Document KzDV8ZJK7aOvj5pM4wOOJbN2Q

5.776 :--j \ . iV* TABLE OF CONTENTS Sec. 1. Short title; contents----------------------------------------------Sec. 2. Declaration of policy-----------------------------------------------Sec. 3. Definitions-----------------------------------------------------------Sec. 4- Criteria- for data development-----------------------------Sec, 5. Premarket screening of chemical substances---------Sec. 6. Hazardous chemical substances---------------------------- . Sec. 7. Imminent hazard-------;----------------------------------------- Sec. 8. Reports ------------------------------------------------------- . Sec. 9. Exemptions and relationship to other Federal laws----- . Sec...10. Coordination, consultation, and cooperation--------------- . Sec. 11. Exports and-Imports----------------------------------------------- . Sec. 12. Review of administrative option---------------------------Sec. 13. Enforcement:-------------------------------------------------------- . Sec. 14. Administrative provisions-------------------------------- . Sec. 15. Miscellaneous provisions--------------------------------------- . Sec. 16. Annual report_--------.------i----------------------------------- Sec. 17. Employee protection------------:--------------------------------- Sec. 18. Authorization for appropriations, fees, and congressional relations---------------------------------------------------:------------ Page 55 55 57 63 70 78 84 86 90 93 96 98 .'P J 102 -- . 0 Cn Ill 115 y "r 117 119 14 7 DECLARATION OF POLICY 8 Sec. 2. (a) Findings.--The Congress finds that-- 9 ,, (1) Human beings and the environment are ex 10 posed each year to a large and constantly growing 11 number of chemical substances. ' 12 (2) Some chemical substances may pose an unrea 13 sonable. risk to human health or the environment. 14 (3) The effective regulation of commerce in the PCB-ARCH-EXT0378026 56 Aj j interest of protecting human beings and the environment NL 2 necessitates adequate data development with respect to, J3 - \i i ,,csj 4 .vs and necessary restrictions on, such substances. (b) Policy.--It is therefore declared to be the policy 5 of the Congress in this Act that-- 6 (1) adequate data should be developed with respect 7 to chemical substances with respect to their effect on 8 human health and the environment; 9 (2) such data development should be the responsi 10 bility of the persons who manufacture, import, or process 11 such chemical substances; 12 (3) adequate authority should exist in the Environ X 13 a X 14 mental Protection Agency to regulate the manufacturing, importation, processing, and distribution in commerce of 15 : 1 16 x0 XX 17 18 f 19 chemical substances which are found to pose an unrea sonable risk to human health and the environment; mrdr (4) such authority should be exercised in such a manner as to assure that technological innovation and commerce in chemical substances and products contain 20 ing chemical substances are not unduly impeded while 21 XA 22 H | 23 ^ 'CVJ 24 ) assuring that the manufacturing, importation, processing, or distribution in commerce of such substances do not pose an unreasonable risk to human health and the environment; (WcL -- " ~~ Z .. * ^ /-VT *- a~S-(,J ^j/c -*i'd ^*<+**% ,?*')"*** PCB-ARCH-EXT0378027 '! I 2 3 (1) "Administrator" means the Administrator of i v 4 the Environmental Protection Agency; . w 5 (2) "category of chemical substances" means a 3 Vc 6 group of chemical substances the members of which are -f t oA y / odg. 7 similar in molecular structure, in physical^or chemical 8 properties, 9 PWWr 10 igjnb&'Srtfk: uMbujzricwrwi 11 except 12 that the term does not mean all new chemical substances; 13 (3) "chemical substance" means (A) an organic 14 or inorganic substance of a particular molecular identity, 15 or a combination of such substances occurring as a residt 16 of a chemical reaction and not separated into its con 17 stituent components; (B) an uncombined radical or 18 element; or (C) any mixture or category of mixtures 19 specified by the Administrator in this discretion with 20 respect to any provision of this Act. In specifying a 21 mixture or category of mixtures under subparagraph 22 (C) the Administrator shall consider the extent to which 23 actions taken ninth raxopct. to a mixture or mixtures so 24 specified could be reasonably and as efficiently taken ' *$vV ft fVw <*thi44\ s (rut* Ais AllA, AJl&U-mIJIl -tkafr rtoo^AjU/ -HjL <rj CUuj Q.C'i'itfi\ A**- PCB-ARCH-EXT0378028 58 1 with respect to the component chemical substances ivhich 2 comprise such mixture or mixtures; . 3 (4) "commerce" means trade, traffic, transporta 4 tion, communication, or exchange (A) between a place in 5 a State and any place outside of such State, or (B) 6 which affects trade, traffic, transportation, communica 7 tion, or exchange described in subparagraph (A) ; 8 (5) "criteria for data development" means a pre- 9 sa'iption of (A) the manner in which data are to be 10 developed with respect to the human health and en 11 vironmental effects of a chemical substance; (B) any 12 analysis that is to be performed on such data, and (C) 13 any requirements to be met in <the design of any test or 14 study necessary to insure the reliability and adequacy of 15 such data; 16 (6) "distribute in commerce" or distribution in 17 commerce" means to sell in commerce, to introduce or 18 deliver for introduction into commerce, or to hold for *19 sale or distribution after introduction into commerce, 20 including use and disposal thereofter; ; ; 21 (7) "environment" includes man and the human 22 environment, water, air, land, all living things therein, 23 and the interrelationships ivhich exist among and be 24 tween these; ! . - . 25 ,(8) "health and safety data": means data that 26 relate to the effect of a chemical substance on human PCB-ARCH-EXT0378029 1 health and the environment, including data developed 2 pursuant to health and safety studies. The term in- 3 eludes consumer or other individual correspondence re 4 garding alleged adverse effects of a chemical substance 5 on human health and the environment, reports of worker 6 illness or injury allegedly related to exposure to a chern- 7 ical substance, and complaints or other notices with re 8 spect to judicial or administrative proceedings initiated 9 by local, State-,, or Federal authorities or other persons 10 on account of any injury to human health and/or the 11 environment that is alleged to have been caused by a 12 -chemical substance; . . 13 (9) "health and safety study" means a study 14 of any effects of a chemical substance on human health 15 and/or the environment. The term includes epidemio 16 logical studies, studies of occupational exposure to a 17 chemical substance, toxicological studies, clinical studies, ^^8' ecological studies, environmental monitoring studies, and 19 . all tests performed pursuant to this Act; . 20 (10) "human health and the environment" should 21 be read as if human health and/or the environment were 22 set forth; ... . \ : 23 (11) "includes" should be read as if the phrase "but 24 not limited to" were also set forth; . 25 (12) "import" means to introduce, transport, or 26 bring (A) into the United States from any place outside ^9_Qnc; r\ _ oc PCB-ARCH 60 1 the United States; or (B) into the customs territory of 2 the United States (as defined in general headnoie 2 to 3 the Tariff Schedules of the United States) from any place 4 outside the customs territory of the United States; 5 (13) "importer" means a person who imports a 6 chemical substance for distribution in commerce for com 7 mercial purpose; 8 (14) "manufacture" means to produce or manufac 9 ture; 10 (15) "manufacturer" means a person ivho manu 11 factures a chemical substance; 12 (16) "mixtuarTer "-'mI---*e--a--n--si a co--m. bination of two.n_or mo--r.e 13 chemical substances (A) that occurs naturally other than 14 in the cause of the manufacture of chemical substance; or 15 (B) that is produced by deliberate mixing according to 16 plan but without intent to cause a chemical reaction and 17 which does not residt in a chemical reaction; 18 (17) "new chemical substance" means a chemi 19 cal substance not included in the inventory compiled 20 and published under Section 8(b); 21 . (18) "paragraph" means a paragraph of the sub 22 section in which the term is used; \ 23 (19) "person" means an individual, corporation, 24 partnership, association, State, municipality, or political 25 subdivision of a State; PCB-ARCH-EXT0378031 61 1 (20) "process'' means to prepare a chemical sub- 2 . stance for distribution in commerce (A) in the 3 same or in a different form, (B) in the same or in a 4 different physical state, or (C) as part of another 5 product; . . 6 (21) "processor" means a person who processes 7 a chemical substance; . , 8 (22) "research and laboratory chemicals" means 9 chemical substances manufactured, processed, or im- 10 ported in small quantities solely for experimental use by 11 . professionally trained personnel; . 12 r . (23) "section" means a section of this Act; 13 (24) "State" means a State, the District of 14 . Columbia, the Commonwealth of Puei to Rico, the Fir- 15 gin Islands, Guam, the Canal Zone, or .-American 16 ....... Samoa; ,, 17 : , ...... (25) "subparagraph" means a subparagraph of the. 18 . paragraph in which the term is used; \.... . - 19 (26) 1 `subsection" means a subsection of the section 20 in which the term is used; . . ^ 21 (27) "test protocol" means a specific method or pro- `* _ . ' , ' 22 cedure to be followed in a test or tests to determine the 23 effects on human health and the:environment of the man- 24 ufacture, processing, importing, or distribution in com- . 25 merce of a chemical substance; . . , PCB-ARCH-EXT0378032 * 62 1 (28) "United States" means all the States; and 2 (29) "unreasonable risk to human health"and the # 1 &- JkvtA 3 environment" 'rneans \. . associated with the manu- . / 4 facture, processing, importation, or distribution in com- \ _ UrloL i|. "Wet 5 merce for a specific purpose r/ mek ri/k" dutu nighr ,.thf I 'i 6 benefits associated\/with such manufacture, processing, 7 importation, or distribution in commerce.^ Any chemical si 3 ^ 'S. 8 substance which has been found, after appropriate eval-u- 9 \ / ative tests (such as tests with/animals) o r other tech . \ . /. . . 10 niques, to have the potential/to induce in human beings \ / ' 11 (1) cancer, (2) gene mutations, or (3) birth defects. ` ` \/ 12 shall be eonotmmd- to present an unreasonable risk to ;1 13 human health or the environment and the Administrator 14 si 15 * 16 * 17 * ^ 18 - ? 19 -> ->5 ^ * 20 lb J 21 *+% <*21 22 1 N 23 fi i u > ^ I I I 25 3 5 26 . . . / . \. importation, or distribution, in commerce. . I 7 . i .7 mr-exjJUSTmrtcHiainwr bemgs wtih^v^peobH'Cr-'mele-sub- 'ess/the Administrator finds, hv rule, that t.hp. benefits ^assSemt^dr^with such, m arm faring processing, . . / . . . j ll +ek%. importation, or distribution in commerce^ outweighsUhe &-k_cl4<e^ JU& sf^JicCcl) 7 ub-kLyu,ejtS,J- -fA t n }neah-\md#r-seciimt-6rftt^^ ' A' Ccrm+J&A. &<w fU*Jr$4sLm.tUm. At'AVw. ----- ------------- fmdirtg-4hvitr4he-hemfils--vutweigh ; *fo-<tvu^0-^.3 afr fUvJLst uLci., G/rfl* the ^ Ss/2.\^ J*<SaM. MAjw th.rur~. -fo M*tlu.tA-C ) C<5!CH, 6e ^xuuiidiAnvs~^m7ras'fwrsi'blrhutnTotlaternktm-8--years ^ ^ |Wl 0*> C$)Jn*Ak ei&a.t^S. i efi* ^ PCB-ARCH-EXT0378033 2 WS&eiAAMfa) General.--(1) If the Administrator 3 determines that-- ' . 4 (A) because of known or anticipated manufactur- 5 ing, 'processing, importing, or distribution in commerce 6 of a chemical substance there is reason to believe that 7 such substance may present an unreasonable risk to 8 human health and the environment: and 9 (B) data development with respect to such risks 10 ^wmllcGmsi^in making a determination of whether an 11 unreasonable risk to human health and the environment 12 does or does not exists <* TUyiJr flpoSS.) A4sk d 13 then he shall, by rule, prescribe criteria for data development *f&, Aa'hitUf4^a 14 for such chemical substance. Such criteria shall include 15 (i) the prescription of the human health and environmental 16 effects for which data are required to be developed; (ii) the 17 date by which such data should be submitted to the Adminis- , 18 trator; and (Hi) a requirement, subject to subsection (d), 19 that such data be developed by each person who is or will be 20 a manufacturer, a processor, or an importer of such sub- 21 stance. ... .. .: 22 . (2) The Administrator shall require, pursuant to each 23 rule issued under paragraph (1), that data be developed with 24 respect to those human health and/or environmental effects 25 which the Administrator specifies to be relevant with respect .. . - 26 to the substance affected by such Anile. In specifying such PCB-ARCH-EXT0378034 64 . . ' ' 1 effects, as to which data development are required, the Ad- ' \ 7 2 ministrator shall consider-- . ; 3 (A) the actual or estimated magnitude and duration 4 of human exposure to such substance, and. the possible 5 consequences thereof ivith respect to human health; 6 and 7 (B) the actual or estimated magnitude and duration 8 of environmental exposure to such substance and the 9 possible consequences thereof with respect to the environ- 10 ment. 11 The human health and environmental effects for ichich cri- . 