NOTES

The Toxic Substances
Control Act of 1976:

An Introductory Background
and Analysis

I. INTRODUCTION

Federal legislation dedicated specifically to the regulation of toxic
metals and synthetic organic chemicals did not exist prior to
January, 1977. Though some degree of control had been exercised
in a limited number of instances, it was accomplished only through
provisions of statutes1 directed to other environmental concerns, at
a date subsequent to manufacture, distribution and widespread use
of the substance, and in many cases, under pressure of public out-
cry stemming from discovery after the fact of the irreversible and
tragic effects of the substance. This absence of specific toxic sub-
stances control authority could not be dismissed as insignificant in
view of the increasing pervasiveness of such substances in our soci-
ety. 2 Nor could it be attributed to lack of notice of the potential
risks which many of them present given the substantial documenta-

1. See note 10 infra.
2. Federal agency reports confirm this trend: approximately 3.5 million chemical

compounds are presently known to exist, [1976] COUNCIL OF ENVIRONMENTAL
QUALITY ANN. REP. 29, with over 250,000 new compounds discovered each year,
COUNCIL OF ENVIRONMENTAL QUALITY, TOXIC SUBSTANCES 3 (1971) [hereinafter
cited as Toxic SUBSTANCES]; over 9,000 synthetic organic compounds are now in
commercial use, each in excess of 1,000 pounds, and 300 to 500 new chemical com-
pounds are introduced annually into commercial use, id.; in 1973, production of the
top fifty chemicals alone totalled 410 billion pounds, U.S. ENVIRONMENTAL PRO-
TECTION AGENCY (E.P.A.), ACTIVITIES OF FEDERAL AGENCIES CONCERNING SE-

LECTED HIGH VOLUME CHEMICALS ii (1975); and since 1966, production of synthetic
organic chemicals has expanded by 255 percent, [1975] COUNCIL OF ENVIRON-
MENTAL QUALITY ANN. REP. 23.



COLUMBIA JOURNAL OF ENVIRONMENTAL LAW

tion of health danger. 3 Prompted by such reports, both the 92d
and 93d Congresses considered a number of toxic substances pro-
posals, but the members' inability to resolve differences between
House and Senate versions prevented final approval of the legisla-
tion during either term. Not until the waning days of the 94th
Congress were both chambers able to reach agreement, and in Oc-
tober, 1976, the Toxic Substances Control Act 4 was signed into law
by the President.

In its final form, the Act is preeminently a compromise, the
product of numerous factors and pressures. Intense lobbying
through three Congresses by public interest, labor, and industry
groups; a belief of legislators in an election year that debate had
continued long enough and that action was necessary now; a feeling
among manufacturers that no more lenient bill was likely, particu-
larly in view of the seemingly imminent election of a Democratic
President who had made the need for environmental protection a
campaign issue of importance; the disinclination of the President to
veto less than one month prior to election day a bill actively sup-
ported by labor unions and public interest groups-these factors
and others contributed to passage of the Act in 1976. And, as with
most compromises, no one was entirely satisfied. Opponents would
have preferred more limited controls, if any at all, but could take
satisfaction in the relatively cautious approach of many provisions
in comparison to stricter measures which might have been agreed
to; supporters were relieved that some comprehensive legislation
had -after so many years become law, but lamented that the ad-
ministering agency had not been given a stronger mandate both in
terms of regulatory power and monetary authorization. More gen-
erally, however, the attitude appeared to be one of pragmatic res-
ignation: that, under the circumstances, the Act as finally approved
was the best that could be achieved.

3. Approximately 60 to 90% of all cancer is believed to be environmentally
caused, id. at 17; 20% of all birth defects are caused by environmental influences,
and another 60% of birth defects are believed to stem from a combination of en-
vironmental and hereditary factors, CONGRESSIONAL RESEARCH SERVICE, EFFECTS
OF CHRONIC EXPOSURE TO Low-LEVEL POLLUTANTS IN THE ENVIRONMENT 135
(1975); and such commonly used and widely dispersed substances as lead, cadmium,
mercury, polychlorinated-biphenyls (PCB's), asbestos, polyvinyl-chloride (PVC),
bischloromethyl-ether (BCME), and fluorocarbons have been cited in recent studies
as posing significant health dangers of cancer, birth defects, genetic mutations, or
other serious diseases, ToxIc SUBSTANCES, supra note 2, at 8-14.

4. Pub. L. No. 94-469, 90 Stat. 2003, (codified at 15 U.S.C.A. § 2601 et seq. (West
Supp. 1977)) [hereinafter cited as the Act.]

[4: 35



TOSCA Background and Analysis

The discussion which follows is divided into two parts. First, the
legislative background of the Act and the development of its major
provisions are traced from the Act's origins in 1971 through passage
five years later. With regard to the proposals of the 92d and 93d
Congresses, the discussion is cursory; as to those of the 94th Con-
gress, its scope is broadened to include recommendations and ac-
tivities of principal toxic substances lobbying interests during 1975
and 1976 and the influence of the Ford Administration on the legis-
lation. Second, key sections of the Act are analyzed. In several
instances, this consists of a summary of a particular provision; in
others, some interpretive discussion based on the legislative history
is included. It must be emphasized, however, that this analysis is
neither a thorough critique of the Act nor a definitive resolution of
its interpretive difficulties. It is intended solely as an introduction
to issues much debated in the past which may arise again in the
course of future litigation.

II. BACKGROUND

A. Council on Environmental Quality (CEQ)
Report on Toxic Substances

When the CEQ was established in early 1970 with Russell Train
as its chairman, one of the first projects undertaken was the de-
velopment of effective legislation to deal generally-rather than on
a case-by-case basis-with the problem of toxic substances. 5

Though the need for new controls seemed probable, the scope of
the problem, the lack of a central source of knowledge to deal with
questions raised, and great uncertainties about toxic substances
generally required that a study be conducted prior to formulation
of legislative proposals. In April, 1971, the results of that study
were published in a report entitled "Toxic Substances." 6 This re-
port-which became the primary impetus for the original Toxic
Substances Control Act legislation introduced in the 92d Congress 7

-- contained four basic findings: first, that production and use of
potentially toxic metals and synthetic organic compounds-such as

5. Hearings on S. 776 Before the Subcomn. on the Etnvironment of the Senate
Comm. on Commerce, 94th Cong., 1st Sess. 202 (1975) [hereinafter cited as S. HEAR.,
94TH CONG.].

6. Toxic SUBSTANCES, supra note 2.
7. S. REP. No. 94-698, 94th Cong., 2d Sess. 3 (1976) [hereinafter cited as S. REP.,

94TH CONG.].

1977]



COLUMBIA JOURNAL OF ENVIRONMENTAL LAW

dyes, plastics and rubber products-were widespread and rapidly
increasing in this country;8 second, that data indicated the potential
or actual danger of many of them; 9 third, that existing authorities
were inadequate to assure their control; 10 and fourth, that com-
prehensive new legal authority was essential for the testing and
regulation of such substances." Concluding that "we need no

8. "These substances enter man's environment-and man himself-through com-
plex and inter-related pathways. Present in air, water, soil, consumer products, and
food, they pervade our environment. . . . Increasingly, all forms of life are being
exposed to potentially toxic substances." Id. at iv.

9. The Council noted that the environmental effects of most chemical substances
were not well understood-particularly the long-term effects. However, it cited
numerous substances known or ttrongly believed to pose health risks and stated:

Many serious effects, including those resulting in cancer (carcinogenicity),
genetic mutations which cause permanent and transmissable change in the genes
of offspring from those of the parent (mutagenicity), and production of physical
or biochemical defects in an offspring (teratogenicity) can occur from metals,
their compounds, and synthetic organic compounds.

Id.
10. The Council surveyed the major regulatory statutes applicable to toxic sub-

stances and concluded that only a small portion of the total number of potentially
hazardous substances could adequately be controlled under the limited foci of exist-
ing authorities. Statutes directed toward control of manufacture and distribution-
the Federal Insecticide, Fungicide, and Rodenticide Act (F.I.F.R.A.), 7 U.S.C. § 136
et seq. (Supp. V 1975), and the Federal Food, Drug, and Cosmetic Act (F.F.D.C.A.),
21 U.S.C. § 301 et seq. (1970)-though potentially effective, could be applied only to
a limited range of substances. Acts regulating the interstate transport of hazardous
substances-the Department of Transportation Act, 49 U.S.C. § 1651 et seq. (1970),
the Transportation of Explosives Act, 18 U.S.C. §§ 831-36 (1970), and the Hazardous
Cargo Act, 46 U.S.C. § 170 (1970)-were directed primarily against hazards involved
in the transportation and accidental spillage of chemicals. Similarly, emission and
effluent control authorities-the Clean Air Act (C.A.A.), 42 U.S.C. §§ 1857-571 (1970),
as amended (Supp. IV 1974), and the Federal Water Pollution Control Act
(F.W.P.C.A.), 33 U.S.C. § 1151 et seq. (1970), as amended in 1972, 33 U.S.C. §§
1251-1376 (Supp. III 1973)-which enable the regulation of pollutants introduced in
relatively large quantities directly into the environment, were limited in their effec-
tive application against minute quantities of dangerous substances which are found
not only in air and water, but in soil, food, and industrial and consumer products as
well. More importantly, though, the Council emphasized that such authorities were
untimely: "The obvious limitation of controls over effluents is that they generally
deal with a problem only after it is manifest. They do not provide for obtaining
information on potential pollutants before widespread damage has occurred." Id. at
20. See generally id. at iv, v, 15-20.

For a list of 27 existing statutes compiled by Dow Chemical Co. in support of its
contention that no further toxic substances legislation was necessary, see Hearings onl
H.R. 7229, HR. 7548, and H.R. 7664 Before the Subcomm. on Consumer Protection
and Finance of the House Comm. on Interstate and Foreign Commerce, 94th Cong.,
1st Sess. 325-326 (1975) [hereinafter cited as H.R. HEAR., 94TH CONG.].

11. Toxic SUBSTANCES, supra note 2, at v-vi.

[4: 35



TOSCA Background and Analysis

longer remain in a purely reactive posture with respect to chemical
hazards,"'12 the Council recommended immediate adoption of legis-
lation designed to restrict or prohibit use or distribution of a chem-
ical before its hazardous effects could be realized.13

In accord with CEQ's recommendation, President Nixon, in his
environmental message to Congress on February 2, 1971,14 called
for legislation to establish a federal regulatory system to protect the
public and the environment from potentially hazardous chemicals.
Specifically, the President proposed:

[T]hat the Administrator of EPA be empowered to restrict the
use or distribution of any substance which he finds is a hazard to
human health or the environment;

• . . that the Administrator be authorized to stop the sale or
use of any substance that violates the provisions of the legislation
and to seek immediate injunctive relief when use or distribution
of a substance presents an imminent hazard to health or the en-
vironment;

. . . that the Administrator be authorized to prescribe mini-
mum standard tests to be performed on substances.15

12. The Council continued:
We need no longer be limited to repairing the damage after it has been done;
nor should we allow the general population to be used as a laboratory for dis-
covering adverse health effects. There is no longer any valid reason for con-
tinued failure to develop and exercise reasonable controls over toxic substances
in the environment.

Id. at 21.
13. Id. at 21-22.
14. The President proposed the Toxic Substances Control Act of 1971 prior to

publication of the CEQ study on which it was based because writing of the study
was not concluded until after his legislative proposals had been formulated. The
Council's findings, however, were substantially complete by December, 1970. Id. at
preface.

15. 7 WEEKLY COMP. OF PRES. Doc. 194 (Feb. 15, 1971). In addition to these
regulatory, imminent hazard, and testing authorities, other notable provisions pro-
posed by the Administration included authority for the Administrator to conduct
necessary research and monitorings, execute reasonable inspections of industry
facilities based on judicially issued warrants, develop an information system and
prediction capability, and require submission of information by chemical manufac-
turers and processors concerning the name, composition, production level, uses, and
test results of any substance produced by them; civil and criminal penalties for viola-
tion of the Act; exemption from all requirements of the Act for substances produced
solely for export and for pesticides, food, drugs, cosmetics, and other substances and
articles regulated under existing federal statutes; and broad preemption of state au-
thority to test or regulate substance subject to such a rule under the federal Act,
unless the state regulation is a total ban of a particular use or uses. See ToxIc SUB-
STANCES, supra note 2, at vi and S. 1478, 92d Cong., 1st Sess. (1971).

1977]



COLUMBIA JOURNAL OF ENVIRONMENTAL LAW

One week later, a bill incorporating these authorities and entitled
the Toxic Substances Control Act of 1971 was transmitted by EPA
Administrator William Ruckleshaus through Executive Message to
the President of the Senate and the Speaker of the House of Rep-
resentatives. 16

B. Congressional Action

Both chambers approved versions of toxic substances legislation
during the 92d Congress, 17 but only after significant changes were
made in the President's proposals. Most important of these-and
the provision which became the major stumbling block to House
and Senate accord on the legislation during the succeeding five
years-was the inclusion of EPA authority to screen new chemicals
prior to marketing. The Senate provision, adopted in lieu of a pro-
posal for pre-market certification of new chemicals, 18 required
manufacturers to submit test results on all new chemical substances
produced by them-except those exempted by the Administrator
-at least 90 days prior to commercial production, and authorized
the Administrator, where warranted by the test data or lack of
them, to restrict the use or distribution of a substance at the end
of the 90 day period, pending the outcome of administrative pro-
ceedings on the restriction. The House bill contained a pre-market
screening provision substantially less universal in application, lim-

16. H.R. REP. No. 92-1477, 92d Cong., 2d Sess. 21 (1972) [hereinafter cited as
H.R. REP., 92D CONG.].

17. Principal toxic substances legislation of the 92d Congress included: S. 1478-
introduced on Apr. 1, 1971 by Senators Hart (D. Mich.), Magnuson (D. Wash.), and
Tunney (D. Cal.), by request of the Nixon administration; Hearings on S. 1478 Be-
fore the Subcomin. on the Environment of the Senate Comm. on Commerce, 92d
Cong., 2d Sess. (1972); reported by the Commerce Committee on May 5, 1972, to-
gether with S. Rep. No. 92-783, 92d Cong., 2d Sess. (1972); Senate debate, amend-
ments, and passage on May 30, 1972, 118 CONG. REC. 19156-74 (1972); Senate recon-
sideration of House amendments on Oct. 14, 1972, 118 CONG. REC. 36252-61 (1972);
H.R. 5276-introduced on Mar. 1, 1971 by Reps. Staggers (D. W. Va.) and Springer
(R. Ill.), by request of the Nixon administration; Hearings on HR. .5276 and H.R.
10840 (and identical bills) Before the Subcomm. on Commerce and Finance of the
House Commn. on Interstate and Foreign Commerce, 92d Cong., 2d Sess. (1972); re-
ported as S. 1478 on Sept. 28, 1972, together with H.R. REP., 92D CONG., supra note
16; House debate, amendments, and passage on Oct. 13, 1972, 118 CONG. REC.
36054-65 (1972).

18. Senator Spong (D. Va.) introduced an amendment which provided for man-
datory pre-market certification by EPA of compliance with testing requirements as to
all new chemical substances. See Amend. No. 338 to S. 1478, 92d Cong., 2d Sess.
(1972). The amendment was rejected by the committee.

[4: 35



1977] TOSCA Background and Analysis

ited to substances designated in advance by the Administrator as
likely to pose substantial danger to health or the environment. 19

Because the House did not approve its version of the legislation
until the final week of the session, adjournment prevented both
appointment of a conference committee to resolve this and other
differences and reconsideration of the legislation by both chambers.
Consequently, Congress failed to complete action on the legislation
during the 92d Congress.

The innovation necessary to bridge the gap existing at the end of
the previous session did not emerge during the 93d Congress, 20 as
the bills introduced in both the House and Senate were essentially
recycled versions of proposals of the 92d Congress. 21 To insure that

19. Other notable additions to House and Senate legislation were all extension of
the Administrator's regulatory authority to existing chemical substances; inclusion of
authority for citizen civil actions against alleged violators of the Act; and, in the
House version only, a nullification of the Administrator's authority to regulate a sub-
stance where an unreasonable risk posed by that substance could be prevented or
sufficiently reduced by actions taken under existing federal statutes. During the 92d
and succeeding Congresses, this provision describing the relationship of the act to
existing federal laws remained a major point of controversy between Senate and
House sponsors.

20. Principal toxic substances legislation of the 93d Congress included: S. 426-
introduced on Jan. 18, 1973 by Senators Byrd (D. W. Va.), Magnuson, Hart and Tun-
ney; Hearings on S. 426, S. 888, and Amends. 1, 8 and 9 Before the Subconim. on
the Environment of the Senate Comm. on Commerce, 93d Cong., 1st Sess. (1973);
reported by the Commerce Committee on June 26, 1973, together with S. REP. No.
93-254, 93d Cong., 1st Sess. (1973); Senate debate, amendments and passage on July
18, 1973, 119 CONG. REC. 24485-501 (1973); H.R. 5356-introduced on Mar. 7, 1973
by Reps. Moss (D. Cal.), Stuckey (D. Ga.), Eckhardt (D. Tex.) and Helstoski (D.
N.J.); Hearings on H.R. 5087, H.R. 5356 and H.R. 1014 Before the Subcomm. on
Commerce and Finance of the House Comm. on Interstate and Foreign Commerce,
93d Cong., 1st Sess. (1973); reported from committee on June 29, 1973, together with
H.R. REP. No. 93-360, 93d Cong., 1st Sess. (1973); House debate, amendments and
passage on July 23, 1973, 119 CONG. REC. 25431-76 (1973).
S. 888 and H.R. 5087 were introduced by request of the Nixon administration and

differed only slightly from the administration proposal of the 92d Congress.
21. Aside from drafting refinements, important changes were few. However, a

number of amendments were offered in committee or on the floor of either chamber to
slow the regulatory mechanisms of the Act and reduce its burden on the chemical
industry. For example, the pre-market screening section of S. 426 was expanded to
include exemption and reimbursement provisions for industry in certain cir-
cumstances, and the Administrator was authorized to reduce the period during which
production was barred where, in his judgment, a substance posed no unreasonable
threat to health or the environment. Similarly, H.R. 5356 contained a comparable
reimbursement provision, an exemption for small businesses from many of the Act's
reporting and recordkeeping requirements, and a provision directing the Adminis-
trator to prepare a detailed economic impact statement at the time he promulgates a
final rule.



COLUMBIA JOURNAL OF ENVIRONMENTAL LAW

toxic substances legislation would not again be doomed by ad-
journment, both houses acted quickly and a conference committee
was appointed in July, 1973, to work out differences between
House and Senate approved versions. However, months of effort
by the committee proved unavailing: Senate conferees refused to
compromise on the issues of pre-market screening and discretion of
the Administrator to utilize the regulatory authorities of the pro-
posed legislation in preference to existing statutes; similarly, the
House conferees-under heavy pressure from industry lobbies-
would not acquiesce to the Senate language. When the 93d Con-
gress adjourned more than one year after the committee was
formed, no accord had been reached.

