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Citation: 1 Legislative History of the Toxic Substances Control Together with a Section-by-Section Index 407 1976

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-- The search text of this PDF is generated from uncorrected OCR text.94TH CONRUSESS HOUSE OF REPRESENTATIVES f REPOBT Id Seaulon j No. 94-1341



### TOXIC SUBSTANCES CONTROL ACT

REPORT

BY THE 

### COMMITTEE ON INTERSTATE AND

FOREIGN COMMERCE together with

SUPPLEMENTAL AND MINORITY VIEWS (Including costestimateoftheCongressional Budget Office) [To accompany H.R. 14032] 

# V

JULY 14, 1976.-Committed to the Committee of the Whole House

on the State of the Union and ordered tobe printed

U.S. GOVERNMENT PRINTING OFFICE

74-MI WASHINGTON z 1976

HeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 407 1976408



### CONTENTS Page Purpose of the legislation

-------------------------------------------- Brief summary------------------------------------------------------ 2 Basis for the legislation --------------------------------------------- 3 Committee consideration --------------------------------------------- 7 Cost of legislation --------------------------------------------------- 8 Section-by-section analysis------------------------------------------- 8 Program oversight--------------------------------------------------- 63 Inflationary impact statement---------------------------------------- 63 Congressional Budget Office cost estimate ---------------------------- 64 Agency reports ---------------------------------------------- 5 Committee amendment ----------------------------------------------- 100 Supplemental views--------------------------------------------------- 135 Minority views ------------------------------------------------------ 139

(11I)

HeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 408 197694TH CONGRESS 

### HOUSE OF 

### REPRESENTATIVES { REPORT 

### Ed,Seasion

-No, 94-1341

TOXIC SUBSTANCES CONTROL ACT

JULY 14, 1970.-Ordered to be printed

Mr. STAGGERS, from theCommittee on Interstate and Foreign Commerce, submitted the following



### REPORT

together with

SUPPLEMENTAL AND MINORITY VIEWS
(Including cost estimate of the Congressional Budget Office)

[To accompany H.R. 14021

The Committee on Interstate and Foreign Commerce, to whom was referred the bill (1.1. 14032) to regulate commerce and protect hlealth and the environmnent by requiring testingand necessary restrictions on certain chemical substances and mixtures, and for other pill,- poses, having considered the same, report favorably thereon with an amendment and recommend that the bill its amended do pass.

The amendment strikes out all after the enacting clause of thebill and inserts a new text which appears in italic type in the reported bill.
PURPOSE OP TimE LEoISlATION
lieCommittee bill takesamajor step forward in providing urgently needed atithority to protect health and the environment from dangeroils celmiIvals. It accomllp1ishes this in a nutmber of ways. Forexample, through its testingand preliarlket notification provisions, thebill provides for the evaluation ofthe hazad-causing potential ofnew chemnicals before coinlmercial intodilm tion begins. ThI its, in addition to the authority totake action against acheminteally-caused harit after its occr'elnce, there will be alithority to prevent such harim from occurring. Farther,iniaTil fact||rers and roeessors ofpotentially hazardous cleticals already on the market may be required totest then to deterime their effects l heitalt and the environment, ad action can be taken against,chemicaIls discovered to be unreasonably hazardotts. In addition, the bill provides for the collection of i;iformation regarding conummercially produced Cl

chemicals sothatthe total exposure to achemlni79-313 0

- 77

- 27

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cal and itstotal effect on health andthe environment canbe monitored and evaIated. BRIEF SUMMARY

Briefly, the bill will-

-Require manufacturers and processors of potentially harmful chemical substances and mixtures to test the substances or mixtures, as required by rules issued by the Administrator of the Environmental Protection Agency, so that their effect on health and the environment may be evaluated. -Require manufacturers of new chemical substances and manufactirers and processors of existing chemical substances for significant new uses to notify the Administrator ninety days in advance ofcommercial production. -Authorize delays or restrictions on the manufacture of a new chemical substance if there is inadequate information to evaluate tie health or environmental effects of the substance and ifin the. absence of such information, the substance may cause or significantly contribute to an unreasonable risk to health or the environment. -Authorize the Administrator to adopt rules to prohibit the manufacture, processing, or distribution of a chemical substance

or mixture, to reluire labeling, or to regulate the manner of disposal of a chemical substance ormixture for which there is a reasonable basisto conclude that itcauses orsignificantly contributes to an unreasonable risk tohealth or environment. -Authorize the Administrator to obtain injunctive relief from a United States district court toprotect the public and the environmlent from an immminently hazardous chemical sulbstance or mixture. -Authorize .the Administrator to require manufacturers and processors to submit reports andmaintain recordsrespecting their commercially produced chemical substances and mixtures, to maintain records respecting adverse health or environmental effects of such substances and mixtures, andto provide available health and safety(latN on them. -Require manufacturers and processors of chemical substances and mixtures to immediately notify the Administrator of information indicating that one of their substances or mixtures

causes or contributes to a substantial risk to health or environment.

-- Permit administrative inspections to enforce the bill and authorize court actions for seizures ofchemical substances and mixtures which have been manufactured or distributed in violation of the requirements of the billorofrules and orders promulgated under it. -Perm'it citizens to bring suits to obtain compliance with the bill. -Permit Federal district courts to order the Administrator to initiate rulemaking proceedings in response to citizen petitions. -Set up procedural mechanisms to insnre that,all interested persons ha'e an opportunity to participate inthe agency rulemaking proceedings.

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-Provide protection for employees who cooperate in the enforcementofthebill. -Provide for evaluation on a continuing basis of the effects on employment ofactionstaken underthebill.

BASIS FOR TilE LEoISIrATION
Chemicals have become a pervasive and enduring part of our environinent. They are in our ar, ourwater, and our soil. They are used in ourmanufacturing processes, and they are essential components for

consumer and industrial goods.Production and useofchemicals have surged in the recent past. For example, in the pastten years,thepro; duction of synthetic organic chemicals has expanded by 233 percent, and over 9,000 synthetic chemical compounds are each now in comnercial Use annually in amounts in excess of 1,000 pounds each.2 In 197:3, production o? the top 150 chemicals alone totaled 410 billion pounds.3Society reaps enormous benefits from chemicals. However, it isgenerally accepted thatas thenumberofchemicals incommercial use is greatly'increased, the risk of producing chemicals that can cause grave and irreversible environmental damage or health problems is also increased.

This vast volume of chemicals have, for the most part, been released intothe environment with little or no knowledge oftheir longterni health or environmental effects. As a result, chemicals currently in commercial and household use are now being found to cause or contribute to health or environmental hazards unknown at the time commercial use of the chemical began. For example, vinyl chloride

was the 23rd most produced chemical when it was discovered to cause cancer, and the chemical has now been implicated as causingbirth defects as well.1 Asbestos, widely used in items ranging from talcum powder to brake linings to wallboard, is now known to cause cancer and other debilitating illnesses. However, such effects were not discovered mtil hundreds of workers had ,leveloped a rare form of ling cancer. as it result of exposure to tile substance. Polychlorinated hiphenyls (PCBs) had been used for forty years and approximately 390,000 tons had been released into the environment before they were recognizedI an enduringenvironmental poison.0 Unfortuintely, such recognition camie toolatet, prevent contamination ofsuch major water systeis as the Great Lakes and the Hudson River.

As the precedingexamples indicate, it is often many years after ex)osure to a harmful chemical before the effects ofits'harm become visible. By that time it may be too late to reverse those effects. As indicated,'hundrds of p(oplc may havebeen exposed to a carcinogen

oran entire river system mn have beenpolluted.

The experience'with chemicals over the past few years has contributed to a growing realization that many ofthe major health prob-

.'ixthl .A iinorit Rrport,Council on Environmen al I'oli'y,1. 23 (1075). ToJIP SiiI" x , s Conell on Envirnnnientil Quality. p. :1 (1975). Aci'iie of Fedcra? .Itcn'irs Conecrrntlf

, RlceledIfigh Volume ('hcniralg,U.

. 14,'nrl-
ron mntal i'rietirm A ey. ESA--560-4-7,-O01, n. II (1975). lofifait. 'rter F.. "Oneogenh. and Mihtngenle Risks In Connunitles with Pol 'vInyl Chloride I'roduet Ftieililits," 271 New York Academy of Science Annals, P). 41-57 (1976).

5 elicoff. .J.. "Arsllos Criteria ])oi'niient Ilighliltghs," Amerlean Sociely of Safety Eniglineers ,Jilrnal

. 1. 261 tMiireh, 11174). 0"i.fec(tq of Chronicle ,Nxposureto Low-Level Pollutants In the Envlronment," Congressional Research Service, p. 2 (1975).

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lemns are caused by environmental factors. For example, approxi- mately 60to 90per cent ofall cancer isbelieved tobeenvironmentally caused.' The National Foundation for the March of Dimes estimates that about 20% of all birth defects as caused by environmental influency, s, including chemicals, on theunborn child, andanother G0% of birth defects arebelieved tobe due to acombination ofenvironmental and hrereditary factors.2 Because diseases caused by environmental factors such as chemicals

are often not susceptible.to directmedical cure, there isan urgent need to prevent such chemically caused harm. The Department ofHealth, Education, and Welfare's Forward Health Plan stresses such prevention, stating:
In recent years, ithasbecomeclear"that only by preventing disease from occurring, rather than treating it late, can we hop to chieve any major improvement in the nation's 

### health

...[Heart disease, cancer, and stroke.] 

### are caused by factors (e.g., tile,environment and individual behavior) that tre not susceptible to direct.medical solution.

. . .It is therefore, a basic premise of the prevention strategry that inuch greater attention and resources must.b directed at preventing theulnlerlying causes of lisease rather than at the disease itself-at controlling cigarette smoking, alcohol abuse,andexposures to toxicchemicals intheenvironInent. than at the diseases which they cause." Silrilarly, the environmental harm caused bychemicals, likehealth effects, may be irreversible, and prevention of such harm is also urgently needed.

Toxc Substanccrs,a 1971 report by the Council on Environmental Quality, reviewed the problems presented by toxic chemicals and coneluded that present autho'ities for protecting against hazardous chemicals are fragmented and inadequate. According to the report, authority is needed to require testing ofchemicals to determine their health and environmental effects, to impose use and distribution restrictions on chemicals where necessary to protect the public health and environment, and to collect information on chemicals and establish a sse"m, for classifying and using such information.

The reolmendations of the report provided the original basis for the toxic substances control legislation. However, subsequent, events have dranratically illustrated the urgent need for the legislation. For exaiinple, a major epidemiological studyby the National CancerInstitute indicates that industrial chemical use and activity have produced

I"Sixth Annual neport," Council on Environmental Quality, p. 17 (11175), Chemicals
oe not, or crursie. tii,' oily environilital factors linked to vaneer.Others inclodp tile Jarge comlonent of lung eancer attributable to eigarptte smoking anti natural agents such am molar rliati Iton.

I'h,- rosts to society from cancer are tretnendous. TlTe Atnerlca,, C'ant'er Societv esti- inteo that 25 percent of the 213 ntl ion trople now living In the United States will ulti- uatol

,'l develol 8(oncl forill of calvcer. ,l'Cancer FaCts anti Figures." Atnerival Cancer Society, p.:1 (1975). Cancer killed all estimated 364,000 AmerieanH In 11175. Ibid. Tt,e econonic eost of cancer are staggering. An esttnated $3 billion Is slent annufally far hospItal care, pivesilat, fees, nu'rses. drg and otlher treatment. If (ie direct and In. direct etOstl (Pc... toss of tirnductIvyI%, Pearning power) are added, the annual costs of cancer lmp to $15 billion. Id. at 31. "''ffet ; of Chronth Exposure to Iow-,Pvcl Ilollutnnts in the Environment. p. 1:15. s"Forward Plan for Health." fiseal years 19t7- Il, t.S. Department of Health, Educa- tion, atnd Welfare. Irblic Ilealth Service, pp. 12, 13, 15, 10, 17 (Juno 1175).

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striking geographic concentrations of cancer deaths.1 An unusually high rate of lung cancer among workers in a plant where bis chloromethyl ether (BCME) was produced as aby-product ofamanufacturingprocesshas ledto theconclusion thatBOMEisahighlypotentcarcinogen. BCME may form spontaneously in ordinary humid air whenever formaldehyde and hydrochloric acid are present together. These two chemicals are widely used in processes such as the treatment of permanent press fabrics, in the manufacture of water repellants, and in the manufacture of ion exchange resin and dispersing agents. Further, tris 2, 3-dibromopropyl phosphate, a fire retardant widely used in such items as children's pajamas, has been shown to have mutagenic effects in microbial systems. And there are, unfortunately, numerous other examples of harm resulting from the ifidustrialusesofchemicals. Because of the lack oftesting by manufacturers and processors of chemicals to determine their health and. environmental effects, the general population anti the environment now serve as the laboratory for discovering adverse health and environmental effects. Aside from the glaring inequities in relying on human experience to indicate when achemical is harmful, such a method is also agrossly inefficient way to identify problems, For example, vinyl chloride and asbestos

were relatively eNsy hazards to identify becanse exposure to these agents could be correlated with incidences of otherwise rare cancers in a uniquely defined group ofworkers, Other kinds ofhazards, and other substances, cannot he expected to present such easily traceable

cause and effect relationships. As a result exposure to an extremely harnimful chemical may continue unabated because the harm it causes will never belinked to'thechemical.

Fortunately our ability to screen and test substances for adverse effects aid our eaKpabilities for monitoring and predicting the health and environmental effects of chemicals are sufficiently well-developem that it is not necessary to choose between the alternatives ofusing the population as guineI pigs or doingwithout thebenefitsprovided bv the increasing use and levelopnent ofchemical prodnets.The vali(ity ofapplying animal test.results tomanisnow firmly based upon empirical evidfence andthus such results providean invaliable tool for predicting human health effects. Further, major methodological advances are occurring with respect toimproving testing and monitoring methods for assessing the long-term effects ofa chemical. For example, methods for detecting low levels ofcarcinogens in the environment have increased significantly in both accuracy and reliability, and itis now possible to detect concentrations ofpolynuclear compounds atI part ofanindiidual compound per billion asopposed to the 1959 sensitivity standlard of 100 parts per billion. Analytical melhodls have improved as well. Illustrative is the salmonella test dev'eloped byDr. Bruce Ames ofthe University ofCalifornia, Berkeley, which is now available for screening for cancer-causing properties of chemicals and which has considerably reduced both the costs and time reqtired for such screening. Althoigh testing and monitoring may



### lHearings on H.i. 7220. It.R, 7548. and uI.R. 7664 before the Subcommittee on Con. sunier Protection and Finance of the House Committee on Interstate and Foreign Com- merce, 94th Cong., lot Bess., p. 132-138 (1075).

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not be able to provide certainty as to the long-term consequences resulting from exposure to a chemical, the predictions from such testing and monitoring can provide a reasonable basis for regulatory action to )rotect against potential long-term adverse effects.

Present,authorities for protecting against and regulating hazardous chemicals are fragmented and inadequate. Although there are a number of Federal laws which now provide some authority forregulation (e.g., the Clean Air Act,theFederal Water Pollutiofi Control Act,the Occupational Safety and Health Actof 1970, and the ConsumerProduct Safety Act) conspicuous gaps exist in the protections provided by such laws. Most significant among the deficiencies are the following: (1) In general, such lawsprovide regulatory authority which is not set in motion until after human or environmental exposure to
a harmful chemical has occurred. (2) The authorities provided to reduce or eliminate the harmful exposure to a chemical may not be adequate or may becumbersome orinefficient. (3) No authority exists for collection of data to determine the totality ofhuman and environmental exposure tochemicals. An example ofthedeficiency described inparagraph (1) is the fact thatthere is presentlyno authority to requiremanufacturers ofpotentially dangerous new chemicals to test the chemical to determine its health and environmental effects before marketing. Thus, although there is some authority to remove harmful chemicals from the workplace, the home, etc, there is no authority which provides a means of assessing the safety of a chemical before exposure occurs. In. addition, since present laws require regulatory agencies to bear the cost of testing to see if a chemical is safe, regulatory action often does not occur until adverse effects of a chemical become evident in the population or in the environment. The inadequacies in current authorities to deal with the recognized harm presented by polychlorinated biphenyls (PCBs) illustrates the deficiencies in present law to deal with known harmful chemicals. Under the Federal Water Pollution Control Act, the Administrator ofthe Environmental Protection Agency has authority to control the discharge of PCBs into the waters. However, there is no means for regulating other avenues through which the environment is exposed to PCBs. For example, an estimated three-fourths of the amount of discarded PCB's have been disposed of in landfills. Under existing law there is no authority to deal with such disposal and even though water emissions may b restricted, environmental exposure. through seepage from landfills will continue tooccur. Intelligent standards for regulating exposures to nchemical in the workplace, the home or elsewhere in the environment cannot be set unless tlhe full extent,of human or environmental exposure is considered. The importance of considering the cumulative impact of all

sourcesofexposure and the synergistic effectsresulting from exposure to a number of chemicals in reguilating hazardous chemicals was pointed outby the National Academy of Sciences--National Academy of Engineers'study which stated: The concept,oftotal bodyburden should be the significant indicator ofexposure, rather than burden acquired in one or

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another part of the environment or from one or another toxic material. People who work ini a factory in which dangerous substances are handled in high concentration may livein an adjacent area in which the same or other substances

are dispersed, thus increasing overall exposure. More than

one organ may be attacked bccause the offending substance is transported l)y two or more media. Synergistic effects among two ormore substances,by which the combined effect is more than the sum of the separate effects should be considered.' Yet.a comlirehiensive data system indicating the totality of human

or environunental exposure doesnot exist. As a result,present regulations controlling workplace exposure, exposure in the horne or elsewhere toi a hazardous chemical may often be based on measurements indicating only one source of exposure, thereby resulting in less than full protection from the hazard.

In summary, the country faces serious risks ofharm tothehealth of its people and to its environment from the substantial use which is made of chemicals, and Federal law isclearly inadequate to deal with such risks. A major element in our efforts to improve the nation's health and environment must be the enactment of protective legisla- tion such as II.R. 14032, The overriding purpose of thebill is to pro- vide protection of health and the environment through authorities which aredesigned topreventharm.

CONIMIrIrE CONSIDERATION
A 1971 report by theCouncil onEnvironmental Qualityhighlighted the growing need for a comprehensive program of toxic substances control. Based upon the Council's recommendations, the Environmental Protection Agency submitted legislative proposals on behalf ofthe Administration to the 92d Congress. The Committee's Subcomuittee on Commiierce and Finance held hearinqrs on IlieAdministration bill, and a Senate-passd bill which made substantial amendments to the Administration bill. Afterexecutive session, the Subcommittee repo4ed a clean bill which represented an accommnmodation between the Admin istration and Seniate-passed bills. This bill with certain further

amutdnuents 

### %Vnsreplortedl by thme full COliillittc(' and pasnsed tile House by arecord vote of 240 to 61. Time did not permit aconference with thil Senate to work out differences before the adjournment ofthe 92dCongress.

In the 93d Congress, the Subcommnittee on Commerce and Finance held hearings on a new bill submitted by the Administration (H.R. 5087) andta bill introduced by the Subcoimmittee chairman, Mr.Moss, and others (H.R. 5356) which substantially followed the bill passed by the House in the 92d Congress. The Subcommittee reported H.R. 5356, with amendments. The bill with certain further amendments was reported by the full Committee and passed the Houseby arecord vote of 324 to 73. However, the conference with the Senate wasunable to work outdifferences inthebillsin thetineremaining.

I Man,Material, and Environment: A Itevort to the Nntional Conmission on Materiali 1oiy", Nationnl Academy of Sciences-Nntnonnl Academy of Engineers, p. 12 (Mnreh 1073).

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In the 94th Congress, the Subcommittee on Consumer Protection and Finance held hearings on June 16, July 9 10, and 11, 1975,which focused on the bills H.R. 7229, H.R.7548 and H.R. 7664, introduced by Mr. Eckhardt, Mr. Brodhead, and Mr. McCollister, respectively. After the hearings, Mr. Eckhardt introduced anew bill, H.R. 10318, which reflected comments received during thehearings. The Subcommittee reported H.R. 10318 on December 3,1975. The full Committee began consideration ofthe legislation on May 26, 1976. The Committee agreed to substitute H.R. 14032, introduced by Mr.Eckhardt and Mr. Broyhill, for H.R.10318. After three days of mark-up, this bill with certain amendments was reported by the full Committee by voice vote. COST or' LEois.ArioN

In accordance with clause 7(a) of rule XIII of the Rules of the House of Representatives, the committee estimates that the following costs will be incurred in carrying out the functionsunder lI.R. 14032:

Fiscal year: Millins 1078 ----------------------------------------------------------- $11.1 1079 ----------------------------------------------------------- 10.1
1980 ------------------------------------------------------------ 11,1 The Environmental Protection Agency, which will administer the bill, hs tarnsmitted itsprojected resource requirements for purposes of the authorization of appropriations contained in IT.R. 14032:

Fiscal year: Miliona

1978 -------------------------------------------------------- $12.625 1979 --------------------------------------------------------- 16.2 1980 --------------------------------------------------------- 17.35 1981 --------------------------------------------------------- 17.:15 1982 --------------------------------------------------------- 17.85


### SECTIoN-BY-SEcTioN ANALYSs

SECTION 1, SHORT TITLE
Section 1of the bill provides that the bill when enacted may be cited as the "Toxic Substances Control Act".

SECTION 2, FINDINGS, POLICY, AND INTENT

Subsection (a) ofsection 2 containsCongressional findingsthat (1) humans and the.environment are being exposed to a large number of chemical substances and mixtures each year; (2) some ofthese chemical substances and mixtures may cause or significantly contribute to

an unreasonable risk to health orthe environment; and (3) the effective regulation ofsuch chemical substances and mixtures in interstate

commerce necessitates the regulation ofsuch substances and mixtures inintrastate commerce aswell.

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The Committee has extended the reach of theregulatory authority ofthebillto allchemical substancesand mixtureswhether ininterstate

commerce ornotsincethe sizeandscopeofthechemical industry makes it impossible to distinguish between those in interstate commerce and those which are not. Further, commerce in those which are arguably only in intrastate commercemay affectcommerce in thosewhich are in interstate commerce, and consequently there cannotbe effective regu- lation of the latter without regulation of the former. Also regulation ofonly those in interstate commerce without regulation ofthe others could depress commerce and discriminate against those in interstate
commerce andadversely burden, obstruct,and affect such commerce. Subsection (b) provides thatitisthepolicyoftheUnited Statesthat (1) hazardous and potentially hazardous chemical substancesandmixtures should be adequately testedwith respecttotheir effect on health and the environment; (2) such testing should be theresponsibility of those who manufactureorprocess thechemical substancesormixtures; (3) adequate authorityshould existtoregulatechemical substances and mixtures which may cause or significantly contribute to anunreasonable risk tohealth or theenvironment, and totake action with respect tochemical substances andmixtures which areimminentlyhazardous; and (4) these authorities should e exercised so as not tounduly impede or create unnecessary economic barriers totechnological innovation while assuring that suchchemical substances andmixtures donot
cause or significantly contribute to an unreasonable risk to health or theenvironment.

Subsection (c) of section 2 provides that it is the intent of Congressthat theAdministrator ofthe Environmental Protection Agency shall carry outthe bill in a reasonable and prudent manner, and that the Administrator shall considerthe environmental, economic, andsocial impact of any action proposed tobe taken under thebill.

The Committee intends subsection (c) forthe guidance ofthe Administrator in fulfilling the purposes ofthe.bill. However, this statement of intent by the Committee,asto the manner in which the Administrator istoexercise.theauthorities and fulfillthe Administrator's responsibilities under thebillisnottobe construed asadirection tot)he Administrator to make any statement of findings in addition tothose required by specificprovisions ofthe bill ortoinvolve the Administrator in any cost-benefit justifications.

SECTION 3, DEFINITIONS
Section 3 defines the terms used in the bill. While most of the definitions arc self-explanatory, a few are of particular importance andmerit discussion.

The term "Administrator" meanstheAdministrator oftheEnvironmental Protection Agency.

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Thebill grants the Administrator certainregulatory authority over "chemical substances" and "mixtures" of chemical substances. The term "chemical substance" is defined in this section to mean any organicor inorganic substance ofaparticularmolecularidentity, including a combination ofsuch substances occurring in whole orin part as
aresultofa chemical reaction orinnature. Theterm alsoincludes any elementoruncombined radical.

The Committee recognizesthat basically everything in our environment is composed of chemical substances and therefore the definition of "chemical substances" isnecessarily somewhat broad. However, because of the breadth of the definition, the Committee has carefully defined the authorities of the Administrator respecting such substances.

Certain categories are specifically exempted from the term "chemical substance" and thus are exempted from coverage under the bill. Pesticides (as defined in the Federal Insecticide, Fungicide, and Rodenticide Act) when manufactured, processed, or distributed in commerce for use. as a pesticide; tobacco or tobacco products; source material, special nuclear material, and byproduct material (as defined in the Atomic,Energy Actof 1954 and regulations issued under that Act) and articles which if sold would be subject to the tax imposed by section 4181 of the Internal Revenue Code of 1954 (i.e., pistols,firearms,revolvers, shellsand cartridges).

Although the language of the bill is clear on itsface as to the exemption for pistols, revolvers, firearms, shells, and cartridges, the Committee wishesto emphasizethatit doesnotintend thatthelegislationbeused as avehicle forgun control. Consequently the Administrator has no authority to regulate ammunition as an unreasonable risk because it injures people when fired from a gun. However, the Committee does not exclude from regulation under the bill chemical components of ammunition which could be hazardous because of their chemical properties.

Also excluded from the definition of the term chemical substance and consequently from coverage underthebillare anyfood, food additive',drug, cosmetic, or device when manufactured, processed, or distributed in commerce foruse as a food, food additive,drug, cosmetic,

or device. Asused in this exclusion, theterms "food", "food additive", "drug", "cosmetic", and "device" have the same meaning as is given them bysection 201 oftheFederal Food, Drug,andCosmetic Act.The intent ofthe Committee in excluding these items is to exclude from coverage underthe bill items which may be regulated under the Federal Food, Drug, and CosmeticAct. By adopting the definitions given the items by that Act the Committee has made the exclusion of these items from the bill coextensive with the authority to regulate them under the Federal Food, Drug, and Cosmetic Act. Thus, if an item cannot be regulated as a food, food additive, drug,cosmetic, or device under that.Act because it doesnot come within the definitions in that Act, it isnot the intent ofthe Committee to exclude it,from coverage under the bill. An amendment was offered during Committee consideration of the bill to add a provision which would add to the exclusion described abovean exclusion of "any substance produced for research anddevel,

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opment purposes and intended only for use in or on any such food, drug,cosmetic, or device". It was stated thatthe intent ofthe amendment was tomake itclear that catalysts, intermediates, and precursors which arc intended for use in the production of drugs in their final dosage.forms or substances which are used in research and development ofdrugs and which do not necessarily become ingredients ofthe drugs in their final dosage forms would not be subject to regulation under the bill. The amendment was withdrawn with the understanding thatthe definition ofthe term "drug" in the Federal Food,Drug, and Cosmetic Act included the items described in the amendment,but that to the extent that any such item isnot included in that definition and thus not subjecttoregulation under that Act, such itemshould be subjectto regulation underthebill.

The definition of "drug" in the Federal Food, Drug, and Cosmetic Act includes "articles intended for use as a component" ofsubstances included in the definition of "drug". As used in that Act, the term "component" doesnotmean onlyanitem whichmaybeidentified asan ingredient ofa drug in its final dosage form. Component includes any item used in the production of the drug. Thus, precursors, intermediates,and catalysts intended foruseintheproduction of drugsintheir finaldosage frm are "drugs" withinthe meaningoftheFederal Food, Drug,and Cosmetic Act.

Further, the Federal Food, Drug,and Cosmetic Act clearly covers drugs during the "investigation" orresearch stage. Consequently, the definition of "drug" in that Act includes chemical substances used for drug research and development. The same is true ofthedefinitions of food,food additives, andcosmetics.

Likewise, the definition of pesticide in the Federal Insecticide, Fungicide, and Rodenticide Act defines "pesticide" to include "(l) any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pest, and (2) any substance or mixture of substances intended foruse asa plantregulator, defoliant,
or desiccant." Thus the definition in that Act would include chemical substances on which research is being performed with the intent that the substance be used for any ofthe purposes described in the definition ofthe term "pesticide". 3uch substances would be subjectto regu- lation under that Act and? by virtue ofthe exemption for pesticides,

areexetopted froni regulationunder thisbill.

Theexclusion from thedefinition for any pesticide, food, food additive, drug, cosmetic, or device ;sconditioned upon its being nmanufacluredor 

### (listribluted in commerce foruse as a pesticide, food, food additive, drug, cosmetic, ordevice. Such acondition isnecessary because
some chemical substances and mixtures which can beusedas pesticides, foods, food additives, drugs, or cosmetics can also be used for other purposes. For example, aluminuni subacetate is used as a burn treatment,but it is alsoused as amordant in dyeingand for flame-proofing. Cuprous oxide is used as a pesticide, but it also is used as a flameretardant.

Aluminum suhacetate when used in dyeing or for flame-proofing could not be regulated under the Federal Food, Drug, and Cosmetic Act, nor could cumrous oxide when used asa flame-retardant be regn- lated under the Federal Insecticide, Fungicide, and Rodenticide Act.

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The Committee bill assuresthattheexemption willextend onlyinsofar

as the exempted substance or mixture is actually manufactured, processed, or distributed in commerce for use as a pesticide, food, food additive, drug,cosmetic,or device andthusissubject toregulation under the Federal Food, Drug, and Cosmetic Actorthe Federal Insecticide, Fungicide, and Rodenticide Act.

Although the term chemical substance excludes mixtures ofcheniical substances, mixtures are notexcluded from regulation under the bill. However, mixtures are regulated in a. different manner than chemical substances--they are not subject to the manufacturing and processing notices for new chemical substances under section 5 and special findings aire required before testing of them may be required

or before they can he subject to rules under section 8(a) requiring recordkee])ing and re)orting forthem. Consequently, it was neceasary to establish chemical substances and mixtures as two separate identifiableterms.

The term "mixture" is defined to mean any combination of two or more chemical substances if ti combination does not occur in nature and isnot, inwhole orin part,,theresultof achemical reaction. Certain combinations of chemical substances which do occur, in whole or in part, as a result of a chemical reaction are included within the term mixture and thereby excluded from the definition of chemical substance. If each ofthe chemical substances comprising thecombination is not a new chemical substance and if the combination could have been manufactured for commercial purposes without a chemical reaction at the time the substances comprising the combination were combined, then the combination will be amixture rather than achemical substance.

The inclusion of such reaction-produced combinations within the definition of mixture is necessary to prevent disparate treatment of identical combinations simply because ofthe number of stepsused in the production ofthe combination. For example, a soapproduct may be manufactured by combining cononutoil soap,sodium tri-poly phosphate, sodium sulplhate, and sodium bicarbonate. When combined, these four inrredients donotreact chemically. Trhus ifamanufacturer combined thefour ingredients,theresultingcombination wouldclearly be consi(ered a mixture. However, if another manufacturer simultaneously mixed two substances which react to form coconut oil soap, the first, ingredient, together with the latter three ingredients, the resulting combination would have been 

### produced in part by a chemical reaction. he two end productswould beidentical, andthey should ba subject.to identical treatment underthebill. The Commitepr definition assuresthatthey will be. Theterna "environment" isbroadly defined toinclude water, air,and land and the interrelationship which exists among and between water, air, land and all living things. Thus by providing for the protection of the environient. the bill includes protection for all living things within the environment.

The term "manufacture" meansto import,produce, ormanufacture. As a result. imnported chemical sulstances and mixtures will be subject to r.'rulation in the same manner asdomestically producedchemical substances and mixtures are. In addition, importers of chemical

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substances and mixtures willhave the sameresponsibilities and obligationsas domestic manufacturers. The bill does not attempt in the definition of the term "mianufacture" to define exactly what activities are to be included in that term because the activities embraced by the term are generally well understood. However, it has conic to the attention ofthe Committee that there are activities incidental to tihe end useor storage ofcertain substances or mixtures which under a literal reading of the definition would make a person engaging in them a manufacturer and thus subject to the provisions of the bill applyingtomanufacturers. For example, there are certain substances or mixtures, such as adhesives, paints, inks, and drying oils, which during storage or upon end use, when exposed to enviromental factors such as air, moisture,

or sunlight, undergo a chemical reaction which produces a different substance or mixture. Similarly, plastic resins subjected to heat for purposes of molding undergo a thermal setting which )roduces a different substance. In such cases, the chemical reaction is merely incidental to the end use or storage of the original substance or mixture. The substance or mixture produced is not used its a chemical substance or mixture, per se. It is not the Committee's intent that a person, such as a painter, who is engaged in the end use or storage activity in which such a chemical reaction occurs is to be considered

a manufacturer because ofthe reaction. Thus, such aperson wouldnot be subject to the notification requirements of section 5even though

a chemical substance resulting from the reaction is not included on the inventory compiled under section 8(b). Substances which occur incidentaly to the storage or end use of such combinations should be considered as byproducts, and the responsibility for meeting the testing, notification, and other requirements witl which inanufacturersmustcomply would fall uponthe manufa(turer ofthe substance

ormixture fromwhich thebyproduct isproduced.

