+(,121/,1(

Citation: 1 Legislative History of the Toxic Substances Control

 Together with a Section-by-Section Index 667 1976

Content downloaded/printed from 

HeinOnline (http://heinonline.org)

Wed Jun 8 13:53:30 2011

-- Your use of this HeinOnline PDF indicates your acceptance

 of HeinOnline's Terms and Conditions of the license

 agreement available at http://heinonline.org/HOL/License

-- The search text of this PDF is generated from 

 uncorrected OCR text.
94TH CoNcGRss HOUSE OF REPRESENTATIVES I Rmorr

4 SeM88n I No. 94-1679

TOXIC SUBSTANCES CONTROL ACT

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

Mr. STAGGES, from the committee of conference,

submitted the following

CONFERENCE REPORT

[To accompany S. 8149]

The committee of conference on the disagreeing votes of the two

Houses on the amendment of the House to the bill (S. 3149) to

regulate commerce and protect human health and the environment by requiring testing and necessary use restrictions on certain chemical

substances, and for other purposes, having met, after full and free

conference, have agreed to recommend and do recommend to their

respective Houscs as follows:

That the Senate recede from its disagreement to the amendment

of the House and agree to the same with an amendment as follows:

In lieu of the matter proposed to be inserted by the House amendment insert the following:

(067)

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

COMMITTEE OF CONFERENCE

The managers on the part of the House and the Senate at the conference on the disagreeing votes of the two Houses on the amendment

of the House to the bill (S. 3149) to regulate commerce and protect,

human health and the environment by requiring testing and necessary

use restrictions on certain chemical substances, and for other purposes,

submit the following joint statement to the House and the Senate in

explanation of the effect of the -ction agreed upon by the managers

and recommended in the accompanying conference report:

The House amendment struck out all of the Senate bill after the enacting clause and inserted a substitute text.

The Senate recedes from its disagreement to the amendment of the

House with an amendment which is a substitute for the Senate bill

and the House amendment. The differences between the Senate bill,

the House amendment, and the substitute agreed to in conference are

noted below, except for clerical corrections, conforming changes made

necessary by agreements reached by the conferees, and minor drafting and clarifying changes.

FINDLNGS, rOLICY, AND INTENT

Senate bi (section 2)

Section 2(a) outlines Congressional policy underlying the Toxic

Substances Control Act. Congress finds that: human beings and the

environment are exposed to nmnerous chemical substances and mixtures; some of these may cause or contribute to an unreasonable risk of

injury to health or the environment; and the effective regulation of

such substances and mixtures in interstate commerce necessitates regulation of intrastate commerce as well.

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

that adequate data on the health and environmental effects of such

chemical substances and mixtures should be developed. Such data development should be the responsibility of those who manufaeture and

process such chemical substances and mixtures. Adequate authority

should exist to regulate chemical substances and mixtures, but the

exercise of such authority should not unduly impede technological

innovation.

Subsection (c) contains a declaration of Congressional intent as to

how the Administrator shall fulfill the responsibilities under this Act.

The Administrator shall carry out this Act in a reasonable and prudent manner and consider the environmental, economic, and social impact of any action -taken or proposed under this Act.

House amendment (section 2)

The H1ouse amendment is nearly identical to the Senate bill.

However, the House amendment confines its datAt development man-

(55)

HeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 668 1976
56

date to hazardous or potentially hazardous substances and mixtures,

in contrast to the broader mandate contained in the Senate bill.

COnference 8ubstitute (section 2)

The conference substitute follows the Senate provision. Adequate

data should be developed concerning the health and environmental

effects of chemical substances and mixtures. Such data development

should be the responsibility of those who manufacture or picess such

substances and mixtures. Adequate authority should exist to regulate

chemical substances and mixtures which present an unreasonable risk

of injury to health or the environment and to take action with respect

to chemical substances and mixtures which are imminent hazards.

I)EFINITIONS

Senate bill (section 3)

The Senate bill includes definitions for the Act, the principal ones

of which are as follows:

1. C]heiuical substance is defined [is (i) any organic or inorganic

substance of a particular molecular identity including a combination

of such substances occrring its a result of a chemical reaction, or (ii)

any element or uncombined radical. The term specifically excludes any mixture; any pesticide; tobacco and tobacco products; special nuclear

materials or by-product materials as defined in the Atomic Energy Act of 1954; articles which if sold would be subject to the tax imposed

by section 4181 of the Internal Revenue Code of 1954 (i.e., pistols,

firearms, revolvers, shells and cartridges) ; any substance found in or

on any food, drug, cosmetic or device and any substance produced for research and development purposes intended only for use in or

on any food, drug cosmetic or device.

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

which exist among and between these.

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

commercial purposes. 4. The tern "mIixtu,'e" means tiny combination of two or more

chemical substances if such substances do not react chemically with

each other and if the combination is not a result of the chemical

react ion. Mixtur also i Icl udes combinations of substances which occur

in nature.

Time Senate bill a!it hIorizes the Administrator to exclde from cover11ge of the Act any chemical suhbstanc'e or mlixt tre if the Administrator

determines, by rule, that the suhstance or mixture. does not present an

I nrensomn)le risk of injiry to health or the enviromnent. However,

the exclusion 1shall not apply to section 7 or section 8(e) of the Senate

bill.

House unt'nednwi.t (section 3)

1. The House definition of "chemical substance" is similar to that

of the Senate bill, except. that the term includes organic or inorganic suibstances or comlbinations of such substances occurnring in nature. The

exclusions fron the definition of chemical substances are similar to the

Senate lill, although the Ihouse amendnment specifically excludes food

additives along with foods, drugs, cosmetics, and devices.

HeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 669 1976
57

2. The ]house amendment defines "environment" to include water,

air and land, and the interrelationships which exist among and between water, air and land, and all living things.

A. The House amendment, like the Senate bill, defines manufacture to mean import, produce, or manufacture, but the definition is

not limited to such activities done for commercial purposes.

4. The term "mixture' is defined to mean any combination of two or more chemical substances if the combination does not occur in nature

and is not, in whole or in part, the result of a chemical reaction. However, certain reaction-produced combinations are included in the

term "mixture" in order to prevent disparate treatment of identical

combinations simply because of the number of steps used in the manu- facture of the combination. If each of the chemical substances comprising the combination is not a new chemical substance and if the com- bination could have been mainufactured for commercial purposes without a chemical reaction occurring at the time the substances comprising

the combination were combined, then the comhination is included

within the term "mixture".

The House bill does not contain general authority for the Admninistrator to exclude any chemical substance or mixture from the pro- visions of the bill. however, section 5 (i) (5) of tile House amendment

authorizes the Administrator to exclude any chemncial substance from

the notification requirements of section 5 if the Administrator determines, by rule, that the substance will not cause or significantly con- tribute to an unmreasonable risk to health or the environment.

Conference 8ubstitute (8ection 3)

The conference substitute adopts the definitions contained in the

House amendment.

The conferees recognize that virtually no chemical substance exists

in a completely pure state and intend that any reference to a chemical

substance includes all impurities and concomitant products, including

incidental reaction products, contaminants, co-products, and trace

materials. Thus the definition of term "chemical substance" shall be

applied to chemical substances as actually produced and marketed.

For example, when the Administrator promulgates a rule under sec- tion 0 (a) to regulate a particular substance, such rule will apply to the

identified substance, including all the impurities and other concomitant

products, without explicitly identifying such impurities and con- comitant products within the rule.

It is expected that the Administrator will develop guidelines for

the purpose of clarifying the extent to which impurities and con- comitant products wiil be included within a reference to "chemical

substance" as it relates to the various provisions of the Act. While

impurities and concomitant products are included within references

to a "chemical substance" under the Act, the Administrator is obviously authorized to move against them separately under the applicable

provisions of the Act.

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

HeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 670 1976
58

example, section 8(d) requires manufacturers, processors, and distributors in commerce to list such studies with the Administrator. MIoreover, section 14(b) contains provisions concerning the availability of

health and safety studies to the public.

The conference substitute defines health and safety study to mean

any study of any effect of a. chemical substance or mixture on health

or the enivironment, including underlying data and epidemiological

studies, studies of occupational exposure to a chemical substance or

mixture, toxicological, chemical, and ecological studies of a chemical

substance or mixture, and any test performed pursuant to this Act.

It is intended that the term be interpreted broadly. Not only is information which arises as a result of a formal, disciplined study included but, other information relating to the effects of a chemcial

substance or mixture on health and the environment is also included.

Any data which bears on the effects of a chemical substance on health

or the environment would be included.

TESTING OP CHEMICAL SUBSTANCES AND MIXTURES

Senate b711 (section 4)

Section 4 authorizes the Administrator to require testing of chemical substances and mixtures to ascertain potential effects on human

health and the environment. Under subsection (a), the Administrator

must, by rule, require the testing of a chemical substance or mixture if

the Adninistrator finds (1) that the chemical substance or mixture

may present an unreasonable risk of injury to health or the environment, or that there may be significant human or environmental exposure because substantial quantities will be produced and such substance or mixture mav perhaps present an adverse effect on health or

the environment; (2) there are insufficient data or experience to reasonably determine or predict its health and environmental effects; and

(3) testing is necessary to develop such data. If no reliable data is

available to the Administrator, the finding that such substance or mixture may perhaps present an adverse effect on health or the envi-ronment shall be presumed. In the case of a mixture, the bill requires an

HeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 671 1976
59

additional finding that testing the chemical substances which comprise

the mixture is not a more efficient and reasonable method to determine

effects on health and the enlvironment. When requiring tests under subsection (a), the Administrator shall consider reasonably ascertainable

costs and other burdens associated with conducting tests and publish

such considerations in the Federal Register.

Subsection (b) sets forth the required contents of the testing rule

and provides an illustrative list of health and environmental effects for

which test standards may be required. This subsection also describes

some of the methodologies which the testing rule may prescribe. In

addition, it describes which manufacturers and processors will be required to conduct the testing.

The Administrator shall review and, if appropriate, revise the

stanlards for development of data at least once per year. Testing rules

shall be issued in accordance with the rulemaking procedures of section 553, of title 5, United States Code, except that the Administrator

shall allow interested persons the opportunity to make oral presentations of data, views, or arguments in -addition to written submissions.

A transcript of such oral presentations is required.

Subsection (c) provides a procedure whereby persons may apply to

the Administrator for an exemption from a testing requirement rule

in order to avoid submission of duplicative data. If an exemption is

granted, a cost-sharing procedure is provided. A person providing

reimbursement, may have access to test data, subject to the confidentiality provisions of section 14.

Subsection (d) requires the Administrator to publish a notice of

receipt of test data in the Federal Register and to make the data

available to the public within 15 days of receipt.

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

The committee shall submit a list of chemical substances and mixtures in the order in which the committee determines the Administrator should promulgate testing rules under subsection (a). Within

12 months after the inclusion of a chemical on such list, the Administrator shall either initiate a rulemaking proceeding under subsection

(a) or publish reasons for not initiating a proceeding in the Federal

Register. Subsection (e) also contains specific conflict of interest provisions applicable to members of the interagency advisory committee.

Subsection (f) specifies required actions by the Administrator in

response to test data or other information which indicate that a substance or mixture has a potential to induce cancer, gene mutations, or

birth defects at levels for which human exposure exists or may exist

with appropriate safety margins. The Administrator shall either take

appropriate action under section 5 (e). 6 (a), or 7 within 180 days after

the date of receipt of such data or information or publish in the Federal Register a finding that no unreasonable risk of injury is presented and reasons for making such a finding. Such requirement shall

not take effect until two years after enactment.

House amendment (section 4)

Like the Senate bill, the House amendment requires that the Administrator find that there are insufficient data and experience upon which

HeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 672 1976
60

to determine or predict the effects of the manufacture, distribution

in commerce, processing, use, or disposal of a chemical substance or

mixture. It also requires a finding that testing of the substance or

mixture is necessary to develop such data. However, the House bill

differs from the Senate bill in that it requires a finding that a chemical substance or mixture may "cause or significantly contribute" to

an unreasonable risk, whereas the Senate bill requires a finding that

the substance or mixture may "present" an unreasonable risk.

Section 4(a) (1) (B) of the House amendment sets foth a second

set of conditions under which the Administrator shall require testing.

If the Administrator finds (1) (A) that a chemical substance or mixture is or will be produced in substantial quantities and (B) (i)

either that it enters or may reasonably be anticipated to enter the

environment in substantial quantities or (ii) there is or may be significant or substantial human exposure to the substance or mixture,

(2) there is an insufficiency of data, and (3) testing is necessary to

develop the data, the Administrator shall, by rule, require testing.

The House amendment requires the Administrator to consult with

the Director of the National Institute for Occupational Safety and

Health before prescribing epidemiologic studies under tie testing requirement rule. The House bill requires the Administrator to make

and publish findings under subsection (a) (1) (A) or (a) (1) (B) before

the issuance of a rule ordering persons to conduct tests. The House

amendment also provides for the expiration of a testing requirement

rule at the end of the reimbursement period.

The House amendment provides for exceptions from the testing rule

in order to avoid submission of duplicative data. If an exemption is

granted, reimbursement requirements similar to those in the Senate

bill apply, except that the reimbursement period may last as long as

five years, instead of the two-year period in the Senate bill. In promulgating rules to use in determining fair and equitable reimbursement,

the House amendment does not require the Administrator to consult

with the Attorney General and the Federal Trade Commission.

With respect to the interagency committee's priority list submitted

to the Administrator, the Ilouse amendment does not require the Administrator either to initiate a rulemaking proceeding or to publish in

the Federal Register the Administrator's reasons for not initiating

such a proceeding. The House amendment does not include the conflict

of interest provisions found in the Senate bill relating to members of

the interagency advisory committee.

Cant erence su.b8titute (section .4)

The conference substitute is similar to the House amendment with

respect to the findings which the Administrator must make in order to

require a manufacturer or processor to test a chemical substance or

mixture, except that the term "presents" is used in lieu of "cause or

significantly contribute to". The conference substitute includes this

term throughout the bill when speaking of a risk.

In using the term, the conferees intend that the Administrator be

able to address substances and mixtures which indirectly present unreasonable risks, as well as those which directly present such risks.

Further, the conferees do not intend that a substance or mixture must

be the single factor which results in the presentation of the risk.

HeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 673 1976
61

Oftentimes an unreasonable risk will be presented because of the

interrelationship or cumulative impact of a number of different substances or mixtures. The conferees intend that the Administrator have

authority to protect health and the environment in such situations.

In following the House language, the conference substitute requires testing not only (1) in situations in which a substance or mixture

may presnt an unreasonable risk, but also (2) in situations in which

there may be substantial environmental or significant or substantial

human exposure to a substance or mixture about which there is inadequate information to predict effects on health or the environment.

In the first situation, the conferees intend to focus the Administrator's attention on those chemical substances and mixtures about

which there is a basis for concern, but about which there is inadequate information to reasonably predict or determine their effects on

health or the environment. The Administrator need not show that the

substance or mixture does or will present a risk.

The second situation reflects the conferees' recognition that there

are certain situations in which testing should be conducted even

though there is an absence of information indicating that the substance

or mixture per 8e may be hazardous.

