Code of Federal Regulations (Last Updated: October 10, 2024) |
Title 40 - Protection of Environment |
Chapter I - Environmental Protection Agency |
SubChapter R - Toxic Substances Control Act |
Part 710 - Compilation of the TSCA Chemical Substance Inventory |
Subpart C - XXX |
§ 710.58 - Confidentiality.
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(a) Any person submitting information under this subpart may assert a business confidentiality claim for the information at the time it is submitted. These claims will apply only to the information submitted with the claim. New confidentiality claims, if necessary, must be asserted with regard to information submitted during the next submission period. Guidance
for asserting confidentiality claims is provided in the instruction booklet identified in § 710.59. Information claimed as confidential in accordance with this section will be treated and disclosed in accordance with the procedures in part 2 of this chapter. (b)
Chemical identity . A person may assert a claim of confidentiality for the chemical identity of a specific chemical substance only if the identity of that substance is treated as confidential in the Master Inventory File as of the time the report is submitted for that substance under this subpart. The following steps must be taken to assert a claim of confidentiality for the identity of a reportable chemical substance:(1) The submitter must submit with the report detailed written answers to the following questions signed and dated by an authorized official.
(i) What harmful effects to your competitive position, if any, do you think would result from the identity of the chemical substance being disclosed in connection with reporting under this subpart? How could a competitor use such information? Would the effects of disclosure be substantial? What is the causal relationship between the disclosure and the harmful effects?
(ii) How long should confidential treatment be given? Until a specific date, the occurrence of a specific event, or permanently? Why?
(iii) Has the chemical substance been patented? If so, have you granted licenses to others with respect to the patent as it applies to the chemical substance? If the chemical substance has been patented and therefore disclosed through the patent, why should it be treated as confidential?
(iv) Has the identity of the chemical substance been kept confidential to the extent that your competitors do not know it is being manufactured or imported for a commercial purpose by anyone?
(v) Is the fact that the chemical substance is being manufactured (including imported) for a commercial purpose available to the public, for example in technical journals, libraries, or State, local, or Federal agency public files?
(vi) What measures have been taken to prevent undesired disclosure of the fact that the chemical substance is being manufactured (including imported) for a commercial purpose?
(vii) To what extent has the fact that this chemical substance is manufactured (including imported) for commercial purposes been revealed to others? What precautions have been taken regarding these disclosures? Have there been public disclosures or disclosures to competitors?
(viii) Does this particular chemical substance leave the site of manufacture (including import) in any form, e.g., as product, effluent, emission? If so, what measures have been taken to guard against the discovery of its identity?
(ix) If the chemical substance leaves the site in a product that is available to the public or your competitors, can the substance be identified by analysis of the product?
(x) For what purpose do you manufacture (including import) the substance?
(xi) Has EPA, another Federal agency, or any Federal court made any pertinent confidentiality determinations regarding this chemical substance? If so, please attach copies of such determinations.
(2) If any of the information contained in the answers to the questions listed in paragraph (b)(1) of this section is asserted to contain confidential business information, the submitter must clearly identify the information that is claimed confidential by marking the specific information on each page with a label such as “confidential business information,” “proprietary,” or “trade secret.”
(c)
Site identity . A submitter may assert a claim of confidentiality for a site only if the linkage of the site with a reportable chemical is confidential and not publicly available. The following steps must be taken to assert a claim of confidentiality for a site identity:(1) The submitter must submit with the report detailed written answers to the following questions signed and dated by an authorized official:
(i) Has site information been linked with a chemical identity in any other Federal, state or local reporting scheme? For example, is the chemical
identity linked to a facility in a filing under the Emergency Planning and Community Right-to-Know Act (EPCRA) section 311, namely through a Material Safety Data Sheet (MSDS)? If so, identify all such schemes. Was the linkage claimed as confidential in any of these instances? (ii) What harmful effect, if any, to your competitive position do you think would result from the identity of the site and the chemical substance being disclosed in connection with reporting under this subpart? How could a competitor use such information? Would the effects of disclosure be substantial? What is the causal relationship between the disclosure and the harmful effects?
(2) If any of the information contained in the answers to the questions listed in paragraph (c)(1) of this section is asserted to contain confidential business information, the submitter must clearly identify the information that is claimed confidential by marking the specific information on each page with a label such as “confidential business information,” “proprietary,” or “trade secret.”
(d) If no claim of confidentiality is indicated on the reporting form submitted to EPA under this subpart, or if confidentiality claim substantiation required under paragraphs (b) and (c) of this section is not submitted with the reporting form, EPA may make the information available to the public without further notice to the submitter.