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Citation: 1 Legislative History of the Toxic Substances Control Together with a Section-by-Section Index 667 1976

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-- The search text of this PDF is generated from uncorrected OCR text.94TH CoNcGRss HOUSE OF REPRESENTATIVES I Rmorr 4 SeM88n I No.94-1679

TOXIC SUBSTANCES CONTROL ACT

Sm-mEM 28, 1070.--Ordered to be printed

Mr. STAGGES, from the committee of conference, submitted thefollowing



### CONFERENCE REPORT

[To accompany S. 8149]

The committee of conference on the disagreeing votes of the two Houses on the amendment of the House to the bill (S. 3149) to regulate commerce and protect human health and theenvironment by requiring testing and necessary use restrictions on certain chemical substances, and for other purposes, having met, after full and free conference, have agreed to recommend and do recommend to their respective Houscsasfollows: That the Senate recede from its disagreement to the amendment ofthe Houseand agree tothe same withan amendment as follows:

In lieu ofthe matter proposed to be inserted by the House amendmentinsertthefollowing:

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HeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 667 1976JOINT EXPLANATORY STATEMENT OFTHE COMMITTEE OF CONFERENCE

The managers on the part ofthe House and the Senate at the conference on the disagreeing votes ofthe two Houses on the amendment of the House to the bill (S. 3149) to regulate commerce and protect, human health and theenvironment by requiring testingand necessary
userestrictions on certain chemical substances,andforotherpurposes, submit the following joint statement to the House and the Senate in explanation of the effect of the -ction agreed upon by the managers and recommended in the accompanying conference report:

The House amendment struck out all ofthe Senatebill afterthe enacting clauseand inserted a substitute text.

The Senate recedes from its disagreement tothe amendment of the House with an amendment which is a substitute for the Senate bill and the House amendment. The differences between the Senate bill, the House amendment, and the substitute agreed to in conference are noted below, except forclerical corrections, conforming changes made necessary by agreements reached by the conferees, and minor draftingand clarifying changes.

FINDLNGS, rOLICY, AND INTENT
Senatebi (section2)

Section 2(a) outlines Congressional policy underlying the Toxic Substances Control Act. Congress finds that: human beings and the environment are exposed to nmnerous chemical substances and mixtures; some ofthese maycause orcontribute toan unreasonable riskof injury to health or the environment; and the effective regulation of such substances andmixtures in interstate commerce necessitates regulationof intrastatecommerce aswell.

Subsection (b) sets forth that itis the policy of the United States that adequate data on the health and environmental effects of such chemical substances and mixtures should be developed. Such datadevelopment should be theresponsibility ofthose whomanufaeture and process such chemical substances and mixtures. Adequate authority should exist to regulate chemical substances and mixtures, but the exercise of such authority should not unduly impede technological innovation.

Subsection (c) contains a declaration of Congressional intent asto how the Administrator shall fulfill the responsibilities underthis Act. The Administrator shall carry out this Actin a reasonable and prudent manner and consider the environmental, economic, and social impact of any action -takenor proposed under this Act. Houseamendment (section2)

The H1ouse amendment is nearly identical to the Senate bill. However, the House amendment confines its datAt development man-
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date to hazardous or potentially hazardous substances and mixtures, in contrast to thebroader mandate contained in the Senate bill. COnference 8ubstitute(section2)

The conference substitute follows the Senate provision. Adequate data should be developed concerning the health and environmental effects of chemical substances and mixtures. Such data development should be the responsibility ofthose who manufacture or picess such substances and mixtures. Adequate authority should exist to regulate chemical substances and mixtures which present an unreasonable risk of injury to health or the environment and to take action with respect to chemical substances and mixtures which are imminent hazards.

I)EFINITIONS Senate bill (section3)

The Senate bill includes definitions for the Act, the principal ones of which are as follows: 1. C]heiuical substance is defined [is (i) any organic or inorganic substance of a particular molecular identity including a combination of such substances occrring its a result ofa chemical reaction, or (ii) any element or uncombined radical. Theterm specifically excludes any mixture; any pesticide; tobacco and tobacco products; special nuclear materials or by-product materials as defined in the Atomic Energy Actof 1954; articles which if sold wouldbesubject tothetax imposed by section 4181 of the Internal Revenue Code of 1954 (i.e., pistols, firearms, revolvers, shells and cartridges) ; any substance found in or on any food, drug, cosmetic or device and any substance produced for research and development purposes intended only for use in or
onany food, drugcosmetic ordevice.

2. The term "environment" includes human beings and their enviroiinient, water, atmosl)llere, and land and the interrelationships which exist among and between these.

3. "Manufacture" means to import, produce, or manufacture for commercial purposes.

4. The tern "mIixtu,'e" means tiny combination of two or more chemical substances if such substances do not react chemically with each other and if the combination is not a result of the chemical reaction. Mixtur also iIcludescombinations ofsubstances which occur in nature.

Time Senate bill a!it hIorizes the Administrator toexclde from cover11geof the Act anychemical suhbstanc'e ormlixttre ifthe Administrator determines, by rule, that the suhstance or mixture.does not present an Inrensomn)le risk of injiry to health or the enviromnent. However, the exclusion 1shall not apply to section 7or section 8(e) ofthe Senate bill.

House unt'nednwi.t(section3) 1. The House definition of "chemical substance" is similar to that of the Senate bill, except. that the term includes organic or inorganic suibstances or comlbinationsof such substancesoccurnring in nature.The exclusions fron the definition ofchemical substances are similarto the Senate lill, although the Ihouse amendnment specifically excludes food additives alongwith foods,drugs,cosmetics, anddevices.

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2. The ]house amendment defines "environment" to include water, air and land, and the interrelationships which exist among and between water, air and land, and all living things.

A. The House amendment, like the Senate bill, defines manufacture to mean import, produce, or manufacture, but the definition is not limited to such activities done for commercial purposes.

4. The term "mixture' is defined tomean any combination oftwo or
more chemical substances if the combination does not occur in nature and is not, in whole or in part, the result of a chemical reaction. However, certain reaction-produced combinations are included in the term "mixture" in order to prevent disparate treatment of identical combinations simply because ofthe number ofsteps used in the manu- facture ofthe combination. If each ofthechemical substances comprising the combination is not a new chemical substance and if the com- bination could have been mainufactured for commercial purposes without a chemical reaction occurring atthetime thesubstances comprising the combination were combined, then the comhination is included within the term "mixture".

The House bill does not contain general authority for the Admninistrator toexclude anychemical substance ormixturefrom thepro- visions of the bill. however, section 5(i) (5) of tileHouse amendment authorizes the Administrator to exclude any chemncial substance from the notification requirements of section 5 if the Administrator determines, by rule, that the substance will not cause or significantly con- tribute to an unmreasonable risk to health or the environment. Conference8ubstitute(8ection3)

The conference substitute adopts the definitions contained in the House amendment.

The conferees recognize that virtually no chemical substance exists in a completely pure state and intend that any reference to a chemical substance includes all impurities and concomitant products, including incidental reaction products, contaminants, co-products, and trace materials. Thus the definition of term "chemical substance" shall be applied to chemical substances as actually produced and marketed. For example, when the Administrator promulgates a rule under sec- tion 0(a) to regulate aparticular substance, such rule will apply tothe identified substance, including all theimpurities and otherconcomitant products, without explicitly identifying such impurities and con- comitant products within the rule.

It is expected that the Administrator will develop guidelines for the purpose of clarifying the extent to which impurities and con- comitant products wiil be included within a reference to "chemical substance" as it relates to the various provisions of the Act. While impurities and concomitant products are included within references to a "chemical substance" under the Act, the Administrator isobviously authorized to move against them separately under the applicable provisionsof theAct.

The term "health and safety study" is important as it describes information to which various provisions ofthe Act are applicable. For

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example, section 8(d) requires manufacturers, processors, and distributorsin commerce to listsuch studies with the Administrator. MIoreover, section 14(b) contains provisions concerning the availability of health and safety studies to the public. The conference substitute defines health and safety study to mean any study of any effect of a.chemical substance or mixture on health

or the enivironment, including underlying data and epidemiological studies, studies of occupational exposure to a chemical substance or mixture, toxicological, chemical, and ecological studies ofa chemical substance or mixture, and any test performed pursuant tothis Act.

It is intended that the term be interpreted broadly. Not only is information which arises as a result of a formal, disciplined study included but, other information relating to the effects of a chemcial substance or mixture on health and the environment is also included. Any data which bears on the effects ofa chemical substance on health

ortheenvironment would beincluded.

TESTING OP CHEMICAL SUBSTANCES AND MIXTURES

Senate b711 (section 4) Section 4 authorizes theAdministrator to require testing ofchemical substances and mixtures to ascertain potential effects on human health and the environment. Undersubsection (a), the Administrator must, by rule, require thetesting ofachemical substance or mixtureif the Adninistrator finds (1) that the chemical substance or mixture may present an unreasonable risk of injury to health orthe environment, or that there maybe significant human or environmental exposure because substantial quantities will be produced and such substance or mixture mav perhaps present an adverse effect on health or the environment; (2) there are insufficientdata or experiencetoreasonably determine or predict its health and environmental effects; and (3) testing is necessary to develop such data. If no reliable data is available to the Administrator, thefinding that such substance ormixture may perhaps present an adverse effect on health or the envi-ronment shall be presumed. In the case of a mixture, the bill requires an

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additional finding thattesting the chemical substances whichcomprise the mixture is not amore efficient and reasonable method to determine effectsonhealth andthe enlvironment. When requiringtests under subsection (a), the Administrator shall consider reasonably ascertainable costs and other burdens associated with conducting tests and publish such considerations in the Federal Register.

Subsection (b) sets forth the required contents ofthe testing rule and providesan illustrative listofhealth andenvironmental effectsfor which test standards may be required. This subsection also describes

some of the methodologies which the testing rule may prescribe. In addition, it describes which manufacturers and processors will be required toconductthe testing.

The Administrator shall review and, if appropriate, revise the stanlards for development ofdata at leastonce per year.Testingrules shall be issued in accordance with the rulemaking procedures ofsection 553, oftitle 5, United States Code, except thattheAdministrator shall allow interested persons the opportunity to make oral presentations ofdata, views, or arguments in-additionto written submissions. A transcript of such oral presentations is required. Subsection (c) provides a procedure whereby persons may apply to the Administrator for an exemption from a testing requirement rule in order to avoid submission of duplicative data. If an exemption is granted, a cost-sharing procedure is provided. A person providing reimbursement, may have access to test data, subject to the confidentialityprovisionsofsection 14.

Subsection (d) requires the Administrator to publish a notice of receipt of test data in the Federal Register and to make the data available to the public within 15 days of receipt.

Subsection (e) establishes an interagency advisory committee comprised of qualified and appropriate Federal officials to make recommendations to the Administrator regarding testing priorities.

The committee shall submit a list of chemical substances and mixtures in the order in which the committee determines the Administrator should promulgate testing rulesunder subsection (a). Within 12 months after the inclusion of a chemical on such list, the Administrator shall either initiate a rulemaking proceeding under subsection (a) or publish reasons for not initiating a proceeding in the Federal Register. Subsection (e) also contains specific conflict ofinterest provisions applicable to members of the interagency advisory committee.

Subsection (f) specifies required actions by the Administrator in response to test data or other information which indicate that a substance or mixture has apotential to induce cancer, gene mutations, or birth defects at levels for which human exposure exists or may exist with appropriate safety margins. The Administrator shall either take appropriate action undersection 5(e). 6(a), or7 within 180days after the date ofreceipt of such data or information orpublish in the Federal Register a finding that no unreasonable risk of injury is presented and reasons for making such a finding. Such requirement shall not take effect until two years after enactment. House amendment (section 

### 4)

Likethe Senate bill, the Houseamendment requiresthattheAdministrator findthatthere are insufficient dataand experience uponwhich

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to determine or predict the effects of the manufacture, distribution in commerce, processing, use, or disposal of a chemical substance or mixture. It also requires a finding that testing of the substance or mixture is necessary to develop such data. However, the House bill differs from the Senate bill in thatit requires a findingthat a chemical substance or mixture may "cause or significantly contribute" to

an unreasonable risk, whereas the Senate bill requires a finding that the substance or mixture may "present" an unreasonable risk. Section 4(a) (1) (B) of the House amendment sets foth a second set of conditions underwhich the Administrator shall require testing. If theAdministrator finds (1) (A) that a chemical substance or mixture is or will be produced in substantial quantities and (B) (i) either that it enters or may reasonably be anticipated to enter the environment in substantial quantities or (ii) there is or may be significant or substantial human exposure to the substance or mixture, (2) there is an insufficiency of data, and (3) testing is necessary to develop the data, the Administrator shall, by rule, require testing.

The House amendment requires the Administrator to consult with the Director of the National Institute for Occupational Safety and Health before prescribing epidemiologic studies under tie testing requirement rule. The House bill requires the Administrator to make andpublishfindings undersubsection (a) (1) (A) or (a) (1) (B) before the issuance of a rule ordering persons to conduct tests. The House amendment also provides for the expiration of a testing requirement ruleattheendofthereimbursement period.

The House amendment provides forexceptions from the testingrule in order to avoid submission of duplicative data. If an exemption is granted, reimbursement requirements similar to those in the Senate bill apply, except that the reimbursement period may last as long as fiveyears, instead ofthetwo-year period inthe Senatebill. In promulgating rules to use in determining fair and equitable reimbursement, the House amendment does not require the Administrator to consult with the Attorney General and the Federal Trade Commission.

With respect to the interagency committee's priority list submitted to the Administrator, the Ilouse amendment does not require the Administrator either toinitiate a rulemaking proceeding orto publish in the Federal Register the Administrator's reasons for not initiating such a proceeding. The House amendment doesnotinclude the conflict of interest provisions found in the Senatebill relating to members of theinteragency advisory committee.
Cant erence su.b8titute (section .4) The conference substitute is similar to the House amendment with respect tothe findings which the Administrator must make in order to require a manufacturer or processor to test a chemical substance or mixture, except that the term "presents" is used in lieu of "cause or significantly contribute to". The conference substitute includes this term throughout thebill when speaking ofarisk.

In using the term, the conferees intend that the Administrator be able to address substances and mixtures which indirectly present unreasonable risks, as well as those which directly present such risks. Further, the conferees do not intend that a substance or mixture must be the single factor which results in the presentation of the risk.

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Oftentimes an unreasonable risk will be presented because of the interrelationship or cumulative impact of a number of different substances or mixtures. Theconferees intend thatthe Administrator have authority to protect health and the environment in such situations.

In following the House language, the conference substitute requires testing not only (1) in situations in which a substance or mixture may presnt an unreasonable risk, but also (2) in situations in which there may be substantial environmental or significant or substantial human exposure to a substance or mixture about which there is inadequate information to predict effects on health or the environment.

In the first situation, the conferees intend to focus the Administrator's attention on those chemical substances and mixtures about which there is a basis for concern, but about which there is inadequate information to reasonably predict or determine their effects on health orthe environment. The Administrator need not show thatthe substanceormixturedoesorwillpresent arisk.

The second situation reflects the conferees' recognition that there

are certain situations in which testing should be conducted even thoughthere isan absenceofinformation indicating thatthesubstance

ormixtureper8emay behazardous.