For example, there are certain combinations ofsubstances, such is adhesives, paints, inks, and drying oils, which during storage orupon end use, when exposed toenvironmental factors such asair, moisture,

or sunlight, undergo a 

### chemical reaction which technically 

### prOduces

a different chemical substance. However, the chemical reaction is merely incidental to tlme storage or end use of the substances. The substance produced is not to be used as itchemical substance, per se. It is the. Committee's intent that a person who is engaged in a
use or storag, nctivity in which such a chemical reaction occurs is not to be subject to the notification requirements of section 5

even though the chemical substance resulting from such activity isnot included on the inventory compiled under 'ection 8(b). Substances which occur incidentally to the storage or use of such combinations should be considered asbyproducts and tme responsibility for meeting the requirements of the bill respecting such byproducts is to be met by the manufacturer of the substance. fromt which the byproduct is produced. During the hearings, a number of witnesses recommended that the bill include a definition of unreasonable risk. Because the determination of unreasonable risk involves a consideration of probability, severity, and similar factors which cannot be defined in precise terms

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and is not a factual determination but.rather requires the exercise of judgment,on the part ofthe person making it,the Committee did not attempt a diefinition of such risk. In general, a determination that a risk associated with a chemica? substance or mixture is unreasonable involves balancing theprobability thatharm will occur and the magnitude and severity o~fthat harm agains theeffect of proposed regulatory action on the availability to society of the benefits of the substance or mixture, taking into account the availability of substitutes for the substance or mixture which do not require regulation, and other adverse effects which such proposed action may have on society.

The balancing process described above does not require a formal benefit-cost analysis under which a monetary value is assigned to the risks associated with a substance anilto thecostto society ofproposed regulatory action on the availability ofsuch benefits. Because a monetatry valuet often cannot be assigned toabenefit orcost, suchan analysiswould notbe veryuseful.'

As noted above,' the Committee recognizes that risk is measured not solely by the prol)alility of harm, but instead includes elements both of probability of harm and severity of harm and those elements may vary in relation to each other. Thus, the Administrator may properly find thai health or the environnment are exposed toan unreasonable risk by a lesser probability of agreater harm as well as by a greater lrobability ofa lesser harm.

Although the standard for defining the regulatory authority ofthe Adninistrator throughout the bill is "unreasonable risk", the implementation of the standard will of neessity vary depending on the specific regulatory authority which the Administrator seeks to exercise. For example, a testing rule under section 4 will ordinarily not result.in deprivingthe public ofthebenefits ofa substance ormixture subject to the rule.This is because such a rule does not prohibit the manufacture, processing,etc., ofexisting substances orofmixtures.At the most a testing rule nay, through section 5(d), delay the Comnerccial availability ofnew substances and new uses of existing substances subject to the testing rule. Similarly, a requirement imposed under section 5(g) (regulation of new substances and significant new uses ofsubstances pending the development ofinformation) will only delay or restrict the availability of a substance subject to it until adequate health and safety data can be developed and evaluated,

However, this is to lie contrasted with the effect ofthe imposition of a requirement under section 6on a substance. Such a requirement may remove a substance from the market or impose lesser restrietions

on its availability and such a requirement is not of limited duration. Thus,the effect on society navbe far reaching. Asa result regulatory effect will be ofgreater significance in a determination ofunreasonable riskfor purposes ofsection 6 than for a determination for purposes of section 4 or 5(g). Conversely, with respect to section 4 or 5(g), be-

'A recent study by the National Academy of Sciences on regulating chemicals agrees. it states: "Inghly formalized meth~ods of benefit-cost analysis seldom can be used for making decisions about regulating chemicals in the environment. Thus the development of such methods should not hne high priority." DecisionMaking for Regulating Chemicals in the E'rironmetnt, Committee on irinciples of Decision Making for Regulating Chrel. cals in the Environment, Environmental Studies Board, Commission on Natural Resources, National Research Council, National Academy of Sciences, ixv (July, 1)75),

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cause the regulatory effect of action taken under either of those sections is lessthan thatof action taken under section 6, the requirements for isdetermination ofunreasonable risk for purposes of section 4 or 5(g) are lessdemanding.

The Committee has limited the Administrator to taking action only apainst unrensonable risks because to do otherwise assumes that a risk-free society is attainable, an assumption that the Committee does
not make.

HeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 423 1976SECTION 4, TESTING OF CHEMICAL SUBSTANCES AND MIXTURES
Section 4 vests in the Administrator the authority necessary to accomplish one of the basic policy objectives of the bill: to require manufacturers and processors to bear the responsibility for adequately testing potentially dangerous chemical substances and mixtures to ascertain their health and environmental effects. The section may be 

### made applicable to existing and new chemical substances and to mixtures. When testingshouldbe required

Sections 4(a) (1) (A) and 4(a) (1) (B) describe when the Administrator shall promulgate rules requiring manufacturers and processors to test a chemical substance or mixture. Both sections 4(a) (1) (A) and 4(a) (1) (B) require the Administrator to make certain findings, and absent those findings testing may not be required. Section '1(a) (1) (A) states that if the Administrator finds that (1) the manutfacture, distribution in commerce, processing, use or disposal of a chemical substance or mixture or any combination of such actions may cause or significantly contribute to an unreasonable risk to health or the environment, (2) there are insufficient data and experience to reasonably determine or predict the effects of such activity, and (3) testing of such substance or mixture is necessary todevelop predictive data, and (4) inthe case ofa mixture,theeffects may not be reasonably and more efficiently determined or predicted by testing the chemical substances which comprise the mixture, then the Administrator shall by rule require testing of the substance

or mixture.

The finding that a substance or mixture may cause or significantly contribute to an unreasonable risk is intended by the Committee to focus the Administrator's attention on those chemical substances andmixtures about which there isabasisfor concern, butabout which there is inadequate information to reasonably predict or determine the effects ofthe substance ormixture on health or the environment. For example, if one substance is structurally similar to a second chemical with known adverse health or environmental effects, the Administrator could reasonably conclude that the first chemical may cause or significantly contribute to an unreasonable risk. Or if there is reliable preliminary data indicating that a substance may be dangerous, again it would be reasonable to conclude that such cheniical may cause or significantly contribute to an unreasonable risk.

It should be noted that the bill does not require the Administrator t9 find that a substance or mixture does cause or significantly contribute to or will cause or significantly contribute toan unreasonable risk.Such a finding requirement would defeat the purpose ofthe section, for if the Administrator is able to make such a determination,

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regulatory action to protect against therisk, not additional testing,is called for. However, theterm "may" as used inthe phrase"may cause or significantly contribute to" does not permit the Administrator to make a finding respecting probability of a risk oil the basis ofmere conjecture orspeetfation, i.e., it may or may not cause arisk.

Section 4(a) (1)(B) sets forth the second set of conditions under which the Administrator is to require testing. If the Administrator finds that (1) a substance or mixture is or will be produced in substantial quantities and thatit enters ormay reasonably be anticipated toenter tiheenvironment in substantial quantitiesorthereisormaybe significant orsubstantial human exposureto the substance ormixture, (2) there are insufficientdata and experience upon whichtodetermine

or predict the effects of the manufacture, distribution in commerce, processing, use,or disposal ofthe substance or mixture, (3) testingis necessary to develop predictive data, and (4) in thecase ofamixture, the effects may not be reasonably and more efficiently determined or predicted by testing the chemicalsubstances which comprise themixture, then the Administrator shall by rule require testing ofthe substance ormixture.

The conditions specified in section 4(a) (1)(B) reflect the Committee's recognition that there are certain situations in which testing is desirable even though there is an absence ofinformation indicating thatthesubstance ormixture maybeharmful. Inmaking thefinding thatthere isor will besubstantial production coupled with substantial environmental or human exposure to a substance ormixture,the Administrator is notlimited toconsideration of sheer volumeofproduction orexposure ataspecific pointin time.The duration of the exposure, the level ofor intensity ofexposure at various periods of time, the number of people exposed, or the extent of environmental exposure are among the considerations which may be relevantinparticular circumstances.

In both sections4(a) (1)(A) and 4(a) (1)(B) a finding that there

are insufficient data and experience upon which to determine or pre- dictthe effects of a substance or mixture is required. The Committee included this finding in each provision to elimihate unnecessary or duplicative testing.The Committee recognizes thatexperience with a chemical substance or mixture, as well as testdata, maybe useful in determining or predicting the effects of a substance or mixture. ExW

erience may be particularly valuable in evaluating acute effects. owever, the value of experience may be diminished with respect to effects ofchronic exposure toa substance ormixture dependingonthe type of suspected harm and the length ofexperience with such substance or mixture.

The additional finding required with respect toa mixture (i.e., that the effects which the mixture's manufacture, distribution in coinmerce,processing, use, or disposal may have on health orthe environment may not be reasonably and more efficiently determined or pre dictedbjtestingthechemical substances whichcomprisethemixture): is also intended to reduce unnecessary or duplicative testing. The assessment ofsafety ofa mixture may wellbe based -,.ponthetoxicity ofparticular components, andtests oftheentiremixture with itsvaryingcomponent ratiosmaybeunnecessary orunrewarding. Atthe same time, the Committee recognizes that there maybe instances in which

79.3 10

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a particular combination must be tested to reasonably evaluate the effectsof themixture. Forinstance, the effect oftwo chemicals, when combined, may be greater than the sun of the effects of the compo- nents taken independently. The Committee bill does notprohibit the Administrator from requiring testing ofthemixture in suchinstances. Contents oftesting 2-ule



### Section 4(b)(1) requires atesting ruleto identify thesubstance or mixture for which testing is required, include the standards for the developmentof testdata, and specify theperiodof timewithin which thetesting results shallbe submittedtothe Administrator.Theperiod specified forconducting the testing and submitting results to theAdininistrator may notbe unreasonable. In determining thestandards forthe development oftest data and theperiod for conductingthetesting,theAdministrator istoconsider the relative costs of various test protocols and methodologies. The Committeerecognizes thattestingmay,in someinstances, involveconsiderable costs for a manufacturer or processor. To the extent consistent with the purpose of the bill and the public need for timely, thorough, and reliable data,theAdministrator should attempt tomin. imize testingcosts.

TheAdministrator is alsoto consider,indetermining thestandards and period for testing, the reasonably foreseeable availability of facilities and personnel forperformingtestingundertherule. Suchconsideration need not be limited to existing testing resources and personnel but might also include the anticipated increase in supply of such resources and personnel to meet increased demand. The testingrule may require the submission ofpreliminary dataprior to the timethefinal data istobesubmitted totheAdministrator. Asa result, the Administrator may check toinsure that thetesting data isbeing developed in a reliable and competent manner incompliance withthe standard for the development of test data. Failure to comply with such standard would, ofcourse, be a prohibited actunder section 15.

Section 4(b) (2) (A) lists some of the health and environmental effects for which a standard for thedevelopment of testdata may be prescribed. It also listssome ofthe testing methodologies which may )el)rescribed in lhe standard, including epidemiology, serial, or hierarchical tests, in vitro tests, and whole animal tests. The Committee considered and rejected an amendment which would have instructed the Administrator to give preference to tests which do not involve the use of animals if other tests provide an adequate and accurate means for ascertaining the effect of a chemical substance or mixture
on health or the environment. The Committee determined not to so limitthe Administrator's discretion since protection ofhuman health demands thatthe Administrator notbe denied the best,mostreliable data possible. However the Committee does notintend that the Ad- ministrator needlessly require whole animal tests.The Administrator should consider alternative test methods. With the development of reliable non-animal tests forl)redicting thelong-term effectsofchemicals on health, the need for animal test data to determine ifa substance or mixture causes or significantly contributes to an unreasonableriskwilldiminish.

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Before prescribing epidemiology tests, the Administrator is required to consult with the Director ofthe National Institute for Occupational Safety and Health. Such consultation will enable the Administrator to acquire the expertise and experience ofthe Director respecting epidemiology tests conducted under the Occupational Safety and Health Act of 1970.

Section 4(h) (2) (B) requires the Administrator to review the testing standards at least every

, twelve months. If necessary, the Administrator shall initiate rulemaking proceedings to make appropriate revisions ofa testingstandard.
Whois toeondurtthetesting

In general tle manufacturers and processors of a chemical substance or mixture subject to a section 4 rule are responsible for the testing required bV the rule. If two or mnore persons ere.subject tothe

sane testing requirement, the Administrator may permittheni to designate one of their number or a qualified third party to conduct the tests and subinit the test.data on their behalf. However, such a designation does not relieve them of their underlying responsibility for compliance with the testing rule. Subsection (b)(3) specifies lhich manufacturers and processors are to do the testing. Under that subsection there must be a relationship between the activity ofthe manufacturer or processor and the finding made in connection with the issuance of the rule. Thus, for example. if the Administrator makes

a finding respecting the manufacture of a substance, the persons engaged in such manufacturing must do the testing. Similarly, if the Administrator makes a finding respecting the use ofa substance, the person responsible for manufacturing or processing the substance for that particular usewould beresponsible fortesting.

A rule under subsection (a) requiring testing ofa substance ormixture shall expire at the end ofthe reimbursement period applicable to the test data to be submitted pursuant to such rule. The reimbursemnent period is the period during which the person who submits test data isentitled tobe reimbursed by anyperson whoreceives anexemption from the testing requirement based on the data submitted bythe first person. Procedures forpromulgating nrle requiring testing Section 4 (h) (5) specifies theprocedures bywhichtheAdministrator is to promulgate a rule under subsection (a). Such rules are to be promulgated in accordance with the informal rulemaking procedures ofsection 553 of title 5of the United States Code. In addition to the procedures outlined in section 553, tie Administrator shall giveinterested persons an opportunity for the oral presentation of data, views,

or arguments, as well as an opportunity tomake written submissions. Atranscript shallbe madeof anyoral presentation. The Administrator may not proniulgate a rule utnder subsection (a) unless the Administrator makes and puhlishes with the rule the findings described in paragraph (1) (A) or (1) (B) ofsubsection (a). Exemptions froin.riesrequsrhngtesting Subsection (c) specifies when the Administrator is to exempt a person from a requirement to conduct tests and submit test data on

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a chemical substance or mixture. To obtain an exemption, an applicant must demonstrate to the satisfaction ofthe Administrator that the chemical substance or'mixture (including any contaminant in the substance or mixture) with respect to which the application is submitted isequivalent tothe substane ormixture for which testdatahas already been submitted or for which test data is being developed, and that testing and submission of data by the applicant would be duplicative.

Theperson granted theexemption must,iftheexemption isgranted within the reunbursement period, provide fair and equitable reimbursement to the person upon whose testing the exemption is based and to any other person who has been required to contribute to the testing costs of such person. If theperson granted the exemption and those who are to be reimbursed are unable to agree upon the amount and method of reimbursement, the Administrator may order the person granted the exemption to provide fair and equitable reimbursemont inany amount determined underrules oftheAdministrator. Tha Committee recognizes that burdens of testing could fall heaviest omi small companies and, therefore, to alleviate such burdens the Administrator, in promulgating such rules, is directed to consider the effect

on the competitive position of the various persons involved and their respective share of the market. The Committee recognizes that such rules will necessarily hav to be somewhat general in scope, for the Administrator cannot he expected to anticipate all ofthe specific situations which may arise. An order requiring reimbursement is to be considered final agency action. PublicPoticeofreceiptoftestdata Subsection (d) requires the Administrator to promptly publish in the Federal Register a noticeof receiptofanytest.data submittedpursuant to a rule uider subsection (a). The notice, subject to the provisions of section 14 (relating to confidentiality) shall identify thesubstance or mixture for which data have been received, list the uses or intended uses of the substance or mixture and the information required under the section 4(a) rule, and (lescrihe the nature ofthe test datal developed. Unless it is )rotected from disclosure by section 14, the data shall be made available by theAdministrator forexamination by any person. Priorities for te8ting Subsection (e) establishes an interagency committee tomakereconimnendations to the Administratr regarding what chemical substances and mixtures should he considered priority candidates fortheissuance of a testing rule under section 4(a). The committee is tobe composed of representatives from the Environmental Protection Agency, the Occupational Safety and Ilealth Administration, the Council on Envirounental Quality, the National Institute for Occupational Safety and health, the National Institute ofEnvironimental Health Sciences, time National Cancer Institute, the National Science Foundation, and the Departinent of Commerce. During Committee deliberations, an amendment specifying that the representative from the.Departiment of Commercebe selected from theNational Oceanic and Atmospheric Agency was offered. Although the amendment was ultimately withHeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 428 197622

drawn, the Committee intends that the representative from the Department ofCommerce be able to share with the interagency committeethe particular expertise andknowledge found inNOA respecting chemical substances and mixtures and their presence in, relationship to, andeffects ontheoceansand theatmosphere.

The interagency committee is to submitits first list of recommendations to the,Administrator within twelve months after the effective date of the bill. Any necessary revisions in the list are to be made at least every six months. The interagency committee's reasons for including a substance or mixture on the list are also tohe submitted to tire Administrator. The bill reported from Subcommittee required the interagency committee to publish its recommendations and supporting reasons in the Federal Register. The substitute adopted by the Committee deletes this requirement. Instead, the Committee bill places the burden on the Administrator for making the list and accompanying reasons available to the public. The Committee bill permits the Administrator to determine the best means for making the information available to the public. The Committee recognizes that individuals throughout the country may be interested in such information, and the Committee does not intend that access to the information be limited to persons who have physical access to the headquarters oraregional office oftheAdministrator.

The Committee bill also provides that the Administrator shall provide a reasonable opportunity to any interested person to file comments on the committee's recommendations. Such comments are also tohe made availabletothepublic.

The Subcommittee bill required the Administrator to either initiate a rulemaking proceeding under subsection (a) to require testing of a chemical substance or mixture recommended )y the interagency committee or to publish in the Federal Register'the Administrator's reasons for not initiating such a proceeding. The substitute adopted by the Committee does not contain such a requirement. Although the Committee intends that the imiferagency committee's recommendations be given great weight by the Administrator, the Committee believes it would le counterproductive to require the Administrator to formally respond in the Federal Register to every chemical suhasfance or mixtire recomnended for testing by the interagency committee on which the Administrator did not take action. The esources of the Administrator should be concentrated on preparing an(l promiulgating testing requirenments and takingother necessary regulatorv action to protect the public from potentially dangerouschemical substances and mixture,.

SECTION .5), MANUFAM'TI-tINO AND) PReOCEsING NOTICES
lht (encral

Section 5 sets out the notification requirements with which manufacturers of lew chemical substances and manufacturers and] processors of existing chemicals for significant new uses must comply. In general, manufacturers ofnew chemical substances must give 90 days notice to the Administrator prior to such mapufacture of the new chemical. *iinilarly, any person whointeuds tomanufacture orprocess

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for commercial purposes an existing chemical for a use which the Administrator has determined, by rule, constitutes a significant new useofthe chemical mustprovide'90 days notice to the Administrator priorto such manufacture or processing.

Notice must include information respectingthe substance, itschemical identity and molecular structure, proposed amount of production, uses, and test data respecting health and environmental effects. Such notice will give the Administrator an opportunity toreview and evalunte information respecting the substance to determine if manufactureor processing shouldbe restrictedor delayed underthe authorities inthis section or other sections of thebill because the substance may behazardous. Forexample, inthe caseofa substance forwhich there isinadequate information to permit a reasoned evaluation of the health and environmental effects and which may, in the absence of such information,
cause or significantly contribute toan unreasonable risk, the Administrator can in section 5(g), through court order andrulemaking, delay the manufacture or processing of thesubstance pending the develop- ment of such information. 

### 'rihe provisions ofsection 5reflectthe Committee's recognition that tile most desirable time to determine the health and environmental effects of a substance isbefore commercial production begins. Not only are human and environmental harm avoided or alleviated, butthecosts ofany regulatory action intermsof loss ofjobs and capital investment are minimized. 

### Notifirationfor ManujactureofNew ChemicalSubstance8 Subsection (a) provides that before a person may manufacture a new chemical substance, that is, a chemical substance which is not included on the inventory published under section 8(b), the person must notify the Administrator at least 90 days before such manufactume unless the substance is exempt from the notification require- ment by the provisions ofsubsection (i). If a rulerequiring testing of the sulbstance has been promulgated under section 4 before the submission of tle notice and is applicable to such person, then the data required to be developed and submitted under the testing rule must be submitted to the Administrator at least ninety days before begin- ningsuch manufacture. Chemical8ubstaneos fora &inificant New Uae Subsection (b)(l) provides that at least,ninety days before begin- ning to manu acture or process a chemical substance for a use which the Administrator determines,by rule, is a significant newuse ofsuch substance, the manufacturer or processor must notify the Administrator unless the substance is exempted from the notification requirements by subsection (i). If before the submission of such notice, the manufacturer or processor is required by atesting rule in effect under section 4 to submit test data forsuch substance, then such person shall sulbliil to the Administrator in accordance with such rule such data at least 9t0 days before beginning such manufacture or processing.

Subsection (b) (2) requires that a determination by the Administrator that a new useofan existing chemical substance is a significant
new use for which notification is required shall be made by rule. In making such a determination, the Administrator is to consider all

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relevant factors, including the projected volume of manufacturing and processing of such substance for such use, the extent to which such use changes the type or form of exposure ofhumans or the en- .vironment to such substance, andthe extentto whichsuch useincreases the magnitude and duration of exposure of humans or the cnvironmenttothe substance.

The Committee has required that the determination that a new use constitutes a significant new use be made by rule in order to assure that such determination will notbe made in an arbitrary manner. Bylimiting thenotification requirements forexistingchemical substances to ones to be manufactured or processed for significant new uses, the Committee intends to indicate that only when a new use of a substance may reasonably be expected to have health or environ- mental importance should it be subjected to the notification require- ment. Ordinarily, where the projected volume of a new use is small, the Committee anticipates that the Administrator would not make a determination that such use constitutes a significant new useunless there is a significant change in the type or form of human or en- vironmental exposure, a significant increase in the magnitude and duration of human or environmental exposure, or unless there are other factors indicating that any such use ofthe substance should be considered significant.

It has been suggested to the Committee that the Administrator could determine that any new use of a particular substance will be considered significant. The Committee does not intend that a new use be considered a significant new use solely on thebasisthat theuse is new. However, because ofthe nature of a substance, it is possible that any new use of it will be significant. Thus a potentially dangerous substance which is manufactured for a particular use may, if manufactured foradifferent usepresent additional health orenviron- mental problems and consemuently there should benotice ofthe intent tomanufacture itforsuchdifferentuse. 

### LlitedChemical

### Sigubtanes Within twelve months after the effective date of the bill, the Administrator shall, byrule, compile a list ofchemical substances the manufacture, processing, distribution in commerce, use, or disposal ofwhich (orany combination thereof) the Administrator findscauses or significantly ontributes toor may cause or significantly contribute to an unreasonable risk. At the same time, the Administrator shall identify those usesof listed chemicals which the Administrator deter- mines, in accordance with section 5(b) (2), are significant, new uses. The Administrator shall revise the list from time totime.

Under subsection (c) before aperson may- (1) Manufacture a listed chemical substance which was a new chemical substance at the time of publication ofthe earliest pro- posed rule listing such substance, or (2) Manufacture or process a listed chemical substance for a use determined by the Administrator to be a significant,new use, the person imust notify the Administrator. unless the substance is exempted from the notification requirements by subsection (i). At

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least 90daysbefore such manufacture orprocessing, health and safety data respecting suchsubstance mustbesubmittedto theAdministrator asprovided insubsection (d).

A rule (and'any amendment to or repeal of such rule) listing a chemical substance is to be promulgated pursuant to the informal rulemaking procedures prescribed by section 553 of title 5, United States Code, except that there is to be an opportunity for the oral presentation of data, views, or arguments. A transcript is tobe kept ofany such oralpresentation.
SuhmissionofTeatData Subsection (d) describes the instances in which a person subject to
a notification requirement respecting achemical substance under subsection (a), (b), or (c) must submit test data to the Administrator before manufacture or processing of such substance can begin. It is important to note that the requirements of subsection (d) respecting submission of data are in addition to the notice requirements of subsection (a), (b), or (c). Compliance with subsection (d) does not waivecompliance with the noticerequirements.

Under subsection (d) (1) if atesting rule undersection 4 respecting itsubstance has been promulgated before submission of the notice required by subsection (a), (b), or (c), then a person who is required by such rule to submit test data forthe substance may not manufactureorprocess such substance until ninetydays aftersubmission ofthe test datarequired bysuch rule.

Even though a personhas been granted an exemption from thetestingrule under section 4, such person is prohibited from manufacturingorprocessing such substance untilninety daysafter thesubmission ofthetest data. It should be noted that if a testing rule under section 4 respecting

a substance has not been promulgated prior to the submission of a noticerequired by section 5,theAdministrator maypromulgate a testing rule under section 4 for such substance. However, such a rule would not delay the manufacture or processing of the substance.

If a person is required by subsection (c) (listed chemical substances) to provide a notice respecting the manufacturing or processing ofa chemical substance and is notrequired by subsection-(d) (1) to submit test data to the Administrator, then subsection (d) (2) imposes certain test data submission requirements on such person. Under subsection (d) (2) such person must submit tothe Administrator data respecting such substance which such person believes showsthat- (1) In the case of a new chemical substance, its manufacture, processinay, distribution in coinierce, use, and disposal (or any combination of such actions) will not cause or significantly contributeto an unreasonable risk to health or the environment, and (2) In the case of a chemical substance.for a significant new use, such use will not cause or significantly contribute to such a risk. Such data must be subinifted ninety days prior to the manufacture

or processing ofsuch substance.

Data submitted under subsection (d) (1) or (d) (2) is to be made available, subject tosection 14, for examination by interested persons.

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Extension of NotivePeriod 

### The Administrator may for good cause extend the ninety-day pe- riods prescribed by subsections (a), (b), (c), and (d) before which the manufacturing or processing of chemical substances subject to such subsections may begin. Subsection (e) provides that an extension may be made only once and only for a period ofnot toexceed ninety days. Notice of an extension together with the reasons for itshall be published in the Federal Register and shall constitute final agency action subjecttojudicial review. ContentofNotUce8

Under subsection (f) (1) the notices required by subsections (a), (b), and (c) respecting the manuacturing orprocessing of a chemical substance are to include the following: (1) the name of the substance; (2) insofar asreasonably ascertainable, (A) itschemical identity and molecular structure, (B) proposed categories of use and amount proposed to be manufactured for each such category, and (C) description of byproducts; (3) a reasonable estimate of the amount ofthesubstance to bemanufactured or processed; and (4) test data in thepossession orcontrol oftheperson giving the notice which relate to the health or environmental effects ofthe substance. Reasonably ascertainable should be interpreted to mean that which can be obtained without unreasonable cost or burden. Such a notice is, subject to section 14,to be made available forexamination by interested persons. Under subsection (f) (2) the Administrator is required to publish in the Federal Register a notice which (1) identifies a chemical substance for which a notice ordata has been submitted under subsection (a), (b), (c), or (d), (2) identifies its uses or intended uses, and (3) ifdata has been submitted, describes the nature of the tests per- formed and the data developed. Such a notice is to be published not laterthan five working days after thedate ofthereceipt ofthe in.formation. Unless the Administrator determines that the public interest requires a more specific identification, chemical substances shall be identified in the Administrator's notice by generic class. ReguiationPendingDevelopment ofInfornation Therewill beinstances in which theAdministrator will haveinsufficient information to make a reasoned evaluation of the health and 

### environmental effects of a chemial substance for which notice has been submitted under subsection (a), (b), or (c) (that is a new chemical substance, a chemical substance tobe manufactured or proc- essed for a significant new uy.!, or alisted chemical substance). The Administrator maydetermine that without such information thesubstance, because of theproposed volume of production ofsuch a substance, the nature or extent of the human orenvironmental exposure which may be expected, the similarity with substances known to be associated with an unreasonable risk to health or the environment,
orother relevant factors, may cause or significantly contribute to such

a risk. Subsection (g) provides theauthority under which such a chemical substance may be regulated (that is,be made subjict to manufacturHeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 433 1976

### 27
ing, processing, or distribution prohibitions or limitations, or labeling or disposal requirements) while in.formation is developed to permit a reasoned evaluation of its health and environmnental effects and to determinB if such regulation should be continued.

Under subsection (g) (1) the process for regulation of a substance under this subsection is begun by an application made 1)y the Adiinistrator, acting through attorneys of the Environmental Protection Agency, to a district court oftheUnited States for the issuance of an injunction to prevent the manufacture, processing, or distribution in commerce ofsuch substance. The district courts are granted jurisdiction to grant such an injunction ifthecourt finds that information available to the Administrator is insufficient to permit a reasoned evaluation of the effects of manufacture, processing, distribution in commerce, use, or disposal of the substance, or any combination of such activities on health or the environment and in the absence of such information, such activity may cause or significantly contribute to an unreasonable risk to health or the environment. In granting jurisdiction to the Federal district courts,the Committee intends that the two-part standard set out in subsection (g)(1) (A) (i) and (ii) forthe issuance ofan injunction totally supplant the traditional elements which aparty ordinarily must showbefore acourt willexercise itsequitablejurisdictionto grantan injunction. The Coln. mittee does not intend that the Administrator he required tomakeany showing other than that which is required for the court to make the two findings described in subsection (g) (1) (A) (i) and (ii). Upon such a showing, the Administrator is entitled to an injunction. See FTC v. NationalConm iqsion on EggNutrition(517 F. 2d 485 (7th Cir. 1975)). Application of any other standard by the court will frustratethe purposes ofthesection.

If the court issues an injunction, the Administrator has five days within which to begin the proceeding for the issuance of a rule to apply to the substance one or more of the requirements described in section 6(a). The purpose of the proceeding is to determine which of the requirements described in section 6(a) (i.e., manufacturing, proc- essing. or distribution limitations orprohibitions, labeling ordisposal rvequirenments) is necessary to apply to adequately protect health or environment from the risk found b;y the court. 

### the reference to section 6(a) is a reference only to the kinds of requirements described therein andis not to he construed asimposing upon the Administrator the duty to imake any ofthe findings contained in section 6 orto meet any ot]er requirement of that section other than the procedural requirementsofsection 6(c) (2) and (3)

The proceeding istobeconducted in accordance viththe procedures described in paragraphs (2) and (3) of section 6(c). The proceeding is to Ibe an expedited one in that a requested hearing is to be held within 15 days of receipt of a request for such a hearing (unless the parties agree to a different time) and the Administrator is to make

a decision on the rule within 30 days ofthe conclusion ofthehearing.

Subsection (g) (3) permits any person to petition the Administrator to initiate a proceeding to amend or repeal a rule issued under subsection (g). Thus,when data sufficient topermit a reasoned evaluHeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 434 197628

ation ofthe health orenvironmental effects of thesubstance have been developed, a person subject to the section 5(g) rule could petition the Administrator to amend or repeal the rule if appropriate in light of the data developed. Within thirty days, the Administrator must by order either grant,or deny the petition. If the petition is granted, ti Administrator shall promptly initiate a proceeding, in accordance with paragraphs (2) and (3) ofsection 6(c) forthe amendment

or repeal of the rule. Itshould be noted that granting the petition does not obligate the Administrator to modify or repeal the rule as requested. Granting a petition only triggers the requirement to initiate a proceeding. Final action by the Administrator will, of course, depend oni the record developed during theproceeding. Petitionfor 'Standards for tMeDevelopnentofTestData Under subsection (h) a person intending to manufacture orprocess a substance for which notice is required under subsection (a), (b),
or (c) and who is not required by a rule under section 4 to submit test data on such substance may petition the Administrator to pre- scribe standards forthe development of test data for such substance. Ti Administrator must act oni the petition within 60 days of its receipt, and, if the Administrator grants the petition, the Administrator must.prescribe such standards within 75 days of granting the petition. Thisprovision isincluded primarily to assist persons intending to manufacture or process a listed cheiical substance for which test.data is required by subsection (d) and to assistpersons who wish to develop data to make the continued imposition of a requirement under subsection (g) no longer necessary. The Committee anticipates that such manufacturers or processors will first consult informally with the Administrator's technical staff to obtain guidance respecting the testing of the substance. Only if such consultation fails tobe productive should a petition be necessary. Ofcourse, the Administrator could issue a rule requiring testingof a substance under section 4 even though the Administrator had previ- ously prescribed a standard for the development of test data in response to apetition under subsection (h). Exemptions Subsection (i) prescribes the situations in which a chemical substance may be manufactured or processed without regard tothe notice and test data submission requirements of subsections (a), (b), (c), and (d).

Paragraph (1) providesthe authority foran exemption with respect tothe manufacturing and processing of achemical substance for test marketing purposes.To obtain such an exemption an application must be submitted totheAdministrator.The application must satisfactorily demonstrate to the Administrator that the manufacture, processing, distribution in commerce, use, and disposal for test. marketing purposesofthe substance for which the application is submitted will not
cause orsignificantly contribute to any unreasonable risk to health or theenvironment. Such anexemption may begranted upon such restrictions as the Administrator considers appropriate. The Administrator is to act upon such an application within 45 days ofits receipt.

