42 U.S.C. § 11042 — Trade secrets

Page 8107 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 11042 These actions should continue unless specifically pro- hibited by law. The head of each executive department or agency shall assist the Environmental Protection Agency in implementing this directive as quickly as possible. This directive is for the internal management of the executive branch and does not create any right or ben- efit, substantive or procedural, enforceable by any party against the United States, its agencies or instru- mentalities, its officers or employees, or any person. The Director of the Office of Management and Budget is authorized and directed to publish this Memorandum in the Federal Register. WILLIAM J. CLINTON. SUBCHAPTER III—GENERAL PROVISIONS § 11041. Relationship to other law (a) In general Nothing in this chapter shall— (1) preempt any State or local law, (2) except as provided in subsection (b), oth- erwise affect any State or local law or the au- thority of any State or local government to adopt or enforce any State or local law, or (3) affect or modify in any way the obliga- tions or liabilities of any person under other Federal law. (b) Effect on MSDS requirements Any State or local law enacted after August 1, 1985, which requires the submission of a mate- rial safety data sheet from facility owners or op- erators shall require that the data sheet be iden- tical in content and format to the data sheet re- quired under subsection (a) of section 11021 of this title. In addition, a State or locality may require the submission of information which is supplemental to the information required on the data sheet (including information on the loca- tion and quantity of hazardous chemicals present at the facility), through additional sheets attached to the data sheet or such other means as the State or locality considers appro- priate. (Pub. L. 99–499, title III, § 321, Oct. 17, 1986, 100 Stat. 1747.) § 11042. Trade secrets (a) Authority to withhold information (1) General authority (A) With regard to a hazardous chemical, an extremely hazardous substance, or a toxic chemical, any person required under section 11003(d)(2), 11003(d)(3), 11021, 11022, or 11023 of this title to submit information to any other person may withhold from such submittal the specific chemical identity (including the chemical name and other specific identifica- tion), as defined in regulations prescribed by the Administrator under subsection (c), if the person complies with paragraph (2). (B) Any person withholding the specific chemical identity shall, in the place on the submittal where the chemical identity would normally be included, include the generic class or category of the hazardous chemical, ex- tremely hazardous substance, or toxic chem- ical (as the case may be). (2) Requirements (A) A person is entitled to withhold informa- tion under paragraph (1) if such person— (i) claims that such information is a trade secret, on the basis of the factors enumer- ated in subsection (b), (ii) includes in the submittal referred to in paragraph (1) an explanation of the reasons why such information is claimed to be a trade secret, based on the factors enumer- ated in subsection (b), including a specific description of why such factors apply, and (iii) submits to the Administrator a copy of such submittal, and the information with- held from such submittal. (B) In submitting to the Administrator the information required by subparagraph (A)(iii), a person withholding information under this subsection may— (i) designate, in writing and in such man- ner as the Administrator may prescribe by regulation, the information which such per- son believes is entitled to be withheld under paragraph (1), and (ii) submit such designated information separately from other information sub- mitted under this subsection. (3) Limitation The authority under this subsection to with- hold information shall not apply to informa- tion which the Administrator has determined, in accordance with subsection (c), is not a trade secret. (b) Trade secret factors No person required to provide information under this chapter may claim that the informa- tion is entitled to protection as a trade secret under subsection (a) unless such person shows each of the following: (1) Such person has not disclosed the infor- mation to any other person, other than a member of a local emergency planning com- mittee, an officer or employee of the United States or a State or local government, an em- ployee of such person, or a person who is bound by a confidentiality agreement, and such person has taken reasonable measures to protect the confidentiality of such informa- tion and intends to continue to take such measures. (2) The information is not required to be dis- closed, or otherwise made available, to the public under any other Federal or State law. (3) Disclosure of the information is likely to cause substantial harm to the competitive po- sition of such person. (4) The chemical identity is not readily dis- coverable through reverse engineering. (c) Trade secret regulations As soon as practicable after October 17, 1986, the Administrator shall prescribe regulations to implement this section. With respect to sub- section (b)(4), such regulations shall be equiva- lent to comparable provisions in the Occupa- tional Safety and Health Administration Hazard Communication Standard (29 C.F.R. 1910.1200) and any revisions of such standard prescribed by the Secretary of Labor in accordance with the final ruling of the courts of the United States in United Steelworkers of America, AFL–CIO–CLC v. Thorne G. Auchter. Page 8108 