15 U.S.C. § 2613 — Confidential information

Page 1884 TITLE 15—COMMERCE AND TRADE § 2613 of this title, 2605 of this title, or subchapter IV, or an order issued in a civil action brought under section 2604 of this title, 2606 of this title or subchapter IV. (2) If a chemical substance, mixture, or article is refused entry under paragraph (1), the Sec- retary of the Treasury shall notify the con- signee of such entry refusal, shall not release it to the consignee, and shall cause its disposal or storage (under such rules as the Secretary of the Treasury may prescribe) if it has not been ex- ported by the consignee within 90 days from the date of receipt of notice of such refusal, except that the Secretary of the Treasury may, pending a review by the Administrator of the entry re- fusal, release to the consignee such substance, mixture, or article on execution of bond for the amount of the full invoice of such substance, mixture, or article (as such value is set forth in the customs entry), together with the duty thereon. On failure to return such substance, mixture, or article for any cause to the custody of the Secretary of the Treasury when de- manded, such consignee shall be liable to the United States for liquidated damages equal to the full amount of such bond. All charges for storage, cartage, and labor on and for disposal of substances, mixtures, or articles which are re- fused entry or release under this section shall be paid by the owner or consignee, and in default of such payment shall constitute a lien against any future entry made by such owner or consignee. (b) Rules The Secretary of the Treasury, after consulta- tion with the Administrator, shall issue rules for the administration of subsection (a) of this section. (Pub. L. 94–469, title I, § 13, Oct. 11, 1976, 90 Stat. 2034; renumbered title I, Pub. L. 99–519, § 3(c)(1), Oct. 22, 1986, 100 Stat. 2989; amended Pub. L. 100–418, title I, § 1214(e)(2), Aug. 23, 1988, 102 Stat. 1156; Pub. L. 102–550, title X, § 1021(b)(4), Oct. 28, 1992, 106 Stat. 3923.) Editorial Notes REFERENCES IN TEXT The Harmonized Tariff Schedule of the United States, referred to in subsec. (a), is not set out in the Code. See Publication of Harmonized Tariff Schedule note set out under section 1202 of Title 19, Customs Duties. AMENDMENTS 1992—Subsec. (a)(1)(B). Pub. L. 102–550 substituted ‘‘section 2604 of this title, 2605 of this title, or sub- chapter IV’’ for ‘‘section 2604 or 2605 of this title’’ in two places and ‘‘section 2604 of this title, 2606 of this title or subchapter IV’’ for ‘‘section 2604 or 2606 of this title’’. 1988—Subsec. (a)(1). Pub. L. 100–418 substituted ‘‘gen- eral note 2 of the Harmonized Tariff Schedule of the United States’’ for ‘‘general headnote 2 to the Tariff Schedules of the United States’’ in introductory text. Statutory Notes and Related Subsidiaries EFFECTIVE DATE OF 1988 AMENDMENT Amendment by Pub. L. 100–418 effective Jan. 1, 1989, and applicable with respect to articles entered on or after such date, see section 1217(b)(1) of Pub. L. 100–418, set out as an Effective Date note under section 3001 of Title 19, Customs Duties. EFFECTIVE DATE Section effective Jan. 1, 1977, see section 31 of Pub. L. 94–469, set out as a note under section 2601 of this title. § 2613. Confidential information (a) In general Except as provided in this section, the Admin- istrator shall not disclose information that is exempt from disclosure pursuant to subsection (a) of section 552 of title 5 by reason of sub- section (b)(4) of that section— (1) that is reported to, or otherwise obtained by, the Administrator under this chapter; and (2) for which the requirements of subsection (c) are met. In any proceeding under section 552(a) of title 5 to obtain information the disclosure of which has been denied because of the provisions of this subsection, the Administrator may not rely on section 552(b)(3) of such title to sustain the Ad- ministrator’s action. (b) Information not protected from disclosure (1) Mixed confidential and nonconfidential in- formation Information that is protected from disclo- sure under this section, and which is mixed with information that is not protected from disclosure under this section, does not lose its protection from disclosure notwithstanding that it is mixed with information that is not protected from disclosure. (2) Information from health and safety studies Subsection (a) does not prohibit the disclo- sure of— (A) any health and safety study which is submitted under this chapter with respect to— (i) any chemical substance or mixture which, on the date on which such study is to be disclosed has been offered for com- mercial distribution; or (ii) any chemical substance or mixture for which testing is required under section 2603 of this title or for which notification is required under section 2604 of this title; and (B) any information reported to, or other- wise obtained by, the Administrator from a health and safety study which relates to a chemical substance or mixture described in clause (i) or (ii) of subparagraph (A). This paragraph does not authorize the disclo- sure of any information, including formulas (including molecular structures) of a chemical substance or mixture, that discloses processes