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### Underparagraph (2), an exemption from thetest datasubmission reqiiremientsofsubsection (d) (2) may beobtained forachemical substance which is equivalent toa chemical substance for which data has been submitted in accordance with such subsection if submission of data for the substance to be exempted would be duplicative of data already submitted to the Administrator. The person requesting the exemption will have the burden of showing that the substances for which the exemption is requested is equivalent to the substance for which data has been submitted and thatsubmission ofdata would be duplicative. If an exemption is granted under this paragraph during 

### the reimbursement period for thepreviously submitted data, thenthe person who submitted such data is to be r-eimbursed by the person receiving theexemption for a portion of the cost,incurred in developingsuch data. Therequirements of section 4 respecting reimbursement also apl)ly toreimbursement provided under this paragraph.

Subsection (i) (3) specifically exempts from the notification requirementsofsubsections (a), (b), and (c) those chenical substances manufactured or processed or proposed to be manufactured or processed in small quantities (as defined by the Administrator by rule) forscientific experimentation oranalysisorforchemicalresearch oranalysis, including research and analysis forthe development ofthe substance

or another chemical substance into a commercial product. All persons engaged in such experimentation, research, or analysis for a manufacturer or processor must ibe notified of any risk to health which the manufacturer orprocessor hasreasontobelieve may be associated with thesubstance.

The exemption is necessary to insure that research and innovation, both academic and commercial, isnot.unduly impeded by the requirements of section 5. For example, researchers in laboratories in colleges and universities, in government agencies, and elsewhere may have important need for new substances on short notice. The subsection (i) (3) exemption will insure that the person who manufactures such new substance forthe researcher will be able to provide tie substance to the researcher without having to wait the ninety days required by the notification period. Furtlir, researchers working for

amanufacturer trying to develop a product mayneed tomake several changes in the substance. It would be unrealistic to require that the Administrator be notified 90 days in advance ofeach change made in the substance during the course of the research or the development period.

The research, analysis, and experimentation performed upon a chemical during its developmental period should give amanufacturer the opportunity to evaluate time )hysical, chemical, )roduction, and performance characteristics ofthe substance. Since theexemption applies only to substances manufactured or processed in small quanti- ties and since the research and analysis will

### be supervised orconducted by technically qualified individuals and since all the individuals exposedtothe chemical substance will be made awareof potentialhealth effects there should not be any unreasonable risk to health presented

asa result oftheexemption.

In limiting the exemption to chemicals manufactured or lrocessed in "small" quantities,your Committee recognizesthattheterm "small"

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cannot be viewed in an absolute sense. The amount of the chemical substance which must be manufactured or processed forresearch and analysis may vary in relationship to the kind of use for which the chemical substance isbeing developed. Obviously a manufacturer must be able to produce a chemical in sufficient quantities during the developmental period to adequately test and evaluate the chemical for its intended use. For instance, laboratory reagents may be tested in terms ofgrams, while textile fibers or paperprocessing haterials may have tobemanufactured in muchgreater quantities inorder tobe adequately evaluated.

The Committee also recogniz~s that a in nufacturer may not be able to fully evaluate a potential product in-house. For example, a manufacturer may have to use an outside testing laboratory or make the product available to a potential industrial user to complete the analysis or experimentation. The fact that the other industrial user may pay forthe costs ofthe substance does not necessarily signal the end ofthe development period. Solong as the purchaser iscontinuing theresearch and evaluation ofthe substanceby individualstechnically qualified toanalyze and evaluate the physical, chemical, and performancecharacteristics ofthesubstance, theexemption continues to apply. Again, such technically qualified individuals would bemade aware of potential health and environmental effects. However, the exemption does not permit the useof the substance in products in a test market situation.

Subsection (g) (4) is designed to prevent a substance from being treated as a new chemical substance solely on the basis ofa change of the inert ingredients of the substance. Under this exemption, if a substance has been included in the inventory under section 8, the substance which is identical to that substance except for its inert ingredients is not to be treated as a new chemical substance and consequently subjecttothenotice requirements ofsubsection (a).

Paragraph (5) authorizes the Administrator, upon application, to issue a rule to exempt the manufacturer ofa new chemical substance from the requirements of this section (or any part of such require- ment) if the Administrator determines that the chemical substance will not cause or significantly contribute to an unreasonable risk to health or the environment. A rule under this paragraph is to be promulgated in accordance with the rulemaking procedures contained in paragraphs (2) and (3) ofsection6(c). Definition

Subsection (j) provides that for purposes of section 5, the terms manufacture" and "process" means to manufacture or process for commercial purposes. Since the term "inanufacture" is defined to include "import", persons who intend to import substances for commercial purposes will he treated the same as a domestic manufacturer under section 5. By use of the term "for commercial purposes" the Committee does notintend torestrictcoverage tosubstances manufactured orprocessed "for sale". Any commercial purpose, such as use as a chemical interMediate in amanufacturing process,issufficienttobringthe manufacture or processing of a substance within the ambit of section 5. The

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31

Committee realizes that there are certain minor reactions occurring incidental tothe mixing process orupon storage ofa mixture, such as 

### the cross-linking of polymers. Such a minor reaction may result in what would technically he considered a "new" chemical substance. However, since the "new" substance is notmanufactured forcommercial purposes per so it wouldnot be subject to the notification provisions of this section.

HeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 438 1976SECTION 6, REGULATION OF IAZARDOUS CHI1CAL SUBSTANCES AND MIXTURES
Section 6 empowers and directs the Administrator to take action toprotectthe public froml.azardous chmeical substancesand mixtures. Such action shall be taken against existing chemical substances, new chemical substances, and mixtures when there is a reasonable basis to conclude that the substance or mixture causes or significantly contributes to or will cause or significantly contribute to an unreasonablerisk. Scopeofregzdlation Section 6(a) provides that if the Administrator finds that there is

a reasonable basis to .onclud( that the manufacture, processing, distribution in commerce, use or disposal ofa chemical substance or mixture (or any coml)ination of such activities) causes or significantly contril)utes to or will calls(- or significantly contribute to an unreasonable riskto health or environment, the Administrator shall by rule take regulatory action necessary to adequately protect against the risk. Absent such a finding, the Administrator may not take action under section 6(a). This standard for taking action recognizes that factual certainty respecting the existence of an unreasonable risk of a particular harm may notfie possible.and the bill does not require it. Such uncertainty is particularly likely to occur true when dealing with the long term
orchronic effects of a substance ormixture.Forexample, cancer does not appear immediately after exposure to a carcinogenic substance or mixture., but instead there may be a latency period of several years before the cancer appears. With mutagens,the effects may notbecome apparent until generations have passed. When, as here, regulatory action is intended to betaken topreventthe occurrence ofharm in the future as well as protect against presently visible harm, such action often must bebased not only consideration offactsbut alsoon consideration of scientific theories, projections of trends from currently available data, modeling using reasonable assumptions, and extrapolations from limited data. Further, regulatory action may be taken

even though there.are uncertainties asto the threshold levels ofcausation. Thus, the bill requies a reasonable basis to conclude that a substance or mixture causes or significantly contributes to or will cause,
or significantly contribute to an unreasonable risk to health or environment. Sueh a judgment may be based upon items such as toxicological, physiological, epidemiological, biochemical, or statistical research or studies or extrapolations therefrom. A finding by the Administrator that there is such a reasonable basis must include adequate reasons and explanations for the Administrator's conclusion. It does not, however, require the factual certainty ofa "finding of fact" of the sort associated with adjudication. (82)

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Theterm "significantly contribute to anunreasonable risk" is used throughout the bill. The Committee has used such term because it recognizes thatan individual substance ormixturemay notbethesole identifiable factor which may cause an unreasonable risk. Because ofthemultiple avenuesby whichhumans andthe environment areexposed to a substance or mixture andbecause substances and mixtures do not occur in the environment in isolation, risks may result from complex interactions or because of cumulative effects. Thus the bill authorizes actions against asubstance ormixture which isonly a con- tributing factor to an unreasonable risk. The bill specifies that the contribution be significant, forthe Committee does not intend to authorizeaction against acontributing factor which is onlyde minimus. However, the Committee recognizes that in many instances it will be impossible frn.theAdministrator to showthequantity ofcontribution toaparticular riskmadebya particularsubstance ormixture,and the Committee does not intendtthat the Administrator be required to do
so in such situations. Nor does the Administrator have to show that a substance or mixture isthe predominant contributing factor. Becauge of potential cumulative or synergistic effects, even a small contribution 

### may be significant. Moreover, because of the dispersion and transformation of chemical substances and mixtures in the environment, the substance or mixture may contribute to a risk indirectly
or directly. The considerations discussed in this paragraph would, ofcourse, apply wheneverthe phrase isusedinthe bill.

A section 6(a) rule may consist of any one or more ofthe following: (1) a requirement prohibiting the manufacturing, processing,
or (listribution in commerce of the substance or mixture or limiting the anount of such substance or mixture which maybemanufactured, processed, or distributed in commerce; (2) a requirement prohibiting the manufacture. processing, ordistribution in commerce ofthe substance or mixture for a particular use orprohibiting the manufacture, processing, or (listribution in commerce ofthe substance or mixture for a particular use in excess of aspecified level ofconcentration; (3)
a requirement limiting the amount ofthe substance ormixture which may le manufactured, processed, or distributed in commerce for a particular useor a particularuse in a concentration in excessofaspec- Sfied level; (4) a requirement that the substance or mixture or any article containing it be marked with or accompanied by appropriate warnings and instructions; (5) arequirement tlt the manufacturers an(d processors of the substance or mixture make and retain records ofthe processes used to manufacture o process the substance or

### mixture; (6) a requirement regulating the manner ormethod of disposal of the substance, mixture or any article containing it by its 

### manufacturer, processor, or by any commercial user; and (7) ifa requiremnent described in clause; (1), (2), or (3) is imposed, a reqirenment that the manufacturers and processors of the substance or mixture proviTe notice of the risk to persons in piosseasion of the substance or 

### mixture and tothe public. The Committee recognizes the inherent interests of the States and political subdivisions resl)eeting disposal of hazardous chemicals within theirjurisdiction. As a result, the Committee has limited the Administrator to prescribing only those disposal requirements which do not violate any law of a State or a poHeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 440 1976

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litical subdivision of a State. In addition, any disposal requirement shall require persons subject to it to notify each State and political subdivision in which a required disposal may occur.

While thebill authorizes theAdministrator to prohibit or limitthe distribution in commerce of substances or mixtures and to prohibit


### or limit the distribution in commerce ofsubstances and mixtures for

a particular use, such authority does not authorize the Administrator toregulate the manner or method oftransporting hazardous chemical substances or mixtures in commerce. For example, the loading, unloading, and storage in connection with transportation in commerce 

### are regulated under the Hazardous Materials Act of 1974, and it is not tie Committee's intenttogrant theAdministrator any regulatory authority under section 6(a) with respect to such loading, unloading,

or storage.

The Committee recognizes that the requirements prescribed by the Administrator under this section may provide protection for em

### ployees in the workplace. For example, by prohibiting the manufacture of a substance, risks toemployees involved in themanufacturing ofthe substance would beeliminated. However, theCommittee wishes to emphasize that none of the authorities included in section 6(a) should be construed as authorizing the Administrator to issue workplace standards directly regulating such matters as the airborne concentrations of a substance to which employees may beexposed orthe
manner in which an employee is permitted to handle a substance. There is no authority in the bill for the Administrator to issue rules respecting personal protective equipment for employees, work practicesin hazardous operations, or procedures for emergency situations. Such direct regulation of the workplace falls under thejurisdiction ofthe Occupational Safety and Health Actof 1970notunderthis bill.

The Committee intends that any requirement prescribed under section 6(a) be the least burdensome possible for those subject to the requirement and for society while providing an adequate margin of protection against the unreasonable risk. The Committee expects that tie determination ofthe least burdensome requirement will be based

on information submitted to the Administ ration during the rulemaking proceeding and other information which is readily available to the Administrator. The Committee does not intend that needed regulation be unreasonablv delaved while the Administrator develops qluantative data comp:aring thei costs ofcontrol imetlhods. Because different environamental or health conditions in different areas of the country may require different forms of regulation to protect against

an unreasonable risk, the bill permits a requirement to be limited in application tospecified geogral)lic areas. Protection aqainst adulterated ormcontaminated substances and mixtures Subsection (b) of section 6 authorizes the Administrator to take action to prevent the adulterat ion or contamination ofsubstances and mixtures. If the Administrator has good cause to believe that a par- ticular manufacturer or processor is manufacturing or processing a substance or mixtume in a manner which unintentionally results in the substance or mixture causing or significantly contributing to or to

79.313 0

- 77

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being likely to cause or significantly contribute to an unreasonable risk, then the Administrator is authorized to take certain action. The Administrator inay by"order require the submission of a description oftherelevant quality control l)rocedures. Further, ifafter ahearing in accordance with section 554 of title 5, United States Code, the Administrator determines on the record that the quality control procedures are inadequate, the Administrator may order the revision of the quality control procedures. In addition, if the Administrator detcrmiijws that the inadequate procedures have resulted in the distribution of a chemical substance or mixture which causes or significantly contributes to an unreasonable risk, the Administrator may require the )erson subject to the order to provide notice of the risk associated with the substance or mixture and to replace or repurchase any substance or mixture produced under the defective quality control procedure as is necessary to protect health orenvironment. Considerations inpromulgatihgseetion6(a)yules Section ((c) requires the Administrator to consider all relevant factors in pronulgating any rule under subsection (a) respecting a sul)stance ormixtur'e. Findinigs mustbe made withrespect totheeffects ofthesubstance or mixture on health and themagnitude ofhuman exposureto the substance ormixture, theeffects ofthe substance ormixtureon theenvironment andthemagnitude ofenvironmental exposure, the benefits ofthe substance or mixture for various uses andthe availability ofother substances or mixtures for such uses, and the reasonably ascertainabl, economic consequences of the rule taking into accountthe impact on smallbusiness.In making the findingrespecting the reasonably ascertainable economic consequences, the Committee anticipates that the Administrator's consideration will include, but not be limited to, major effects of the rule on the national economy andthe rule'seffect on technological innovation, theenvironment, and tie public health. Of course, because basic information regarding economic effects on the regulated industry is within the particular expertise of the industry, the Committee expects the industry to come forward with such data. The economic consequences of a rule should include the positive impact a regulatory limitation orproscription will have on the developnment and use ofsubstitutes aswell asthe negative impact on the manufacturer or processor of the regulated substance, Likewise, the economic savings tosociety resulting from the removal of an unreasonable risk-mustle a key ele-ment in any consideration ofeconomic consequences. The Comnmittee doesnot intend that

a chemical which causes or significantly contributes to an unreasonable risk should be permitted to be marketed solely because it would

cause economic costs to producers ifit werenot permittedto be sold.

An additional fin(ling is required if the Administrator determines that the risk to health or the environment could have been eliminated

or reduced to itsufficient extpnt by actions taken under another Federal law administere( in whole o'r in part, by the Administrator. In such a situation, the Administrator must make a finding that,it is in the l)ublic interest totake action under thebill rather thanunder such other Federal law. 'Ihe fact that a risk could be subject to regulation

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underoneoftheotherFederal laws administered by theAdministrator does not trigger the additional finding requirement. Instead, the Administrator must determine that the risk could be eliminated or reduced to a suflicient extent under the other law before the finding is required. It is particularly appropriate that this initial decision bu vested in the Administrator since the determination involves Acts administered 1)y the Administrator and thus is clearly within the experti.-e of the Administrator. In making tie finding, the Administrator isto take into consideration allaspects ofthe risk,the authorities available to enforce actions under the Toxic Substances Control Act and such other laws, a comparison of the estimated costs of complying, and the relative efficiency of actions under the respectivB laws. The consideration of comparative costs of complying with action under this bill and under other laws should be based upon information readily available to the Administrator. Consideration of the relative efficiency of actions under this Act and underother laws should include consideration of the time and resources needed totake such actions.

The purpose of the.Committee in requiring "findings" with respect to the considerations listed in subparagraphs (A), (B), (C), and (D) of subsection () (1) is to assure that the basis for the Administrator's rule ispublicly enumerated. Section 553 oftitle5, United States Code, which would otherwise solely govern the promulgation ofsuch

a rule, requires that an agency incorporate in any ruleadopted a concise general statement ofits basis and purpose. By requiring suchfindings, the Committee is emphasizing that those key considerations enumerated in subparagraphs (A), (B), (C), and (D) ofsubsection (e)(1) will beaddressed in such a statement ofbasisand purpose.The findings need not be.detailed or voluminous, nordoes the Committee expect the findings to be based solely on factual evidence. The Committee recognizes that, particularly wiith respect to such issues as the effects of a substance or mixture on health or the environment, the Administrator's findings may necessarily deal with projections from imperfect data, experiments and simulations, educated predictions, differing assessments of possible risks, etc. The findings are to be issued at,the time the rule under subsection (a) is promulgated, and there will not be any judicial review of such findings separate and apart. from the review of the rule issued under section 6(a). Procedures far promlgatilng8ection6(a) ruics Hules under section 6(a) are to be promulgated pursuant to the procedures of section 553 of title 5ofthe United States Code, except that the Administrator is required to give interested persons an op- portunity for the oral presentation ofdata, views, or arguments, and in certain instances an opportunity for cross-examination must be provided. Ifthe Administrator determines that it is necessary to resolve disputed issues of material fact, then an interested person is entitled to conduct or have conducted by the Administrator such cross-examination as the Administrator determines (1) to be appropriate in view of any need for expedition in the rulemaking proceeding, the nature of the issues involved, the number of participants and the nature of

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their interests, and (2) to be required for a full and true disclosuw'e with respect,to disputed issues ofmaterial fact. By limitingthe crossexamination to disputed issuesofmaterial fact, theCommitteeintends, to limit cross-examination to those issues characterized as issues of adjudicative fact thetruth or falsity ofwhichissubject toevidentiary proof and which could reasonably b~e expected to affectthe outcome of the rule. The burden of showing that any issue is a "disputed issuo of material fact" rests on the l)erson seeking to engage in crossexamination.

In view ofthe large number ofpersons who may be interested in a rulemaking 1)roceeding, the Committee felt it was necessary to give the Administrator the express author'ity to group, for cross-examination llurposes, ,sons with the sanie orsiuiular interests and provide for their rel)resentaltion by a single representative. Further, the Administrator may determine to conduct such cross-examination on behalfofsuch a group. If a person who isa member ofagroup isunable to agree upon group representation, theperson shall not be denied the opportunity to conduct or have conducted cross-examination as to issues affecting the person's particular interest if the person satisfies the Administrator that the person made a good faith effort to agree upon group representation and if the Administrator determines that there are substantial and relevant issues which are not adequately presentedbythegrouprepresentative.

It wasthe ]'dgment ofthe Committee that more effective, workable and meaningful ruleswill bepromulgated ifinterested personsdohave the opportni ty to make oral presentations, and where appropriate end necessary, 'have an opportunity toconduct cross-examination and present rebuttal evidence. IIowever, it is not the Committee's intent to create a cmnbersome, timeconsuming administrative procedure which will delay necessary regulation. Thus, not only does the Committee limit the instances in which cross-examination is required to those in which the Administrator determines that it is necessary and appropriate, but also the Committee.authorizes the Administrator to issue proceLural rules forthe conduct oforal presentations (including cross-examination) and to impose time limits on such presentations as may be appropriate in view of any need for expedition, the nature of the issues involved, and the number ofparticipants and the nature of their interests. In order to provide to the extent possible that all relevant interests be repi-esented in rulemaking proceedings so that the rules adopted best serve the public interest, the Administrator is authorized toprovide compensation for reasonable attorneys' fees, expert wit'ness fees, and other costs of participating in the rulemaking proceeding. Such fees and costs may be provided to any person who represents an interest which will substantially contribute to a fail-determination of the issues to e resolved in the proceeding ifthe economic interest of the,pers-on issmall in comparison tothe costsofeffective participation by that person in the proceeding or ifthe person demonstrates tothe satisfaction of the Administrator that the person does not have sufficient resources to participate in the proceeding in the absence ofcompensation. In determining ifa person represents an interest which will substantially contribute to a fair determination of the issues,the AdHeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 444 1976

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ministrator is to take into account the number and complexity ofthe issues and whether representation of such interest will contribute to widespread public participation and to representation of a fair balance ofinterests for the resolution ofthe issues.

In determining whether compensation should be provided and the amount of such compensation, the Administrator shall take into account the financial burden which willbeincurred asaresult ofparticipation. However, the Committee does not intend toimply that in all instances a person must be able to demonstrate a financial burden before the Administrator may provide the person with compensation. Demonstration offinancial buirden is required unless a person has an economic interest which is small in comparison tothe costs ofeffective participation in the proceeding. Thus when the economic interest is small, no showing of financial burden is required. However, in light of the possibility that there may be competing requests for assistance in connection with proceedings under this section, a consideration of financial burden will be relevant in determining who should be the recipients of compensation and the amount of compensation. In considering the financial burden tobeincurred,.the Administrator should not look solely at the costs of participating in the section 6proceeding, but should instead view such costs in light ofthe overall activities of the person applying for compensation and the person's resources. For example, a person requesting compensation could show that such person rel)resents interests which may require participation in other judicial or administrative proceedings and that such participation might have to be curtailed orlimited because ofa commitment ofresources to the proceedingz with respect towhich such request made and the Administrator should consider such information.

A determination ofreasonable attorneys' and expert witnesses' fees should not be influenced by the fact that a person is a salaried employee of a public interest or foundation funded organization. The Committee intends that reasonable fees be those which are commensurate with those at which such professionals would normally be compensated for performance of similar services. The fact that attorneys

or experts may be employed by citizens' groups or foundations at salaries or hourly rates which may be below the standard commercial rates such professionals might normally receive isnot relevant to any computation ofthe rate ofcompensation under thebill. Even in situations where a lawyer or expert initially renders services without expectation of receiving any compensation, fees are to be awarded at prevailing market rates. It may well be that an attorney will agree to provide representation of an interest in a proceeding because of a belief that such representation furthers a public interest. Representation of such interests should not have to rely upon the charity of counsel. This intent reflects the well-settled judicial rule that fee awards are to be made without reference to the fee arrangements that exist between an attorney and client. Asthe court stated in Millerv. Amuemenwnt Enterprise8, Inc.,426 F. 2d 532, 538-539 (5th Cir. 1970):
What is required isnot an obligation topay attorneys' fees. Rather what-and all-that is required is the existence ofa relationship of attorney and client, a status which exists wholly independently of "ompensation.

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Similarly, the United States Court of Appeals for the District of Columbia Circuit has ruled that fee awards in litigation undertaken to further the public interest must be computed so as to bring the attorneys' rate of compensation up to that of the prevailing market rate. See Wildemess Society v. Morton, 495 F. 2d 1026, 1037 (]).C. Cir. 1974), revcrsed onothergrounds, subnom.AlyeakaPipelineCo.v. Wildernes8 Society,421 U.S. 240 (1975), and NationalTreasuryEmplo'yees v.Nixon, 521 F. 2d 317, (1975). Provision is made in section 19 (judicial review), section 20 (citizens' civil action), and section 21 (citizens' petition) for the award of reasonable attorneys' and expert witnesses' fees in actions under such sections. The considerations enumerated here respecting a determination of the reasonableness of

afeealsoapply tothose sections. Effectivedateof8ection6(a) rules

Subsection (d) states that the Administrator is to specify in any rule under subsection (a) the (lateon which it shall take effect. Such effective date is to be as soon as feasible. In certain circumstances a proposed rule may be declared effective immediately upon its publication inthe Federal Register.IftheAdministrator determines thatthe manufacture, processing, distribution in commerce, use,or disposal of
a substance or mixture subject tothe proposed rule is likely toresult in an unreasonable riskofseriousor widespread harm tohealth or the environment before such effective date and that making the proposed rule immediately effective is necessary to protect the public interest, then the Administrator may declare the rule effective immediately upon itspublication intheFederal Register.However, iftheproposed rule would prohibit the manufacture, processing, or distribution of

a substance or mixture, a court must have first granted relief in an action under section 7 with respect tothe risk beforethe Administrator may make a rule prohibiting the manmifacture, processing or distribution of a substance or mixture immediately effective. It is because of the severity of a rule which prohibits the manufacture, processing, ordistribution in commerce ofasubstance ormixture,that the Committee required an action be brought under section 7 (imminent hazard) tohave a Federal district courtfind thatthe substance or mixture is an imminent hazard. However, because the Committee recognizes the difficulties inbringing such an action against all persons who may be engaged in the manufacture, processing, or distribution ofa substance or mixture, the Committee has required that such an action be brought against only one such person under section 7 or that the Admiinistrator have brought an in rein action against a substance, mixture, or articleunder seefion 7. Onceacourtfinds an imminent hazard in the action under section'7, abanningrule ofgeneral applicability may then bemade immediately effective with respect to all others.

If aproposed rule ismade immediately effective, the Administrator must expeditiously provide for an op)ortunity for a hearing on the rule. If a hearing'is requested, the Administrator shall commence the hearing within five days from the(lateofreceipt ofthe request for the hearing, unless the Administrator and the person making the request agree upon a later date. The hearing mustbe conducted in accordance

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with the procedures setoutin subsection (c)(2) and (c)(3). Afterthe hearing is concluded, the Administrator must within ten days, either affirm, modify,orrevoketherule.

SECTION 7, IMMINENT IHAZARD
Section 7(a) grants the Administrator authority tobring a district court action for seizure of an imminently hazardous chemical substance, mixture, or article containing such substance or mixture. Actions are also authorized against any person who manufactures, processes, or distributes in commerce an imminently hazardous chemical substance, mixture, or article. If the Administratorhas notused the authority provided in section 6(d) (2.) (A) (i) to make a section 6(a) rule immediately effective in order to protect against an imminently hazardous chemical substance, mixture, or article, theAdministrator mustbring an action under section 7.The Committeehas required such action in order to insure that protection is provided against imminently hazardous substances, mixtures, and articles. Of course, there may be instances in which the Administrator may put a rule into effect immediately under section 6(d) (2) (A) (i) and will alsobring an action under section 7 in order to obtain the forms of relief avai able under section 7 which are not available under section 6. Forexample, section 7authorizes the seizure ofimminently hazardous substances, mixtures, or articles containing them, and under section 7thecourt may require therecall, repurchase,

or replacement of imminently hazardous items in addition to any other relief necessary toprotect health orthe environment. Subsection (b) gives the United States district courts jurisdiction to grant such temporary or permanent relief as may 'be necessary to protect health or the environment from the imminent hazard. Such relief may include a requirement that manufacturers, processors, or distributors provide notice ofthe risk tothe public and to any known purchasers, recall, and replace or repurchase the substance, mixture,
or article. Seizure and condemnation of the substance, mixture, or article is authorized. Subsection (c) relates tovenue, serviceofprocess, andconsolidation. Subsection (d) providesthat where appropriate, the Administrator shall initiate a proceeding for the promulgation of a rule under section 6(a) concurrently with the filing of an action under this section. Under subsection (e) theAdministrator may direct attorneys ofthe Environmental Protection Agency to apear and represent the Administratorin any actionunderthissection.

Subsection (f) defines the term "imminently hazardous chemical substance or mixture". 

### Theterm meansany chemical substance ormixture which causes or significantly contributes to an imminent and unreasonable risk of serious or widespread harm to health or the environment. 'Sucha risk shall beconsidered imminent ifitisshown that themanufacture, processing, distribution in commerce, use, ordisposal ofthe substance or mixture oranycombination ofsuch actionsislikely to result in such harm to health or theenvironment before a final rule under section 6 can protect against the risk. Such protection would not necessarily occur upon the effective date ofa rule under section 6.

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Instead, consideration must be given to the time it may take to impleinent andenforce such arule.

It should be noted that.while the unreasonable risk ofharm must be imminent, the physical manifestations ofthe harm itself need not be. An imminent hazard may be found at any point.in the chain of events which may ultimately resultin damage tothe health orenvironment. The observance of harm is not essential toestablish that an imminent hazard of such occurrence exists. Obviously, action under the section mustbe able to occur early enough toprevent the final injury from materializing.

SECTION 8, REPORTING AND RETENTION OF INFORMATION
Subsection (a) of section 8authorizes theAdministrator topromulgaterules under which each person (other than a small manufacturer

or processor) who nmanufactures orprocesses orproposes tomanufacture or process itchemical substance shall maintain such records and submit such reports to the Administrator as the Administrator may reasonably require. The Administrator also is authorized to promulgate rules under which manufacturers and processors (other than small manufacturers and processors) of mixtures shall maintain records and submit reports,but only totheextent theAdministrator determines isnecessary for the effective enforcement ofthebill. The anthority to require ti maintenance of records and submission of reports by manufacturers of chemical substances in small quantities solely for scientific experimentation or analysis or for chemical research or analysis on such substance or another substance is similarly limited to reports and records necessary for the effective enforcement of the bill. The Committee has specified a different standard for requiring reporting for manufacturers or processors of mixtures and research substances because the Committee anticipates that in implementing its regulatory functions the need for information from such manufacturers and pocessors will not be as great as it will be with respectto othermanufacturers orprocessors.

As a further limitation, section 8(a) (1) (A) 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 components of a mixture unless the Administrator finds that, such recordkeeping or reporting is necessary for the effective enforcement of the bill A mixture manufacturer may make an infinite number of changes in the proportions of substances comprising a mixture, and the Committee wishes to protect such manufacturers from having to document ofall such changes unlesssuch changescould affecthealth or the environment. In most instances, the information relevant for the Administrator for the enforc.nent of the bill will be the particular substances used in a mixture and the range of )roportions. Documentation of each specific alteration in proportion would in most instances he unnecessarily burdensome and have little relevance tothe effective enforcement ofthebill.

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uired under subsection (b) not later than one hundred and eighty
aysafter theeffective date ofthebill. P'aragraph (2) of subsection (a) provides examples of the kinds of information which the Administrator may require to be reported. Included are the common or trade names, chemical identity, and molecular structure insofar as known to the person making tile reportor insofar as reasonably ascertainable; the categories orproposed categories of use, insofar as known to the person making the report
or insofar as reasonably ascertainable; reasonable estimates of the amount of each substance and mixture to be manufactured or processed and, insofar as known to the person making the report or insofar as reasonably ascertainable, a reasonable estimate ofthe amount of the substance or mixture tobe manufactured o' l)rocesse(l for each category orproposed category ofuse; a description of the byproducts resulting from the manufacture, processing, use, or disposal, insofar as known totheperson makingthe report orinsofar as reasonably ascertainable; all existing data concerning the adverse environmental and health effects ofsuch substanceormixture, insofar asknown tothe person makin g the report; andestimates ofthenumberofpersonswho will be exposedtothe substance ormixture in workplaces andtheduration of such exposure, insofar as known to the person making the report. Information should be considered reasonably ascertainable if the manufacturer or processor required toobtain the information can do so without incurring unreasonable costs or burdens.

To the extent feasible, the Administrator shall not require unnecessary or duiplicative reporting. The Committee realizes that recordkeeping and reporting may be atime-consuming andresource-consuming undertaking. Under section 3503 of title 44 ofthe United States Code (the Federal Reports Act), the Office of Management and Budget is required to review the collection of information required by the Environmental Protection Agency to assure that such information isobtained with a minimum ofburden on business enterprises and other persons and that unnecessary duplication is avoided. The Committee intends that every effort be made to realize this objective. For instance, where information respecting the chemical identity and molecular structure of chemicals comprising a mixture is obtained from the manufacturers ofthe chemical components, itwould be duplicative for the Administrator to require similar reporting from the mixture manufacturer, and should if feasible be avoided. Further, every effort should be made to utilize information reasonably available from other Federal entities rather than seeking the same information from manufacturers and processors.

The Administrator should consider the vast size ofthe chemical industry in developing proposed rulesfor reporting. There are approximately 1,000 companies in the basic chemical industry. In addition, there are 3,100 allied establishments and another 7,400 companies which process chemical substances and mixtures. Clearly, indiscriminate reporting requirements could result in an inundation ofunnecessary and duplicative information. Because reporting and recordkeeping requirements under section 8 (a) may impose a particularly heavy burden on small manufacturers

or processors, the Committee bill provides an exemption from such

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reporting and recordkeeping for small manufacturers and processors. However,theAdministrator mayby rulerequire asmall manufacturer

or processor ofa chemical substance to submit information respecting the substance to the Administrator for purposes ofcompiling the inventory of existing chemical substances required under section 8(b). In addition, the Administrator may by rule require small manufacturers or processors of a chemical substance or mixture subject to a proposed rule or a final rule under sections 4, 5(g), 5(c), or 6 to maintain records and submit reports on such substance or mixture. In addition, ifreliefhasbeen granted in an imminent hazard proceeding under section 7 with respect to a substance or mixture, the Administrator may 1y rule require a small manufacturer or processor of the substance or mixture to maintain records and submit reports on the substance or mixture. Thus, reporting and recordkeeping by small manufacturers and processors isto beheld to aminimum. At thesame time the Administrator will not be denied information necessary for determining whetherto promulgate a rule under sections 4,5, or 6 or necessary for the enforcement of such a rule or an order issued in an actionbrought undersection 7.

