§ 177.81 - Petition for establishment, modification, or revocation of a food additive regulation.

(a) Who may submit a petition. Any person may submit a petition requesting the Agency to issue a regulation to establish, modify, or revoke a food additive regulation.

(b) Where to submit petition. A petition shall be submitted to: Office of Pesticide Programs (H7504C), Document Processing Desk - PETN, U. S. Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.

(c) Identification of petitioner. A petition must be signed by the petitioner or the petitioner's authorized representative, and must state the petitioner's mailing address and telephone number.

(d) Material to be in English language. The petition shall be written in the English language. If any part of the accompanying material is written in a language other than English, it shall be accompanied by an accurate and complete English translation.

(e) Format for data submission. Data and information submitted in support of a petition shall be on separate sheets or sets of sheets of paper, suitably identified. If an item of data has already been submitted to the Agency, the petitioner may cite it rather than resubmitting it. The data shall be submitted in the manner specified by § 158.32 of this chapter.

(f) Confidentiality of data and information in petition, amendment, or supplement—(1) Asserting confidentiality claims. A petitioner may assert a claim that data and information in a petition, or any amendment or supplement to a petition, other than the summary described in § 177.102(j), are entitled to confidential treatment under part 2 of this chapter. To assert such a claim, the petitioner must mark those portions of the petition, amendment, or supplement, and those portions of any data and information submitted in support of the petition, amendment, or supplement, with the words “trade secret,” “proprietary,” or other words that indicate the data or information are claimed to be confidential business information. If the data and information have also been submitted to EPA under FIFRA, the person shall assert the confidentiality claim in accordance with § 158.33 of this chapter.

(2) Effect of asserting confidentiality claim. If a petitioner asserts a confidentiality claim in accordance with this paragraph for any data or information in a petition, amendment, or supplement, the Agency will disclose that data or information only in accordance with parts 2, 158, 178, and 179, of this chapter, and FIFRA and FFDCA, as applicable.

(3) Failure to assert confidentiality claim. If a petitioner does not assert a claim that specific data and information in a petition, or any amendment or supplement to a petition, are entitled to confidential treatment under part 2 of this chapter in accordance with paragraph (e)(1) of this section at the time of submission of the petition, amendment, or supplement, the Agency will treat that data and information as available for disclosure to the public without further notice to the petitioner.