Legislative history of the Toxic Substances Control Act, together with a section-by-section index

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Title:
Legislative history of the Toxic Substances Control Act, together with a section-by-section index
Physical Description:
vii, 801 p. : ; 24 cm.
Language:
English
Creator:
United States -- Congress. -- House. -- Committee on Interstate and Foreign Commerce
Library of Congress -- Environment and Natural Resources Policy Division
Publisher:
U.S. Govt. Print. Off.
Place of Publication:
Washington
Publication Date:

Subjects

Subjects / Keywords:
Poisons -- Law and legislation -- United States   ( lcsh )
Genre:
federal government publication   ( marcgt )
bibliography   ( marcgt )
non-fiction   ( marcgt )

Notes

Bibliography:
Bibliography: p. 791-792.
Additional Physical Form:
Also available in electronic format.
Statement of Responsibility:
prepared by the Environment and Natural Resources Policy Division of the Library of Congress for the House Committee on Interstate and Foreign Commerce.
General Note:
Reuse of record except for individual research requires license from LexisNexis Academic & Library Solutions.
General Note:
CIS Microfiche Accession Numbers: CIS 77 H502-3
General Note:
Reuse of record except for individual research requires license from Congressional Information Service, Inc.
General Note:
Includes index.
General Note:
At head of title: Committee print.

Record Information

Source Institution:
University of Florida
Rights Management:
All applicable rights reserved by the source institution and holding location.
Resource Identifier:
aleph - 022382933
oclc - 02720172X
Classification:
lcc - KF49
System ID:
AA00025884:00001

Full Text




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[COMMITTEE PRINT]


LEGISLATIVE


HISTORY OF THE


TOXIC


SUBSTANCES


CONTROL ACT


TOGETHER WITH

A SECTION-BY-SECTION INDEX
PREPARED) BY THE

ENVIRONMENT AND NATURAL RESOURCES
POLICY DIVISIONN
OF TiHE


LIBRARY


OF CONGRESS


FOR TIHE

HOUSE COMMITTEE ON


INTERSTATE


AND FOREI TGN


COMMERCE


DECEMBER 197(6


Printed for the use of the
Committee on Interstate and Foreign Commerce

U.S. GOVERNMENT PRINTING OFFICE


WASHINGTON : 1976


79-3130























COMMITTEE ON INTERSTATE AND FOREIGN COMMERCE


HARLEY 0. STAGGERS, West Virginia, Chairman


JOHN E. MOSS, California
JOHN D. DINGELL, Michigan
PAUL G. ROGERS, Florida
LIONEL VAN DEERLIN, California
FRED B. ROONEY, Pennsylvania
JOHN M. MURPHY, New York
DAVID B. SATTERFIELD III, Virginia
BROCK ADAMS, Washington
W. S. (BILL) STUCKEY, JR., Georgia
BOB ECKHARDT, Texas
RICHARDSON PREYER, North Carolina
JAMES W. SYMINGTON, Missouri
CHARLES J. CARNEY, Ohio
RALPH H. METCALFE, Illinois
GOODLOE E. BYRON, Maryland
JAMES H. SCHEUER, New York
RICHARD L. OTTINGER, New York
HENRY A. WAXMAN, California
ROBERT (BOB) KRUEGER, Texas
TIMOTHY E. WIRTH, Colorado
PHILIP R. SHARP, Indiana
WILLIAM M. BRODHEAD, Michigan
JAMES J. FLORIO, New Jersey
ANTHONY TOBY MOFFETT, Connecticut
JIM SANTINI, Nevada
ANDREW MAGUIRE, New Jersey
MARTIN A. RUSSO, Illinois


SAMUEL L. DEVINE, Ohio
JAMES T. BROYHILL, North Carolina
TIM LEE CARTER, Kentucky
CLARENCE J. BROWN, Ohio
JOE SKUBITZ, Kansas
JAMES M. COLLINS, Texas
LOUIS FREY, JR., Florida
JOHN Y. McCOLLISTER, Nebraska
NORMAN F. LENT, New York
H. JOHN HEINZ III, Pennsylvania
EDWARD R. MADIGAN, Illinois
CARLOS J. MOORHEAD, California
MATTHEW J. RINALDO, New Jersey
W. HENSON MOORE, Louisiana


W. E. WILLIAMSON, Clerk
KENNETH J. PAINTER, Assistant Clerk

Professional Staff


CHARLES B. CURTIS
LEE S. HYDE
ELIZABETH HARRISON
JEFFREY H. SCHWARTZ


WILLIAM P. ADAMS
ROBERT R. NORDHAUS
BRIAN R. MOIa
KAREN NELSON


MARGOT DINNEEN
LEWIS E. BERRY, Minority Counsel


(1)













LETTER OF TRANSMITTAL


TIlE LIBRARY OF CONGRESS,
CONGRESSIONAL RESEARCH SERVICE,
Wash idto D.C., Norember 15, 1976.
Hon. HAI.RLEYv 0. STA.GGERS,
Charn'/ni. Commfflttec on Interarxfate adl Foreign Conmerce, U.S.
House of Represnv/at;rs, ,1F(is5hnqgton, D.C.
DEAR MRh. CHAII.IRANx : In response to your requ(e-t, we hliave prepared
a legislative history of the Toxic Siubstances Control Act, Public Law
94-469.
This document contains the major bills, reports, and debates which
Co 1pri0se the action of the 94th Congress concerning tlhe act. Appen-
(lices contain a report of tlhe Couincil on Environmental Quality which
originally proposed this legislation and a bibliography of Congres-
sional documents concerning Toxic Substances Control legislation
from 1971 to 1976. A section-by-section index is includ(led to permit
easier access to Iprovisions of concern.
The history sliould be of considerable aid to legislators, public offi-
cials, industries, and( the general public who are affected by this act
and ,who wish to ndlerstand(l the Congre-.-ional intent of Public Law
94-469.
The author of this report was John K. Blo(dgett, Analyst, of tlie
Environment and Natural Resources Policy Division.
We hope this document will serve your Conmmittee's needs for a his-
tory of Congrressional action on tlis act.
Sincerely,
NORMA N BECK M.AN,
Actng Director.
(III)






























































4













FOREWORD


This committee print compiles the significant documents and de-
bates comprising the legislative history of S. 3149, the Toxic Sub-
stances Control Act. signed into law (Public Law 94-469) on Octo-
ber 11, 1976.
Congressional activity concerning this act extends back to 1971,
when the Council on Environmental Quality published a report. "Toxic
Substances." This rel)ort is reprinted as an appendix. The major Con-
gressional (locilments and debates of the full period of action on toxic
substances control-1971 to 1976-are listed in the bibliography.
In the debates, references to specific sections are in boldface type;
these refer to the section numbers of the bill un(ler consideration. A
table at the. beginning of the index correlates the section numbers of
the major bills and of the act (all of which are identical except for the
last few sections).
JOHN E. BLi)(;:TT,
.4ianystE) E o rviroment Om, fatuifIal
Resourees Poiry Divi;son.



















Digitized by the Internet Archive
in 2013













http://archive.org/details/leehisto00unit
















CONTENTS


Page
Chapter I: Toxic Substances C (introl Aet -------------- ----- 2
Public Law 94-469 -------- ----------- 3
President's approval ------------ ------- ------ 53
(hIpter II: S. 3149------------------ 55
S. 3149-------------- ------------- --- 57
Senate Report No. 94-698 ------------- -- ------- 155
Senate debate. Ma r'h 26. 197;-----_----------------- 207
Chapter III: H.R. 14032 -.- 25---------------- ---------- 2!5
H.R. 14032_ ----------------------------- -------- ------ 217
HIou.se Report No. ')4-1341-------- -- --------------- 407
House debate, Augi-t 2'. 1976-------------------------- 517
Chapter IV ('Conference Report---------------- 665
(',nferen(ce' r-leprt. I',,ike Re.lirt No). 94-1679)_. ---.----- 6W7
Senate c'n1-i(deration if conference report, Seiteinler 2^. 10 76---_ 721
House c Appendlix I: C'uin'icil on, E,11vironmeintal Qua;ility repoirt-To.iic' nifu.tn'
(1971) ------------------------------------- 75-,
Apiiendlix II BilTliograihy---('ngressional (docinlents 1971-197---------- 7S9
Sect ion-by-section inl-ex :
Table c'mpiaring stectionso uf Pul)lic Law 94-469. H.R. 14032. and
S. 3149--------------------------- ----------------------------- 75
Index -------------------------------------------------- --------- -75
(VII)































































































b




























CHAPTER I


TOXIC SIU'STACES CONTROL ACT-
PIITBLIC LAW 194-4(6)














PUBLIC LAW 94-469-OCT. 11, 1976


Public Law 94-469
94th Congress /


An Act


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.

Be t enachted by the St nate and ilou.e of Representatives of the
n itt d States of Anrm rit/< in Congiess assemn bled,
SECTION 1. SHORT TITLE AND TABLE OF CONTENTS.
This Act may be cited as thle "Toxic Substanrces Control Act".


Oct. 11, 1976
[S. 3149]


Toxic Substances
Control Act.
15 USC 2601
note.


TABLE OF CONTENTS


Sec. 1. Short title and table of contents.
Sec. 2. Findings, policy, and intent.
Sec. 3. Definitions.
Sei-. 4. Testing if che .lemnical substances and mixtures.
Sec. 5. Manufacturing and processing notices.
Sec. 6. Regulation (if hazardous chemical substances and mixtures.
Se,. 7. Imminent hazards.
See. 8. Reporting and retention of information.
Sec. 9. Relationship to other Federal laws.
Sec. 10. Research, development, collection, dissemination, and utilization of data.
Sec. 11. Inspections and subpoenas.
Sec. 12. Exports.
Sec. 13. Entry into customs territory of the United States.
Sec. 14. Disclosure of data
Sec. 15. Prohibited acts.
Sec. 16. Penalties.
Sec. 17. Specific enforcement and seizure.
Sec. IS. 'reemption.
Sec 19. Judicial review.
Sec. 20. Citizens' civil actions.
Sec. 21. Citizens' petitions.
Sec. 22. National defense waiver.
Sec. 23. Employee protection.
Sec. 24. Employment effects.
Sec. 25. Studies.
Sec. 26. Administration of the Act.
Sfc. 27. Development and evaluation of test methods.
Sec. 28. State programs.
See, 29. Authorization for appropriations.
Sec. 30. Annual report.
Sec. 31. Effective date.
SEC. 2. FINDINGS, POLICY, AND INTENT.
(a) FINDINGS.-The Congress finds that-
(1) human beings and the environment are being exposed each
year to a large number of chemical substances and mixtures;
(2) among the many chemical substances and mixtures which
are constantly being developed and produced, there are some
whose manufacture, processing, distribution in commerce, use, or
disposal may present an unreasonable risk of injury to health or
the environment; and
(3) the effective regulation of interstate commerce in such
chemical substances and mixtures also necessitates the regulation
of intrastate commerce in such chemical substances and mixtures.
(b) PoLmcy.-It is the policy of the United States that-
(1) adequate data should be developed with respect to the effect
of chemical substances and mixtures on health and the environ-


15 USC 2601.


90 STAT. 2003










PUBLIC LAW 94-469-OCT. 11, 1976


15 USC 2602.










7 USC 136 note.



42 USC 2011
note.
26 USC 4181.

26 USC 4182,
4221.

21 USC 321.


USC 453.
USC 601.


21 USC 1033.


ment and that the development of such data should be the respon-
sibility of those who manufacture and those who process such
chemical substances and mixtures;
(2) adequate authority should exist to regulate chemical sub-
stances 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;
and
(3) authority over chemical substances and mixtures should be
exercised in such a manner as not to impede unduly or create
unnecessary economic barriers to technological innovation while
fulfilling the primary purpose of this Act to assure that such inno-
vation and commerce in such chemical substances and mixtures
do not present an unreasonable risk of injury to health or the
environment.
(c) INTENT OF CONGRESS.-It is thle intent of Congress that the
Administrator shall carry out this Act in a reasonable and prudent
manner, and that the Administrator shall consider the environmental,
economic, and social impact of any action the Administrator takes or
proposes to take under this Act.
SEC. 3. DEFINITIONS.
As used in this Act:
(1) the term "Administrator" means the Administrator of the
Environmental Protection Agency.
(2) (A) Except as provided in subparagraph (B), the term "chem-
ical substance" means any organic or-morganic substance of a particu-
lar molecular identity, including-
(i) any combination of such substances occurring in whole or
in part as a result of a chemical reaction or occurring in nature,
and
(ii) any element or uncombined radical.
(B) Such term does not. include-
(i) any mixture,
(ii) any pesticide (as defined in the Federal Insecticide, Fungi-
cide, and Rodenticide Act) when manufactured, processed, or
distributed in commerce for use as a pesticide,
(iii) tobacco or any tobacco product,
(iv) any source material, special nuclear material, or byproduct
material (as such terms are defined in the Atomic Energy Act
of 1954 and regulations issued under such Act),
(v) any article the sale of which is subject to the tax imposed
by section 4181 of the Internal Revenue Code of 1954 (deter-
mined without regard to any exemptions from such tax provided
by section 4182 or 4221 or any other provision of such Code), and
(vi) any food, food additive, drug, cosmetic, or device (as such
terms are defined in section 201 of thlie Federal Food, Drug, and
Cosmetic Act) when manufactured, processed, or distributed in
commerce for use as a food, food additive, drug, cosmetic, or
device.
The term "food" as used in clause (vi) of this subparagraph includes
poultry and poultry products (as defined in sections 4(e). and 4(f)
of the Poultry Products Inspection Act), meat and meat food prod-
ucts (as defined in section 1(j) of the Federal Meat Inspection Act),
and eggs and egg products (as defined in section 4 of the Egg Prod-
ucts Insnection Act).
(3) The term "commerce" means trade, traffic, transportation, or
other commerce (A) between a place in a State and any place outside


90 STAT. 2004










PUBLIC LAW 94-469-OCT. 11, 1976 90 STAT. 2005

of such State, or (B) which affects trade, traffic, transportation, or
commerce described in clause (A).
(4) The terms "distribute in commerce" and "distribution in com-
minerce" when used to describe an action taken with respect to a chem-
ical substance or mixture or article containing a substance or mixture
mean to sell, or the sale of, the substance, mixture, or article in com-
merce; to introduce or deliver for introduction into commerce, or the
introduction or delivery for introduction into commerce of, the sub-
stance, mixture, or article; or to hold, or the holding of, the substance,
mixture, or article after its introduction into commerce.
(5) The term "environment" includes water, air, and land and the
interrelationship which exists among and between water, air, and land
and all living things.
(6) The term "health and safety study" means any study of any
effect of a chemical substance or mixture on health or the environ-
minent or on both, including underlying data and epidemiological
studies, studies of occupational exposure to a chemical substance or
mixture, toxicological, clinical, and ecological studies of a chemical
substance or mixture, and any test performed pursuant to this Act.
(7) The term "manufacture" means to import into the customs
territory of the United States (as defined in general headnote 2 of
the Tariff Schedules of the United States), produce, or manufacture. 19 Usc 1202.
(8) The term "mixture" means 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; except
that such term does include any combination which occurs, in whole
or in part, as a result of a chemical reaction if none of the chemical
substances comprising the combination is f new chemical substance
and if the combination could have been manufactured for commer-
cial purposes without a chemical reaction at the time the chemical
substances comprising the combination were combined.
(9) The term "new chemical substance" means any chemical sub-
stance which is not included in the chemical substance list compiled
and published under section 8(b). Pos, p. 2027.
(10) The term "process" means the preparation of a chemical sub-
stance or mixture, after its manufacture, for distribution in
commerce-
(A) in the same form or physical state as, or in a different
form or physical state from, that in which it was received by the
person so preparing such substance or mixture, or
(B) as part of an article containing the chemical substance
or mixture.
(11) The term'"processor" means any person who processes a chemi-
cal substance or mixture.
(12) The term "standards for the development of test data" means
a prescription of-
(A) the-
(i) health and environmental effects, and
(ii) information relating to toxicity, persistence, and other
characteristics which affect health and the environment,
for which test data for a chemical substance or mixture are to
be developed and any analysis that is to be performed on such
data, and
(B) to the extent necessary to assure that data respecting such
effects and characteristics are reliable and adequate-
(i) the manner in which such data are to be developed,
(ii) the specification of any. test protocol or methodology
to be employed in the development of such data, and










90 STAT. 2006


PUBLIC LAW 94-469-Ocr. 11, 1976

(iii) such other requirements as are necessary to provide
such assurance.
(13) The term "State" means any State of the United States, the
District of Columbia, the Commonwealth of Puerto Rico, the Virgin
Islands, Guam, the Canal Zone, American Samoa, the Northern
Mariana Islands, or any other territory or possession of the United
States.
(14) The term "United States", when used in the geographic sense,
means all of the States.


SEC. 4. TESTING OF CHEMICAL SUBSTANCES AND MIXTURES.
15 USC 2603. (a) TESTING REQUIREMENTS.-If the Administrator finds that-
(1) (A) (i) the manufacture, distribution in commerce, proc-
essing, use, or disposal of a chemical substance or mixture, or that
any combination of such activities, may present an unreasonable
ri Ik of injury to health or the environment,
(ii) there are insufficient data and experience upon which the
effects of such manufacture, distribution in commerce, processing,
use, or disposal of such substance or mixture or of any combina-
tion of such activities on health or the environment can reason-
ably be determined or predicted, and
(iii) testing of such substance or mixture with respect to such
effects is necessary to develop such data; or
(B) (i) a chemical substance or mixture is or will be produced
in substantial quantities, and (I) 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 such substance or mixture,
(ii) there are insufficient data and experience upon which the
effects of-the manufacture, distribution in commerce, processing,
use, or disposal of such substance or mixture or of any combina-
tion of such activities on health or the environment can reason-
ably be determined or predicted, and
(iii) testing of such substance or mixture with respect to such
effects is necessary to develop such data; and
(2) in the case of a mixture, the effects which the mixture's
manufacture, distribution in commerce, processing, use, or dis-
posal or any combination of such activities may have on health or
the environment may not be reasonably and more efficiently deter-
mined or predicted by testing the chemical substances which com-
prise the mixture;
Rules. the Administrator shall by rule require that testing be conducted on
such substance or mixture to develop data with respect to the health
and environmental effects for which there is an insufficiency of data
and experience and which are relevant to a determination that the
manufacture, distribution in commerce, processing, use, or disposal
of such substance or mixture, or that any combination of such activities,
does or does not present an unreasonable risk of injury to health or
the environment.
(b) (1) TESTING REQUIREMENT RuIL.E.-A rule under subsection (a)
shall include-
(A) identification of the chemical substance or mixture for
which testing is required under the rule,
Standards for (B) standards for the development of test data for such sub-
development of stance or mixture, and
test data. (C) with respect to chemical substances which are not new
Data, submittal to chemical substances and to mixtures, a specification oi the period
Administrator. (which period may not be of unreasonable duration) within










PUBLIC LAW 94-469-OCT. 11, 1976 90 STAT. 2007

which the persons required to conduct the testing shall submit to
the Administrator data developed in accordance with the stand-
ards referred to in subparagraph (B).
In determining the standards and period to be included, pursuant to
subparagraphs (B) and (C), {n a rule under subsection (a), the
Administrator's considerations shall include the relative costs of the
various test protocols and methodologies which may be required under
the rule and the reasonably foreseeable availability of the facilities
and personnel needed to perform the testing required under the rule.
Any such rule may require the submission to the Administrator of pre-
liminary data during the period prescribed under subparagraph (C).
(2) (A) The health and environmental effects for which standards
for the development of test data may be prescribed include carcino-
genesis, mutagenesis, teratogenesis, behavioral disorders, cumulative
or synergistic effects, and any' other effect which may present an unrea-
sonable risk of injury to health or the environment. The characteristics
of chemical substances and mixtures for which such standards may
be prescribed include persistence, acute toxicity, subacute toxicity,
chronic toxicity, and any other characteristic whIch may present such
a risk. The methodologies that. may be prescribed in such standards
include epidemiologic studies, serial or hierarchical tests, in vitro tests.
and whole animal tests, except that before prescribing epidemiologic
studies of employees, the Administrator shall consult with the Director
of the National Institute for Occupational Safety and Health.
(B) From time to time, but not less than once each 12 months, the Review of
Administrator shall review the adequacy of the standards for develop- standards.
mnent of data prescribed in rules under subsection (a) and shall, if
necessary, institute proceedings to make appropriate revisions of such
standards.
(3) (A) A rule under subsection (a) respecting a chemical substance
or mixture shall require the persons described in subparagraph (B)
to conduct tests and submit data to the Administrator on such sub-
stance or mixture, except that the Administrator may permit two or
more of such persons to designate one such person or a qualified third
party to conduct such tests and submit such data on behalf of the per-
sons making the designation.
(B) The following persons shall be required to conduct tests and
submit data on a chemical substance or mixture subject to a rule under
subsection (a) :
(i) Each person who manufactures or intends to manufacture
such substance or mixture if the Administrator makes a finding
described in subsection (a) (1) (A) (ii) or (a) (1) (B) (ii) with
respect to the manufacture of such substance or mixture.
(ii) Each person who processes or intends to process such sub-
stance or mixture if the Administrator makes a finding described
in subsection (a) (1) (A) (ii) or (a) (1) (B) (ii) with respect to
the processing of such substance or mixture.
(iii) Each person who manufactures or processes or intends to
manufacture or process such substance or mixture if the Adminis-
trator makes a finding described in subsection (a) (1) (A) (ii) or
(a) (1) (B) (ii) with respect to the distribution in commerce, use,
or disposal of such substance or mixture.
(4) Any rule under subsection (a) requiring the testing of and
submission of data for a particular chemical substance or mixture
shall expire at the end of the reimbursement period (as defined in sub-
section (c) (3) (B)) which is applicable to test data for such substance
or mixture unless the Administrator repeals the rule before such date;










90 STAT. 2(0M








Oral presentation
and written
submissions.
Transcript.
Publication.


Application.
















Fair and
equitable
reimbursement.











Rules.