The Administrator, after consultation with the Small Business Administration, shall by rule prescribe standards for determining what manufacturers and l)rcessors will be considered "small" manufacturers and pcessors. In prescribing such standards, the Committee antici)ates that the Administrator will takeinto account such relevant factors as the number ofemployees, the resources reasonably available for recordkeeping or reporting, the volume of production of substances and mixtures for which reporting or recordkeeping may be required in relation to the volume ofsuch production by others, and whether a company is independently owned and operated. In thecase ofa company which is owned orcontrolled by another company, such factors are tobeappliedtoboth companies. Subsection (b) requires theAdministrator to compile, keep current, and publish an inventory of existing chemical substances manufactured or processed for commercial purposes in the United States. The inventory is to be used by manufacturers and processors todetermine ifa chemical substance is a "new" substance subject to the premarket notification requirements ofsection 5.TheAdministrator is toinitially publish the inventory within one year after the effective date of the bill. Subsection (b) provides thattheinventory shall at leastinclude each chemical substance which any person reports undersection 5 orunder section 8(a) ismanufactured or processed inthe United States orwas manufactured or processed in theUnited States within threeyears before.the effective (lateoftherules promulgated under section 8(a) for purposes ofcompilingthe subsection (b) inventory. However, the Administrator. to alleviate reporting requirements and expedite thecompilation of the initial list,may wish to utilize reports ofcommercially produced chemical substances prepared by other governmental offices and departments, such asthe International Trade Commission and the Bureau of Mines. However, the Administrator maynot rely exclusively upon such reports,but must givemanufacturers and processors the

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opportunity to report substances manufactured orprocessed for commercial purposes which are not included within such reports.

In submitting reports with respect to existing chemical substances which the Administrator will use in compiling theinventory, amanufacturer may report substances whicli areproduiced only intermittently but which are a part ofthe manufacturer s product line. Manymanufacturers, particularly those who produce in batch lots, may not be currently producing the full range ofsubstancesthey customarily offer. Howeve', so long itsthe manufacturer has )roduced the substance for commercial purposes within the three year period (lescribed in section 8(b) (1), the manufacturer should re)ort thesubstance anditshould be included in the inventory.

Par1-agraph 2ofsubihetin: (b) provides thatto theextent consistent withthe purposes ofthisbill, theAdministrator mayin compiling and maintaining the inventory, list, a category of chemical substances rather than list individually each chemical substance within the category. By listing a category of chemical substances, minor modifications or variations in the formulation or structure of a chemical substance which would have insignificant health or environmental consequences would not automatically be subject to the notification requirements ofsection 5. Forinstance,the Administrator couldus categories so that reporting wouhil not be required as a result of changes such as the following: polymers or co-polymers which vary only in the.proportion of starting materials or catalysts used, orin molecular weight, molecular weightdistribution, chainstructure orcrystallinity; changes within an existing chemical substance in the proportions of colorants, stabilizers, antioxidants, fillers, solvents, carriers, surfactants, plasticizers, and other adjuvants which are themselves reported
as existing substances; variations in theproportion ofalloyed metals in iron and steel products and other metal alloys; variations in naturally occurring substances or mixtures (such ascrude oil, natural gas, minerals, or ores) and the resulting variations in extracts or refined products therefrom; variations in reported reactive mixtures whose commercial or end-use product iselectric energy (batteries) ;and salts which result front time combination of an existing inorganic anion with an existing inorganic cation.

The Committee realizesthat manychemical companies, particularly snmall ones, are able to compete in the chemical industry only by continually reformulating or making slight changes in existing chemical substances. It would be extremely burdensome on them as well as on the Administrator if every insignificant change were subject to the premarket notification requirements of section 5.By using categories in the inventory, the Administrator will be able to minimize such burdens. However, the Committee also realizes that minor modifications of innocuous compounds may produce highly toxic chemicals. Thus, tIme use ofcategories should belimited to areas where the effects ofsuch minor niodifications are well understood tohave insignificant healthandenvironmental consequences. Subsection (c) specifies that any person whomanufactures or processes or distributes in coumnierce a chemical substance or mixture or proposesto engage in such anactivity shall, as required by theAdnuinistrator by rule, maintain records ofadverse reactions to health orthe

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environment alleged to have been caused by the substance ormixture. The Administrator may require that records relating to the alleged adverse reactions to thehealth ofemployees beretained forup tofifty years, and that other records be retained for up to five years. Upon request, each person who is required to maintain such records shall permit inspection of the records and submit copies to the Administrator. Subsection (d) authorizes the Administrator to promulgate rules requiring persons who manufacture, process, or distribute in commerce or wno propose to manufacture, process, or distribute in commnerce a chemical substance or mixture to submit lists of health and safety studies conducted or initiated byor forsuch personorknown to such person, and to submit copies of such studies. In addition, the Administrator may by rule require any person who has possession of such astudy to submit copies ofthestudy totheAdministrator. Subsection (e) requires anyperson who manufactures, processes, or distributes in commerce a chemical substance or mixture to immediately inform the Administrator ofany information which reasonably supports the conclusion that the substance or mixture causes or significantly contributes to a substantial risk to health or the environment. However, if the person has actual knowledge that the Administrator has already been adequately informed of, the information, notification ofthe Administrator is not requirel. The requirement of subsection (e) isto insure bystatutethattheAdministrator isimmediately informed of such information, and it is not intended to limit the authority of the Administrator under subsection (a) to require reporting of data concerning the adverse environmental and health effects of asubstance or mixture. Subsection (f) specifies that for purposes of section 8, the terms "manufacture" and "proceess" mean manufacture or process for commercial purposes. Section 3(7) defines "manufacture" to mean "import, produce, or manufacture". Thusthe provisions ofsection 8 apply topersons who manufacture, proceed, orimport chemical substancesor mixtures solely forcommercial purposes.

SFCTION 9, REhATIONSIIIP 1} OTIOER FEDERAL LAWS
Because other Federal laws to someextent provide forregulation of toxic chemicals, it is necessary to define the relationship between the regulatory authority of this bill and that provided tinder other Federal laws. It is the'intent of the Committee that any overlapping or duplicatory regulation be avoided while providing for the fullest pos- sible measure of protection to health and the environment.

Section 9(a) sets out the relationship between the bill and other Federal laws not administered by theAdministrator. If the Administrator has reason to believe that the manufacture, processing, distribution in commerce, use, or disposal of a chemical substance or mixture (or any combination of such activities) causes or signifi- cantly contributes to or is likely to cause or significantly contribute to an unreasonable risk and if the Administrator determines that such risk may be prevented or reduced to a sufficient extent by action taken under a Federal law not administered bytheAdministraHeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 452 197646

tor,then the Administrator isrequired to report to the agency which administers such law a description ofsuch risk. Such description shall include a specification of the activity or combination of activities which the Administrator has reason tobelieve so causes orcontributes to such risk. The report shall include a detailed statement of the information on which it is based, shall be published in the Federal Register,and shallrequest theagencytowhich itismade- (1) To determine if the risk described in the report may be prevented or sufficiently reduced by action taken under its law, and (2) If itdetermines it may be soprevented orreduced, to issue

an order declaring whether or not the activity specified in the report causes or significantly contributes to such risk. The agency receiving the request from the Administrator shall issue the requested order and determination within such timeas theAdministrator specifies in the request. However, theAdministrator mustgive the otheragency atleastninetydays. If the other agency takes one of two alternative courses of actions specified in section 9(a) (2), then the Administrator is barred from acting under section 6 or 7 with respect to the risk about which the Administrator notified the other agency. First, if tile other agency issues an order declaring that the activity ,pecified in the report does
not cause orsignificantly contribute tothe riskdescribed inthe report, the Administrator may not take any action under section 6or 7 with tespect to such risk. AIternatively, if within ninety daysofthe publication in the Federal Register of the other agency's *responseto the Administrator's request, the other agency initiates action under its law which is adequate toprotect against such risk, the Administrator is precluded from taking any action under section Gor 7with respect to suchrisk.

The requirement thatthe other agency initiate action isnot intended to indicate that formal action by the other agency be undertaken within the specified time period, for time constraints may preclude any formal regulatory actions within such period. So longastileother agency has officially initiated an action which will culminate as soon
as practicable in effective regulatory action to protect against the unreasonable risk and sets forth a general time schedule of steps for such action, the requirements of section 9(a) (2) (B) shouldbe deemed satisfied. However, the provisions of section 9(a) (2) (B) would not be satisfiedby the merely open-ended possibility of action by the other
agency. Subsection (b) indicates the relationship between the bill and other law administered in whole or in part by the Administrator. Under subsection (b) if a risk to health or the environment associated with

a chemical substance or mixture could be eliminate(] or reduced to it sufficient extent by actions taken under the authorities contained in another Federal law administered bv the Administrator, the Administrator is required to use the other law unless the Administrator determines that it is in the public interest to protect against the risk by takingaction underthebill.

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lution Control Act establishes a specific timetable within which the Administrator is to establish eflluent limitations, list categories of sources, andestablish standards ofperformance fornew sourceswithin such categories. The Committee wishes to emphasize that nothing in the bill should be construed to relieve the Administrator from complying with any suchstatutorymandates.

Subsection c) provides that for purposes of section 4(b) (1) of the Occupational Safety andHealth Actof 1970, theAdministrator in exercising any authority under the bill shall not be deemed to be exercising statutory authority to prescribe or enforce standards or regulations affecting occupational safety and health. Consequently authorities granted under the bill will not preempt action under such Act.

Subsection (d) requires the Administrator to consult and coordinate with the Secretary of Health, Education and Welfare and the heads ofother appropriate Federal departments, agencies, andinstrumentalities in order to achieve the maximum enforcement of the bill while imposing the least burden of duplication. The Administrator must report annually to the Congress on actions taken to coordinate with other Federal (epartments, agencies, and instrumentalities and
on actions taken to coordinate the authority under the bill with authority granted under other laws administered by the Administrator.

SFECTION 10, RESEARCH, COLLECTION, DISSEMINATION, AND UTILIZATION
OF DATA
Section 10(a) requires the Administrator, in consultation and coop- eration with the Secretary of Health, Education, and Welfare and heads ofother appropriate departments and agencies toconduct such research and monitoring as is necessary to carry out the purposes of the bill. The Committee has required consultation and cooperation with other agencies and departments in order to insure that the Administrator does not duplicate the efforts ofotheragencies in conducting research under the bill. Such duplication should be.avoided both in research conducted by the Administrator as well as in research conducted pursuant to contracts entered into by the Administrator. Section 10(b) requires the Administrator to establish and coordinate the activities of an interagency committee to design, establish, and coordinate a system for the collection, dissemination, and use of data submitted to the Administrator. The Administrator is to establish and coordinate a retrieval system for toxicological and other scientific data which could be useful to the Administrator in carrying out,the purposes of thebill. The system Rhall be developed for use by all Federal and other departments and agencies with responsibilities in the area ofregulation or study ofchemeial substances and mixtures andtheir effects on health or theenviromnent. The Committeeexpects that in developing the retrieval system the,Administrator will utilize existing Federal data systems to the fullest extent possible.

Presently the collection ofdata onchemicals which may beharmful is fragmented among several Federal departments and agencies. The Committee feels that there is an urgent need for the development of a systematic bank of information which can be queried by any

HeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 454 1976regulatory agency faced with a problem respecting a substance or mixture or by any agency or department interested in research on a substance or mixture. One ofthe majorproblems confronting regu- latory agencies is the uncertainties regarding the total exposure of humans or the environment to a chemical substance or mixture. Exposure to a chemical may come simultaneously front several different

sourcesorthrough two or moremedia. Aspointed out by theNational Academy of Sciences in its report, DeaeonMakingfor Regulatin ChemicalsintheEnvironment,itisessential that each agency's standards reflect appreciation of such multiple exposures.' The development of a.comprehensive data system should help make this possible.

SECTION I11 INSPECTIONS
Subsection (a) authorizes the Administrator or a duly designated representative to conduct inspections for the purposes of enforcing the bill or any rule ororder promulgated under the bill. Inspections

are authorized of any establishment, facility, or other premise in which chemical substances or mixtures are manufactured, processed, stored, or held before or after distribution in commerce and of any conveyance used to transport a substance or mixture in connection with its distribution in commerce. An inspection may be made only upon presenting appropriate credentials and a written notice to the owner, operator, or agent in charge ofthe premises orconveyance to be inspected. Separate notices must be given for each inspection, but not for each e'ntry made during the period covered by an inspection. Inspections are to be comnmenced and completed with reasonable promptness and shall be conducted at,reasonable times, within reasonable limits, and in a reasonable mainer. Subsection (b) sets out the scope of the inspections. An inspection shall extend to all things within the premises or conveyance bearing
on whether the requirements of the bill have been complied with. However, no inspection mtay exend to financial data, sales data other than shipment data, pricing data. personnel dlata, or research data (other than research data required by this Act). unless the nature and extent of such data are described with reasonable specificity in the written notice.
SECTION 12, Y 'X'ORTS
Subsection (a) ofsection 12 provides that with certain exceptions this bill (otlr iIhan section 8 (relatig to reportilg (1nd rccordkeep- ing)) shall not applY to 'nov chomill i suilbstance. mixtuire, or article containing a substance or nuixtuNre ifit can be shown that such clmial substance, nlixture or artic, is being maim factI Ied. processedc, sold, orheld for sale, for export from the United States,unless such chellie'll SlllStalwP, imixture or article was, in flirt. Icianufacitured, pro(essed,sold,or held forsale, for use in the United States. Thus., for X01111he, a nmanufacturer facing an enforce lient proce(liiigfor ai11- facturinga1 suhstance for doiiesti, use in violation of the bill could

'Dcrdston fMaking for Ucrqvltig hietnfal inothe Enilronnint, (nmcnlitee on Prin. el"Irdcof Dpel Ilon Making for Rii'gilatng Clemienl Ill tle Environment. Enrrmn ental StAdlec Board. Commiion on Nnatural ectsources, Nntional Research Couneil, National Academy ofSciences, p. Ili (July 1975).

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not claim the benefits of the exemption under this section in order toexportthenoncomplying substance.

In order to qualifyfor the export exemption, a chemical substance, mixture, or article or container in which it is enclosed when distributed in commerce must bear a stamp or label stating that it is intended forexport.

The export,exemption shall not apply to any chemical substance, mixture, or article, if the Administrator finds that it will cause or significantly contribute to an unreasonable risk to health within the United States or to the environment of the United States. The Administrator may require testing inder section 4 of an otherwise exempt chemical substance or mixture to determine whether it causes or significantly contributes to an unreasonable risk to health within the United States or to the environment of the United States.

Subsection (h) provides that if any person exports or intends to export to a foreign country a chemical substance ormixture for which (1) the submission of data is required under section 4 or 5(d), (2) a rule has been proposed orpromulgated under sections5 or 6, or (3) an action is pending or relief has been granted under section 7, the person shall notify the Administrator. The Administrator must filr- nish to tie government ofthe country of destination timely notice of the availability of data submitted under section 4 or 5 or of the rule,action, orreliefundersection5,6,or7.

SECTION 13, ENTRYf INTO CUSTOMS TERRITORY OF TilE UNITED STATES Subsection (a) provides that the Secretary of the Treasury is to refuse entryintotheUnited States ofanychemical substance, mixture, or article containing such substance or mixture if it fails to comply with any rule in effect underthebill, orifitisoffered forentry in vio- lation ofsection 5,arule or an orderundersection 5 or6,oranorderis- sued in an action under section 15 or section 7. The Secretary ofthe Treasury is required tonotify the consignee ofanychemical substance, mixture or article which isrefused entry. The Secretary is to causeits disposal or storage ifit has niotbeen exported within 90days from the date the consignee receives notice of refusal ofentry. Of course, the Committee intends that the Secretary consult with the Administrator priorto taking such action. The Secretary may not release tothecon- signee any substance, mixture, or article refused entry,except theSeeretary may, pending a review by the Administrator of the entry refusal, release the substance, mixture or article to the consignee on execution ofbond forthe amount ofthe full invoice ofthe sub3tance, mixture or article together with the duty thereon.The consignee shall be liable tothe United States for liquidated damages equal tothe full amount ofthe bond ifthe substance, mixture or article isnot returned to the custody of the Secretary oftie Treasury when demanded. The Secretary of

### the Treasury, afterconsultation with the Administrator, is to issue rules for the enforcement of this section.

SECTION 14, DISCLOSURE OF DATA In order to insure that fle Administrator have full and complete access to information relevant to achieving the objectives of tie bill,

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H.R. 14032 gives the Administrator broad information gathering authority. However, the Committee recognizes that some information which the Administrator may obtain will be oftremendous competitive,valuetothe person p.roviding it. Accordingly, section 14 contains specific prohibitions against release of such information so that the competitive position of those supplying the information will be protected. Except for certain authorized disclosures, subsection (a) prohibits the Administrator or any representative of the Administrator from disclosing any information reported to or otherwise obtained under this bill which is exempt from disclosure under section 552 of title 5 of the United States Code (commonly referred to as the Freedom of Information Act) because ofsubsection (b) (4) ofthat Act.That subsectionprovides that the mandatory disclosure provisions oftheFreedomofInformation Actdonotapplytomattersthat are"trade secrets and commercial or financial information obtained from a person and privileged orconfidential." Thus any information which falls within the term "trade secrets and commercial or financial information obtained from a person and privileged or confidential" is generally protected from disclosure by section 14. Such information may,however, be disclosed to officers and employees of the United States in connection with their official duties forprotection of health or the environment or for specific law enforcement purposes. Such information may also bedisclosed tocontractors withthe United Statrs and employees of such contractors if in the opinion of the Admin.strator disclosure is necessary for the satisfactory performance of.tim contract. Such information may also be disclosed when relevant to any proceeding under this Act, except that disclosure shall be made in a manner designed to preserve confidentiality tothe extent practicable without impairing theproceeding. The Committee adopted the language of subsection (b) (4) of the Freedom of Information Act (5 U.S.C. 552(b) (4)) as the criterion for information which merits confidential treatment for several

reasons. Since there is a body of case law interpreting subsection (b) (4), the confidentiality criterion will be more definite. Further, since the Administrator must handle requests for information under both this bill and the Freedom of Information Act, use of the same standard will promote uniformity in the handling of such requests. As a result, them should be greater certainty as to the rights of industry to have data withheld and the rights of the public to obtain data. Subsection (b) (1) ofsection 14provides thatsubsection (a) doesnot prohibit the disclosure ofanyhealth and safety study submitted under the bill or any data submitted from such a study wvith respect to (1) any chemical substance or mixture which on the date the information is to be disclosed has been offered for commercial distribution or (2) any substance or mixture for which testing is required under section 4 or for which notification is required under section 5.However, ifa health and safety study contains (1) data which discloses processes used in the manuifacturing or processing of a chemical substance or mixture,or (2) data disclosing the portion of a mixture cmprised by any of thechemical substances in the mixturm..,nd if sidi dta would

107-l5 a - 77- 3D

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otherwise be entitled to protection from disclosure under subsection (a), then such data is not to be disclosed. In referring to data "disclosing the portion of the mixture comprised by any of the chemical substalces in the mixture," the Committee intends toprotect confidential trade secret information respecting the specific formulation ofa mixture. IIowever, the Committee does not intend to prohibit the Adininistrator from disclosing the chemical substances comprising the mixture by thwir orderofquantity in themixture. Subsection (b) (2) providesthat ifareqist ismade underthe Freedorn of Information Act for health and safety information obtained under this bill, the Administrator maiy not deny the request on the basis ofthe exemption provided in subsections 

### (b) (3) or (b) (4) of 5 U.S.C.552. Thus,health and safety information which isnot'subject to the prohibition on disclosure presciril(d bysection 14(a) of the bill is notexempt from disclosure under subsection (a) ofsection 552 by I'irtue of subsection (b) (4) of that section. In addition,in considering a request underthe Freedom ofInformation Act, theAdministratormay not disregard section 14(b)'s specific exemption forhealth and safety information from section 14(a)'s prohibition on disclosure and assert, that section 14(a) provides itstatutory exemption from disclosure,of such information.

The piurpose of subsection (b) is toclarify that health and safety information is not entitled to confidential treatment either tinder subsection (a) orthe Freedomit ofInformation Act. The subsection should not be construed toimply that inthe absenceofsuch aprovision, health and safety information would be entitled to such confidential treatment.

Su)section (c) provides that any person submitting data under the bill may designate that data which the person believes is entitled to confidential treatment. Such data may be submnkitted separately from the other data. If tihe Administrator proposes to release data which has been so designated, the Administrator shall notify in writing and by certified mail the person who submitted the data. If the release of data is m1adle pursiant to arequest un(ler theFreedom ofInformation Act, the notice must be given immediately upon approval ofthe request by thle Administrator. Simeh immediate notification is required

so that'any disclosinme required under the Freedom of Information Act shall not 1be rmul uly delave(l bY therequirements of thissubsection. The Adniistrator may not release the i designated data until the exiration of30(days after tile persoln submitting tie data has received the notice. Stibsection (d) )roviles criminal penilties for officers and ciiiplovees oftile United States timnd forimer officers and employees who knowingly and willfully disclose information prot(ted from disclosi 1I 

### b,"section 14. Penalties of itll to one year iiil1risrnent or a lineof il; to$5,000 orboth are provided. Since this sullsection provides for criminal penalties, section 1905 of title 18 of the United States Code (respecting criminal iemilties for disclosure (if confidential information) is waived.

Subsection (e) provides that ill information reported to or otherwise obtaited by the Admiinistrator in mderthe bill shall le madeavailal)h, 1 upon written request of any duly authorized committee of the

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Congrss to such committee. It is theCommittee's view that the inher

### ent authority of Congress, asthe constitutionally established legisla- tivebranch, assuresaccesstosuchinformation, and thustheprovision is not necessary to assure such access. Rather, the provision was included merely to give expression to such power and sets forth proceduresforthe exercise ofthepower.

SECTION 15, PROMIBITED ACTS
Section 15 makes itunlawful for anyperson to fail orrefuseto comply with any section of the bill, or any rule, order or requirement promulgated under the bill. Specifically, the section forbids any person to fail or refuse to comply with any rule or order promulgated under section 4, any requirement prescribed by section 5, or any rule

or order promulgated under section 5 or 0.It also forbids anyperson to useforcommercial purposes a chemical substance or mixturewhich theperson knew orhad reason to know was manufactured, processed,

or distributed in commerce in violation of section 5, a rule or order under section 5 or section 6, or an order issued in an action under section 5or 7. The term used for commercial purposes is intended to be interpreted broadly toinclude anyuseinmanufacturing, processing,

or distribution in commerce or any other activity forcommercial purposes. Further, the section forbids 

### any person to fail orrefuse to establisli or maintain records, submit reports, notices orother information or permit access to or copying of records as required by the bill

or any ruleunder thebill. In addition, this section forbids any person to fail orrefuse to permitentry or inspection asrequired by section 11.

SECTION 16, PENALTIES
Section 16 states the penalties for violations of section 15 of the bill. Subsection (a) providesthat any person who violates aprovision of section 15 shall be liable fora civil penalty ofup to $25,000 for each such violation. Each day a violation continues shall constitute a separate violation. A civil penalty is to be assessed by the Administrator by an order made on the record after opportunity for a hearing in accordance with the provision of section 554 of title 5of the United States Code. Theopportunity forahearingshallbeprovidedbygiving written notice to any person who may be subject tothe order.

The notice shall inform the person that the Administrator proposes to issue an order assessing a civil penalty. The Administrator must provide the plerson an opportunity to request. within fifteen days of receipt ofthe notice, a hearing on the order. Although commission of

one of the acts prohibited by section 15 automatically makes one subject to the assessment ofa civil penalty, the Administrator may take into consideration certain mitiiratinar'circumstances in determining the amount ofthecivil penalty.The Administrator shall considerthe nature, circumstances, extent, and trr-vity of the violation. The Administrator shall also consider the ability ofthe violator to pay, the effect on the violator's ability to continu' to do business, any history of prior violations, the degree of culpability, and other matters as justice may require. The Administrator is granted discretion to cornHeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 459 1976

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promise, modify, or remit any civil penalty which may be imposed under subsection (a). Althouigh no time period is provided in the statute, it is anticipated thatany compromise, modification, orremission would occurwithin a reasonable time after assessment ofthecivil penalty.

Any person who requested ahearing respecting the assessment of a civil penalty and who is aggrieved by an order assessing such a penalty may file apetition forjudicial reviewoftheorder with theUnited States (ourt of Appeals for theDistrict ofColumbia or for any other circuit in which the person resides or transacts business. The petition must be filed within thirty days after the.date the order making the assessn-nt is issued.

Actiwis for collection of civil penalties shall be brought by theAttorney General.

Subsection (b) provides that anyperson who knowinglyor willfully violates any provision of section 15 shall be subject upon conviction to

a fine ofnot more than $25,000 for each day of violation or imprisonmentfornotmorethan oneyear,orboth.

Under subsection (c) theAdministrator isauthorized torequire any person who has manufactured, processed,or distributed in commerce a chemical substance ormixturein violation of a requirement underparagraph (1) or (2) ofsection 6(a) to give notice ofthe risk associated with the substance or mixture. Such person may be required to give such notice toprocessors ordistributors in commerce and,.totheextent reasonably ascertainable, to any other person in possession of or exposed to such substance ormixture. Such person may also be required togive public noticeofthe risk and toeitherreplace orrepurchase the substance or mixture. The determination thatthe personhas manufactured, processed, or distributed in commerce a chemical sibstance or mixture in violation of a requirement under section 6(a) (1) or (2) must be made by order made on the record after opportunity for an agency hearing.

SECTION 17, SPECIFIC ENFORCEMENT AND SEIZURE
Section 17 provides for injunctive enforcement of requirements of the bill. It also provides for seizure of anychemical snbstance ormixture which was manufactured, processed, or distributed in commerce in violation of the bill or any rule or order under the bill. Seizure is also provided for any article containing such a substance ormixture.

Subsection (a) plrovides that the ITnited States district courts will have jurisdiction to restrain any violation of section 15 (prohibited acts) or to restrain any person from manufacturing or processing a chemic2l substance before the expiration of any applicable period under section 5.In addition, the district courts are granted jurisdiction to restrain any person from taking any action prohibited by a ruleor order under'section 5or 6or to compel thetaking ofanyaction required by orunder the bill. This subsection also contains )rovisions relating to venue, service of )rocess and subpoena of witnesses. Under subsection (b) any chemical substance or imixture which was manufactured, processed or distributed in commerce in violation of the bill or of any rule or order promulgated under the bill or any

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article containing such substance ormixture shall be liable tobe pro- ceeded against for seizureandcondemnation. Actions forsuch seizure and condemnation may bebrought inany United States districtcourt within the jurisdiction of which such substance, mixture, or article is found, and the proceedings shall conform asnearly as possible to proceedings inrein inadmiralty.

SECTION 18, PREEMPTION
Section 18(a) provides generally that nothing inthe bill shalleffect 

### the authority of a State orpolitical subdivision to establish or continuein effect regulation ofany chemical substance,mixture orarticle containing achemical substance ormixture.However, except asotherwiseprovided, rules undersection 5and 6shall preempt nonidentical State and local requirements respecting the same chemical substance, mixture, or article containing a substance ormixture, ifthe State or local requirement addresses the same risk to health or environment associated with thechemical substance, mixture, or article. Similarly, if the Administrator establishes a testing rule under section 4, no State orpolitical subdivisionmay establish oreontinue ineffect atestingrule for purposessimilar tothose forwhich the testingis required 

### undersection4. However,rulesunder section6(a) (5)relatingtodisposal donotpre- empt,any State or local requirements. Further, if a State or local requirement is adopted under the authority ofthe Clean AirActorany other Federal law,the Federal rule shall notpreempt theState orlocal requirement. Thus, for instance, State emission standards, effluent limitations, orother regulatory requirements adopted under th Clean Air Act or Federal Water Pollution Control Act would notbe pre- erupted by rules issued under (his bill, even though the State or local requirement were more stringent. This would be the case ifa State limitation, standard, or requirement were adopted, submitted, and approved as part.ofa State implementation plan required under Federal law. Similarly, the preemption would not apply to a State or local limitation, standard, or requirement. if it were adopted under the State or local government's authority which is preserved by a provision of Federal law, such as a section 116 ofthe Clean Air Act
or sections 1414(e) or 1424(c) of the Public Health Service Act (relatingto safedrinking water).

The Committee recognizes thetraditional role ofthe State and local governments in providing forthe protection of theircitizens. As aresult in addition to the specific exemptions from the preemption pro- vision, the Committee bill provides a means whereby a State orpoliti- cal subdivision may seek an exemption from the Federal preemption in orderto provide ahigher degree ofprotection fortheircitizens than that provided by regulations under thisbill. Under subsection (b), the Administrator mnavby rule exempt from the preemption provisions a requirement of a State or political subdivision ifthree conditions are satisfied. First, compliance with the State or local requirement must notcause a violation ofthe applicable requirement under the bill, Sec

### ond,the Stateor political subdivision requirement must provide asig- nificantly higher degrw ofprotection from the risk.Third, the State

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### or local requirement must not through difficulties in marketing, distribution. or other factors, unduly burden interstate commerce.

SECTION 10, JUDICIAL REVIEW 

### Section 19 setsout theprocedures forjudicial review ofrules issued under sections 4, 5,or 6ofthe bill. Subsection (a) provides that peti- tions for judicial review must be filed within 60 days following the promulgation ofarule under section4,5,or 6.Such petitionsaretobe filed with the United States Court of Appeals for the District of ColumbiaCircuit or for the circuit in which the petitioner resides or inwhich thepetitioner'sprincipalplaceofbusinessislocated.Thesubsection containsprovisions for filingthe record ofthe proceedings on whichtherule wasbased.The Committee anticipates that ordinarily a certified list ofthe record may be provided in accordance with appli- cable appellate rules ofprocelure unlessthe court requests otherwise.

Therecord means anyrule, anytranscriptrequired ofanyoralpres- entation, any written submission ofinterested parties and any other information which the Administrator considers to be relevant to the rule and withrespect towhich theAdministrator,onorbeforethedate ofpromulgation of therule,publisheda noticeintheFederal Register identifying the information. Such notice need only list the information;itneednotsummarizesuchinformation.

By sodefining therecord, the Committee intends thatthepublic be fully apprised ofthebasisfortheAdministrator's action.The Administratorshould include in therecord thosedocuments in theAdminis- trator's possession which are ofmaterial relevance to therule,including, ofcourse, thosewhich contradict as well as supporttheAdministrator's position. The Committee expects that theAdministrator will, throughout the proceedings for the issuance of a rule, keep current and make available upon request a listing of information to be included in therecord, as well aspermit access toand copying of documentstobeincludedintherecord.

Subsection (b) describes when the Court mayrequire the Administrator to provide an opportunity for the petitioner to adduce additional data,views or arguments. The petitioner must show that,such data, views, or arguments are material and that there are reasonable grounds for the petitioner's failure to adduce such data, views, or arguments intheproceeding beforetheAdministrator.

Subsection (c) grants the court jurisdiction to review the rule in accordance with chapter 7of title 5ofthe United States Code and to grant appropriate relief. Any rule promulgated by the Administrator under section 4, 5, or 6 is to be affirmed unless the determination or findings required to be made under the applicable section are not supported by substantial evidence on the record taken as a whole. Thus, it is the intent that the traditional p)resumption ofvalidity ofan agency rule would remain in effect. The Committee recognizes that in rulemaking proceedings which are e.sentially informal and which involve both determinnble facts and policy judgments derived therefrom, the traditionial standard for revie*v is that,of "arbitrary and capricious." The use of the substantial evidence standard for such rulemaking is not, however, without precedent, and the courts have

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adequately adapted to it.1 The Committee has chosen to adopt the "substantial evidencetest," fortheCommittee intendsthatthe reviewing court engage ina searching review of theAdministrator's reasons and explanations for the Administrator's conclusions. However, the Committee does notintend to imply thattheCourt isto substitute its judgment forthe policyjudgment oftheAdministrator. The udgment of the court shall be final subject to review by the Supreme Court. Further, such judgnent. may include an award of costs of suit and reasonable fees for attorneys and expert witnesses if the court determines that such is appropriate. Such costs o.f suit and fees may also be awarded by the Supreme Court in its decision

on review of any such judgmnent. 

### Subsection (d) provides that the remedies provided in this section

shall be in addition to andnot in lieu of any other remedies provided 

### by law.

SECTION 20, CITIZENS CIVIL ACTIONS Section 20 authorizes actions by individuals to restrain violations

of the bill and to compel theAdministratorto perform any statutory 

### duty arising under the bill. Such citizen actions can provide an important aid in enforcing the bill. In adopting the provision your Committee is following the ample precedent established in other Federal laws. The Clean Air Act, Federal Water Pollution Control Act, Noise Control Act, the Consumer Product Safety Act, and 

### title XIV of the Public Health Service Act (relating to safe drinking
water) all contain similar provisions. In addition a number of States 

### authorize citizen enforcement actions. Subsection (a) authorizes any person to commence a civil action
to (1) restrain violations of the bill or any 

### rule prescribed under section 4 (tasting), section (manufacturing andprocessing notices) and section 6 (regulation), or (2) compel the Administrator to per

### form any nondiscretionary act or duty under the bill. Actions shall be btrought in 

### thedistrictcourt in w dich tie allged violation occurred



### orin which the defendant resides orhas his orher principalplace of business. The districtcourts shall have jurisdiction without regard tothe amount in controversy, or the citizenship of the parties. Citizen suits against persons alleged to be in violation of the bill or a rule issued under section 4,
, or 6 may be. brought against the United States ec1 against any other governmental instmmentality or agency, but only to te extent permitted by the Eleventh Amendment to the Constitestion. The section does not authorizethe collection of damages

in any such suit.