No fewer than nine toxic substances bills were introduced during
the 94th Congress in an effort to create a compromise that would
break the deadlock of the previous four years and clear the way for
final approval of the Act. The first of these-S. 776-was intro-
duced on February 20, 1975, by Senator Tunney (D. Cal.), for
himself and Senators Magnuson (D. Wash.) and Hart (D. Mich.).
Though generally similar in content to Senate passed legislation of
previous sessions, the bill broadened the Administrator's authority
and foreshadowed the increasing complexity that would charac-
terize much of the 94th Congress toxic substances legislation. 22

After subcommittee hearings in early spring, 23 a staff working draft
was released in June and was received with strong criticism by
some members of the chemical industry who feared what they con-
sidered to be the potentially prohibitive cost of the bill. 24 This

22. Most notable of the changes were these: pre-market screening requirements,
previously applicable only to new chemical substances, were extended to include
"significant new uses" of existing substances; the reporting section was strengthened
by requiring industry to submit all health and safety studies to EPA and to maintain
records of adverse reactions to human health or the environment alleged to have
resulted from exposure to a chemical substance; the Administrator was empowered
to authorize reasonable inspections of industry facilities, a power which previously
had been conditioned on a judicially issued warrant; the Administrator's authority to
disclose information submitted under the Act was broadened by a provision requir-
ing only his determination that disclosure is "necessary to protect health or the envi-
ronment"; the determination whether a risk can be sufficiently reduced by actions
taken under existing federal laws became discretionary, thereby increasing the Ad-
ministrator's freedom to utilize this Act; and an employee protection section was
added to prevent retaliatory discharge of workers based on actions taken to carry out
the purposes of the Act. S. 776, 94th Cong., 1st Sess. (1975).

23. S. HEAR., 94TH CONG., supra note 5, at pts. 1 and 2.
24. See notes 63-65 and accompanying text infra.

[4: 35



TOSCA Background and Analysis

fear-also shared by some members of the subcommittee-and
memories of past unwillingness of the House to support similarly
stringent Senate measures contributed to a decision by its spon-
sors, after one day of additional hearings on the cost issue in Oc-
tober, to postpone further action on S. 776.

In the House, three toxic substances bills were introduced in
early 1975: H.R. 7229, by Rep. Eckhardt (D. Tex.), on May 21;
H.R. 7548, by Rep. Brodhead (D. Mich.), on June 3; and H.R.
7664, by Rep. McCollister (R. Neb.), on June 5. These proposals
embodied a wide range of viewpoints respecting the appropriate
level of toxic substances regulation-as described by Rep. Van
Deerlin (D. Cal.), chairman of the subcommittee to which they
were referred for hearings, 25 they represented a range of "two to
ten on the Richter scale. "26 Rep. McCollister's H.R. 7664 deferred
in large part to the viewpoint of the chemical industry and most
resembled the generally unrestrictive House legislation of preced-
ing Congresses; Rep. Eckhardt's H.R. 7229 struck a middle ground
between House and Senate bills approved in 1972 and 1973,
though it retained a limited pre-market screening provision similar
to those previously adopted by the House and rejected by the Sen-
ate; and Rep. Brodhead's H.R. 7548 most nearly approximated
the degree of stringency considered necessary by environmental
lobbies. 27

In an effort to resolve the vast differences between these three
versions of the Act and to alleviate the paramount concern of in-
dustry over potential scope, scale, and cost of the testing and sc-
reening programs, Rep. Eckhardt introduced a fourth bill-H.R.
103 18-on October 22, for himself and Rep. Van Deerlin. The crit-
ical elements of this compromise were the inclusion of universal
pre-market screening of all new chemical substances and significant
new uses of existing chemical substances, and the explicit exclusion
of chemical mixtures from the statutory definition of chemical sub-
stance. Thus, the regulatory powers of the Administrator were
augmented to a level similar to that contained in Senate approved
legislation, but the number of chemicals subject to those powers
and the economic burden on the chemical industry were limited by

25. H.R. HEAR., 94rH CONG., supra note 10.
26. [1975] 6 ENVIR. REP. (BNA) 480.
27. For a comparison of major provisions of these bills, see notes 124 and 144

in fra.

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COLUMBIA JOURNAL OF ENVIRONMENTAL LAW

the inapplicability of the pre-market screening provisions to mix-
tures and by the inclusion of partial exemptions for mixtures in the
testing and reporting sections. With these and other innovative
provisions,2 8 H.R. 10,318 was approved by the subcommittee in
early December after minor amendment, and was reintroduced in
the House on January 28, 1976, as H.R. 11576 in order to accom-
modate fourteen other members who wished to be included, along
with the three original sponsors, as co-sponsors of the legislation.29

These developments seemed to indicate a growing consensus in
the House in support of a single draft of the Act, but agreement
was still far from unanimous. On March 4, Rep. McCollister, for
himself and Rep. Broyhill (R. NC) and at the request of the Ford
Administration, introduced H.R. 12336-an amended version of his
previously offered H.R. 7664-"in the spirit of compromise" and in
an attempt to "strike a balance between the ill-conceived approach
of H.R. 10318 and the more careful and selective approach of H.R.
7664. '"3 Though H.R. 12336 did indeed have the outward appear-
ance of compromise, containing as it did a mix of provisions drawn
from earlier bills, the primary reliance by its drafters on H.R. 7664
and H.R. 7229 gave McCollister's proposal a conservative, industry-
oriented character.31 The bill was referred to the House Interstate

28. Another obvious compromise was the bifurcation of the much disputed sec-
tion concerning the relationship of the Act to existing federal laws: where a risk
could be sufficiently reduced pursuant to an existing law not administered by the
Administrator, the Administrator was required to notify the other agency and defer to
its jurisdiction; where the risk could be dealt with under existing laws administered
in whole or in part by the Administrator, those laws were to be utilized unless the
risk could be ''more appropriately protected against" under the Toxic Substances
Control Act. In addition to inspection and reporting provisions similar to those of S.
776, H.R. 10318 created authority for citizen petitions to the Administrator for is-
suance of a rule and established a seven-member inter-agency advisory committee to
compile a priority listing for testing chemicals and mixtures. If the Administrator
initiated no rulemaking with respect to a substance within twelve months after inclu-
sion on the list, he was required to publish in the Federal Register his reasons for
inaction.

29. In addition to Reps. Eckhardt, Van Deerlin (D. Cal.), and Brodhead (D.
Mich.), H.R. 11576 was co-sponsored by Reps. Metcalfe (D. I1l.), Schelier (D. N.Y.),
Ottinger (D. N.Y.), Edgar (D. Pa.), Edwards (D. Cal.), Eilberg (D. Pa.), Harrington
(D. Mass.), Hechler (D. W. Va.), Holtzman (D. N.Y.), Koch (D. N.Y.), Nix (D. Pa.),
Richmond (D. N.Y.), Studds (D. Mass.), and Zefferetti (D. N.Y.).

30. 122 CONG. REC. E1070-71 (daily ed. Mar. 4, 1976).
31. Aside from increased reporting requirements for large manufacturers and a

provision similar to that in H.R. 10318 concerning the relationship of the Act to exist-
ing laws, the substance of H.R. 7664 remained largely intact: the Administrator was
given discretion whether to require testing of substances found to be potentially
hazardous; pre-market screening was included only in limited form; rules regulating

[4: 35



TOSCA Background and Analysis

and Foreign Commerce Committee, where a compromise between
H.R. 1157632 and H.R. 12336 was not achieved until June.

In contrast to the numerous House versions, S. 776 remained
throughout the first session the only toxic substances bill before the
Senate. By February, 1976, however, members of the Senate
Commerce Subcommittee on the Environment still had not re-
solved their doubts about the potential costs of S. 776 and the
likelihood of its approval by both chambers and the executive
branch. Therefore, in executive session meetings of the Commerce
Committee on February 3, 4, and 17, Senator Hartke (D. Ind.) pro-
posed and urged adoption of a substituted text derived substantially
from H.R. 11576. 33 After several days of markup and some further
amendment directed primarily toward increased public disclosure
of the reasons for administrative action or inaction under the Act,
the substitute-S. 3149--was accepted. One month later, on
March 16, it was reported out of committee and introduced in the
Senate 34 by Senator Tunney, for himself and Senator Hartke. 35 As
reported, the bill conformed closely to the substance and the lan-
guage of H.R. 11576. In comparison to the myriad differences
existing between S. 776 and earlier House bills, the characteristics
of S. 3149 which materially distinguished it from H.R. 11576 were
relatively few. 36 On March 26, without significant amendment of

substances could not be made immediately effective by the Administrator except
through court action under the imminent hazard authority; inspections were con-
ditioned on judicially issued warrants; no citizen civil action or petition authority
was included; and the bulk of reporting and recordkeeping requirements was made
inapplicable to small businesses.

32. The bill number H.R. 11576 will be used here in the interest of clarity to
designate the version of H.R. 10318 approved by the House subcommittee. However,
even after H.R. 10318 was amended and reintroduced as H.R. 11576, it was generally
known by its original number.

33. See note 29 and accompanying text supra.
34. S. REP., 94TH CONG., supra note 7.
35. On Mar. 17, 1976, additional co-sponsors were added: Senators Magnuson,

Pearson (R. Kan.), Durkin (D. N.H.), Hart, Moss (D. Utah), Stevens (R. Ala.), Steven-
son (D. I11.), and Weicker (R. Conn.).

36. The major difference was the requirement in S. 3149 that the Administrator
publicly account for his failure to initiate authorized actions. For example, the Ad-
ministrator was required prior to expiration of the 90 (lay notice period to publish in
the Federal Register his reasons for failure to take action against a new chemical
substance after notification of its intended production. Where test data indicated the
potential of a substance to induce cancer, gene mutations, or birth defects in humans,
the Administrator was required-not merely authorized-to take "appropriate" reg-
ulatory action or publish in the Federal Register his reasons for determining that no
unreasonable risk is presented.

1977]



COLUMBIA JOURNAL OF ENVIRONMENTAL LAW [4: 35

its major provisions, the bill was overwhelmingly approved in the
Senate by a vote of 60 to 13.37

Not until May, 1976, did the House committee reach a prelimi-
nary accommodation between the majority and minority forces on a
draft of the House bill. On May 26, Rep. Eckhardt introduced
H.R. 1403238 as legislation carefully drafted to meet "the urgent

need for an effective means of controlling toxic chemicals
[without] an undue regulatory burden placed on the chemical in-
dustry."3 9 The effect of this accommodation was to cast in doubt
once again the likelihood of House and Senate accord on toxic sub-
stances legislation, an accord which, based on the close similarities
of H.R. 11576 and S. 3149, had seemed imminent. Important
changes were made in the subcommittee bill, most of which were
intended to mollify the chemical industry and neutralize or dilute
the regulatory authority of the Administrator. This was effected not
simply by obvious amendment of key provisions, but by numerous,
seemingly minor, drafting alterations as well. 40 Most crucial, how-

Other additions to S. 3149 were more elaborate specification of rulemaking proce-
dures; expansion of the employee protection provision; and authority of the Adminis-
trator to impose production, distribution, and use quotas in certain instances, sub-
poena documents and witnesses, and award attorneys fees where equitable.

37. Two notable amendments to § 6 of S. 3149, concerning regulation of sub-
stances found to pose an unreasonable risk, were adopted prior to Senate passage of

the bill. First, Senator Nelson (D. Wisc.) proposed that PCB's be singled out for
immediate regulation and, two years after enactment, total ban, subject to exceptions
deemed non-hazardous by the Administrator. Second, Senator Cannon (R. Nev.) of-
fered an amendment limiting the Administrator's authority to make immediately ef-
fective a proposed rule regulating an existing chemical substance. For debate,
amendments, and passage of S. 3149, see 122 CONG. REC. S4379-S4420 (daily ed.
Mar. 26, 1976).

38. H.R. 14032 was a product of committee members' belief that legislation could
be drafted "which would be satisfactory to all of us." 122 CONG. REC. E2914 (daily
ed. May 26, 1976) (statement by Rep. Eckhardt). Based on an amended version of
H.R. 11576, the bill was drafted and sponsored principally by Reps. Eckhardt and
Broyhill (R. N.C.). Other co-sponsors were Reps. Murphy (D. N.Y.), Van Deerlin,
Moss, Rooney (D. Pa.), Scheuer, Carney (D. Ohio), Moffett (D. Conn.), Rinaldo (R.
N.J.), and Lent (R. N.Y.).

39. Id.
40. For example, throughout the bill the threshold standard for justifying regula-

tory action was changed from "cause or contribute to an unreasonable risk" to "cause
or significantly contribute to" such a risk; in the testing section, a cost factor was
added to the relevant considerations in promulgating a testing rule and a representa-
tive of the Commerce Department was included in the inter-agency committee
which recommends testing priorities; in the imminent hazard section, the definition
of such a hazard as a substance "which causes or contributes to an imminent and
unreasonable risk to health or the environment," became a substance "which causes



1977] TOSCA Background and Analysis

ever, were amendments to the enforcement provisions of the bill.
Under H.R. 11576, the Administrator could, based on a specified
finding, make a proposed rule immediately effective to hold off the
market or otherwise regulate a new chemical substance. However,
under H.R. 14032, the Administrator could effect such results only
through court action, a much slower and more cumbersome pro-
cess. When House and Senate versions of the legislation were sent
to conference committee later in the year, that provision became
the point most difficult to resolve.

According to Rep. McCollister, H.R. 14032, as introduced and
presented to the committee, constituted "a very delicate balance
. . . that [could] be destroyed rather readily."41 Not surprisingly,
then, the committee was unreceptive to further adjustment of that
balance. With several non-substantive exceptions, all amendments
were rejected, and, on June 9, the bill was favorably reported by
the committee. 42 On August 23, after lengthy floor debate, the

or significantly contributes to an imminent and unreasonable risk of serious wide-
spread harm to health or the environment"; and in the section concerning relation-
ship of the Act to existing laws, the authority of the Administrator to disregard other
laws adlinistered by him which might be utilized to reduce a risk was conditioned
not on a finding of appropriateness, but on a determination that use of the Act is "in
the public interest."

Other notable changes were the inclusion of anl exemption for small businesses
from most of the reporting and recordkeeping requirements; an extension of the
scope of federal preemption so that all state regulation of a substance regulated
under the federal Act is prohibited; and further limitations on disclosure of informa-
tion submitted pursuant to the Act with specification of criminal penalties for know-
ing violation.

41. 122 CONG. REC. H8810 (daily ed. Aug. 23, 1976).
42. H.R. REP. No. 94-1341, 94th Cong., 2d Sess. (1976) [hereinafter cited as H.R.

REP., 94TH CONG.]. Dissension on the part of some members of the committee is
evidenced by the supplementary statements which accompanied the Report. Reps.
Collins (R. Tex.) and Devine (R. Ohio) charged that the bill would prove "ruinous-
to much of the chemical industry and specifically criticized the inclusion of citizen
civil action, citizen petition, and employee protection provisions. Rep. Dingell (D.
Mich.) called for authority directed explicitly to the regulation of PCB's, and joined
in a minority statement with Reps. Moss, Metcalfe, Brodhead, Moffett, and Maguire
(D. N.J.) which listed eight major inadequacies of the legislation as reported. Spe-
cifically, the statement criticized (1) the failure to require that the Administrator act
on the recommendations of the inter-agency testing priority committee or explain his
inaction; (2) the requirement that the Administrator seek a court injunction to pre-
vent marketing of a new substance after the 90 clay notice period where information
is insufficient to determine a risk; (3) the failure to require that the Administrator
explain why a new substance was permitted to be marketed without regulation; (4)
the requirement that the Administrator seek a court injunction to immediately regu-
late a chemical determined to pose an unreasonable risk; (5) the requirement that the



COLUMBIA JOURNAL OF ENVIRONMENTAL LAW [4: 35

House approved H.R. 14032 by a vote of 319 to 45. Particularly
notable among the amendments 43 approved was a proposal by Rep.
Moore (R. La.) to permit either chamber of the Congress to invali-
date EPA-approved toxic substances regulations within 60 days
after promulgation. Inclusion of such a provision by the House was
tantamount to a request that the President veto the entire bill in
light of his recent veto of pesticide legislation based on constitu-
tional objections to just such a provision. 44

After amending S. 3149 to contain the language of the H.R.
14032 as finally passed, the House requested a conference with the
Senate; on August 31, the request was agreed to, and the confer-
ence committee meetings commenced on September 1.45 The issue

Administrator make a "cumbersome and time consuming" determination of the pub-
lic interest where a risk can be regulated by other laws under his authority; (6) the
preemption of state authority to regulate toxic substances, thus precluding states from
taking stronger action; (7) the failure to provide the Administrator with subpoena
power for information gathering purposes; and (8) the failure to provide EPA with a
firm mandate supported by adequate funding and time-phased enforcement require-
ments. Id. at 135-38.

43. Also agreed to was an amendment offered by Reps. Dingell and Gude (R.
Md.) to regulate and eventually ban PCB's. For debate, amendments, and passage,
see 122 CONG. REC. H8803-66 (daily ed. Aug. 23, 1976).

44. To infer that Rep. Moore may have intended by this amendment to inject a
fatal flaw into the legislation is not unreasonable in view of the fact that he voted
against the bill despite adoption by the House of his amendment as § 32 of the
House bill. Subsequently, Senate conferees refused to accept this provision, and it
was omitted from the conference agreement. Had it been included, the Act almost
certainly would have been vetoed by the President, whose constitutional objections
to such a procedure were well-known to the Congress. On August 13, 1976, Presi-
dent Ford vetoed an extension of F.I.F.R.A., 7 U.S.C. § 136 et seq. (Supp. V 1975),
solely because a similar section had been included, and, in so doing, he explained
his objections:

[Such provisions] are contrary to the general principle of separation of power
whereby Congress enacts laws but the President and the agencies of government
execute them. Furthermore, they violate Article I, section 7 which requires that
resolutions having the force of law be sent to the President for his signature or
veto. There is no provision in the Constitution for the procedure contemplated
by this bill.

122 CONG. REC. H8787 (daily ed. Aug. 23, 1976). Thus, adoption by the conference
committee of § 32 of the House bill would have supplied a constitutional basis for
veto of the legislation, a basis entirely unrelated to issues of toxic substances control.

See Rep. Broyhill's defense-in the face of strong criticism from Reps. Moore and
Levitas (R. Ga.)-of the House conferees' decision to accede to the objections of the
Senate conferees on this issue. 122 CONG. REC. H11345 (daily ed. Sept. 28, 1976).

45. House conferees were Reps. Staggers, Murphy, Stuckey, Eckhardt, Broyhill,
McCollister, Brodhead, Scheuer, and Rinaldo. Subsequently appointed was Rep. De-
vine, to replace Rep. McCollister who resigned in order to devote time to his Senate



TOSCA Background and Analysis

most responsible for the toxic substances deadlock in the 92d and
93d Congresses-the scope of pre-market screening-was not a
problem in this conference, having been largely resolved during
the preceding several months. Instead, the committee was faced
with the closely related and equally difficult question of how much
authority the Administrator should have to hold new chemicals off
the market once notified of intended manufacture. As previously
noted, the Senate version of S. 3149 authorized the Administrator
to make immediately effective a proposed rule upon termination of
the 90 day notice period, pending completion of administrative
hearings on the rule. The House amendment, on the other hand,
required the Administrator first to seek a court injunction. The
greater part of conference deliberations was directed toward resolu-
tion of this issue as, once again, irreconcilable viewpoints on a
single dominant issue threatened to stall the legislation in the final
weeks of the session.

Resolved with comparatively little difficulty were other points of
controversy, such as whether the Administrator should be required
to publish in the Federal Register his reasons for failure to (1) take
regulatory action against a new chemical substance prior to expira-
tion of the notice period and (2) require testing of a substance
within one year after its inclusion on the interagency advisory
committee's testing priority list.46 Also disputed-as they had been
during each Congress considering this legislation-were the rela-
tionship of the Act to existing federal laws and the authority of the
Administrator to utilize the regulatory provisions of this Act against
a risk which is subject to provisions of other laws administered by
him.. The ultimate resolution of these and other issues by the con-
ference committee was substantially a product of the urgent need
for control of hazardous chemicals, concession by industry that
some increase in regulation was inevitable, and a strong desire on
the part of the legislation's sponsors to achieve some constructive,
tangible results and to prevent the recurrence of stalemate. Though
not willing to concede unilaterally on key provisions in order to
reach an agreement, the conferees were more amenable during this
Congress to accommodation and settlement. Consequently, the bill

campaign. Senate conferees were Senators Magnuson, Hartke, Hart, Durkin, Tunney,
Baker, and Stevens.