PUBLIC LAW 94-469-OCT. 11, 1976


and a rule under subsection (a) requiring the testing of and submission
of data for a category of chemical substances or mixtures shall expire
with respect to a chemical substance or mixture included in the cate-
gory at the end of the reimbursement period (as so defined) which is
applicable to test data for such substance or mixture unless the Admin-
istrator before such date repeals the application of the rule to such
substance or mixture or repeals the rule.
(5) Rules issued under subsection (a) (and any substantive amend-
minent thereto or repeal thereof) shall be promulgated pursuant to
section 553 of title 5, United States Code, except that (A) the Admin-
istrator shall give interested persons an opportunity for the oral pres-
entation of data, views, or arguments, in addition to an opportunity to
make written submissions; (B) a transcript shall be made of any oral
presentation; and (C) the Administrator shall make and publish with
the rule the findings described in paragraph (1)(A) or (1)(B) of
subsection (a) and, in the case of a rule respecting a mixture, the
finding described in paragraph (2) of such subsection.
(c) EXEMFPTION.-(1) Any person required by a rule under subsec-
tion (a) to conduct tests and submit data on a chemical substance or
mixture may apply to the Administrator (in such form and manner
as the Administrator shall prescribe) for an exemption from such
requirement.
(2) If, upon receipt of an application under paragraph (1), the
Administrator determines that-
(A) the chemical substance or mixture with respect to which
such application was submitted is equivalent to a chemical sub-
stance or mixture for which data lhas been submitted to the Admin-
istrator in accordance with a rule under subsection (a) or for
which data is being developed pursuant to such a rule, thd
(B) submission of data by the applicant on such substance or
mixture would be duplicative of data which has been submitted
to the Administrator in accordance with such rule or which is
being developed pursuant to such rule,
the Administrator shall exempt, in accordance with paragraph (3)
or (4), the applicant from conducting tests and submitting data on
such substance or mixture under the rule with respect to which such
application was submitted.
(3) (A) If the exemption under paragraph (2) of any person from
the requirement to conduct tests and submit test data on a chemical
substance or mixture is granted on the basis of the existence of previ-
ously submitted test data and if such exemption is granted during the
reimbursement period for such test data (as prescribed by subpara-
graph (B)), then (unless such person and the persons referred to in
clauses (i) and (ii) agree on the amount and method of reimburse-
ment) the Administrator shall order the person granted the exemption
to provide fair and equitable reimbursement (in an amount deter-
mined under rules of the Administrator)- V
(i) to the person who previously submitted stch test data, for
a portion of the costs incurred by such person in. complying with
the requirement to submit such data, and
(ii) to any other person who has been required under this sub-
paragraph to contribute with respect to such costs, for a portion
of the amount such person was required to contribute.
In promulgating rules for the determination of fair and equitable
reimbursement to the persons described in clauses (i) and (ii) for
costs incurred with respect to a chemical substance or mixture, the
Administrator shall, after consultation with the Attorney General


3










PUBLIC LAW 94-469-OCT. 11, 1976

and the Federal Trade Commission, consider all relevant factors,
including the effect on the competitive position of the person required
to provide reimbursement in relation to the person to be reimbursed
and the share of the market for such substance or mixture of the per-
son required to provide reimbursement in relation to the share of such
market of the persons to be reimbursed. An order under this sub-
paragraph shall, for purposes of judicial review, be considered final
agency action.
(B) For purposes of subparagraph (A), the reimbursement period
for any test data for a chemical substance or mixture is a period-
(i) beginning on the date such data is submitted in accordance
with a rule promulgated under subsection (a), and
(ii) ending-
(I) five years after the date referred to in clause (i), or
II) at the expiration of a period which begins on the date
referred to in clause (i) and which is equal to the period
which the Administrator determines was necessary to develop
such data,
whichever is later.
(4) (A) If the exemption under paragraph (2) of any person from
the requirement to conduct tests and submit test data on a chemical
substance or mixture is granted on the basis of the fact that test data
is being developed by one or more persons pursuant to a rule promul-
gated under subsection (a), then (unless such person and the persons
referred to in clauses (i) and (ii) agree on the amount and method
of reimbursement) the Administrator shall order the person granted
the exemption to provide fair and equitable reimbursement (in an
amount determined under rules of the Administrator)-
(i) to each such person who is developing such test data, for a
portion of the costs incurred by each such person in complying
with such rule, and
(ii) to any other person who has been required under this sub-
paragraph. to contribute with respect to the costs of complying
with such rule, for a portion of the amount such person was
required to contribute.
In promulgating rules for the determination of fair and equitable
reimbursement to the persons described in clauses (i) and (ii) for
costs incurred with respect to a chemical substance or mixture, the
Administrator shall, after consultation with the Attorney General and
the Federal Trade Commission, consider the factors described in the
second sentence of paragraph (3) (A). An order under this subpara-
graph shall, for purposes of judicial review, be considered final agency
action.
(B) If any exemption is granted under paragraph (2) on the basis
of the fact that one or more persons are developing test data pursuant
to a rule promulgated under subsection (a) and if after such exemp-
tion is granted the Administrator determines that no such person has
complied with such rule, the Administrator shall (i) after providing
written notice to the person who holds such exemption and an oppor-
tunity for a hearing, by order terminate such exemption, and (ii)
notify in writing such person of the requirements of the rule with
respect to which such exemption was granted.
(d)NoTIcE.-Upon the receipt of any test data pursuant to a rule
under subsection (a), the Administrator shall publish a notice of the
receipt of such data in the Federal Register within 15 days of its
receipt. Subject to section 14, each such notice shall (1) identify the
chemical substance or mixture for which data have been received;
(2) list the uses or intended uses of such substance or mixture and the


90 STAT. 2009







Reimbursement
period.




































Publication in
Federal Register.


79-313 0 77 2










PUBLIC LAW 94-469-OCT. 11, 1976


Post, p. 2034.
Committee to
make
recommendations
to
Administrator.






















Reromnienda-
tions, list of
chemical
substances and
mixtures.










Publication in
Federal Register;,
transmittaj to
Administrator.





List revision,
publication in
Federal Register.


information required by the applicable standards for the development
of test data; and (3) describe the nature of the test data developed.
Except as otherwise provided in section 14, such data shall be made
available by the Administrator for examination by any person.
(e) PRIORITY LIST.-(1) (A) There is established a committee to
make recominenwndations to the Administrator respecting the chemical
substances and mixtures to which the Administrator should give
priority consideration for the promulgation of a rule under subsec-
tion (a). In making such a recommendation with respect to any chem-
ical substance or mixture, the committee shall consider all relevant.
factors, including-
(i) the quantities in which the substanceor mixture is or will
be manufactured,
(ii) the quantities in which the substance or mixture enters or
N ill center the environment,
(iii) the number of individuals who are or will be exposed to the
substance or mixture in their places of employment and the dura-
tion of such exposure,
(iv) the extent to which human beings are or will be exposed to
the sul)stance or mixture,
(v) the extent to which the substance or mixture is closely
related to a chemical substance or mixture which is known to
present an unreasonable risk of injury to health or the environ-
ment,
(vi) the existence. of data concerning the effects of the substance
or mixture on health or'the environment,
(vii) thle extent to which testing of the substance or mixture
may result in the development of data upon which the effects of
the sui,)-tance or mixture on health or the environment oan rea-
sonal)ly be determined or predicted, and
(viii) the reasonably foreseeable availability of facilities and
personnel for performing testing on the substance or mixture.
The recommendations of the comi ,ittee shall be in the form of a list
of chenii.al substances and miixtures which shall beset forth, either by
individual sulistance or mixture or by groups of substances or mix-
tures, in the order in which the committee determines the Administra-
tor should take action under subsection (a) with respect to the
substances and mixtures. In establishing such list, the committee shall
give priority attention to tho-e chemical substances and mixtures -
whichl are known to cause or contribute to or which are suspected o(
causitig or cont ributing to cancer, gene mutations, or birth defects. The
commiiiittee shall designate chemical substances and mixtures on the list
with respect. to which the committee determines the Administrator
should, within 12 months of -the date on which such substances and
iiiixtures are first designated, initiate a proceeding under subsection
(a). The total number of chemical substances and mixtures on the list
which are designated under the preceding sentence may not, at any
time. exceed. 50.
(B) As soon as practicable but not later than nine months after
the effective date of this Act, the committee shall publishli in the Fed-
eral Register and transimit to the Administrator the list and designa-
tions required by subparagraph (A) together with the reasons for the
committee's inclusion of each chemical substance or mixture on the list.
At least. every six months after the date of the transmission to the Ad-
miinistrator of the list pursuant to the proceeding sentence, the conmmit-
tee shall make such revisions in the list, as it determines to be necessary
and shall transmit them to the Administrator together with the com-
mittee's reasons for the revisions. Upon receipt of any such revision,


90 STAT. 2010










PUBLIC LAW 94-469-OCT. 11, 1976 90 STAT. 2011

the Administrator shall publish in the Federal Register the list with
such revision, the reasons for such revision, and the designations made
under subparagraph (A). The Administrator shall provide reasonable Comments.
opportunity to any interested person to file with the Administrator
written comments on the committee's list, any revision of such list
by the committee, and designations made by the committee, and shall
make such comments available to the public. Within the 12-month Publication in
period beginning on the date of the first inclusion on the list of a Federal Register.
chemical substance or mixture designated by thle committee under sub-
paragraph (A) the Administrator shall with respect to such chemical
substance or mixture either initiate a rulemaking proceeding under
subsection (a) or if such a proceeding is not initiated within such
period, publish in the Federal Register the Administrator's reason for
not initiating such a proceeding.
(2) (A) The committee established by paragraph (1) (A) shall con- Membership.
sist of eight members as follows:
(i) One member appointed by the Administrator from the
Environmental Protection Agency.
(ii) One member appointed by the Secretary of Labor from
officers or employees of the Department of Labor engaged in the
Secretary's activities under the Occupational Safety and Health
Act of 1970.
(iii) One member appointed by the Chairman of the Council
on Environmental Quality from the Council or its officers or
employees.
(iv) One member appointed by the Director of the National
Institute for Occupational Safety and Health from officers or
employees of the Institute.
(v) One member appointed by the Director of the National
Institute of Environmental Health Sciences from officers or
employees of the Institute.
(vi) One member appointed by the Director of the National
Cancer Institute from officers or employees of the Institute.
(vii) One member appointed by the Director of the National
Science Foundation from officers or employees of the Foundation.
(viii) One member appointed by the Secretary of Commerce
from officers or employees of the Department of Commerce.
(B) (i) An appointed member may designate an individual to serve
on the committee on the member's behalf. Such a designation may be
made only with the approval of the applicable appointing authority
and only if the individual is from the entity from which the member
was appointed..
(ii) No individual may serve as a member of the committee for more
than four years in the aggregate. If any member of the committee
leaves the entity from which the member was appointed, such member
may not continue as a member of the committee, and the member's
position shall be considered to be vacant. A vacancy in the committee
shall be filled in the same manner in which the original appointment
was made.
(iii) Initial appointments to the committee shall be made not later
than the 60th day after the effective date of this Act. Not later than
the 90th day after such date the members of the committee shall hold a
meeting for the selection of a chairperson from among their number.
(C) (i) No member of the committee, or designee of such member,
shall accept employment or compensation from any person subject to
any requirement of this Act or of any rule promulgated or order issued
thereunder, for a period of at least 12 months after termination of
service on the committee.


89-139 (360) 0 76 --










PUBLIC LAW 94-469-OCT. 11, 1976


Publication in
Federal Register.


5 USC 701.


Infra.





Publication in
Federal Register.
Post, p. 2034.

15 USC 2604.


(ii) No person, while serving as a member of the committee, or des-
ignee of such member, may own any stocks or bonds, or have any
pecuniary interest, of substantial value in any person engaged in the
manufacture, processing, or distribution in commerce of any chemical
substance or mixture subject to any requirement of this Act or of any
rule promulgated or order issued thereunder.
(iii) The Administrator, acting through attorneys of the Environ-
mental Protection Agency, or the Attorney General may bring an
action in the appropriate district court of the United States to restrain
any violation of this subparagraph.
(D) The Administrator shall provide the committee such admin-
istrative support services as may be necessary to enable the committee
to carry out its function under this subsection.
(f) REQUIRED ACTIONs.-Upon the receipt of-
(1) any test data required to be submitted under this Act, or
(2) any other information available to the Administrator,
which indicates-to the Administrator that there may be a reasonable
basis to conclude that a chemical 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 Administra-
tor shall, within the 180-day period beginning on the date of the receipt
of such data or information, initiate appropriate action under section
5, 6, or 7 to prevent or reduce to a sufficient extent such risk or publish
in the Federal Register a finding that such risk is not unreasonable. For
good cause shown the Administrator may extend such period for an
additional period of not more than 90 days. The Administrator shall
publish in the Federal Register notice of any such extension and the
reasons therefore. A finding by the Administrator that a risk js not
unreasonable shall be considered agency action for purposes of judicial
review under chapter 7 of title 5, United States Code. This subsection
shall not take effect until two years after the effective date of this Act.
(g) PETITION FOR STANDARDS FOR THE DEVELOPMENT OF TEST DATA.-
A person intending to manufacture or process a chemical substance
for which notice is required under section 5 (a) and who is not required
under a rule under subsection (a) to conduct tests and submit data
on such substance may petition the Administrator to prescribe stand-
ards for the development of test data for suc'i substance. The Admin-
istrator shall by order either grant or deny any such petition within
60 days of its receipt. If the petition is granted, the Administrator
shall prescribe such standards for such substance within 75 days of
the date the petition is granted. If the petition is denied, the Admin-
istrator shall publish, subject to section 14, in the Federal Register the
reasons for such denial.
SEC. 5. MANUFACTURING AND PROCESSING NOTICES.
(a) IN GENERAL.-(1) Except as provided in subsection (h), no
person may-
(A) manufacture a new chemical substance on or after the 30th
day after the date on which the Administrator first publishes the
list required by section 8(b), or
(B) manufacture or process any chemical substance fora use
which the Administrator has determined, in accordance with
paragraph (2), is a significant new use,
unless such person submits to the Administrator, at least 90 days before
such manufacture or processing, a notice, in accordance with subsection
(d), of such person's intention to manufacture or process such. sub-
stance and such person complies with any applicable requirement of
subsection (b).


90 STAT. 2012










PUBLIC LAW 94-469-OCT. 11, 1976 90 STAT. 2013

(2) A determination by the Administrator that a use of a chemical
substance is a significant new use with respect to which notification
is required under paragraph (1) shall be made by a rule promulgated
after a consideration of all relevant factors, including-
(A) the projected volume of manufacturing and processing of
a chemical substance,
(B) the extent to which a use changes the type or form of
exposure of human beings or the environment to a chemical
substance,
(C) the extent to which a use increases the magnitude and
duration of exposure of human beings or the environment to a
chemical substance, and
(D) the reasonably anticipated manner and methods of manu-
facturing, processing, distribution in commerce, and disposal of
a chemical substance.
(b) SuBmssloN OF TEST DATA.-(1) (A) If (i) a person is required
by subsection (a) (1) to submit a notice to the Administrator before
beginning the manufacture or processing of a chemical substance,
and (ii) such person is required to submit test data for such sub-
stance pursuant to a rule promulgated under section 4 before the
submission of such notice, such person shall submit to the Adminis-
trator such data in accordance with such rule at the time notice is
submitted in accordance with subsection (a) (1).
(B) If-
(i) a person is required by subsection (%)(1) to submit a
notice to the Administrator, and
(ii) such person has been granted an exemption under section
4(c) from the requirements of a rule promulgated under section
4 before the submission of such notice,
such person may not, before the expiration of the 90 day period which
begins on the date of the submission in accordance with such rule of
the test data the submission or development of which was the basis
for the exemption, manufacture such substance if such person is
subject to subsection (a)(1)(A) or manufacture or process such
substance for a significant new use if the person is subject to subsection
(a)(1) (B).
(2)(A)If a person-
(i) is required by subsection (a)(1) to submit a notice to the
Administrator before beginning the manufacture or processing
of a chemical substance listed under paragraph (4), and
(ii) is not required by a rule promulgated under section 4
before th6 submission of such notice to submit test data for such
substance,
such person shall submit to the Administrator data prescribed by
subparagraph (B) at the time notice is submitted in accordance with
subsection (a) (1).
(B) Data submitted pursuant to subparagraph (A) shall be data
which the person submitting the data believes show that-
-_(i) in the case of a substance with respect to which notice is
required under subsection (a) (1) (A), the manufacture, process-
ing, distribution in commerce, use, and disposal of the chemical
substance or any combination of such activities will not present
an unreasonable risk of injury to health or the environment, or
(ii) in the case of a chemical substance with respect to which
notice is required under subsection (a) (1) (B), the intended
significant new use of the chemical substance will not present an
unreasonable risk of injury to health or the environment.










90 STAT. 2014


Post, p. 2034.



















Oral
presentation.
Transcript.
Publication.





Publication in
Federal Register.


PUBLIC LAW 94-469-OCT. 11, 1976


(3) Data submitted under paragraph (1) or (2) shall be made
available, subject to section 14, for examination by interested persons.
(4)(A)(i) The Administrator may, by rule, compile and keep
current a list of chemical substances with respect to which the
Administrator finds that the manufacture, processing, distribution in
commerce, use, or disposal, or any combination of such activities,
presents or may present an unreasonable risk of injury to health or
the environment.
(ii) In making a finding under clause (i) that the manufacture,
processing, distribution in commerce, use, or disposal of a chemical
substance or any combination of such activities presents or may present
an unreasonable risk of injury to health or the environment, the
Administrator shall consider all relevant factors, including-
(I) the effects of the chemical substance on health and the
magnitude of human exposure to such substance; and
(II) the effects of the chemical substance on the environment
and the magnitude of environmental exposure to such substance.
(B) The Administrator shall, in prescribing a rule under subpara-
graph (A) which lists any chemical substance, identify those uses,
if any, which the Administrator determines, by rule under subsection
(a) (2), would constitute a significant new use of such substance.
(C) Any rule under subparagraph (A), and any substantive
amendment or repeal of such a rule, shall be promulgated pursuant
to the procedures specified in section 553 of title 5, United States
Code, except that (i) the Administrator shall give interested persons
an opportunity for the oral presentation of data, views, or arguments,
in addition to an opportunity to make written submissions, (ii) a
transcript shall be kept of any oral presentation, and (iii) the Admin-
istrator shall make and publish with the rule the finding described
in subparagraph (A).
(c) EXTENSION OF NOTICE PERIOD.-The Administrator may for
good cause extend for additional periods (not to exceed in the aggre-
gate 90 days) the period, prescribed by subsection (a) or (b) before
which the manufacturing or processing of a chemical substance sub-
ject to such subsection may begin. Subject to section 14, such an
extension and the reasons therefore shall be published in the Federal
Register and shall constitute a final agency action subject to judicial
review.
(d) CONTENT OF NOTICE; PUBLICATIONS IN THE FEDERAL REGISTER.-
(1) The notice required by subsection (a) shall include-
(A) insofar as known to the person submitting the notice or
insofar as reasonably ascertainable, the information described in
subparagraphs (A), (B), (C), (D), (F), and (G) of section
8(a) (2), and
(B) in such form and manner as the Administrator may pre-
scribe, any test data in the possession or control of the person
giving such notice which are related to the effect of any manu-
facture, processing, distribution in commerce, use, or disposal of
such substance or any article containing such substance, or of any
combination of such activities, on health or the environment, and
(C) a description of any other data concerning the environ-
mental and health effects of such substance, insofar as known to
the person making the notice or insofar as reasonably ascertain-
able.
Such a notice shall be made available, subject to section 14. for exam-
ination by interested persons.
(2) Subject to section 14, not later than five days (excluding Satur-
days, Sundays and legal holidays) after the date of the receipt of a


I







15


PUBLIC LAW 94-469-OCT. 11, 1976

notice under subsection (a) or of data under subsection (b), the
Administrator shall publish in the Federal Register a notice which-
(A) identifies the chemical substance for which notice or data
has been received;
(B) lists the uses or intended uses of such substance; and
(C) in the case of the receipt of data under subsection (b),
describes the nature of the tests performed on such substance and
any data which was developed pursuant to subsection (b) or a
rule under section 4.
A notice under this paragraph respecting a chemical substance shall
identify the chemical substance by generic class unless the Administra-
tor determines that more specific identification is required in the
public interest.
(3) At the beginning of each month the Administrator shall pub-
lish a list in the Federal Register of (A) each chemical substance for
which notice has been received under subsection (a) and for which
the notification period prescribed by subsection (a), (b), or (c) has not
expired, and (B) each chemical substance for which such notifica-
tion period has expired since the last publication in the Federal Regis-
ter of such list.
(e) REGULATION PENDING DEVELOPMENT OF INFORMATION.-(1) (A)
If the Administrator determines that-
(i) the information available to the Administrator is insuf-
ficient to permit a reasoned evaluation of the health and environ-
mental effects of a chemical substance with respect to which notice
is required by subsection (a) ; and
(ii)(I) in the absence of sufficient information to permit the
Administrator to make such an evaluation, the manufacture,
processing, distribution in commerce, use, or disposal of such
substance, or any combination of such activities, may present an
unreasonable risk of injury to health or the environment, or
(II) such substance is or will be produced in substantial quan-
tities, and such substance either 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,
the Administrator may issue a proposed order, to take effect on the
expiration of the notification period applicable to the manufacturing
or processing of such substance under subsection (a), (b), or (c), to
prohibit or limit the manufacture, processing, distribution in com-
merce, use, or disposal of such substance or to prohibit or limit any
combination of such activities.
(B) A proposed order may not be issued under subparagraph (A)
respecting a chemical substance (i) later than 45 days before the
expiration of the notification period applicable to the manufacture or
processing of such substance under subsection (a), (b), or (c), and
(ii) unless the Administrator has, on or before the issuance of the
proposed order, notified, in writing, each manufacturer or processor,
as the case may be, of such substance of the determination which
underlies such order.
(C) If a manufacturer or processor of a chemical substance to be
subject to a proposed order issued under subparagraph (A) files with
the Administrator (within the 30-day period beginning on the date
such manufacturer or processor received the notice required by subpar-
agraph (B) (ii)) objections specifying with particularity the provi-
sions of the order deemed objectionable and stating the grounds
therefore, the proposed order shall not take effect.


90 STAT. 2015































Proposed order.










PUBLIC LAW 94-469-OCT. 11, 1976


Injunction,
application.