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 11042 1 So in original. Probably should be ‘‘claimant’’. (d) Petition for review (1) In general Any person may petition the Administrator for the disclosure of the specific chemical identity of a hazardous chemical, an ex- tremely hazardous substance, or a toxic chem- ical which is claimed as a trade secret under this section. The Administrator may, in the absence of a petition under this paragraph, initiate a determination, to be carried out in accordance with this subsection, as to whether information withheld constitutes a trade se- cret. (2) Initial review Within 30 days after the date of receipt of a petition under paragraph (1) (or upon the Ad- ministrator’s initiative), the Administrator shall review the explanation filed by a trade secret claimant under subsection (a)(2) and de- termine whether the explanation presents as- sertions which, if true, are sufficient to sup- port a finding that the specific chemical iden- tity is a trade secret. (3) Finding of sufficient assertions (A) If the Administrator determines pursu- ant to paragraph (2) that the explanation pre- sents sufficient assertions to support a finding that the specific chemical identity is a trade secret, the Administrator shall notify the trade secret claimant that he has 30 days to supplement the explanation with detailed in- formation to support the assertions. (B) If the Administrator determines, after receipt of any supplemental supporting de- tailed information under subparagraph (A), that the assertions in the explanation are true and that the specific chemical identity is a trade secret, the Administrator shall so notify the petitioner and the petitioner may seek ju- dicial review of the determination. (C) If the Administrator determines, after receipt of any supplemental supporting de- tailed information under subparagraph (A), that the assertions in the explanation are not true and that the specific chemical identity is not a trade secret, the Administrator shall no- tify the trade secret claimant that the Admin- istrator intends to release the specific chem- ical identity. The trade secret claimant has 30 days in which he may appeal the Administra- tor’s determination under this subparagraph to the Administrator. If the Administrator does not reverse his determination under this subparagraph in such an appeal by the trade secret claimant, the trade secret claimaint 1 may seek judicial review of the determination. (4) Finding of insufficient assertions (A) If the Administrator determines pursu- ant to paragraph (2) that the explanation pre- sents insufficient assertions to support a find- ing that the specific chemical identity is a trade secret, the Administrator shall notify the trade secret claimant that he has 30 days to appeal the determination to the Adminis- trator, or, upon a showing of good cause, amend the original explanation by providing supplementary assertions to support the trade secret claim. (B) If the Administrator does not reverse his determination under subparagraph (A) after an appeal or an examination of any supple- mentary assertions under subparagraph (A), the Administrator shall so notify the trade se- cret claimant and the trade secret claimant may seek judicial review of the determination. (C) If the Administrator reverses his deter- mination under subparagraph (A) after an ap- peal or an examination of any supplementary assertions under subparagraph (A), the proce- dures under paragraph (3) of this subsection apply. (e) Exception for information provided to health professionals Nothing in this section, or regulations adopted pursuant to this section, shall authorize any person to withhold information which is re- quired to be provided to a health professional, a doctor, or a nurse in accordance with section 11043 of this title. (f) Providing information to Administrator; availability to public Any information submitted to the Adminis- trator under subsection (a)(2) or subsection (d)(3) (except a specific chemical identity) shall be available to the public, except that upon a showing satisfactory to the Administrator by any person that the information (or a particular part thereof) to which the Administrator has ac- cess under this section if made public would di- vulge information entitled to protection under section 1905 of title 18, such information or part shall be considered confidential in accordance with the purposes of that section, except that such information or part may be disclosed to other officers, employees, or authorized rep- resentatives of the United States concerned with carrying out this chapter. (g) Information provided to State Upon request by a State, acting through the Governor of the State, the Administrator shall provide to the State any information obtained under subsection (a)(2) and subsection (d)(3). (h) Information on adverse effects (1) In any case in which the identity of a haz- ardous chemical or an extremely hazardous sub- stance is claimed as a trade secret, the Governor or State emergency response commission estab- lished under section 11001 of this title shall iden- tify the adverse health effects associated with the hazardous chemical or extremely hazardous substance and shall assure that such informa- tion is provided to any person requesting infor- mation about such hazardous chemical or ex- tremely hazardous substance. (2) In any case in which the identity of a toxic chemical is claimed as a trade secret, the Ad- ministrator shall identify the adverse health and environmental effects associated with the toxic chemical and shall assure that such infor- mation is included