46. In both instances, the Senate bill required publication and the House amend-
ment did not.

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COLUMBIA JOURNAL OF ENVIRONMENTAL LAW

that emerged from conference was a lengthy, complex, and, at
times, convoluted compromise, particularly with respect to the au-
thority of the Administrator to screen new chemical substances. 47

On September 14, agreement among the conferees was
reached48 and two weeks later, on September 28, S. 3149 was ap-
proved by both chambers without amendment. 49 Because the Ford
administration favored a less stringent version of the legislation
forwarded to the White House for his signature, there was, even at
that late date, some expectation that President Ford might veto the
Act after adjournment of Congress on October 2, thereby preclud-
ing any possibility of congressional override. In fact, that expectation
was not discredited until the final day before a pocket veto would
have become effective, and on October 11, S. 3149 was signed
into law.50

C. Lobbying and Pressure Groups

The effects of multifarious public interest, labor, industry, and
government groups on the development of the Toxic Substances
Control Act are not easily overestimated. Since its inception in
1971, the Act has been the focus of substantial lobbying activity,
and its final form is in no small measure the result of that activ-
ity.5 ' Particularly during the 94th Congress, the Act became the

47. Its provisions will be discussed in Part III infra.
48. Nine days thereafter the committee filed its report. H.R. REP. No. 94-1679,

94th Cong., 2d Sess. (1976) [hereinafter cited as CONF. REP., 94TH CONG.].
49. S. 3149 passed the Senate by a vote of 73 to 6 and the House by a vote of 360

to 35. For debate and final passage, see 122 CONG. REC. S16802-09, H11343-48 (daily
ed. Sept. 28, 1976).

50. For discussion of the role of the Ford Administration with regard to toxic
substances legislation during the 94th Congress, see notes 75-86 and accompanying
text infra.

51. Introducing S. 3149 in the Senate on March 26, 1976, Senator Tunney de-
scribed industry's efforts to defeat the legislation:

It is indeed unfortunate that while the record of chemical dangers continues to
grow, segments of the chemical industry have presented roadblocks at every
juncture of this bill's development. There is no question in my mind that a stat-
ute would now be on the books providing effective protection against chemical
hazards had it not been for the concerted effort of certain segments of the chem-
ical industry to gut the essential provisons of this legislation ....

I must say that I have never seen such an effective lobbying effort as was done
against this legislation.

122 CONG. REC. S4397-98 (daily ed. Mar. 26, 1976).

[4: 35



TOSCA Background and Analysis

object of intense lobbying activity as the various interests sensed
that 1976 would be a year in which elected officials would be most
sensitive to public concern for protection from the dangers of toxic
chemicals and that, after five years of debate over legislation the
need of which had been widely acknowledged in 1971, congres-
sional inaction had continued long enough. These efforts took many
forms, ranging from informal meetings with legislators to public ac-
tion campaigns on a far grander scale.5 2 Though dollar estimates
of resources expended by interest groups with respect to this leg-
islation are difficult to determine, 53 it seems probable that the
amounts may have been substantial, particularly on the part of in-
dustry.

52. Other lobbying activities included subsidizing cost analysis studies (see notes
63-65 and accompanying text infra), arranging briefings for legislators, funding con-
gressional breakfasts, motivating public sentiment through periodical publications,
and initiating and stimulating public letter writing campaigns. A striking illustration
of this last activity is a letter, signed by Dow Chemical Co. President, Earle B.
Barnes, which describes a planned campaign in opposition to toxic substances bills
of the 94th Congress:

Before long we will want to encourage the broadest and strongest possible
grass roots political action campaign in opposition to Toxic Substances legisla-
tion. Hopefully, it will be based on mail to and calls on Senators and Represen-
tatives from employees, relatives, friends, distributors, vendors, customers, state
organizations, etc. The objectives are to kill the bills or to register a minority
vote sufficient to sustain a hoped-for veto or, as a last resort, to get the bills
moderated significantly through floor amendments in the House....

Now, the time is near for our big push. We are not alone in this effort. Numer-
ous other companies are also rallying grass roots campaigns....

122 CONG. REC. S4401-02 (daily ed. Mar. 26, 1976). The letter included summaries of
the legislation, lists of Representatives and Senators, and tips on how best to corre-
spond with them, and concluded with an offer of prepared paragraphs and sentences
"which people may wish to draw upon in framing their own letters on their own
(non-Dow) stationery." Id.

53. Aside from difficulties inherent in quantifying in terms of dollars the re-
sources directed toward support of or opposition to a particular piece of legislation,
lobbying groups often prefer that such financial information not become a matter of
public record. From a public relations standpoint, this is understandable considering
the detrimental publicity which a particular group or company is likely to receive if
it is known to be spending large amounts of money to defeat legislation intended to
control dangerous chemicals. Financial reporting mandated by the Federal Regula-
tion of Lobbying Act, 2 U.S.C. §§ 261-70 (1970), is of little use because the informa-
tion required to be submitted by lobbyists is general in nature and because the stat-
ute does not preclude an organization from masking its accounting by filing through
a number of individuals rather than as a single entity. For reports submitted pertain-
ing to a period of heavy lobbying with respect to this Act during 1976, see 122
CONG. REC. pt. 11 (daily ed. Aug. 10, 1976).

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COLUMBIA JOURNAL OF ENVIRONMENTAL LAW

Because of its tremendous size and resources,5 4 the chemical
industry-more than any other interest group-was equipped to
initiate and maintain a prolonged and extensive campaign. Not sur-
prisingly, however, manufacturers did not in all cases present a
consistent viewpoint, and some were more amenable than others to
the prospect of stricter regulation. In testimony before the House
subcommittee, Dow Chemical Co. General Counsel James H.
Hanes characterized the early House bills as the "Chemical Indus-
try Control Act"55 and expressed Dow's complete opposition to any
increase in control because "from both the public's and the indus-
try's standpoint a law is not needed and should not be passed."-56

According to Dow, new legislation would further constrict an al-
ready overregulated industry, causing inflation and unemployment
and stifling necessary creativity.5 7 On the other hand, Rohm and
Haas Co. President Vincent Gregory, Jr., announced his company's
early support for the relatively stringent S. 776 and the "philoso-
phy and reasoning behind it. "58

A more moderate approach-most representative of the views of
the industry as a whole-was advocated by the two organizations
most active in lobbying during the 94th Congress: the Manufactur-
ing Chemists Association (M.C.A.)59 and the Synthetic Organic
Chemical Manufacturers Association (S.O.C.M.A.). 60 Though con-
ceding the necessity of some new authority, these groups em-

54. Annual sales of the chemical industry now exceed $100 billion annually. S.
REP., 94TH CONG., supra note 7, at 3.

55. - H.R. HEAR., 94TH CONG., supra note 10, at 322.
56. Id. This viewpoint was expressed also by Elmer Fike, President of Fike

Chemical Co. and chairman of the legislative committee of the Chemical and
Specialties Management Council, a group of small eastern chemical manufacturers.
Citing excessive regulatory legislation as the primary reason for the rise of the na-
tional debt to $500 billion, Fike, on behalf of small manufacturers, deprecated the
value of federal regulatory agencies, any one of which "has such broad and loosely
defined powers that they can, by legal means or by pure harassment, force us into
bankruptcy at any time they choose." A better alternative, he suggested, would be
"voluntarism." Id. at 94-102.

57. Id. at 323 (statement by Dow General Counsel Hanes).
58. S. HEAR., 94TH CONG., supra note 5, at 69. The Rohm and Haas Co. was at

that time involved in litigation stemming from 20 to 25 employee deaths since 1962,
allegedly from lung cancer resulting from exposure to BCME, a chemical treatment
for fabrics.

59. M.C.A. is a non-profit trade organization having 184 U.S. company members
representing 90% of the production capacity of industrial chemicals in the U.S.

60. S.O.C.M.A. is a non-profit trade association of 74 manufacturers of organic
chemicals.

[4: 35



TOSCA Background and Analysis

phasized that "selectivity should be the key feature of the thrust of
any new law" since sweeping, duplicative controls intended to do
more than close the gaps in existing laws would have detrimental
effects on the industry and, as a consequence, on the entire
economy.6 1 Similarly, they considered careful, reasoned adminis-
tration essential: "Any law, however carefully drafted, must be ad-
ministered reasonably and prudently, and all aspects of its potential
impact on productivity and technology must be evaluated care-
fully. "62

The paramount concern of all segments of the chemical industry
with respect to this legislation was undoubtedly its potential cost.
To alleviate uncertainty as to precisely what that would be, Dow
Chemical Co., M.C.A., and the EPA conducted independent cost
analysis studies which attempted to project, based on the pro-
visions of S. 776, costs of screening, testing, delays, bans and re-
strictions, and any other costs. Instead of resolving the issue, how-
ever, the inconsistent conclusions of the studies only heightened
the controversy: Dow estimated an overall annual cost to industry
of $2 billion; M.C.A. projected a range from $358 million to $1.325
billion, depending on the degree of testing needed; and EPA pre-
dicted a range of $78.5 million to $141.5 million. By request of
Senator Hart, the General Accounting Office (G.A.O.) reviewed

61. S. HEAR., 94TH CONG., supra note 5, at 124-25 (statement by M.C.A. rep-
resentative Dr. C. Boyd Shaffer).

62. Id. With regard to specific provisions of the bills before the 94th Congress,
industry representatives recommended that the subcommittee: condition testing
rules on a finding that the chemical substance is likely to pose a substantial un-
reasonable risk to health or the environment; adopt the limited pre-market screening
procedure included in H.R. 7664; exempt mixtures, catalysts, research and laboratory
chemicals, and test-marketing chemicals from the scope of the Act; delete authority
of the Administrator to make immediately effective a proposed regulatory rule, and
require in all rulemaking advance notice of proposed rules, right to comment, and an
opportunity for public hearing with cross-examination of witnesses; provide less
stringent requirements for small businesses; permit the Administrator to take action
pursuant to the Act only upon a finding that the risks involved cannot be dealt with
under existing law; limit retention of health and safety studies to ten years; delete
authority for citizen civil actions against the Administrator as to performance of dis-
cretionary duties; and provide for total pre-emption of state regulatory authority over
a chemical substance already subject to federal controls. For these and other recom-
mendations, see H.R. HEAR., 94TH CONG., supra note 10, at 284-93, 313-23, 391-96;
S. HEAR., 94TH CONG., supra note 5, at 123-37, 328-33.

For an exchange of views between an executive of E.I. DuPont de Nemours and
Co. and principal Senate sponsors of the Act, see Heckert, Toxic Substances: A Case
for Common Sense, 8 NAT'L J. 462, (1976); and Tunney, Hartke & Hart, S3149: The
Toxic Substances Control Act, id., at 834-35.

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COLUMBIA JOURNAL OF ENVIRONMENTAL LAW

each study to determine the cause of the vast variation in appraisal.
In a report63 submitted to the Senate subcommittee, the G.A.O.
emphasized that, because of the numerous variables involved, any
prediction would be uncertain; nevertheless, it concluded cau-
tiously that it would "feel least uncomfortable" with an estimate
within the range of $100 million to $200 million per year. 64 The
G.A.O. noted as a final caveat that none of the studies had consid-
ered benefits and that, whatever the costs, the benefits to society
as a whole might still exceed them, particularly where chemicals
banned were dangerous to health. 65

Public interest organizations, such as the Sierra Club, the En-
vironmental Defense Fund (E.D.F.), the Natural Resources De-
fense Council (N.R.D.C.), and Ralph Nader's Public Citizens'
Health Group, utilized many of the traditional lobbying methods
noted earlier. 66 Undoubtedly, though, the greatest impetus to leg-
islative concern were events over which those groups had no di-
rect control: the recent disasters associated with such substances as
mercury, B.C.M.E., vinyl chloride, arsenic, and asbestos, and the
press reports of them. 67 Such events lent credibility to the view

63. S. HEAR., 94TH CONG., supra note 5 at pt. 2 (U.S. GENERAL ACCOUNTING

OFFICE, A COMPARISON OF THREE ESTIMATES OF COSTS OF THE PROPOSED TOXIC

SUBSTANCES CONTROL ACT, and accompanying testimony by Harry S. Havens, Di-
rector, Office of Program Analysis, General Accounting Office (G.A.O.) at 82-98).

64. Id. at 97-98. In his testimony before the Senate subcommittee, Harry S. Ha-
vens, the Director of the Office of Program Analysis of the G.A.O. reviewed briefly
the basis for the G.A.O.'s conclusions. He characterized the Dow study as the "least
reliable" and stated that the $2 billion estimate was "highly questionable" because
based on a greatly overstated estimate of costs. Id. at 84-85. As to the M.C.A.
study-also known as the Snell report-he cited several defects, the most significant
of which was the inclusion of questionable "maintenance of innovation" costs, con-
sisting largely of an exaggerated increase in research and development costs. Id. Ha-
vens described the EPA study as "closer than the industry studies to an accurate
picture of what the legislation will entail," id. at 84, but he commented that certain
of its assumptions and statements were inadequately documented. Id. at 88.

65. This is precisely the view advocated by Sierra Club representative Linda Bil-
lings with respect to the cost issue in testimony before the House subcommittee: that
the costs of regulation "should be balanced by also considering the cost to society of
not doing so." H.R. HEAR., 94TH CONG., supra note 10, at 161. Among those costs
she included losses in labor productivity due to illness, losses in lifetime earnings to
those seriously disabled, costs of treating diseases, and, most importantly, "the incal-
culable cost in human suffering, not to mention serious environmental costs .... "
Id. She suggested that manufacturers would be more prudent to "spend money in
testing . . . than to later be required to put out even more money in the event of
damage suits." Id.

66. See note 52 supra.
67. The widely acclaimed CBS news documentary entitled The American Way of

[4: 35



TOSCA Background and Analysis

of these groups that toxic substances legislation was necessary not
simply as a "gap-filler" between existing laws, but as authority for a
comprehensive system of federal control over the introduction of
hazardous substances into the environment.68 According to E.D.F.
counsel Jacqueline Warren, the three essential elements of such
legislation were (1) reporting and recordkeeping requirements to
assure dissemination of information, (2) mandatory pre-screening of
all chemicals in order to detect harmful substances before health
disasters occur, and (3) adequate administrative authority to act

Cancer was shown specially for House and Senate members, and Sen. Tunney com-
mented in subcommittee hearings that it "presented an excellent case for the Toxic
Substances Control Act." S. HEAR., 94TH CONG., supra note 5, pt. 1, at 1-2. Through-
out the 94th Congress, accounts of chemical dangers were drawn from newspapers
around the nation and introduced into the Congressional Record in support of the
Act. As much as any direct lobbying activity, such reports argued persuasively in
favor of stringent regulation and gave credence to the contentions of consumer and
environmental advocates. See 122 CONG. REC. H1206-08 (daily ed. Feb. 19, 1976),
E1449-50 (daily ed. Mar. 22, 1976), S4005-07, E1487-89 (daily ed. Mar. 23, 1976),
S4142 (daily ed. Mar. 24, 1976), S4239-40, E1544-45, E1554-56 (daily ed. Mar. 25,
1976), E1649-51, E1676-78 (daily ed. Mar. 30, 1976), E1710-11, E1714-16 (daily ed.
Mar. 31, 1976), E1725-26 (daily ed. Apr. 1, 1976), E1847-48 (daily ed. Apr. 6, 1976),
E1879 (daily ed. Apr. 7, 1976), E1942 (daily ed. Apr. 9, 1976), E2016-18 (daily ed.
Apr. 13, 1976), S10145-46 (daily ed. June 22, 1976), S13666-67 (daily ed. Aug. 5,
1976).

68. Specifically, public interest advocates recommended to House and Senate
panels that they: require the manufacturer to carry the burden of proof concerning
the safety of a chemical which may pose a risk or about which insufficient informa-
tion exists to make a determination; require pre-market certification by the Adminis-
trator of all new chemical substances; require the Administrator to issue temporary
restrictions where the outcome of testing is pending or issue immediately effective
rules where data is insufficient to determine absence of risk, where a chemical is
determined to pose a risk, or where a substance is found to present an imminent
hazard; delete any exemption for test-marketing of chemicals; provide for broad re-
porting and retention of data requirements, particularly respecting health and safety
studies; delete provisions depriving the Administrator of authority under the Act
where a risk might be dealt with pursuant to other laws and provide instead that
nothing in this Act shall be construed to limit the authority and responsibility of the
Administrator or other federal officials under any other federal law; delete the
exemption for exports; authorize the Administrator to disclose information submitted
pursuant to the Act where the interest of public health and safety is served thereby;
permit states to regulate toxic substances at any level equal to or more stringent than
the federal regulations; provide for citizen civil actions by "interested or aggrieved
persons" where there is a failure of the Administrator to perform any non-
discretionary duty under the Act; and provide adequate authorization to assure that
EPA is well staffed and well funded. For these and other recommendations, see H.R.
HEAR., 94TH CONG., supra note 10, at 157-200; S. HEAR., 94TH CONG., supra note 5,
at 137-76.

See discussion of the cost issue by Sierra Club representative Linda Billings, at
note 65 supra.

1977]



COLUMBIA JOURNAL OF ENVIRONMENTAL LAW

quickly and decisively against potential or actual hazards. 69

N.R.D.C. representative J.G. Speth warned, however, that the
existence, without more, of discretionary EPA authority to test,
screen, and regulate would not be enough:

The legislation should require EPA in mandatory terms to
regulate substances that pose an unreasonable risk; otherwise
you run the risk that EPA will not act. . . . And the legislation
should have careful deadlines for EPA action; otherwise you
run the risk of prolonged delay and repeated postponements.
Give EPA a discretionary framework for aggressive action but
no mandate to act aggressively . . . and you will get some regu-
lation of toxic substances but not much. 70

Public interest advocates were not alone in their efforts to get
stringent toxic substances legislation approved by the 94th Con-
gress. An important factor in the success of that body in finalizing
the Act in 1976 was the heightened level of activity by labor groups
toward that end. Though several union representatives testified
during the 92d Congress, 71 not until 1975 did a concerted effort
materialize in support of stricter controls. 72 In testimony before
House and Senate subcommittees, labor representatives voiced
general sympathy with the concerns raised by public interest
groups, but directed their testimony more particularly to the fail-
ure of existing laws-specifically, the Occupational Safety and
Health Act (O.S.H.A.)--to adequately protect the worker until
after the toxic substance and its attendant hazards have been intro-
duced into the workplace. The Toxic Substances Control Act was
characterized as an urgently needed remedy to the existing "body
in the morgue" system which uses workers as guinea pigs to de-
termine the toxicity of inadequately tested chemicals. 73 Thus,
union representatives made recommendations pertaining primarily
to provisions intended to supplement O.S.H.A., coordinate with

69. H.R. HEAR., 94TH CONG., supra note 10, at 175-76.
70. Id. at 193-94.
71. See Hearings on S. 1478 Before the Subcomm. on the Environment of the

Senate Comm. on Commerce, 92d Cong., 2d Sess. (1972).
72. Labor groups represented at hearings during the 94th Congress included the

Oil, Chemical and Atomic Workers International Union, AFL-CIO; the United
Steelworkers of America; the United Paper Workers International Union; the Textile
Workers Union of America, AFL-CIO; and various departments of the AFL-CIO.

73. H.R. HEAR., 94TH CONG., supra note 10, at 87 (statement of Anthony Maz-
zocchi, Citizenship-Legislative Director, Oil, Chemical and Atomic Workers Interna-
tional Union, AFL-CIO).