(2) (A) (i) Except as provided in clause (ii), if with respect to a
chemical substance with respect to which notice is required by subsec-
tion (a), the Administrator makes the determination described in
paragraph (1) (A) and if-
(I) the Administrator does not issue a proposed order under
paragraph (1) respecting such substance, or
(II) the Administrator issues such an order respecting such
substance but such order does not take effect because objections
were filed under paragraph (1) (C) with respect to it,
the Administrator, through attorneys of the Environmental Protection
Agency, shall apply to the United States District Court for the Dis-
trict of Columbia or the United States district court for the judicial
district in which the manufacturer or processor, as the case may be, of
such substance is found, resides, or transacts business for an injunction
to prohibit or limit the manufacture, processing, distribution in com-
merce, use, or disposal of such substance (or to prohibit or limit any
combination of such activities).
(ii) If the Administrator issues a proposed order under paragraph
(1) (A) respecting a chemical substance but such order does not take
effect because objections have been filed under paragraph (1) (C) with
respect to it, the Administrator is not required to apply for an injunc-
tion under clause (i) respecting such substance if the Administrator
determines, on the basis of such objections, that the determinations
under paragraph (1) (A) may not be made.
(B) A district court of the United States which receives an appli-
cation under subparagraph (A) (i) for an injunction respecting a
chemical substance shall issue such injunction if the court finds that-
(i) the information available to the Administrator is insufficient
to permit a reasoned evaluation of the health and environmental
effects of a chemical substance with respect to which notice is
required by subsection (a) ; and
(ii) (I) in the absence of sufficient information to permit the
Administrator to make such an evaluation, the manufacture, proc-
essing, distribution in commerce, use, or disposal of such
substance, or any combination of such activities, may present an
unreasonable risk of injury to health or the environment, or
(II) such substance is or will be produced in substantial quan-
tities, and such substance either 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.
(C) Pending the completion of a proceeding for the issuance of an
injunction under subparagraph (B) respecting a chemical substance,
the court may, upon application of the Administrator made through
attorneys of the Environmental Protection Agency, issue a temporary
restraining order or a preliminary injunction to prohibit the manu-
facture, processing, distribution in commerce, use, or disposal of such
a substance (or any combination of such activities) if the court finds
that the notification period applicable under subsection (a), (b), or
(c) to the manufacturing or processing of such substance may expire
before such proceeding can be completed.
(D) After the submission to the Administrator of test data sufficient
to evaluate the health and environmental effects of a chemical sub-
stance subject to an injunction issued under subparagraph (B) and
the evaluation of such data by the Administrator, the district court
of the United States which issued such injunction shall, upon petition,
dissolve the injunction unless the Administrator has initiated a pro-


90 STAT. 2016










PUBLIC LAW 94-469-OCT. 11, 1976 90 STAT. 2017

ceeding for the issuance of a rule under section 6(a) respecting the
substance. If such a proceeding has been initiated, such court shallcon-
tinue the injunction in effect until the effective date of the rule pro-
mulgated in such proceeding or, if such proceeding is terminated
without the promulgation of a rule, upon the termination of the pro-
ceeding, whichever occurs first.
(f) PNoTcioN AGAISTr UwmASONAm RIxsKs.-(1) If the Admin-
istrator finds that there is a reasonable basis to conclude that the manu-
facture, processing, distribution in commerce, use, or disposal of a
chemical substance with respect to which notice is required by subsec-
tion (a), or that any combination of such activities, presents or will
present an unreasonable risk of injury to health or environment before
a rule promulgated under section 6 can protect against such risk, the
Administrator shall, before the expiration of the notification period
applicable under subsection (a), (b), or (c) to the manufacturing or
processing of such substance, take the action authorized by paragraph
(2) or (3) to the extent necessary to protect against such risk.
(2) The Administrator may issue a proposed rule under section Proposed rule.
6(a) to apply to a chemical substance with respect to which a finding
was made under paragraph (1) -
(A) a requirement limiting the amount of such substance
which may be manufactured, processed, or distributed in'
commerce,
(B) a requirement described in paragraph (2), (3), (4), (5),
(6),or (7) of section 6(a),or
(C) any combination of the requirements referred to in sub-
paragraph (B).
Such a proposed rule shall be effective upon its publication in the Fed- Publication in
eral Register. Section 6(d) (2) (B) shall apply with respect to such Federal Register.
rule.
(3) (A) The Administrator may-
(i) issue a proposed order to prohibit the manufacture, process- Proposed order.
ing, or distribution in commerce of a substance with respect to
which a finding was made under paragraph (1), or
(ii) apply, through attorneys of the Environmental Protection Injunction
Agency, to the United States District Court for the District of application.
Columbia or the United States district court for the judicial dis-
trict in which the manufacturer, or processor, as the case may be,
of such substance, is found, resides, or transacts business for an
injunction to prohibit the manufacture, processing, or distribu-
tion in commerce of such substance.
A proposed order issued under clause (i) respecting a chemical
substance shall take effect on the expiration of the notification period
applicable under subsection (a), (b), or (c) to the manufacture or
processing of such substance.
(B) If the district court of the United States to which an applica-
tion has been made under subparagraph (A) (ii) finds that there is a
reasonable basis to conclude that the manufacture, processing,
distribution in commerce, use, or disposal of the chemical substance
with respect to which such application was made, or that any combina-
tion of such activities, presents or will present an unreasonable risk
of injury to health or the environment before a rule promulgated
under section 6 can protect against such risk, the court shall issue
an injunction to prohibit the manufacture, processing, or distribution
in commerce of such substance or to prohibit any combination of such
activities.










90 STAT. 2018


















Publication in
Federal Register.


























Fair and
equitable
reimbursement.


PUBLIC LAW 94-469-OCT. 11, 1976

(C) The provisions of subparagraphs (B) and (C) of subsection
(e) (1) shall apply with respect to an order issued under clause (i)
of subparagraph (A) ; and the provisions of subparagraph (C) of sub-
section (e) (2) shall apply with respect to an injunction issued under
subparagraph (B).
(D) If the Administrator issues an order pursuant to subparagraph
(A) (i) respecting a chemical substance and objections are filed in
accordance with subsection (e) (1) (C), the Administrator shall seek
an injunction under subparagraph (A) (ii) respecting such substance
unless the Administrator determines, on the basis of such objections,
that such substance does not or will not present an unreasonable risk
of injury to health or the environment.
(g) STATEMENT OF REASONS FOR NOT TAKING AcTiow.-If the
Administrator has not initiated any action under this section or section
6 or 7 to prohibit or limit the manufacture, processing, distribution
in commerce, use, or disposal of a chemical substance, with respect to
which notification or data is required by subsection (a) (1) (B) or (b),
before the expiration of the notification period applicable to the manu-
facturing or processing of such substance, the Administrator shall
publish a statement of the Administrator's reasons for not initiating
such action. Such a statement shall be published in the Federal Reg-
ister before the expiration of such period. Publication of such state-
ment in accordance with the preceding sentence is not a prerequisite
to the manufacturing or processing of the substance with respect to
which the statement. is to be published.
(h) EXE rPTION.S.-(1) The Administrator may, upon application,
exempt any person from any requirement of subsection (a) or (b) to
permit such person to manufacture or process a chemical, substance
for test marketing purposes-
(A) upon a showing by such person satisfactory to the Admin-
istrator that the manufacture, processing, distribution in
commerce, use, and disposal of such substance, and that any com-
bination of such activities, for such purposes will not present any
unreasoniible risk of injury' to health or the environment, and
(B) under such restrictions as the Administrator considers
appropriate.
(2) (A) The Administrator may, upon application, exempt any per-
son from the requirement of subsection (b) (2) to submit data for a
chemical substance. If, upon receipt of an application under the pre-
ceding sentence, the Administrator determines that-
(i) the chemical substance with respect to which such applica-
tion was submitted is equivalent to a chemical substance for which
data has been submitted to the Administrator as required by sub-
section (b) (2), and
(ii) submission of data by the applicant on such substance
would be duplicative of data which has been submitted to the
Administrator in accordance with such subsection,
the Administrator shall exempt the applicant from the requirement
to submit such data on such substance. No exemption which is granted
under this subparagraph with respect to the submission of data for a
chemical substance may take effect before the beginning of the reim-
bursement period applicable to such data.
(B) If the Administrator exempts any person, under subparazraphl
(A), from submitting data required under subsection (b)(2) for a
chemical substance because of the existence of previously submitted
data and if such exempt ion is granted during the reimbursement period
for such data, then (unless such person and the persons referred to in










PUBLIC LAW 94-469-OCT. 11, 1976

clauses (i) and (ii) agree on the amount and method of reimburse-
ment) the Administrator shall order the person granted the exemption
to provide fair and equitable reimbursement (in an amount determined
under rules of the Administrator)-
(i) to the person who previously submitted the data on which
the exemption was based, for a portion of the costs incurred by
such person in complying with the requirement under subsection
(b) (2) to submit such data, and
(ii) to any other person who has been required under this sub-
paragraph to contribute with respect to such costs, for a portion
of the amount such person was required to contribute.
In promulgating rules for the determination of fair and equitable
reimbursement to the persons described in clauses (i) and (ii) for
costs incurred with respect to a chemical substance, the Administrator
shall, after consultation with the Attorney General and the Federal
Trade Commission, consider all relevant factors, including the effect
on the competitive position of the person required to provide reim-
bursement in relation to thle persons to be reimbursed and the share of
the market for such substance of the person required to provide reim-
bursement in relation to the share of such market of the persons to be
reimbursed. For purposes of judicial review, an order under this
subparagraph shall be considered final agency action.
(C) For purposes of this paragraph, the reimbursement period for
any previously submitted data for a chemical substance is a period-
(i) beginning on the date of the termination of the prohibition.
imposed under this section, on the manufacture or processing of
such substance by the person who submitted such data to the
Administrator, and
(ii) ending-
(I) five years after the date referred to in clause (i), or
(II) at the expiration of a period which begins on the
date referred to in clause (i) and is equal to the period which
the Administrator determines was necessary to develop such
data,
whichever is later.
(3) The requirements of subsections (a) and (b) do not apply with
respect to the manufacturing or processing of any chemical sub-
stance which is manufactured or processed, or proposed to be manu-
factured or processed, only in small quantities (as defined by the
Administrator by rule) solely for purposes of-
(A) scientific experimentation or analysis, or
(B) chemical research on, or analysis of such substance or
another substance, including such research or analysis for the
development of a product,
if all persons engaged in such experimentation, research, or analysis
for a manufacturer or processor are notified (in such form and manner
as the Administrator may prescribe) of any risk to health which the
manufacturer, processor, or the Administrator has reason to believe
may be associated with such chemical substance.
(4) The Administrator may, upon application and by rule, exempt
the manufacturer of any 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 dis-
posal of such chemical substance, or that any combination of such
activities, will not present an unreasonable risk of injury to health or
the environment. A rule promulgated under this paragraph (and any
substantive amendment to, or repeal of, such a rule) shall be promul-
gated in accordance with paragraphs (2) and (3) of section 6(c).


90 STAT. 2019




















Reimbursement
period.


89-139 (300) 0 76 -- 3







20


90 STAT. 2020


PUBLIC LAW 94-469-OCT. 11, 1976


(5) The Administrator may, upon application, make the require-
ments of subsections (a) and (b) inapplicable with respect to the
manufacturing or processing of any chemical substance (A) which
exists temporarily as a result of a chemical reaction in the manufac-
turing or processing of a mixture or another chemical substance, and
(B) to which there is no. and will not be, human or environmental
exposure.
Publication in (6) Immediately upon receipt of an application under paragraph
Federal Register. (1) or (5) the Administrator shall publish in the Federal Register
Comments. notice of the receipt of such application. The Administrator shall give
interested persons an opportunity to comment upon any such applica-
tion and shall, within 45 days of its receipt, either approve or deny the
Publication in application. The Administ rator shall publish in the Federal Register
Federal Register. notice of the approval or denial of such an application.
(i) DEFINITION.-For purposes of this section, the terms "manufac-
ture" and "process" mean manufacturing or processing for commercial
purposes.
SEC. 6. REGULATION OF HAZARDOUS CHEMICAL SUBSTANCES AND
MIXTURES.
15 USC 2605. (a) SCOPE OF REGULATION.-If the Administ rator finds that there is
a reasonable basis to conclude that the manufacture, processing, dis-
tribution in commerce, use, or disposal of a chemical substance or
mixture, or that any combination of such activities, presents or will
present an unreasonable risk of injury to health or the environment,
the Administrator shall by rule apply one or more of the following
requirements to such substance or mixture to the extent necessary to
protect adequately against such risk using the least burdensome
requirements:
(1) A requirement (A) prohibiting the manufacturing, process-
ing, or distribution in commerce of such substance or mixture, or
(B) limiting the amount of such substance or mixture which may
be manufactured, processed, or distributed in commerce.
(2) A requiremnent-
(A) prohibiting the manufacture, processing, or distribu-
tion in commerce of such substance or mixture for (i) a
particular use or (ii) a particular use in a concentration in
excess of a level specified by the Administrator in the rule
imposing the requirement, or
(B) limiting the amount of such substance or mixture
which may be manufactured, processed, or distributed in
commerce for (i) a particular use or (ii) a particular use
in a concentration in excess of a level specified by the
Administrator in the rule imposing the requirement.
(3) A requiremnlent'.that such substance or mixture or any
article containing, such substance or mixture be marked with or
accoml)anied by clear and adequate warnings and instructions
with respect to its use, distribution in commerce, or disposal or
with respect to any combination of such activities. The form and
content of such warnings and instructions shall be prescribed by
the. Administ rator.
(4) A requirement that manufacturers and processors of such
substance or mixture make and retain records of the processes
used to manufacture or process such substance or mixture and
monitor or conduct tests which are reasonable and necessary to
assure compliance with the requirements of any rule applicable
under this subsection.










PUBLIC LAW 94-469-OCT. 11, 1976 90 STAT. 2021

(5) A requirement prohibiting or otherwise regulating any
manner or method of commercial use of such substance or
mixture.
(6) (A) A requirement prohibiting or otherwise regulating any
manner or method of disposal of such substance or mixture, or
of any article containing such substance or mixture, by its manu-
facturer or processor or by any other person who uses, or disposes
of, it for commercial purposes.
(B) A requirement under subparagraph (A) may not require
any person to take any action which would be in violation of
any law or requirement of, or in effect for, a State or political
subdivision, and shall require each person subject to it to notify
each State and political subdivision in which a required disposal
may occur of such disposal.
(7) A requirement directing manufacturers or processors of
such substance or mixture (A) to give notice of such unreasonable
risk of injury to distributors in commerce of such substance or
mixture and, to the extent reasonably ascertainable, to other per-
sons in possession of such substance or mixture or exposed to such
substance or mixture, (B) to give public notice of such risk of
injury, and (C) to replace or repurchase such substance or
mixture as elected by the person to which the requirement is
directed.
Any requirement (or combination of requirements) imposed under
this subsection may be limited in application to specified geographic
areas.
(b) QUALITY CONTROL.-If the Administrator has a reasonable
basis to conclude that a particular manufacturer or processor is manu-
facturing or processing a chemical substance or mixture in a manner
which unintentionally causes the chemical substance or mixture to
present or which will cause it to present an unreasonable risk of
injury to health or the environment-
(1) the Administrator may by order require such manufac-
turer or processor to submit a description of the relevant quality
control procedures followed in the manufacturing or processing
of such chemical substance or mixture; and
(2) if the Administrator determines-
(A) that such quality control procedures are inadequate
to prevent the chemical substance or mixture from presenting
such risk of injury, the Administrator may order the manu-
facturer or processor to revise such quality control procedures
to the extent necessary to remedy such inadequacy; or
(B) that the use of such quality control procedures has
resulted in the distribution in commerce of chemical substances
or mixtures which present an unreasonable risk of injury to
health or the environment, the Administrator may order the
manufacturer or processor to (i) give notice of such risk to
processors or distributors in commerce of any such sub-
stance or mixture, or to both, and, to the extent reasonably
ascertainable, to any other person in possession of or exposed
to any such substance, (ii) to give public notice of such risk,
and (iii) to provide such replacement or repurchase of any
such substance or mixture as is necessary to adequately pro-
tect health or the environment.
A determination under subparagraph (A) or (B) of paragraph (2) Hearing.
shall be made on the record after opportunity for hearing in accord-
ance with section 554 of title 5, United States Code. Any manufacturer







22


90 STAT. 2022




Statement,
publication.




























5 USC 556, 557.
Notice,
publication.
Written data,
views, arguments,
submittal.
Hearing.
Final rule.

Informal
hearings.


PUBLIC LAW 94-469-OCT. 11, 1976


or processor subject to a requirement to replace or repurchase a chem-
ical substance or mixture may elect either to replace or repurchase
the substance or mixture and shall take either such action in the man-
ner prescribed by the Administrator.
(c) PROMULGATION OF SUBSECTION (a) Ru,.ES.-(1) In promniulgat-
ing any rule under subsection (a) with respect to a chemical substance
or mixture, the Administrator shliall consider and publish a statement
with respect to-
(A) the effects of such substance or mixture on health and tilhe
magnitude of the exposure of human beings to such substance or
mixture,
(B) the effects of ,ich substance or mixture on the environment
and the magnitude of the exposure of the environment to such
substance or mixture,
(C) the benefits of such substance or mixture for various uses
and the availability of substitutes for such uses, and
(D) the reasonably ascertainable, economic consequences of the
rule, after consideration of the effect on the national economy,
small bu.ine.s, technological innovation, the environment, and
public health.
If the Administrator determines that a risk of injury to health or the
environment could be eliminated or reduced to a sufficient extent by
actions taken under another Federal law (or laws) administered in
whole or in part by the Administrator, the Administrator may not
projimulgate a rule under subsection (a) to protect against such risk
of injury unless the Administrator finds, in the Administrator's dis-
cretion, that it is in the public interest to protect against such risk
under this Act. In making such a finding the Administ-atorCshall con-
sider (i) all relevant aspects of the risk, as determined by the Adminis-
trator in the Administrator's discretion, (ii) a comparison of the
estimated co-,ts of complying with actions taken under this Act and
under such law (or laws), and (iii) the relative efficiency of actions
under this Act and under suclh law (or laws) to protect against such
risk of injury.
(2) When prescribing a rule under subsection (a) the Adminis-
trator sliall proceed in accordance with section 553 of title 5, United
States Code (without regard to any reference in such section to sec-
tions 556 and 557 of such title), and shall also (A) publish a notice of
proposed rulemaking stating with particularity the reason for the
proposed rule: (B) allow interested persons to submit written data.
views, and arguments, and make all such submissions publicly avail-
able; (C) provide an opportunity for an informal hearing in accord-
ance with paragraph (3); (D) promulgate, if appropriate, a final
rule based on tlhe matter in the rulemaking record (as defined in section
19(a)), and (E) make and publish with the rule the finding described
in siubsect ion (a).
(3) Informal hearings required by paragraph (2) (C) shall be con-
ducted by the Administrator in accordance with the following
requirements:
(A) Subject to subparagraph (B), an interested person is
entitled-
(i) to present such person's position orally or by docu-
,mentarv submissions (or both), and
(ii) if the Administrator determines that there are dis-
puted issues of material fact it is necessary to resolve, to
present such rebuttal submissions and to conduct (or have
conducted under subparagraph (B) (ii)) such cross-examina-







23


PUBLIC LAW 94-469-OCT. 11., 1976 90 STAT. 2023

tion of persons as the Administrator determines (I) to be
appropriate, and (II) to be required for a full and true dis-
closure with respect to such issues.
(B) The Administrator may prescribe such rules and make such Rules.
rulings concerning procedures in such hearings to avoid unneces-
sary costs or delay. Such rules or rulings may include (i) the
imposition of reasonable time limits on each interested person's
oral presentations, and (ii) requirements that any cross-examina-
tion to which a person may be entitled under subparagraph (A)
be conducted by the Administrator on behalf of that person in such
manner as the Administrator determines (I) to be appropriate,
and (II) to be required for a full and true disclosure with respect
to disputed issues of material fact.
(C) (i) Except as provided in clause (ii), if a group of persons
each of whom under subparagraphs (A) and (B) would be
entitled to conduct (or have conducted) cross-examination and
who are determined by the Administrator to have the same or
similar interests in the proceeding cannot agree upon a single
representative of such interests for purposes of cross-examination,
the Administrator may make rules and rulings (I) limiting the
representation of such interest for such purposes, and (II) gov-
erning the manner in which such cross-examination shall be
limited.
(ii) When any person who is a member of a group with respect
to which the Administrator has made ai determination under
clause (i) is unable to agree upon group representation with the
other members of the group, then such person shall not be denied
under the authority of clause (i) the opportunity to conduct (or
have conducted) cross-examination as to issues affecting the per-
son's particular interests if (I) the person satisfies the Admin-
istrator that the person has made a reasonable and good faith
effort to reach agreement upon group representation with the
other members of the group and (II) the Administrator deter-
mines that there are substantial and relevant issues which are not
adequately presented by the group representative.
(D) A verbatim transcript shall be taken of any oral presen- Verbatim
station made, and cross-examination conducted in any informal transcript.
hearing under this subsection. Such transcript shall be available
to the public.
(4) (A) The Administrator may, pursuant to rules prescribed by the Compensation.
Administrator, provide compensation for reasonable attorneys' fees,
expert witness fees, and other costs of participating in a rulemaking
proceeding for the promulgation of a rule under subsection (a) to
any person-
(i) who represents an interest which would substantially con-
tribute to a fair determination of the issues to be resolved in the
proceeding, and
(ii) if-
(I) the economic interest of such person is small in com-
parison to the costs of effective participation in the proceed-
ing by such person, or
(II) such person demonstrates to the satisfaction of the
Administrator that such person does not have sufficient
resources adequately to participate in the proceeding without
compensation under this subparagraph.
In determining for purposes of clause (i) if an interest will substan-
tially contribute to a fair determination of the issues to be resolved in







24


90 STAT. 2024






















Publication in
Federal Register.
















Notice.


PUBLIC LAW 94-469-OCT. 11, 1976


a proceeding, the Administrator shall take into account the number
and complexity of such issues and the extent to which representation
of such interest will contribute to widespread public participation in
the proceeding and representation of a fair balance of interests for
the resolution of such issues.
(B) In determining whether compensation should be provided to
a person under subparagraph (A) and the amount of such compensa-
tion, the Administrator shall take into account the financial burden
which will be incurred by such person in participating in the rule-
making proceeding. The Administrator shall take such action as
may be necessary to ensure that the aggregate amount of compensa-
tion paid under this paragraph in any fiscal year to all persons who,
in rulemiking proceedings in which they receive compensation, are
persons who either-
(i) would be regulated by the proposed rule, or
(ii) represent persons who would be so regulated,
may not exceed 25 per centumni of the aggregate amount paid as com-
pensation under this paragraph to all persons in such fiscal year.
(5) Paragraph (1), (2), (3), and (4) of this subsection apply
to the promulgation of a rule repealing, or making a substantive
aniendment to, a rule promulgated under subsection (a).
(d) EFrECTIVE DATE.-(1) The Administrator shall specify in any
rule under subsection (a) the date on which it shall take effect, which
date shall be as soon as feasible.
(2) (A) The Administrator may declaree a proposed rule under sub-
section (a) to be effective upon its publication in the Federal Register
and until the effective date of final action taken, in accordance with
subparagraph (B), respecting such rule if-
(i) the Administrator determines that-
(I) the manufacture, processing, distribution in com-
merce, use, or disposal of the chemical substance or mixture
subject to such proposed rule or any combination of such
activities is likely to result in an unreasonable risk of serious
or widespread injury to health or the environment before
such effective date; and
(II) making such proposed rule so effective is necessary to
protect the public interest; and
(ii) in the case of a proposed rule to prohibit the manufacture,
processing, or distribution of a chemical substance or mixture
because of the risk determined under clause (i)(I), a court has
in an action under section 7 granted relief with respect to such
risk associated with such substance or mixture.
Such a proposed rule which is made so effective shall not, for pur-
poses of judicial review, be considered final agency action.
(B) If the Administrator makes a proposed rule effective upon its
publication in the Federal Register, the Administrator shall, as expe-
ditiously as possible, give interested persons prompt notice of such
action, provide reasonable opportunity, in accordance with paragraphs
(2) and (3) of subsection (c), for a hearing on such rule, and either
promulgate such rule (as proposed or with modifications) or revoke
it; and if such a hearing is requested, the Administrator shall com-
mence the hearing within five days from the date such request is made
unless the Administrator and the person making the request agree
upIon a later date for the hearing to begin, and af.er the hearings
concluded the Administrator shall, within ten days of the conclusion
of the hearing, either promulgate such rule (as proposed or with
modifications) or revoke it.


