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S. 3149 (94th): Toxic Substances Control Act


The text of the bill below is as of Oct 11, 1976 (Passed Congress).

Summary of this bill

Source: Wikipedia

The Toxic Substances Control Act (TSCA) is a United States law, passed by the United States Congress in 1976 and administered by the United States Environmental Protection Agency, that regulates the introduction of new or already existing chemicals. When the TSCA was put into place, all existing chemicals were considered to be safe for use and subsequently grandfathered in. Its three main objectives are to assess and regulate new commercial chemicals before they enter the market, to regulate chemicals already existing in 1976 that posed an "unreasonable risk to health or to the environment", as for example PCB's, lead, mercury and radon, and to regulate these chemicals' distribution …


PUBLIC LAW 94-469—OCT. 11, 1976                                    90 STAT. 2003

Public Law 94-469
94th Congress
                                       An Act
To regulate commerce and protect human health and the environment by                        Oct. 11, 1976
  requiring testing and necessary use restrictions on certain chemical substances,            rg 314,91
  and for other purposes.                                                                     '• '    •'

  Be it enacted hy the Seriate and House of Represerdatives of the
United States of Ameiica in Gonqress assembled.                    Toxic Substances
SECTION 1. SHORT TITLE AND TABLE OF CONTENTS.                       °" ™ ^'
  This Act may be cited as the "Toxic Substances Control Act".     15 USC 2601
                                                                                          note.
                                 TABLE OF CONTENTS
Sec.    1. Short title and table of contents.
Sec.    2. Findings, policy, and intent.
Sec.    3. Definitions.
Sec.    4. Testing of chemical substances and mixtures.
Sec.    5. Manufacturing and processing notices.
Sec.    6. Regulation of hazardous chemical substances and mixtures.
Sec.    7. Imminent hazards.                                                                          • '
Sec.    8. Reporting and retention of information.
Sec.    9. Relationship to other Federal laws.
Sec.    10. Research, development, collection, dissemination, and utilization of data.
Sec.    11. Inspections and subpoenas.
Sec.    12. Exports.
Sec.    13. Entry into customs territory of the United States.
Sec.    14. Disclosure of data.
Sec.    15. Prohibited acts.
Sec.    16. Penalties.
Sec.    17. Specific enforcement and seizure.
Sec.    18. Preemption.
Sec.    19. Judicial review.
Sec.    20. Citizens' civil actions.
Sec.    21. Citizens' petitions.
Sec.    22. National defense waiver.
Sec.    23. Employee protection.                                                            .; : - j >'ri \
Sec.    24. Employment effects.
Sec.    25. Studies.
Sec.    26. Administration of the Act.
Sf c.   27. Development and evaluation of test methods.
Sec.    28. State programs.
Sec.    29. Authorization for appropriations.                                               ; u, 'V     ffc
Sec.    30. Annual report.
Sec.    31. Effective date.
SEC. 2. FINDINGS, POLICY, AND INTENT.
  (a) FiNDiNtJS.—The Congress finds that—                               15 USC 2601.
       (1) human beings and the environment are being exposed each
    year to a large number of chemical substances and mixtures ;
       (2) among the many chemical substances and mixtures which
    are constantly being developed and produced, there are some
    whose manufacture, processing, distribution in commerce, use, or
    disposal may present an unreasonable risk of injury to health or
    the environment; and
       (3) the effective regulation of interstate commerce in such
    chemical substances and mixtures also necessitates the regulation
    of intrastate commerce in such chemical substances and mixtures.
  (b) POLICY.—It is the policy of the United States that—                        •r
       (1) adequate data should be developed with respect to the effect
    of chemical substances and mixtures on health and the environ-

90 STAT. 2004 PUBLIC LAW 94-469—OCT. 1 1 , 1976 ment and t h a t the development of such data should be the respon- sibility of those who manufacture and those who process such chemical substances and m i x t u r e s ; (2) adequate authority should exist to regulate chemical sub- stances and mixtures which present an unreasonable risk of injury to health or the environment, and to take action with respect to chemical substances and mixtures which are imminent h a z a r d s ; and (3) authority over chemical substances and mixtures should be exercised in such a manner as not to impede unduly or create unnecessary economic barriers to technological innovation while fulfilling the p r i m a r y purpose of this Act to assure t h a t such inno- vation and commerce in such chemical substances and mixtures do not present an unreasonable risk of injury to health or the environment. (c) I N T E N T OF CONGRESS.—It is the intent of Congress t h a t the Administrator shall carry out this Act in a reasonable and prudent manner, and t h a t the Administrator shall consider the environmental, economic, and social impact of any action the Administrator takes or proposes to take under this Act. SEC. 3. DEFINITIONS. 15 u s e 2602. As used in this A c t : (1) the term " A d m i n i s t r a t o r " means the Administrator of the Environmental Protection Agency. (2) ( A ) E x c e p t as provided in s u b p a r a g r a p h ( B ) , t h e term "chem- ical substance" means any organic or inorganic substance of a particu- lar molecular identity, including— (i) any combination of such substances occurring in whole or in p a r t as a result of a chemical reaction or occurring in n a t u r e , and (ii) any element or uncombined radical. ( B ) Such term does not include— (i) any mixture, (ii) any pesticide (as defined in the Federal Insecticide, F u n g i - 7 u s e 136 note. cide, and Rodenticide Act) when manufactured, processed, or distributed in commerce for use as a pesticide, (iii) tobacco or any tobacco product, (iv) any source material, special nuclear material, or byproduct material (as such terms are defined in the Atomic E n e r g y Act 42 u s e 2011 of 1954 and regulations issued under such A c t ) , note. (v) any article the sale of which is subject to the t a x imposed 26 u s e 4181. hj section 4181 of the I n t e r n a l Revenue Code of 1954 (deter- mined without regard to any exemptions from such tax provided 26 u s e 4182, by section 4182 or 4221 or any other provision of such Code), and 4'221. (yi) any food, food additive, d r u g , cosmetic, or device (as such terms are" defined in section 201 of the Federal Food, D r u g , and 21 u s e 321. Cosmetic Act) when manufactured, processed, or distributed in commerce for use as a food, food additive, d r u g , cosmetic, or device. The term "food" as used in clause (vi) of this subparagraph includes poultry and poultry products (as defined i n sections 4 ( e ) and 4 ( f ) 21 u s e 453. of the P o u l t r y Products Inspection A c t ) , meat and meat food prod- 21 u s e 601. ucts (as defined in section 1(]) of the F e d e r a l Meat Inspection A c t ) , and eggs and egg products (as defined in section 4 of t h e E g g P r o d - 21 u s e 1033. ucts Insnection A c t ) . (3) T h e term "commerce" means trade, traffic, transportation, or other commerce ( A ) between a place in a State and any place outside
PUBLIC LAW 94-469—OCT. 11, 1976 90 STAT. 2005 of such State, or (B) which affects trade, traffic, transportation, or commerce described in clause (A). (4) The terms "distribute in commerce" and "distribution in com- merce"' when used to describe an action taken with respect to a chem- ical substance or mixture or article containing a substance or mixture mean to sell, or the sale of, the substance, mixture, or article in com- merce ; to introduce or deliver for introduction into commerce, or the introduction or delivery for intr-oduction into commerce of, the sub- stance, mixture, or article; or to hold, or the holding of, the substance, mixture, or article after its introduction into commerce. (5) The term "environment" includes water, air, and land and the i interrelationship which exists among and between water, air, and land and all living things. (6) The term "health and safety study" means any study of any effect of a chemical substance or mixture on health or the environ- ment or on both, including underlying data and epidemiological studies, studies of occupational exposure to a chemical substance or mixture, toxicological, clinical, and ecological studies of a chemical substance or mixture, and any test performed pursuant to this Act. (7) The term "manufacture" means to import into the customs territory of the United States (as defined in general headnote 2 of the Tariff Schedules of the United States), produce, or manufacture. 19 USC 1202. (8) The term "mixture" means any combination of two or more chemical substances if the combination does not occur in nature and is not, in whole or in part, the result of a chemical reaction; except that such term does include any combination which occurs, in whole or in part, as a result of a chemical reaction if none of the chemical substances comprising the combination is a new chemical substance and if tlie combination could have been manufactured for commer- cial purposes without a chemical reaction at the time the chemical substances comprising the combination were combined. (9) The term "new chemical substance" means any chemical sub- stance which is not included in the chemical substance list compiled and published under section 8 (b). Post, p. 2027. (10) The term "process" means the preparation of a chemical sub- stance or mixture, after its manufacture, for distribution in commerce— (A) in the same form or physical state as, or in a different form or physical state from, that in which it was received by the person so preparing such substance or mixture, or (B) as part of an article containing the chemical substance .;;:;>• or mixture. (11) The term "processor" means any person who processes a chemi- cal substance or mixture. (12) The term "standards for the development of test data" means a prescription of— (A) the— (i) health and environmental effects, and (ii) information relating to toxicity, persistence, and other characteristics which affect health and the environment, for which test data for a chemical substance or mixture are to be developed and any analysis that is to be performed on such data, and - (B) to the extent necessary to assure that data respecting such effects and characteristics are reliable and adequate— (i) the manner in which such data are to be developed, (ii) the specification of any test protocol or methodology to be employed in the development of such data, and
90 STAT. 2006 PUBLIC LAW 94-469—OCT. 1 1 , 1976 (iii) such other requirements as are necessary to provide such assurance. (13) The term " S t a t e " means any State of the United States, the District of Columbia, the Commonwealth of Puerto Rico, t h e Virgin Islands, Guam, the Canal Zone, American Samoa, the Northern Mariana Islands, or any other territory or possession of the United States. (14) T h e term "United States", when used in the geographic sense, means all of the States. SEC. 4. TESTING OF CHEMICAL SUBSTANCES AND MIXTURES. 15 u s e 2603. (a) TESTING REQUIREMENTS.—If the Administrator finds that— (1) ( A ) (i) the manufacture, distribution in commerce, proc- ~^ essing, use, or disposal of a chemical substance or mixture, or t h a t any combination of such activities, may present an unreasonable risk of injury to health or the environment, (ii) there are insufficient data and experience upon which the effects of such manufacture, distribution in commerce, processing, use, or disposal of such substance or mixture or of any combina- tion of such activities on health or the environment can reason- ably be determined or predicted, and (iii) testing of such substance or mixture with respect to such effects is necessary to develop such d a t a ; or ( B ) (i) a chemical substance or mixture is or will be produced in substantial quantities, and ( I ) it enters or m a y reasonably be anticipated to enter the environment in substantial quantities or ( I I ) there is or may be significant or substantial human exposure to such substance or mixture, (ii) there are insufficient data and experience upon which t h e effects of the manufacture, distribution in commerce, processing, use, or disposal of such substance or mixture or of any combina- tion of such activities on health or the environment can reason- ably be determined or predicted, and (iii) testing of such substance or mixture with respect to such effects is necessary to develop such d a t a ; and (2) in the case of a mixture, the effects which the mixture's manufacture, distribution in commerce, processing, use, or dis- posal or any combination of such activities may have on health or the environment may not be reasonably and more efficiently deter- mined or predicted by testing the chemical substances which com- prise the m i x t u r e ; Rules. the Administrator shall by rule require t h a t testing be conducted on such substance or mixture to develop data with respect to the health and environmental effects for which there is an insufficiency of data and experience and which are relevant to a determination that the manufacture, distribution in commerce, processing, use, or disposal of such substance or mixture, or t h a t any combination of such activities, does or does not present an unreasonable risk of injury to health or the environment. (b) (1) TESTING REQUIREMENT R U L E . — A rule under subsection (a) shall include— ( A ) identification of the chemical substance or mixture for which testing is required under the rule, Standards for ( B ) standards for the development of test data for such sub- development of stance or mixture, and test data. ( C ) with respect to chemical substances which are not new Data, submittal to chemical substances and to mixtures, a specification of the period Administrator. (which period m a y not be of unreasonable duration) within
PUBLIC LAW 94-469—OCT. 11, 1976 90 STAT. 2007 which the persons required to conduct the testing shall submit to the Administrator data developed in accordance with the stand- ards referred to in subparagraph (B). In determining the standards and period to be included, pursuant to subparagraphs (B) and (C), in a rule under subsection (a), the Administrator's considerations shall include the relative costs of the various test protocols and methodologies which ma^ be required under the rule and the reasonably foreseeable availability of the facilities and personnel needed to perform the testing required under the rule. Any such rule may require the submission to the Administrator of pre- liminary data during the period prescribed under subparagraph (C). (2) (A) The health and environmental effects for which standards for the development of test data may be prescribed include carcino- genesis, mutagenesis, teratogenesis, behavioral disorders, cumulative or synei'i^istic effects, and any other effect which may present an unrea- sonable risk of injury to health or the environment. The characteristics of chemical substances and mixtures for which such standards may be prescribed include persistence, acute toxicity, subacute toxicity, chronic toxicity, and any other characteristic which may present such a risk. The methodologies that may be prescribed in such standards Consultations. include epidemiologic studies, serial or hierarchical tests, in vitro tests, and whole animal tests, except that before prescribing epidemiologic studies of employees, the Administrator shall consult with the Director of the National Institute for Occupational Safety and Health. (B) From time to time, but not less than once each 12 months, the Review of Administrator shall review the adequacy of the standards for develoj)- standards. ment of data prescribed in rules under subsection (a) and shall, if necessary, institute proceedings to make appropriate revisions of such standards. (3) (A) A rule under subsection (a) respecting a chemical substance or mixture shall require the }>ersons described in subparagraph (B) to conduct tests and submit data to the Administrator on such sub- stance or mixture, except that the Administrator may permit two or more of such persons to designate one such person or a qualified third party to conduct such tests and submit such data on behalf of the pei'- sons making the designation. (B) The following persons shall be required to conduct tests and submit data on a chemical substance or mixture subject to a rule under subsection (a) : (i) Each person who manufactures or intends to manufacture such substance or mixture if the Administrator makes a finding described in subsection (a) (1) (A) (ii) or (a) (1) (B) (ii) with respect to the manufacture of such substance or mixture. (ii) Each pereon who processes or intends to j^rocess such sub- stance or mixture if the Administrator makes a finding described in subsection (a) (1) (A) (ii) or (a) (1) (B) (ii) with respect to the processing of such substance or mixture. (iii) Each person who manufactures or processes or intends to manufacture or process such substance or mixture if the Adminis- trator makes a finding described in subsection (a) (1) (A) (ii) or (a) (1) (B) (ii) with respect to the distribution in commerce, use, or disposal of such substance or mixture. (4) Any rule under subsection (a) requiring the testing of and submission of data for a particular chemical substance or mixture shall expire at the end of the reimbursement period (as defined in sub- section (c) (8) (B)) which is applicable to test data for such substance or mixture unless the Administrator repeals the rule before such date;
90 STAT. 2008 PUBLIC LAW 94-469—OCT. 11, 1976 and a rule under subsection (a) requiring the testing of and submission of data for a category of chemical substances or mixtures shall expire with respect to a chemical substance or mixture included in the cate- gory at the end of the reimbursement period (as so defined) which is applicable to test data for such substance or mixture unless the Admin- istrator before such date repeals the application of the rule to such substance or mixture or repeals the rule. (5) Rules issued under subsection (a) (and any substantive amend- ment thereto or repeal thereof) shall be promulgated pursuant to Oral presentation section 553 of title 5, United States Code, except that (A) the Admin- and written istrator shall give interested persons an opportunity for the oral pres- submissions. entation of data, views, or arguments, in addition to an opportunity to Transcript. make written submissions; (B) a transcript shall be made of any oral Publication. presentation; and (C) the Administrator shall make and publish with the rule the findings described in paragraph (1)(A) or (1)(B) of subsection (a) and, in the case of a rule respecting a mixture, the finding described in paragraph (2) of such subsection. Application. (c) ExEMPTioisr.— (1) Any person required by a rule under subsec- tion (a) to conduct tests and submit data on a chemical substance or mixture may apply to the Administrator (in such form and manner as the Administrator shall prescribe) for an exemption from such requirement. (2) If, upon receipt of an application under paragraph (1), the Administrator determines that— (A) the chemical substance or mixture with respect to which such application was submitted is equivalent to a chemical sub- stance or mixture for which data has been submitted to the Admin- istrator in accordance with a rule under subsection (a) or for which data is being developed pursuant to such a rule, and (B) submission of data by the applicant on such substance or mixture would be duplicative of data which has been submitted to the Administrator in accordance with such rule or which is being developed pursuant to such rule, the Administrator shall exempt, in accordance with paragraph (3) or (4), the applicant from conducting tests and submitting data on such substance or mixture under the rule with respect to which such application v>'as submitted. Fair and (3) (A) If the exemption under paragraph (2) of any person from equitable the requirement to conduct tests and submit test data on a chemical reimbursement. substance or mixture is granted on the basis of the existence of previ- ouslv submitted test data and if such exemption is granted during the reimbursement period for such test data (as prescribed by subpara- graph ( B ) ) , then (unless such person and the persons referred to in clauses (i) and (ii) agree on the amount and method of reimburse- ment) the Administrator shall order the person granted the exemption to provide fair and equitable reimbursement (in an amount deter- mined under rules of the Administrator) — (i) to the person who previously submitted such test data, for a portion of the costs incurred by such person in complying with the requirement to submit such data, and (ii) to any other person who has been required under this sub- paragraph to contribute with respect to such costs, for a portion of the amount such person was required to contribute. Rules. In promulgating rules for the determination of fair and equitable reimbursement to the persons described in clauses (i) and (ii) for costs incurred with respect to a chemical substance or mixture, the Administrator shall, after consultation with the Attorney General
