[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: 40CFR172.52]



[Page 266]

 

                   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 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 Office of Pesticide Programs' Document Processing Desk at the 

appropriate address as set forth in 40 CFR 150.17(a) or (b).

    (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.



[59 FR 45612, Sept. 1, 1994, as amended at 71 FR 35546, June 21, 2006]