[4: 35



TOSCA Background and Analysis

the National Institute for Occupational Safety and Health
(N.I.O.S.H.) and the Occupational Safety and Health Administra-
tion (O.S.H. Adm'n), and prohibit employer discrimination.74

The role of the Ford Administration with respect to this legisla-
tion resembled in many ways that of the interest groups discussed
above, as officials sought, primarily through testimony, to influence
its development. During the early months of 1975, the President's
top environmental advisors-EPA Administrator Russell Train and
CEQ Chairman Russell Peterson-actively urged that "a systematic
and comprehensive approach to the control of toxic substances be
provided," 75 and announced Administration support for regulatory
authorities significantly more stringent than those advocated by
the Nixon Administration during either of the previous two Con-
gresses. In testimony before the Senate subcommittee in March,
1973, Train described the elements which he considered critical to
an effective program, 76 and gave a qualified endorsement to S. 776:

First, the legislation would provide authority to collect neces-
sary information about the chemicals now in production....

Second, pre-market notification would be required for new
chemicals and significant new uses of existing chemicals....

Third, one of the key provisions .. . is the development of the
standards for test protocols, . . . to insure that the environment
does not become the testing laboratory and the general public
the test species for chemicals with uncertain effects.

Finally, the proposed legislation would provide for appro-
priate legal, administrative, and enforcement tools such as civil,

74. Specifically, they urged that the bill: provide for high priority testing by EPA
of thosd substances known to present occupational hazards; direct the Administrator
to inform both O.S.H. Adm'n and N.I.O.S.H. and provide them with all relevent data
where he determines that a chemical substance poses an unreasonable risk; contain
specific language to preclude possible conflict of authority between O.S.H. Adm'n
and EPA; establish a permanent inter-agency advisory committee made up of rep-
resentatives of the federal agencies concerned; prohibit employer discrimination and
use of threat by management of job losses resulting from actions by the employee or
the EPA pursuant to the Act; and establish special financial assistance programs-
i.e., economic dislocation assistance and retraining and relocation aid for workers
displaced by EPA actions. For these and other recommendations, see id. at 85-94; S.
HEAR., 94TH CONG., supra note 5, at 246-89.

75. Id. at 212.
76. The close similarity between the program outlined by Train and that pro-

posed by E.D.F. counsel Jacqueline M. Warren is striking and suggests that the Ad-
ministration's traditional sympathy for the interests of the chemical industry had lost
some ground-at least for the moment-to the environmentalist viewpoint. For War-
ren's testimony, see note 65 and accompanying text supra.

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criminal, and injunctive relief provisions; citizen suit provisions;
and appropriate inspection authority.

With regard to S.776, . . . I am pleased to note that it con-
tains the authorities I believe are essential for effective toxic sub-
stances control legislation and we are in accord with many of its
provisions. 77

The most basic change in the Administration's position was a
clear recognition of the concept of pre-market screening of all new
chemicals as essential to effective regulation. In reference to the
provision of H.R. 7229 incorporating the more limited approach
advocated by the previous Administration, 78 CEQ Chairman Peter-
son expressed the Council's primary concern that it would not "en-
sure that the impact of any new chemical substance is adequately
assessed and prepared for before commercial production begins. "79

He characterized as "essential," therefore, the inclusion of language
clearly indicating that "pre-market notification can be required of
all new chemical substances. "80 Commenting on that same provi-
sion of H.R. 7229, Deputy EPA Administrator John Quarles ex-
pressed emphatic agreement:

We feel very strongly that that provision would hobble the
administration of this program and would essentially prohibit any
effective application of the pre-market notification provision....
Therefore, if you are serious about pre-market notification, and
we are serious about that, because we feel it is one of the key
provisions of the bill-then the provision requiring the Adminis-
trator to publish a list before that whole mechanism is activated
is going to be very self-defeating. In our judgment that is the
single most offensive feature of any of the bills under considera-
tion. 81

77. S. HEAR., 94TH CONG., supra note 5, at 212.
78. See notes 18 & 19 and accompanying text supra and notes 144-46 and accom-

panying text infra. This limited approach subjected to pre-market screening re-
quirements only those substances included by the EPA Administrator on a list of
substances likely to pose a substantial risk. In effect, such approach required near-
clairvoyant powers on the part of the Administrator to predict, without benefit of
notification by the manufacturer, which substances would be marketed and the risks
which they might pose. According to Deputy EPA Administrator John R. Quarles: "It
would be very difficult or virtually impossible for any administrator or his staff to be
able to anticipate all the new chemicals that might be developed or all the significant
uses for which existing chemicals might be applied. H.R. HEAR., 94TH CONG.,
supra note 10, at 212.

79. Id.
80. Id.
81. Two other provisions found in several of the bills were singled out for par-

ticular criticism in testimony by Train and Quarles. First, Senator Tunney's "watch-

[4: 35



1977] TOSCA Background and Analysis

In November, 1975, however, the Ford Administration sudden-
ly abandoned its stated position and endorsed the concept of lim-
ited pre-market screening and a modified version of Rep. McCollis-
ter's first bill H.R. 7664. This reversal in attitude in the area of
toxic substances control came as a great surprise to many, includ-
ing, no doubt, the administration's environmental spokesmen Train,
Quarles, and Peterson. The turnaround stemmed not from a scien-
tific re-evaluation of the issues, but from a determination by Office
of Management and Budget (OMB) Director James Lynn that
pre-market notification as to all new substances "could be overly
burdensome" to manufacturers and the government's regulatory
workload.82 Accordingly, Lynn advised Rep. McCollister in a letter
of November 13 that "the Administration had reassessed its previ-
ous position with regard to toxic substances control legislation and
would support H.R. 7664 with some modification."8 3 This amended
version was introduced in March, 1976, by Reps. McCollister and
Broyhill as H.R. 12336.84

Despite continued opposition by the Administration to major as-
pects of both House and Senate majority bills throughout the sec-

dog" provision, precluding the Administrator from forwarding any budget estimates,
legislative proposals, comments on legislation, or testimony to the Office of Man-
agement and Budget (OMB) for review without also transmitting those materials to
Congress, was criticized as "not a toxic substance provision" and likely, if included
in the bill, to cause a veto of the entire Act. Second, authority of the Administrator to
make immediately effective any rule proposed during the 90 day pre-market review
period, was characterized as an unnecessary and undesirable abridgment of the
well-established procedure of rulemaking. Train and Quarles urged deletion of both
provisions. Id. at 211-12; S. HEAR., 94TH CONG., supra note 5, at 202-03. For these
and more specific criticisms of S. 776, see id. at 73-88, letter from Quarles to Sen.
Magnuson.

82. According to the National Journal and congressional subcommittee staff in-
volved with the legislation, early endorsements of universal pre-market screening
had been approved at relatively low levels of Lynn's OMB office, and not by Lynn
himself. One week prior to the letter to McCollister detailing the reversal, chemical
industry representatives met with top OMB staff for purposes which are not known,
though it seems probable that the Toxic Substances Control Act would have been
discussed. Lynn, who had vigorously opposed the concept of pre-market screening
when he served as General Counsel to the Commerce Department in 1971, then met
to discuss the bills with President Ford, who decided during the course of the meet-
ing to overrule his top environmental advisors. Neither Train nor Peterson was in-
vited to the meeting. Magida, Emiron men t Report/Toxic substances debate focuses
on notification and testing, 8 NAT'L J. 206, 207 (1976).

83. This description of Lynn's letter to McCollister and an explanation of the
recommended modifications of H.R. 7664 were contained in a Feb. 5, 1976, letter
from EPA Administrator Train to Rep. Staggers. H.R. REP., 94TH CONG., supra note
42, at 81-95.

84. See notes 30 & 31 and accompanying text supra.



COLUMBIA JOURNAL OF ENVIRONMENTAL LAW

ond session of the 94th Congress, President Ford signed S. 3149
without apparent misgivings, calling it "one of the most important
pieces of environmental legislation that has been enacted by the
Congress." 8 5 His brief statement upon signing the Act emphasized
congressional intent to fill gaps between existing statutes, and con-
cluded with the following caveat concerning proper administration
of its provisions:

This bill provides broad discretionary authority to protect the
health and environment. It is critical, however, that the legisla-
tion be administered in a manner so as not to duplicate existing
regulatory and enforcement authorities. . . . I am certain that
the Environmental Protection Agency realizes that it must care-
fully exercise its discretionary authority so as to minimize the
regulatory burden consistent with the effective protection of the
health and environment.8 6

President Ford's cautious explanation of the Act's intended pur-
pose and proper administration is an analysis with which many
might disagree. It is incongruous that the President, after praising
the significance of the legislation, should adopt an interpretation of
it most characteristic of the viewpoint of the chemical industry,
which for years had fought to prevent its enactment.

III. ANALYSIS
8 7

Section 2-Findings, Policy, and Intent88

The basis of the Act is set forth in subsection (a) and consists of
three congressional findings: first, that humans and the environ-

85. 12 WEEKLY COMP. OF PREs. DoC. 1489 (Oct. 18, 1976).
86. Id.
87. Some sections of the Act are more administrative than substantive in content

and are, therefore, less controversial. In the interest of brevity, they will not be con-
sidered in this analysis. Such sections include (citations to 15 U.S.C.A. (West Supp.
1977) are noted in brackets): § 10 [§ 2609]-Research, Development, Collection, Dis-
semination, and Utilization of Data; § 11 [§ 2610]-Inspections and Subpoenas; § 12
[§ 26111-Exports; § 13 [§ 26121-Entry into Customs Territory of the United
States; § 15 [§ 2614]-Prohibited Acts; § 16 [§ 2615]-Penalties; § 22 [§ 2621]-
National Defense Waiver; § 23 [§ 2622]-Employee Protection; § 24 [8 2623]-
Employment Effects; § 25 [§ 2624]-Studies; § 26 [8 2625]-Administration of the
Act; § 27 [§ 2626]-Deuelopinent and Evaluation of Test Methods; § 28 [§ 2627]-
State Programs; § 29 [§ 2628]-Authorization for Appropriations; § 30 [§ 2629]-
Annual Report; § 31 [§ 2630]-Effective Date.

For a discussion of the constitutionality of an inspection provision substantially
similar to that adopted in § 11 of the Act, see Comment, The Constitutionality of
General Inspections Under the Occupational Health and Safety Act of 1970, in this
issue infra.

88. 15 U.S.C.A. § 2601 (West Supp. 1977).

[4: 35



TOSCA Background and Analysis

ment are exposed to a large number of chemical substances and
mixtures; second, that some of those substances "may present an
unreasonable risk of injury to health or the environment;"8 9 and
third, that there is a need to regulate intrastate commerce of such
substances if interstate commerce is to be regulated effectively. In
this subsection and throughout the Act, the central concern is the
"unreasonable risk"-not risks generally-which may arise from
exposure to chemical substances and mixtures: Thus, Congress did
not intend through this Act to achieve a zero-risk environment.90

The statement of policy in subsection (b) is balanced: that data
development respecting chemical substances and mixtures is
needed and is the responsibility of industry; that adequate author-
ity should exist to regulate substances "which present an unreason-
able risk" and to act with respect to imminent hazards; and that the
authority should be exercised so as not to stifle technological inno-
vation "while fulfilling the primary purpose of this Chapter to as-
sure that such innovation and commerce . . . do not present an
unreasonable risk of injury to health or the environment." 9'

The declaration of congressional intent in subsection (c) is a note
of caution to the Administrator: he shall carry out the Act in a
"reasonable and prudent manner, and . . . shall consider the en-
vironmental, economic, and social impact of any action" taken or
proposed. 92 The House Committee Report notes, however, that
this subsection is intended only as guidance for the Administrator
and is not to involve him in any "cost-benefit justifications." 3

Though Section 2 was the focus of relatively little controversy,
resolution by the conference committee of two differences betveen
the Senate bill and the House amendment is notable here. First,
the basic standard of "presents" or "may present" found throughout
the section is a compromise between narrower House language
("may cause or significantly contribute to"94 ) and broader Senate

89. 15 U.S.C.A. § 2601(a)(2) (West Supp. 1977).
90. Rep. Broyhill, one of the chief sponsors of the Act, explained:
The general standard for taking action under the legislation is that the substance
may present an unreasonable risk. The conferees intend to limit the Adminis-
trator to taking action only against unreasonable risks because to (1o otherwise
assumes that a risk-free society is attainable, an assumption that Congress does
not make.

122 CONG. REC. H11344 (daily ed. Sept. 28, 1976).
91. 15 U.S.C.A. § 2601(b)(3) (West Supp. 1977).
92. 15 U.S.C.A. § 2601(c) (West Stpp. 1977).
93. H.R. REP., 94TH CONG., supra note 42, at 9.
94. H.R. 14032, § 2, 122 CONG. REC. H8849 (daily ed. Aug. 23, 1976).

1977]



COLUMBIA JOURNAL OF ENVIRONMENTAL LAW [4: 35

wording ("may cause or contribute to"95 ). Second, whereas the
House amendment confined its data development mandate to
"hazardous and potentially hazardous" 96 substances, the final Act
adopted the Senate bill's more inclusive mandate with respect to
all substances, regardless of hazard.

Section 3-Definitions97

Of the fourteen terms98 defined by this section, four are consid-
ered here:

(1) "chemical substance '"99 -This definition is important primarily
because it excludes from the regulatory reach of the Act (a) mix-
tures (except where explicitly included); (b) pesticides; 00 (c) to-
bacco or any tobacco products; (d) source material, special nuclear
material, or byproduct material;' 0 ' (e) any food, food additive,
drug, cosmetic, or device, 10 2 and (f) any article the sale of which is

95. S. 3149, § 2, 122 CONG. REC. S4420 (daily ed. Mar. 26, 1976).
96. H.R. 14032, § 2(b)(1), 122 CONG. REC. H8849 (daily ed. Aug. 23, 1976).
97. 15 U.S.C.A. § 2602 (West Supp. 1977).
98. These terms are: Administrator, chemical substance, commerce, distribution

in commerce, environment, health and safety study, manufacture, mixture, new
chemical substance, process, processor, standards for the development of test data,
State, and United States.

99. "Except as provided in subparagraph (B) [which lists exemptions from this
definition], the term 'chemical substance' means any organic or inorganic substance
of a particular 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." 15 U.S.C.A. § 2602(2)(A) (West Supp.
1977).

100. This term is defined in the F.I.F.R.A., 7 U.S.C. § 136 (Supp. V 1975). With
regard to that definition the House Report states:

[T]he F.I.F.R.A. defines "pesticide" to include "(1) any substance or mixture of
substances intended for preventing, destroying, repelling, or mitigating any pest,
and (2) any substance or mixture of substances intended for use as a plant reg-
ulator, defoliant, or desiccant." Thus the definition in that Act would include
chemical substances on which research is being performed with the intent that
the substance being used for any of the purposes be subject to regulation under
that Act and, by virtue of the exemption for pesticides, are exempted from regu-
lation under this bill.

H.R. REP., 94TH CONG., supra note 42, at 11.
101. These terms are defined in the Atomic Energy Act of 1954, 42 U.S.C. § 2011

et seq. (1970), and regulations issued thereunder.
102. These terms are defined in the F.F.D.C.A., 21 U.S.C. § 321 et seq. (1970).

With regard to those definitions the House Report states:
The definition of "drug" in the [F.F.D.C.A.] includes "articles intended for

use as a component" of substances included in the definition of "drug". As used
in that Act, the term "component" does not mean only an item which may be
identified as an ingredient of a drug in its final dosage form. Thus, precursors,



TOSCA Background and Analysis

subject to the tax imposed by § 4181 of the Internal Revenue
Code. 103 Exclusions (b) and (e) are conditioned on manufacture and
distribution in commerce of the substance or object for use specifi-
cally as a pesticide, food, food additive, drug, cosmetic, or device.
To the extent that it can be used for other purposes, the item is
subject to regulation under this Act. 10 4

The Senate Committee Report cautions that these exemptions
are to be narrowly drawn in order to prevent a situation where
"new unpredictable uses . . . may not be properly controlled under
the provisions of this Act because of the existence of an exclu-
sion. '' 10 5 Because they were intended to avoid jurisdictional overlap
between existing regulatory statutes and this Act, such exclusions
are specific and are applicable only where an item is defined in
accord with the relevant statutory definition.

Consistent with this restrictive interpretation of exemptions is a
broad reading of the term "chemical substance." According to the
Conference Committee Report, "any reference to a chemical sub-
stance includes all impurities and concomitant products, including
incidental reaction products, contaminants, co-products, and trace
materials.' 1 6 Thus, a regulating rule applied to a particular sub-
stance would likewise apply to any impurities without specifically
identifying them.

(2) "mixture"- 07 -Early versions of the legislation drew no dis-

intermediates, and catalysts intended for use in the production of drugs in their
final dosage form are "drugs" within the meaning of the [F.F.D.C.A.].

Further, the [F.F.D.C.A.] clearly covers drugs during the "investigation" or
research stage. Consequently, the definition of "drug" in that Act includes chem-
ical substances used for drug research and development. The same is true of the
definitions of food, food additives, and cosmetics.

H.R. REP., 94TH CONG., supra note 42, at 11.
The term "food" also includes poultry and poultry products under the Poultry

Products Inspection Act, 21 U.S.C. § 453 (1970), meat and meat products under the
Federal Meat Inspection Act, 21 U.S.C. § 601 (1970), and eggs and egg products
under the Egg Products Inspection Act, 21 U.S.C. § 1033 (1970).

103. Among such articles are pistols, firearms, revolvers, shells, and cartridges. 26
U.S.C. § 4181 (1970).

104. H.R. REP., 94TH CONG., supra note 42, at 11-12.
105. S. REP., 94TH CONG., supra note 7, at 15.
106. CONF. REP., 94TH CONG., supra note 48, at 57.
107. "The term 'mixture' means any combination of two or more chemical sub-

stances if the combination does not occur in nature and is not, in whole or 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 a new chemical substance and if

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COLUMBIA JOURNAL OF ENVIRONMENTAL LAW

tinction between mixtures and other chemical substances and sub-
jected them to equal requirements under the Act. To alleviate in-
dustry fears that each slight change in formulation or physical
blend would constitute a different chemical substance subject indi-
vidually to the Act's provisions, Rep. Eckhardt's compromise bill
H.R. 10318 introduced such a distinction and limited the applica-
bility of key sections of the Act in the case of mixtures.' 0 8 This
concept is maintained in the final version: mixtures are not subject
to pre-market screening under § 5109 and special findings are
necessary before testing of them may be required under § 4110 or
before they can be subjected to reporting and recordkeeping rules
under § 8.111

Though the Senate bill contained this distinction, it defined
"mixture" narrowly to include only combinations of substances
which do not react chemically with each other. The conference
committee adopted the broader House amendment definition
which included combinations resulting from reactions of existing
substances where the combination could also have been produced
by non-reactive means. As explained in the House Report, "[t]he
two end products would be identical, and they should be subject to
identical treatment under the bill."-112

(3) "manufacture" ' 113-The Act defines this term to mean "import
into the customs territory of the United States .... , produce or
manufacture," thus subjecting imported chemicals to the same re-
quirements as domestically produced substances. The Senate bill
limited the term's scope to such activities done "for commercial
purposes." Where this qualification is intended under the final Act,
it is explicitly stated within the section to which it is applicable.114

(4) "health and safety study""15-This term denotes information
basic to the reporting provisions of § 8,116 and by its terms it is lib-
erally defined to include "any study of any effect of a chemical sub-

the combination could have been manufactured for commercial purposes without a
chemical reaction at the time the chemical substances comprising the combination
were combined." 15 U.S.C.A. § 2602(8) (West Supp. 1977).

108. See notes 28 & 29 and accompanying text supra.
109. By its terms, § 5 applies only to chemical substances. 15 U.S.C.A. § 2604(a)

(West Supp. 1977).
110. 15 U.S.C.A. § 2603(a)(2) (West Supp. 1977).
111. 15 U.S.C.A. § 2607(a)(1)(B) (West Supp. 1977).
112. H.R. REF., 94TH CONG., supra note 42, at 12.
113. 15 U.S.C.A. § 2602(7) (West Supp. 1977).
114. See 15 U.S.C.A. § 2604(i) (West Supp. 1977).
115. 15 U.S.C.A. § 2602(6) (West Supp. 1977).
116. 15 U.S.C.A. § 2607 (West Supp. 1977).

