[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: 40CFR152.43]

[Page 14]
 
                   TITLE 40--PROTECTION OF ENVIRONMENT
 
         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
 
PART 152--PESTICIDE REGISTRATION AND CLASSIFICATION PROCEDURES--Table of Contents
 
                   Subpart C--Registration Procedures
 
Sec. 152.43  Alternate formulations.

    (a) A product proposed for registration must have a single, defined 
composition, except that EPA may approve a basic formulation and one or 
more alternate formulations for a single product.
    (b) An alternate formulation must meet the criteria listed in 
paragraph (b) (1) through (4) of this section. The Agency may require 
the submission of data to determine whether the criteria have been met.
    (1) The alternate formulation must have the same certified limits 
for each active ingredient as the basic formulation.
    (2) If the alternate formulation contains an inert ingredient or 
impurity of toxicological signficance, the formulation must have the 
same upper certified limit for that substance as the basic formulation;
    (3) The label text of the alternate formulation product must be 
identical to that of the basic formulation.
    (4) The analytical method required under Sec. 158.180 must be 
suitable for use on both the basic formulation and the alternate 
formulation.
    (c) Notwithstanding the criteria in this section, the Agency may 
determine that an alternate formulation must be separately registered. 
If EPA makes this determination, the Agency will notify the applicant of 
its determination and its reasons. Thereafter the application for an 
alternate formulation will be treated as an application for new 
registration, and the alternate formulation will be assigned a new 
registration number.