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Proposed Amendments to the
Toxic Substances Control Act (TSCA):
A Side-by-Side Comparison with Current Law
Linda-Jo Schierow
Specialist in Environmental Policy
July 28, 2010
Congressional Research Service
7-5700
www.crs.gov
R41335
CRS Report for Congress
P
repared for Members and Committees of Congress
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Proposed Amendments to the Toxic Substances Control Act

Summary
The Toxic Substances Control Act (TSCA) was signed in 1976 by President Gerald R. Ford.
Thirty-five years of experience with TSCA implementation and enforcement have demonstrated
the strengths and weaknesses of the law and led many to propose legislative changes to TSCA’s
core provisions. On April 15, 2010, Senator Lautenberg introduced comprehensive legislation (S.
3209) to amend TSCA Title I, and Representatives Waxman and Rush posted draft TSCA reform
legislation on the home page of the House Committee on Energy and Commerce. This report
compares key provisions of S. 3209, as introduced, the House draft of April 16, 2010, and current
law (15 U.S.C. 2601 et seq.).
Both proposals would amend TSCA to shift the burden of demonstrating safety from the U.S.
Environmental Protection Agency (EPA) to manufacturers and processors of chemicals, and
would prohibit manufacture, processing, and distribution of any chemical substance or mixture
for which safety has not been demonstrated to EPA’s satisfaction. Although they propose
somewhat different safety standards for EPA to enforce, both proposals suggest a health-based
standard. In contrast, current law requires that a chemical not pose “an unreasonable risk of injury
to health or the environment,” and that regulation should control any unreasonable risk to the
extent necessary using the “least burdensome” means of available control. This TSCA standard
has been interpreted to require cost-benefit balancing. To facilitate safety assessment, the
proposals would require data development and submission to EPA for all chemicals in commerce.
TSCA amendments would direct EPA to target chemicals with particular characteristics (for
example, persistence in the environment) for earlier evaluation and possible risk management.
Any regulatory action would be expedited, for example, by allowing EPA to issue orders rather
than rules.
The proposals differ in many details and in several noteworthy ways. For example, for all existing
chemicals that have not been placed on a priority list, data sets must be submitted within 14 years
of the date of enactment of S. 3209, but within five years of enactment of the House draft. The
proposals also treat the identification of chemicals of highest concern differently. The House draft
directs EPA to expedite action for 31 specified chemicals and chemical groups, while S. 3209
leaves identification of such chemicals to the Administrator’s discretion. These and other
provisions of the two legislative proposals are compared with current law in Tables 1 through 6.

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Contents
Introduction ................................................................................................................................ 1
Effects of the Proposals on Current Law...................................................................................... 1
Alternative Approaches to Reform .............................................................................................. 3

Tables
Table 1. Titles and Definitions in Selected Provisions of TSCA (15 U.S.C. 2601 et seq.),
the Safe Chemicals Act (S. 3209), as Introduced, and the House Draft (April 16, 2010)
of the Toxic Chemicals Safety Act of 2010 ............................................................................... 5
Table 2. Testing in Selected Provisions of TSCA (15 U.S.C. 2601 et seq.), the Safe
Chemicals Act (S. 3209), as Introduced, and the House Draft (April 16, 2010) of the
Toxic Chemicals Safety Act of 2010....................................................................................... 11
Table 3. Notices in Selected Provisions of TSCA (15 U.S.C. 2601 et seq.), the Safe
Chemicals Act (S. 3209), as Introduced, and the House Draft (April 16, 2010) of the
Toxic Chemicals Safety Act of 2010....................................................................................... 17
Table 4. Restrictions in Selected Provisions of TSCA (15 U.S.C. 2601 et seq.), the Safe
Chemicals Act (S. 3209), as Introduced, and the House Draft (April 16, 2010) of the
Toxic Chemicals Safety Act of 2010....................................................................................... 27
Table 5. Reporting Requirements in Selected Provisions of TSCA (15 U.S.C. 2601 et
seq.), the Safe Chemicals Act (S. 3209), as Introduced, and the House Draft (April 16,
2010) of the Toxic Chemicals Safety Act of 2010 ................................................................... 35
Table 6. Other Selected Provisions of TSCA (15 U.S.C. 2601 et seq.), the Safe Chemicals
Act (S. 3209), as Introduced, and the House Draft (April 16, 2010) of the Toxic
Chemicals Safety Act of 2010 ................................................................................................ 39

Contacts
Author Contact Information ...................................................................................................... 57

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Proposed Amendments to the Toxic Substances Control Act

Introduction
In 1976, President Gerald R. Ford signed the Toxic Substances Control Act (15 U.S.C. 2601 et
seq.; TSCA).1 Thirty-five years of experience with TSCA implementation and enforcement have
demonstrated the strengths and weaknesses of the law and led many to propose legislative
changes to TSCA’s core provisions in Title I.2 In 2010, Senator Lautenberg introduced
comprehensive legislation (S. 3209) to amend TSCA, and Representatives Waxman and Rush
posted draft TSCA reform legislation on the home page of the House Committee on Energy and
Commerce. The latter House draft bill was subjected to stakeholder comments and critiques in a
series of meetings during the spring. A revised proposal may be introduced later during the 111th
Congress.
This report compares key provisions of S. 3209, as introduced, the House draft of April 16, 2010,
and current law. The major provisions of TSCA Title I are summarized in Tables 1 through 6. The
first column of each table describes the provisions of TSCA Title I. The second and third columns
summarize provisions of S. 3209 and the House draft, respectively, that are related to the TSCA
provisions in the first column. New provisions that would be added to the end of TSCA Title I by
one or both proposals—for example, those related to reduced use of animals for toxicity testing—
are summarized in Table 6.
Effects of the Proposals on Current Law
The basic organization of TSCA would be unaffected by the proposals. For example, provisions
related to testing would still be in Section 4, requirements for notifying EPA when a new
chemical or new use is proposed would still be in Section 5, and regulatory authorities would
remain in Section 6. Also unaffected would be recently enacted changes, such as a provision that
bans exports of elemental mercury.
However, most of the original Title I provisions would be amended or deleted by the proposed
legislation, and both proposals would make important changes to current law. For example, both
proposals would shift the burden of demonstrating the safety of chemicals from the U.S.
Environmental Protection Agency (EPA) to manufacturers and processors, and would prohibit
manufacture, processing, and distribution of any chemical substance or mixture for any use for
which safety had not been demonstrated to EPA’s satisfaction. Exemptions from prohibitions
would be allowed for particular uses only if a use was “in the paramount interest of national
security”; lack of the chemical use “would cause significant disruption in the national economy”;
the use was essential or critical and there was no safer feasible alternative; or the chemical use,
relative to alternatives, provided a benefit to health, the environment, or public safety.
In addition, the proposals would require data development and submission to EPA for all
chemicals in commerce, rather than only for chemicals that EPA has found “may present an
unreasonable risk of injury to health or the environment” and for which EPA has demonstrated a

