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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 cost estimate of the Congressional 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

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408

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 1976
94TH CONGRESS HOUSE OF REPRESENTATIVES { REPORT

Ed ,Seasion -No, 94-1341

TOXIC SUBSTANCES CONTROL ACT

JULY 14, 1970.-Ordered to be printed

Mr. STAGGERS, from the Committee 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 testing and 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 the bill

and inserts a new text which appears in italic type in the reported

bill.

PURPOSE OP TimE LEoISlATION

lie Committee bill takes a major step forward in providing urgently

needed a tithority to protect health and the environment from dangeroils celmiIvals. It accomllp1ishes this in a nutmber of ways. For example,

through its testing and preliarlket notification provisions, the bill provides for the evaluation of the hazad-causing potential of new chemnicals before coinlmercial intodilm ti on begins. ThI its, in addition to the

authority to take action against a cheminteally-caused harit after its occr'elnce, there will be alithority to prevent such harim from occurring.

Fart her, iniaTil fact||rers and roeessors of potentially hazardous cleticals already on the market may be required to test then to deterime

their effects l heitalt and the environment, ad action can be taken

against, chemicaIls discovered to be unreasonably haza rdotts. In addition, the bill provides for the collection of i;iformation regarding

conummercially produced Cl chemicals so that the total exposure to a chemlni79-313 0 - 77 - 27

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cal and its total effect on health and the environment can be 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 of commercial 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 if in 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 or mixture for which there is a reasonable basis to conclude that it causes or significantly contributes

to an unreasonable risk to health or environment.

-Authorize the Administrator to obtain injunctive relief from a

United States district court to protect the public and the environmlent from an immminently hazardous chemical sulbstance or

mixture.

-Authorize .the Administrator to require manufacturers and

processors to submit reports and maintain records respecting their

commercially produced chemical substances and mixtures, to

maintain records respecting adverse health or environmental

effects of such substances and mixtures, and to 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 of chemical substances and mixtures which have been manufactured or distributed in violation

of the requirements of the bill or of rules 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 in the agency rulemaking

proceedings.

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-Provide protection for employees who cooperate in the enforcement of the bill.

-Provide for evaluation on a continuing basis of the effects on

employment of actions taken under the bill.

BASIS FOR TilE LEoISIrATION

Chemicals have become a pervasive and enduring part of our environinent. They are in our ar, our water, and our soil. They are used

in our manufacturing processes, and they are essential components for

consumer and industrial goods. Production and use of chemicals have

surged in the recent past. For example, in the past ten years, the pro;

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. 3 Society reaps enormous benefits from chemicals. However, it

is generally accepted that as the number of chemicals in commercial 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 into the environment with little or no knowledge of their 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 causing birth 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 subst ance. Polychlorinated hiphenyls (PCBs) had been used for forty years and approximately 390,000 tons had been released into the environment before

they were recognized I an enduring environmental poison.0 Unfortuintely, such recognition camie too late t, prevent contamination of such

major water systeis as the Great Lakes and the Hudson River.

As the preceding examples indicate, it is often many years after

ex)osure to a harmful chemical before the effects of its'harm become

visible. By that time it may be too late to reverse those effects. As

indicated,'hundrds of p(oplc may have been exposed to a carcinogen

or an entire river system mn have been polluted.

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

.'ixthl .A ii norit Rrport, Council on Environm en al I'oli'y, 1. 23 (1075).

ToJIP SiiI" , x s Conell on Envirnnnientil Quality. p. :1 (1975). A ci'iie of Fedcra? .Itcn'irs Conecrrntlf , Rlceled Ifigh 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 e licoff. .J.. "Arsllos Criteria ])oi'niient Ilighliltghs," Amerlean Sociely of Safety Eniglineers ,Jilrnal . 1. 261 tMiireh, 11174). 0 "i.fec(tq of Chronicle ,Nxposure to 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 60 to 90 per cent of all cancer is believed to be environmentally 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 the unborn child, and another G0% of

birth defects are believed to be due to a combination of environmental

and hrereditary factors.2

Because diseases caused by environmental factors such as chemicals

are often not susceptible. to direct medical cure, there is an urgent need

to prevent such chemically caused harm. The Department of Health,

Education, and Welfare's Forward Health Plan stresses such prevention, stating:

In recent years, it has become clear" 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 the ulnlerlying causes of lisease rather

than at the disease itself-at controlling cigarette smoking, alcohol abuse, and exposures to toxic chemicals in the environInent. than at the diseases which they cause."

Silrilarly, the environmental harm caused by chemicals, like health

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 of chemicals 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 study by the National Cancer Institute 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 ca lvcer. ,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 a by-product of a manufacturing process has led to the conclusion that BOME is a highly potent carcinogen. 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 ifidustrial uses of chemicals.

Because of the lack of testing 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 a chemical is harmful, such a method is also a grossly 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 of workers, Other kinds of hazards, 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 be linked to'the chemical.

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 of using the population as guineI pigs or doing without the benefits provided bv the increasing use and levelopnent of chemical prodnets. The vali(ity of applying animal test. results to man is now firmly based upon empirical evidfence and thus such results provide an invaliable tool for predicting human health effects. Further, major methodological advances are occurring with respect to improving testing and

monitoring methods for assessing the long-term effects of a chemical.

For example, methods for detecting low levels of carcinogens in the

environment have increased significantly in both accuracy and reliability, and it is now possible to detect concentrations of polynuclear compounds at I part of an indiidual compound per billion as oppose d

to the 1959 sensitivity standlard of 100 parts per billion. Analytical melhodls have improved as well. Illustrative is the salmonella test dev'eloped by Dr. Bruce Ames of the University of California, 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

l Hearings 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 for regulation

(e.g., the Clean Air Act, the Federal Water Pollutiofi Control Act, the

Occupational Safety and Health Act of 1970, and the Consumer Product Safety Act) conspicuous gaps exist in the protections provided by such laws. Most significant among the deficiencies are the following: (1) In general, such laws provide 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 be cumbersome or inefficient.

(3) No authority exists for collection of data to determine the

totality of human and environmental exposure to chemicals.

An example of the deficiency described in paragraph (1) is the fact

that there is presently no authority to require manufacturers of potentially 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

of the 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 to occur.

Intelligent standards for regulating exposures to n chemical 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

sources of exposure and the synergistic effects resulting from exposure

to a number of chemicals in reguilating hazardous chemicals was

pointed out by the National Academy of Sciences--National Academy of Engineers'study which stated:

The concept, of total body burden should be the significant indicator of exposure, 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

live in 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 or more 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 does not 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 of harm to the health of

its people and to its environment from the substantial use which is

made of chemicals, and Federal law is clearly 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 the bill is to pro- vide protection of health and the environment through authorities

which are designed to prevent harm.

CONIMIrIrE CONSIDERATION

A 1971 report by the Council on Environmental Quality highlighted 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

of the Administration to the 92d Congress. The Committee's Subcomuittee on Commiierce and Finance held hearinqrs on I lie Administration

bill, and a Senate-passd bill which made substantial amendments to

the Administration bill. After executive session, the Subcommittee repo4ed a clean bill which represented an accommnmodation between the

Admin ist ration and Seniate-passed bills. This bill with certain further a mutdnuents %Vns replortedl by thme full COliillittc(' and pasnsed tile

House by a record vote of 240 to 61. Time did not permit a conference

with thil Senate to work out differences before the adjournment of the

92d Congress.

In the 93d Congress, the Subcommnittee on Commerce and Finance

held hearings on a new bill submitted by the Administration (H.R.

5087) andt a 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 House by a record vote

of 324 to 73. However, the conference with the Senate was unable to

work out differences in the bills in the tine remaining.

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 a new bill, H.R. 10318,

which reflected comments received during the hearings. The Subcommittee reported H.R. 10318 on December 3,1975. The full Committee

began consideration of the 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 functions under 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 its projected 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

SECTI oN-BY-SEcTioN ANALYSs

SECTION 1, SHORT TITLE

Section 1 of 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) of section 2 contains Congressional findings that (1)

humans and the. environment are being exposed to a large number of

chemical substances and mixtures each year; (2) some of these chemical substances and mixtures may cause or significantly contribute to

an unreasonable risk to health or the environment; and (3) the effective regulation of such chemical substances and mixtures in interstate

commerce necessitates the regulation of such substances and mixtures

in intrastate commerce as well.

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The Committee has extended the reach of the regulatory authority of the bill to all chemical substances and mixtures whether in interstate

commerce or not since the size and scope of the chemical 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 commerce may affect commerce in those which are in

interstate commerce, and consequently there cannot be effective regu- lation of the latter without regulation of the former. Also regulation of only those in interstate commerce without regulation of the others

could depress commerce and discriminate against those in interstate

commerce and adversely burden, obstruct, and affect such commerce.

Subsection (b) provides that it is the policy of the United States that

(1) hazardous and potentially hazardous chemical substances and mixtures should be adequately tested with respect to their effect on health

and the environment; (2) such testing should be the responsibility of

those who manufacture or process the chemical substances or mixtures;

(3) adequate authority should exist to regulate chemical substances and

mixtures which may cause or significantly contribute to an unreasonable risk to health or the environment, and to take action with respect

to chemical substances and mixtures which are imminently hazardous;

and (4) these authorities should e exercised so as not to unduly impede or create unnecessary economic barriers to technological innovation while assuring that such chemical substances and mixtures do not

cause or significantly contribute to an unreasonable risk to health or

the environment.

Subsection (c) of section 2 provides that it is the intent of Congress that the Administrator of the Environmental Protection Agency shall carry out the bill in a reasonable and prudent manner, and that

the Administrator shall consider the environmental, economic, and social impact of any action proposed to be taken under the bill.

The Committee intends subsection (c) for the guidance of the Administrator in fulfilling the purposes of the. bill. However, this statement of intent by the Committee, as to the manner in which the Administrator is to exercise. the authorities and fulfill the Administrator's

responsibilities under the bill is not to be construed as a direction to t)he

Administrator to make any statement of findings in addition to those

required by specific provisions of the bill or to involve 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

and merit discussion.

The term "Administrator" means the Administrator of the Environmental Protection Agency.

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The bill grants the Administrator certain regulatory authority over

"chemical substances" and "mixtures" of chemical substances. The

term "chemical substance" is defined in this section to mean any organic or inorganic substance of a particular molecular identity, including a combination of such substances occurring in whole or in part as

a result of a chemical reaction or in nature. The term also includes any

element or uncombined radical.

The Committee recognizes that basically everything in our environment is composed of chemical substances and therefore the definition

of "chemical substances" is necessarily 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 Act of 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, fi rearms, revolvers, shells and cartridges).

Although the language of the bill is clear on itsface as to the

exemption for pistols, revolvers, firearms, shells, and cartridges, the

Committee wishes to emphasize that it does not intend that the legislation be used as a vehicle for gun 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 under the bill are any food, food additive', drug, cosmetic, or device when manufactured, processed, or distributed in commerce for use as a food, food additive, drug, cosmetic,

or device. As used in this exclusion, the terms "food", "food additive",

"drug", "cosmetic", and "device" have the same meaning as is given

them by section 201 of the Federal Food, Drug, and Cosmetic Act. The

intent of the Committee in excluding these items is to exclude from

coverage under the bill items which may be regulated under the Federal Food, Drug, and Cosmetic Act. 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 does not come within the definitions in that

Act, it is not the intent of the 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

above an exclusion of "any substance produced for research and devel,

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opment purposes and intended only for use in or on any such food,

drug, cosmetic, or device". It was stated that the intent of the amendment was to make it clear 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 of drugs and which do not necessarily become ingredients of the

drugs in their final dosage forms would not be subject to regulation

under the bill. The amendment was withdrawn with the understanding that the definition of the 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 is not included in that definition

and thus not subject to regulation under that Act, such item should be

subject to regulation under the bill.

The definition of "drug" in the Federal Food, Drug, and Cosmetic

Act includes "articles intended for use as a component" of substances

included in the definition of "drug". As used in that Act, the term "component" does not mean only an item which may be identified as an

ingredient of a drug in its final dosage form. Component includes any item used in the production of the drug. Thus, precursors, intermediates, and catalysts intended for use in the production of drugs in their

final dosage frm are "drugs" within the meaning of the Federal Food,

Drug, and Cosmetic Act.

Further, the Federal Food, Drug, and Cosmetic Act clearly covers

drugs during the "investigation" or research stage. Consequently, the

definition of "drug" in that Act includes chemical substances used for

drug research and development. The same is true of the definitions of

food, food additives, and cosmetics.

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 for use as a plant regulator, 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 of the purposes described in the definition of the term "pesticide". 3uch substances would be subject to regu- lation under that Act and? by virtue of the exemption for pesticides,

are exetopted froni regulation under this bill.

The exclusion from the definition for any pesticide, food, food additive, drug, cosmetic, or device ;s conditioned upon its being nmanufaclured or (list ribluted in commerce for use as a pesticide, food, food additive, drug, cosmetic, or device. Such a condition is necessary because

some chemical substances and mixtures which can be used as 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 also used as a mordant in dyeing and 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 as a flame-retardant be regn- lated under the Federal Insecticide, Fungicide, and Rodenticide Act.

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The Committee bill assures that the exemption will extend only insofar

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 and thus is subject to regulation under

the Federal Food, Drug, and Cosmetic Act or the Federal Insecticide,

Fungicide, and Rodenticide Act.

Although the term chemical substance excludes mixtures of cheniical substances, mixtures are not excluded 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 for them. Consequently, it was neceasary

to establish chemical substances and mixtures as two separate identifiable terms.

The term "mixture" is defined to mean any combination of two or

more chemical substances if ti combination does not occur in nature

and is not, in whole or in part,, the result of a chemical 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 of the chemical substances comprising the combination

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 a mixture rather than a chemical substance.

The inclusion of such reaction-produced combinations within the

definition of mixture is necessary to prevent disparate treatment of

identical combinations simply because of the number of steps used in

the production of the combination. For example, a soap product may be manufactured by combining cononut oil soap, sodium tri-poly phosphate, sodium sulplhate, and sodium bicarbonate. When combined,

these four inrredients do not react chemically. Trhus if a manufacturer

combined the four ingredients, the resulting combination would clearly

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 products would be identical, and they should

ba subject. to identical treatment under the bill. The Commitepr definition assures that they will be.

The terna "environment" is broadly defined to include 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" means to import, produce, or manufacture.

