[Title 40 CFR 158.50]
[Code of Federal Regulations (annual edition) - July 1, 1996 Edition]
[Title 40 - PROTECTION OF ENVIRONMENT]
[Chapter I - ENVIRONMENTAL PROTECTION AGENCY--(Continued)]
[Subchapter E - PESTICIDE PROGRAMS]
[Part 158 - DATA REQUIREMENTS FOR REGISTRATION]
[Subpart A - General Provisions]
[Sec. 158.50 - Formulators' exemption.]
[From the U.S. Government Publishing Office]




  40
  PROTECTION OF ENVIRONMENT
  11
  1996-07-01
  1996-07-01
  false
  
  158.50
  Sec. 158.50
  
    PROTECTION OF ENVIRONMENT
    ENVIRONMENTAL PROTECTION AGENCY--(Continued)
    PESTICIDE PROGRAMS
    DATA REQUIREMENTS FOR REGISTRATION
    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 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]