1 For a summary of TSCA provisions and history, see CRS Report RL31905, The Toxic Substances Control Act
(TSCA): A Summary of the Act and Its Major Requirements.
2 For more information about issues revolving around TSCA, see CRS Report RL34118, The Toxic Substances Control
Act (TSCA): Implementation and New Challenges.
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data need, as required under current law. The proposed amendments to TSCA would increase
public access to information about EPA’s decisions as well as to some information about
chemicals that currently is treated as confidential business information. Based on the data
received, EPA would be directed to target chemicals with particular characteristics (for example,
persistence in the environment) for early evaluation and possible risk management.
Once a chemical has been evaluated and EPA has determined whether (or under what conditions)
use of the chemical was safe, the proposals would require risk management action to promptly
reduce use of, or exposure to, the chemicals of highest concern, and to encourage development of
“safer alternatives.” Action would be expedited by allowing EPA to issue administrative orders
instead of rules (which must be promulgated under current law), exempting certain EPA decisions
from judicial review, and removing certain TSCA requirements that are in addition to
requirements specified in the Administrative Procedure Act (5 U.S.C. 553) for notice and
comment rulemaking.
The scope of EPA oversight also would be expanded by S. 3209 and the House draft. Both
include language that would allow EPA to define various distinct forms of substances that are the
same in terms of molecular identity but differ in structure and function, such as manufactured
nanoscale forms of carbon and silver. The proposals explicitly include within the scope of
environmental risks that EPA may consider and manage those found in the indoor environment;
currently, TSCA applies only to chemicals in the ambient environment. The proposed
amendments also appear to more clearly authorize EPA control of risks posed by articles formed
from a substance.
Both proposals would authorize EPA activities not currently authorized under TSCA to allow
implementation of international agreements pertaining to persistent organic pollutants and other
hazardous chemicals. For example, the proposals would authorize EPA to regulate chemicals
manufactured solely for export. The authority provided by S. 3209 is specific to three
international agreements, while the authority provided by the House draft applies more generally
to any international agreement concerning chemicals. Both proposals would prohibit production
and use of some chemicals, but S. 3209 prohibits production and use when it is inconsistent with
U.S. obligations under the treaties, while the House draft directs EPA to ban activities only with
respect to chemicals that are intentionally produced and are not already regulated under U.S. law.
The effect of TSCA on state and local chemical laws also would be modified by the proposals.
Current law, TSCA Section 18, generally does not preempt state laws. However, if EPA requires
testing of a chemical under section 4, no state may require testing of the same substance for
similar purposes. Similarly, if EPA prescribes a rule or order under section 5 or 6, no state or
political subdivision may have a requirement for the same substance to protect against the same
risk, unless the state or local requirement is identical to the federal requirement, is adopted under
authority of another federal law, or generally prohibits the use of the substance in the state or
political subdivision. TSCA authorizes states and political subdivisions to petition EPA, and
authorizes EPA to grant petitions, by rule, to exempt a law in effect in a state or political
subdivision under certain circumstances. A petition may be granted if compliance with the
requirement would not cause activities involving the substance to be in violation of the EPA
requirement, and the state or local requirement provides a significantly higher degree of
protection from the risk than the EPA requirement does, but does not “unduly burden interstate
commerce.” The proposed amendments would simplify this section of TSCA. S. 3209 states that
TSCA would not preempt laws relating to a chemical substance, mixture, or article unless they
were less stringent than federal law. The House draft provides that the act does not affect the right
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of a state or locality to adopt or enforce its own requirements unless compliance with both the
state or local requirements and TSCA is “impossible.”
Several novel provisions are included in both legislative proposals. One provision, for example,
would require definition and listing of localities with populations that are “disproportionately
exposed” to toxic chemicals. EPA would be directed to develop an action plan to reduce exposure
in such “hot spots.” Another provision would direct the EPA Administrator to coordinate with the
Secretary of Health and Human Services to conduct a biomonitoring study to determine whether a
chemical that research has indicated may be present in human biological substances and that may
have adverse effects on human development in fact is present in pregnant women and infants. If
the chemical is found to be present, manufacturers and processors must disclose to EPA,
commercial customers, consumers, and the general public all known uses of the chemical and all
articles in which the chemical is expected to be present.
Children’s environmental health also is addressed by the proposals. Both proposals would
establish a children’s environmental health research program at EPA and an advisory committee
to provide independent advice relating to implementation of TSCA and protection of children’s
health.
The proposals also would establish at least four research centers to encourage the development of
safer alternatives to existing hazardous chemical substances. “Green chemistry and engineering”
also would be promoted through grants.
Finally, the proposed amendments would direct EPA to minimize use of animals in toxicity
testing. An advisory committee would be established to publish a list of testing methods that
reduce use of animals. So-called “alternative testing methods” have been under development for
many years, but remain a minor component of toxicity testing programs.
Alternative Approaches to Reform
The proposals differ in many details (which will not be summarized here) and in several
noteworthy ways that are summarized in Tables 1 through 6. One significant difference is the
length of time each allows before all chemicals in commerce must be tested for toxicity. For all
existing chemicals that have not been placed on a priority list, data sets must be submitted within
14 years of the date of enactment of S. 3209. The House draft allows five years for data
development.
Another difference that may spur debate is the definition of the safety standard that chemicals are
required to meet. The House draft would require that a chemical substance or mixture “is not
reasonably anticipated to present a risk of injury to health or the environment,” “provides a
reasonable certainty of no harm, including to vulnerable populations,” taking into account
aggregate and cumulative exposure to a chemical, “and protects the public welfare from adverse
effects, including effects on the environment.” S. 3209 would require that EPA ensure “aggregate
exposure and cumulative exposure of the general population or of any vulnerable population to
the chemical substance or mixture presents a negligible risk of any adverse effect.” Although they
propose somewhat different safety standards, both proposals propose a health-based standard,
which might generally discourage consideration of other factors, such as benefits of chemical use
or costs of alternative chemicals in similar applications. (However, EPA would be authorized to
consider such benefits and costs under certain circumstances. See in Table 4 under the heading
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Proposed Amendments to the Toxic Substances Control Act

“Exceptions to prohibitions and other restrictions” the description of TSCA 6(e) as it would be
amended.) In contrast, current law requires that a chemical not pose “an unreasonable risk of
injury to health or the environment,” and that regulation should control any unreasonable risk to
the extent necessary using the “least burdensome” means of available control. This TSCA
standard has been interpreted to require cost-benefit balancing.
The proposals also treat the identification of chemicals of highest concern differently. The House
draft directs EPA to expedite action for 31 specified chemicals and chemical groups, “for which
risk to health and the environment have been well documented yet sufficient risk management
actions have not been taken,” according to the bill. S. 3209 leaves identification of such
chemicals to the Administrator’s discretion, directing her to “act quickly to manage risks from
chemical substances that clearly pose the highest risks to human health or the environment.”
Finally, only the House draft addresses “persistent and bioaccumulative” chemicals directly. The
bill directs EPA to promulgate a rule establishing a methodology for evaluation of risk from such
chemical substances and requires use of the methodology for assessing and ensuring the safety of
such chemicals on the priority list.
These and other similarities and differences are summarized in Tables 1 through 6.

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Table 1. Titles and Definitions in Selected Provisions of TSCA (15 U.S.C. 2601 et seq.), the Safe Chemicals Act (S. 3209), as
Introduced, and the House Draft (April 16, 2010) of the Toxic Chemicals Safety Act of 2010
Provision
15 U.S.C. 2601 et seq.
S. 3209
House Draft of April 16, 2010
Title
Toxic Substances Control Act (TSCA)
Safe Chemicals Act of 2010 (SCA)
Toxic Chemicals Safety Act of 2010
(TCSA)
Revised definitions
TSCA definitions are in section 3 (15
S. 3209 section 4 amends definitions in
Section 3 of the House draft amends
U.S.C. 2602.)
TSCA section 3.
definitions in TSCA section 3.
Chemical substance
“[A]ny organic or inorganic substance of a
Same as TSCA, but also includes in the
Same as S. 3209 with regard to inclusion
particular molecular identity, including -
definition “any chemical substance
of articles. New subparagraph allows EPA
(i) any combination of such substances
contained in or formed into an article.” In
to define more than one form of a
occurring in whole or in part as a result of
addition, adds a new subparagraph to the
chemical substance with a particular
a chemical reaction or occurring in nature
definition authorizing EPA to determine
molecular identity based on variations in
and (ii) any element or uncombined
that “a variant of a chemical substance is a
substance characteristics. New forms of
radical.” The term does not include any
new chemical substance,” notwithstanding
existing chemical substances are defined to
mixture, pesticide, tobacco, nuclear
molecular identity.
be new chemical substances.
material, firearm, shell or cartridge for a
firearm, food, food additive, drug,
cosmetic, or device regulated by other
specified federal laws.
Distribute in commerce /
“[T]o sell, or the sale of the substance,
Amends the TSCA definition to include
Same as S. 3209.
Distribution in commerce
mixture, or article in commerce; to
“to export or offer for export the
introduce or deliver for introduction into
substance, mixture, or article.”
commerce, or the introduction or delivery
for introduction into commerce of, the
substance, mixture, or article; or to hold,
or the holding of, the substance, mixture,
or article after its introduction into
commerce.”
Health and safety study
“[S]tudy of any effect of a chemical
Amends the definition to specifical y
Same as S. 3209.
substance or mixture on health or the
include any test that relates to a chemical
environment or on both, including
substance or mixture or to a specific
underlying data and epidemiological studies, chemical identity.
studies of occupational exposure to a
chemical substance or mixture,
toxicological, clinical, and ecological studies
of a chemical substance or mixture, and
any test performed pursuant to this
chapter” [which corresponds to TSCA].
CRS-5

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Provision
15 U.S.C. 2601 et seq.
S. 3209
House Draft of April 16, 2010
Environment
“[I]ncludes water, air, and land and the
Amends the definition to include
Same as S. 3209.
interrelationship which exists among and
“ambient” and “indoor air.”
between water, air, and land and all living
things.”
Mixture
“[A]ny combination of two or more
Same as TSCA but amends the definition
Same as S. 3209.
chemical substances if the combination
to include any mixture contained in or
does not occur in nature and is not, in
formed into an article.
whole or in part, the result of a chemical
reaction; except that such term does
include any combination which occurs, in
whole or in part, as a result of a chemical
reaction if none of the chemical substances
comprising the combination is a new
chemical substance and if the combination
could have been manufactured for
commercial purposes without a chemical
reaction at the time the chemical
substances comprising the combination
were combined.”
Standards for the development of
A “prescription of (A) the - (i) health and
Eliminates this definition.
Same as S. 3209.
test data
environmental effects, and (ii) information
relating to toxicity, persistence, and other
characteristics which affect health and the
environment, for which test data for a
chemical substance or mixture are to be
developed and any analysis that is to be
performed on such data, and (B) to the
extent necessary to assure that data
respecting such effects and characteristics
are reliable and adequate (i) the manner in
which such data are to be developed,
(i ) the specification of any test protocol or
methodology to be employed in the
development of such data, and (iii) such
other requirements as are necessary to
provide such assurance.”
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Provision
15 U.S.C. 2601 et seq.
S. 3209
House Draft of April 16, 2010
New chemical substance
“[A]ny chemical substance which is not
Revises the definition, eliminating
Same as S. 3209. In addition, refers to any
included in the chemical substance list
reference to listing under 15 U.S.C.
chemical substance that does not have a
compiled and published under section
2607(b) and instead referring to any
declaration under section 5(c)(1)(A),
2607(b) of this title, [corresponding to
chemical substance that does not have a
“except that, with respect to the first year
TSCA section 6(b)].”
submitted declaration under amended
after the date of enactment … such term
TSCA section 8(a).
shal not include a chemical substance
distributed in commerce as of such date of
enactment.”
New definitions

