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e-CFR data is current as of January 19, 2021

Title 40Chapter ISubchapter RPart 710 → Subpart C


Title 40: Protection of Environment
PART 710—COMPILATION OF THE TSCA CHEMICAL SUBSTANCE INVENTORY


Subpart C—Review Plan


Contents
§710.41   Scope.
§710.43   Persons subject to substantiation requirement.
§710.45   Contents of substantiation.
§710.47   When to submit substantiation or information on previous substantiation.
§710.49   Failure to report.
§710.51   Electronic filing.
§710.53   Recordkeeping requirements.
§710.55   Claim review, duration of protection, TSCA Inventory maintenance, posting results, and extension.

Source: 85 FR 13068, Mar. 6, 2020, unless otherwise noted.

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§710.41   Scope.

This subpart applies to the substantiation and review of claims of confidentiality asserted in Notices of Activity Form A to protect the specific chemical identities of chemical substances.

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§710.43   Persons subject to substantiation requirement.

(a) Who must substantiate. Any person who filed a Notice of Activity Form A requesting to maintain an existing confidentiality claim for a specific chemical identity must substantiate that confidentiality claim as specified in §§710.45 and 710.47 unless eligible for an exemption in paragraph (b) of this section.

(b) Exemptions. (1) Any person who completed the voluntary substantiation process set forth in §710.37(a)(1) is exempt from the substantiation requirement of this subpart pertaining to the submission of answers to the questions in §710.45(b)(1) through (6). All remaining requirements of §710.45 must be met in accordance with the deadline specified in §710.47(a), including the requirement to submit answers to the questions in §710.45(b)(7) and (8), signed and dated by an authorized official, and to complete the certification statement in §710.37(e).

(2) A person who has previously substantiated the confidentiality claim for a specific chemical identity that the person requested to maintain in a Notice of Activity Form A, by submitting information that is responsive to all questions in §710.45, is exempt from the substantiation requirement of this subpart if both of the following conditions are met:

(i) The previous substantiation was submitted to EPA on or after November 1, 2015; and

(ii) The person reports to EPA the submission date, submission type, and case number, transaction ID, or equivalent identifier for the previous submission that contained the substantiation, not later than the deadline specified in §710.47.

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§710.45   Contents of substantiation.

(a) The submission. A person substantiating a confidentiality claim for a specific chemical identity must submit written answers to the questions in paragraph (b) of this section, signed and dated by an authorized official, and complete the certification statement in §710.37(e). If any of the information contained in the answers to the questions listed in paragraph (b) of this section is itself claimed as confidential, the submitter must clearly indicate such by marking that information as confidential business information.

(b) Substantiation questions. (1) Will disclosure of the information claimed as confidential likely cause substantial harm to your business's competitive position? If you answered yes, describe the substantial harmful effects that would likely result to your competitive position if the information is disclosed, including but not limited to how a competitor could use such information and the causal relationship between the disclosure and the harmful effects.

(2) To the extent your business has disclosed the information to others (both internally and externally), has your business taken precautions to protect the confidentiality of the disclosed information? If yes, please explain and identify the specific measures, including but not limited to internal controls, that your business has taken to protect the information claimed as confidential.

(3)(i) Is any of the information claimed as confidential required to be publicly disclosed under any other Federal law? If yes, please explain.

(ii) Does any of the information claimed as confidential otherwise appear in any public documents, including (but not limited to) safety data sheets; advertising or promotional material; professional or trade publications; state, local, or Federal agency files; or any other media or publications available to the general public? If yes, please explain why the information should be treated as confidential.

(iii) Does any of the information claimed as confidential appear in one or more patents or patent applications? If yes, please provide the associated patent number or patent application number (or numbers) and explain why the information should be treated as confidential.

(4) Is the claim of confidentiality intended to last less than 10 years? If yes, please indicate the number of years (between 1-10 years) or the specific date/occurrence after which the claim is withdrawn.

