(a) Making confidentiality claims—(1) Generally. Any person submitting information under this part may assert a confidentiality claim for that information, except for information described in paragraph (a)(2) of this section. All such confidentiality claims must be asserted at the time the information is submitted. Instructions for asserting confidentiality claims are provided in the document identified in § 705.35. Information claimed as confidential business information in accordance with this section will be treated and disclosed in accordance with the procedures in 40 CFR part 703 and TSCA section 14.
(2) Exceptions. Confidentiality claims cannot be asserted for the following:
(i) Specific chemical identity if the chemical is on the public (non-confidential) TSCA Inventory or reported as non-confidential in an LVE;
(ii) For processing and use data elements required by §§ 705.15(c)(1) through (7) and 705.18(a)(3)(i) through (vii);
(iii) When a response is left blank or designated as “not known or reasonably ascertainable;”
(iv) For specific chemical identity by submitters of article importer forms described in § 705.18(a);
(v) For all generic chemical names;
(vi) For any PFAS that are on the public (non-confidential) TSCA Inventory, the chemical's CASRN;
(vii) For the Inventory Accession Numbers for PFAS that are on the confidential TSCA Inventory; or,
(viii) For LVE numbers.
(3) All existing information concerning environmental and health effects. (i) Any person submitting a health and safety study, or information from a healthy and safety study, under this part may only assert a confidentiality claim for information that discloses processes used in the manufacturing or processing of a chemical substance or mixture or, in the case of a mixture, the release of data disclosing the portion of the mixture comprised by any of the chemical substances in the mixture.
(ii) If any information submitted under § 705.15(f) is claimed as confidential business information, a person who submits the information must provide EPA, at the time of submission, a sanitized copy for public release, removing only that information that is claimed as confidential business information.
(iii) Any person who has previously submitted information under § 705.15(f) and claimed it as confidential business information is required to reassert and re-substantiate the confidential business information claim if they seek to maintain the claim of confidential business information. Such persons are required to submit s a revised sanitized copy.
(b) Substantiation of confidentiality claims. (1) Unless exempted, all confidentiality claims require substantiation at the time of submission and must be signed and dated by an authorized official.
(2) Confidentiality claims for the following data elements are exempt from the substantiation requirement in paragraph (b)(1) of this section:
(i) Volume. Production volume information required pursuant to §§ 705.15(d)(1), (5), and (6) and 705.18(a)(4) and (b)(3)(i).
(ii) Primary submitter. Joint submission information from the primary submitter, consisting of trade name and supplier identification required pursuant to § 705.15(b)(1)(i) and (ii).
(iii) Secondary submitter. Joint submission information from the secondary submitter, consisting of the percentage of formulation required pursuant to § 705.15(b)(1)(i) and (ii).
(c) Marking information claimed as confidential business information in confidentiality substantiation documentation. If any of the information contained in the answers to the questions listed in paragraph (e) of this section is asserted to contain information that itself is considered to be confidential, you must clearly identify the information that is claimed confidential.
(d) Certification statement for claims. An authorized official representing a person asserting a claim of confidentiality must certify that the submission complies with the requirements of this part by signing and dating the following certification statement:
“I certify that all claims for confidentiality asserted with this submission are true and correct, and all information submitted herein to substantiate such claims is true and correct. Any knowing and willful misrepresentation is subject to criminal penalty pursuant to 18 U.S.C. 1001. I further certify that: (1) I have taken reasonable measures to protect the confidentiality of the information; (2) I have determined that the information is not required to be disclosed or otherwise made available to the public under any other Federal law; (3) I have a reasonable basis to conclude that disclosure of the information is likely to cause substantial harm to the competitive position of my company; and (4) I have a reasonable basis to believe that the information is not readily discoverable through reverse engineering.”