PUBLIC LAW 94-469—OCT. 11, 1976 90 STAT. 2009 and the Federal Trade Commission, consider all relevant factors, including the effect on the competitive position of the person required to provide reimbursement in relation to the person to be reimbursed and the share of the market for such substance or mixture of the per- son required to provide reimbursement in relation to the share of such market of the persons to be reimbursed. An order under this sub- paragraph shall, for purposes of judicial review, be considered final agency action. (B) For purposes of subparagraph (A), the reimbursement period Reimbursement for any test data for a chemical substance or mixture is a period— period. (i) beginning on the date such data is submitted in accordance with a rule promulgated under subsection (a), and (ii) ending— (I) five years after the date referred to in clause (i), or (II) at the expiration of a period which begins on the date referred to in clause (i) and which is equal to the period which the Administrator determines was necessary to develop such data, whichever is later. (4) (A) If the exemption under paragraph (2) of any person from the requirement to conduct tests and submit test data on a chemical substance or mixture is granted on the basis of the fact that test data is being developed by one or more persons pursuant to a rule promul- gated under subsection (a), then (unless such person and the persons referred to in clauses (i) and (ii) agree on the amount and method of reimbursement) the Administrator shall order the person granted the exemption to provide fair and equitable reimbursement (in an amount determined under rules of the Administrator)— (i) to each such person who is developing such test data, for a portion of the costs incurred by each such person in complying with such rule, and (ii) to any other person who has been required under this sub- paragraph to contribute with respect to the costs of complying with such rule, for a portion of the amount such person was required to contribute. In promulgating rules for the determination of fair and equitable reimbursement to the persons described in clauses (i) and (ii) for costs incurred with respect to a chemical substance or mixture, the Administrator shall, after consultation with the xittorney General and the Federal Trade Commission, consider the factors described in the second sentence of paragraph (3) (A). An order under this subpara- graph shall, for purposes of judicial review, be considered final agency action. (B) If any exemption is granted under paragraph (2) on the basis of the fact that one or more persons are developing test data pursuant to a rule promulgated under subsection (a) and if after such exemp- tion is granted the Administrator determines that no such person has complied with such rule, the Administrator shall (i) after providing written notice to the person who holds such exemption and an oppor- tunity for a hearing, by order terminate such exemption, and (ii) notify in writing such person of the requirements of the rule with respect to which such exemption was granted. (d) NOTICE.—^Upon the receipt of any test data pursuant to a rule Publication in under subsection (a), the Administrator shall publish a notice of the Federal Register. receipt of such data in the Federal Register within 15 days of its receipt. Subject to section 14, each such notice shall (1) identify the chemical substance or mixture for which data have been received; (2) list the uses or intended uses of such substance or mixture and the
90 STAT. 2010 PUBLIC LAW 94-469—OCT. 11, 1976 information required by the applicable standards for the development of test data; and (3) describe the nature of the test data developed. Post, p. 2034. Except as otherwise provided in section 14, such data shall be made available by the Administrator for examination by any person. Committee to (e) PRIORITY LIST,— (1) (A) There is established a committee to make make recommendations to the Administrator respecting the chemical recommendations to substances and mixtures to which the Administrator should give Administrator. priority consideration for the promulgation of a rule under subsec- tion (a). In making such a recommendation with respect to any chem- ical substance or mixture, the committee shall consider all relevant factors, including— (i) the quantities in which the substance or mixture is or will be manufactured, (ii) the quantities in which the substance or mixture enters or will enter the environment, (iii) the number of individuals who are or will be exposed to the substance or mixture in their places of employment and the dura- tion of such exposure, (iv) the extent to which human beings are or will be exposed to the substance or mixture, (v) the extent to which the substance or mixture is closely related to a chemical substance or mixture which is known to present an unreasonable risk of injury to health or the environ- ment, (vi) the existence of data concerning the effects of the substance or mixture on health or the environment, (vii) the extent to which testing of the substance or mixture may result in the development of data upon which the effects of the substance or mixture on health or the environment can rea- sonably be determined or predicted, and (viii) the reasonably foreseeable availability of facilities and personnel for performing testing on the substance or mixture. Recommenda- The recommendations of the committee shall be in the form of a list tions, list of of chemical substances and mixtures which shall be set forth, either by chemical individual substance or mixture or by groups of substances or mix- substances and tures, in the order in which the committee determines the Administra- mixtures. tor should take action under subsection (a) with respect to the substances and mixtures. In establishing such list, the committee shall give priority attention to those chemical substances and mixtures which are known to cause or contribute to or which are suspected of causing or contributing to cancer, gene mutations, or bii-th defects. The committee shall designate chemical substances and mixtures on the list with respect to which the committee determines the Administrator should, within 12 months of the date on which such substances and mixtures are first designated, initiate a proceeding under subsection (a). The total number of chemical substances and mixtures on the list which are designated under the preceding sentence may not, at any time, exceed 50. Publication in (B) As soon as ])racticable but not later than nine months after Federal Register; the effective date of this Act, the committee shall publish in the Fed- transmittal to eral Register and transmit to the Administrator the list and designa- Administrator. tions required by subparagraph (A) together with the reasons for the committee's inclusion of each chemical substance or mixture on the list. At least every six months after the date of the transmission to the Ad- ministrator of the list pursuant to the preceeding sentence, the connnit- tee shall make such revisions in the list as it determines to be necessary and shall transmit them to the Administrator together with the com- Publication in mittee's reasons for the revisions. Upon receipt of any such revision, Federal Register.
PUBLIC LAW 94-469—OCT. 11, 1976 90 STAT. 2011 the Administrator shall publish in the Federal Register the list with such revision, the reasons for such revision, and the designations made under subparagraph (A). The Administrator shall provide reasonable Comments. opportunity to any interested person to file with the Administrator written comments on the committee's list, any revision of such list by the committee, and designations made by the committee, and shall make such comments available to the public. Within the 12-month Publication in period beginning on the date of the first inclusion on the list of a Federal Register. chemical substance or mixture designated by the committee under sub- paragraph (A) the Administrator shall with respect to such chemical substance or mixture either initiate a rulemaking proceeding under subsection (a) or if such a proceeding is not initiated within such period, publish in the Federal Register the Administrator's reason for not initiating such a proceeding. (2) (A) The committee established by paragraph (1) (A) shall con- Membership. sist of eight members as follows: (i) One member appointed by the Administrator from the Environmental Protection Agency. (ii) One member appointed by the Secretary of Labor from officers or employees of the Department of I^bor engaged in the Secretary's activities under the Occupational Safety and Health Act of 1970. (iii) One member appointed by the Chairman of the Council on Environmental Quality from the Council or its officer's or employees. (iv) One member appointed by the Director of the National Institute for Occupational Safety and Health from officers or employees of the Institute. (v) One member appointed by the Director of the National Institute of Environmental Health Sciences from officers or employees of the Institute. (vi) One member appointed by the Director of the National Cancer Institute from officers or employees of the Institute. (vii) One member appointed by the Director of the National Science Foundation from officers or employees of the Foundation, (viii) One member appointed by the Secretary of Commerce from officers or employees of the Department of Commerce. (B) (i) An appointed member may designate an individual to serve on the committee on the member's behalf. Such a designation may be made only with the approval of the applicable appointing authority and only if the individual is from the entity from which the member was appointed. (ii) No individual may serve as a member of the committee for more than four years in the aggregate. If any member of the committee leaves the entity from which the member was appointed, such member maj^ not continue as a member of the committee, and the member's position shall be considered to be vacant. A vacancy in the committee shall be filled in the same manner in which the original appointment was made. (iii) Initial appointments to the committee shall be made not later than the 60th day after the effective date of this Act. Not later than the 90th day after such date the members of the committee shall hold a meeting for the selection of a chairperson from among their number. (C) (i) No member of the committee, or designee of such member, shall accept employment or compensation from any person subject to any requirement of this Act or of any rule promulgated or order issued thereunder, for a period of at least 12 months after termination of service on the committee.
90 STAT. 2012 PUBLIC LAW 94-469—OCT. 11, 1976 (ii) No person, while serving as a member of the committee, or des- ignee of such member, may own any stocks or bonds, or have any pecuniary interest, of substantial value in any person engaged in the manufacture, processing, or distribution in commerce of any chemical substance or mixture subject to any requirement of this Act or of any rule promulgated or order issued thereunder. (iii) The Administrator, acting through attorneys of the Environ- mental Protection Agency, or the Attorney General may bring an action in the appropriate district court of the United States to restrain any violation of this subparagraph. (D) The Administrator shall provide the committee such admin- istrative support services as may be necessary to enable the committee to carry out its function under this subsection. (f) REQUIRED ACTIONS.—Upon the receipt of— (1) any test data required to be submitted under this Act, or (2) any other information available to the Administrator, which indicates to the Administrator that there may be a reasonable basis to conclude that a chemical substance or mixture presents or will present a significant risk of serious or widespread harm to human beings from cancer, gene mutations, or birth defects, the Administra- tor shall, within the 180-day period beginning on the date of the receipt of such data or information, initiate appropriate action under section 5, 6, or 7 to prevent or reduce to a sufficient extent such risk or publish in the Federal Register a finding that such risk is not unreasonable. For good cause shown the Administrator may extend such period for an Publication in additional period of not more than 90 days. The Administrator shall Federal Register, publish in the Federal Register notice of any such extension and the reasons therefor. A finding by the Administrator that a risk is not unreasonable shall be considered agency action for purposes of judicial 5 use 701. review under chapter 7 of title 5, United States Code. This subsection shall not take effect until two years after the effective date of this Act. (g) PETITION FOR STANDARDS FOR THE DEVELOPMENT OF TEST DATA.— A person intending to manufacture or process a chemical substance Infra. for which notice is required under section 5(a) and who is not required under a rule under subsection (a) to conduct tests and submit data on such substance may petition the Administrator to prescribe stand- ards for the development of test data for sucli substance. The Admin- istrator shall by order either grant or deny anj^ such petition within 60 days of its receipt. If the petition is granted, the Administrator shall prescribe such standards for such substance within 75 days of Publication in the date the petition is granted. If the petition is denied, the Admin- Federal Register, istrator shall publish, subjex?t to section 14, in the Federal Register the Post, p. 2034. reasons for such denial. SEC. 5. MANUFACTURING AND PROCESSING NOTICES. 15 use 2604. (a) I N GENERAL.—(1) Except as provided in subsection (h), no person may— (A) manufacture a new chemical substance on or after the 30th day after the date on which the Administrator first publishes the list required by section 8 (b), or (B) manufacture or process any chemical substance for a use which the Administrator has determined, in accordance with paragraph (2), is a significant new use, unless such person submits to the Administrator, at least 90 days before such manufacture or processing, a notice, in accordance with subsection (d), of such person's intention to manufacture or process such sub- stance and such person complies with any applicable requirement of subsection (b).
PUBLIC LAW 94-469—OCT. 11, 1976 90 STAT. 2013 (2) A determination by the Administrator that a use of a chemical substance is a significant new use with respect to wliich notification is required under paragraph (1) shall be made by a rule promulgated after a consideration of all relevant factors, including— (A) the projected volume of manufacturing and processing of a chemical substance, (B) the extent to which a use changes the type or form of exposure of human beings or the environment to a chemical substance, (C) the extent to which a use increases the magnitude and duration of exposure of human beings or the environment to a chemical substance, and (D) the reasonably anticipated manner and methods of manu- facturing, processing, distribution in commerce, and disposal of a chemical substance. (b) SUBMISSION OF TEST DATA.—(1) (A) If (i) a person is required by subsection (a) (1) to submit a notice to the Administrator before beginning the manufacture or processing of a chemical substance, and (ii) such person is required to submit test data for such sub- stance pursuant to a rule promulgated under section 4 before the submission of such notice, such person shall submit to the Adminis- trator such data in accordance with such rule at the time notice is submitted in accordance with subsection (a) (1). (B) I f - (i) a person is required by subsection (a) (1) to submit a notice to the Administrator, and (ii) such person has been granted an exemption under section 4(c) from the requirements of a rule promulgated under section 4 before the submission of such notice, such person may not, before the expiration of the 90 day period which begins on the date of the submission in accordance with such rule of the test data the submission or development of which was the basis for the exemption, manufacture such substance if such person is subject to subsection (a) (1) (A) or manufacture or process such substance for a significant new use if the person is subject to subsection (a)(1)(B). (2) (A) If a person— (i) is required by subsection (a) (1) to submit a notice to the Administrator before beginning the manufacture or processing of a chemical substance listed under paragraph (4), and (ii) is not required by a rule promulgated under section 4 before the submission of such notice to submit test data for such substance, such person shall submit to the Administrator data prescribed by subparagraph (B) at the time notice is submitted in accordance with subsection (a) (1). (B) Data submitted pursuant to subparagraph (A) shall be data which the person submitting the data believes show that— (i) in the case of a substance with respect to which notice is required under subsection (a) (1) (A), the manufacture, process- ing, distribution in commerce, use, and disposal of the chemical substance or any combination of such activities will not present an unreasonable risk of injury to health or the environment, or (ii) in the case of a chemical substance with respect to which notice is required under subsection ( a ) ( 1 ) ( B ) , the intended significant new use of the chemical substance will not present an unreasonable risk of injury to health or the environment.
90 STAT. 2 0 1 4 PUBLIC LAW 9 4 - 4 6 9 ~ 0 C T . 11, 1976 (3) D a t a submitted under p a r a g r a p h (1) or (2) shall be made Post, p. 2034. available, subject to section 14, for examination by interested persons, (4) ( A ) (i) T h e Administrator m a y , by rule, compile a n d keep current a list of chemical substances with respect t o which t h e Administrator finds t h a t t h e manufacture, processing, distribution i n commerce, use, or disposal, or any combination of such activities, presents or m a y present an unreasonable risk of injury t o health or the environment. (ii) I n making a finding under clause (i) t h a t t h e manufacture, processing, distribution in commerce, use, or disposal of a chemical substance or any combination of such activities presents or may present an unreasonable risk of injury to health or t h e environment, t h e Administrator shall consider all relevant factors, including— ( I ) the effects of t h e chemical substance on health a n d t h e magnitude of human exposure t o such substance; a n d ( I I ) t h e effects of t h e chemical substance on t h e environment and t h e magnitude of environmental exposure t o such substance. ( B ) T h e Administrator shall, in prescribing a rule under subpara- g r a p h ( A ) which lists any chemical substance, identify those uses, if any, which t h e Administrator determines, by rule under subsection (a) ( 2 ) , would constitute a significant new use of such substance. (C) A n y rule under s u b p a r a g r a p h ( A ) , a n d any substantive amendment or repeal of such a rule, shall be promulgated pursuant to t h e procedures specified in section 553 of title 5, United States Oral Code, except t h a t (i) t h e Administrator shall give interested persons presentation. an opportunity for t h e oral presentation of data, views, or arguments, Transcript. in addition t o an opportunity to make written submissions, (ii) a Publication. transcript shall be kept of any oral presentation, and (iii) the Admin- istrator shall make a n d publish with t h e rule t h e finding described in s u b p a r a g r a p h ( A ) . (c) E X T E N S I O N o r NOTICE P E R I O D . — T h e A d m i n i s t r a t o r may for good cause extend for additional periods (not to exceed in the aggre- gate 90 days) t h e period, prescribed by subsection ( a ) or (b) before which t h e manufacturing or processing of a chemical substance sub- Publication in ject t o such subsection m a y begin. Subject t o section 14, such a n Federal Register, extension a n d t h e reasons therefor shall be published in t h e Federal Register a n d shall constitute a final agency action subject to judicial review. ( d ) CONTENT o r NOTICE ; PUBLICATIONS I N T H E FEDERAL REGISTER.— (1) T h e notice required by subsection ( a ) shall include— ( A ) insofar as known to t h e person submitting t h e notice or insofar as reasonably ascertainable, t h e information described i n subparagraphs ( A ) , ( B ) , ( C ) , ( D ) , ( F ) , a n d ( G ) of section 8(a) (2),and ( B ) in such form a n d manner as t h e Administrator m a y pre- scribe, any test data in t h e possession or control of t h e person giving such notice which a r e related t o t h e effect of a n y manu- facture, processing, distribution in commerce, use, or disposal of such substance or any article containing such substance, or of a n y combination of such activities, on health or the environment, a n d ( C ) a description of any other data concerning the environ- mental a n d health effects of such substance, insofar as known t o t h e person making t h e notice or insofar as reasonably ascertain- able. Such a notice shall be made available, subject to section 14, for exam- ination by interested persons. (2) SuDJect t o section 14, not later t h a n five days (excluding Satur- days, Sundays a n d legal holidays) after t h e date of t h e receipt of a
PUBLIC LAW 94-469—OCT. 11, 1976 90 STAT. 2015 notice under subsection (a) or of data under subsection (b), the Administrator shall publish in the Federal Register a notice which— (A) identifies the chemical substance for which notice or data has been received; (B) lists the uses or intended uses of such substance; and (C) in the case of the receipt of data under subsection (b), describes the nature of the tests performed on such substance and any data which was developed pursuant to subsection (b) or a rule under section 4. A notice under this paragraph respecting a chemical substance shall identify the chemical substance by generic class unless the Administra- tor determines that more specific identification is required in the public interest. (3) At the beginning of each month the Administrator shall pub- lish a list in the Federal Register of (A) each chemical substance for which notice has been received under subsection (a) and for which the notification period prescribed by subsection (a), (b), or (c) has not expired, and (B) each chemical substance for which such notifica- tion period has expired since the last publication in the-Federal Regis- ter of such list. (e) REGULATION PENDING DEVELOPMENT OF INFORMATION.— (1) (A) If the Administrator determines that— (i) the information available to the Administrator is insuf- ficient to permit a reasoned evaluation of the health and environ- mental effects of a chemical substance with respect to which notice is required by subsection ( a ) ; and (ii) (I) in the absence of sufficient information to permit the Administrator to make such an evaluation, the manufacture, processing, distribution in commerce, use, or disposal of such substance, or any combination of such activities, may present an unreasonable risk of injury to health or the environment, or (II) such substance is or will be produced in substantial quan- tities, and such substance either enters or may reasonably be anticipated to enter the environment in substantial quantities or there is or may be significant or substantial human exposure to the substance, the Administrator may issue a proposed order, to take effect on the Proposed order, expiration of the notification period applicable to the manufacturing or processing of such substance under subsection (a), (b), or (c), to prohibit or limit the manufacture, processing, distribution in com- merce, use, or disposal of such substance or to prohibit or limit any combination of such activities. (B) A proposed order may not be issued under subparagraph (A) respecting a chemical substance (i) later than 45 days before the expiration of the notification period applicable to the manufacture or processing of such substance under subsection (a), (b), or (c), and (ii) unless the Administrator has, on or before the issuance of the proposed order, notified, in writing, each manufacturer or processor, as the case may be, of such substance of the determination which underlies such order. (C) If a manufacturer or processor of a chemical substance to be subject to a proposed order issued under subparagraph (A) files with the Administrator (within the 30-day period beginning on the date such manufacturer or processor received the notice required by subpar- agraph (B) (ii)) objections specifying with particularity the provi- sions of the order deemed objectionable and stating the grounds therefor, the proposed order shall not take effect.