As a result. imnported chemical sulstances and mixtures will be subject to r.'rulation in the same manner as domestically produced chemical substances and mixtures are. In addition, importers of chemical

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substances and mixtures will have the same responsibilities and obligations as 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 of the Committee that

there are activities incidental to tihe end use or storage of certain 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 applying to manufacturers.

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 of the reaction. Thus, such a person would not

be subject to the notification requirements of section 5 even 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 inanufacturers must comply would fall upon the manufa(turer of the substance

or mixture from which the byproduct is produced.

For example, there are certain combinations of substances, such is

adhesives, paints, inks, and drying oils, which during storage or upon

end use, when exposed to environmental factors such as air, 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 it chemical 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 is not

included on the inventory compiled under 'ection 8(b). Substances

which occur incidentally to the storage or use of such combinations

should be considered as byproducts 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 of the 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 the probability that harm will occur and the magnitude and severity o~f that harm agains the effect 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 anil to the cost to society of proposed

regulatory action on the availability of such benefits. Because a monetatry valuet often cannot be assigned to a benefit or cost, such an analysis would not be very useful.'

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 to an unreasonable risk by a lesser probability of a greater harm as well as by a

greater lrobability of a lesser harm.

Although the standard for defining the regulatory authority of the

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 depriving the public of the benefits of a substance or mixture

subject to the rule. This is because such a rule does not prohibit the

manufacture, processing, etc., of existing substances or of mixtures. At

the most a testing rule nay, through section 5(d), delay the Comnerccial availability of new 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 of substances pending the development of information) 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 of the imposition of a requirement under section 6 on a substance. Such a requirement

may remove a substance from the market or impose lesser rest rietions

on its availability and such a requirement is not of limited duration.

Thus, the effect on society nav be far reaching. As a result regulatory effect will be of greater significance in a determination of unreasonable

risk for purposes of section 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." Decision Making 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 less than that of action taken under section 6, the requirements

for is determination of unreasonable risk for purposes of section 4 or

5 (g) are less demanding.

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.

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SECTION 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 testing should be 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

to develop predictive data, and (4) in the case of a mixture, the effects

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

and mixtures about which there is a basis for concern, but about which

there is inadequate information to reasonably predict or determine

the effects of the substance or mixture 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 to an unreasonable

risk. Such a finding requirement would defeat the purpose of the section, for if the Administrator is able to make such a determination,

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regulatory action to protect against the risk, not additional testing, is

called for. However, the term "may" as used in the phrase "may cause

or significantly contribute to" does not permit the Administrator to

make a finding respecting probability of a risk oil the basis of mere

conjecture or speetfation, i.e., it may or may not cause a risk.

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 that it enters or may reasonably be anticipated

to enter tihe environment in substantial quantities or there is or may be

significant or substantial human exposure to the substance or mixture,

(2) there are insufficient data and experience upon which to determine

or predict the effects of the manufacture, distribution in commerce,

processing, use, or disposal of the substance or mixture, (3) testing is

necessary to develop predictive data, and (4) in the case of a mixture,

the effects may not be reasonably and more efficiently determined or

predicted by testing the chemicalsubstances which comprise the mixture, then the Administrator shall by rule require testing of the substance or mixture.

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 of information indicating that the substance or mixture may be harmful.

In making the finding that there is or will be substantial production coupled with substantial environmental or human exposure to a substance or mixture, the Administrator is not limited to consideration of

sheer volume of production or exposure at a specific point in time. The

duration of the exposure, the level of or intensity of exposure at various periods of time, the number of people exposed, or the extent of

environmental exposure are among the considerations which may be

relevant in particular circumstances.

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

are insufficient data and experience upon which to determine or pre- dict the 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 that experience with a

chemical substance or mixture, as well as test data, may be 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 of chronic exposure to a substance or mixture depending on the

type of suspected harm and the length of experience with such substance or mixture.

The additional finding required with respect to a mixture (i.e., that

the effects which the mixture's manufacture, distribution in coinmerce, processing, use, or disposal may have on health or the environment may not be reasonably and more efficiently determined or pre

dicted bj testing the chemical substances which comprise the mixture):

is also intended to reduce unnecessary or duplicative testing. The

assessment of safety of a mixture may well be based -,.pon the toxicity of particular components, and tests of the entire mixture with its varying component ratios may be unnecessary or unrewarding. At the same

time, the Committee recognizes that there may be instances in which

79.3 1 0 . 77 - 28

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a particular combination must be tested to reasonably evaluate the

effects of the mixture. For instance, the effect of two chemicals, when

combined, may be greater than the sun of the effects of the compo- nents taken independently. The Committee bill does not prohibit the

Administrator from requiring testing of the mixture in such instances.

Contents of testing 2-ule

Section 4(b) (1) requires a testing rule to identify the substance or

mixture for which testing is required, include the standards for the

development of test data, and specify the period of time within which

the testing results shall be submitted to the Administrator. The period specified for conducting the testing and submitting results to the Adininistrator may not be unreasonable.

In determining the standards for the development of test data and the period for conducting the testing, the Administrator is to consider

the relative costs of various test protocols and methodologies. The

Committee recognizes that testing may, in some instances, involve considerable 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, the Administrator should attempt to min.

imize testing costs.

The Administrator is also to consider, in determining the standards

and period for testing, the reasonably foreseeable availability of facilities and personnel for performing testing under the rule. Such consideration 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 testing rule may require the submission of preliminary data prior to the time the final data is to be submitted to the Administrator. As a result, the Administrator may check to insure that the testing data is being developed in a reliable and competent manner in compliance with the

standard for the development of test data. Failure to comply with such standard would, of course, be a prohibited act under section 15.

Section 4(b) (2) (A) lists some of the health and environmental

effects for which a standard for the development of test data may be prescribed. It also lists some of the testing methodologies which may )e l)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

limit the Administrator's discretion since protection of human health

demands that the Administrator not be denied the best, most reliable

data possible. However the Committee does not intend that the Ad- ministrator needlessly require whole animal tests. The Administrator

should consider alternative test methods. With the development of

reliable non-animal tests for l)redicting the long-term effects of chemicals on health, the need for animal test data to determine if a substance or mixture causes or significantly contributes to an unreasonable risk will diminish.

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Before prescribing epidemiology tests, the Administrator is required to consult with the Director of the National Institute for Occupational Safety and Health. Such consultation will enable the

Administrator to acquire the expertise and experience of the 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 of a testing standard.

Who is to eondurt the testing

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 to the

sane testing requirement, the Administrator may permit theni 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 of the 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 of a substance, the

person responsible for manufacturing or processing the substance for

that particular use would be responsible for testing.

A rule under subsection (a) requiring testing of a substance or mixture shall expire at the end of the 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 is entitled to be reimbursed by any person who receives an exemption from the testing requirement based on the data submitted by the

first person.

Procedures for promulgating nrle requiring testing

Section 4 (h) (5) specifies the procedures by which the Administrator

is to promulgate a rule under subsection (a). Such rules are to be

promulgated in accordance with the informal rulemaking procedures of section 553 of title 5 of the United States Code. In addition to the

procedures outlined in section 553, tie Administrator shall give interested persons an opportunity for the oral presentation of data, views,

or arguments, as well as an opportunity to make written submissions.

A transcript shall be made of any oral 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) of subsection (a).

Exemptions froin. ries requsrhng testing

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 of the Administrator that

the chemical substance or' mixture (including any contaminant in the

substance or mixture) with respect to which the application is submitted is equivalent to the substane or mixture for which test data has

already been submitted or for which test data is being developed, and

that testing and submission of data by the applicant would be

duplicative.

The person granted the exemption must, if the exemption is granted

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 the person 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 in any amount determined under rules of the Administrator. 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 of the specific situations which may arise. An order requiring reimbursement is to be

considered final agency action.

Public Potice of receipt of test data

Subsection (d) requires the Administrator to promptly publish in

the Federal Register a notice of receipt of any test. data submitted pursuant to a rule uider subsection (a). The notice, subject to the provisions of section 14 (relating to confidentiality) shall identify the substance 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 of the test

datal developed. Unless it is )rotected from disclosure by section 14,

the data shall be made available by the Administrator for examination

by any person.

Priorities for te8ting

Subsection (e) establishes an interagency committee to make reconimnendations to the Administratr regarding what chemical substances

and mixtures should he considered priority candidates for the issuance

of a testing rule under section 4(a). The committee is to be 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 of Environimental 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 Commerce be selected from the National Oceanic and Atmospheric

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drawn, the Committee intends that the representative from the Department of Commerce be able to share with the interagency committee the particular expertise and knowledge found in NOA respecting

chemical substances and mixtures and their presence in, relationship

to, and effects on the oceans and the atmosphere.

The interagency committee is to submit its 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 to he 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 or a regional office of the Administrator.

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 to he made available to the public.

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 suhasf ance 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 taking other necessary regulatorv action to protect the public from potentially dangerous chemical 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 of new chemical substances must give 90 days

notice to the Administrator prior to such mapufacture of the new

chemical. *iinilarly, any person who inteuds to manufacture or process

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for commercial purposes an existing chemical for a use which the

Administrator has determined, by rule, constitutes a significant new

use of the chemical must provide'90 days notice to the Administrator

prior to such manufacture or processing. Notice must include information respecting the substance, its chemical 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 to review and evalunte information respecting the substance to determine if manufacture or processing should be restricted or delayed under the authorities

in this section or other sections of the bill because the substance may

be hazardous.

For example, in the case of a substance for which there is inadequate 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 to an unreasonable risk, the Administrator can in section 5 (g), through court order and rulemaking, delay the manufacture or processing of the substance pending the develop- ment of such information. 'rihe provisions of section 5 reflect the Committee's recognition that tile most desirable time to determine the

health and environmental effects of a substance is before commercial

production begins. Not only are human and environmental harm

avoided or alleviated, but the costs of any regulatory action in terms of

loss of jobs and capital investment are minimized.

Notifiration for Manujacture of New Chemical Substance8

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 of subsection (i). If a rule requiring 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- ning such manufacture.

Chemical 8ubstaneos for a &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 new use of such

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 a testing rule in effect under section 4 to submit test data for such 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 use of an 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 of humans or the en- .vironment to such substance, and the extent to which such use increases the magnitude and duration of exposure of humans or the cnvironment to the 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 not be made in an arbitrary manner.

By limiting the notification requirements for existing chemical 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 use unless 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 of the 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 the basis that the use is new. However, because of the 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 for a different use present additional health or environ- mental problems and consemuently there should be notice of the intent

to manufacture it for such different use.

Llited Chemical Sigubtanes

Within twelve months after the effective date of the bill, the Administrator shall, by rule, compile a list of chemical substances the manufacture, processing, distribution in commerce, use, or disposal of which (or any combination thereof) the Administrator finds causes

or significantly ontributes to or may cause or significantly contribute

to an unreasonable risk. At the same time, the Administrator shall

identify those uses of 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 to time.

Under subsection (c) before a person may- (1) Manufacture a listed chemical substance which was a new

chemical substance at the time of publication of the 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 90 days before such manufacture or processing, health and safety

data respecting such substance must be submitted to the Administrator

asprovided in subsection (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 to be kept

of any such oral presentation.

Suhmission of Teat Data

Subsection (d) describes the instances in which a person subject to

a notification requirement respecting a chemical 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

waive compliance with the notice requirements.

Under subsection (d) (1) if a testing rule under section 4 respecting it substance 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 for the substance may not manufacture or process such substance until ninety days after submission of the

test data required by such rule.

Even though a person has been granted an exemption from the testing rule under section 4, such person is prohibited from manufacturing or processing such substance until ninety days after the submission

of the test 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

notice required by section 5, the Administrator may promulgate 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 of a chemical substance and is not required 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 to the Administrator data

respecting such substance which such person believes shows that-

(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 contribute to 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 of such substance.

Data submitted under subsection (d) (1) or (d) (2) is to be made

available, subject to section 14, for examination by interested persons.

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Extension of Notive Period

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 of not to exceed

ninety days. Notice of an extension together with the reasons for

it shall be published in the Federal Register and shall constitute final

agency action subject to judicial review.

Content of NotUce8

Under subsection (f) (1) the notices required by subsections (a),

(b), and (c) respecting the manuacturing or processing of a chemical substance are to include the following: (1) the name of the substance; (2) insofar as reasonably ascertainable, (A) its chemical 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 of the substance to be manufactured or processed; and (4) test

data in the possession or control of the person giving the notice which

relate to the health or environmental effects of the 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 for examination 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 or data has been submitted under subsection

(a), (b), (c), or (d), (2) identifies its uses or intended uses, and

(3) if data has been submitted, describes the nature of the tests per- formed and the data developed. Such a notice is to be published not

later than five working days after the date of the receipt of the 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.

Reguiation Pending Development of Infornation

There will be instances in which the Administrator will have insufficient 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 to be manufactured or proc- essed for a significant new uy.!, or a listed chemical substance). The

Administrator may determine that without such information the substance, because of the proposed volume of production of such a substance, the nature or extent of the human or environmental exposure which may be expected, the similarity with substances known to be

associated with an unreasonable risk to health or the environment,

or other relevant factors, may cause or significantly contribute to such

a risk.

Subsection (g) provides the authority under which such a chemical

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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 proce ss 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 of the United States for the issuance of an

injunction to prevent the manufacture, processing, or distribution

in commerce of such substance. The district courts are granted jurisdiction to grant such an injunction if the court 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) for the issuance of an injunction totally supplant the

traditional elements which a party ordinarily must show before a court

will exercise its equitable jurisdiction to grant an injunction. The Coln.

mittee does not intend that the Administrator he required to make any

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. National Conm iqsion on Egg Nutrition (517 F. 2d 485 (7th

Cir. 1975)). Application of any other standard by the court will

frustrate the purposes of the section.

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 or prohibitions, labeling or disposal

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 and is not to he construed as imposing upon the Administrator

the duty to imake any of the findings contained in section 6 or to meet

any ot]er requirement of that section other than the procedural requirements of section 6(c) (2) and (3) The proceeding is to be conducted in accordance vith the 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 of the conclusion of the hearing.

Subsection (g) (3) permits any person to petition the Administrator to initiate a proceeding to amend or repeal a rule issued under

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ation of the health or environmental effects of the substance 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) of section 6(c) for the amendment

or repeal of the rule. It should 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 the proceeding.

Petition for 'Standards for tMe Developnent of Test Data

Under subsection (h) a person intending to manufacture or process

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 for the 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. This provision is included primarily to assist persons intending to manufacture or process a listed cheiical substance for which

test. data is required by subsection (d) and to assist persons 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 Administ rator's technical staff

to obtain guidance respecting the testing of the substance. Only if

such consultation fails to be productive should a petition be necessary. Of course, the Administrator could issue a rule requiring testing of a

substance under section 4 even though the Administrator had previ- ously prescribed a standard for the development of test data in response to a petition under subsection (h).

