Sec. 13. Confidential information
2,203 words·~10 min read·
/bill/113/s/1009/is/section-13A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
Section 14 (15 U.S.C. 2613) is amended to read as follows: Except as provided in subsections
(c)and (e), the Administrator shall not disclose information described in subsection (b)— that is reported to, or otherwise obtained by, the Administrator under this Act; and for which the requirements of subsection
(d)are met. Information referred to in subsection
(a)includes confidential information that is exempt from disclosure pursuant to subsection
(a)of section 552 of title 5, United States Code, under subsection (b)(4) of that section. The following information submitted by a manufacturer, processor, or distributor is presumed to be protected from disclosure: Specific information describing the manufacture, processing, or distribution in commerce of a chemical substance, mixture, or article. Marketing and sales information. Information identifying suppliers or customers. The identity of constituents in a mixture and the respective percentages of those constituents. Specific information about the use, function, or application of a chemical substance or mixture in a process, mixture, or product. Specific production or import volumes of a manufacturer and specific volumes aggregated across manufacturers if the Administrator determines that disclosure of the aggregated data could reveal confidential information. The specific identity of a chemical substance, including the chemical name, molecular formula, Chemical Abstracts Service number, and other information that would identify a specific chemical substance, if— the specific identity was claimed as confidential information at the time it was submitted; and the claim has not subsequently been withdrawn or found by the Administrator not to warrant protection as confidential information under subsection (g). Notwithstanding subsections
(a)and (b), and except as provided in paragraph (2), the following information shall not be protected from disclosure: For information submitted after the date of enactment of the Chemical Safety Improvement Act , the identity of a chemical substance if the person submitting the information does not meet the requirements of subsection (d). A safety assessment developed or a safety determination made under section 6. Health and safety data that are submitted under this Act with respect to a chemical substance or mixture that has been offered for commercial distribution as of the date on which the study is to be disclosed or for which testing is required under section 4. Health and safety data in notices of substantial risk submitted under section 8(e) and in the underlying studies. General information describing the manufacturing volumes, expressed in ranges would not reveal confidential information. General descriptions of industrial, commercial, or consumer functions and uses of a chemical substance or mixture. Information elements contained in submissions described in paragraph
(1)that are otherwise eligible for protection under this section shall be protected from disclosure if the submitter complies with subsection (d). For information to be protected from disclosure under this section, a person who submits information to the Administrator under this Act shall— indicate the information that the person believes is entitled to protection from disclosure under this section in a submission to the Administrator in such manner and at such time as the Administrator shall prescribe; and except in the case of information described in subparagraphs
(A)through
(F)of subsection (b)(2), submit written documentation justifying why the information qualifies for protection from disclosure. An authorized official of the person described in subparagraph
(A)shall certify that the information that has been submitted is true and correct. A person submitting information under this Act related to a chemical identity and who claims protection from disclosure for that identity shall provide the Administrator with— information establishing that— the person takes reasonable measures to protect the confidentiality of the chemical identity; the chemical identity is not required to be disclosed, or otherwise made available, to the public under any other Federal law in connection with one or more uses subject to this Act; disclosure of the chemical identity is likely to cause substantial harm to the competitive position of the person; and the chemical identity is not reasonably believed to be readily discoverable through reverse engineering; the time period for which protection of the chemical identity from disclosure is necessary; a generic name for the chemical substance that the Administrator may disclose to the public, subject to the condition that the generic name discloses a maximum amount of information on the chemical structure of the substance while protecting those features of the chemical structure that are considered confidential and the disclosure of which would potentially harm the competitive position of the person; and in the event the Administrator makes a request under subsection (f)— redocumentation and recertification of the information submitted under subsection (a); or withdrawal of the claim for protection of the chemical identity from disclosure. The Administrator shall develop guidance, after notice and opportunity to comment, on the determination of generic names for confidential chemical identities. Subsection
(a)shall not apply if— the information is to be disclosed to an officer or employee of the United States in connection with the official duties of that person under any law for the protection of human health or the environment or for specific law enforcement purposes; the information is to be disclosed to a contractor with the United States and employees of that contractor if, in the opinion of the Administrator, the disclosure is necessary for the satisfactory performance by the contractor of a contract with the United States for the performance of work in connection with this Act and under such conditions as the Administrator shall specify; the Administrator determines that disclosure is necessary to protect human health or the environment; the information is to be disclosed to a State or political subdivision of a State, on written request, for the purpose of development, administration, or enforcement of a law, if— one or more applicable agreements with the Administrator ensure that the recipient government will take appropriate steps, and has adequate authority, to maintain the confidentiality of the information in accordance with procedures as stringent as those which the Administrator uses to safeguard the information; and the Administrator notifies the person who submitted the information that the information has been disclosed to a State or political subdivision of a State; a health professional employed by a Federal or State agency or a treating physician or nurse in a nonemergency situation provides a written statement of need and a written confidentiality agreement, subject to the conditions that— the written statement of need is a statement that the person has a reasonable basis to suspect that— the information is needed for purposes of diagnosis or treatment of one or more