### Under tisprovision, the personbringingthe suitserves asaprivate attorney-general to protect the public interest. Thusitis simportant thatthe plaintiff he a competent and "appropriately" interested rresentative ofthe public interest. Thr Committee believes that the wisest

means of assuring this is to rely upon the court's inherent porer to dismiss collusive suits and upon the broad rights of intervention in suits under this section.

I See andutri! Unot Department, A eL-CIO v. I no soian, 4 t) f.2d47 (D.C. Ci

. 1074).

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To assist persons bringing suits under the section and similar sections ofother laws administered by the Administrator, theCommittee recommends that the Administrator adoptuniform policiesandprocedures: (1) governing the Administrator's role in such suits as intervenoror amicus; (2) specifying theextent to whichtheAdministrator will comment on proposed consent orders; and (3) providing for cooperation with parties instituting civil enforcement actionsto insure that the Administrator's expertise and factual data is made available tosuch parties to the fullest extent possible. Subsection (b) specifiescertain limitations onthecommencement of

a civil action under this section. Prior tothe commencement of a civil action to restrain a violation of the bill or a rule.under the bill, the plaintiffnmst give 60daysnotice tothe Adminiistrator and thealleged violator. If the Administrator has institutL-d and is diligently prosecuting a civil action againstthealleged violator tocompel compliance,

no suit may be brought under the section. However, if the Administrator's action is not commenced until after the notification, theperson who gave notification may intervene in the Administrator's suit as a matter of right. Sixty days notification to the Administrator is also a prerequisite tothe commencement ofan action againsttheAdministrator tocompel the performance of a nondiscretionary act or duty, except in the case of an action involving an imminent hazard. In the case ofthe alleged imminent hazard, the notification period is 10 days. Subsection (c) authorizes the Administrator to intervene asa matter of right in any civil action under thissection to which the Administrator is not a party. The award ofthe costs of suit and reasonable fees for attorneys and expert witnesses is authorized, if appropriate.

Nothing in this section shall restrict the right of -anyperson under any statute or the common law to seek enforcement of'the bill, or any rule under the bill, or to seek other relief. Subsection (d) provides that, upon application of the defendant, a court may consolidate two or morecivil actions brought under subsection (a) involving the same defendant and the same issues or violations when suchf actions are pending in two or morejudicial districts.

SECTION 21, CITIZENS' PETITIONS
Section 21 provides an important mechanism for public initiation of actions to protect the health and environment..Under section 21(a) any person may petition the Administrator to initiate a proceeding for the issuance, amendment orrepeal of a rule under section 4, 5(c), or6(a). Subsection (b)sets out the procedures for such citizen petitions. Aiy petition is tobe filed in the principal office of the Administrator, and it must set forth the facts which the petitioner claims establish that it. is necessary to issue, amend, or repeal a rule under section 4, 5(c), or 6(a). A petition for amendment or repeal of an existing rule should contain newly discovered, noncumnulative information which was not presented for the Admin;strator's consideration in proinulgatini the rule oron anv appeal of the rule, and failure to include such information would be adequate basis fordenying the petiHeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 464 1976

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tion. Otherwise, the provisions ofthis section could vitiate the proce- dures provided in section 19 for review of a rule.under section 4, 5,

or 6.

The Administrator may hold public hearingsor conductany investigational proceeding appropriate to determine whether ornot apeti- tion should begranted. Within 90days the Administratormusteither grantordenythepetition.Ifthepetitionisgranted,theAdministrator shall promptly commence an appropriate proceeding to take the action requested. If the petition is denied, the Administrator must publish inthe Federal Registerthe reasons forthedenial. Ifthe Administrator denies the petition, or ifthe Administrator fails to act on the petition within the specified 90-day period, the petitioner may commence a civil action in a United States district courttocompel the initiation ofthe requested-rulemakingproceeding. Suchaction mustbefiledwithin 60days. Subsection (b) (4) (B) sets out provisions applicable to the civil actionin the caseofa petition requesting theissuance of arule under section 4,5(c), or 6(a). Subsection (b)(4)(B) does not apply with respect to civil actions respecting petitions for amendment or repeal ofrules.Subsection '(b) (4.) (B) providesthepetitioner fortheissuance of a rule with an opportunity for a de novo proceeding before the court. If the petitioner makes certain requisite showings, the court shall order the Administrator to initiate the requested action unless the court finds that the failure of the Administrator to initiate the requestedaction wasnotunreasonable. In the case of apetition forthe issuance of a rule under section 4, the petitioner must show that the manufacture, distribution in commerce, processing, use or disposal of the substance or mixture to be subject to the rule may cause or significantly contribute to an unreasonable risk to health ortheenvironment. If the petition was for the issuance of a rule under section 5(c), the petitioner must show that the manufacture, processing, distribution in commerce, use or disposal ofthe substance requested to be subject to the rule
causes or significantly contributes to or may cause or significantly contribute to an unreasonable risk to health or the environment. If the netition requests the issuance of a rule under section 6(a), the petitioner must show that there is a reasonable basis to conclude that the manufacture, processing, distribution in commerce, use or disposal of the substance or mixture causes or significantly contributes to or will cause or significantly contribute to an unreasonable risk tohealth ortheenvironment. If the petitionermakes therequisite shoNwin, the court shall order the Administrator to initiate the requested rulemakinz action unless the court finds that the failure ofthe Administrator to initiate such action wasnot unreasonable. In making the latter determination, the court is toconsider the priorities ofthe Administrator, thp resources availabletotheAdministrator totakethe action requeeted by thepeti- tioner, and other relevant factors. The Committee intends that the court carefully rev;ew the Administrator's priorities and resources to determine ifthe failure oftheAdministrator toinitiate the requested action was unreasonable in lightoftheriskdemonstrated bythepeti- tioner.

HeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 465 1976Although the court may order the Administrator to initiate the requested rulemaking proceeding, the court may not determine what the final outcome of the rulemaking proceeding should be nor does the court's determination that a proceeding should be commenced relieve the Administrator of any responsibility to make any findings which are requisite in the exercise of any of the authorities under sections 4, 5 or 6. Costs of suits and reasonable fees for attorneys and expert witnesses may be awarded if the court determines it is appropriale. The remedies provided by section 21 shall be in addition to, not in lieu of, other remedies provided by law.

SECTION 22, NATIONAL DEFENSE WAIVER
Section 22 provides that the Administrator shall waive compliance with any provision ofthe bill upon a request and a determination by the President that the waiver is necessary in the interest ofnational defense. If a waiver is provided the Administrator must maintain a written record of thebasis for the waiver and make the record available for in eahera examination when relevant in a judicial proceedingunderthe 

### bill. Th.eAdministrator is topublish a Federal Register notice informing the public that the waiver was granted for national defense purposes unless upon request, of the President, the Administrator determines to omit.the publication because it would be contrary to the interests of national defense. In such a situation the Administrator shall submit notice to the Armed Services Committees of the Senate and House of Representatives.

SECTION 23, EMPLOYEE PROTECTION
Section 23 provides protection for employees who may cooperate with the Administrator.

Subsection (a) prohibits any employer from discharging any employee or otherwise discriminating against any employee with respect to compensation, terms, conditions, or privileges of employment,because the employee (or persons acting under request ofthe employee) has commenced, caused to be commenced, or is about to commence a proceeding underthebill. Protection isalsoprovided foranyemployee who has testified, or is about to testifyin any such proceeding, orhas assisted or participated in a proceeding or any other action to carry out thepurposes ofthe bill.

Under subsection (b) any employee who believes that lie or she has been discharged orotherwise discriminated against in violation of the section may file a complaint with the Secretary of Labor. The Secretary shall conduct an investigation of the alleged violation. The investigation must be completed within thirty days of tIe receipt of the complaint. Both the complainant and the per'son1 alleged to have (""nimitted the violation shall Ibe notified in writing of the results of the investigation. Within ninety days of the receipt of the complaint, the Seretary shall. 1n1less there is a settlement respecting the complaint, issue an order providing appropriate relief or denying the complaint. Such order shall be made on the record after notice and opportunity for agency hearing. If the Secretary determines that a

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violation of this section has occurred, the Secretary shall order the person who committed theviolation totake affirmative actionto abate it, 

### to reinstate the complainant along with compensation including back pay, terms, conditions, and privileges of the complainant's employment; compensatory damages; and where appropriate, exemplary damages. Costs and expenses reasonably incurred by the complainant inbringingthecomplaintmay alsobeassessed. Subsection (c)provides forjudicial review ofanorderoftheSecretary. Any adversely affected person may obtain review ofthe Secretary's order in the'United States Court ofAppeals for the circuitin which the violation allegedly occurred. The petition for review must be filed within 60 days from the issuanceofthe Secretary's order and review shall conform to chapter7oftitle5oftheUnited States Code. Subsection (d) provides Torenforcement ofordersbytheSecretary in the district court for the district in which the violation occurred. The district courts are grantedjurisdiction to grant all appropriate relief.Such actionsshall beheard anddecided expeditiously. Subsection (e) provides that the section shall not apply to any employee who deliberately caused a violation of any requirement of the bill, unless the employee was acting under directions from the employer.

SECTION 24, EMPLOYMENT EFFECTS


### Section 24 (a) provides forcontinuing evaluations ofthe potential effects on employment of anyrule or order under section 4,5or 6or
a.requirement ofsection 5. Subsection (b) authorizes the Administrator upon request of an employee to investigateanydischarge orlayofforthreatened discharge

or layoff or other adverse effects on employment allegedly resulting from a rule or order under section 4, 5or 6or a requirement of section 5.The Administrator shall ifrequested by any interested person hold public hearings on any matter involved in the investigation unlessthe Administrator determines thattherearenoreasonable grounds for holding such hearings. The person requesting the hearing must be notified in writing ofany determination not to hold a requested hearing. Ifpublichearings are held,theAdministrator mustprovide atleast five days noticetothe person makingtherequest fortheinvestigation and to any person identified in such requests. A transcript shall be made of the hearings and each employee who requested a hearing 'and the employer ofsuch employees shall be required to present information rosipectinw the adverse effects or threatened adverse effects. Upon completion of the investigation, the Administrator shall make findings of fact and any recommendations deemed appropriate. Such findings and recommendations shall ie made available to the public. Subsection (b) also provides for subpoenas, oaths and payment of witnessfees.

SECTION 25. STUDIES 

### Subsection (a) requires the Administrntor to conduct a study of all Federal laws administered by the Administrator to determine whether and under what conditions. ifany. indemnification should be accorded any person as aresult ofaction taken by the Administrator

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under such laws. The General Accounting Office is to review and colnmenton theadequacy ofthe study. Subsection (b) requires the CouiAcil on Environmental Quality to coordinate a study of the feasibility of establishing a standard classification system of chemical substances and related substances and a standard means for storing and obtaining rapid access to information respecting such substances.

SECTION 260, ADMINISTIATION OF' TIIE ACT
Section 26(a) provides that upon request by the Administrator, each Federal departinent and agency is authol'zed to make its services, personnel, and facilities available to the Administrator to assist in the administration of the bill and to furnish to the Adlninistrator such information, data, estimates, and statistics and to allow the Admninistrator access to all infornation in its possession as the Admninistrator liay reasonably determnine to be necessary forthe administration ofthe bill.

Subsection (b) provides that the Administrator may byrule require the payment of reasonable fees from any person required to submit data under section 4 or 5 to defray the cost ofadministration ofthe bill. The fee may inot exceed $2,500. In setting the fee the Adninistrator must take into account the ahIility to piy ofthe person required to submit the data and the cost of the Administrator of reviewing the data. Such fees may be shared in cases where the expenses of testing

are also shared.

Subsection (c) authorizes the Administrator to take action with respect to categories of chemical substances or mixtures rather than with respect to individual chemical substances or mixtures. For example, if under section 4(a) the Administrator finds that the manufacture, distribution in comlmerce, processing, use. or disposal of a category ofchemical substances may cause or significantly contribute to an unreasonable risk, that there are insufficient,data andexperience with respect tothat category, and thattesting ofthat category ofsubstances is necessary to develop data, the Administrator coula issue a section 4(a) testing rule respecting the category of chemical substances. Of course, once test data has been submitted by a manufacturer or processor with respect to a substance within the category, such data may provide a basis for manufacturers and processors of other chemical substances within the categrory to apply asprovided in section 4(c) for an exemption from the testing r'equirement and thereby unnecessary time and expensecould be saved theaffected manufacturers and processors by not having to test each minor modification ofsubstanceswithin the category. It should be noted that intakingaction under any provision of the bill respecting a category of chemical substances, tihe Administrator will nothave tomaketherequisite findingfor suchaction with respect to every chemical within thecategory. The Committee agrees with the National Academy of Science recommnendation that the EPA adopt, whenever scientifically possible, a generic approach fortheregulation ofchemicals.,

"Deelslonmaklng for Regulating Chemicals in the Environment", p. 43 (1975).

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The subsection defines the terms category of chemical substances and category ofmixtures. '

Subsection (d) directs the establishment within the Environmental Protection Agency of an identifiable office to carry outthe following: (1) The provision of technical and other nonfinancial assistance to manufacturers and processors respectingthe requirements ofthe bill which theymustmeet. (2) Informing manufacturers and processors of the policy of the agency respecting the application to themofthe requirements ofthe bilI. (3) Informing manufacturers and processors ofthe means and methods by which they may comply with such requirements. The office to be created should provide'an important means of insuring that manufacturers and processors are fully informed of the provisions of the bill. The services of tle office should beparticularly helpful to small and medium-sized manufacturers and processors which typically do not have an extensive legal staffto deal with the complexities of the bill and rules promulgated under it, and the Committee intends that the assistance office focus itseffortson helping such small and mediumn-sized manufacturers and processors. The office should answer general inquiries concerning procedurdl and substantive requirements of the bill and rules promulgated under it as well as respond to requestsrespecting the policy oftheagency respect- ing the application of requirements to a specific manufacturer or processor. In addition, the Committee anticipates that the office will provide assistanceto manufacturers and processors by referring them toother offices within the agency when it is necessary for inquiriesto be handled by another office. Ofcourse, the provisions of section 14 respecting disclosure of data would apply to any information received by the assistance office from a manufacturer or processor.

In addition to responding to inquiries, the office should through publication of pamphlets, circulars, and other methods conduct gen- eral educational efforts designed to reach manufacturers and processors and inform them oftile requirements ofthe legislation.

Certain regulatory statutes contain provisions granting general rulemaking authority to the agencies administering the statutes. See, e.g., section 701 of the Federal Food, Drug,and Cosmetic Act. However, such provisions have been construed to grant such agencies substantive rulemaking authority. Thebill contains specific grantsofsubstantive rulenaking authority tothe Administrator (see, e.g., sections 4, 5, 6,and 8) and the Committee does not intend that the Administrator have any substantive rulemaking authority which is not spe- cifically granted. A general rulemaking authority is not needed to authorize the issup ofprocedural, interpretative, or similar adlministrativerules,' consequently, such a provision isnot included inthebill.

SECTION 27, DEVELO')PMENT AND EVALUATION OF TEST 'METHODS
This section provides authority for the conduct of and financial assistance for projects for thedevelopment and evaluatior{'finexpen- sive and efficient methods for determining and evaluating the health



### I See authorities cited in Morrow v. COlayton, 320 F2d 30, 44 (1903).

HeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 469 197663

and environnental effects ofclhemical substances and mixtures, which methods may beused in developing testdata tocomply witha section 4 testing rule. Tihe Secretary of Health, Education, and Welfare will, in consultation with the Administrator and acting through tie office oftheAssistant Secretary forIlealth, administerthissection.

The Secretary is to make, annual reports to Congress respecting grants and contracts inade wnder this section and is to periodically publish in the Federal Register reports describing the progress and resultsofprojects assistedby such grants andcontracts. In adopting this section tile Committee has indicated its intent that efforts should be made to develop and evaluate inexpensive fnd efficient testing methods. Such methods could significantly reduce the cost and time involved in complying withtestingrules under section 4.

SECTION 28, AUTHORIZATION OF AP'PROPIUATIONS
Section 28 authorizes to be appropriated to the Administrator for carrying out 

### the bill $11,100,00o for the 1978 fis'al year, $10,100,000 for the 1979 fiscal year, and $11,100,000 for the 1980 fiscal year. No part of the funds so authorized to be appropriated shall he used to construct any research laboratories.

SECTION 29, ANNUAL REPORT
Section 29 requires the Administrator to prepare and submit to the President and the Congress annually a comprehensive report on the administration of 

### le bill. The report shall include information regarding testing required uider section 4; notices under section 5; action taken umder section 5(g) ;rules issued under section 6; judicial actions taken inder the bill; and a summary of najor problems encountered in tle administration of the bill and recommendations for additional legislation.

SECTION 30, EFPECTIVE DATE
Section 30 provides that the effective date of the bill shall be October 1,1977.

PRomORA-3 OVERSIoIIT

The bill provides new authority for the Administrator of tile Environmnental Protection Ageney. c¢onsequently, no oversight activities have been conduicted by the conimnittee with respect to such authorities and no oversight rel)orts have been made by the Committee's Subcommittee on In'estigations and Oversight or the Committee on Government 

### Opelations.

INFLATrIONARY IMPACT S'r.'lTEsIENT
Pu'suant to rule XT, clause 2(1) (4) ofthe Rules of the House of Representatives, the Committee imakes thefollowingstatement regarding the inflationary impact of the reported bill: Information available to the Committee indicates that the inflationary impact of the bill would be extremely slight. The EnvironHeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 470 197664

mental Protection Agency has estimated that the annual cost of the legislation to the regulated industry will range between $80 to $140 million. The General Accounting Office reviewed the EPA estimate and concluded that it was probably realistic, although testing costs could be somewhat higher than estimated by EPA, resulting in total annual costs to industry of $100 to $200 million.

Taking into account such annual costs to industry of $100 to $200 million and projected EPA expenditures of$11 million annually, the inflationary impact ofthelegislation should be extremely small. These annual costs are equivalent to about one percent of the annual cost of $20billion which will be expended for water and airpollution controls during the 1973-1982 period, as estimated by the Council ofEnvironmental Quality. A study performed by Ohase Econometrics, Inc., MaroecomnnicA zspects ofFederalConirolProgrami,,concludes that

an annual expenditure of $20 billion during the 1973-1982 period would result.in an average annual rate of increase of 0.2 percent for the Wholesale Price Index, 0.1 percent for the GNP PriceIndex, and 0.2 percent for the Consiuner tWice Index. Since the estimated expenditure for this bill is only a fraction of that utilized in the Chase Econometrics, Inc. study, the inflationary impact would be substantially lower than that 1projected in that study. As a result, the Committee concludes that. the inflationary impact of costs of the bill will be extremely slight.

Co-xossro-,L BLW-IET OFFICE COST ESTIMA'rE
JULY 1, 1976. 1. Bill Number: II.R. 14032.

2. Bill Title:Toxic Substances Control Act. 3. Purpose ofBill: This bill establishes procedures and authorizes the appropria- tion of funds to regulate potentially toxic chemical substances. It mandates the Administrator of the Environmental Protection Agency (EPA) to develop regulations to ensure adequate testing of potentially toxic chemicals. It requires that the Administrator be notified of theimpending introduction of any new chemical or significant new uses ofexisting ones, and empowers him to delay such introduction up to ninety days. The bill also authorizes the Administrator to issue rules which prohibit or limit the 1nnufacturing, processing, or distribution ofdangerous chemicals ormixtures, and tocarry outinspections. Variousguidelines and procedures are established for the Administrator to follow in implementing the bill, as well as for citizens' civil actions and petitionsto the Administrator.

The bill authorizes appropriations of $11.1 million for fiscal year 1918, $10.1 million for fiscal year 1979,and $11.11 million for fiscal year 1980 for the purpose of carrying out this Act. This is
an authorization bill, which requires subsequent appropriation ietion. 4. Cost Estimate: This bill would authorize appromiations for the 

### toxic substances control j)ruorani for fiscal years 1978 through 1980. Thebudget impact ofthisbill isshown below.

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lin millions of dollars]

Fiscal year1978 1979 1980 1981 1982 1983

Authonrzation level... 11.10 10.10 11.11

- - -----------------...
.. . .. . Estimated cost--------- 8.30 9.50 10.80 2.70 0.90 0.11

All costs,ill tisbill fall withii Function 300. 5. Basisof Estimate :The Office ofToxic Substances ill EPA, which will imflCment this bill. estinates that general a 1)atelliltand con- trol activities (e.g.. pIroIIliilgIt ing testing gililleS 1lnd motitoring
Dew ellelical iliiroductiolls) will require sevenity-five percent of the 111lthorized :1111o0nl1ts. Researich ipojets are estimated to require twenty percent ofthe funds, and (lnforcetnenI etiorts. five plrcent. EPA antici 1 itcs tile following spending rates for lhesc types ofaccounits.

PERCENTAGE OUTLAY DISTRIBUTION

Year I Year 2 Year3 Year 4

Abatement andcontrol

....... . .. .... .... 84 12 4

------------- Research

....... ............................... 45 35 15 Enforcement ......................- 60 27 10 3
0.

.tilnatc (03omparison :None.
7. Previons ('B) Est ilnate : None. 8. Estinmte ])repared By Leo ,1.Corbett (225-5275) 9. Estimate Approved 1y JAM.s l,. hBUM, A

.,8dt D 'ircctorfor1h dqetAnalysi8.

Ao CY REV' 0l'l'S

.NVIItl1NM1VNT\, 1'It, (TION A(WNCY,
Wa. ington,D.C., Jurnl 27,1976. 11011, HAIIV0. S'rAttnlE1ItS, Chahl'wan.(OwnIIIi/ce on I/ershaI ,IndForeh,'. Comm ree,Houseof Repre'cltat;1'es, Wa7.Ylhgtol, P.C. Di..n Mit. (C8lnMAH : "h is is in response to your requests of,Jne3, 1975 and ,J tile 17, 1975, for the views of the Elviroilnelltll Protection Agency oil M1.71. 229 and 11.11. 7(64. similar versions of the "Toxic sntbstales ('onl rol Acit." Ietling before your ('on nittee.

This Agency nId ot hercOl1erled Federal delartnilenits aln(1 agencies li'lii, just recentlv collmpleled the deevelopllenli of tie Adlninistrtionl's )osiion oln S. 716. :1simi.u11t version of tile Toxic Sustllnces Control Act that is )eludillg hefore the Seltit ('ollmmerce ('omntittee. Becalse itii.iY of the provisions in the ]loise hills ifr( identi(-al or similar to pl'ovisions ill 

### tlhe sella(e bill. and ill order to expedite ir 8'omments to you with regard to this legi.lation, we are stil littinlg oilr detailed ( 

### ~lnnlql

,, on tIllte Selnate hill to volt. Illese coiielliiets o the simililar ,Senate legisl'ltion '111ad olt, testilnony nyow sclteduhled to l)e preselnted

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### 68

before your Subcommittee on Consumer Protection and Finance on July 10, 1975,will constitute our report to you oil tile toxic suibstances control letrislation. Subject to adoption of the Administration's recommendations on this le,'islation as set out in oiu] attache( report oi S. 776, and as will be iucluded in our testimony before the Subcoilulnittee, we would urge enactmeutofthe Toxic Substances Control Act.

Mv staff' and 1 stand ready to assist your Committee in any way possible towad(he ienactment of saltisfactory legislation to control lh1flar-(l1S sulhstfanr,oS.

We are ndvised 1)y the Office ofManagement and Budget that there isno ol);ection to0 b subission ofthis report from the standpoint of 

### theproirram ofthe President. Sincerely yours, 

### yotr uN R. QUARI.,s, Jr., ActrmgAdministrator.

En ,losllre. EN'mmmoNmvw'r~, "PROTEcTIONAoF.Nc-'v, Wlashinqton,D.0.,,Juve23,1975. 1ion.WAITImR G.MAONTTsON, Chai,,uan, Comn tteron.Comrn ec,

.S. ,olate, Washingloa,

### D.C. DEAr MR.CIAmM,%,fN : This is in respon.se toyour request ofMarch 6, 1975, forthe views ofthe Environmental Protection Agency on S. 776, the "Toxic Substances ControlAct."

We are in accord with the objectives of S. 776 and the general approach taken inthe bill to control toxic substances. As we testified before your Subcommittee on the Environment on March 10, 1975, tile bill contains the authorities which we believe are essential for effective toxic substances control legislation. We urged the enactment of toxic substances control legislation and indicated that we would have sugaestions on some ofthe specific provisions ofS. 776 when we submitted our report.

We note that, S.776 contains significant improvements over some of the toxic substances control bills that have been before ihe Committee the past four years. Many of these improvements are consistent with past EPA recommendations. It is not our intention in our report by ceoneentrating on suggested revisions to the bill to detract from or fail torecognize the effort and improvements already evident in S.776.

We have already stated in our testimony our objection to the provision that would preclude the Administrator from forwarding any budget estimates, legislative poposals, comments on legislation, or testimony to the Office ofManagement and Budget prior to thetransmission ofthese same materials to the Congress. We also stated in our testimionY that.to designate by statute the specific responsibility ofan Assistant A(hninistrator may tend to create a problem of iinternal management.

We will discuss below anumber ofadditional areas in S.776where

we have particular l)rol)lems and where we believe ameindments are in order. Theses proposed amendnents are; set out in an attachment to this letter along with a number of important, additional amendmentsand briefexplanations ofeach. We urgethat all oftheseamendmentsbe favorably considered by theCommittee.

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This report on S. 776, including the attached proposed amendments

were jointly developed with the other concerned Federal departments and agencies and representsthe views ofthe Administration on S. 776.

POLICY OF ADMINISTRATION

We are proposing that the"Declaration ofPolicy" section ofthe bill include recognition of the role of this legislation in complementing and supplementing a number of present Federal programs that deal with various aspects oftoxic substance control. We arealso proposing that, the general requirement of the bill for consultation and coordination make specific reference to this policy statement. Such amendments would be of great assistance in the day to day administration ofthis legislation, bothby assuring tlie regard for the responsibilities of other agencies, and by helping to establish the atmosphere of cooperation and interchange which is vital to the successful operation ofcomprehensive toxicsubstances legislation.

In line with this policy, and because of thespecial role ofthe Occupational Safety and Health Act of 1970 in providing workers with protection from unsafe or unhealthful working conditions which may ie created through the manufacture, distribution or useoftoxic substances, we are also proposing some language for the bill and some language for the Committee report to assure that there will be no question about the respective regulatory jurisdictionsof EPA andthe DepartmentofLabor.

DEFINITIONS

We are proposing that fhe definition of "clielical substance" be amended to provide the Administrator with some flexibility to exclude, in al)propriate situations, certain substances from the definitions and thus from the requirements of the Act.or from particular provisions of the Act. It would be almost impossible todraft thebills to exempt certain substances from the Act or,as more likely the case, fromn certain provisions of the Act in each situation where such is necessary. Scientific laboratory reagents are an example. Here it may very we)l be appropriate to exclude such products from the testing and regulatory provisions, but not necessarily the reporting and adverse effects provisions when they are used by certain research or scientific lrboratories; on the other hand, we would not likely wish to exclude high school laboratories front any labeling requirenents. An exclusion may also be in order for a sulstance not manufactured in

comuercial quantitics. An excessive burden and inconvenience to time industry orthe user would be averted with thisflexibility in the Act.

We a'nticiprate that the Administrator would exercise his discretion to exclude from the lefinition of chemical substances most substances manufactured in less than commercial quantities for tie purpose of testing. Thus, most substances manufactured in less than commercial quiantities would be exempt from the testing provisions of the bill. The prol)Osel amendment would however enable EPA to require testing in those cases where the potential thr'eat to health and the environrment showe( such testingto benecessiry.

We are also l)rol)osing to adhl to the Act a definition for a "new chemical substance." This is necessary in order that chemical substances which were used in previous years for somepurpose, and such

HeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 474 1976use discontinued, do not become classified as existing chemicals, and thus exempt from certain requirements relating to new substances.

TESTING
Th'le. testing provisions 1provide that standards for test protocols would be promulgated, rather than the test protocol itself. Testing would be required only for substances which the Administrator determines m111ay luu estua, fl lasonalle riskto health or tie environment, where there are insufflicient data to conclude that such a risk does or does not exist, and where testing would assist in making such a determination. 'Iliere is a provision in thetesting requirement of the bill that we foresee as an undue burden upon the Administrator. While we agree that provision should be made for the sharing oftesting costs in the event that there is more than one manufacturer of a substance for which testing is required, we are very reluctant to become involved in designating which manufacturer (orpossibly athirdparty) should conduct the tests if the parties cannot reach an agreement. We are therefore recommending deletion of the provisions authorizing the Admninist rator to designate which party should do the testing. A further amendment we are proposing with regard to the testing provisions is a specific requirement that the Administrator must consider alternative methods for meeting the standards for test protocols propose]d by i manufacturer, sucl, as onethat might be less costly or moreeffective. This would insure that industry is allowed to use the best test protocolsin meetingthe testingstandards.

I'REMAn;(ET SCREENING
We are proposing an amendment which will delete the authority in the bill to treat a.rule proposed under sectioni 6 during the premarket review period of a product as a final rule. Thus a chemical substance

or product may be manufactured and distributed after the premarket review period unless a restriction is obtained under the imminent hazard provision of the Act. The substance or product, however,.remains subject to all other provisions of the Act rind a rule proosing restrictions on the substance orp~roduct may beproposed immediately during thepremarket review period undersection 6andtilerulemaking proceedings initiated at that time. If it appears that the manufacture, processing, or distribution of a chemical substance or ,product will result in any unreasonable threat to human health or the environment prior to tie completion of the rulemaking proemdihgs, action may b taken to restrict or ban it under the immuinent hazard provisions of the bill, thus preventing it from becoming a threat to health or the environment.

QUOTAS

Another difficulty we have with S. 776 concerns therequirement that the Administrator provide for the assignment of quotas in any regulation limiting the amount ofasubstance which may bemanufactured, imported, or distributed. The mandatory requirement of a quota sysHeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 475 1976

### 69

ten would make the regulatory process vastly more cumbersome and difficult to administer. Thus, we recommend that the quota provision be deleted. The Act already provides that when it is necessary to adopt arule with respect toachemical substance toprotect against an mreasonable risk, the Administrator shall select the least stringent requirementl practicable consistent with protection of health and the environment. In our view, restrictions limiting the amount of a substance thatmay bemanufactured would be the most stringent requiremueat, other than a total ban, and the establishment of quotas would seldom be necessary. Nevertheless, we strongly recommend against becoming involved in the establishment ofquotas for various manufacturers,even in such limited situations.

ECONOMIC IMI'ACT
S. 776 would require that the Administrator consider a number of relevant, factors in promulgating rules with respect to a chemical substance. We are proposing that a specific )rovision be added that he also must consider the economic impact of such action, including, but not limited to, consideration of th. effects on business, employ- 'meat, and the national economy. Consideration of these factors are already inherent in the requireiment 'that he consider all relevant factors. This amendment is submitted in lieu ofother proposals thathave already been made for the mandatory preparation of detailed Pconoinmic'impact statements at the time a regulation is promulgated.

HIEALTH AND) SAF"TY STUiIEs

We are proposing a revision ofthe requirement for the submission of health und safety studies, or lists of such studies, in order to provide some flexibility in this requirement. Thisshould lessen theburden to industry in conplpiling the lists or submitting the studies, and to EPA in not beingoverburdened with information it does not need or cannot effectively use. The amendment would require submission of listsof oil-goinghand new studies, rather than the study, with a right
to require tile submission of a given study. It would authorize the A(ministrator to provide by regulation the types of studies to be included on the lists and the'humily[ r ofyears for which prior studies
must be listed. The amendment would also provide that a person would list studies which he knows are being made orhave beenimade.

CON'FIDENTIAL INFORMATION We are recomnmending that the confidentiality provision, section 15 of S. 776, Ile amended in several respects. First, the substantive criterionm for withholding data as confidential should le the test established by the Freedom of Information Act, 5 U.S.C. 552(b) (4). Our l)rol)osed amendment would have the effect of requirmg nondisclosure of information obtained under the Toxic Substances Control Act which way be wilhheld under 5 U.S.C. 552(b) (4), i.e., "trade
secrets and commercial or financial information obtained from a person mid pivileged or confidential." This will make.the

### confidentiality standard more definite (because there exists a b(dy ofcase law interpreting5 U.S.C.552(b) (4) ),and will promote uniformity.

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### 70

In addition to the exemption for disclosure to Federal officers and employees, a separate provision should allow disclosure to EPA contractors and their employees, under appropriate safeguards and after appl)roriate EPA findings that disclosure is necessary. ETA accomplishes it great deal of its investigatory and analytical tasks by conI tract. Ifcolit actors are not allowed access toinformation under this bill. EPA could not perform its duties satisfactorily without.substantial manpower increases. The recently-enacted Privacy Act, 15 U.S.C. 5521. provides that, for pirposes of the section of the Privacy Act which imposes penalties on Government employees for wrongful use
or disclosure of information entitled to confidentiality, Government contraictors and their employecs are to ieconsidered Government employees (5U.S.C. 552a(m) 

### ). We recommend inclusion ofsuch aprovision in the toxic substances bill. Our proposed amendments allow disclosure to contractors, and include a penalty for wrongful disclosure of information b)y Government employees (including contractors and their employees).