90 STAT. 2016 PUBLIC LAW 94-469—OCT. 11, 1976 Injunction, (2) (A) (i) Except as provided in clause (ii), if with respect to a application. chemical substance with respect to which notice is required by subsec- tion (a), the Administrator makes the determination described in paragraph (1) (A) and if— (I) the Administrator does not issue a proposed order under paragraph (1) respecting such substance, or (II) the Administrator issues such an order respecting such substance but such order does not take effect because objections were filed under paragraph (1) (C) with respect to it, the Administrator, through attorneys of the Environmental Protection Agency, shall apply to the United States District Court for the Dis- trict of Columbia or the United States district court for the judicial district in which the manufacturer or processor, as the case may be, of such substance is found, resides, or transacts business for an injunction to prohibit or limit the manufacture, processing, distribution in com- merce, use, or disposal of such substance (or to prohibit or limit any combination of such activities). (ii) If the Administrator issues a proposed order under paragraph (1) (A) respecting a chemical substance but such order does not take effect because objections have been filed under paragraph (1) (C) with respect to it, the Administrator is not required to apply for an injunc- tion under clause (i) respecting such substance if the Administrator determines, on the basis of such objections, that the determinations under paragraph (1) (A) may not be made. (B) A district court of the United States which receives an appli- cation under subparagraph (A) (i) for an injunction respecting a chemical substance shall issue such injunction if the court finds that— (i) the information available to the Administrator is insufficient to permit a reasoned evaluation of the health and environmental effects of a chemical substance with respect to which notice is required by subsection ( a ) ; and (ii) (I) in the absence of sufficient information to permit the Administrator to make such an evaluation, the manufacture, proc- essing, distribution in commerce, use, or disposal of such substance, or any combination of such activities, may present an unreasonable risk of injury to health or the environment, or (II) such substance is or will be produced in substantial quan- tities, and such substance either enters or may reasonably be anticipated to enter the environment in substantial quantities or there is or may be significant or substantial human exposure to the substance. (C) Pending the completion of a proceeding for the issuance of an injunction imder subparagraph (B) respecting a chemical substance, the court may, upon application of the Administrator made through attorneys of the Environmental Protection Agency, issue a temporary restraining order or a preliminary injunction to prohibit the manu- facture, processing, distribution in commerce, use, or disposal of such a substance (or any combination of such activities) if the court finds that the notification period applicable under subsection (a), (b), or (c) to the manufacturing or processing of such substance may expire before such proceeding can be completed. (D) After the submission to the Administrator of test data sufficient to evaluate the health and environmental effects of a chemical sub- stance subject to an injunction issued under subparagraph (B) and the evaluation of such data by the Administrator, the district court of the United States which issued such injunction shall, upon petition, dissolve the injunction unless the Administrator has initiated a pro-
PUBLIC LAW 94-469—OCT. 11, 1976 90 STAT. 2017 ceeding for the issuance of a rule under section 6(a) respecting the substance. If such a proceeding has been initiated, such court shall con- tinue the injunction in effect until the effective date of the rule pro- mulgated in such proceeding or, if such proceeding is terminated without the promulgation of a rule, upon the termination of the pro- ceeding, whichever occurs first. (f) PROTECTION AGAINST UNREASONABLE RISKS.—(1) If the Admin- istrator finds that there is a reasonable basis to conclude that the manu- facture, processing, distribution in commerce, use, or disposal of a chemical substance with respect to which notice is required by subsec- tion (a), or that any combination of such activities, presents or will present an unreasonable risk of injury to health or environment before a rule promulgated under section 6 can protect against such risk, the Administrator shall, before the expiration of the notification period applicable under subsection (a), (b), or (c) to the manufacturing or processing of such substance, take the action authorized by paragraph (2) or (3) to the extent necessary to protect against such risk. (2) The Administrator may issue a proposed rule under section Proposed rule. 6(a) to apply to a chemical substance with respect to which a finding was made under paragraph (1)— (A) a requirement limiting the amount of such substance which may be manufactured, processed, or distributed in commerce, (B) a requirement described in paragraph (2), (3), (4), (5), (6), or (7) of section 6(a), or (C) any combination of the requirements referred to in sub- paragraph (B). Such a proposed rule shall be effective upon its publication in the Fed- Publication in eral Register. Section 6 ( d ) ( 2 ) ( B ) shall apply with respect to such Federal Register. rule. (3) (A) The Administrator may— (i) issue a proposed order to prohibit the manufacture, process- Proposed order. ing, or distribution in commerce of a substance with respect to which a finding was made under paragraph (1), or (ii) apply, through attorneys of the Environmental Protection Injunction, Agency, to the United States District Court for the District of application. Columbia or the United States district court for the judicial dis- trict in which the manufacturer, or processor, as the case may be, of such substance, is found, resides, or transacts business for an injunction to prohibit the manufacture, processing, or distribu- tion in commerce of such substance. A proposed order issued under clause (i) respecting a chemical substance shall take effect on the expiration of the notification period applicable under subsection (a), (b), or (c) to the manufacture or processing of such substance. (B) If the district court of the United States to which an applica- tion has been made under subparagraph (A) (ii) finds that there is a reasonable basis to conclude that the manufacture, processing, distribution in commerce, use, or disposal of the chemical substance with respect to which such application was made, or that any combina- tion of such activities, presents or will present an unreasonable risk of injury to health or the environment before a rule promulgated under section 6 can protect against such risk, the court shall issue an injunction to prohibit the manufacture, processing, or distribution in commerce of such substance or to prohibit any combination of such activities.
90 STAT. 2018 PUBLIC LAW 94-469—OCT. 11, 1976 (C) The provisions of subparagraphs (B) and (C) of subsection (e) (1) shall apply with respect to an order issued under clause (i) of subparagraph ( A ) ; and the provisions of subparagraph (C) of sub- section (e) (2) shall apply with respect to an injunction issued under subparagraph (B). (D) If the Administrator issues an order pursuant to subparagraj)h (A) (i) respecting a chemical substance and objections are filed in accordance with subsection (e) (1) (C), the Administrator shall seek an injunction under subparagraph (A) (ii) respecting such substance unless the Administrator determines, on the basis of such objections, that such substance does not or will not present an unreasonable risk of injury to health or the environment. (g) STATEMENT or REASONS FOR NOT TAKING ACTION.—If the Administrator has not initiated any action under this section or section 6 or 7 to prohibit or limit the manufacture, processing, distribution in commerce, use, or disposal of a chemical substance, with respect to which notification or data is required by subsection ( a ) ( 1 ) ( B ) or (b), before the expiration of the notification period applicable to the manu- facturing or processing of such substance, the Administrator shall publish a statement of the Administrator's reasons for not initiating Publication in such action. Such a statement shall be published in the Federal Reg- Federal Register. ister before the expiration of such period. Publication of such state- ment in accordance with the preceding sentence is not a prerequisite to the manufacturing or processing of the substance with respect to which the statement is to be published. (h) EXEMPTIONS.— (1) The Administrator may, upon application, exempt any person from any requirement of subsection (a) or (b) to permit such person to manufacture or process a chemical substance for test marketing purposes^— (A) upon a showing by such person satisfactory to the Admin- istrator that the manufacture, processing, distribution in commerce, use, and disposal of such substance, and that any com- bination of such activities, for such purposes will not present any unreasonable risk of injury to health or the environment, and (B) under such restrictions as the Administrator considers appropriate. (2) (A) The Administrator may, upon application, exempt any per- son from the requirement of subsection (b) (2) to submit data for a chemical substance. If, upon receipt of an application under the pre- ceding sentence, the Administrator determines that— (i) the chemical substance with respect to which such applica- tion was submitted is equivalent to a chemical substance for which data has been submitted to the Administrator as required by sub- section (b)(2), and (ii) submission of data by the applicant on such substance would be duplicative of data which has been submitted to the Administrator in accordance with such subsection, the Administrator shall exempt the applicant from the requirement to submit such data on such substance. No exemption which is granted under this subparagraph with respect to the submission of data for a chemical substance may take effect before the beginning of the reim- bursement period applicable to such data. Fair and (B) If the Administrator exempts any person, under subparagraph equitable (A), from submitting data required under subsection ("b) (2) for a reimbursement. chemical substance because of the existence of previously submitted data and if such exemption is granted during the reimbursement period for such data, then (unless such person and the persons referred to in
PUBLIC LAW 94-469—OCT. 11, 1976 90 STAT. 2019 clauses (i) and (ii) agree on the amount and method of reimburse- ment) the Administrator shall order the person granted the exemption to provide fair and equitable reimbursement (in an amount determined under rules of the Administrator) — (i) to the person who previously submitted the data on which the exemption was based, for a portion of the costs incurred by such person in complying with the requirement under subsection (b) (2) to submit such data, and (ii) to any other person who has been required under this sub- paragraph to contribute with respect to such costs, for a portion of the amount such person was required to contribute. In promulgating rules for the determination of fair and equitable reimbursement to the persons described in clauses (i) and (ii) for costs incurred with respect to a chemical substance, the Administrator shall, after consultation with the Attorney General and the Federal Trade Commission, consider all relevant factors, including the effect on the competitive position of the person required to provide reim- bursement in relation to the persons to be reimbursed and the share of the market for such substance of the person required to provide reim- bursement in relation to the share of such market of the persons to be reimbursed. For purposes of judicial review, an order under this subparagraph shall be considered final agency action. (C) For purposes of this paragraph, the reimbursement period for Reimbursement any previously submitted data for a chemical substance is a period— period. (i) beginning on the date of the termination of the prohibition, imposed under this section, on the manufacture or processing of such substance by the person who submitted such data to the Administrator, and (ii) ending— (I) five years after the date referred to in clause (i), or (II) at the expiration of a period which begins on the date referred to in clause (i) and is equal to the period which the Administrator determines was necessary to develop such data, whichever is later. (3) The requirements of subsections (a) and (b) do not apply with respect to the manufacturing or processing of any chemical sub- stance which is manufactured or processed, or proposed to be manu- factured or processed, only in small quantities (as defined by the Administrator by rule) solely for purposes of— (A) scientific experimentation or analysis, or (B) chemical research on, or analysis of such substance or another substance, including such research or analysis for the development of a product, if all persons engaged in such experimentation, research, or analysis for a manufacturer or processor are notified (in such form and manner as the Administrator may prescribe) of any risk to health which the manufacturer, processor, or the Administrator has reason to believe may be associated with such chemical substance. (4) The Administrator may, upon application and by rule, exempt the manufacturer of any new chemical substance from all or part of the requirements of this section if the Administrator determines that the manufacture, processing, distribution in commerce, use, or dis- posal of such chemical substance, or that any combination of such activities, will not present an unreasonable risk of injury to health or the environment. A rule promulgated under this paragraph (and any substantive amendment to, or repeal of, such a rule) shall be promul- gated in accordance with paragraphs (2) and (3) of section 6(c).
90 STAT. 2020 PUBLIC LAW 94-469—OCT. 1 1 , 1976 (5) T h e Administrator may, upon application, make the require- ments of subsections (a) and (b) inapplicable with respect to the manufacturing or processing of any chemical substance ( A ) which exists temporarily as a result of a chemical reaction in the manufac- t u r i n g or processing of a mixture or another chemical substance, and ( B ) to which there is no, and will not be, h u m a n or environmental exposure. Publication in (6) Immediately upon receipt of an application under p a r a g r a p h Federal Register. (1) or (5) the Administrator shall publish in the Federal Register Comments. notice of the receipt of such application. The Administrator shall give interested persons an opportunity to comment upon any such applica- tion and shall, within 45 days of its receipt, either approve or deny the Publication in application. The Administrator shall publish in the Federal Register Federal Register. notice of the approval or denial of such an application. (i) D E F I N I T I O N . — F o r purposes of this section, the terms "manufac- t u r e " and "process" mean manufacturing or processing for commercial purposes. SEC. 6. REGULATION OF HAZARDOUS CHEMICAL SUBSTANCES AND MIXTURES. 15 u s e 2605. (a) SCOPE or REGULATION.—If the Administrator finds t h a t there is a reasonable basis to conclude t h a t the manufacture, processing, dis- tribution in commerce, use, or disposal of a chemical substance or mixture, or t h a t any combination of such activities, presents or will present an unreasonable risk of injury to health or the environment, the Administrator shall by rule apply one or more of the following requirements to such substance or mixture to the extent necessary to protect adequately against such risk using the least burdensome requirements: (1) A requirement ( A ) prohibiting the manufacturing, process- ing, or distribution in commerce of such substance or mixture, or ( B ) limiting the amount of such substance or mixture which may be manufactured, processed, or distributed in commerce. (2) A requirement— ( A ) prohibiting the manufacture, processing, or distribu- tion in commerce of such substance or mixture for (i) a particular use or (ii) a particular use in a concentration in excess of a level specified by the Administrator in the rule imposing the requirement, or ( B ) limiting the amount of such substance or mixture which may be manufactured, processed, or distributed in commerce for (i) a particular use or (ii) a particular use in a concentration in excess of a level specified by t h e Administrator in the rule imposing t h e requirement. (3) A requirement t h a t such substance or mixture or any article containing such substance or mixture be marked with or accompanied by clear and adequate warnings and instructions with respect to its use, distribution in commerce, or disposal or with respect to any combination of such activities. T h e form and content of such warnings and instructions shall be prescribed by the Administrator. (4) A requirement t h a t manufacturers and processors of such substance or mixture make and retain records of the processes used to manufacture or process such substance or mixture and monitor or conduct tests which are reasonable and necessary to assure compliance with the requirements of any rule applicable under this subsection.