used in the manufacturing or processing of a chemical substance or mixture or, in the case of a mixture, the portion of the mixture com- prised by any of the chemical substances in the mixture. (3) Other information not protected from dis- closure Subsection (a) does not prohibit the disclo- sure of— (A) any general information describing the manufacturing volumes, expressed as spe- cific aggregated volumes or, if the Adminis- Page 1885 TITLE 15—COMMERCE AND TRADE § 2613 trator determines that disclosure of specific aggregated volumes would reveal confiden- tial information, expressed in ranges; or (B) a general description of a process used in the manufacture or processing and indus- trial, 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 custom- arily would be shared with the general pub- lic or within an industry or industry sector. (4) Bans and phase-outs (A) In general If the Administrator promulgates a rule pursuant to section 2605(a) of this title that establishes a ban or phase-out of a chemical substance or mixture, the protection from disclosure of any information under this sec- tion with respect to the chemical substance or mixture shall be presumed to no longer apply, subject to subsection (g)(1)(E) and subparagraphs (B) and (C) of this paragraph. (B) Limitations (i) Critical use In the case of a chemical substance or mixture for which a specific condition of use is subject to an exemption pursuant to section 2605(g) of this title, if the Adminis- trator establishes a ban or phase-out de- scribed in subparagraph (A) with respect to the chemical substance or mixture, the presumption against protection under such subparagraph shall only apply to informa- tion that relates solely to any conditions of use of the chemical substance or mix- ture to which the exemption does not apply. (ii) Export In the case of a chemical substance or mixture for which there is manufacture, processing, or distribution in commerce that meets the conditions of section 2611(a)(1) of this title, if the Administrator establishes a ban or phase-out described in subparagraph (A) with respect to the chemical substance or mixture, the pre- sumption against protection under such subparagraph shall only apply to informa- tion that relates solely to any other manu- facture, processing, or distribution in com- merce of the chemical substance or mix- ture for the conditions of use subject to the ban or phase-out, unless the Adminis- trator makes the determination in section 2611(a)(2) of this title. (iii) Specific conditions of use In the case of a chemical substance or mixture for which the Administrator es- tablishes a ban or phase-out described in subparagraph (A) with respect to a specific condition of use of the chemical substance or mixture, the presumption against pro- tection under such subparagraph shall only apply to information that relates solely to the condition of use of the chem- ical substance or mixture for which the ban or phase-out is established. (C) Request for nondisclosure (i) In general A manufacturer or processor of a chem- ical substance or mixture subject to a ban or phase-out described in this paragraph may submit to the Administrator, within 30 days of receiving a notification under subsection (g)(2)(A), a request, including documentation supporting such request, that some or all of the information to which the notice applies should not be dis- closed or that its disclosure should be de- layed, and the Administrator shall review the request under subsection (g)(1)(E). (ii) Effect of no request or denial If no request for nondisclosure or delay is submitted to the Administrator under this subparagraph, or the Administrator denies such a request under subsection (g)(1)(A), the information shall not be pro- tected from disclosure under this section. (5) Certain requests If a request is made to the Administrator under section 552(a) of title 5 for information reported to or otherwise obtained by the Ad- ministrator under this chapter that is not pro- tected from disclosure under this subsection, the Administrator may not deny the request on the basis of section 552(b)(4) of title 5. (c) Requirements for confidentiality claims (1) Assertion of claims (A) In general A person seeking to protect from disclo- sure any information that person submits under this chapter (including information described in paragraph (2)) shall assert to the Administrator a claim for protection from disclosure concurrent with submission of the information, in accordance with such rules regarding a claim for protection from disclosure as the Administrator has promul- gated or may promulgate pursuant to this subchapter. (B) Inclusion An assertion of a claim under subpara- graph (A) shall include a statement that the person has— (i) taken reasonable measures to protect the confidentiality of the information; (ii) determined that the information is not required to be disclosed or otherwise made available to the public under any other Federal law; (iii) a reasonable basis to conclude that disclosure of the information is likely to cause substantial harm to the competitive position of the person; and (iv) a reasonable basis to believe that the information is not readily discoverable through reverse