12 teria for data development map be prescribed include carcino- 13 genesis, mutagenesis, teratogenesis, behavioral disorders, 14 acute toxicity, subacute toxicity, chronic toxicity, cumulative 15 or synergistic effects, ecological effects, persistence, and any 16 other effects that may cause an unreasonable risk to human 17 health and the environment. The methodologies that may be 18 prescribed in criteria for data development include epidemi- 19 ology, serial, battery, or hierarchical tests; in vitro tests; and 20 whole animal tests. ' 21 (3) From time to time, but not less than once each 12 22 months, the Administrator: shall revieiv the adequacy of the 23 criteria for data development established under this subsec- 24 tion, and shall promulgate appropriate revisions thereof. . . . : . ... . . . \ 25 (b) New Chemical Substances.--Within 1 year PCB-ARCH-EXT0378035 65 j after the date of enactment of this Act, and from time to 2 time thereafter, the Administrator shall by rule, prescribe 3 criteria for data development, pursuant to subsection (a), 4 that shall be applicable to new chemical substances and 5 categories of new chemical substances. 6 . (c) Existing Chemical Substances.--(1) Within 7 1 year after the date of enactment of this Act, the Ad8 ministrator shall establish, and shall thereafter continually 9 maintain, a list of not- less--than-SOO' chemical substances, 10 (other than new chemical substances) which are, in the Ad- ^ 11 ministrator's discretion, the highest priority candidates for 12 the establishment of criteria for data development pursuant 13 to subsection (a). From time to time thereafter, but not 14 less than once every 2 years, the Administrator shall v 15 review and revise such list. Whenever the Administrator 16 promulgates, or determines not to promidgate, a final rule 17 pursuant to subsection (a), with respect to any chemical 18 substance so listed, the Administrator shall delete 19 such substance from such list and shall make any necessary . *4- ^ 't* <d ' 20 additions tormmnUiUrflH^iiiAofsuchAistr. Such list, and any 21 revisions thereof, shall subject to section 14 (c) or (e) be 22 published in the Federal Register together with the following 23 information with respect to each chemical substance listed, 24 to the extent that such information can be reasonably ascer- 25 tained by the Administrator: PCB-ARCH-EXT0378036 1 (A) the volume of production and use thereof; 2 (B) categories of use thereof; 3 (C) the magnitude, means, and duration of expo- 4 sure to human beings and the environment that are 5 associated with such substance; . 6 (D) the extent to which such substance is phys- 7 ically or chemically similar to chemical substances with 8 known adverse effects on human health and the environ- 9 ment; and 10 (E) any other property, or possible property, of 11 such substance that may form a reasonable basis for . 12 placing such substance on such list. 13 (2) Within 1 year after the initial publication of the 34 list under paragraph (1), the Administrator shall promul- 15 gate initial criteida for data development pursuant to sub- 16 section (a), with respect to any or all of the chemical sub- 17 stance which appear on such list. The Administrator may 18 promulgate criteria for data development pursuant to sub- 19 section (a) for any other chemical substance. 20 (d) Exemption.--(T) The Administrator may per- 21 mit two or more persons who are required to develop data 22 in accordance with subsection (a) to designate one such 23 person, or a qualified and independent third party, to de- 24 velop such data pursuant to a cost-sharing arrangement. 25 If such an arrangement is made and approved by the Ad- 67 1 ministratm', the remaining such 'persons shall he exempted, 2 pursuant to paragraph (2). 3 (2) (A) The Administrator shall exempt a person 4 from the obligation to develop data in accordance with swb- 5 section (a), upon a determination that the data to be de- q velopcd by such person would be duplicative, of data previous- 7 ly received or which are in the process of being developed:, 8 Provided, That no exemption shall be granted before the 9 person petitioning for such exemption-- 10 (i) has demonstrated, to the satisfaction of the Ad- 11 ministrator, that the chemical substance for which the 12 exemption is requested (including any contaminants 13 and/or byproduct impurities present in it) is equivalent 14 to the chemical substance upon which the original test 15 data was, or is in the process of being, developed; and 16 (H) agrees to provide reimbursement, pursuant to 17 subparagraphs (B) and (C). 18 (B) If the Administrator exempts a person from the 19 obligation to develop data in accordance with subsection (a) 20 because of the existence of previously submitted data or data 21 which are in the process of being developed, and if such 22 exemption takes effect during the reimbursement period for 23 such data, as defined in subparagraph (C), the Administra- 24 tor shall, as a condition of such exemption, order such person 25 to provide fair and equitable reimbursement, on the basis of PCB-ARCH-EXT0378038 68 1 market shares and other appropriate factors, by agreement 2 or in an amount and subject to conditions determined under 3 rules of the Administrator-- 4 (i) to any person luho previously submitted data or 5 is developing such data, as a consequence of the avail- 6 ability of which such exemption is granted, for a por- 7 tion of the relevant costs incurred by such person, and 8 (ii) to any other person who has previously been 9 required under this paragraph to contribute with respect 10 to such data. 11 An order under this paragraph shall be considered a final 12 agency action for purposes of judicial review. 13 (C) For purposes of subparagraph (B), the reimburse- 14 ment period for any previously submitted data or data in the 15 process of being developed is a period-- , s 16 (i) beginning on the earliest date on which a rete ll vant exemption was granted under paragraph (1) ; and 18 (ii) ending 2 years after the data, with respect to 19 which such exemption was granted, were submitted to the 20' Administrator (or at the expiration of a period after such 21 date equal in length to the period which the Administra- 22 tor determines was necessary to develop the previously 23 submitted data). Y . ; 24 (3) In any case in which a person provides reimburse- 25 ment, in accordance with paragraph '(2), section 14 (c) shall PCB-ARCH-EXT0378039 69 1 not be construed to prevent such person from having access to 2 any data submitted as a result of the data development with 3 respect to which such contribution or reimbursement was 4 provided. 5 (e) Submission.--When the criteria for data develop- 6 ment are satisfied by a person required to develop data in ac- 7 cordance with subsection (a), such data shall be submitted 8 promptly, but not less than 10 days later, to the Administra- 9 tor. The Administrator may require such a person to submit 10 preliminary data or other information during the course of 11 data development in accordance with subsection (a). 12 (f) Notice.--Upon the receipt of any data under this 13 section, and subject to sections 14(c) or 14(e), the Adminis- 14 trator shall promptly publish a notice of such receipt in the - 15 Federal Register. Each such notice shall (1) identify the 16 chemical substance for which data have been received; (2) 17 list the uses or intended uses of such substance, and in- 18 formation required by the applicable criteria; and (3) deig scribe the nature of the data developed. Such data shall be 20 made available by the Administrator for examination by any 21 person, except as otherwise provided in sections 14(c) or 22 14(e). 23 (g) Procedure.--Rules issued under this section (and 24 amendments thereto or repeals thereof) shall be promulgated 25 pursuant to section 553 of title 5, United States Code. In PCB-ARCH-EXT0378040 I 1 rsC * & 70 I 1 ^ ^ 1 promulgating, amending, or repealing any criteria for data 8 2 development or any other ride under this section (1) the 3 Administrator shall give interested persons an opportunity > \ 4 /or oral presentation of data, views, or arguments, in 3 ui _ t ... , x 5 addition to an opportunity to make written submission; and 4 V . . . 6 (2) a transcript shall be made of any oral presentation. V7 8 ) Commencing 270 days 9 after the date of enactment of this Act, a manufacturer or im- 10 porter shall notify the Administrator, of the planned manufac- 11 ture orjmportation of anewjehgmiQaCsubstqnce ^ihen-4hem-a A J 12 vAs-khrtf-f-at least 90 days prior to the commencement of such 13 manufacture or importation. Such notice shall be accompanied 14 by any pertinent information referred to in section 8(a)(1),' 15 whether or not the Administrator has required the submis- lv ' ' V ^ \tr ' ` :-j . - V.' v'.i .) * 3 M 7 ^ i :3 16 sion thereof under section 8(a) (1). .. 17 (2) The Administrator shall jjive priority attention to 18 a chemical substance with respect t which information is 19 received indicating that serious economic.or other hardships 20 are likeluJojtesulLit there is any significant delay in manu- 21 facture or importation. If the Administrator finds that such 22 a substance does not present an unreasonable risk to human $ 23 health and the environment, he may reduce the number of 24 days, after submission of such information, during which ;v. r$ v * PCB-ARCH-EXT0378041 71 1 tor shall promptly publish his findings and the basis therefor 2 in the Federal Register. 3 (b) Submission of Data--After the effective date 4 of any criteria for data development issued under sec- 5 tion 4(a), any manufacturer, processor, or importer of a 6 new chemical substance that is covered by such criteria, and 7 who first manufactures, processes, or imports such substance 8 after such date, shall submit to the Administrator (in addi- 9 tion to the information required in subsection (a)), at least 10 90 days prior to such manufacture, processing, or importa- 11 tion, the data developed in accordance with such criteria. 12 (c) Data Availability.--The Administrator shall 13 promptly publish in the Federal Register (subject to section 14 , 14(c) and 14(e)) the identity of each chemical substance for 15 which a notice has been received under subsection (a) or 16 Yb), intended use or distribution of such substance, and a 17 statement of the availability of any data and other informa- 18 tion submitted. 19 (d) Extension.--The Administrator may extend, for 20 an additional period beyond the 90-day period referred to in .21 subsection (a) or (b), the date after which a new chemical 22 substance may be manufactured, processed, or imported for 23 any particular distribution in commerce. Such additional 24 period may not exceed 90 days and shall not be imposed except 25 for good cause shown. Notice of any such extension, and the PCB-ARCH-EXT0378042 72 1 reasons therefor, shall be 'published in the Federal Register. 2 Such an extension shall constitute a final action for purposes 3 of judicial review. 4 (e) ORDERS.--(1)(A) If the Administrator finds, dur- 5 ing the 90-day period referred to in subsection (a) or (b) 6 or during any extension thereof, with respect to any new 7 chemical substance for which notification is required under 8 this section-- . . . 9 (i) that such new chemical substance is covered by 10 criteria for data development promulgated under section 11 4(a), but that such criteria require additions or revisions 12 with respect to such substance; or 13 (ii) that such new chemical substance is not covered . . . ' 's 14 by criteria for data development promulgated under 15 section 4(a), but that such criteria should be established; 16 he shall issue an order in accordance with this subsection. . 17 Such an order shall appropriately prohibit or restrict the 18 manufacture, processing, or distribution in commerce of such 19 new chemical substance pending the completion of a rule- 20 making proceeding under section 4(a) and the submission of 21 any data required thereunder, as described under subpara- 22 graph (B); shall contain a proposed ride under section 4(a) ; 23 andshall be immediately effective.' . . - . . 