[4: 35



1977] TOSCA Background and Analysis

stance or mixture on health or the environment or both .... "7

The Conference Report emphasizes its broad scope:

It is intended that the term be interpreted broadly. Not only is
information which arises as a result of a formal, disciplined study
included, but other information relating to the effects of a chem-
ical substance or mixture on health and the environment is also
included. Any data which bears on the effects of a chemical sub-
stance on health or the environment would be included. 118

The most basic term---"unreasonable risk"-is not defined by the
Act. The House committee had earlier considered inclusion of such
a definition, but rejected it because the committee felt such a de-
termination to be incapable of sufficiently precise definition.11 9 The
conference committee omitted a related provision of the Senate bill
which defined "unreasonable adverse effects on the environment"
as "any unreasonable risk to man or to the environment taking into
account the economic, social, and environmental costs and benefits
of the use of any chemical substance."' 20 Though "unreasonable
risk" is not explicitly defined by the Act, it appears, based on these
sources, that a balancing-of-factors approach to determine existence
of such a risk was intended by the drafters. This analysis is sup-
ported by the language of § 2(c) of the Act.121

117. This includes "underlying data and epidemiological studies, studies of oc-
cupational exposure to a chemical substance or mixture, toxicological, clinical, and
ecological studies of a chemical substance or mixture, and any test performed pur-
suant to this chapter." 15 U.S.C.A. § 2602(6) (West Supp. 1977).

118. CONF. REP., 94TH CONG., supra note 48, at 58.
119. See H.R. REP., 94TH CONG., supra note 42, at 14. The House committee

continued:
In general, a determination that a risk associated with a chemical substance or
mixture is unreasonable involves balancing the probability that harm will occur
and the magnitude and severity of that harm against the effect of proposed reg-
ulatory action on the availability to society of the benefits of the substance or
mixture, taking into account the availability of substitutes for the substance or
mixture which do not require regulation, and other adverse effects which such
proposed action may have on society.

Id.
120. S. 3149, § 3(a)(15), 122 CONG. REC. S4420 (daily ed. Mar. 26, 1976). This

definition was included in the Senate bill through a floor amendment offered by
Senator Allen (D. Ala.). Its purpose was to define "unreasonable risk" and "immi-
nent hazard" in a manner consistent with those terms as defined under F.I.F.R.A., 7
U.S.C. § 136 et seq. (Supp. V 1975). Introducing the amendment, Allen stated: "My

amendment would provide that whenever the term 'unreasonable risk' is used it
will be in accord with the meaning of 'unreasonable adverse effect' as defined in
my amendment and as defined in the [F.I.F.R.A.]." 122 CONG. REC. S4407 (daily ed.
Mar. 26, 1976).

121. See notes 92-96 and accompanying text supra.
A prima facie finding of unreasonable risk is, in effect, established under § 4(f)

where information indicates to the Administrator a reasonable basis to conclude that



COLUMBIA JOURNAL OF ENVIRONMENTAL LAW

Section 4-Testing of Chemical Substances and Mixtures122

Subsection (a) mandates that the Administrator require testing,
if, with regard to a chemical substance or mixture, he makes one of
several enumerated findings. The most important of these are: that
it "may present an unreasonable risk of injury to health or the en-
vironment," or that it "is or will be produced in substantial quan-
tities;" and, in the case of a mixture, that its effects may not be
"more reasonably and more efficiently determined" by testing the
components of the mixture.123 Though several early bills had given
the Administrator whole or partial discretion whether to require
testing based on similar findings, 124 both the Senate bill and the
House amendment prescribed mandatory testing, as does the final
Act.

With respect to the findings which the Administrator must make,
the House and Senate versions were similar in substance except
that the House amendment necessitated a finding that the sub-
stance "cause or significantly contribute to" an unreasonable risk.
The conference committee adopted the House language for subsec-
tion (a) generally, but substituted the Senate bill standard-
"presents or may present"-for the narrower standard of the House
amendment. That phrase, the committee explained, is to be liber-
ally construed and should enable the Administrator to address sub-

a substance "presents or will present a significant risk of serious or widespread harm
to human beings from cancer, gene mutations, or birth defects." 15 U.S.C.A.
§ 2603(f) (West Supp. 1977). See notes 137 & 38 and accompanying text infra.

122. 15 U.S.C.A. § 2603 (West Supp. 1977).
123. 15 U.S.C.A. § 2603(a) (West Supp. 1977).
124. Three early House bills of the 94th Congress-H.R. 7664, H.R. 7229, and

H.R. 7548-illustrate widely varying approaches to this testing authority. H.R. 7664
provided that the Administrator "may" prescribe testing of a chemical substance
where he finds it "necessary to protect against an unreasonable risk to health or the
environment." H.R. 7229 stated that the Administrator "shall" prescribe testing
where he determines that a substance "presents an unreasonable risk " and
"may" take such action where insufficient data exists to make such a determination.
Substantially more inclusive than either of these was H.R. 7548 which provided that
the Administrator "shall" prescribe testing where a substance "may possibly present
an unreasonable risk" and insufficient data exists to conclude that such risk does or
does not exist, or "is produced in substantial quantities, or enters the environment in
substantial quantities, or will result . . . in substantial exposure . . . , or is closely
related to chemicals known to be hazardous, or is listed by another Federal agency
as carcinogenic, teratogenic, or mutagenic .. "

Though § 4(a) as enacted adopts a fully mandatory approach, the partial exemption
for mixtures is a significant limitation on the number of chemicals potentially subject
to a testing rule.

[4: 35



TOSCA Background and Analysis

stances which "indirectly present unreasonable risks, as well as
those which directly present such risks."' 125 This interpretation was
confirmed by Rep. Murphy, House Manager of the legislation, who
suggested, through specific examples, that Very slight evidence of a
hazard might be enough to trigger the testing authority. 126

The finding with respect to production or exposure of a sub-
stance is intended to reflect a need for testing even if no informa-
tion exists indicating that the substance may be per se hazardous.
According to the House Report, a finding of substantial exposure is
not an inflexible standard, and, in addition to volume of production
or exposure at a given time, the Administrator should consider
such factors as the duration, intensity, and extent of human and
environmental exposure. 127

Subsection (b) sets forth various procedural details of the testing
authority. Among these are the contents of a testing rule, 128 factors
to be considered by the Administrator in prescribing test stan-
dards, a requirement that he occasionally review and revise those
standards, a requirement that manufacturers of a substance conduct
testing and submit data on such substance, and the procedure for
issuance of a testing rule.129

Subsection (c) is intended to prevent duplication of data and
needless expense to manufacturers by permitting the Administrator

125. CONF. REP., 94TH CONG., supra note 48, at 60. The committee continued:
"Further, the conferees do not intend that a substance or mixture must be the single
factor which results in the presentation of the risk. Oftentimes an unreasonable risk
will be presented because of the interrelationship or cumulative impact of a number
of different substances or mixtures." Id. at 60-61.

126. For example, if one substance is structurally similar to a second chemical
with known adverse health or environmental effects, the Administrator could
reasonably conclude that the first chemical may present an unreasonable risk
and therefore require testing of it to determine its health and environmental
effects. Or if there is reliable preliminary data indicating that a substance may be
dangerous, again it would be reasonable to conclude that the chemical may pre-
sent an unreasonable risk and that additional testing should be done.

122 CONG. REC. H11346 (daily ed. Sept. 28, 1976).
127. H.R. REP., 94TH CONG., su pra note 42, at 18.
128. A subsection (a) rule shall include the name of the substance, standards for

development of test data, and the time period for submission of results. 15 U.S.C.A.
§ 2603(b)(1) (West Supp. 1977).

129. This procedure is drawn from the Administrative Procedure Act (A.P.A.), 5
U.S.C. § 553 (1977), except that interested persons shall have opportunity to give oral
argument in addition to written submissions, and the Administrator must publish in
the Federal Register his justification for the rule. 15 U.S.C.A. § 2603(b)(5) (West
Supp. 1977).

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to grant exemptions from testing requirements and to order re-
imbursement by one manufacturer to another for testing costs. 130

If on application the Administrator determines that a substance
is equivalent to another substance for which data has been or is
being submitted and that submission of test data by the applicant
would be duplicative, the Administrator must grant an exemption
to the applicant. If an exemption is granted, the Administrator shall
order the person exempted to provide "fair and equitable reim-
bursement" for a portion of the testing costs to the persons who
previously submitted or are submitting test data on the substance.
Absent agreement among the parties, the Administrator is to de-
termine the proper amount of reimbursement, considering "all rel-
evant factors including the relative competitive positions" of the
parties involved to insure that small businesses are not assessed an
undue percentage of the testing costs.

Subsection (d) assures public access to test data submitted pur-
suant to this section by requiring the Administrator to publish in
the Federal Register within 15 days of receipt of any test data the
name of the substance, a list of intended uses, and a description of
the test data. It further provides that the test data shall be made
available to anyone, except as otherwise provided in § 14 of the
Act 131 concerning disclosure of data.

Subsection (e) establishes an interagency advisory committee 132

to make recommendations to the Administrator regarding the sub-
stances to be given top priority consideration for a testing rule. It
requires that the committee compile a "priority list"'133 of 50 sub-
stances and periodically publish that list in the Federal Register,
and it directs that within two months of inclusion of a substance on

130. S. REP., 94TH CONG., supra note 7, at 16.
131. 15 U.S.C.A. § 2613 (West Supp. 1977).
132. One member is to be appointed by each of the following: the Administrator

of EPA, the Secretary of Labor, the Chairman of CEQ, the Director of the National
Institute for Occupational Safety and Health (N.I.O.S.H.), the Director of the Na-
tional Institute of Environmental Health Sciences (N.I.E.H.S.), the Director of the
National Cancer Institute, the Director of the National Science Foundation, and the
Secretary of Commerce. Id. § 2603(e)(2)(A).

133. In compiling this list, the committee shall consider such factors as the quan-
tities in which a substance will be manufactured, the quantities in which it will
enter the environment, the number of individuals likely to be exposed in their places
of employment, the likely extent of human exposure, the extent it is related to a
substance known to be hazardous, the existence of data concerning its effects, the
probable success of testing to determine its effects, and the reasonably foreseeable
availability of facilities and personnel for performing testing. Id. § 2603(c)(1)(A).

[4: 35



TOSCA Background and Analysis

the list, the Administrator either initiate a rulemaking proceeding
to establish a testing rule or publish in the Federal Register his
reasons for inaction.

The language of this subsection is adopted primarily from the
Senate bill, though the House amendment did not differ signifi-
cantly. Most notable variations were the absence in the latter of any
provision for publication by the committee of its priority list or for
explanation by the Administrator of his failure to act with respect
to a listed substance. As to the requisite specificity of the Adminis-
trator's explanation, the legislative history is inconclusive. Accord-
ing to the Senate committee, his statement should be "specific and
. . . explain in some detail why the conditions for testing under
subsection (a) are absent.' 134 The conference committee, on the
other hand, indicated that the Administrator should not "divert
from the regulatory activities of the Agency an inordinate amount
of resources to justify the failure to require testing."'135 By holding
the Administrator accountable to the committee, at least insofar as
he must respond to its recommendations, this provision gives the
committee more than the purely advisory function delegated to it
by the House amendment. The Conference Report makes clear,
however, that though the interagency committee recommendations
shall be given "great weight . . . , the decision to require testing
rests with the Administrator.' 136

Subsection (f)137 requires that the Administrator, within 180 days
of receipt of information indicating ". . . 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,"
either (1) take action under the Act against the substance to pre-
vent or reduce the risk or (2) publish in the Federal Register a
finding that such risk is not unreasonable. This subsection is a
modified version of a similar but more broadly applicable Senate
bill provision which required only that the information indicate that
a substance "has the potential .. . to induce in human beings (1)
cancer, (2) gene mutations, or (3) birth defects. "138

134. S. REP., 94TH CONG., supra note 7, at 17.
135. CONF. REP., 94TH CONG., supra note 48, at 62.
136. Id.
137. This subsection takes effect two years after date of enactment. 15 U.S.C.A.

§ 2603(f)(2) (West Supp. 1977).
138. S. 3149, § 4(f), 122 CONG. REC. S4420 (daily ed. Mar. 26, 1976). The House

amendment contained no equivalent authority.

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COLUMBIA JOURNAL OF ENVIRONMENTAL LAW

Subsection (g)--drawn from § 5(h) of the House amendment-
authorizes any person intending to manufacture or process a sub-
stance not subject to a testing rule to petition the Administrator to
prescribe standards, and sets time limitations for the procedure.
According to the House Report, this petition procedure is intended
for use only after informal consultation with appropriate EPA offi-
cials fails to provide guidance. 139

Section 5-Manufacturing and Processing Notices140

This section is the heart of the Act. In conference committee,
where much of the language was drafted, it was the center of con-
tention,' 41 and as enacted it represents more clearly than any other
section the compromise necessary to finalize this legislation. The
primary purpose of § 5 is to insure review and evaluation of chemi-
cal substances to determine whether regulation of their manufac-
ture, processing, distribution, use or disposal is appropriate. 142 Its
basic premise is that "the most desirable time to determine the
health and environmental effects of a substance, and to take action
to protect against any potential adverse effects, occurs before com-
mercial production begins."' 4 3

The principal stumbling block to final approval in previous
years-whether to require universal or limited pre-market notifica-
tion of new chemical substances-was substantially resolved prior
to conference. 144 Universal notification was finalized in subsection

139. H.R. REP., 94TH CONG., supra note 42, at 62.
140. 15 U.S.C.A. § 2604 (West Supp. 1977).
141. See note 45 and accompanying text supra.
142. CONF. REP., 94TH CONG., supra note 48, at 65.
143. 1I.
144. During the 94th Congress, a wide range of pre-market notification proposals

were devised. H.R. 7664 contained the most limited version, requiring prior notifica-
tion only for those new chemical substances listed in advance by the Administrator
as "likely to pose substantial danger to health or the environment," defined as "an
unreasonable risk of death, of widespread or severe personal injury or illness, or of
widespread or severe hirm to the environment." An amended but similarly restricted
procedure was incorporated in the House amendment-H.R. 14032-which applied
notification requirements to a new substance (not a mixture) listed in advance by the
Administrator as one which he finds "causes or significantly contributes to or may
cause or significantly contribute to an unreasonable risk to health or the environ-
ment." Uses of existing substances found by the Administrator to be "significant new
uses" were also subject to the requirements.

At the opposite extreme, H.R. 7548 dispensed with the prior listing, applied notifi-
cation requirements to all new chemical substances, and required that the Adminis-
trator explicitly certify each substance before marketing was permitted. Universal

[4: 35



1977] TOSCA Background and Analysis

(a), which prohibits any person from manufacturing a new chemical
substance1 45 or manufacturing or processing an existing chemical
substance for a use determined by the Administrator to be a "sig-
nificant new use" without giving notice to the Administrator at
least 90 days before commencing production. Where the Senate
bill also mandated notification for significant new distributions or
disposals, the final Act instead requires only that the Administrator
consider those factors, in addition to others, in determining that a
use is a significant new use.146

Subsections (b) through (d) detail the elements of the notification
process. These include a description of the instances in which a
person required to give notice must submit test data before pro-
duction may begin, a requirement that data submitted be made
available to interested persons, authority for the Administrator by
rule to compile a list of substances which he finds "present ...or
may present" an unreasonable risk, 147 authority for the Adminis-
trator, upon good cause, to extend for up to 90 additional days the
period of notification, and a description of the contents of a sub-
section (a) notice and of various publications to be made by the
Administrator upon receipt of such notice.

Subsections (e) and (f)-the most controversial provisions of § 5
-prescribe the authority of the Administrator to screen new chem-

notification was adopted by S. 776, H.R. 10318, H.R. 11576, S. 3149, and the Act as
finally enacted, and was extended in each of these to include "significant new uses"
of existing substances. To reduce the burden on industry and EPA, mixtures were
excluded, first in part, then entirely. The certification procedure of H.R. 7548 was
never seriously considered by the 94th Congress because, in view of the large
number of new chemical substances introduced each year, it was promptly dismissed
as administratively infeasible and prohibitively expensive.

145. "New chemical substance" denotes a substance not included on the inven-
tory of all chemicals manufactured or processed in the United States which the Ad-
ministrator is required by § 8(b) of the Act to publish. See notes 192-94 and accom-
panying text infra.

146. A use is designated a "significant new use" by the Administrator based on
consideration of factors listed in § 5(a)(2) of the Act: the projected volume of man-
ufacturing and processing, the extent to which the use changes the type or form of
human or environmental exposure, the extent to which a use increases the duration
of exposure, and the reasonably anticipated manner and methods of manufacturing,
processing, distribution, and disposal of the substance.

147. Inclusion of a substance on this list increases the data submission require-
ments with which a manufacturer or processor of such substance must comply prior
to commencement of production. 15 U.S.C.A. § 2604(b)(2) (West Supp. 1977). The
significance of this authority is doubtful, however, because of the requirement that a
substance can be listed only by full compliance with the rulemaking procedure de-
scribed at note 129 supra. 15 U.S.C.A. § 2604(b)(4) (West Supp. 1977).



COLUMBIA JOURNAL OF ENVIRONMENTAL LAW

ical substances and significant new uses upon expiration of the
notification period. 148 The Senate bill provided broad and im-
mediate regulatory powers, 149 while the House amendment con-
tained a far more cumbersome mechanism. 150 Drawing in part
from § 701 of the F.F.D.C.A., the conference committee devised a
hybrid substitute which "represents a melding of the Senate bill
and the House amendment."' 151 Essentially, this compromise pre-

148. Subsection (e) provides that if the Administrator finds (1) that insufficient
information exists to evaluate the effects of a new chemical and (2) that, absent such
data, it "may present an unreasonable risk" or that it will be produced in substantial
quantity with significant environmental or human exposure, he may-though he is
not required to-issue an order effective on expiration of the notice period to pro-
hibit or limit the manufacture, processing, distribution, use, or disposal of the sub-
stance. The manufacturer may prevent that order from becoming effective by filing,
within stated time limits, an objection "specifying with particularity the provision of
the order deemed objectionable." The Administrator must then either withdraw the
order or apply to a District Court to enforce it through an injunction which shall
issue if the court makes findings identical to those made by the Administrator. The
court is authorized to issue a temporary injunction if it determines that the notifica-
tion period may expire prior to completion of the proceeding.

Under subsection (f), if the Administrator finds reasonable basis to conclude that a
new chemical substance "presents or will present" an unreasonable risk before a
regulation can become effective under § 6 of the Act, the Administrator is required to
take one of the following actions: (1) issue a proposed rule under § 6(a) to limit-but
not prohibit-the manufacture, processing, distribution, use, or disposal of the sub-
stance, and publish it in the Federal Register, at which time it becomes immediately
effective; (2) issue a proposed order prohibiting such activities, but which is subject
to the elaborate procedures described in subsection (e); or (3) apply to a District
Court for a prohibitory injunction which shall issue if the court makes a finding
identical to that made by the Administrator. The requirements which may be
adopted under the first of these actions range from labeling or recordkeeping to pro-
hibition of a particular use or limitation of the amount which can be produced. How-
ever, prohibition of a particular use may not be promulgated unless there is more
than one practical use of the substance. CONF. REP., 94TH CONG., supra note 48, at
70-71. Prohibition of the only use of a substance would effectively prohibit all uses
of the substance. Such an action is permitted only upon compliance by the Adminis-
trator with the procedures applicable to alternatives (2) and (3) above.