engineering. (C) Additional requirements for claims re- garding chemical identity information In the case of a claim under subparagraph (A) for protection from disclosure of a spe- cific chemical identity, the claim shall in- clude a structurally descriptive generic Page 1886 TITLE 15—COMMERCE AND TRADE § 2613 name for the chemical substance that the Administrator may disclose to the public, subject to the condition that such generic name shall— (i) be consistent with guidance developed by the Administrator under paragraph (4)(A); and (ii) describe the chemical structure of the chemical substance as specifically as practicable while protecting those features of the chemical structure— (I) that are claimed as confidential; and (II) the disclosure of which would be likely to cause substantial harm to the competitive position of the person. (2) Information generally not subject to sub- stantiation requirements Subject to subsection (f), the following infor- mation shall not be subject to substantiation requirements under paragraph (3): (A) Specific information describing the processes used in manufacture or processing of a chemical substance, mixture, or article. (B) Marketing and sales information. (C) Information identifying a supplier or customer. (D) In the case of a mixture, details of the full composition of the mixture and the re- spective percentages of constituents. (E) Specific information regarding the use, function, or application of a chemical sub- stance or mixture in a process, mixture, or article. (F) Specific production or import volumes of the manufacturer or processor. (G) Prior to the date on which a chemical substance is first offered for commercial dis- tribution, the specific chemical identity of the chemical substance, including the chem- ical name, molecular formula, Chemical Ab- stracts Service number, and other informa- tion that would identify the specific chem- ical substance, if the specific chemical iden- tity was claimed as confidential at the time it was submitted in a notice under section 2604 of this title. (3) Substantiation requirements Except as provided in paragraph (2), a person asserting a claim to protect information from disclosure under this section shall substan- tiate the claim, in accordance with such rules as the Administrator has promulgated or may promulgate pursuant to this section. (4) Guidance The Administrator shall develop guidance regarding— (A) the determination of structurally de- scriptive generic names, in the case of claims for the protection from disclosure of specific chemical identity; and (B) the content and form of the statements of need and agreements required under para- graphs (4), (5), and (6) of subsection (d). (5) Certification An authorized official of a person described in paragraph (1)(A) shall certify that the statement required to assert a claim sub- mitted pursuant to paragraph (1)(B), and any information required to substantiate a claim submitted pursuant to paragraph (3), are true and correct. (d) Exceptions to protection from disclosure Information described in subsection (a)— (1) shall be disclosed to an officer or em- ployee of the United States— (A) in connection with the official duties of that person under any Federal law for the protection of health or the environment; or (B) for a specific Federal law enforcement purpose; (2) shall be disclosed to a contractor of the United States and employees of that con- tractor— (A) if, in the opinion of the Administrator, the disclosure is necessary for the satisfac- tory performance by the contractor of a con- tract with the United States for the per- formance of work in connection with this chapter; and (B) subject to such conditions as the Ad- ministrator may specify; (3) shall be disclosed if the Administrator de- termines that disclosure is necessary to pro- tect health or the environment against an un- reasonable risk of injury to health or the envi- ronment, without consideration of costs or other nonrisk factors, including an unreason- able risk to a potentially exposed or suscep- tible subpopulation identified as relevant by the Administrator under the conditions of use; (4) shall be disclosed to a State, political subdivision of a State, or tribal government, on written request, for the purpose of adminis- tration or enforcement of a law, if such entity has 1 or more applicable agreements with the Administrator that are consistent with the guidance developed under subsection (c)(4)(B) and ensure that the entity will take appro- priate measures, and has adequate authority, to maintain the confidentiality of the infor- mation in accordance with procedures com- parable to the procedures used by the Admin- istrator to safeguard the information; (5) shall be disclosed to a health or environ- mental professional employed by a Federal or State agency or tribal government or a treat- ing physician or nurse in a nonemergency sit- uation if such person provides a written state- ment of need and agrees to sign a written con- fidentiality agreement with the Adminis- trator, subject to the conditions that— (A) the statement of need and confiden- tiality agreement are consistent with the guidance developed under subsection (c)(4)(B); (B) the statement of need