individuals; one or more individuals being diagnosed or treated have been exposed to the chemical substance concerned; and knowledge of the specific chemical identity of the chemical substance will assist in diagnosis or treatment; and the confidentiality agreement provides that the person will not use the specific chemical identity for any purpose other than the health needs asserted in the statement of need, except as may otherwise be authorized by the terms of the agreement or by the person submitting the specific chemical identity to the Administrator; a treating physician or nurse requests the information, subject to the conditions that— the treating physician or nurse determines that— a medical emergency exists; the specific chemical identity of the chemical substance concerned is necessary for or will assist in emergency or first-aid diagnosis or treatment; and the one or more individuals being diagnosed or treated have likely been exposed to the chemical substance concerned; if requested by the person submitting the specific chemical identity to the Administrator, the treating physician or nurse provides a written statement of need and a confidentiality agreement as described in paragraph (5); and the written confidentiality agreement or statement of need is submitted as soon as practicable, but not necessarily before the information is disclosed; the Administrator determines that disclosure is necessary in a proceeding under this Act, subject to the condition that the disclosure is made in such a manner as to preserve confidentiality to the maximum extent practicable without impairing the proceeding; or the information is to be disclosed, on written request of any duly authorized committee of the Congress, to that committee. The Administrator shall protect from disclosure information described in subsection
(b)that meets the requirements of subsection (d)(2) for the period of time requested by the person submitting the claim or for such period of time as the Administrator, after reviewing the request for confidential treatment and the documentation, otherwise determines to be reasonable, unless— prior to the expiration of the period, the person notifies the Administrator that the person is withdrawing the confidentiality claim, in which case, the Administrator shall promptly make the information available to the public; or prior to the expiration of the period, the Administrator otherwise becomes aware that the need for protection from disclosure can no longer be substantiated, in which case the Administrator shall take the actions described in subsection (g)(2). The Administrator may request— at any time, a person who has requested protection from disclosure for the identity of a substance under subsection
(d)to redocument the confidentiality claim of the person; and any person who has requested that confidential information be protected from disclosure under section 8(b) to reassert the confidentiality claim of the person after the chemical substance is identified as a high-priority substance under section 4(e). Except as provided in subsection (b)(2), the Administrator shall— review a request received under this section to maintain the confidentiality of information submitted under this Act; and determine whether to approve, modify, or deny that request. The Administrator shall deny a claim to protect a chemical identity from disclosure only if the person who has submitted the request fails to meet the requirements of subsection (d). The Administrator shall provide to the person who has submitted the request a written statement of the reasons for the denial or modification of the claim. If it is not feasible for the Administrator to review each request under this section, the Administrator shall review a representative subset. Except as provided in subsections
(c)and (e), if the Administrator denies a request under paragraph (1), the Administrator shall notify, in writing and by certified mail, the person who submitted the request of the intent of the Administrator to release the information. Except as provided in clause (ii), the Administrator may not release information under this subsection until the date that is 30 days after the date on which the person who submitted the request receives notification under subparagraph (A). For information under paragraph
(3)or
(8)of subsection (e), the Administrator may not release that information until the date that is 15 days after the date on which the person who submitted the request receives a notification, unless the Administrator determines that release of the information is necessary to protect against an imminent and substantial harm to human health or the environment, in which case, no prior notification is necessary. For information under paragraph
(6)or
(7)of subsection (e), no prior notification is necessary. A person who receives notification under this subsection may, if the person believes disclosure of the information is prohibited under subsection (a), before the date on which the information is to be released, bring an action to restrain disclosure of the information in— the district court of the United States in the district in which— the complainant resides or has the principal place of business; or the information is located; or the United States District Court for the District of Columbia. The Administrator shall not disclose any information under this section prior to the date on which the applicable court rules on an action under subparagraph (A). In carrying out this subsection, the Administrator shall employ the procedures in part 2 of title 40, Code of Federal Regulations (or successor regulations). Subject to paragraph (2), any officer or employee of the United States or former officer or employee of the United States, who— by virtue of that employment or official position has obtained possession of, or has access to, material the disclosure of which is prohibited by subsection (a); and knowing that disclosure of that material is prohibited by subsection (a), willfully discloses the material in any manner to any person not entitled to receive that material, shall be— guilty of a misdemeanor and fined under title 18, United States Code, imprisoned for not more than 1 year, or both; and removed from office or employment. Section 1905 of title 18, United States Code, shall not apply with respect to the publishing, divulging, disclosure, making known of, or making available, information reported or otherwise obtained under this Act. For the purposes of this subsection, any contractor of the United States who is furnished information in accordance with subsection (e)(2), including any employee of that contractor, shall be considered to be an employee of the United States. Except as otherwise provided in this section, the Administrator shall have no authority— to require the documentation or redocumentation of a claim for the protection from disclosure of information submitted to the Administrator under this Act prior to the date of enactment of the Chemical Safety Improvement Act ; or to impose redocumentation requirements under this Act that are more extensive than those required under this section. .
Connectionstraces to 1
Traces to 1 document
U.S. Code
Citation graph
cites case law
Sec. 13
Confidential information
Cites 1Cited by 0 across 0 sources