Theconference substitute followstheHouse amendmentwithrespect to the contents of the testing rule. The Senate provision concerning which manufacturers and processors are required toconduct the testing and submit test data is included. Like both the Senate bill and the house amendment, the conference substitute permits the Administrator to grant exemptions from a testingrule. To grant an exemp- tion, the Administrator must determine whether the chemical substance or mixture is equivalent to a chemical substance or mixture for which test data is already beingdeveloped. In making this determination the conferees expect the Administrator to look at any contaminants in the chemical substance or mixture for which an exemp- tion is being sought and ascertain whether any contaminants present might cause differences in test data which would be significant and which would, therefore, cause the Administrator to determine that the chemical substances or mixtures in that instance were not equivalent.It also followsthe I-louseamendment concerning reimbursement, except that the Administrator must consult with the Attorney General and the Federal Trade Commission in issuing rules which establish the general criteria for determining reimbursement.

The conference substitute retains a modified version ofthe Senate provision on the interagency committee which is established to make recommendations concerning testing priorities to the Administrator.

The Administrator shall provide administrative servicesto support such activities. These services shall encompass such things as clerical staff assistance and supplies. The conferees recognize the importance ofthe interagency committee recommendations and expect the interagency committee to deliberate with care; therefore, the conferees intend that members of the interagency committee shall be given adequate support services by EPA. They also shall be relieved of responsibilities withinthe entitytheyrepresent to theextent necessary to carry out their duties to the committee. Each entity represented shallprovide itsmember withprofessional andresearchservices. Here,

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asin all places inthebillwhere specific officers oftheFederal Government are referred to by title,theconferees intend thatsuch references be construed to mean successors to such offices as affected by any reorganization plan or the like.

The interagency committee may designate.a maximum of 50 substances or mixtures with respect to which the Administrator should initiate a testing rulemaking proceeding within a year.No more than 50 substances or mixtures may be sodesignated at any onetime. If the Administrator does not take such action within a year, the Administrator must publish inthe Federal Register an explanation as towhy such action has notbeentaken.

The conferees have given discretion to the interagency committee

as to how many substances or mixtures should be designated. Although the committee may designate up to 50 substances or mixtures at any one time, the conferees wish to stress that the committee need not designate the maximum number. While it is intended that the recommendations of the interagency committee be given great weightby the Administrator, itshouldbeemphasized thatthedecision torequire testingrests withtheAdministrator.

The conferees do not intend that, in complying with the requirements of the statute, the Administrator divert from the regulatory activities ofthe Agency an inordinate amount ofresources to justify thefailure torequire testing. If the Administrator receives information which indicates to the Administrator that there may be a reasonable basis to conclude that

a substance or mixture presents or will present a significant risk of serious orwidespread harm to human beings from cancer, gene mutations, or birth defects, the Administrator shall initiate appropriate action under section 5, 6, or 7 to protect against the risk or publish in the Federal Register a finding that the risk is not unreasonable. Such action must be taken within 180 days ofthe receipt ofthe data, except that the Administrator may extend that period for an additional 1s0 days for good cause. This requirement does not take effect until twoyears after thedateofenactment.

The conference substitute adopts apro ision contained in theHouse amendment which enables any person who intends to manufacture or process a chemical substance which is not subject to a rule under section 4(a) to petition the Administrator to prescribe standards for the development of test data for such substance. The Administrator must

grant,or denythe petition within sixty(lays.Ifthe petition isgranted, the Administrator shall prescribe such standards within seventy-five

days of thedate on which the petition is granted. Any denial of such

apetition mustbepublished in theFederal Register.

MANUFACTURING AND PROCESSING NOTICES

Serate bill (section 5)

The Senate bill requires any manu'facturer of a new chemical substance to notify the Administrator at least ninety days prior to the commencement ofcommercial manufacture ofthe new substance. The notice is toinclude thecommon andthetradename ofthe substance, its chemical identity andmolecular structure, categories or proposedcateHeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 675 197683
gories ofuse,reasonable estimatesoftheamount tobe manufactured or processed, a description ofthe by-products, estimates ofthe number of people who will be exposed to the substance in their places of employment, and existing data concerning environmental and health effects ofthesubstance. In addition, if a testing rule applicable to the substance is in effect priorto submission ofthe notice, the manufacturer is required to submit along with the notification, the test data required to be developedbytlietesting rule.

The ninety day notification period may be extended by the Administrator for an additional ninety days for good cause shown. Notice of such extension must be )ublishedin the Federal Register. Similar notification is required of any person intending to manufacture orprocess a chemical substance for a distribution incommerce, use, or disposal that hasbeen identified by theAdministrator, by rule,

asnsignificant newuse, distribution,ordisposal. TheAdministrator is, by rule, toestablish criteria defining a significant new distribution in commerce, use, or disposal. In establishing such criteria, the Administrator is totake into account the projected volume of production and category or categories ofuses, increases in magnitude and duration of human or environmental exposure, routes ofexposure, and the human health andenvironmental effects. The Senate bill authorizes the Administrator to issue immediately effective administrative orders during the notification period to halt

or limit the manufacture, processing, distribution in commerce, use or disposal of new chemical substances subject to the notification requirements intwo situations.

First, the Administrator is required to issue such an order if the Administrator finds that a testing requirement under section 4(a) should be established or modified. The order is to remain in effect until an expedited rulemaking proceeding under section 4(a) to requiretestingcan be completed, thetesting performed andthe test data submitted. Second, if the Administrator finds that a new substance l)resents or is likely topresent an unreasonable riskofinjury tohealth

or tie environment, the Administrator is also required to issue aii immediately effective order. If such an order is issued, the Administrator must conduct an expedited rulemaking proceeding in accordance with the l)ro'isions ofsectign 6(c) (2) and (3).

If the Administrator does not take action to prohibit or limit the manufacture, processing, distribution in commerce, use or disposal of

a new substance (luring the notification period, the Administrator is required to publish astatement of reasons in theFederal Register for not taking such action. The statement must be published prior to the expiration ofthenotification period.Manufacture orprocessing ofthe

new substance may commence following publication of the Administrator's statement. Failure to take action against a substance is an actionsubject toiudicial review.

The Senate bill provides certain exemptions from the requirement to submit manufacturing and processing notice. The Administrator is authorized to grant such an exemption for test marketing or other specially limited purposes. In addition, the Administrator may exempt chemical substances which are intermediate reaction products

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formed during the manufacture of another chemical substance and to which there isno human or environmental exposure. In addition, the notification provisions of the Senate bill do not apply to any chemical substance manufactured in small quantities solely for scientific experimentation or analysis or for chemical research or analysis, including such research or analysis forthe development of a product. However, the Administrator may, by rule, require notification prior to the manufacture or processing of such a substance upon a finding thatthe substance may cause or contribute to an unreasonable risk of injury to health or the environment. Although the section, by its terms,does not apply tomixtures, the Administrator isauthorized to specify any mixture which shall be subject to the provisions of the section.
Houseamendment (section5) Likethe Senate bill, the House amendment requires manufacturers of new chemical substance to notify the Administrator ninety days prior to the commencement of commercial manufacture of such new substance. The notice is to include information similar to that required bytheSenate bill, including test data required tobe developed by any applicable testing rule which has been promulgated under section4priorto thesubmission ofthenotice.

In addition, the I-louse amendment requires the Administrator to compile and maintain a list of chemical substances which cause or significantly contribute toor may cause or significantly contribute to

an unreasonable risk to health orthe environment. Ifa person intends to manufacture a 'new chemical substance included on this list and if no testing rule applicable to the substance has been issued under section 4, the person must submit to the Administrator information which the person believes indicates that the chemical substance will not causeor significantly contribute to an unreasonable risk. Such informationmustbesubmitted along withthe notice.

TheHouse amendment alsorequires manufacturers or processors of

an existing chemical substance for a new use which has been designated by the Administrator, by rule, as a significant new use, to provide similar notice ninety days prior to such manufacture or processing. The House amendment does not require notification prior to the manufacture or processing of a chemical substance for a significant new distribution in commerce ordisposal.

In instances in which there is inadequate information to evaluate the effects of anew substance or of an existing substance for a significant new use, the Administrator is authorized to seek a court injunction tohalt manufacture, processing or distribution in commerce. The Federal district courts are empowered to grant injunctions ifthe court finds that (1) there is inadequate information to reasonably evaluate thehealth anL _nvironmental effects ofthenew substance and (2) in the absence of such information, the substance may cause or significantly contribute to an unreasonable risk. If an injunction is granted, the Administrator shall conduct an expedited rulemaking proceeding to determine if a lesser restriction (rather than a total halt of manufacture, processing or distribution) would be adequate to protect health or the environment until adequate test data isdevelopedand evaluated.

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The House amendment does not require the Administrator to publish a statement of reasons for not taking action during the notification period to prohibit or limit the manufacture, processing, distribution, use or disposal of a new substance orof an existing substance manufactured or processed for a s;ignificant new use.

The House amendment also provides for exemptions from thenotification reqdfirements. The Administrator is authorized toprovide an exemption for the manufacture and processing of a substance for test marketing purposes. The House bill specifically exempts from the notification requirements those chemical substances manufactured or processed in small quantities for scientific experimentation or analysis

or forchemical reearch or analysis on such substance oranother substance, including research and analysis for the development ofa substance or another substance into a commercial product. However, all persons engaged in such experimentation, research or analysis for a manufacturer orprocessor must benotified ofany risk tohealth which the manufacturer or processor has reason tobejieve may beassociated withthesubstance.

The Iouse amendment authorizes the Administrator, by rule, to exempt a manufacturer or processor of any new chemical substance from all orpartofthe requirements ofthis sectioniftheAdministrator determines that such chemical substance will not cause or signifi- cantly contribute to an unreasonable risk to health or the environment. The hII(se amendment also contains an exemption clarifying that, a chemical substance which, except. for its inert,ingredients, is i(lentical to a chemical substance contained on the section 8(b) inventory will not betreated as anew chemical substance. 'he House amendment doesnot authorize theAdministrator tospec. ifythat a manufacturer of a mixture shall be subject to the notification requircements. Conferencesudbstitute (section5)

In geniral.-Section5 sets out the notification requirements with which manufacturers of new chemical substances and manufacturers and procvoiors of existing substances for significant new uses must comply. The requirements are intended to provide the Administrator with an opportunity to review and evaluate information with respect to the substance to determine ifmanufacture, processing, distribution in commerce, use or disposal should be limited, delayed or prohibited because, data is insufficient to evaluate the health anid environmental effects or beceuse the substance orthe new usepresents orwill present
an unreasonnble risk ofinjuryto health ortheenvironment.

The provisions of the section reflect the conferees recognition that the most desirabh, time to determine the health and environmental effects of a substance, and to take action to protect against any potential adverse effects, occurs before commercial production begins. Not only is human and environmental harm avoided oralleviated, but the (oA of tmiy rgulatory action in terms of loss of jobs a1(1 capital investment is minimized. For these reasons theconferees have giventhe Administrator broad authority to actduring thenotification period.

Any person who intends to manufacture a new chemical substance

or manufacture or process achemical substance for a use which the Administrator, by rule,has determined is a significant new use, must

HeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 678 1976give the Administrator at least 90 days notice before beginning such manufacture or processing, The 90-day period shall begin upon receipt of the notice by the Administrator or the Administrator's duly designated representative.

The conferees have notincluded the Senateprovision whichrequires notification of significant new distributions or disposals. However, the conference substitute requires that the Administrator consider the reasonably anticipated manner and method of manufacturing, processing, distribution in commerce and disposal of a substance in determining when ause will beconsidered asignificant new use. Thus, the conferees intend that any potential thrat., to health or the environinent from the manufacture, processinv-, distribution in commerce, or disposal of a substance associated with a new use be considered by the Administrator when determining the significance of a new use, In addition, the Administrator shall consider the projected volume of manufacturing and processing of the substance for a use, the extent to which a use changes the type or form of exposure of human beings or the environment to a substance, and the extent to which such use increases the magnitude and duration of human or environmental exposure to a substance. Thus, a significant increase in tli projected volume ofmanufacture or processing for a substance, a significant change in the type or form of human or environmental exposure, or a significant 'increase in the magnitude or duration of human or environmental exposure could be the basis for determining that auseis a significant new use.

Slibmissionoftest data.-Subsection (b) describes the instances in which a person subject to a notification requirement with respect to a chemical substance under subsection (a) must submit test data to the Administrator before manufacture ofthe substance or manufacture or processing ofthe substance for a significant new usecanbegin. If a rule under section 4 respecting a substance has been promulgated before submission of the notice required by subsection (a), then a person who is required bythe section 4 rule to submit test data for the substance must submit'such test data at the time the notice is submitted in accordance with subsection (a). This assures thatthe Administrator will have at least 90 days to evaluate thetest data before the manufacture or processing begins. If a person has been granted an exemption from a testing rule under section 4 applicable to anew substance or to a significant new use of an existing substance, such person shall not begin manufacture or processing until 90 (lays after the dale of submission ofthe test data on which the exemption is based.

It should be noted that ifa testing rule under section 4 respecting

a substance has not been promulgatitd prior to the, submission of a notice required by section 5, the Administrator may promulgate a testing rule under section 4 for such substance without taking separate action under this section. However, such a rule would not delay themanufacture orprocessing ofthe substance.

The conferees adopted a provision from the House bill to insure that information respecting the health and environmental effects of anychemical substance which theAdministrator hasidentified as asuspect chemical substance is submitted at the time ofnotification. Under

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the conference substitutethe Administrator may,byrule,compile alist of chemical substances the manufacture, processing, distribution in commerce, use or disposal of which presents or may present an unreasonable risk ofinjury to health orenvironment. Ifa testingruleunder section 4 has not been promulgated with respect to such substance before the submission of the notice, then the person submitting the notice must submittotheAdministrator data whichthe person believes shows the manufacture, processing, distribution in commerce, use and disposal of the substance or any combination of such activities will not present an unreasonable risk to health or the environment.

Eteiision of o/kce perod.-The Administrator, for good cause, may extend the 90 day notification period for additional periodsnotto exceed in the aggregate 90 days. Notice ofany extension together with the reasons for it shall be published in the Federal Register and shall constitute final agency action subjecttojudical review.

The conferees intend that tme Administrator have a large degree of flexibility in extending the notification period, sothat manufacture or processing may begin as soon as the Administrator has sufficient information toev'aluate the substance. Forexample, iftheAdministratorexl)eCts that sufficient,data will be available 30 days afterthe origi- nal notification p)eriod will expire, then the conferees expect that the Administrator will settle on an extension period which will reasonably acnimodate production of that data and time foradministrative con- sideration. If production ofthe data isdelayed, of course theAdministrator may extend the original extension period. However, in no case may the extensions exceed a total of 90 days. Every time that the notification period isextended, theAdministrator must publish notice of the extension in the Federal Register along with reasons therefor. Covtent ofnotice;publicatior~ inthe FederalRegiter.-Theconfeirence substitute requires the noticerequired under'subsection (a) to include certain information described in section 8(a) (Reporting and Rotention of Information) whether or not the Administrator has required its submission under that section; anytest data in the posses- sion or control of the person giving the notice which is related to the effects on health or the environment of any manufacture, processing, (listribntiou in coninmerce, use or disposal of the substance; and a description of any other data concerning the health and environmental effects of the substance, insofar as known to the person making the report orinsofar as reasonably ascertainable. The notice shallbe made available, subject to section 141, for examination byinterested persons.