The conference substitute follows the House amendment with respect

to the contents of the testing rule. The Senate provision concerning which manufacturers and processors are required to conduct the testing and submit test data is included. Like both the Senate bill and

the house amendment, the conference substitute permits the Administrator to grant exemptions from a testing rule. To grant an exemp- tion, the Administrator must determine whether the chemical substance or mixture is equivalent to a chemical substance or mixture

for which test data is already being developed. In making this determination the conferees expect the Administrator to look at any contaminants in the chemical substance or mixture for which an exemp- tion is being sought and ascertain whether any contaminants present might cause differences in test data which would be significant and

which would, therefore, cause the Administrator to determine that

the chemical substances or mixtures in that instance were not equivalent. It also follows the I-louse amendment concerning reimbursement,

except that the Administrator must consult with the Attorney General and the Federal Trade Commission in issuing rules which establish the general criteria for determining reimbursement.

The conference substitute retains a modified version of the Senate

provision on the interagency committee which is established to make

recommendations concerning testing priorities to the Administrator.

The Administrator shall provide administrative services to support such activities. These services shall encompass such things as clerical

staff assistance and supplies. The conferees recognize the importance

of the interagency committee recommendations and expect the interagency committee to deliberate with care; therefore, the conferees

intend that members of the interagency committee shall be given

adequate support services by EPA. They also shall be relieved of

responsibilities within the entity they represent to the extent necessary

to carry out their duties to the committee. Each entity represented shall provide its member with professional and research services. Here,

HeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 674 1976
62

as in all places in the bill where specific officers of the Federal Government are referred to by title, the conferees intend that such references

be construed to mean successors to such offices as affected by any reorganization plan or the like.

The interagency committee may designate. a maximum of 50 substances or mixtures with respect to which the Administrator should

initiate a testing rulemaking proceeding within a year. No more than

50 substances or mixtures may be so designated at any one time. If the

Administrator does not take such action within a year, the Administrator must publish in the Federal Register an explanation as to why

such action has not been taken.

The conferees have given discretion to the interagency committee

as to how many substances or mixtures should be designated. Although the committee may designate up to 50 substances or mixtures

at any one time, the conferees wish to stress that the committee

need not designate the maximum number. While it is intended that

the recommendations of the interagency committee be given great

weight by the Administrator, it should be emphasized that the decision

to require testing rests with the Administrator.

The conferees do not intend that, in complying with the requirements of the statute, the Administrator divert from the regulatory

activities of the Agency an inordinate amount of resources to justify

the failure to require testing.

If the Administrator receives information which indicates to the

Administrator that there may be a reasonable basis to conclude that

a substance or mixture presents or will present a significant risk of

serious or widespread harm to human beings from cancer, gene mutations, or birth defects, the Administrator shall initiate appropriate

action under section 5, 6, or 7 to protect against the risk or publish

in the Federal Register a finding that the risk is not unreasonable.

Such action must be taken within 180 days of the receipt of the data,

except that the Administrator may extend that period for an additional days for good 1s0 cause. This requirement does not take effect

until two years after the date of enactment.

The conference substitute adopts a pro ision contained in the House

amendment which enables any person who intends to manufacture or

process a chemical substance which is not subject to a rule under section 4(a) to petition the Administrator to prescribe standards for the

development of test data for such substance. The Administrator must

grant, or deny the petition within sixty (lays. If the petition is granted, the Administrator shall prescribe such standards within seventy-five

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

a petition must be published in the Federal Register.

MANUFACTURING AND PROCESSING NOTICES

Serate bill (section 5)

The Senate bill requires any manu'facturer of a new chemical substance to notify the Administrator at least ninety days prior to the

commencement of commercial manufacture of the new substance. The

notice is to include the common and the trade name of the substance, its

chemical identity and molecular structure, categories or proposed cateHeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 675 1976
83

gories of use, reasonable estimates of the amount to be manufactured or

processed, a description of the by-products, estimates of the number of

people who will be exposed to the substance in their places of employment, and existing data concerning environmental and health

effects of the substance.

In addition, if a testing rule applicable to the substance is in

effect prior to submission of the notice, the manufacturer is required

to submit along with the notification, the test data required to be developed by t lie testing rule.

The ninety day notification period may be extended by the Administrator for an additional ninety days for good cause shown. Notice

of such extension must be )ublished in the Federal Register.

Similar notification is required of any person intending to manufacture or process a chemical substance for a distribution in commerce,

use, or disposal that has been identified by the Administrator, by rule,

as n significant new use, distribution, or disposal. The Administrator is,

by rule, to establish criteria defining a significant new distribution in

commerce, use, or disposal. In establishing such criteria, the Administrator is to take into account the projected volume of production and

category or categories of uses, increases in magnitude and duration of

human or environmental exposure, routes of exposure, and the human

health and environmental effects.

The Senate bill authorizes the Administrator to issue immediately

effective administrative orders during the notification period to halt

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

or disposal of new chemical substances subject to the notification requirements in two situations.

First, the Administrator is required to issue such an order if the

Administrator finds that a testing requirement under section 4(a)

should be established or modified. The order is to remain in effect

until an expedited rulemaking proceeding under section 4(a) to require testing can be completed, the testing performed and the test data

submitted. Second, if the Administrator finds that a new substance

l)resents or is likely to present an unreasonable risk of injury to health

or tie environment, the Administrator is also required to issue aii immediately effective order. If such an order is issued, the Administrator must conduct an expedited rulemaking proceeding in accordance

with the l)ro'isions of sectign 6(c) (2) and (3).

If the Administrator does not take action to prohibit or limit the

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

a new substance (luring the notification period, the Administrator is

required to publish a statement of reasons in the Federal Register for

not taking such action. The statement must be published prior to the

expiration of the notification period. Manufacture or processing of the

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

action subject to iudicial review.

The Senate bill provides certain exemptions from the requirement

to submit manufacturing and processing notice. The Administrator is

authorized to grant such an exemption for test marketing or other

specially limited purposes. In addition, the Administrator may

exempt chemical substances which are intermediate reaction products

HeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 676 1976
64

formed during the manufacture of another chemical substance and

to which there is no human or environmental exposure. In addition,

the notification provisions of the Senate bill do not apply to any

chemical substance manufactured in small quantities solely for scientific experimentation or analysis or for chemical research or analysis,

including such research or analysis for the development of a product.

However, the Administrator may, by rule, require notification prior

to the manufacture or processing of such a substance upon a finding

that the substance may cause or contribute to an unreasonable risk of

injury to health or the environment. Although the section, by its

terms, does not apply to mixtures, the Administrator is authorized to

specify any mixture which shall be subject to the provisions of the

section.

House amendment (section 5)

Like the Senate bill, the House amendment requires manufacturers

of new chemical substance to notify the Administrator ninety days

prior to the commencement of commercial manufacture of such new

substance. The notice is to include information similar to that required by the Senate bill, including test data required to be developed

by any applicable testing rule which has been promulgated under

section 4 prior to the submission of the notice.

In addition, the I-louse amendment requires the Administrator to

compile and maintain a list of chemical substances which cause or

significantly contribute to or may cause or significantly contribute to

an unreasonable risk to health or the environment. If a person intends

to manufacture a 'new chemical substance included on this list and

if no testing rule applicable to the substance has been issued under

section 4, the person must submit to the Administrator information

which the person believes indicates that the chemical substance will

not cause or significantly contribute to an unreasonable risk. Such information must be submitted along with the notice.

The House amendment also requires manufacturers or processors of

an existing chemical substance for a new use which has been designated by the Administrator, by rule, as a significant new use, to

provide similar notice ninety days prior to such manufacture or processing. The House amendment does not require notification prior to

the manufacture or processing of a chemical substance for a significant new distribution in commerce or disposal.

In instances in which there is inadequate information to evaluate

the effects of a new substance or of an existing substance for a significant new use, the Administrator is authorized to seek a court injunction to halt manufacture, processing or distribution in commerce.

The Federal district courts are empowered to grant injunctions if the

court finds that (1) there is inadequate information to reasonably evaluate the health anL _nvironmental effects of the new substance and

(2) in the absence of such information, the substance may cause or

significantly contribute to an unreasonable risk. If an injunction is

granted, the Administrator shall conduct an expedited rulemaking

proceeding to determine if a lesser restriction (rather than a total

halt of manufacture, processing or distribution) would be adequate

to protect health or the environment until adequate test data is developed and evaluated.

HeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 677 1976
65

The House amendment does not require the Administrator to

publish a statement of reasons for not taking action during the

notification period to prohibit or limit the manufacture, processing,

distribution, use or disposal of a new substance or of an existing substance manufactured or processed for a s;ignificant new use.

The House amendment also provides for exemptions from the notification reqdfirements. The Administrator is authorized to provide an

exemption for the manufacture and processing of a substance for test

marketing purposes. The House bill specifically exempts from the

notification requirements those chemical substances manufactured or

processed in small quantities for scientific experimentation or analysis

or for chemical reearch or analysis on such substance or another substance, including research and analysis for the development of a substance or another substance into a commercial product. However, all

persons engaged in such experimentation, research or analysis for a

manufacturer or processor must be notified of any risk to health which

the manufacturer or processor has reason to bejieve may be associated

with the substance.

The Iouse amendment authorizes the Administrator, by rule, to

exempt a manufacturer or processor of any new chemical substance

from all or part of the requirements of this section if the Administrator

determines that such chemical substance will not cause or signifi- cantly contribute to an unreasonable risk to health or the environment. The hII(se amendment also contains an exemption clarifying that, a chemical substance which, except. for its inert, ingredients, is

i(lentical to a chemical substance contained on the section 8(b) inventory will not be treated as a new chemical substance.

'he House amendment does not authorize the Administrator to spec.

ify that a manufacturer of a mixture shall be subject to the notification requircements.

Conference sudbstitute (section 5)

In geniral.-Section 5 sets out the notification requirements with

which manufacturers of new chemical substances and manufacturers

and procvoiors of existing substances for significant new uses must

comply. The requirements are intended to provide the Administrator

with an opportunity to review and evaluate information with respect

to the substance to determine if manufacture, processing, distribution

in commerce, use or disposal should be limited, delayed or prohibited

because, data is insufficient to evaluate the health anid environmental

effects or beceuse the substance or the new use presents or will present

an unreasonnble risk of injury to health or the environment.

The provisions of the section reflect the conferees recognition that

the most desirabh, time to determine the health and environmental

effects of a substance, and to take action to protect against any potential adverse effects, occurs before commercial production begins. Not

only is human and environmental harm avoided or alleviated, but the

(oA of tmiy rgulatory action in terms of loss of jobs a1(1 capital investment is minimized. For these reasons the conferees have given the

Administrator broad authority to act during the notification period. Any person who intends to manufacture a new chemical substance

or manufacture or process a chemical substance for a use which the

Administrator, by rule, has determined is a significant new use, must

HeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 678 1976
give the Administrator at least 90 days notice before beginning such

manufacture or processing, The 90-day period shall begin upon receipt of the notice by the Administrator or the Administrator's duly

designated representative.

The conferees have not included the Senate provision which requires

notification of significant new distributions or disposals. However,

the conference substitute requires that the Administrator consider

the reasonably anticipated manner and method of manufacturing,

processing, distribution in commerce and disposal of a substance in

determining when a use will be considered a significant new use. Thus,

the conferees intend that any potential thrat., to health or the environinent from the manufacture, processinv-, distribution in commerce, or disposal of a substance associated with a new use be considered by the Administrator when determining the significance

of a new use, In addition, the Administrator shall consider the

projected volume of manufacturing and processing of the substance

for a use, the extent to which a use changes the type or form of exposure of human beings or the environment to a substance, and the

extent to which such use increases the magnitude and duration of

human or environmental exposure to a substance. Thus, a significant

increase in tli projected volume of manufacture or processing for a

substance, a significant change in the type or form of human or environmental exposure, or a significant 'increase in the magnitude or

duration of human or environmental exposure could be the basis for

determining that a use is a significant new use.

Slibmission of test data.-Subsection (b) describes the instances in

which a person subject to a notification requirement with respect to a

chemical substance under subsection (a) must submit test data to

the Administrator before manufacture of the substance or manufacture or processing of the substance for a significant new use can begin.

If a rule under section 4 respecting a substance has been promulgated before submission of the notice required by subsection (a),

then a person who is required by the section 4 rule to submit test data

for the substance must submit'such test data at the time the notice

is submitted in accordance with subsection (a). This assures that the

Administrator will have at least 90 days to evaluate the test data before the manufacture or processing begins. If a person has been

granted an exemption from a testing rule under section 4 applicable

to a new substance or to a significant new use of an existing substance,

such person shall not begin manufacture or processing until 90 (lays

after the dale of submission of the test data on which the exemption

is based.

It should be noted that if a testing rule under section 4 respecting

a substance has not been promulgatitd prior to the, submission of a

notice required by section 5, the Administrator may promulgate a

testing rule under section 4 for such substance without taking separate action under this section. However, such a rule would not delay

the manufacture or processing of the substance.

The conferees adopted a provision from the House bill to insure

that information respecting the health and environmental effects of

any chemical substance which the Administrator has identified as a suspect chemical substance is submitted at the time of notification. Under

HeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 679 1976
67

the conference substitute the Administrator may, by rule, compile a list

of chemical substances the manufacture, processing, distribution in

commerce, use or disposal of which presents or may present an unreasonable risk of injury to health or environment. If a testing rule under

section 4 has not been promulgated with respect to such substance

before the submission of the notice, then the person submitting the

notice must submit to the Administrator data which the person believes

shows the manufacture, processing, distribution in commerce, use and

disposal of the substance or any combination of such activities will

not present an unreasonable risk to health or the environment.

Eteiision of o/kce perod.-The Administrator, for good cause,

may extend the 90 day notification period for additional periods not to

exceed in the aggregate 90 days. Notice of any extension together with

the reasons for it shall be published in the Federal Register and shall

const itute final agency action subject to judical review.

The conferees intend that tme Administrator have a large degree of

flexibility in extending the notification period, so that manufacture or

processing may begin as soon as the Administrator has sufficient

information to ev'aluate the substance. For example, if the Administrator exl)eCts that sufficient, data will be available 30 days after the origi- nal notification p)eriod will expire, then the conferees expect that the

Administrator will settle on an extension period which will reasonably

acnimodate production of that data and time for administrative con- sideration. If product ion of the data is delayed, of course the Administrator may extend the original extension period. However, in no case

may the extensions exceed a total of 90 days. Every time that the

notification period is extended, the Administrator must publish notice

of the extension in the Federal Register along with reasons therefor.