We also belie'e that the provisions relating to qualified scientists an( individual names are not necessary. The term "qualified scientists" would be diflicult to interpret, and in any event a scientist would have no greater rights under the subsection than would any person under our (proposed) basic confidentiality criterion. We believe that the Federal Privacy Act and the Freedom of Information Act provide ample protection ofthe rightsofindividuals whosenames aPl)eal in health and safety records.

Finally, with regard to access of information by Congress, we believe that such confidential information shouldbemade availableupon written request.

EXEF311ON FROM FEDERAL IPREEMIMiON

We do not l'ecoiinleiil tile provisions ofS. 776 which would allow State and local agencies to petition the Administrator for exemption from the Federal preemption requirements. State anl local agencies would be allowed to regulate any toxic substance until such time as the Administrator putsinto effect regulations fortesting orrestricting

a substance. Thereafter, they could impose only a total ban on a substance. In view of the fact that the bill authorizes the Administrator toregulate with respect to geographicareas there wouldappear to be n1 need for a State or local agency to duplicate any regulations with respect to a substance after Federal regunlations are in effect.

INTERAGENCY COOPERATION AND COORDINAT]ON
Several amendments are being proposed to the Act to provide for the maximum cooperation and coordination among the several agencies of the Federal Government. which have programs and responsibilities concerned with toxic substances. These amendments also would clarify that the Act is intended to complement and supplement existing laws and regulations such as the occupational health and safety requirements.

A number of Federal agencies, particularly the Department of Health, Education, and Welfare and tie Occupational Health and Safety Administration of the Department of Labor have extensive

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resl)onsibilities relating to toxic substaiees and human health and would stand to benllefit from various provisions of the Act. For exiiniple, test results and other dlat generated in this area would, of
course,be vainable to tlhei and should be 

### made available to 

### all ageneies conceried.

We ilre also reconimiieniding that 

### Ileprovision contained in previous bills before the Congress directing (ieCouncil oil Environmental Qualit vto coordinate astulyon the feasibility ofestablishing astandard classification system for cheniical compoundstnl(] imeans ofobtaining rapid access t;) information on such substances be restored to the Act. This section provides CEQ the lead in establishing information systems in a manner eurrently heing initiated, This is being done in eoi) unlioll with the agencies that woul have been represented on the interagency eoiniiiittee ats set, out. ill the lrovision proposed to be deleted. , APPR(iPR!ATION

We wish tomake clear thatourbudget requests overthe past several years have included funds to 

### handle work 

### antlicip)ated to bie required under toxic substances legislation, in the expectation that. it would by

now have beenia reality. Consequently, considerable ground work has been laid and we anticipate that activities during fiscal year 1976 cal

e met within the $8 million requested in the President's budget. Furthermore, we would point outthatEPA wishestoremain in accord with the Presidelt's stated policy ofholding uiew% spending to an absolute minimum. Consequently we would point out that the authorization levels in S. 770 are i excess of amounts required toimplement its provisions.

We have outlined above in our letter a number of the proposed aiimetdnients to the Act whic.h we consider important; the attachment contains both these and additional anndments which we believe are of equal importance. We strongly believe that the adoption of these amlendillentswoul iinprove and strengthen thelegislation andenable EPA to protect the health and the environment to the greatest practical extent while at the same time relieving the industry as well as the Government ofsomeburdensonme requirements.

With the favorable consideration of these proposed amendments,

wewould urgetheenactment ofS.776.

My staff and I stand ready to assist your Committee in any way posslble.

We are advised by the Office ofManagement and Budget that there is no objection totle sul)mission ofthis report from the standpoint of the pro ram of the President. Sicerelyyours, ,JoiNIt.QUARULES, Jr., ActingAdministrator.

Toxic SUBSTANCES CONTROl, ACT

P'ROPOSE) AMENI)MENTS BY EPA AND OTHER FEDERAL AGENCIES TO S. 776 1.Definitions

a. Page 4, lines 1and 2, delete the language "or in some otherway suitable for formation of a group for the purposes ofthis Act".

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Explanation.-Thisamendment would delete the open-ended authority to designate almost any grouping as a "catcgory of chemical substances".

b. Page 4, line 5, delete paragniph (3) and insert, new paragraph 

### (3).

"(3) 'Chemical .substance' means any chemical substance which (A) has an organic or inorganic. pill iular molecular identify; (B) is ally combined or uncomibined radical or element,; or (C) is any mixtire; Provided, however, the Administrator nay by regulation exclude from thisdefinition as it,amppliestothisAct, or toanyprovision ofthis Act, certain categories ofchemical substances such as scientific laboratory reagents and samples, or chemical substances not manufactured in commercial quantiti s."

l.,,,aat'o.-This amiended definition of a "chenmical substance" would provide the Administrator with flexibility to excli(le, in appropriale cases, substances from the requirements of the Act, or a iartivullar ir-ovision. whre it does 

### not need 

### to he regulated, 

### Cannot be effectively regulated, or where meeting the requirements might be

an undue blrden. Scientific laboratory reagents, samples, and other chemical substances manufactured in less than commercial quantities a1re examples.

We urge the following language 1e, included in the committee report with respecttothisdefinition: "Chemical substance would he defined to permit the Administrator the flexibility to provide by regulation for exempting chemical substances in certain categories or in lessthan commercial quantities from certain provisions of the bill. With respect to those chemical substances, it is anticipated that,the Administrator will exercise his discretion toexclude, and thereby exelpt, most of ihem from the testing provisions of the bill. The Administrator retains the authority to require testing in those eases where lip finds apotentinl threatto health and the environment which idicates thalt such testing is necessary."

c. Page 5, line 2, lelete the period and insert a semicolon after ''stmdies' ant 

### lelete reii 

### ain

### der of piragraibph; and 

### on ]ine 12, 

### delete "stludy" and insrt lv, including health and sit My datal developed pursuant to such study,".

Faplrtmatn.-Corr'espondence relating to alleged a(hverse effects

on health and similar reports are already required tobe Inaintaineld in the section S(d) regarding records, and an amendment is proposed to authorize the Administrator to require submission of such records. There is no need to includeunconfirned complaints and noticesin the definition of health and safety data anl confusion results when this is attempted. It is also ltoposed to specifically provide that a health and safety "study" includes health and safety data developed pllrsiailt to such astudy. d. Page 6i. ilesert ifter line 1-1 tle followinig and ren iiiber other pararaphs accordingly. "(15) 'new chemical substance' nieansnay chemical substanee which has not been nanufactured or impored in commercial quantities ite the ITuiled Stles diii'imllr tlie IS-uonlhii period ilm diahely prior to the effective date of this Act, regardless of its commercial production
or imporitation ii tlie United States prior to such lime."

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Explanahon.-Adefinition of"new chemical substance" isnecessary in order that chemical substances that were used in prior years and

were discontinued do not become classified as existing chemicals for
purposes ofthe Act.
2. Testing

a. Page9,afterline8,insertnewparagraph (4) asfollows: "(4) TheAdmijistrator will consideralternative methods for meeting the standards for test protocols proposed bfy any person or governmental entity which is a manufacturer, processor, or importer of such chemical substance."

Eirplanatiov.-This amendment would specifically direct the Administrator to consider alternative methods formeeting thestandards for test protocols proposed by a manufacturer, such as les costly or

moreeffective testprotocols.

b. Page 9, line 14, delete the last two sentences in paragraph (1) beginning with "If", and insert in lieu thereof: "If such an arrangement is made the Administrator shall be notified and the remaining such persons shall be exempted from requirements to perform tests."

Explaiation.-Wedo notbelieve that the Administrator should become involved in designating which party (or a third party) should perform tests iftle parties cannot agree among themselves. If a costsharing arrangement is made for one ofthe parties to do thetesting, however, provision should be made to exempt theother parties from thetesting requirements.

c. Page 11, line 15, insert after "arguments," the following: "and permit cross-examination to such extent and in such manner as in his discretion lie determines is necessary and appropriate in view of the natnure of the issue involved, the number of the participants and the natureoftile interestsofsuch airticipants,'".

Explanotian.-Thisamendment would permit limited cross-examination asis provided in the section 6 rulemaking procedures torestrict toxic chemicals.
3. Premarketscreening;imminent hazard

a. Page 12, line 3, after "substance" add the.following sentence: "Subsequent, submission or request for submission of additional information shall aot,be regarded as changing the date of such notice."~

Page 13, line 4, delete entire subsection (e) ; online 25, deletebeginning with "Unless" through "90 days" on line 2, page 14, and insert in lieu thereof "Ninety days"; renumber following subsections accordingly.

Page 14, line 10. after "suibstance" insert "before or," Page 22, line 13, after "environment," insert "that, Ahould be corrected immediately, and".

Explwantion.-These amendments will delete the authority in the bill to trieat a rule proposed under section Gduring the prenmirket review period of a product, as a final mile. Thus a chemical substance

or product may he manufactured and (listributed after the premarket review period unless a restriction is obtained under the imminent hazard provision of the Act. The substance or product, however, remains subject to all other provisions ofthe Act and a rule proposing

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### 74

restrictions onl the substance orproduct may be proposed immediately during the lremarket review period under section 6 and tie rulemaking proceedings initiated at that time.

If it appears that tilt,manufacture, processing, or distribution ofa chenical substance or product will result in any unreasonable threat to hunion health or the environuent prior to the coll)letion of the rule-making proceedings, action may be taken to restrict or ban it under the imminent hazard provisions ofthe bill, thus preventing it, frombecoming a threat tohealth or theenvironment.

The other ainendments would clarify the date ureinarlkpt notice comrirences, that restrictive rulesunder section 6 may be promulgated before or after manufacture or distribution of it suilbstance, and that

an imminent hazard is a risk that should be corrected immediately. I. les8tr';ctions on hazardous

### chemicalsubstances

a. Pago 17, line 23, delete "condition" and insert in lien thereof "circumstances", and insert the following language in the committee report with respect to section 6ofthebill:

"The provisrons of section 6 of S. 776 provide EPA with regulatory authority which will complement and supplement existing authority to contiol hazardous substances but not to preempt authority already vested by statute in other Federal departments or agencies. Proposed new section 9(b) would preclude EPA from taking action under sections 6 and 7which the Secretary ofLabor (ould take under the Occupational Safety and Health Act. Thus, for examnple, theAdministrator of EPA could not, tnder section 6(a) (3) require that

a substance be,labeled sotas to prescribe requirements for its safe and healthful use which apply solely to workers in their place of employment. The Department ofLabor, pursuant to theOccupational 

### Safet.y and Health Act of 1970, already has authorityto prescribe safe and healthful working conditions: Similarly, sect ion 6(b) (2) shall not,be construed to allow the Administrator ofEPA to eslablish occupational safety and health standards."

l%,planedNoa.-The clarification to paragraph 6(a)(2), together with the addition of legislative history, with respect to paragraplhs 6(a) (3) and 6(h) (2), will assist in implemnentation oftle bill's policy to "compnlement and suplement" existing authority. These changes will assist in avoiu ijm overlap letween EIA and the )el)artrnent of Labor's workplace safety and health authority.

b. Page 18, line 17. page 20, line 23, page 21, lines fl and 12, delete "adulterated" (or "ahdulteration") and insert in lierr thereof "contrrruiirated" (or "ot ariiruidtion")

Ex'ajla/n,7tOi.-W'e believe that the terinr "coat rr niirited" (or "Colltanrination") woild lrore clearly express tire intent of these plrovisio.s istead of "(d lult vated" wliich is often irderstood or defined as aninteritioul ri't.

C.Page.19 liire 11, deleteeat ire paragrapli (3). Erllantiuof.-We believe that the Administrator should not becorir, involved in assi n uuotasto indistry.Thi maidatory requirerienit ofaquoti systei voluld iakethe remilatorvy l)ro'ess vastl." more

llinhluersolue:uru1l difficruhl to 

### administer.Tire Act already 

### l)rovidesthat wlueru it is nvessary to adopt a rule wiith respect to i cierruial subHeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 481 19761 75

stance toprotect against an unreasonable risk, tileAdministrator shall select the least stringent requirement practicable consistent with protection of tihe health and the environment. It is expected that the establishnent, of quotas would seldom, if ever, be necessary as such would be a most stringent requirement. Nevertheless, we strongly iceomimend against becoming involved in the establishment of quotas.

d. Page 20, after line 15, insert thefollowing: "(4) the economic impact ofsuch action, including, but.not limited to, consideration of the effects on business, enmployment, and tile national economy." '1xplanation.-This amendment would specifically require tile Admiinistrator to consider economic impact in piromulgating regulations, ar'eady imnherent i t lilt requirement that Ie consider all relevant facfors. ''his would be in lieu of )roposals that,have been made for tile iianidatory lrel)aration of detailed economic impact statements for issluince at tile inieany regulation is

### promiulgated.
55.Suis by I.S. attorneysinstead ofbyAdministrator

Page 22, line 17, delete all after "may" through "so,", line 19 and insel in lieu thereof:

"request a United States Attorney to petition an appropriate distritcomit oftile

### United States".

Page 19, line 3, lelete "AdUminist rator orthe". Page 46, line 7, delete "Administrator (or Attorney General on his beuhalf)" anl insert inl lieu thereof "Attorney General". Page 46, line 8, after "commenced" delete "and is diligently prosecuting" on lines

### 8and9.

EAxphnaion.--These amendments would carry out the long-time policy ofhaving the Justice ])epartment responsible for litigation instead ofeach Agency. In the citizen suit provisions, we believe that it is suficient if

### the Attorney (enerl hascommenced an action and that it is not neciessi my to imipose a further requirement that lie be diligently prosecut ingit, mt concept which isat best difficult to litigate and at worst could lead tocomiter-productive courtaction. 6.

,Submission ofrecords;hea7thandsafetystudie8

a.Page 25, line 3,add at end ofsentence: "The Administrator may require copies ofsuch records pursuant to his responsibilitiesrandersections 4,5,6,and 7ofthisAct."

E'planation.-Whih,the bill provides that records of adverse health effects caused by chemical substances are required to be maintained, no provision is made to require sub-mission of such records. Thisamendment would correct thatomission.

b. Page 25, line .l4 delete subsection (e) and insert in lieu thereof: "(e) Ilealth and Safety Studies. The Administrator shall promul- 

### galte rcg 

### n fiios nde

### r whi.l he my require any 

### iperson who 

### manufactures, processes, or distributes in commerce any chemical substance (or with respect to paragraplh (3), any person -vho

### has possession of
astmd) to sumilit tohim-- "( 

### Lists of health and safety stil(1ies in prOLZress On or iniliated after the (late of enactment ofthis Act, conducted by or forsuch person, orknowntosuch person;

HeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 482 1976"(2) Listsofhealth andsafety studies conducted byor forsuch person, or known to have been made by any person, prior to the date ofenactment ofthisAct; "(3) Copies of any such studies appearing oil a list submitted pursuant to paragraphs (1) or (2). or otherwise known by him," r.,

xplawaton.-Thisamendment would revise the provision requir- ing industry to report on or submit all health and safety studies. It would require submission of lists ofon-going and new studies rather han tlt siud witi) i right to require submission of studies. It. woul aulihorize tle Admiistrator to provide by regulation for the typesofstudies tobeincluded onthe lists, andthe number ofyears of prior studies for particular types of studies; and would require aper- so to also list studies which lie. klows are being luade or have been nladO. 7.Additionalexemptions;additional limitatio on.atthority

a. Page 26, line 8, delete "or"; line 10, after "Act)" insert.a comma and add "cosmetics (as such term is defined in section 201(i) of the Federal Food, Drug, and Cosmetic Act),"; line 18, replace the period with asemnicolon, and addthefollowing:

"(3) any source material, special nuclear material or byproduct niaterial as defined in the Atoluic Enernry Art of 1.4 (42 

### U.S.C. 2011), as amended, and regulations issued pursuant thereto; or

"(4) tobacco and tobacco products." Ea'plana/ion.Webelieve that cosmetics should also be exempted and materials regulated under the.AEC Act, and do notbelieve that tobacco and tobacco products should be regulated under the Toxic Substances Control Act.

1. Pae 26, after line 18, add new subsection (b) as follows, and renumber other subsections accordiinglv:

"(b) Notwithstanding any provisioi ofthis Act, the Administrator shall have no iiithoitv under sedtions 6 and 7 of this Act to take any action which the Secretary of Labor is authorized to take pursualt, to lie Occupatiolill Safet'N and IMeaIt 1 Act. In exereisinig aiuithority puinsuall to this Act, th'eAdnministrator shall not, for the pur)oses of applylyinr section 4(b)(1) of the Occupational Safety and Health Act, lie deeinod to he exercising statutory autlioritv to prescribe or enforce stldirds or regulations affecting occupational safety and lalth."

EAxplamntio.-The purpose of these changes is to eliminate the possibility of jurisdictional conflicts between EPA and the Depart- lent of labor where actions taken by one authority llight otherwise p~reclude orduplicate action oftheother. 8. liifraqcecil roope'atin.and Coordilatio Paue 3i. after line 17, add the following new paragr'aph: "(5) such authority over ehienicals be exercised in such a manner as to (oniplent and suppleineut existing Federal policies, reguila- lions. ind 1)11lic laws regairding the protection of health and the environment, including occupational health, constuner safety, food, drug, and cosmetic authorities."

Page 28. line 3, delete the sentence after "coordination.-" and insert inlieuthereof:

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"In administering the provisions ofthis Act, the Administrator shall consult and coordinnte with the relevant agencies and instrumentalities of the Federal Government in accordance with the policies set forth insection2 (b) ofthisAct." Page 30.,line 2, delete,the last sentence of subsection (a) and insert in lieu thereof: "The Administrator is authorized to miake contracts and grants for research and monitoring as necessary to carry out the purposes ofthis Actin consultat ionwith the Seeretary ofHealth, Education, andWe]- fare onsuch contract and grant programs."

Page 30, line 7, delete entire subsection (b) and insert new subsection (b) asfollows: "(b) The Council on Environmental Quality in consultation with the Administrator, the Secretary ofHealth, Education, and Welfare, the Secretary of Commerce, and the heads of other appropriate departments or agencies, shall coordinate a study of the feasibility of establishing (1) a standard classification systemn for chemical compounds and related substances, and (2) a standard means for storing and for obtaining rapid access to information respecting such materails.A report on such study shallbepublished within 

### 18 months after enactment ofthisAct."

Explan4tion.-Theseproposed amendments areintended to clearly set forth that it, is the policy of the Act that there be the maximum cooperation and coordination among the several agencies of the Federal (overnmnt which have programs and responsibilities concerned with toxic substances; that the Act is intended to complement and supplement existing laws and regulations such as the Federal occupational health andsafety requirements; andthat appropriate provisions

are made to establish and to have access to informatioi relating to chemical compounds,

A number ofFederal agencies, particularlythe Occupational Health and Safety Administration of the Departnmient of Labor have extensive responsibilities relatingtotoxic substanecs and human health and would stand tobenefit from various provisions ofthe Act. The testing ofchemicals as they relate to the programs ofthese agencies and the test results and otler information and data generated by the legislation would, ofcourse,bevaluable tothem and must bemade available.

One of these amendments specifically provides that the EPA Administrator will consult with the Secretary of Health, Education,and Welfare on any contract,and grant programs for carrying out theresearch and monitoring activities under the Act, but not necessarily

on each individual contract orgrant.

We are alsorecommending that,the provision contained in thepreviousbills before the Congress directing the Council on Environmental Quality to coordinate a study on the feasibility ofestablishing astandard classification system for chemical compounds and means of obtaining rapid access to the information on such substances berestored to the Act. This section provides CEQ tohave thelead in establishing information systems in a manner currently being initiated. This is beinfr done in conjunction with the agencies that would have been represented on the interagency committee as set out in the provision proposed tobedeleted.

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### 79

9.Additionalassistantadministrator Page 28, line 15, delete subsection (a), renumber subsections (b) and (c) accordingly.



### Ewplanation.-Thisamendment would delete the provision for a special category Assistant Administrator for Toxic Substances. 10.Administrativeinspection. Page 31,line 6, insert "(a)" after "See. 12", and after line 21 insert

new subsection (b) : "(b) Notwithstanding the provisions of subsoction (a), the Administrator shall have authority to inspect financial data records pertaining to testing costs when he orders contribution orreimbursement for the costs ofperforming tests in connection with the provisions of sections4(c) and5(f)."

Explanation.-Sections 4(c) and 5(f) authorize the Administrator to determine the equitable contribution or reimbursement of testing costs where more than one person benefits from the testing. This amendment would authorize access tofinancial data on testing costs in order for theAdministrator tocarry out the requirement to apportion thecosts amongthosebenefitingfromthe testing.
11. Disclosureof confidentialinformation Page 34, line 18, delete entire section 15 and insert in lieu thereof the following revised section:

"4CONFIDENTIAIATY

"SEC. 15. (a) GENERAT.-Any information reported to,or otherwise obtained by, the Administrator or his representative under this Act, which is exempt from mandatory disclosure by reason of section 552 (b) (4) oftitle ,5, United States Code, shall beentitled to confidential treatment and shall not be disclosed by the Administrator or by any officer or employee ofthe United States, except thatsuch information .may be disclosed- "(1) to officers and employees of the United States in connection with theirofficial duties;

"(2) to contractors with the United States and employees of such contractors, if in the opinion of the Administrator such disclosure is necessary for the satisfactory performance by the contractor of 

### a contract with the United States entered into on
orafter the effective (late ofthisAct forthe performance of work inconnection withthisAct;

"(3) when relevant in any procceding under tlis Act, except that disclosure in such a proceeding siall be made in such manner
as to lrescrve confidentiality to the extent practicable without impairing the proceeding; or "(4) to the extent that the Adininislrator determines it isnecessary to protect,health ortheenvironment. "(b) Accss in- Co,oaFss.-Notwithstanding any limitation contained in subsection (a) or any other provision oflaw,, all information reported to or otherwise obtained by the Administrator or his representative under this Act shall be made available upon written request of any duly authorized committee of the Congress.

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### .- (1) Any officer or employee, of the United States, or former officer oremployee of the United States, who by virtue of his employment or official posi- tion has obtained possession of, or has access to, material which is entitled to conlidential treatment under subsection (a), and who knowing that disclosure ofthe specific material is prohibited bythis section, willfully discloses the material in any manner to any person not entitled to receive it, shall be guilty of a misdemeanor and fined
notiore than $5,000. "(2) For the purposes ofthis subsection (c), any contractor with the United States who is furnished information pursuant to subsection (a) (2), and any employee of any such contractor, shall be considered to be an employee of the United States."

Explanaton. -This section should be amended in several respects. First, the substantive criterion for withholding data as confidential should be the test established 'by the Freedom of Information Act, 5U.S.C. 552(b) (4). Our proposed amendment would have the effect of requiringnondisclosure of information obtained under the Toxic Substances Control Act which may be withheld under 5 U.S.C. 552 (b) (4), i.e., "trade secrets and commercial or financial information obtained from a person and privileged or confidential." This will make the confidentiality standard more definite (because there exists

a body of case law interpreting 5U.S.C. 552(b) (4)), and will promote uniformity. In addition to the exemption for disclosure to Federal officers and employees, a separate provision should allow disclosure to EPA contractors and their employees, under appropriate safeguards and after appropriate EPA findings that disclosure is necessary. EPA accomlplishes a great deal of its investigatory and analytical tasks by contract. If contractors are.not allowed access to information underthis bill, EPA could not perform its duties satisfactorily without substantial manpower increases. The recently-enacted Privacy Act, 5 U.S.C. 552a, providesthat, for purposes of the section of the Privacy Act which imposes penalties on Government employees for wrongful

use or disclosure of information entitled to confidentiality, Governmnent contractors and theiremployees aretobe considered Government employees (5 U.S.C. 552a(m)). We recommend inclusion of such a provlison in thetoxic substances proposed bill. Our amendments allow disclosure to contractors, and include a penalty for wrongful disclosure ofinformation by Government employees (including contractors and theiremployees).

We also belie-e that the provisrions relating to qualified scientists and individual names arenot necessary. Theterm "qualified scientists" would be difficult to interpret, and in any event ascientist wouldhave

no greater rights under the subsection than would any person under

our (proposed) basic confidentiality criterion. We believe that the F'ederal Privacy Act and the Freeclom of Information Act provide anmple protection of the rights of individuals whose names appear in health and safety records. Finally, with regard to access of information by Congress, we believe that release of such confidential information should be upon written request.

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12. State exemptionfrowtFederalpreempthkm

Page42, li

### ne 14, deletesubsection (b). E'xplanation.-This amendment would delete the provision that would allow State and local governments to petition to be exempted from Federal preemption requirements.
13. Citizen8u-it8fordiscretionaryaction

Page 45, line 13, delete language after "Act" through line 16, and insert in lieu thereof: "which isnot discretionary with the Administrator.".

Explanaton.-Thisamendment would makethe provision conform with the usual citizen suit provision an1(1 not authorize suits against the Administrator for diseretionar, acts. It would thus l)revent the )osibility of every decision of the Administrator from being redecided in tile districtcourts. 1.;. Indemnnifirationstudy

Page 52, line 17, delete all of section 25 and renumber section 26 aecor'dinghyl.

1:.'/danation.--Thisamendment would delete the requirement for

astily on Federal indehnnifivation under laws administered by EPA. We believe suifficient information already existsto recommend against indeninifi.ation underprogramns administered by EPA. 15. Allhnl;sion

. ofbtidqetsantdteatmonyto('angress Page 54, line 15, delete all ofsubsection (C). /.'clanation.-Thisamendment would delete the requirement that Agency budget requests, testimony and conmnents on legislation must not be submitted to 0MB prior io submission to Congress. We conf inue to object tothis provision. 16.

### AddwNomtl minrellancau8amend(m'nt's 'age 2, line 16, add after "substances": "which may present an unreasonable risk to health or (lie environment".

Page 3,line 8,insert after "to" the following: "ensure that adequate testing is 

### (on(huted by those persons who 

### manufacture, import or |l'oCess, tOo"

.

Page 5, line 17, after "ecological studies" insert "monitoring studies"'.

Page 8, line 'I,delete "proscribed' and insert "prescribed". Page' 8, line 20, insert tifter "that" "one or more ofthe following". Page S. ine 2-1, insert after "svnergistie properties," "persistence,". Page I0. line (i,delete "section 5(g)" and insert "section 5(f)". Page 22. line 12, delete ''any". Page 22. line 11, delete "ilhrent" and insert in lieu thereof "risk". Page 2 Ii

. 15. delete the period and add "if approprinte.". P]nge 33. line 20, delete "delivery" and insert in lieu thereof "release"; line 22, delete "tIree montlhs" and insert in lieu thereof "90 (lays"; nnd (on line 25, delete "delivery" and insert in lieu thereof ''melense''.

Page 3-4, line 1,after "decision" insert "by the Administrator"; line 4, delete "article, together with the" and insert in lieu thereof "article ias set- forth in the Customs entry plus the estimated"; line 5, delete

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"forfeiture of" and insert in lieu thereof "liability for assessment of liquidated damages equal to"; line 6, delete "refusal" and insert in lieu thereof "failure"; line 10, delete "delivery" and insert in lieu thereof "release"; line 11, insert acomma after "payment" and delete "of" and the comma after "charges"; and on line 16, delete "of subsection (a)".

Page39,line 5,"section 17," should read "section 16,". Eaxplonton.-These amendments are technical corrections or are otherwise self-explanatory.

U.S. ENVIRONMENTAL PROTECTIoN AGENCY, 0Washington,D.C., February 5, 1976. 

### H-on. HARLEY 

### 0. STAGOERS, Chairman,Committee on InterstateandForeignCommerce,House ofRepresentatives, Vashington,D.C.
DEAR Mn. CHAIR.fAN: On November 13, 1975, Mr. James T. Lynn, Director, Office of Management of Budget advised Congressman McCollister of your Subcommittee on Consumer Protection and Finance that the Administration had reassessed its previous position with regard to the toxic substances control legislation and would support IJ.R.7664with somemodification.

Enclosed are the Administration's proposed amendments for modifying H.R. 7664. The enclosure summarizes several of the more significant proposals toamend H.R.7664 andcontains all oftheproposed amendments and abriefexplanationofeach.

These proposed amendments to H.R. 7664 were jointly developed with the other concerned Federal departments and agencies and represent the views of the Administration on the toxic substances control legislation.

With thefavorable consideration oftheseproposed amendments we would urge theenactment ofH.R.7664. Sincerely yours, RUSSELL E. TRAIN, 

### Administrator.
Enclosure.

PROPOSE) AMENDMENTS TO 

### H.R. 7664, THE "Toxic SUBSTANCES CONTROL ACT OF 1975" 

### nY Mn. MCCOLLISTER

Summarized below are several ofthe significant proposals toamend H.R. 7664. A number of other amendments have also been developed which would improve the effectiveness ofthebill. All ofthe proposed amendments are set out and explained in the pages following this summary.
DEFINITIONS

We are proposing that the definition of "chemical substalice" be amended toprovide the Administrator with some flexibilitytoexclude, in appropriate situations, certain.substances from the definitions and thus from therequirements oftheAct or from particular provisionsof the Act. It would be almost impossible to draft the bill to exempt certain substances from the Act or, as more likely thecase, from certain provisions oftheAct in each situation where such is appropriate.

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### 82

Scientific laboratory reagents are an example. Here it may very well be appropriate to exclude such products from the testing and regulatory provisions, but not necessarily the reporting and adverse effects provisions when they arc used by certain research or scientific laboratories; on the other hand, we would not likely wish to exclude high school laboratories from any labeling requirements. An exclusion may alsobe in order fora substance notmanufactured in commercial quantities. An excessive burden and inconvenience to the industry or the

userwouldbeaverted withthisflexibility intheAct.

TESTING There is a provision in the testing requirement ofthe bill that we foresee as an undue burden upon the Administrator. While we agree that provision should be made for the sharing of testing costs inthe event that there is more than one manufacturer of a substance for which testing is required, we are very reluctant tobecome involved in designating which manufacturer (or possibly a third party) should conduct the tests if the parties cannot reach an agreement. We are therefo'e recommending deletion of the provisions authorizing the Administrator to designate which party should do the testing.

Weare also proposing that thecriterion by whichthe Administrator would require testing be revised so as to 'authorize the requirement when a chemical may pose an unreasonable risk to health or the environment, rather than when "necessary to protect aainst unreasonable risk to health or the environment". When the latter positive situation occurs, presumably the Administrator would take action under section 6.

PRFMARKET NOTIFICATION Section 5of 11.R. 7664 provides that within eighteen months after enactment of the Act the Administrator shall by rule compile a list of chemical substances (or chemical substances with respect to a particular use or uses) which the Administrator finds are likely to pose substantial danger to health or environment. Substantial danger to health or the environment isdefined to mean an unreasonable risk of death, or widespread or severe personal injury or illness, or of widespread or severe harm tothe environment. If a newchemical substance

or a significant new use ofa chemical substance is on the list,the Administrator would receive 90 days premarket notification from the manufacturer or processor. The substantial danger test above is so strict that it,would place an impossible burden on the Administrator to know or predict,in advance when such a new chemnical or new use will come about, and any substance placed on the list would almost certainly be subject to the imminent hazard provisions of section 7 upon manufacture. We are proposing instead an "unreasonable risk" standard for promulgating the list. This would not have the defects outlined above and would focus preinarket notification on harmful chemicals and not require notification on all new substances.

QUOTAS An amendment is being proposed to the quota provisions of H.R. 7664 to provide cooperative action with the Secretary of Commerce

70-313 0

. 77

- 32

HeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 489 1976where quotas have to beestablished. The Act provides that when it is necessary to adopt a rule with respect to a chemical substance to protect against an unreasonable risk, the Administrator shall select the least stringent requirement practicable consistent with protection of health and theenvironment. Restrictions limiting theamount ofasubstance that may be manufactured would be the most stringent requirement, other than a total ban, and the establishment of quotas would seldom be necessary. However, in the event quotas have to be established we recommend that the Secretary of Commerce be involved in setting them.

ECONOIC IMPACT

H.R. 7664 would require that the Administrator consider a number (f relevant factors in promulgating rules with respect to a chemical substance. We are proposing that a specific provision be added that he also must consider the economic impact of such action, including, but not limited to, consideration of the effects on business, employment, and the national economy. Consideration of these factors is already inherent in the requirement that he consider all relevant factors.We suggestthis amendment in lieu ofthe mandatory preparation of detailed economic impact statements at the time a regulation is promulgated and suggest the economic impact statement provision be deleted.

IEI'ORTINO INITIAls MANUFACTURE
We propose to amend the provisions requiring manufacturers, importers, anti processors to make reports tothe Administrator so as to give the Administrator the authority to require 

### when appropriate that the manufacturer of

### anew chemical substance submit a report on that substance on the day its manufacture for commercial purposes begins. Only by this means will the Administratorbe ableto maintain

a complete inventory ofchemical substances. An inventory isnecessary if tie Administrator is to have any idea what chemicals are being marketed and which may needtoberegulated.