I







25


PUBLIC LAW 94-469-OCT. 11, 1976

(e) POLYCHLORINATED BILPiENYLS.-(1) Within six months after
the effective date of this Act the Administrator shall promulgate
rules to-
(A) prescribe methods for the disposal of polychlorinated
biphenyls, and
(B) require polychlorinated biphenyls to be marked with clear
and adequate warnings, and instructions with respect to their
processing, distribution in commerce, use, or disposal or with
respect to any combination of such activities.
Requirements prescribed by rules under this paragraph shall be con-
sistent with the requirements of paragraphs (2) and (3).
(2) (A) Except as provided under subparagraph (B), effective one
year after the effective date of this Act no person may manufacture,
pi)rocess, or distribute in commerce or use any polychlorinated biphenyl
in any manner other than in a totally enclosed manner.
(B) The Administrator may by rule authorize the manufacture,
processing, distribution in commerce or use (or any combination of
such activities) of any polychlorinated bipIhenyl in a maimnner other than
in a totally enclosed manner if the Administrator finds that such manu-
facture, processing, distribution in commerce, or use (or combination
of such activities) will not present an unreasonable risk of injury to
health or the environment.
(C) For the purposes of this paragraph, the term "totally enclosed
manner" means any manner which will ensure that any exposure of
human beings or the environment to a polychlorinated biphenyl will
be insignificant as determined by the Administrator by rule.
(3)(A) Except as provided in subparagraphs (B) and (C)-
(i) no person may manufacture any polychlorinated biphenyl
after two years after the effective date of this Act, and
(ii) no person may process or distribute in commerce any poly-
chlorinated biphenyl after two and one-half years after such date.
(B) Any person may petition the Administrator for an exemption
from the requirements of subparagraph (A), and the Administrator
may grant by rule such an exemption if the Administrator finds
that-
(i) an unreasonable risk of injury to health or environment
would not result, and
(ii) good faith efforts have been made to develop a chemical
substance which does not present an unreasonable risk of injury
to health or the environment and which may be substituted for
such polychlorinated biphenyl.
An exemption granted under this subparagraph shall be subject to
such terms and conditions as the Administrator may prescribe and
shall be in effect for such period (but not more than one year from
the date it is granted) as the Administrator may prescribe.
(C) Subparagraph (A) shall not apply to the distribution in coin-
merce of any polychlorinated biphenyl if such polychlorinated
biphenyl was sold for purposes other than resale before two and one
half years after the date of enactment of this Act.
(4) Any rule under paragraph (1), (2)(B), or (3)(B) shall be
promulgated in accordance with paragraphs (2), (3), and (4) of sub-
section (c).
(5) This subsection does not limit the authority of the Adminis-
trator, under any other provision of this Act or any other Federal law,
to take action respecting any polychlorinated biphenyl.


90 STAT. 2025

Rules.


















"Totally enclosed
manner."






Petition for
exemption.







Terms and
conditions.


79-313 0 77 3







26


90 STAT. 2026


Civil action.
15 USC 2606.


















Jurisdiction.


PUBLIC LAW 94-469-OCT. 11, 1976


SEC. 7. IMMINENT HAZARDS.
(a) ACTIONS AUTHiORIZED AND REQUIRED.-(1) The Administrator
may commence a civil action in an appropriate district court of the
United States-
(A) for seizure of an imminently hazardous chemical sub-
stance or mixture or any article containing such a substance or
mixture,
(B) for relief (as authorized by subsection (b)) against any
person who manufactures, processes, distributes in commerce, or
uses, or disposes of, an imminently hazardous chemical substance
or mixture or any article containing such a substance or mix-
ture, or
(C) for both such seizure and relief.
A civil action may be commenced under this paragraph notwith-
standing the existence of a rule under section 4, 5, or 6 or an order
under section 5, and notwithstanding the pendency of any adminis-
trative or judicial proceeding under any provision of this Act.
(2) If the Administrator has not made a rule under section 6(a)
immediately effective (as authorized by subsection 6(d) (2) (A) (i))
with respect to an imminently hazardous chemical substance or mix-
ture, the Administrator shall commence in a district court of the United
States with respect to such substance or mixture or article containing
such substance or mixture a civil action described in subparagraph
(A), (B),or (C) of paragraph (1).
(b) RELIEF AUTHORIZED.-(1) The district court of the United
States in which an action under subsection (a) is brought shall have
jurisdiction to grant such temporary or permanent relief a& may be
necessary to protect health or the environment from the unreasonable
risk associated with the chemical substance, mixture, or article involved
in such action.
(2) In the case of an action under subsection (a) brought against
a person who manufactures, processes, or distributes in commerce a
chemical substance or mixture or an article containing a chemical sub-
stance or mixture, the relief authorized by paragraph (1) may include
the issuance of a mandatory order requiring (A) in the case of pur-
chasers of such substance, mixture, or article known to the defendant,
notification to such purchasers of the risk associated with it; (B) pub-
lic notice of such risk; (C) recall; (D) the replacement or repurchase
of such substance, mixture, orarticle; or (E) any combination of the
actions described in the preceding clauses.
(3) In the case of an action under subsection (a) against a chemi-
cal substance, mixture, or article, such substance, mixture, or article
may be proceeded against by process of libel for its seizure and con-
demnation. Proceedings in such an action shall conform as nearly as
possible to proceedings in rem in admiralty.
(c) VENUE AND CONSOLImATION.-(1) (A) An action under subsec-
tion (a) against a person who manufactures, processes, or distributes a
chemical substance or mixture or an article containing a chemical sub-
stance or mixture may be brought in the United States District Court
for the District of Columbia or for any judicial district in which any
of the defendants is found, resides, or transacts business; and process
in such an action may be served on a defendant in any other district
in which such defendant resides or may be found. An action under sub-
section (a) against a chemical substance, mixture, or article may be
brought in any United States district court within the jurisdiction of
which the substance, mixture, or article is found.
(B) In determining the judicial district in which an action may be
brought under subsection (a) in instances in which such action may


i







27


PUBLIC LAW 94-469-OCT. 11, 1976 90 STAT. 2027

be brought in more than one judicial district, the Administrator shall
take into account the convenience of the parties.
(C) Subpeonas requiring attendance of witnesses in an action
brought under subsection (a) may be served in any judicial district.
(2) Whenever proceedings under subsection (a) involving identi-
cal chemical substances, mixtures, or articles are pending in courts in
two or more judicial districts, they shall be consolidated for trial by
order of any such court upon application reasonably made by any
party in interest, upon notice to all parties in interest.
(d) ACTION UNDER SECTION 6.-Where appropriate, concurrently
with the filing of an action under subsection (a) or as soon thereafter
as may be practicable, the Administrator shall initiate a proceeding
for the promulgation of a rule under section 6(a).
(e) REPRESENTATION.-Notwithstanding any other provision of law,
in any action under subsection (a), the Administrator may direct
attorneys of the Environmental Protection Agency to appear and
represent the Administrator in such an action.
(f) DEFINITION.-For the purposes of subsection (a), the term
"imminently hazardous chemical substance or mixture" means a chemi-
cal substance or mixture which presents an imminent and unreason-
able risk of serious or widesl)read injury to health or the environment.
Such a risk to health or the environment shall be considered imminent
if it is shown that the manufacture, processing, distribution in com-
merce, use, or disposal of the chemical substance or mixture, or that any
combination of such activities, is likely to result in such injury to
health or the environment before a final rule under section 6 can
protect against such risk.
SEC. 8. REPORTING AND RETENTION OF INFORMATION.
(a) REPORTS.-(1) The Administrator shall promulgate rules Rules.
under which- 15 USC 2607.
(A) each person (other than a small manufacturer or proc-
essor) who manufactures or processes or proposes to manufacture
or process a chemical substance (other than a chemical substance
described in subparagraph (B)(ii)) shall maintain such rec-
ords, and shall submit to the Administrator such reports, as the
Administrator may reasonably require, and
(B) each person (other than a small manufacturer or proc-
essor) who manufactures or processes or proposes to manufacture
or process-
(i) a mixture, or
(ii) a chemical substance in small quantities (as defined
by the Administrator by rule) solely for purposes of scientific
experimentation or analysis or chemical research on, or
analysis of, such substance or another substance, including
any such research or analysis for the development of a
product,
shall maintain records and submit to the Administrator reports
but only to the extent the Administrator determines the main-
tenance of records or submission of reports, or both, is necessary
for the effective enforcement of this Act.
The Administrator may not require in a rule promulgated under this
paragraph the maintenance of records or the submission of reports
with respect to changes in the proportions of the components of a
mixture unless the Administrator finds that the maintenance of such
records or the submission of such reports, or both, is necessary for
the effective enforcement of this Act. For purposes of the compilation







28


90 STAT. 2028


Standards.


PUBLIC LAW 94-469-OCT. 11, 1976


of the list of chemical substances required under subsection (b), the
Administrator shall promulgate rules pursuant to this subsection not
later than 180 days after the effective date of this Act.
(2) The Administrator may require under paragraph (1) mainte-
nance of records and reporting with respect to the following insofar
as known to the person making the report or insofar as reasonably
ascertainable:
(A) The common or trade name, the chemical identity, and the
molecular structure of each chemical substance or mixture for
which such a report is required.
(B) The categories or proposed categories of use of each such
substance or mixture.
(C) The total amount of each such substance and mixture
manufactured or processed, reasonable estimates of the total
amount to be manufactured or processed, the amount manufac-
tured or processed for each of its categories of use, and reasonable
estimates of the amount to be manufactured or processed for each
of its categories of use or proposed categories of use.
(D) A description of the byproducts resulting from the manu-
facture, processing, use, or disposal of each such substance or
mixture.
(E) All existing data concerning the environmental and health
effects of such substance or mixture.
(F) The number of individuals exposed, and reasonable esti-
mates of the number who will be exposed, to such substance or
mixture in their places of employment and the duration of such
exposure.
(G) In the initial report under paragraph (1) on such substance
or mixture, the manner or method of its disposal, and in any
subsequent report on such substance or mixture, any change in
such manner or method.
To the extent feasible, the Administrator shall not require under
paragraph (1), any reporting which is unnecessary or duplicative.
(3) (A) (i) The Administrator may by rule require a small manu-
facturer or processor of a chemical substance to submit to the Admin-
istrator such information respecting the chemical substance as the
Administrator may require for publication of the first list of chemi-
cal substances required by subsection (b).
(ii) The Administrator may by rule require a small manufacturer
or processor of a chemical substance or mixture-
(I) subject to a rule proposed or promulgated under section 4,
5(b) (4), or 6, or an order in effect under section 5(e), or
(II) with respect to which relief has been granted pursuant to
a civil action brought under section 5 or 7,
to maintain such records on such substance or mixture, and to submit
to the Administrator such reports on such substance or mixture, as
the Administrator may reasonably require. A rule under this clause
requiring reporting may require reporting with respect to the matters
referred to in paragraph (2).
(B) The Administrator, after consultation with the Administrator
of the Small Business Administration, shall -by rule prescribe stand-
ards for determining the manufacturers and processors which qualify
as small manufacturers and processors for purposes of this paragraph
and paragraph (1).
(b) INVENTORY.-(1) The Administrator shall compile, keep cur-
rent, and publish a list of each chemical substance which is manufac-
tured or processed in the United States. Such list shall at least include
each chemical substance which any person reports, under section 5 or







29


PUBLIC LAW 94.--469-OCT. 11, 1976 90 STAT. 2029

subsection (a) of this section, is manufactured or processed in the
United States. Such list may not include any chemical substance
which was not manufactured or processed in the United States within
three years before the effective date of the rules promulgated pur-
suant to the last sentence of subsection (a) (1). In the case of a chemi-
cal substance for which a notice is submitted in accordance with
section 5, such chemical substance shall be included in such list as of
the earliest date (as determined by the Administrator) on which such
substance was manufactured or processed in the United States. The
Administrator shall first publish such a list not later than 315 days
after the effective date of this Act. The Administrator shall not include
in such list any chemical substance which is manufactured or processed
only in small quantities (as defined by the Administrator by rule)
solely for purposes of scientific experimentation or analysis or chemi-
cal research on, or analysis of, such substance or another substance,
including such research or analysis for the development of a product.
(2) To the extent consistent with the purposes of this Act, the
Administrator may, in lieu of listing, pursuant to paragraph (1), a
chemical substance individually, list a category of chemical substances
in which such substance is included.
(c) RECORDS.-Any person who manufactures, processes, or distrib-
utes in commerce any chemical substance or mixture shall maintain
records of significant adverse reactions to health or the environment,
as determined by the Administrator by rule, alleged to have been
caused by the substance or mixture. Records of such adverse reactions
to the health of employees shall be retained for a period of 30 years
from the date such reactions were first reported to or known by the
person maintaining such records. Any other record of such adverse
reactions shall be retained for a period of five years from the date
the information contained in the record was first reported to or known
by the person maintaining the record. Records required to be main-
tained under this subsection shall include records of consumer allega-
tions of personal injury or harm to health, reports of occupational
disease or injury, and reports or complaints of injury to the environ-
ment submitted to the manufacturer, processor, or distributor in com-
merce from any source. Upon request of any duly designated
representative of the Administrator, each person who is required to
maintain records under this subsection shall permit the inspection of
such records and shall submit copies of such records.
(d) HEALTH AND SAFETY STUDIES.-The Administrator shall pro- Rules.
niulgate rules under which the Administrator shall require any person
who manufactures, processes, or distributes in commerce or who pro-
poses to manufacture, process, or distribute in commerce any chemical
substance or mixture (or with respect to paragraph (2), any person
who has possession of a study) to submit to the Administrator-
(1) lists of health and safety studies (A) conducted or initiated
by or for such person with respect to such substance or mixture
at any time, (B) known to such person, or (C) reasonably ascer-
tainable by such person,except that the Administrator may exclude
certain types or categories of studies from the requirements of this
subsection if the Administrator finds that submission of lists of
such studies are unnecessary to carry out the purposes of this Act;
and
(2) copies of any study contained on a list submitted pursuant
to paragraph (1) or otherwise known by such person.
(e) NOTICE TO ADMINISTRATOR OF SUBSTANTIAL RIsKS.-Any person
who manufactures, processes, or distributes in commerce a chemical
substance or mixture and who obtains information which reasonably











PUBLIC LAW 94-469-OCT. 11, 1976


15 USC 2608.






Report.











Publication in
Federal Register.


supports the conclusion that such substance or mixture presents a
substantial risk of injury to health or the environment shall imme-
diately inform the Administrator of such information unless such
person has actual knowledge that the Administrator has been ade-
quately informed of such information.
(f) DEFINITIONS.-For purposes of this section, the terms "manufac-
ture" and "process" mean manufacture or process for commercial
purposes.
SEC. 9. RELATIONSHIP TO OTHER FEDERAL LAWS.
(a) LAWS NOT ADMINISTERED BY THE ADMINISTRATOR.-(1) If
the Administrator has reasonable basis to conclude that the manufac-
ture. processing, distribution in commerce, use, or disposal of a chemical
substance or mixture, or that any combination of such activities, pre-
sents or will present an unreasonable risk of injury to health or the
environment and 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 the Administrator,
the Administrator shall submit to the agency which administers such
law a report which describes such risk and includes in such description
a specification of the activity or combination of activities which the
Administrator has reason to believe, so presents such risk. Such report
-hall also request such agency-
(A) (i) to determine if the risk described in such report may
be Prevented or reduced to a sufficient extent by action taken under
such law, and
(ii) if the agency determines that such risk may be so prevented
or reduced, to issue an order declaring whether or not the activity
or combination of activities specified in the description of such
risk presents such risk; and
(B) to respond to the Administrator w ith respect to the matters
descrilb(d in suhpa ragra ph (A).
Any report of the Administrator shall include a detailed statement of
the information on which it is based and shall be published in the
Federal Register. The agency receiving a request under such a report
shall make the requested determination, issue the requested order,
and make the requested response within such time as the Administrator
specifies in the request, but such time specified may not be less than
90 da ys from the date the request was made. The response of an agency
shall be accompanied by a detailed statement of the findings and
,oone]isions of the agency and shall be published in the Federal Regis-
ter.
('2) If the Administrator makes a report under paragraph (1) with
respect to a chemical substance or mixture and the agency to which
such report was made either-
(A) issues an order declaring that the activity or combination
of activities specified in the description of the risk described in
the report does not present the risk described in the report, or
(B) initiates, within 90 days of the publication in the Federal
Register of the response of the agency under paragraph (1), action
under the law (or laws) administered by such agency to protect
against such risk associated with such activity or combination of
activities,
the Administrator may not take any action under section 6 or 7 with
respect to such risk.
(3) If the Administrator has initiated action undei section 6 or 7
with respect to a risk associated with a chemical substance or mixture
which was the subject of a repoil made to an agency under paragraph
(1), such agency shall before taking action under the law (or laws)


90 STAT. 2030











PUBLIC LAW 94-469-OCT. 11, 1976

administered by it to protect against such risk consult with the Admin-
istrator for the purpose of avoiding duplication of Federal action
against such risk.
(b) LAws ADMINISTERED BY THE ADMINISTRATOR.-The Administra-
tor shall coordinate actions taken under this Act with actions taken
under other Federal laws administered in whole or in part by the
Administrator. If the Administrator determines that a risk to health or
the environment associated with a chemical substance or mixture could
be eliminated or reduced to a sufficient extent by actions taken utinder
the authorities contained in such other Federal laws, the Administrator
shall use such authorities to protect against such risk unless the Admin-
istrator determines, in the Administrator's discretion, that it is in the
public interest to protect against such risk by actions taken under
this Act. This subslection shall not be construed to relieve the Admin-
istrator of any requirement imposed on the Administrator by such
other Federal laws.
(c) OCCUPATIONAL SA.ETY AND HE.AI:rH.-In exercising any author-
ity under this Act, 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.
(d) COORDINATION.-In administering this Act, the Administrator
shall consult and coordinate with the Secretary of Health, Education,
and Welfare and the heads of any other appropriate Federal execu-
tive department or agency, any relevant independent regulatory
agency, and any other appropriate instrumentality of the Federal Gov-
ernment for the purpose of achieving the maximum enforcement of this
.Act while imposing the least burdens of duplicative requirements on
those subject to the Act and for other purposes. The Administrator
shall, in the report required by section 30, report, annually to the
Congress on aFctions taken to coordinate with such other Federal
departments, agencies, or instrumentalities, and on actions taken to
coordinate the authority under this Act with the authority granted
under other Acts referred to in subsection (b).
SEC. 10. RESEARCH, DEVELOPMENT, COLLECTION, DISSEMINATION,
AND UTILIZATION OF DATA.
(a) AUTHORITY.-The Administrator shall, in consultation and
cooperation with the Secretary of Health, Education, and Welfare
and with other heads of appropriate departments and agencies, con-
duct such research, development, and monitoring as is necessary to
carry out the purposes of this Act. The Administrator may enter into
contracts and may make grants for research, development, and mnoni-
toring utinder this subsection. Contracts may be entered into under this
subsection without regard to sections 3648 and 3709 of the Revised
Statutes (31 U.S.C. 529. 14 U.S.C. 5).
(b) DATA SYSTEMS.-(1) The Administrator shall establish, admin-
ister, and be responsible for the continuing activities of an interagency
committee which shall design, establish, and coordinate an efficient and
effective system, within the Environmental Protection Agency, for
the collection, dissemination to other Federal departments and agen-
cies, and use of data submitted to the Administrator under this Act.
(2) (A) The Administrator shall, in consultation and cooperation
with the Secretary of Health, Education, and Welfare and other heads
of appropriate departments and agencies design, establish, and coordi-
nate an efficient and effective system for the retrieval of toxicological
and other scientific data which could be useful to the Administrator in
carrying out the purposes of this Act. Systematized retrieval shall be
developed for use by all Federal and other departments and agencies


90 STAT. 2031

















29 USC 651 note.















15 USC 2609.







32


90 STAT. 2032


15 USC 2610.


PUBLIC LAW 94-469-OCr. 11, 1976


with responsibilities in the area of regulation or study of chemical
substances and mixtures and their effect on health or the environment.
(B) The Administrator, in consultation and cooperation with the
Secretary of Health, Education, and Welfare, may make grants and
enter into contracts for the development of a data retrieval system
described in subparagraph (A). Contracts may be entered into under
this subparagraph without regard to sections 3648 and 3709 of the
Revised Statutes (31 U.S.C. 529,41 U.S.C. 5).
(c) SCREENING TECHNIQUEs.-The Administrator shall coordinate,
with the Assistant Secretary for Health of the Department of Health,
Education, and Welfare, research undertaken by the Administrator
and directed toward the development of rapid, reliable, and economical
screening techniques for carcinogenic, mutagenic, teratogenic, and
ecological effects of chemical substances and mixtures.
(d) MONI[TORING.-The Administrator shall, in consultation and
cooperation with the Secretary of Health, Education, and Welfare,
establish and be responsible for research aimed at the development, in
cooperation with local, State, and Federal agencies, of monitoring
techniques and instruments which may be used in the detection of toxic
chemical substances and mixtures and which are reliable, economical,
and capable of being implemented under a wide variety of conditions.
(e) BAsIc RESEARCH.-The Administrator shall, in consultation and
cooperation with the Secretary of Health, Education, and Welfare,
establish research programs to develop the fundamental scientific basis
of the screening and monitoring techniques described in susections
(c) and (d), the bounds of the reliability of such techniques, and the
opportunities for their improvement.
(f) TRAINING.-The Administrator shall establish and promote
programs and workshops to train or facilitate the training of Federal
laboratory and technical personnel in existing or newly developed
screening and monitoring techniques.
(g) EXtcIANGE OF RESE.ARC'H AND DEVELOPMENT REsuLTs.-The
Administrator shliall, in consultation with the Secretary of Health,
Education, and Welfare and other heads of appropriate departments
and agcc-ies, establish and coordinate a system for exchange among
Federal, State, and local authorities of research and development
results respecting toxic chemical substances and mixtures, including
a system to facilitate and promote the development of standard daLta
format and analysis and consistent testing procedures.
SEC. 11. INSPECTIONS AND SUBPOENAS.
(a) IN GENERAL.-For purposes of administering this Act, the
Administrator, and any duly designated representative of the Admin-
istrator, may inspect any establishment, facility, or other premises in
which chemical substances or mixtures are manufactured, processed,
store(l, or held before or after their distribution in commerce and any
conveyance being used to transport chemical substances, mixtures, or
such articles in connection with distribution in commerce. Such an
inspection may only be made upon the presentation of appropriate
credentials and of a written notice to the owner, operator, or agent in
charge of the premises or conveyance to be inspected. A separate notice
shall be given for each such inspection, but a notice shliall not, be
required for each entry made during the period covered by time inspec-
tion. Each such inspection shall be commenced and completed with
reasonable promptness and shall be conducted at reasonable tines,
within reasonable limits, and in a reasonable manner.
(b) ScorE.-(1) Except as provided in paragraph (2), an inspec-
tion conducted under subsection (a) shall extend to all things within







33


PUBLIC LAW 94-469-OCT. 11, 1976

the premises or conveyance inspected (including records, files, papers,
processes, controls, and facilities) bearing on whether the requirements
of this Act applicable to the chemical substances or mixtures within
such premises or conveyance have been complied with.
(2) No inspection under subsection (a) shall extend to-
(A) financial data,
B) sales data (other than shipment data),
C) pricing data,
(D) personnel data, or
(E) research data (other than data required by this Act or
under a rule promulgated thereunder),
unless the nature and extent of such data are described with reasonable
specificity in the written notice required by subsection (a) for such
inspection.
(c) SUBPOENAS.-In carrying out this Act, the Administrator may
by subpoena require the attendance and testimony of witnesses and
the production of reports, papers, documents, answers to questions,
and other information that the Administrator deems necessary. Wit-
nesses shall be paid the same fees and mileage that are paid witnesses
in the courts of the United States. In the event of contumacy, failure,
or refusal of any person to obey any such subpoena, any district court
of the United States in which venue is proper shall have jurisdiction
to order any such person to comply with such subpoena. Any failure
to obey such an order of the court is punishable by the court as a con-
tempt thereof.
SEC. 12. EXPORTS.
(a) IN GENERAL.-(1) Except as provided in paragraph (2) and
subsection (b), this Act (other than section 8) shall not apply to any
chemical substance, mixture, or to an article containing a chemical
substance or mixture, if-
(A) it can be shown that such substance, mixture, or article is
being manufactured, processed, or distributed in commerce for
export from the United States, unless such substance, mixture, or
article was, in fact, manufactured, processed, or distributed in
commerce, for use in the United States, and
(B) such substance, mixture, or article (when distributed in
commerce), or any container in which it is enclosed (when so dis-
tributed), beirs a stamp or label stating that such substance, mix-
ture, or article is intended for export.
(2) Paragraph (1) shall not apply to any chemical substance, mix-
ture, or article if the Administrator finds that the substance, mixture,
or article will present an unreasonable risk of injury to health within
the United States or to the environment of the United States. The
Administrator may require, under section 4, testing of any chemical
substance or mixture exempted from this Act by paragraph (1) for
the purpose of determining whether or not such substance or mixture
presents an unreasonable risk of injury to health within the United
States or to the environment of the United States.
(b) NOTICE.-(1) If any person exports or intends to export to a
foreign country a chemical substance or mixture for which the submis-
sion of data is required under section 4 or 5(b), such person shall
notify the Administrator of such exportation or intent to export and
the Administrator shall furnish to the government of such country
notice of the availability of the data submitted to the Administrator
under such section for such substance or mixture.
(2) If any person exports or intends to export to a foreign country
a chemical substance or mixture for which an order has been issued


") STAT. 2033


15 USC 2611.







34


90 STAT. 2034


15 USC 2612.
19 USC 1202.





Notification.





