Covtent of notice; publicatior~ in the Federal Regiter.-The confei rence substitute requires the notice required under'subsection (a) to

include certain information described in section 8(a) (Reporting and

Rotention of Information) whether or not the Administrator has

required its submission under that section; any test data in the posses- sion or control of the person giving the notice which is related to the

effects on health or the environment of any manufacture, processing, (list ribntiou in coninmerce, use or disposal of the substance; and a description of any other data concerning the health and environmental

effects of the substance, insofar as known to the person making the

report or insofar as reasonably ascertainable. The notice shall be made

available, subject to section 141, for examination by interested persons. InI order that the public receive timely notihcation of any new

(hemical substance or any significant new use of an existing chemical

substance, the conference substitute includes a provision which requires the Administrator to publish in the Federal Register a notice which

identifies the chemical substance, lists the uses or intended uses of the

substance, and describes the nature of tests performed on such substance and any data developed pursuant to subsection (b) or a rule

under section 4. Such publication must occur within 5 days after the

Adm;nistr.alr receives notice from the person who intends to manfactumre Or process. The conference substitute also requires the Administrator to publish monthly a list of each chemical substance for which notice has been

HeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 680 1976
68

received under subsection (a) and for which the notification period

has not expired. The Administrator must also include on the list those

substances for which the notification period has expired since the last,

monthly publication.

Regulation pending developvwnt of inforrmation.-Subsection (a)

sets out the procedures under which the Administrator can halt or limit

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

of a new substance or an existing substance for t significant new use

when there is insufficient information to evaluate the health and environmental effects of the substance.

Action to prohibit or limit manufacture, processing, distribution in

commerce, use, or disposal is requiret i instances in which the Administrator determines that:

(1) Information available to the Administrator is insufficient to

permit a reasoned evaluation of the health and enviroiunental effects of the substance, and

(2) (a). In the absence of information sufficient to permit the

Administrator to make such an evaluation, the manufacture, proc- essing, distribution in commerce, use, or disposal of the substance

may l)resent an unreasonable risk of injury to health or the

environnient, or

(b). The substance is or will be produced in substantial quantities, and (i) enters or may reasonably be anticipated to enter the

environment in substantial quantities or (ii) there is or may be

significant or substantial human exposure to the substance.

If the Administrator makes the above determination at least 45 days

before the expiration of the notification period, then the Administrator

may issue a proposed order to prohibit or limit the manufacture, processing, distribution in commerce, use or disposal of the substance. A

limitation on manufacture or processing could, of course, include a

labeling requirement. The proposed order will take effect upon the

expiration of the notification period unless the manufacturer or processor subject to the order files objections with the Administrator,

specifying with particularity the provision of the order deemed objectionalle and stating the giounds for the objection. To prevent the

order from becoming effective, the objections must be flied within 30

days after the manufacturer or processor has received in writing from

the Administrator a notice of the proposed order. The conferees wish

to stress that the Administrator' must provide actual notice in writing

to the manufacturer or processor who will be subject to the order.

Notice is not to be published in the Federal Register, but is, of course,

available to the public if it is not prohibited from disclosure under

section 14. . This provision thus represents a melding of the Senate bill and the

Houge amendment. In order to insur'e that timely action may be taken

by the Administrator, the conference substitute authorizes the Administrator to issue an administrative order to take effect immediately

upon the expiration of the notification period. However, to protect

against unilateral action by the administrator without, an adequate basis for action, the confere'nce substitute borrows the procedure from

section 701(e) of the Federal Food, Drug, and Cosmetic Act which

permits the filing of objections by manufacturers and processors spe79-313 0 - 77 - 44

HeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 681 1976
69

cifying with particularity the provisions of the order deemed objectionable and stating the grounds for the objections.

If such objections are filed, then the Administrator is instructed to

seek an injunction in a Federal district court to prohibit or limit the

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

the substance. Of course, if the objections filed with the Administrator

indicate to the Administrator that the injunction is not necessary,

then the Administrator is not required to seek the injunction.

If the court finds in such injunction action that (1) information

available to the Administrator is insufficient to permit a reasoned

evaluation of the health and environmental effects of the substance,

and (2) (A) in the absence of such information, the manufacture, processing, (listribution in commerce, use, or disposal of the substance may

present an unreasonable risk of injury to health or the environment

or (B) such substance is or will be produced in substantial quantities

and it enters or may reasonably be anticipated to enter the environment in substantial quantities or there is or may be significant or substantial human exposure to the substance, thei the court shall grant

an injunction. The conferees intend that this two-part standard totally

supplant the traditional elements which a party must ordinarily show

before a court will exercise its equitable jurisdiction to grant an injunction. The conferees do not intend that the Administrator be required to make any showing other than that which is required for the

court to make the two findings described above. Application of any other standard by the court would frustrate the purposes of this section that suspect. chemicals be adequately tested to determine their

health and environmental effects before commercial manufacture or

processing begins.

The conference substitute authorizes such courts to grant a

temporary restraining order or a preliminary injunction to prohibit

manufacture, processing or distribution of a new substance or of an

existing substance for a significant new use if the court finds that

the notification period may expire before the action for an injunction

can be completed. The conferees recognize that a manufacturer or

processor, merely by beginning to manufacture, process, or distribute

aL new chemical or an existing chemical for a significant new use,

coul (lefeat the objective of section 1, to totally prevent environnttal or human exposure to suspect new chemical substances or significant new uses of existing chemical substances until adequate testing

can be performed and the data evaluated. Therefore, the conferees intend that the court freely exercise the authority to grant preliminary

relief as is necessary to preserve the status quo in order to insure that

the policy of this section can be fulfilled.

After submission of adequate test data to the Administrator and

evaluation of such data, the district courts may, upon petition, dissolve the injunction unless the Administrator has initiated a proceeding under section 6(a) with respect to the substance. In such a situation, the injunction shall remnaini in effect until the effective date of a

rule under section 6 (a) or until the section 6 proceeding is terminated,

whichever occurs first.

Protection again.St unrea8onable riak.-Section 5(f) of the conference substitute requires the Administrator to take immediate action

HeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 682 1976
70

to prohibit or limit human or environmental exposure to a new chemical substance or to al existing chemical substance for a significant

new use in certain situations. In section 5(f) the conference substitute

authorizes the Administrator to issue a proposed rule under section

6(a), but such rule is to be effective upon its publication in the Federal Register. Such action is authorized in instances in which there

is a reasonable basis to conclude that the manufacture, processing, distribution in commerce, use, or disposal of the substance presents or will

present an unreasonable risk of injury to health or tile. environment

before a rule promulgated rider section 6(a) could protect against tile risk. The conferees recognize, of course, that there is authority in

section 6(d) under which the Administrator may make. a proposed section 6(a) rule immediately effective. However, to invoke the section

6(d) authority the Administrator must find an imminent, unreasonable risk of serious or widespread injury. With respect to new chemical substanccs or substances for significant new uses, immediate action

is authorized under section 5(f) when there is an imminent, unreasonable risk of injury, regardless of whether the injury will be serious or

widespread.

The section 6 (a) rule proposed and made immediately effective pur- suant to the authority of this section may (A) limit tie amount of a

substance which may. he manufactured,'processed, or (listrihuted in

commerce, (B) conl .i any of the requirements described in para- graph (2), (3), (4), (5) (6). or (7) of subsection 6(a), or (C) contain any combination of the requirements described in clauses (A) and

(B). Iinmediately following tile publication in the Federal Register of a sect ion 6 (a) rule as authorized by this section, the Administrator

must conduct an expedited rulemaking proceeding in accordance with

the provisions of section G(d) (2).

A rule under section 6(a) authorized by this section may not totally

)rohibit the manufacture, processing, or distribution in commerce of

a new substance or an existing substance for a significant new use.

In order to totally prohil)it. the manu fact ure, processing, or distribution in commerce of a new sulst ance. or of an existing substance for a

sign;fivant ne, w use, the Administrator must either issue a proposed order which shall be subject to all the procedures applicable to the

sithation when there is an insufficiency of information, as described

above, or obtain a court injunction. If the court finds that there is a

reasonalble basis to conclude that the nanufacture, processing, distribition in commerce. use or disposal of a new substance or of an existing substance for a significant new use presents or will present al un- reasonable risk of injury to health Or tile environment, tile co0urt shall

issue ail injunction. Again, the conferees intend that the court will

not use the normal equity standard to determine if an injunction should

be issued. Instead, the standard set out in section 5(f) (3) (B) of the

conference substitute is intended to totally replace the normal injunction standard.

The conferees recognize that there will be instances in which there

are a limited number of practical uses for a chemical substance and

that by issuing an immediately effective proposed .rule )rohibiting those uses, the Administrator could effectively prohibit, manufacture

or processing altogether. The conferees view such a prohibition as a

HeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 683 1976
71

total prohibition of manufacture or processing and intend that the

Administrator comply with the procedures of section 5 (f) (3) in

order to obtain a total prohibition on manufacture or processing. The

authority to issue an immediately effective rule to prohibit inmanufacture or processing for a use should be utilized only when there is more

than one practical use of a substance and when 'the prohibition does

not effectively ban all such uses. Likewise, the conferees do not intend

that the Admiiinistrator utilize the authority to issue an immediately effective proposed rule so severely limiting the amount of a substance

which may be manufactured, pr~ocessed, or distributed in commerce

as to effectively prohibit manufacture, processing, or distribution,

StatCndt of reasas for not lakivg aetvin.-If, within the notification period, the Administrator has not initiated action under this section or section 6 or 7 to prohibit or limit the manufacture, processing,

distribution in commerce, use or disposal of certain new chemical substances or of existing chemical substances for significant new uses, then

subsection (g) requires the Administrator to issue a statement of reasons in the Federal Register for not initiating such action. The statenient must be published prior to the expiration of the notification

period. The chemical substances for which such a statement is required

are those for which the Administrator, because of prior administrative

act ion with respect to such chemical substances, has indicated there

may be particular cause for concern. Specifically, a statement of reasons

for not initiating action is required if a testing rule under section 4

applies to a new substance or an existing substance for a significant

new use, or if a substance is listed under section 5(b) (4). In addition,

if notifieation is reruired because a use constitutes a significant new use

and. if no act ion is initiated during the notification period, the Administ rator must issue a statement of reasons for not initiaing,, such action.

Publication of the statement of reasons in accordance with this subsection is not a prerequisite to the manufacture or processing of the

substance with respect, to which the st atement is to be published. Thus,

the Administrator, merely by not issuing the statement of reasons,

cannot delay the beginnig of manufacture or processing of a new

substance or a substance for a significant new use. Nonetheless, the

Adotinistrator must perform this non-discretionary duty and will

subject himself not only to criticism by the Congress for not doing so, but, may also subject himself to suit under section 20 of this Act or

other provisions of law relating to the required performance of nondiscretionary duties.

E.rm.ption.-Subsection (h) describes the situations in which a

chemical substance may be manufactured or processed without regard

to the notice and test data sul)mission requirements of subsections (a)

and (b). Paragraph (1) provides the autbority for granting an exemption for test marketing purposes. Under paragraph (2) an

exentl)tion front the test data submission requirements of subsection

(b) may be obtained if submission of data for the substance to be

exempted would be, duplicative of data already submitted to the

Administrator. Paraqraph (3) adopts the lanf.uaue in the House

amendment specifically exemintlnr from the notification retuiremnents

those chemical substances manufactured or processed or pronosed to

be manufactured or processed in small quantities (as defined by the

HeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 684 1976
72

Administrator by rule) for scientific experimentation or analysis or

for chemical research or analysis, including research and analysis for

the development of the substance or another chemical substance nto

a commercial product. All persons engaged in such experimentation,

research, or analysis for a manufacturer or processor must be notified

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

Under paragraph (4), the Administrator may, upon application and

by rule, exempt the manutfacturer of a new chemical substance from

all or part of the requirements of this section if the Administrator determines that the manufacture, processing, distribution in commerce,

use or disposal of the substance will not present an unreasonable risk

of injury to health or the environment. A rule granting such an exemption must be promulgated in accordance with paragraphs (2), (3), and

(4) of section 6(c).

Paragraph (5) authorizes the Administrator to make the requirements of subsection (a) and (b) inapplicable with respect to the manufacture or processing of a chemical substance which may temporarily exist as a result of a chemical reaction in the manufacture or processing of a mixture or another chemical substance. and to which there

is not or will not be any human or environmental exposure.

The conference substitute deletes the provision in the House amendment which clarified that a chemical substance is not to be treated as a

new chemical substance solely, because of the change in proportions of

inert ingredients. This provision of the House amendment was deleted

because under the definition of "mixture" in section 3 of the conference

substitute the same result would occur, as any change in inert ingredients would constitute a new mixture not a new chenmical substance.

Mixtures are not covered by section 5.

Deflition.--The termns "manufacture" and "process" as used in this

section mean to manufacture or to process for commercial purposes.

Since the teim "manufacture" is defined to include import, persons who

intend to import substances for commercial purposes will be treated

in the same manner as domestic manufacturers under section 5.

REGULATION OF CHEMICAL SKItSTANCEN AND M iXTUtIE6

,enate bill (section 6)

The Senate bill requires the Administrator to impose restrictions on

a chemical substance or mixture if the Administrator finds that the

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

presents or is likely to present all mreasonable risk of injury to health

or the environimemit. The Administrator shall impose one or more of

several specified requirements as is necessary to adequately protect

against tlie risk, using the least burdensome of effective controls.

A range of requirements is provided, from complete prohibitions on

the manufacturing, processing, or distribution in cominmerce to labeling

requirements. Among these is the authority to regulate the manner or

method of use or disposal of such substance or mixture and the authority to require manufacturers or processors to replace or repurchase

substances or mixtures found to present unreasonable risks.

The Senate bill also contains the authority to limit the amount of a

substance or mixture which may be manufactured, processed, or disHeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 685 1976
73

tributed in commerce, or which may be manufactured, processed, or

distributed in commerce for a particular use. A procedure for assigning permissible quotas if the applicable parties are unable to a.ree is

provided. Supervision by the Attorney General and the Federal rrade

Commission is provided for any voluntary efforts to establish quotas. The Senate bill anthorizes the Admuinistrator to order manufacturers

or processors to submit descriptions of relevant quality control procedures if the Administrator has good cause to believe that the manufacture or processing causes the adulteration of a chemical substance or

mixture. If the Administrator determines that the quality control pro- cedures of the maufacturer or processor are inadequate,'the Adinunistrator may order revisions in the quality control procedures to the

extent necessary to remedy t Ile inadequac. The Senate bill also requires the Administrator to consider relevant

factors in imposing retrictions and to make findings with respect to

certain factors.

The Senate bill contains a specific rulemaking procedure for rules

imposing restrictions under this section. The procedure is an informal

one, similar to the procedures in section 553 of title 5, United States

Code, but there are exceptions, including an otl)portunity for an informal hearing. An opportunity for appropriate cross-examination in the

hearing is provided under the sul)ervision of the Administrator. Participants in a rulemahing proceeding may be compensated by the

Administrator under specified criteria.

Thet Administrator may specify the date on which a rule under this

section becomes effective, which shall be as soon as administratively

feasible.

The Administrator may waive the required notice and comment

period in those situations where compliance with the rulemaking pro- visions would present an unreasonable risk of death, serious or substantial personal injury, or serious or substantial environmental harm.

Finally, the Senate bill provides for the control of polychlorinated

biphenyIs (PCBs). Effective one year after the date of enactment of

the Act, PCBs may not be used in any manner other than a totally enclosed manner, except that the Administrator may, by rule, authorize

exceptions if the Administrator finds that no unreasonable risk of

injury to health or the environment is presented. Effective two

years after the date of enactment, the manufacture of any polychlo- rinated biphenyl would become unlawful. Effective two and one-half

years after such date, the processing or distribution in commerce of

PCB's would become unlawful, except, that the Administrator may make exceptions if no unreasonable risk of injury to health or the

environment is presented. Disposal regulations coneerning PCB's

shall be promulgated within six months after the date of enactment.