Adverse effect
No comparable definition.
“A biochemical change, anatomic change,
Similar to S. 3209, except that it does not
functional impairment, or pathological
refer to a “pathological lesion.”
lesion, or its known precursor, that”
either a) “affects or alters performance of
an anatomic structure of a vital system of
an organism or progeny;” (b) “causes
irreversible change in homeostasis of an
organism;” (c) “increases the susceptibility
of an organism or progeny … to other
chemical or biological stressors or reduces
the ability of an organism or progeny of an
organism to respond to additional health
or environmental challenges;” or (d)
“affects, alters, or harms the environment
such that the health of humans or other
organisms is directly or indirectly
threatened.”
Aggregate exposure
No comparable definition.
Total exposure to a chemical substance or Same as S. 3209.
mixture regardless of the source of
exposure, including activities involved in
the manufacture, processing, distribution,
use, or disposal of chemicals used in food,
cosmetics, or medical devices.
Bioaccumulative
No comparable definition.
As defined in the policy statement entitled
Similar to S. 3209, but specifies that
“Category for Persistent, Bioaccumulative,
revisions are “[i]n order to reflect best
and Toxic New Chemical Substances” (64
available science.”
Federal Register 60194, Nov. 4, 1999). EPA
is authorized to revise this definition.
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Provision
15 U.S.C. 2601 et seq.
S. 3209
House Draft of April 16, 2010
Chemical identity
No comparable definition.
Each common and trade name, the most
Similar to S. 3209, but refers to the 9th
current internationally standardized name,
Collective Index of the internationally
the Chemical Abstracts Service
standardized name (rather than the most
registration number, and the molecular
current index) and the molecular identity,
structure of a chemical substance, and for
as well as the molecular structure, and
a mixture, the chemical identities and
does not specifically refer to chemical
proportions of the components.
identities in a mixture.
Cumulative exposure
No comparable definition.
The sum of aggregate exposure to each
Similar to S. 3209, but exposure is
chemical substance that contributes
cumulative across chemical substances that
“appreciably to the risk of an adverse
contribute “appreciably to the risk of the
effect,” and mixtures containing those
same or similar adverse effect.”
chemical substances.
End consumer
No comparable definition.
An “individual or other entity that
No comparable definition.
purchases and uses or consumes a
chemical substance, mixture, or article.”
Federal agency
No comparable definition.
“[A]ny department, agency, or other
Similar to S. 3209, but also refers to any
independent agency or establishment of
“other instrumentality” of the Federal
the Federal Government including any
Government.
Government corporation, and the
Government Printing Office.”
Persistent
No comparable definition.
As defined in the policy statement entitled
Similar to S. 3209, but specifies that
“Category for Persistent, Bioaccumulative,
revisions are “[i]n order to reflect best
and Toxic New Chemical Substances” (64
available science.”
Federal Register 60194, Nov. 4, 1999).
Authorizes EPA to revise this definition by
rule.
Person
No comparable definition.
An “individual, trust, firm, joint stock
No comparable definition.
company, corporation (including a
government corporation), partnership,
association, State, municipality,
commission, political subdivision of a State,
or any interstate body and shall include
each Federal agency and any officer, agent,
or employee thereof.”
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Provision
15 U.S.C. 2601 et seq.
S. 3209
House Draft of April 16, 2010
Reasonable certainty of no harm
No comparable definition.
“[I]n establishing whether a chemical
No comparable definition.
substance or mixture meets the safety
standard under this subchapter, aggregate
exposure and cumulative exposure of the
general population or of any vulnerable
population to the chemical substance or
mixture presents a negligible risk of any
adverse effect …”
Special substance characteristics
No comparable definition.
Defines “special substance characteristics”
Defines “substance characteristic” as “the
to mean “such physical, chemical, or
physical and chemical characteristics that
biological characteristics, other than
may vary for such substance, and whose
molecular identity, that the Administrator
variation may bear on the toxicological
determines, by order or rule, may
properties of the chemical substance.”
significantly affect the risks posed by
Includes structure and composition, size,
substances exhibiting those
shape, surface structure, reactivity, and
characteristics.” Allows consideration of
“other characteristics that may bear on
size, shape, reactivity, and any other
toxicological properties.”
properties that may significantly affect
risks posed.
Toxic
No comparable definition.
Satisfies one of the following conditions:
Similar to S. 3209, but omits the first
has a toxicological property meeting
condition – that is, it does not define the
criteria for Category 1 or 2 for any
term by reference to the categories of the
toxicity endpoint established by the
Globally Harmonized System for the
Globally Harmonized System for the
Classification and Labeling of Hazardous
Classification and Labeling of Hazardous
Substances. Also, the word “exposed” is
Substances; “causes an adverse effect that
omitted from the third defining condition.
has been demonstrated in humans or
other exposed organisms;” or “the weight
of evidence … demonstrates the potential
for an adverse effect in humans or other
exposed organisms.”
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Provision
15 U.S.C. 2601 et seq.
S. 3209
House Draft of April 16, 2010
Toxicological property
No comparable definition.
“[A]ctual or potential toxicity or other
Same as S. 3209.
adverse effects of a chemical substance or
mixture, including actual or potential
effects of exposure” on mortality,
morbidity, reproduction, growth and
development, the immune system, the
endocrine system, brain or nervous
system, other organ systems, or “any
other biological functions in humans or
nonhuman organisms.”
Vulnerable population
No comparable definition.
A “population that is subject to a
Similar to S. 3209, except that workers
disproportionate exposure to, or potential are included in the definition without
for a disproportionate adverse effect from
regard to their work with chemicals.
exposure to, a chemical substance or
mixture …” and includes those who work
with chemical substances and mixtures,
individuals with preexisting medical
conditions, the elderly, pregnant women,
infants, children, adolescents, and
“members of any other appropriate
population identified by the
Administrator.”
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Table 2. Testing in Selected Provisions of TSCA (15 U.S.C. 2601 et seq.), the Safe Chemicals Act (S. 3209), as Introduced, and
the House Draft (April 16, 2010) of the Toxic Chemicals Safety Act of 2010
Provision
15 U.S.C. 2601 et seq.
S. 3209
House Draft of April 16, 2010
Testing authorities and requirements
TSCA 4(a) [15 U.S.C. 2603(a)] directs the
Amends TSCA 4(b) to authorize EPA to
Similar to S. 3209, but requires submission
EPA Administrator to promulgate a rule
require, by rule or by order, testing and
of a minimum data set for mixtures as well
requiring that testing be conducted on a
submission of test results by a specified
as chemical substances. Also, the House
substance or mixture to develop health
date “as necessary for making any
draft explicitly authorizes collection of
and environmental effects data if: (1) the
determination or carrying out any
data in addition to the minimum data set
manufacture, processing, distribution, use,
provision” of TSCA.
(see below), and does not authorize
or disposal of the chemical “may present
chemical sample collection. An amended
an unreasonable risk of injury to health or
Authorizes EPA to require submission of a TSCA 6(b) authorizes the Administrator
the environment,” or (2) the chemical is
sample of any chemical for the purpose of
to require submission of additional
produced in very large volume and there is conducting tests and making a
information pursuant to a rule or order
a potential for a substantial quantity to be
determination or carrying out any
under amended TSCA 4(b) in order to
released into the environment or for
provision of the act.
inform risk assessment in support of a
substantial or significant human exposure.
Amends TSCA section 4(a) to direct the
safety determination.
In either case, EPA also must find that (a)
EPA Administrator within one year of
existing data are insufficient to resolve the
enactment of S. 3209 to promulgate a rule
question of safety, and (b) testing is
establishing a minimum data set and
necessary to develop the data.
requiring submission to EPA of such data
by manufacturers and processors of new
chemical substances or existing chemical
substances on a priority list [established in
amended TSCA 6(a)]. Also requires
updates of minimum data set submissions.
Test rule requirements
TSCA 4(b) [15 U.S.C. 2603(b)] requires
Amended TSCA 4(c) is similar to 15
Similar to S. 3209, but refers to
EPA in any test rule to identify the
U.S.C. 2603(b), but is applicable to EPA
“methodology” rather than “standards for
chemical substance or mixture for which
orders as well as rules.
the development of test data.”
testing is required, specify standards for
the development of test data, and specify
the period during which test results must
be submitted.
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Provision
15 U.S.C. 2601 et seq.
S. 3209
House Draft of April 16, 2010
Deadlines for data submission
No comparable provision.
Amended TSCA 4(a) requires submission
Amended TSCA 4(a) requires minimum
to EPA of the minimum data set within 18
data set submission within 18 months of
months of the date that EPA places a
the date that EPA places a chemical on the
chemical on the chemical substance
chemical substance priority list, at the time
priority list, or at the time notice is
notice is provided to EPA that a new
provided to EPA [under revised TSCA
chemical will be manufactured, or, for
section 5(a)] that a new chemical will be
existing chemicals not placed on the
manufactured. Amended TSCA 6(b)(2)
priority list, within 5 years of the date of
requires submission of the minimum data
enactment of the draft bill.
set within 30 months of the date that EPA
places a chemical on the chemical

substance priority list, or for existing
chemicals not placed on the priority list,
within 14 years of the date of enactment
of S.3209.
Persons required to submit data
TSCA 4(b) [15 U.S.C. 2603(b)] requires
Amended TSCA 4(c) directs EPA to
Same as S. 3209.
manufacturers and processors to conduct
specify in any rule or order persons
tests in response to a rule issued by EPA,
required to conduct tests and submit data,
but al ows EPA to permit such persons to
but allows designation of a single data
designate one person or a qualified third
provider, as is allowed under current law.
party to conduct such tests and submit
data on their behalf.
Failure to submit data
No comparable provision.
Amended TSCA 4(b)(3) authorizes EPA
Amended TSCA 4(b)(1)(B) provides the
to, by order, prohibit manufacture,
same authority as S. 3209.
processing, or distribution in commerce
for a chemical if a manufacturer or
processor fails to submit required data.
Exemption
TSCA 4(c) [15 U.S.C. 2603(c)] al ows
Amended TSCA 4(d) would have the same Similar to 15 U.S.C. 2603(c), but applies to
manufacturers and processors to request
effect as TSCA, except exemptions could
orders as well as rules.
an exemption, and directs EPA to grant an
apply to orders as well as rules, and the
exemption if data would be duplicative.
bill does not provide that the
Provides for reimbursement by the
Administrator’s order to reimburse is a
exempted persons to manufacturers and
final agency action for the purpose of
processors who collected and submitted
judicial review.
data. EPA is required to order a
manufacturer or processor who is exempt
to reimburse the entity that submitted
data. Such an order is a final agency action
for the purpose of judicial review.
CRS-12

.