24 (B) Upon the issuance of any order under subpara- 25 graph (A) , the Administrator shall proceed with a rulemak- PCB-ARCH-EXT0378043 73 4 ing 'procedure as expeditiously as practicable under section 4 2 (a). During the course of, or upon the completion of, such 3 rulemaking, the Administrator shall, if necessary, appro- 4 priately modify or rescind any order issued under sub- ft 5 paragraph (A). If criteria for data development are estab- g lished as a result of such rulemaking, any provision of such 7 order restricting the manufacture, processing, or distribution 8 in commerce of such substance shall remain in effect, unless 9 modified or rescinded, pending the submission of such data 10 to the Administrator and the completion of procedures de ll scribed in subsection (b) or any extension imposed under 12 subsection (d). 13 (2) (A) If the Administrator finds, during the 90-day 14 period referred to in subsection (a) or (b) or during any 15 extension thereof, with respect to any new chemical sub- 16 stance for, which notification is required under this section, 17 that a rule is appropriate under section 6(a), he shall issue 18 an order in accordance ivith this subsection. Such an order. . 19 shall appropriately prescribe such requirements as are au- 20 thorized under section 6(a); shall contain a proposed rule 21 under section 6(a); and shall be immediately effective. 22 (B) Upon the issuance of any order under subparagraph . 23 (A), the Administrator shall proceed uriih a rulemaking pro- 24 cedure as expeditiously as practicable under section 6(a). 25 During the course of, or upon the completion of such rule- t PCB-ARCH-EXT0378044 . - 74 1 making, the Administrator shall, if necessary, appropriately 2 modify or rescind any order issued under subparagraph (A). 3 .(f) Failure To Issue Order.--Unless the Adminis- 4 trator, within 90 days after the submission under subsection 5 (a) or (b) of data and information with respect to a new 6 chemical substance, or within such period as extended under 7 subsection (d), issues an order under subsection. (e) with 8 respect to such substance, manufacturing, processing, or im- 9 porting, as appropriate, may commence. 'The--Admbms- 1C ^rator,nU'ailureH,&Assue-suchum-~ordxr--unde-r--siibsection~fe) 11 is-mi-uction-^bject~to~jiidiciabn'eview~Inr-accordan-ce~with 12 sectionrdr2fa)r Nothing in this subsection prohibits the Ad- 13 ministrator from-- . .. 14 (1) promulgating a rule pursuant to section 6 or 4, 15 with respect to such a substance, after such mahufactur- 16 ing, processing, or importing has commenced; 17 (2) taking action against any chemical substance 18 which is found to be an imminent hazard pursuant to 19 section 7; or : , 20 (3) taking any other action authorized by this Act. 21 -'(g) Exemption.--(1) Upon petition, the Administra- 22 tor shall exempt any person from the obligation to submit 23 data under this section, if he determines that the submission 24 of data by such person would be duplicative of data pre- 25 viously received: Provided, That no such determination PCB-ARCH-EXT0378045 75 1 shall be made before the person petitioning for such exemp- 2 tion has demonstrated, to the satisfaction of the Adminis- 3 trator, that the chemical substance for ichich the exemption is 4 requested (including any contaminants and/or byproduct 5 impurities present in it) is equivalent to the chemical sub- 6 stance upon which the original test data was developed and 7 that reimbursement to the manufacturer, processor, or 8 importer of such chemical substance as provided in para- 9 graphs (2) and (3) shall be a condition precedent to the 10 granting of any exemption to manufacturers, processors, or 11 importers by the Administrator. Any person to whom an 12 exemption has been granted under this paragraph shall not 13 manufacture, process, or distribute in commerce such new 14 chemical substance prior to the date after which such sub- 15 stance may be manufactured, processed, or imported under 16 this section. Any chemical substance, or any manufacturer, 17 processor, or importer thereof referred to in the preceding 18 sentence, shall be subject to all the other provisions of this 19 Act. . . . " ... , ' -,,vV. . . , 20 (2) If the Administrator exempts any person from sub- 21 mitting data under this section because of the existence of 22 previously submitted data, and if such exemption takes 23 effect during the reimbursement period for such data, as 24. defined in paragraph (3), the Administrator shall order the 25 exempt person to provide fair and equitable reimbursement, 52-905 0 - 75 - 6 . . PCB-ARCH-EXT0378046 76 1 on the basis of market shares and other appropriate factors, 2 by agreement or in an amount and subject to conditions 3 determined under rides of the Administrator-- 4 (A) to any person who previously submitted data, 5 as a consequence of the availability of which such 6 exemption is granted, for a portion of the, relevant 7 costs incurred by such person, and 8 (B) to any other person ivho has previously been 9 required under this paragraph to contribute with respect 10 to such data. 11 An order under this paragraph shall be considered a final 12 agency action, for purposes of judicial review. 13 (3) For purposes of paragraph (2), the reimburse- 14 ment period for any previously submitted data is a period-- t 15 (A) beginning on the earliest date (after submis- 16 sion of such data), on which a person who previously 17 submitted data on which the exemption was based, was 18 no longer prohibited from proceeding with the manu- 19 facture and distribution in commerce of a chemical sub- 20 stance to which such data applied, and 21 (B) ending two years after such date (or, if later, 22 at the expiration of a period after such date equal in 23 length `to the period which the Administrator determines 24 was necessary to, develop the previously-submitted data). 25 (4) In any case in which a person provides reimburse- t i PCB-ARCH-EXT0378047 < 77 1 merit in accordance with paragraph (2), section 14(c) shall 2 not he construed to prevent such person from having access 3 to any data submitted as a result of the data development with 4 respect to which such reimbursement was provided. 5 (h) Significant New Use.--(1) Within 6 months 6 after the date of enactment of this Act, and from time to time 7 thereafter, the Administrator shall, by rule, establish criteria 8 defining a significant new distribution in commerce of a 9 chemical substance. In establishing such criteria, the Admin- 10 istrator shall take into account-- . ` . 11 (A) projected volume of production; 12 (B) projected category or categories or uses; 13 (C) projected increase in magnitude and duration 14 of human and environmental exposure; 15 (D) route or routes of exposure of human beings 16 or of the environment that are attributable to such signif- 17 icant new use; and , 18 (E) the human health and environmental effects 19 thereof. .... : . . : 20 (2) A chemical: substance may not be manufactured or 21 imported for a use that is identified by the Administrator, 22 in a rule, as a significant new distribution in commerce, un- 23 less, at least 90 days prior to such manufacture or importa- 24 tion, the person intending to manufacture or import such 25 substance for such use submits a notice of his intention to do PCB-ARCH-EXT0378048 1 so and any data required to be developed under section 4(a) i> 2 to the Administrator. Any such use of such substance shall be 3 subject to all of the provisions of this section. 4 (i) Special Exemption.---The Administrator may, 5 upon application and by rule, exempt any person from the 6 foregoing requirements of this section for the purpose of per- 7 mitting such person to manufacture, process, import or dis- 8 tribute in commerce a new chemical substance to which a rule < 9 under section 4(a) is applicable for test marketing purposes 10 or specially limited purposes (1) upon a showing by such per il son that such activity will not pose an unreasonable risk to 12 human health and/or the environment and (2) under such 13 restrictions as the Administrator considers appropriate. % 15 ^^Ect^.i(~a)0hEisWP^M---If the Administrator determines 16 that a rule with respect to a chemical substance is necessary 17 to protect against an unreasonable risk to human health * 1 18 and the environment, he shall prescribe such a rule , under 19 this section. Such a rule shall impose one or more of the 20 following types of requirements to the extent necessary to 21 protect against any such risk: I 22 (1) Requirements (A) prohibiting the manufac- 23 tuning, processing, importing, or distribution in com- 24 merce of the chemical substance involved, or (B) limiting 25 , the amount of such substance which may be manufac- 26 lured, processed, imported or distributed in commerce. PCB-ARCH-EXT0378049 1 (2) Requirements (A) prohibiting the manufac- 2 luring, processing, importing, or distribution in com 3 merce of the chemical substance involved for a par- 4 ticular distribution in commerce, or (B) limiting the 5 .. amount of, or regulating the conditions under which, such 6 substances may be manufactured, processed, imported 7 . and/or distributed in commerce for such particular dis- 8 tribution. . . ' 9 (3) Requirements mandating that the chemical 10 substance involved, or an article containing such sub- 11 . stance, be marked with or accompanied by clear and ade- 12 : quate warnings and instructions with respect to its use or 13 disposal, in such form and bearing such content as the 14 Administrator determines to be appropriate: Provided, 15 That the Administrator shall consider the extent to which 16 , it is required to be marked under any other Federal law 17 . so that uniform markings may be developed to the maxi- 18 mum extent practicable. . . 19 (4) Requirements mandating that persons subject to 20 requirements described in paragraphs (1), (2) , or (3), 21 make and retain records, and monitor or conduct tests, 22 . which are reasonable and necessary to assure compliance 23 : with such, requirements. .. ... 24 The Administrator shall, in addition, by rule, direct manu- 25 facturers, importers, and processors of chemical substances ^ to make and retain records of the processes used to manu- i i 80 1 facture or process such substances and to monitor or conduct . i . . v-,'vV 2 tests necessary to determine whether such substances, as manu- `-l 3 factured, imported, or processed by them, are adulterated 4 (within the meaning of subsection (e)(2)), and to retain rec- 5 ords of such tests. Any records or data required under this 4 6 subsection shall not be considered research data or process 'I. 7 technology for purposes of section 14(a). 8 . (b) Review.--As soon as practicable, the Administrator 9 shall conduct and complete a systematic and comprehensive 10 revieiu of the chemical substances subject to this Act, for the 11 purpose of determining the extent to which rules under this 12 section are warrantedA statement of the progress made to- 13 ward meeting this objective shall be transmitted to the Con- 14: gress by the Administrator as a part of each annual report 15 required by section 16. 16 (c) Applicability.--(1) The applicability of any rule 17 issued und&r this section may be limited to specified geo- 18 graphic areas, if there is a valid reason for such limita- 19 tion in terms of the nature and extent of the risk involved. 20 (2) The authority of the Administrator, under subsec- 21 tion (a), to prescribe a rule prohibiting the manufacturing, 22 processing, importing, or distnbution in commerce of a chem- 23 {cai substance for a particular use or other distribution in 24 commerce includes the authority to prohibit such distribution 25 for a particular use in a concentration in excess of the level 2 specified in such rule. - PCB-ARCH-EXT0378051 ' . o 81 1 (3) Rules limiting the amount of a chemical substance 2 which may be manufactured, processed, imported, or dis- 3 tributed in commerce, or limiting the quantity of such sub- 4 stance which may be manufactured, processed, imported, or 5 distributed for a particular distribution or use, shall, upon 6 the petition of any manufacturer, processor, importer, or dis- 7 tributor in commerce thereof, provide for assigning production, 8 processing, and distribution quotas, to the extent necessary, 9 with respect to the chemical substance involved. The permissi- 10 ble quota for each person who applies to manufacture, 11 process, or import such substance or to engage in its dis- 12 tribution in commerce shall be determined in accordance 13 with criteria which the Secretary of Commerce, in consulta- 14 tion with the Administrator and. the Attorney General, shall 15 prescribe by rule. Such criteria shall take into account all 16 relevant factors, including (A) effects on competition; (B) 17 the market shares, productive capacity, and product and raw 18 material inventories of the precursors of the chemical sub- 19 stance of persons applying for quotas; (C) emergency condi- 20 tions;. and (D) effects on technological innovation. 