Sec. 14. Confidential information
4,155 words·~19 min read·
/bill/114/hr/2576/eas/section-14·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
Section 14 of the Toxic Substances Control Act ( 15 U.S.C. 2613 ) is amended to read as follows: Except as otherwise provided in this section, the Administrator shall not disclose 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— that is reported to, or otherwise obtained by, the Administrator under this Act; and for which the requirements of subsection
(d)are met. The following information specific to, and submitted by, a manufacturer, processor, or distributor that meets the requirements of subsections
(a)and
(d)shall be presumed to be protected from disclosure, subject to the condition that nothing in this Act prohibits the disclosure of any such information, or information that is the subject of subsection (g)(3), through discovery, subpoena, other court order, or any other judicial process otherwise allowed under applicable Federal or State law: Specific information describing the processes used in manufacture or processing of a chemical substance, mixture, or article. Marketing and sales information. Information identifying a supplier or customer. Details of the full composition of a mixture and the respective percentages of constituents. Specific information regarding the use, function, or application of a chemical substance or mixture in a process, mixture, or product. Specific production or import volumes of the manufacturer. Specific aggregated volumes across manufacturers, if the Administrator determines that disclosure of the specific aggregated volumes would reveal confidential information. Except as otherwise provided in this section, the specific identity of a chemical substance prior to the date on which the chemical substance is first offered for commercial distribution, 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 in a notice under section 5. Notwithstanding subsections
(a)and (b), the following information shall not be protected from disclosure: Subject to clause (ii)— any health and safety study that is submitted under this Act with respect to— any chemical substance or mixture that, on the date on which the study is to be disclosed, has been offered for commercial distribution; or any chemical substance or mixture for which— testing is required under section 4; or a notification is required under section 5; or any information reported to, or otherwise obtained by, the Administrator from a health and safety study relating to a chemical substance or mixture described in item
(aa)or
(bb)of subclause (I). Nothing in this subparagraph authorizes the release of any information that discloses— a process used in the manufacturing or processing of a chemical substance or mixture; or in the case of a mixture, the portion of the mixture comprised by any chemical substance in the mixture. For information submitted after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act , the specific identity of a chemical substance as of the date on which the chemical substance is first offered for commercial distribution, 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. Any general information describing the manufacturing volumes, expressed as specific aggregated volumes or, if the Administrator determines that disclosure of specific aggregated volumes would reveal confidential information, expressed in ranges. A general description of a process used in the manufacture or processing and industrial, commercial, or consumer functions and uses of a chemical substance, mixture, or article containing a chemical substance or mixture, including information specific to an industry or industry sector that customarily would be shared with the general public or within an industry or industry sector. Any information that is eligible for protection under this section and is submitted with information described in this subsection shall be protected from disclosure, if the submitter complies with subsection (d), subject to the condition that information in the submission that is not eligible for protection against disclosure shall be disclosed. If the Administrator promulgates a rule pursuant to section 6(d) that establishes a ban or phase-out of the manufacture, processing, or distribution in commerce of a chemical substance, subject to paragraphs (2), (3), and
(4)of subsection (g), any protection from disclosure provided under this section with respect to the specific identity of the chemical substance and other information relating to the chemical substance shall no longer apply. If a request is made to the Administrator under section 552(a) of title 5, United States Code, for information that is subject to disclosure under this subsection, the Administrator may not deny the request on the basis of section 552(b)(4) of title 5, United States Code. A person seeking to protect any information submitted under this Act from disclosure (including information described in subsection (b)) shall assert to the Administrator a claim for protection concurrent with submission of the information, in accordance with such rules regarding a claim for protection from disclosure as the Administrator has promulgated or may promulgate pursuant to this title. An assertion of a claim under subparagraph
(A)shall include a statement that the person has— taken reasonable measures to protect the confidentiality of the information; determined that the information is not required to be disclosed or otherwise made available to the public under any other Federal law; a reasonable basis to conclude that disclosure of the information is likely to cause substantial harm to the competitive position of the person; and a reasonable basis to believe that the information is not readily discoverable through reverse engineering. In the case of a claim under subparagraph