Provision
15 U.S.C. 2601 et seq.
S. 3209
House Draft of April 16, 2010
Cessation of manufacture or
No comparable provision.
Amended TSCA 4(b)(4) explicitly exempts
Same as S. 3209.
processing
from requirements any manufacturer or
processor who has submitted a
declaration of cessation of manufacture or
processing of a chemical substance.
Contents of minimum data set
No comparable provision.
Amended TSCA 4(a) directs EPA to
Same as S. 3209.
include in the minimum data set
information on substance characteristics
and on hazard, exposure, and use of
chemical substances and mixtures,
information that the EPA anticipates will
be useful in conducting safety standard
determinations as required by amended
TSCA section 6(b). Allows EPA to provide
for varied or tiered testing for different
chemicals or categories of chemicals.
Prescribed data needs
TSCA 4(b) [15 U.S.C. 2603(b)] authorizes
Amended TSCA 4(c) authorizes EPA to
Similar to S. 3209, but explicitly includes
EPA to prescribe data development
prescribe data development standards for
authority to prescribe testing for
standards for effects which may present an effects which may be considered in a safety endocrine disruption, the presence of the
unreasonable risk of injury to health or the determination, assessing exposure,
chemical substance or mixture in animal
environment and for characteristics of
including presence in human tissues and
or human biological media, and the
chemical substances and mixtures which
fluids, and characteristics of chemicals that
chemical characteristic of bioaccumulation.
may present such a risk, as well as for
may present an adverse effect. Also
methodologies including epidemiological
authorizes EPA to prescribe biomonitoring
studies, serial or hierarchical tests, in vitro
studies, in addition to methodologies
tests, and whole animal tests.
already permitted under 15 U.S.C.
2603(b).
Petition for standards for
TSCA 4(g) [15 U.S.C. 2603(g)] authorizes
Eliminates this provision.
Same as S. 3209.
development of test data
manufacturers to petition EPA to
prescribe standards for the development
of test data for a new chemical.
CRS-13

.

Provision
15 U.S.C. 2601 et seq.
S. 3209
House Draft of April 16, 2010
Alternatives to animal testing
No comparable provision.3
Requires that animal tests are consistent
No comparable provision.
with provisions of amended TSCA section
31, promoting alternatives to animal
testing.
Review and revision of data needs
TSCA 4(b) [15 U.S.C. 2603(b)]Requires
Changes the interval between required
Similar to current law, but refers to
annual review and revision, if necessary, of
reviews and revisions, if necessary, from
“methodology” rather than “standards for
standards for the development of data.
one to 3 years.
the development of test data.”
Rulemaking process
TSCA 4(b) [15 U.S.C. 2603(b)] directs
Amended TSCA 4(c) omits TSCA
Same as S. 3209.
EPA to issue test rules pursuant to 5
requirements for rulemaking that go
U.S.C. 553 (Administrative Procedure Act,
beyond the requirements of 5 U.S.C. 553.
procedures for informal notice and
Amended TSCA 4(b) authorizes EPA to
comment rulemaking). In addition, persons issue orders in lieu of rules.
must be given an opportunity for oral
presentation of data, views, or arguments
and to make written submissions; a
transcript must be made of oral
presentations; and the Administrator must
publish findings required by TSCA
4(a)(1)(A) or (B).
Interagency testing committee
TSCA 4(e) [15 U.S.C. 2603(e)] establishes
Amended TSCA 6(a)(3) is similar to 15
Amended TSCA 4(e) is similar to S. 3209).
an interagency committee to advise the
U.S.C. 2603(e), but also directs the
Administrator regarding chemicals that
committee to make recommendations for
should receive priority consideration for
issuance of test orders under amended
promulgation of a test rule [under
section 4(b) and placement of chemical
subsection (a)].
substances on the priority list.

3 However, EPA “is committed to examining alternative test methods that reduce the number of animals needed for testing, reduce pain and suffering of test animals, and whenever
possible, replace animals in testing with validated in vitro (non-animal) test systems. EPA has released guidance on this issue …” (U.S. EPA, “Fact Sheet on Animal Welfare,”
April 2001, EPA 745-F-99-003, http://www.epa.gov/HPV/pubs/general/anfacs.pdf.
CRS-14

.

Provision
15 U.S.C. 2601 et seq.
S. 3209
House Draft of April 16, 2010
Committee recommendations for
TSCA 4(e) [15 U.S.C. 2603(e)] directs the
Changes the directive to the committee
Similar to current law, but authorizes
testing
interagency testing committee to establish
with respect to the basis for
consideration of chemicals posing “a
a prioritized list of chemicals for the
recommendations for issuance of test
substantial hazard to” rather than those
Administrator to consider testing and to
rules or orders. Recommendations must
posing “an unreasonable risk of injury to”
designate up to 50 chemicals on the list as
be based on “al factors relevant to risk,”
health or the environment, and directs the
the highest priority. In selecting chemicals, including presence in biological and
committee to provide priority attention to
the committee is authorized to consider
environmental media, use, production
chemicals suspected of causing or
all relevant factors, including “the extent
volume, toxicity, persistence, or
contributing to “adverse effects on health
to which the substance or mixture is
bioaccumulation. Directs the committee
or the environment” rather than those
closely related to a chemical substance or
to form one or more lists of chemical
that might cause or contribute to cancer,
mixture which is known to present an
substances and mixtures that specify, by
gene mutations, or birth defects. The
unreasonable risk of injury to health or the individual substance or by groups,
chemicals listed are to be those that
environment.” Priority attention is to be
recommendations for testing or placement should be subject to test rules or orders,
given to chemicals “known to cause or
on the priority list.
in the view of the committee.
contribute to or which are suspected of
causing or contributing to cancer, gene
mutations, or birth defects.”
Public notice
TSCA 4(d) [15 U.S.C. 2603(d)] requires
Amended TSCA 4(e) is similar to 15
Similar to 15 U.S.C. 2603(d), but applies
that EPA provide public notice of receipt
U.S.C. 2603(d) in requiring public notice of also to data submitted in accord with an
of data and make data available for
the receipt of data, but applies also to data EPA order.
examination by any person (subject to
submitted in accord with an EPA order,
section 14).
and requires that data be made available
on the internet.
Judicial review prohibited
No comparable provision.
Amended TSCA 6(a)(4) protects from
No comparable provision.
judicial review the following: a decision
whether to place a particular chemical
substance on the priority list; a response
to a petition to place a particular chemical
on the priority list; and the issuance of a
recommendation by the interagency
committee.
Failure of EPA to establish the priority list
or to update it is defined to be a failure to
perform a nondiscretionary duty and
subject to judicial review.
CRS-15

.

Provision
15 U.S.C. 2601 et seq.
S. 3209
House Draft of April 16, 2010
Required actions
TSCA 4(f) [15 U.S.C. 2603(f)] requires the
Eliminates this provision, but TSCA 4(a)
Eliminates this provision, but TSCA 4(a)
EPA Administrator to respond within 180
as amended requires EPA, within 180 days
as amended requires, within 6 months of
days to new information indicating “that
of receipt of a data submission, to
the submission of all required information,
there may be a reasonable basis to
determine, by order, whether the
EPA must make the safety determination
conclude that a chemical substance or
manufacturers and processors of the
based on known or anticipated uses using
mixture presents or will present a
substance have established that the
the best available science and regarding
significant risk of serious or widespread
substance meets the safety standard. If
any adverse effect. If data are not
harm to human beings from cancer, gene
data are not submitted, S. 3209 authorizes
submitted, that is grounds for determining
mutations, or birth defects.” Requires EPA
EPA to prohibit, by order, manufacture,
that the manufacturers and processors
to “initiate appropriate action under
processing, or distribution in commerce of have not met the safety standard.
section 5, 6, or 7 to prevent or reduce to
the substance, mixture, or article
a sufficient extent such risk or publish in
containing the substance.
the Federal Register a finding that such risk
is not unreasonable.” A finding that a risk
is not unreasonable is a final agency action
for purposes of judicial review.
Requests from other federal agencies
No comparable provision.
Amended TSCA 4(f) authorizes any federal Same as S. 3209.
agency to request that EPA seek
information unavailable to the other
agency which it has determined would
assist it in carrying out its duties or
exercising its authority. Requires EPA to
collect and provide such information to
the requesting agency or to publish in the
Federal Register the reason for not doing
so.
Certification
No comparable provision.
Amended TSCA 4(g), 5(e), 6(h), and 8(h)
Amended TSCA 8(h) requires each
require that each submission of
submission of information that is required
information under a rule or order be
pursuant to amended TSCA section 4, 5,
accompanied by a certification of the
6, or 8, or pursuant to a rule or order
accuracy, reliability, and completeness (to
issued under one of those sections, other
the extent reasonably ascertainable) of the than a submission under section 8(f)
information provided. Such certification
(relating to submissions from federal
must be signed by a responsible official of
agencies), to be accompanied by a
the manufacturer or processor.
certification of the accuracy, reliability, and
completeness (to the extent reasonably
ascertainable) of the information provided.
Such certification must be signed by a
responsible official of the manufacturer or
processor.
CRS-16

.