21 (d) Factors.--In promulgating rules under subsection 22 (af, the Administrator shall consider relevant factors, 23 including-- 1 24 ^ (1) the effects of the substance on health, and the 25 magnitude and duration of human exposure to it; PCB-ARCH-EXT0378052 1 (2) the effects of the substance on the environment, and. the magnitude and duration of environmental ex posure to it; and 4 (3) the benefits of the substance for a distribution in 5 commerce, and the availability of less hazardous alter- g natives. ; 7 (e) Effective Date--The Administrator shall spec- g ify the proposed effective date of any rule proposed under 9 subsection (a). The effective date shall not be later than 10 6 months after the date on which any such rule is promidgated 11 as a final rule, unless the Administrator, for good cause 12 shown, determines that a later date is appropriate. 13 (f) Quality Control of Adulterated Chemical 34 Substances.--(1) If the Administrator has good cause to 15 believe that a particular chemical substance is being manu- 16 factured, imported, or processed in a manner which permits 17 or causes the adulteration of such chemical substance-- 18 (A) the Administrator shall (i) require from manu- 19 facturers, importers, or processors a detailed descnption 20 of quality control procedures followed in such manu al facturing, processing, or importing, and (ii) take any 22 other actions that are authorized by this Act; and 23 (B) if the Administrator thereafter determines by 24 mde that such quality control procedures are inadequate 25 to prevent the adulteration of such chemical substance, the 1 Administrator may order manufacturers, importers, or 2 processors to revise such quality control procedures to the 3 extent which the Administrator finds reasonable and nec 4 essary to remedy such inadequacy, 5 ... t (2) As used, in . this subsection, ' a chemical substance 6 is adulterated if it, or any precursor substance used or pro ` IN 7 duced in its manufacture or processing, contains any other g chemical substance or contaminant which itself, or in com- 9 bination with such chemical substance, is found by the Ad- /x 10 ministrator to pose or be likely to pose an unreasonable risk 11 to human health and/or the environment. 12 (g) Procedure.--Rules issued under subsections (a) 13 and (f) (and amendments thereto or repeals thereof) shall 14 be promulgated pursuant to section 553 of title 5, United 15 States Code; except that in promulgating any such rule, 16 amendment, or repeal (A) the Administrator shall give 17 interested persons an opportunity for the oral presentation 18 of data, views, or arguments, in addition to an opportunity 19 to make written submissions; (B) a transcript shall be made 20 of any oral presentation; and (C) the Administrator shall 21 provide for cross-examination to such extent, and in such 22 manner, as the Administrator, in his discretion, determines 23 i.s necessary and appropriate in view of the nature of the issue 'h& T^ltA 24 involved, the number of the participants, and the nature of ^ ^ 25 the interests of such participants. ^iuL sCXd cj cL.4-ob.tJL. A* ^Ur- . ej 4Ll ^L-f- tc7~ <fYt ~V\ (f.'b C'H.-'-v J.iVWrvK1! | tX**S a~y\ TU?>\--. ,, . PCB-ARCH-EXT0378054 1 2 84 'J imminent hazard shall 3 be considered to exist when the evidence is sufficient to shoiu 4 that the manufacturing, processing, importing, or distribution 5 in commerce of a chemical substance, or of a product contain- , kAjJL 4 K 6 ing such substance, will rcMdh^nr^v-wvrms&nabk=^$k*~4o * kAv<A4. <SV -S** X.eA**~ 7 dmmmd^alttt-mdHh^mnrmment, prior to the completion <5u<v4*^3cX 8 of an administrative hearing or other proceeding -hd-d-pm1- ?4kw #y* 9 <ii.wmMo44m-A'et. Qcf 10 (b) Determination.--If the Administrator determines 11 that an imminent hazard exists, he shall (1) petition an 12 appropriate district court of the United States, or he may 13 request the United States attorney for such district to do so, 14 to restrict the manufacture, processing, importing, or distribu- 15 tion in commerce of the chemical substance or of the product 16 responsible for the hazard, or to take such other action as is 17 appropriate; er-f2j>by snspenuion-ordemissued-in-aceordance 18 ivttk^subsectimtr-{-c)~restri<tt~Jhe-manufacturing-,-processing,- 19 impoH%ngpof~distTihxdionmn-ccm,merc^mf-ttherchefTrULcahsvb- 20 stamee--or^f^hu~produot--responsible~for the ' hazard. -The 23 ivarranted: . . < . 24 (c) Suspension Order.--(1) Except as provided in - ' ' .. * ' .* ' 25 paragraph (3), the Administrator shall publish his intent x PCB-ARCH-EXT0378055 <3k d shall o show 'ibiition witain- . 4dsh-4o a A iplction kfr-pm'- ermines 'ion an he may ) do so, istribuproduct m as is yrdance cessing,Jat'subxfc--The tot-done may~be ruled in s intent 85 1 to issue a suspension order in the Federal Register and shall 2 notify, to the [maximum extent practicable, any person 3 against whom such^an order is' applicable. Such pub- 4 lication and notice shall 'include findings pertaining to the - . / ' 5 Administrator's determination'that an imminent hazard exists. . > 6 A person as to whom such/an order is .applicable shall there- 7 after be granted an opportunity, in accoraaiwe with the pro . . / , . \. 8 visions of paragraph (2), for an expedited hearing before the 9 Administrator on the question of whether ail imminent hazard 10 exists. ; 11 (2) If no request for a hearing is submitted to the Ad- 12, ministrator luithin 5 days after such publication or notifica- \ / ' . 13 tion to such person, the suspension /order may be issued and 14 shall take effect and shall^notjoe^subject to judicial review. 15 If a hearing is requested, At '$%all commence within 5 days of 16 the receipt of the request/for'a\earing, unless the person 17 requesting such hearing and the Administrator agree that 18 it shall commence at a later time. WitmqAlO days after the 19 conclusion of any such hearing,: the Administrator shall 20 render a final order on the J,ssue of_juspension. 21 (3) If the Administrator determines mat an emergency 22 exists and that as a consequence thereofJie is unable to comply 23 with paragraphs (1) and (2), the/Administrator shall issue 24 a, suspension order .prior to me notification required under 25 paragraph (1), in lohipn event the procedures specified in PCB-ARCH-EXT0378056 86 1 paragraph (2) shall apply, except that the suspension order 2 . shall he i.n effect . X pending/the. . expeditious ' . completion of such 3 procedures. 4 (1) The Administrator shall, 6 h^ide^re^mr^mn^nax^a^^^or importer of a chemical,, 7 substance other than a mixture, and may, at his discretion. 8 require manufacturers, importers, or 'processors of_mir,t.v.re$ 9 tn m.mntniv, o vonnvrl noy^ fn enhomii <y,,f>h 10 nually and at more frequent intervals as prescribed) as he 11 may reasonably require. The Administrator may require 12 any or all of the following information: 13 (A) the common or trade name, the chemical iden- 14 tity, the molecular structure and location of manufacture 15 of each chemical substance for which a report is re- 16 quired, insofar as known to the person making the 17 report or insofar as reasonably ascertainable; 18 (B) the categories or proposed categories of use of 19 each Such substance, insofar as known to the person 20 making the report, or insofar as reasonably ascertain- 21 able; . " - ' x ' -: : . . . ... - \ ' - 22 (C) reasonable estimates of the amounts of each 23 substance manufactured, imported, or processed by such 24 person for each such use or other distribution in 25 commerce; PCB-ARCH-EXT0378057 87 1 (D) a description of cmy byproducts resulting from 2 the manufacture, processing, or distribution in commerce 3 of each such substance, insofar as known to the person 4 making the report or insofar as reasonably ascei'tainable; 5 and . 6 (E) the number of workers exposed, or projected to 7 i be exposed, to such chemical substance during its manu 8 facture, importation, or processing by such person, as 9 appropriate, and the levels of exposure to such substance. 10 (2) As used in this subsection, the term "byprod- 11 net" means a chemical substance ivhich is produced or re- 12 suits, as a consequence of the manufacture, importation, 13 processing, or distribution in commerce of some other 14 chemical substance. . 15 (b) Inventory--The Administrator shall compile and 16 publish, within 150 days after the enactment of this Act, and 17 shall periodically update, a listing of each chemical substance 18 which any manufacturer, processor or importer reports (un- 19 der this section) is manufactured, processed or imported into 20 the United States. A chemical substance shall be included in 21 such listing as of the earliest date (as determined by the Ad- 22 ministrator) on which such substance was manufactured or 23 processed in or, imported into the United States. 24 (c) Submission.--Test data or other information re- 25 quired to be submitted pursuant to this Act shall be sub- PCB-ARCH-EXT0378058 <71 - . 88 mittedto the Administrator promptly but not later than 10 W. 2, days after it becomes available. The Administrator may p require the submission of preliminary and other reports ^ during the course of any monitoring or testing. > person who man > ufactures, processes, imports, or distributes in commerce a y chemical substance shall maintain records of health and safety . -{hi aU L`S tMsCAA&'tfn 8^ data^with respect to effects alleged or shown to have been 9, caused by such substance. Upon the receipt or development ' .. ` * of any such data such person shall immediately transmit such yy data to the Administrator. . . . . A person is- who manufactures, imports, processes, or distributes in com- ^ merce any chemical substance shall report to the Adminis* . jjj, trator with respect to any such substance-- $ 16 (A) a list of all health and safety studies in prog *- 17 ress on the date of enactment of this Act, that have been -i 5- 18 conducted by or for the person and such list shall be up 19 dated by such person immediately upon the initiation of T 20 any such study after the date of enactment of this Act; 21 and Sad - iL. ci*^<- L{ . r 22 gJuL ju-vc (B) a list of all health ana safety studies^conducted I ; " \ : . ' , . > ? 23 'by or for such person within ttie~=4Q~year period prior A I 24 to the date of enactment of this Act^ Such list shall be 25 submitted to the Administrator, within^ 180 days after the 5 26 date of enactment of this Aci^ff , ,, ., ew t i*s^'{*-*" tv"l, -iDiAJkt-$4+*Act & &4wV> i / PCB-ARCH-EXT0378059 89 1 The Administrator may require the submission of any study 2 appearing on such lists. 3 (2) (A) Any verson whojnanufactiires. imvorts. moc- 4 esses, or distributes inor 5 any chemical substances liability insurer, Audi renort to lly, 6 Administrator anv^and _gll .health and safety studies_jum-_ 7 ducted bv such nep-^p in.curor. or known to such person 8 jor insurer, lohich indicates that ami chemical suhsffq.nr.e-heinn. 9 pi mqmdgd, processed, or distributed in com- 10 merce may have adverse effects on human health or the 11 ^environment. , 12 (jB) As used in this paragraph, the term "chemical sub- 13 stances liability insurer" means a legally constituted and au- 14 thorized entity that-- . I** ; (i) has entered into a contract or agreement, or that 16 is otherwise legally obligated, to pay or compensate any 11 injured person for losses associated with a chemical sub 18 stance subject- to this Act; or 19 (ii) has insured a manufacturer, processor, or dis 20 tributor in commerce of a chemical substance subject to 21 this Act against rislcs to human health or the environ 22 ment, or both, associated with any such chemical 23 substance. 24 (f) Comments.--Whenever the Administrator deter 25 mines that such action would be necessary to assist him in 26 carrying out his responsibilities and authorities under this PCB-ARCH-EXT0378060 1 Act, he may, by publishing a notice in the Federal Register, 2 invite and afford1all interested persons an opportunity to pro3 vide information and comment in writing respecting the 4 health or environmental effects of a chemical substance. Such 5 an invitation and opportunity shall not be deemed a proceed6 ing for purposes of requiring the release of information 7 under section 14(c) (1) (B). 