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

Title 40Chapter ISubchapter RPart 710Subpart C → §710.45

Title 40: Protection of Environment
Subpart C—Review Plan

§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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