Table 3. Notices in Selected Provisions of TSCA (15 U.S.C. 2601 et seq.), the Safe Chemicals Act (S. 3209), as Introduced, and
the House Draft (April 16, 2010) of the Toxic Chemicals Safety Act of 2010
Provision
15 U.S.C. 2601 et seq.
S. 3209
House Draft of April 16, 2010
Notices concerning new chemicals or
TSCA 5(a) [15 U.S.C. 2604(a)] prohibits
Amended TSCA 5(a) is similar to current
Amended TSCA 5(a) is similar to S. 3209
uses
manufacture of a new chemical and
law, but it also requires notice prior to
in that it prohibits manufacturing and
prohibits manufacture or processing of any processing of a new chemical substance.
processing of new chemical substances
chemical for a use which is a significant
Requires notice prior to manufacture or
unless notice is provided to EPA. The
new use unless notice is submitted to EPA
processing of an existing chemical that has
House draft also requires notice prior to
90 days prior to such manufacture or
met the safety standard for a use, at a
manufacture or processing of a new
processing.
production volume, or in a manner other
mixture or an existing chemical or mixture
than specified in the safety determination.
for a use that EPA determines is a new use
[see “New use determination” below].
It is unclear whether notice is required for
an existing chemical for which EPA has not
made a safety determination when a new
use is proposed. However, it appears that
the law would require a new declaration
under amended TSCA 8(a) and data
submission under amended TSCA 5(b)
prior to manufacturing or processing.
CRS-17

.

Provision
15 U.S.C. 2601 et seq.
S. 3209
House Draft of April 16, 2010
Chemicals of concern list (priority list) TSCA 5(b)(4) [15 U.S.C. 2604(b)(4)]
Amended TSCA 6(a) directs EPA by order Similar to S. 3209, but does not require
authorizes EPA to “by rule, compile and
to develop and publish a priority list of not the list to be developed and published “by
keep current a list of chemical substances
less than 300 chemical substances “for
order” and includes mixtures. The House
with respect to which the Administrator
which safety standard determinations shall
draft also does not explicitly require that
finds that the manufacture, processing,
first be made” within 18 months of S. 3209 EPA consider listing recommendations
distribution in commerce, use, or disposal,
enactment. Chemicals must be selected
provided by the Interagency Prioritization
or any combination of such activities,
based on: available scientific evidence,
and Testing Committee.
presents or may present an unreasonable
relative risk, presence in biological and
risk of injury to health or the
environmental media, use, production
environment.” In listing decisions the
volume, toxicity, persistence,
Administrator is directed to consider “all
bioaccumulation, “or other properties
relevant factors, including – (1) the effects
indicating risk.” Requires removal of a
of the chemical substance to health and
substance from the list only after a safety
the magnitude of human exposure to such
standard determination has been made for
substance; and (11) the effects of the
it. Requires EPA to add chemical
chemical substance on the environment
substances or mixtures periodical y to
and the magnitude of environmental
keep the number greater than 300 at all
exposure to such substance. Any rule
times until al substances and mixtures
listing a chemical must identify “uses that
distributed in commerce have had a safety
the Administrator determines, by rule
standard determination.
under subsection (a)(2), would constitute
a significant new use of such substance.”
EPA must give due consideration in listing
decisions to recommendations provided
Any rulemaking under this provision must
by the Interagency Prioritization and
be promulgated pursuant to the
Testing Committee which is to base its
procedures specified in 5 U.S.C. 553 and
recommendations on the criteria listed
must provide opportunity for oral and
(above) in amended TSCA 6(a).
written presentation of data, views, or
arguments. In addition, a transcript must
be kept of any oral presentation and the
Administrator must make and publish with
the rule the finding that an activity related
to the chemical “presents or may present
an unreasonable risk of injury to health or
the environment.”
CRS-18

.

Provision
15 U.S.C. 2601 et seq.
S. 3209
House Draft of April 16, 2010
Notice content
TSCA 5(d) [15 U.S.C. 2604(d)] requires
Amended TSCA 5(c) requires a notice to
Similar to S. 3209, but the statement
that notices contain the information
include the declaration made under
required is that the chemical is
required by TSCA 8(a)(2)(A)-(D), (F), and
amended TSCA 8(a)(2), the minimum data
“reasonably anticipated to meet the safety
(G). [See “Reporting and record keeping”
set, and a statement that the chemical will
standard under section 6(b),” and the
below.]
meet the safety standard.
House draft requires a justification for
such statement.
Special substance characteristics
No comparable provision.
Directs Administrator to determine by
No comparable provision.
order or rule that a variant of a chemical
substance exhibiting one or more “special
substance characteristics” [such as size or
reactivity, as defined in amended TSCA
3(24)] is a new use or a new chemical
substance.
CRS-19

.

Provision
15 U.S.C. 2601 et seq.
S. 3209
House Draft of April 16, 2010
Safety determination for new chemical No specific provision, but TSCA requires
Amended TSCA 5(a) prohibits
Amended TSCA 5(a) imposes an additional
or new use
an EPA finding that manufacture,
manufacture and processing of a chemical
condition on any new chemical or use:
processing, distribution in commerce, use,
for which notice is required unless the
manufacture or processing is permitted
and disposal of a chemical “may present an Administrator finds either: 1) that the
only if the Administrator finds it “is not
unreasonable risk of injury to health or the manufacturers and processors have
reasonably anticipated to present a risk of
environment,” when the agency issues a
established that the chemical meets the
injury to health or the environment, based
test rule under TSCA 4(a). Similarly, EPA
safety standard under proposed TSCA
upon anticipated use and production
must find that a chemical substance
6(b), or 2) that the new chemical
volume, toxicity, persistence,
“presents an unreasonable risk” before
substance or its metabolite or degradation
bioaccumulation, or other properties
EPA can issue a rule to ensure that risks
product is not and is not expected to be—
indicating risk,” or the manufacturer or
are adequately regulated.
manufactured in a volume of more than
processor has established “that the
one million pounds annually or released
anticipated use of the chemical substance
into the environment in a volume of more
or mixture meets the safety standard
than 100,000 pounds annual y; a known,
under amended TSCA 6(b).”
probable, or suspected reproductive,
developmental, neurological, or
immunological toxicant, carcinogen,
mutagen, or endocrine disruptor, or has
other toxicological properties of concern;
persistent and bioaccumulative; found in
human cord blood, or otherwise found in
human blood, fluids, or tissue, unless it is
natural y present at the level commonly
found in that medium; or found in food,
drinking water, ambient or indoor air,
residential soil, or house dust, unless it is
natural y present at the level commonly
found in that medium.
With respect to a new use of a chemical
for which the Administrator previously has
made the safety determination,
manufacturers must provide evidence that
permits the Administrator to amend the
safety determination.
CRS-20

.

Provision
15 U.S.C. 2601 et seq.
S. 3209
House Draft of April 16, 2010
EPA’s response to notice
No comparable provision.
Requires EPA to determine within 180
Requires EPA to determine within 90 days
days after receiving notice and data
after receiving notice and data whether
whether it has been established that the
the chemical substance or mixture “is not
chemical substance or mixture meets the
reasonably anticipated to present a risk of
safety standard under amended TSCA
injury to health or the environment,”
section 6(b).
under amended TSCA 5(a)(1)(B). Within 6
months of that determination, the
Administrator is required to “complete
the safety standard determination for any
chemical … that may be reasonably
anticipated to present a risk of injury to
health or the environment.”
New use determination
Directs EPA to designate a significant new
Designates use of an existing chemical as
Similar to S. 3209. Designates use as new if
use of an existing chemical by
new if at the time of enactment of S. 3209
– “(i) no manufacturer or processor has
promulgating a rule after considering “all
– such use was not ongoing, use would be
previously declared the use under section
relevant factors, including – (A) the
at a significantly increased volume, or the
8(a)(2); (i ) the manufacturer or processor
projected volume of manufacturing and
person who would be manufacturing or
proposing the use has not previously
processing of a chemical substance, (B) the processing the chemical had not previously declared the use under section 8(a)(2); or
extent to which a use changes the type or
done so.
(iii) the proposed use will result in
form of exposure of human beings or the
manufacturing or processing of the
environment to a chemicals substance, (C)
chemical substance or mixture at a
the extent to which a use increases the
significantly increased volume from that
magnitude and duration of exposure of
previously declared under section 8(a)(2).”
human beings or the environment to a
chemical substance, and (D) the
reasonably anticipated manner and
methods of manufacturing, processing,
distribution in commerce, and disposal of a
chemical substance.”
CRS-21

.