9 10 Act shall not apply 11 to-- 12 (1) any pesticide (as defined in the Federal In- 13 secticide, Fungicide, and Rodenticide Act) when manu- 14 : factured, processed, or distributed in commerce for use 15 as a pesticide; , 16 (2) drugs Jas such term is defined in section 201 17 (g) of the Federal Food, Drug, and Cosmetic Act); cvAL A-oirk cctcsi oAAi h cm a & r 18 ^ (3) food (as defined in section 201(f) of the Federal 19 Food, Drug, and CosmeticAct, including poultry and 20 poultry products (asdefined in section 4 (e) and (f) 21 of the Poultry Products Inspection Act), meat and 22 meat food products (as defined in section 1(f) of the 23 Federal Meat Inspection Act) and egg and egg products 24 (as defined in section 4 of the Egg Products Inspection 25 Act) ) ; PCB-ARCH-EXT0378061 91 1 (4) tobacco or tobacco products; and 2 (5) research and laboratory chemicals; except that 3 (A) such chemical substances shall be subject to section 4 (8) (e)(2); and (B) the Administrator may by rule 5 include such chemicals within coverage under any other 6 provision of this Act, in vjhole or in part, if he deter 7 mines that such inclusion is necessary to protect against 8 unreasonable risks to human health and the environ 9 ment. : . . . .. . '.... 10 (b) Absence of Authority.--The Administrator 11 shall have no authority under sections 5(e), 6, and 7 to take 12 action to prevent or reduce an unreasonable risk to human 13 health and, the environment associated with the manufacture, 14 processing, or distribution in commerce of a chemical sub- 15 stance or an article containing such substance-- 16 (1) to the extent that the Administrator in his 17 discretion determines the risk associated with such sub 18 stance or article may be prevented or reduced to a 19 sufficient extent under any Federal law administered, 20 . in whole or in part by the Administrator, unless he 21 finds that the risk associated with such substance or 22 such article cannot be prevented or reduced as effectively 23 by his action under such other.^Federal law: and 24 (2) to the extent that such authority under section 25 5(e), 6, or 7 would duplicate the authority contained in 52-905 O - 75 - 7 a NS PCB-ARCH-EXT0378062 1 any other Federal law (other than the National Envi- 2 ronmental Policy Act of 1969) not administered in 3 whole or in part hy the Administrator, except that nothing 4 contained. herein shall prevent the A dministrator_Jrom 5 considering the full range of risks to human health and 6 the environment in taking action under such section 5 (e), 7 6, or 7 to prohibit the manufacture. importation,. or 8 processing of a chemical substance or in taking such other 9 action which does not duplicate the authority contained 10 in such other Federal law. 11 (c) Notice.--Whenever the Administrator determines 12 that any chemical substance may pose an unreasonable risk to 13 human health and the environment and that such risk 14 could be prevented or reduced to a sufficient extent by actions 15 taken under other Federal laws not administered by the 16 Administrator, he shall transmit, and give public notice of 17 such transmittal, any data received from manufacturers, im- 18 porters, or processors, or data otherwise in his possession IS which is relevant to such risk, to the Federal agency, inde- 20 pendent regulatory agency, or other instrumentality of the 21 Federal Government which has legal authority to take action. 22 Whenever such transmittal occurs, such Federal agency, in- 23 dependent regulatory agency, or .other instrumentality, shall, 24 within 180 days thereafter, or in the case of an imminent 25 . hazard, within 30 days thereafter, (1) complete such action as PCB-ARCH- 93 1 is necessary to prevent or reduce any such unreasonable risk in 2 accordance with such other Federal law, or (2) publish in the 3 Federal Register reasons for declining to take any such action. 4 Nothing contained in this subsection shall (A) affect the 5 manner in ivhich final action is taken by such agency with 6 respect to such risk, or (B) in any way affect the extent to 7 which human health and the environment is to be protected 8 under such other Federal law. 9 The Administrator, in cooperation with other 12 appropriate Federal agencies, shall establish and be respon13 sible for'"lhe'~'bontinuing activities of an interagency coordi14 noting committee. The committee shall design and coordinate 15 an. efficient and effective system for the collection, utilization 16 and dissemination of data that are (A) submitted to the 17 Administrator under the terms of this Act, (B) in the pos18 session of other Federal agencies, or (C) are available to the 19 Administrator or to other Federal agencies; and which could 20 be useful to the Administrator, in carrying out the purposes 21 of this Act, or useful to other Federal agencies charged with 22 responsibility for collecting data on and regulating chemical 23 substances. This system shall be made available for use by 24 all Federal agencies and other interested agencies and pern 25 sons icho have responsibilities with respect to the regulation PCB-ARCH-EXT0378064 1 or study of chemical substances in terms of their effect on 2 hitman health and the environment. . 3 (2) The Administrator, in consultation with other appro- 4 priate Federal agencies, is authorized to .make contracts 5 and grants for the development of a data retrieval system 6 suitable for carring out the purposes described in paragraph 7 (1). . . . 8 (3) The interagency coordinating committee shall be 9 responsible for coordinating the regulatory responsibilities 10 and research activities of all Federal agencies with respect to 11 chemical substances, in order to avoid duplication and pro12 mote efficiency: Provided, That nothing contained in this 13 paragraph shall affect the authority of any Federal agency ]4 or the administering officers thereof. The Administrator shall 15 report annually to the Congress on actions taken to coordinate 16 with other Federal agencies, and on the activities of the inter im agency coordinating committee in carrying out its responsi- 18 bilities under this subsection. ... 19 (b) Consultation.--Prior to the establishment and 20 publication of a priority list under section 4(c)(1) and the 21 promulgation of initial criteria for data development, sections 22 4(b) and 4(c)(2), and from time to time thereafter, the 23 Administrator shall solicit and conside^' the views of the 24 Department of Health, Education, and Welfare, the inter25 agency coordinating committee established under subsection PCB-ARCH 95 .1 (a)(1), and other appropriate.,Federal agencies with respect ' . _ ,...__ 4 \ '... . ". 2 to the establishment and revisionpf such list and the promul- 3 gation of such criteria. At his discretion, the Administrator 4 shall also solicit comments from such Department, committee, 5 and agencies on the Administrators other duties under this 6 Act. The Secretary of Health, Education, and Welfare, 7 utilizing the expertise of the National Institute of Environ- 8 mental Health Sciences, 'the National Institute of Occupa- 9 tional Safety and Health, or any other agency of that De- 10 partment, and any other Federal agency from which views 11 have been solicited, shall cooperate and respond to any such 12 solicitation received. ^ 1; . 13 (c) Cooperation of Federal Agencies--Upon re- 14 quest by the Administrator, each Federal agency is author- , ; ' . , ' (; 15 ized-- - . .... ; - ... ' .- /; . 16 (1) to make its services, personnel, and facilities 17 available (with or without reimbursement as determined 18 by the Administrator) to the Administrator to assist him 19 in the performance of his duties under this Act; and 20 (2) to furnish to the Administrator such informa- 21 tion, data, estimates, and statistics, and to allow the ' 22 Administrator access to all information in its possession 23 as the Administrator, may reasonably determine to be 24 necessary far the performance of his duties.under this 25 Act. - . . V PCB-ARCH-EXT0378066 96 1 (d) Research and Monitoring.--The Administrator 2 shall, in consultation and cooperation with the Secretary of 3 Health, Education, and Welfare, other Federal agencies, and 4 the interagency coordinating committee established under 5 section 10(a), conduct, and cause to be conducted by appro- Q priate Federal agencies, such research and monitoring as is 7 necessary to carry out the purposes of this Act. 8 ^j^oRtF-anP^imports"^. . ! 9 . ' ^^tiFfalWxpd^Sr--(1) This Act shall not apply 10 to any chemical substance, or to any article containing such 11 substance, if (A) it can be shown that such substance or 12 article is manufactured, processed, sold, or held for sale for 13 export from the United States (or that such substance was 0 j 14 imported for export), unless such substance or article is, in 15 fact, manufactured, processed, or distributed in commerce for 16 use in the United States, and (B) such substance or article, 17 when distributed in commerce, or any container in which it 18 is enclosed when so distributed, bears a stamp or label stating 19 that such chemical substance or article is intended for export; 20 except that (A) any manufacturer, processor, or exporter t i 21 of such chemical substance who, but for this section, would f- ! 22 be subject to section 8 shall remain subject to the reporting i. 23 requirements of section 8; (B) this-subsection shall not apply 24 to any such substance or article if the Administrator finds 25 that it will, directly or indirectly, pose an unreasonable risk 26 to health within the United States and to the environment -; PCB-ARCH-EXT0378067 . i of the United States; and (C) such chemical shall he subject 2 to sections 4 and 5. .. ; . 3 (2) If the submission of test data is required for a 4 chemical substance under section 4 or 5, or if rules applicable 5 to such substance, or to an article containing such substance, 6 have been prescribed or proposed under section 5 or 6, the 7 Administrator -- ... , .. . . 8 , (A) shall (subject to section 14(c) or section 14(e)) 9 furnish to the governments of the foreign nations to 10 which he knows such substance or article is exported, or 11 is intended to be exported, notice of the availability of the 12 data submitted to the Administrator under section 4 or 13 5 concerning such chemical substance; . 14 (B) may require warning labels to be affixed to 15 any package containing such substance or article; and 16 (C) shall make available to any such government, 17 upon request, notice of any rule applicable to such 18 substance or article which has been prescribed or pro- 19 posed by the Administrator under this Act. ^ 20 (1) The Secretary of the Treasury shall 21 refuse entry into the customs territory of the United States 22 of any chemical substance or of any article containing such 23 a substance if such substance or article fails to conform with 24 the requirements of this Act, or if it is otherwise prohibited 25 pursuant to this Act from being distributed in commerce. If 20 such a substance or article is refused entry, the Secretary of PCB-ARCH- 98 1 the Treasury shall (1) refuse delivery to the consignee and 2 (2) cause the disposal or storage thereof if it is not exported 3 hy the consignee within 3 months from the date of receipt of 4 notice of such refusal, under such regulations as the Secretary 5 of the Treasury may prescribe. Notwithstanding the foregoing, 6 the Secretary of the Treasury may deliver such substance or 7 article to the consignee pending examination and decision in 8 the matter, upon execution by the consignee of a bond for 9 the amount of the full invoice value of such substance or 10 article, together with the duty thereon, and providing for 11 forfeiture of the full amount of such bond by the consignee 12 on refusal to return such substance or article to the custody 13 of such Secretary, when demanded for any cause, or for 14 any other purpose. All charges for storage, cartage, and 15 labor on substances or articles which are refused admis16 sion or delivery under this section shall be paid by the 17 owner or consignee. In default of payment of such charges, they shall constitute a lien against any future entry into 19 the United States made hy such owner or consignee. 20 (2) The Secretary of the Treasury, after consultation 21 with the Administrator, shall issue regulations for the ad- 22 ministration and enforcement of paragraph (1). 23 % : .. - 24(1) Not later than . 