149. The Senate bill directed the Administrator to issue an immediately effective
rule halting or limiting the manufacture, processing, distribution, use, or disposal of a
new chemical substance if he found either (1) that a testing rule under § 4 should be
promulgated or modified, or (2) that the substance "presents or is likely to present"
an unreasonable risk. S. 3149, § 5(e), 122 CONG. REC. S4423 (daily ed. Mar. 26,
1976).

150. The House amendment authorized the Administrator to apply to a District
Court for an injunction which could be granted only upon a finding by the court that
insufficient data existed to evaluate the effects of the chemical substance and that,
absent such data, the substance "may cause or significantly contribute to" an un-
reasonable risk. H.R. 14032, § 5(g), 122 CONG. REC. H8852 (daily ed. Aug. 23, 1976).

151. CONF. REP., 94TH CONG., supra note 48, at 68.

[4: 35



TOSCA Background and Analysis

serves the Senate bill's grant of authority to the Administrator to
issue a regulatory rule or order effective immediately upon expira-
tion of the notification period. However, "to protect against unilat-
eral action by the Administrator without an adequate basis for ac-
tion,"152 it provides that the manufacturer of the substance at issue
may file timely objections and thereby prevent that rule or order
from becoming effective. If objections are filed-and in cases of
significance it seems probable that they would be-the Adminis-
trator must apply to a District Court for enforcement of the regula-
tion, in accord with the House amendment procedure.

The crucial element of this conference substitute is the provision
for objection by a manufacturer or processor. As noted, the statute
provides that a proposed order will not take effect if objections are
filed "specifying with particularity the provisions of the order
deemed objectionable.' '153 However, it is unclear-and the legisla-
tive history is divided-on the question of whether the Adminis-
trator may refuse to recognize an inadequately stated objection. In
a House speech, Rep. Broyhill stated the purpose of the provision
as one only of notice to the Administrator that the order is objec-
tionable, implying no power by him to scrutinize the sufficiency of
the complaint.' 5 4 Senator Magnuson, on the other hand, advanced
a significantly different interpretation in the Senate, where he cited
legal precedent construing the analogous provision in § 701 of the
F.F.D.C.A. to permit the designated Agency official to disregard
objections not supported by reasonable grounds.' 5 5 The Confer-

152. Id.
153. 15 U.S.C.A. § 2604(e)(1)(C) (West Supp. 1977).
154. The purpose of this provision is to put the Administrator on notice as to
the objections of the manufacturer or proce'ssor. However, the Administrator
could not put the proposed order into effect because he determined that the
objections of the manufacturer were either unmeritorious or not of sufficient
specificity. It is enough that the Administrator be on notice that objections do lie
against the proposed order.

122 CONG. REC. H11344 (daily ed. Sept. 28, 1976).
155. Senator Magnuson explained:
As the entire procedure is similar to that contained under section 701(e) of the
Federal Food, Drug and Cosmetic Act, the provision will operate in the same
manner.

For example, under the case law developed pursuant to that section-Pfizer,
Inc. v. Richardson, C.A.2, 1970, 434 F.2d 536-as it applies to this act, the Ad-
ministrator may require that reasonable grounds be stated by a manufacturer or
processor as a condition for recognizing that objections have been filed. Thus,
under the procedure adopted by the conference, the Administrator may indeed

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COLUMBIA JOURNAL OF ENVIRONMENTAL LAW

ence Report does not explicitly resolve this disagreement. How-
ever, it does note that the "conference substitute borrows the pro-
cedure from section 701(e) of the [F.F.D.C.A.] . ".. -156 thus
seeming, by implication at least, to lay a basis for Magnuson's not
unreasonable conclusion that case law interpretation of the existing
statute should be applicable to a similar provision in the new Act.
Furthermore, Broyhill's contention that the Administrator has no
authority to question the sufficiency of objections would effectively
make surplusage of the statutory requirements of specificity and
particularity.

Subsection (g), adopted from the Senate bill,' 57 directs the Ad-
ministrator, if he has initiated no action within the notification
period against a substance with respect to which notification was
given, to publish in the Federal Register a statement of his reasons
for not acting. The Senate provision, known as the Durkin amend-
ment, specified no exceptions, while the House amendment con-
tained no comparable requirement. Because both House and Sen-
ate conferees considered this an issue of some importance, a
compromise was devised by the conference committee limiting the
applicability of the provision. As enacted, the chemical substances
for which such a statement is required are those subject to a test-
ing rule under § 4, those listed under § 5(b) as potentially hazard-
ous, and those for which notification is required as a significant
new use. With respect to the content of the Administrator's publi-
cation, Senator Magnuson stated the appropriate response: "that
the Administrator's response must be .. .that no unreasonable risk
exists or that a testing need does not exist.' 58 His explanation is
confirmed by the Senate Report. 159

exercise flexibility in determining whether or not objections have been filed and
thus whether or not his order is rendered ineffective.

If the Administrator determines that valid objections have been filed, then he
is required either to seek an injunction or to dismiss the order. If he decides the
objections are not reasonable, then the proposed order becomes effective upon
the expiration of the pre-market notification. Any manufacturer who disagrees
with the Administrator's determination that the grounds are not reasonable is
entitled to judicial review under chapter 7 of title 5, United States Code.

Id. at S16803.
156. CONF. REP., 94TH CONG., supra note 48, at 68.
157. S. 3149, § 5(f), 122 CONG. REC. S4423 (daily ed. Mar. 26, 1976).
158. 122 CONG. REC. S16803 (daily ed. Sept. 28, 1976).
159. "It is anticipated that the Administrator's statement in the Federal Register

will be specific and contain sufficient information explaining why there are no un-
reasonable risks which should have been protected against or a need for more test
data." S. REP., 94TH CONG., supra note 7, at 18.

[4: 35



1977] TOSCA Background and Analysis

Subsection (h) authorizes the Administrator to grant certain
exemptions 160 from the provisions of § 5 of the Act and directs that
he publish a notice of all applications for exemptions and of their
dispositions. 161

Section 6-Regulation of Hazardous Chemical
Substances and Mixtures162

Subsection (a) directs the Administrator to take regulatory action
by rule against an existing chemical substance or mixture for which
he finds there is reasonable basis to conclude that the manufacture,
processing, distribution, use, or disposal "presents or will present"
an unreasonable risk. This basic finding was adopted in lieu of
a narrower House standard ("causes or significantly contributes
to"'163) and a broader Senate test ("presents or is likely to pre-
sent. "164) Subsection (a) further provides that such action shall con-
sist of the least burdensome yet effective of several enumerated
requirements ranging from total prohibition of the substance to
mere notice of potential risk. Both the House and Senate Reports
suggest that this authority is to be interpreted broadly and should
extend to situations where absolute certainty of causality and of the
existence of an unreasonable risk is impossible, as is likely to occur
with respect to chronic and synergistic effects of a substance. 165

160. The following exemptions are authorized: (1) from the notification require-
ments where a substance is intended for test-marketing purposes, upon a showing of
no unreasonable risk and under such restrictions as the Administrator considers ap-
propriate; (2) from the data submission requirements where submission would be
duplicative; (3) from the notification requirements where a substance is intended for
scientific experimentation if all persons engaged in such activities are notified of the
risks; (4) from any or all § 5 requirements where a new chemical substance is deter-
mined by rule not to present an unreasonable risk; and (5) from the notification and
data submission requirements where a substance which exists only temporarily as a
result of a chemical reaction will cause no human or environmental exposure.

161. Omitted from § 5 of the Act was a Senate bill provision authorizing the Ad-
ministrator to "specify any mixture which shall be subject to the provisions of this
section." S. 3149, § 5(j), 122 CONG. REc. S4424 (daily ed. Mar. 26, 1976). As enacted,
§ 5 is inapplicable to mixtures.

162. 15 U.S.C.A. § 2605 (West Supp. 1977).
163. H.R. 14032, § 6(a), 122 CONG. REC. H8854 (daily ed. Aug. 23, 1976).
164. S. 3149, § 6(a), 122 CONG. REC. S4424 (daily ed. Mar. 26, 1976).
165. The authority of section 6(a) is broad enough to authorize the control of
those chemical substances or mixtures which may not be the sole cause of an
unreasonable risk .. . The authority is also broad enough to reach those chemical
substances which may enhance the toxic properties of other substances or mix-
tures through the processes known as synergism or potentiation.

S. REP., 94TH CONG., supra note 7, at 20.
This standard for taking action recognizes that factual certainty respecting the



COLUMBIA JOURNAL OF ENVIRONMENTAL LAW

However, this subsection does not grant authority either to regu-
late the transportation of hazardous substances or to promulgate
work place standards.' 66

Subsection (b) authorizes the Administrator to review and revise
a manufacturer's quality control procedures where the Adminis-
trator has reasonable basis to conclude that the manufacturing is
being conducted in a manner which unintentionally causes a sub-
stance to present an unreasonable risk. A Senate bill provision
granting authority to assign production, distribution, and use
quotas was omitted in conference because of its potential effect on
the competitive position of a manufacturer.16 7

Outlined in subsection (c) are provisions relevant to promul-
gation of a subsection (a) rule. The Administrator is directed to
"consider and publish a statement with respect to" the effects of a
substance on the environment and humans, the magnitude of ex-
posure, the benefits of its use, and the "reasonably ascertainable
economic consequences of the rule ....... 168 According to the
Senate Report, consideration of this economic factor should insure
that benefits are balanced against costs incurred, but it must not be
permitted to overshadow non-quantitative concerns.' 69 This subsec-
tion also requires that the Administrator use other federal regu-
latory statutes administered in whole or in part by him if he finds
that a risk can be eliminated or sufficiently reduced by actions

existence of an unreasonable risk of a particular harm may not be possible and
the bill does not require it. Such uncertainty is particularly likely to occur true
when dealing with the long term or chronic effects of a substance or mixture ...
When, as here, regulatory action is intended to be taken to prevent the occur-
rence of harm in the future as well as protect against presently visible harm, such
action often imist be based not only on consideration of facts but also on consid-
eration of scientific theories, projections of trends from currently available data,
modeling using reasonable assumptions, and extrapolations from limited data.
Further, regulatory action may be taken even though there are uncertainties as to
the threshold levels of causation.

H.R. REP., 94TH CONG., su pra note 42, at 32.
166. Id. at 34. See also 122 CONG. REC. E5585 (daily ed. Oct. 1, 1976) (statement

by Rep. Murphy of New York).
167. S. 3149, § 6(a)(2), 122 CONG. REC. S4424 (daily ed. Mar. 26, 1976).
168. 15 U.S.C.A. § 2605(c)(1) (West Supp. 1977).
169. The Report states:
In comparing risks, costs, and benefits, however, it is important to recognize that
one is weighing noncommensurates, and it is not feasible to reach a decision just
on the basis of quantitative comparisons. The burdens of human suffering and
premature death are extraordinary and must be given full consideration in such
decisions.

S. REP., 94TH CONG., supra note 7, at 13.

[4: 35



1977] TOSCA Background and Analysis

taken under them, unless he finds also that it is in the "public
interest" to utilize § 6 of this Act. The finding of "public interest"
is explicitly committed to the discretion of the Administrator and,
according to the Conference Report, is not subject to judicial re-
view. 1 7 0 A similar deferral provision appears in § 9 of the Act. 17 1

Finally, subsection (c) describes the rulemaking procedure applica-
ble to § 6(a) rules1 7 2 and provides authority to the Administrator to
grant fees for attorneys and experts where, in light of enumerated
criteria, such an award is appropriate. 173

Subsection (d) directs the Administrator to specify the date on
which a rule shall become effective, "which date shall be as soon as
feasible." It further provides discretionary authority to make a pro-
posed rule immediately effective upon publication in the Federal
Register if the Administrator determines that a substance is "likely
to result in an unreasonable risk of serious and widespread injury

early effectiveness is "necessary to protect the public inter-
est," and, in the case of a proposed rule of prohibition, judicial

170. CONF. REP., 94TH CONG., supra note 48, at 76.
171. See notes 200-05 and accompanying text infra.
172. The procedure set forth in the A.P.A., 5 U.S.C. § 553 (1977), is modified to

include, inter alia, opportunity for an informal hearing with cross-examination and
verbatim transcripts for public scrutiny. Elements of the hearing procedure are also
specified.

173. 15 U.S.C.A. § 2605(c)(4) (West Supp. 1977). This attorney's fees provision is
based upon statutory authority regarding participation in rulemaking proceedings be-
fore the Federal Trade Commission (FTC), 15 U.S.C. § 57(a)-(h) (Supp. V 1975). The
FTC has adopted implementing regulations, 16 C.F.R. § 1.17 (1977), which may pro-
vide the basis for similar EPA regulations. An extensive legislative history to aid in
the interpretation of the provision enacted here appears in H.R. REP., 94TH CONG.,
supra note 42, at 37-39. To insure legislative consistency, that section of the House
Report was introduced verbatim into the Congressional Record by Senator Magnu-
son. Only a small portion of it is included here:

Such fees and costs may be provided to any person who represents an interest
which will substantially contribute to a fair determination of the issues to be

resolved in the proceeding if the economic interest of the person is small in
comparison to the costs of effective participation by that person in the proceed-
ing or if the person demonstrates to the satisfaction of the Administrator that the
person does not have sufficient resources to participate in the proceeding in the
absence of compensation. In determining if a person represents an interest
which will substantially contribute to a fair determination of the issues, the Ad-

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

122 CONG. REC. S16804-05 (daily ed. Sept. 28, 1976).



COLUMBIA JOURNAL OF ENVIRONMENTAL LAW

relief under § 7174 of the Act concerning imminent hazards has
been granted with respect to the substance. Where a proposed rule
is made effective upon publication, a specified expedited rulemak-
ing procedure is to be utilized promptly. 175

Subsection (e) sets forth special, time-phased requirements for
PCB's, the only substance which is explicitly regulated by the Act.
That this subsection was added to both Senate and House versions
of the Act by floor amendment despite opposition to singling out
one substance to the exclusion of others, is a reflection of the ex-
tremely hazardous nature of PCB's. 17

6 This subsection outlines a
phased withdrawal of PCB's: within six months from date of enact-
ment, rules must be promulgated to regulate disposal and labeling;
-after one year, manufacturing, processing, or distribution in other
than totally enclosed systems is prohibited; after two years, all
manufacture is prohibited; after two and one-half years, all pro-
cessing or distribution is prohibited. Exemptions can be granted by
the Administrator where, pursuant to a petition, he finds no unrea-
sonable risk will result and good faith efforts have been made to
develop a substitute.177

Paragraph (5) of subsection (e) explicitly states that inclusion of
special provisions for regulation of PCB's does not in any way limit
the authority of the Administrator to take action respecting PCB's
under any other provision of the Act or any other Federal statute.

Section 7-Imminent Hazards178

Subsection (a) authorizes the Administrator to initiate a District
Court proceeding for seizure or other relief against an imminently

174. 15 U.S.C.A. § 2606 (West Supp. 1977).
175. 15 U.S.C.A. § 2605(d)(2)(B) (West Supp. 1977). This subsection was drawn

from the House amendment. H.R. 14032, § 6(d), 122 CONG. REC. H8849 (daily ed.
Aug. 23, 1976). The Senate version differed significantly only in the authority of the
Administrator to make immediately effective a proposed rule of prohibition, without
first securing judicial relief under the imminent hazard authority. S. 3149, § 6(d), 122
CONG. REG. S4420 (daily ed. Mar. 26, 1976).

176. During debate in the House, Rep. Leggett (D. Cal.) quoted EPA Adminis-
trator Train: "So far as I am concerned, there is absolutely no disagreement what-
soever that PCB's should be eliminated, all uses should be gotten rid of just as
rapidly as we can." 122 CONG. REC. H8832 (daily ed. Aug. 23, 1976).

177. According to Rep. Broyhill, PCB's already in existence are also exempted:
"Equipment now in existence containing PCB's is clearly exempted from this ban.
Similarly, any PCB substance in existence would also be exempted from the ban on
processing and distributing in commerce if sold or used to maintain existing equip-
ment or transported for purposes of disposal." 122 CONG. REC. H11344 (daily ed.
Sept. 28, 1976).

178. 15 U.S.C.A. § 2606 (West Supp. 1977).

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TOSCA Background and Analysis

hazardous substance or an article containing the substance, or
against any person who manufactures, processes, distributes, or
disposes of it. To insure that this authority is utilized, § 7(a) action
is mandatory if a regulatory rule has not been made immediately
effective under § 6(d) with respect to the imminent hazard. Subsec-
tion (b) grants jurisdiction to the court to adopt "such temporary or

permanent relief as may be necessary to protect" against unreason-
able risk. Relief against a person may include requirements of
notification to customers of the risk, notice to the public of the
risk, recall or replacement of the substance, or any combination of
these.

This authority drew criticism from environmentalists who urged

that the Administrator be authorized to take all necessary action-
including prohibition and seizure-against imminent hazards with-
out first having to secure a court order. 179 According to this view,
the judicially-triggered mechanism is too cumbersome to effectively
control substances posing imminent danger, and, therefore, the
probable consequence of the inclusion of such a procedure in § 7 of

the Act is virtual assurance that the imminent hazard authority will
seldom be utilized. If past experience is any indication of future
conduct, this analysis is not unfounded. 180 Further, because all re-
strictions short of prohibition or seizure can be made immediately
effective against an imminent hazard pursuant to § 6(d) of the Act
without resort to the courts, it is unlikely that EPA-already
"overcommitted, understaffed, and battle-weary"' 8 1-will expend
its limited resources in initiation of a potentially time-consuming
and costly court action to achieve prohibition of the substance,
however justified that final measure of protection may be. 18 2

Subsections (c), (d), and (e) outline provisions relating to concur-
rent promulgation of a rule under § 6(a) of the Act and to pro-

179. H.R. HEAR., 94TH CONG., supra note 10, at 177.
180. Existing statutes incorporating a procedure which does not require court ac-

tion are F.I.F.R.A., 7 U.S.C. § 136 et seq. (Supp. V 1975), and the F.F.D.C.A., 21
U.S.C. § 301 et seq. (1970). According to E.D.F. counsel Warren, "a bit of research
into recent cases will indicate that the ony [sic] actions that are ever taken in case of
imminent hazard are under those acts." H.R. HEAR., 94TH CONG., supra note 10, at
178.

181. Id. at 193 (statement by N.R.D.C. representative Speth).
182. By entrusting the final decision to individual judges-some of whom may be

unsympathetic to environmental concerns or unable to comprehend the often techni-
cal problems-rather than the agency of the government whose function it is to pro-
tect the environment, the possibility is increased that a prohibition, even where jus-
tified, will be denied based on whim or an insufficient understanding of the prob-
lemis involved.

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cedural aspects of imminent hazard litigation under § 7(a), such as
venue, consolidation, and representation of the Administrator.

The term "imminently hazardous chemical substance or mixture"
is defined in subsection (f) as "a chemical substance or mixture
which presents an imminent and unreasonable risk of serious or
widespread injury to health or the environment." A risk is "immi-
nent" if production, distribution, or use of the chemical "is likely to
result in such injury to health or the environment before a final
rule under [§ 6] can protect against such risk."18 3 According to the
Conference Report, the phrase "widespread injury" is intended to
denote not merely geographically widespread injury, but "an un-
reasonable risk of harm affecting a substantial number of people,

"1184even though it is within a rather limited geographic area ....
With respect to the relation of physical harm to the imminent risk
concept, the Report states clearly that it is the risk which must be
imminent and not the actual injury or its physical manifestations. 185

Recognition of this distinction and of the fundamental importance
of "risk" independent of "actual injury" is crucial if the intent of
the conferees is to be realized: that "action under the imminent
hazard section be able to occur early enough to prevent the final
injury from materializing.' ' 86

Section 8-Reporting and Retention of Infornation'87

Subsection (a) mandates that the Administrator issue rules re-
quiring manufacturers and processors (other than those considered
small businesses) to maintain and submit such records as the Ad-
ministrator "may reasonably require," or, in the case of mixtures or

183. 15 U.S.C.A. § 2606(f) (West Supp. 1977). Section 7 of the Senate bill defined
an imminent hazard as existing where "continued use of a chemical substance would
be likely to result in unreasonable adverse effects on the environment or will involve
an unreasonable hazard to the survival of a species declared endangered .. . S.
3149, § 7 (a), 122 CONG. REC. S4420 (daily ed. Mar. 26, 1976). See notes 120 & 121
and accompanying text supra.