Provision
15 U.S.C. 2601 et seq.
S. 3209
House Draft of April 16, 2010
Regulation pending development of
TSCA 5(e) [15 U.S.C. 2604(e)] authorizes
This provision is eliminated. Amended
Same as S. 3209.
information
the Administrator to issue a proposed
TSCA 5(a) requires submission of data and
order to prohibit or limit manufacture,
a safety determination prior to production
processing, distribution in commerce, use,
and distribution of a new chemical or of an
or disposal of a new chemical or significant existing chemical for a new use.
new use in the event that the
Administrator determines that: the
information available “is insufficient to
permit a reasoned evaluation of the health
and environmental effects” of the
chemical; and either the chemical may
present an unreasonable risk, or it will be
produced in substantial quantities and
“may reasonably be anticipated to enter
the environment in substantial quantities
or there is or may be significant or
substantial human exposure to the
substance.” If EPA makes such a
determination but no order is issued or
objections are filed to the order, then EPA
must apply to the District Court to
prohibit or limit activities with respect to
the chemical, unless EPA finds on the basis
of the objections that the determination
cannot be made.
Statement of reasons for not taking
If EPA does not take action with respect
No comparable provision.
No comparable provision.
action
to a chemical covered by a test rule
[under TSCA 4(a)], a significant new use
rule [under TSCA 5(a)(1)(B)], or listed
under TSCA 5(b)(4), then TSCA 5(g)
directs the Administrator to publish a
statement of reasons for not taking action.
CRS-23

.

Provision
15 U.S.C. 2601 et seq.
S. 3209
House Draft of April 16, 2010
Submission of test data with notice
TSCA 5(b) [15 U.S.C. 2604(b)] requires
Amended TSCA 5(b) requires submission
Similar to S. 3209, but also requires
persons who propose to manufacture a
of any data required for a chemical under
submission of the minimum data set for
new chemical or to manufacture or
a test rule or order.
each new use.
process a chemical for a significant new
use to submit with such notice any test
For each new chemical, requires
data that are required by rule under TSCA submission of the minimum data set
4(a). If no test data are required under
established under amended TSCA 4(a).
TSCA 4(a), but the chemical has been
With respect to a new use of a chemical
listed under TSCA 5(b)(4), indicating that
for which the Administrator previously has
the Administrator has determined that it
made the safety determination,
“presents or may present an unreasonable
manufacturers must provide an update for
risk,” manufacturers and processors must
the minimum data set.
submit data showing that manufacture,
processing, distribution in commerce, use,
With respect to a new use of a chemical
and disposal (in the case of a new chemical which has not been evaluated for safety,
or mixture), or the new use (in the case of manufacturers must submit to EPA a new
a significant new use), “will not present an
or updated declaration under amended
unreasonable risk of injury to health or the TSCA 8(a) and comply with amended
environment.“
TSCA 5(b).
Public availability of data
TSCA 5 [15 U.S.C. 2604] directs EPA to
Requires EPA to make data available on
Requires EPA to publish each new
make such data publicly available, subject
the internet, subject to amended TSCA
chemical and new use pre-manufacture
to protections for confidential business
14.
notice. Also requires that EPA publish
information in section 14.
notice regarding the chemical identity,
intended uses, the nature and results of
tests performed, and availability of the
declaration under amended section 8(a)
and the minimum data set under amended
TSCA 4(a). Internet publication is not
explicitly required.
Exemptions from notice requirements

General authority
TSCA 5(h)(4) [15 U.S.C. 2604(h)(4)]
Eliminates this provision.
Same as S. 3209.
authorizes EPA upon application and by
rule to exempt a manufacturer of a new
chemical substance from notification and
data requirements, if the Administrator
determines it will not “present an
unreasonable risk of injury to health or the
environment.” Any such rule must be
promulgated in accord with TSCA section
6(c)(2) and (3) (see below).
CRS-24

.

Provision
15 U.S.C. 2601 et seq.
S. 3209
House Draft of April 16, 2010
Intermediate production chemicals
TSCA 5(h)(5) [15 U.S.C. 2604(h)(5)]
Same as current law.
Same as current law.
authorizes exemptions upon application
for production-related (temporary, so-
called “intermediate”) chemicals when no
human or environmental exposure will
occur.
Test marketing
TSCA 5(h)(1) [15 U.S.C. 2604(h)(1)]
Amended TSCA 5(d)(1) is similar to
Amended TSCA 5(d)(1) is similar to
authorizes EPA to exempt any person
current law but a person must show that
current law but specifies that exemptions
from notification or data requirements so
it “will not endanger the health [sic] or the are made “by order,” authorizes
as to permit manufacture or processing
environment.”
exemptions for mixtures as well as
for test marketing purposes, if the person
chemical substances, and requires that the
applies for such exemption and
“Test marketing” is defined in amended
applicant show the chemical or mixture
demonstrates the chemical will not
TSCA 5(f) to exclude provision of a
will not present “a substantial” risk.
present an “unreasonable risk.”
chemical or article containing a chemical
to an end consumer.
Equivalent chemicals and duplicative TSCA 5(h)(2) [15 U.S.C. 2604(h)(2)]
Amended TSCA 5(d) allows manufacturers Amended TSCA 5(d)(2) concerns any new
data
allows manufacturers and processors of
and processors of new chemicals or
use of a chemical substance or mixture
new chemicals or chemicals with significant chemicals with new uses to request, and
subject to a data collection rule or order
new uses that are on the priority list but
EPA to grant, full or partial exemption
under section 4. The House draft directs
are not subject to a section 2603 data
from data submission requirements if the
the Administrator upon application to
submission requirement to request from
chemical is equivalent to a chemical
exempt the manufacturer or processor of
EPA an exemption from the requirement
substance for which data have been
such a chemical or mixture from the
in 2604(b)(2) that they submit data
submitted and submission would be
amended TSCA 5 requirement to submit
showing that manufacture, processing,
duplicative of data previously submitted to
data along with the required new use
distribution in commerce, use, and
EPA. Provides for reimbursement by the
notice, if the chemical is equivalent to a
disposal of the chemical substance, or the
exempted persons to those who collected
substance for which data have been
significant new use, will not present an
and submitted data in the same manner as
submitted previously and submission
unreasonable risk. Directs EPA to grant
current law.
would be duplicative. Provides for
such exemption if the chemical is
reimbursement by the exempted persons
equivalent to a substances for which data
to those who col ected and submitted data
has been submitted and data would be
in the same manner as current law.
duplicative. Provides for reimbursement by
the exempted persons to manufacturers
and processors who collected and
submitted data. EPA is required to order a
manufacturer or processor who is exempt
to reimburse the entity that submitted
data. Such an order is a final agency action
for the purpose of judicial review.
CRS-25

.

Provision
15 U.S.C. 2601 et seq.
S. 3209
House Draft of April 16, 2010
Smal quantities
TSCA 5(h)(3) [15 U.S.C. 2604(h)(3)]
Same as current law.
Amended TSCA 5(d)(3) is similar to
exempts from notification and data
current law, but it also applies to mixtures.
requirements manufacturing and
processing of smal quantities for purposes
of scientific experimentation or chemical
research on, or analysis of, such
substances or another substance, including
product development.
EPA response to exemption
TSCA 5(h)(6) [15 U.S.C. 2604(h)(6)]
Same as current law.
Same as current law.
requests
requires EPA to publish notices of, and
request comments on, requests for
exemptions that the agency receives. EPA
must issue an approval or disapproval
within 45 days.
Extension of the notice period
Authorizes EPA to extend the period
Eliminates this provision.
Same as S. 3209.
between notice and manufacture for
additional periods of up to a total of 90
days “for good cause.”
Publication of notice
Requires notice to be available for
Similar to current law, but specifies that
Similar to current law, but requires notice
examination by interested persons, subject EPA must make notices available on the
to include a description of the results of
to disclosure restrictions at TSCA 14 [15
internet and requires disclosure of the
tests performed, and discloses the
U.S.C. 2613]. [See “Disclosure of data”
availability of the minimum data set. In
availability of the declaration under section
section below.] Directs EPA to publish a
addition, requires EPA to make available
8(a) and the minimum data set under
notice identifying the chemical, listing the
on the internet a list of chemical
section 4(a). Does not require internet
intended uses, and describing the nature of substances for which notice has been
availability. [Also, see “Disclosure of data”
tests performed and data that were
received monthly. [Also, see “Disclosure
section below.]
developed pursuant to a rule.
of data” section below.]
“Manufacture” and “process”
TSCA 5(i) [15 U.S.C. 2604(i)] defines
Amended TSCA 5(f) provides the same
Same as current law.
“manufacture” and “process” as used in
definition as current law.
TSCA section 5 to mean manufacturing
and processing for commercial purposes.
CRS-26

.