26 go days following the promulgation of any rule or order ' i: PCB-ARCH-EXT0378069 1 under this Act or the failure to issue an order .under section 2 5(f) ^^etition~fa^uAv^g:H~r^ . . -"*K ' ' '' - ' ^frerdevCwf such ride or order with the United States Court 4 of Appeals for the District of Columbia, or for the circuit 5 in which such person resides or has his principal place of 6 business. Copies of the petition shall be forthvith transmitted 7 by the clerk of such court to the Administrator and to the 8 Attorney General. The Administrator shall transmit to the 9 Attorney General, who shall file in the court, the record of , 10 the proceedings on which the Administrator based his rule or 11 order, as provided in section 2112 of title 28, United States 12 Code. For purposes of this section, the term "record'' means 13 (A) such rule; (B) the transcript required of any oral pres- 14 entation; (C) any written submission of interested parties; 15 (D) any statement of purpose and justification required. 16 under section 14 (f); and (E) any other information which IT the Administrator considers relevant to such rule. 18 (2) If the petitioner applies to the court for leave to 19 make additional submissions and shows to the satisfaction of 20 the court that such additional submissions are material and 21 that there are reasonable grounds for the petitioner s failure 22 to make such submissions in the proceeding before the Admin- 23 Istratov, ike court may order the Administrator to provide 24 additional opportunity to make such submissions. The Ad- 25 ministrator may modify or set aside the rule or order involved PCB-ARCH-EXT0378070 100 1 by reason of the additional submissions and shall file such 2 modified or new rule or order with the return of such additional 3 submissions. The court shall thereafter review such neiv or 4 modified rule or order. -, . .. . .. 5 . (3) (A) Upon the filing of a petition under paragraph 6 (1), the court shall have jurisdiction (i) to review the rule or 7 order involved, in accordance with chapter 7 of title 5, United 8 States Code, and (ii) to grant appropriate relief, including 9 interrim relief, as provided in such chapter, except that any 10 rule or order promulgated by the Administrator under section 11 6 and reviewed under this section shall be affirmed, unless the 12 findings required to be made under the applicable section are 13 not supported by substantial evidence on the record as required 14 to be developed, or as actually developed, in accordance with 15 this At- - ' ' 16 (B) The judgment of the court affirming or setting 17 aside, in whole or in part, a rule or order reviewed in accord- 18 ance with this section shall .be final, subject to review by the 19 Supreme Court of the United States upon certiorari or cer- 20 tification, as provided in section 1254 of title 28, United 21 States Code. V T . ^ 22 . ny person may 23 petition the Administrator to commence a proceeding for the 24 issuance, amendment, or revocation of a rule under sections .. : ' 25. 4(a), 6(a), 6(f), or 8(a), or an order under sections 5(e) 26 or 7(b). ,. ; , : : ' , ' PCB-ARCH-EXT0378071 101 1 (2) Such a petition shall he filed in the principal office of 2 the Administrator and shall set forth (A) the basis for which 3 it is claimed establish that such ride or order or an amend- 4 ment or revocation thereof is necessary, and (B) a brief . 5 description of the content of the ride or order or amendment 6 thereof which it is claimed should be issued, amended, or re- 7 voiced by the Administrator. 8 (3) The Administrator may hold a public hearing or 9 may conduct such investigation or proceeding as he deems ap- 10 propriate in order to determine whether or not such peti- 11 tion should be granted. . 12 (4) Within 120 days after the filing of a petition de- 13 scribed in paragraph (2)~ the Administrator shall either 14 grant or deny such petition. If the Administrator grants such 15 petition, he shall promptly commence -an appropriate pro- 16 ceeding under section 4, 6, or 7. If the Administrator denies 17 such petition, he shall publish such denial, including the; rea- 18 sons therefor, in the Federal Register. 19 (5) (A) If the Administrator denies the petition under 20 this section (or if he fails to grant or deny such petition within 21 the 120-day period) the petitioner may commence a civil ac- 22 tion in a district court of the United States to compel the Ad- 23 ministrator to initiate a proceeding with respect to the action 21 requested. Any such civil action shall be filed within 60 days ^ after the Administrator's denial of the petition, or (if the Ad- 0 ministrator fails to grant or deny the petition within 120 days PCB-ARCH-EXT0378072 102 j after the filing of the petition) ivithin 60 days after the expira- 2 tion of the 120-day period. , . 3 (B) If the petitioner can demonstrate to the satisfaction 4 of the court, by a preponderance of the evidence in a cle novo 5 proceeding before such court, that such chemical substance g presents an unreasonable risk to human health and the en7 vironment, or both, the court shall order the Administrator to 8 . initiate an action to prevent sucli unreasonable risk. 9 (C) In any civil action under this subsection, the district 10 court shall have no authority to compel the Administrator to 11 take any action other than the initiation of a rulemaking or 12 other proceeding under section 4, 6, or 7. . 13 (6) The remedies under this section shall be in addition 14 to, and not in lieu of, other remedies provided by law. 15 (7) Paragraphs (4) and (5) shall not become effective 16 with respect to petitions submitted under section 4(a) until . L7 2 years after the date of enactment of this Act. ' 18 19 20 for any person to-- shall be unlawful 21 (1) fail or refuse to comply with any provision of 22 sections 4, 5, or 6, or any rule or order prescribed under 23 any of those sections or any order under section 7(b). ' 24 V (2) fail or refuse to comply ivith section 8 or any 25 rule or order prescribed undei' that section; PCB-ARCH-EXT0378073 1 (3) fail or refuse to permit access to or copying 2 of records, fail or refuse to permit entry or inspection, 3 or fail to take any other action required under section 4 14(a); . 5 (4) fail or refuse to comply with instructions issued 6 in accordance with a rule described in section 6(a)(3); 7 (5) distribute in commerce, or use for commercial 8 purpose, a chemical substance ivhich such person knew 9. or had reason to know was manufactured or distributed 10 in oommerce in violation of section 5 or 6; 11 (6) violate any condition specified by the Adminis- 12 trator under section 14 (c) (2) ; or 13 (7) fail or refuse to comply with any rule or regu- 14 lation promulgated pursuant to this Act. . 15 (b) Penalties.--(1)(A) Any person who violates 16 a provision of subsection (a) shall be liable to the United 17 States for a civil penalty. Each day of a continuing viola- 18 tion is a separate violation for purposes of this subsection. 19 The amount of such civil penalty shall be assessed by 20 the Administrator by written notice after completion of 21 procedures specified under section 554 of title 5, United 22 States Code. In determining the amount of such penalty, the 23 Administrator shall take into account the nature, circum- 24 stances, extent, and gravity of the violation or violations and, 25 with respect to the violator, ability to pay, effect on ability to PCB-ARCH- 104 continue to do business, any history of prior such violations, 2 the degree of culpability, and such other, matters as justice 3 may require: Provided, that the amount of each penalty shall 4 not exceed $25,000 for each such violation. 5 (B) Any person who is aggrieved by the assessment of a civil penalty under this subsection may appeal such 7 decision of the Administrator by bringing a civil action 8 against the Administrator for rescission or modification of 9 such penalty, in the district court of the United States for 10 the District of Columbia or for any judicial district in which 11 he resides or transacts business, within 30 days from the 12 date on which he is notified of such decision by certified 13 mail. In any such judicial proceeding, the factual findings 14 of the Administrator shall be sustained if supported by sub- 15 stantial evidence on the record considered as a whole. 16 (C) The Administrator may, in his discretion, com- 17 promise, modify, or remit, ivith or without conditions, any 18 civil penalty imposed or subject to imposition under this 19 subsection. The amount of such penalty, when finally deter- 20 mined, or the amount agreed upon in compromise, may be 21 deducted from any sums owing by the United States to the 22 person charged. . .V;. 23 (D) If any person fails to pay an assessment of a civil . 24 penalty after it has become final and the time for appeal has 25 run, or after the appropriate court has entered final judgment PCB-ARCH-EXT0378075 105 1 in favor of the Administrator, the Attorney General shall 2 recover the amount assessed (plus interest at currently prevail- 3 ing rates from such date) in any appropriate district court 4 of the United States. In such action, the validity, amount, 5 and appropriateness of such penalty shall not be subject to 6 review. . . 7 (2) (A) Any person who knowingly or willfully violates 8 any provision of subsection (a) shall, in addition to or in 9 lieu of a civil penalty imposed under subsection (a) be 10 liable, upon conviction, to a fine of not more than $25,000 11 for each day of violation, or to imprisonment for not more 12 than 1 year, or both. 13 (B) As used in this paragraph the term "knowingly" 14 means having actual knowledge. . 15 (c) Injunctions--(1) Upon application by the Ad- 16 ministrator or the Attorney General, the district courts of 17 the United States shall have jurisdiction to restrain any act 18 prohibited under subsection (a) or to compel the taking of 19 any action required by this Act or any rule issued thereunder. 20 (2) (A) The court in which an action is filed under l 21 paragraph (1) or section 7 shall have power to grant such 22 temporary or permanent relief as may be necessary to protect 23 human health and the environment from an unreasonable 24 risk associated with the chemical substance involved in such 25 action. Such relief may require (in the case of an action PCB-ARCH-EXT0378076 106 2 under paragraph (1) or under section 7) a mandatory 2 order requiring (i) notification of such risk to those pur- 3 chasers of such substance or of an article containing such sub- 4 stance who are known to the defendant; (ii) public notice; 5 (Hi) recall; and (iv) the replacement or refund of such sub- g stance or article. A manufacturer, processor, importer, or dis- 7 tributor in commerce of such svibstance or article may be re ft quired by such an order to reimburse any other person (in- 9 eluding wholesalers, retailers,, and distributors) for such other 10 person's expenses in connection with implementing such order, 11 if the court determines that such reimbursement woidd be 12 equitable. 13 (B) An action under paragraph (1) or under sec- 14. iion 7 may be maintained in the United States District Court 15 for the District of Columbia or in the district court of the 16 United States for any judicial district in which any of the 17 defendants is found, resides, or transacts business. In any 4 18 such action, process may be served on a defendant in any 19 other district in which such defendant resides or may be 20 found. Subpenas requiring attendance of witnesses in such 21 an action may run into any other judicial district. The 22 court shall take into account the convenience of the parties 23 in determining the appropriate judicial district for an action 24 under this subsection which may otherwise be brought in 25 more than one judicial district. , v PCB-ARCH-EXT0378077 107 1 (d) Seizure.--A chemical substance, or an article con- 2 taining such a substance, which toas manufactured, 'processed, 3 or distributed in commerce in violation of this Act, or luhich 4 is the subject of an action under section 7, shall be liable 5 to be proceeded against by process of libel for the seizure and 6 condemnation of such substance or article in any district 7 court of the United States within the jurisdiction of which 8 such substance or article is found. Such proceedings shall 9 conform as nearly as possible to proceedings in rem in 10 admiralty. 11 (e.) Specific Relief.--In any action requesting 12 equitable relief, under any Act administered by the Adminis- 13 trator, or instituted at the request of the Administrator, where 14 a risk to human health is alleged and established, a failure by 15 the party requesting such relief to prove that demonstrable 16 harm to health noio exists or ivill result, shall not, in and of 17 itself, constitute a permissible basis upon which to deny such 18 relief. When such risk is established, the court shall consider 19 the probability that demonstrable harm exists or will result and 20 the human health consequences from such harm. The preceding 21 two sentences shall govern all proceedings in actions brought 22 after the date of enactment of this Act and all further pro- 23 ceedings in actions then pending, except to the extent that in 24 the opinion of the court their application in a particular 52-905 O - 75 - 8 PCB-ARCH-EXT0378078 108 V 11 action then pending would not he feasible or would ivork i 2 injustice. 