Exemptions

Subsection (i) prescribes the situations in which a chemical substance may be manufactured or processed without regard to the notice

and test data submission requirements of subsections (a), (b), (c),

and (d).

Paragraph (1) provides the authority for an exemption with respect

to the manufacturing and processing of a chemical substance for test

marketing purposes. To obtain such an exemption an application must

be submitted to the Administrator. The application must satisfactorily demonstrate to the Administrator that the manufacture, processing, distribution in commerce, use, and disposal for test. marketing purposes of the substance for which the application is submitted will not

cause or significantly contribute to any unreasonable risk to health or

the environment. Such an exemption may be granted upon such restrictions as the Administrator considers appropriate. The Administrator

is to act upon such an application within 45 days of its receipt.

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Under paragraph (2), an exemption from the test data submission

reqiiremients of subsection (d) (2) may be obtained for a chemical substance which is equivalent to a 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 that submission of data would be

duplicative. If an exemption is granted under this paragraph during

the reimbursement period for the previously submitted data, then the

person who submitted such data is to be r-eimbursed by the person

receiving the exemption for a portion of the cost, incurred in developing such data. The requirements of section 4 respecting reimbursement

also apl)ly to reimbursement provided under this paragraph.

Subsection (i) (3) specifically exempts from the notification requirements of subsections (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) for scientific experimentation or analysis or for chemical research or analysis, including research and analysis for the development of the substance

or another chemical substance 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 or processor has reason to believe may be associated with

the substance.

The exemption is necessary to insure that research and innovation,

both academic and commercial, is not. 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 for the researcher will be able to provide tie substance to the researcher without having to wait the ninety days required by the notification period. Furtl ir, researchers working for

a manufacturer trying to develop a product may need to make several

changes in the substance. It would be unrealistic to require that the

Administrator be notified 90 days in advance of each 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 a manufacturer

the opportunity to evaluate time )hysical, chemical, )roduction, and

performance characteristics of the substance. Since the exemption applies only to substances manufactured or processed in small quanti- ties and since the research and analysis will be supervised or conducted

by technically qualified individuals and since all the individuals exposed to the chemical substance will be made aware of potential health

effects there should not be any unreasonable risk to health presented

as a result of the exemption.

In limiting the exemption to chemicals manufactured or lrocessed

in "small" quantities, your Committee recognizes that the term "small"

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cannot be viewed in an absolute sense. The amount of the chemical

substance which must be manufactured or processed for research and

analysis may vary in relationship to the kind of use for which the

chemical substance is being 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 of grams, while textile fibers or paper processing haterials may have to be manufactured in much greater quantities in order to be 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 for the costs of the substance does not necessarily signal the

end of the development period. So long as the purchaser is continuing

the research and evaluation of the substance by individuals technically qualified to analyze and evaluate the physical, chemical, and performance characteristics of the substance, the exemption continues to apply. Again, such technically qualified individuals would be made aware of

potential health and environmental effects. However, the exemption does not permit the use of 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 of a 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 subject to the notice requirements of subsection (a).

Paragraph (5) authorizes the Administrator, upon application, to

issue a rule to exempt the manufacturer of a 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) of section 6 (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

not intend to restrict coverage to substances manufactured or processed "for sale". Any commercial purpose, such as use as a chemical interMediate in a manufacturing process, is sufficient to bring the 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 to the mixing process or upon storage of a 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 not manufactured for commercial purposes per so it would not be subject to the notification provisions of this section.

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SECTION 6, REGULATION OF IAZARDOUS CHI1CAL SUBSTANCES AND

MIXTURES

Section 6 empowers and directs the Administrator to take action

to protect the public from l.azardous chmeical substances and mixtures.

Such action shall be taken against existing chemical substances, new

chemical substances, and mixtures when the re is a reasonable basis

to conclude that the substance or mixture causes or significantly contributes to or will cause or significantly contribute to an unreasonable risk.

Scope of regzdlation

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 of a 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 risk to 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 not fie possible. and the bill does not require it. Such uncertainty

is particularly likely to occur true when dealing with the long term

or chronic effects of a substance or mixture. For example, 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 not become

apparent until generations have passed. When, as here, regulatory

action is intended to be taken to prevent the occurrence of harm in the

future as well as protect against presently visible harm, such action

often must be based not only consideration of facts but also on 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 as to the threshold levels of causation. 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 of a "finding of fact"

of the sort associated with adjudication.

(82)

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The term "significantly contribute to an unreasonable risk" is used

throughout the bill. The Committee has used such term because it

recognizes that an individual substance or mixture may not be the sole

identifiable factor which may cause an unreasonable risk. Because

of the multiple avenues by which humans and the environment are exposed to a substance or mixture and because 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 a substance or mixture which is only a con- tributing factor to an unreasonable risk. The bill specifies that the

contribution be significant, for the Committee does not intend to authorize action against a contributing factor which is only de minimus.

However, the Committee recognizes that in many instances it will be

impossible frn. the Administrator to show the quantity of contribution

to a particular risk made by a particular substance or mixture, and the

Committee does not intendt that the Administrator be required to do

so in such situations. Nor does the Administrator have to show that

a substance or mixture is the 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,

of course, apply whenever the phrase is used in the bill.

A section 6(a) rule may consist of any one or more of the following: (1) a requirement prohibiting the manufacturing, processing,

or (listribut ion in commerce of the substance or mixture or limiting the anount of such substance or mixture which may be manufactured,

processed, or distributed in commerce; (2) a requirement prohibiting the manufacture. processing, or distribution in commerce of the substance or mixture for a particular use or prohibiting the manufacture,

processing, or (listribution in commerce of the substance or mixture

for a particular use in excess of a specified level of concentration; (3)

a requirement limiting the amount of the substance or mixture which

may le manu factured, processed, or distributed in commerce for a

particular use or a particular use in a concentration in excess of a spec- 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) a requirement tlt the manufacturers

an(d processors of the substance or mixture make and retain records

of the processes used to manufacture o process the substance or mixture; (6) a requirement regulating the manner or method of disposal of the substance, mixture or any article containing it by its manufacturer, processor, or by any commercial user; and (7) if a 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 to the public. The Committee recognizes the inherent interests of the States and political subdivisions resl)eeting disposal of

hazardous chemicals within their jurisdiction. 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 the bill authorizes the Administrator to prohibit or limit the

distribution in commerce of substances or mixtures and to prohibit

or limit the distribution in commerce of substances and mixtures for

a particular use, such authority does not authorize the Administrator

to regulate the manner or method of transporting 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 intent to grant the Administrator 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 employees in the workplace. For example, by prohibiting the manufacture of a substance, risks to employees involved in the manufacturing of the substance would be eliminated. However, the Committee 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 be exposed or the

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 practices in hazardous operations, or procedures for emergency situations.

Such direct regulation of the workplace falls under the jurisdiction of the Occupational Safety and Health Act of 1970 not under this 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 of the 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 of control 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 to specified geogral)lic areas.

Protection aqainst adulterated orm contaminated substances and

mixtures

Subsection (b) of section 6 authorizes the Administrator to take

action to prevent the adulterat ion or contamination of substances 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 - 29

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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

of the relevant quality control l)rocedures. Further, if after a hearing

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 or environment.

Considerations in prom ulgatihg seetion 6(a) yules

Section ((c) requires the Administrator to consider all relevant

factors in pronulgating any rule under subsection (a) respecting a

sul)stance or mixtur'e. Findinigs must be made with respect to the effects

of the substance or mixture on health and the magnitude of human exposure to the substance or mixture, the effects of the substance or mixture on the environment and the magnitude of environmental exposure,

the benefits of the substance or mixture for various uses and the availability of other substances or mixtures for such uses, and the reasonably ascertainabl, economic consequences of the rule taking into

account the impact on small business. In making the finding respecting

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

and the rule's effect on technological innovation, the environment, 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 or proscription will have on the developnment and use of substitutes as well as the

negative impact on the manufacturer or processor of the regulated

substance, Likewise, the economic savings to society resulting from the

removal of an unreasonable risk -must le a key ele-ment in any considerat ion of economic consequences. The Comnmittee does not 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 if it were not permitted to 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 it sufficient 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 to take action under the bill rather than under such

other Federal law. 'Ihe fact that a risk could be subject to regulation

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under one of the other Federal laws administered by the Administrator

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 Administrat or is to take into consideration all aspects of the 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 under other laws

should include consideration of the time and resources needed to take

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 is publicly enumerated. Section 553 of title 5, United States

Code, which would otherwise solely govern the promulgation of such

a rule, requires that an agency incorporate in any rule adopted a concise general statement of its basis and purpose. By requiring such findings, the Committee is emphasizing that those key considerations

enumerated in subparagraphs (A), (B), (C), and (D) of subsection

(e) (1) will be addressed in such a statement of basis and purpose. The

findings need not be. detailed or voluminous, nor does 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 promlgatilng 8ection 6(a) ruics

Hules under section 6(a) are to be promulgated pursuant to the

procedures of section 553 of title 5 of the United States Code, except

that the Administrator is required to give interested persons an op- portunity for the oral presentation of data, views, or arguments, and

in certain instances an opportunity for cross-examination must be

provided.

If the 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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& 37

their interests, and (2) to be required for a full and true disclosuw'e

with respect, to disputed issues of material fact. By limiting the crossexamination to disputed issues of material fact, the Committee intends,

to limit cross-examination to those issues characterized as issues of

adjudicative fact the truth or falsity of which is subject to evidentiary

proof and which could reasonably b~e expected to affect the 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 of the large number of persons 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 or siuiular interests and provide

for their rel)resentalt ion by a single representative. Further, the Administrator may determine to conduct such cross-examination on behalf of such a group. If a person who is a member of a group is unable

to agree upon group representation, the person 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 presented by the group representative.

It was the ]'dgment of the Committee that more effective, workable

and meaningful rules will be promulgated if interested persons do have

the opportni ty to make oral presentations, and where appropriate

end necessary, 'have an opportunity to conduct 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 for the conduct of oral 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 of participants 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 to provide 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 if the economic interest of

the, pers-on is small in comparison to the costs of effective participation

by that person in the proceeding or if the person demonstrates to the

satisfaction of the Administrator that the person does not have sufficient resources to participate in the proceeding in the absence of compensation. In determining if a 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 of the

issues and whether representation of such interest will contribute to

widespread public participation and to representation of a fair balance of interests for the resolution of the issues.

In determining whether compensation should be provided and the

amount of such compensation, the Administrator shall take into account the financial burden which will be incurred as a result of participation. However, the Committee does not intend to imply that in all

instances a person must be able to demonstrate a financial burden

before the Administrator may provide the person with compensation.

Demonstration of financial buirden is required unless a person has an

economic interest which is small in comparison to the costs of effective

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 to be incurred,.the Administrator should

not look solely at the costs of participating in the section 6 proceeding, but should instead view such costs in light of the 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 or limited because of a commitment of resources to the proceedingz with respect to which such request made and

the Administrator should consider such information.

A determination of reasonable 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 is not relevant to any

computation of the rate of compensation under the bill. 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. As the court stated in Miller v.

Amuemenwnt Enterprise8, Inc., 426 F. 2d 532, 538-539 (5th Cir. 1970):

What is required is not an obligation to pay attorneys' fees.

Rather what-and all-that is required is the existence of a

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 on other grounds, sub nom. Alyeaka Pipeline Co. v.

Wildernes8 Society, 421 U.S. 240 (1975), and National Treasury Emplo'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

a fee also apply to those sections.

Effective date of 8ection 6 (a) rules

Subsection (d) states that the Administrator is to specify in any rule under subsection (a) the (late on 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 in the Federal Register. If the Administrator determines that the

manufacture, processing, distribution in commerce, use, or disposal of

a substance or mixture subject to the proposed rule is likely to result

in an unreasonable risk of serious or widespread harm to health 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 its publication in the Federal Register. However, if the proposed 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 to the risk before the 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, or distribution in commerce of a substance or mixture, that

the Committee required an action be brought under section 7

(imminent hazard) to have a Federal district court find that the substance or mixture is an imminent hazard. However, because the Committee recognizes the difficulties in bringing such an action against all

persons who may be engaged in the manufacture, processing, or distribution of a 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 article under seefion 7. Once a court finds an imminent hazard in the action under section' 7, a banning rule of general applicability may then be made immediately effective with respect to

all others.

If a proposed rule is made 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 (late of receipt of the request for the

hearing, unless the Administrator and the person making the request

agree upon a later date. The hearing must be conducted in accordance

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with the procedures set out in subsection (c) (2) and (c) (3). After the

hearing is concluded, the Administrator must within ten days, either

affirm, modify, or revoke the rule.

SECTION 7, IMMINENT IHAZARD

Section 7(a) grants the Administrator authority to bring 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 Administrator has not used 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, the Administrator must bring an action under section 7. The Committee has 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 also bring 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. For example, section 7 authorizes the seizure

of imminently hazardous substances, mixtures, or articles containing

them, and under section 7 the court may require the recall, repurchase,

or replacement of imminently hazardous items in addition to any

other relief necessary to protect health or the 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 of the risk to the 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 to venue, service of process, and consolidation.

Subsection (d) provides that 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) the Administrator may direct attorneys of the

Environmental Protection Agency to apear and represent the Administrator in any action under this section.

Subsection (f) defines the term "imminently hazardous chemical

substance or mixture". The term means any chemical substance or mixture which causes or significantly contributes to an imminent and unreasonable risk of serious or widespread harm to health or the environment. 'Such a risk shall be considered imminent if it is shown that

the manufacture, processing, distribution in commerce, use, or disposal

of the substance or mixture or any combination of such actions is likely

to result in such harm to health or the environment before a final rule

under section 6 can protect against the risk. Such protection would

not necessarily occur upon the effective date of a rule under section 6.

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Instead, consideration must be given to the time it may take to impleinent and enforce such a rule.

It should be noted that. while the unreasonable risk of harm must

be imminent, the physical manifestations of the harm itself need not

be. An imminent hazard may be found at any point. in the chain of

events which may ultimately result in damage to the health or environment. The observance of harm is not essential to establish that an imminent hazard of such occurrence exists. Obviously, action under the

section must be able to occur early enough to prevent the final injury

from materializing.

