After the Administrator issued the notice, he determined not to 
initiate a Special Review, because of a proposal by an applicant for 
registration or amended registration to change the terms and conditions 
of registration of the product in a way which would reduce the risk 
sufficiently to eliminate the need for a Special Review; and
    (3) The application for registration or amended registration now 
proposes that the terms and conditions which served as the basis of the 
earlier determination be eliminated, or be modified in a way which might 
increase the risk which was the subject of the notice under 
Sec. 154.21(a).
    (b) The Administrator will not approve an application for 
registration or amended registration of a pesticide product except by 
use of the procedures specified in paragraph (c) of this section, if:
    (1) The application proposed registration of a product for a use 
which earlier had been the subject of a Notice of Special Review issued 
under Sec. 154.25;
    (2) After the Administrator issued that Notice, he determined not to 
issue a notice under FIFRA section 3(c)(6) or 6(b) because of a proposal 
by an applicant for registration or amended registration to change the 
terms and conditions of registration of the product in a way which would 
reduce the risk sufficiently to eliminate the need for issuance of a 
notice under FIFRA section 3(c)(6) or 6(b); and
    (3) The application for registration or amended registration now 
proposes that the terms and conditions of registration which served as 
the basis for the earlier determination now be eliminated or be modified 
in a way which might increase the risk which was the subject of the 
Notice of Special Review.
    (c) An application to which paragraph (a) or (b) of this section 
applies may not be approved until:
    (1) The Administrator issues a notice for publication in the Federal 
Register which describes why the application is subject to the 
provisions of this section, states that the Administrator proposes to 
approve the application and his reasons, solicits public comment on 
whether the application should be approved, and provides a period not 
less than 30 days for comments to be submitted; and
    (2) If any substantive comments are submitted in response to the 
notice, the Administrator issues a second notice for publication in the 
Federal Register responding to the comments.