Tlousc amendment (8ectioz. 6)

The standard for taking action against unreasonable risks under this

section in the House amendment is slightly different from that contained in the Senate bill. If the Administrator finds that there is a

reasonable basis on which to conclude that the manufacture, process- ing, distribution in commerce, use, or disposal of a chemical substance

or mixture, or any combination of such actions causes or significantly

contributes to, or will cause or significantly contribute to, an unreaHeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 686 1976
74

sonable risk to health or the environment, the Administrator shall

inpose requirements as necessary to protect against the risk. The requirements generally are similar to tie requirements of the Senate bill,

with several exceptions. The Administrator may not regulate the manner or method of use. Nor may the Administrator impose replacement

or repurchase requirements for substances regulated. Requirements regulating the manner or method of disposal may not require any

person to take an action in violation of a State or local law. Also, a

person subject to a disposal requirement shall notify the State in

whichi a required disposal may occur of such requirement. The House

amendment does not contain authority to impose manufacturing or

processing quotas. The House amendment provides a procedure for protecting against unintentional contamination of a chemical substance due to the manner

of manufacturing or processing. Quality control procedures may be

required to be submitted. If found inadequate, the Administrator may order such procedures to be changed. In addition, if the quality control procedures have resulted in the distribution in commerce of substances or mixtures which cause or significantly contribute to an unreasonable risk to health or the environment, the Administrator may require manufacturers or processors to give notice and to replace or

I'epurchase any such substance or mixture as is necessory to protect health or the environment,

In promulgating any rule under section 6(a), the Administrator

shall consideI all relevant factors and make findings with respect to

certain factors.

Tie Administrator sliall not promulgate a rule under this section

if the risk could be eliminated or reduced to a sufficient extent under

another federal law administered bv the Administrator unless the

Administrator makes at finding that it is in the public interest to do so, taking into consideration i number of enluerated factors,

The rulemaking procedures of the House amendment are generally similarto those contained in the Senate bill.

Tile Administrator may make a rule immediately effective if all unreasonable risk of serious'or widespread harm to health or the environmnent will occur prior to the Completion of the. rulemaking proceedings, and making tile ruie so effective is necessary to protect the p1l)liw Interest. If a proposed rule totally prohibits'tie manufacture, process- ing 01' distribution of a chemical substance o1 mixture, it court must have previously taken act ion against a substance or mixture in an imminent hazard proceeding under section 7. An expedited rulemaking

procedure is provided for immediately effective rules.

The provision of tie House amendment relating to PCBs is similar

to the Senate bill with a few exceptions. For example, the prohibitions effecl ive in one year apply only to the manufacture, processing or distribution in commerce for a use other than a use in a totally enclosed

manner. In addition, exemptions from the prohibitions :elating to

the maniufactilre, processing, and distribution of PCB's may be

granted, if the Administrator determines that the exemption is necessary to protect health or the environment, and good faith efforts have

been made to develop substitutes.

HeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 687 1976
75

Conferenee substitute (section 6)

The conference substitute requires the Administrator to take action tinder this section against chemical substances or mixtures for which

there is a reasonable- basis to conclude that the manufacture, process- ing, distribution in commerce, use, or disposal of such chemical substances or mixtures, or any combination of such activities, presents or

will present anl unreasonable risk of injury to health or the environmnent. Requirements shall be imposed to the extent necessary to protect

against the risk.

The requirements must be the least burdensome feasible for those

subject to the requirement and for society while providing for an adequate margin of protection against the unreasonable risk.

The requirements which may be imposed are similar to those ineluded in both the Senate bill and the House amendment. The Administrator ma.y impose requirements regulating the manner or method

of the commercial use of a substance a mixture and also requirements regulating the manner or method of disposal of a substance or mixture or an article containing a substance or mixture by the manufacturer or processor or by any other person who uses or disposes of it

for comnnercial Ipurposes. The provision of the TIouse amendmnnt that

it disposal requirement may not require tiny person to take action in

violation of any State law or political subdivision is included. The

Confe rence so bst it ute also includes the Senate provision which authorizes the Administrator to require replacetlent or repurchase by manufacturers or processors of substances or mixtures with respect to which

action has been taken under this section.

The provisions of the House bill relating to quality control are

included.

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

The conferees appreciate that if the Administrator chooses to impose a )roduction litnitation on any chemical substance, such limita- tion, if not carefully drawn, couldl produce monopoly profits. The

conferees believe thnt the Ad ninistrator should consult with the Attorney General and the Federal Trade Commission in order to avoid

t1, anticompetitive consequenuces. , 'I'l conference substitute requires the Administrator to consider

certain enumerated factors and to publish a statement in the Federal

Register with respect to thetn at the time of promulgation of a rule

under section 6(a). Specifically, the Administrator ttust, consider and

plublish a statetntt concerning the effects of the substance or mixture

on health find the mnagnitude of hutan exposure to such substance or

mixture; the effects of the substance or mixture oti the environment

nd thl tuagnitude or environtuental exposture to such suhstance. or

mixtum'e, he benefits of such substance or tmixture for various uses

and the availability of substitutes for such uses; and the reasonably ascertainable economic consequences of the rule, after consideration of the efrects on the national economy: small business, innovation,

the enviromnent. and the public health. This requirement was contained in Iol ht the Senate bill and the Hotise amendment. The putrpose in requiring such a statement is to assure that the basis for the Aqhnin- istrator's rule are publicly enumerated. By requiring the statements,

HeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 688 1976
76

the conferees intend to empl)hasize key considerations which must be

addressed. The conferees do not inten(I that the statement be detailed

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

under suction 0 (a).

Moreover, if tlhe Administrator determines that a risk may be eliminated or rediced to a sufficient extent by actions taken under another Federal law adiniiisteried by the Adm~iinist rator, action may not

be taken uider this section unless tile Administrator finds, in the

Administrator's discretion, that it is in the public interest to take

action under this Act. By committing such determination to the Admimlist rator's discretion, the conferees intend that such determination

not be subject to judicial review.

The I-louse provision relating to compensation for the costs of parficipating in a rulemaking proceeding and the provisions relating to

the effective date of a rule are included. Generally rules are to be effective as soon as procedurally and administratively feasible. However, proposed rules may be declared to be immediately effective by the

Administrator in certain instances. The rule may be Aeclared immediately effective if the Administrator determines that the manufacture,

processing, (list ributi in in commerce, use, or disposal of a substance

or mixture is likely to result in an unreasonable risk of serious or

widespread injury to health or the environment before the normal effective (late and making the rule immediately effective is necessary to

protect the public interest. Ill tile case of a ruhl to prohibit the mannfacture, processing, or the distribution, a court must have granted relief in an imminent hazard action under section 7. An expe dited rulemaking procedure is provided if a i'le is made immediatelv effective.

ihe conference substitute includes procedures cont'ine(l in both

bills for prescribing rules. In general, rules under this section are to be

prescribed in accordance with the informal rulemaking procedures of

section 553 of title 5, Uniled States Code, (.xcept that an Opportunity

for an oral hearing and for limited cross-examination is provided. The

procedures are patterned after those contained in section 18 of the

M[agnuson-Moss Warranty-Federal Trade Commission Improvements

Act.

The Senate bill, unlike the House amendment, specifically authorizes

file Administrator to conduct cross-examination on biehalf of the participants to ilie proieeingi. Althoigh lthe c'onfernce substitute retains

lie Senite provision, the conferees expect that ill most instauces the

participants themselves vouhd conduct the croF,s-(xan mi nt ion, subject

to the Administrator's time limitations and other rules.

When the Act states that the t ranscripts shall be available to the

pmblic, the conferees intend that such availability be construed in a

reasonable manner. No person may )e denied access to such information. but at tle same time the Adninistrator shall not be required to

assume the burden of copying what may be a formidable amount of

material. Therefore. the conferees intend that the Administrntor furnish copies of transcripts as long as a supply exists within EPA. However, if the amount. of material is vast. or if EPA has run out of copies,

then tihe persC-on may inspect the transcript, which shall be available at

every regional office of EPA. EPA may photocopy a reasonable numHeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 689 1976
77

ber of pages, such as 200, but shall in Pll cases afford any person the

opportunity to photocopy as much of the transcript as the person desires. The cost of copying pages beyond a reasonable number- shall be

borne by the person; however, the Administrator shall not charge ah'

unreasonable fee per page.

Generally, the provisions of the Senate bill relating to the control of

polychlorinlated biphenyls are included. The standard that must be

satisfied before exemptions from the complete ban on polychlorinated

lfiphenyls are granted contains elements of both the House and Senate

provisions. Exemptions may he granted only if the Administrator

finds that there is no unreasonable risk to health or the environment,

and that, good faith efforts have been made to develop a substitute. So

that existing PCBs may be reused rather than disposed of, the prohibitions (10 not apply to distributions in commerce of PCBs gold for purposes other thain resale before the effective date of the prohibition on

distribution of PCBs.

IMMINENT HAZARDS

Senate bill (8eation 7)

The Senate bill authoriz-s the Administrator to initiate a judicial proceeding against an imminently hazardous chemical substance or

mixture or against any person who manufactures, processes, distributes

in commerce, uses or disposes of such substance or mixture or against both. The court is authorized to grant such temporary or permanent relief as is necessaryv to protect against the hazard. Such relief may

include seizure and condemnation of the imminently hazardous substance or mixture. Further, the court is specifically authorized to

require manufacturers, processors, or distributors to provide notice

of the hazard to purchasers of the substance or mixture and to the

public, and to recall and replace or repurchase the substance or mixture. Under the Senate bill an imminent hazard is considered to exist

when the evidence is sufficient to show that a situation exists in which

the continued use of a substance or mixture would be likely to result

in unreasonable adverse effects on the environment or an unreasonable

hazard to the survival of an endangered species. An unreasonable

adverse effect is defined to mean an unreasonable risk to man or the

environment taking into account the economic, social, and environmental costs and benefits of the use of the substance or mixture.

IIuse amendment (8pctian 7)

The House amendment differs from the Senate bill in three ways.

First, in addition to authorizing action against imminently hazardous

substances and mixtures, the House amendment explicitly authorizes

actions against articles containing such substances or mixtures. Second,

if the Administrator has not acted under section 6(d) of the House

amendment which authorizes immediate administrative action against

an imminent hazard, the Administrattir is required to take action

under section 7. Third, the House amendment differs from the Senate

bill in its definition of an imminent hazard. Under the House amendment an imminently hazardous chemical substance or mixture is one

which causes or significantly contributes to an imminent and unreasonable risk of serious or widespread harm to health or the environment. Such risk shall be considered imminent if it is shown that the

HeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 690 1976
78

manufacture, processing, distribution in commerce, use or disposal

of a substance or mixture is likely to result in an unreasonable risk

of serious or widespread harm to health or the environment before

a final rule under section 6 can protect against the risk.

Conference 8ubtitute (8ection 7)

The conference substitute follows the House language with a clarification (contained in the Senate bill) that relief is authorized against

persons who use or dispose of an imminently hazardous substance or

mixture in addition to persons who manufacture, process, or distribute

in commerce such substances or mixtures. If the Administrator has

not used the authority provided in section 6(d) (2) (A) (i) to make a

section 6 (a) rule iniediately effective in order to protect against an

imminently hazardous substance or mixture, the Administrator mist

bring an action under section 7. The conferees have imposed such a

nondiscretionary duty upon the Administrator to insure that protection is provided against imminently hazardous substances, mixtures,

and articles containing such substances and mixtures.

The conferees wish to note that while the unreasonable risk of injury

must be imminent, the physical manifestations of the injumy itself

need not be. Rather, an imminent hazard may be found at any point

in the chain of events which may ultimately result in injury to health

or the environment. The observance of actual injury is not essential

to establish that an imminent hazard exists. The conferees intend that

action under the imminent hazard section be able to occur early enough

to prevent the final injury from materializing. In using the term

"widespread injury" the conferees do not intend that the imminent

hazard authority with respect to widespread harm be limited to instances in which the risk of injury is geographically widespread.

Rather an unreasonable risk of harm affecting a substantial number

of people, even though it is within a rather limited geographic area,

should be deemed adequate to satisfy the requirement of an unreasonable risk of widespread injury to health. Of course if the risk of injury to health or environment'is serious, it need not be widespread.

REPORTING AND IETENTION OF INFORMATION

Senate bill (8ectio n 8)

Section 8 sets forth requirements for reporting and retention of information. Under subsection (a) the Administrator shall issue rules

which require each person who manufactures or processes a chemical

substance or mixture to maintain records and to make such reports as

the Administrator may reasonably require. Such rules shall require

manufacturers or processors of chemical substances or mixtures who

produce such substances or mixtures in small quantities solely for

scientific experimentation or analysis for chemical research or analysis

to maintain records and to submit reports only to the extent necessary

for the effective enforcement of the Act. This subsection also contains

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

To determine which substances are new chemical substances for the

purpose of the pre-market notification provisions of section 5, subHeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 691 1976
79

section (b) requires the Administrator to publish an inventory of

existing chemical substances or mixtures which any person report to

be commercially manufactured or processed within the United States

under subsection (a) or under section 5(a). The Administrator shall

publish such list not later than 270 days after the date of enactment.

Subsection (c) requires any person who manufactures, processes,

or distributes chemical substances or mixtures to maintain records of

adverse reactions to health or the environment alleged to have been

caused by any such substance or mixture. These records shall be maintained for 5 years from the date the information was reported to such

person, except that reports dealing with adverse reactions of employees

shall be retained for 30 years. Subsection (d) requires the Administrator to promulgate rules with

respect to the submission of lists of health and safety studies conducted

or initiated by any manufacturer, processor, or distributor in commerce

of any chemical substance or mixture. The Administrator may require

the submission of any study appearing on the list.

Subsection (e) requires manufacturers, processors, or distributors in

commerce of a elemical substance or mixture as well as their liability

insurers to inform the Administrator when they receive information

which supports the conclusion that such substance or mixture causes

or contributes to anl unreasonable risk of injury to health or the environment. Such persons are relieved of such requirement when they

have reason to believe that the Administrator has been adequately informed of the risk.

Moume amendment (section8)

Subsection (a) of the House amendment is substantially similar to

the Senate bill except that it exempts small manufacturers or processors from the reporting requirements. The Administrator may, by

rule, require such persons to maintain records and submit reports on

a chemical substance or mixture subject to a rule or a proposed rule

under section 4,15(c), 5 (g), or 6. In addition, if relief has been granted in an imminent hazard proceeding under section 7, the Administrator

may. by rule, require a small manufacturer or processor to maintain

records and submit reports. After consultation with the Administrator of the Small Business Administration, the Administrator, shall,

by rule, prescribe standards for determining which manufacturers and

processors will be considered "small" manufacturers and processors. As a further limitation, section 8(a) (1) (B) specifies that the Administrator may not require the maintenance of records or the submission of reports with respect, to changes in the proportions of the

compoments of a mixture, unless the Administrator finds that such

recordkeeping or reporting is necessary for the effective enforcement

of the Act.