SECTION 8, REPORTING AND RETENTION OF INFORMATION

Subsection (a) of section 8 authorizes the Administrator to promulgate rules under which each person (other than a small manufacturer

or processor) who nmanufactures or processes or proposes to manufacture or process it chemical 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 to the extent the Administrator determines is necessary for the effective enforcement of the bill. 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

respect to other manufacturers or processors.

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 of all such changes unless such changes could affect health 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

to the effective enforcement of the bill. - The Administrator must promulgate rules to obtain the information necessary to compile the list of existing chemical substances reHeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 448 1976
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uired under subsection (b) not later than one hundred and eighty

ays after the effective date of the bill.

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 report or insofar as reasonably ascertainable; the categories or proposed

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 of the amount

of the substance or mixture to be manufactured o' l)rocesse(l for each

category or proposed category of use; a description of the byproducts

resulting from the manufacture, processing, use, or disposal, insofar as known to the person making the report or insofar as reasonably

ascertainable; all existing data concerning the adverse environmental

and health effects of such substance or mixture, insofar as known to the

person makin g the report; and estimates of the number of persons who

will be exposed to the substance or mixture in work places and the duration of such exposure, insofar as known to the person making the

report. Information should be considered reasonably ascertainable if

the manufacturer or processor required to obtain 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 a time-consuming and resource-consuming undertaking. Under section 3503 of title 44 of the 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 is obtained with a minimum of burden 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 of the chemical components, it would 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 of the chemical industry in developing proposed rules for 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 of unnecessary 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, the Administrator may by rule require a small manufacturer

or processor of a chemical substance to submit information respecting

the substance to the Administrator for purposes of compiling 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, if relief has been 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 is to be held to a minimum. At the same

time the Administrator will not be denied information necessary for

determining whether to promulgate a rule under sections 4, 5, or 6 or

necessary for the enforcement of such a rule or an order issued in an

action brought under section 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 take into account such relevant

factors as the number of employees, 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 of such production by others, and

whether a company is independently owned and operated. In the case

of a company which is owned or controlled by another company, such

factors are to be applied to both companies.

Subsection (b) requires the Administrator 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 to determine

if a chemical substance is a "new" substance subject to the premarket

notification requirements of section 5. The Administrator is to initially

publish the inventory within one year after the effective date of the bill.

Subsection (b) provides that the inventory shall at least include each

chemical substance which any person reports under section 5 or under

section 8(a) is manufactured or processed in the United States or was

manufactured or processed in the United States within three years before. the effective (late of the rules promulgated under section 8 (a) for

purposes of compiling the subsection (b) inventory. However, the Administrator. to alleviate reporting requirements and expedite the compilation of the initial list, may wish to utilize reports of commercially produced chemical substances prepared by other governmental offices

and departments, such as the International Trade Commission and the

Bureau of Mines. However, the Administrator may not rely exclusively upon such reports, but must give manufacturers and processors the

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opportunity to report substances manufactured or processed 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 the inventory, a manufacturer may report substances whicli are produiced only intermittently but which are a part of the manufacturer s product line. Many manufacturers, particularly those who produce in batch lots, may not be

currently producing the full range of substances they customarily offer.

Howeve', so long its the manufacturer has )roduced the substance for

commercial purposes within the three year period (lescribed in section

8(b) (1), the manufacturer should re)ort the substance and it should be

included in the inventory.

Par1-agraph 2 of subihet in: (b) provides that to the extent consistent

with the purposes of this bill, the Administrator may in 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 of section 5. For instance, the Administrator could us 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, or in molecular

weight, molecular weight distribution, chain structure or crystallinity;

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 the proportion of alloyed metals

in iron and steel products and other metal alloys; variations in naturally occurring substances or mixtures (such as crude 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 is electric energy (batteries) ; and salts

which result front time combination of an existing inorganic anion

with an existing inorganic cation.

The Committee realizes that many chemical 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 of categories should be limited to areas where the effects

of such minor niodifications are well understood to have insignificant

health and environmental consequences.

Subsection (c) specifies that any person who manufactures or processes or distributes in coumnierce a chemical substance or mixture or

proposes to engage in such an activity shall, as required by the Adnuinistrator by rule, maintain records of adverse reactions to health or the

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environment alleged to have been caused by the substance or mixture.

The Administrator may require that records relating to the alleged adverse reactions to the health of employees be retained for up to fifty

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 by or for such person or known 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 a study to submit copies of the study to the Administrator.

Subsection (e) requires any person who manufactures, processes, or

distributes in commerce a chemical substance or mixture to immediately inform the Administrator of any 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 of the Administrator is not requirel. The requirement of

subsection (e) is to insure by statute that the Administrator is immediately 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 a substance 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". Thus the provisions of section 8 apply

to persons who manufacture, proceed, or import chemical substances or

mixtures solely for commercial purposes.

SFCTION 9, REhATIONSIIIP 1} OTIOER FEDERAL LAWS

Because other Federal laws to some extent provide for regulation 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 the Administrator. If the Administrator has reason to believe that the manufactu re, 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 by the AdministraHeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 452 1976
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tor, then the Administrator is required to report to the agency which

administers such law a description of such risk. Such description shall

include a specification of the activity or combination of activities

which the Administrator has reason to believe so causes or contributes

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 shall request the agency to which it is made-

(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 it determines it may be so prevented or reduced, 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 time as the Administrator specifies in the request. However, the Administrator must give

the other agency at least ninety days.

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 or significantly contribute to the risk described in the report,

the Administrator may not take any action under section 6 or 7 with

tespect to such risk. AIternatively, if within ninety days of the publication in the Federal Register of the other agency's *response to the

Administrator's request, the other agency initiates action under its

law which is adequate to protect against such risk, the Administrator

is precluded from taking any action under section G or 7 with respect

to such risk.

The requirement that the other agency initiate action is not 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 long as tile other

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) should be deemed

satisfied. However, the provisions of section 9(a) (2) (B) would not

be satisfied by 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 taking action under the bill.

Other laws administered by the Administrator mandate specilic

actions by the Administrator. For instance, the Federal Water PolHeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 453 1976
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lution Control Act establishes a specific timetable within which the

Administrator is to establish eflluent limitations, list categories of

sources, and establish standards of performance for new sources within

such categories. The Committee wishes to emphasize that nothing in

the bill should be construed to relieve the Administrator from complying with any such statutory mandates.

Subsection c) provides that for purposes of section 4(b) (1) of

the Occupational Safety and Health Act of 1970, the Administrator 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 of other appropriate Federal departments, agencies, and instrumentalities 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 of other appropriate departments and agencies to conduct 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 of other agencies 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 the bill. The system Rhall be developed for use by all Federal and other departments and agencies with responsibilities in the area of regulation or study of chemeial substances and mixtures

and their effects on health or the enviromnent. The Committee expects that in developing the retrieval system the, Administrator will utilize

existing Federal data systems to the fullest extent possible. Presently the collection of data on chemicals which may be harmful

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

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regulatory 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 of the major problems 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

sources or through two or more media. As pointed out by the National

Academy of Sciences in its report, Deaeon Making for Regulatin Chemicals in the Environment, it is essential that each agency's standards reflect appreciation of such multiple exposures.' The development of a. comprehensive data system should help make this possible.

SECTION I 11 INSPECTIONS

Subsection (a) authorizes the Administrator or a duly designated representative to conduct inspections for the purposes of enforcing the bill or any rule or order 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 of the premises or conveyance 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 dlat a, 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 1 2, Y 'X'ORTS

Subsection (a) of section 12 provides that with certain exceptions this bill (otlr i Ihan section 8 (relatig to reportilg (1nd rccordkeep- ing)) shall not applY to 'nov chomill i suilbstance. mixtuire, or article

containing a substance or nuixtuNre if it can be shown that such clmial substa nce, nlixture or artic, is being maim fact I Ied. processedc, sold, or held 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 for sale, for use in the Un ited Stat es. Thus., for X01111he, a nmanufacturer facing an enforce lient proce(liiig for ai11- facturing a1 suhstance for doiiesti, use in violation of the bill could

'Dcrdston fMaking for Ucrqvltig hietnfal ino the Enilronnint, (nmcnlitee on Prin. el"Irdc of Dpel Ilon Making for Rii'gilatng Clemienl Ill tle Environment. Enr rmn ental StAdlec Board. Commiion on Nnatural ectsources, Nntional Research Couneil, National Academy of Sciences, p. Ili (July 1975).

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not claim the benefits of the exemption under this section in order

to export the noncomplying 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 for export. 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 or mixture for which

(1) the submission of data is required under section 4 or 5(d), (2)

a rule has been proposed or promulgated under sections 5 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 of the country of destination timely notice of the availability of data submitted under section 4 or 5 or of the

rule, action, or relief under section 5, 6, or 7.

SECTION 13, ENTRYf INTO CUSTOMS TERRITORY OF TilE UNITED STATES

Subsection (a) provides that the Secretary of the Treasury is to refuse entry into the United States of any chemical substance, mixture,

or article containing such substance or mixture if it fails to comply with any rule in effect under the bill, or if it is offered for entry in vio- lation of section 5, a rule or an order under section 5 or 6, or an order is- sued in an action under section 15 or section 7. The Secretary of the

Treasury is required to notify the consignee of any chemical substance, mixture or article which is refused entry. The Secretary is to cause its

disposal or storage if it has niot been exported within 90 days from the date the consignee receives notice of refusal of entry. Of course, the Committee intends that the Secretary consult with the Administrator prior to taking such action. The Secretary may not release to the con- signee any substance, mixture, or article refused entry, except the Seeretary may, pending a review by the Administrator of the entry refusal, release the substance, mixture or article to the consignee on

execution of bond for the amount of the full invoice of the sub3tance, mixture or article together with the duty thereon. The consignee shall be liable to the United States for liquidated damages equal to the full

amount of the bond if the substance, mixture or article is not returned

to the custody of the Secretary of tie Treasury when demanded. The Secretary of the Treasury, after consultation 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 of tremendous competitive, value to the 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 of subsection (b) (4) of that Act. That subsection provides that the mandatory disclosure provisions of the Freedom of Information Act do not apply to matters that are "trade secrets

and commercial or financial information obtained from a person and

privileged or confidential." 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 for protection of health or the environment or for specific law enforcement purposes. Such information may

also be disclosed to contractors with the 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 to the extent practicable without

impairing the proceeding.

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) of section 14 provides that subsection (a) does not

prohibit the disclosure of any health 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, if a

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 the chemical 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 to protect confidential trade secret information respecting the specific formulation of a

mixture. IIowever, the Committee does not intend to prohibit the Adininistrator from disclosing the chemical substances comprising the

mixture by thwir order of quantity in the mixture.

Subsection (b) (2) provides that if a reqist is made under the Freedorn of Information Act for health and safety information obtained

under this bill, the Administrator maiy not deny the request on the

basis of the exemption provided in subsections (b) (3) or (b) (4) of 5

U.S.C. 552. Thus, health and safety information which is not'subject to

the prohibition on disclosure presciril(d by section 14 (a) of the bill is

not exempt from disclosure under subsection (a) of section 552 by I'irtue of subsection (b) (4) of that section. In addition, in considering a

request under the Freedom of Information Act, the Administrator may

not disregard section 14(b)'s specific exemption for health and safety

information from section 14 (a)'s prohibition on disclosure and assert,

that section 14(a) provides it statutory exemption from disclosure, of

such information.

The piurpose of subsection (b) is to clarify that health and safety information is not entitled to confidential treatment either tinder subsection (a) or the Freedomit of Information Act. The subsection should

not be construed to imply that in the absence of such a provision, health

and safety information would be entitled to such confidential

treat ment.

Su)section (c) provides that any person submitting data under the

bill may designate that data which the person believes is entitled to

confiden tial 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 a request un(ler the Freedom of Information

Act, the notice must be given immediately upon approval of the 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 the requirements of this subsection.

The Ad n iistrator may not release the i designated data until the exiration of 30( days after tile persoln submitting tie data has received

the notice.

Stibsection (d) )roviles criminal penilties for officers and ciiiplovees of tile 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

line of il; to $5,000 or both 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 obtai ted by the Admiinistrator in mder the bill shall le made availal)h, upon 1 written request of any duly authorized committee of the

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Congrss to such committee. It is the Committee's view that the inherent authority of Congress, as the constitutionally established legisla- tive branch, assures access to such information, and thus the provision

is not necessary to assure such access. Rather, the provision was included merely to give expression to such power and sets forth procedures for the exercise of the power.

SECTION 15, PROMIBITED ACTS

Section 15 makes it unlawful for any person to fail or refuse to 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 promul gated

under section 4, any requirement prescribed by section 5, or any rule

or order promulgated under section 5 or 0. It also forbids any person

to use for commercial purposes a chemical substance or mixture which

the person knew or had 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 5 or 7. The term used for commercial purposes is intended to

be interpreted broadly to include any use in manufacturing, processing,

or distribution in commerce or any other activity for commercial purposes. Further, the section forbids any person to fail or refuse to establisli or maintain records, submit reports, notices or other information or permit access to or copying of records as required by the bill

or any rule under the bill. In addition, this section forbids any person

to fail or refuse to permit entry or inspection as required by section 11.

SECTION 16, PENALTIES

Section 16 states the penalties for violations of section 15 of the

bill.

Subsection (a) provides that any person who violates a provision of

section 15 shall be liable for a civil penalty of up 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 5 of the United

States Code. The opportunity for a hearing shall be provided by giving

written notice to any person who may be subject to the 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 of the notice, a hearing on the order. Although commission of

one of the acts prohibited by section 15 automatically makes one subject to the assessment of a civil penalty, the Administrator may take

into consideration certain mitiiratinar'circumstances in determining

the amount of the civil penalty. The Administrator shall consider the

nature, circumstances, extent, and trr-vity of the violation. The Administrator shall also consider the ability of the 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

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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 that any compromise, modification, or remission would occur within a reasonable time after assessment of the civil

penalty.

Any person who requested a hearing respecting the assessment of a

civil penalty and who is aggrieved by an order assessing such a penalty may file a petition for judicial review of the order with the United

States (ourt of Appeals for the District of Columbia 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 the Attorney General.

Subsection (b) provides that any person who knowingly or willfully

violates any provision of section 15 shall be subject upon conviction to

a fine of not more than $25,000 for each day of violation or imprisonment for not more than one year, or both.

Under subsection (c) the Administrator is authorized to require any

person who has manufactured, processed, or distributed in commerce a

chemical substance or mixture in violation of a requirement under paragraph (1) or (2) of section 6(a) to give notice of the risk associated

with the substance or mixture. Such person may be required to give

such notice to processors or distributors in commerce and,.to the extent

reasonably ascertainable, to any other person in possession of or exposed to such substance or mixture. Such person may also be required

to give public notice of the risk and to either replace or repurchase the

substance or mixture. The determination that the person has 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 any chemical snbstance or mixture 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 or mixture.