InI order that the public receive timely notihcation of any new (hemical substance or any significant new use of an existing chemical substance, theconference substitute includes aprovision which requires the Administrator to publish in the Federal Register a notice which identifies the chemical substance, lists the uses or intended uses of the substance, and describes the nature of tests performed on such substance and any data developed pursuant to subsection (b) or a rule under section 4. Such publication must occur within 5 days after the Adm;nistr.alr receives notice from the person who intends to manfactumre Or process.

Theconference substitute alsorequires the Administrator to publish monthly a list of each chemical substance for which notice has been

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received under subsection (a) and for which the notification period has not expired. The Administrator must also include on the listthose substances for which thenotification period has expired since the last, monthly publication.

Regulationpending developvwnt of inforrmation.-Subsection (a) setsout theprocedures underwhichtheAdministrator canhalt orlimit the manufacture,processing, distribution inconnerce, use, ordisposal of a new substance or an existing substance for t significant new use when there is insufficient information to evaluate the health and environmental effectsofthe substance.

Action to prohibitor limit manufacture, processing, distribution in commerce, use, ordisposal isrequiret i instances inwhich theAdministrator determines that: (1) Information available tothe Administrator isinsufficientto permit a reasoned evaluation ofthe health and enviroiunental effectsofthe substance, and (2) (a). In the absence of information sufficient to permit the Administrator tomake such an evaluation, the manufacture, proc- essing, distribution in commerce, use, or disposal of the substance may l)resent an unreasonable risk of injury to health or the environnient, or (b). The substance isor willbe produced in substantial quantities, and (i) enters or may reasonably be anticipated to enter the environment in substantial quantities or (ii) there is or may be significant or substantial human exposure to the substance. If theAdministrator makes theabove determination atleast45 days before theexpiration ofthenotification period,then theAdministrator may issue aproposed order toprohibit or limitthe manufacture, processing, distribution in commerce, use or disposal of the substance. A limitation on manufacture or processing could, of course, include a labeling requirement. The proposed order will take effect upon the expiration ofthe notification period unless the manufacturer or processor subject to the order files objections with the Administrator, specifying withparticularity the provision ofthe order deemed objectionalle and stating the giounds for the objection. To prevent the order from becoming effective, the objections must be flied within 30 days after themanufacturer or processor has received in writing from the Administrator anotice ofthe proposed order. The conferees wish to stressthat theAdministrator' must provide actual notice in writing to the manufacturer or processor who will be subject to the order. Notice isnot tobe published in the Federal Register, but is, ofcourse, available to the public if it is not prohibited from disclosure under section 14.

. This provision thus represents a melding of the Senate bill and the Houge amendment. In order to insur'e that timely action may be taken bythe Administrator, the conference substitute authorizes theAdministrator to issue an administrative order to take effect immediately upon the expiration of the notification period. However, to protect against unilateral action by the administrator without, an adequate basis for action, the confere'nce substitute borrows the procedure from section 701(e) of the Federal Food, Drug, and Cosmetic Act which permits the filing of objections by manufacturers and processors spe79-313 0

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cifying with particularity the provisions ofthe order deemed objectionable and statingthegrounds fortheobjections.

If such objections are filed, then the Administrator is instructed to seek an injunction in a Federal district court to prohibit or limit the manufacture, processing, distribution in commerce, use or disposal of the substance. Of course, ifthe objections filed with theAdministrator indicate to the Administrator that the injunction is not necessary, then the Administrator isnot required to seek the injunction. If the court finds in such injunction action that (1) information available to the Administrator is insufficient to permit a reasoned evaluation of the health and environmental effects ofthe substance, and (2) (A) in theabsenceofsuch information, the manufacture, processing, (listribution in commerce, use, or disposal of the substance may present an unreasonable risk of injury to health or the environment

or (B) such substance isor will be produced in substantial quantities and it enters or may reasonably be anticipated to enter the environment in substantial quantities or there isormay besignificant or substantial human exposure to the substance, thei the court shall grant
an injunction. Theconferees intendthat this two-part standard totally supplant the traditional elements which a partymust ordinarily show before a court will exercise its equitable jurisdiction to grant an injunction. The conferees do not intend that the Administrator be required to make any showing other than that which is required for the court to make the two findings described above. Application of any other standard by the court would frustrate the purposes of this section that suspect. chemicals be adequately tested to determine their health and environmental effects before commercial manufacture or processing begins.

The conference substitute authorizes such courts to grant a temporary restraining order or a preliminary injunction to prohibit manufacture, processing or distribution of a new substance or of an existing substance for a significant new use if the court finds that the notification period may expire before the action for an injunction

can be completed. The conferees recognize that a manufacturer or processor, merely by beginning to manufacture, process, or distribute aL

new chemical or an existing chemical for a significant new use, coul (lefeat the objective of section 1,to totally prevent environnttal or human exposure to suspect new chemical substances or significant new uses ofexisting chemical substances until adequatetesting

can be performed and the data evaluated. Therefore, the conferees intend that the court freely exercise the authority to grant preliminary reliefas is necessary to preserve the status quo in order toinsure that the policyofthissectioncan befulfilled.

After submission of adequate test data to the Administrator and evaluation of such data, the district courts may, upon petition, dissolve the injunction unless the Administrator has initiated a proceeding under section 6(a) with respect to the substance. In such a situation,the injunction shall remnaini in effect until theeffective date of a rule under section 6(a) or untilthe section 6 proceeding is terminated, whichever occurs first.

Protection again.St unrea8onable riak.-Section 5(f) of the conference substitute requires theAdministrator totake immediate action

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to prohibit or limit human or environmental exposure to a new chemical substance or to al existing chemical substance for a significant
new usein certain situations. In section 5(f) theconference substitute authorizes the Administrator to issue a 

### proposed rule under section 6(a), but such rule is to be effective upon its publication in the Federal Register. Such action is authorized in instances in which there isa reasonable basis toconclude that the manufacture, processing,distribution in commerce, use, or disposalofthesubstance presents orwill present an unreasonable risk of injury to health or tile.environment before a rule promulgated rider section 6(a) could protect against tile risk. The conferees recognize, of course, that there is authority in section 6(d) under which the Administrator may make.a proposed section 6(a) rule immediately effective. However, to invoke the section 6(d) authority the Administrator must find an imminent, unreasonable risk of serious or widespread injury. With respect to new chemical substanccs or substances for significant new uses,immediate action is authorized under section 5(f) when there is an imminent, unreasonable risk ofinjury,regardless of whether the injury willbe serious or widespread.

The section 6(a) rule proposed and made immediately effective pur- suant to the authority ofthis section may (A) limit tie amount ofa substance which may. he manufactured,'processed, or (listrihuted in commerce, (B) conl .i any of the requirements described in para- graph (2), (3), (4), (5) (6). or (7) of subsection 6(a), or (C) contain any combination of therequirements described inclauses (A) and (B). Iinmediately following tile publication in the Federal Register of asect ion 6(a) rule as authorized by this section, the Administrator must conduct an expedited rulemaking proceeding in accordance with the provisions ofsection G(d) (2).

A rule under section 6(a) authorized by this section may nottotally )rohibit the manufacture, processing, or distribution in commerce of
a new substance or an existing substance for a significant new use. In order to totally prohil)it.the manu facture, processing, or distribution in commerce of a new sulst ance. or of an existing substance for a sign;fivant ne, w use, the Administrator must either issue a proposed order which shall be subject to all the procedures applicable to the sithation when there is an insufficiency of information, as described above, or obtain a court injunction. If the court finds that there is a reasonalble basis to conclude that the nanufacture, processing, distribitionincommerce. useordisposal ofa newsubstance orof anexisting substance for a significant new use presents or will present al un- reasonable risk of injury to health Ortile environment, tile co0urt shall issue ail injunction. Again, the conferees intend that the court will

notusethe normal equity standard to determine ifan injunction should be issued. Instead, the standard set out in section 5(f) (3) (B) of the conference substitute isintended to totally replace the normal injunction standard. The conferees recognize that there will be instances in which there
are a limited number of practical uses for a chemical substance and that by issuing an immediately effective proposed .rule )rohibiting those uses, the Administrator could effectively prohibit, manufacture
or processing altogether. The conferees view such a prohibition as a

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total prohibition of manufacture or processing and intend that the Administrator comply with the procedures of section 5 (f) (3) in order to obtain a total prohibition on manufacture orprocessing. The authority to issue an immediately effective rule to prohibit inmanufacture or processingfor ause should be utilized onlywhen there is more than one practical use of a substance and when 'the prohibition does noteffectively ban all such uses. Likewise, the conferees donot intend that the Admiiinistrator utilize the authority to issue an immediately effective proposed rule so severely limiting the amount of a substance which may be manufactured, pr~ocessed, or distributed in commerce as to effectively prohibit manufacture, processing, or distribution,

StatCndtof 

### reasas fornot

### lakivg aetvin.-If,within the notification period, the Administrator has not initiated action under this section or section 6or 7 toprohibit orlimitthe manufacture, processing, distribution in commerce, useor disposal ofcertain new chemical substancesorof existing chemical substances for significantnew uses,then subsection (g) requires the Administrator to issue a statement of reasons in the Federal Register for not initiating such action. The statenient must be published prior to the expiration of the notification period. The chemical substances for which such a statement isrequired

arethose for which the Administrator, becauseofprior administrative action with respect to such chemical substances, has indicated there maybeparticularcause forconcern. Specifically, a statementofreasons for not initiating action is required if a testing rule under section 4 applies to a new substance or an existing substance for a significant

new use, or ifasubstance is listed under section 5(b) (4). In addition, if notifieation is reruiredbecause a use constitutesa significant new use and. ifno action isinitiated during thenotification period, the Administrator must issue astatement of reasons for not initiaing,, such action.

Publication ofthe statement ofreasons in accordance with this subsection is not a prerequisite to the manufacture or processing of the substance with respect,to which the statement istobe published. Thus, the Administrator, merely by not issuing the statement of reasons, cannot delay the beginnig of manufacture or processing of a new substance or a substance for a significant new use. Nonetheless, the Adotinistrator must perform this non-discretionary duty and will subject himself not only to criticism by the Congress for not doing so, but, may also subject himself to suit under section 20 of this Act or other provisions of law relating to the required performance of nondiscretionary duties.

E.rm.ption.-Subsection (h) describes the situations in which a chemical substance maybe manufactured orprocessed without regard to the notice and test data sul)mission requirements of subsections (a) and (b). Paragraph (1) provides the autbority for granting an exemption for test marketing purposes. Under paragraph (2) an exentl)tion front the test data submission requirements of subsection (b) may be obtained if submission of data for the substance to be exempted would be, duplicative of data already submitted to the Administrator. Paraqraph (3) 

### adopts the lanf.uaue in the 

### House amendment specifically exemintlnr from thenotification 

### retuiremnents those chemical substances manufactured or processed or pronosed to be manufactured or processed in small quantities (as defined by the

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Administrator by rule) for scientific experimentation or analysis or for chemical research or analysis, including research and analysis for the development of the substance or another chemical substance nto

a commercial product. All persons engaged in such experimentation, research, or analysis for a manufacturer orprocessor mustbe notified

or any risk to health which the manufacturer or processor or Administrator has reason to believe may be associated with the substance.

Underparagraph (4), the Administrator may,upon application and by rule, exempt the manutfacturer of a new chemical substance from all or partofthe requirements ofthis section ifthe Administrator determines that the manufacture, processing, distribution in commerce,
use or disposal ofthe substance will not present an unreasonable risk ofinjury to health ortheenvironment. A rule grantingsuch anexemption mustbepromulgated inaccordance with paragraphs (2), (3), and (4) of section 6(c).

Paragraph (5) authorizes the Administrator to make the requirements of subsection (a) and (b) inapplicable with respecttothemanufacture or processing of a chemical substance which may temporarily exist as a result of a chemical reaction in the manufacture orprocessing ofa mixture or another chemical substance.and to which there is not or will not be any human or environmental exposure. Theconference substitute deletes the provision in the House amendment which clarified that a chemical substance is nottobe treated as a new chemical substance solely,because ofthe change in proportions of inert ingredients. Thisprovision ofthe House amendment wasdeleted because underthe definition of "mixture" in section 3 ofthe conference substitute the same result would occur, as any change in inert ingredients would constitute a new mixture not a new chenmical substance. Mixtures arenotcovered by section5.

Deflition.--Thetermns "manufacture" and "process" asused in this section mean to manufacture or to process for commercial purposes. Since theteim "manufacture" isdefined toinclude import, persons who intend to import substances for commercial purposes will be treated in the same manner as domestic manufacturers under section 5.

REGULATION OF CHEMICAL SKItSTANCEN AND MiXTUtIE6
,enate bill (section 6)

The Senate bill requires the Administrator to impose restrictions on a chemical substance or mixture if the Administrator finds that the manufacture, processing, distribution in commerce. use, or disposal presents or islikelyto present all mreasonable risk ofinjury to health

or the environimemit. The Administrator shall impose one or more of several specified requirements as is necessary to adequately protect against tlie risk,using the least burdensome of effective controls.

Arange ofrequirements is provided, from complete prohibitions on the manufacturing, processing, or distribution in cominmerce to labeling requirements. Among these is the authority toregulate the manner or method ofuse ordisposal of such substance ormixture and the authority to require manufacturers or processors to replace or repurchase substances or mixtures found to present unreasonable risks.

The Senate bill also contains the authority to limitthe amount of a substance or mixture which may be manufactured, processed, or disHeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 685 197673

tributed in commerce, or which may be manufactured, processed, or distributed in commerce for a particular use. A procedure for assigning permissible quotas ifthe applicable parties are unable to a.ree is provided. Supervision bythe Attorney General and the Federal rrade Commission is provided for any voluntary efforts to establish quotas.

The Senatebill anthorizes theAdmuinistrator toorder manufacturers

or processors to submit descriptions of relevant quality control proceduresifthe Administrator hasgood cause to believe that the manufacture or processing causes the adulteration of a chemical substance or mixture. If the Administrator determines that the quality control pro- cedures ofthemaufacturer or processor are inadequate,'the Adinunistrator may order revisions in the quality control procedures to the extentnecessary toremedy tIle inadequac.

The Senate bill also requires the Administrator to consider relevant factors in imposing retrictions and to make findings with respect to certain factors.

The Senate bill contains a specific rulemaking procedure for rules imposing restrictions under this section. The procedure is an informal one, similar to the procedures in section 553 of title 5, United States Code, butthere are exceptions, including an otl)portunity for an informal hearing. An opportunity for appropriate cross-examination in the hearing is provided under the sul)ervision ofthe Administrator. Participants in a rulemahing proceeding may be compensated by the Administrator under specified criteria.

ThetAdministrator may specify the date on which a rule underthis section becomes effective, which shall be as soon as administratively feasible.

The Administrator may waive the required notice and comment period in those situations where compliance with the rulemaking pro- visions would present an unreasonable risk of death, serious or substantial personal injury, orserious orsubstantial environmental harm.