IIEALTII AND SAFETY STUDIES; ADVERSE REACTIONS
We are proposing that a provision be added tothe reporting section requiring the submission of lists of health and safety stuTes. The amnendnment would require submission of lists of on-going and new studies, rtther than the study, with a right to require the submission of a given sthdy. It would aithorize the Administrator toprovide by regulation tHie types of studies to be includued on the lists and the number of years for which prior studies must be listed. The amendment would also provide that a person would list studies which he knows are being made or have been made. We are also suggesting a provision be added to the reporting section requiring records of adverse reactions to human health or the environment be available for submnission totheAdministrator athisrequest.

SMALL BUSINESS EXEPIITION
We recognize that there may be a need due to a financial burden for exempting some small businesses from some of the reporting reHeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 490 197684

quirements of the Act. At the same time, some businesses manufacture such toxic substances that they need to be regulated no matter how small they are. Therefore, we propose an amendinent which provides the Administrator with authority to exempt a small business

concern from the reporting provisions for reasons of undue financial burden but requires the report of initial manufacture and prohibits exemption where a chemical substance may present an unreasonable risk to health or the environment, making it subject to sections 4(a) (testing), 5(a) (list of "risk' chemicals), or 6(a) (regulation of "risk" chemicals). The Administrator is required to consult with the Admuinistrator of the Smiall Business Administration in defining "small business concern".

RELATIONSHIP OF OTHER LAWS
Tie bill would in some instances provide authority to regulate toxic chemical substances which it may be possible to regulate under

a law administered by another agency. When this occurs, there is the question of which authority should govern. We propose that authority not be exercised under section 6 (regulation of chemicals) and section 7 (imminent hazards) where action is more aI)lpropriate under the law of some other agency. Other agencies would be requested by the Administrator to determine if a risk is presented or is lkely to be presented by a chemical substance or mixture, and ifsuch risk can be prevented orreduced to a sufficient extent byactions under their law.The agencies would then eitherdetermine that the substance

or niixtltre does not.pose or is not likely to pose an unreasonable risk to health or 

### theenvironment or initiate action toprotect against such

a risk. Questions which could occur over the validity of actions taken under the Toxic Substances Control Act where other authorities existwould be avoided under thisamendment.

EXE3MIrION FROM FEDERAL I'IRLMI'I(.N"
We do not recoinniend the provisions of IMR. 7664 which would allow State and local agencies topetition theAdministratorforexemption from the Federal preemption requirements. State and local agencies would eallowed to.regulate any toxic substance until such time

as the Administrator puts into effect regulations for testing or Iestricting a substance. Thereafter, they could impose only a total ban

on a substance. In view of the fact that the bill authorizes the Administrator to regulate with respect to geographic areas there would appear to be no need for a State or local agency to duplicate any regulations with respect to a substance after Federal regulations are ineffect.

PRoi-osEI) AMENDMENT8 TO H-.R.7664, TilE Toxic SUIsTANCES CoNTROL AcT

AUTHORITY TO EXEMVIPT IN DEFINITION Page 4, line 2, delete the period after "rixture" and insert a semicolon and the following:

HeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 491 1976"Provided, however, the Administrator may by regulation exclude from this definition as it applies to this Act, or to any provision of thisAct,certain categorieso chemical substances, including laboratory reagents, catalysts, selected mixtures, and chemical substances not manufactured incommercial quantities."

Explanation.-Thisamended definition of a "chemical substaice" would provide the Administrator with flexibility to exclude, in appropriate cases, a substance from the requirements of the Act, or
rom a particular provision (not already excluded) where such sul)- stance does not need to be regulate(], cannot be effectively regulated,

or where meeting the requirements mighthean undue burden.

NEW CHEMICAL SUBSTANCES Page 4, after line 19, insert the following as paragraph (8) and renumber paragraph (8) as paragraph (9). " (8) The term "new chemical substance" means any chenlical substance not included in the inventory of chemical substances comlpiled and published under section 8(b)." ixllaiwtwin.-I-.R. 7664 needs to be modified to ensure that the Administrator may issue a re(jlmirmuent for reportingof"new chemical substances" at the time of manufacture. A "new chemiral substanice"

can be,defined by reference to the inventory of all existing chemical substances to be published by EPA according to section 8(b) as amended.

TESTING-SFCTION 4
1. ,.tavdards for Test Protocol,?

a. Page 6, line 17, change title of section 4 to "STANDARDS FOR TEST PROTOCOLS"

E'xplanation. Conforming amendment (see Explanation in b. below).

b. Page 6,lines 18-25, delete all ofsubsection (a) and insert in lieu thereof the following: Section 4. (a) If the Administrator determines that- (1) the manufacture, distribution in commerce, processhig, use or disposal ofa chemical substance may pose an unreasonable risk to health or the environment; and (2) that testing such chemical substance is necessary to detremine whether an unre4isonable risk to human health and the environment does or does not exist; then he may, by rule, prescribe, standards for a test protocol for such substance, and require, in accordance with subsection (d), that

one or more persos formulateia test protocol for such substance in accordance with such standards, and perform the tests required by such p!'otocol. E.plavvtion.-Ifthe Administrator could demonstrate that testing is "necessary to protect against unreasonable irisk to health or the environment" (H.R. 7664), presumiably hie could take restrictive action under section 6.The revised sectioni 4(a) is aIfar more appropriatQ dctcrmnjnation 

### f~lr issiip tigjp ;'quircieer 

### in that it

HeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 492 1976reflects the uncertainty of the risk that would prompt the Administrator to require testing. The,revised language permits the Administrator to prescribe the standards for a test protocol rather than the protocol itself, which would be.developed by the affected manufacturer in accordance with the standards. The advantage is flexibility, in that the protocol can bemore closely tailored to the chemical substance and the questions it poses; and through standards the Agency can require results of testing rather than specific testing methods.

In addition, instead of being required in each instance to follow narrowly defined l)rocedures for testing, the industry should have the flexibility when appropriate to develop efficient test protocols in accordance. with the Administrator's standards.

c. Page 7, line 9to 14. Delete lines 9to 14 and insert in lieu thereof the following: (3) the extent to which testing of such substance may resuit in the ds- elopment of data upon which the effects of such substance or mixture on health or the environment can reasonably be determined or predicted; (4) the existence of data concerning the effects of the chemical substance or mixture on health or the environent; and Earplanatwn.-These two amendments donot alter the intent ofthe original provisions butconform the hinguage to the use o.f "standards for test protocols" instead of "test protocols."

d. Page 7, line 21. Delete line 21 through "tests" and substitute the following: (c) Standards for a test protocol may require that such protocol may include, but is not limited to, tests /.1-planation-Jt is necessary to make clear that standards for test, protocols do not necessarily entail development of specific test protocols but rather methodologies or guidelines for development of test pr,,1ocols. It is also necessary to make clear that the test protocol is not limited to those tests specifically named.

e.Additional conforming amendnments to sections 5and 8. Page 11, line 14: delete "in accordance with a test protocol" and insert in lieu thereof "under a test, protocol, in accordance with standards".

Page 11, line 15: insert a comma after "4". Page 12, line 1: delete "bi accordance. with a test protocol" and insert in lieu thereof "under a test protocol, in accordance with standards".

Page 12, line 2: insert a comna after "4". Page 12, line 11: insert "standards for ,t"after "applicable". Page 12, line 12: delete "has" and insert in lien thereof "have". Page 12, lines 13 and 17-18: insert "standards for" before "a test protocol". f. Additional conforming amendments to section 3, DEFINITIONS:

Page 5. lines 3-16, definition of "test protocol": dete the dash.on line 3 and subparagraph heading "(A)" on line 5; delete the conriia

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### 87

at theend ofline 9and insert in lieuthereof aperiod; and delete lines 

### 10-16.

Page 4, line 23: insert a new paragraph after new paragraph (9)

as follows and renumier subsequent paragraphs accordinglyi: (10) theterm "standards for a test protocol" means standards prescribing the nature and quality of a test protocol, including: (A) themanner in which test protocols are tobe developed to determine the human health and environmental effectsof a chemical substance, (B) any analysis that is to be performed on test data developed, and (C) any requirements to be met in the design of any test protocol necessary to insure the reliability and adequacy of test data developed. 2.Designating

### whoshouldperfoiintesting Page 8, line 11, delete the last sentence in paragraph (d) beginning with "If"through line21, and insert inlieu thereof: Ifsuch an arrangement ismade the Administrator shall be notified and the remaining such persons shall be exempted from requirements toperform tests. Explanato.-Wedo not believe thatthe Administrator should be

### conie ,involved in (esignating 

### which larty (or a thi'd party) should perforin tests ifthe parties cannot agree among themselves. If a costsharing arrangement is mnade for one ofthe parties to do the testing, however, provision should be made to exempt the other parties from tho testing requirements. 3. Timelysubmi, usio oftestdata Page 8,line 22 :delete section (e) and insert in lieu thereof: (e) Any manufacturer, processor, or iml)orter who is requnired to )erform the tests called for in a test protocol under this section shall promptly transmit to the Administrator the test data developed ptlrsuant tosuch test protocol. Explanation.-Thisamendmnent will ensure that the test data shall be promptly transmitted tothe Administrator after completion.

PREMARKFT NOTIFICATION LIST

a. Page 10, line 1, Section title, after "SCREENING", delete remainder ofsection title.

b. Page 10. line 8. after "finds", delete remainder of l)aragraph through line 13:, and add in lieu thereofthe following:
may pose an unreasonable risk to health or the environment.

c. Page 15. line 13, after "substances", delete "as likely to pose substantial danger" and add in lieu thereof "which may posean unreasonable risk".

Explanation.-Thesubstantial danger testin the current provision is so strict that no substance would be placed on the list unless atthe

same time it was subject to regulations applicable to a Hazardous

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## 8$

Chemical Substance under section 6 and an Imminent Hazard under section 7. The proposed "unreasonable risk" standard for the list would focus preinarket notification on harmful chemicals and not requirenotification on all new substances.

AMENDMENTS TO SECTION 0-REGULATIONS
1.Asigning Quota8

Page 18, line 13, delete "uses, shall include provision for" and insert in lien thereof "uses shall be prescribed by the Administrator inconsultation with the Secretary of Commerce. The Secretary of Commerce in consultation with the Administrator shall by rule provide
for".

Page 18, line 14, after "quotas" add "to the extent necsssary". Page 18, line 19 and 20,delete "TieAdministrator shallbyrule prescribe criteria which" and insert "Such criteria". Page 18, line 22, after "the" delete "market shares, productive capacity"11(1 insert "curret and past market shares, productive capacitY, Captivye Consump 1tion,". Ak:/)Ia/?lo,.-'his amendment is being proposed to the quotas provisionsof I[.R.7064 to provide cooperative action with the Secretary of Commerce where quotas have to be established. The Act provides that when it is necessary to adopt a rule with respect to Ia lhemical substanee to protect against an unreasonable risk, the Administrator shall select the least.stringent requirement practicable cousistent with protection of health and the environment. Restrictions limiting the anommnt of asubstance that may be manufactured would be tm(e mIjost. strinigenat requirement, other than a total ban, and the establishment of quotas would seldom be necessary. However, in the
event quotas have to be established we recommend that the Secretary ofCommerce beinvolved insettingthem.
2. EroiomcImpact Analysis Page 19, line 11: delete "and"; Page 19, line 13: delete the period and insert ill lieu thereof: "; and"; Page 19, after line 13: add a new subparagraplh

- as follows: (4) the economic impact of such action, including but not limited to, consideration of effects on business, employment, and the national economy. Page21, line 21:delete 

### all ofsubsection (g). A'n Wa/ion.-This amuediment would specifically require the Adumillistrotor to consider economic impact in promulgating regulations, alreadv inhvvent ill the requirement thai he consider all relevant factors. This would he in liu of the mandatory )rel)aration of detailed econoli imillact statements for issuance lit 

### the time any regulation is required, which provision is deleted by tie amendment.

AMEND3ENTS TO SECTION N, RIEI'ORTS

1. Reportlir!litial Manfacture

a. Page 24, line 23, after "any" insert "person who is a". b. Page 24, line 25-page 25, line 1: delete "and at such more frequent time" and insert inlieu thereof "or such times".

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## 89

Explanation.-Authorityshould be provided in the legislation enabling the Administrator to learn of the existence of a new chemical substance as soon as manufacture begins. This is minimal authority, intended to inform him of theinitiation ofthe manufacture of anew chemical substance. Therefore, the amendment authorizes the Administrator to require ofa chemical manufacturer that heinitially reports

on the day on which manufacture ofa new emical begins and provides the other specified information. This amendment would also permit the reporting time in periods useful to the Administrator and geared to the different types of reports which lie haa authority to request. Such periods may be more or less frequent than one year. 2. ReportingAdulteration Page 25, line 16: Between lines 16 and 17insert a new subparagraph (E) as follows, and renumber subsequent subparagraphs accordingly: (E) Records pertaining to quality control procedures and adulteration asdefined in subsectionb(e). k'rplonat/or..-Whihsmubsection ((e) authorizes the Administrator
to require a mnaInufacturer orprocessor to submita description ofquality control procedures, there should be additional authority to obtain records pertineat to such proce(lures, such as those denionstrating the procedures are being followed, and toincidents ofadulteration.
3.ReportigHealthandSafety Studie8:Adverse Reactions Page 2.5, line 1,after "require," insert "on any chemical substance manufactured, imnported, or processed,". Page25, afterline21, insert thefollowing: (G) 1He0alth and safety information including: (i) list- of health and safety studies in progress on
or initiated after the date ofenactment of this Act, conducted by or for such pei'son, or known to such person; (ii) lists of health and safety studies conducted by

or for such person, or known to have been made by any per.-oi prior to the date of enactment of this Act; (iii) at the request of the Administrator, copies of any such studies appearing ol a list submitted pursuant to paragraphs (i) or (ii), in the possession or control of such person. (11) Records of adverse reactions to human health or the environment or adverse results in health and safety studies known or alleged to have been caused by the chemical substance. Such records niay consists of, but not be limited to, consuiter tllegations of personal injury or harm to health, reports ofoccupational (lisease or injur.

, tmid reportsof complaints of injury to the environment submitted to the person by individuals orgovernmental agencies. The Administrator

may require copies of such records pursuant to his responsibilities under sections 4, 5, 6, and 7 of this Act. E,,7planaton.-The proposed aniendment would require the submission of lists of health and safety studies and would require submission of lists of on-going and new studies rather than the study itself with a right to require thesubmission ofagiven study.It woull authorize the Administrator to provide by regulation the types of

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studies to be included on the lists and the number of years for which prior studies must be listed.T1he amendment would provide thataperson would list studies which he knows are being made or have been made, The amendnient also provides that records ofadverse reactions to human health or theenvironment beavailable for submission tothe Administrator at hisrequest. 

### 4.Exemptions8 fron ReportingRequiremeft8

a.

Page 24,lines22 and 23:delete"Except asprovided insubsections (b) and (c), the" andinsert inlieuthereof "The". b.Page 26, line 6: after line 6,insert anew paragraph (4)as follows: (4) (A) The Administrator may, by rule, exempt from or modify for any manufacturer, importer,or processor who is

a small business concern all or part ofthe reporting requirenients of this section where such requirements would cause an undue financial burden on such small business; provided, however, no exemption or modification shall be authorized mntil afterthe initial reporting ismadeunderthis section and suchexemption ormodification shall discontinue whenthereis

a significant change in the amount ofthe substance manufactured, imported orprocessed from the amount last reported. (B) No exemption or modification of reporting requireinents shall be authorized under paragraph (4) (A) with respect, to a chemical substance or an article containing such substances- (i) for which a testing requirement, has been l)rescribed undersection 4 (a) ofthisAct; (ii) which is contained in the list of chemical substances which the Administrator has by rule identified and published in theFederal Register unler section 5(a) ofthisAct; or (iii) which iscovered by a rule under section 6ofthis Act. (C)Forpurposesofthis subsection theAdministrator shall define asmall business concern,inconsultation with the Administratorof the Small Business Administration.
c. Page 27: Delete all of subsection (c)and renumber subsection 

### (d) as (c). Explavatlon.-Sulsection (b)of the existing II.R. 7664 is asmall business reportingexemption provision.The amendmentwould elimniIIate that blanket exemption and provide that there is authority to exeml)t for reasons of undue financial burden.Subsection (c)of the existing I.1. 7664 requires the Administrator to make specified exemlptions,an authority which is provided for in the amendmentto the definition of"ehemical substances" at page 4, line 2.
5.

Jflvetdory

a. Page 26, line7, delete entire section (b) and insertin lieu thereof: (b) The Administrator shall compile, keep current, and publish an inventory of each chemical substance which any person reports under subsection (a)which is manufactured

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### 91

or processed ill the United States. Achemical substance shall be il nciledp in such an inventory as ofthe earliest (late (as detemimed by tie A(111iinistrator) on which such substance was unmnifactuie(d or 1)recessed in tile United States. IK'.,.il<mi/wo.--S feh al inventory would b~e useful to the Administrator in conlucti g his resplonsil)ilties underthe Act.

IiEATION5I1i11 TO OTHER LAWS 1.Page 28, after line 8: insert a new paragraph (2) as follows, and reumber subsequent paragral)hs accordingly : (2) any source material, special nuclear material, or byproduct material as defined in the Atomic Energy Act of 1954 (42 S(C 2011). asamonded, anitl regulations issued p1ursuant.thereto; A'.rxp1anaton.-T'l'lit amne(Ilnent adds aclass of materials to the cx- emlpion provision, as those materials are already adequately regu- lated under existinglaw.

2. Page 28, line 24 : delete all of subsections (1), (c), and (d) and insert the followingsubsections inlieuthereof. b) LawsNot Administered by theAdministrator: 1) If the Administrator has reason to believe that,tile manufactur'e, lrocessing, (listrihuition in commerce, use, or disposal ofachemical substance ormixture posesor may pose ain unreasonable risk to healt.h1 or tile environment, and if such risk may Ihe prevented or reduced by action taken under
a law not administered hy the Administrator, the Administrator shall request the agency which administers such law (A) todetermine ifthere is such arisk and (B) iftheagency determines that there is such risk to determine if such rish may be l)revented or reduce( to a sufficient extent,by action taken under such law. Any such reqost shall be accolmpanied ly a detailed statemnent of the information on which it is base(. Tihe agency receiving the request, shall make the Ie- (utested determination within such tinle as the Administrator spe('ifivs in the request, but such timne specified may not be less than ninety days from the date the request was made. The report ofani agency in response to a request made under his paragraph shall heaccomlpanied by a detailed statement of the findings an( conclusions oftle agencyrespecting the deterimnations requestetl tohe made. (2) If tfhe Administrator makes a request iunder pari- graph (1) with resl)ect to a chemical substance or mixture and tlie agency to which such redhilest was iiade either- (A) determines that such sihstnce or iixture -ldoes not pose or is not,likely to pose an unreasonable risk to health orthe environment, or (B) initiates, within the time specified in the request under piaragraph (1) in response to such request, action under the law (or laws) administered by such agency to protect against such arisk,

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the Administrator may nottake any action under section 6or 7ofthisActwit1h respectto such substanceor mixture. (8 If the Administrator has initiated action under section 6 or witI resl)ect,to a chemical substance or mixture which

was the subject of a request made to an agency under paragraph (I), such agency shall before taking action under the law (orlaws) adlmnistered by it.to prolect against.such risk
to health or the environment assoeiate'd with such substance

ormixture consult with theAdministrator forthe purpose of avoiding duplication of Federal action against the risk. (c) Laws Administered by the Administrator.--The Adniinistrator shall coordinate actionstaken under thisAct with actions taken undcrother Federal lawsa(lministered in whole

orin part by the Administrator. The Administrator shall use the authoriiies contained in such other Federal laws to protect against anyrisk to heallh or the environment associated with a cheimica'l substance ormixture unless the Administrator determines tlimt snitli risk may bemore al)propriately procteit against umnder this Act. This subsection shall not be. construed to relieve the. Administrator of any requirement imposed on the Administrator by such other Federal laws. (d) Occupational Safiety anld Ifealth.-In exercising any authority under this Act,'the Administrator shall not, for purposes of section 4(b)(1) of the Occupational Safty and Health Actof 1970, ble deenied tobe exercising statutory authority to prescribe or enforce standards or regulations affecting occupational safety and health. (e) Coordination.-In administering this Act, the Administrator shall consult and coordinate with the Secretary of Health, Education, and Welfare and heads of any other appropriate Federal executive department or agency, ally relevant independent regulatory agency, and any other appropriate instrumentality of the Federal Governmiient for the purnose ofachieving the maximumn enforcement ofthisAct while imposing the least burdens ofduplication on those subjectto the Act and for otherpurposes. Explanation.--Theproposed amendment provides that the Administrator hasno authority under section 6 (regulation ofchemicals) and section 7 (imminent hazards) if the following occurs. Other agencies would be remested by the.Administratlor to determine ifa risk ispresented or islikely to be presented by a chemical substance or mixture, and ifsuch risk can be prevented or reduced to a sufficient extent by actions under another law. The agencies would then either determine that the siblstance or mixture does not pose or is not likely to pose an unreasonable risk to health ortheenvironment or initiate actionwithin 90 daysto protect airainst such a risk. I.R.7664 could presently be interpreted so as to draw into question man- regulatory actions that would he taken under theToxic Substances Control Act. The commitment, of resources and protracted delays which could result from litigation could undermine the implementation of this legislation and seriously detract from effective use of this authority toprotect health and the environment.

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ADVISORY PANELS Page 30, line 9:delete all ofsection 10 Chemical Substances Board, and lienmbnilrsubsequent sections accordingly. Explamtihn.-Thie section would add a substantial administrative step to ,a complicated regulatory procedure, in that till rules to be proposed rider sections 4,5, and 6 (except in two specified instances) would have to b1, presented to the Board for a scientific report. There is, of course, a need for sentific advice. However ETA al

### iead'y has a

### Tlazarduis Materials Advisor' Committee full, qualified and able to advise on matters pertaining to toxic siibstiances. The Agency program office would 1he stafled with a substantinl ilIIImlhmr of qualified scieitists. As with the Ageiey'sPesticide Program,the Administrator would draw on themany outside sourcesof advicein order to .issile his decisions we soundly based in scienitifii 

### knowledge, b1it

as I mat ie' ofcoilrse i2tli h ,i] i'i,,lc-deii1akingprocess. Ihe icadet(nIc ('OIIIIlIII itY an(1 slch national groups as NAS, NSF. and Nil[ are Sour'ces preseitly relied upon. In ddition, EPA will submit its draft. regulatio ns to othercoemrned ageicies as astandiard executivebranch proceduire 

### to csrine adequate input 

### mth ofa sciemtific and substantive
liat ire.

INSIEt'TI(ON (O1' iiCOIDiis lil IIEIMil,'HSEMENT FOR TIS'I'INO Page 35 after line 2insert new siihsection (h) as follows and retiumber existing suihsections (b) and (c) aeordingly: (b)Notwit

### listanding tle provisions of subsection (a), the Admiiiistrator shall have authority to inspect financial data records pertaining to testing 

### costs whn lie orders coltrililion or reiiiibu'semient, for the costs of performing tests iil (oiliect ion withI theprovisions of section 5(f). F./)lamdloi. Section 5(f) authorizes the Administrator to deteriliiime the 

### equitable cootrilmtioii or reihiliirsemiCent of testing costs where illor tIh ti one person benefits from the testing. This amend

### iniiit would 

### aulthlrize access to financial 

### (ltaoil testing 

### costs ill order for tlie Administrator to carry out the requirement to apportion the costs among those henefiting from the testing.

I)S(ISLSUREII' ((I(NFII)ENTIAI, INIFOIMATION Page .(, line I-t. delete entiie section U5 and iiisert in lien thereof the following revised section:

CON~i IE11N.'XTIAi1.1TY

S.:C. 15. (a) GiENFRAL.--The "se by any person to his own a('ainitave. or revealing, other thai to ti;e Admini.strator or fl'em's o' ciii)1ovees of theEnvironmental Prot eet ion A ugecy who have Tineed to know for the prformiaice of their oflicial dlutios, or to officers or employees of another Federal agencv whohave a need toknow fortheperformance oftheir official duties, or to the cou'ts when relevant in any judicial

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proceeding underthisAct anyinformation acquired pursuant to this Act concerning trade secrets, information which is likely to cause substantial harm to the competitive position of the persoii submitting tlie information, or which would likely impair the Government's ability to obtain necessary information in the fillureisprohibited. (b) DATA 11031 IiEALTI ANi) SAFETY STTi)Wjs.-.Sitbscction (a) does not prohibit the disclosure of- (1) any health and safety study submitted under this Act with respect to- (A) any chemical substance or mixttre which on the date the study is to be disclosed has been offered for com

### inercial distibition, or (13) any chemical substance ormixture forwhich testing is required iunder section 4or for which notification isrequired under section 5, and (2) any data reported to, or otherwise obtained by the Admitistrator from such

### a study. This subsection does not authorize the release of data which disvloses processes used in the manufacturing or processing of a chentical siibstanlce or mixture. or proprietary formulations. (v) REIEASE OF INOICMATIX TO OIN')'TRA'Tttlts.-(1) Notwithstanding any limilation in subsection (a) such informiation may be disclosed to contractors with the United States 

### and eml)loyees of such contractors ifin the opition ofthe Administrator such disclosure is necessary for 

### the satisfactory performance by the contractor of 

### a contract 

### with the United States entered into on or after the effective date of this Act for tile performance ofwork in coniection with this Act. (d) CIiiMINAI, PENALTY "Oa WRONGiUL I)St'LSVtI.- (1) 

### Any officer or eiii)loyee ofthe United States. or former officer

or employee (if the United States, who by possession of. or who has ncces, to, material which is prohibited from release under stibseetiot (a), and whoknowing Ihatdisplostu'e ofthe speeitic Iiaterial is prohibited by this section, willfully dis- 

### ('loses th' 

### iiiiitcria1 ill mitty mannelr to pny person not elititled
to receive it. shall be guilty of a misdenleanoir and fined not

more thal $5,000. (2) For the purpose ofthis subsection, ay Conltitltor with tie United States and 1u1y employee of any such conti'icto 

## 11'ho is furnihv.d information pit'suait to subsection (C) (1) shal lbe conside'red tobt11 vi 

### ctployee of tihe Unite(d States. 1"pll fl0itol,-This section shou be a(1 

### ieilded in se erialI respects. 'lhis legislatio"I requires suilstiaitial itiformmation to be su1illitted to Ihe ( o\'verniienl upon specific request ofthe Ad1i itistritor. fif addition. the legislatioll doesnot precllue voluntarY sulbliiission ofitiformnation prior to or after iitaunuftcture. If inidividuls are not assured 

### that trade secret and confidential information as outlined in this section will not be released except toauthorized individuals it is highly likely that infornuttion which tile 

### Agrency could itilize would either 

### l)e difficult to obtain in a timely fashion and/or simply not available. It is

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imlortant. however, that all information obtained pursuant to the A~t be mude available to coilrctors of tile United States if such disclosure is 

### nece.sal

' 

### y for tle siltisfactoly )er foIlti~flne 

### of the 

### conira(t. Since miuich of InhA-ency's workloa 

### IIII4l u mtedllvy will he 

### contractualthis plrovisil is vital to the legislation's successful iniplenientation.

EN VIlONMENTAh ]I'll l'iION AN1) ASSESS ENT Page 43. line IT insert after "resoires to" "p

### redict. fnld".

llajt/ioa. The ((lltelt of section 1Isholihi reflect tile intention ofthe title which isto peril it 

### PA in association witli other 

### agencies Io lecome invol

### ved il prediting and assessing 

### tleen

### vironfuient al cons0(pentes of tile introduction of new chemical sulbstances intothe envirolnient.

STATE EIN EM I 'ION FIRl)

. FFI IIAM I PI1 EE.MPTION Page 45,line 14,delete suhse't ion (b).

wp.ie 11116010.-'l'hi. a lend(1en1 woul dhelete lie 

### provision tlit w(uld allow 

### Stale and local t.oi1 ro ie1is to 

### ltition toh)l eXeIl)ted front F 

### 1ederal pre11 m)ption requilements.

,1UlDIIAL II' IlAV I'agP 17, line 10: delete "no(*"; line 11 :insert "not" after "are".

.'planeltvi .- The al eiii(lnvnt wouhl Irovidle that the Adiinisirator's iliilm's shall le 1lirinied Iluiless not slipported by the record. I'liis. Ilie l)('sol contesting the rules must slit()w that the recorddoes not slippolrt tlieni. rather thiln Ihis burden being on the1' Administra-

or. COMIl-IloLIII ( EiNERIAI, OF TIlE UN I'TIE) S TIES, Vashhiqton,D.C... July!/!

. 197:5.

-1011.IIATLEY 0. STAErS, Chairman, Cornomllice Onlhitersac (old 

### Forc.u,. (om1erc. Hou1s'e ofhRepir.sentiets.
DEmAU MN. C ral.YN : This refers to your letter of 11une

. 1975, re

### questingOur report oi I 

### .R. 722). 9Ith Congress, the "ToxicShlIstances Control Act."

In general, we observe that the objeetive of the legtislation, whiich is to regllalto tile usIe lnt dis+enilaition of certain 

### toxic chemicals, is similar tothat ofthe Federal Insecticide, FuIgicde and Rodentivide Act (FIFRA), 7U.S.C. §+135 c/ v(iq., (19TI) isamended 

### bY Pub. L. No. 92-516, approved Octolhr 21. 1972. with re(pect 

### to 1ia-iv )1,st ivides. Inthis conmelimu, we note tha 

### lt ul).L. No. 91-51. approved July 2, 1975, provides for the extension of 

### tile nitlorization of a)- pro)riations for FIIFRA until Sel)lmher 30, 1975. h'lle purpose of )oth FlFRA and II.R. 7229 is 

### to protect hunall 

### ealthind(he environent 

### by requiring adequate testing and other lIrog1rams nnd proce(luI res telated to specifie (a lrouls sllbstances. 

### 'le Administrator of the Environmental Protection Agency (EPA) would Ie Iesponsible for' execution of the provisions of 1I.1. 7229 and is also responsible for administerin- FIFRA. In view of the similarity of objectives and the responsibility of the EPA Administrator writh

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respect both to toxic chemicals and toinsecticides, fungicides androdenticides, we believe it desirable that, insofar as possible, the terms and conditions under which both laws are administered should be uniform, particulhrly with respect to certain substances which, under the respective definitions, could be controlled under the provisions of eitherII.R. 7229 or F1FRA. Therefore, with respect to the following specific provisions of II.R. 7229, the Committee may wish to consider adopting the substance ofrelated provisionsof FIFRA :
1. In section 3(4) of II.R. 7221) the terii "comiiierce" is defined in terms ofinterstate commerce. Thus only toxic sub.tances involved in interstate coiiiineree would he covered, unli1w pc ticides, which are regulated under FJFRA if disseiiinate(lin tinstate coulieree as well. We believe irectireess of admniistration of both the toxic chemicals control law and FIFRA woulh be enhained if this term is uniformly applied under both laws. Thus, we suggest tilel(lefllition of commerce in II.R. 7229 be revised to (onfori with the concept of intrastate regulation found in FIFIRA 1lv amending sulbparagraph (B) of section 3(4) to read "within a ,tate." and adding a
newsuiiparagraph (C) tored "which affects trade.traflic, tranisportation, or exc'hanlge described in sul paragraplhs (A) and (B) of this paragralph." See 7 

### U.S.C. §136j, Pub. L. No. 92-516, section 12, S. Rep. No. (7)1, 92nd Cong., 2nd Sess.-1)(1972) on I I.R. 10729.

2. Section 11 of II.R. 7229 provides for inspections of records and properties ofpersons engaged in manufacturing. processing, and distributing chemical substances controlled under the proposed law hIy tis Administrator of the EPA or his deoignee. We believe it would ho advisable, in the interest of uniformity, to imlend section 11 to emform with tile inspection procedures aid authorities provided iii 7 I .L".( '. 13:l;gZwithreslect itojIestitides.
3. Subsection 17(c) ofI.R. 7229 provides for seizure of substances manufactured or distributed in violation ofthe proposed law. Again. in the interest of uiiformity in adminiitmatnton of two similr and related statutes, we suggest alindi, nt of the seizure iprovision of IT.R. 7229 to conform with tIhe stop sale, use, removal and seizure provisions of 7 U.S.C. 136k, Pub.L. No. 92-516, section 13. Setion 9(b)(1) of the bill provides that. the Administrator of 

### El'A would have no authority to act under sections 6 and 7 of the piopnepd Act toprev(ent orrediice an unreasonable risk tohealth orthe enivironient if: (A) the ciutirety oftherisk involved isdesigned tobe prot(cted agoainst by another Fe(eral l11w not administered in whole

or in part by 

### tlie Admniiistratom': or (1B) if the Administrator determines that the cut i'ety of the risk could be stiliciently prevented or redmedby actioi talken nder such otherFederal law. In the interest of (larity, we b'lieve ;ection 9(h) (1) should be amenided to .specifvwhichotherprotective laws are meant. We suggest. lantmimge aloln.g thv lilines of the followingz a; a sulstitute for section 9(h)(1): "(b) (1) 'Tlie Administrator shall have no authority under sections 6 and 7ofthis Act to take action toprevent orreduce anlunreasonable risk to health or theenvironment associated with aparticular chemical substance or article containing such substance ifsuch risk tohealth

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or. the environment could be prevented orreduced to 

### asufficienit extent bY actll s Inellk miler any other Federal law; incilldig 

### Ille Atomiic 'nIiergy Act of 195I,tie Clean Air Act, t,1w Federal Water Pollution 

### ('ont trol 

### Ak't,the Ftde'al Illizardohls SubstanIes 

### Act, i e Occupational Safety al(d 

### lHealth Act of 

### 1970, the ('onslllSel' ]1

### 2oidct Safety Act,sublaIt 3ofpatrt F oftitle 111 of Ihe,Public IlealtIh Service Act (relating to 

### electo nic prodhuct radiation), 42 U.S.C. 

### 20't2 )',t eq., 

### Pub. L. No. 90-602, 

### ()ctober 18, 1968, Jiild tl 

### Acts administe'ed 

### by tile Secrtary of Iransplortatio relating to( 

### lit, tralsportatiml 

### of hazardous

Sublstllc('." Th'liswas 1hw languaulge included ill 11 sirelar prov'ision ofH.T. 5,356, 

### :l ('onigless. t,, paSst by tle 

### I1o1s of Renpresent tit Ns ,uly 23, 1973, m(l1 provi'es it

### specific statement of tile legislative alilthIorites to 

### leconsidIeed by the A(llminislt Ilitorill dhteiriiinitgwhetlier ijon will be tln uider'Jlil act such itsthat prplolSed by I1.E. 7229 or anotlhe appl icablh, statilte. Sitios 

### 1(a) an(d 

### 10(b) (3) 

### ofthe bill would .it lhlrizc theAdIllnlistrator of the En'ionmetntal Protection .reitcv to Iliake contl'icts and gwl'its for resciarch and monitoing as ne(ssary to cary out,the )u1rpose of this 

## Ae ( and for development of itdata retrievll system Suitable for c'rrying ou t ihe piil-oSeS of till' Act. Ill order tllt this 

### Oflive lImay lih11ve access to recolrd(s (.onnivPcted with Such contracts and .ilailts, 11;1(1 to flvilitate our1 aulit of them, we recommend that the followiitg iwt se,tiolt be iivorporl-ltld il 

### 1.11. 7229: "Sv,. (it) Each reciplimlt of Fvdhvral tissistiimte unde,"this Act, purS"IIillf to gl'lltS, SIl]grI'Ijt5s (ollitIt(ts, Smll)(Oliltlacts. loanls or other :ll'lan~znlt l h-rqqed into otlhe' thanl 11 I for'ill adhvertising, andi whicih are Itlherwise :111llio'izcd bY this 

### A'ct. shall keep 1 su(h records :Is te lidiinistr'afor slill prvvscihe,, incl(ll-(li1.. recorls which fully dis.lose te ll illil and dislIosilioll bv sllvl r'ecilient oftile proceeds of

### SlIch as,istailv.t

### lie total 

### cost of tl' )roject or 

### Illdertaklng ill ('o1- ne(tion with which such assshiltC'e is giveI o2 

### 11sed, tle amount of that piortion of tlhe rost of tIlle projec. o) 0 hIIl(,l('atiiu, slipplied by other sources. and "mh1 Otbr reiciords us will fucilitil 

### t J1ll effective i(ldit.

"(1)) The inlllil1istratorn Id

### the

### ('olllip iiolhr u' 1eral oftheUnited Slths. 01' all.N' of

### tlhivr dily alltho2zd represenltativtes, shll, Inlitil tile .X)ilrlitioll of thre,Y'ears after voiplet iou of

### tileo proe'c or 

### li(lirtalk- im, referired to ill slmbset io (a) of this sect0ion. have access foi-the puro'l);(' of alldit and examination t any bIooks. documents. 