Table 4. Restrictions in Selected Provisions of TSCA (15 U.S.C. 2601 et seq.), the Safe Chemicals Act (S. 3209), as Introduced,
and the House Draft (April 16, 2010) of the Toxic Chemicals Safety Act of 2010
Provision
15 U.S.C. 2601 et seq.
S. 3209
House Draft of April 16, 2010
Regulation
TSCA 6(a) [15 U.S.C. 2605(a)] directs EPA by
S. 3209 does not require rulemaking, but
Like S. 3209, the House draft does not
rule to apply one or more requirements “to
section 7 amends TSCA 6(b) and (c) to
require rulemaking. The House draft
the extent necessary to protect adequately
authorize EPA to specify allowed uses of
amends TSCA 6(c) to authorize EPA to
against” an “unreasonable risk” “using the
any substance that meets the safety
impose restrictions on particular chemicals
least burdensome requirements,” if EPA finds
standard and to impose conditions on its
to ensure that uses meet the safety
that “there is a reasonable basis to conclude
manufacture, processing, use, distribution
standard. Restrictions become effective
that the manufacture, processing, distribution
in commerce, or disposal to “ensure the
one year after publication of the
in commerce, use, or disposal of a chemical
safety standard is met.” Restrictions apply
determination.
substance or mixture … presents or will
as soon as the safety determination is
present an unreasonable risk of injury to
published.
EPA is authorized to impose the same
health or the environment.” Specifies various
restrictions permitted under current law,
regulatory options. Authorizes regulations
Many of the conditions that EPA is
except the bill omits the option of
to—prohibit or limit the amount of substance
authorized to impose are the same as the
requiring manufacturers or processors to
manufactured, processed, or distributed in
regulatory options listed in current law,
give notice of unreasonable risk of injury
commerce, generally or for a specific use;
but S. 3209 eliminates a total prohibition,
to distributors or the public or to replace
require labeling, recordkeeping, provision of
as wel as the option of requiring
or repurchase a substance. In addition, the
notice to distributors and to the public of
manufacturers or processors to give
House draft authorizes EPA to impose a
unreasonable risk of injury, or replacement or
notice of unreasonable risk of injury to
requirement that the manufacturers and
repurchase of a substance; and specify
distributors or the public or to replace or
processors of a chemical substance or
methods of disposal.
repurchase a substance. These conditions
mixture or article containing it develop a
presumably would not be needed because
risk reduction management plan to achieve
TSCA 6(c) [15 U.S.C. 2605(c)] specifies
substances not meeting the safety standard a risk reduction specified by the
procedures for rulemaking that allow for
would not be produced, unless
Administrator.
informal hearings and requires EPA to publish
manufacturers and processors applied for
a statement describing the health and
and received an exemption (see below). In

environmental effects, level of exposure,
addition, S. 3209 differs from current law
benefits of the substance, and “reasonably
because the bill does not authorize
ascertainable economic consequences of the
conditions that are limited in application to
rule, after consideration of the effect on the
specified geographic areas, nor does it
national economy, smal business,
prohibit requirements that a person take
technological innovation, the environment,
an action that would be in violation of a
and public health.” Requires that EPA’s
law or requirement of a state or political
decisions be based on the rulemaking record.
subdivision.
Directs EPA to promulgate needed rules
under other environmental laws, unless it is in
the public interest to issue rules under TSCA.
CRS-27

.

Provision
15 U.S.C. 2601 et seq.
S. 3209
House Draft of April 16, 2010
General process for safety
No comparable provision.
Amended TSCA 6(b) establishes that
Similar to S. 3209 in that it assigns the
determinations
manufacturers and processors of a
burden of proving that a chemical meets
chemical substance are responsible for
the safety standard to manufacturers and
proving that the substance meets the
processors and directs the Administrator
applicable safety standard, and that the
to determine “based on … best available
EPA Administrator has the responsibility
science” whether a manufacturer or
of determining within 180 days of data
processor has shown that a chemical
submission whether the manufacturers
meets the safety standard.
and processors have met the burden of
proof.
The proposals differ in several ways. The
House draft requires the Administrator to
Requires that EPA produce a risk
make a safety determination within 6
assessment addressing health and
months of the date of data submission and
environmental impacts using “the best
requires the EPA determination to be
available science” in support of any
based on “known or anticipated uses” of
determination that a manufacturer or
the chemical and “regarding any adverse
processor of a chemical substance has met effect.” The House draft also requires that
the burden of proof. The “current best
the safety standard “takes into account
available science” must be determined
aggregate and cumulative exposure to a
considering “the most recent
chemical substance or mixture” and
recommendations of the National
“provides a reasonable certainty of no
Academy of Sciences on ways to better
harm, including to vulnerable populations,
protect people, including pregnant women, and protects the public welfare from
infants, children and other vulnerable
adverse effects, including effects on the
populations from harm by exposure to
environment.” Final y, the House draft
toxic substances when assessing such
does not explicitly require an EPA risk
potential risks.” Risk assessments must be
assessment.
transparent and understandable to the
public and to risk managers.
No risk assessment is required when EPA
determines that the burden of proof has
not been met, and such determination is
not subject to judicial review.
Safety of chemicals for export
No comparable provision.
Directs EPA to consider risks that a
No comparable provision.
chemical manufactured for export may
pose in the United States during
production and distribution in commerce,
including in imported products containing
the substance.
CRS-28

.

Provision
15 U.S.C. 2601 et seq.
S. 3209
House Draft of April 16, 2010
Safety determinations for existing

chemicals
Initial submission
No comparable provision.
Amended TSCA 4(a) requires submission
Amended TSCA 4(a) requires submission
to EPA of the minimum data set within 18
of the minimum data set within 18 months
months of the date that EPA places a
of the date that EPA places a chemical on
chemical on the chemical substance
the chemical substance priority list or, for
priority list. Amended TSCA 6(b)(2)
existing chemicals not placed on the
requires submission of the minimum data
priority list, within 5 years of the date of
set within 30 months of the date that EPA
enactment of the House draft bill. Like S.
places a chemical on the chemical
3209, the House draft requires
substance priority list or, for existing
manufacturers and processors to submit a
chemicals not placed on the priority list,
statement that the chemical will meet the
within 14 years of the date of enactment
safety standard.
of S. 3209. In addition to data,
manufacturers and processors are
required to submit to EPA a statement
that the chemical will meet the safety
standard.
EPA’s response
No comparable provision.
Within 180 days of receipt of a data
Within 6 months of the submission of al
submission, EPA is directed to determine,
required information, EPA shal make the
by order, whether the manufacturers and
safety determination based on known or
processors of the substance have
anticipated uses using the best available
established that the substance meets the
science and regarding any adverse effect. If
safety standard. If data are not submitted,
data are not submitted, that is grounds for
S. 3209 authorizes EPA to prohibit, by
determining that the manufacturers and
order, manufacture, processing, or
processors have not met the safety
distribution in commerce of the substance, standard. The Administrator must make
mixture, or article containing the
publicly available the determination with a
substance. If EPA determines that the
list of allowed uses and any conditions on
substance meets the safety standard, the
those uses necessary to ensure that the
al owed uses of the substance must be
safety standard is met. If EPA fails to
specified as well as any conditions on
publish or renew a determination before
those specified uses to ensure that the
the applicable deadline, the Administrator
safety standard is met. If EPA fails to meet
must publish notice of such failure in the
the deadline for a safety determination,
Federal Register.
manufacturers and processors are
required to provide to EPA, the public,
their employees, and customers written
notice that a determination by EPA of the
safety of the chemical is pending.
CRS-29

.

Provision
15 U.S.C. 2601 et seq.
S. 3209
House Draft of April 16, 2010
Resubmission
No comparable provision.
Amended TSCA 6(b)(2) provides that at
Amended TSCA 6(b)(5) provides that a
least every 15 years, manufacturers and
safety determination remains in effect for
processors of each chemical substance
up to 15 years, if no new use or
must submit the minimum dataset and
information warrants a redetermination.
indicate whether the substance and
specified uses meet the safety standard.
Redetermination
No comparable provision.
EPA may initiate a redetermination of
The Administrator may renew a
whether the chemical meets the safety
determination for additional 15 year
standard if new information raises a
periods but the burden of proof for
question in that regard, on the receipt of a renewal remains with the manufacturers
renewal submission, or 15-years following
and processors.
the previous determination.
Petition for redetermination
No comparable provision.
Authorizes any person to petition the
No comparable provision.
Administrator for a redetermination. The
Administrator must decide whether to
make the requested redetermination and
publish the decision and its basis in the
Federal Register within 180 days.
Restrictions on substances that do
No comparable provision, but TSCA 6(a)
Amended TSCA 6(b) prohibits
Similar to S. 3209 but also immediately
not meet the safety standard
directs EPA by rule to apply one or more
manufacture, processing, and distribution
prohibits activities with respect to a new
requirements (such as labeling or banning
in commerce of a chemical substance,
use of an existing substance, mixture, or
particular uses) “to the extent necessary to
mixture, or article if EPA makes a safety
article if EPA determines that the
protect adequately against” an “unreasonable
determination and does not determine
manufacturers and processors have not
risk” “using the least burdensome
that a substance meets the safety standard. shown that the use meets the safety
requirements,” if the Administrator finds that
Such prohibition is effective immediately
standard.
“there is a reasonable basis to conclude that
for a new chemical or after one year for
the manufacture, processing, distribution in
any other chemical.
commerce, use, or disposal of a chemical
substance or mixture, or that any combination
of such activities, presents or will present an
unreasonable risk of injury to health or the
environment.”
Unrestricted distribution in
No comparable provision, but current law
No comparable provision. S. 3209
Authorizes manufacture, processing, and
commerce
allows unrestricted distribution in commerce
prohibits manufacture, processing, and
distribution in commerce for any chemical
of chemicals and mixtures unless EPA
distribution in commerce of a chemical
substance or mixture that EPA determines
determines that a substance presents an
substance, mixture, or article for uses not
meets the safety standard without
unreasonable risk and then promulgates a rule specified in the safety determination.
imposition of conditions.
to regulate it.
CRS-30

.

