[Code of Federal Regulations]
[Title 40, Volume 23]
[Revised as of July 1, 2007]
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 
 
                 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.