PUBLIC LAW 94-469—OCT. 11, 1976 90 STAT. 2021 (5) A requirement prohibiting or otherwise regulating any manner or method of commercial use of such substance or mixture. {6) (A) A requirement prohibiting or otherwise regulating any manner or method of disposal of such substance or mixture, or of any article containing such substance or mixture, by its manu- facturer or processor or by any other person who uses, or disposes of, it for commercial purposes. (B) A requirement under subparagraph (A) may not require any person to take any action which would be in violation of any law or requirement of, or in effect for, a State or political subdivision, and shall require each person subject to it to notify each State and political subdivision in which a required disposal may occur of such disposal. (7) A requirement directing manufacturers or processors of such substance or mixture (A) to give notice of such unreasonable risk of injury to distributors in commerce of such substance or mixture and, to the extent reasonably ascertainable, to other per- sons in possession of such substance or mixture or exposed to such substance or mixture, (B) to give public notice of such risk of injury, and (C) to replace or repurchase such substance or mixture as elected by the person to which the requirement is directed. Any requirement (or combination of requirements) imposed under this subsection may be limited in application to specified geographic areas. (b) QUALITY CONTROL.—If the Administrator has a reasonable basis to conclude that a particular manufacturer or processor is manu- facturing or processing a chemical substance or mixture in a manner which unintentionally causes the chemical substance or mixture to present or which will cause it to present an unreasonable risk of injury to health or the environment— (1) the Administrator may by order require such manufac- turer or processor to submit a description of the relevant quality control procedures followed in the manufacturing or processing of such chemical substance or mixture; and (2) if the Administrator determines— (A) that such quality control procedures are inadequate to prevent the chemical substance or mixture from presenting such risk of injury, the Administrator may order the manu- facturer or processor to revise such quality control procedures to the extent necessary to remedy such inadequacy; or (B) that the use of such quality control procedures has resulted in the distribution in commerce of chemical substances or mixtures which present an unreasonable risk of injury to health or the environment, the Administrator may order the manufacturer or processor to (i) give notice of such risk to processors or distributors in commerce of any such sub- stance or mixture, or to both, and, to the extent reasonably ascertainable, to any other person in possession of or exposed to any such substance, (ii) to give public notice of such risk, and (iii) to provide such replacement or repurchase of any such substance or mixture as is necessaiy to adequately pro- tect health or the environment. A determination under subparagraph (A) or (B) of paragraph (2) Hearing, shall be made on the record after opportunity for hearing in accord- ance with section 554 of title 5, United States Code. Any manufacturer
90 STAT. 2022 PUBLIC LAW 94-469—OCT. 1 1 , 1976 or processor subject to a requirement to replace or repurchase a chem- ical substance or mixture may elect either to replace or repurchase the substance or mixture and shall take either such action in the man- ner prescribed by the Administrator. Statement, (c) PROMULGATION" OF SUBSECTION (a) K U L E S . — ( 1 ) I n p r o m u l g a t - publication. ing any rule under subsection (a) with respect to a chemical substance or mixture, the Administrator shall consider and publish a statement with respect to— ( A ) the ejffects of such substance or mixture on health and the magnitude of the exposure of human beings to such substance or mixture, ( B ) the effects of such substance or mixtui'e on the environment and the magnitude of the exposure of the environment to such substance or mixture, (C) the benefits of such substance or mixture for various uses and the availability of substitutes for such uses, and ( D ) the reasonably ascertainable economic consequences of the rule, after consideration of the effect on the national economy, small business, technological innovation, the environment, and public health. If the Administrator determines that a risk of injury to health or the environment could be eliminated or reduced to a sufficient extent by actions taken under another Federal law (or laws) administered in whole or in p a r t by the Administrator, the Administrator may not promulgate a rule under subsection (a) to protect against such risk of injury unless the Administrator finds, in the Administrator's dis- cretion, t h a t it is in the public interest to protect against such risk under this Act. I n making such a finding the Administrator shall con- sider (i) all relevant aspects of the risk, as determined by the Adminis- t r a t o r in the Administrator's discretion, (ii) a comparison of the estimated costs of complying with actions taken under this Act and under such law (or l a w s ) , and (iii) the relative efficiency of actions under this Act and under such law (or laws) to protect against such risk of injury. (2) W h e n prescribing a rule under subsection (a) the Adminis- t r a t o r shall proceed in accordance with section 553 of title 5, United States Code (without regard to any reference in such section to sec- 5 u s e 556, 557. tions 556 and 557 of such t i t l e ) , and shall also (A) publish a notice of Notice, proposed rulemaking stating with particularity the reason for the publication. proposed rule; ( B ) allow interested persons to submit written data, Written data, views, and arguments, and make all such submissions publicly avail- views, arguments, able; (C) provide an opportunity for an informal h e a r i n g in accord- submittal. ance with p a r a g r a p h (3) ; ( D ) promulgate, if appropriate, a final Hearing. rule based on the matter in the rulemaking record (as defined in section Final rule. 1 9 ( a ) ) , and ( E ) make and publish with the rule the finding described in subsection ( a ) . Informal (3) Informal hearings required by p a r a g r a p h (2) (C) shall be con- ducted by the Administrator in accordance with the following requirements: ( A ) Subject to s u b p a r a g r a p h ( B ) , an interested person is entitled— (i) to present such person's position orally or by docu- mentary submissions (or b o t h ) , and (ii) if the Administrator determines that there are dis- puted issues of material fact it is necessary to resolve, to present such rebuttal submissions and to conduct (or have conducted under subparagraph ( B ) ( i i ) ) such cross-examina-
PUBLIC LAW 94-469—OCT. 11, 1976 90 STAT. 2023 tion of persons as the Administrator determines (I) to be appropriate, and (II) to be required for a full and true dis- closure with respect to such issues. (B) The Administrator may prescribe such rules and make such Rules. rulings concerning procedures in such hearings to avoid unneces- sary costs or delay. Such rules or rulings may include (i) the imposition of reasonable time limits on each interested person's oral presentations, and (ii) requirements that any cross-examina- tion to which a pereon may be entitled under subparagraph (A) be conducted by the Administrator on behalf of that person in such manner as the Administrator determines (I) to be appropriate, and (II) to be required for a full and true disclosure with respect to disputed issues of material fact, (C) (i) Except as provided in clause (ii), if a group of persons each of whom under subparagraphs (A) and (B) would be entitled to conduct (or have conducted) cross-examination and who are determined by the Administrator to have the same or similar interests in the proceeding cannot agree upon a single representative of such interests for purposes of cross-examination, the Administrator may make rules and rulings (I) limiting the representation of such interest for such purposes, and (II) gov- erning the manner in which such cross-examination shall be limited. (ii) When any person who is a member of a group with respect to which the Administrator has made a determination under clause (i) is unable to agree upon group representation with the other members of the group, then such person shall not be denied under the authority of clause (i) the opportunity to conduct (or have conducted) cross-examination as to issues affecting the per- son's particular interests if (I) the person satisfies the Admin- istrator that the person has made a reasonable and good faith effort to reach agreement upon group i-epresentation with the other members of the group and (II) the Administrator deter- mines that there are substantial and relevant issues which are not adequately presented by the group representative. (D) A verbatim transcript shall be taken of any oral presen- Verbatim tation made, and cross-examination conducted in any informal transcript. hearing under this subsection. Such transcript shall be available to the public. (4) (A) The Administrator may, pursuant to rules prescribed by the Compensation. Administrator, provide compensation for reasonable attorneys' fees, expert witness fees, and other costs of participating in a rulemaking proceeding for the promulgation of a rule under subsection (a) to any person— (i) who represents an interest which would substantially con- tribute to a fair determination of the issues to be resolved in the proceeding, and (ii)if- (I) the economic interest of such person is small in com- parison to the costs of effective participation in the proceed- ing by such person, or (II) such person demonstrates to the satisfaction of the Administrator that such person does not have sufficient resources adequately to participate in the proceeding without compensation under this subparagraph. In determining for purposes of clause (i) if an interest will substan- tially contribute to a fair determination of the issues to be resolved in
90 STAT. 2024 PUBLIC LAW 94-469—OCT. 11, 1976 a proceeding, the Administrator shall take into account the number and complexity of such issues and the extent to which representation of such interest will contribute to widespread public participation in the proceeding and representation of a fair balance of interests for the resolution of such issues. (B) In determining whether compensation should be provided to a person under subparagraph (A) and the amount of such compensa- tion, the Administrator shall take into account the financial burden which will be incurred by such person in participating in the rule- making proceeding. The Administrator shall take such action as may be necessary to ensure that the aggregate amount of compensa- tion paid under this paragraph in any fiscal year to all persons who, in rulemaking proceedings in which they receive compensation, are persons who either— (i) would be regulated by the proposed rule, or (ii) represent persons who would be so regulated, may not exceed 25 per centum of the aggregate amount paid as com- pensation under this paragraph to all persons in such fiscal year. (5) Paragraph (1), (2), (3), and (4) of this subsection apply to the pronmlgation of a rule repealing, or making a substantive amendment to, a rule promulgated under subsection (a). (d) EFFECTIVE DATE.— (1) The Administrator shall specify in any rule under subsection (a) the date on which it shall take effect, which date shall be as soon as feasible. Publication in (2) (A) The Administrator may declare a proposed rule under sub- Federal Register. section (a) to be effective upon its publication in the Federal Register and until the effective date of final action taken, in accordance with subparagraph (B), respecting such rule if— (i) the Administrator determines that— (I) the manufacture, processing, distribution in com- merce, use, or disposal of the chemical substance or mixture subject to such proposed rule or any combination of such activities is likely to result in an unreasonable risk of serious or widespread injury to health or the environment before such effective date; and (II) making such proposed rule so effective is necessary to protect the public interest; and (ii) in the case of a proposed rule to prohibit the manufacture, processing, or distribution of a chemical substance or mixture because of the risk determined under clause (i) ( I ) , a court has in an action under section 7 granted relief with respect to such risk associated with such substance or mixture. Such a proposed rule which is made so effective shall not, for pur- poses of judicial review, be considered final agency action. Notice. (B) If the Administrator makes a proposed rule effective upon its publication in the Federal Register, the Administrator shall, as expe- ditiously as possible, give interested persons prompt notice of such action, provide reasonable opportunity, in accordance with paragraphs (2) and (3) of subsection (c), for a hearing on such rule, and either promulgate such rule (as proposed or with modifications) or revoke it; and if such a hearing is requested, the Administrator shall com- mence the hearing within five days from the date such request is made unless the Administrator and the person making the request agree upon a later date for the hearing to begin, and after the hearing is concluded the Administrator shall, within ten days of the conclusion of the hearing, either promulgate such rule (as proposed or with modifications) or revoke it.
PUBLIC LAW 94-469—OCT. 11, 1976 90 STAT. 2025 (e) PoLYCHLORiNATED BiPHENYLS.—(1) Within six months after Rules, the effective date of this Act the Administrator shall promulgate rules to— (A) prescribe methods for the disposal of poly chlorinated biphenyls, and (B) require polychlorinated biphenyls to be marked with clear and adequate warnings, and instructions with respect to their processing, distribution in commerce, use, or disposal or with respect to any combination of such activities. Requirements prescribed by rules under this paragraph shall be con- sistent with the requirements of paragraphs (2) and (3). (2) (A) Except as provided under subparagraph (B), effective one year after the effective date of this Act no person may manufacture, process, or distribute in commerce or use any polychlorinated biphenyl in any manner other than in a totally enclosed manner. (B) The Administrator may by rule authorize the manufacture, processing, distribution in commerce or use (or any combination of such activities) of any polychlorinated biphenyl in a manner other than in a totally enclosed manner if the Administrator finds that such manu- facture, processing, distribution in commerce, or use (or combination of such activities) will not present an unreasonable risk of injury to health or the environment. (C) For the purposes of this paragraph, the term "totally enclosed "Totally enclosed manner'' means any manner which will ensure that any exposure of manner." human beings or the environment to a polychlorinated biphenyl will be insignificant as determined by the Administrator by rule. (3) (A) Except as provided in subparagraphs (B) and (C) — (i) no person may manufacture any polychlorinated biphenyl after two years after the effective date of this Act, and (ii) no person may process or distribute in commerce any poly- chlorinated biphenyl after two and one-half years after such date. (B) Any pereon may petition the Administrator for an exemption Petition for from the requirements of subparagraph (A), and the Administrator exemption, may grant by rule such an exemption if the Administrator finds that— (i) an unreasonable risk of injury to health or environment would not result, and (ii) good faith efforts have been made to develop a chemical substance which does not present an unreasonable risk of injury to health or the environment and which may be substituted for such polychlorinated biphenyl. An exemption granted under this subparagraph shall be subject to Terms and such terms and conditions as the Administrator may prescribe and conditions, shall be in effect for such period (but not more than one year from the date it is granted) as the Administrator may prescribe. (C) Subparagraph (A) shall not apply to the distribution in com- merce of any polychlorinated biphenyl if such polychlorinated biphenyl was sold for purposes other than resale before two and one half years after the date of enactment of this Act. (4) Any rule under paragraph (1), ( 2 ) ( B ) , or (3) (B) shall be promulgated in accordance with paragraphs (2), (3), and {4) of sub- section (c). (5) This subsection does not limit the authority of the Adminis- trator, under any other provision of this Act or any other Federal law, to take action respecting any polychlorinated biphenyl.