shall be a state- ment that the person has a reasonable basis to suspect that— (i) the information is necessary for, or will assist in— (I) the diagnosis or treatment of 1 or more individuals; or (II) responding to an environmental re- lease or exposure; and (ii) 1 or more individuals being diagnosed or treated have been exposed to the chem- Page 1887 TITLE 15—COMMERCE AND TRADE § 2613 ical substance or mixture concerned, or an environmental release of or exposure to the chemical substance or mixture con- cerned has occurred; and (C) the person will not use the information for any purpose other than the health or en- vironmental needs asserted in the statement of need, except as otherwise may be author- ized by the terms of the agreement or by the person who has a claim under this section with respect to the information; (6) shall be disclosed in the event of an emer- gency to a treating or responding physician, nurse, agent of a poison control center, public health or environmental official of a State, po- litical subdivision of a State, or tribal govern- ment, or first responder (including any indi- vidual duly authorized by a Federal agency, State, political subdivision of a State, or trib- al government who is trained in urgent med- ical care or other emergency procedures, in- cluding a police officer, firefighter, or emer- gency medical technician) if such person re- quests the information, subject to the condi- tions that such person shall— (A) have a reasonable basis to suspect that— (i) a medical, public health, or environ- mental emergency exists; (ii) the information is necessary for, or will assist in, emergency or first-aid diag- nosis or treatment; or (iii) 1 or more individuals being diag- nosed or treated have likely been exposed to the chemical substance or mixture con- cerned, or a serious environmental release of or exposure to the chemical substance or mixture concerned has occurred; and (B) if requested by a person who has a claim with respect to the information under this section— (i) provide a written statement of need and agree to sign a confidentiality agree- ment, as described in paragraph (5); and (ii) submit to the Administrator such statement of need and confidentiality agreement as soon as practicable, but not necessarily before the information is dis- closed; (7) may be disclosed if the Administrator de- termines that disclosure is relevant in a pro- ceeding under this chapter, subject to the con- dition that the disclosure is made in such a manner as to preserve confidentiality to the extent practicable without impairing the pro- ceeding; (8) shall be disclosed if the information is re- quired to be made public under any other pro- vision of Federal law; and (9) shall be disclosed as required pursuant to discovery, subpoena, other court order, or any other judicial process otherwise allowed under applicable Federal or State law. (e) Duration of protection from disclosure (1) In general Subject to paragraph (2), subsection (f)(3), and section 2607(b) of this title, the Adminis- trator shall protect from disclosure informa- tion described in subsection (a)— (A) in the case of information described in subsection (c)(2), until such time as— (i) the person that asserted the claim no- tifies the Administrator that the person is withdrawing the claim, in which case the information shall not be protected from disclosure under this section; or (ii) the Administrator becomes aware that the information does not qualify for protection from disclosure under this sec- tion, in which case the Administrator shall take any actions required under sub- sections (f) and (g); and (B) in the case of information other than information described in subsection (c)(2)— (i) for a period of 10 years from the date on which the person asserts the claim with respect to the information submitted to the Administrator; or (ii) if applicable before the expiration of such 10-year period, until such time as— (I) the person that asserted the claim notifies the Administrator that the per- son is withdrawing the claim, in which case the information shall not be pro- tected from disclosure under this sec- tion; or (II) the Administrator becomes aware that the information does not qualify for protection from disclosure under this section, in which case the Administrator shall take any actions required under subsections (f) and (g). (2) Extensions (A) In general In the case of information other than in- formation described in subsection (c)(2), not later than the date that is 60 days before the expiration of the period described in para- graph (1)(B)(i), the Administrator shall pro- vide to the person that asserted the claim a notice of the impending expiration of the pe- riod. (B) Request (i) In general Not later than the date that is 30 days before the expiration of the period de- scribed in paragraph (1)(B)(i), a person re- asserting the relevant claim shall submit to the Administrator a request for exten- sion substantiating, in accordance with subsection (c)(3), the need to extend the period. (ii) Action by Administrator Not later than the date of expiration of the period described in paragraph (1)(B)(i), the Administrator shall, in accordance with subsection (g)(1)— (I) review the