[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: 40CFR152.116]



[Page 29]

 

                   TITLE 40--PROTECTION OF ENVIRONMENT

 

         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)

 

PART 152_PESTICIDE REGISTRATION AND CLASSIFICATION PROCEDURES--Table of 

Contents

 

                 Subpart F_Agency Review of Applications

 

Sec.  152.116  Notice of intent to register to original submitters of 

exclusive use data.



    (a) Except as provided in paragraph (c) of this section, at least 30 

days before registration of a product containing an active ingredient 

for which a previously submitted study is eligible for exclusive use 

under FIFRA sec. 3(c)(1)(D)(i), the Agency will notify the original 

submitter of the exclusive use study of the intended registration of the 

product. If requested by the exclusive use data submitter within 30 

days, the Agency will also provide the applicant's list of data 

requirements and method of demonstrating compliance with each data 

requirement.

    (b) Within 30 days after receipt of the Agency's notice, or of the 

applicant's list of data requirements, whichever is later, the exclusive 

use data submitter may challenge the issuance of the registration in 

accordance with the procedures in Sec.  152.99 (b) and (c). If the 

Agency finds that the challenge has merit, it will issue a notice of 

denial of the application. The applicant may then avail himself of the 

hearing procedures provided by FIFRA sec. 3(c)(6). If the Agency finds 

that the challenge is without merit, it will deny the petition and 

register the applicant's product. Denial of the petition is a final 

Agency action.

    (c) If an applicant has submitted to the Agency a certification from 

an exclusive use data submitter that he is aware of the applicant's 

application for registration, and does not object to the issuance of the 

registration, the Agency will not provide the 30-day notification 

described in paragraph (a) of this section to that exclusive use data 

submitter.