40 CFR § 725.80 - General provisions for confidentiality claims.

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§ 725.80 General provisions for confidentiality claims.

(a) A person may assert a claim of confidentiality for any information submitted to EPA under this part. However,

(1) Any person who asserts a claim of confidentiality for portions of the specific microorganism identity must provide the information as described in § 725.85.

(2) Any person who asserts a claim of confidentiality for a use of a microorganism must provide the information as described in § 725.88.

(3) Any person who asserts a claim of confidentiality for information contained in a health and safety study of a microorganism must provide the information described in § 725.92.

(b) Any claim of confidentiality must accompany the information when it is submitted to EPA.

(1) When a person submits any information under this part, including any attachments, for which claims of confidentiality are made, the claim(s) must be asserted by circling the specific information which is claimed and marking the page on which that information appears with an appropriate designation such as “trade secret,” “TSCA CBI,” or “confidential business information.”

(2) If any information is claimed confidential, the person must submit two copies of the document including the claimed information.

(i) One copy of the document must be complete. In that copy, the submitter must mark the information which is claimed as confidential in the manner prescribed in paragraph (b)(1) of this section.

(ii) The second copy must be complete except that all information claimed as confidential in the first copy must be deleted. EPA will place the second copy in the public file.

(iii) If the submitter does not provide the second copy, the submission is incomplete and the review period does not begin to run until EPA receives the second copy, in accordance with § 725.33.

(iv) Any information contained within the copy submitted under paragraph (b)(2)(ii) of this section which has been in the public file for more than 30 days will be presumed to be in the public domain, notwithstanding any assertion of confidentiality made under this section.

(3) A person who submits information to EPA under this part must reassert a claim of confidentiality and substantiate the claim each time the information is submitted to EPA.

(c) Any person asserting a claim of confidentiality under this part must substantiate each claim in accordance with the requirements in § 725.94.

(d) EPA will disclose information that is subject to a claim of confidentiality asserted under this section only to the extent permitted by the Act, this subpart, and part 2 of this title.

(e) If a submitter does not assert a claim of confidentiality for information at the time it is submitted to EPA, EPA may make the information public and place it in the public file without further notice to the submitter.