request submitted under clause (i); (II) make a determination regarding whether the claim for which the request was submitted continues to meet the rel- evant requirements of this section; and (III)(aa) grant an extension of 10 years; or (bb) deny the request. (C) No limit on number of extensions There shall be no limit on the number of extensions granted under this paragraph, if Page 1888 TITLE 15—COMMERCE AND TRADE § 2613 the Administrator determines that the rel- evant request under subparagraph (B)(i)— (i) establishes the need to extend the pe- riod; and (ii) meets the requirements established by the Administrator. (f) Review and resubstantiation (1) Discretion of Administrator The Administrator may require any person that has claimed protection for information from disclosure under this section, whether before, on, or after June 22, 2016, to reassert and substantiate or resubstantiate the claim in accordance with this section— (A) after the chemical substance is des- ignated as a high-priority substance under section 2605(b) of this title; (B) for any chemical substance designated as an active substance under section 2607(b)(5)(B)(iii) of this title; or (C) if the Administrator determines that disclosure of certain information currently protected from disclosure would be impor- tant to assist the Administrator in con- ducting risk evaluations or promulgating rules under section 2605 of this title. (2) Review required The Administrator shall review a claim for protection of information from disclosure under this section and require any person that has claimed protection for that information, whether before, on, or after June 22, 2016, to reassert and substantiate or resubstantiate the claim in accordance with this section— (A) 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; (B) if the Administrator has a reasonable basis to believe that the information does not qualify for protection from disclosure under this section; or (C) for any chemical substance the Admin- istrator determines under section 2605(b)(4)(A) of this title presents an unrea- sonable risk of injury to health or the envi- ronment. (3) Period of protection If the Administrator requires a person to re- assert and substantiate or resubstantiate a claim under this subsection, and determines that the claim continues to meet the relevant requirements of this section, the Adminis- trator shall protect the information subject to the claim from disclosure for a period of 10 years from the date of such determination, subject to any subsequent requirement by the Administrator under this subsection. (g) Duties of Administrator (1) Determination (A) In general Except for claims regarding information described in subsection (c)(2), the Adminis- trator shall, subject to subparagraph (C), not later than 90 days after the receipt of a claim under subsection (c), and not later than 30 days after the receipt of a request for extension of a claim under subsection (e) or a request under subsection (b)(4)(C), review and approve, approve in part and deny in part, or deny the claim or request. (B) Reasons for denial If the Administrator denies or denies in part a claim or request under subparagraph (A) the Administrator shall provide to the person that asserted the claim or submitted the request a written statement of the rea- sons for the denial or denial in part of the claim or request. (C) Subsets The Administrator shall— (i) except with respect to information de- scribed in subsection (c)(2)(G), review all claims or requests under this section for the protection from disclosure of the spe- cific chemical identity of a chemical sub- stance; and (ii) review a representative subset, com- prising at least 25 percent, of all other claims or requests for protection from dis- closure under this section. (D) Effect of failure to act The failure of the Administrator to make a decision regarding a claim or request for protection from disclosure or extension under this section shall not have the effect of denying or eliminating a claim or request for protection from disclosure. (E) Determination of requests under sub- section (b)(4)(C) With respect to a request submitted under subsection (b)(4)(C), the Administrator shall, with the objective of ensuring that informa- tion relevant to the protection of health and the environment is disclosed to the extent practicable, determine whether the docu- mentation provided by the person rebuts what shall be the presumption of the Admin- istrator that the public interest in the dis- closure of the information outweighs the public or proprietary interest in maintain- ing the protection for all or a portion of the information that the person has requested not be disclosed or for which disclosure be delayed. (2) Notification (A) In general Except as provided in subparagraph (B) and subsections (b), (d), and (e), if the Ad- ministrator denies or denies in part a claim or request under paragraph (1), concludes, in accordance with this section, that the infor- mation does not qualify for protection from disclosure, intends to disclose information pursuant to subsection (d), or promulgates a rule under section 2605(a) of this title estab- lishing a ban or phase-out with respect to a chemical substance