[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: 40CFR158.50]



[Page 84-85]

 

                   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.  158.50  Formulators' exemption.



    (a) FIFRA section 3(c)(2)(D) provides that an applicant for 

registration of an end-use pesticide product need not submit or cite any 

data that pertain to the safety of another registered pesticide



[[Page 85]]



product which is purchased by the applicant and used in the manufacture 

or formulation of the product for which registration is sought.

    (b) This exemption applies only to data concerning safety of a 

product or its ingredients, not to efficacy data. Data concerning safety 

includes toxicity, metabolism, environmental fate, product chemistry, 

and residue chemistry data.

    (c) This exemption does not apply to data concerning the safety of 

the applicant's end-use product itself, unless the composition of the 

applicant's product and that of the purchased product are identical, 

i.e., data which this part indicates must be developed by tests using 

the end-use product for which registration is sought as the test 

substance. These requirements can be identified by the notation ``EP*'' 

in the ``test substance'' column of the tables in subparts C and D of 

this part and these are the minimum data requirements that the applicant 

described in paragraph (a) of this section (i.e., the ``formulator'') 

must satisfy.

    (d) The data to which this exemption applies usually will concern 

the safety of one or more of the end-use product's active ingredients, 

specifically, those active ingredients which are contained in the 

purchased product. These data requirements normally can be identified by 

the notations ``TGAI'' (technical grade of active ingredient), ``PAI'' 

(pure active ingredients), ``PAIRA'' (pure active ingredient, 

radiolabeled), or ``TEP'' (typical end-use product) in the ``test 

substance'' column of the tables in subparts C and D of this part.

    (e) EPA interprets FIFRA section 3(c)(2)(D) as allowing an applicant 

to use the formulator's exemption with respect to a data requirement 

concerning the safety of an ingredient of his product only if:

    (1) His application indicates that the ingredient's presence in his 

product is attributable solely to his purchase from another person of an 

identified, registered product containing that ingredient and his use of 

the purchased product in formulating his product; and

    (2) The purchased product is a registered manufacturing-use product 

whose label does not prohibit its use for making an end-use product with 

any use for which the applicant's product will be labeled; or

    (3) The purchased end-use product is a registered end-use product 

labeled for each use for which the applicant's product will be labeled.

    (f) Notwithstanding FIFRA section 3(c)(2)(D), EPA will not approve 

an application unless there is available to EPA for its review whatever 

data is necessary in order to make the required risk/benefit finding 

under FIFRA section 3(c)(5) or section 3(c)(7).



[49 FR 42881, Oct. 24, 1984, as amended at 53 FR 15999, May 4, 1988]