3 (f) Citizen's Civil Action.--(1) Except as pro 4 vided in paragraph (2), any interested person may com 5 mence a civil action for injunctive relief on Ms own behalf-- 6: (A) against any person (including (i) the United 7 States, and (ii) any other governmental instrumentality 8 or agency to the extent permitted by the eleventh arnend- 9 ment to the Constitution) who is alleged to be in viola 10 tion of any ride or order prescribed under section 4, 5, 11 or 6; or 12 (B) against the Administrator where there is alleged 13 a failure of the Administrator to perform any act or 14 duty under this Act which is not, discretionary. 15 Any action under subparagraph (A) shall be brought in the 16 distnct court of the United States for the district in which 17 the alleged, violation occurred. Any action brought under 18 subpamgraph (B) shall be brought in such district court for 19 the District of Columbia, or. in such district court for the 20 judicial district in which the plaintiff: is domiciled. The dis 21 trict courts shall have jurisdiction over -suits brought under 22 this section, without regard to the amount in controversy or 23 the citizenship of the parties. 24 (2) No civil action may be commenced-- 25 (A) under paragraph (1) (A)-- 26 (i) prior to 60 days after the plaintiff has PCB-ARCH-EXT0378079 109 1 . given notice of ihe alleged, violation to the Adminis 2 trator, and to any alleged violator of the rule or 3 order, or 4 (ii) if the Administrator (or Attorney General 5 on his behalf) has commenced and is diligently 6 prosecuting a civil action in a court of the United 7 States to require compliance with the rule or order1: 8 Provided, That when such action is commenced after 9 notice has been given, any such person giving such 10 notice may intervene as a matter of right in such 11 action; or 12 (B) under paragraph (1)(B), prior to 60 days 13 after the plaintiff has given notice of such action to the 14 Administrator, except that such action may be brought 15 10 days after such notification in the case of an action 16 under this section for an alleged failure of the Admin 17 istrator to act under section 7'. 18 Notice under this subsection shall be given in such manner 19 as the Administrator shall prescnbe by rule. 20 (3) (A) In any action under this section, the Adminis- 21 trator, if not a party, may intervene as a matter of right. 22 (B) The court, in issuing any final order in any action 23 b'ought pursuant to paragraph (1), may award reasonable 24 fees for attorneys and expert zoitnesses, whenever the court 25 determines that such an award is appropriate. PCB-ARCH-EXT0378080 110 1 (G) 'Nothing in this section shall restrict any right which 2 any person (or class of persons) may have under any statute 3 or of common law to seek enforcement of any rule or order or 4 to seek any other relief. : . . 5 (D) For purposes of this subsection, the term "person' 6 means an individual, corporation, partnership, association, 7 State, municipality, or political subdivision of a State. . 8 (4) When actions brought under paragraph (1)(A) 9 involving the same defendant and the same issues or viola- 10 tions are pending in two or more jurisdictions, such pending 11 proceedings, upon application of the defendant reasonably 12 made to the court of one such jurisdiction, may, if the court 13 in its discretion so decides, be consolidated for trial by order 14 of such court. If mo ordei' for consolidation is so made within 15 a reasonable time, `the defendant may apply to the court of 16 one such jurisdiction, and such court (after giving all parties 17 reasonable notice and opportunity to be heard) may by order, 18 unless good cause to the contrary is shown, specify a- distinct 19 of reasonable proximity to the applicant's principal place of 20, business, in ivhich all such pending proceedings shall be con- 21 solidated for trial and tried. Such order of consolidation 22 shall not apply so as to require the removal of any case the 23 date for trial of which has been fixed. The court granting 24 such order shall give prompt notification thereof to the other 25 courts having jurisdiction of the cases covered thereby. PCB-ARCH-EXT0378081 Ill 2 ^SWc.dA4i'i((gi)--I-NSPEBTfONSA^The Administrator may 3 authorize any officer, employee, or agent to enter upon, 4 inspect, and examine at reasonable times and in a reasonable 4 5 manner the records and properties of persons to the extent that. 6 such records and properties relate to the manufacturing, * 7 processing, importing, or distribution in commerce of a ch&mi- 8 cal substance, or an article containing such substance, subject 9 to this Act. Any such officer, employee, or agent shall, upon 10 request, display proper credentials. Unless the owner, opera- 11 tor, or agent in charge of such records and properties so con- 12 sents in writing, no inspection authonzed by this section shall 13 extend to'(1) financial data other than that relating to the 14 costs of data development under section (4) or (5); (2) 15 sales data other than shipments data including information 15 relating to quantities and destinations; (3) pricing data; 1^ (4) personnel data other than job assignments, work history 15 of production workers, and curricula vitae of individuals 19 responsible for developing data under section 4; (5) research data (other than data required by this Act) ; or (6) process 31 technology (other than information relating to the authority 33 of the Administrator under section 6). " (b) Subpoena Power.--In carrying out his duties 34 under the provisions of this Ad, the Administrator may by 3^ subpoena require the attendance and testimony of witnesses and 52-905 O -75-9 PCB-ARCH-EXT0378082 112 j the production of reports, papers, documents, answers to ques- 2 tions, or other information that the Administrator deems ad- 3 visable in carrying out his functions under this Act. Witnesses 4 shall be paid the same fees and mileage that are paid witnesses g in the courts of the United States. In the event of contumacy, g failure, or refusal of any person to obey any such order, any 7 distriot court of the United States in which venue is proper g shall have jurisdiction to order any such person to comply 9 therewith. The failure to obey such order of the Court is 10 punishable by the Court as a contempt thereof. 11 Any information reported 12 to, or otherwise obtained by, the Administrator or his repre- 13 sentative, under this Act, which is a trade seci'et or another 14 confidential matter referred to in section 1905 of title 18, 15 United States Code, which if disclosed would result in signifi- 16 cant competitive damage, shall be considered confidential and 17 shall not be disclosed; except that such information may be 18 disclosed--' . 19 (A) to officers or employees of the United States, 20 (B) when relevant in any proceeding under this 21 Act, except that disclosure in such a proceeding shall 22 be made in such manner as to preserve confidentiality 23 to the extent practicable without impairing the pro 24 ceeding, or 25 (C) to the extent that the Administrator deter- -t PCB-ARCH-EXT0378083 113 1 mines it. is necessary to protect human health and the 2 environment. 3 , (2) Notwithstanding any Umitqfyps confined in swbsec- 4 tion (a) or any other vrovision of lam, nil ir 5 representative shall be made available, upon request to quali- 7 fied scientists under conditions .s" 8 to ensure that release of such infonnatioiujwilL-iwi result 9 in significant competitive damage to 1the originator of the 10 mformatienr- . 11 (3) Notwithstanding any limitation contained in sub- 12 section (a) or in any other provision of law, all information 13 reported to or othenuise obtained by the Administrator or his 14 representative shall be made available upon request of any 15 duly authorized committee of the Congress. 16 , (4) Names of individuals maintained in records per il taining to health and safety data shall only be made public 18 after written permission is obtained by the Administrator 19 from the individuals in question. The confidentiality of medi- 20 oal records shall be maintained insofar as it is reasonable 21 and appropriate for purposes of this Act. 22 (5) Not less than 30 days prior to the public disclosure 23 of any information obtained from any person under this Act, 24 or the disclosure of such information to qualified scientists 25 u nder paragraph (2) (other than any disclosure under para- ./ PCB-ARCH-EXT0378084 9 114 graph (1) (A) or (B) or paragraph (3)), tuhich is desig- r ' ^ ^2 naied fy stiCh person to he a trade secret, or other confidential ,v> matter referred to in section 1905 of title 18, United States Code, the Administrator shall, to the extent practicable, notify iL.t g V ($ Jc i y ^ and provide a summary of the information to be disclosed to the person from which such information was obtained. The .. . ,, , . Administrator shall provide such person a reasonable op * g Portunity to submit comments to the Administrator with respect to the release of such information.^The Administrator g shall take all reasonable steps to assure, prior to the disclosure . of such information, that the prohibitions contained in para- 12 graph (1) shall not be violated. ''. ` . 13 (d) Assistant Administrator--The President, by 14 and ivith the advice and consent of the ' Senate, shall appoint 15 an Assistant Administrator for Toxic Substances of the En- 16 vironmental Protection Agency. Such assistant administrator 17 shall be a qualified individual who is, by reason of back- 18 ground and experience, especially qualified to direct a pro- 19 gram concerning the effects of chemicals on human health 20 and the environment. Such Assistant Administrator shall be 21 responsible for the collection of data, the preparation of 22 studies, and the making of recommendations to the Adminis- 23 trator for regulatory and other actions to carry out the 24 purposes, and to facilitate the administration, of this Act. . 25 (e) National Defense Waiver:--The Administra- PCB-ARCH-EXT0378085 115 1 tor shall waive compliance with any provision of this Act 2 upon the request of the Secretary of Defense, and upon a 3 determination by the President that the requested waiver is 4 necessary in the interest of national defense. The Adminis- 5 trator shall maintain a written record of the basis uponwhich 6 such waiver teas granted and shall make such record available 7 for in camera examination when relevant in a judicial pro- 8 ceeding under this Act. Upon the issuance of such a waiver, 9 the Administrator shall publish in the Federal Register a 10 notice that the waiver was granted for national defense pur- 11 poses, unless, upon the request of the Secretary of Defense, 12 the Administrator omits such publication because the Adminis- 13 trator determines that such publication would be contrary to 14 the interests of national defense, in which event the Adminis- 15 trator shall submit notice thereof to the Armed Services . 16 Committee of the Senate and of the House of Representatives. 17 (f) Statement of Purpose and Justification.-- 18 Any proposed or final rule or order issued under this Act 19 shall be acco?npanied by a statement of purpose and justifi- 20 cation. Such a statement shall be considered part of the 21 "record of the proceedings" for purposes of judicial review 22 under section 12(a). : 23 ... 'SBmmsimfW' . 24 . '^^M^(^^^^t^MES^-Except for an action under 25 section 6, any action which may be taken by the Admin- PCB-ARCH-EXT0378086 1 istrator under any provision of this Act, with respect to a 2 chemical substance, may be taken with respect to a cate- 3 gory of chemical substances or to classes of uses of chemi- 4 cal substances. Whenever the Administrator takes an action 5 with respect to a category of chemical substances under 6 any provision of this Act, any reference in this Act to a 7 chemical substance (insofar as such reference relates to 8 such action) shall be deemed to be a reference to each chemical 9 substance in any such category. ' 10 (b) State Regvlation.-(I) Nothing in this Act 11 shall affect the authority of any State or local govern- 12 ment to regulate any chemical substance, or to establish 18 and enforce standards for test protocols for chemical sub- 14 stances to protect human health and the environment, ex- 15 cept that-- 16 (A) if the Administrator prescribes, under section 17 6 a rule applicable to a chemical substance, a State 18 or local government may not, aftei' the effective date of 19 such rule, establish or continue to enforce any differ- 20 ent restriction of its own on the manufacture, processing, 21 or distribution in commerce of such substance for pur- 22 poses similar to those set forth in such ride, other than a 23 total prohibition on the use or distribution of such sub- 24: stance within the territorial jurisdiction of such govern- 25 . ment; and '/ V ` : . 