Finally, the Senate bill provides for the control of polychlorinated biphenyIs (PCBs). Effective one year after the date ofenactment of the Act, PCBsmay not be used in any manner other than atotally enclosed manner, except that the Administrator may, by rule, authorize exceptions if the Administrator finds that no unreasonable risk of injury to health or the environment is presented. Effective two years after the date of enactment, the manufacture of any polychlo- rinated biphenyl would become unlawful. Effective two and one-half years after such date, the processing or distribution in commerce of PCB's would become unlawful, except,that the Administrator may make exceptions if no unreasonable risk of injury to health or the environment is presented. Disposal regulations coneerning PCB's shall be promulgated within six months after the date of enactment. Tlousc amendment (8ectioz.6)

The standard fortakingaction against unreasonablerisks underthis section in the House amendment is slightly different from that contained in the Senate bill. If the Administrator finds that there is a reasonable basis on which to conclude that the manufacture, process- ing, distribution in commerce, use, or disposal of achemical substance
or mixture, or any combination of such actions causes or significantly contributes to, or will cause or significantly contribute to, an unreaHeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 686 197674

sonable risk to health or the environment, the Administrator shall inpose requirements as necessary to protect against the risk. The requirements generally aresimilar totierequirements oftheSenatebill, with several exceptions. TheAdministrator may notregulate themanneror method ofuse. Nor maythe Administrator impose replacement
or repurchase requirements for substances regulated. Requirements regulating the manner or method of disposal may not require any person to take an action in violation of a State or local law. Also, a person subject to a disposal requirement shall notify the State in whichi a required disposal may occur of such requirement. The House amendment does not contain authority to impose manufacturing or processing quotas. The House amendment provides a procedure for protecting against unintentional contamination ofachemical substance duetothemanner of manufacturing or processing. Quality control procedures may be required to be submitted. If found inadequate, theAdministrator may order such procedures to be changed. In addition, ifthe quality control procedures have resulted in the distribution in commerce of substances or mixtures which cause or significantly contribute to an unreasonable risk to health or the environment, the Administrator may require manufacturers or processors to give notice and to replace or I'epurchase any such substance or mixture as is necessory to protect health or the environment, In promulgating any rule under section 6(a), the Administrator shall consideI all relevant factors and make findings with respect to certain factors.

Tie Administrator sliall not promulgate a rule under this section ifthe risk could be eliminated or reduced to a sufficient extent under another federal law administered bv the Administrator unless the Administrator makes at finding thatit isin the public interest todo so, taking into consideration i number of enluerated factors,

The rulemaking procedures of the House amendment are generally similartothose contained intheSenate bill.

Tile Administrator may make a ruleimmediately effective ifall unreasonable risk ofserious'or widespread harmto health orthe environmnent will occurprior to theCompletion ofthe.rulemaking proceedings, and making tile ruieso effective is necessary to protect the p1l)liw Interest. If a proposed rule totally prohibits'tie manufacture, process- ing 01' distribution ofa chemical substance o1 mixture, itcourt must 

### have previously taken action against a substance or mixture in an imminent hazard proceeding under section 7. An expedited rulemaking procedure isprovided forimmediately effective rules.

The provision oftie House amendment relating to PCBs is similar to theSenate bill with afew exceptions. Forexample, the prohibitions effecl ive in one year apply onlyto the manufacture, processing or distribution in commerce for ause other than a use in atotally enclosed
manner. In addition, exemptions from the prohibitions :elating to the maniufactilre, processing, and distribution of PCB's may be granted, if the Administrator determines that the exemption isnecessary to protect health or the environment, and good faith effortshave been madeto developsubstitutes.

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Confereneesubstitute (section6)

The conference substitute requires the Administrator to take action tinder this section against chemical substances or mixtures for which there is a reasonable-basis to conclude that the manufacture, process- ing, distribution in commerce, use, or disposal of such chemical substances ormixtures, or any combination ofsuch activities, presents or will present anl unreasonable risk of injury to health or the environmnent. Requirements shall beimposed tothe extent necessary toprotect against therisk.

The requirements must be the least burdensome feasible for those subject to the requirement and for society whileproviding for an adequate margin ofprotection against the unreasonable risk.

The requirements which may be imposed are similar to those ineluded in both the Senate bill and the House amendment. The Administratorma.y impose requirements regulating themannerormethod ofthe commercial use of a substance a mixture and also requirements regulating the manner or method of disposal of a substance or mixture or an article containing a substance or mixture by the manufacturer orprocessor orby any other person who uses ordisposes of it for comnnercial Ipurposes. The provision ofthe TIouse amendmnnt that itdisposal requirement may not require tiny person to take action in violation of any State law or political subdivision is included. The Conference sobstit ute also includes theSenate provision which authorizes theAdministrator torequire replacetlent or repurchase by manufacturers orprocessors ofsubstances ormixtures with respect to which action hasbeen taken underthis section.

The provisions of the House bill relating to quality control are included.

The provisions of the Senate bill which authorize tie Administrator to assign manufacturing or processing quotas are not included.

The conferees appreciate that ifthe Administrator chooses to impose a )roduction litnitation on any chemical substance, such limita- tion, if not carefully drawn, couldl produce monopoly profits. The conferees believe thnt the Ad ninistrator should consult with the Attorney General and the Federal Trade Commission in order to avoid t1, anticompetitive consequenuces.

,'I'l conference substitute requires the Administrator to consider certain enumerated factors and to publish a statement in the Federal Register with respect to thetn at the time ofpromulgation of a rule under section 6(a). Specifically, theAdministrator ttust,consider and plublish a statetntt concerning the effects of the substance or mixture on health find the mnagnitude ofhutan exposure to such substance or mixture; the effects of the substance or mixture oti the environment

nd thl tuagnitude or environtuental exposture to such suhstance. or mixtum'e, he benefits of such substance or tmixture for various uses and the availability of substitutes for such uses; and the reasonably ascertainable economic consequences of the rule, after consideration ofthe efrects on the national economy: small business, innovation, the enviromnent. and the public health. This requirement was contained inIol ht the Senate bill and the Hotise amendment. The putrpose in requiring such a statementisto assurethatthe basis forthe Aqhnin- istrator's rule are publicly enumerated. By requiring the statements,

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the conferees intend to empl)hasize key considerations which must be addressed. The conferees do not inten(I that the statement be detailed

or voluminous. A succinct and precise statement of these key considerations will suflice. Of course, the statements will provide part of the rulemaking record for judicial review of a rule promulgated undersuction0 (a).

Moreover, iftlhe Administrator determines that a risk may be eliminated or rediced to a sufficient extent by actions taken under another Federal law adiniiisteried by the Adm~iinistrator, action may not be taken uider this section unless tile Administrator finds, in the Administrator's discretion, that it is in the public interest to take action under this Act. By committing such determination to the Admimlistrator's discretion, the conferees intend that such determination notbe subjecttojudicial review. The I-louse provision relating to compensation for the costs ofparficipating in a rulemaking proceeding and the provisions relating to the effective date of a rule are included. Generally rules are to be effective as soon as procedurally and administratively feasible. However, proposed rules maybe declared tobeimmediately effective bythe Administrator in certain instances. The rule may be Aeclared immediately effective if the Administrator determines that the manufacture, processing, (listributiin in commerce, use, or disposal of a substance

or mixture is likely to result in an unreasonable risk of serious or widespread injury to health or the environment before the normal effective (lateand making the rule immediately effective isnecessary to protect the public interest. Ill tile case of a ruhl to prohibit the mannfacture, processing,or the distribution, a court must have granted relief in an imminent hazard action under section 7.An expedited rulemaking procedure isprovided ifa i'le ismade immediatelv effective. ihe conference substitute includes procedures cont'ine(l in both bills forprescribing rules. Ingeneral, rules underthissection are tobe prescribed in accordance with the informal rulemaking procedures of section 553 of title 5,Uniled States Code, (.xcept that an Opportunity for an oral hearing and for limited cross-examination isprovided. The procedures are patterned after those contained in section 18 of the M[agnuson-Moss Warranty-Federal Trade Commission Improvements Act. The Senate bill,unlike theHouse amendment, specifically authorizes file Administrator to conduct cross-examination on biehalf of the participants to ilie proieeingi. Althoighlthe c'onfernce substitute retains lie Senite provision, the conferees expect that ill most instauces the participants themselves vouhd conduct the croF,s-(xan mint ion, subject to the Administrator's time limitations and other rules.

When the Act states that the t ranscripts shall be available to the pmblic, the conferees intend that such availability be construed in a reasonable manner. No person may )edenied access to such information. but at tle same time the Adninistrator shall not be required to
assume the burden of copying what may be a formidable amount of material. Therefore. the conferees intend that the Administrntor furnish copies oftranscripts aslong asa supply exists within EPA. However, if the amount. ofmaterial is vast. orif EPA has run outofcopies, then tihe persC-on may inspect the transcript, which shall be available at every regional office of EPA. EPA may photocopy a reasonable numHeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 689 197677

ber of pages, such as 200, but shall in Pll cases afford any person the opportunity to photocopy as much ofthe transcript as theperson desires. The cost of copying pages beyond a reasonable number-shall be borne by the person; however, the Administrator shall not charge ah' unreasonable fee perpage. Generally, the provisions oftheSenate billrelatingtothecontrol of polychlorinlated biphenyls are included. The standard that must be satisfied before exemptions from the complete ban on polychlorinated lfiphenyls are granted containselements ofboth the House and Senate provisions. Exemptions may he granted only if the Administrator finds that there isno unreasonable risk to health or the environment, and that,good faith efforts have been made to develop a substitute. So that existingPCBsmay bereused ratherthan disposedof,theprohibitions (10 not apply todistributions in commerce of PCBsgold forpurposes other thain resale before the effective dateof the prohibition on distribution of PCBs.

IMMINENT HAZARDS Senatebill (8eation7)

The Senate bill authoriz-s the Administrator to initiate ajudicial proceeding against an imminently hazardous chemical substance or mixture oragainst anyperson whomanufactures,processes, distributes in commerce, uses ordisposes ofsuch substance or mixture or against both. The court is authorized to grant such temporary or permanent relief as is necessaryv to protect against the hazard. Such relief may include seizure and condemnation of the imminently hazardous substance or mixture. Further, the court is specifically authorized to require manufacturers, processors, or distributors to provide notice of the hazard to purchasers of the substance or mixture and to the public, and to recall and replace or repurchase the substance or mixture. Under the Senate bill an imminent hazard is considered toexist when the evidence is sufficientto show that asituation exists in which the continued use of a substance or mixture would be likely to result in unreasonable adverse effects onthe environment or an unreasonable hazard to the survival of an endangered species. An unreasonable adverse effect is defined to mean an unreasonable risk to man or the environment taking into account the economic, social, and environmental costs and benefits ofthe use of the substance ormixture.
IIuse amendment (8pctian 7)

The House amendment differs from the Senate bill in three ways. First,in addition to authorizing action against imminently hazardous substances and mixtures, the House amendment explicitly authorizes actions against articlescontaining such substances ormixtures. Second, if the Administrator has not acted under section 6(d) of the House amendment which authorizes immediate administrative action against

an imminent hazard, the Administrattir is required to take action under section 7. Third, the House amendment differs from the Senate bill in its definition ofan imminent hazard. Under the House amendment an imminently hazardous chemical substance or mixture is one which causes or significantly contributes to an imminent and unreasonable risk of serious or widespread harm tohealth or theenvironment. Such risk shall be considered imminentif it is shown that the

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manufacture, processing, distribution in commerce, use or disposal of a substance or mixture is likely to result in an unreasonable risk of serious or widespread harm to health or the environment before

a final rule under section 6can protect against the risk. Conference8ubtitute (8ection 7)

Theconference substitute follows theHouse language with aclarification (contained inthe Senate bill) that reliefis authorized against persons who use or dispose of an imminently hazardous substance or mixture in addition topersonswho manufacture, process, ordistribute in commerce such substances or mixtures. If the Administrator has not used the authority provided in section 6(d) (2) (A) (i) to make a section 6(a) rule iniediately effective in order to protect against an imminently hazardous substance or mixture, the Administrator mist bring an action under section 7. The conferees have imposed such a nondiscretionary duty upon the Administrator to insure that protection is provided against imminently hazardous substances, mixtures, and articles containing such substances and mixtures.

The conferees wish tonote thatwhiletheunreasonable riskofinjury must be imminent, the physical manifestations of the injumy itself need not be. Rather, an imminent hazard may be found at any point in the chain of events which may ultimately result in injury tohealth

or the environment. The observance of actual injury is not essential to establish that an imminent hazard exists. The conferees intendthat action undertheimminent hazard section be abletooccur early enough to prevent the final injury from materializing. In using the term "widespread injury" the conferees do not intend that the imminent hazard authority with respect to widespread harm be limited to instances in which the risk of injury is geographically widespread. Rather an unreasonable risk of harm affecting a substantial number of people, even though it is within a rather limited geographic area, should be deemed adequate to satisfy the requirement of an unreasonable risk of widespread injury to health. Of course if the risk of injuryto health or environment'is serious,itneed notbe widespread.

REPORTING AND IETENTION OF INFORMATION

Senatebill (8ectio n8) Section 8 sets forth requirements for reporting and retention of information. Under subsection (a) the Administrator shall issue rules which require each person who manufactures or processes a chemical substance or mixture to maintain records and to make such reports as the Administrator may reasonably require. Such rules shall require manufacturers or processors of chemical substances or mixtures who produce such substances or mixtures in small quantities solely for scientific experimentation or analysis for chemical research or analysis
to maintain records and to submit reports only tothe extent necessary forthe effective enforcement of the Act.This subsection also contains

an illustrative list ofthe kinds of information which the Administrator may require from manufacturers or processors of chemical substances.

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section (b) requires the Administrator to publish an inventory of existing chemical substances or mixtures which any person report to be commercially manufactured or processed within the United States under subsection (a) or under section 5(a). The Administrator shall publish such listnot later than 270 days after the date ofenactment. Subsection (c) requires any person who manufactures, processes,
or distributes chemical substances or mixtures to maintain records of adverse reactions to health or the environment alleged to have been caused by any such substance or mixture. These records shallbe maintained for 5years from the date theinformation was reported to such person,except thatreportsdealing withadverse reactions ofemployees shallbe retained for30years. Subsection (d) requires theAdministrator topromulgate ruleswith respect to the submission oflistsofhealthand safety studiesconducted

or initiated byany manufacturer, processor, ordistributor incommerce ofany chemical substance or mixture.The Administrator may require the submission ofanystudy appearing on the list. Subsection (e) requiresmanufacturers, processors, ordistributors in

commerce of a elemical substance or mixture as well as their liability insurers to inform the Administrator when they receive information which supports the conclusion that such substance or mixture causes
or contributes to anl unreasonable risk of injury to health or the environment. Such persons are relieved of such requirement when they have reason to believe that the Administrator hasbeen adequately informed ofthe risk.
Moumeamendment (section8)

Subsection (a) of the House amendment is substantially similar to the Senate bill except that it exempts small manufacturers or processors from the reporting requirements. The Administrator may, by rule, require such persons to maintain records and submit reports on a chemical substance or mixture subject to a rule or a proposed rule under section 4,15(c), 5(g), or 6.In addition, ifrelief hasbeen granted in an imminent hazard proceeding under section 7, theAdministrator may. by rule, require a small manufacturer or processor to maintain records and submit reports. After consultation with the Administrator of the Small Business Administration, the Administrator, shall, byrule,prescribe standards for determining whichmanufacturers and processors will beconsidered "small" manufacturers and processors. As a further limitation, section 8(a) (1) (B) specifies that the Administrator may not require the maintenance of records or the submission of reports with respect, to changes in the proportions of the compoments of a mixture, unless the Administrator finds that such recordkeeping or reporting is necessary for the effective enforcement of the Act. With respect to the.inventory of existing chemical substances required by subsection (b), the Ilouse amendment provides that the inventory shall include at least each chemical substance which any person reports under section 5 or undersection 8(a) was commercially manufactured or processed in the United States within 3 years before the effective date of the rules promnulgated under section 8(a). The House amendment requires the publication of such inventory within Iyear after the effective date of the Act.

