40 CFR § 172.52 - Notification exemption process.
(a) Initiation of the exemption process. Pesticides may be added to the list of exemptions in § 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 § 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 § 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.