[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: 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.