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Subsection (c) differs from the Senate bill in that it allows the Administrator to determine, by rule, the requirements respecting the maintenance of records of adverse reactions to health or the environment alleged to have been caused by a substance or mixture. The Administrator may require that records relating to adverse reactions to employee health beretained forupto50years. Subsection (d) concerning submission oflists ofhealth and safety studiesissimilartotheSenatebill.

Subsection (e) ofthe House amendment (loes not require liability insurers to report to the Administrator information which supports the conclusion that a substance or mixture may cause or significantly contribute to an unreasonable risk of injury. Manufacturers, processors, and distributors must report information relatingto a substantial risk to health or time environment unless they have actual knowledge that the Administrator has been adequately informed of such risk.

Subsection (f) of the House amendment provides definitions of "manufacture" and "process" for the purposes of section 8. Conference substitutc (8ecthm 8)

Theconference substitute follows with somemodification theHouse amendment of section 8which outlines the policies and )rocedures for reporting and retention ofinformation. Subsection (a) identifieswhich persons must, pursuant to rules promulgated by the Administrator, maintain records and makereports.The conference substitute provides

an illustrative list of the kinds of activities for which recordkeeping and reporting may be required. The list includes such information as the identity of the chemical, categories ofuse, amounts manufactured

or processed, by products, existing data, employees exposed, and the

manner or method of disposal. The information specified may be required by the Administrator "insofar asknown totheperson maldng the report or insofar as reasonably ascertainable". The conferees intend that the "reasonably ascertainable" standard be an objective, rather than a. subjective'one. Thus, the manufacturer or processor must provide information of which a reasonable person similarly situated mightbeexpected tohaveknowledge.

Tho conference substitute retains the exemptions in the House amendment relating to reporting by small businesses. The intent of the conferees is to protect small manufacturers and processors from unreasonably burdensome reporting requirements. However, the conferees do no intend to deny the Administrator access to information which may be necessary either to determine whether a rule or order should be promulgated or to enforce a final rule or order. Therefore, the conferees have specifically authorized the Administrator to obtain reports from small manufacturers and processors of a chemical substance or mixture with respect to which a rule has been proposed or promulgated under section 4, 5(b) (4), or 6,or with respect to which

an order or rule is in effect under section 5(e) or 5(f). Thus, once a rule has been proposed, the Administrator may, by rule, issued in accordance with the informal rulemaking procedures of section 5.53 of title 5, United States Code, require reporting from small manufacturers and processors. Under such procedures, theAdministrator will

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be able to obtain timely access to needed information. Similarly, reporting may be obtained from smallmanufacturers and processors of

a substance ormixture with respect to which relief has been granted ina civil actionunder section5or7.

The conference substitute adopts, with someclarification, the House amendment in subsection (b) which requires the Administrator to compile,keep current,and publish aninventoryof chemicalsubstances and mixtures manufactured or processed in the United States. The conference committee compromised onthe datethat theAdministrator shall first publish the inventory, which publication shall take place 315days aftertheeffective date ofthe Act.

The conference substitute accepts the substance ofthe Senate bill in subsection (c), which states that records of significant adverse reactions (as defined by the Administrator by rule) shall be retained for five years after such reactions are reported. Under this provision an officer or employee designated by the Administrator may inspect the records maintained on adverse reactions. The conferees intend that persons under contract with the Administrator be considered employees of the Administrator. Such contractors and their employees may have access to records for purposes ofthis section and throughout the Act. The conferees recognize the special dangers presented to persons who are exposed to substances on a daily basis; therefore, records of adverse occupational effects must be retained for thirty years.

The seriousness, duration, and the frequency ofreactions should be taken into account in establishing what constitutes a significant adverse reaction. For example, if an individual reports that a chemical substance causes his or her eyes to become inflamed and to tear, such reaction may be attributed to an isolated allergic reaction. However,if several persons report a similar reaction, then the reaction may indeed be significant. Because the ultimate significance of adverse reactions is difficult to predict, the conferees intend that the requirement to retain records err on the side of safety. Some very serious neurological disorders, for instance, atfirst present what appear tobe trifling symptons.

The conference substitute includes the Senate version of subsection (d) concerning health and safety studies with slight modifications.Aswith the provision concerning adverse reactions,the conferees emphasize the importance of gaining information which errs on the side of too much rather than too little. Ofcourse, the Administrator isto avoid imposing unnecessary or overly burdensome 'reporting requirements. In cases where test results are'submitted, supporting data andthesources forsuch data mustbeincluded.

The conference substitute follows the House amendment for subsection (e) which provides that any manufacturer, processor, or distributor of achemical substance or mixture who obtains information supporting the conclusion that such substanceor mixture presents

a substantial risk of injury to health or the environment shall notify the Administrator, unless such person has actual knowledge that the Administrator already possesses the information.

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Senate bill (8ection 9) Section 9(a) ofthe Senate bill provides that if the Administrator (A) has reason to believe thatthe manufacture, processing, distribution in commerce, use, or disposal of a chemical substance or mixture

causesor contributes to, or is likely tocause orcontribute to,an unreasonable risk of injury to health or the environment, and (B) determines, in the Administrator's discretion, that such risk may be prevented or reduced to a sufficient extent by action taken under a Federal law not administered by EPA, then the Administrator must request the agency which administers such lawto issue an order. Such agency shall consider all data submitted by the Administrator and issue an order declaring whether or not the manufacture, processing, distribution in commerce, use, or disposal of such substance or mixture causes or contributes to or is likely to cause or contribute to such a risk. If such agency makes such determination it shall also determine ifsuch risk may be prevented or reduced to a sufficientextent byaction takenunder thelaw (or laws) administered by the agency. The Administrator may specify the time within which the other agency must issue the order, but such time may not be less than 90 days from the datethe request was made. Theother agency mustissue

a report including a detailed statement of its findings and conclusionsinresponse totheAdministrator's request.

The Administrator shall not take any action under section 6 or 7 of this Act if such other agency (A) issues an order declaring that there is no unreasonable risk of injury, or (B) initiates action under the law (or laws) administered bysuc~i agency withing0 daysof pub- lication in the Federal Register of its report'in response to the EPA req est,

Section 9(a) ofthe Senate bill also states that nothing in this seetion shall prevent the Administrator from making any subsequent request or taking subsequent action under the Toxic Substances Control Act with respect to such risks ifthe requirements of section 9(a)

are satisfied.

Section 9(a) of the Senate bill provides that if the Administrator has initiated action umder section 6 or 7 of this bill with respect to a risk of injury which is the subjectofa requesttoanother agency,such other agency must consult with the Administrator to avoid duplica- tion ofFederal action againstsuch riskbefore taking action under the laworlawsitadministers.

Section 9(b) ofthe Senate bill directs the Administrator tocoordinate actions taken underthis bill with actions taken under other Federal laws administered wholly orpartially by the Administrator. The Administrator must use the authorities contained in such other Federal laws to protect against any risktohealth ortheenvironment associated with a chemical substance ormixture unless theAdministrator, in the Administrator's discretion, determines that such risk might be
more appropriately protected against under this Act. Section 9(b) does not relieve the Administrator of any duties or responsibilities imposed by other Federal law. Nor does section 9(b) affect any final action taken under such other Federal law or the extent to which

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human health or the environment is protected under such other law. Section 9(c) of the Senate bill states that, in exercising any authority under this bill, the Administrator shall not, for purposes of section 4(b) (1) of the Occupational Safety and Health Act of 1970, be deemed tobe exercising statutory authority toprescribe or enforce standards or regulations affecting occupational safety and health.

Section 9(d) ofthe Senate.billrequires theAdministrator to consult and coordinate with the Secretary of Health, Education, and Welfare andtheheads ofother appropriate Federal agencies, departments

or instrumentalities for the purpose of achieving the maximum enforcemnent of this legislation while imposing the least burdens of duplicative requirements on those subject to the bill, and for other purposes. The Administrator shall report annually to the Congress

on actions taken to so coordinate authority under'this bill with tie authority granted under other EPA-administered laws and laws administered byotherFederal agencies.

Section 9(e) of the Senate bill provides that nothing in section 9 limits any requirement of section 4, 5 (other than section 5(e) (2)), or 8,or rulespromulgated thereunder. Ilouseamendmnt(section9)

Section 9(a) ofthe House bill is similarto section 9(a) of the Senate bill; however, there are certain differences. First, the Administrator's determination that an unreasonable risk to health or the environment may be prevented or reduced to a sufficient extent by action taken under a Federal law not administered by theAdministrator isnotdiscretionary. Second, ifsuch adetermination ismade,the Administrator shall submoit a report to the agency administering such other law. Such report shall describe such risk and include aspecification ofthe activity or activities which the Administrator has reason to believe caused or contributed to such risk. Such report shall request such agency todetermine whether the risk might be prevented or reduced to a sufficient extent by action taken under such law. Conditioned upon such a determination shall be a request that the agency issue an order declaring whether the activity

or activities specified in theAdministrator's description caused or significantly contributed to such risk, which determination and order shall be reported to the Administrator.

Like the Senate bill, section 9(b) of the House bill requires the Administrator to coordinate actions taken under this legislation with actions taken under other laws administered in whole or in part by the Administrator; however, the language of the House bill differs regarding the Administrator's authority to regulate a risk to health

or the environment associated with a chemical substance or mixture. Unless the Administrator determines that it is in the public interest to protectagainst such riskby actions taken under this Act,the House amendment requirestieAdministratortousethe authorities contained in other laws, ifsuch risk couldbe eliminated orreduced toa sufficient extent. Sections 9(c) and (d) of theHouse amendment are identical to the Senate bill. The House amendment contains no provision similar to section9(e) ofthe Senatebill.

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### The conferees have drawn from both the Senate bill and the House amendment to assure that overlapping or duplicative regula- tion is avoided while attempting to provide forthe greatest possible

measure of protection tohealth and the 

### environment.

Section 9(a) establishes the relationship between the Act and Federal lawsnot administered bytheAdministrator. IftheAdministrator has a reasonable basis to conclude that the manufacture, processing, distribution in commerce, use, or disposal of a chemical subtance or mixture presents or will present anunreasonable risk ofinjury and if the Administrator makes a discretionary determination (which is not subject tojudicial review) that the risk may beprevented or reduced to a sufficient extent by action taken under a Federal law not administered by the Administrator, then the Administrator must give the other agency an opportunity to act toprotect against the risk before the Administrator uses the authorities in section 6 or 7 to protect against the risk.

If the Administrator determines that another Federal law contains authorities adequate to prevent or reduce the suspected risk to a sufficient extent, the Administrator shall submit to the agency which administers the law a report which describes the risk, including a specification of the activity or combination of activities associated with the substance or mixture which the Administrator believes presents the risk. The report must also include a detailed statement ofthe information on which it is based. The report shall alsorequest the agency to determine if the risk described in the report may be prevented or sufficiently reduced by action taken under its law and, ifsuch determination is affirmative, to issue anorderdeclaring whether or notthe activity specified in thereport presents anunreasonable risk. The agency receiving the request from the Administrator must respond to the Administrator within such time as the Administrator specifies. -owever, the Administrator must give the other agency at least90days. Section 9(a) prohibits the Administrator from acting under section 6 or 7 with respect to the risk about which the Administrator notified the other agency if theother agency takesone of two alternativecourses ofaction. First, ifthe otheragency issues an order declaring that the activity specified in the Administrator's report does not present the unreasonible risk described in the report,then theAdministrator may not take action under section 6 or 7with respect to such risk. Alternatively, if within 90 daysofthe publication inthe Federal Register of the other agency's response, the other agency initiates action toprotect igainst suchrisk, then theAdministrator isprecluded from taking action uinder section 6 or 7with respect to such risk. If the other agency does not take one,ofthese actions, then theAdministrator is periitted to act under section 6 or 7 to protect against the risk.

The conferees recognize that the other agency may not because of time constraints be able to initiate formal regulatory actionto protect against the risk within the specified time period. As long as the other agency has officially initiated anaction which willculminate assoon as

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practicable in effective regulatory action to protect against the unreasonable risk and sets forth ageneral time schedule of steps for such action, the requirement should be deemed satisfied. 

### However, the requireinent that the other agency initiate action to protect against the risk isnot satisfied by themere open-ended possibility ofaction bythe other agency. Subsection (b) establishes the relationship between this Act and other laws administered in whole or in part by the Administrator. Subsection (b) requires theAdministrator to coordinate actionstaken under this Act with actions taken under other Federal laws administered bytheAdministrator. If the Administrator determines that a risk to health or the environment associated with a substance ormixture could be eliminated or reduced to a sufficient extent by actions taken under the authorities contained in other Federal laws, then theAdministrator shall use such other authorities unless the Administrator determines, in theAdministrator's discretion, that it is in thepublic interest to protect against such risk under thisAct. While itis clearthat theAdministrator's determination that it isin the public interest to use this Act, is a completely discretionary decision not subject to judicial review in any manner, it is expected that the Administrator will review the other authorities and present the results ofthat review atthe same time the Administrator takes action under this Act. Whilethe Administrator's decision to use this Act,, notwithstanding the other authorities, is unreviewable by any court,a reviewing court is expected to require that the Administrator have examined the other authorities and present the results of that examination when making the finding that itis in the public interest to use thisAct. Ofcourse, the requirement to examine otherEPA laws and to make determinations applies onlywhen the Administrator takes regulatory action to protect against an unreasonable risk under this Act. It does not apply when the Administrator takes action necessary for the administration or enforcement of the Act, such as issuing recordkeeping requirements. This provision is not to be construed to relieve the Administrator of any requirement imposed by other Federal laws upontheAdministrator, and of course nothing in this Act shall affect any final action taken under other Federal laws administered by the Administrator

or in any way affect the extent to which health or the environment istobeprotected undersuch otherFederal laws.

SECTION 10. RESEARCH, DENELAVPIENT, COLLECTION, DISSEMINATION AND
UTILIZATION OF DATA
Senatehill (section10)

Section 10 authorizes the Administrator to conduct research and monitoring in cooperation with the Secretary of Health, Education, and Welfare and the heads of other appropriate agencies, as is necessary to carry out the purposes ofthe Act.

The Administrator shall undertake and support programs of research and monitoring of polychlorinated biphenyls to develop safe methods of disposal. The Administrator shall also establish, administer, and assume responsibility for the activities of an interagency

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committee toconstruct within the EPA anefficient system forthecollection, dissemination, and use ofdata submitted tothe Administrator under this Act among other Federal agencies. This interagency committee shall also direct its attention to coordinating the regulation of chemical substances among the federal agencies. The Administrator shall design, establish, and coordinate all effective system for the retrieval of toxicological and other scientific data which could be useful to the Administrator in carrying out this Act. This section also authorizes the Administrator to make grants and to enter into contracts in order tocarry outhisresponsibilities under thissection. 