184. CONF. REP., 94TH CONG., supra note 48, at 78.
185. The Report states:

The conferees wish to note that while the unreasonable risk of injury must be
imminent, the physical manifestations of the injury itself need not be. Rather, an
imminent hazard may be found at any point in the chain of events which may
ultimately result in injury to health or the environment. The observance of actual
injury is not essential to establish that an imminent hazard exists.

Id.
186. Id.
187. 15 U.S.C.A. § 2607 (West Supp..1977).

[4: 35



TOSCA Background and Analysis

chemical substances for research, as determined by the Adminis-
trator to be "necessary for the effective enforcement of this Act."'""
Along with a caveat that the Administrator shall not require any
unnecessary or duplicative reporting, a list is provided illustrative
of the kinds of information with respect to which recordkeeping
and reporting may be required "insofar as known to the person
making the report or insofar as reasonably ascertainable."1 8 9

The potentially discriminatory effect of regulation on small man-
ufacturers and processors was a major concern of industry through-
out the development of the Act. To alleviate this concern, less de-
manding provisions were added to this subsection to protect small
businesses from "unreasonably burdensome reporting require-
ments."'190 As enacted, § 8(a) authorizes the Administrator to re-
quire reporting from small manufacturers only under certain
specified circumstances. 191

Subsection (b) directs the Administrator to compile, keep cur-
rent, and publish an inventory of each chemical substance manufac-
tured or processed in the United States. Because it is this inven-
tory which determines whether a particular substance is a "new
chemical substance" for purposes of pre-market notification pur-
suant to § 5 of the Act, it is critical that existing substances be
precisely defined to include only the particular substance and vari-
ations of it which do not affect its toxicity.' 92 On the other hand,

188. Regarding interpretation of this phrase, Senator Magnuson stated:
[T]he phrase "effective enforcement of this [A]ct" . . . should be used broadly. It
is not meant to imply that such records and reports may only be required in
order to effectively bring an enforcement action under section 16 [of the Act].
Rather it should be interpreted to mean requiring records and gathering reports
so that the authorities of the act may be indeed invoked, if necessary.

122 CONG. REC. S16804 (daily ed. Sept. 28, 1976).
189. The list includes: (1) the trade name, chemical identity, and molecular struc-

ture; (2) the categories of use; (3) the amounts; (4) a description of byproducts; (5) all
existing data concerning the environmental and health effects; (6) the number of
individuals exposed or who will be exposed; and (7) the method of disposal.

190. CONF. REP., 94TH CONG., supra note 48, at 80.
191. The Administrator may by rule require reporting by a small manufacturer

with respect to substances subject to a testing rule under § 4, a rule under § 5(b)(4)
including the substance on a list of potentially hazardous substances, a regulatory
rule under § 6, a regulatory order under § 5(e), or with respect to which relief has
been granted pursuant to a civil action under § 5 or § 7. 15 U.S.C.A. § 2607(a)(3)(A)
(West Supp. 1977).

192. Senator Magnuson emphasized the importance of narrow definition:
With respect to the 8(b) inventory and its relationship to pre-market notification,
EPA must be careful not to define contaminants too broadly with respect to sub-
stances on the section 8(b) inventory. If EPA were to do so, then there would be

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it would be pointless and administratively infeasible to list as a
unique chemical substance each slight modification in formulation.
Accordingly, § 8(b)(2) of the Act authorizes the Administrator, in
lieu of individual listings, to "list a category of chemical substances"
in which a particular chemical substance is included. The House
Report explains that this provision is intended to relieve chemical
companies, particularly small ones, from an "extremely burden-
some" situation where every insignificant change in a chemical's
structure-no matter how innocuous its effects on health or the
environment-would automatically be subject to the notification
requirements of § 5.193 The committee cautioned, however, that
categories should be utilized only where the modification is under-
stood to have an insubstantial effect on the toxicity of a sub-
stance. 194

Section (c) requires any manufacturer, processor, or distributor
of a chemical substance or mixture to maintain records of "signifi-
cant adverse reactions"'195 to health or the environment alleged to
have been caused by any substance or mixture. Duration of reten-
tion of these records is specified' 96 and inspection by a representa-
tive of the Administrator is authorized. Among the records which
shall be retained are "consumer allegations of personal injury or
harm to health, reports of occupational disease or injury, and re-
ports or complaints of injury to the environment ... ."

Subsection (d) provides that the Administrator shall promulgate
rules which require any manufacturer, processor, or distributor of a
chemical substance or mixture to submit lists of health and safety
studies conducted or initiated by or for them, known to them, or
reasonably ascertainable by them, except that the Administrator

no pre-market notification for chemical substances with new or different contam-
inants than those which appear on the section 8(b) inventory.

122 CONG. REC. S 16803 (daily ed. Sept. 28, 1976).
193. H.R. REP., 94TH CONG., supra note 42, at 44.
194. Id.
195. As to definition of a "significant adverse reaction," the Conference Report

states:
The seriousness, duration, and the frequency of reaction should be taken into
account .... Because the ultimate significance of adverse reactions is difficult to
predict, the conferees intend that the requirement to retain records err on the
side of safety. Some very serious neurological disorders, for instance, at first pre-
sent what appear to be trifling symptoms.

CONF. REP., 94TH CONG., supra note 48, at 81.
196. The periods are thirty years from discovery for reports of occupational effects

and five years from discovery for other reports.

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TOSCA Background and Analysis

may exclude certain types where submission is unnecessary to
carry out the purposes of the Act. Though the Act also states that
the Administrator "shall require" submission of copies of the listed
studies, the House Report interprets identical language in the
House amendment to mean that copies "may" be required, 197 and
the Senate bill explicitly adopted that approach. 198 Because of the
potential volume and number of such studies, this interpretation
seems preferable to a literal reading of the mandatory language of
the Act.

Subsection (e) directs any manufacturer, processor, or distributor
to notify the Administrator immediately of any information which
"supports the conclusion that such substance or mixture presents a
substantial risk of injury to health or the enivronment . ...
unless the person has actual knowledge that the Administrator al-
ready possesses the information. The Senate Report emphasizes
that any such information must be given proper attention by the
EPA in order to avoid a recurrence of tragedy similar to that which
occurred at the Kepone plant in Hopewell, Virginia, after an em-
ployee complaint submitted to the Department of Labor was in-
adequately dealt with. 199

Section 9-Relationship To Other Federal LaIws 200

During the six year history of the Act, this section was debated
extensively: industry sought to limit the Administrator's regulatory
authority to that of a gapfiller in order to avoid duplicative or over-
lapping regulation, while environmentalists urged that the Admin-
istrator be free to utilize whatever authority would provide the
greatest measure of protection to health and the environment
under all circumstances. As enacted, § 9 is a bifurcated com-
promise, distinguishing laws not administered by the Administrator
from those in whole or in part under his authority. The section is
complex and presents potential for much litigation.

Subsection (a) provides that if the Administrator has a reasonable
basis to conclude that a substance "presents or will present" an
unreasonable risk, and if, in his discretion, 201 he determines that

197. H.R. REP., 94TH CONG., supra note 42, at 45.
198. S. 3149, § 8(d)(2), 122 CONG. REC. S4420 (daily ed. Mar. 26, 1976).
199. S. REP., 94TH CONG., supra note 7, at 22.
200. 15 U.S.C.A. § 2608 (West Suipp. 1977).
201. Under the House amendment, this determination was not committed to the

Administrator's discretion and was, therefore, subject to judicial review. H.R. 14032,
§ 9(a), 122 CONG. REC. H8849 (daily ed. Aug. 23, 1976).

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the risk may be "prevented or reduced to a sufficient extent" by
action taken under a Federal law not administered by him, he shall
request the administering agency to determine if such risk can be
adequately addressed under its authority. Thereafter, the Adminis-
trator is prohibited from acting under § 6 or 7 of the Act with
respect to the substance if the other agency either issues an order
declaring that no risk is presented or within 90 days of its response
initiates an action under its authority to prevent the risk.

Subsection (b) directs the Administrator to coordinate actions
taken under this Act with those taken under other laws adminis-
tered in whole or in part by him. If he makes findings similar to
those made by him under subsection (a) but with respect to other
statutes administered by him, he is required to use those other
authorities to protect against the risk unless he determines, in his
discretion, that "it is in the public interest to protect against such
risk by actions taken under this [Act]." 202 With regard to that de-
termination, the Conference Report states that, though it is dis-
cretionary and, therefore, not reviewable, the Administrator should
review the other authorities and present his findings at the time he
takes action under the Act.20 3 Similarly, a reviewing court is "ex-
pected to require that the Administrator have examined the other
authorities and present the results of that examination" when mak-
ing his findings as to the public interest. 20 4

Subsections (c) and (d) relate specifically to coordination with
other agencies and the submission to Congress by the Adminis-
trator of an annual report on any coordination actions. 2°5

202. 15 U.S.C.A. § 2608(b) (West Supp. 1977). The finding of "public interest"-
drawn from the House amendment-was adopted in preference to the seemingly
broader, yet equally amorphous, Senate bill language that a risk "may be more ap-
propriately protected against" under the Act. S. 3149, § 9(b), 122 CONG. REC. S4420
(daily ed. Mar. 26, 1976).

203. CONF. REP., 94TH CONG., supra note 48, at 85.
204. Id.
205. Omitted was a Senate bill provision that "[n]othing contained in this section

shall limit any requirement of section 4, 5 (other than section 5(e)(2)), or 8, or rules
promulgated thereunder." S. 3149, § 9(e), 122 CONG. REC. S4420 (daily ed. Mar. 26,
1976). The Conference report noted, however, with regard to subsection (b) that:

[T]he requirement to examine other EPA laws and to make determinations ap-
plies only when the Administrator takes regulatory action to protect against an un-

reasonable risk under this Act. It does not apply when the Administrator takes
action necessary for the administration or enforcement of the Act, such as issuing
recordkeeping requirements.

CONF. REP., 94TH CONG., supra note 48, at 85.

Subsection (a), by its terms, only restricts the Administrator's authority to act
against an unreasonable risk under § 6 or § 7.

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1977] TOSCA Background and Analysis

Section 14-Disclosure of Data20 6

Industry's principal objection to this section stemmed from a fear
that trade secrets or confidential financial information would be pub-
licly disclosed. 20 7 Accordingly, subsection (a) was drafted to explic-
itly prohibit disclosure by the Administrator of information which falls
within the trade secrets and commercial or financial information
exemption of the Freedom of Information Act (F.O.I.A.). 20 8

Such information must be disclosed, however, to officers or em-
ployees of the United States in connection with their official duties,
to contractors with the United States where determined by the
Administrator to be necessary for the satisfactory performance of a
contract, or where the Administrator determines that disclosure is
'necessary to protect health or the environment against an unrea-
sonable risk." Further, such information "may be disclosed when
relevant in any proceeding under this Act .. "

By particular reference to only one of the eight exemptions from
disclosure listed under the F.O.I.A., the drafters have created an
ambiguity as to whether the other seven were intended, for pur-
poses of this Act, to be nullified by implication. Though this infer-
ence draws support from some rather obfuscatory discussion of the
subsection by the conference committee, 2°9 other language of the
Report seems to suggest more clearly that, though exemption (b)(4)
is emphasized, all other exemptions are applicable as well. 210 The

206. 15 U.S.C.A. § 2613 (West Supp. 1977).
207. S. HEAR., 94TH CONG., supra note 5, at 127.
208. 5 U.S.C. § 552 (1977). § 552(b)(4) provides: "(b) This section does not apply

to matters that are--(4) trade secrets and commercial or financial information ob-
tained from a person and privileged or confidential."

209. In any proceeding under section 552(a) of title 5 to obtain information
which the Administrator has refused to release on the basis that disclosure is
prohibited by section 14(a) of this Act, the Administrator may not rely on section
552(b)(3) of title 5 to sustain the refusal to disclose the information. Thus the
Administrator will have to show that the information falls within section
552(b)(4) of title 5. Of course, section 552 of title 5 is the vehicle through which
the public can obtain information from the Federal government, and all the pro-
visions of that section will apply to requests for information obtained under this
Act.

CONF. REP., 94TH CONG., supra note 48, at 90-91.
210. In reference to disclosure of health and safety studies, the Report states:
[T]he Administrator may not deny a request under section 552 of title 5, United
States Code, on the basis that such information is included in the exceptions to
mandatory disclosure enumerated in subsection (b)(3) or (b)(4) of such section. It
is also intended that the Administrator not use exception (b)(7) of section 552 of
title 5, relating to matters under investigation, in an excessive manner as a de-
vice for withholding information submitted under this Act. In order to be with-



COLUMBIA JOURNAL OF ENVIRONMENTAL LAW

committee's discussion of other exemptions would be unnecessary
if all exemptions other than that for trade secrets and commercial
information were intended to be inapplicable to the disclosure pro-
visions of this Act. Thus, one might reasonably conclude that the
Administrator can deny requests for information on the basis of
each 552(b) exemption unless it is within one of the three pro-
visions of mandatory disclosure described in subsection (a).

Subsection (b) exempts health and safety studies from the pro-
hibition in subsection (a).

Except in case of data required to be disclosed under subsection
(a), subsection (c) pennits a manufacturer, processor, or distributor
to designate and submit separately data which he or she believes is
entitled to confidential treatment, and, thereafter, requires that the
Administrator notify such person of intended release of the data 30
days prior to release. Where disclosure of data is necessary to pro-
tect health or the environment, the notice period is 15 days; where
release iis necessary to protect against an imminent hazard, the
period is 24 hours.

Subsection (d) specifies criminal penalties for wrongful disclosure
(defined as knowing and willful): up to $5,000 or imprisonment for
up to one year, or both. Subsection (e) mandates disclosure of any
information to a congressional committee if requested in writing. 211

Section 17-Specific Enforcement and Seizure212

This section grants jurisdiction over civil actions to District
Courts on application by the Administrator or the Attorney General
to restrain any violation of the Act, or of any regulations or orders
issued under it, and to compel the taking of any action required by
or under the Act. It further authorizes those officials to require
violators to give notice of their illegal acts-both to the general
public and to those in possession of violating substances-and to
replace or repurchase such substances. Subsection (b) authorizes
actions against a substance for seizure or condemnation.

During Senate Commerce Committee consideration of S. 3149,

held under that exception, the information must be the subject of an ongoing,
active investigation.

Id. at 91.
211. Subsections (b) through (e) were drawn with minor modification from the

House amendment. H.R. 14032, § 14(b)-(e), 122 CONG. REC. H8849 (daily ed. Aug.
23, 1976). The Senate bill contained no equivalent provisions.

212. 15 U.S.C.A. § 2616 (West Supp. 1977).

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TOSCA Background and Analysis

an amendment was introduced which was intended to overrule for
purposes of this Act the controversial decision of the Eighth Circuit
Court of Appeals in Reserve Mining Co. v. United States,213 as it
related to the issue of the burden of proof that a plaintiff must
sustain in order to gain judicial relief. In an attempt to insure that
"proof of demonstrable hazard to the public health" would not be
deemed a prerequisite to relief by courts under § 17 of the Act,
amendment # 21 was introduced in committee to prohibit a court
from denying equitable relief under any statute administered by
the EPA where a risk to public health is alleged and established. 214

This amendment was directed to situations in which evidence of a
serious potential hazard exists though evidence is inconclusive. Be-
cause the Senate Committee felt that United States Court of Ap-
peals decisions since Reserve Mining had clarified the standard in
accord with the intention of the amendment, it was not included
in S. 3149 as reported to the full Senate.2 15 During Senate debate
on the legislation in March, 1976, Senator Nelson introduced into
the Congressional Record a Library of Congress American Law Di-
vision opinion in support of the conclusion reached by the Senate
Committee. 

216

Section 18-Preemption217

This section describes the relationship between state and federal
laws for the regulation of chemical substances and mixtures. Sub-
section (a) asserts the right of a state to regulate, except in two
instances: first, a state may not establish or enforce a requirement
for testing of a substance "for purposes sirnilar to those for which
testing" has been required by the Administrator under § 4 of the
Act; and second, a state may not establish or enforce a requirement
applicable to a substance and designed to protect against a risk if
the Administrator has, pursuant to §§ 5 or 6 of the Act, prescribed a

213. 498 F.2d 1073 (8th Cir. 1974). In that decision, a three-judge panel denied a
request for an injunction against the clumping of mining wastes into Lake Superior
by the Reserve Mining Co. because the plaintiff had failed to establish a demonstra-
ble hazard to the public health. Specifically, the court stated: "[W]e are a court of
law, governed by rules of proof, and unknowns may not be substituted for proof of a
demonstrable hazard to the public health." Id. at 1084.

214. S. REP., 94TH CONG., supra note 7, at 26.
215. Id.
216. 122 CONG. REC. S4418-19 (daily ed. Mar. 26, 1976).
217. 15 U.S.C.A. § 2617 (West Supp. 1977).

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requirement applicable to that same substance and designed to
protect against the same risk.

Preemption in the second instance is nullified, however, if the
state requirement is identical to that prescribed by the Adminis-
trator, is adopted under the authority of another federal law, or is a
total prohibition of the use of a substance. The provision regarding
state requirements adopted under the authority of another federal
law is explained more fully in the House Report. That Report cites
"state emission standards, effluent limitations, or other regulatory
requirements adopted under the Clean Air Act or Federal Water
Pollution Control Act" as examples of state or local requirements
which would not be preempted, even though they might be more
stringent than the federal requirements.218 The theory of the excep-
tion for state regulations which totally prohibit use of a substance
within its boundaries is that the interest of a state in adequately
protecting its citizens is preserved thereby, without significantly
interfering with the interstate commerce of chemical substances
and mixtures. 2 19 Though it does maintain one element of the
state's prerogative, the drastic, "all-or-nothing" nature of the ex-
ception severely limits its utility in all but the most extreme situa-
tions. For that reason, its practical value may be minimal.

Subsection (b) authorizes the Administrator, upon application
from a state, to exempt by rule from subsection (a)(2) a state re-
quirement if compliance with it would not be in violation of the
applicable federal requirement prescribed under the Act; if it pro-
vides a "significantly higher degree of protection" from a risk than
does the federal requirement; and if it does not unduly burden
interstate commerce.

218. Other illustrations included:
[T]his would be the case if a State limitation, standard or requirement were
adopted, submitted, and approved as part of a State implementation plan re-
quired under Federal law. Similarly, the preemption would not apply to a State
or local limitation, standard, or requirement if it were adopted under the State or
local government's authority which is preserved by a provision of Federal law,
such as section 116 of the Clean Air Act or sections 1414(e) or 1424(c) of the
Public Health Service Act (relating to safe drinking water).

H.R. REP., 94TH CONG., supra note 42, at 54. See also 122 CONG. REC. S4416 (daily
ed. Mar. 26, 1976) (statement by Senator Tunney).

219. In a House speech, Rep. Murphy of N.Y. cited the following example:
For instances (sic), a State could totally prohibit the use within its boundaries of
a detergent containing a particular chemical substance. However, the State could
not prohibit the manufacture or processing within the State of either the sub-
stance or the detergent, nor could it prohibit or limit interstate distribution of the
substance ....