90 STAT. 2026 PUBLIC LAW 94-469—OCT. 1 1 , 1976 SEC. 7. IMMINENT HAZARDS. Civil action. ( a ) ACTIONS AUTHORIZED AND REQUIRED.— (1) T h e A d m i n i s t r a t o r 15 u s e 2606. m a y commence a civil action i n a n appropriate district court of t h e United States— ( A ) for seizure of an imminently hazardous chemical sub- stance or mixture or any article containing such a substance or mixture, ( B ) for relief (as authorized by subsection ( b ) ) against a n y person who manufactures, processes, distributes in commerce, or uses, or disposes of, an imminently hazardous chemical substance or mixture or any article containing such a substance or mix- ture, or (C) for both such seizure and relief. A civil action m a y be commenced under this p a r a g r a p h notwith- standing the existence of a rule under section 4, 5, or 6 or a n order under section 5, a n d notwithstanding t h e pendency of a n y adminis- trative or judicial proceeding under any provision of this Act. (2) I f t h e Administrator has not made a rule under section 6 ( a ) immediately effective (as authorized by subsection 6 ( d ) ( 2 ) ( A ) ( i ) ) with respect to a n imminently hazardous chemical substance or mix- ture, the Administrator shall commence in a district court of the United States with respect to such substance or mixture or article containing such substance or mixture a civil action described in s u b p a r a g r a p h ( A ) , ( B ) , o r ( C ) of p a r a g r a p h ( 1 ) . Jurisdiction. (b) R E L I E F AUTHORIZED.— (1) T h e district court of t h e United States in which an action under subsection ( a ) is brought shall have jurisdiction to g r a n t such temporary or permanent relief as may be necessary to protect health or t h e environment from the unreasonable risk associated with the chemical substance, mixture, or article involved in such action. (2) I n t h e case of an action under subsection ( a ) brought against a person who manufactures, processes, or distributes i n commerce a chemical substance or mixture or an article containing a chemical sub- stance o r mixture, the relief authorized by p a r a g r a p h (1) may include t h e issuance of a mandatory order requiring ( A ) i n t h e case of pur- chasers of such substance, mixture, or article known t o t h e defendant, notification to such purchasers of the risk associated with i t ; ( B ) pub- lic notice of such risk; ( C ) recall; ( D ) t h e replacement or repurchase of such substance, mixture, or article; or ( E ) any combination of t h e actions described in the preceding clauses. (3) I n t h e case of a n action under subsection ( a ) against a chemi- cal substance, mixture, or article, such substance, mixture, or article may be proceeded against by process of libel for its seizure a n d con- demnation. Proceedings in such an action shall conform as nearly as possible to proceedings in rem in admiralty. (c) V E N U E AND CONSOLIDATION.—(1) ( A ) A n action u n d e r subsec- tion ( a ) against a person who manufactures, processes, or distributes a chemical substance or mixture or an article containing a chemical sub- stance or mixture may be brought in the United States District Court for the District of Columbia or for any judicial district in which any of the defendants is found, resides, or transacts business; a n d process in such a n action may be served on a defendant in any other district in which such defendant resides or may be found. A n action under sub- section ( a ) against a chemical substance, mixture, or article m a y be brought in any United States district court within the jurisdiction of which the substance, mixture, or article is found. ( B ) I n determining t h e judicial district in which an action m a y be brought under subsection ( a ) in instances in which such action m a y
PUBLIC LAW 94-469—OCT. 11, 1976 90 STAT. 2027 be brought in more t h a n one judicial district, t h e Administrator shall take into account the convenience of the parties. (C) Subpeonas requiring attendance of witnesses in an action brought under subsection (a) may be served in any judicial district. (2) Whenever proceedings under subsection (a) involving identi- cal chemical substances, mixtures, or articles are pending in courts in two or more judicial districts, they shall be consolidated for trial by order of any such court upon application reasonably made by any p a r t y in interest, upon notice to all parties in interest. ( d ) A C T I O N U N D E R SECTION 6.—Where a p p r o p r i a t e , concurrently with the filing of an action under subsection (a) or as soon thereafter as may be practicable, t h e Administrator shall initiate a proceeding for the promulgation of a rule under section 6 ( a ) . (e) REPRESENTATION,—Notwithstanding any other provision of law, in any action under subsection ( a ) , the Administrator may direct attorneys of the Environmental Protection Agency to appear and represent the Administrator in such an action. (f) D E F I N I T I O N . — F o r the purposes of subsection ( a ) , the term "imminently hazardous chemical substance or m i x t u r e " means a chemi- cal substance or mixture which presents an imminent a n d unreason- able risk of serious or widespread injury t o health or the environment. Such a risk to health or the environment shall be considered imminent if it is shown t h a t the manufacture, processing, distribution in com- merce, use, or disposal of the chemical substance or mixture, or t h a t any combination of such activities, is likely to result in such injury t o health or the environment before a final rule under section 6 can protect against such risk. SEC. 8. REPORTING AND RETENTION OF INFORMATION. (a) REPORTS.— (1) T h e Administrator shall promulgate rules Rules, under which— 15 USC 2607. ( A ) each person (other t h a n a small manufacturer or proc- essor) who manufactures or processes or proposes to manufacture or process a chemical substance (other than a chemical substance described in s u b p a r a g r a p h ( B ) ( i i ) ) shall maintain such rec- ords, and shall submit t o t h e Administrator such reports, as the Administrator may reasonably require, a n d ( B ) each person (other t h a n a small manufacturer or proc- essor) who manufactures or processes or proposes t o manufacture or process— (i) a mixture, or (ii) a chemical substance in small quantities (as defined by the Administrator by rule) solely for purposes of scientific experimentation or analysis or chemical research on, or analysis of, such substance or another substance, including any such research or analysis for the development of a product, shall maintain records a n d submit to the Administrator reports but only to the extent the Administrator determines the main- tenance of records or submission of reports, or both, is necessary for the effective enforcement of this Act. T h e Administrator m a y not require in a rule promulgated under this p a r a g r a p h the maintenance of records or the submission of reports with respect to changes in the proportions of t h e components of a mixture unless the Administrator finds t h a t the maintenance of such records or the submission of such reports, or both, is necessary for the effective enforcement of this Act. F o r purposes of t h e compilation
90 STAT. 2028 PUBLIC LAW 94-469—OCT. 11, 1976 of the list of chemical substances required under subsection (b), the Administrator shall promulgate rules pursuant to this subsection not later than 180 days after the effective date of this Act. (2) The Administrator may require under paragraph (1) mainte- nance of records and reporting with respect to the following insofar as known to the person making the report or insofar as reasonably ascertainable: (A) The common or trade name, the chemical identity, and the molecular structure of each chemical substance or mixture for which such a report is required. (B) The categories or proposed categories of use of each such substance or mixture. (C) The total amount of each such substance and mixture manufactured or processed, reasonable estimates of the total amount to be manufactured or processed, the amount manufac- tured or processed for each of its categories of use, and reasonable estimates of the amount to be manufactured or processed for each of its categories of use or proposed categories of use. (D) A description of the byproducts resulting from the manu- facture, processing, use, or disposal of each such substance or mixture. (E) All existing data concerning the environmental and health effects of such substance or mixture. (F) The number of individuals exposed, and reasonable esti- mates of the number who will be exposed, to such substance or mixture in their places of employment and the duration of such exposure. (G) In the initial report under paragraph (1) on such substance or mixture, the manner or method of its disposal, and in any subsequent report on such substance or mixture, any change in such manner or method. To the extent feasible, the Administrator shall not require under paragraph (1), any reporting which is unnecessary or duplicative. (3)(A)(i) The Administrator may by rule require a small manu- facturer or processor of a chemical substance to submit to the Admin- istrator such information respecting* the chemical substance as the Administrator may require for publication of the first list of chemi- cal substances required by subsection (b). (ii) The Administrator may by rule require a small manufacturer or processor of a chemical substance or mixture— (I) subject to a rule proposed or promulgated under section 4, 5(b) (4), or 6, or an order in effect under section 6(e), or (II) with respect to which relief has been granted pursuant to a civil action brought under section 5 or 7, to maintain such records on such substance or mixture, and to submit to the Administrator such reports on such substance or mixture, as the Administrator may reasonably require. A rule under this clause requiring reporting may require reporting with respect to the matters referred to in paragraph (2). Standards. (B) The Administrator, after consultation with the Administrator of the Small Business Administration, shall by rule prescribe stand- ards for determining the manufacturers and processors which qualify as small manufacturers and processors for purposes of this paragraph and paragraph (1). (b) INVENTORY.—(1) The Administrator shall compile, keep cur- rent, and publish a list of each chemical substance which is manufac- tured or processed in the United States. Such list shall at least include each chemical substance which any person reports, under section 5 or
PUBLIC LAW 94-469—OCT. 1 1 , 1976 9 0 STAT. 2029 subsection ( a ) of this section, is manufactured or processed in t h e United States. Such list m a y n o t include a n y chemical substance which was not manufactured or processed in the United States within three years before t h e effective date of t h e rules promulgated pur- suant to the last sentence of subsection (a) ( 1 ) . I n the case of a chemi- cal substance for which a notice is submitted i n accordance with section 5, such chemical substance shall be included in such list as of the earliest date (as determined by the Administrator) on which such substance was manufactured or processed in the United States. T h e Administrator shall first publish such a list not later t h a n 315 days after the effective date of this Act. T h e Administrator shall not include in such list any chemical substance which is manufactured or processed only i n small quantities (as defined by t h e Administrator by rule) solely for purposes of scientific experimentation or analysis o r chemi- cal research on, or analysis of, such substance or another substance, including such research or analysis for the development of a product. (2) T o t h e extent consistent with t h e purposes of this Act, t h e Administrator may, in lieu of listing, pursuant to p a r a g r a p h ( 1 ) , a chemical substance individually, list a category of chemical substances in which such substance is included, (c) RECORDS.—Any person who manufactures, processes, or distrib- utes in commerce a n y chemical substance or mixture shall maintain records of significant adverse reactions to health or t h e environment, as determined by t h e Administrator by rule, alleged t o have been caused by the substance or mixture. Records of such adverse reactions to t h e health of employees shall be retained for a period of 30 years from t h e date such reactions were first reported to or known by t h e person maintaining such records. A n y other record of such adverse reactions shall be retained for a period of five years from t h e date the information contained in the record was first reported to or known by the person maintaining the record. Records required to be main- tained under this subsection shall include records of consumer allega- tions of personal injury or h a r m to health, reports of occupational disease or injury, and reports or complaints of injury to t h e environ- ment submitted t o the manufacturer, processor, or distributor in com- merce from a n y source. Upon request of a n y duly designated representative of t h e Administrator, each person who is required to maintain records under this subsection shall permit the inspection of such records and shall submit copies of such records. ( d ) H E A L T H AND SAFETY S T U D I E S . — T h e A d m i n i s t r a t o r shall p r o - Rules, nmlgate rules under which t h e Administrator shall require any person who manufactures, processes, or distributes in commerce or who pro- poses to manufacture, process, or distribute in commerce any chemical substance or mixture (or with respect t o p a r a g r a p h ( 2 ) , any person who has possession of a study) to submit to t h e Administrator— (1) lists of health and safety studies ( A ) conducted or initiated by or for such person with respect to such substance or mixture at any time, ( B ) known t o such person, or ( C ) reasonably ascer- tainable by such person, except t h a t the Administrator may exclude certain types or categories of studies from the requirements of this subsection if the Administrator finds t h a t submission of lists of such studies are unnecessary to carry out t h e purposes of this A c t ; and (2) copies of any study contained on a list submitted pursuant to p a r a g r a p h (1) or otherwise known b y such person. (e) NOTICE TO ADMINISTRATOR OF SUBSTANTIAL R I S K S . — A n y person who manufactures, processes, or distributes i n commerce a chemical substance or mixture a n d who obtains information which reasonably 89-194 O—78—pt. 2 36
90 STAT. 2030 PUBLIC LAW 94-469—OCT. 1 1 , 1976 supports the conclusion t h a t such substance or mixture presents a substantial risk of injury to health or the environment shall imme- diately inform the Administrator of such information unless such person has actual knowledge t h a t the Administrator has been ade- quately informed of such information. (f) D E F I N I T I O N S . — F o r purposes of this section, the terms "manufac- t u r e " and "process" mean manufacture or process for commercial purposes. SEC. 9. RELATIONSHIP TO OTHER FEDERAL LAWS. 15 u s e 2608. (a) L A W S N O T ADMINISTERED BY T H E ADMINISTRATOR.—(1) If Report. the Administrator has reasonable basis to conclude t h a t t h e manufac- ture, processing, distribution in commerce, use, or disposal of a chemical substance or mixture, or t h a t any combination of such activities, pre- sents or will present an unreasonable risk of injury to health or the environment and determines, in the Administrator's discretion, t h a t such risk may be prevented or reduced to a sufficient extent by action taken under a Federal law not administered by the Administrator, the Administrator shall submit to the agency which administers such law a report which describes such risk and includes in such description a specification of the activity or combination of activities which the Administrator has reason to W i e v e so presents such risk. Such report shall also request such agency— (A) (i) to determine if the risk described in such report may be prevented or reduced to a sufficient extent by action taken under such law, and (ii) if the agency determines t h a t such risk may be so prevented or reduced, to issue an order declaring whether or not the activity or combination of activities specified in the description of such risk presents such risk; and ( B ) to respond to the Administrator with respect to the matters described in subparagraph ( A ) . Publication in Any report of the Administrator shall include a detailed statement of Federal Register, the information on which it is based and shall be published in the Federal Register. The agency receiving a request under such a report shall make the requested determination, issue the requested order, and make t h e requested response within such time as the Administrator specifies in the request, but such time specified may not be less t h a n 90 days from the date the request was made. The response of an agency shall be accompanied by a detailed statement of the findings and conclusions of the agency and shall be published in the Federal Regis- ter. (2) If the Administrator makes a report under p a r a g r a p h (1) with respect to a chemical substance or mixture and the agency to which such report was made either— ( A ) issues an order declaring t h a t the activity or combination of activities specified in the description of the risk described in the report does not present the risk described in the report, or ( B ) initiates, within 90 days of the publication in the Federal Register of the response of the agency under p a r a g r a p h ( 1 ) , action under the law (or laws) administered by such agency to protect against such risk associated Avith such activity or combination of activities, the Administrator may not take any action under section 6 or 7 with respect to such risk. (3) If the Administrator has initiated action under section 6 or 7 with respect to a risk associated with a chemical substance or mixture which was the subject of a report made to an agency under p a r a g r a p h (1), such agency shall before t a k i n g action under the law (or laws)
PUBLIC LAW 94-469—OCT. 1 1 , 1976 90 STAT. 2031 administered by it t o protect against such risk consult with the A d m i n - istrator for t h e purpose of avoiding duplication of Federal action against such risk. (b) L A W S ADMINISTERED BY T H E ADMINISTRATOR.—The A d m i n i s t r a - tor shall coordinate actions taken under this A c t with actions taken under other Federal laws administered in whole o r in p a r t by t h e Administrator. I f the Administrator determines t h a t a risk to health or the environment associated with a chemical substance or mixture could be eliminated or reduced to a sufficient extent by actions taken under the authorities contained in such other Federal laws, the Administrator shall use such authorities to protect against such risk unless the Admin- istrator determines, in the Administrator's discretion, that it is in the public interest to protect against such risk by actions taken under this Act. This subsection shall not be construed to relieve the Admin- istrator of a n y requirement imposed on t h e Administrator by such other Federal laws. (c) OCCUPATIONAL SAFETY AND H E A L T H . — I n exercising any a u t h o r - ity under this Act, the Administrator shall not, for purposes of section 4 ( b ) ( 1 ) of the Occupational Safety a n d H e a l t h A c t of 1970, be 29USC651 note, deemed t o be exercising statutory authority t o prescribe or enforce standards or regulations affecting occupational safety and health. (d) COORDINATION.—In administering this Act, t h e Administrator shall consult and coordinate with the Secretary of Health, Education, and Welfare a n d t h e heads of a n y other appropriate Federal execu- tive department or agency, a n y relevant independent regulatory agency, and any other appropriate instrumentality of the Federal Gov- ernment for the purpose of achieving the maximum enforcement of this Act v.hile imposing the least burdens of duplicative requirements on those subject to t h e Act and for other purposes. T h e Administrator shall, in t h e report required by section 30, report annually to t h e Congress on actions taken t o coordinate with such other Federal departments, agencies, or instrumentalities, a n d on actions taken to coordinate the authority under this Act with the authority granted under other Acts referred to in subsection ( b ) . SEC. 10. RESEARCH, DEVELOPMENT, COLLECTION, DISSEMINATION, AND UTILIZATION OF DATA. (a) AUTHORITY.—The Administrator shall, in consultation a n d 15 USC 2609. cooperation Avith t h e Secretary of Health, Education, a n d Welfare and with other heads of appropriate departments a n d agencies, con- duct such research, development, a n d monitoring as is necessary t o carry out the purposes of this Act. T h e Administrator may enter into Contracts, contracts and may make grants for research, development, and moni- toring under this subsection. Contracts may be entered into under this subsection without regard t o sections 3648 a n d 3709 of t h e Revised Statutes (31 U.S.C. 529,14 UJ6.C. 5 ) . ' 41 USC 5. (b) DATA SYSTEMS.— (1) T h e Administrator shall establish, admin- ister, and be responsible for the continuing activities of an interagency committee which shall design, establish, and coordinate an efficient and effective system, within the Environmental Protection Agency, for the collection, dissemination to other Federal departments a n d agen- cies, a n d use of data submitted t o the Administrator under this Act. (2) ( A ) T h e Administrator shall, in consultation a n d cooperation with the Secretary of Health, Education, and Welfare and other heads of appropriate departments and agencies design, establish, and coordi- nate an efficient a n d effective system for the retrieval of toxicological and other scientific data which could be useful to the Administrator in carrying out the purposes of this Act. Systematized retrieval shall be developed for use by all Federal and other departments and agencies
90 STAT. 2032 PUBLIC LAW 94-469—OCT. 11, 1976 with responsibilities in the area of regulation or study of chemical substances and mixtures and their effect on health or the environment. (B) The Administrator, in consultation and cooperation with the Secretary of Health, Education, and Welfare, may make grants and enter into contracts for the development of a data retrieval system described in subparagraph (A). Contracts may be entered into under this subparagraph without regard to sections 3648 and 3709 of the Revised Statutes (31 U.S.C. 529,41 U.S.C. 5). (c) SCREENING TECHNIQUES.—The Administrator shall coordinate, with the Assistant Secretary for Health of the Department of Health, Education, and Welfare, research undertaken by the Administrator and directed toward the development of rapid, reliable, and economical screening techniques for carcinogenic, mutagenic, teratogenic, and ecological effects of chemical substances and mixtures. (d) MONITORING.—The Administrator shall, in consultation and cooperation with the Secretary of Health, Education, and Welfare, establish and be responsible for research aimed at the development, in cooperation with local. State, and Federal agencies, of monitoring techniques and instruments which may be used in the detection of toxic chemical substances and mixtures and which are reliable, economical, and capable of being implemented under a wide variety of conditions. (e) BASIC RESEARCH.—The Administrator shall, in consultation and cooperation with the Secretary of Health, Education, and Welfare, establish research programs to develop the fundamental scientific basis of the screening and monitoring techniques described in subsections (c) and (d), the bounds of the reliability of such techniques, and the opportunities for their improvement. (f) TRAINING.—The Administrator shall establish and promote programs and workshops to train or facilitate the training of Federal laboratory and technical pei-sonnel in existing or newly developed screening and monitoring techniques. (g) EXCHANGE OF RESEARCH AND DEVELOPMENT RESULTS.—The Administrator shall, in consultation with the Secretary of Health, Education, and Welfare and other heads of appropriate departments and agencies, establish and coordinate a system for exchange among Federal, State, and local authorities of research and development results respecting toxic chemical substances and mixtures, including a system to facilitate and promote the development of standard data format and analysis and consistent testing procedures. SEC. 11. INSPECTIONS AND SUBPOENAS. 15 use 2610. (a) I N GENERAL.—For purposes of administering this Act, the Administrator, and any duly designated representative of the Admin- istrator, may inspect any establishment, facility, or other premises in which chemical substances or mixtures are manufactured, processed, stored, or held before or after their distribution in commerce and any conveyance being used to transport chemical substances, mixtures, or Notice. such articles in connection with distribution in commerce. Such an inspection may only be made upon the presentation of appropriate credentials and of a written notice to the owner, operator, or agent in charge of the premises or conveyance to be inspected. A separate notice shall be given for each such inspection, but a notice shall not be required for each entry made during the period covered by the inspec- tion. Each such inspection shall be commenced and completed with reasonable promptness and shall be conducted at reasonable tihies, within reasonable limits, and in a reasonable manner. (b) SCOPE.—(1) Except as provided in paragraph (2), an inspec- tion conducted under subsection (a) shall extend to all things within