or mixture, the Adminis- trator shall notify, in writing, the person that asserted the claim or submitted the re- quest of the intent of the Administrator to disclose the information or not protect the information from disclosure under this sec- Page 1889 TITLE 15—COMMERCE AND TRADE § 2613 tion. The notice shall be furnished by cer- tified mail (return receipt requested), by personal delivery, or by other means that al- lows verification of the fact and date of re- ceipt. (B) Disclosure of information Except as provided in subparagraph (C), the Administrator shall not disclose infor- mation under this subsection until the date that is 30 days after the date on which the person that asserted the claim or submitted the request receives notification under sub- paragraph (A). (C) Exceptions (i) Fifteen day notification For information the Administrator in- tends to disclose under subsections (d)(3), (d)(4), (d)(5), and (j), the Administrator shall not disclose the information until the date that is 15 days after the date on which the person that asserted the claim or submitted the request receives notifica- tion under subparagraph (A), except that, with respect to information to be disclosed under subsection (d)(3), if the Adminis- trator determines that disclosure of the information is necessary to protect against an imminent and substantial harm to health or the environment, no prior no- tification shall be necessary. (ii) Notification as soon as practicable For information the Administrator in- tends to disclose under paragraph (6) of subsection (d), the Administrator shall no- tify the person that submitted the infor- mation that the information has been dis- closed as soon as practicable after disclo- sure of the information. (iii) No notification required Notification shall not be required— (I) for the disclosure of information under paragraphs (1), (2), (7), or (8) of subsection (d); or (II) for the disclosure of information for which— (aa) the Administrator has provided to the person that asserted the claim a notice under subsection (e)(2)(A); and (bb) such person does not submit to the Administrator a request under sub- section (e)(2)(B) on or before the dead- line established in subsection (e)(2)(B)(i). (D) Appeals (i) Action to restrain disclosure If a person receives a notification under this paragraph and believes the informa- tion is protected from disclosure under this section, before the date on which the information is to be disclosed pursuant to subparagraph (B) or (C) the person may bring an action to restrain disclosure of the information in— (I) the United States district court of the district in which the complainant re- sides or has the principal place of busi- ness; or (II) the United States District Court for the District of Columbia. (ii) No disclosure (I) In general Subject to subsection (d), the Adminis- trator shall not disclose information that is the subject of an appeal under this paragraph before the date on which the applicable court rules on an action under clause (i). (II) Exception Subclause (I) shall not apply to disclo- sure of information described under sub- sections (d)(4) and (j). (3) Request and notification system The Administrator, in consultation with the Director of the Centers for Disease Control and Prevention, shall develop a request and notification system that, in a format and lan- guage that is readily accessible and under- standable, allows for expedient and swift ac- cess to information disclosed pursuant to paragraphs (5) and (6) of subsection (d). (4) Unique identifier The Administrator shall— (A)(i) develop a system to assign a unique identifier to each specific chemical identity for which the Administrator approves a re- quest for protection from disclosure, which shall not be either the specific chemical identity or a structurally descriptive generic term; and (ii) apply that identifier consistently to all information relevant to the applicable chem- ical substance; (B) annually publish and update a list of chemical substances, referred to by their unique identifiers, for which claims to pro- tect the specific chemical identity from dis- closure have been approved, including the expiration date for each such claim; (C) ensure that any nonconfidential infor- mation received by the Administrator with respect to a chemical substance included on the list published under subparagraph (B) while the specific chemical identity of the chemical substance is protected from disclo- sure under this section identifies the chem- ical substance using the unique identifier; and (D) for each claim for protection of a spe- cific chemical identity that has been denied by the Administrator or expired, or that has been withdrawn by the person who asserted the claim, and for which the Administrator has used a unique identifier assigned under this paragraph to protect the specific chem- ical identity in information that the Admin- istrator has made public, clearly link the specific chemical identity to the unique identifier in such information to the extent practicable. (h) Criminal penalty for wrongful disclosure (1) Individuals subject to penalty (A) In general Subject to subparagraph (C) and paragraph (2), an individual described in subparagraph