### Houeamemdment(section10) TheHouse version of section 10 is substantially similarto the Senate bill. However, the House amendment omits the requirement that the Administrator undertake and support programs of research and monitoring ofpolychlorinated biphenyls. The House amendment contains additional specific provisions for various research programs such
as the development of rapid, reliable and economical screening and monitoring techniques for carcinogenic, mutagenic, teratogenic, and ecological effectsofchemicalsubstances andmixtures. Conference8ub8titute (oetion 

### 10)

The conference substitute includes provisions found in both the Senate bill and the House amendment, but generally follows the language from the House version. Subsection (a) requires theAdininistrator to conduct such research, development, and ionitoring as is necessary to carry out the purposes of this Act. In doing so, the Administrator must consult and cooperate with the Secretary of Health, Education, and Welfare and with heads of other appropriate departments and agencies. The Administrator may enter into contracts and make grants for the purpose of research and development inthisarea. Subsection (b) authorizes the establislunent ofan interagency committee whoseprimary responsibility shall be todesign an efficient system within the Environmental Protection Agency for the collection ofdata (submitted to the Administrator under thisAct), the dissemination of such data to other instrumentalities ofthe Feneral Government, andtheuse ofsuch data. Subsection (b) specifies thatan efficient and effective data retrieval system shallbe developed. The conferees emphasize that sufficientdata is necessary for successful implementation of this Act, yet they also acknowledge the burdenplaced on industry by excessive or duplicative reporting. It isessential thattoxicological'and other relevant scientific data already in the possession of the Federal Government be made available to the Administrator. The efficient exchange of information among Federal agencies and departments will facilitate implenuenta- tionof this Act, and every effort should be made to achieve thisgoal and to avoid duplicative requirements in information-gathering.

Subsections (c), (d), (e), (f), and (g) ofthe conference substitute adopt provisions from theHouse amendment which concern research and development in the area ofdata collection. The conferees donot intend that such projects should detract from the primary purposes of the Act, but rather that those purposes should be enhanced by

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allowing the development ofproper tools. Thus the purpose of these subsections is to provide the means to an end, They should in no case detract from the main purposes of the Act nor Trom other equally important research conducted by the Administrator, but should contribute to the achievement of those purposes where appropriate. Of course, such research and development should not duplicate any research and development already being conducted by other Federal agencies and departments. Thus,careful coordination andconsultation with such departments andagencies isrequired.

INSPECTIONS AND SUBPOENAS

Senate bill (section 11)

TheSenate bill authorizes the Administrator orany duly designated representative to inspect any establishment, facility or other premises in which chemical substancesormixtures are manufactured, processed, storedorheld beforeorafter distribution incommerce. Inspections are also authorized of conveyances used to transport chemical substances

or mixtures in connection with distribution in commerce. Inspections mayextend to allthings within thepremises or conveyances inspected bearing on whether the requirements of the Act have been complied with.

The Senatebill also authorizes the Administratortoissuesubpoenas to require the attendance and testimony ofwitnesses and the production ofreports, papers,documents, and answersto questions orotherin formation necessary forthe Administrator carry out hisorher duties underthe Act.
House amendment (section11)

The House amendment contains a similarprovision authorizing inspections for the purpose of enforcement of the Act. However, the House amendment providesthatnoinspection shall extend tofinancial data, sales data other than shipmentdata, pricing data,personnel data,

or research data (other than research data required bytheAct) unless the nature and extent of the data are described with reasonable specificity in the written notice presented tothe owner, operator or agent in charge of the premises or conveyance to be.inspected. The House amendmentcontained nosubpoena authority. Cmferencesubstitute (section11)

The conference substitute includesthe.provision from the Senatebill with the addition ofthe House provision relating to inspections offinancial data, sales data other than shipment data, pricing data, personnel data or research data (other than research data required bythe Act or pursuant to any rule issued under theAct). The conferees recognize that the Administrator will have access to much information under section 5and section 8 oftheAct. Therefore, the conferees expect, that the Administrator will use the subpoena authority only when information otherwise available through voluniary means or uider other provisions ofthisActis inadequate tomeet the Administrator's needs under this Act.

It should be noted that the conferees intend that representatives of the Administrator authorized to make inspections should have the

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### opportunity to record the results of such inspections because such recordsmight berequired atsome later date; therefore, itis intended that persons making the inspection shall be allowed, for example, to photocopy records or photograph premises.

EXPORTS


### Sentebill (section12)

Thissection outlines thepolicyforchemicalsubstances andmixtures manufactured, processed, sold, orheld forsalesolely forexport from the United States. Subsection (a) provides thatunless ti Administrator finds that such substances or mixtures willcause orcontribute to an unreasonable risk to the health of persons within the United States or the environment of the United States, such substances are exempt from the Act (other than the reporting requirements of section 8) ifproper labeling shows that they are intended forexport use only.



### Rowever, subsection (b) allowstheAdministratortorequiretesting under section 4 to see if such substance or mixture may cause or contribute to a risk ofhealth within theUnited Statesorto theenvironmentofthe United States. Subsection (b) alsorequiresthat anyperson 

### engaged in export activities shall notify the Administrator if such activities involve chemical substances or mixtures for which data is required under section 4 or 5or for which a rule has been proposed



### or promulgated under section 5 or 6or for which action is pending

or relief has been granted under section 7.Should any such circumstance arise, the Administrator shall furnish the appropriate foreign government with relevant information pertaining to the chemical substance subjecttothelimitationsofsection 14. Houseamendment (sectio"123)



### Except forminordifferences inlanguage,theHouse amendmentfollows theSenate provision. TheHouseprovision alsospecifically covers articles containingchemical substances. ConfereMwe substitUte(section

### 123)

The conference substitute follows the policy set forth in both the Senateand Houseprovisions toprotect the health andenvironment of persons in the United States and to provide information to foreign governments regardingchemical substances and mixtures, sothatsuch foreign governments can protecttheir own citizens.

ENTRY INTO CUSTO3S TERRITORY OF THE UNITED STATES


### SenatebVl (section13)

The Senate bill instructs the Secretary of the Treasury to refuse entry into the United States of any chemical substance or mixture 

### offered for entry if it fails to conform with any requirement of the Act or any rulein effect under the Actor ifit is otherwise prohibited from being distributed in commerce. 

### If a substance or mixture is refused entry, 

### the Secretary ofthe Treasury is required to notify the consignee of the entry refusal. If the substance or mixture is not exported within 90 days, the Secretary is to cause the disposal or storage ofthe substance ormixture.

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### Homseamendment(section13)

TheHouse amendmentcontains asimilarprovision. Conferenm substitute(seotion18)

The conference substitute adopts the provision found in both the Senate bill and the House amendment relating to entry into the customs territory of the United States. Although the Secretary of the Treasury is authorized to cause the disposal of substances and mixtures which have been refused entry and are not exported within 90 days, the conferees intend that the Secretary consult with the Administrator before determining the disposal methods for the substance or mixture.

DISCLOSURE Or DATA
Senate bill (section 14)

The Senate bill provides generally that all information obtained by the Administrator under this Act shall be subject to the Freedom of Information Act (5 U.S.C. 552). The Freedom of InformationAct makes such information available to the public upon request, unless the information requested falls into one of nine exceptions.

The Senate bill also requires the disclosure of data in certain further specified situations. If officers or employees of the United States request information in connection with theirofficial dutiesunder laws protecting human health or the environment or for specific law enforcement purposes, then the Administrator must disclose the information to them.

Likewise, the Administrator must disclose information to the public whenever the Administrator determines it is necessary to protect human health or the environment. If the Administrator determines that disclosure of information is necessary for a contractor or the contractor's employee to perform official duties satisfactorily under contracts for the United States in connection with this Act,then the Administrator must disclosethe information. Finally,theAdministrator must disclose information to any duly authorized committee of Congressuponwritten request.
Houee amendment (8cti(n 14)

The House amendment contains some similarities to, but also some differences from, the Senate bill. Whereas the Senate bill states that the Freedom ofInformation Actapplies except incertain areas where disclosure is mandatory, the House bill statutorily prohibits the disclosure of information which falls into one of the exemption categories (subsection (b) (4) (5 U.S.C. 552(b) (4))) of the Freedom of Information Act.

Subsection (b) (4) ofthat Act encompasses matters that are trade secrets and commercial orfinancial information obtained from a perso and privileged or confidential. TheAdministrator maynot disclose information under that classification except to officers or employees of the United States in connection with their duties to protect health

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serve confidentiality as much as possible without impairing the proceeding.

Subsection (b) (1) specifically provides that disclosure of any health and safety study for any chemical substance or mixture which is already being distributed or for which testing is required under section 4 or for which notification is required under section 5,is not prohibited. Data in such a study which discloses a manufacturing process orthe proportions of a mixture may not be disclosed if such process or proportions would otherwise be entitled toprotection from disclosure.

Subsection (c) authorizes any person who submits data under the billtodesignate information hebelievesisentitled toconfidential treatwent under section (it). Designated information may not be released for 30 daysafter notification ofreleasehas been receivedby theperson submitting such data. Conference siubstitute (section, 14)

The conference substitute adopts elements of both the Senate bill and the House amendment. The prohibition against disclosure ofinformation exempt from mandatory disclosure under section (a) of section 552 of title 5, United States Code, by reason of its falling within the exemption under suhsection (b)(4) of such section, is included. Section 14 applies to any release of information obtained tinder theAct.

Mandatory exceptions from this prohibition are also provided. Disclosure of iniformation described in section 552(b)(4) of title 5 is required in thefollowingsituations: (1) Toofficers or employees ofthe Uinited States in conneection with their official duties to protect health or the environment, and forspecific law enforcemenlt purl)oss. (2) To contractors with the United States when tihe Administrator determines it to be necesary for the satisfactory performance of their duties in connection' with this Act and under such conditions as necessary to preser e confidentiality as the Administrator may specify.. (3) If the Administraitor dutermines it necessary to protect health or the ,nvironment against an unreasonable risk of injury to ]lalth orthe enviromnent. In addition, the Administrator may disclose such information when relevant under a proceeding under this Act, except that disclosure under such proceeding shall be mnadc in such a manner as to preserve confidentiality tothe extent practicable withoutimpairing the hearing. It is intended that the Administrator exercise due care to prevent the release of confidential information to competitors of persons submitting data merely because the competitors havejoined the proceeding. In any procee'ding undei rsection 552(a) oftitde 5to o)tain information which the Administrator has refused to release on the basis that disclosureisprohibited by section 14(a) ofthis Act, the Administrator may,not rely on section 5.1;2(b) (3) of title 5 to sustain the refusal to disclose the'information. Thus the Administrator will have to show that the infomiation falls within sectioo 552(b) (4) of title 5. Of course, section 552,oftitle 5isthe vehicle through which the publiccan obtain information from the Fe(eral governmnt, and all the l)roviHeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 703 1976

### 91

sions of that section will apply to requests for information obtained under this Act. Theconference substitute specifically provides that disclosureofany health and safety study or information from such a study on any substance or mixture which isalready being distributed or forwhich testing is required under section 4 or for which notification is required under section 5, is not prohibited. Data in such a study which discloses manufacturing processes or the proportions of a mixture may not be disclosed if such processes or proportions would otherwise be entitled toprotection fromdisclosure.However, any restriction on the release of such data will not apply to the health and safety study in whichit iscontained or from which itisderived. Tocomply with such restriction the Administrator need only to exclude such data when releasing such study.

If a request ismadetothe Administrator forhealth and safety study information whichisnotentitled toprotection,the Administrator may not deny arequest under section 552 oftitle 5,United States Code, on thebasisthatsuch information isincluded in the exceptions to mandatory disclosure enumerated in subsection (b) (3) or (b) (4) of such section. It is also intended that the Administrator not use exception (b) (7) of section 552 oftitle 5,relating to mattersunderinvestigation, in an excessi4 manner as a device for withholding information subinitted under this Act. In order to be withheld under that exception, theinformation mustbethe subjectofanongoing, activeinvestigation. In submitting data, a person may designate data which the person believes isentitled to confidential treatment under thisAct and submit it,separately. If the Administrator proposes to release for inspection designated data, the Administrator must give 30 days notice to the person who submitted the information. Thirty days advance notice need not be given when information is to be released under one of the mandatory exceptions described above or when disclosure is not prohibited because the information is health and safety data. When disclosure is proposed because it is necessary to protect health and the environment from an unreasonable risk, the Administrator shall provide the person submitting the data written notice by certified mail of the proposed release at least 15 days prior to the release. The purpose of this provision is to provide the person submitting the data an opportunity to seek to stop the proposed release ifthat person disputes the Administrator's determination. The conferees recognize that there may arise emergency situations in which the Administrator determines that earlier release is necessary. In such
cases, where the occurrence of the unreasonable risk is imminent, the Administrator need give notice only 24 hours prior to release. The required notice need not be given in writingbutmay be made by some other means such astelephone or telegraph.

The criminal penalties for wrongful disclosure contained in the I-rousebill havebeenincluded inthe conference substitute.

PROJUBITED ACTS ,enate 

### bil (section 15)

The Senate bill makes it unlawful for any person to fail or refuse to comply with any rule or order promulgated under section

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4, 5, or 6, or any requirement prescribed by section 5 or 6. It also makes it unlawful forany person to useor dispose of achemical substance or mixture which the person knew or had reason to know was manufactured, processed or distributed in commerce in violation of section 5or a rule or order under section 6. Failure or refusal to establish ormaintain records, submitreports, notices, or other information or to permit access to, or copying of, records is also unlawful. Finally,the Senate amendment makes unlawful the failure or refusal topermitentry or inspectionasrequired by section 11.
Houseamendrnent(section15) The House amendment makes it unlawful for any person to fail or refuse to comply with any rule or order promulgated under section 4, 5or 6 or any requirement prescribed by section5. It also makes itunlawful for any person to use forcommercial purposes achemical substance or mixture which the person using such substance or mixture knew orhad reason to know wasmanufactured, processed or distributedincommerce in violationofsection5,aruleororderunder section 5or 6or an order issued in an action brought under section5or7. The House provisions respecting maintenance of records, submission of reports, entry, and inspections are identical to the Senate bill. Conferencesubstitute(section15)

The conference substitute incorporates the provisions of the House bill withaconforming amendment making violations ofthe provisions of section 6 relating to polychlorinated biphenyls an unlawful act.

PENALTIES Senatebill(section16)

Thissection outlinesthe penalties and procedures forassessing penalties against persons who violate section 15. Subsection (a) provides for civil penalties of up to$25,000 per day per violation. Taking relevant factors into account, the Administrator shall assess the amount of such civil penalties in an order made on the record after the opportunity for an adjudicative hearing and proper notification ofthe person in violation of this Act. Such person may file a petition for judicial review of an order assessing civil penalties in U.S. Court of Appeals within thirty days; however, if aperson failstopay such assessment after it has become a final and unappealable order or after the Court ofAppeals has found in favor of the Administrator, then the Attorney General shall recover the amount assessed. Subsection (b) provides for criminal penalties of up to $25,000 per day or up to one year's imprisonment, or both, per violation for any person whoknowingly orwillfullyviolatesthisAct.
Houseanednient(seetion16) The House amendment follows subsections (a) and (b) ofthe Senate provision. In addition, subsection (c) of the House Amendment provides that the Administrator may require aperson who has manufactured, processed, or distributed a chemical substance or mixture in violation of regulations issued under paragraphs (1) o2 (2) of section 6(a) to give notice ofthe risk associated with that substance to any person who may be exposed to it and to the public at large.

HeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 705 1976The Administrator may also require such person to either replace or repurchase the substance foundto bein violation. The Administrator may choose any or allofthe remedies set forthin subsection (c) ;however, ineach case the order must bemade on the record with full opportunity for anagency hearing. Conferencesub8titute(section16)

The conference substitute adopts the provisions found in bothbills concerning civil and criminal penalties for violations of this Act. Under subsection (a), the Administrator shall assess the amount of civil penalties up to $25,000 per day per violation; however, the Administrator must take into account such factors asthe gravity and extent ofthe violation, the ability to pay oftheperson held in violation,and anypriorhistory ofviolations underthisAct.

Criminal penalties may be imposed on persons who "knowingly or willfully" violate anyprovisionofsection 15, which setsforthunlawful acts.
SPECIFIC ENFORCEMENT AND SEIZUIl

Senatebill(aection17)

The Senate bill grantsthe United States district courtsjurisdiction, upon application of the Administrator or the Attorney General, to restrain any violation ofsection 15, torestrain any person from manufacturing or processing a chemical substance before the expiration of the notification period under section 5, and to restrain any person from taking any action prohibited by arequirement prescribed under section 5 or 6 or rules or orders issued under section 5 or 6. In addition, thecourts are grantedjurisdiction todirect any manufacturer or processor ofa chemical substance ormixture who isnotin compliance with any order issued under section 5(e) orany rule issued undersection 4 or 6 to give notice of such fact to persons within the chain of distribution and to the public, and to either replace or repurchase the substance or mixture.TheSenate provision also authorizes the district bution and to the public, and to either replace or repurchase the substance or mixture. The Senate provision also authorizes the district, courts to compel the taking of any action required by or under the Act. In addition, the Senate bill provides that any substance ormixture manufactured or processed or distributed in commerce in violation ofthe Act or any rule or order promulgated under the Act shall be liable to be proceeded against for seizure and condemnation.
Hou8e amendment (8ection 17) The ]House amendment grants jurisdiction to the district courts to restrain any violation of section 15, torestrain any person from manufacturing or processing a substance before the expiration of the notification period under section 5, and to restrain any person from taking awtion prohibited by section 5 or a rule ororder under section 5 or 6. Jurisdiction is also granted to compel the taking of any action requiredby orunderthisAct. Theseizure authorityinthe Houseamendment is similar to that found in the Senate bill, except that seizure and condemnation of articles containing chemical substances or mixtures tminufactured, processed or distribnted in commerce in violation ofthe Act or any rule or order promulgated underthe Act isspecifically authori7ed.

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Qon/erenwe substitute

The conference substitute grants the district courts of the United States jurisdiction to restrain any violation of section 15, to restrain any person from manufacturing or processing a substance before the expiration of the notification period under section 5, and to restrain any person from taling any action prohibited by section 5 or 6 or a rule or order under section 5 or 6. The provision also grants such courts jurisdiction over actions to direct any manufacturer or processor of a chemical substance or mixture manufactured or processed in violation of any order issued under section 5 or any rule or order issued under section 6 to give notice of the risk associated with the substance or mixture to persons in the chainof distribution and tothe public. The courts also have jurisdiction to require manufacturers or processors to either replace or repurchase the substance or mixture, whichever the person to whom the requirement is directed elects. The conference substitute also grants jurisdiction to compel the taking of any action required by or under the Act. The seizure authority in the conference substitute is identical to that contained in the House amendment.

PREEM ITION Senate bill (section 18)

This section outlines the relationship between State authority and the authority under this Act to regulate chemical substances or mixtures. Subsection (a) asserts the State's authority to regulate, with certain limitations. No State may require testing which duplicates testing required by the Administrator under a section 4 testing rule. Further, iftheAdministrator has prescribed a requirement under section 5or 6to protect against a particular riskassociated with achemical substance or mixture, a State may not prescribe any different requirement (other than a totalban) with respect tothat riskunless the State obtains permission from the Administrator todo so. 

### rhe Administrator may, by rule, grant such permission if the Administrator findsthat compliance with theState requirement would not result in a violation of this Act., would result in a significantly higher degree of protection, and would not unduly burden interstate

commerce. Houseamendment(8ection18)

The House amendment is similar to the Senate bill. However, rules promulgated under section 6(a) (5) do notpreeript State laws. Moreover, rules pronmulgated under other Federal authorities such as the Clean Air Act, are not preempted by requirements under this Act.

Like the Senate bill,the House amnendment authorizes the Administrator to exempt, by rule, States from prohibitions under subsection (a) inthe same mannerasthe Senate bill. 

### Conferencesubstitute (section 18)

The conference substitute provides that no State or political subdivision may establish similar requirements for the testing of a substance or miixture after the Administrator has issued a rule under section4 respecting the substance ormixture. Nor may any State regulate any risk associated with a substance or mixture iftie Administrator has prescribed a rule or order under section 5 or 6, which is

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designed to protect against the risk to health or the environment, unless the rule (A) is identical to that issue under this Act, (B) is adopted under the authority of anotherFederal law, or (C) prohibits the use of such substance ormixture otherthan inits use inthemanufacture or processing ofother chemical substances or mixtures.

In addition to the specific exemptions from the preemption pro- vision, the conference substitute provides a means whereby a State or political subdivision may seek an exemption from the preemptive effects of a Federal requirement in order to provide a higher degree of protection for their citizens than that provided by a requirement under this Act. The Administrator may, by rule,grant an exemption if compliance with the State or local requirement will not cause a violation of the applicable requirement under this Act, if the State

or local requirement will provide a significantly higher degree ofprotection from the risk, and if the State or local requirement will not unduly burden interstate commerce.

JUDICIAL REVIEW
Senate bill (section 19)

The Senate's provision authorized pre-enforcement judicial review of any rule under the Act or an order issued under section 5(e). Any rule promulgated under section 3(b), 5 or 6 shall not be affirmed 1i1il.s. SIpl)Jorte(d by sulstantial evidence on the record takenas a whole. Ilou,8e amendment (section 19)

The House provision authorizes pre-enforcement judicial review of rules issued under section 4, 5 or 6(a). Such rules shall not be affirmed unless supported by substantial evidence based on therecord takenas awhole. Conference substitute (section 19)

Section 19 ofthe conference substitute provides forjudicial review in the courts of appeals oftheUnited States forcertain rules promulgated under the Act. Thejurisdiction for preenforcement review and review of determinations of the Administrator relating to cross-examination is exclusively vested in such courts. Not later than 60 days after the date ofpromulgation of a rule under section 4(a), 5(a) (2), 5(b) (4), 6((a), 6(e), or 8 any person may file a petition for judicial review oftherulein the appropriate U.S.court ofappeals. The section specifically defines the rulemaking record toinclude the rule being reviewed (which would include the statement ofbasis and purpose pursuant to section 553(c) oftitle 5,United States Code), any transcript required to be made of an oral presentation, any written submission of interested parties, and anyother information which the Administrator considers to be relevant to the rule and with respect to which the Administrator published anotice in theFederal Register identifying the information on orbefore the date ofthe promulgation of such rule, In addition certain findings and statements required to be made with respect to specific rules must also be included inthe rulemaking record. In the case of a rule under section 4(a), the finding required by that section must be included in the record. In the

case of a rule under section 5(b) (4), the finding required to be made

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by that section must be included in that record. In the case ofa rule under section 6(a), the finding required by section 5(f) or section 6(a), as the case may be, and the statement required by section 6(c) (1) mustbeincluded'in therulemaking record.

The section includes authority for the submission ofadditional data and oral or written views and for the modification ofthe rule being reviewed. Generally section 706 of title 5, United States Code, applies to review of a rule under this section. However, in thecase ofreview of

a rule under section 4(a), 5(b) (4), 6(a) or 6(e), the bill provides that thecourts shallhold unlawful and set aside such ruleifthecourt finds that the rule isnot supported by substantial evidence intherulemaking record taken as awhole. Thisprovision is inlieu ofparagraph 2(E) of section 706 of title 5. It is theintent ofthe conferees that the traditional presumption of validity of an agency rule is to remain ineffect. Theconferees recognize thatin rulemaking proceedings such

as those contained in this bill, which are essentially informal and which involve both determinable facts and policyjudgments derived therefrom, the traditional standard for review is that of "arbitrary and capricious". However, the conferees have adopted the "substantial evidence" test because they intend that the reviewing court focus on therulemaking record to see iftheAdministrator's action is supported by that record. Of course, the conferees do not intend that the court substitute itsjudgmentforthat oftheAdministrator.

Further,in the caseofreview ofa rule under section 6(a), the court shall set the rule aside if it finds that action bythe Administrator in excluding or limiting cross-examination or rebuttal submissions pre- cluded disclosure of disputed issues of material fact necessary for a fair determination of the rulemaking proceeding taken as a whole. Also, in review of such rules, section 706(2) (D) will not apply with respect to review ofthe Administrators actions respectig limitations
orexclusions ofcross-examination or rebuttal submissions, and review of such actions can occur only during preenforcement judicial review. Section 19 also provides that the court may not review the contents and adequacy ofany statement required to be made pursuant to section 6(c) (1) or any statement of basis and purpose required by section 553(c) oftitle' ofUnited States Code to be incorporated ini the rule except as part of a review of a rulemaking record taken as a whole.

Section 19 provides that in ajudicial review proceeding under this section the court may award the costs of suit and reasonable fees for attorneys and expert witnesses if the court determines that such an award is appropriate. In addition, in any review of such an action the Supreme Court may also award such costs of suit andreasonable fees. he section also provides that the remedies provided in section 19 shallbe in addition to, and notin lieu of, any other remedies provided by law. This provision should notbe construed, however, tonegate the provision in this section which specifically provides that the United States courts of appeals shall have exclusive jurisdiction ofany action to obtain judicial review (other than in an enforcement proceeding) ifany district court ofthe United States would have hadjurisdiction ofsuch anaction butforthe provisionsofthis section.

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CITIZEN'S CIVIL ACTIONS

Senate bill (8ection 20)

Subsection (a) authorizes any person to commence a civil action in specified district courts against (A) any person including the United States or any governmental agency or instrumentality alleged to be in violation of this Act or any rule or order prescribed under sections 4, 5, or 6(a). Such suitsmay also bebrought to compel the Administrator to perform any nondiscretionary act or duty. Subsections (b), (c),and (d) specify certain procedural provisions. No action may begin until the Administrator and the alleged violator have received proper noticeofthealleged violation. If theAdministrator has instituted a civil action against an alleged violator to compel compliance, thennoactionmaybebroughtunderthissection. However, if the Administrator does not commence such action until after the person bringing the citizen's civil action has notified the alleged violator of intention to sue under this Act, then the person who gave such notification may intervene in the suit brought by the Administrator. The Administrator may intervene in any civil action under this section to which the Administrator is not a party.The court may award the costs of the suit and reasonable fees for attorneys and expert witnesses. The court may also consolidate two or more civil actions involving the same defendant, the same issues, or the same allegedviolations when appropriate.
House amendment (section 0)

The House amendment contains the same provision as the Senate bill. 

### Conference substitute (section

### 20)

Theconference substitutecontains theprovisionincluded inboththe Senate bill andthe Houseamendment with aclarification thatcitizen's civil actions may also be brought for violations of an order under section 5 or 6.
CITIZENS' PETrIONS

Senate bill (section21) Section 21 ofthe Senate bill authorizes any person to petition the Administrator to issue a rule or order or to take other action forthe purpose ofprotecting against an unreasonable risk ofinjury tohealth

or the environment. If thepetition is denied or notacted upon within 90 days, the petitioner may bring a civil action in a United States district court to compel the Administrator to initiate the requested action. If the petitioner demonstrates by a preponderance of the evidence in ade novo proceeding thatthe action requested inthe petition conforms to the applicable requirements of the Act, the court shall orderthe Administrator toinitiatetherequested action.
House amendment (section 21) The House amendment authorizes any person to petition the Administrator to initiate a proceeding for the issuance, amendment, or repeal ofa rule undersection 4, 5(c), or 6(a). If the petition isdenied, the petitioner may file a civil action to compel the Administrator

HeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 710 1976to initiate the rulemaking proceeding. If the petitioner requests the issuance of a rule under section 4, 5(c), or 6(a) (as opposed to the modification or repeal of such a rule) thepetitioner has an opportunity fora de nove proceeding before thecourt. If the petitioner makes the requisite showings for the applicable provision, the court must order the Administ.rator to initiate the requested action unless the
court finds that the failure of the Administrator to initiate the requested action wasnotunreasonable. Conference 8ubstitute (section 21)

The conference substitute authorizes any person to petition the Administrator to initiate a proceeding for the issuance, amendment or repeal of an action under section 4, 5(e), 6, or 8 ofthe Act. It should be noted that a petition under this section may be used to initiate a proceeding under section 5(f) since aproceeding under that section is for the issuance of a rule under section 6(a). The Administrator must grant or deny any petition under this section within 90 days after it is filed.

The conference substitute thereafter provides for different judicial review of the Administrator's denial of a petition, depending upon whether such petitionseeksthe issuance ofarule ororderorthe amendment or repeal ofan existingrule ororder. The substitute affords greater rights to a person petitioning for the issuance of a ruleor order because in such a situation the Administrator will notpreviously have addressed the issueby rule or order.If the Administrator denies or fails to respond to a petition for the issuance of a rule or order, the petitioner may commence a civil action in a United States district court to compel the Administrator to take the action requested in the petition. In the court, the petitioner isentitled to a de nero proceeding. If the petitioner demonstrates to the court by a preponderance of the evidence that there is an adequate basis for the issuance of the rule or order requested, the court shall order the Administrator to initiate therequested action. The court may defer requiring the Administrator to take the requested action ifit finds that the extent ofrisk of injury to health or the environent alleged by tie petitioler is less than those risks of injury which the Administrator is addressing under this Act andthere

are insufficient resources todo both. If a deferral is granted, the conferees anticipate that theAdministrator mayseekextensions asneeded.

The conference suibstitute provides different treatment for review of petitions for amendment. or rel)eal of rules or orders, because the Administrator already will have addressed the general subjectmatter in an existing rule or order and the Administrator's determination will have been subject to review under section 19 of this Act. Therefore, theconferee's min interest,isto make certain that any such petitioner receive timely consideration of such petition. By requiring the Administrator to acton any such petition within 90 dlays, theconferees will facilitate such a petitioner's right to seek judicial review should the Administrator deny the petition. Otherwise, the Administrator could avoid anyjudicial review simply by failing to take any action. Fhe conferees believe that a petition for amendment orrepeal ofaii existinog rule or order should contain newly discovered, noncumulative

HeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 711 1976material which was not presented for the Administrator's consideration in promulgating the rule or order. Failure to include such information would be an adequate basis for denying thepetition. At the same time, theconferees do not intend that theAdministrator be subjected to constant petitions challenging rules or orders for which adequate judicial review is provided under section 19. Therefore, if the Administrator denies a petition to amend or repeal an action under section 4, 5(e), 6, or 8, the conference substitute permits review ofsuch denial onlyunder theAdministrative Procedure Act.