PUBLIC LAW 94-469—OCT. 1 1 , 1976 90 STAT. 2033 the premises or conveyance inspected (including records, files, papers, processes, controls, and facilities) bearing on whether the requirements of this Act applicable to the chemical substances or mixtures within such premises or conveyance have been complied with. (2) No inspection under subsection (a) shall extend to— ( A ) financial data, ( B ) sales data (other t h a n shipment d a t a ) , (C) pricing data, ( D ) personnel data, or ( E ) research data (other than data required by this Act or under a rule promulgated t h e r e u n d e r ) , unless the nature and extent of such data are described with reasonable specificity in the written notice required by subsection (a) for such inspection. (c) SUBPOENAS.—In carrying out this Act, the Administrator may by subpoena require the attendance and testimony of witnesses and the production of reports, papers, documents, answers to questions, and other information t h a t the Administrator deems necessary. Wit- nesses shall be paid the same fees and mileage t h a t are paid witnesses in the courts of the United States. I n the event of contumacy, failure, or refusal of any person to obey any such subpoena, any district court of t h e United States in which venue is proper shall have jurisdiction to order any such person to comply with such subpoena. A n y failure to obey such an order of the court is punishable by the court as a con- tempt thereof. SEC. 12. EXPORTS. (a) I N GENERAL.— (1) Except as provided in p a r a g r a p h (2) and 15 USC 2611. subsection ( b ) , this Act (other than section 8) shall not apply to any chemical substance, mixture, or to an article containing a chemical substance or mixture, if— ( A ) it can be shown t h a t such substance, mixture, or article is being manufactured, processed, or distributed in commerce for export from the United States, unless such substance, mixture, or article was, in fact, manufactured, processed, or distributed in commerce, for use in the United States, and ( B ) such substance, mixture, or article (when distributed in commerce), or any container in which it is enclosed (when so dis- tributed) , bears a stamp or label stating t h a t such substance, mix- ture, or article is intended for export. (2) P a r a g r a p h (1) shall not apply to any chemical substance, mix- ture, or article if the Administrator finds t h a t the substance, mixture, or article will present an unreasonable risk of injury to health within the United States or to the environment of the United States. T h e Administrator may require, under section 4, testing of any chemical substance or mixture exempted from this Act by p a r a g r a p h (1) for the purpose of determining whether or not such substance or mixture presents an unreasonable risk of injury to health within the United States or to the environment of the United States. (b) NOTICE.— (1) If any person exports or intends to export to a foreign country a chemical substance or mixture for which the submis- sion of data is required under section 4 or 5 ( b ) , such person shall notify the Administrator of such exportation or intent to export and the Administrator shall furnish to the government of such country notice of the availability of the data submitted to the Administrator under such section for such substance or mixture. (2) I f any person exports or intends to export to a foreign country a chemical substance or mixture for which an order has been issued
90 STAT. 2034 PUBLIC LAW 94-469—OCT. 1 1 , 1976 under section 5 or a rule has been proposed or promulgated under sec- tion 5 or 6, or with respect to which an action is pending, or relief has been granted under section 5 or 7, such person shall notify the Admin- istrator of such exportation or intent to export and the Administrator shall furnish to the government of such country notice of such rule, order, action, or relief. SEC. 13. ENTRY INTO CUSTOMS TERRITORY OF THE UNITED STATES. 15 u s e 2612. (a) IN" GENERAL.— (1) The Secretary of the Treasury shall refuse entry into the customs territory of the United States (as defined in 19 u s e 1202. general headnote 2 to the Tariff Schedules of the United States) of any chemical substance, mixture, or article containing a chemical sub- stance or mixture offered for such entry if— ( A ) it fails to comply with any rule in effect under this Act, or ( B ) it is offered for entry in violation of section 5 or 6, a rule or order under section 5 or 6, or an order issued in a civil action brought under section 5 or 7. Notification. (2) I f a chemical substance, mixture, or article is refused entry under p a r a g r a p h ( 1 ) , the Secretary of the Treasury shall notify the consignee of such entry refusal, shall not release it to the consignee, and shall cause its disposal or storage (under such rules as the Secre- t a r y of the Treasury may prescribe) if it has not been exported by the consignee within 90 days from the date of receipt of notice of such refusal, except t h a t the Secretary of the Treasury may, pending a review by the Administrator of the entry refusal, release to the con- signee 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 e n t r y ) , 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 demanded, such consignee shall be liable to the United States for liqui- dated 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 refused 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 consultation with the Administrator, shall issue rules for the administration of subsec- tion (a) of this section. SEC. 14. DISCLOSURE OF DATA. 15 u s e 2613. (a) I N GENERAL.—Except as provided by subsection ( b ) , any information reported to, or otherwise obtained by, the Administrator (or any representative of the Administrator) under this Act, which is exempt from disclosure pursuant to subsection (a) of section 552 of title 5, United States Code, by reason of subsection (b) (4) of such section, shall, notwithstanding the provisions of any other section of this Act, not be disclosed by the A d m i n i s t r a t o r or by any officer or employee of the United States, except t h a t such information— (1) shall be disclosed to any officer or employee of the United States— ( A ) in connection with the official duties of such officer or employee under any law for the protection of health or the environment, or ( B ) for specific law enforcement purposes; (2) shall be disclosed to contractors with the United States and employees of such contractors if in the opinion of the Administra-
PUBLIC LAW 94-469—OCT. 11, 1976 90 STAT. 2035 tor such disclosure is necessary for the satisfactory performance by the contractor of a contract with the United States entered into on or after the date of enactment of this Act for the performance of work in connection with this Act and under such conditions as the Administrator may specify; (3) shall be disclosed if the Administrator determines it neces- sary to protect health or the environment against an unreasonable risk of injury to health or the environment; or (4) may be disclosed when relevant in any proceeding under this Act, except that disclosure in such a proceeding shall be made in such manner as to preserve confidentiality to the extent practicable without impairing the proceeding. In any proceeding under section 552(a) of title 5, United States Code, 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 Administrator's action. (b) DATA FROM HEALTH AND SAFETY STUDIES.—(1) Subsection (a) does not prohibit the disclosure of— (A) any health and safety study which is submitted under this Act 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 commercial distribution, or (ii) any chemical substance or mixture for which testing is required under section 4 or for which notification is required under section 5, and (B) any data reported to, or otherwise obtained by, the Admin- istrator from a health and safety study which relates to a chemical substance or mixture described in clause (i) or (ii) of subpara- graph (A). This paragraph does not authorize the release of any data which dis- closes processes used in the manufacturing or processing of a chemical substance or mixture or, in the case of a mixture, the release of data disclosing the portion of the mixture comprised by any of the chemical substances in the mixture. (2) If a request is made to the Administrator under subsection (a) of section 552 of title 5, United States Code, for information which is described in the first sentence of paragraph (1) and which is not information described in the second sentence of such paragraph, the Administrator may not deny such request on the basis of subsection (b) (4) of such section. (c) DESIGNATION AND RELEASE OF CONFIDENTIAL DATA.—(1) In sub- mitting data under this Act, a manufacturer, processor, or distributor in commerce may (A) designate the data which such person believes is entitled to confidential treatment under subsection (a), and (B) submit such designated data separately from other data submitted under this Act. A designation under this paragraph shall be made in writing and in such manner as the Administrator may prescribe. (2) (A) Except as provided by subparagraph (B), if the Adminis- Notification. trator proposes to release for inspection data which has been desig- luited imder paragraph (1)(A), the Administrator shall notify, in writing and by certified mail, the manufacturer, processor, or distrib- utor in commerce who submitted such data of the intent to release such data. If the release of such data is to be made pursuant to a request made under section 552(a) of title 5, United States Code, such notice shall be given immediately upon approval of such request by the Administrator. The Administrator may not release such data until
90 STAT. 2036 PUBLIC LAW 94-469—OCT. 1 1 , 1976 the expiration of 30 days after the manufacturer, processor, or distrib- utor in commerce submitting such data has received the notice required by this subparagraph. Notification. ( B ) (i) S u b p a r a g r a p h ( A ) shall not apply to the release of infor- mation under p a r a g r a p h ( 1 ) , ( 2 ) , ( 3 ) , or (4) of subsection ( a ) , except t h a t the A d m i n i s t r a t o r may not release data under p a r a g r a p h (3) of subsection (a) unless the Administrator has notified each manufac- turer, processor, and distributor in commerce who submitted such data of such release. Such notice shall be made in writing by certified mail at least 15 days before the release of such data, except t h a t if the Administrator determines t h a t the release of such data is necessary to protect against an imminent, unreasonable risk of injury to health or the environment, such notice may be made by such means as the Administrator determines will provide notice at least 24 hours before such I'elease is made. (ii) S u b p a r a g r a p h ( A ) shall not apply to the release of information described in subsection ( b ) ( 1 ) other t h a n information described in the second sentence of such subsection. (d) CRIMINAL P E N A L T Y FOR WRONGFUL DISCLOSURE.— (1) Any officer or employee of the United States or former officer or employee of the United States, who by virtue of such employment or official position has obtained possession of, or has access to, material the dis- closure of which is prohibited by subsection ( a ) , and who knowing t h a t disclosure of such material is prohibited by such subsection, will- fully discloses the material in any manner to any person not entitled to receive it, shall be guilty of a misdemeanor and fined not more t h a n $5,000 or imprisoned for not more t h a n one year, or both. Section 1905 of title 18, United States Code, does not apply with respect t o the publishing, divulging, disclosure, or m a k i n g known of, or making available, information reported or otherwise obtained under this Act. (2) F o r the purposes of p a r a g r a p h ( 1 ) , any contractor with the United States who is furnished information as authorized by subsec- tion (a) ( 2 ) , and any employee of any such contractor, shall be con- sidered to be an employee of the United States. (e) ACCESS BY CONGRESS.—Notwithstanding any limitation con- tained in this section or any other provision of law, all information reported to or otherwise obtained by the Administrator (or any repre- sentative of the A d m i n i s t r a t o r ) under this Act shall be made available, upon written request of any duly authorized committee of the Con- gress, to such committee. SEC. 15. PROHIBITED ACTS. 15 u s e 2614. I t shall be unlawful for any person to— (1) fail or refuse to comply with (A) any rule promulgated o r order issued under section 4, ( B ) any requirement prescribed by section 5 or 6, or (C) any rule promulgated or order issued under section 5 or 6; (2) use for commercial purposes a chemical substance or mix- ture which such person knew or had reason to know was manufac- tured, processed, or distributed in commerce in violation of section 5 or 6, a rule or order under section 5 or 6, or an order issued in action brought under section 5 or 7 ; (3) fail or refuse to (A) establish or maintain records, ( B ) submit reports, notices, or other information, or (C) permit access to or copying of records, as required by this Act or a rule there- u n d e r ; or (4) fail or refuse to permit entry or inspection as required by section 11.
PUBLIC LAW 94-469—OCT. 1 1 , 1976 90 STAT. 2037 SEC. 16. PENALTIES. (a) C I V I L . — (1) A n y person who violates a provision of section 15 15 USC 2615. shall be liable to the United States for a civil penalty in an amount not to exceed $25,000 for each such violation. E a c h day such a viola- tion continues shall, for purposes of this subsection, constitute a sepa- rate violation of section 15. (2) ( A ) A civil penalty for a violation of section 15 shall be assessed Hearing, by the Administrator by an order made on the record after oppor- tunity (provided in accordance with this s u b p a r a g r a p h ) for a hearing in accordance with section 554 of title 5, United States Code. Before issuing such an order, the Administrator shall give written notice to the person to be assessed a civil penalty under such order of the Admin- istrator's proposal to issue such order and provide such person an opportunity to request, within 15 days of t h e date the notice is received by such person, such a hearing on the order. ( B ) I n determining the amount of a civil penalty, the Administra- tor shall take into account the nature, circumstances, extent, and gravity of t h e violation or violations and, with respect to the violator, ability to pay, effect on ability to continue to do business, any history of prior such violations, the degree of culpability, and such other matters as justice may require. (C) T h e Administrator may compromise, modify, or remit, with or without conditions, any civil penalty which may be imposed under this subsection. The amount of such penalty, when finally determined, or the amount agreed upon in compromise, may be deducted from any sums owing by the United States to t h e person charged. (3) A n y person who requested in accordance with p a r a g r a p h (2) Petition for ( A ) a hearing respecting the assessment of a civil penalty and who is judicial review, a^ggrieved by an order assessing a civil penalty may file a petition for judicial review of such order with the United States Court of Appeals for the District of Columbia Circuit or for any other circuit in which such person resides or transacts business. Such a petition may only be filed within the 30-day period beginning on t h e date the order making such assessment was issued. (4) I f any person fails to pay an assessment of a civil penalty— ( A ) after the order making the assessment has become a final order and if such person does not file a petition for judicial review of the order in accordance with p a r a g r a p h ( 3 ) , or ( B ) after a court in an action brought under p a r a g r a p h (3) has entered a final judgment in favor of the Administrator, the Attorney General shall recover the amount assessed (plus interest at currently prevailing rates from the date of the expiration of the 30- day period referred to in p a r a g r a p h (3) or the date of such final judgment, as the case may be) in an action brought in any appropriate district court of t h e U n i t e d States. I n such an action, the validity, amount, and appropriateness of such penalty shall not be subject to review. (b) CRIMINAL.—Any person who knowingly or willfully violates any provision of section 15 shall, in addition to or in lieu of any civil penaxty v/hich may be imposed under subsection (a) of this section for such violation, be subject, upon conviction, to a fine of not more t h a n $25,000 for each day of violation, or to imprisonment for not more than one year, or both. SEC. 17. SPECIFIC ENFORCEMENT AND SEIZURE. (a) SPECIFIC ENroRCEMENT.—(1) T h e district courts of t h e U n i t e d 15 USC 2616. States shall have jurisdiction over civil actions to— ( A ) restrain any violation of section 15,
90 STAT. 2038 PUBLIC LAW 94-469—OCT. 11, 1976 (B) restrain any person from taking any action prohibited by section 5 or 6 or by a rule or order under section 5 or 6, (C) compel the taking of any action required by or under this Act, or (D) direct any manufacturer or processor of a chemical sub- stance or mixture manufactured or processed in violation of sec- tion 5 or 6 or a rule or order under section 5 or 6 and distributed in commerce, (i) to give notice of such fact to distributors in commerce of such substance or mixture and, to the extent reason- ably ascertainable, to other persons in possession of such sub- stance or mixture or exposed to such substance or mixture, (ii) to give public notice of such risk of injury, and (iii) to either replace or repurchase such substance or mixture, whichever the person to which the requirement is directed elects. (2) A civil action described in paragraph (1) may be brought— (A) in the case of a civil action described in subparagraph (A) of such paragraph, in the United States district court for the judi- cial district wherein any act, omission, or transaction constituting a violation of section 15 occurred or wherein the defendant is found or transacts business, or (B) in the case of any other civil action described in such para- graph, in the United States district court for the judicial district wherein the defendant is found or transacts business. In any such civil action process may be served on a defendant in any judicial district in which a defendant resides or may be found. Sub- poenas requiring attendance of witnesses in any such action may be served in any judicial district. (b) SEIZURE.—Any chemical substance or mixture which was manu- factured, processed, or distributed in commerce in violation of this Act or any rule promulgated or order issued under this Act or any article containing such a substance or mixture shall be liable to be proceeded against, by process of libel for the seizure and condemnation of such substance, mixture, or article, in any district court of the United States within the jurisdiction of which such substance, mixture, or article is found. Such proceedings shall conform as nearly as possible to proceed- ings in rem in admiralty. SEC. 18. PREEMPTION. 15 use 2617. (a) EFFECT ON STATE LAW.— (1) Except as provided in paragraph (2), nothing in this Act shall affect the authority of any State or politi- cal subdivision of a State to establish or continue in effect regulation of any chemical substance, mixture, or article containing a chemical substance or mixture. (2) Except as provided in subsection (b) — (A) if the Administrator requires by a rule promulgated under section 4 the testing of a chemical substance or mixture, no State or political subdivision may, after the effective date of such rule, establish or continue in effect a requirement for the testing of such substance or mixture for purposes similar to those for which test- ing is required under such rule; and (B) if the Administrator prescribes a rule or order under sec- tion 5 or 6 (other than a rule imposing a requirement described in subsection (a) (6) of section 6) which is applicable to a chemical substance or mixture, and which is designed to protect against a risk of injury to health or the environment associated with such substance or mixture, no State or political subdivision of a State may, after the effective date of such requirement, establish or continue in effect, any requirement which is applicable to such sub- stance or mixture, or an article containing such substance or mix-
PUBLIC LAW 94-469—OCT. 11, 1976 90 STAT. 2039 ture, and which is designed to protect against such risk unless such requirement (i) is identical to the requirement prescribed by the Administrator, (ii) is adopted under the authority of the Clean Air Act or any other Federal law, or (iii) prohibits the use of such substance or mixture in such State or political subdivision (other than its use in the manufacture or processing of other substances or mixtures), (b) EXEMPTION.—^Upon application of a State or political subdivi- Application, sion of a State the Administrator may by rule exempt from subsection ( a ) ( 2 ) , under such conditions as may be prescribed in such rule, a requirement of such State or political subdivision designed to protect against a risk of injury to health or the environment associated with a chemical substance, mixture, or article containing a chemical sub- stance or mixture if— (1) compliance with the requirement would not cause the manufacturing, processing, distribution in commerce, or use of the substance, mixture, or article to be in violation of the applicable requirement under this Act described in subsection (a) (2), and (2) the State or political subdivision requirement (A) provides a significantly higher degree of protection from such risk than the requirement under this Act described in subsection (a) (2) and (B) does not, through difficulties in marketing, distribution, or other factors, unduly burden interstate commerce. SEC. 19. JUDICIAL REVIEW. (a) I N GENERAL.— (1) (A) Not later than 60 days after the date Petition. of the promulgation of a rule under section 4(a), 5(a)(2), 5(b) (4), 15 use 2618. 6(a), 6(e), or 8, any person may file a petition for judicial review of such rule with the United States Court of Appeals for the District of Columbia Circuit or for the circuit in which such person resides or in which such person's principal place of business is located. Courts of appeals of the United States shall have exclusive jurisdiction of any action to obtain judicial review (other than in an enforcement proceeding) of such a rule if any district court of the United States would have had jurisdiction of such action but for this subparagraph. (B) Courts of appeals of the United States shall have exclusive Jurisdiction. jurisdiction of any action to obtain judicial review (other than in an enforcement proceeding) of an order issued under subparagraph (A) or (B) of section 6(b) (1) if any district court of the United States would have had jurisdiction of such action but for this subparagraph. (2) Copies of any petition filed under paragraph (1) (A) shall be Petition copies, transmitted forthwith to the Administrator and to the Attorney Gen- transmittal to eral by the clerk of the court with which such petition was filed. The Administrator and Attorney provisions of section 2112 of title 28, United States Code, shall apply General. to the filing of the rulemaking record of proceedings on which the Administrator based the rule being reviewed under this section and to the transfer of proceedings between United States courts of appeals. (3) For purposes of this section, the term "rulemaking record" "Rulemaking means— record." (A) the rule being reviewed under this section; (B) in the case of a rule under section 4(a), the finding required by such section, in the case of a rule under section 5(b) (4), the finding required by such section, in the case of a rule under section 6(a) the finding required by section 5(f) or 6(a), as the case may be, in the case of a rule under section 6(a), the statement required by section 6(c) (1), and in the case of a rule under section 6(e), the findings required by paragraph (2)(B) or (3)(B) of such section, as the case may be;
9 0 STAT. 2040 PUBLIC LAW 94-469—OCT. 1 1 , 1976 (C) a n y transcript reouired to be made of oral presentations made in proceedings f'^r the promulgation of such r u l e ; ( D ) any written submission of interested parties respecting the promulgation of such rule; a n d Publication in ( E ) a n y other information which t h e Administrator considers Federal Register. to be relevant to such rule and which the Administrator identified, on or before the date of the promulgation of such rule, in a notice published in the Federal Ecgister. (b) ADDITIONAL SUBMISSIONS AND PRESENTATIONS ; MODIFICATIONS.— If in a n action under this section t o review a rule the petitioner or t h e Administrator applies t o t h e court for leave t o make additional oral submissions or written presentations respecting such rule a n d shows to the satisfaction of the court t h a t such submissions and presentations would be material and t h a t there were reasonable grounds for t h e sub- missions a n d failure to make such submissions a n d presentations in the proceeding before t h e Administrator, t h e court m a y order t h e Administrator t o provide additional opportunity t o make such sub- missions a n d presentations. T h e Administrator m a y modify or set aside t h e rule being reviewed or make a new rule by reason of t h e additional submissions a n d presentations a n d shall file such modified or new rule with t h e return of such submissions a n d presentations. Review. T h e court shall thereafter review such new or modified rule. (c) STANDARD OF R E V I E W . — ( 1 ) ( A ) U p o n t h e filing of a petition under subsection (a) (1) for judicial revicAV of a rule, the court shall have jurisdiction (i) t o g r a n t a p p r o p r i a t e relief, including interim relief, as provided in chapter 7 of title 5, United States Code, a n d (ii) except as otherwise provided in s u b p a r a g r a p h ( B ) , t o review such rule in accordance with chapter 7 of title 5, United States Code. ( B ) Section 706 of title 5, United States Code, shall apply t o review of a rule under this section, except that— (i) in the case of review of a rule under section 4 ( a ) , 5 ( b ) ( 4 ) , 6 ( a ) , or 6 ( e ) , the standard for review prescribed by p a r a g r a p h (2) ( E ) of such section 706 shall n o t apply a n d t h e court shall hold unlawful a n d set aside such rule if the court finds t h a t the rule is not supported by substantial evidence i n t h e rulemaking record (as defined in subsection ( a ) ( 3 ) ) taken as a whole; (ii) i n the case of review of a rule under section 6 ( a ) , the court shall hold unlawful and set aside such rule if it finds that— ( I ) a determination by the Administrator under section 6(c) (3) t h a t the petitioner seeking review of such rule is not entitled to conduct (or have conducted) cross-examination or to present rebuttal submissions, or ( I I ) a rule of, or ruling by, t h e Administrator under sec- tion 6(c) (3) limiting such petitioner's cross-examination or oral presentations, has precluded disclosure of disputed material facts which w a s necessary to a fair determination by the Administrator of t h e rulemaking proceeding taken as a whole; a n d section 706(2) ( D ) shall not apply with respect to a determination, rule, or ruling referred t o in subclause ( I ) or ( I I ) ; a n d (iii) the court may not review the contents and adequacy of— ( I ) any statement required to be made pursuant t o section 6(c)(1),or ( I I ) a n y statement of basis a n d purpose required by sec- tion 553(c) of title 5, United States Code, to be incorporated in the rule except as p a r t of a review of t h e rulemaking record taken as a whole.