(A)for protection against disclosure of a specific chemical identity, the claim shall include a structurally descriptive generic name for the chemical substance that the Administrator may disclose to the public, subject to the condition that the generic name shall— be consistent with guidance issued by the Administrator under paragraph (3)(A); and describe the chemical structure of the substance as specifically as practicable while protecting those features of the chemical structure— that are considered to be confidential; and the disclosure of which would be likely to cause substantial harm to the competitive position of the person. No person may assert a claim under this section for protection from disclosure of information that is already publicly available. Except for information described in subsection (b), a person asserting a claim to protect information from disclosure under this Act shall substantiate the claim, in accordance with the rules promulgated and consistent with the guidance issued by the Administrator. The Administrator shall develop guidance regarding— the determination of structurally descriptive generic names, in the case of claims for the protection against disclosure of specific chemical identity; and the content and form of the statements of need and agreements required under paragraphs (4), (5), and
(6)of subsection (e). An authorized official of a person described in paragraph (1)(A) shall certify that the statement required to assert a claim submitted pursuant to paragraph (1)(B) and any information required to substantiate a claim submitted pursuant to paragraph
(2)are true and correct. Information described in subsection (a)— shall be disclosed if the information is to be disclosed to an officer or employee of the United States in connection with the official duties of the officer or employee— under any law for the protection of health or the environment; or for a specific law enforcement purpose; shall be disclosed if the information is to be disclosed to a contractor of 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 subject to such conditions as the Administrator may specify; shall be disclosed if the Administrator determines that disclosure is necessary to protect health or the environment; shall be disclosed if 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 1 or more applicable agreements with the Administrator that are consistent with the guidance issued under subsection (d)(3)(B) ensure that the recipient will take appropriate measures, and has adequate authority, to maintain the confidentiality of the information in accordance with procedures comparable to the procedures used by the Administrator to safeguard the information; shall be disclosed if a health or environmental 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 agrees to sign a written confidentiality agreement with the Administrator, subject to the conditions that— the statement of need and confidentiality agreement are consistent with the guidance issued under subsection (d)(3)(B); the written statement of need shall be a statement that the person has a reasonable basis to suspect that— the information is necessary for, or will assist in— the diagnosis or treatment of 1 or more individuals; or responding to an environmental release or exposure; and 1 or more individuals being diagnosed or treated have been exposed to the chemical substance concerned, or an environmental release or exposure has occurred; and the confidentiality agreement shall provide that the person will not use the information for any purpose other than the health or environmental needs asserted in the statement of need, except as otherwise may be authorized by the terms of the agreement or by the person submitting the information to the Administrator, except that nothing in this Act prohibits the disclosure of any such information through discovery, subpoena, other court order, or any other judicial process otherwise allowed under applicable Federal or State law; shall be disclosed if in the event of an emergency, a treating physician, nurse, agent of a poison control center, public health or environmental official of a State or political subdivision of a State, or first responder (including any individual duly authorized by a Federal agency, State, or political subdivision of a State who is trained in urgent medical care or other emergency procedures, including a police officer, firefighter, or emergency medical technician) requests the information, subject to the conditions that— the treating physician, nurse, agent, public health or environmental official of a State or a political subdivision of a State, or first responder shall have a reasonable basis to suspect that— a medical or public health or environmental emergency exists; the information is necessary for, or will assist in, emergency or first-aid diagnosis or treatment; or 1 or more individuals being diagnosed or treated have likely been exposed to the chemical substance concerned, or a serious environmental release of or exposure to the chemical substance concerned has occurred; if requested by the person submitting the information to the Administrator, the treating physician, nurse, agent, public health or environmental official of a State or a political subdivision of a State, or first responder shall, as described in paragraph (5)— provide a written statement of need; and agree to sign a confidentiality agreement; and the written confidentiality agreement or statement of need shall be submitted as soon as practicable, but not necessarily before the information is disclosed; may be disclosed if the Administrator determines that disclosure is relevant in a proceeding under this Act, subject to the condition that the disclosure shall be made in such a manner as to preserve confidentiality to the maximum extent practicable without impairing the proceeding; shall be disclosed if the information is to be disclosed, on written request of any duly authorized congressional committee, to that committee; or shall be disclosed if the information is required to be disclosed or otherwise made public under any other provision of Federal law. Subject to paragraph (2), the Administrator shall protect from disclosure information described in subsection
(b)that meets the requirements of subsections
(a)and (d), unless— the person that asserted the claim notifies the Administrator that the person is withdrawing the claim, in which case the Administrator shall promptly make the information available to the public; or the Administrator otherwise becomes aware that the information does not qualify or no longer qualifies for protection against disclosure under subsection (a), in which case the Administrator shall take any actions required under subsection (g)(2). Subject to paragraph (2), the Administrator shall protect from disclosure information, other than information described in subsection (b), that meets the requirements of subsections