With respect to the. inventory of existing chemical substances required by subsection (b), the Ilouse amendment provides that the

inventory shall include at least each chemical substance which any

person reports under section 5 or under section 8 (a) was commercially

manufactured or processed in the United States within 3 years before

the effective date of the rules promnulgated under section 8(a). The

House amendment requires the publication of such inventory within

I year after the effective date of the Act.

HeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 692 1976
80

Subsection (c) differs from the Senate bill in that it allows the

Administrator to determine, by rule, the requirements respecting the

maintenance of records of adverse reactions to health or the environment alleged to have been caused by a substance or mixture. The Administrator may require that records relating to adverse reactions to

employee health be retained for up to 50 years.

Subsection (d) concerning submission of lists of health and safety

studies is similar to the Senate bill.

Subsection (e) of the House amendment (loes not require liability

insurers to report to the Administrator information which supports

the conclusion that a substance or mixture may cause or significantly

contribute to an unreasonable risk of injury. Manufacturers, processors, and distributors must report information relating to a substantial risk to health or time environment unless they have actual knowledge that the Administrator has been adequately informed of such

risk.

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

Conference substitutc (8ecthm 8)

The conference substitute follows with some modification the House

amendment of section 8 which outlines the policies and )rocedures for

reporting and retention of information. Subsection (a) identifies which

persons must, pursuant to rules promulgated by the Administrator,

maintain records and make reports. The conference substitute provides

an illustrative list of the kinds of activities for which recordkeeping

and reporting may be required. The list includes such information as

the identity of the chemical, categories of use, amounts manufactured

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

manner or method of disposal. The information specified may be

required by the Administrator "insofar as known to the person maldng

the report or insofar as reasonably ascertainable". The conferees intend that the "reasonably ascertainable" standard be an objective,

rather than a. subjective'one. Thus, the manufacturer or processor

must provide information of which a reasonable person similarly situated might be expected to have knowledge.

Tho conference substitute retains the exemptions in the House

amendment relating to reporting by small businesses. The intent of

the conferees is to protect small manufacturers and processors from

unreasonably burdensome reporting requirements. However, the conferees do no intend to deny the Administrator access to information

which may be necessary either to determine whether a rule or order

should be promulgated or to enforce a final rule or order. Therefore,

the conferees have specifically authorized the Administrator to obtain

reports from small manufacturers and processors of a chemical substance or mixture with respect to which a rule has been proposed or

promulgated under section 4, 5 (b) (4), or 6, or with respect to which

an order or rule is in effect under section 5(e) or 5(f). Thus, once a

rule has been proposed, the Administrator may, by rule, issued in accordance with the informal rulemaking procedures of section 5.53 of

title 5, United States Code, require reporting from small manufacturers and processors. Under such procedures, the Administrator will

HeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 693 1976
81

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

a substance or mixture with respect to which relief has been granted

in a civil action under section 5 or 7.

The conference substitute adopts, with some clarification, the House

amendment in subsection (b) which requires the Administrator to

compile, keep current, and publish an inventory of chemical substances

and mixtures manufactured or processed in the United States. The

conference committee compromised on the date that the Administrator

shall first publish the inventory, which publication shall take place

315 days after the effective date of the Act.

The conference substitute accepts the substance of the Senate bill in

subsection (c), which states that records of significant adverse reactions (as defined by the Administrator by rule) shall be retained for

five years after such reactions are reported. Under this provision an

officer or employee designated by the Administrator may inspect the

records maintained on adverse reactions. The conferees intend that

persons under contract with the Administrator be considered employees of the Administrator. Such contractors and their employees

may have access to records for purposes of this section and throughout the Act. The conferees recognize the special dangers presented to

persons who are exposed to substances on a daily basis; therefore,

records of adverse occupational effects must be retained for thirty

years. The seriousness, duration, and the frequency of reactions should be

taken into account in establishing what constitutes a significant adverse reaction. For example, if an individual reports that a chemical

substance causes his or her eyes to become inflamed and to tear, such

reaction may be attributed to an isolated allergic reaction. However, if

several persons report a similar reaction, then the reaction may indeed be significant. Because the ultimate significance of adverse reactions is difficult to predict, the conferees intend that the requirement to retain records err on the side of safety. Some very serious

neurological disorders, for instance, at first present what appear to be

trifling symptons.

The conference substitute includes the Senate version of subsection (d) concerning health and safety studies with slight modifications. As with the provision concerning adverse reactions, the conferees

emphasize the importance of gaining information which errs on the

side of too much rather than too little. Of course, the Administrator is to avoid imposing unnecessary or overly burdensome 'reporting requirements. In cases where test results are'submitted, supporting data

and the sources for such data must be included.

The conference substitute follows the House amendment for subsection (e) which provides that any manufacturer, processor, or

distributor of a chemical substance or mixture who obtains information supporting the conclusion that such substance or mixture presents

a substantial risk of injury to health or the environment shall notify

the Administrator, unless such person has actual knowledge that the

Administrator already possesses the information.

HeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 694 1976
RELATIONSHIP TO OTHER FEDERAL LAWS

Senate bill (8ection 9)

Section 9 (a) of the Senate bill provides that if the Administrator

(A) has reason to believe that the manufacture, processing, distribution in commerce, use, or disposal of a chemical substance or mixture

causes or contributes to, or is likely to cause or contribute to,an unreasonable risk of injury to health or the environment, and (B) determines, in the Administrator's discretion, that such risk may be

prevented or reduced to a sufficient extent by action taken under a

Federal law not administered by EPA, then the Administrator must

request the agency which administers such law to issue an order. Such

agency shall consider all data submitted by the Administrator and

issue an order declaring whether or not the manufacture, processing, distribution in commerce, use, or disposal of such substance or mixture causes or contributes to or is likely to cause or contribute to

such a risk. If such agency makes such determination it shall also determine if such risk may be prevented or reduced to a sufficient extent

by action taken under the law (or laws) administered by the agency.

The Administrator may specify the time within which the other

agency must issue the order, but such time may not be less than 90

days from the date the request was made. The other agency must issue

a report including a detailed statement of its findings and conclusions in response to the Administrator's request. The Administrator shall not take any action under section 6 or 7

of this Act if such other agency (A) issues an order declaring that

there is no unreasonable risk of injury, or (B) initiates action under

the law (or laws) administered by suc~i agency within g0 days of pub- lication in the Federal Register of its report'in response to the EPA

req est,

Section 9(a) of the Senate bill also states that nothing in this seetion shall prevent the Administrator from making any subsequent

request or taking subsequent action under the Toxic Substances Control Act with respect to such risks if the requirements of section 9 (a)

are satisfied.

Section 9 (a) of the Senate bill provides that if the Administrator

has initiated action umder section 6 or 7 of this bill with respect to a

risk of injury which is the subject of a request to another agency, such

other agency must consult with the Administrator to avoid duplica- tion of Federal action against such risk before taking action under the

law or laws it administers.

Section 9(b) of the Senate bill directs the Administrator to coordinate actions taken under this bill with actions taken under other Federal laws administered wholly or partially by the Administrator. The

Administrator must use the authorities contained in such other Federal laws to protect against any risk to health or the environment associated with a chemical substance or mixture unless the Administrator,

in the Administrator's discretion, determines that such risk might be

more appropriately protected against under this Act. Section 9(b)

does not relieve the Administrator of any duties or responsibilities imposed by other Federal law. Nor does section 9(b) affect any final

action taken under such other Federal law or the extent to which

HeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 695 1976
88

human health or the environment is protected under such other law.

Section 9(c) of the Senate bill states that, in exercising any authority under this bill, the Administrator shall not, for purposes of

section 4(b) (1) of the Occupational Safety and Health Act of 1970,

be deemed to be exercising statutory authority to prescribe or enforce

standards or regulations affecting occupational safety and health.

Section 9(d) of the Senate. bill requires the Administrator to consult

and coordinate with the Secretary of Health, Education, and Welfare and the heads of other appropriate Federal agencies, departments

or instrumentalities for the purpose of achieving the maximum enforcemnent of this legislation while imposing the least burdens of

duplicative requirements on those subject to the bill, and for other

purposes. The Administrator shall report annually to the Congress

on actions taken to so coordinate authority under'this bill with tie

authority granted under other EPA-administered laws and laws

administered by other Federal agencies.

Section 9(e) of the Senate bill provides that nothing in section 9

limits any requirement of section 4, 5 (other than section 5 (e) (2)), or

8, or rules promulgated thereunder.

Ilouse amendmnt (section 9)

Section 9 (a) of the House bill is similar to section 9 (a) of the Senate bill; however, there are certain differences. First, the Administrator's determination that an unreasonable risk to health or the

environment may be prevented or reduced to a sufficient extent by

action taken under a Federal law not administered by the Administrator is not discretionary. Second, if such a determination is made, the

Administrator shall submoit a report to the agency administering such

other law. Such report shall describe such risk and include a specification of the activity or activities which the Administrator has reason

to believe caused or contributed to such risk.

Such report shall request such agency to determine whether the risk

might be prevented or reduced to a sufficient extent by action taken

under such law. Conditioned upon such a determination shall be a

request that the agency issue an order declaring whether the activity

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

shall be reported to the Administrator.

Like the Senate bill, section 9(b) of the House bill requires the

Administrator to coordinate actions taken under this legislation with

actions taken under other laws administered in whole or in part by

the Administrator; however, the language of the House bill differs

regarding the Administrator's authority to regulate a risk to health

or the environment associated with a chemical substance or mixture.

Unless the Administrator determines that it is in the public interest

to protect against such risk by actions taken under this Act, the House

amendment requires tie Administrat or to use the authorities contained

in other laws, if such risk could be eliminated or reduced to a sufficient

extent.

Sections 9(c) and (d) of the House amendment are identical to the

Senate bill. The House amendment contains no provision similar to

section 9(e) of the Senate bill.

HeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 696 1976
Conferenee 8ub8titute (aeotima 9)

The conferees have drawn from both the Senate bill and the

House amendment to assure that overlapping or duplicative regula- tion is avoided while attempting to provide for the greatest possible

measure of protection to health and the environment.

Section 9 (a) establishes the relationship between the Act and Federal laws not administered by the Administrator. If the Administrator

has a reasonable basis to conclude that the manufacture, processing,

distribution in commerce, use, or disposal of a chemical subtance or

mixture presents or will present an unreasonable risk of injury and if

the Administrator makes a discretionary determination (which is not

subject to judicial review) that the risk may be prevented or reduced

to a sufficient extent by action taken under a Federal law not administered by the Administrator, then the Administrator must give the

other agency an opportunity to act to protect against the risk before

the Administrator uses the authorities in section 6 or 7 to protect

against the risk.

If the Administrator determines that another Federal law contains authorities adequate to prevent or reduce the suspected risk

to a sufficient extent, the Administrator shall submit to the agency

which administers the law a report which describes the risk, including a specification of the activity or combination of activities associated with the substance or mixture which the Administrator believes

presents the risk. The report must also include a detailed statement

of the information on which it is based. The report shall also request

the agency to determine if the risk described in the report may be

prevented or sufficiently reduced by action taken under its law and,

if such determination is affirmative, to issue an order declaring whether or not the activity specified in the report presents an unreasonable

risk.

The agency receiving the request from the Administrator must respond to the Administrator within such time as the Administrator

specifies. -owever, the Administrator must give the other agency at

least 90 days.

Section 9(a) prohibits the Administrator from acting under section 6 or 7 with respect to the risk about which the Administrator

notified the other agency if the other agency takes one of two alternative courses of action. First, if the other agency issues an order declaring that the activity specified in the Administrator's report does not

present the unreasonible risk described in the report, then the Administrator may not take action under section 6 or 7 with respect to such

risk. Alternatively, if within 90 days of the publication in the Federal

Register of the other agency's response, t he other agency initiates

action to protect igainst such risk, then the Administrator is precluded

from taking action uinder section 6 or 7 with respect to such risk. If

the other agency does not take one, of these actions, then the Administrator is periitted to act under section 6 or 7 to protect against the

risk.

The conferees recognize that the other agency may not because of

time constraints be able to initiate formal regulatory action to protect

against the risk within the specified time period. As long as the other

agency has officially initiated an action which will culminate as soon as

HeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 697 1976
85

practicable in effective regulatory action to protect against the unreasonable risk and sets forth a general time schedule of steps for such

action, the requirement should be deemed satisfied. However, the requireinent that the other agency initiate action to protect against the

risk is not satisfied by the mere open-ended possibility of action by the

other agency.

Subsection (b) establishes the relationship between this Act and

other laws administered in whole or in part by the Administrator.

Subsection (b) requires the Administrator to coordinate actions taken

under this Act with actions taken under other Federal laws administered by the Administrator.

If the Administrator determines that a risk to health or the environment associated with a substance or mixture could be eliminated or

reduced to a sufficient extent by actions taken under the authorities

contained in other Federal laws, then the Administrator shall use such

other authorities unless the Administrator determines, in the Administrator's discretion, that it is in the public interest to protect against

such risk under this Act. While it is clear that the Administrator's determination that it is in the public interest to use this Act, is a completely discretionary decision not subject to judicial review in any

manner, it is expected that the Administrator will review the other

authorities and present the results of that review at the same time the

Administrator takes action under this Act. While the Administrator's

decision to use this Act,, notwithstanding the other authorities, is unreviewable by any court, a reviewing court is expected to require that

the Administrator have examined the other authorities and present the results of that examination when making the finding that it is in

the public interest to use this Act. Of course, the requirement to examine other EPA laws and to make determinations applies only when

the Administrator takes regulatory action to protect against an unreasonable risk under this Act. It does not apply when the Administrator takes action necessary for the administration or enforcement of

the Act, such as issuing recordkeeping requirements.

This provision is not to be construed to relieve the Administrator

of any requirement imposed by other Federal laws upon the Administrator, and of course nothing in this Act shall affect any final action

taken under other Federal laws administered by the Administrator

or in any way affect the extent to which health or the environment

is to be protected under such other Federal laws.

SECTION 10. RESEARCH, DENELAVPIENT, COLLECTION, DISSEMINATION AND

UTILIZATION OF DATA

Senate hill (section 10)

Section 10 authorizes the Administrator to conduct research and

monitoring in cooperation with the Secretary of Health, Education,

and Welfare and the heads of other appropriate agencies, as is necessary to carry out the purposes of the Act.

The Administrator shall undertake and support programs of research and monitoring of polychlorinated biphenyls to develop safe

methods of disposal. The Administrator shall also establish, administer, and assume responsibility for the activities of an interagency

HeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 698 1976
86

committee to construct within the EPA an efficient system for the collection, dissemination, and use of data submitted to the Administrator

under this Act among other Federal agencies. This interagency committee shall also direct its attention to coordinating the regulation of

chemical substances among the federal agencies. The Administrator

shall design, establish, and coordinate all effective system for the retrieval of toxicological and other scientific data which could be useful to the Administrator in carrying out this Act. This section also

authorizes the Administrator to make grants and to enter into contracts in order to carry out his responsibilities under this section.

