[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: 40CFR172.52]

[Page 266-267]
 
                   TITLE 40--PROTECTION OF ENVIRONMENT
 
         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
 
PART 172--EXPERIMENTAL USE PERMITS--Table of Contents
 
   Subpart C--Notification for Certain Genetically Modified Microbial 
                               Pesticides
 
Sec. 172.52  Notification exemption process.

    (a) Initiation of the exemption process. Pesticides may be added to 
the list of exemptions in Sec. 172.45(d) by rule at EPA's initiative or 
in response to a petition submitted in accordance with paragraph (b) of 
this section.
    (b) Petitions for exemption from the requirement for a Notification-
-(1) Who may submit a petition. Any person may

[[Page 267]]

submit a petition requesting an exemption from the notification 
requirements of this subpart for a specific microbial pesticide or class 
of microbial pesticides.
    (2) Where to submit a petition. All petitions shall be submitted to 
the following location: Registration Division (7507C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460.
    (3) Content of petition. Each petition shall contain the following:
    (i) Name and address of petitioner and name, address, and telephone 
number of a person who may be contacted for further information.
    (ii) Description of the exemption requested, including the specific 
microbial pesticide or class of microbial pesticides to be tested under 
the petition for exemption.
    (iii) Basis for the petitioner's contention that the specific 
microbial pesticide or class of microbial pesticides meet the criteria 
of Sec. 172.3 for small-scale tests of pesticides that do not require an 
EUP.
    (iv) Discussion of the extent to which the microbial pesticide or 
class of microbial pesticides covered by the petition differ from 
microbial pesticides that are already registered or subject to an EUP 
under the Act.
    (4) Administrative action on a petition. EPA will review and 
evaluate petitions as expeditiously as possible and may request further 
information from the petitioner to assess the proposed exemption 
adequately. No later than 180 days after the submission of a petition, 
or 90 days after the last submission of additional information by the 
petitioner, whichever is later, EPA will take one of the following 
actions with respect to the petition:
    (i) Grant the petition and publish a notice of proposed rulemaking 
in the Federal Register for a 45-day comment period proposing the 
exemption requested by the petitioner.
    (ii) Grant the petition and publish a notice of proposed rulemaking 
in the Federal Register for a 45-day comment period proposing an 
exemption under such terms and conditions as EPA deems appropriate.
    (iii) Deny the petition and provide the petitioner with a written 
explanation of EPA's decision.
    (5) Confidential business information (CBI) claims. To assert a 
claim of confidentiality, the petitioner must comply with the applicable 
procedures in Sec. 172.46(d).
    (6) Supplements, amendments, and withdrawals. The petitioner may 
supplement, amend, or withdraw his or her petition in writing without 
EPA approval at any time prior to the granting or denial of the petition 
under paragraph (b)(4) of this section. The withdrawal of a petition 
shall be without prejudice to the resubmission of the petition at a 
later date.