(a)and
(d)for a period of 10 years, unless, prior to the expiration of the period— the person that asserted the claim notifies the Administrator that the person is withdrawing the claim, in which case the Administrator shall promptly make the information available to the public; or the Administrator otherwise becomes aware that the information does not qualify or no longer qualifies for protection against disclosure under subsection (a), in which case the Administrator shall take any actions required under subsection (g)(2). Not later than the date that is 60 days before the expiration of the period described in subparagraph (B), the Administrator shall provide to the person that asserted the claim a notice of the impending expiration of the period. Not later than the date that is 30 days before the expiration of the period described in subparagraph (B), a person reasserting the relevant claim shall submit to the Administrator a request for extension substantiating, in accordance with subsection (d)(2), the need to extend the period. Not later than the date of expiration of the period described in subparagraph (B), the Administrator shall, in accordance with subsection (g)(1)(C)— review the request submitted under subclause (I); make a determination regarding whether the claim for which the request was submitted continues to meet the relevant criteria established under this section; and grant an extension of 10 years; or deny the request. There shall be no limit on the number of extensions granted under subparagraph (C), if the Administrator determines that the relevant request under subparagraph (C)(ii)(I)— establishes the need to extend the period; and meets the requirements established by the Administrator. The Administrator may review, at any time, a claim for protection of information against disclosure under subsection
(a)and require any person that has claimed protection for that information, whether before, on, or after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act , to withdraw or reassert and substantiate or resubstantiate the claim in accordance with this section— after the chemical substance is identified as a high-priority substance under section 4A; for any chemical substance for which the Administrator has made a determination under section 6(c)(1)(C); for any inactive chemical substance identified under section 8(b)(5); or in limited circumstances, if the Administrator determines that disclosure of certain information currently protected from disclosure would assist the Administrator in conducting safety assessments and safety determinations under subsections
(b)and
(c)of section 6 or promulgating rules pursuant to section 6(d). The Administrator shall review a claim for protection of information against disclosure under subsection
(a)and require any person that has claimed protection for that information, whether before, on, or after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act , to withdraw or reassert and substantiate or resubstantiate the claim in accordance with this section— as necessary to determine whether the information qualifies for an exemption from disclosure in connection with a request for information received by the Administrator under section 552 of title 5, United States Code; if the Administrator has a reasonable basis to believe that the information does not qualify for protection against disclosure under subsection (a); or for any substance for which the Administrator has made a determination under section 6(c)(1)(B). If the Administrator makes a request under subparagraph
(A)or (B), the recipient of the request shall— reassert and substantiate or resubstantiate the claim; or withdraw the claim. Protection from disclosure of information subject to a claim that is reviewed and approved by the Administrator under this paragraph shall be extended for a period of 10 years from the date of approval, subject to any subsequent request by the Administrator under this paragraph. The Administrator shall— develop a system to assign a unique identifier to each specific chemical identity for which the Administrator approves a request for protection from disclosure, other than a specific chemical identity or structurally descriptive generic term; and apply that identifier consistently to all information relevant to the applicable chemical substance; annually publish and update a list of chemical substances, referred to by unique identifier, for which claims to protect the specific chemical identity from disclosure have been approved, including the expiration date for each such claim; ensure that any nonconfidential information received by the Administrator with respect to such a chemical substance during the period of protection from disclosure— is made public; and identifies the chemical substance using the unique identifier; and for each claim for protection of specific chemical identity that has been denied by the Administrator or expired, or that has been withdrawn by the submitter, provide public access to the specific chemical identity clearly linked to all nonconfidential information received by the Administrator with respect to the chemical substance. Except as provided in subsection (b), the Administrator shall, subject to subparagraph (C), not later than 90 days after the receipt of a claim under subsection (d), and not later than 30 days after the receipt of a request for extension of a claim under subsection (f), review and approve, modify, or deny the claim or request. If the Administrator denies or modifies a claim or request under subparagraph (A), the Administrator shall provide to the person that submitted the claim or request a written statement of the reasons for the denial or modification of the claim or request. The Administrator shall— except for claims described in subsection (b)(8), review all claims or requests under this section for the protection against disclosure of the specific identity of a chemical substance; and review a representative subset, comprising at least 25 percent, of all other claims or requests for protection against disclosure. The failure of the Administrator to make a decision regarding a claim or request for protection against disclosure or extension under this section shall not be the basis for denial or elimination of a claim or request for protection against disclosure. Except as provided in subparagraph