15 USC 2613.


PUBLIC LAW 94-469-OCT. 11, 1976


under section 5 or a rule has been proposed or promulgated under sec-
tion 5 or 6, or with respect to which an action is pending, or relief has
been granted under section 5 or 7, such person shall notify the Admin-
istrator of such exportation or intent to export and the Administrator
shall furnish to the government of such country notice of such rule,
order, action, or relief.
SEC. 13. ENTRY INTO CUSTOMS TERRITORY OF THE UNITED STATES.
(a) IN- GENERIAL.-(1) The Secretary of the Treasury shall refuse
entry into the customs territory of the United States (as defined in
general headnote 2 to the Tariff Schedules of the United States) of
any chemical substance, mixture, or article containing a chemical sub-
stance or mixture offered for such entry if-
(A) it fails to comply with any rule in effect under this Act, or
(B) it is offered for entry in violation of section 5 or 6, a rule or
order under section 5 or 6, or an order issued in a civil action
brought under section 5 or 7.
(2) If a chemical substance, mixture, or article is refused entry
under paragraph (1), the Secretary of the Treasury shall notify the
consignee of such entry refusal, shall not release it to the consignee,
and shall cause its disposal or storage (under such rules as the Secre-
tary of the Treasury may prescribe) if it has not been exported by the
consignee within 90 days from the date of receipt of notice of such
refusal, except that the Secretary of the Treasury may, pending a
review by the Administrator of the entry refusal, release to the con-
signee such substance, mixture, or article on execution of bond for the
amount of the full invoice of such substance, mixture, or article (as
such value is set forth in the customs entry), together with the duty
thereon. On failure to return such substance, mixture, or article for
any cause to the custody of the Secretary of the Treasury when
demanded, such consignee shall be liable to the United States for liqui-
dated dalnages equal to the full amount of such bond. All charges for
storage, cartage, and labor on and for disposal of substances, mixtures,
or articles which are refused entry or release under this section shall
be paid by the owner or consignee, and in default of such payment
shall constitute a lien against any future entry made by such owner or
consignee.
(b) RuLES.-The Secretary of the Treasury, after consultation with
the Admninistrator, shall issue rules for the administration of siibsec-
tion (a) of this section.
SEC. 14. DISCLOSURE OF DATA.
(a) IN GENERAL.-Except as provided by subsection (b), any
information reported to, or otherwise obtained by, the Administrator
(or any representative of the Administrator) under this Act, which is
exempt from disclosure pursuant to subsection (a) of section 552 of
title 5, United States Code, by reason of subsection (b) (4) of such
section, shall, notwithstanding the provisions of any other section of
this Act, not be disclosed by the Administrator or by any officer or
employee of the United States, except that such information-
(1) shall be disclosed to any officer or employee of the United
States-
(A) in connection with the official duties of such officer
or employee under any law for the protection of health or
the environment, or
(B) for specific law enforcement purposes;
(2) shall be disclosed to contractors with the United States and
employees of such contractors if in the opinion of the Administra-







35


PUBLIC LAW 94-469-OCT. 11, 1976 90 STAT. 2035

tor such disclosure is necessary for the satisfactory performance
by the contractor of a contract with the United States entered into
on or after the date of enactment of this Act for the performance
of work in connection with this Act and under such conditions
as the Administrator may specify;
(3) shall be disclosed if the Administrator determines it neces-
sary to protect health or the environment against an unreasonable
risk of injury to health or the environment; or
(4) may be disclosed when relevant in any proceeding under
this Act, except that disclosure in such a proceeding shall be
made in such manner as to preserve confidentiality to the extent
practicable without impairing the proceeding.
In any proceeding under section 552(a) of title 5. United States Code,
to obtain information the disclosure of which has been denied because
of the provisions of this subsection, the Administrator may not rely on
section 552(1) (3) of such title to sustain the. Administrator's action.
(b) I)ATA FRO3M IEALTIH AND SAFETY STUDIES.-(1) Subsection (a)
does not prohibit the disclosure of-
(A) any health and safety study which is submitted under this
Act with respect to-
(i) any chemical substance or mixture which, on the date
on which such study is to be disclosed has been offered for
commercial distribution, or
(ii) any chemical substance or mixture for which testing is
required under section 4 or for which notification is required
under section 5, and
(B) any data reported to, or otherwise obtained by, the Admin-
istrator from a hliealth and safety study which relates to a chemical
substance or mixture described in clause (i) or (ii) of subpara-
graph (A).
This paragraph does not authorize the release of any data which dis-
closes processes used in the manufacturing or processing of a chemical
substance or mixture or, in the case of a mixture, the release of data
disclosing the portion of the mixture comprised by any of the chemical
substances in the mixture.
(2) If a request is made to the Administrator under subsection (a)
of section 552 of title 5, United States Code. for information which is
described in the first sentence of paragraph (1) and which is not
information described in the second sentence of such paragraph, the
Administrator may not deny such request on the basis of subsection
(b) (4) of such section.
(e) )ESIGN.\TION AND RELEASE OF CONFIDENTIAL DATA.-(1) In sub-
mitting data under this Act, a mniantfacturer, processor, or distributor
in commerce may (A) designate the data which such person believes
is entitled to confidential treatment under subsection (a), and (B)
submit such designated data separately from other data submitted
under this Act. A designation under this paragraph shall be made in
writing and in such manner as the Administrator may prescribe.
(2) (A) Except as provided by subparagraph (B), if the Adminis-
trator proposes to release for inspection data which has been desig-
nated under paragraph (1)(A), the Administrator shall notify, in
writing and by certified mail, the manufacturer, processor, or distrib-
utor in commerce who submitted such data of the intent to release such
data. If the release of such data is to be made pursuant to a request
made utinder section 552(a) of title 5, United States Code, such notice
shall be given immediately upon approval of such request by the
Administrator. The Administrator may not release such data until







36


90 STAT. 2036


Notification.
































15 USC 2614.


PUBLIC LAW 94-469-OCT. 11, 1976


the expiration of 30 days after the manufacturer, processor, or distrib-
utor in commerce submitting such data has received the notice required
by this subparagraph.
(B) (i) Subparagraph (A) shall not apply to the release of infor-
mation under paragraph (1), (2), (3), or (4) of subsection (a), except
that the Administrator may not release data under paragraph (3) of
subsection (a) unless the Administrator has notified each manufac-
t irer, processor, and distributor in commerce who submitted such data
of such release. Such notice shall be made in writing by certified mail
at least 15 days before the release of such data, except that if the
Administrator determines that the release of such data is necessary
to protect against an imminent, unreasonable risk of injury to health
or the environment, such notice may be made by such means as the
Administrator determines will provide notice at least 24 hours before
such release is made.
(ii) Suibparagraph (A) shall not apply to the release of information
described in subsection (b)(1) other than information described in
the second sentence of such subsection.
(d) CRIMINAL PENALTY FOR WRONGFUL DISCLOSURE.-(1) Any
officer or employee of the United States or former officer or employee
of the United States, who by virtue of such employment or official
position has obtained possession of, or has access to, material the dis-
closure of which is prohibited by subsection (a), and who knowing
that disclosure of such material is prohibited by such subsection, will-
fully discloses the material in any manner to any person not entitled to
receive, it. shall be guilty of a misdemeanor and fined not More than
$).000 or imprisoned for not more than one year, or both. Section
1905 of title 18, United States Code, does not apply with respect to
the publishing, divulging, disclosure, or making known of, or making
available, information reported or otherwise obtained under this Act.
(2) For the purposes of paragraph (1), any contractor with the
United States who is furnished information as authorized by subsec-
tion (a) (2), and any employee of any such contractor, shall be con-
sidered to be an employee of the United States.
(e) ACCESS BY CONGRESS.-Notwithstan(lding any limitation con-
tained in this section or any other provision of law, all information
reported to or otherwise obtained by the Administrator (or any repre-
seintative of the Administrator) under this Act shall be made available,
upon written request of any duly authorized committee of the Con-
gress, to such committee.
SEC. 15. PROHIBITED ACTS.
It shall be unlawful for any person to-
(1) fail or refuse to comply with (A) any rule promulgated or
order issued under section 4, (B) any requirement prescribed by
section 5 or 6, or (C) any rule promulgated or order issued under
section 5 or 6;
(2) use for commercial purposes a chemical substance or mix-
ture which such person knew or had reason to know was manufac-
tured, processed, or distributed in commerce in violation of section
5 or 6, a rule or order under section 5 or 6, or an order issued in
action brought under section 5 or 7;
(3) fail or refuse to (A) establish or maintain records, (B)
submit reports, notices, or other information, or (C) permit access
to or copying of records, as required by this Act or a rule there-
under; or
(4) fail or refuse to permit entry or inspection as required by
section 11.







37


PUBLIC LAW 94-469-OCT. 11, 1976


SEC 16. PENALTIES.
(a) CxvI.-(1) Any person who violates a provision of section 15
shall be liable to the United States for a civil penalty in an amount
not to exceed $25,000 for each such violation. Each day such a viola-
tion continues shall, for purposes of this subsection, constitute a sepa-
rate violation of section 15.
(2) (A) A civil penalty for a violation of section 15 shall be assessed
by the Administrator by an order made on the record after oppor-
tunity (provided in accordance with this subparagraph) for a hearing
in accordance with section 554 of title 5, United States Code. Before
issuing such an order, the Administrator shall give written notice to
the person to be assessed a civil penalty under such order of the Admin-
istrator's proposal to issue such order and provide such person an
opportunity to request, within 15 days of the date the notice is received
by such person, such a hearing on the order.
(B) In determining the amount of a civil penalty, the Administra-
tor shall take into account the nature, circumstances, extent, and
gravity of the violation or violations and, with respect to the violator,
ability to pay, effect on ability to continue to do business, any history
of prior such violations, the degree of culpability, and such other
matters as justice may require.
(C) The Administrator may compromise, modify, or remit, with
or without conditions, any civil penalty which may be imposed under
this subsection. The amount of such penalty, when finally determined,
or the amount agreed upon in compromise, may be deducted from
any sums owing by the United States to the person charged.
(3) Any person who requested in accordance with paragraph (2)
(A) a hearing respecting the assessment of a civil penalty and who is
aggrieved by an order assessing a civil penalty may file a petition for
judicial review of such order with the United States Court of Appeals
for the District of Columbia Circuit or for any other circuit in which
such person resides or transacts business. Such a petition may only be
filed within the 30-day period beginning on the date the order making
such assessment was issued.
(4) If any person fails to pay an assessment of a civil penalty-
(A) after the order making the assessment has become a final
order and if such person does not file a petition for judicial review
of the order in accordance with paragraph (3), or
(B) after a court in an action brought under paragraph (3)
has entered a final judgment in favor of the Administrator,
the Attorney General shall recover the amount assessed (plus interest
at currently prevailing rates from the date of the expiration of the 30-
day period referred to in paragraph (3) or the date of such final
judgment, as the case may be) in an action brought in any appropriate
district court of the United States. In such an action, the validity,
amount, and appropriateness of such penalty shall not be subject to
review.
(b) CRIM3INAL-Any person who knowingly or willfully violates
any provision of section 15 shall, in addition to or in lieu of any civil
penalty which may be imposed under subsection (a) of this section for
such violation, be subject, upon conviction, to a fine of not more than
$25,000 for each day of violation, or to imprisonment for not more
than one year, or both.
SEC. 17. SPECIFIC ENFORCEMENT AND SEIZURE.
(a) SpEcFIC ENFORCEMEN'T.-(1) The district courts of the United
States shall have jurisdiction over civil actions to-
(A) restrain any violation of section 15,


90 STAT. 2037


15 USC 2615.



Hearing.
















Petition for
judicial review.


15 USC 2616.







38


90 STAT. 2038


15 USC 2617.


PUBLIC LAW 94-469-OCT. 11, 1976


(B) restrain any person from taking any action prohibited by
section 5 or 6 or by a rule or order under section 5 or 6,
(C) compel the taking of any action required by or under this
Act, or
(D) direct any manufacturer or processor of a chemical sub-
stance or mixture manufactured or processed in violation of sec-
tion 5 or 6 or a rule or order under section 5 or 6 and distributed
in commerce, (i) to give notice of such fact to distributors in
commerce of such substance or mixture and, to the extent reason-
ably ascertainable, to other persons in possession of such sub-
stance or mixture or exposed to such substance or mixture, (ii) to
give public notice of such risk of injury, and (iii) to either replace
or repurchase such substance or mixture, whichever the person to
which the requirement is directed elects.
(2) A civil action described in paragraph (1) may be brought-
(A) in the case of a civil action described in subparagraph (A)
of such paragraph, in the United States district court for the judi-
cial district wherein any act, omission, or transaction constituting
a violation of section 15 occurred or wherein the defendant is found
or transacts business, or
(B) in the case of any other civil action described in such para-
graph, in the United States district court for the judicial district
wherein the defendant is found or transacts business.
In any such civil action process may be served on a defendant in any
judicial district in which a defendant resides or may be found. Sub-
poenas requiring attendance of witnesses in any such action may be
served in any judicial district.
(b) SEIZTRE.-Any chemical substance or mixture which was manu-
factured, processed, or distributed in commerce in violation of this Act
or any rule promulgated or order issued under this Act or any article
containing such a substance or mixture shall be liable to be proceeded
against, by process of libel for the seizure and condemnation of such
substance, mixture, or article, in any district court of the United States
within the jurisdiction of which such substance, mixture, or article is
found. Such proceedings shall conform as nearly as possible to proceed-
ings in rem in admiralty.
SEC. 18. PREEMPTION.
(a) EFFECT ON STATE LAW.-(1) Except as provided in paragraph
(2), nothing in this Act shall affect the authority of any State or politi-
cal subdivision of a State to establish or continue in effect regulation
of any chemical substance, mixture, or article containing a chemical
substance or mixture.
(2) Except as provided in subsection (b)-
(A) if the Administrator requires by a rule promulgated under
section 4 the testing of a chemical substance or mixture, no State or
political subdivision may, after the effective date of such rule,
establish or continue in effect a requirement for the testing of such
substance or mixture for purposes similar to those for which test-
ing is required under such rule; and
(B) if the Administrator prescribes a rule or order under sec-
tion 5 or 6 (other than a rule imposing a requirement described
in subsection (a) (6) of section 6) which is applicable to a chemical
substance or mixture, and which is designed to protect against a
risk of injury to health or the environment associated with such
substance or mixture, no State or political subdivision of a State
may, after the effective date of such requirement, establish or
continue in effect, any requirement which is applicable to such sub-
stance or mixture, or an article containing such substance or nmix-








39


PUBLIC LAW 94-469-OCT. 11, 1976

ture, and which is designed to protect against such risk unless such
requirement (i) is identical to the requirement prescribed by the
Administrator, (ii) is adopted under the authority of the Clean
Air Act or any other Federal law, or (iii) prohibits the use of such
substance or mixture in such State or political subdivision (other
than its use in the manufacture or processing of other substances
or mixtures).
(b) EXEMPrION.-Upon application of a State or political subdivi-
sion of a State the Administrator may by rule exempt from subsection
(a) (2), under such conditions as may be prescribed in such rule, a
requirement of such State or political subdivision designed to protect
against a risk of injury to health or the environment associated with
a chemical substance, mixture, or article containing a chemical sub-
stance or mixture if-
(1) compliance with the requirement would not cause the
manufacturing, processing, distribution in commerce, or use of the
substance, mixture, or article to be in violation of the applicable
requirement under this Act described in subsection (a) (2), and
(2) the State or political subdivision requirement (A) provides
a significantly higher degree of protection from such risk than the
requirement under this Act described in subsection (a) (2) and
(B) does not, through difficulties in marketing, distribution, or
other factors, unduly burden interstate commerce.
SEC. 19. JUDICIAL REVIEW.
(a) IN GENERAL.-(1)(A) Not later than 60 days after the date
of the 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
such rule with the United States Court of Appeals for the )District of
Columbia Circuit or for the circuit in which such person resides or in
which such person's principal place of business is located. Courts
of appeals of the United States shall have exclusive jurisdiction of
any action to obtain judicial review (other than in an enforcement
proceeding) of such a rule if any district court of the United States
would have had jurisdiction of such action but for this subparagraph.
(B) Courts of appeals of the United States shall have exclusive
jurisdiction of any action to obtain judicial review (other than in an
enforcement proceeding) of an order issued under subparagraph (A)
or (B) of section 6(b)(1) if any district court of the United States
would have had jurisdiction of such action but for this subparagraph.
(2) Copies of any petition filed under paragraph (1)((A) shall be
transmitted forthwith to the Administrator and to the Attorney Gen-
eral by thlie clerkc of the court with which such petition was filed. Tihe
provisions of section 2112 of title 28, United States Code. shall apply
to the filing of the rulenaking record of proceedings on wlhicli tlihe
Admiinistrator based the rule being reviewed under this section and to
the transfer of proceedings between United States courts of appeals.
(3) For purposes of this section, the term "rulemaking record"
means-
(A) the rule being reviewed under this section;
(B) in the case of a rule under section 4(a),the finding required
by such section, in the case of a rule under section 5(b) (4), the
finding required by such section, in the case of a rule under section
6(a) the finding required by section 5(f) or 6(a), as the case may
be, in the case of a rule under section 6 (a), the statement required
by section 6(c) (1), and in the case of a rule under section 6(e),
the findings required by paragraph (2) (B) or (3) (B) of such
section, as the case may be;


90 STAT. 2039







Application.














Petition.
15 USC 2618.







Jurisdiction.



Petition copies.,
transmittal to
Administrator
and Attorney
General.


"Rulemaking
record."







40


90 STAT. 2040




Notice,
publication in
Federal Register.












Review.


PUBLIC LAW 94-469-OCT. 11, 1976

(C) any transcript required to be made of oral presentations
made in proceedings for the promulgation of such rule;
(D) any written submission of interested parties respecting the
promulgation of such rule; and
(E) any other information which the Administrator considers
to be relevant to such rule and which the Administrator identified,
on or before the date of the promulgation of such rule, in a notice
published in the Federal Register.
(b) ADDITIONAL SUBMISSIONS AND PRESENTATIONS; MODIFICATIONS.-
If in an action under this section to review a rule the petitioner or the
Administrator applies to the court for leave to make additional oral
submissions or written presentations respecting such rule and shows
to the satisfaction of the court that such submissions and presentations
would be material and that there were reasonable grounds for the sub-
missions and failure to make such submissions and presentations in
the proceeding before the Administrator, the court may order the
Administrator to provide additional opportunity to make such sub-
missions and presentations. The Administrator may modify or set
aside the rule being reviewed or make a new rule by reason of the
additional submissions and presentations and shall file such modified
or new rule with the return of such submissions and presentations.
The court shall thereafter review such new or modified rule.
(c) STANDARD OF REVIEW.-(1) (A) Upon the filing of a petition
under subsection (a)(1) for judicial review ef a, rule, the court shall
have jurisdiction (i) to grant appropriate relief, including interim
relief, as provided in chapter 7 of title 5, United States Code, and
(ii) except as otherwise provided in subparagraph (B), to review
such rule in accordance with chapter 7 of title 5, United States Code.
(B) Section 706 of title 5, United States Code, shall apply to review
of a rule under this section, except that-
(i) in the case of review of a rule under section 4(a), 5(b) (4),
6(a), or 6(e), the standard for review prescribed by paragraph
(2) (E) of such section 706 shall not apply and the court 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 (as defined inii subsection (a) (3)) taken as a whole;
(ii) in the case of review of a rule under section 6(a), the court
shall hold unlawful and set aside such rule if it finds that-
(I) a determination by the Administrator under section
6(c) (3) that the petitioner seeking review of such rule is not
entitled to conduct (or have conducted) cross-examination or
to present rebuttal submissions, or
(II) a rule of, or ruling by, the Administrator under sec-
tion 6(c)(3) limiting such petitioner's cross-examination or
oral presentations,
has precluded disclosure of disputed material facts which was
necessary to a fair determination by the Administrator of the
rulemaking proceeding taken as a whole; and section 706(2) (D)
shall not apply with respect to a determination, rule, or ruling
referred to in subclause (I) or (II); and
(iii) the court may not review the contents and adequacy of-
(I) any statement required to be made pursuant to section
6(c) (1),or
(II) any statement of basis and purpose required by sec-
tion 553(c) of title 5, United States Code, to be incorporated
in the rule
except as part of a review of the rulemaking record taken as a
whole.











PUBLIC LAW 94-469-OCT. 11, 1976

The term "evidence" as used in clause (i) means any matter in the
rulemaking record.
(C) A determination, rule, or ruling of the Administrator described
in subparagraph (B)(ii) may be reviewed only in an action under
this section and only in accordance with such subparagraph.
(2) The judgment of the court affirming or setting aside, in whole
or in part, any rule reviewed in accordance with this section shall be
final, subject to review by the Supreme Court of the United States
upon certiorari or certification, as provided in section 1-234 of title 28,
United States Code.
(d) FFES AND COSTS.-The decision of the court in an action coim-
menced under subsection (a), or of the Supreme Court of the United
States on review of such a decision, may include an award of costs of
suit and reasonable fees for attorneys and expert witnesses if the court
determines that such an award is appropriate.
(e) OTHER REMEDIES.-The remedies as provided in this section shall
be in addition to and not in lieu of any other remedies provided by law.
SEC 20. CITIZENS' CIVIL ACTIONS.
(a) IN GENERAL.-Except as provided in subsection (b), any person
may commence a civil action-
(1) against any person (including (A) the United States, and
(B) any other governmental instrumentality or agency to the
extent permitted by the eleventh amendment to the Constitut ion)
who is alleged to be in violation of this Act or any.rule promul-
gated under section 4, 5, or 6 or order issued under section 5
to restrain such violation, or
(2) against the Administrator to compel the Administrator
to perform any act or duty under this Act which is not discre-
tionary.
Any civil action under paragraph (1) shall be brought in the United
States district court for the district in which the alleged violation
occurred or in which the defendant resides or in which the defendant's
principal place of business is located. Any action brought under para-
graph (2) shall be brought in the United States District Court for
the District of Columbia, or the United States district court for the
judicial district in which the plaintiff is domiciled. The district courts
of the United States shall have jurisdiction over suits brought under
this section, without regard to the amount in controversy or the citizen-
ship of the parties. In any civil action under this subsection process
may be served on a defendant in any judicial district in which the
defendant resides or may be found and subpoenas for witnesses may
be served in any judicial district.
(b) LIMrrITATION.-No civil action may be commenced-
(1) under subsection (a) (1) to restrain a violation of this Act
or rule or order under this Act-
(A) before the expiration of 60 days after the plaintiff
has given notice of such violation (i) to the Administrator,
and (ii) to the person who is alleged to have committed such
violation, or
(B) if the Administrator has commenced and is diligently
prosecuting a proceeding for the issuance of an order under
section 16(a) (2) to require compliance with this Act or with
such rule or order or if the Attorney General has commenced
and is diligently prosecuting a civil action in a court of the
United States to require compliance with this Act or with
such rule or order, but if such proceeding or civil action is
commenced after the giving of notice, any person giving such
notice may intervene as a matter of right in such proceeding
or action; or


90 STAT. 2041

"Evidence."