122 CONG. REC. H11346 (daily ed. Sept. 28, 1976).

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TOSCA Background and Analysis

Section 19-Judicial Review 220

Subsection (a) authorizes "any person" to file, not later than 60
days -after the promulgation of a rule under specified sections of the
Act, 221 a petition for judicial review of such rule with a United
States Circuit Court of Appeals, and elaborately defines the ele-
ments of the "rulemaking record." Subsection (b) empowers the
court to order the Administrator to provide opportunity to make
additional submissions and presentations for the record, on the
basis of which the Administrator may modify or set aside the rule
under review.

Subsection (c) 'provides that 5 U.S.C. § 706, concerning judicial
review of administrative agency actions, shall apply to review of a
rule under this section, with several enumerated exceptions, two of
which are noted here. First, in the case of review of a rule under
§§ 4(a), 5(b)(4), 6(a), or 6(e), 222 the court shall set aside the rule if it
finds the rule is not supported by substantial evidence in the
rulemaking record. Second, in the case of review of a rule under
§ 6(a), the court shall set aside a rule if it finds that a denial or
limitation by the Administrator of cross-examination or of presenta-
tion by the petitioner of rebuttal submissions has precluded disclo-.
sure of disputed material facts necessary to a fair determination by
the Administrator.

The traditional standard of review in essentially informal rule-
making proceedings such as those contained in the Act is that of
"arbitrary and capricious, an abuse of discretion, or otherwise not
in accordance with law." 223 This relatively relaxed test has been
replaced under the Act, however, by the substantial evidence
standard in order to focus the attention of the reviewing court on
the rulemaking record "to see if the Administrator's action is sup-
ported by that record." 224 Adoption of this latter standard was the
subject of criticism at congressional hearings 225 because it may se-

220. 15 U.S.C.A. § 2618 (West Supp. 1977).
221. The following sections, as codified in 15 U.S.C.A. (West Supp. 1977), are

specified: § 2603(a)-testing rule; § 2604(a)(2)-rule determining significant new
uses; § 2604(b)(4)-rule listing chemical substances that present or may present an
unreasonable risk; § 2605(a)-rule imposing requirements on chemical substances or
mixtures in order to protect against unreasonable health or environmental risks;
§ 2605(e)-rule regulating PCB's; § 2607-rule requiring recordkeeping or reporting.

222. See note 221 supra.
223. CONF. REP., 94TH CONG., supra note 48, at 96. See generally Citizens to

Preserve Overton Park v. Volpe, 401 U.S. 402 (1971).
224. CONF. REP., 94TH CONG., supra note 48, at 96.

225. H.R. HEAR., 94TH CONG., supra note 10, at 179-80.

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verely impair the Administrator's ability to take prompt action
under key provisions of the Act. Some of the principal rulemaking
provisions in §§ 4 or 5 are triggered by a finding of insufficiency of
information and are intended to generate precisely the kind of clear
evidence necessary to satisfy the standard. To require, then, that
all such rules be supported by substantial evidence in the rulemak-
ing record seems paradoxical. Indeed, this difficulty in establishing
a substantial evidence basis for administrative agency determina-
tions in an area of much scientific uncertainty has been recognized
in decisions of several United States Circuit Courts of Appeals. 226

Senator Magnuson was not unaware of the dilemma which this
presents to the Administrator. In a Senate floor speech subsequent
to conference, he suggested that the standard should not be strict-
ly applied with respect to administrative agency determinations
which, by nature, cannot be based on a solid factual foundation
demonstrable in the record. Explaining that "it is not anticipated
that this review standard will unduly hinder the Administrator,"
Magnuson stated that with respect to testing requirements based
on an insufficiency of data under § 4 "it would not ordinarily be
appropriate for the Administrator to develop 'substantial evidence'
of that insufficiency." 227 To satisfy the statutory standard, he con-

226. Associated Industries of N.Y. State, Inc. v. United States Dep't of Labor, 487
F.2d 342, 354 (2d Cir. 1973) (Friendly, J.); Industrial Union Dep't, AFL-CIO v.
Hodgson, 499 F.2d 467, 473-76 (D.C. Cir. 1974) (McGowan, J.); Synthetic Organic
Chem. Mfrs. Ass'n v. Brennan, 503 F.2d 1155, 1157 (3d Cir. 1974); and Florida Peach
Growers' Ass'n v. United States Dep't of Labor, 489 F.2d 120, 127 (5th Cir. 1974).

As explained by J. McGowan in Hodgson:

[S]ome of the questions involved . . .are on the frontiers of scientific knowledge,
and consequently as to them insufficient data is presently available to make a
fully informed factual determination. Decision making must in that circumstance

depend to a greater extent upon policy judgments and less upon purely factual
analysis. . . . Judicial review of inherently legislative decisions of this sort is
obviously an undertaking of different dimensions.

The paramount objective is to see whether the agency, given an essentially
legislative task to perform, has carried it out in a manner calculated to negate the
dangers of arbitrariness and irrationality in the formulation of rules for general
application in the future. Automotive Parts & Accessories Ass'n v. Boyd, 132 U.S.
App. D.C. 200, 407 F.2d 330, 338 (1968).

499 F.2d at 474-75.
For further discussion of this issue under the Act and the potential use of in vitro

tests to evaluate quickly the long-term effects of a substance, see In Anticipation:
Comparing the 1976 Toxic Substances Control Bills, 6 ELR 10138, 10140-41 (1976);
and From Microbes to Men: The New Toxic Substances Control Act and Bacterial
Mutagenicitql/CarcinogenicitiI Tests, id. at 10248.

227. 122 CONG. REC. S16804 (daily ed. Sept. 28, 1976). Though the Conference

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19771 TOSCA Background and Analysis

tinued, the Administrator need only have made "a reasonable effort
to find data . . . ," and, with respect to substances for which pre-
market notification is required, he "should not be required to look
beyond the notification documents." 228

Subsection (d) authorizes the court to include as part of its deci-
sion an award of costs and fees for attorneys and expert witnesses if
the court "determines that such an award is appropriate." 229 Sub-
section (e) provides that the remedies set forth in this section shall
be in addition to, not in lieu of, other penalties provided by law.

Section 20--Citizens' Civil Actions230

Ample precedent for a citizen civil action provision had been
established by similar authorities in existing environmental stat-
utes. 231 Though some legislators feared its potentially burdensome
impact on EPA, the courts, and the chemical industry, 232 public
interest groups lobbied strongly for its inclusion, and identical
Senate bill and House amendments were finalized by the confer-
ence committee in this section. Subsection (a) authorizes any per-

Report does not explicitly consider these potential difficulties, the intent of the con-
ferees is clearly expressed that a court shall not substitute its judgment for that of the
Administrator. CONF. REP., 94TH CONG., su pra note 48, at 96.

228. 122 CONG. REG. S16804 (daily ed. Sept. 28, 1976).
229. An extensive legislative history to aid in interpretation of this and similar

attorney's fees provisions appearing later in the statute was read into the Congres-
sional Record by Senator Tunney and again later by Senator Magnuson. That history
reads in part:

[I]n typical circumstances, the court should follow prevailing case law which
holds that a successful plaintiff "should ordinarily recover an attorneys' fee un-
less special circumstances would render such an award unjust."
. . ."Plaintiff" in this sense is used to mean the parties seeking to enforce the
rights granted by this section and can include an intervenor, or a defendant in
some cases....

For purposes of the award of fees and costs, it is "appropriate" to make awards
where the parties have vindicated rights through a consent judgment, or without
formally obtaining relief, or where such award is in the public interest without
regard to the outcome of the litigation....

122 CONG. REC. S4416-17 (daily ed. Mar. 26, 1976) and S16804 (daily ed. Sept. 28,
1976).

230. 15 U.S.C.A. § 2619 (West Supp. 1977).
231. Such provisions appear in § 304 of the C.A.A., 42 U.S.C. § 1857h-z (1970), as

amended (Supp. IV 1974); § 505 of the F.W.P.C.A., 33 U.S.C. § 1365 (Supp. III
1973); and § 12 of the Noise Control Act, 42 U.S.C. § 4911 (Supp. V 1975). See H.R.
REP., 94TH CONG., supra note 42, at 56. See generally Note, Judicial Review of EPA
Action Under the Citizen Suit Provision, 3 COLUM. J. ENVT'L L. 262 (1977).

232. H.R. REP., 94TH CONG., supra note 42, at 139-41.



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son to commence an action in a District Court against any person
or government agency alleged to be in violation of the Act, of any
rule promulgated under §§ 4, 5 or 6, or of any order issued under
§ 5. It further authorizes such an action against the Administrator
to compel any duty under the Act which is not discretionary. Sub-
section (b) limits this right by providing that no action may be
commenced until 60 days have expired after notification of the de-
fendant, 233 or if the Administrator or Attorney General has already
commenced and is "diligently prosecuting" an action to require
compliance. Subsections (c) and (d) describe aspects of the litiga-
tion, such as intervention, consolidation, preemption of remedies,
and authority for the court to award costs and reasonable fees for
attorneys and experts where it "determines that such an award is
appropriate. "

234

Though subsection (a) provides that an action may be com-
menced to compel the Administrator to perform "any act or duty
under this Act which is not discretionary," neither the words of the
statute nor its legislative history explicitly specify-except in a very
few instances 235-how such an act or duty is to be distinguished
from one that is discretionary. Use of the verb "shall" rather than
"may" in particular provisions of the Act may have been intended
to designate non-discretionary powers subject to review; however,
at least one decision of the District of Columbia Circuit Court of
Appeals has held that ". . . preclusion of judicial review cannot be
found in the mere fact that a statute is drafted in permissive rather
than mandatory terms." 236 Thus, though the statutory phrasing is
persuasive as to legislative intent, it is not by itself determinative
and must be considered in light of its context and relevant history.

233. In the case of an action for failure of the Administrator to file an imminent
hazard action, the 60 day period is reduced to 10 days.

234. See note 229 su pra.
235. For example, 15 U.S.C.A. §§ 2605(c)(1) and 2608(b) (West Stpp. 1977).
236. In Environmental Defense Fund v. Hardin, 428 F.2d 1093, 1096-97 (D.C.

Cir. 1970), the court stated:
Related to the question of standing is respondents' argument that the decision

to suspend the registration of a pesticide as an "imminent hazard" is committed
by statute to unreviewable administrative discretion . . . . Preclusion of judicial
review is not lightly to be inferred, however; it requires a strong showing of
clear evidence of legislative intent. That evidence cannot he found in the mere
fact that a statute is drafted in permissive rather than mandatory terms. Although
the F.I.F.R.A. provides that the Secretary "may" suspend the registration of an
economic poison that creates an imminent hazard to the public, we conclude that
his decision is not thereby placed beyond judicial scrutiny.

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TOSCA Background and Analysis

This holding-together with the inference which might be drawn
from the drafters' explicit designation of discretionary powers in
several provisions-provides the basis for an argument that acts or
duties of the Administrator which are phrased in permissive terms,
in addition to those in mandatory terms, should be subject to judi-
cial scrutiny.

Section 21--Citizens' Petitions237

The Senate bill and the House amendment differed in a subtle
yet significant way with respect to the scope of this section: S. 3149
authorized petitions only for issuance of a restrictive rule or order,
while H.R. 14032 permitted petitions for issuance, repeal, or modi-
fication of such a rule or order. By increasing the actions which a
petitioner may request under this provision, the House amend-
ment provided a means apart from the rulemaking procedure itself
whereby all regulatory rules may be challenged. Though on its face
more neutral than the Senate provision, the House language posed
an added danger that EPA's regulatory efforts would be hampered
by vexatious litigation intended to divert the limited resources of
the agency from promulgation of stricter controls to defense of
existing controls. The Senate version, on the other hand, served to
reinforce and direct the agency's enforcement efforts under the Act
because it limited petitions to requests for increased regulation. 238

As enacted, § 21 adopts the House approach and subsection (a)
authorizes "any person" to petition the Administrator to initiate a
proceeding for the issuance, amendment, or repeal of a rule or
order pursuant to specified provisions of the Act. 239 Subsection (b)
outlines the procedures attendant to a petition: within 90 days after
filing, the Administrator must either grant or deny the petition; if
he denies it, he must publish in the Federal Register his reasons;
within 60 days after denial, the petitioner may commence a civil

237. 15 U.S.C.A. § 2620 (West Supp. 1977).
238. The ability of a petitioner to "direct" the efforts of EPA is limited under the

final Act by a provision in subsection (b): if a court determines, after finding in favor
of the petitioner seeking to initiate rulemaking, that the extent of the risk alleged by
the petitioner is less than the extent of risks with respect to which the Administrator
is already taking action and there are insufficient resources to act against both, the
court may permit deferral of action on the petition until such time as the court pre-
scribes. 15 U.S.C.A. § 2620(b)(4)(B) (West Stpp. 1977).

239. A petition under this section may be used to initiate a proceeding under
§ 5(f) since a proceeding under that section is for the issuance of a rule under § 6(a).
CONF. REP., 94TH CONG., stpra note 48, at 98.

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action in a District Court to compel the Administrator to take the
desired action.

Thereafter, subsection (b) provides different types of review for
petitions seeking to initiate rulemaking and those seeking to amend
an existing rule or order. With respect to the former, the
petitioner is entitled to have his or her petition considered in a de
novo proceeding. If the petitioner demonstrates by a preponder-
ance of the evidence that there is an adequate basis as prescribed
in the Act for the issuance of the rule or order, the court shall
order that the petition be granted. If, however, the petition seeks
to amend an existing rule or order, no special provisions are
specified and, according to the Conference Report, court review of
denial of a petition is permitted only as prescribed in the A.P.A. 240

The provision of greater rights to a person seeking a new rule is
based on the conferrees' belief that only such requests will not have
been previously addressed by the Administrator. As to requests for
amendment or repeal of an existing rule, the conferees' main con-
cern was to make certain that "any such petitioner receive timely
consideration of such petition." 24'

Subsection (b) provides further that the court may award costs
and fees for attorneys and experts if it "determines that such an
award is appropriate," 242 and that the remedies under this section
are in addition to, and not in lieu of, other remedies provided
by law.

IV. CONCLUSION

The Toxic Substances Control Act has repeatedly been hailed as
the most important environmental legislation to come before the
94th Congress. 243 A more realistic appraisal, perhaps, is that its
true importance is as yet undetermined. To be sure, it creates val-
uable and needed authorities for testing, screening, regulation, and

240. Id. at 99.
241. Id. at 98-99. Regarding the substance of a petition to amend, the Report

continued: "The conferees believe that a petition for amendment or repeal . . .
should contain newly discovered, noncumulative material which was not presented
for the Administrator's consideration in promulgating the rule or order. Failure to
include such information would be an adequate basis for denying the petition." Id.

242. See note 229 supra.
243. Statement by President Ford, note 85 and accompanying text supra; state-

ment by CEQ Chairman Peterson, H.R. HEAR., 94TH CONG., supra note 10, at 69;
statement by Senator Magnuson, 122 CONG. REC. S16802 (daily ed. Sept. 28, 1976);
statement by Rep. Murphy (of N.Y.), id. at H11345.

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TOSCA Background and Analysis

reporting with respect to chemical substances and mixtures; it em-
powers the EPA for the first time to control a chemical in a com-
prehensive rather than a piecemeal manner; and it places the bur-
den of research and testing upon the chemical industry where it
rightly belongs. Yet, it is far from perfect. The Act is a compromise
with the economic realities of our time-or, more skeptically, with
what the chemical industry would have us believe them to be.
Further, it does not recognize as an attainable goal a zero-risk en-
vironment, but is directed solely to the amorphous, litigable, and
more easily circumvented concept of "unreasonable risk." More
specifically, it provides no time-phased schedule for the testing and
regulation of existing chemicals, rejects pre-market certification of
all new chemicals as a viable regulatory tool, and creates enforce-
ment mechanisms which, because of their complexity, may hinder
EPA's efforts to screen harmful substances from the market. Fi-
nally, it fails to authorize sufficient funds to assure full and success-
fil implementation of its provisions. 244

The crucial cause of uncertainty in predicting the future success
or failure of the Act, however, is the tremendous discretion which
it vests in the Administrator of the EPA to determine risks, to
promulgate rules, to issue orders and initiate court actions, to grant
exemptions, and, of course, to take no action at all. This element of
discretion places a heavy burden on the Administrator to insure
that the provisions of the Act are effectively utilized. Should he fail
to adequately exercise his powers, the judicial review and citizen
action provisions in §§ 19 through 21 provide means to compel him
to do so. Ultimately, however, such mechanisms cannot assure the
successful implementation of this Act; as it is drafted, only the Ad-
ministrator can accomplish that. 24 5

244. Authorization for appropriations to carry out the Act is as follows: $10.1 mil-
lion for the fiscal year ending September 30, 1977; $12.625 million for the fiscal year
ending September 30, 1978; and $16.2 million for the fiscal year ending September
30, 1979. 15 U.S.C.A. § 2628 (West Supp. 1977). Given the complexity of the toxic
substances problem, this authorization is surprisingly low, and the Act is subject to
valid criticism on that basis. However, EPA budget requests called for an amount
even less than that ultimately approved because, as Acting EPA Administrator
Quarles explained, EPA budget requests for previous years had included funds to
handle work anticipated to be required should toxic substances legislation be ap-
proved. H.R. REP., 94TH CONG., supra note 42, at 71. It seems probable that the
agency's recommendations for authorization were more an estimate of what OMB
determined the President's budget would permit than of the amount reasonably
necessary to appropriately carry out the broad purposes of the Act.

245. Early indications are not encouraging as administrative difficulties have hin-

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At the least, the Toxic Substances Control Act of 1976 is a be-
ginning, representing years of effort by legislators and lobbyists to
obtain the strongest possible reform. Given the intense and pro-
longed opposition of the chemical industry and the high probability
of veto by Presidents more sympathetic to the concerns of man-
ufacturers than to the pleas of environmentalists, this initial legisla-
tion should not, because of its inadequacies, be dismissed as insig-
nificant. Authority now exists pursuant to which the Administrator
can act, by regulation, order, and court action, "to assure that ...
innovation and commerce in ...chemical substances and mixtures
do not present an unreasonable risk of injury to health or the envi-
ronment.- 246 Should this authority prove insufficient to effect that
broad purpose of the Act, then it is the responsibility of Congress
swiftly and finally to remedy that insufficiency through stronger
legislative measures.

Joel Reynolds

dered implementation of the Act since its effective date on January 1, 1977. On Feb-
ruary 17, 1977, the Office of Toxic Substances issued a draft implementation plan
suggesting priorities to be given to the various authorities and outlining proposed
timetables applicable to such authorities. U.S. ENVIRONMENTAL PROTECTION
AGENCY, ASSESSMENT AND CONTROL OF CHEMICAL PROBLEMS: AN APPROACH To

IMPLEMENTING THE TOXIC SUBSTANCES CONTROL ACT, Draft #3 (1977). Thus far,

that timetable has not been followed, and as of December 31, 1977, only one set of
final rules had been promulgated pursuant to the Act. These rules define inventory
reporting procedures under § 8(a). 42 Fed. Reg. 64572 (1977). Proposed regulations
with respect to the following areas have also been published: procedures for
rulemaking under § 6, id. at 20640; reporting procedures for chlorofluorocarbons
under § 6(a), id. at 24542; and marking and disposal of PCB's under § 6(e), id. at
26563. In addition, numerous miscellaneous notices have been published, including
the following: guidance on notification of substantial risk under § 8(e), id. at 45362;
Interagency Toxic Substances Strategy Committee work plan pertaining to data col-
lection and research, id. at 57866; and temporary rules concerning compensation for
public participation in rulemaking under § 6, id. at 60911.

For a recent newspaper report of the administrative problems which have compli-
cated initial efforts by EPA to implement the Act, see Vinocur, Major Enforcement
Gaps Hobble Law to Control Toxic Substances, N.Y. Times, Oct. 30, 1977, at 1,
col. 4.

246. 15 U.S.C.A. § 2601(b)(3) (West Supp. 1977).

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