(e) Substantiation requirements for all types of confidentiality claims. For each data element that is claimed as confidential business information, you must submit with your report detailed written answers to the following questions:
(1) Substantial harm due to release. Please specifically explain what harm to the competitive position of your business would be likely to result from the release of the information claimed as confidential business information. How would that harm be substantial? Why is the substantial harm to your competitive position likely (i.e., probable) to be caused by release of the information rather than just possible? If you claimed multiple types of information to be confidential (e.g., site information, exposure information, environmental release information, etc.), explain how disclosure of each type of information would be likely to cause substantial harm to the competitive position of your business. (40 CFR 703.5(b)(3))
(2) Precautions to protect confidentiality. 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 business information. If the same or similar information was previously reported to EPA as non-confidential (such as in an earlier version of this submission), please explain the circumstances of that prior submission and reasons for believing the information is nonetheless still confidential.
(3) Disclosure under Federal law or publicly available information. (i) Is any of the information claimed as confidential business information required to be publicly disclosed under any other Federal law? If yes, please explain.
(ii) Does any of the information claimed as confidential business information 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. If this chemical is patented and the patent reveals the information you are claiming to be confidential business information, please explain your reasons for believing the information is nonetheless still confidential.
(4) Duration of claims. Is the claim of confidentiality intended to last less than 10 years (see TSCA section 14(e)(1)(B))? If yes, please indicate the number of years (between 1-10 years) or the specific date after which the claim is withdrawn.
(5) Previously disclosed information. 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.
(f) Additional requirements for specific chemical identity. A person may assert a claim of confidentiality for the specific chemical identity of a chemical substance as described in §§ 705.15(b)(1)(i) and 705.18(b)(2)(i) only if the identity of that chemical substance is treated as confidential in the Master Inventory File (or as a confidential LVE) as of the time the report is submitted for that chemical substance, if that substance is currently on the Inventory or is an LVE. Any person who asserts a claim of confidentiality for the specific chemical identity under this paragraph must provide a generic chemical name. To assert a claim of confidentiality for the identity of a reportable chemical substance, you must submit with the report detailed written answers to the questions from paragraph (b) of this section and to the following questions.
(1) Chemical substance in U.S. commerce. Is this chemical substance publicly known (including by your competitors) to be in U.S. commerce? 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) (40 CFR 703.5(b)(4)). If no, please complete the certification statement:
“I certify that on the date referenced, I searched the internet for the chemical substance identity (i.e., by both chemical substance name and CASRN). I did not find a reference to this chemical substance and have no knowledge of public information that would indicate that the chemical is being manufactured or imported by anyone for a commercial purpose in the United States. [provide date].”
(2) Leave manufacturing site. Does this particular chemical substance leave the site of manufacture (including import) in any form, e.g., as a product, effluent, emission? If yes, please explain what measures have been taken to guard against the discovery of its identity.
(3) Chemical identity. 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, emission), in light of existing technologies and any costs, difficulties, or limitations associated with such technologies? Please explain why or why not.
(4) Chemical name. Would disclosure of the specific chemical name release confidential process information? If yes, please explain.
(g) Joint submissions. If a primary submitter asks a secondary submitter to provide information directly to EPA in a joint submission under §§ 705.15(b)(1)(i) and 705.18(b)(2)(i), only the primary submitter may assert a confidentiality claim for the data elements that it directly submits to EPA. The primary submitter must substantiate those claims that are not exempt under paragraph (b)(2) of this section. The secondary submitter is responsible for asserting all confidentiality claims for the data elements that it submits directly to EPA and for substantiating those claims that are not exempt under paragraph (b)(3) of this section.
(h) No claim of confidentiality. Except for the chemical identity on article importer forms submitted under § 705.18(a), information not claimed as confidential business information in accordance with the requirements of this section may be made public (e.g., by publication of specific chemical name and CASRN on the public portion of the TSCA Inventory). EPA will provide advance public notice of specific chemical identities to be added to the public portion of the TSCA Inventory.