117 1 (B) if the Administrator prescribes, under section 2 4, a rule applicable to a chemical substance, a State 3 or local government may not, after the effective date 4 of such rule impose requirements of its own applicable 5 to such substance for purposes similar to those set 6 forth in such rule. 7 (2) The Administrator may, by rule, upon the peti- 8 tion of any State or local government or upon his own 9 initiative, exempt any State or local government from a pro- 10 hibition in paragraph (1). Such an exemption shall be 11 granted unless the Administrator finds that it will, because of 12 difficulties in marketing, distribution, or other factors, result 13 in placing an unreasonable burden upon commerce or will not 14 result in a higher degree of protection accorded human health 15 and/or the environment. 16 '(c) Advisory Committees.--Nothing contained herein 17 shall prevent the Administrator from establishing any ad- 18 visory committee under the Federal Advisory Committee Act 19 (Public Law 92-463, 86 Stat. 770) to provide technical ad- 20 nice to the Administrator with respect to his functions under 21 this Act. No such advisory committee may be established for 22 any other purpose. . . 23 ' . : ; -ih-.-,,7rrT; -.ay-i , y,-i.=as . ' . . . 24 ^BecT'W^.:The Administrator shall report to the Congress . . - 'Ws**--' ... 25 not later than March ! of the year following the date of enact- PCB-ARCH-EXT0378088 118 1 merit of this Act and each year thereafter on all activities re- 2 lating to, and all measures taken to implement and cari'y out, 3 this Act during the preceding calendar year. Each such report 4 shall include-- . 5 (1) a, thorough appraisal, including analysis, esti- 6 mates, and long-term projections, as to the relationship 7 . between chemical substances; human health and the en- 8 viromnent; and the provisions of, and activities under, 9 this Act; , . 10 (2) a survey and summary, in such detail as is 11- deemed advisable, of the criteria for data development 12 established under section 4 and of the data and other in- 13 formation submitted to the Administrator under this Act; 14 (3) a survey and summary of new chemical sub- 15 stances manufactured, processed, or imported, including 16 new uses; , 17 (4) a survey and summary of any rules promul- 18 gated under section 6; the effectiveness of such rules in 19 protecting human health and the environment; and any 20 enforcement measures in support thereof; 21 (5) a summary of outstanding problems confronting 22 the administration of this Act, in order of priority, and 23 a short-term and long-range plans for solving such 24 problems and for other activities to implement the pur- 25 poses of this Act; and p: r if 4 \ *. : PCB-ARCH-EXT0378089 od 1 119 (6) such recommendations for additional legislation 2 as are deemed necessary or appropriate. 3 . |fj& 4 ~%SeC: 1 o employer may discharge 5 any employee or otherwise discriminate against any era- 6 ployee ivith respect to his compensation, terms, conditions, . ' . . 7 or privileges of employment because the employee (or any 8 person acting pursuant to a request of the employee) has-- 9 (1) commenced, caused to be commenced, or is about 10 to commence or cause to be commenced a proceeding DO 11 under this Act; . . 12 (2) testified or is about to testify in any such pro 13 ceeding; or 14 (3) assisted or participated or is about to assist or 15 participate in any manner in such a proceeding or in ; : . .... , , ' Sr 16 any other action to carry out the purposes of this Act. i7 (b) Remedy.--(1) Any employee who believes that 18 he has been discharged or otherwise discriminated against by ... . 19 any person in violation of subsection (a) may, within 30 20 days after such alleged violation occurs, file (or have any 21 person file on his behalf) a complaint with the Secretary of 22 Labor (hereinafter in this section referred to as the "Sec- 23 retary") alleging such, discharge or discrimination. Upon 24 receipt of such a complaint, the Secretary shall notify the 25 person named in the complaint of the filing of the complaint. PCB-ARCH-EXT0378090 120 1 (2) (A) Upon receipt of a complaint filed under para- 2 graph (1), the Secretary shall conduct an investigation of 3 the violation alleged in the complaint. Within 30 days of the 4 receipt of such complaint, the Secretary shall complete such 5 investigation and shall notify in writing the complainant (and 4 6 any person acting in his behalf) and the person alleged to 7 have committed such violation of the results. Within 90 days g of the receipt of such complaint the Secretary shall, unless 9 the proceeding on the complaint is terminated by the Secre- 10 tary on the basis of a settlement entered into by the Seere- 11 tary and the person alleged to have committed such violation, 12 issue an order either providing the relief prescribed by 13 subparagraph (B) or denying the complaint. An order of 14 the Secretary shall be made on the record after notice and 15 opportunity for agency hearing. The Secretary may not V 16 enter into a settlement terminating a proceeding on a com- 17 plaint without the participation and consent of the com- * 18 plainant. ' 19 (B) If in response to a complaint filed under paragraph, 20 (A) the Secretary determines that a violation of subsection 21 (a) has occurred, the Secretary shall order the person who 22 committed such violation to take affirmative action to abate 23 the violation, as the Secretary deems appropriate, including 24 requiring (i) such person to reinstate the complainant to 25 his former position together with the compensation (include PCB-ARCH-EXT0378091 121 ^ ing back pay), terms, conditions, and privileges of his em- 2 ployment, (ii) compensatory damages, and (Hi) where 3 appropriate, exemplary damages. If such an order is issued, 4 the Secretary, at the request of the complainant, shall assess 5 against the person against whom the order is issued a sum q equal to the aggregate amount of all costs and expenses 7 (including attorney s fees) reasonably incurred, as deter- g vlined by the Secretary, by the complainant for, or in con- 9 nection with, the bringing of the complaint, upon ivhich the 10 order was issued, . ' . 11 (c) Review.--(1) Any person advei'sely affected or 12 aggrieved by an order issued under subsection (b) may 13 obtain review of the order in the United States Court of 14 Appeals for the circuit in. which the violation, with respect 15 to which the order was issued, allegedly occurred. The yeti- 16 tion for review must be filed within 60 days from the 17 issuance of the Secretary s order. The commencement of pro- IQ ceedings under this subparagraph shall not,, unless ordered 19 by the court,-operate as a stay of the Secretary s order. 20 (2) An order of the Secretary, with respect to ivhich 21 review could have been obtained under paragraph (1), shall 22 not be subject to judicial review in any criminal or other 23 civil proceeding. . ; 24 (d) Enforcement.--(1) Whenever a person has failed 25 to comply with an order issued under subsection (b)(2), PCB-ARCH-EXT0378092 122 1 the Secretary shall 'file a civil action in the United States 2 district court for the district in which the violation was found 3 to occur to enforce such order. In actions brought undo' this 4 subsection, the district courts shall have junsdiction to grant 5 all appropriate relief including, but not limited, to, injunctive 6 relief and compensatory and exemplary damages in addi- 7 tion to those which may have been imposed by such order 8 of the Secretary. Civil actions filed under this subsection shall 9 be heard and decided expeditiously. 10 (e) Orders.--In carrying out his duties under the pro-. 11 visions of this section, the Secretary of Labor may order the 12 attendance and testimony of witnesses and the production of 13 reports, papers, documents, answers to questions, or other in- 14 formation that, he deems advisable in carrying out his func- 15 tions under this section. Witnesses shall be paid the same fees 16 and mileage that are paid witnesses in the courts of the United 17 States. In the event of contumacy, failure, or refusal of any 18 person to obey any such order, any district court of the 19 United States in which venue is propel' shall have jurisdiction 20 to order any such person to comply therewith. The failure to 21 obey such order of the Court is punishable by the Court as a . 22 contempt thereof. . : 23 (f) Employment Effects.--(1) The Administrator 24 shall conduct continuing evaluations of the potential loss or 25 shifts of employment which may result from the issuance of PCB-ARCH-EXT0378093 123 1 any rule or order under this Act, including, where appro- 2 priate, investigating threatened plant closures or reductions in 3 employment allegedly resulting from such rule or order. 4 (2) Any employee who is discharged or whose employ- 5 ment is otherwise interrupted, or is threatened with discharge 6 or such interruption, or othenvise discriminated against by 7 any person because of the 7'esults of any rule or order issued 8 under this. Act, or a representative of such employee, may 9 request the Administrator to conduct a full investigation 10 of the matter. The Administrator shall thereupon investigate 11 the matter and, at the request of any interested party, shall 12 hold a public hearing on not less than 5 days' notice, and 13 shall at such hearings require the parties, including the 'em- 14 ployer involved, to present information relating to the actual 15 or potential effect of such rule or order on employment and 16 on any alleged discharge, interruption of employment, or 17 other discrimination and the detailed reasons or justification 18 therefor.. Any such hearing shall be of record and shall be 19 conducted in accordance with section 554 of title V, United 20 States Code. 21 (3) Upon receiving the report of any such investigation, 22 the Administrator shall make findings of fact as to the effect 23 of such rule or order on employment and the alleged dis- 24 charge, interruption of employment, or dism'imination and 25 shall make such recommendations as he deems appropriate. PCB-ARCH-EXT0378094 124 1 Such report, findings, and recommendations shall be available 2 to the public. 3 (4) Nothing in this subsection shall be construed to re- 4 quire the Administrator to modify or withdraw any rule 5 or order issued under this Act. -i 7 ZCOft&RESSI0'N`A L~REL'ATI0ArS?r1 8 ABe'c: 18. (a) AuthOrizATlONrkThere is authorized to 9 be appropriated to the Administrator, for purposes of carry- 10 ing out this Act, not to exceed $11,100,000 for the fiscal year 11 ending June 30,1976, not to exceed $2,600,000 for the tran- 12 sitional quarter ending September 30,1976, and not to exceed 13 $10,100,000 for the fiscal year ending September 30, 1977. 11 No part of the funds so authorized to be appropriated shall be 15 used to co'nstruct any research laboratories. 16 (b) Fees.--The Administrator may, by rule, require the 1^ payment of a reasonable fee from any pet'son required to sub- * .18' mil information under sections 4 and 5 to defray the cost of 19 administering this Act. Such rules shall not provide for any 29 fee in excess of $2,500. In setting such a fee, the Administra- 21 tor shall take into account the ability to pay of the person 22 required to submit the data and the cost of the Administrator 28 of reviewing such data. Such rules may provide for sharing 21 such a fee, in any case in which the expenses of testing are 26 shared under section 4(d). . p PCB-ARCH-EXT0378095 125 1 (c) Congressional Relations.--Whenever*' the Ad- 2 ministrator submits, in connection with this Act, any budget 3 requests', supplemental budget estimates, legislative recom- 4 mendations, prepared testimony for congressional hearings, 5 or comments on legislation to the President or to the Office of 6 Management and Budget, he shall concuri'ently transmit a 7 copy thereof to the Congress. No officer or agency of the 8 United States shall have any authority to require the Admin- 9 istrator to submit budget requests or estimates, legislative rec- 10 ommendations, prepared testimony for congressional hearings, 11 or comments on legislation relating to this Act to any officer 12 or agency of the United States for approval, comments, or 13 review, prior to the submission of such recommendations, 14 testimony, or comments to the Congress. , . ")-xregitla4e"eom- - ; PCB-ARCH-EXT0378096