Houe amemdment (section 10)

The House version of section 10 is substantially similar to the Senate bill. However, the House amendment omits the requirement that

the Administrator undertake and support programs of research and

monitoring of polychlorinated biphenyls. The House amendment contains additional specific provisions for various research programs such

as the development of rapid, reliable and economical screening and

monitoring techniques for carcinogenic, mutagenic, teratogenic, and

ecological effects of chemical substances and mixtures.

Conference 8ub8titute (oetion 10)

The conference substitute includes provisions found in both the

Senate bill and the House amendment, but generally follows the

language from the House version. Subsection (a) requires the Adininistrator to conduct such research, development, and ionitoring as is

necessary to carry out the purposes of this Act. In doing so, the

Administrator must consult and cooperate with the Secretary of

Health, Education, and Welfare and with heads of other appropriate departments and agencies. The Administrator may enter into contracts and make grants for the purpose of research and development

in this area.

Subsection (b) authorizes the establislunent of an interagency committee whose primary responsibility shall be to design an efficient system within the Environmental Protection Agency for the collection

of data (submitted to the Administrator under this Act), the dissemination of such data to other instrumentalities of the Feneral Government, and the use of such data.

Subsection (b) specifies that an efficient and effective data retrieval

system shall be developed. The conferees emphasize that sufficient data

is necessary for successful implementation of this Act, yet they also

acknowledge the burden placed on industry by excessive or duplicative reporting. It is essential that toxicological'and other relevant scientific

data already in the possession of the Federal Government be made

available to the Administrator. The efficient exchange of information

among Federal agencies and departments will facilitate implenuenta- tionof this Act, and every effort should be made to achieve this goal and to avoid duplicative requirements in information-gathering.

Subsections (c), (d), (e), (f), and (g) of the conference substitute

adopt provisions from the House amendment which concern research

and development in the area of data collection. The conferees do not

intend that such projects should detract from the primary purposes of the Act, but rather that those purposes should be enhanced by

HeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 699 1976
87

allowing the development of proper tools. Thus the purpose of these

subsections is to provide the means to an end, They should in no case

detract from the main purposes of the Act nor Trom other equally

important research conducted by the Administrator, but should contribute to the achievement of those purposes where appropriate. Of

course, such research and development should not duplicate any research and development already being conducted by other Federal

agencies and departments. Thus, careful coordination and consultation

with such departments and agencies is required.

INSPECTIONS AND SUBPOENAS

Senate bill (section 11)

The Senate bill authorizes the Administrator or any duly designated

representative to inspect any establishment, facility or other premises

in which chemical substances or mixtures are manufactured, processed,

stored or held before or after distribution in commerce. Inspections are

also authorized of conveyances used to transport chemical substances

or mixtures in connection with distribution in commerce. Inspections

may extend to all things within the premises or conveyances inspected bearing on whether the requirements of the Act have been complied

with.

The Senate bill also authorizes the Administrator to issue subpoenas

to require the attendance and testimony of witnesses and the production of reports, papers, documents, and answers to questions or other in

formation necessary for the Administrator carry out his or her duties

under the Act.

House amendment (section 11)

The House amendment contains a similar provision authorizing inspections for the purpose of enforcement of the Act. However, the

House amendment provides that no inspection shall extend to financial

data, sales data other than shipment data, pricing data, personnel data,

or research data (other than research data required by the Act) unless

the nature and extent of the data are described with reasonable specificity in the written notice presented to the owner, operator or agent

in charge of the premises or conveyance to be. inspected. The House

amendment contained no subpoena authority.

Cmference substitute (section 11)

The conference substitute includes the. provision from the Senate bill

with the addition of the House provision relating to inspections of financial data, sales data other than shipment data, pricing data, personnel data or research data (other than research data required by the

Act or pursuant to any rule issued under the Act).

The conferees recognize that the Administrator will have access to

much information under section 5 and section 8 of the Act. Therefore,

the conferees expect, that the Administrator will use the subpoena

authority only when information otherwise available through voluni ary means or uider other provisions of this Act is inadequate to meet

the Administrator's needs under this Act.

It should be noted that the conferees intend that representatives of

the Administrator authorized to make inspections should have the

HeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 700 1976
88

opportunity to record the results of such inspections because such

records might be required at some later date; therefore, it is intended

that persons making the inspection shall be allowed, for example, to

photocopy records or photograph premises.

EXPORTS

Sente bill (section 12)

This section outlines the policy for chemical substances and mixtures

manufactured, processed, sold, or held for sale solely for export from

the United States. Subsection (a) provides that unless ti Administrator finds that such substances or mixtures will cause or contribute

to an unreasonable risk to the health of persons within the United

States or the environment of the United States, such substances are

exempt from the Act (other than the reporting requirements of section 8) if proper labeling shows that they are intended for export use

only.

Rowever, subsection (b) allows the Administrator to require testing

under section 4 to see if such substance or mixture may cause or contribute to a risk of health within the United States or to the environment of the United States. Subsection (b) also requires that any person

engaged in export activities shall notify the Administrator if such

activities involve chemical substances or mixtures for which data is

required under section 4 or 5 or for which a rule has been proposed

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

or relief has been granted under section 7. Should any such circumstance arise, the Administrator shall furnish the appropriate foreign

government with relevant information pertaining to the chemical

substance subject to the limitations of section 14.

House amendment (sectio" 123)

Except for minor differences in language, the House amendment follows the Senate provision. The House provision also specifically covers

articles containing chemical substances.

ConfereMwe substitUte (section 123)

The conference substitute follows the policy set forth in both the

Senate and House provisions to protect the health and environment of

persons in the United States and to provide information to foreign

governments regarding chemical substances and mixtures, so that such

foreign governments can protect their own citizens.

ENTRY INTO CUSTO3S TERRITORY OF THE UNITED STATES

Senate bVl (section 13)

The Senate bill instructs the Secretary of the Treasury to refuse

entry into the United States of any chemical substance or mixture

offered for entry if it fails to conform with any requirement of the

Act or any rule in effect under the Act or if it is otherwise prohibited

from being distributed in commerce. If a substance or mixture is

refused entry, the Secretary of the Treasury is required to notify the

consignee of the entry refusal. If the substance or mixture is not

exported within 90 days, the Secretary is to cause the disposal or

storage of the substance or mixture.

HeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 701 1976
89

Homse amendment (section 13)

The House amendment contains a similar provision.

Conferenm substitute (seotion 18)

The conference substitute adopts the provision found in both the

Senate bill and the House amendment relating to entry into the

customs territory of the United States. Although the Secretary of

the Treasury is authorized to cause the disposal of substances and

mixtures which have been refused entry and are not exported within

90 days, the conferees intend that the Secretary consult with the

Administrator before determining the disposal methods for the substance or mixture.

DISCLOSURE Or DATA

Senate bill (section 14)

The Senate bill provides generally that all information obtained

by the Administrator under this Act shall be subject to the Freedom

of Information Act (5 U.S.C. 552). The Freedom of Information Act

makes such information available to the public upon request, unless

the information requested falls into one of nine exceptions.

The Senate bill also requires the disclosure of data in certain further specified situations. If officers or employees of the United States

request information in connection with their official duties under laws

protecting human health or the environment or for specific law enforcement purposes, then the Administrator must disclose the information to them.

Likewise, the Administrator must disclose information to the public whenever the Administrator determines it is necessary to protect

human health or the environment. If the Administrator determines

that disclosure of information is necessary for a contractor or the

contractor's employee to perform official duties satisfactorily under

contracts for the United States in connection with this Act, then the

Administrator must disclose the information. Finally, the Administrator must disclose information to any duly authorized committee of

Congress upon written request.

Houee amendm ent (8 cti(n 14)

The House amendment contains some similarities to, but also some

differences from, the Senate bill. Whereas the Senate bill states that

the Freedom of Information Act applies except in certain areas where

disclosure is mandatory, the House bill statutorily prohibits the disclosure of information which falls into one of the exemption categories (subsection (b) (4) (5 U.S.C. 552(b) (4))) of the Freedom of

Information Act.

Subsection (b) (4) of that Act encompasses matters that are trade

secrets and commercial or financial information obtained from a perso and privileged or confidential. The Administrator may not disclose

information under that classification except to officers or employees of the United States in connection with their duties to protect health

or the environment or for specified law enforcement purposes or

to contractors with the United States or their employees in connection with this Act. Such information may be disclosed when

relevant to a proceeding under this Act, but the disclosure must preHeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 702 1976
90

serve confidentiality as much as possible without impairing the

proceeding.

Subsection (b) (1) specifically provides that disclosure of any

health and safety study for any chemical substance or mixture which

is already being distributed or for which testing is required under

section 4 or for which notification is required under section 5, is not

prohibited. Data in such a study which discloses a manufacturing

process or the proportions of a mixture may not be disclosed if such

process or proportions would otherwise be entitled to protection from

disclosure.

Subsection (c) authorizes any person who submits data under the

bill to designate information he believes is entitled to confidential treatwent under section (it). Designated information may not be released

for 30 days after notification of release has been received by the person

submitting such data.

Conference siubstitute (section, 14)

The conference substitute adopts elements of both the Senate bill

and the House amendment. The prohibition against disclosure of information exempt from mandatory disclosure under section (a) of

section 552 of title 5, United States Code, by reason of its falling within the exemption under suhsection (b)(4) of such section, is

included. Section 14 applies to any release of information obtained

tinder the Act.

Mandatory exceptions from this prohibition are also provided. Disclosure of iniformation described in section 552(b)(4) of title 5 is

required in the following situations:

(1) To officers or employees of the Uinited States in conneection

with their official duties to protect health or the environment, and

for specific law enforcemenlt purl)oss. (2) To contractors with the United States when tihe Administrator determines it to be necesary for the satisfactory performance of their duties in connection' with this Act and under such

conditions as necessary to preser e confidentiality as the Administrator may specify..

(3) If the A dministraitor dutermines it necessary to protect health or the ,nvironment against an unreasonable risk of injury

to ]lalth or the enviromnent.

In addition, the Administrator may disclose such information when

relevant under a proceeding under this Act, except that disclosure

under such proceeding shall be mnadc in such a manner as to preserve

confidentiality to the extent pract icable without impairing the hearing.

It is intended that the Administrator exercise due care to prevent the

release of confidential information to competitors of persons submitting data merely because the competitors have joined the proceeding.

In any procee'ding undei r section 552 (a) of titde 5 to o)tain information which the Administrator has refused to release on the basis that

disclosure is prohibited by section 14(a) of this Act, the Administrator

may, not rely on section 5.1;2(b) (3) of title 5 to sustain the refusal to

disclose the'information. Thus the Administrator will have to show

that the infomiation falls within sectioo 552(b) (4) of title 5. Of

course, section 552, of title 5 is the vehicle through which the public can

obtain information from the Fe(eral governmnt, and all the l)roviHeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 703 1976
91

sions of that section will apply to requests for information obtained

under this Act.

The conference substitute specifically provides that disclosure of any

health and safety study or information from such a study on any substance or mixture which is already being distributed or for which testing is required under section 4 or for which notification is required

under section 5, is not prohibited. Data in such a study which discloses manufacturing processes or the proportions of a mixture may

not be disclosed if such processes or proportions would otherwise be

entitled to protection from disclosure. However, any restriction on the

release of such data will not apply to the health and safety study in

which it is contained or from which it is derived. To comply with such

restriction the Administrator need only to exclude such data when

releasing such study.

If a request is made to the Administrator for health and safety study

information which is not entitled to protection, the Administrator may

not deny a request under section 552 of title 5, United States Code, on

the basis that such information is included in the exceptions to mandatory disclosure enumerated in subsection (b) (3) or (b) (4) of such

section. It is also intended that the Administrator not use exception

(b) (7) of section 552 of title 5, relating to matters under investigation,

in an excessi4 manner as a device for withholding information subinitted under this Act. In order to be withheld under that exception,

the information must be the subject of an ongoing, active investigation.

In submitting data, a person may designate data which the person

believes is entitled to confidential treatment under this Act and submit

it, separately. If the Administrator proposes to release for inspection

designated data, the Administrator must give 30 days notice to the

person who submitted the information. Thirty days advance notice

need not be given when information is to be released under one of

the mandatory exceptions described above or when disclosure is not

prohibited because the information is health and safety data. When

disclosure is proposed because it is necessary to protect health and

the environment from an unreasonable risk, the Administrator shall

provide the person submitting the data written notice by certified

mail of the proposed release at least 15 days prior to the release.

The purpose of this provision is to provide the person submitting

the data an opportunity to seek to stop the proposed release if that

person disputes the Administrator's determination. The conferees

recognize that there may arise emergency situations in which the

Administrator determines that earlier release is necessary. In such

cases, where the occurrence of the unreasonable risk is imminent, the

Administrator need give notice only 24 hours prior to release. The

required notice need not be given in writing but may be made by some

other means such as telephone or telegraph.

The criminal penalties for wrongful disclosure contained in the

I-rouse bill have been included in the conference substitute.

PROJUBITED ACTS

,enate bil (section 15)

The Senate bill makes it unlawful for any person to fail or

refuse to comply with any rule or order promulgated under section

HeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 704 1976
02

4, 5, or 6, or any requirement prescribed by section 5 or 6. It also

makes it unlawful for any person to use or dispose of 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 or a rule or order under section 6. Failure or refusal to establish or maintain records, submit reports, notices, or other information or to permit access to, or copying of, records is also unlawful.

Finally, the Senate amendment makes unlawful the failure or refusal

to permit entry or inspection as required by section 11.

House amendrnent (section 15)

The House amendment makes it unlawful for any person to fail or

refuse to comply with any rule or order promulgated under section 4,

5 or 6 or any requirement prescribed by section 5. It also makes it unlawful for any person to use for commercial purposes a chemical substance or mixture which the person using such substance or mixture

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 6 or an order issued in an action brought under section 5 or 7. The

House provisions respecting maintenance of records, submission of

reports, entry, and inspections are identical to the Senate bill.

Conference substitute (section 15)

The conference substitute incorporates the provisions of the House

bill with a conforming amendment making violations of the provisions

of section 6 relating to polychlorinated biphenyls an unlawful act.

PENALTIES

Senate bill (section 16)

This section outlines the penalties and procedures for assessing penalties against persons who violate section 15. Subsection (a) provides

for civil penalties of up to $25,000 per day per violation. Taking relevant factors into account, the Administrator shall assess the amount

of such civil penalties in an order made on the record after the opportunity for an adjudicative hearing and proper notification of the

person in violation of this Act. Such person may file a petition for

judicial review of an order assessing civil penalties in U.S. Court of

Appeals within thirty days; however, if a person fails to pay such assessment after it has become a final and unappealable order or after

the Court of Appeals has found in favor of the Administrator, then

the Attorney General shall recover the amount assessed.

Subsection (b) provides for criminal penalties of up to $25,000

per day or up to one year's imprisonment, or both, per violation for

any person who knowingly or willfully violates this Act.

House anednient (seetion 16)

The House amendment follows subsections (a) and (b) of the Senate provision. In addition, subsection (c) of the House Amendment

provides that the Administrator may require a person who has manufactured, processed, or distributed a chemical substance or mixture

in violation of regulations issued under paragraphs (1) o2 (2) of

section 6(a) to give notice of the risk associated with that substance

to any person who may be exposed to it and to the public at large.

HeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 705 1976
The Administrator may also require such person to either replace or

repurchase the substance found to be in violation. The Administrator

may choose any or all of the remedies set forth in subsection (c) ; however, in each case the order must be made on the record with full opportunity for an agency hearing.

Conference sub8titute (section 16)

The conference substitute adopts the provisions found in both bills

concerning civil and criminal penalties for violations of this Act.

Under subsection (a), the Administrator shall assess the amount of

civil penalties up to $25,000 per day per violation; however, the

Administrator must take into account such factors as the gravity and

extent of the violation, the ability to pay of the person held in violation, and any prior history of violations under this Act.

Criminal penalties may be imposed on persons who "knowingly or

willfully" violate any provision of section 15, which sets forth unlawful

acts.

SPECIFIC ENFORCEMENT AND SEIZUIl

Senate bill (aection 17)

The Senate bill grants the United States district courts jurisdiction,

upon application of the Administrator or the Attorney General, to

restrain any violation of section 15, to restrain any person from manufacturing or processing a chemical substance before the expiration of the notification period under section 5, and to restrain any person

from taking any action prohibited by a requirement prescribed under

section 5 or 6 or rules or orders issued under section 5 or 6. In addition, the courts are granted jurisdiction to direct any manufacturer or

processor of a chemical substance or mixture who is not in compliance

with any order issued under section 5 (e) or any rule issued under section 4 or 6 to give notice of such fact to persons within the chain of

distribution and to the public, and to either replace or repurchase the

substance or mixture. The Senate provision also authorizes the district

bution and to the public, and to either replace or repurchase the substance or mixture. The Senate provision also authorizes the district,

courts to compel the taking of any action required by or under the

Act. In addition, the Senate bill provides that any substance or mixture manufactured or processed or distributed in commerce in violation of the Act or any rule or order promulgated under the Act shall

be liable to be proceeded against for seizure and condemnation.

Hou8e amendment (8ection 17)

The ]House amendment grants jurisdiction to the district courts to

restrain any violation of section 15, to restrain any person from manufacturing or processing a substance before the expiration of the notification period under section 5, and to restrain any person from taking

awtion prohibited by section 5 or a rule or order under section 5 or 6.

Jurisdiction is also granted to compel the taking of any action required by or under this Act. The seizure authority in the House amendment is similar to that found in the Senate bill, except that seizure

and condemnation of articles containing chemical substances or mixtures tminufactured, processed or distribnted in commerce in violation

of the Act or any rule or order promulgated under the Act is specifically authori7ed.

HeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 706 1976
94

Qon/erenwe substitute

The conference substitute grants the district courts of the United

States jurisdiction to restrain any violation of section 15, to restrain

any person from manufacturing or processing a substance before the

expiration of the notification period under section 5, and to restrain

any person from taling any action prohibited by section 5 or 6 or a

rule or order under section 5 or 6. The provision also grants such

courts jurisdiction over actions to direct any manufacturer or processor of a chemical substance or mixture manufactured or processed

in violation of any order issued under section 5 or any rule or order

issued under section 6 to give notice of the risk associated with the

substance or mixture to persons in the chain of distribution and to the

public. The courts also have jurisdiction to require manufacturers or

processors to either replace or repurchase the substance or mixture,

whichever the person to whom the requirement is directed elects. The

conference substitute also grants jurisdiction to compel the taking of

any action required by or under the Act. The seizure authority in the

conference substitute is identical to that contained in the House

amendment.

PREEM ITION

Senate bill (section 18)

This section outlines the relationship between State authority and

the authority under this Act to regulate chemical substances or mixtures. Subsection (a) asserts the State's authority to regulate, with

certain limitations. No State may require testing which duplicates

testing required by the Administrator under a section 4 testing rule.

Further, if the Administrator has prescribed a requirement under section 5 or 6 to protect against a particular risk associated with a chemical substance or mixture, a State may not prescribe any different requirement (other than a total ban) with respect to that risk unless the

State obtains permission from the Administrator to do so.

rhe Administrator may, by rule, grant such permission if the

Administrator finds that compliance with the State requirement would

not result in a violation of this Act., would result in a significantly higher degree of protection, and would not unduly burden interstate

commerce.

House amendment (8ection 18)

The House amendment is similar to the Senate bill. However, rules

promulgated under section 6(a) (5) do not preeript State laws. Moreover, rules pronmulgated under other Federal authorities such as the

Clean Air Act, are not preempted by requirements under this Act.

Like the Senate bill, the House amnendment authorizes the Administrator to exempt, by rule, States from prohibitions under subsection

(a) in the same manner as the Senate bill.

Conference substitute (section 18)

The conference substitute provides that no State or political subdivision may establish similar requirements for the testing of a substance or miixture after the Administrator has issued a rule under

section 4 respecting the substance or mixture. Nor may any State regulate any risk associated with a substance or mixture if tie Administrator has prescribed a rule or order under section 5 or 6, which is

HeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 707 1976
95

designed to protect against the risk to health or the environment,

unless the rule (A) is identical to that issue under this Act, (B) is

adopted under the authority of another Federal law, or (C) prohibits

the use of such substance or mixture other than in its use in the manufacture or processing of other chemical substances or mixtures.

In addition to the specific exemptions from the preemption pro- vision, the conference substitute provides a means whereby a State or

political subdivision may seek an exemption from the preemptive

effects of a Federal requirement in order to provide a higher degree of protection for their citizens than that provided by a requirement

under this Act. The Administrator may, by rule, grant an exemption

if compliance with the State or local requirement will not cause a

violation of the applicable requirement under this Act, if the State

or local requirement will provide a significantly higher degree of protection from the risk, and if the State or local requirement will not

unduly burden interstate commerce.

JUDICIAL REVIEW

Senate bill (section 19)

The Senate's provision authorized pre-enforcement judicial review

of any rule under the Act or an order issued under section 5(e). Any

rule promulgated under section 3(b), 5 or 6 shall not be affirmed

1i1il.s. SIpl)Jorte(d by sulstantial evidence on the record taken as a whole.

Ilou,8e amendment (section 19)

The House provision authorizes pre-enforcement judicial review of

rules issued under section 4, 5 or 6(a). Such rules shall not be

affirmed unless supported by substantial evidence based on the record

taken as a whole.

Conference substitute (section 19)

Section 19 of the conference substitute provides for judicial review

in the courts of appeals of the United States for certain rules promulgated under the Act. The jurisdiction for preenforcement review and

review of determinations of the Administrator relating to cross-examination is exclusively vested in such courts. Not later than 60 days after the date of promulgation of a rule under section 4(a), 5(a) (2),

5(b) (4), 6((a), 6(e), or 8 any person may file a petition for judicial review of the rule in the appropriate U.S. court of appeals.

The section specifically defines the rulemaking record to include the

rule being reviewed (which would include the statement of basis and

purpose pursuant to section 553 (c) of title 5, United States Code), any transcript required to be made of an oral presentation, 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 published a notice in the Federal Register identifying the information on or before the date of the promulgation of such rule, In addition certain findings and statements required

to be made with respect to specific rules must also be included in the

rulemaking record. In the case of a rule under section 4(a), the finding required by that section must be included in the record. In the

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

HeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 708 1976
06

by that section must be included in that record. In the case of a rule

under section 6(a), the finding required by section 5(f) or section

6(a), as the case may be, and the statement required by section 6(c)

(1) must be included'in the rulemaking record.

The section includes authority for the submission of additional data

and oral or written views and for the modification of the rule being

reviewed.

Generally section 706 of title 5, United States Code, applies to

review of a rule under this section. However, in the case of review of

a rule under section 4(a), 5(b) (4), 6(a) or 6(e), the bill provides that the courts shall hold unlawful and set aside such rule if the court

finds that the rule is not supported by substantial evidence in the rulemaking record taken as a whole. This provision is in lieu of paragraph 2 (E) of section 706 of title 5. It is the intent of the conferees that the

traditional presumption of validity of an agency rule is to remain

in effect. The conferees recognize that in rulemaking proceedings such

as those contained in this bill, which are essentially informal and

which involve both determinable facts and policy judgments derived

therefrom, the traditional standard for review is that of "arbitrary and capricious". However, the conferees have adopted the "substantial

evidence" test because they intend that the reviewing court focus on

the rulemaking record to see if the Administrator's action is supported by that record. Of course, the conferees do not intend that the court

substitute its judgment for that of the Administrator.

Further, in the case of review of a rule under section 6 (a), the court

shall set the rule aside if it finds that action by the Administrator in

excluding or limiting cross-examination or rebuttal submissions pre- cluded disclosure of disputed issues of material fact necessary for a

fair determination of the rulemaking proceeding taken as a whole.

Also, in review of such rules, section 706(2) (D) will not apply with

respect to review of the Administrators actions respectig limitations

or exclusions of cross-examination or rebuttal submissions, and review

of such actions can occur only during preenforcement judicial review.

Section 19 also provides that the court may not review the contents and adequacy of any statement required to be made pursuant to

section 6(c) (1) or any statement of basis and purpose required by section 553(c) of title ' of United States Code to be incorporated ini

the rule except as part of a review of a rulemaking record taken as a

whole.

Section 19 provides that in a judicial review proceeding under this

section the court may award the costs of suit and reasonable fees for

attorneys and expert witnesses if the court determines that such an

award is appropriate. In addition, in any review of such an action the

Supreme Court may also award such costs of suit and reasonable fees. he section also provides that the remedies provided in section 19

shall be in addition to, and not in lieu of, any other remedies provided by law. This provision should not be construed, however, to negate the

provision in this section which specifically provides that the United

States courts of appeals shall have exclusive jurisdiction of any action

to obtain judicial review (other than in an enforcement proceeding) if any district court of the United States would have had jurisdiction of such an action but for the provisions of this section.

HeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 709 1976
97

CITIZEN'S CIVIL ACTIONS

Senate bill (8ection 20)

Subsection (a) authorizes any person to commence a civil action in

specified district courts against (A) any person including the United

States or any governmental agency or instrumentality alleged to be

in violation of this Act or any rule or order prescribed under sections

4, 5, or 6(a). Such suits may also be brought to compel the Administrator to perform any nondiscretionary act or duty.

Subsections (b), (c), and (d) specify certain procedural provisions.

No action may begin until the Administrator and the alleged violator

have received proper notice of the alleged violation. If the Administrator has instituted a civil action against an alleged violator to compel

compliance, then no action may be brought under this section. However,

if the Administrator does not commence such action until after the

person bringing the citizen's civil action has notified the alleged violator of intention to sue under this Act, then the person who gave

such notification may intervene in the suit brought by the Administrator. The Administrator may intervene in any civil action under

this section to which the Administrator is not a party. The court may

award the costs of the suit and reasonable fees for attorneys and

expert witnesses. The court may also consolidate two or more civil

actions involving the same defendant, the same issues, or the same

alleged violations when appropriate.

House amendment (section 0)

The House amendment contains the same provision as the Senate

bill.

Conference substitute (section 20)

The conference substitute contains the provision included in both the

Senate bill and the House amendment with a clarification that citizen's

civil actions may also be brought for violations of an order under

section 5 or 6.

CITIZENS' PETrIONS

Senate bill (section 21)

Section 21 of the Senate bill authorizes any person to petition the

Administrator to issue a rule or order or to take other action for the

purpose of protecting against an unreasonable risk of injury to health

or the environment. If the petition is denied or not acted upon within

90 days, the petitioner may bring a civil action in a United States

district court to compel the Administrator to initiate the requested

action. If the petitioner demonstrates by a preponderance of the evidence in a de novo proceeding that the action requested in the petition

conforms to the applicable requirements of the Act, the court shall

order the Administrator to initiate the requested action.

House amendment (section 21)

The House amendment authorizes any person to petition the Administrator to initiate a proceeding for the issuance, amendment, or

repeal of a rule under section 4, 5 (c), or 6 (a). If the petition is denied,

the petitioner may file a civil action to compel the Administrator

HeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 710 1976
to initiate the rulemaking proceeding. If the petitioner requests the

issuance of a rule under section 4, 5(c), or 6(a) (as opposed to the

modification or repeal of such a rule) the petitioner has an opportunity for a de nove proceeding before the court. If the petitioner makes

the requisite showings for the applicable provision, the court must

order the Administ.rator to initiate the requested action unless the

court finds that the failure of the Administrator to initiate the requested action was not unreasonable.

Conference 8ubstitute (section 21)

The conference substitute authorizes any person to petition the Administrator to initiate a proceeding for the issuance, amendment or

repeal of an action under section 4, 5 (e), 6, or 8 of the Act. It should

be noted that a petition under this section may be used to initiate a

proceeding under section 5(f) since a proceeding under that section is

for the issuance of a rule under section 6(a). The Administrator must

grant or deny any petition under this section within 90 days after it is

filed.

The conference substitute thereafter provides for different judicial

review of the Administrator's denial of a petition, depending upon

whether such petition seeks the issuance of a rule or order or the amendment or repeal of an existing rule or order.

The substitute affords greater rights to a person petitioning for the

issuance of a rule or order because in such a situation the Administrator will not previously have addressed the issue by rule or order. If the

Administrator denies or fails to respond to a petition for the issuance

of a rule or order, the petitioner may commence a civil action in a

United States district court to compel the Administrator to take the

action requested in the petition. In the court, the petitioner is entitled

to a de nero proceeding. If the petitioner demonstrates to the court

by a preponderance of the evidence that there is an adequate basis

for the issuance of the rule or order requested, the court shall order

the Administrator to initiate the requested action.

The court may defer requiring the Administrator to take the requested action if it finds that the extent of risk of injury to health or

the environent alleged by tie petitioler is less than those risks of injury which the Administrator is addressing under this Act and there

are insufficient resources to do both. If a deferral is granted, the conferees anticipate that the Administrator may seek extensions as needed.

The conference suibstitute provides different treatment for review

of petitions for amendment. or rel)eal of rules or orders, because the

Administrator already will have addressed the general subject matter

in an existing rule or order and the Administrator's determination

will have been subject to review under section 19 of this Act. Therefore, the conferee's min interest, is to make certain that any such petitioner receive timely consideration of such petition. By requiring the

Administrator to act on any such petition within 90 dlays, the conferees

will facilitate such a petitioner's right to seek judicial review should

the Administrator deny the petition. Otherwise, the Administrator

could avoid any judicial review simply by failing to take any action.

Fhe conferees believe that a petition for amendment or repeal of aii

existinog rule or order should contain newly discovered, noncumulative

HeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 711 1976
material which was not presented for the Administrator's consideration in promulgating the rule or order. Failure to include such information would be an adequate basis for denying the petition.

At the same time, the conferees do not intend that the Administrator be subjected to constant petitions challenging rules or orders for

which adequate judicial review is provided under section 19. Therefore, if the Administrator denies a petition to amend or repeal an

action under section 4, 5(e), 6, or 8, the conference substitute permits

review of such denial only under the Administrative Procedure Act.