15 USC 2619.














Jurisdiction.








Notice.


79-313 0 77 4







42


90 STAT. 2042


Notice.





Rule.


15 USC 2620.






Public hearing.


PUBLIC LAW 94-469-OCT. 11, 1976


(2) under subsection (a) (2) before the expiration of 60 days
after the plaintiff has given notice to the Administrator of the
alleged failure of the Administrator to perform an act or duty
which is the basis for such action or, in the case of an action under
such subsection for the failure of the Administrator to file an
action under section 7, before the expiration of ten days after
such notification.
Notice under this subsection shall be given in such manner as the
Administrator shall prescribe by rule.
(c) GENERAL.-(1) In any action under this section, the Adminis-
trator, if not a party, nmay intervene as a matter of right.
(2) The court, in issuing any final order in any action brought pur-
suant to subsection (a), may award costs of suit and reasonable fees
for attorneys and expert witnesses if the court determines that such
an award is appropriate. Any court, in issuing its decision in an action
brought to review such an order, may award costs of suit and reason-
able fees for attorneys if the court determines that such an award
is appropriate.
(3) Nothing in this section shall restrict any right which any person
(or class of persons) may have under any statute or common law to
seek enforcement of this Act or any rule or order under this Act
or to seek any other relief.
(d) CONSOLTDATION.-When two or more civil actions brought under
subsection (a) involving the same defendant and the sqn-W issues or
violations are pending in two or more judicial districts, such pending
actions, upon application of such defendants to such actions which is
made to a court in which any such action is brought, may, if such court
in its discretion so decides, be consolidated for trial by order (issued
after giving all parties reasonable notice and opportunity to be heard)
of such court and tried in-
(1) any district which is selected by such defendant and in
which one of such actions is pending,
(2) a district which is agreed upon by stipulation between all
the parties to such actions and in which one of such actions is
pending, or
(3) a district which is selected by the court and in which one
of such actions is pending.
The court issuing such an order shall give prompt notification of the
order to the. other courts in which the civil actions consolidated under
the order a re. pending.
SEC. 21. CITIZENS' PETITIONS.
(a) IN GENERAL.-Any person may petition the Administrator to
initiate ai proceeding for the issuance, amendment, or repeal of a rule
under section 4, 6, or 8 or an order under section 5(e) or (6) (b) (2).
(b) PRoc. uREs.-(1) Such petition shall be filed in the principal
office of the Administrator and shall set forth the facts which it is
claimed establish that it is necessary to issue, amend, or repeal a rule
under section 4, 6, or 8 or an order under section 5(e), 6(b) (1) (A),
or 6(b) (1) (B).
(2) The Administrator may hold a public hearing or may conduct
such investigation or proceeding as the Administrator deems appro-
priate in order to determine whether or not such petition should be
granted.
(3) Within 90 days after filing of a petition described in paragraph
(1), the Administrator shall either grant or deny the petition. If the
Administrator grants such petition, the Administrator shall promptly







43


PUBLIC LAW 94-469-OCT. 11, 1976 90 STAT. 2043

commence an appropriate proceeding in accordance with section 4,
5,6, or 8. If the Administrator denies such petition, the Administrator Publication in
shall publish in the Federal Register the Administrator's reasons Federal Register.
for such denial.
(4) (A) If the Administrator denies a petition filed under this Civil action.
section (or if the Administrator fails to grant or deny such petition
within the 90-day period) the petitioner may commence a civil action
in a district court of the United States to compel the Administrator
to initiate a rulemaking proceeding as requested in the petition. Any
such action shall be filed within 60 days after the Administrator's
denial of the petition or, if the Administrator fails to grant or deny
the petition within 90 days after filing the petition, within 60 days
after the expiration of the 90-day period.
(B) In an action under subparagraph (A) respecting a petition
to initiate a proceeding to issue a rule under section 4, 6. or 8 or an
order under section 5(e) or 6(b) (2), the petitioner shall be provided
an opportunity to have such petition considered by the court in a
de novo proceeding. If the petitioner demonstrates to the satisfaction
of the court by a preponderance of the evidence that-
(i) in the case of a petition to initiate a proceeding for the
issuance of a rule under section 4 or an order under section 5(e)-
(I) information available to the Administrator is insuffi-
cient to permit a reasoned evaluation of the health and
environmental effects of the chemical substance to be subject
to such rule or order; and
fi (II) in the absence of such information, the substance may
present an unreasonable risk to health or the environment,
or the substance is or will be produced in substantial quan-
tities 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 it; or
(ii) in the case of a petition to initiate a proceeding for the
issuance of a rule under section 6 or 8 or an order under section
6(b) (2), there is a reasonable basis to conclude that the issuance
of such a rule or order is necessary to protect health or the
environment against an unreasonable risk of injury to health or
the environment.
the court shall order the Administrator to initiate the action requested
by the petitioner. If the court finds that the extent of the risk to
health or the environment alleged by the petitioner is less than the
extent of risks to health or the environment with respect to which
the Administrator is taking action under this Act and there are
insufficient resources available to the Administrator to take the action
requested by the petitioner, the court may permit the Administrator
to defer initiating the action requested by the petitioner until such time
as the court prescribes.
(C) The court in issuing any final order in any action brought pur-
suant to subparagraph (A) may award costs of suit and reasonable
fees for attorneys and expert witnesses if the court determines that
such an award is appropriate. Any court, in issuing its decision in an
action brought to review such an order, may award costs of suit and
reasonable fees for attorneys if the court determines that such an
award is appropriate.
(5) The remedies under this section shall be in addition to, and not
in lieu of, other remedies provided by law.'











90 STAT. 2044

15 USC 2621.




Publication in
Federal Register.
Notice to
congressional
committee.




15 USC 2622.














Notification.


Investigation.
Notification.








Notice, hearing.


PUBLIC LAW 94-469-OCT. 11, 1976


SEC. 22. NATIONAL DEFENSE WAIVER.
The Administrator shall waive compliance with any provision of
this Act upon a request and determination by the President that the
requested waiver is necessary in the interest of national defense. The
Administrator shall maintain a written record of the basis upon
which such waiver was granted and make such record available for in
camera examination when relevant in a judicial proceeding under
this Act. Upon the issuance of such a waiver, the Administrator shall
publish in the Federal Register a notice that the waiver was granted
for national defense purposes, unless, upon the request of the Presi-
dent, the Administrator determines to omit such publication because
the publication itself would be contrary to the interests of national
defense, in which event the Administrator shall submit notice thereof
to the Armed Services Committees of the Senate and the House of
Representatives.
SEC. 23. EMPLOYEE PROTECTION.
(a) IN GENERAL.-NO employer may discharge any employee or
otherwise discriminate against any employee with respect to the
employee's compensation, terms, conditions, or privileges of employ-
ment because the employee .(or any person acting pursuant to a request
of the employee) has-
(1) commenced, caused to be commenced, or is about to com-
mence or cause to be commenced a proceeding under this Act;
(2) testified or is about to testify in any such proceeding; or
(3) assisted or participated or is about to assist or participate
in any manner in such a proceeding or in any other action to
carry out the purposes of this Act.
(b) REMEDY.-(1) Any employee who believes that the employee
has been discharged or otherwise discriminated against by any person
in violation of subsection (a) of this section may, within 30 days after
such alleged violation occurs, file (or have any person file on the
employee's behalf) a complaint with the Secretary of Labor (here-
inafter in this section referred to as the "Secretary") alleging such
discharge or discrimination. Upon receipt of such a complaint, the
Secretary shall notify the person named in the complaint of the filing
of the complaint.
(2) (A) Upon receipt of a complaint filed under paragraph (1), the
Secretary shall conduct an investigation of the violation alleged in the
complaint. Within 30 days of the receipt of such complaint, the Secre-
tary shall complete such investigation and shall notify in writing the
complainant (and any person acting on behalf of the complainant)
and the person alleged to have committed such violation of the results
of the investigation conducted pursuant to this paragraph. Within
ninety days of the receipt of such complaint the Secretary shall, unless
the proceeding on the complaint is terminated by the Secretary on the
basis of a settlement entered into by the Secretary and the person
alleged to have committed such violation, issue an order either pro-
viding the relief prescribed by subparagraph (B) or denying the
complaint. An order of the Secretary shall be made on the record after
notice and opportunity for agency hearing. The Secretary may not
enter into a settlement terminating a proceeding on a complaint with-
out the participation and consent of the complainant.
(B) If in response to a complaint filed under paragraph (1) the
Secretary determines that a violation of subsection (a) of this section
has occurred, the Secretary shall order (i) the person who committed
such violation to take affirmative action to abate the violation. (iin)







45


PUBLIC LAW 94-469-OCT. 11, 1976

such person to reinstate the complainant to the complainant's former
position together with the compensation (including back pay), terms,
conditions, and privileges of the complainant's employment, (ii) com-
pensatory damages, and (iv) where appropriate, exemplary damages.
If such an order issued, the Secretary, at the request of the complain-
ant, shall assess against the person against whom the order is issued a
sum equal to the aggregate amount of all costs and expenses (including
attorney's fees) reasonably incurred, as determined -by the Secretary,
by the complainant for, or in connection with, the bringing of the com-
plaint upon which the order was issued.
(c) REVTEW.-(1) Any employee or employer adversely affected or
aggrieved by an order issued under subsection (b) may obtain review
of the order in the United States Court of Appeals for the circuit in
which the violation, with respect to which the order was issued,
allegedly occurred. The petition for review must be filed within sixty
days from the issuance of the Secretary"s order. Review shall conform
to chapter 7 of title 5 of the United States Code.
(2) An order of the Secretary, with respect to which review could
have been obtained under paragraph (1), shall not be subject to
judicial review in any criminal or other civil proceeding.
(d) ENFORCEMENT.-Whenever a person has failed to comply with
an order issued under subsection (b) (2), the Secretary shall file a civil
action in the United States district court for the district in which the
violation was found to occur to enforce such order. In actions brought
under this subsection, the district courts shall have jurisdiction to
grant all appropriate relief, including injunctive relief and compensa-
tory and exemplary damages. Civil actions brought under this sub-
section shall be heard and decided expeditiously.
(e) ExcLusioN.-Subsection (a) of this section shall not apply with
respect to any 'employee who, acting without direction from the
employee's employer (or any agent of the employer), deliberately
causes a violation of any requirement of this Act.
SEC. 24. EMPLOYMENT EFFECTS.
(a) IN GENERAL.-The Administrator shall evaluate on a continuing
basis the potential effects on employment (including reductions in
employment or loss of employment from threatened plant closures)
of-
(1) the issuance of a rule or order under section 4, 5, or 6, or
(2) a requirement of section 5 or 6.
(b) (1) INWVSTIGATIONs.-Any employee (or any representative of
an employee) may request the Administrator to make an investigation
of-
(A) a discharge or layoff or threatened discharge or layoff of
the employee, or
(B) adverse or threatened adverse effects on the employee's
employment,
allegedly resulting from a rule or order under section 4, 5, or 6 or a
requirement of section 5 or 6. Any such request shall be made in writ-
ing, shall set forth with reasonable particularity the grounds for the
request, and shall be signed by the employee, or representative of such
employee, making the request.
(2)(A) Upon receipt of a request made in accordance with para-
graph (1) the Administrator shall (i) conduct the investigation
requested, and (ii) if requested by any interested person, hold public
hearings on any matter involved in the investigation unless the Admin-
istrator, by order issued within 45 days of the date such hearings are


90 STAT. 2045


















Civil action.

Jurisdiction.








Evaluation.
15 USC 2623.













Public hearings.







46


90 STAT. 2046


Notification.

Publication in
Federal Register.










Recommenda-
tions.


15 USC 2624.







Submittal to
Congress.
GAO review.


Consultation.





Report to
Congress.


15 USC 2625.


PUBLIC LAW 94-469-OCT. 11, 1976

requested, denies the request for the hearings because the Adminis-
trator determines there are no reasonable grounds for holding such
hearings. If the Administrator makes such a determination, the
Administrator shall notify in writing the person requesting the hear-
ing of the determination and the reasons therefore and shall publish the
determination and the reasons therefore in the Federal Register.
(B) If public hearings are to be held on any matter involved in an
investigation conducted under this subsection-
(i) at least five days' notice shall be provided the person mak-
ing the request for the investigation and any person identified in
such request,
(ii) such hearings shall be held in accordance with section
6(c) (3), and
(iii) each employee who made or for whom was made a request
for such hearings and the employer of such employee shall be
required to present information respecting the applicable matter
referred to in paragraph (1)(A) or (1)(B) together with the
basis for such information.
(3) Upon completion of an investigation under paragraph (2), the
Administrator shall make findings of fact, shall make such recom-
mendations as the Administrator deems appropriate, and shall make
available to the public such findings and recommendations.
(4) This section shall not be construed to require the Administrator
to amend or repeal any rule or order in effect under thisAct.


SEC. 25. STUDIES.
(a) INDEMNIFIcATION STUDY.-The Administrator shall conduct a
study of all Federal laws administered by the Administrator for the
purpose of determining whether and under what conditions, if any,
indemnification should be accorded any person as a result of any action
taken by the Administrator under any such law. The study shall-
(1) include an estimate of the probable cost of any indemnifica-
tion programs which may be recommended;
(2) include an examination of all viable means of financing the
cost of any recommended indemnification; and
(3) be completed and submitted to Congress within two years
from the effective date of enactment of this Act.
The General Accounting Office shall review the adequacy of the study
submitted to Congress pursuant to paragraph (3) and shall report the
results of its review to the Congress within six months of the date
such study is submitted to Congress.
(b) CLASSIFICATION, STORAGE, AND RETRIEVAL STUDY.-The Council
on Environmental Quality, in consultation with the Administrator,
the Secretary of Health, Education, and Welfare, the Secretary of
Commerce, and the heads of other appropriate Federal departments or
agencies, shall coordinate a study of the feasibility of establishing (1)
a standard classification system for chemical substances and related
substances, and (2) a standard means for storing and for obtaining
rapid access to information respecting such substances. A report on
such study shall be completed and submitted to Congress not later than
18 months after the effective date of enactment of this Act.
SEC. 26. ADMINISTRATION OF THE ACT.
(a) COOPERATION OF FEDERAL AGENCIES.-Upon request by the
Administrator, each Federal department and agency is authorized-
(1) to make its services, personnel, and facilities available
(with or without reimbursement) to the Administrator to assist
the Administrator in the administration of this Act; and







47


PUBLIC LAW 94-469-OCT. 11, 1976

(2) to furnish to the Administrator such information, data,
estimates, and statistics, and to allow the Administrator access to
all information in its possession as the Administrator may reason-
ably determine to be necessary for the administration of this Act.
(b) FEES.-(1) The Administrator may, by rule, require the pay-
ment of a reasonable fee from any person required to submit data
under section 4 or 5 to defray the cost of administering this Act. Such
rules shall not provide for any fee in excess of $2,500 or, in the case of
a small business concern, any fee in excess of $100. In setting a fee
under this paragraph, the Administrator shall take into account the
ability to pay of the person required to submit the data and the cost
to the Administrator of reviewing such data. Such rules may provide
for sharing such a fee in any case in which the expenses of testing are
shared under section 4 or 5.
(2) The Administrator, after consultation with the Administrator
of the Small Business Administration, shall by rule prescribe stand-
ards for determining the persons which qualify as small business
concerns for purposes of paragraph (1).
(c) ACTION WITH RESPECT TO CATEGORIES.-(1) Any action author-
ized or required to be taken by the Administrator under any provision
of this Act with respect to a chemical substance or mixture may be
taken by the Administrator in accordance with that provision with
respect to a category of chemical substances or mixtures. Whenever
the Administrator takes action under a provision of this Act with
respect to a category of chemical substances or mixtures, any reference
in this Act to a chemical substance or mixture (insofar as it relates
to such action) shall be deemed to be a reference to each chemical
substance or mixture in such category.
(2) For purposes of paragraph (1):
(A) The term "category of chemical substances" means a group
of chemical substances the members of which are similar in molec-
ular structure, in physical, chemical, or biological properties, in
use, or in mode of entrance into the human body or into the
environment, or the members of which are in some other way suit-
able for classification as such for purposes of this Act, except that
such term does not mean a group of chemical substances which are
grouped together solely on the basis of their being new chemical
substances.'
(B) The term "category of mixtures" means a group of mix-
tures the members of which are similar in molecular structure, in
physical, chemical, or biological properties, in use, or in the mode
of entrance into the human body or into the environment, or the
members of which are in some other way suitable for classification
as such for purposes of this Act.
(d) ASSISTANCE OFFIrcE.-The Administrator shall establish in the
Environmental Protection Agency an identifiable office to provide
technical and other nonfinancial assistance to manufacturers and
processors of chemical substances and mixtures respecting the require-
ments of this Act applicable to such manufacturers and processors, the
policy of the Agency respecting the application of such requirements
to such manufacturers and processors, and the means and methods by
which such manufacturers and processors may comply with such
requirements.
(e) FINANCIAL DISCLOSURES.-(1) Except as provided under para-
graph (3), each officer or employee of the Environmental Protection
Agency and the Department of Health, Education, and Welfare who-
(A) performs any function or duty under this Act, and


90 STAT. 2047













Consultation.
Rule.










Definitions.













Establishment.








48


90 STAT. 2048


Report to
Congress.









Penalty.





Appointment.












5 USC app. II.


PUBLIC LAW 94-469-OCT. 11, 1976


(B) has any known financial interest (i) in any person subject
to this Act or any rule or order in effect under this Act, or (ii) in
any person who applies for or receives any grant or contract under
this Act,
shall, on February 1, 1978, and on February 1 of each year thereafter,
file with the Administrator or the Secretary of Health, Education, and
Welfare (hereinafter in this subsection referred to as the "Secre-
tary"), as appropriate, a written Statement concerning all such inter-
ests held by such officer or employee during the preceding calendar
year. Such statement shall be made available to the public.
(2) The Administrator and the Secretary shall-
(A) act within 90 days of the effective date of this Act-
(i) to define the term "known financial interests" for pur-
poses of paragraph (1), and
(ii) to establish the methods by which the requirement to
file written statements specified in paragraph (1) will be
monitored and enforced, including appropriate provisions for
review by the Administrator and the Secretary of such state-
ments; and
(B) report to the Congress on June 1, 1978, and on June 1 of
each year thereafter with respect to such statements and the
actions taken in regard thereto during the preceding calendar
year.
(3) The Administrator may by rule identify specific positions with
the Environmental Protection Agency, and the Secretary may by rule
identify specific positions with the Department of Health, Education,
and Welfare, which are of a nonregulatory or nonpolicymaking
nature, and the Administrator and the Secretary may by rule provide
that officers or employees occupying such positions shall be exempt
from the requirements of paragraph (1).
(4) This subsection does not supersede any requirement of chapter
11 of title 18, United States Code.
(5) Any officer or employee who is subject to, and knowingly vio-
lates, this subsection or any rule issued thereunder, shall be fined not
more than $2,500 or imprisoned not more than one year, or both.
(f) STATEMENT OF BASIS AND PURPOSE.-Any final order issued
under this Act shall be accompanied by a statement of its basis and
purpose. The contents and adequacy of any such statement shall not
be subject to judicial review in any respect.
(g) ASSISTANT ADMINISTRAToR.-(1) The President, by and with
the advice and consent of the Senate, shall appoint an Assistant
Administrator for Toxic Substances of the Environmental Protection
Agency. Such Assistant Administrator shall be a qualified individual
who is, by reason of background and experience, especially qualified
to direct a program concerning the effects of chemicals on human
health and the environment. Such Assistant Administrator shall be
responsible for (A) the collection of data, (B) the preparation of
studies, (C) the making of recommendations to the Administrator for
regulatory and other actions to carry out the purposes and to facili-
tate the administration of this Act, and (D) such other functions as
the Administrator may assign or delegate.
(2) The Assistant Administrator to be appointed under paragraph
(1) shall (A) be in addition to the Assistant Administrators of the
Environmental Protection Agency authorized by section 1(d) of Reor-
ganization Plan No. 3 of 1970, and (B) be compensated at the rate of
pay authorized for such Assistant Administrators.








49


PUBLIC LAW 94-469-OCT. 11, 1976 90 STAT. 2049

EC. 27. DEVELOPMENT AND EVALUATION OF TEST METHODS.
(a) IN GENERAL.-The Secretary of Health, Education, and Welfare, Consultation.
a consultation with the Administrator and acting through the Assist- 15 USC 2626.
nt Secretary for Health, may conduct, and make grants to public and
nonprofit private entities and enter into contracts with public and
private entities for, projects for the development and evaluation of
expensive and efficient methods (1) for determining and evaluating
he health and environmental effects of chemical substances and mix-
ures, and their toxicity, persistence, and other characteristics which
fleet health and the environment, and (2) which may be used for the
development of test data to meet the requirements of rules promulgated
underr section 4. The Administrator shall consider such methods in
prescribing under section 4 standards for the development of test data.
(b) APPROVAL BY SECRETARY.-No grant may be made or contract Grants or
entered into under subsection (a) unless an application therefore has contracts.
een submitted to and approved by the Secretary. Suclh an application application.
hall be submitted in such form and manner and contain such informa-
ion as the Secretary may require. The Secretary may apply such
onditio'ns to grants and contracts under subsection (a) as thle Secre-
ary determines are necessary to carry out the purposes of such subsec-
ion. Contracts may be entered into under such subsection without
egard to sections 3648 and 3709 of the Revised Statutes (31 U.S.C.
9; 41 U.S.C. 5).
(c) ANNUAL REPORTS.-(1) The Secretary shall prepare and sub- Report to
ait to the President and the Congress on or before January 1 of each President and
,ear a report of the number of grants made and contracts entered into Congress.
inder this section and the results of such grants and contracts.
(2) The Secretary shall periodically publish in the Federal Register Publication in
reports describing the progress and results of any contract entered Federal Register.
nto or grant made under this section.
&EC. 28. STATE PROGRAMS.
(a) IN GENERAL.-FOr the purpose of complementing (but not reduc- 15 USC 2627.
ag) the authority of, or actions taken by, thie Administrator under
his Act, the Administrator may make grants to States for the estab-
ishment and operation of programs to prevent or eliminate unreason-
ble risks within the States to health or the environment which are asso-
iated with a chemical substance or mixture and with respect to which
lie Administrator is unable or is not likely to take action under this
lct for their prevention or elimination. The amount of a grant under
his subsection shall be determined by the Administrator, except that
to grant for any State program may exceed 75 per centum of the
establishment and operation costs (as determined by the Admin-
strator) of such program during the period for which the grant is
aade.
(b) APPROVAL BY ADMINISTRATOR.-(1) No grant may be made under Grants,
ubsection (a) unless an application therefore is submitted to and application.
approved by the Administrator. Such an application shall be sub-.
nitted in such form and manner as the Administrator may require and
halil-
(A) set foith the need of the applicant for a grant under subsec-
tion (a),
(B) identify the agency or agencies of the State which shall
establish or operate, or both, the program for which the applica-
tion is submitted,
(C) describe the actions proposed to be taken under such pro-
gram,








50


90 STAT. 2050


Application
approval.