(B)and subsections (c), (e), and (f), if the Administrator denies or modifies a claim or request under paragraph (1), intends to release information pursuant to subsection (e), or promulgates a rule under section 6(d) establishing a ban or phase-out of a chemical substance, the Administrator shall notify, in writing and by certified mail, the person that submitted the claim of the intent of the Administrator to release the information. Except as provided in subparagraph (C), the Administrator shall not release information under this subsection until the date that is 30 days after the date on which the person that submitted the request receives notification under subparagraph (A). For information under paragraph
(3)or
(8)of subsection (e), the Administrator shall not release that information until the date that is 15 days after the date on which the person that submitted the claim or request receives a notification, unless the Administrator determines that release of the information is necessary to protect against an imminent and substantial harm to health or the environment, in which case no prior notification shall be necessary. For information under paragraphs
(4)and
(6)of subsection (e), the Administrator shall notify the person that submitted the information that the information has been disclosed as soon as practicable after disclosure of the information. Notification shall not be required— for the disclosure of information under paragraph (1), (2), (7), or
(9)of subsection (e); or for the disclosure of information for which— a notice under subsection (f)(1)(C)(i) was received; and no request was received by the Administrator on or before the date of expiration of the period for which protection from disclosure applies. With respect to notifications provided by the Administrator under paragraph
(2)with respect to information pertaining to a chemical substance subject to a rule as described in subsection (c)(3), there shall be a rebuttable presumption that the public interest in disclosing confidential information related to a chemical substance subject to a rule promulgated under section 6(d) that establishes a ban or phase-out of the manufacture, processing, or distribution in commerce of the substance outweighs the proprietary interest in maintaining the protection from disclosure of that information. A person that receives a notification under paragraph
(2)with respect to the information described in subparagraph
(A)may submit to the Administrator, before the date on which the information is to be released pursuant to paragraph (2)(B), a request with supporting documentation describing why the person believes some or all of that information should not be disclosed. Not later than 30 days after the Administrator receives a request under subparagraph (B), the Administrator shall determine whether the documentation provided by the person making the request rebuts or does not rebut the presumption described in subparagraph (A), for all or a portion of the information that the person has requested not be disclosed. The Administrator shall make the determination with the objective of ensuring that information relevant to protection of health and the environment is disclosed to the maximum extent practicable. Not later than 30 days after making the determination described in subparagraph (C), the Administrator shall make public the information the Administrator has determined is not to be protected from disclosure. If the Administrator does not receive, before the date on which the information described in subparagraph
(A)is to be released pursuant to paragraph (2)(B), a request pursuant to subparagraph (B), the Administrator shall promptly make public all of the information. If a person receives a notification under paragraph
(2)and believes disclosure of the information is prohibited under subsection (a), before the date on which the information is to be released pursuant to paragraph (2)(B), the person may bring an action to restrain disclosure of the information in— the United States district court of the district in which the complainant resides or has the principal place of business; or the United States District Court for the District of Columbia. The Administrator shall not disclose any information that is the subject of an appeal under this section before the date on which the applicable court rules on an action under subparagraph (A). The Administrator, in consultation with the Director of the Centers for Disease Control and Prevention, shall develop a request and notification system that allows for expedient and swift access to information disclosed pursuant to paragraphs
(5)and
(6)of subsection
(e)in a format and language that is readily accessible and understandable. Subject to paragraph (2), a current or former officer or employee of the United States described in subparagraph
(B)shall be guilty of a misdemeanor and fined under title 18, United States Code, or imprisoned for not more than 1 year, or both. A current or former officer or employee of the United States referred to in subparagraph
(A)is a current 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. 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 purposes of this subsection, any contractor of the United States that is provided 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, section 8, or any other applicable Federal law, the Administrator shall have no authority— to require the substantiation or resubstantiation of a claim for the protection from disclosure of information reported to or otherwise obtained by the Administrator under this Act before the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act ; or to impose substantiation or resubstantiation requirements under this Act that are more extensive than those required under this section. Nothing in this Act prevents the Administrator from reviewing, requiring substantiation or resubstantiation for, or approving, modifying or denying any claim for the protection from disclosure of information before the effective date of such rules applicable to those claims as the Administrator may promulgate after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act . .
Connectionstraces to 1
Traces to 1 document
U.S. Code
Citation graph
cites case law
Sec. 14
Confidential information
Cites 1Cited by 0 across 0 sources