PUBLIC LAW 94-469—OCT. 11, 1976 90 STAT. 2041 The term "evidence" as used in clause (i) means any matter in the "Evidence." rulemaking record. (C) A determination, rule, or ruling of the Administrator described in subparagraph (B) (ii) may be reviewed only in an action under this section and only in accordance with such subj)aragraph. (2) The judgment of the court affirming or setting aside, in whole or in part, any rule reviewed in accordance with this section shall be final, subject to review by the Supreme Court of the United States upon certiorari or certification, as provided in section 1254 of title 28, United States Code. (d) FEES AND COSTS.—The decision of the court in an action com- menced under subsection (a), or of the Supreme Court of the United States on review of such a decision, may include an award of costs of suit and reasonable fees for attorneys and expert witnesses if the court determines that such an award is appropriate. (e) OTHER REMEDIES.—The remedies as provided in this section shall be in addition to and not in lieu of any other remedies provided by law. SEC. 20. CITIZENS' CIVIL ACTIONS. (a) I N GENERAL.—Except as provided in subsection (b), any person 15 USC 2619. may commence a civil action— (1) against any person (including (A) the United States, and (B) any other governmental instrumentality or agency to the extent permitted by the eleventh amendment to the Constitution) who is alleged to be in violation of this Act or any>rule promul- gated under section 4, 5, or 6 or order issued under section 5 to restrain such violation, or (2) against the Administrator to compel tjie Administrator to perform any act or duty under this Act which is not discre- tionary. Any civil action under paragraph (1) shall be brought in the United States district court for the district in which the alleged violation occurred or in which the defendant resides or in which the defendant's principal place of business is located. Any action brought under para- graph (2) shall be brought in the United States District Court for the District of Columbia, or the United States district court for the judicial district in which the plaintiff is domiciled. The district courts Jurisdiction, of the United States shall have jurisdiction over suits brought under this section, without regard to the amount in controversy or the citizen- ship of the parties. In any civil action under this subsection process may be served on a defendant in any judicial district in which the defendant resides or may be found and subpoenas for witnesses may be served in any judicial district. (b) LIMITATION.—No civil action may be commenced— (1) under subsection (a) (1) to restrain a violation of this Act or rule or order under this Act— (A) before the expiration of 60 days after the plaintiff Notice. has given notice of such violation (i) to the Administrator, and (ii) to the person who is alleged to have committed such violation, or (B) if the Administrator has commenced and is diligently prosecuting a proceeding for the issuance of an order under section 16(a) (2) to require compliance with this Act or with such rule or order or if the Attorney General has commenced and is diligently prosecuting a civil action in a court of the United States to require compliance with this Act or with such rule or order, but if such proceeding or civil action is commenced after the giving of notice, any person giving such notice may intervene as a matter of right in such proceeding or action; or
90 STAT. 2042 PUBLIC LAW 94-469—OCT. 1 1 , 1976 Notice. (2) under subsection (a) (2) before the expiration of 60 days after the plaintiff has given notice to the Administrator of the alleged failure of the Administrator to perform an act or d u t y which is the basis for such action or, in the case of an action under such subsection for the failure of the Administrator to file an action under section 7, before the expiration of ten days after such notification. Rule. Notice under this subsection shall be given in such manner as the Administrator shall prescribe by rule. (c) GENERAL.— (1) I n any action under this section, the Adminis- trator, if not a p a r t y , may intervene as a matter of right. (2) The court, in issuing any final order in any action brought pur- suant to subsection ( a ) , may award costs of suit and reasonable fees for attorneys and expert witnesses if the court determines t h a t such an award is appropriate. A n y court, in issuing its decision in an action brought to review such an order, may award costs of suit and reason- able fees for attorneys if the court determines t h a t such an award is appropriate. (3) Nothing in this section shall restrict any r i g h t which any person (or class of persons) may have under any statute or common law to seek enforcement of this Act or any rule or order under this Act or to seek any other relief. (d) CONSOLIDATION.—When two or more civil actions brought under subsection (a) involving the same defendant and the sq,me issues or violations are pending in two or more judicial districts, «uch pending actions, upon application of such defendants to such actions which is made to a court in which any such action is brought, may, if such court in its discretion so decides, be consolidated for trial by order (issued after giving all parties reasonable notice and opportunity to be heard) of such court and tried in— (1) any district which is selected by such defendant and in which one of such actions is pending, (2) a district which is agreed upon by stipulation between all the parties to such actions and in which one of such actions is pending, or (3) a district which is selected by the court and in which one of such actions is pending. T h e court issuing such an order shall give p r o m p t notification of the order to the other courts in which the civil actions consolidated under the order are pending. SEC. 21. CITIZENS' PETITIONS. 15 u s e 2620. (a) I N GENERAL.—Any person may petition the Administrator to initiate a proceeding for the issuance, amendment, or repeal of a rule under section 4, 6, or 8 or an order under section 5(e) or ( 6 ) ( b ) ( 2 ) . (b) PROCEDURES.— (1) Such petition shall be filed in the principal office of the Administrator and shall set forth the facts which it is claimed establish t h a t it is necessary to issue, amend, or repeal a rule under section 4, 6, or 8 or an order under section 5 ( e ) , 6 ( b ) (1) ( A ) , or 6 ( b ) ( 1 ) ( B ) . Public hearing. (2) The Administrator may hold a public hearing or may conduct such investigation or proceeding as the Administrator deems appro- priate in order to determine whether or not such petition should be granted. (3) W i t h i n 90 days after filing of a petition described in p a r a g r a p h (1), the Administrator shall either g r a n t or deny the petition. If the Administrator g r a n t s such petition, the Administrator shall promptly
PUBLIC LAW 94-469—OCT. 11, 1976 90 STAT. 2043 commence an appropriate proceeding in accordance with section 4, 5,6, or 8. If the Administrator denies such petition, the Administrator Publication in shall publish in the Federal Register the Administrator's reasons Federal Register. for such denial. (4) (A) If the Administrator denies a petition filed under this Civil action, section (or if the Administrator fails to grant or deny such petition within the 90-day period) the petitioner may commence a civil action in a district court of the United States to compel the Administrator to initiate a rulemaking proceeding as requested in the petition. Any such action shall be filed within 60 days after the Administrator's denial of the petition or, if the Administrator fails to grant or deny the petition within 90 days after filing the petition, within 60 days after the expiration of the 90-day period. (B) In an action under subparagraph (A) respecting a petition to initiate a proceeding to issue a rule under section 4, 6, or 8 or an order under section 5(e) or 6(b) (2), the petitioner shall be provided an opportunity to have such petition considered by the court in a de novo proceeding. If the petitioner demonstrates to the satisfaction of the court by a preponderance of the evidence that— (i) in the case of a petition to initiate a proceeding for the issuance of a rule under section 4 or an order under section 5(e) — (I) information available to the Administrator is insuffi- cient to permit a reasoned evaluation of the health and environmental effects of the chemical substance to be subject to such rule or order; and ( I I ) in the absence of such information, the substance may present an unreasonable risk to health or the environment, or the substance is or will be produced in substantial quan- tities and it enters or may reasonably be anticipated to enter the environment in substantial quantities or there is or may be significant or substantial human exposure to it; or (ii) in the case of a petition to initiate a proceeding for the issuance of a rule under section 6 or 8 or an order under section 6(b) (2), there is a reasonable basis to conclude that the issuance of such a rule or order is necessary to protect health or the environment against an unreasonable risk of injury to health or the environment. the court shall order the Administrator to initiate the action requested by the petitioner. If the court finds that the extent of the risk to health or the environment alleged by the petitioner is less than the extent of risks to health or the environment with respect to which the Administrator is taking action under this Act and there are insufficient resources available to the Administrator to take the action requested by the petitioner, the court may permit the Administrator to defer initiating the action requested by the petitioner until such time as the court prescribes. (C) The court in issuing any final order in any action brought pur- suant to subparagraph (A) maj^ award costs of suit and reasonable fees for attorneys and expert witnesses if the court determines that such an award is appropriate. Any court, in issuing its decision in an action brought to review such an order, may award costs of suit and reasonable fees for attorneys if the court determines that such an award is appropriate. (5) The remedies under this section shall be in addition to, and not in lieu of, other remedies provided by law.