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

rule or order under'section 5 or 6 or to compel the taking of any action

required by or under 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 or mixture shall be liable to be pro- ceeded against for seizure and condemnation. Actions for such seizure

and condemnation may be brought in any United States district court

within the jurisdiction of which such substance, mixture, or article

is found, and the proceedings shall conform as nearly as possible to

proceedings in rein in admiralty.

SECTION 18, PREEMPTION

Section 18 (a) provides generally that nothing in the bill shall effect

the authority of a State or political subdivision to establish or continue in effect regulation of any chemical substance, mixture or article

containing a chemical substance or mixture. However, except as otherwise provided, rules under section 5 and 6 shall preempt nonidentical

State and local requirements respecting the same chemical substance, mixture, or article containing a substance or mixture, if the State or

local requirement addresses the same risk to health or environment

associated with the chemical substance, mixture, or article. Similarly, if the Administrator establishes a testing rule under section 4, no

State or political subdivision may establish or eontinue in effect a testing rule for purposes similar to those for which the testing is required

under section 4.

However, rules under section 6(a) (5) relating to disposal do not pre- empt, any State or local requirements. Further, if a State or local requirement is adopted under the authority of the Clean Air Act or any other Federal law, the Federal rule shall not preempt the State or local

requirement. Thus, for instance, State emission standards, effluent

limitations, or other 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 if a State

limitation, standard, or requirement were adopted, submitted, and

approved as part. of a 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 of the Clean Air Act

or sections 1414(e) or 1424(c) of the Public Health Service Act (relating to safe drinking water).

The Committee recognizes the traditional role of the State and local

governments in providing for the protection of their citizens. As a result in addition to the specific exemptions from the preemption pro- vision, the Committee bill provides a means whereby a State or politi- cal subdivision may seek an exemption from the Federal preemption in order to provide a higher degree of protection for their citizens than

that provided by regulations under this bill. Under subsection (b), the

Administrator mnav by rule exempt from the preemption provisions a

requirement of a State or political subdivision if three conditions are

satisfied. First, compliance with the State or local requirement must

not cause a violation of the applicable requirement under the bill, Second, the State or political subdivision requirement must provide a sig- nificantly higher degrw of protection 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 sets out the procedures for judicial review of rules issued

under sections 4, 5, or 6 of the bill. Subsection (a) provides that peti- tions for judicial review must be filed within 60 days following the

promulgation of a rule under section 4, 5, or 6. Such petitions are to be

filed with the United States Court of Appeals for the District of

Columbia Circuit or for the circuit in which the petitioner resides or

in which the petitioner's principal place of business is located. The subsection contains provisions for filing the record of the proceedings on

which the rule was based. The Committee anticipates that ordinarily a

certified list of the record may be provided in accordance with appli- cable appellate rules of procelure unless the court requests otherwise.

The record means any rule, any transcript required of any oral pres- entation, any written submission of interested parties and any other

information which the Administrator considers to be relevant to the rule and with respect to which the Administrator, on or before the date

of promulgation of the rule, published a notice in the Federal Register identifying the information. Such notice need only list the information; it need not summarize such information.

By so defining the record, the Committee intends that the public be fully apprised of the basis for the Administrator's action. The Administrator should include in the record those documents in the Adminis- trator's possession which are of material relevance to the rule, including, of course, those which contradict as well as support the Administrator's position. The Committee expects that the Administrator 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 the record, as well as permit access to and copying of documents to be included in the record.

Subsection (b) describes when the Court may require 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 in the proceeding before the Administrator.

Subsection (c) grants the court jurisdiction to review the rule in

accordance with chapter 7 of title 5 of the 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 of validity of an

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 evidence test," for the Committee intends that the reviewing court engage in a searching review of the Administrator's reasons

and explanations for the Administrator's conclusions. However, the

judgment Committee does not intend to imply that the Court is to substitute its for the policy judgment of the Administrator.

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 and not 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 the Administrator to 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 and processing notices)

and section 6 (regulation), or (2) compel the Administrator to perform any nondiscretionary act or duty under the bill. Actions shall

be btrought in the district court in w tie dich allged violation occurred

or in which the defendant resides or has his or her principal place of

business. The district courts shall have jurisdiction without regard

to the 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 instmmentalit y or agency,

but only to te exten t permitted by the Eleventh Amendment to the

Constitestion. The section does not authorize the collection of damages

in any such suit. Under tis provision, the person bringing the suit serves as a private

attorney-general to protect the public interest. Thus itis simportant

that the plaintiff he a competent and "appropriately" interested rresentative of the 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.2d 47 (D.C. Ci .

1074).

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To assist persons bringing suits under the section and similar sections of other laws administered by the Administrator, the Committee

recommends that the Administrator adopt uniform policies and procedures: (1) governing the Administrator's role in such suits as intervenor or amicus; (2) specifying the extent to which the Administrator

will comment on proposed consent orders; and (3) providing for cooperation with parties instituting civil enforcement actions to insure

that the Administrator's expertise and factual data is made available

to such parties to the fullest extent possible.

Subsection (b) specifies certain limitations on the commencement of

a civil action under this section. Prior to the commencement of a civil

action to restrain a violation of the bill or a rule. under the bill, the

plaintiff nmst give 60 days notice to the Adminiistrator and the alleged violator. If the Administrator has institutL-d and is diligently prosecuting a civil action against the alleged violator to compel compliance,

no suit may be brought under the section. However, if the Administrator's action is not commenced until after the notification, the person 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

to the commencement of an act ion against the Administrator to compel

the performance of a nondiscretionary act or duty, except in the case

of an action involving an imminent hazard. In the case of the alleged imminent hazard, the notification period is 10 days. Subsection (c) authorizes the Administrator to intervene as a matter of right in any civil action under this section to which the Administrator is not a party. The award of the costs of suit and reasonable

fees for attorneys and expert witnesses is authorized, if appropriate. Nothing in this section shall restrict the right of -any person 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 more civil actions brought under subsection (a) involving the same defendant and the same issues or violations when suchf actions are pending in two or more judicial 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 or repeal of a rule under section 4, 5(c),

or6(a).

Subsection (b) sets out the procedures for such citizen petitions. Aiy petition is to be 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

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tion. Otherwise, the provisions of this 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 hearings or conduct any investigational proceeding appropriate to determine whether or not a peti- tion should be granted. Within 90 days the Administrator must either

grant or deny the petition. If the petition is granted, the Administrator

shall promptly commence an appropriate proceeding to take the

action requested. If the petition is denied, the Administrator must

publish in the Federal Register the reasons for the denial.

If the Administrator denies the petition, or if the 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

court to compel the initiation of the requested -rulemaking proceeding. Such action must be filed within 60 days. Subsection (b) (4) (B) sets out provisions applicable to the civil

action in the case of a petition requesting the issuance of a rule 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 of rules. Subsection '(b) (4.) (B) provides the petitioner for the issuance

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

requested action was not unreasonable.

In the case of a petition for the 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 or the environment. 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 of the 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 to health or the environment.

If the petitioner makes the requisite shoNwin, the court shall order

the Administrator to initiate the requested rulemakinz action unless

the court finds that the failure of the Administrator to initiate such

action was not unreasonable. In making the latter determination, the

court is to consider the priorities of the Administrator, thp resources

available to the Administrator to take the action requeeted by the peti- tioner, and other relevant factors. The Committee intends that the

court carefully rev;ew the Administrator's priorities and resources to

determine if the failure of the Administrator to initiate the requested action was unreasonable in light of the risk demonstrated by the peti- tioner.

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Although 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 of the bill upon a request and a determination by

the President that the waiver is necessary in the interest of national

defense. If a waiver is provided the Administrator must maintain a

written record of the basis for the waiver and make the record available for in eahera examination when relevant in a judicial proceeding under the bill. Th.e Administrator is to publish 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 of the employee)

has commenced, caused to be commenced, or is about to commence a

proceeding under the bill. Protection is also provided for any employee

who has testified, or is about to testify in any such proceeding, or has

assisted or participated in a proceeding or any other action to carry

out the purposes of the bill.

Under subsection (b) any employee who believes that lie or she

has been discharged or otherwise 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 the violation to take affirmative action to 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

in bringing the complaint may also be assessed.

Subsection (c) provides for judicial review of an order of the Secretary. Any adversely affected person may obtain review of the Secretary's order in the'United States Court of Appeals for the circuit in

which the violation allegedly occurred. The petition for review must

be filed within 60 days from the issuance of the Secretary's order and

review shall conform to chapter 7 of title 5 of the United States Code.

Subsection (d) provides Tor enforcement of orders by the Secretary

in the district court for the district in which the violation occurred.

The district courts are granted jurisdiction to grant all appropriate

relief. Such actions shall be heard and decided 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 for continuing evaluations of the potential

effects on employment of any rule or order under section 4, 5 or 6 or

a. requirement of section 5.

Subsection (b) authorizes the Administrator upon request of an

employee to investigate any discharge or layoff or threatened discharge

or layoff or other adverse effects on employment allegedly resulting

from a rule or order under section 4, 5 or 6 or a requirement of section 5. The Administrator shall if requested by any interested person

hold public hearings on any matter involved in the investigation unless the Administrator determines that there are no reasonable grounds

for holding such hearings. The person requesting the hearing must

be notified in writing of any determination not to hold a requested

hearing.

If public hearings are held, the Administrator must provide at least

five days notice to the person making the request for the investigation

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 of such 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

witness fees.

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. if any. indemnification should be

accorded any person as a result of action taken by the Administrator

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under such laws. The General Accounting Office is to review and colnment on the adequacy of the 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 infornat ion in its possession as the Admninistrator liay reasonably determnine to be necessary for the administration of the bill.

Subsection (b) provides that the Administrator may by rule require the payment of reasonable fees from any person required to submit

data under section 4 or 5 to defray the cost of administration of the

bill. The fee may inot exceed $2,500. In setting the fee the Adninistrator must take into account the ahIility to piy of the 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 of chemical substances may cause or significantly contribute

to an unreasonable risk, that there are insufficient, data and experience

with respect to that category, and that testing of that category of substances 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 as provided in

section 4(c) for an exemption from the testing r'equirement and

thereby unnecessary time and expense could be saved the affected manufacturers and processors by not having to test each minor modification of substances within the category.

It should be noted that in takingaction under any provision of the

bill respecting a category of chemical substances, tihe Administrator

will not have to make the requisite finding for such action with respect

to every chemical within the category.

The Committee agrees with the N ational Academy of Science recommnendation that the EPA adopt, whenever scientifically possible, a

generic approach for the regulation of chemicals.,

"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 of mixtures. ' Subsection (d) directs the establishment within the Environmental

Protection Agency of an identifiable office to carry out the following:

(1) The provision of technical and other nonfinancial assistance to manufacturers and processors respecting the requirements

of the bill which they must meet.

(2) Informing manufacturers and processors of the policy of

the agency respecting the application to them of the requirements

of the bilI.

(3) Informing manufacturers and processors of the 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 be particularly helpful to small and medium-sized manufacturers and processors which typically do not have an extensive legal staff to deal with the

complexities of the bill and rules promulgated under it, and the

Committee intends that the assistance office focus its efforts on 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 requests respecting the policy of the agency respect- ing the application of requirements to a specific manufacturer or

processor. In addition, the Committee anticipates that the office will

provide assistance to manufacturers and processors by referring them

to other offices within the agency when it is necessary for inquiries to

be handled by another office. Of course, 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 of tile requirements of the 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. The bill contains specific grants of substantive rulenaking authority to the 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 of procedural, interpretative, or similar adlministrative rules,' consequently, such a provision is not included in the bill.

SECTION 2 7, DEVELO')PMENT AND EVALUATION OF TEST 'METHODS

This section provides authority for the conduct of and financial

assistance for projects for the development and evaluatior{'f inexpen- sive and efficient methods for determining and evaluating the health

I See authorities cited in Morrow v. COlayton, 320 F 2d 30, 44 (1903).

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and environnental effects of clhemical substances and mixtures, which

methods may be used in developing test data to comply with a section 4

testing rule. Tihe Secretary of Health, Education, and Welfare will,

in consultation with the Administrator and acting through tie office

of the Assistant Secretary for Ilealth, administer this section.

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

results of projects assisted by such grants and contracts.

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 with testing rules under section 4.

SECTION 28, AUTHORIZATION OF AP'PROPIUATIONS

Section 28 authorizes to be appropriated to the Administrator for

carrying out the bill $1 1,100,00o 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) of the Rules of the House of

Representatives, the Committee imakes the followingstatement 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 1976
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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 of the legislation should be extremely small. These

annual costs are equivalent to about one percent of the annual cost of

$20 billion which will be expended for water and air pollution controls

during the 1973-1982 period, as estimated by the Council of Environmental Quality. A study performed by Ohase Econometrics, Inc.,

Maroecomnnic A zspects of Federal Conirol Programi,, 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 Price Index, 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 of Bill:

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 the impending introduction of any new

chemical or significant new uses of existing 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 of dangerous chemicals or mixtures, and to carry out inspections. Various guidelines and procedures are established for the Administrator to follow in implementing the bill, as well as for citizens' civil actions

and petitions to 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.

The budget impact of this bill is shown 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 tis bi ll fall wit hii Function 300.

5. Basis of Estimate : The Office of Toxic Substances ill EPA, which

will imflCment this bill. estinates that general a 1

)atellilt and 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 of the funds, and (lnforcetnenI etiorts. five plrcent. EPA ant ici

1 itcs tile following spending rates for lhesc types of accounits.

PERCENTAGE OUTLAY DISTRIBUTION

Year I Year 2 Year 3 Year 4

Abatement and control ....... . .. .... .... 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 . ,8 dt D 'ircctor for 1h dqet Analysi8.

Ao CY REV' 0l'l'S

.NVIItl1N M1VNT \, 1'It, (TION A(WNCY,

Wa. ington, D.C., Jurnl 27, 1976.

11011, HAIIV 0. S'rAttnlE1ItS,

Chahl'wan. (Own III i/ce on I/ershaI ,Ind Foreh,'. Comm ree, House of

Repre'cltat;1'es, Wa7.Ylhgtol, P.C.

Di..n Mit. (C8lnMAH : "h is is in response to your requests of ,Jne 3,

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

sntbsta les ('onl rol Acit." Ietling before your ('on nittee.