(5) Has EPA, another Federal agency, or court made any confidentiality determination regarding information associated with this chemical substance? If yes, please provide the circumstances associated with the prior determination, whether the information was found to be entitled to confidential treatment, the entity that made the decision, and the date of the determination.

(6) Is the confidential chemical substance publicly known (including by your competitors) to have ever been offered for commercial distribution in the United States? If yes, please explain why the specific chemical identity should still be afforded confidential status (e.g., the chemical substance is publicly known only as being distributed in commerce for research and development purposes, but no other information about the current commercial distribution of the chemical substance in the United States is publicly available).

(7) Does this particular chemical substance leave the site of manufacture (including import) or processing in any form, e.g., as a product, effluent, or emission? If yes, please explain what measures have been taken, if any, to guard against the discovery of its identity.

(8) If the chemical substance leaves the site in a form that is available to the public or your competitors, can the chemical identity be readily discovered by analysis of the substance (e.g., product, effluent, or emission), in light of existing technologies and any costs, difficulties, or limitations associated with such technologies? Please explain why or why not.

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§710.47   When to submit substantiation or information on previous substantiation.

(a) All persons required to substantiate a confidentiality claim pursuant to §710.43(a) or (b)(1) must submit their substantiation not later than November 1, 2020.

(b) All persons who seek an exemption under §710.43(b)(2) must submit the information specified in §710.43(b)(2)(ii) not later than November 1, 2020.

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§710.49   Failure to report.

If neither the substantiation required under §710.43(a) or (b)(1), nor the information specified in §710.43(b)(2)(ii), is submitted to EPA in accordance with the provisions of this subpart, then EPA will deny the confidentiality claim in accordance with the procedures set forth in TSCA section 14(g)(2) and 40 CFR part 2, subpart B.

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§710.51   Electronic filing.

EPA will accept information submitted under this subpart only if submitted in accordance with §710.39.

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§710.53   Recordkeeping requirements.

Each person who is subject to this part must retain records that document any information reported to EPA. Records must be retained for a period of 5 years beginning on the last day of the submission period.

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§710.55   Claim review, duration of protection, TSCA Inventory maintenance, posting results, and extension.

(a) Review criteria and procedures. Except as set forth in this subpart, confidentiality claims for specific chemical identities asserted in Notices of Activity Form A will be reviewed and approved or denied in accordance with the criteria and procedures in TSCA section 14 and 40 CFR part 2, subpart B.

(b) Duration of protection from disclosure. Except as provided in 40 CFR part 2, subpart B, and section 14 of TSCA, a specific chemical identity that is the subject of an approved confidentiality claim under this subpart will be protected from disclosure for a period of 10 years from the date on which the confidentiality claim was first asserted by any submitter after June 22, 2016, unless, prior to the expiration of the period, the claimant notifies EPA that the person is withdrawing the confidentiality claim, in which case EPA will not protect the information from disclosure; or EPA otherwise becomes aware that the information does not qualify for protection from disclosure, in which case EPA will take the actions described in TSCA section 14(g)(2) to notify the claimant of EPA's intent to disclose the information.

(c) Updating the TSCA Inventory. EPA will periodically update the TSCA Inventory based on the results of the reviews of the confidentiality claims asserted in Notices of Activity Form A.

(d) Posting of annual goals and numbers of reviews completed. At the beginning of each calendar year until all reviews are completed, EPA will publish an annual goal for reviews and the number of reviews completed in the prior year on the Agency website. Determination of annual review goals will take into consideration the number of claims needing review, available resources, and a target completion date for all reviews under this subpart not later than February 19, 2024.

(e) Extension. If EPA determines that the target completion date in paragraph (d) of this section cannot be met based on the number of claims needing review and the available resources, then EPA will publish a document in the Federal Register announcing the extension of the deadline to complete its review of all confidentiality claims under this subpart for not more than two additional years, together with an explanation of the reasons for the extension.

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