in the computer database re- quired by section 11023(j) of this title and is pro- vided to any person requesting information about such toxic chemical. Page 8109 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 11043 2 So in original. Probably should be ‘‘limitation’’. (i) Information provided to Congress Notwithstanding any limitatio 2 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 to a duly authorized committee of the Congress upon written request by such a com- mittee. (Pub. L. 99–499, title III, § 322, Oct. 17, 1986, 100 Stat. 1747.) § 11043. Provision of information to health pro- fessionals, doctors, and nurses (a) Diagnosis or treatment by health professional An owner or operator of a facility which is subject to the requirements of section 11021, 11022, or 11023 of this title shall provide the spe- cific chemical identity, if known, of a hazardous chemical, extremely hazardous substance, or a toxic chemical to any health professional who requests such information in writing if the health professional provides a written statement of need under this subsection and a written con- fidentiality agreement under subsection (d). The written statement of need shall be a statement that the health professional has a reasonable basis to suspect that— (1) the information is needed for purposes of diagnosis or treatment of an individual, (2) the individual or individuals being diag- nosed or treated have been exposed to the chemical concerned, and (3) knowledge of the specific chemical iden- tity of such chemical will assist in diagnosis or treatment. Following such a written request, the owner or operator to whom such request is made shall promptly provide the requested information to the health professional. The authority to with- hold the specific chemical identity of a chemical under section 11042 of this title when such infor- mation is a trade secret shall not apply to infor- mation required to be provided under this sub- section, subject to the provisions of subsection (d). (b) Medical emergency An owner or operator of a facility which is subject to the requirements of section 11021, 11022, or 11023 of this title shall provide a copy of a material safety data sheet, an inventory form, or a toxic chemical release form, includ- ing the specific chemical identity, if known, of a hazardous chemical, extremely hazardous sub- stance, or a toxic chemical, to any treating phy- sician or nurse who requests such information if such physician or nurse determines that— (1) a medical emergency exists, (2) the specific chemical identity of the chemical concerned is necessary for or will as- sist in emergency or first-aid diagnosis or treatment, and (3) the individual or individuals being diag- nosed or treated have been exposed to the chemical concerned. Immediately following such a request, the owner or operator to whom such request is made shall provide the requested information to the physi- cian or nurse. The authority to withhold the specific chemical identity of a chemical from a material safety data sheet, an inventory form, or a toxic chemical release form under section 11042 of this title when such information is a trade secret shall not apply to information re- quired to be provided to a treating physician or nurse under this subsection. No written con- fidentiality agreement or statement of need shall be required as a precondition of such dis- closure, but the owner or operator disclosing such information may require a written con- fidentiality agreement in accordance with sub- section (d) and a statement setting forth the items listed in paragraphs (1) through (3) as soon as circumstances permit. (c) Preventive measures by local health profes- sionals (1) Provision of information An owner or operator of a facility subject to the requirements of section 11021, 11022, or 11023 of this title shall provide the specific chemical identity, if known, of a hazardous chemical, an extremely hazardous substance, or a toxic chemical to any health professional (such as a physician, toxicologist, or epi- demiologist)— (A) who is a local government employee or a person under contract with the local gov- ernment, and (B) who requests such information in writ- ing and provides a written statement of need under paragraph (2) and a written confiden- tiality agreement under subsection (d). Following such a written request, the owner or operator to whom such request is made shall promptly provide the requested information to the local health professional. The authority to withhold the specific chemical identity of a chemical under section 11042 of this title when such information is a trade secret shall not apply to information required to be provided under this subsection, subject to the provi- sions of subsection (d). (2) Written statement of need The written statement of need shall be a statement that describes with reasonable de- tail one or more of the following health needs for the information: (A) To assess exposure of persons living in a local community to the hazards of the chemical concerned. (B) To conduct or assess sampling to deter- mine exposure levels of various population groups. (C) To conduct periodic medical surveil- lance of exposed population groups. (D) To provide medical treatment to ex- posed individuals or population groups. (E) To conduct studies to determine the health effects of exposure. (F) To conduct studies to aid in the identi- fication of a chemical that may reasonably be anticipated to cause an observed health effect. (d) Confidentiality agreement Any person obtaining information under sub- section (a) or (c) shall, in accordance with such