This Agency nId ot her cOl1erled Federal delartnilenits aln(1 agencies

li'lii, just recentlv collmpleled the deevelopllenli of tie Adlninistrtionl's

)osiion oln S. 716. :1 simi.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 t his legi.lation, we are stil lit tinlg 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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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

enactmeut of the Toxic Substances Control Act.

Mv staff' and 1 stand ready to assist your Committee in any way

possible towad (he i enactment of salt isfact ory legislation to control

lh1flar-(l1S sulhstfanr, oS.

We are ndvised 1)y the Office of Management and Budget that there

is no ol);ection to 0 b subission of this report from the standpoint of

the proirram of the President. Sincerely yours, yotr uN R. QUARI.,s, Jr.,

A ctrmg A dministrator.

En ,losllre.

EN'mmmoNmvw'r~, "PROTEcTION AoF.Nc-'v,

Wlashinqton, D.0., ,Juve 23, 1975.

1ion. WAITImR G. MAONTTsON,

Chai,,uan, Comn tter on. Comrn ec,

.S. ,olate, Washinglo a, D.C.

DEAr MR. CIAmM,%,fN : This is in respon.se to your request of March 6,

1975, for the views of the Environmental Protection Agency on S. 776,

the "Toxic Substances Control Act."

We are in accord with the objectives of S. 776 and the general

approach taken in the 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 of the specific provisions of S. 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 to recognize 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 of Management and Budget prior to the transmission of these same materials to the Congress. We also stated in our

testimionY that. to designate by statute the specific responsibility of an

Assistant A(hninistrator may tend to create a problem of iinternal

management.

We will discuss below a number of additional areas in S. 776 where

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 amendments and brief explanations of each. We urge that all of these amendments be favorably considered by the Committee.

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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 represent s the views of the Administration on S. 776.

POLICY OF ADMINISTRATION

We a re proposing that the "Declaration of Policy" section of the bill

include recognition of the role of this legislation in complementing

and supplementing a number of present Federal programs that deal

with various aspects of toxic substance control. We are also 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

of this legislation, both by 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

of comprehensive toxic substances legislation.

In line with this policy, and because of the special role of the 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 use of toxic 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 jurisdictions of EPA and the

Department of Labor.

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 to draft the bills

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

com uercial quantitics. An excessive burden and inconvenience to time

industry or the user would be averted with this flexibility 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 testing to be necessiry.

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 some purpose, and such

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use 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 risk to 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 of testing 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 (or possibly a third party) 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 one that might be less costly or

more effective. This would insure that industry is allowed to use the

best test protocols in meeting the 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 proo sing

restrictions on the substance or p~roduct may be proposed immediately

during the premarket review period under section 6 and tile rulemaking

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 the requirement that

the Administrator provide for the assignment of quotas in any regulation limiting the amount of a substance which may be manufactured,

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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 a rule with respect to a chemical substance to protect 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 that may be manufactured 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 of quotas 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 of other proposals that have

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 of the requirement for the submission

of health und safety studies, or lists of such studies, in order to provide some flexibility in this requirement. This should lessen the burden

to industry in conplpiling the lists or submitting the studies, and to

EPA in not being overburdened with information it does not need or

cannot effectively use. The amendment would require submission of

lists of 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 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 beeni made.

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 Substance s 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 of case law interpret ing 5 U.S.C. 552 (b) (4) ), and will promote uniformity.

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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. If colit actors are not allowed access to information 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 ie considered Government employees (5 U.S.C. 552a(m) ). We recommend inclusion of such a provision in the toxic substances bill. Our proposed amendments allow

disclosure to cont ractors, 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 protect ion of the rights of individuals whose names

aPl)eal in health and safety records.

Finally, with regard to access of information by Congress, we believe that such confidential information should be made available upon

written request.

EXEF311ON FROM FEDERAL IPREEMIMiON

We do not l'ecoiinleiil tile provisions of S. 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 puts into effect regulations for testing or restricting

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 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 Ile provision contained in previous

bills before the Congress directing (ie Council oil Environmental

Qualit v to coordinate a stuly on the feasibility of establishing a standard classification system for cheniical compounds tnl(] imeans of obtaining 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) unl ioll 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 to make clear that our budget requests over the 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 beeni a 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 out that EPA wishes to remain in accord

with the Presidelt's stated policy of holding uiew% spending to an absolute minimum. Consequently we would point out that the authorization levels in S. 770 are i excess of amounts required to implement 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

amlendillents woul iinprove and strengthen the legislation and enable

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 of some burdensonme requirements.

With the favorable consideration of these proposed amendments,

we would urge the enactment of S. 776.

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

posslble.

We are advised by the Office of Management and Budget that there

is no objection to tle sul)mission of this report from the standpoint of

the pro ram of the President.

Sicerely yours,

,JoiN It. QUARULES, Jr.,

Acting Administrator.

Toxic SUBSTANCES CONTROl, ACT

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

1. Definitions

a. Page 4, lines 1 and 2, delete the language "or in some other way

suitable for formation of a group for the purposes of this Act".

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Explanation.-This amendment 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 this definition as it, ampplies to this Act, or to any provision of this Act, certain categories of chemical 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 respect tot hisdefinition:

"Chemical substance would he defined to permit the Administrator

the flexibility to provide by regulation for exempting chemical substances in certain categories or in less than commercial quantities from

certain provisions of the bill. With respect to those chemical substances, it is anticipated that, the Administrator will exercise his discretion to exclude, 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 a potentinl threat to 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 lelet e reii a in der of piragraibph; and on ]ine 12, delete "stludy" and i nsrt 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 to be 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 include unconfirned complaints and not ices in 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 a study. d. Page 6i. ilesert ifter line 1-1 t le followinig and ren iiiber other

pararaphs accordingly.

"(15) 'new chemical substance' nieans nay 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.-A definition of "new chemical substance" is necessary

in order that chemical substances that were used in prior years and

were discontinued do not become classified as existing chemicals for

purposes of the Act.

2. Testing

a. Page 9, after line 8, insert new paragraph (4) as follows:

"(4) The Admijistrator will consider alternative 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 for meeting the standards

for test protocols proposed by a manufacturer, such as les costly or

more effective test protocols.

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.-We do not believe that the Administrator should become involved in designating which party (or a third party) should

perform tests if tle parties cannot agree among themselves. If a costsharing arrangement is made for one of the parties to do the testing,

however, provision should be made to exempt the other parties from

the testing 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

nature of tile interests of such airticipants,'".

Explanotian.-This amendment would permit limited cross-examination as is provided in the section 6 rulemaking procedures to restrict

toxic chemicals.

3. Premarket screening; 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) ; on line 25, delete beginning 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 G during the prenmirket review period of a product, as a final mile. Thus a chemical substance

or product may he manufactured and (list ributed 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 and a rule proposing

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restrictions onl the substance or product 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 of a

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 of the bill, thus preventing it,

from becoming a threat to health or the environment.

The other ainendments would clarify the date ureinarlkpt notice

comrirences, that restrictive rules under 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 chemical substances

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 6 of the bill:

"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 7 which the Secretary of Labor (ould take under

the Occupational Safety and Health Act. Thus, for examnple, the Administrator of EPA could not, tnder section 6(a) (3) require that

a substance be, labeled sot as to prescribe requirements for its safe

and healthful use which apply solely to workers in their place of

employment. The Department of Labor, pursuant to the Occupational 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 of EPA 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 of tle 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 sa fety 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 vat ed" wliich is often irderstood or defined as

an int erit ioul ri't.

C. Page. 19 liire 11, delete eat ire paragrapli (3).

Erllantiuof.-We believe that the Administrator should not becorir, involved in assi n uuotas to indistry. Thi maidatory requirerienit of a quoti systei voluld iake the remilatorvy l)ro'ess vastl." more

llinhluersolue :uru1l difficruhl to administer. Tire Act already l)rovides that

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stance to protect against an unreasonable risk, tile Administrator shall

select the least st ringent 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 the following:

"(4) the economic impact of such 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 inie any regulation is promiulgated.

55. Suis by I.S. attorneys instead of by Administrator

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 distrit comit of tile United States".

Page 19, line 3, lelete "AdUminist rator or the".

Page 46, line 7, delete "Administrator (or Attorney General on his

beuhal f)" anl insert inl lieu thereof "Attorney General".

Page 46, line 8, after "commenced" delete "and is diligently prosecuting" on lines 8 and 9.

EAxphnaion.--These amendments would carry out the long-time policy of having the Justice ])epartment responsible for litigation instead of each Agency. In the citizen suit provisions, we believe that it

is suficient if the Attorney (enerl has commenced an act ion and that

it is not neciessi my to imi pose a further requirement that lie be diligently prosecut ing it, mt concept which is at best difficult to litigate and

at worst could lead to comiter-productive court act ion.

6. ,Submission of records; hea7th and safety studie8

a. Page 25, line 3, add at end of sentence:

"The Administrator may require copies of such records pursuant to

his responsibilities rander sections 4, 5, 6, and 7 of this Act."

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.

This amendment would correct that omission.

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 w hi.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

a stmd) to sumilit to him--

"( Lists of health and safety stil(1ies in prOLZress On or iniliated after the (late of enactment of this Act, conducted by or

for such person, or known to such person;

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"(2) Lists of health and safety studies conducted by or for such

person, or known to have been made by any person, prior to the

date of enactment of this Act;

"(3) Copies of any such studies appearing oil a list submitted

pursuant to paragraphs (1) or (2). or otherwise known by him,"

r., xplawaton.-This amendment would revise the provision requir- ing industry to report on or submit all health and safety studies. It

would require submission of lists of on-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

types of studies to be included on the lists, and the number of years of

prior studies for particular types of studies; and would require a per- so to also list studies which lie. klows are being luade or have been

nladO.

7. Additional exemptions; 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 a semnicolon, and add the following: "(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.We believe that cosmetics should also be exempted and materials regulated under the. AEC Act, and do not believe 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 of this 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 Sa fet'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 or duplicate action of the other.

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 in lieu thereof :

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"In administering the provisions of this Act, the Administrator shall

consult and coordinnte with the relevant agencies and instrumentalities of the Federal Government in accordance with the policies set

forth in section 2 (b) of this Act."

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 of this

Act in consultat ion with the Seeretary of Health, Education, and We]-

fare on such contract and grant programs."

Page 30, line 7, delete entire subsection (b) and insert new subsection (b) as follows:

"(b) The Council on Environmental Quality in consultation with

the Administrator, the Secretary of Health, Education, and Welfare,

the Secretary of Commerce, and the heads of other appropriate 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 shall be published within 18 months after

enact ment of this Act."

Explan4tion.-These proposed amendments are intended 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 (overn mnt 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 and safety requirements; and that appropriate provisions

are made to establish and to have access to informatioi relating to

chemical compounds,

A number of Federal agencies, particularly the Occupational Health

and Safety Administration of the Departnmient of Labor have extensive responsibilities relating to toxic substanecs and human health and

would stand to benefit from various provisions of the Act. The testing

of chemicals as they relate to the programs of these agencies and the

test results and otler information and data generated by the legislation would, of course, be valuable to them and must be made 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 the research and monitoring activities under the Act, but not necessarily

on each individual contract or grant.

We are also recommending that, the provision contained in the previous bills before the Congress directing the Council on Environmental

Quality to coordinate a study on the feasibility of establishing a standard classification system for chemical compounds and means of obtaining rapid access to the information on such substances be restored

to the Act. This section provides CEQ to have the lead 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 to be deleted.

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9. Additional assistant administrator

Page 28, line 15, delete subsection (a), renumber subsections (b)

and (c) accordingly.

Ewplanation.-This amendment would delete the provision for a

special category Assistant Administrator for Toxic Substances.

10. Administrative inspection.

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 or reimbursement

for the costs of performing tests in connection with the provisions of

sections 4(c) and 5(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 to financial data on testing costs in

order for the Administrator to carry out the requirement to apportion

the costs among those benefiting from the testing.

11. Disclosure of confidential information

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) of title ,5, United States Code, shall be entitled to confidential

treatment and shall not be disclosed by the Administrator or by any

officer or employee of the United States, except that such information

.may be disclosed-

"(1) to officers and employees of the United States in connection with their official 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

or after the effective (late of this Act for the performance of work

in connection with this Act;

"(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 is necessary to protect, health or the environment.

"(b) Accss in- Co,oaFss.-Notwithstanding any limitation contained in subsection (a) or any other provision of law,, 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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"(c) CRUMINAL PENALTY FOR WRONGFUL DiscLosun .- (1) Any officer or employee, of the United States, or former officer or employee 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 of the specific material is prohibited by this

section, willfully discloses the material in any manner to any person

not entitled to receive it, shall be guilty of a misdemeanor and fined

not iore than $5,000.

"(2) For the purposes of this 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,

5 U.S.C. 552(b) (4). Our proposed amendment would have the effect

of requiring nondisclosure 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 5 U.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 under this

bill, EPA could not perform its duties satisfactorily without substantial manpower increases. The recently-enacted Privacy Act, 5

U.S.C. 552a, provides that, 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 their employees are to be considered Government

employees (5 U.S.C. 552a(m)). We recommend inclusion of such a

provlison in the toxic substances proposed bill. Our amendments allow

disclosure to contractors, and include a penalty for wrongful disclosure of information by Government employees (including contractors

and their employees).

We also belie-e that the provisrions relating to qualified scientists

and individual names are not necessary. The term "qualified scientists"

would be difficult 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

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 exemption frowt Federal preempthkm

Page 42, li ne 14, delete subsection (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. Citizen 8u-it8 for discretionary action

Page 45, line 13, delete language after "Act" through line 16, and

insert in lieu thereof:

"which is not discretionary with the Administrator.".

Explanaton.-This amendment would make the 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 dist rict courts.

1.;. Indemnnifiration study

Page 52, line 17, delete all of section 25 and renumber section 26

aecor'dinghyl.

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

a st ily on Federal indehnnifivation under laws administered by EPA.

We believe suifficient information already exists to recommend against

indeninifi.at ion under programns administered by EPA.

15. Allhnl;sion . of btidqets antd teatmony to ('angress

Page 54, line 15, delete all of subsection (C).

/.'clanation.-This amendment 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 to this provision.

16. AddwNomtl min rellancau8 amend(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 of the 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

''mel en se''.

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 a comma after "payment" and delete "of" and the comma after "charges"; and on line 16, delete "of subsection (a)".

Page 39, line 5, "section 17," should read "section 16,".

Eaxpl o nton.-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 Interstate and Foreign Commerce, House

of Representatives, 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. 7664 with some modification.