Report to
Congress.










15 USC 2628.






Report to
President and
Congress.
5 USC 2629.


PUBLIC LAW 94-469-OCT. 11, 1976


(D) contain or be supported by assurances satisfactory 'to the
Administrator that such program shall, to the extent feasible,
be integrated with other programs of the applicant for environ-
mental and public health protection,
(E) provide for the making of such reports and evaluations
as the Administrator may require, and
(F) contain such other information as the Administrator may
prescribe.
(2) The Administrator may approve an application submitted in
accordance with paragraph (1) only if the applicant has established to
the satisfaction of the Administrator a priority need, as determined
under rules of the Administrator, for the grant for which the appli-
cation has been submitted. Such rules shall take into consideration the
seriousness of the health effects in a State which are associated( with
chemical substances or mixtures, including cancer, birth defects, and
gene .mutations, the extent of the exposure in a State of human beings
and the environment to cheinical substances and mixtures, and the
extent to which chemical substances and mixtures are manufactured,
processed, used, and disposed of in a State.
(c) ANNUAL REPOuRTs.-Not later than six months after the end of
each of the fiscal years 1979, 1980, and 1981, the Administrator shall
submit to the Congress a report respecting the programs assisted by
grants under subsection (a) in the preceding fiscal year and the extent
to which the Administrator has disseminated informinati'on respecting
such programs.
(d) AIUTHORIZATION.-For the purpose of making grants under
subsection (a) there are authorized to be appropriated $1,500,000 for
the fiscal year ending September 30, 1977, $1.500,000 for the fiscal year
ending September 30, 1978, and $1,500,000 for the fiscal year ending
September 30, 1979. Sums appropriated under this subsection shall
remain available until expended.
SEC. 29. AUTHORIZATION FOR APPROPRIATIONS.
There are authorized to be appropriated to the Administrator for
purposes of carrying out this Act (other than sections 27 and 28 and
subsections (a) and (c) through (g) of section 10 thereof) $10,100,000
for the fiscal year ending September 30, 1977, $12,625,000 for the fiscal
year ending September 30, 1978, $16,200,000 for the fiscal year ending
September 30, 1979. No part of the funds appropriated under this
section may be used to construct any research laboratories.
SEC. 30. ANNUAL REPORT.
The Administrator shall prepare and submit to the President and
the Congress on or before January 1, 1978, and on or before January 1
of each succeeding year a comprehensive report on the administration
of this Act during the preceding fiscal year. Such report shall include-
(1) a list of the testing required under section 4 during the year
for which the report is made and an estimate of the costs incurred
during such year by the persons required to perform such tests;
(2) the number of notices received during such year under
section 5, the number of such notices received during such year
under such section for chemical substances subject to a section 4
rule, and a summary of any action taken during such year under
section 5 (g);
(3) a list of rules issued during such year under section 6;
(4) a list, with a brief statement of the issues, of completed or
pending judicial actions under this Act and administrative actions
under section 16 during such year;











PUBLIC LAW 94-469-OCT. 11, 1976


(5) a summary of major problems encountered in the adminis-
tration of this Act; and
(6) such recommendations for additional legislation as the Recommenda-
Administrator deems necessary to carry out the purposes of this tons.
Act.
SEC. 31. EFFECTIVE DATE.
Except as provided in section 4(f), this Act shall take effect on 15 USC 2601
January 1, 1977. note.

Approved October 11, 1976.


LEGISLATIVE HISTORY:
HOUSE REPORTS: No. 94-1341 accompanying H.R. 14032 (Comm. on Interstate and
Foreign Commerce) and No. 94-1679 (Comm. of Conference).
SENATE REPORTS: No. 94-698 (Comm. on Commerce) and No. 94-1302 (Comm. of
Conference).
CONGRESSIONAL RECORD, Vol. 122 (1976):
Mar. 26, considered and passed Senate.
Aug. 23, considered and passed House, amended, in lieu of H.R. 14032.
Sept. 28, Senate and House agreed to conference report.
WEEKLY COMPILATION OF PRESIDENTIAL DOCUMENTS, Vol. 12, No. 42:
Oct. 12, Presidential statement.


Note.-A change has been made in the slip law format to provide for one-time
preparation of copy to be used for publication of both slip laws and the United
States Statutes at Large volumes. Comments from users are invited by the Office of
the Federal Register, National Archives and Records Service, Washington, D.C.
20408.


90 STAT. 2051




~~1













[Excerpt from Weekly Compilation of Presidential Documents. vol. 12, No. 42. Oct. 18,
1976. p. 1489]
STATEMENT OF THE PRESIDENT OX. SIGNING S. 3149 INTO LAW--
OCTOBER 12, 1976
I have signed S. 3149, the Toxic Substances Control Act. I believe
this legislation may blie one of the most important piece. of environ-
mental legislation that has been enacted by the Congress.
This toxic substances control legislation provides- broad authority to
regulate any of tlhe tens of thousands of clhemnical in conlimnerce. Only
a few of these chemicals have been tested for their long-term effects on
human health or thle environment. Through the testing and reporting
requirements of the law, our understanding of these chemficals -should
be greatly enhanced. If a chemical is found to present, a danger to
health or the environment. appropriate regulatory action can be taken
before it is too late to undo tlie damage.
The legislation provides that thle federall Government through the
Environmental Protection Agency may require the testing of selected
new chemicals prior to their production to determine if they will pose
a risk to health or the environment." Manufacturers of all selected new
chemicals will be required to notify the Agency at least 90 days before
commencing commercial production. Tlhe Agency may promulgate
regulations or go into court to restrict the production or usv of a chem-
ical or to even ban it if such drastic action is necessary.
The bill closes a gap in our current array of laws to protect the
health of our people and the environment. The Clean Akir Act ;ind the
Water Pollution Control Act protect the air and water from toxic
contaminants. The Food and Drug Act and th(e Safe Drinking Water
Act are used to protect the food we eat and tlhe water we drink against
hazardous contaminants. Other provisions of existing laws protect
tlie health and the environment against other polluting contaminants
such as pesticides and radiation. However, none of the existing stat-
utes provide comprehensive protection.
This bill provides broad disretionary authority to protect the health
and environment. It is critical, however, that the legislation be admin-
istered in a manner so as not to duplicate existing regulatory and en-
forcement authorities.
In addition, I am certain that the Environmental Protection Agency
realizes that. it must carefully exercise its discretionary authority so
as to minimize the regulatory burden consistent with the effective pro-
tection of the health and environment.
The administration, the majority and minority members of the
Congress, the chemical industry, labor, consumer, environmental, and
other groups all have contributed to the bill as it has finally been
enacted. It is a strong bill and will be administered in a way which
focuses on the most critical environmental problems not covered by
existing legislation while not overburdening either the regulatory
agency, the regulated industry, or the American people.
(53)


































CHAPTER II


S. 3149 TOGETHER WITH REPORT AND DEIrATE
NoTE.-S. 3149 was introduced as a clean bill; the original bill on which
hearings were held was S. 776.


































I






57


Calendar No. 668
94T, CONGRESS
2D SESON 3149
~S. 3149


[Report No. 94-698]


IN THE SENATE OF THE UNITED STATES
MARCH 16,1976
Mr. TUNNEY (for himself and Mr. ABTKE) introduced the following bill;
which was read twice and referred to the Committee on Commerce
MARCH 16,1976
Reported by Mr. TLNNEY, without amendment


A BILL
To regulate commerce and protect human health and the environ-
ment by requiring testing and necessary use restrictions on
certain-chemical substances, and for other purposes.
1 Be it enacted by the Senate and House of Representa-
2 ties of the United Slates of America in Congress assembled,
3 SHORT TITLE AND TABLE OF CONTENTS
4 SE'CTION 1. This Act may be cited as the "Toxic Sub-
5 stances Control Act".
TABLE OF CONTENTS
Sec. 1. Short title and table of contents.
Sec. 2. Findings, policy, and intent.
Sec. 3. Definitions and exclusions.
Sec. 4. Testing of chemical substances and mixtures.
Sec. 5. Premarket notification of chemical substances.
Sec. 6. Regulation of chemical substances and mixtures.
Sec. 7. Imminent hazards.
Sec. 8. Reporting and retention of information.







58


2
TABLE OF CONTENTS-Continued
Sec. 9. Relationship to other Federal laws.
Sec. 10. Research, collection, dissemination, and utilization of data.
Sec. 11. Inspections.
Sec. 12. Exports.
Sec. 13. Entry into customs territory of the United States.
Sec. 14. Disclosure of data.
Sec. 15. Prohibited acts.
Sec. 16. Penalties.
Sec. 17. Specific enforcement and seizure.
Sec. 18. Preemption.
Sec. 19. Judicial review.
Sec. 20. Citizen's civil action.
Sec. 21. Citizen's petitions.
Sec. 22. National defense waiver.
Sec. 23. Employee protection.
Sec. 24. Studies.
Sec. 25. Administration of Act.
Sec. 26. Authorization for appropriations.
Sec. 27. Annual report.

1 FINDINGS, POLICY, AND INTENT

2 SEc. 2. (a) FINDINGS.-The Congress finds that-

3 (1) humans and the environment are being ex-

4 posed to a large number of chemical substances and

5 mixtures each year;

6 (2) among the many chemical substances and mix-

7 tures constantly being developed and produced are some

8 whose manufacture, processing, distribution in corn-

9 merce, use, or disposal may cause or contribute to an

10 unreasonable risk of injury to health or the environ-

11 ment; and

12 (3) the effective regulation of such chemical sub-

13 stances and mixtures in interstate commerce necessitates
14 the regulation of such chemical substances and mixtures

15 in intrastate commerce as well.






59


3

1 (b) POLICY.--It is the policy of the United States
2 that-
3 (1) adequate data shliould be developed with re-
4 spect to chemical substances and mixtures concerning
5 their effect on human health and the environment and

6 that such data development should be the responsibil-
7 ity of those who manufacture and those who process
8 such chemical substances and mixtures;
9 (2) adequate authority should exist to regulate
10 chemical substances and mixtures which cause or con-
11 tribute to an unreasonable risk of injury to health or the
12 environment, and to take action with respect to chemical
13 substances and mixtures which are imminent hazards;
14 and
15 (3) authority over chemical substances and mix-
16 tures should be exercised in such a manner as not to
17 impede unduly or create unnecessary economic barriers
18 to technological innovation while fulfilling the primary

19 purpose of this Act to assure that such innovation and
20 commerce in such chemical substances and mixtures do
21 not cause or contribute to an unreasonable risk of injury
22 to health or the environment.
23 (c) INTENT OF CONGREss.-It is the in-tent of Con-
24 gress that the Administrator shall carry out this Act in a
25 rea-onable and prudent manner, and 'that the Adminisitrator






60


4
i shall consider the environmental, economic, and social impact

2 of any action the Administrator takes or proposes to take
3 under this Act.
4 DEFINITIONS AND EXCLUSIONS

5 SEC. 3. (a) DEFINITIONS.-As used in this Act:

6 (1) The term "Administrator" means the Admiinlstra-
7 tor of the Environmental Protection Agency.

8 (2) (A) Except as provided in subparagiraph (B), the
9 term "chemical substance" means-

10 (i) any organic or inorganic substance of a par-
11 ticular molecular identity including a combination of
12 such substances occurring as a result of a chemical
13 reaction, or

14 (ii) any element or uncombined radical.
15 (B) Such term does not include-
16 (i) any mixture,
17 (ii) any pesticide (as defined in the Federal In-
18 secticide, Fungicide and Rodenticide Act) when manu-

19 factured or distributed in commerce for use as a pesti-
20 cide,
21 (iii) tobacco or any tobacco product,

22 (iv) any source material, special nuclear material,
23 or byproduct material (as such terms are defined in the
24 Atomic Energy Act of 1954 and regulations issued under
25 such Act),






61


5

1 (v) any article which, if sold by the manufacturer,
2 would be subject to the tax imposed by section 4181 of
3 the Internal Revenue Code of 1954 (determined without
4 regard to any exemptions from such tax provided by sec-
5 tlon 4182 or 4221 or any other provision of such Code),

6 and
7 (vi) any substance found in or on any food, or
8 any drug, cosmetic, or device (as such terms are de-
9 fined in section 201 of the Federal Food, Drug, and
10 Cosmetic Act) when (A) manufactured or distributed
11 in commerce for use in or on any such food, or as any
12 such drug, cosmetic, or device, or (B) produced for
13 research and development purposes and intended only
14 for use in or on any such food, or as any such drug,
1 cosmetic, or device.
16 The term "food" as used in clause (vi) of this subparagraph
17 includes poultry and poultry products (as defined in sections
18 4 (e) and 4(f) of the Poultry Products Inspection Act),
19 meat and meat food products (as defined in section 1 (j) of
20 the Federal Meat Inspection Act), and eggs and egg prod-
21 ucts (as defined in section 4 of the Egg Products Inspection
22 Act).
23 (3) The term "commerce" means trade, traffic, or trans-
24 portation (A) between a place in a State and any place






62


6
1 outside of such State, or (B) which affects such trade,
2 traffic, or transportation.
3 (4) The term "distribute in commerce" or "distribu-
4 tion in commerce" when used to describe an action taken
5 with respect to a chemical substance or mixture means to
6 sell, or the sale of, the substance or mixture; to introduce or
7 deliver for introduction into commerce, or the introduction or
8 delivery for introduction into commerce of, the substance or
9 mixture; or to hold, or the holding of, the substance or
10 mixture after its introduction into commerce.
11 (5) The term "environment" includes humans and
12 their environment, water, atmosphere, and land and the
13 interrelationships which exist among and between these.
1-1 (6) The term "health and safety study" means any
15 study of any effects of a chemical substance or mixture on

16 health or the environment, including epidemiological studies,
17 studies of occupational exposure to a chemical substance or

18 inixture, toxicological, clinical; and ecological studies of a
19 chemical substance or mixture, and any test performed pur-
20 suant to this Act.

21 (7) The term "manufacture" means to import, produce,
22 or manufacture for commercial purposes.
23 (8) The term "mixture" means any combination of two
24 or more c.hi.mica9l substances if such substances (A) do not






63


7
1 react chemically with each other and if the combination is not
2 the result of a chemical reaction, or (B) occur in nature.
3 (9) The term "new chemical substance" means any
4 chemical substance not included in the chemical substance
5 list compiled and published under section 8 (b).

6 (10) The term "process" means the preparation of a
7 chemical substance or mixture for distribution in commerce-

8 (A) in the same form or physical state, or in a
9 different form or physical state from that in which it

10 was received by the person making such preparation, or
11 (B) as part of an article containing the chemical
12 substance or mixture.
13 (11) The term "processor" means any person who
14 processes a chemical substance or mixture.
35 (12) The term "standards for the development of test
16 data" means a prescription of-

17 (A) the-
18 (i) health and environmental effects, and

19 (ii) type of information relating to toxicity,
20 persistence, and other characteristics which relate to
21 effects on health and the environment
22 for which test data for a chemical substance or mixture
23 are to be developed and any analysis that is to be per-
24 formed on suelh data, and






64


8

1 (B) to the extent necessary to assure that such data
2 are reliable and adequate, the manner in which such
3 data are to be developed, the specification of any test
4 protocol or methodology to be employed in the develop-
5 ment of data respecting such effects and characteristics,

6 and such other requirements as are necessary to provide
7 such assurance.

8 (13) The term "State" means any of the several
9 States, the District of Columbia, the Commonwealth of
10 Puerto Rico, the Virgin Islands, Guam, the Canal Zone,
11 American Samoa, or the Trust Territory of the Pacific

12 Islands.

13 (14) The term "United States", when used in the
14 geographic sense, means all the States.
15 (b) EXCLUSIONs.-The Administrator may exclude
16 from coverage of this Act or any provision of this Act any
17 chemical substance or mixture if the Administrator deter-
18 mines, by rule, that such substance or mixture does not

19 present an unreasonable risk of injury to health or the
20 environment, except that any such exclusion shall not apply
21 to section 7 or 8(e). Any such rule shall (A) be pro-
22 mulgated pursuant to the procedures specified in section
23 6(c) (2), (3), (4), and (5) and (B) may be modified,
24 amended, or revoked in accordance with the requirements






65


9
1 of this subsection and pursuant to the procedures specified
2 in such section 6(c) (2), (3), (4), and (5).
3 TESTING OF CHEMICAL SUBSTANCES AIND MIXTURES
4 SEC. 4. (a) TESTING EEQUIREMENTS.-If the Ad-
5 ministrator finds that-

6 (1) (A) (i) the manufacture, processing, distribu-
7 tion in commerce, use, or disposal of a chemical sub-
8 stance or mixture may present an unreasonable risk of
9 injury to health or the environment, or (ii) (I) that the
10 manufacture, processing, distribution in commerce, use,
11 or disposal of a chemical substance or mixture may
12 present significant human or environmental exposure
13 because it is or will be produced in substantial quantities
14 or for other reasons, and (II) that such substance or
15 mixture may perhaps present an adverse effect on health
16 or the environment,
17 (B) there are insufficient data or experience upon
18 which the effects of such manufacture, processing, dis-
19 tribution in commerce, use, or disposal on health or
20 the environment can reasonably be determined or pre-
21 dieted, and
22 (0) testing of such substance or mixture with
23 respect to such effects is necessary to develop such data;
24 and






66


10

1 (2) in the case of a mixture, the effects which the
2 mixture's manufacture, distribution in commerce, proc-
3 essing, use, or disposal may have on health or the en-
4 vironment may not be reasonably and more efficiently
5 determined or predicted by testing the chemical sub-
6 stances which comprise the mixture;
7 the Administrator shall by rule require that testing be con-
8 ducted on such substance or mixture to develop data with
9 respect to the health and environmental effects for which
10 there is an insufficiency of data or experience and which
11 are relevant to a determination that the manufacture, -distri-
12 button in commerce, processing, use, or disposal of such
13 substance or mixture does or does not cause or contribute to
14 an unreasonable risk of injury to health or the environment.
15 In requiring tests under this subsection, the Administrator
16 shall consider the reasonably ascertainable costs and other
17 burdens associated with conducting such tests in light of the
18 possible risks of injury to health or the environment and shall
19 publish the same in the Federal Register. The finding in
20 paragraph (1) (A) (ii) (II) shall be presumed if the Ad-
21 ministrator has no reliable data or experience available to
22 him concerning the chemical substance or mixture. The find-
23 ing in paragraph (1) (A) (ii) (II) shall not be subject to
24 judicial review on any ground other than the fact that such
25 finding was not made.








11
1 (b) (1) TESTING REQUIREMENT RULE.-A rule under
2 subsection (a) requiring the testing of a chemical substance
3 or mixture shall include-
4 (A) identification of the substance or mixture for
5 which testing is required,

6 (B) standards for the development of test data for
7 such substance or mixture, and
8 (C) with respect to chemical substances which are
9 not new chemical substances a specification of the period
10 (which period may not be of unreasonable duration)
11 within which the persons required to conduct the testing

12 shall submit to the Administrator data developed in
13 accordance with the standards referred to in subpara-
14 graph (B).
15 Such a rule may require the submission of preliminary data
16 during the period prescribed under subparagraph (0).
17 (2)" (A) The health and environmental effects for which
18 standards for the development of test data may be pre-
19 scribed include carcinogenesis, mutagenesis, teratogenesis,
20 behavioral disorders, cumulative or synergistic effects, and
21 any other effect which may cause or contribute to an unrea-
22 sonable risk of injury to health or the environment, and the
23 characteristics of chemical substances and mixtures for which
24 such standards may be prescribed include persistence, acute
25 toxicity, subacute toxicity, chronic toxicity, and any other






68


12
I characteristic which may cause or contribute to such a risk
2 of injury. The methodologies that may be prescribed in such
3 standards include epidemiology, serial, or hierarchical tests;
4 in vitro tests; and whole animal tests.

5 (B) From time to time, but not less than once each
Pr'
6 12 months, the Administrator shall review the adequacy
7 of the standards for development of data prescribed in rules
8 under subsection (a) and shall, if necessary, institute pro-
9 ceedings to make appropriate revisions of such standards.

10 (3) (A) A rule under subsection (a) respecting a
11 chemical substance or mixture shall require the persons
12 described in subparagraph (B) to conduct tests and submit
13 data on such substance or mixture, except that the Admin-

14 istrator may permit two or more of such persons to designate
15 one such person or a qualified third party to conduct such

16 tests and submit such data on behalf of the persons making
17 the designation.

18 (B) The following persons shall be required to conduct
19 tests and submit data on a chemical substance or mixture

20 subject to a rule under subsection (a):

21 (i) Each person who manufactures or intends to
22 manufacture such substance or mixture if the Adminis-
23 trator made a finding described in subsection (a) (1)

24 (B) with respect to the manufacture of the substance






69


13
I or mixture which such person is engaged in or intends
2 to engage in.
3 (ii) Each person who processes or intends to process
4 such substance or mixture if the Administrator made a
5 finding described in subsection (a) (1) (B) with respect

6 to the processing of the substance which such person
7 is engaged in or intends to engage in.

8 (iii) Each person who manufactures or processes or
9 intends to manufacture or process such substance or mix-
10 ture if, with respect to the distribution in commerce, dis-
11 posal or use of such substance or mixture manufactured

12 or processed or to be manufactured or processed by such
13 person, the Administrator made a finding described in
14 subsection (a) (1) (B).
15 (4) Rules issued under subsection (a) (and any amend-
16 ment thereto or repeal thereof) shall be promulgated pur-
17 suant to section 553 of title 5, United States Code, except
18 that in promulgating, amending, or repealing any such rule
19 (A) the Administrator shall give interested persons an op-
20 portunity for the oral presentation of data, views, or argu-
21 ments, in addition to an opportunity to make written sub-

22 missions; and (B) a transcript shall be made of any oral
23 presentation.
24 (c) EXEMPTION.-(1) Any person required by a rule







70


14
1 under subsection (a) to conduct tests and submit data on a
2 chemical substance or mixture may apply to the Adminis-

3 trator (in such form and manner as the Administrator shall
4 prescribe) for an exemption from such requirement.