NATIONAL DEFENSE WAIVER Senatebill (section22)

The Senate bill directsthe Administrator to waive compliance with nny provision of this Act upon the request of the Secretary of Defense and a determination by the President that the interest of national defense requires such a waiver. The Administrator shall maintain awritten record ofthe basisforthe waiver. In addition, the Administrator shall publish notice of the waiver in the Federal Register, unless the Administrator determines, upon request from the Secretary ofDefense, that such publication is contrary to national defense interests, in which case, the Administrator shall notify the Armed Services Committees of the Senate and the House of Representatives.
House amendment (section22)

The House amendment is similar to the policies and procedures ofthe Senate bill except that onlythe President,not the Secretary of Defense, is authorized to request a national defense waiver from the Administrator and to request that publication of the waiver not be placed inthe FederalRegister fornationaldefense reasons. 

### Conference8UbstitUte (section

### R2)

The conference substitute includes the provision of the House amendment.

EMPLOYEE PROTECTION Senate bill (section23) Section 23 ofthe Senate billprovides protection foremployees who cooperate with the Administrator in carrying out the Act. The provision prohibits any employer from discharging any employee or otherwise discriminating against the employee with respect to compensation, terms, conditions, orprivileges ofemployment because the employee commenced,caused tobe commenced, orisabouttocommence
a proceeding under theAct.Protection isprovided for employees who have testified or are about to testify in any proceeding under the Act

or who have assisted or participated in a proceeding or any other ac-' tiontocarry outthepurposes oftheAct.The Secretary ofLabor shall conduct investigations ofalleged violations and issueordersto require any person who violates the prohibitions totake affirmative action to remedy any such violation. Any person adversely affected by anorder ofthe Secretary may obtainjudicial review ofthe order in the United Statescourt ofappeals forthecircuit in whichthe violation allegedly occurred. The Secretary is authorized toenforce theorders in the disHeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 712 1976100

trictcourt ofthe United States for the district in which theviolation 

### occurred.
Houeamendment (section23) TheHouse amendment contains an identical provision. Oonference8ub8titlte(section

### 23)

The conference substitute adopts the provision found in both the SenatebillandHouse amendment.

EMPLOYMENT EFFECTS
Senate bill (aection

### .3(f))

The Administrator shall conduct continuing evaluation of the effecton employment of rules or orders under thisAct. Any employee who isdischarged orwhose employment isthreatened or who isotherwise discriminated against as a result of any action under this Act may request investigation of the matter by the Administrator. The Administrator shall investigate the matter. If any interested party requests a hearing, the Administrator shall conduct a public hearing in accordance with section 554 oftitle 5, United StatesCode, atwhich ,he parties are required to present information on any employment effects.

Upon receipt of the investigation report, the Administrator shall make findings offact as to the employment effects and shall make appropriate recommendations which shall be available to the public.
Joueamendnwvt (section

# 04)

The I-louse amendment issimilar to theSenate bill.The House provision differs from the Senate's primarily as to whether and how a hearing requested by an interested person shall be conducted. Upon request, the Administrator must hold a public hearing unless the Administrator determinesthat there areno reasonable grounds for such hearing. The hearing need not be a formal adjudicative hearing under 5U.S.C. 554. Provision is made for subpoenas, oaths, and paynient of witness fees in connection with any investigation or public hearing conducted under this section. Conferencesubstitute(8ection

## £4)

The conference substitute follows the House amendment with two modifications. First, if the Administrator determines that there are
no reasonable grounds for holding a hearing,the Administrator must
so find, by order, within 45 days of the date within which time such hearing isrequested. Second, ifa hearing is held,it shallbe inaccordance with the requirements of section 6(c) (3) of this Act.

STUDIES Senatebill (section

## .4)
TheSenate bill requires the General Accounting Office toconduct a study ofall Federal laws administered bythe Administrator to deterninewhether andunder whatconditions,ifany, idemnification should be accorded any person as a resultof action taken bythe Administrator under such laws. The Senate bill also requires the Council on Environmental Quality to coordinate a study of the feasibility of

19.313 0

- 77

- 40

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establishing a standard classification system of chemical substances and related substances and a standard method forstoring and obtaining rapid access to information respecting such substances.
Houseamend-ment (section25)

The House amendment contains a similar provision except that the indemnification study shall be conducted by the Administrator and reviewed by the General Accounting Office.
Con/erenwesubstitute (section25)

The conference substitute includes the House provision.

ADMINISTRION OF THE ACT
Senate bill (section26) Subsection (a) gives authority to each federal department and agency to cooperate with theAdministrator, upon request, by sharing services ofpersonnel, facilities, and information in order to carry out the purposes of thisAct. Subsection (b) provides that the Administrator may, by rule, require payment from any person submitting data pursuant to section 4 or 5to help defray administrative costs, provided that no such fee exceeds $2,500.

Under subsection (c), the Administrator may act with respect to categories of cmical substances or mixtures. For purposes of this section, a category includes chemical substances or mixtures grouped hv virtue of similarity of chemical structure, physical, chemical, or biological properties, useor mode ofentry intothehuman body or environment, or someother suitable grouping.

Under subsection (d), any proposed orfinal ruleor orderunder this Act shall be accompanied by a statement ofpurpose andjustification, which identifies the basis for the action. This statement shall become part ofthe "record ofthe proceedings" forpurposes ofjudicial review under section 19(a).

Subsection (e) directs'the President to appoint by and with the advice and consent of the Senate, an Assistant Administrator ofthe Environmental Protection Agency toadminister this Act.The Assistant Administrator slhall be qualified to direct a program concerning the effects of chemicals on health and the environment by reason of background and experience.
Hou.eamendment (section£6')

The House amendment contains provisions similar to the Senate billconcerning cooperation among federal agencies and feesto be paid by persons submitting data under section 4 or 5to defray administrative costs, except. that no small businesses shall be required to pay administrative fees exceeding $100. The House amendment also inincludes a provision on categories similar to that in the Senate bill.

No provision is made in the House amendment for apl)ointment of

an Assistant Administrator forToxic Substances. However, theHouse amnendmenit establishes an oflice within the Environmental Protection Agency to provide technical andother nonfinancial assistance to manufacturers and processors of chemical substances and mixtures concerning the requirements and application of this Act.

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### 1M2

The House amendment does notcontain a specific provision requir ing that each proposed or final rule pr order be accompanied by s statement ofpurpose orjustification.

The House amendment in section 29 provides that each officer and employee ofthe Environmental Protection Agency and the Secretary ofHealth, Education, andWelfare whoperform anyfunction or duty underthe billand who has anyknown financial interest in any person subject to the bill or in any person who applied for or received any financial assistance pursuant to the bill must, beginning February 1, 1977, annually file with the appropriate agency or department a statement concerning all such interests during the preceding calendar year. Such statement must be available to the public.

The I-ouseamendment alsodirects theAdministrator andtheSecretary, within 90 days after enactment,to define "known financial interest" andtoestablish methods tomonitor, enforce, and reviewthe filing of such statements. They are also directed to report eachyear to Congress onJune 1regarding such disclosures and actions taken concerningthem duringthepreceding calendar year.

Officers or employees in designated positions ofa nonregulatory or nonpolicymaking nature maybe exempted, by rule,from the requirements ofthis section.

The House amendment states that any officer or employer who is subject to, ant knowingly violates, this section or any regulations issued thereunder is to be fined not more than $2,500 or imprisoned fornotmorethanone year,orboth. Cmofereneesub8titute (8ection£6)

The conference substitute incorporates provisions from both the Senate bill and theHouse amendment. Subsection (a) gives authority to each federal agency and department to cooperate with the Administratortocarry outthe purposes ofthis Act.

The Administrator is authorized to require, by rule, payment of reasonable fees fromany person required tosubmit data.under sections 4 and 5 in order todefray the costs of administering this Act. In no
case shall suchfeesexceed $2,500, or$100 in thecaseofa smallbusiness. In all cases when setting such fees, the Administrator shall take into account the ability to pay of persons submitting data.

The conference substitute includes the House provision concerning categories in subsection (c). The conferees expect that the Administrator will find the authority to categorize especially helpful in promulgating rules under section 5(a) (2) concerning what constitutes significant newuseofchemical substances.

The conference substitute adopts the provision from the House amendment whichestablishes an office within EPAtoprovide technical and other nonfinancial assistance to manufacturers, processors of chemicals, and others. The purpose of the office is to help manufacturers and processors understand the requirements ofthe Act in order to assist in itsefficient implementation and to avoid unnecessary confusion, which might prove detrimental to the chemical industry and the public interest.

. The conference substitute adopts the House provision on financial disclosures for which the Senate bill had no comparable provision.

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The procedures and penalties are designed to make sure that persons who perform regulatory functions under this Act divulge any known financial interest such persons may havein any person subject to this Act. Subsection (f) of the conference substitute modifies the requirement in the Senate amendment that each proposed or final rule or order be accompanied by a statement of basis and purpose to apply only tofinalorders.

The conference substitute includestheprovision foundin the Senate bill that the President appoint, with the advice and consent of the Senate, an Assistant Administrator for Toxic Substances who shall direct iiprogram concerning the effects ofchemicals onhuman health and the environment and perform other duties and responsibilities under this Act. While the Assistant Administrator for Toxic Substances will be assigned responsibilities pursuant tothis Act,the Administrator may assign additional duties.Ofcourse this position will be in addition to the eisting five assistant administrator positions established by Reorganization Plan No.3of 1970.

DEVEOPMENT AND EVALUATION OF TEST METHODS

Senate bill

The Senate bill contains no provision respecting development and evaluation of test methods.
HIoueamendment (8ection

### 27)

The House amendment authorizes the Secretary of Health, Education, and Welfare, in consultation with the Administrator and acting through the Office of the Assistant Secretary for Health, to conduct projects for the development and evaluation of inexpensive and efficient methods for determining and evaluating the health and environmentaleffects ofchemicalsubstances andmixtures. Conf erenwesubstitute (section27) The House provision is included.

STATE PROGRAMS Senate bill (section 25) Section 25 authorizes theAdministrator to assist up to three states in the establishment of demonstration programs to complement federal efforts under the Act. Subsection (a) describes the functions of such programs. Subsection (b) requires the Administrator to submit unnual reports to the Congress on the demonstration programs. Subsection (c) authorizes appropriation of funds to assist the states in funding the demonstration programs. Grants shall not exceed 75 percent of the cost of any demonstration program. Subsection (d) provides that, assistance slhall be available to those states which can establish a priority need for such assistance. The Senate bill authorizesa maximum appropriation of$2 million for the fiscal year ending September 30, 1977,$2 million forthefiscal year ending September30, 1978, and $2million forthe fiscal year ending September 30, 1979.

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Hou8eamend~nent (section28) The House amendment is similar to the Senate bill, but differs in that grants are authorized only to assist states in addressing risks associated with substances and mixtures which the Administrator is unabletoaddress. Tim House amendment does not restrict the number ofprograms which the Administrator may approve. The House amendment authorizes an annual appropriation of $1 million for the fiscal years ending September 30, 1978, September 30, 1979 and September 30, 1980. Conference substitute (section28)

The conference substitute generally follows the House amendment with some modification. The.Administrator may make grantsto States to establish programs to )revent or eliminate unreasonable risks associated with chemical substances ormixtures against which theAdministrator isnot able ornot likely to take action under thisAct.The confereesagreed to a compromise on the authorization for such programs of$1.5 million for each ofthe fiscal years 1977 through 1979.

.%UTHORIZATrON FOR APPROPRIATIONS
Senate bill (section .7)

Section 27 of the Senate bill authorizes to be appropriated to the Administrator $11,100,000 for the fiscal year ending June 30, 1976, $2,600,000 for the period beginning July 1, 1976 and-ending September 30, 1976, and $10,100,000 for the fiscal year ending September 30, 1977. This section prohibits using funds for construction of research laboratories. Section 27(b) of the Senate bill requires that the Administrator submit concurrently to the Congress any budget requests, supplemental budget estimates, legislative recommendations, prepared testimony for Congressional hearings, or comments on legislation to the President or to the Office of Management and Budget connected with thisAct.
House amendment (8ection30)

The House amendment authorizes to be appropriated $12,625,000 for the fiscal year ending September 30, 1978, $16,200,000 for the fiscal year ending September 30, 1979, and $17,350,000 for the fiscal year ending September 30, 1980. The House amendment contained no provision relating tosimultaneous submissions. Conferenwe substitute (section29)

The conference substitute authorizes to be appropriated to carry out the purposes of this Act asfollows: $10,100,000 for thefiscal year ending September 30, 1977; $12,625,000 for the fiscal year ending September 30, 1978; and $16,200,000 for the fiscal year ending September 30,1979. The conference substitute contains no provision for simultaneous submission ofmaterials toCongress and theOffice ofManagement and Budget.

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ANNUAL REPORT
Senatebill (section28)

The Senate bill requires the Administrator to submit to both the President andtheCongressa comprehensive annualreport. Thereport shall include (1) a list of the testing required under section 4 and

an estimate of the costs incurred by the person required to perform the tests; (2) the number of notices received under section 5, the number of notices received under section 5 for chemical substances subject to a section 4 rule, and a summary of any action taken during the premarket notification period; (3) a list of rules issued under section 6; (4) alist, with abrief statement of the issues, ofcompleted orpendingjudicial actions underthebill; (5) asummary of major problems encountered in administration of the bill; and (6) such recommendations for additional legislation as the Administrator deems necessary tocarry outthe purposes ofthebill.
Houseanendnent(section31)

The House amendment is almost identical to the Senate bill. The only difference occurs with respect to thedate that the Administrator must submit the first annual report. The House amendment specifies that the Administrator shall submit the first annual report on or bebeforeJanuary 1,1979. Conferencesubstitute (section30)

The conference substitute generally follows the provision of the Senate bill. Thefirst submission is due on or before January 1, 1978.

REVIEW Senatebill

The Senatebillcontained norulereviewprovision. Iouse anendment (section 32)

Section 32 ofthe House amendment provides that either House of Congress may veto a rule issued by the Administrator, the Secretary ofthe Treasury, or the Secretary of Health, Education, and 1Welfare under this Act, by adopting a resolution of disapproval within 60 days. Conferencesubstitute

The House recedes.

EF'ECTIVE DATE Senatebill

The Senate bill contained no specific provision specifying an effective date; therefore, the legislation is totake effect upon enactment. houseamemdment (section33)

The House amendment provides that thelegislation shall takeeffect October 1, 1977. Conferencesubstitute

The conference substitute establishes the effective date as January 1, 1977, except that section 4(f) shall not become effective for twoyears.

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HARLEY0. STAGGras, JOHNM.MURY, W. S.STUoKEY, BOBE&KHARDT, RALPH

### H. METCALWz, WILLIAM BRoCD.EAD, JAMEs H. SCHEuRR, SAMUEL L. DEvxNw, JAMES 

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WARREN G.MAGUNSON, VANCE HARTKE, Pnnp

### A. HART, JoN 

### A. DuRKiN, JOHN V.TuNN Y,
HOWARD BAKER, T.E.STmvxs, 

### Mangeraon thePart oftheSenate.

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