Enclosed are the Administration's proposed amendments for modifying H.R. 7664. The enclosure summarizes several of the more significant proposals to amend H.R. 7664 and contains all of the proposed

amendments and a brief explanation of each.

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 the favorable consideration of these proposed amendments we

would urge the enactment of H.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 of the significant proposals to amend

H.R. 7664. A number of other amendments have also been developed

which would improve the effectiveness of the bill. All of the 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 to provide the Administrator with some flexibility to exclude,

in appropriate 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 to draft the bill to exempt

certain substances from the Act or, as more likely the case, from certain provisions of the Act in each situation where such is appropriate.

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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

also be in order for a substance not manufactured in commercial quantities. An excessive burden and inconvenience to the industry or the

user would be averted with this flexibility in the Act.

TESTING

There is a provision in the testing 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 of testing 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 (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.

We are also proposing that the criterion by which the 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 5 of 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 is defined to mean an unreasonable risk of

death, or widespread or severe personal injury or illness, or of widespread or severe harm to the environment. If a new chemical substance

or a significant new use of a 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

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where quotas have to be established. 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 the environment. Restrictions limiting the amount of a substance 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 suggest this amendment in lieu of the 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 to the Administrator so as to

give the Administrator the authority to require when appropriate

that the manufacturer of a new chemical substance submit a report on

that substance on the day its manufacture for commercial purposes

begins. Only by this means will the Administrator be able to maintain

a complete inventory of chemical substances. An inventory is necessary

if tie Administrator is to have any idea what chemicals are being

marketed and which may need to be regulated.

IIEALTII AND SAFETY STUDIES; ADVERSE REACTIONS

We are proposing that a provision be added to the 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, rtt her than the study, with a right to require the submission

of a given sthdy. It would aithorize the Administrator to provide 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 to the Administrator at his request.

SMALL BUSINESS EXEPII TION

We recognize that there may be a need due to a financial burden

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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 if such

risk can be prevented or reduced to a sufficient extent by actions under

their law. The agencies would then either determine that the substance

or niixt ltre does not. pose or is not likely to pose an unreasonable risk

to health or the environment or initiate action to protect against such

a risk.

Questions which could occur over the validity of actions taken

under the Toxic Substances Control Act where other authorities

exist would be avoided under this amendment.

EXE3MIrION FROM FEDERAL I'IRLMI'I(.N"

We do not recoinniend the provisions of IMR. 7664 which would

allow State and local agencies to petition the Administ rator for exemption from the Federal preemption requirements. State and local agencies would e allowed 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

in effect.

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:

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"Provided, however, the Administrator may by regulation exclude

from this definition as it applies to this Act, or to any provision of

this Act, certain categories o chemical substances, including laboratory

reagents, catalysts, selected mixtures, and chemical substances not

manufactured in commercial quantities."

Explanation.-This amended 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 might he an 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(jlmi rmuent for reporting of "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 of subsection (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 of a 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 formulatei a test protocol for such substance in accordance with such standards, and perform the

tests required by such p!'otocol.

E.plavvtion.-If the 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 a Ifar more appropriatQ dctcrmnjnation f~lr issiip tigjp ;'quircieer in that it

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reflects 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

be more 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 9 to 14. Delete lines 9 to 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 do not alter the intent of the

original provisions but conform 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 5 and 8.

Page 11, line 14: delete "in accordance with a test protocol" and

insert in lieu thereof "under a test, protocol, in accordance with

standa rds".

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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at the end of line 9 and insert in lieu thereof a period; 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) the term "standards for a test protocol" means standards prescribing the nature and quality of a test protocol,

including:

(A) the manner in which test protocols are to be developed

to determine the human health and environmental effects of 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 who should perfoiin testing

Page 8, line 11, delete the last sentence in paragraph (d) beginning

with "If" through line 21, 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.

Explanato.-We do not believe that the Administrator should beconie in (esignating ,involved which larty (or a thi'd party) should

perforin tests if the parties cannot agree among themselves. If a costsharing arrangement is mnade for one of the parties to do the testing,

however, provision should be made to exempt the other parties from

tho testing requirements.

3. Timely submi, usio of test data

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 to such test protocol.

Explanation.-This amendmnent will ensure that the test data shall

be promptly transmitted to the Administrator after completion.

PREMARKFT NOTIFICATION LIST

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

b. Page 10. line 8. after "finds", delete remainder of l)aragraph

through line 13:, and add in lieu thereof the 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 pose an unreasonable risk".

Explanation.-The substantial danger test in the current provision is so strict that no substance would be placed on the list unless at the

same time it was subject to regulations applicable to a Hazardous

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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 require notification 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 in consultation 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 "Tie Administrator shall by rule 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 capaci tY, Captivye Consump1 t ion,".

Ak:/)Ia/?lo,.-'his amendment is being proposed to the quotas

provisions of 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 a substance 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

of Commerce be involved in setting them.

2. Eroiomc Impact 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.

Page 21, line 21: delete all of subsection (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 in lieu thereof "or such times".

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Explanation.-Authority should 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 the initiation of the manufacture of a new

chemical substance. Therefore, the amendment authorizes the Administrator to require of a chemical manufacturer that he initially reports

on the day on which manufacture of a 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. Reporting Adulteration

Page 25, line 16: Between lines 16 and 17 insert a new subparagraph

(E) as follows, and renumber subsequent subparagraphs accordingly:

(E) Records pertaining to quality control procedures and

adulteration as defined in subsection b(e).

k'rplonat/or..-Whih smubsection ((e) authorizes the Administrator

to require a mnaInufacturer or processor to submit a description of quality 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 to incidents of adulteration.

3. Reportig Health and Safety Studie8: Adverse Reactions

Page 2.5, line 1, after "require," insert "on any chemical substance

manufactured, imnported, or processed,".

Page 25, after line 21, insert the following:

(G) 1He0alth and safety information including:

(i) list- of health and safety studies in progress on

or initiated after the date of enactment 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 tl legations of personal injury or harm to health,

reports of occupational (lisease or injur. , tmid reports of complaints of injury to the environment submitted to the person

by individuals or governmental 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 the submission of a given 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 that a person would list studies which he knows are being made or have been

made, The amendnient also provides that records of adverse reactions

to human health or the environment be available for submission to the

Administrator at his request.

4. Exemptions8 fron Reporting Requirem eft8

a. Page 24, lines 22 and 23: delete "Except as provided in subsections

(b) and (c), the" and insert in lieu thereof "The".

b. Page 26, line 6: after line 6, insert a new 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 of the 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 after the initial reporting is made under this section and

such exemption or modification shall discontinue when there is

a significant change in the amount of the substance manufactured, imported or processed 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 under section 4 (a) of this Act;

(ii) which is contained in the list of chemical substances which the Administrator has by rule identified

and published in the Federal Register unler section 5(a)

of this Act; or

(iii) which is covered by a rule under section 6 of this

Act.

(C) For purposes of this subsection the Administrator shall

define a small business concern, in consultation with the Administrator of 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 a small

business reporting exemption provision. The amendment would 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 amendment to the

definition of "ehemical substances" at page 4, line 2.

5. Jflvetdory

a. Page 26, line 7, delete entire section (b) and insert in 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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or processed ill the United States. A chemical substance shall

be il nciledp in such an inventory as of the earliest (late (as detemimed by tie A (111iinist rator) 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 Administrat or in conluct i g his resplonsil)ilties under the 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). as amonded, anitl regulations issued p1ursuant. thereto;

A'.rxp1anaton.-T'l'lit amne(Ilnent adds a class of materials to the cx- emlpion provision, as those materials are already adequately regu- lated under existing law.

2. Page 28, line 24 : delete all of subsections (1), (c), and (d) and

insert the following subsections in lieu thereof.

b) Laws Not Administered by the Administrator:

1) If the Administrator has reason to believe that, tile

manufactur'e, lrocessing, (list rihuition in commerce, use, or

disposal of a chemical substance or mixture poses or 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) to determine if there is such a risk and (B) if the agency 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 of ani agenc y in response to a request made under

his paragraph shall he accomlpanied by a detailed statement

of the findings an( conclusions of tle agency respecting the

deterimnat ions requestetl to he 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 or the 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 a risk,

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the Administrator may not take any action under section 6 or

7 of this Act wit1h respect to such substance or mixt ure.

(8 If the Administrator has initiated action under section

6 or wit I 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 (or laws) adlmnistered by it. to prolect against. such risk

to health or the environment assoeiate'd with such substance

or m ixture consult with the Administrator for the purpose of

avoiding duplication of Federal act ion against the risk.

(c) Laws Administered by the Administrator.--The Adniinistrator shall coordinate actions taken under this Act with

actions taken undcr other Federal laws a(lministered in whole

or in part by the Administrator. The Administrator shall use

the authoriiies contained in such other Federal laws to protect against any risk to heallh or the environment associated

with a cheimica'l substance or mixture unless the Administrator determines tlimt snitli risk may be more 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 Act of 1970, ble deenied to be 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 of achieving the maximumn enforcement of this Act while

imposing the least burdens of duplication on those subject to

the Act and for other purposes.

Explanation.--The proposed amendment provides that the Administrator has no authority under section 6 (regulation of chemicals) and

section 7 (imminent hazards) if the following occurs. Other agencies

would be remested by the. Administratlor to determine if a risk is presented or is likely to be presented by a chemical substance or mixture,

and if such 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 or the environment or initiate action within

90 days to 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 the Toxic 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 to protect health

and the environment.

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ADVISORY PANELS

Page 30, line 9: delete all of sect ion 10 Chemical Substances Board,

and lienmbnilr subsequent sect ions accordingly.

Explamtihn.-Thie section would add a substantial administrative

step to ,a complicated regulatory procedure, in that till rules to be

proposed rider sect ions 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 aliead'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 A geiey's Pesticide Program, the Administ rator would draw on the many out side sources of advice in order

to .issile his decisions we soundly based in scienitifii knowledge, b1it as I m at ie' of coilrse i2t li h ,i] i'i,,lc-deii1akin gprocess. I he ica det(nIc

('OIIIIlIII itY an(1 slch national groups as NAS, NSF. and Nil[ are

Sour'ces preseitly relied upon. In ddit ion, EPA will submit its draft.

regu lat io ns to other coemrned ageicies as a standiard executive branch

proceduire to csrine adequate input mth of a sciemtific and substantive

liat ire.

I NSIEt'TI(ON (O1' iiCOIDiis lil IIEIMil,'HSEMENT FOR TIS'I'INO

Page 35 after line 2 insert new siihsection (h) as follows and retiumber existing suihsections (b) and (c) aeordingly:

(b) Not wit list anding tle provisions of subsection (a), the

Admiiiistrator shall have authority to inspect financial data

records pertaining to testing costs whn lie orders coltri lilion or reiiiibu'semient, for the costs of performing tests iil

(oiliect ion withI the provisions 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 amendiniiit would aulthlrize access to financial (lta oil 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, ot her thai to ti;e Admini.strator or

fl'em's o' ciii)1ovees of t he Environmental Prot eet ion A ugecy

who have Ti need to know for the prformiaice of their oflicial dlutios, or to officers or employees of another Federal

agencv who have a need to know for the performance of their

official duties, or to the cou'ts when relevant in any judicial

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proceeding under this Act any information 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 fill ure is prohibited.

(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 cominercial distibition, or

(13) any chemical substance or mixture for which testing is required iunder section 4 or for which notification

is required 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 if in the opition of the 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 of work in coniection with this Act.

(d) CIiiMINAI, PENALTY "Oa WRONGiUL I)St'LS VtI.- (1)

Any officer or eiii)loyee of the 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 who knowing I hat displostu'e of the

speeitic Iiaterial is prohibited by this section, will fully d is-

('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 of this 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 l be conside'red to bt11 vi ctployee of tihe Unite(d States.

1"pll fl0itol,-This sect ion shou be ieilded a(1 in se erialI respects.

'lhis legislatio"I requires suilstiaitial itiformmation to be su1illitted to

Ihe ( o\'verniienl upon specific request of the Ad1i itist ritor. fif addit ion. the legislatioll does not precllue voluntarY sulbliiission of itiformnation 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 to authorized individuals it is highly likely

that infornut tion 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 silt isfactoly )er foIlti~flne of the conira(t. Since miuich of Inh A-ency's workloa IIII4l u mtedllvy will he cont ractual this plrovisil is vital to the legislation's successful in iplenientat ion.

EN VIlONMENTAh ]I'll l'iION AN1) ASSESS ENT

Page 43. line IT insert after "resoi res to" "p redict. fnld".

llajt/ioa. The ((lltelt of section 1I sholihi reflect tile intention

of the title which is to peril it PA in association witli other agencies I o lecome invol ved il prediting and assessing t le en vi ronfuient al cons0(pentes of tile introduction of new chemical sulbstances into the envi rolnient.

STATE EIN EM I 'ION FIRl) . FFI IIAM I PI1 E E.MPTION

Page 45, line 14, delete suhse't ion (b).

wp.ie 11116010.-'l'hi. a le nd(1en1 woul dhelete lie provision tlit

w(uld allow Stale and local ro ie1is t.oi1 to ltition to h)l eXeIl)ted

front F 1ederal pre11 m)ption requilements.

,1UlDIIAL II' I lAV

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 record does

not slippolr t tlieni. rather thiln Ihis burden being on the1' Administra- o r.

COMIl-IloLIII ( EiNERIAI, OF TIlE UN I'TIE) S TIES, Vashhiqton, D.C... July!/! . 197:5.

-1011. IIATLEY 0. STAErS,

Chairman, Cornomllice On lhitersac (old Forc.u,. (om1erc. Hou1s'e

of hRepir.sentiets.

DEmAU MN. C ra l.YN : This refers to your letter of 11une . 1975, requesting Our report oi I .R. 722). 9It h Congress, the "Toxic ShlIstances

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 to that of the Federal Insecticide, FuIgicde and Rodentivide

Act (FIFRA), 7 U.S.C. §+ 135 c/ v(iq., (19TI) is amended bY Pub. L.

No. 92-516, approved Octolhr 21. 1972. with re(pect to 1ia-iv )1,st ivides. In this 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 ealth ind (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 to insecticides, fungicides and rodenticides, 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

either II.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 of related provisions of FIFRA :

1. In section 3(4) of II.R. 7221) the terii "comiiierce" is defined

in terms of interstate commerce. Thus only toxic sub.tances involved

in interstate coiiiineree would he covered, unli 1w pc ticides, which are

regulated under FJFRA if disseiiinate(l in t instate 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 tile l(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

new suiiparagraph (C) to red "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 of persons 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;gZ wit h reslect ito jIest itides.