5 (2) If, upon receipt of an application under paragraph
6 (1), the Administrator determines that-
7 (A) the chemical substance or mixture with respect
8 to which such application was submitted is equivalent
9 to a chemical substance or mixture for which data has
10 been submitted to the Administrator in accordance with
11 a rule under subsection (a) or for which data is being
12 developed pursuawt to such a rule, and
13 (B) submission of data by the applicant on such
14 substance or mixture would be duplicative of data which
15 has been submibted to the Administrator in accordance
16 with such rule or which is being developed pursuant to
17 such rule,
18 the Administrator shall exempt, in accordance with para-
19 graph (3) or (4), the applicant from conducting tests and
20 submitting data on such substance or mixture.
21 (3) (A) If the exemption of any person from 'thie re-

22 quirement to conduct tests and submit test data on a chemical
23 substance or mixture is granted on the basis of the existence
24 of previously submitted test data and if such exemption is






71

15
1 granted during the reimbursement period for such test data
2 (as prescribed by subparagraph (B)), then (unless such
3 person and the persons referred to in clauses (i) and (ii)
4 agree on the amount and method of reimbursement) the
5 Administrator shall order the person granted the exemption
6 to provide fair and equitable reimbursement (in an amount
7 determined under rules of the Administrator)-

8 (i) to the person who previously submitted such test
9 data, for a portion of the costs incurred by such person
10 in complying with the requirement to submit such data,
11 and
12 (ii) to any other person who has been required
13 under this subparagraph to contribute with respect to
14 -such costs, for a portion of the amount such person was
15 required to contribute.
16 In promulgating rules for the determination of fair and
17 equitable reimbursement to the persons described in clauses
18 (i) and (ii) for costs incurred with respect to a chemical
19 substance or mixture, the Administrator shall, after consul-
20 station with the Attorney General and the Federal Trade
21 Oommnission, consider all relevant factors, including the
22 effect on competition within the chemical industry and the
23 share of the market for such substance or mixture of the
24 person required to provide reimbursement in relation to the






72


16
1 share of such market of the persons to be reimbursed. An
2 order under this subparagraph for purposes of judicial
3 review shall be considered final agency action.
4 (B) For purposes of subparagraph (A), the reimburse-
5 ment period for any test data for a chemical substance or
6 mixture is a period-
7 (i) beginning on the date such data was submitted
8 in accordance with a rule promulgated under subsection
9 (a), and

10 (ii) ending-
11 (I) two years after the date referred to in
12 clause (i), or

13 (II) at the expiration of a period which begins
14 on the date referred to in clause (i) and is equal to
15 the period which the Administrator determines was
16 necessary to develop such data,
17 whichever is later.

18 (4) (A) If the exemption of any person from the re-
19 quirement to conduct tests and submit test data on a chemical
20 substance or mixture is granted on the basis of the fact that
21 test data is being developed by one or more persons pursuant
22 to a rule promulgated under subsection (a), then (unless
23 such person and the persons referred to in clauses (i) and
24 (ii) agree on the amount and method of reimbursement) the
25 Administrator shall issue an order to the person granted the









17
1. exemption to provide fair and equitable reimbursement (in

2 an amount determined under rules of the Administrator)-
3 (i) to each such person who is, developing such test
4 data, for a portion of the costs incurred by each such
5 person in complying with such rule, and

6 (ii) to any other person who has been required
7' under this subparagraph to contribute with respect to

8 the costs of complying with such rule, for a portion of
9 the amount such person was required to contribute. *

10 In promulgating rules for the determination of fair and
11 equitable reimbursement to the persons described in clauses

12 (i) and (ii) for costs incurred with respect to a chemical
13 substance or mixture the Administrator shall, after consul-
14 tation' with tire Attorney Oeneral and the Federal Trade
15- Oommission, consider all relevant factors, including die
16' effect on competition within the chemical industry and the
17 share.-of thM market for such substance or mixture of the
18g person required to provide reimbursement in relation to the
19i share. of such market of-thle persons to be' rehnimbursed. An

20 order under' this subparagraph for purposes of judicial
21 review'shall be considered final agency action.
22" (B) If an exemption'is granted on the basis of the fact
23 that one or more persons are developing test data pursuant to
24 a rule promulgated under subsection (a) and if after -such
25, exemption. is granted the Administrator determines that no


79-313 0 77 6






74


18
1 such person has complied with such rule, the Administrator
2 shall (i) after providing written notice to the person who
3 holds such exemption and an opportunity for a hearing, by
4 order terminate such exemption, and (ii) notify in writing
5 such person of the requirements of the rule with respect to
6 which such exemption was granted.
7 (5) If a person provides reimbursement pursuant to an
s order issued under paragraph (3) (A) or (4) (A) in con-
9 nection with an exemption from a rule promulgated under
o10 subsection ('a), such person may, subject to section 14, have
11 access to test data the submission or development of which
12 was the basis for such exemption.
13 (d) NOTICE.-Upon the receipt of any test data pur-
14 suant to a rule under subsection (a), the Administrator shall
15 (subject to section 14) publish a notice of the receipt of
16 such data in the Federal Register and make the data avail-
17 able to the public within 15 days of receipt. Each such
18 notice shall (1) identify the chemical substance or mixture
19 for which data have been received; (2) list the uses or in-
20 tended uses of such substance or mixture and the information
21 required by the applicable standards for the development of
22 test data; and (3) describe the nature of the test data
23 developed.
24 (e) PRIORITY LIST.- (1) (A) There is established
25 a committee to make recommendations to the Administrator






75


19
1 respecting the chemical substances and mixtures to which the

2 Administrator should give priority consideration for the
3 promulgation of a rule under subsection (a). In making such
4 a determination with respect to any chemical substance or
5 mixture, the committee shall consider all relevant factors,

6 including-
7 (i) the quantities in which the substance or mix-
8 ture is or will be manufactured,
9 (ii) the quantities in which the substance or mixture
10 enters or will enter the environment,
11 (iii) the number of persons who are or will be
12 exposed to the substance or mixture in their places of
13 employment and the duration of such exposure,
14 (iv) the extent to which humans are or will be ex-
15 posed to the substance or mixture,
16 (v) the extent -to which the substance or mixture is
17 closely related to a chemical substance or mixture which
18 is known to cause or contribute to an unreasonable risk
19 to health or the environment,
20 (vi) the existence of data concerning the effects of
21 the substance or mixture on health or the environment,
22 and
23 (vii) the extent to which testing of the substance
24 or mixture may result in the development of data upon
25 which the effects of the substance or mixture on health






76

20

1 or the environment can reasonably be determined or
2 predicted.
3 The rccoimcndalions of the committee shall be in the form
4 of a list of chemical substances and mixtures which shall
5 be listed, either by individual substance or mixture or by

6 groups of substances or mixtures, ,in the order in which the
7 committee determines the Administrator should take action

8 under subsection (a) with respect to the substances and
9 mixtures. The committee shall give priority attention in
10 establishing such list to those chemical substances and mix-
11 tures which are known or are suspected of causing or con-

12 tributing to (i) cancer, (ii) gene mutations, or (iii) birth
13 defects.
14 (B) As soon as practicable but not later than nine
15 months after the date of the enactment of this Act, the com-
16 mittee shall publish in the Federal Register the list required
17 by subparagraph (A) together with the reasons for the com-
18 mittec's inclusion of each chemical substance or mixture on
19 the list. At least every 6 months after the publication of
20 the list pursuant to the preceding sentence, the committee
21 shall make such revisions in the list as it determnnines to be
22 necessary and shall publish the list in the Federal Register
23 with the committee's revisions (if any) and the reasons for
2-1 the revisions. Within the 12-month period beginning on the
25 date of the inclusion of a chemical substance or mixture on









21
i such a list the Admninistrator shall with respect to such

2 chemical substance or mixture either (i) initiate a rule-
3 making proceeding under section 4 (a) or (ii) if such a
4 proceeding is not initiated within such period, publish in
5 the Federal Register the Administrator's reasons for not

6 initiating such a proceeding.
7 (C) The Administrator may promulgate a rule under
8 subsection (a) with respect to a chemical substance or mix-
9 turc (i) which is not contained on a list puldlislicd under
10 this subsection or (ii) whether or not tlhe Admini.-trator has
11 published in the Federal Registcr reasons for not initiating

12 a proceeding under subparagraph (B).
1 (2) (A) The committee established by paragraph (1)
14 (A) shall consist of seven members as follows:
15 (i) One member (or designee of the member)

10 appointed from the Department of Commerce by the
17 Secretary.
IP (ii) One member (or designee of the member)

s19 appointed from the Environmental Protection Agency
20 by the Administrator.
21 (iii) One member (or designee of the member)
22 appointed by the Secretary of Labor from officers of
23 the Department of Labor engaged in the Secretary's
24 activities under the Occupational Safety and Health
25 Act of 1970.






78


22

1 (iv) One member (or designee of the member)
2 appointed from the Council on Environmental Quality
3 by the Chairman of the Council.
4 (v) One member (or designee of the member)
5 appointed from the National Institute for Occupational
6 Safety and Health by the Director of the Institute.
7 (vi) One member (or the designee of the member)
8 appointed from the National Institute of Environmental
9 Health Sciences by the Director of the Institute.

10 (vii) One member (or designee of the member)
11 appointed from the National Cancer Institute by the
12 Director of the Institute.
13 (viii) One member (or designee of the member)
14 appointed from the National Science Foundation by
35 the Dirhector of the Foundation.
16 A member may designate an individual to serve on the
17 member's behalf only with the approval of the applicable
18 appointing authority and only if the individual is from the
19 entity from which the member was appointed. A vacancy in
20 the committee shall be filled in the same manner in which
21 the original appointment was made.
22 (B) (i) The term of office of a member of the committee
23 is 4 years, except that of the members first appointed,
21 four members shall have initial terms of 2 years. Any






79


23
1 member appointed to fill a vacancy occurring prior to the
2 expiration of the term for which the member's predecessor
3 was appointed shall be appointed only for the remainder of
4 such term. If any member of the committee leaves the office
5 or entity from which the member was appointed, such mem-
6 ber's term of office shall be terminated and the member's
7 position shall be considered as being vacant. A member may

8 serve after the expiration of the member's term of office until
9 a successor has taken office. Members may be reappointed.

10 (ii) Initial appointments to the committee shall be
11 made not later than the 60th day after the date of the
12 enactment of this Act. Not later than the 90th day after

13 such date of enactment the members of the committee shall
14 hold a meeting for the selection of a chairman from among
15 their number and to determine, by lot, the four members
16 who shall have initial terms of 2 years.
17 (C) (i) No member of the committee, or designee of
18 such member, shall accept employment or compensation

19 from any person subject to any requirement of this Act, or
20 rules issued thereunder, for a period of at least 24 months
21 after termination of employment with such agency.
22 (ii) No person, while serving as a member of such
23 committee, or designee of such member, may own any stocks
24 or bonds, or have any pecuniary interest in any firm, asso-






80


24
1 ciation, or corporation engaged mi the manufacture, process-
2 ing, or distribution of any chemical substance or mixture
3 subject to the provisions of this Act.
4 (iii) The Administrator or the Attorney General may
5 bring an action in the appropriate district court of the United
6 States to restrain any violations of this subparagraph.
7 (D) The Administrator shall provide the committee
8 such administrative and staff support services as may be
9 necessary for the committee to carry out its functions under
10 this subsection.

11 (f) REQUIRED ACTIONS.- (1) Upon the receipt of
12 (A) any test data required to be submitted under this section
13 or under section 5, or (B) any other information available to
14 the Administrator which indicates that a chemical substance
15 or mixture has the potential, at levels for which human ex-
16 posuirc exists or may exist and with appropriate safety mar-
17 gins, to induce in human beings (1) cancer, (2) gene
18 mutations, or (3) birth defects, the Administrator shall take
19 appropriate action under section 5(e), 6(a), ox 7, within
20 180 days after the receipt of such data or information to limit
21 exposure of human beings with respect to such substance or
22 mixture, or he shall publish in the Federal Register his find-
23 ing that no unreasonable risk of injury is presented and rea-
24 sons therefore. Any such finding under this subsection that no









25
1 unreasonable risk is presented shall be rekviewable in accord-
2 ance with chapter 7 of title 5, United States Code.
3 (2) Nothing contained in this subsection shall require
4 the Administrator to take action under section 5 (e), 6 (a),
5 or 7, or publish his reasons for failing to take such action,
6 until 2 years after the date of enactment of this Act.
7 PREMARKET NOTIFICATION OF CHEMICAL SUBSTANCES
8 SEC. 5. (a) GENERAL.- (1) Commencing 1 year and
9 30 days after the date of enactment of this Act, a
10 manufacturer shall notify the Administrator, who shall
11 notify the public as required in subsection (c), of any
12 planned manufacture of a new chemical substance, at least
13 90 days prior to the commencement of such manufacture.
14 Such notice to the Administrator shall be accompanied by
15 all pertinent information referred to in section 8(a) (2),
16 whether or not the Administrator has required the sfbmis-
17 sion thereof under section 8 (a) (2), except that with respect
18 to the information referred to under section 8 (a) (2) (E),
19 such manufacturer may submit a description: of such infor-
20 mation, as defined by the Administrator, by rule.
21 (2) The Administrator shall give priority attention to
22 a chemical substance with respect to which information is
23 received indicating that serious economic or other hardships
24 are likely to result if. there is any delay in manufacture,






82


2g6
1 If the Administrator finds that such a substance does not
2 present an unreasonable risk to human health and the
3 environment, he may reduce the number of days, after sub-
4 mission of such information, during which manufacture may
5 not occur. The Administrator shall promptly publish (sub-
6 ject to section 14) his findings and the basis therefore in the
7 Federal Register.

8 (b) SUBMISSION OF DATA.-Any manufacturer of a
9 new chemical substance that is covered by section 4 (a) shall
o10 submit to the Administrator (in addition to the information
11 required in subsection (a)) the data developed in accord-
12 ance with such requirement-at least 90 days prior to such
13 manufacture, and the Administrator shall make it publicly
14 available in accordance with subsection (c).
15 (c) DATA AvAILABIITY.-Within 15 days after re-
16 ceipt, the Administrator shall promptly publish in the Fed-
17 eral Register (subject to section 14) the identity of each
18 chemical substance for which a notice has been received un-
19 der subsection (a) or (b), the intended use or distribution
20 of such substance, and a statement that the data and other
21 information is available. The 90 days referred to in subsec-
22 tions (a) and (b) shall begin upon publication under this
23 subsection in the Federal Register.
24 (d) ExTENSION.-The Administrator may extend, for
25 an additional period beyond the 90-day period referred to






83

27
1 in subsection (a) or (b), the date after which a new chemi-
2 cal substance may be manufactured. Such additional period
3 may not exceed 90 days and shall not be imposed except

4 for good cause shown. Notice of any such extension, and
5 the reasons therefore, shall be published (subject to section

6 14) in the Federal Register. Such an extension shall consti-
7 tute a final action for purposes of judicial review.

8 (e) ORDERS.--(1) (A) If the Admiiiistrator finds, dur-
9 ing the 90-day period referred to in subsection (a) or (b)
10 mo during any extension thereof, with respect to any new
11 chemical substance for which notification is required under

12 this section-
13 (i) that such new chemical substance is covered by
14 a test requirement under section 4 (a), but thit such
15 requirement requires addition or revisions with respect
16 to such substance; or
17 (ii) that such new chemical substance is not cov-
18 ered by such a requirement under section 4 (a), but
19 'that such requirement should be established;
20 he shall issue an order in accordance with this subsection.
21 Such an order shall appropriately prohibit or restrict the
22 manufacture, processing, distribution in commerce, use, or
23 disposal of such new chemical substance pending the comple-
24 tion of a rulemaking proceeding under section 4 (a) and
25 the submission of any data required thereunder, as described






84

28
Sunder subparagraph (B) ; shall contain a proposed rule

2 under section 4 (a) ; and shall be immediately effective.
3 (B) Upon the issuance of any order under subpara-

4 graph (A), the Administrator shall proceed with a rulemak-
5 ing procedure as expeditiously as practicable under section 4

6 (a) and in accordance with subparagraph (0). During the
7 course of, or upon the completion of, such rulemakling, the

8 Administrator shall, if necessary, appropriately modify or
9 rescind any order issued under subparagraph (A). If any

10 testing requirements are established as a result of such rule-
11 making, any provision of such order restricting the manu-

12 facture, processing, distribution in commerce, use, or disposal
13 of such substance shall remain in effect, unless modified or
14 rescinded, pending the submission of such data to the Ad-
15 ministrator and the completion of procedures described in

16 subsection (b) or any extension imposed under subsection

17 (d).
18 (0) If the Administrator issues an order under sub-
19 paragraph (A), the Administrator shall provide interested

20 persons reasonable opportunity, in accordance with section
21 4(b) (4) to make presentations and submissions with re-
22 spect to such order. If such presentation or submission is

23 requested, the Administrator shall comply within 30 days
24 from the date such request is made unless the Administra-
25 tor and the person making the request agree upon a later






85


29
1 date. Within 10 days after such presentations and submis-
2 sion are concluded, the Administrator shall consider such
3 presentations and submissions and affirm, modify, or revoke
4 such order.
5 (2) (A) If the Administrator finds, during the 90-day
6 period referred to in subsection (a) or (b) or during any
7 extension thereof, with respect to any new chemical substance
8 for which notification is required under this section, that a
9 rule is appropriate under section 6 (a), he shall issue an
10 order in accordance with this subsection. Such an order.

11 shall appropriately prescribe such requirements as are, au-
12 thorized under section 6(a) ; shall contain a proposed rule
13 under section 6 (a) ; and shall be immediately effective.
14 (B) Upon the issuance of any order under subpara-
15 graph (A), the Administrator shall proceed with a rule-
16 making procedure as expeditiously as practicable under see-
17 tion 6(a) and in accordance with subparagraph (0).
18 During the course of, or upon the completion of such rule-
19 making, the Administrator shall, if necessary, appropriately
20 modify or rescind any order issued under subparagraph (A).
21 (0) If the Administrator issues an order under sub-
22 paragraph (A), -the A&ndministrator shall provide interested
23 persons reasonable opportunity, in accordance with section
24 6(c) (2) and (3) for an informal hearing with respect to
25 such order. If such hearing is requested, the A&dministrator .






86


30
1 shall comply within 30 days from the date such request is

2 made unless the Administrator and the person making the
3 request agree upon a later date. Within 10 days after such
4 hearing is concluded, the Administrator shall consider the

5 information presented at such hearing and affirm, modify,

6 or revoke such order.
7 (f) STATEMENT OF REASONS FOR NOT TAKING Ac-
8 TION.-Prior to the expiration of 90 days after the date
9 of publication under subsection (c), of data and informa-
10 tion with respect to a new chemical substance, or prior to
11 the expiration of such period as extended under subsection

12 (d), the Administrator shall publish a statement of his
13 reasons in the Federal Register, if he decides not to take
14 action under subsection (e) or section 7 with respect to
15 such chemical substance during such period. Manufacture

16 may commence following publication of the Administrator's
17 statement. The Administrator's failure to issue such an order

18 under subsection (e) or take action under section 7 is an
19 action subject to judicial review in accordance with section

20 19. Nothing in this subsection prohibits the Administrator
21 from-

22 (1) promulgating a rule pursuant to section 6 or 4,
23 with respect to such a substance, after such manufacture
24 has commenced;I

25 (2) taking action against any chemical substance






87


31
1 which is found to be an imminent hazard pursuant to

2 section 7; or
3 (3) taking any other action authorized by this Act.
4 (g) EXEMPTION.- (1) The Administrator may upon
5 application (made in such form and manner as the Adminis-
6 trator may prescribe) exempt any person from the require-
7 ment of subsection (b) or (h) to submit data for a chemical
8 substance or mixture. If, upon receipt 'of an application
9 under the preceding sentence, the Administrator determines
10 that-
11 (A) the chemical substance or mixture with respect
12 to which such application was submitted is equivalent
13 to a chemical substance or mixture for which data has
14 been submitted'to the Administrator in accordance with
15 subsection (b) or (h),and
16 (B) submission of data by the applicant with re-
17 6pect to such substance would be duplicative of data
18 which has been submitted to the Administrator in
19 accordance with such subsection,
20 the Administrator shall exempt the applicant from submit-
21 ting such data with respect to such substance. No exemption
22 granted under this subparagraph with respect to the submis-
23 sion of data for a chemical substance or mixture may take
24 effect before the beginning of the reimbursement period
25 applicable to such data.






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3 2.

1 (2) If the Administrator, under paragraph. (1), ex-
2 empts any person from submitting under. subsection (b) or
3 (h) data for a chemical substance or mixture because of
4 the existence of. previously submitted. data and if such exemp-
5 tion is granted during the reimbursement period for such
6 data, then (unless such. person and the. persons referred to
7 in subparagraphs (A) and: (B) agree on the amount and
8 method of reimbursement) the Administrator .shall order, the
9 person granted the exemption to provide fair and equitable
10 reimbursement (in an amount determined under rules of the
11 Administrator) -

12. (A) to., the person who previously submitted the
13. data on which the exemption was based, for a portion of
14. the costs incurred by such person in complying,' with the
15 requirement under subsection (b) or- (h) to submit
16 such data, and:
17 (B) to any other person who has -been required
18 under this subparagraph to contribute with respect to
19 such costs, for. a portion of the amount'such; person
20 was required to contribute..

21 In promulgating. rules for the determination of. fair and
22 equitable reimbursement to. the. persons described in. -sub-
23 paragraphs (A) and (B) for costs incurred with respect to.
24 a chemical substance or mixture, the Adminlstrator.shall,-
25 after consulting with the Attorney. General and the Federal






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33
1 Trade Commission, consider all relevant factors, including

2 the effect on competition within the chemical industry and
3 the share of the market for such substance or mixture of the
4 person required to provide reimbursement in relation to the
5 share of such market of the persons to be reimbursed. An

6 order under this subparagraph shall be considered final
7 agency action, for purposes of judicial review.

8 (3) For purposes of this paragraph, 'the reinibursemnent
9 period for any previously submitted data for a chemical

10 substance or mixture is a period-

11 (A) beginning on the date of the termination of
12 the prohibition, imposed under this section, on the manu-
13 facture or processing of such substance by the person
14 who submitted such data to the Administrator, and

15 (B) ending-
16 (i) two years after the date referred to in
17 subparagraph (A), or

18 (ii) at the expiration of a period which begins
19 on the date referred to in subparagraph (A) and is
20 equal to the period which the Administrator deter-
21 mines was necessary to develop such data,
22 whichever is later.

23 (h) SIGNIFICANT NEW USE.- (1) Within 6 months
24 after the date of enactment of this Act, and from time to
25 tine thereafter, the Administrator shall, by rule, establish
S.3149-3


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34
1 criteria defining a significant new distribution in commerce,
2 use, or disposal of a chemical substance. In establishing such
3 criteria, the Administrator shall take into account-
4 (A) projected volume of production;
5 (B) projected category or categories of uses;
6 (0) projected increase in magnitude and durationd
7 of human and environmental exposure;
8 (D) route or routes of exposure of human beings
9 or of the environment that are attributable to such
10 significant new use; and
11 (E) the human health and environmental effects
12 thereof.
13 (2) A chemical substance may not be manufactured or
14 processed for a distribution in commerce, use, or disposal
15 that is identified by the Administrator, in a rule, as a sig-
16 nificant new distribution in commerce, use, or disposal, unless,
17 at least 90 days prior to such manufacture or processing,
18 the person intending to manufacture or process such substance

19 for such distribution in commerce, use, or disposal submits a
20 notice of his intention to do so and any data required to be
21 developed under section 4 (a) to the Administrator. Any such
22 use of such substance shall be subject to all of the provisions
23 of this section.
24 (i) SPECIAL EXEMPTION.-The Administrator may,