NATIONAL DEFENSE WAIVER

Senate bill (section 22)

The Senate bill directs the Administrator to waive compliance with

nny provision of this Act upon the request of the Secretary of Defense and a determination by the President that the interest of national defense requires such a waiver. The Administrator shall

maintain a written record of the basis for the waiver. In addition, the

Administrator shall publish notice of the waiver in the Federal

Register, unless the Administrator determines, upon request from

the Secretary of Defense, that such publication is contrary to national

defense interests, in which case, the Administrator shall notify the

Armed Services Committees of the Senate and the House of

Representatives.

House amendment (section 22)

The House amendment is similar to the policies and procedures of the Senate bill except that only the President, not the Secretary of

Defense, is authorized to request a national defense waiver from the

Administrator and to request that publication of the waiver not be

placed in the Federal Register for national defense reasons.

Conference 8UbstitUte (section R2)

The conference substitute includes the provision of the House

amendment.

EMPLOYEE PROTECTION

Senate bill (section 23)

Section 23 of the Senate bill provides protection for employees who

cooperate with the Administrator in carrying out the Act. The provision prohibits any employer from discharging any employee or

otherwise discriminating against the employee with respect to compensation, terms, conditions, or privileges of employment because the

employee commenced, caused to be commenced, or is about to commence

a proceeding under the Act. Protection is provided for employees who

have testified or are about to testify in any proceeding under the Act

or who have assisted or participated in a proceeding or any other ac-'

tion to carry out the purposes of the Act. The Secretary of Labor shall

conduct investigations of alleged violations and issue orders to require

any person who violates the prohibitions to take affirmative action to

remedy any such violation. Any person adversely affected by an order

of the Secretary may obtain judicial review of the order in the United

States court of appeals for the circuit in which the violation allegedly occurred. The Secretary is authorized to enforce the orders in the disHeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 712 1976
100

trict court of the United States for the district in which the violation

occurred.

Houe amendment (section 23)

The House amendment contains an identical provision.

Oonference 8ub8titlte (section 23)

The conference substitute adopts the provision found in both the

Senate bill and House amendment.

EMPLOYMENT EFFECTS

Senate bill (aection .3(f) )

The Administrator shall conduct continuing evaluation of the effect on employment of rules or orders under this Act. Any employee

who is discharged or whose employment is threatened or who is otherwise discriminated against as a result of any action under this Act

may request investigation of the matter by the Administrator. The

Administrator shall investigate the matter. If any interested party

requests a hearing, the Administrator shall conduct a public hearing

in accordance with section 554 of title 5, United States Code, at which

,he parties are required to present information on any employment

effects.

Upon receipt of the investigation report, the Administrator shall

make findings of fact as to the employment effects and shall make appropriate recommendations which shall be available to the public.

Joue amendnwvt (section 04)

The I-louse amendment is similar to the Senate bill. The House provision differs from the Senate's primarily as to whether and how a

hearing requested by an interested person shall be conducted.

Upon request, the Administrator must hold a public hearing unless

the Administrator determines that there are no reasonable grounds for

such hearing. The hearing need not be a formal adjudicative hearing

under 5 U.S.C. 554. Provision is made for subpoenas, oaths, and paynient of witness fees in connection with any investigation or public

hearing conducted under this section.

Conference substitute (8ection £4)

The conference substitute follows the House amendment with two

modifications. First, if the Administrator determines that there are

no reasonable grounds for holding a hearing, the Administrator must

so find, by order, within 45 days of the date within which time such

hearing is requested. Second, if a hearing is held, it shall be in accordance with the requirements of section 6(c) (3) of this Act.

STUDIES

Senate bill (section .4)

The Senate bill requires the General Accounting Office to conduct a

study of all Federal laws administered by the Administrator to deternine whether and under what conditions, if any, idemnification should

be accorded any person as a result of action taken by the Administrator under such laws. The Senate bill also requires the Council on Environmental Quality to coordinate a study of the feasibility of

19.313 0 - 77 - 40

HeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 713 1976
101

establishing a standard classification system of chemical substances

and related substances and a standard method for storing and obtaining rapid access to information respecting such substances.

House amend-ment (section 25)

The House amendment contains a similar provision except that the

indemnification study shall be conducted by the Administrator and

reviewed by the General Accounting Office.

Con/erenwe substitute (section 25)

The conference substitute includes the House provision.

ADMINISTRION OF THE ACT

Senate bill (section 26)

Subsection (a) gives authority to each federal department and

agency to cooperate with the Administrator, upon request, by sharing

services of personnel, facilities, and information in order to carry out

the purposes of this Act.

Subsection (b) provides that the Administrator may, by rule, require payment from any person submitting data pursuant to section

4 or 5 to help defray administrative costs, provided that no such fee

exceeds $2,500.

Under subsection (c), the Administrator may act with respect to

categories of cmical substances or mixtures. For purposes of this

section, a category includes chemical substances or mixtures grouped

hv virtue of similarity of chemical structure, physical, chemical, or

biological properties, use or mode of entry into the human body or environment, or some other suitable grouping.

Under subsection (d), any proposed or final rule or order under this

Act shall be accompanied by a statement of purpose and justification,

which identifies the basis for the action. This statement shall become

part of the "record of the proceedings" for purposes of judicial review

under section 19(a).

Subsection (e) directs'the President to appoint by and with the

advice and consent of the Senate, an Assistant Administrator of the

Environmental Protection Agency to administer this Act. The Assistant Administrator slhall be qualified to direct a program concerning

the effects of chemicals on health and the environment by reason of

background and experience.

Hou.e amendment (section £6')

The House amendment contains provisions similar to the Senate

bill concerning cooperation among federal agencies and fees to be paid

by persons submitting data under section 4 or 5 to defray administrative costs, except. that no small businesses shall be required to pay

administrative fees exceeding $100. The House amendment also inincludes a provision on categories similar to that in the Senate bill.

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

an Assistant Administrator for Toxic Substances. However, the House

amnendmenit establishes an oflice within the Environmental Protection

Agency to provide technical and other nonfinancial assistance to manufacturers and processors of chemical substances and mixtures

concerning the requirements and application of this Act.

HeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 714 1976
1M2

The House amendment does not contain a specific provision requir

ing that each proposed or final rule pr order be accompanied by s

statement of purpose or justification.

The House amendment in section 29 provides that each officer and

employee of the Environmental Protection Agency and the Secretary

of Health, Education, and Welfare who perform any function or duty

under the bill and who has any known financial interest in any person

subject to the bill or in any person who applied for or received any

financial assistance pursuant to the bill must, beginning February 1,

1977, annually file with the appropriate agency or department a

statement concerning all such interests during the preceding calendar

year. Such statement must be available to the public.

The I-ouse amendment also directs the Administrator and the Secretary, within 90 days after enactment, to define "known financial interest" and to establish methods to monitor, enforce, and review the filing

of such statements. They are also directed to report each year to Congress on June 1 regarding such disclosures and actions taken concerningthem during the preceding calendar year.

Officers or employees in designated positions of a nonregulatory or

nonpolicymaking nature may be exempted, by rule, from the requirements of this section.

The House amendment states that any officer or employer who is

subject to, ant knowingly violates, this section or any regulations

issued thereunder is to be fined not more than $2,500 or imprisoned

for not more than one year, or both.

Cmoferenee sub8titute (8ection £6)

The conference substitute incorporates provisions from both the

Senate bill and the House amendment. Subsection (a) gives authority

to each federal agency and department to cooperate with the Administrator to carry out the purposes of this Act.

The Administrator is authorized to require, by rule, payment of

reasonable fees from any person required to submit data. under sections

4 and 5 in order to defray the costs of administering this Act. In no

case shall such fees exceed $2,500, or $100 in the case of a small business.

In all cases when setting such fees, the Administrator shall take into

account the ability to pay of persons submitting data.

The conference substitute includes the House provision concerning

categories in subsection (c). The conferees expect that the Administrator will find the authority to categorize especially helpful in promulgating rules under section 5(a) (2) concerning what constitutes

significant new use of chemical substances.

The conference substitute adopts the provision from the House

amendment which establishes an office within EPA to provide technical

and other nonfinancial assistance to manufacturers, processors of

chemicals, and others. The purpose of the office is to help manufacturers and processors understand the requirements of the Act in order

to assist in its efficient implementation and to avoid unnecessary confusion, which might prove detrimental to the chemical industry and

the public interest. . The conference substitute adopts the House provision on financial

disclosures for which the Senate bill had no comparable provision.

HeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 715 1976
1'03

The procedures and penalties are designed to make sure that persons

who perform regulatory functions under this Act divulge any known

financial interest such persons may have in any person subject to this

Act.

Subsection (f) of the conference substitute modifies the requirement in the Senate amendment that each proposed or final rule or

order be accompanied by a statement of basis and purpose to apply

only to final orders.

The conference substitute includes the provision found in the Senate

bill that the President appoint, with the advice and consent of the

Senate, an Assistant Administrator for Toxic Substances who shall

direct ii program concerning the effects of chemicals on human health

and the environment and perform other duties and responsibilities

under this Act.

While the Assistant Administrator for Toxic Substances will be

assigned responsibilities pursuant to this Act, the Administrator may

assign additional duties. Of course this position will be in addition to

the eisting five assistant administrator positions established by

Reorganization Plan No. 3 of 1970.

DEVEOPMENT AND EVALUATION OF TEST METHODS

Senate bill

The Senate bill contains no provision respecting development and

evaluation of test methods.

HIoue amendment (8ection 27)

The House amendment authorizes the Secretary of Health, Education, and Welfare, in consultation with the Administrator and acting

through the Office of the Assistant Secretary for Health, to conduct

projects for the development and evaluation of inexpensive and efficient methods for determining and evaluating the health and environmental effects of chemical substances and mixtures.

Conf erenwe substitute (section 27)

The House provision is included.

STATE PROGRAMS

Senate bill (section 25)

Section 25 authorizes the Administrator to assist up to three states

in the establishment of demonstration programs to complement federal efforts under the Act. Subsection (a) describes the functions of

such programs. Subsection (b) requires the Administrator to submit

unnual reports to the Congress on the demonstration programs. Subsection (c) authorizes appropriation of funds to assist the states in

funding the demonstration programs. Grants shall not exceed 75

percent of the cost of any demonstration program. Subsection (d)

provides that, assistance slhall be available to those states which can

establish a priority need for such assistance. The Senate bill authorizes a maximum ap propriation of $2 million for the fiscal year ending

September 30, 1977, $2 million for the fiscal year ending September 30,

1978, and $2 million for the fiscal year ending September 30, 1979.

HeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 716 1976
104

Hou8e amend~nent (section 28)

The House amendment is similar to the Senate bill, but differs

in that grants are authorized only to assist states in addressing risks

associated with substances and mixtures which the Administrator is

unable to address.

Tim House amendment does not restrict the number of programs

which the Administrator may approve. The House amendment authorizes an annual appropriation of $1 million for the fiscal years

ending September 30, 1978, September 30, 1979 and September 30,

1980.

Conference substitute (section 28)

The conference substitute generally follows the House amendment

with some modification. The. Administrator may make grants to States

to establish programs to )revent or eliminate unreasonable risks associated with chemical substances or mixtures against which the Administrator is not able or not likely to take action under this Act. The conferees agreed to a compromise on the authorization for such programs

of $1.5 million for each of the fiscal years 1977 through 1979.

.%UTHORIZATrON FOR APPROPRIATIONS

Senate bill (section .7)

Section 27 of the Senate bill authorizes to be appropriated to the

Administrator $11,100,000 for the fiscal year ending June 30, 1976,

$2,600,000 for the period beginning July 1, 1976 and-ending September 30, 1976, and $10,100,000 for the fiscal year ending September 30,

1977. This section prohibits using funds for construction of research

laboratories.

Section 27(b) of the Senate bill requires that the Administrator

submit concurrently to the Congress any budget requests, supplemental budget estimates, legislative recommendations, prepared testimony for Congressional hearings, or comments on legislation to the

President or to the Office of Management and Budget connected with

this Act.

House amendment (8ection 30)

The House amendment authorizes to be appropriated $12,625,000

for the fiscal year ending September 30, 1978, $16,200,000 for the

fiscal year ending September 30, 1979, and $17,350,000 for the fiscal

year ending September 30, 1980. The House amendment contained no

provision relating to simultaneous submissions.

Conferenwe substitute (section 29)

The conference substitute authorizes to be appropriated to carry

out the purposes of this Act as follows: $10,100,000 for the fiscal year

ending September 30, 1977; $12,625,000 for the fiscal year ending

September 30, 1978; and $16,200,000 for the fiscal year ending September 30,1979.

The conference substitute contains no provision for simultaneous

submission of materials to Congress and the Office of Management and

Budget.

HeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 717 1976
105

ANNUAL REPORT

Senate bill (section 28)

The Senate bill requires the Administrator to submit to both the

President and the Congress a comprehensive annual report. The report

shall include (1) a list of the testing required under section 4 and

an estimate of the costs incurred by the person required to

perform the tests; (2) the number of notices received under section 5, the number of notices received under section 5 for chemical

substances subject to a section 4 rule, and a summary of any action

taken during the premarket notification period; (3) a list of rules

issued under section 6; (4) a list, with a brief statement of the issues,

of completed or pending judicial actions under the bill; (5) a summary

of major problems encountered in administration of the bill; and

(6) such recommendations for additional legislation as the Administrator deems necessary to carry out the purposes of the bill.

House anendnent (section 31)

The House amendment is almost identical to the Senate bill. The

only difference occurs with respect to the date that the Administrator

must submit the first annual report. The House amendment specifies that the Administrator shall submit the first annual report on or bebefore January 1,1979.

Conference substitute (section 30)

The conference substitute generally follows the provision of the

Senate bill. The first submission is due on or before January 1, 1978.

REVIEW

Senate bill

The Senate bill contained no rule review provision.

Iouse anendment (section 32)

Section 32 of the House amendment provides that either House of

Congress may veto a rule issued by the Administrator, the Secretary of the Treasury, or the Secretary of Health, Education, and 1W elfare

under this Act, by adopting a resolution of disapproval within 60

days.

Conference substitute

The House recedes.

EF'ECTIVE DATE

Senate bill

The Senate bill contained no specific provision specifying an effective date; therefore, the legislation is to take effect upon enactment.

house amemdment (section 33)

The House amendment provides that the legislation shall take effect

October 1, 1977.

Conference substitute

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

two years.

HeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 718 1976
719

106

HARLEY 0. STAGGras,

JOHN M. MURY,

W. S. STUoKEY,

BOB E&KHARDT,

RALPH H. METCALWz,

WILLIAM BRoCD.EAD,

JAMEs H. SCHEuRR,

SAMUEL L. DEvxNw,

JAMES T. BROrYHH,

MArrEw J. RINALMo,

Managera on the Part of the Rauoe.

WARREN G. MAGUNSON,

VANCE HARTKE,

Pnnp A. HART,

JoN A. DuRKiN,

JOHN V. TuNN Y,

HOWARD BAKER,

T. E. STmvxs,

Mangera on the Part of the Senate.

HeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 719 1976
HeinOnline -- 1 Legislative History of the Toxic Substances Control Act: Together with a Section-by-Section Index 720 1976