[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: 40CFR152.90]



[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.