[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: 40CFR152.90]

[Page 20]
 
                   TITLE 40--PROTECTION OF ENVIRONMENT
 
         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
 
PART 152--PESTICIDE REGISTRATION AND CLASSIFICATION PROCEDURES--Table of Contents
 
  Subpart E--Procedures To Ensure Protection of Data Submitters' Rights
 
Sec. 152.90  The selective method.

    An applicant may comply with this subpart by listing the specific 
data requirements that apply to his product, its active ingredients, and 
use patterns, and demonstrating his compliance for each data requirement 
by submitting or citing individual studies, or by demonstrating that no 
study has previously been submitted to the Agency. This section 
summarizes the procedures that an applicant must follow if he chooses 
the selective method of demonstrating compliance. Sections 152.91 
through 152.96 contain specific procedures for citing or submitting a 
study or demonstrating a data gap.
    (a) List of data requirements. Each applicant must submit a list of 
the data requirements that would apply to his pesticide, its active 
ingredients, and its use patterns, if the product were being proposed 
for registration under FIFRA section 3(c)(5) for the first time. The 
applicant need not list data requirements pertaining to any ingredient 
which qualifies for the formulator's exemption.
    (1) If a Registration Standard has been issued for any active 
ingredient, the applicant must list the applicable data requirements 
enumerated in that Standard for the active ingredient and, if end use 
products are covered by the Registration Standard, for such products 
containing that active ingredient.
    (2) If a Registration Standard has not been issued, or if an issued 
Registration Standard does not cover all data requirements for products 
containing the active ingredient in question, the applicant must list 
the applicable requirements as prescribed by 40 CFR part 158. All 
required (R) studies, and any studies that could be conditionally 
required (CR) based upon composition, use pattern, or the results of 
required studies, are to be listed. The applicant may demonstrate via 
the data gap procedures in Sec. 152.96 that a conditional requirement 
need not be satisfied by the submission or citation of data at the time 
of application.
    (b) Methods of demonstrating compliance. The applicant must state 
for each data requirement on the list required by paragraph (a) of this 
section which of the following methods of compliance with the 
requirement he is using, and shall provide the supporting documentation 
specified in the referenced section.
    (1) Existence of or granting of a data waiver. Refer to Sec. 152.91.
    (2) Submission of a new valid study. Refer to Sec. 152.92.
    (3) Citation of a specific valid study previously submitted to the 
Agency by the applicant or another person, with any necessary written 
authorizations or offers to pay. Refer to Sec. 152.93.
    (4) Citation of a public literature study. Refer to Sec. 152.94.
    (5) Citation of all pertinent studies previously submitted to the 
Agency, with any necessary written authorizations or offers to pay. 
Refer to Sec. 152.95.
    (6) Documentation of a data gap. Refer to Sec. 152.96.