Page 1890 TITLE 15—COMMERCE AND TRADE § 2614 (B) shall be fined under title 18 or impris- oned for not more than 1 year, or both. (B) Description An individual referred to in subparagraph (A) is an individual who— (i) pursuant to this section, obtained possession of, or has access to, information protected from disclosure under this sec- tion; and (ii) knowing that the information is pro- tected from disclosure under this section, willfully discloses the information in any manner to any person not entitled to re- ceive that information. (C) Exception This paragraph shall not apply to any medical professional (including an emer- gency medical technician or other first re- sponder) who discloses any information ob- tained under paragraph (5) or (6) of sub- section (d) to a patient treated by the med- ical professional, or to a person authorized to make medical or health care decisions on behalf of such a patient, as needed for the di- agnosis or treatment of the patient. (2) Other laws Section 1905 of title 18 shall not apply with respect to the publishing, divulging, disclo- sure, or making known of, or making avail- able, information reported to or otherwise ob- tained by the Administrator under this chap- ter. (i) Applicability (1) In general Except as otherwise provided in this section, section 2607 of this title, or any other applica- ble Federal law, the Administrator shall have no authority— (A) to require the substantiation or re- substantiation of a claim for the protection from disclosure of information reported to or otherwise obtained by the Administrator under this chapter prior to June 22, 2016; or (B) to impose substantiation or resubstan- tiation requirements, with respect to the protection of information described in sub- section (a), under this chapter that are more extensive than those required under this sec- tion. (2) Actions prior to promulgation of rules Nothing in this chapter prevents the Admin- istrator from reviewing, requiring substan- tiation or resubstantiation of, or approving, approving in part, or denying any claim for the protection from disclosure of information before the effective date of such rules applica- ble to those claims as the Administrator may promulgate after June 22, 2016. (j) Access by Congress Notwithstanding any limitation contained in this section or any other provision of law, all in- formation reported to or otherwise obtained by the Administrator (or any representative of the Administrator) under this chapter shall be made available, upon written request of any duly au- thorized committee of the Congress, to such committee. (Pub. L. 94–469, title I, § 14, Oct. 11, 1976, 90 Stat. 2034; renumbered title I, Pub. L. 99–519, § 3(c)(1), Oct. 22, 1986, 100 Stat. 2989; amended Pub. L. 114–182, title I, § 11, June 22, 2016, 130 Stat. 481.) Editorial Notes AMENDMENTS 2016—Pub. L. 114–182 amended section generally. Prior to amendment, section related to disclosure of data. Statutory Notes and Related Subsidiaries EFFECTIVE DATE Section effective Jan. 1, 1977, see section 31 of Pub. L. 94–469, set out as a note under section 2601 of this title. § 2614. Prohibited acts It shall be unlawful for any person to— (1) fail or refuse to comply with any require- ment of this subchapter or any rule promul- gated, order issued, or consent agreement en- tered into under this subchapter, or any re- quirement of subchapter II or any rule pro- mulgated or order issued under subchapter II; (2) use for commercial purposes a chemical substance or mixture which such person knew or had reason to know was manufactured, processed, or distributed in commerce in viola- tion of section 2604 or 2605 of this title, a rule or order under section 2604 or 2605 of this title, or an order issued in action brought under sec- tion 2604 or 2606 of this title; (3) fail or refuse to (A) establish or maintain records, (B) submit reports, notices, or other information, or (C) permit access to or copy- ing of records, as required by this chapter or a rule thereunder; or (4) fail or refuse to permit entry or inspec- tion as required by section 2610 of this title. (Pub. L. 94–469, title I, § 15, Oct. 11, 1976, 90 Stat. 2036; renumbered title I and amended Pub. L. 99–519, § 3(b)(1), (c)(1), Oct. 22, 1986, 100 Stat. 2988, 2989; Pub. L. 114–182, title I, § 19(l), June 22, 2016, 130 Stat. 508.) Editorial Notes AMENDMENTS 2016—Par. (1). Pub. L. 114–182 substituted ‘‘any re- quirement of this subchapter or any rule promulgated, order issued, or consent agreement entered into under this subchapter, or’’ for ‘‘(A) any rule promulgated or order issued under section 2603 of this title, (B) any re- quirement prescribed by section 2604 or 2605 of this title, (C) any rule promulgated or order issued under section 2604 or 2605 of this title, or (D)’’. 1986—Par. (1)(D). Pub. L. 99–519 added cl. (D). Statutory Notes and Related Subsidiaries EFFECTIVE DATE Section effective Jan. 1, 1977, see section 31 of Pub. L. 94–469, set out as a note under section 2601 of this title. § 2615. Penalties (a) Civil (1) Any person who violates a provision of sec- tion 2614 or 2689 of this title shall be liable to the United States for a civil penalty in an amount not to exceed $37,500 for each such viola-