### lapers, and(r'cords 

### of Stich recipients which ill lile ol)i ll of the Adminis- llllnlr or 1v Ct'(omptro)lhlr Gener(al 111,11. be re'lated or pertinent to tile

iZ'2iIIIs. qllJ)h'(rIa ('o(ll Il .ft'. .lcoil trl .it. loaliso' other

,ll'flle' nll flts I'rFe(id to il ,lihsec(tio( (n)." Section 25 

### a of thea 

### hill would require our Oflice to illlk, a study of 

### all Fedh'raI laws hdmilnisterd yhv 

### EPA.for tlhe puI.pose ofdetermi' m, whetherv and under,whill co~ndilios. ifali'. indcllmmficatioll should he(1 ac(orded Jil, yv

lerSint as nresult of,' :ait m taken hv

### t lie i Adfinis ha- 

## tot' uider 'nIV ha adllist-eod hv' tile AlZnc'y. Til'e study. wlich would

### Ib 

### 1 lequlired to 

### lbe voilplhled 'Ilo lessthal 2years from 

### thie date (If eliactillnlt * * *." would include Jll estimate of the probable costs of any indemnificat ion progrilis recommended and til1 examination of

HeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 504 197698

all viable means of financing the cost of any recommended indemnification.

The proposed study would require intimate knowledge not only of all the laws administered by EPA but also of the manner in which such laws have been administered. Such a study would be a large and costly unldertaking for our Office that might necessitate tile diversion of some of our limited manpower resources from other important work. EPA already has most of the knowledge required for such a study and should be able to make it at sulstantially less cost than our Office. We reconlnend, therefore, that the Committee consider requiringEPA to make the proposed study. If desired, our Office could review EPA's study and provide a report on its adequacy either to the Comnnittee or tothe Congress.

It should also Ibe noted that there is

### a p)rovision under FIFRA (section 15, Pub. L. No. 92-516), 7 U.S.C. §136m, which authorizes EPA to indemnify pesticide nmnufactitrers who suffer losses by reason of suspension or cancellation of their pesticide registrations. EPA's Deputy Administrator for Pesticide Programs told us that EPA was opposed to enactment of this provision into FIFRA and that he had supported the deletion of this provision from FIFRA in testimony before tihe! louse ('ommittee on Agriculture on ,htte 20, 1919,in the

course of oversight hearings on the Federal Environmental Pesticide Control Act, Pub, L. No. 92-516, October 21, 1972, 7 

### U'.SC. §§ 1,36
et v,. (1970). Supp. III. lie also stated that no payments had been nuide under the inhmn 

### itYv provision by EPA since it was elacted on October 21, 1972. The EAA position favoring repeal ofthe indetnnit, lprovision was also stated by the Assistant A(hituistrator, Water and Ilazardous Materials at a liearintg of the Subcommittee on the Environment, Senate Coinitittee on Commerce on May 

### 5. 1)75.

Section 26(c) of ilie bill woild require that copies of any budget requests, legrislatie recommuendations, a d otler materials sul)t itted to the President or to the Office ofManagement and Budget (0MB) in connection with atrying out the provisions of IT.R. 7229 be sulmitted concurrenitly totie Congress.

It is not at all cleatr that the agency ludget submissions, as such, would Ie helpftl to the Congress. Agency budget submissionsto OM1 arc subject toJ an intensive hearimg process. field investigations, and frequeitly. resibltissions. In sone Cases where agency prg ms involve siniilat or related prgrais of other agencies, there is need for elimnation of dulicative requests and for iidjlistineut of the level of~programs 1oaissit' effective ititeragettey collalborationi.

The Committee may wish to consider, as an alternative, making arrangfeitentsfor the*advance delivery of upproved agency budget requests prior to le formal stilutission'ofthe President's Buidget. Arratigeents along these lines have been 1ade in the past with ilie a)propriations comm 

### ittees in order to ellable 

### hese committees to undertake hearings at an earlier date. In some cases, it hits been possilal, to release agency budget justifications as early as tie first week of )ecember.

In this connection, we note that a similar provision was enacted as section 27(k) of the Consumer Product Safety Act, Public Law 92-1573, approved October 27, 1972, 15 U.S.C. §2076(k). In the light ofexperience it now appears that thisprovision plates an agency adHeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 505 1976g9o

ministrator in a very difficult,position due to the conflict between a congressional mandate to supply information to the Congress concurrently with suhlmissions to tlhe )flice of Management atid Budget and the provisions of 31 U.S.C. §15 as interpreted by 0MB in its Circular A-10which require agenciesto (1) prepare budgets within guidelines (funding and personnel) provided by OMB; (2) submit budget requests to the Congress through 0MB; ind (3) defend budgets prepared under OrB guidelines in its congressional appropriations hearings. The problems raised by this conflict were discussed in some detail hy the Chaiirnmn ofthe Consumer Product Safety Commission at an oversight hearing of the Consumer Subcommittee oftile Senate Committee on ('ommeree on February 27, 1975. The,Chairman summarized his views on thequestion by stating that; "theconflict between section 27(k) and the OMB's interim'atation ofthe Chairman's duties

asa membI1)herof theexeeutive branch raises soinevery seriousquestions which need resolution."

We r-ecommend :aainst 

### eclaelment of the proposed p,'ovision in se'- tion 20((4) of IH.R. 722) pending resolution of the conflicts discussed by the Chairman of tOhe Consumer Pl'oducts Safety Commission to whieh referenoe ismade above.

There isno provision in 1I.R. 7229 tht.,EPA submit an annual re- )ort to the Congress describing its actiVitiesunder the Act duringthe pr'evious fiscal year, We suggest that such a provision beincluded in thehill. Ii this regard. consideration should also be given to requiring that the annual report include an evahation of EPA's effectiveness in Parrying out its reslmnsibilities under tile Act. It is our view that pro"inlm evaluation is a fundamental part of effective program ad- ninistration and the responsibility for evaluations should rest initially upon the responsible agencies. In line with this concept, we believe theCongress should attempt to specify the kinds of information and tesls which will enahle it to better assess how well programs are working and whether alternative approaches may offer greater prolmise. Sincerely yours, PAu, G. Dpr-iivo (Fortei (7omytnprollerGeneral ofthe United8iaes).

TI IE 1.NuE.I, COUNSEL, OFTIlt TiE.%sUmiy,
Iloji. IIAiiiEY 0. S'I'AflfG iS, 

### 1jVaOsd qto ,D.C.,A

### u q



### u t

### 21, 1976.

('h(I;manli. (ommith, e on /Itritah,andForeqn(ommyercc, Ilme of

]E)u MR.C IAi IMAx Reference is made to your request for the Viewsof hiis I)elmtainent on I. R. 7229. tlie "Toxic Substlanes Control 

### Actl ."

The hill would estahlish Various standards. rules and procedures under which the Administrator of the Environmental Protection Agency would control or restrict tie use or distribution of certain chemical substances, in order to protect health and the environment.

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Section 13 ofthe proposed bill relates to the enforcement responsibility of the Secretary of the Treasury with regard to imports of chenical substances covered by the Act into the customs territory of the United States. The Departnent recommends that section 13 be amended as follows (language to be added is italic; language to be deleted isbracketed) :

"SEC. 13(a)

. . . If a chemical substance or article isrefused entry, hereunder, the Secretary of the Treasury shall refuse [delivery] release to the consignee.aid shall cause the disposal or storage of any substance or article refused [delivery] releasewhich has not been exported by the consignee within [three months] 90 days from the date ofreceipt ofnotice of such refusal under such regulations asthe Secretary ofthe Treasury may prescribe, exceptthat the Secretary of the Trea'sury may [deliver] releasetothe consignee such substance or article pending examination and decision bytheAdministratorin the matter on execution ofa bond for the amount ofthe full invoicevalue of such substance or article as set forth in the Custo-ms entr. [together with] plus the estimatedduty thereon, and providinqfor l;ability forassessmentofliquidated damagesequalto thefullaniont ofsuch bondby the eon.Rqneeon [refusal]failuretoreturn such substance or article [for any cause] to the custody of the Secretary of the Treasury, when demanded, for the purpo.;o of excluding them from the cointry or for any other purpose [such consignee shall forfeit the full amount of such bond]. All charges for storage, cartage, and labor on substances or articles which are refused admission or [delivery] releaseunder this section shall be paid by the owner or consignee, and in default of such payment shall constitute a lien against any future entry into the U ited State8 made by such owner or consignee."

The Department hasno independent knowledge of the need forthe bill and no commuents on its general merits. It,is believed that,enactment of the proposed legislation would increase Customs workload to some extent, although no unusual administrative difficulties are anticipated.

The Department has been advised by the Office ofManagement and Budget that there isno objection from the standpoint ofthe Administration's program to the submission ofthis report toyour Committee. Sincerely yours, DONALD L.E.RrToan, AetingGeneralCounel.

COMMMMrrrrE AM.IENDMrENT

* * *

HeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 507 1976SUPPLEMENTAL VIEWS BY CONGRESSMAN JOIN 1). I)INGELL

I believe that it isnecessary to put a specific requirement into II.R. 14032 to ensure that EPA will take prompt measures to deal with PCI's.Unfortunately, one of the bill's shortcomings is its failure to mandate action on hazarlous chemicals in a timely fashion. There is no slpecific directive for tile Administrator to take action to control the nost hazardous chemicals within a certain )eriod oftime. All of tileAgency's actions are discretionary, and subject to the viscissitudes of political pressures and budget starvation. Fron what we can see of EPA's past record, we cannot be particularly sanguine about the. Agency's ability to act quickly.

With this knowledge. brought on by retrospective studieson PCB's, it isclearthat Stepsto ( coatrol production, use, aud dis)osal are needed, to protect the health and well-being ofhuman and other life forms.If .Jpalhl, ,s tle largest producer of electronic equipment, can replace PC'Bs with sonle other, more neutral comlponent, then the U.S. can follow suit. The To-i Substances Control Act would he considerably strengthened by l)roviding ameansto control PCB's. I)uringtheComnmittee consi(leration of H.R. 14032. I offered an anendment-which

was rejected-to prescribe methods formanufacture, use,and disposal, and eventually phase-out of PCB's. This amendment is sorely needed to prevent fnrtlir contamination, death and future PCB iicidents. The problems associated with widespread use and dispersal of PCB's (Polyehlorinated Biphenyls) are a prime example ofthe type of chemical hazard to which the Toxic Substances Control Act should immediately address itself. PCB's like their chemically similar cohort DDT, arc e'xtremely stable (long-lived) which leads totherisk ofbioaccumulation and concentration in fish and other aquatic animals as well its in the tissues of man. The dangers involved for man include numbness and pain in the extremities, reduced sensitivity to pain and/orheat, slowed nervous reactions, acne-like skin eruption, temporary failure ofeyesight, sense ofweakness and cancer of the liver.

In 191168, in Yusho, Japan, PCB's leached intorice oil used for cooking and affected 1,000 people in varying degrees depending upon exposure levels. The intake of0.5-2gralsbythosecontaminated resulted in a wide variety of illnesses, particularly affecting theskin, eyes, and
nervous system. The children born of pregnant women who ingested the contaminated oil were also affected with skin disorders and were smaller in size. Although direct proof was lacking, PCB contamination was also suspected as, at least, aco-factor in somedeaths andstill births. Percentages ofPCB's found intheblood of Americans, both urban and rural dwellers, have been found to equal those ofthe Yusho incident. Disruption of the normal function of the liver from PCB's at those low levels (0.5-2 grams) causes the skin disease named after the (133)

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### 134

victims at Yusho. Besides Yusho disease, low exposures can cause metabolic disturbances, embryo abnormalities, abortions and iniscarriages. Laboratory experiments document this knowledge. The distribution of PCB is ubiquitous. Now banned for most uses in Japan, PCB's stillremain in theenvironment frompast usessuch asfoodcontainercardboards and wrappings, boat paints,fireproofing, and textile coatings.

PCB contamination of waterways is of equal severity throughout the United States, and especially in the Great Lakes area and the Northeast. Commercial fishing in Lake Michigan ceased in 1971 due to pollution from PCB's,and -recentlyit has been feared thatall commercial fishing on the Great Lakes-a $95 million annual industrycould be shut down because of PCB contamination. In addition, ithas been warned that PCB's could cause the imminent collapse ofthe$350 million-a-year sportsfishingtouristindustry inthe UpperGreat Lakes. Early this year the Hudson River was closed as a commercial fishe T for most slecies of fish (particularly striped bass) due to high levels ofPCB's which exceed Federal standards. It has been estimated that 22 million pounds of Hudson River striped bass are consumed each yearfrom both commercial andsportcatches.

Air is the major agent of transport for PCB's followed by water. 

### The leaching an( vaporizing of PCB's from materials and dump sites release from 1-2 thousand tons of the contaminant a year. Industrial spills have led the FI)A to advise the public not to eat the fish from the IIudlson River. Lake Ontario, Lake Michigan, Pensacola Sound and the Milwaukee and Ohio Rivers where gross contamination with PCB's has been measured. One hundred gallons ofPCB's can contaminate 10 trillion gallons of 112,0.

My ameldment was improperly criticized for singling out one specific. chemical for action when no other hazardous chemicals were specified foraction in the bill. It isentirely proper for Congress to set priorities foraction in any piece oflegislation and PCB's have proven themiselves dreadfully toxic and extremely persistent. Because ofthis, it. is incumbent upon Congress to direct 'EPA to take prompt action oil PC13's. I urge my colleagues to support my amendment on the Floor of the House during consideration ofthis measure. JoN D. DINGELL.

HeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 509 1976SUPPLEMENTAL VIEWS OF MESSRS. MOSS, DINGELL, METCALFE, BRODIIEAD, MOFFETT, AND MAGUIRE TO II.R. 1403'2, TIE TOXIC SUBSTANCES CONTROL ACT OF 1976

In the most routine and necessary activities, tile American public is exposed to thousands ofuntested chenical substances each day.The growing body of evidence indicating someofthese chemicals fortheir damage to liuman health and the environment leads us to support stioagtoxic substancescontrol legislation. I.R. 10432 contains a number of provisions which we expect will be effective in providing this protection, and we are graleful for the 

### ('trorts ofthose who crafted thiscompromise bill and successful shep- herded it through tile full comminittec consideration. However, we believe the compromise falls short in several key areas. 'h'lme following provisions need to bc strengthened in order to provide adequate protection forpublichealth.

SiCTION 4(E). AcTION BIY 'rm ADMINISTIRATOR ON ADVISOIRY COMM-rTEE

PIIORITY LIST Section 4(e) of K.M.10318, the bill reported by the Subcommittee

on Consumer Protection and Finance, established an interagency advisory committee to make recommendations to EPA of chem~icals whicih should be tested. A list of chemicals, ranked in priority for action, was to be periodically submitted to EPA, and the complete list, was to be published in the Federal Register. Within 12 months ofreceiving the listthe Administrator was required to either l)romulgate a rule requiring testing or to publish in the Federal Register the
reasons for not taking action. 11.R, 1.1032 changed the 

### provision in two importantrespects: (1) The requirementthat tile listbe published in theFederal Register was replaced by a requirement that tileAdministrator merely make the list availab~le to the public; and (2) the requirement 

### liat theAdministrator act onthe recommendations within 12 months om publish reasons for not doing so was also deleted.

Removal of the data certain within which the Administrator must act or explain why he or she is not acting undermines the likelihood that the agency will deal expeditiously on the interagency advisory committee recommendations for testing of key toxic chemicals. Publication of agency decisions to actor not act pursuant to tie authorities granted by this bill is also an important oversight tool for Congress and the"public to determine whether the agency is properly carrying out its mission. If a chemical is important enough to be listed, it isimportant enough for the Administrator to consider action tn it, either affirmatively or negatively, within one year of being listed. (135)

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### 136

SECTION 5.INADEQUATE i'IEMARiKET TESTING AUTIORUTY
Section 5 of 1I.R. 10318 required that a manfacturer give the Environmental Protection Agency 90-day premarket notification of intent to begin commercial production. The Administrator was to review the notice and determine whether or not it contained sufficient safety information. ln cases where safety information was insufficient and testing would provide that information, the Administrator was authorized to promulgate regulations to halt manufacture until adequlte safely information could be developed. Under tile subcommittee bill, such regulations could be made immediately effective. H.R.14032 changed section 5 to remove this "authorityto act after receiving notification. The substitute instead requires the Administrator to petition tie U.S. district court to enjoin manufacture of tile chemical or its distribution incommerce before the Administrator can proceed with a rulemaking under section 5(g) to impose manufacturIng limitationsor prohibitions.

Requiring EPA to petition the courts to prohibit marketing of a chemical about which there is inadequate safety information, rather than allowing the agency to require proper testing priorto

### marketing, places 1 r1riunecessary 1 urden ) upon the courts.and the agency. Furthermore, it places within the courts the decisionmaking which )roperly belongs to tileAdministrator.

SECTiON 5. EXI'I,AN.\TION BIY Tr ADMINISTRATORI OF Wily HE on SHE IS
TARING ACrIoN Olt NOT TAKING ACTION

At the expiration ofthe premarket notification period the Administrator has the option of initiating regulatory action or allowing tie chemical to he marketed with no further action, or in some cases requiring further testing. At this point, the Administrator should give the public an explnnation of what lie or slhehasdecided todo andwhy. The frequent complaint that Government agencies are impenetrable 

### bureaucracies is due in part to the absence of provisions such as this which would require sm explanation to the imblic ani tile Congress about a decision not to act under the discretionary provisions of tile bill. It has an additional benefit in that theexplanation would enhance congressional andi public oversight of the Agency's decisionmaking criteria and framework.

sEcToN (3.DELEGIATON OF THE AUTHORITY TO ISSUE AN IMMEDIATEIY
EFFECTIVE RULE 

### 'rile committee hill inappropriately deleted section 6(d) in H.R. 10318 which permitted the Administ'rator to declare a proposed action prohibiting Ianufact ure, processing or (listribution -of a chemical shbstance ormixture to be inmediately effective when such asubstance poses an unreasonable risk. Such 

### aprocedure is essential toprotect tile 

### public health and environment during thependency of administrative docisionnlaking. By contrast, H.R. 14032 would allow the public and the environment to be exposed to potentially lethal chemicals during agency deliberations which include hearing and limited cross-examination ofwitnesses.Thebottomlineis thatlives, not short-termprofits,

HeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 511 1976137

are at risk during whatever timeisrequired for EPAto actunder the procedures established by H.R. 14032. Thisis adramatic concession of thepublicinteresttoprivate,commercial concern. Authority for expedited agency action is grounded inthe Administrative Procedure Act, which the courts have routinely held gives an agency needed discretion toact quickly. The deleted section was more cautious than the APA required in that it mandated that the agency provide an opportunity for oral presentations expeditiously after the Administrator has acted.

A common theme in recent callsfor regulatory reform is complaint about cumbersome procedures. The change in this section removes tile Administrator's authority to move quickly when circumstances require.

SE(CTjIN n. CUMBEIRSOME FINlDINGS WILL D)EIAY PROM31i AND EFFECTIVE
ACTION
Section 6(c) ofII.R. 14032 requires the Administrator to determine wvhether the risk could be eliminated by taking action under another Federal law administered bythe Admiiistrator. fsuch isthecase, the Adininistrator must make a complicated finding that it was in the public interest to regutlate tindersection 6(a) ratherthan theotherlaw. 

### 'l'lh finding ]ins to take into consideration all aspects of the risk, as well as make coninparisons between this law and the other laws ofthe costs ofcomlplying. and ofthe "relative efficiency ofactions." The proce(ure estalished by the committee bill appears likely todelay effective a('tion by tile Administrator because it imposes unnecessary and tine-consuinng requirements for findings as to the relative efficiency ofthe l)roceeding uinder thisactor another statute.

SECTION 18. PRiEMIMION (iF HTATE RIULATIONS
Section 18(a) of 11.11. 10318 allowed States to ban use ofchenical sustantes independlent ofany EPA action. 11.R. 14032insection 18(b) denies Stales the authority to regulate a risk associated with a par- ticular chemical if the Federal Government has already acted with respect to that risk. A limited exemption to ths preemptive policy is allowed ifEPA determines, after substantial review, toallow a State to act toprotect itscitizens. Traditionally States have been most sensitive to the health concerns of theircitizens. As a consequence, States havebeen granted widelatilde uider the Commerce clause ofthe Constitution to act.on behalfof their citizens even when those regulated are marketing their products through thechannels ofinterstate commerce. Congress hasalso enacted legislation which liberally defines the I-ole ofthe States in important health and safety laws (Clear Air Act, 52 U.S.C. Section 1857(d) Federal Water Pollution Control Act, 42 IT.S.C. section 1376).

Unfortunately. II.R. 14032 imnposes on States a substantial barrier to action to proect their citizens when EPA has taken limited steps to regulate itparticular chemical. They must apply tothe Administrator for approval oftheir actions. Thisclearance can begranted only after detailed inquiries by the Administrator, inquiries which will be directed tothe States ;with their attendantcosts.Finally, both theaction

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ofthe State and the action ofthe Administrator would be reviewable in court. Such procedural roadblocks protect manufacturers but do littletoprotect thepublic.

ADDITIONAL RECOMMENDATIONS
Lackofenforcementschedule

Oln serious inatdequacy in the Toxic Substances Control Act is the la(k(of lilly tiole-)liIsed enforcement requirements. We can look for models to the aiir and wter pollution control statutes eurently in effeet. Ifthis legislation does nothave careful deadlines forEPAaction, the likely result, will be prolonged delay and repeated postponements.

EPA should be required to publish criteria for identifying those substances for which regulations would be required, within sixmonths.
One yearlifter puiblication of the criteria the Agency should be requirel to pl)blish alist ofall existing substances whiih should be regillated 111(1I to divide the list into three groups relative to the need for timely actiolt. EA'A should then issue regulations fortheIighest priority'group within 2years,tle second group within 3years,and tie third group within 4 years. The Administrator should be reqluilrcd to Jmatike

anaanual review and revision of the lists. Under such a plan EPA would he re(qlIir'ed to issle regulations for all chemicals which were found to le )osing an tinreasonable risk to health or the environment within 71/2 vea is after enactment of the legislation.

It.isessential for the protection of public lcalth and tile environment that the legislation seek to give the EPA a firm mandlate for a comi)relensive al)l)ioach to protection from lazards due to chemical silstmices. Suchvwill only be achieved through legislative directives and ale( itte financial sulpport. As it stiainds now, the bill gives the ElA tan iminprcise hirectivie and inadequate funding. In light of 111111- til)le liizards the public till(] the environment face, the lack of a precise mandiated for prompt anl comprehensive action renders this legislation inadequate. Subporneapocr The committee bill does not provide the agency with subpoena power forsuch prl)loSes asz 'athering information forinvestigating violations ofthe act, for dleciding whether to take regulatory action, or for analyzing inforlfiition in the agency's possession. It. is inconceivable the agency can o)erate properly without the authority to denltlifld information unler traditional al;)ropriate safeguards.

JOIN E. Moss. JohN D. DINGEL. RALPH H. METCALFE.
WILLIAMr M.f BRODIIEAD. TonY MOFFEr. ANDREW MAoUIRE,

HeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 513 1976MINORITY VIEWS ON H.R. 1403'2 TOXIC SUBSTANCES
CONTROL

Tile bill, II.R. 14032, which was reported by the Committee on Interstate and Foreign Commerce on June 9, would givethe Administrator of tihe Environmental Protection Agency broad new powers
over this country's chemical industry. In its barest form, the bill authorizes the EPA to require that, manufacturers-perform tests prescribedI by the,Agency, and give the Agency advance notification of its intent to market.new chemicals orexisting chemicals for new uses. Funther. EPA is authorized to issue rules regulating the manufacturing. processi-ng, use or disposal of a chemical as well as require that ihecom)any maintain records and submit rel)orts as required by the EPA.

The House has passed Toxic Substances legislation in both the 92d and 93d Congresses, but, this bill goes far beyond anything we have

ever voted on. W1e are especially disappointed that the committee abandoned the approach adopted' in the 93d Congress with respect to premarket notification and screening (section 5). In earlier bills, the Administrator of EPA was athiorized to compile a list of those clemicals which lie finds pose a danger to health or the environment and the manufacturer of a listed chemical must then pirovide EPA with notice prior to marketing. In this manner the Administrator's attention would be focused on those potentially dangerous chemicals. The bill reported by thecommittee, on the other hland, would require that manufacturers of all new chemicals and new uses of existing chemicals notify and supply EPA with specified information 90 days prior to manufacture or marketing. EPA could extend that period another 90days. This approach is objectionable because EPA will have to draw upon already limited staff and resources to give each reported substance or use thorough scrutiny within the time allotted. Further,we fear that,EPA will be ableto hold upthe manufacturiig of a chemical for up to 6 months for nobetter reason than administrative backlog.

We fear that this legislation will prove ruinous for the small companies which make up much of this country's chemical industry. Industry estimates put the cost of this legislation at between $358 million and $1.3 billion annually. Even the General Accounting Office estimated an annual costofas much as $200 million. Further, it
can cost as much as $800,000 to test a single chemical. Although we hope that EPA would not beso unreasonable as to routinely require testing of this magnitude, the costs of testing could be considerable, and the costsof testing will fall heaviest on smaller c6mpanies.

Further, in theinore than 100 pages making up this legislation, there is set out an incredibly complicated regulatory maze which is guaranteed to completely baffle any layman attempting to pick his (139)

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way through it. And the bill will be augmented by more rules and regulations issued by the EPA. As we add these increased layers of bureaucracy, it will become more and more difficult to develop and process new chemlical compounds. This will not present a great prob- hII to the large chemical companies with their vast legal staffs. But for the small company, the time and expense offighting the bureaucratic machine.is well as the significant costsof testing, may serve to discourage hiiii froii midertaking the project at all. This isespecially true when lie is not able.to predict the market a particular chemical may have.

We fear that the end result of this bill will be a long-range and insidious effect oil inventiveness and innovation in the American chemical industry. Faced with extensive testing, the burden of pre- market screening, and the rigors of regulation under this bill, development and innova~tion inthe chemical industry will inevitably be curtailed. Althoulgh the above observations are of a general nature, we are specifically concerned about sections 20,21, 23, and 24, and recommend tiat they be deleted from the legislation. We donot,believe that these Eprovisions do anything to improve the legislation but, in fact, could

olised to harass companies regulated byEPA.

Section 20 provides that anyperson maybringa civil action against
a conpany regulated under Nhis act or against the EPA in order to enforcee the act. Further, the bill specifies that.complete costs of the suit, .pls attorneys' and expert witnesses' fees, will be paid. If any individual hias any idea about suing, lie will find an eager lawyer who will bring this case to the.already overcrowded judicial docket. Section 21 provides that any person may petition EPA to issue a rule requiring testing or regulating ofa substance. IfEPA deniesthe petition anti if the petitioner cali show, by a preponderance of the evidence in a de novo proceeding in U.S. district court, that the substance may cause or contribute to an unreasonable risk,the courtmust order EPA to begin the requested proceeding. The citizen petition provision, with itsrequirement.for a trial denovo, will forcethe Fed- eral courts to hear complex, scientific testimony and make technical decisions more appropriately left to an expert regulatory agrency. In essence, the court will be called upon to second-guess the*jiigment of the EPA in areas in which it.has no expertise. Requiring that courts consider and decide technical and scientific factual questions rather than questions oflaw, notonly places an undue burden on the Federal courts but also destroys the purpose for creating EPA as an expert agency. Further, this provision substantially diminishes the agency's ability todetermine itspriorities andchannel itsresources.

Section 23 is entitled "Employee Protection" and would prohibit an employer from disciplining anl employee because that employee may have or is about to issue a complaint with the EPA. Of couse, this means that any time there is an incompetent employee who has been put on notice that he is doing apoorjob, one can anticipate that he willcommence a proceeding against the company. He will,thereby, have the Secretary ofLabor and the Administrator of the EPApro- tecting him until thecase is disposed of-possibly years inthe future. This section, along with section 24, which authorizes EPA to conHeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 515 1976

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duct investigations, issue subpoenas and hold hearings to determine the effects on employment from threatened plantclosing which might be brought about by this act, provide so much potential for harass. ment that we strenuously object to their inclusion in any final legislation. Finally, we note that Section 14(c) of the bill provides that information reported or obtained by the Administrator under this bill shall be made available upon written request of any duly authorized Committee of Congress. We firmly believe that suieh a provision is needed in that both courts and Attorneys General of the United States have traditionally taken the position that disclosure to Congress of"trade secret" information which was statutorily obtained by agencies of the United States Government would be a breach of confidentiality. A clear example of this position is enunciated in the case ofHearstv. Black, 87 F. 2d 68 (D.C. 1936). In thiscase, the Federal Communications Commission was enjoined from turning over to a Senate Committee certain material which the agency was statutorily requiredl to treat as confidential. In the Hearstcase there was no provision similar to section 14(e) ;if there had been Hearst would have had no case. Our position then is that Congress does have the power to acquire information of this sort, but not without the benefit of legislation that specifies that Congress can acquire it. 'he question of inherent authority is a matter forthe courts todetermine.

This provision in thebill raisesan equally important question which the committee chose not to address. That question is: What is Congress' obligation to keep "trade secret" material confidential? This bill recognizes that there is certain information that should be kept confidential by the Executive Branch, but then Congress grants itself

access to this information with no restrictons on disclosuure. We believe thatif Congress grantsitselfaccess to this t1,pe ofmaterial then Congress should establish the internal mechanism&s that would insure that "trade secrets" be kept confidential. Bear in mind that Congress is continually requiring the busines community to turn over highly valuable and sometimes sensitive material toFederal agencies, and the business community is complying. They are complying because they understand that their trade secret and proprietary data will not be disclosed. If itbecomes painfully apparent tothe businesscommunity that these valuable materials will not be safeguarded, webelieve that this climate ofcooperation will seriously deteriorate.

SAAUEL L. DEVINE. JAMES M. CoiLIx.

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