90 STAT. 2044 PUBLIC LAW 94-469—OCT. 11, 1976 SEC. 22. NATIONAL DEFENSE WAIVER. 15 use 2621. The Administrator shall waive compliance with any provision of this Act upon a request and determination by the President that the requested waiver is necessary in the interest of national defense. The Administrator shall maintain a written record of the basis upon which such waiver was granted and make such record available for in camera examination when relevant in a judicial proceeding under Publication in this Act. Upon the issuance of such a waiver, the Administrator shall Federal Register. publish in the Federal Register a notice that the waiver was granted Notice to for national defense purposes, unless, upon the request of the Presi- congressional dent, the Administrator determines to omit such publication because committee. the publication itself would be contrary to the interests of national defense, in which event the Administrator shall submit notice thereof to the Armed Services Committees of the Senate and the House of Representati ves. SEC. 23. EMPLOYEE PROTECTION. 15 u s e 2622. (a) I N GENERAL.—No employer may discharge any employee or otherwise discriminate against any employee with respect to the employee's compensation, terms, conditions, or privileges of employ- ment because the employee (or any person acting pursuant to a request of the employee) has— (1) commenced, caused to be commenced, or is about to com- mence or cause to be commenced a proceeding under this Act; (2) testified or is about to testify in any such proceeding; or (3) assisted or participated or is about to assist or participate in any manner in such a proceeding or in any other action to carry out the purposes of this Act. (b) REMEDY.—(1) Any employee who believes that the employee has been discharged or otherwise discriminated against by any person in violation of subsection (a) of this section may, within 30 days after such alleged violation occurs, file (or have any person file on the employee^ behalf) a complaint with the Secretary of Labor (here- inafter in this section referred to as the "Secretary") alleging such Notification. discharge or discrimination. Upon receipt of such a complaint, the Secretary shall notify the person named in the complaint of the filing of the complaint. Investigation. (2) (A) Upon receipt of a complaint filed under paragraph (1), the Secretary shall conduct an investigation of the violation alleged in the Notification. complaint. Within 30 days of the receipt of such complaint, the Secre- tary shall complete such investigation and shall notify in writing the complainant (and any person acting on behalf of the complainant) and the person alleged to have committed such violation of the results of the investigation conducted pursuant to this paragraph. Within ninety days of the receipt of such complaint the Secretary shall, unless the proceeding on the complaint is terminated by the Secretary on the basis of a settlement entered into by the Secretary and the person alleged to have committed such violation, issue an order either pro- viding the relief prescribed by subparagraph (B) or denying the Notice and complaint. An order of the Secretary shall be made on the record after hearing. notice and opportunity for agency hearing. The Secretarv may not enter into a settlement terminating a proceeding on a complaint with- out the participation and consent of the complainant. (B) If in response to a complaint filed under paragraph (1) the Secretary determines that a violation of subsection (a) of this section has occurred, the Secretary shall order (i) the person who committed such violation to take affirmative action to abate the violation, (ii)
PUBLIC LAW 94-469—OCT. 1 1 , 1976 90 STAT. 2045 such person to reinstate the complainant to the complainant's former position together with the compensation (including back p a y ) , terms, conditions, and privileges of the complainant's employment, (iii) com- pensatory damages, and (iv) where appropriate, exemplary damages. If such an order issued, the Secretary, at the request of the complain- ant, shall assess against the person against whom the order is issued a sum equal to the aggregate amount of all costs and expenses (including attorney's fees) reasonably incurred, as determined by the Secretary, by the complainant for, or in connection with, the bringing of the com- plaint upon which the order was issued. (c) R E V I E W . — ( 1 ) A n y employee or employer adversely affected or aggrieved by an order issued under subsection (b) may obtain review of the order in the United States Court of Appeals for the circuit in which the violation, with respect to which the order was issued, allegedly occurred. The petition for review must be filed within sixty days from the issuance of the Secretary's order. Review shall conform to chapter 7 of title 5 of the United States Code. (2) A n order of the Secretary, with respect to which review could have been obtained under p a r a g r a p h ( 1 ) , shall not be subject to judicial review in any criminal or other civil proceeding. (d) ENTORCEMENT.—Whenever a person has failed to comply with Civil action, an order issued under subsection (b) ( 2 ) , the Secretary shall file a civil action in the United States district court for the district in which the violation was found to occur to enforce such order. I n actions brought Jurisdiction, under this subsection, the district courts shall have jurisdiction to grant all appropriate relief, including injunctive relief and compensa- tory and exemplary damages. Civil actions brought under this sub- section shall be heard and decided expeditiously. (e) EXCLUSION.—Subsection (a) of this section shall not apply with respect to any employee who, acting without direction from the employee's employer (or any agent of the employer), deliberately causes a violation of any requirement of this Act. SEC. 24. EMPLOYMENT EFFECTS. (a) I N GENERAL.—^The Administrator shall evaluate on a continuing Evaluation, basis the potential effects on employment (including reductions in 15 USC 2623. employment or loss of employment from threatened plant closures) of— (1) the issuance of a rule or order under section 4, 5, or 6, or (2) a requirement of section 5 or 6. (b) (1) INVESTIGATIONS.—^Any employee (or any representative of an employee) may request the Administrator to make an investigation of— ( A ) a discharge or layoff or threatened discharge or layoff of the employee, or ( B ) adverse or threatened adverse effects on the employee's employment, allegedly resulting from a rule or order under section 4, 5, or 6 or a requirement of section 5 or 6. A n y such request shall be made in writ- ing, shall set forth with reasonable particularity the grounds for the request, and shall be signed by the employee, or representative of such employee, making the request. (2) ( A ) U p o n receipt of a request made in accordance with para- Public hearings, g r a p h (1) the Administrator shall (i) conduct the investigation requested, and (ii) if requested by any interested person, hold public hearings on any matter involved in the investigation unless the Admin- istrator, by order issued within 45 days of the date such hearings are 89-194 O—78—pt. 2 37
90 STAT. 2046 PUBLIC LAW 94-469—OCT. 11, 1976 requested, denies the request for the hearings because the Adminis- trator determines there are no reasonable grounds for holding such Notification. hearings. If the Administrator makes such a determination, the Publication in Administrator shall notify in writing the person requesting the hear- Federal Register. ing of the determination and the reasons therefor and shall publish the determination and the reasons therefor in the Federal Register. (B) If public hearings are to be held on any matter involved in an investigation conducted under this subsection— (i) at least five days' notice shall be provided the person mak- ing the request for the investigation and any person identified in such request, (ii) such hearings shall be held in accordance with section 6(c) (3), and (iii) each employee who made or for whom was made a request for such hearings and the employer of such employee shall be required to present information respecting the applicable matter referred to in paragraph (1)(A) or (1)(B) together with the basis for such information. Recommenda- (3) Upon completion of an investigation under paragraph (2), the tions. Administrator shall make findings of fact, shall make such recom- mendations as the Administrator deems appropriate, and shall make available to the public such findings and recommendations. (4) This section shall not be construed to require the Administrator to amend or repeal any rule or order in effect under this Act. SEC. 25. STUDIES. 15 u s e 2624. (a) INDEMNIFICATION STUDY.—^The Administrator shall conduct a study of all Federal laws administered by the Administrator for the purpose of determining whether and under what conditions, if any, indemnification should be accorded any person as a result of any action taken by the Administrator under any such law. The study shall— (1) include an estimate of the probable cost of any indemnifica- tion programs which may be recommended; (2) include an examination of all viable means of financing the cost of any recommended indemnification; and Submittal to (3) be completed and submitted to Congress within two years Congress. from the effective date of enactment of this Act. GAO review. The General Accounting Office shall review the adequacy of the study submitted to Congress pursuant to paragraph (3) and shall report the results of its review to the Congress within six months of the date such study is submitted to Congress. G>nsultation. (b) CLASSIFICATION, STORAGE, AND RETRIEVAL STUDY.—The Council on Environmental Quality, in consultation with the Administrator, the Secretary of Health, Education, and Welfare, the Secretary of Commerce, and the heads of other appropriate Federal departments or agencies, shall coordinate a study of the feasibility of establishing (1) a standard classification system for chemical substances and related substances, and (2) a standard means for storing and for obtaining Report to rapid access to information respecting such substances. A report on G>ngres8. such study shall be completed and submitted to Congress not later than 18 months after the effective date of enactment of this Act. SEC. 26. ADMINISTRATION OF THE ACT. 15 u s e 2625. (a) COOPERATION OF FEDERAL AGENCIES.—Upon request by the Administrator, each Federal department and agency is authorized— (1) to make its services, personnel, and facilities available (with or without reimbursement) to the Administrator to assist the Administrator in the administration of this Act; and
PUBLIC LAW 9 4 ^ 6 9 — O C T . 11, 1976 90 STAT. 2047 (2) to furnish t o the Administrator such information, data, estimates, and statistics, and to allow the Administrator access t o all information in its possession as the Administrator may reason- ably determine to be necessary for the administration of this Act. (b) F E E S . — (1) T h e Administrator may, by rule, require the pay- ment of a reasonable fee from a n y person required to submit data under section 4 or 5 to defray the cost of administering this Act. Such rules shall not provide for any fee in excess of $2,500 or, in the case of a small business concern, any fee in excess of $100. I n setting a fee under this p a r a g r a p h , the Administrator shall take into account t h e ability to p a y of t h e person required t o submit the data and the cost to the Administrator of reviewing such data. Such rules may provide for sharing such a fee in any case in which the expenses of testing are shared under section 4 or 5. (2) T h e Administrator, after consultation with the Administrator Consultation, of t h e Small Business Administration, shall by rule prescribe stand- R"l«- ards for determining t h e persons which qualify as small business concerns for purposes of p a r a g r a p h ( 1 ) . (c) A C T I O N W I T H RESPECT TO CATEGORIES.— (1) A n y action a u t h o r - ized or required to be taken by the Administrator under any provision of this A c t with respect to a chemical substance or mixture may be taken by t h e Administrator in accordance with t h a t provision with respect to a category of chemical substances or mixtures. Whenever the Administrator takes action under a provision of this A c t with respect to a category of chemical substances or mixtures, any reference in this A c t to a chemical substance or mixture (insofar as it relates to such action) shall be deemed to be a reference t o each chemical substance or mixture in such category. (2) F o r purposes of p a r a g r a p h (1) : Definitions. ( A ) T h e term "category of chemical substances" means a group of chemical substances the members of which are similar in molec- ular structure, in physical, chemical, or biological properties, in use, or in mode of entrance into the h u m a n body or into t h e environment, or the members of which are in some other way suit- able for classification as such for purposes of this Act, except t h a t such term does not mean a group of chemical substances which are grouped together solely on the basis of their being new chemical substances. ( B ) T h e term "category of mixtures" means a g r o u p of mix- tures the members of which are similar in molecular structure, in physical, chemical, or biological properties, in use, or in the mode of entrance into the human body or into t h e environment, or t h e members of which are in some other way suitable for classification as such for purposes of this Act. (d) ASSISTANCE O F F I C E . — T h e Administrator shall establish in the Establishment. Environmental Protection Agency a n identifiable office to provide technical a n d other nonfinancial assistance t o manufacturers and processors of chemical substances and mixtures respecting the require- ments of this Act applicable to such manufacturers and processors, the policy of the Agency respecting the application of such requirements to such manufacturers and processors, and the means and methods by which such manufacturers a n d processors m a y comply with such requirements. (e) FINANCIAL DISCLOSURES.— (1) Except as provided under para- g r a p h ( 3 ) , each officer or employee of the Environmental Protection Agency and the Department of Health, Education, and Welfare who— ( A ) performs any function or duty under this Act, and
90 STAT. 204S PUBLIC LAW 94-469—OCT. 11, 1976 ( B ) has any known financial interest (i) in any person subject to this Act or any rule or order in effect under this Act, or (ii) i n any person who applies for or receives any g r a n t or contract under this Act, shall, on F e b r u a r y 1,1978, and on F e b r u a r y 1 of each year thereafter, file with the Administrator or the Secretary of Health, Education, and Welfare (hereinafter i n this subsection referred t o as t h e "Secre- t a r y " ) , as appropriate, a written statement concerning all such inter- ests held by such officer or employee d u r i n g t h e preceding calendar year. Such statement shall be made available to the public. (2) T h e Administrator and the Secretary shall— ( A ) act within 90 days of the effective date of this Act— (i) t o define the term "known financial interests" for pur- poses of p a r a g r a p h ( 1 ) , and (ii) to establish t h e methods by which the requirement t o file written statements specified in p a r a g r a p h (1) will be monitored and enforced, including appropriate provisions for review by the Administrator and the Secretary of such state- ments; and Report to ( B ) report t o the Congress on J u n e 1, 1978, and on J u n e 1 of Congress. each year thereafter with respect t o such statements a n d t h e actions taken in regard thereto d u r i n g t h e preceding calendar year. (3) T h e A d m i n i s t r a t o r may by rule identify specific positions with the Environmental Protection Agency, and the Secretary may by rule identify specific positions with the Department of Health, Education, and Welfare, which are of a nonregulatory or nonpolicymaking nature, and the Administrator and the Secretary may by rule provide t h a t officers or employees occupying such positions shall be exempt from t h e requirements of p a r a g r a p h ( 1 ) . (4) T h i s subsection does not supersede any requirement of chapter 11 of title 18, United States Code. Penalty. (5) A n y officer or employee who is subject to, a n d knowingly vio- lates, this subsection or any rule issued thereunder, shall be fined n o t more t h a n $2,500 or imprisoned not more t h a n one year, or both. (f) STATEMENT OF BASIS AND P U R P O S E . — A n y final order issued under this A c t shall be accompanied by a statement of its basis a n d purpose. T h e contents a n d adequacy of a n y such statement shall n o t be subject t o judicial review in any respect. Appointment. ( g ) ASSISTANT ADMINISTRATOR.— (1) T h e President, by a n d witli the advice a n d consent of t h e Senate, shall appoint a n Assistant Administrator for Toxic Substances of the Environmental Protection Agency. Such Assistant Administrator shall be a qualified individual who is, by reason of background a n d experience, especially qualified to direct a p r o g r a m concerning t h e effects of chemicals on human health a n d t h e environment. Such Assistant Administrator shall be responsible for ( A ) t h e collection of data, ( B ) t h e preparation of studies, ( C ) the making of recommendations t o the Administrator for regulatory a n d other actions t o carry out the purposes and to facili- tate t h e administration of this Act, a n d ( D ) such other functions as the Administrator may assign or delegate. (2) T h e Assistant Administrator to be appointed under p a r a g r a p h (1) shall ( A ) be in addition to t h e Assistant Administrators of t h e Environmental Protection Agency authorized by section 1 ( d ) of Reor- 5 u s e app. II. ganization P l a n No. 3 of 1970, and ( B ) be compensated a t the rate of pay authorized for such Assistant Administrators.
PUBLIC LAW 94-469—OCT. 11, 1976 90 STAT. 2049 SEC. 27. DEVELOPMENT AND EVALUATION OF TEST METHODS. (a) I N GENERAL.—The Secretary of Health, Education, and Welfare, Consultation. in consultation with t h e Administrator and acting t h r o u g h the Assist- 15 u s e 2626. ant Secretary for Health, may conduct, and make grants to public and nonprofit private entities a n d enter into contracts with public and private entities for, projects for t h e development a n d evaluation of inexpensive and efficient methods (1) for determining and evaluating the health a n d environmental effects of chemical substances and mix- tures, a n d their toxicity, persistence, a n d other characteristics which affect health and the environment, and (2) which may be used for t h e development of test data to meet the requirements of rules promulgated under section 4. T h e Administrator shall consider such methods in prescribing under section 4 standards for the development of test data. (b) APPROVAL BY SECRETARY.—No g r a n t m a y be m a d e o r contract Grants or entered into under subsection ( a ) unless an application therefor h a s contracts, been submitted to and approved by the Secretary. Such an application application. shall be submitted in such form and manner and contain such informa- tion as t h e Secretary m a y require. T h e Secretary m a y apply such conditions to grants and contracts under subsection (a) as t h e Secre- t a r y determines are necessary to carry out the purposes of such subsec- tion. Contracts m a y be entered into under such subsection without regard to sections 3648 a n d 3709 of t h e Revised Statutes (31 U.S.C. 529;41U.S.C. 5). (c) A N N U A L REPORTS.—(1) T h e Secretary shall prepare and sub- Report to mit to t h e President a n d t h e Congress on or before J a n u a r y 1 of each President and year a report of the number of grants made and contracts entered into Congress. under this section and the results of such grants and contracts. (2) The Secretary shall periodically publish in the Federal Register Publication in reports describing t h e progress a n d results of any contract entered Federal Register. into or g r a n t made under this section. SEC. 28. STATE PROGRAMS. (a) I N GENERAL.—For the purpose of complementing (but not reduc- 15 u s e 2627. ing) t h e authority of, or actions taken by, the Administrator under this Act, t h e Administrator may make g r a n t s to States for t h e estab- lishment and operation of programs to prevent or eliminate unreason- able risks within the States to health or the environment which are asso- ciated with a chemical substance or mixture and with respect to which the Administrator is unable or is n o t likely to take action under this Act for their prevention or elimination. T h e amount of a g r a n t under this subsection shall be determined by t h e Administrator, except t h a t no g r a n t for a n y State p r o g r a m m a y exceed 75 p e r centum of t h e establishment a n d operation costs (as determined by t h e Admin- istrator) of such p r o g r a m during t h e period for which t h e grant is made. (b) APPROVAL BY ADMINISTRATOR.—(1) No g r a n t m a y be m a d e u n d e r Grants, subsection (a) unless an application therefor is submitted t o a n d application. approved by t h e Administrator. Such an application shall be sub- mitted in such form and manner as the Administrator may require and shall— ( A ) set forth the need of the applicant for a g r a n t under subsec- tion ( a ) , ( B ) identify t h e agency or agencies of the State which shall establish or operate, or both, t h e p r o g r a m for which t h e applica- tion is submitted, (C) describe t h e actions proposed to be taken under such pro- gram,
90 STAT. 2050 PUBLIC LAW 94-469—OCT. 11, 1976 (D) contain or be supported by assurances satisfactory to the Administrator that such program shall, to the extent feasible, be integrated with other programs of the applicant for environ- mental and public health protection, (E) provide for the making of such reports and evaluations as the Administrator may require, and (F) contain such other information as the Administrator may prescribe. Application, (2) The Administrator may approve an application submitted in approval. accordance with paragraph (1) only if the applicant has established to the satisfaction of the Administrator a priority need, as determined under rules of the Administrator, for the grant for which the appli- cation has been submitted. Such rules shall take into consideration the seriousness of the health effects in a State which are associated with chemical substances or mixtures, including cancer, birth defects, and gene mutations, the extent of the exposure in a State of human beings and the environment to chemical substances and mixtures, and the extent to which chemical substances and mixtures are manufactured, processed, used, and disposed of in a State. Report to (c) ANNUAL KEPORTS.—Not later than six months after the end of Congress. each of the fiscal years 1979, 1980, and 1981, the Administrator shall submit to the Congress a report respecting the programs assisted by grants under subsection (a) in the preceding fiscal year and the extent to which the Administrator has disseminated information respecting such programs. (d) AUTHORIZATION.—For the purpose of making grants under subsection (a) there are authorized to be appropriated $1,500,000 for the fiscal year ending September 30,1977, $1,500,000 for the fiscal year ending September 30, 1978, and $1,500,000 for the fiscal year ending September 30, 1979. Sums appropriated under this subsection shall remain available until expended. SEC. 29. AUTHORIZATION FOR APPROPRIATIONS. f 15 use 2628. There are authorized to be appropriated to the Administrator for purposes of carrying out this Act (other than sections 27 and 28 and subsections (a) and (c) through (g) of section 10 thereof) $10,100,000 for the fiscal year ending September 30,1977, $12,625,000 for the fiscal year ending September 30, 1978, $16,200,000 for the fiscal year ending September 30, 1979. No part of the funds appropriated under this section may be used to construct any research laboratories. SEC. 30. ANNUAL REPORT. Report to The Administrator shall prepare and submit to the President and President and the Congress on or before January 1,1978, and on or before January 1 G>ngres8. of each succeeding year a comprehensive report on the administration 15 u s e 2629. of this Act during the preceding fiscal year. Such report shall include— (1) a list of the testing required under section 4 during the year for which the report is made and an estimate of the costs incurred during such year by the persons required to perform such tests; (2) the number of notices received during such year under section 5, the number of such notices received during such year under such section for chemical substances subject to a section 4 rule, and a summary of any action taken during such year under section 5 ( g ) ; (3) a list of rules issued during such year under section 6; (4) a list, with a brief statement of the issues, of completed or pending judicial actions under this Act and administrative actions under section 16 during such year;
PUBLIC LAW 94-469—OCT. 11, 1976 90 STAT. 2051 (5) a summary of major problems encountered in the adminis- tration of this Act; and (6) such recommendations for additional legislation as the Recommenda- Administrator deems necessary to carry out the purposes of this *'°"®' Act. SEC. 31. EFFECTIVE DATE. Except as provided in section 4(f), this Act shall take effect on 15 USC 2601 .Fanuary 1,1977. note. Approved October 11, 1976. LEGISLATIVE HISTORY: HOUSE REPORTS: No. 94-1341 accompanying H.R. 14032 (Comm. on Interstate and Foreign Commerce) and No. 94-1679 (Comm. of Conference). SENATE REPORTS: No. 94-698 (Comm. on Commerce) and No. 94-1302 (Comm. of Conference). CONGRESSIONAL RECORD, Vol. 122 (1976): Mar. 26, considered and passed Senate. Aug. 23, considered and passed House, amended, in lieu of H.R. 14032. Sept. 28, Senate and House agreed to conference report. WEEKLY COMPILATION OF PRESIDENTIAL DOCUMENTS, Vol. 12, No. 42: Oct. 12, Presidential statement.