3. Subsection 17(c) of I.R. 7229 provides for seizure of substances

manufactured or distributed in violation of the 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 to prev(ent or rediice an unreasonable risk to health or the

enivironient if: (A) the ciutirety of the risk involved is designed to be

prot(cted agoainst by another Fe(eral l11w not administered in whole

or in part by tlie Admniiistrat om': or (1B) if the Administrator determines that the cut i'ety of the risk could be stiliciently prevented or

red med by actioi talken nder such other Federal law.

In the interest of (larity, we b'li eve ;ection 9(h) (1) should be

amenided to .specifv which ot her protective 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 7 of this Act to take action to prevent or reduce anl unreasonable

risk to health or the environment associated with a particular chemical substance or art icle containing such substance if such risk to health

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or. the environment could be prevented or reduced to a sufficienit extent

bY actll s Inellk miler any other F ederal law; incilldig Ille Atomiic

'nIiergy Act of 195 I, 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, subla It 3 of pat rt F of t it le 111 of I he, Public I lealt Ih Service Act ( relating

to electo )',t nic prodhuct radiation), 42 U.S.C. 20't2 eq., Pub. L. No.

90-602, ()ctober 18, 1968, Jiild tl Acts administe'ed by tile Secrtary of Iransplortatio relating to( lit, t ralsportat iml of hazardous

Sublstllc('." Th'lis was 1hw languaulge included ill 11 sirelar prov'ision of H.T. 5,356,

:l ('onigless. t,, paSst by t le I1o1s of Renpresent tit Ns ,uly 23, 1973, m(l1 provi'es it specific st atement of tile legislative alilthIorites to

le considIeed by the A(llminislt Ilitor ill dhteiriiinitg whetlier ijon will

be tln uider'Jlil act such its that prplolSed by I1.E. 7229 or anotlhe

appl icablh, statilte.

Sit ios 1(a) an(d 10(b) (3) of the bill would .it lhlrizc the AdIllnlistrator 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 it data 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 flvilitat e 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 Ifor'ill adhvertising, andi

whicih are Itlherwise :111 llio'izcd bY this A'ct. shall keep su(h 1 records

:Is te lidiinistr'afor slill prvvscihe,, incl(ll-(li1.. recorls which fully

dis.lose te ll illil and dislIosilioll bv sllvl r'ecilient of tile 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 t he ('olllip iiolhr u' 1eral of the United

Slths. 01' all.N' of tlhivr dily alltho2zd represenltativt es, 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- l lllnlr or 1v Ct'(omptro)lhlr Gener(al 111,11. be re'lated or pertinent to tile

iZ'2i IIIs. qllJ)h'(rIa ('o(ll Il .ft'. .lcoil trl .it. loalis o' other , ll'flle' flts nll 

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 of dete rmi' m, whetherv and under, whill co~ndilios. if ali'. indcllmmficatioll should he(1

ac(orded Jil, yv lerSint as n result o f ,' :ai t m taken hv t lie Adfinis i ha- tot' uider 'nIV ha adllist-eod hv' tile AlZnc'y. Til'e study. wlich

would Ib 1 lequli red to lbe voilplhled 'Ilo less thal 2 years from thie date

(If eliactillnlt * * *." would include Jll estimate of the probable costs

of any indemnificat ion progrilis recommended and til1 examination of

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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 requiring EPA 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 to the 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 nmnu factitrers 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 fa voring repeal of the indetnnit,

lprovision was also stated by the Assistant A(hituistrator, Water and

I lazardous 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 otle r materials sul)t itted

to the President or to the Office of Management and Budget (0MB)

in connection with atrying out the provisions of IT.R. 7229 be sulmitted concurrenitly to tie Congress.

It is not at all cleatr that the agency ludget submissions, as such,

would Ie helpftl to the Congress. Agency budget submissions to OM1

arc subject toJ an intensive hearimg process. field investigations, and

frequeit ly. 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 iidjlist ineut of the level of~ programs 1o aissit' effective ititeragettey collalborationi.

The Committee may wish to consider, as an alternative, making

arrangfeitents for the* advance deli very of upproved agency budget

requests prior to le formal stilutission'of the 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

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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-10 which require agencies to (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 of the Consumer Product Safety Commission

at an oversight hearing of the Consumer Subcommittee of tile Senate

Committee on ('ommeree on February 27, 1975. The, Chairman summarized his views on the question by stating that; "the conflict between

section 27(k) and the OMB's interim'atation of the Chairman's duties

as a membI1)her of t he exeeut ive branch raises soine very serious questions which need resolut ion."

We r-ecommend :a ainst 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 is made above.

There is no provision in 1I.R. 7229 tht., EPA submit an annual re-

)ort to the Congress describing its act iVit ies under the Act during the pr'evious fiscal year, We suggest that such a provision be included in

the hill.

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 the Congress 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

prolmis e.

Sincerely yours,

PAu, G. Dpr-iivo (For tei (

7omytnproller General

of the United 8iaes).

TI IE 1.NuE.I, COUNSEL, OF TIlt TiE.%sUmiy,

Iloji. I IAiiiEY 0. S'I'AflfG iS, 1jVaOsd qto , D.C., A u q u t 21, 1976.

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

]E)u MR. C IAi IMA x Reference is made to your request for the

Views of hiis I)elmt ainent on I. R. 7229. t lie "Toxic Substlanes Cont rol 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 of the 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 is bracketed) :

"SEC. 13(a) . . . If a chemical substance or article is refused 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] release which has not been

exported by the consignee within [three months] 90 days from the

date of receipt of notice of such refusal under such regulations as the

Secretary of the Treasury may prescribe, except that the Secretary of

the Trea'sury may [deliver] release to the consignee such substance or

article pending examination and decision by the Administrator in the

matter on execution of a bond for the amount of the full invoice value

of such substance or article as set forth in the Custo-ms entr.

[together with] plus the estimated duty thereon, and providinq for

l;ability for assessment of liquidated damages equal to the full aniont

of such bond by the eon.Rqnee on [refusal] failure to return 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] release under this section shall be paid by the owner or consignee, and in default of such payment shall constitute a lien

against any future entry into the U ited State8 made by such owner

or consignee."

The Department has no independent knowledge of the need for the

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 of Management and

Budget that there is no objection from the standpoint of the Administration's program to the submission of this report to your Committee.

Sincerely yours, DONALD L. E. RrToan,

A eting General Counel.

COMMMMrrrrE AM.IENDMrENT

* * *

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SUPPLEMENTAL VIEWS BY CONGRESSMAN

JOIN 1). I)INGELL

I believe that it is necessary 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 of time. All of

tile Agency'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 t his knowledge. brought on by retrospective studies on PCB's,

it is clear that Steps to ( coatrol production, use, aud dis)osal are needed,

to protect the health and well-being of human and other life forms. If

.Jpalhl, ,s t le largest producer of electronic equipment, can replace

PC'Bs with sonle other, more neut ral comlponent, then the U.S. can

follow suit. The To-i Substances Control Act would he considerably strengthened by l)roviding a means to cont rol PCB's. I)uring the Comnmittee consi(leration of H.R. 14032. I offered an anendment-which

was reject ed-to prescribe methods for manufacture, 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 of the 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 to the risk of bioaccumulation 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/or heat, slowed nervous reactions, acne-like skin eruption, temporary failure of eyesight, sense of weakness and cancer of the liver.

In 191168, in Yusho, Japan, PCB's leached into rice oil used for cooking and affected 1,000 people in varying degrees depending upon exposure levels. The intake of 0.5-2 grals by those contaminated resulted

in a wide variety of illnesses, particularly affecting the skin, 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, a co-factor in some deaths and still

births.

Percentages of PCB's found in the blood of Americans, both urban

and rural dwellers, have been found to equal those of the 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

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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 still remain in the environment from past uses such as food container cardboards 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 -recently it has been feared that all commercial fishing on the Great Lakes-a $95 million annual industrycould be shut down because of PCB contamination. In addition, it has

been warned that PCB's could cause the imminent collapse of the $350

million-a-year sportsfishing tourist industry in the Upper Great 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

of PCB's which exceed Federal standards. It has been estimated that

22 million pounds of Hudson River striped bass are consumed each

year from both commercial and sport catches.

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 of PCB'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 for action in the bill. It is entirely proper for Congress to set

priorities for act ion in any piece of legislation and PCB's have proven themiselves dreadfully toxic and extremely persistent. Because of this,

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 of this measure.

JoN D. DINGELL.

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SUPPLEMENTAL 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 of untested chenical substances each day. The

growing body of evidence indicating some of these chemicals for their

damage to liuman health and the environment leads us to support sti oag toxic substances control 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 of those who crafted this compromise 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 protect ion for public health.

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

of receiving the list the Administrator was req uired 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 important respects: (1) The req uirement that tile list be published in the Federal Register was replaced by a requirement that tile Administrator merely make the list availab~le to the public; and (2) the

requirement liat the Administrator act on the 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 act or 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 is important enough for the Administrator to consider action

tn it, either affirmatively or negatively, within one year of being listed.

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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 "authority to 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 in commerce before the Administrator can

proceed with a rulemaking under section 5(g) to impose manufacturIng limitations or 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 prior to marketing,

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

SECTiON 5. EXI'I,AN.\TION BIY Tr ADMINISTRATORI OF Wily HE on SHE IS

TARING ACrIoN Olt NOT TAKING ACTION

At the expiration of the 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 slhe has decided to do and why. 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 the explanation 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 (list ribution -of a chemical

shbstance or mixture to be inmediately effective when such a substance

poses an unreasonable risk. Such a procedure is essential to protect tile

public health and environment during the pendency 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 of witnesses. The bottomline is that lives, not short-term profits,

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are at risk during whatever time is required for EPA to act under the

procedures established by H.R. 14032. This is a dramatic concession of

the public interest to private, commercial concern.

Authority for expedited agency action is grounded in the Administrative Procedure Act, which the courts have routinely held gives an

agency needed discretion to act 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 calls for 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) of II.R. 14032 requires the Administrator to determine

wvhether the risk could be eliminated by taking action under another

Federal law administered by the Admiiistrator. f such is the case, the

Adininistrator must make a complicated finding that it was in the

public interest to regutlate tinder section 6(a) rather than the other law.

'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 of the

costs of comlplying. and of the "relative efficiency of actions." The proce(ure estalished by the committee bill appears likely to delay effective a('tion by tile Administrator because it imposes unnecessary and

tine-consuinng requirements for findings as to the relative efficiency

of the l)roceeding uinder this act or another statute.

SECTION 18. PRiEMIMION (iF HTATE RIULATIONS

Section 18(a) of 11.11. 10318 allowed States to ban use of chenical

sustantes independlent of any EPA action. 11.R. 14032 in section 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 if EPA determines, after substantial review, to allow a State

to act to protect its citizens.

Traditionally States have been most sensitive to the health concerns

of their citizens. As a consequence, States have been granted wide latilde uider the Commerce clause of the Constitution to act. on behalf of

their citizens even when those regulated are marketing their products

t hrough the channels of interstate commerce. Congress has also enacted

legislation which liberally defines the I-ole of the 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 it particular chemical. They must apply to the Administrator

for approval of their actions. This clearance can be granted only after

detailed inquiries by the Administrator, inquiries which will be directed to the States ;with their attendant costs. Finally, both the action

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of the State and the action of the Administrator would be reviewable

in court. Such procedural roadblocks protect manufacturers but do

little to p rotect the public.

ADDITIONAL RECOMMENDATIONS

Lack of enforcement schedule

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. I f this legislation does not have careful deadlines for EPA action,

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 requi red, within six months.

One year lifter puiblication of the criteria the Agency should be requ irel to pl)blish a list of all existing substances wh iih should be regillated 111(1I to divide the list i nto three groups relative to the need for

timely act iolt. EA'A should then issue regulations for the Iighest priority' group within 2 years, tle second group within 3 years, and tie third

group within 4 years. The Administrator should be reqluilrcd to Jmatike

ana anual 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 tin reasonable risk to health or the environment

within 71/2 vea is after enactment of the legislation.

It. is essential 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. Such vwill 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.

Subpornea pocr

The committee bill does not provide the agency with subpoena power

for such prl)loSes asz 'athering information for investigating violations

of the act, for dleciding whether to take regulatory action, or for analyzin g in forlfiition in the agency's possession. It. is inconceivable the

agency can o)erate properly without the authority to denltlifld informatio n unler traditional al;)ropriate safeguards.

JOIN E. Moss.

JohN D. DINGEL.

RALPH H. METCALFE.

WILLIAMr M.f BRODIIEAD.

TonY MOFFEr.

ANDREW MAoUIRE,

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MINORITY 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 give the 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 or existing 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 ihe com)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 the committee, 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 90 days. 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 able to hold up the manufacturiig of a chemical for up to 6 months for no better 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 cost of as 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 be so unreasonable as to routinely require testing of this magnitude, the costs of testing could be considerable,

and the costs of 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

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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 of fighting the bureaucratic machine. is well as the significant costs of testing, may serve to

discourage hiiii froii midertaking the project at all. This is especially 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 in the chemical industry will inevitably be

curtailed.

Althoulgh the above observations are of a general nature, we are specifically concerned about sect ions 20, 21, 23, and 24, and recommend

t iat they be deleted from the legislation. We do not, believe that these

Eprovisions do anything to improve the legislation but, in fact, could

o lised to harass companies regulated by EPA.

Section 20 provides that any person may bring a 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, attorneys' .pls 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 of a substance. If EPA denies the

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 court must

order EPA to begin the requested proceeding. The citizen petition

provision, with its requirement. for a trial de novo, will force the 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 of law, not only 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 to determine its priorities and channel its resources.

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 a poor job, one can anticipate that he will commence a proceeding against the company. He will, thereby, have the Secretary of Labor and the Administrator of the EPA pro- tecting him until the case is disposed of-possibly years in the future.

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duct investigations, issue subpoenas and hold hearings to determine

the effects on employment from threatened plant closing 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

of Hearst v. Black, 87 F. 2d 68 (D.C. 1936). In this case, 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 Hearst case 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 for the courts to determine.

This provision in the bill raises an 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 that if Congress grants itself access to this t1,pe of material 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 to Federal 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 it becomes painfully apparent to the business community

that these valuable materials will not be safeguarded, we believe that

this climate of cooperation will seriously deteriorate.

SAAUEL L. DEVINE.

JAMES M. CoiLIx.

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