Provision
15 U.S.C. 2601 et seq.
S. 3209
House Draft of April 16, 2010
Uses restricted for substances
No comparable provision.
Amended TSCA 6(b) prohibits
Authorizes EPA to impose conditions on
meeting the safety standard
manufacture, processing, and distribution
manufacture, processing, use, distribution
in commerce of a chemical substance,
in commerce, or disposal of a chemical
mixture, or article for any use not
substance or mixture to ensure that it
specified in the safety determination if EPA meets the safety standard. After one year,
determines that the chemical and its
prohibits activities with respect to a
specified uses meet the safety standard.
chemical if such conditions are not met.
Effective date of Section 6 rules
TSCA 6(d) [15 U.S.C. 2605(d)] directs EPA to
Amended TSCA 6(i) directs EPA to specify Amended TSCA 6(c) directs EPA to make
make such rules effective ”as soon as feasible,” a date on which a rule or order shall take
conditions imposed in a safety standard
and allows EPA to make a proposed rule
effect and that such date should be “as
determination effective one year after
effective upon publication until the effective
soon as feasible.”
publication.
date of the final rule if there is an
unreasonable risk of serious or widespread
injury to health or the environment and a
court has granted relief under section 7.
Quality control
TSCA 6(b) [15 U.S.C. 2605(b)] authorizes
Amended TSCA 6(d) is similar to current
The House draft is similar to current law
EPA to review and regulate a manufacturer’s
law but applies when there is “a
but applies when there is a reasonable
or processor’s quality control procedures if
reasonable basis to conclude” that the
basis to conclude that the manner of
there is “a reasonable basis to conclude” that
manner of manufacturing or processing
manufacturing or processing “causes the
the manner of manufacturing or processing
“may present a substantial endangerment
chemical substance or mixture to present
“unintentional y causes a chemical … to
to health or the environment.” Does not
or which will cause it to present a
present or which will cause it to present an
require such determination to be made on
substantial risk of injury to health or the
unreasonable risk of injury to health or the
the record after opportunity for hearing.
environment.” The word “unintentionally”
environment.” EPA also is authorized to order
is removed.
the manufacturer or processor to provide
notice to its customers of such risk and to
replace or repurchase the substance as is
necessary to adequately protect health or the
environment. Requires any determination that
a chemical presents an unreasonable risk to
be made on the record after opportunity for
hearing.
Resale of used articles
No comparable provision.
Restrictions established under sections
No comparable provision.
4(a)(3), 4(b)(3), 6(b)(2)(A)(iv), 6(b)(3),
8(b)(6), 8(c)(3), or 29 do not apply to
resale of an article subject to a restriction
under amended TSCA 6(b) if the article
has previously been used.
CRS-31

.

Provision
15 U.S.C. 2601 et seq.
S. 3209
House Draft of April 16, 2010
Delay of effective date of
No comparable provision.
Authorizes EPA to order delay in the
No comparable provision.
restrictions
effective date of a restriction for 3 years
for retail sales to an end consumer of a
chemical substance, mixture, or article
subject to a restriction under sections
4(a)(3), 4(b)(3), 6(b)(2)(A)(iv), 6(b)(3),
8(b)(6), 8(c)(3), or 29, if necessary and
appropriate, if it “will not present a
substantial endangerment to human health
or the environment.” EPA authority does
not extend to any retailer who has failed
to comply with an order requesting
information under amended TSCA section
8.
Exceptions to prohibitions and
No comparable provision.
Amended TSCA 6(e) authorizes EPA to
Same as S. 3209.
other restrictions
grant, by order, exemptions (and renewals
of exemptions) to restrictions established
under sections 4(a)(3), 4(b)(3),
6(b)(2)(A)(iv), 6(b)(3), 8(b)(6), 8(c)(3), and
29 for particular uses. Exemptions and
renewals may be granted for up to 5 years,
if manufacturers and processors “have
established by clear and convincing
evidence that the uses to be exempted
meet the exemption criteria.” Those
criteria are: 1) that the exemption is in the
paramount interest of national security; 2)
lack of availability would cause significant
disruption in the national economy; or 3)
the use is a critical or essential use, and
there is no safer feasible alternative, or the
specified use compared to available
alternatives provides benefit to health, the
environment, or public safety. The
manufacturer or processor must notify
customers and the public of any
exemptions granted. EPA is directed to
impose any condition on a granted
exemption that is necessary to ensure the
protection of human health and the
environment.
CRS-32

.

Provision
15 U.S.C. 2601 et seq.
S. 3209
House Draft of April 16, 2010
Certification
No comparable provision.
Amended TSCA 4(g), 5(e), 6(h), and 8(h)
Amended TSCA 8(h) requires each
require that each submission of
submission of information that is required
information under a rule or order be
pursuant to amended TSCA section 4, 5,
accompanied by a certification of the
6, or 8, or pursuant to a rule or order
accuracy, reliability, and completeness (to
issued under one of those sections, other
the extent reasonably ascertainable) of the than a submission under section 8(f)
information provided. Such certification
(relating to submissions from federal
must be signed by a responsible official of
agencies), to be accompanied by a
the manufacturer or processor.
certification of the accuracy, reliability, and
completeness (to the extent reasonably
ascertainable) of the information provided.
Such certification must be signed by a
responsible official of the manufacturer or
processor.
Mercury
15 U.S.C. 2605(f) prohibits federal agencies
Amended TSCA 6(g) is the same as
Same as S. 3209.
from conveying, selling, or distributing
current law.
elemental mercury to any federal agency, state
or local government, or private entity, except
to facilitate storage at a federal agency.
Polychlorinated biphenyls (PCBs)
TSCA 6(e) [15 U.S.C. 2605(e)] directs EPA to
Amended TSCA 6(f) is similar to existing
Same as current law.
prescribe methods of disposal for PCBs and
law but authorizes the Administrator to
to require PCBs to be marked with clear and
act by order or rule, and to grant
adequate warnings and instructions regarding
exemptions from the general prohibitions
processing, distribution in commerce, use, or
when the activities “will not present a
disposal. Prohibits use of any PCB other than
substantial endangerment to health or the
“in a total y enclosed manner,” unless EPA
environment” rather than when activities
finds that such activity “will not present an
“will not present an unreasonable risk.”
unreasonable risk of injury to health or the
environment.” Prohibits manufacture,
processing, and distribution in commerce.
Authorizes any person to petition for an
exemption and authorizes EPA to grant such
exemption if EPA finds that an unreasonable
risk would not result, and “good faith efforts
have been made to develop a chemical
substance which does not present an
unreasonable risk … and which may be
substituted for such [PCB].” Requires use of
rulemaking procedure in TSCA 6(c).
CRS-33

.

Provision
15 U.S.C. 2601 et seq.
S. 3209
House Draft of April 16, 2010
Imminent hazards

Relief
Authorizes an appropriate district court to
Similar to current law, but authorizes
Similar to current law, but authorizes
grant relief necessary to protect health or the
court to grant relief necessary to protect
court to grant relief necessary to protect
environment from unreasonable risk.
health or the environment from “the risk
health or the environment from “imminent
associated with the activity involved in the
and substantial endangerment.”
action.”
Civil actions
TSCA 7(a) [15 U.S.C. 2606(a)] authorizes EPA Similar to current law, but authorizes EPA
Same as S. 3209.
to begin a civil action: for seizure of “an
action against a person when a chemical,
imminently hazardous” chemical substance,
mixture, or article “may present an
mixture, or article; for relief against any
imminent and substantial endangerment to
person who manufactures, processes,
health or the environment.” S. 3209 does
distributes in commerce, or uses, or disposes
not require EPA to commence action if
of such chemical or article; or for both
the agency has not made a rule effective
seizure and relief. Requires EPA to commence immediately concerning the chemical.
such civil action if the agency has not made a
rule under TSCA 6(a) effective immediately.
Requires that EPA “where appropriate,
concurrently with the filing of an action …
initiate a proceeding for the promulgation of a
rule” under TSCA 6(a). Defines “imminently
hazardous chemical substance or mixture” to
mean a chemical that “presents an imminent
and unreasonable risk of serious or
widespread injury to health or the
environment.”
CRS-34

.

Table 5. Reporting Requirements in Selected Provisions of TSCA (15 U.S.C. 2601 et seq.), the Safe Chemicals Act (S. 3209), as
Introduced, and the House Draft (April 16, 2010) of the Toxic Chemicals Safety Act of 2010
Provision
15 U.S.C. 2601 et seq.
S. 3209
House Draft of April 16, 2010
Reporting and record keeping
TSCA 8(a) [15 U.S.C. 2607(a)] authorizes
Amended TSCA 8(a) requires
Same as S. 3209.
(declaration)
EPA, to the extent necessary for the
manufacturers and processors to submit a
effective enforcement of the law, to
declaration of current manufacturing or
promulgate rules requiring maintenance of
processing for each substance, mixture, or
records and submission of reports to EPA
article manufactured or processed
by persons who manufacture or process
containing information that will assist the
or who propose to manufacture or
Administrator in making a safety
process a chemical substance. Prohibits a
determination or otherwise in
rule requiring maintenance of records or
administering the law. Each declaration
submission of reports with respect to
must be accompanied by certification of its
changes in the proportions of the
accuracy, reliability, and
components of a mixture unless necessary
comprehensiveness. Amended TSCA 8(b)
for effective enforcement.
authorizes EPA by rule or order to
require any person who manufactures,
processes, distributes in commerce, uses,
or disposes of a chemical substance,
mixture, or article to maintain records of
and report any information that would
assist the Administrator in administering
TSCA. Authorizes EPA to require
information concerning chemical identity.
Failure to submit declaration
No comparable provision.
EPA may by order prohibit manufacture,
Same as S. 3209.
processing, or distribution of any
substance if a manufacturer or processor
violates EPA requirements for submitting
or updating declarations.
Smal quantities for research and
Exempts from reporting requirements
Authorizes EPA by rule to define
Same as S. 3209.
development
processors and manufacturers who are
manufacture, processing, distribution in
small (as determined by the Administrator
commerce, use, or disposal of a chemical
after consultation with the Smal Business
substance in small quantities solely for
Administration), and directs EPA to limit
purposes of research, and to issue a rule
record keeping and report requirements
or order under this subsection only if EPA
for those who manufacture or process a
determines maintenance of records or
chemical in small quantities solely for
submission of reports is necessary for
purposes of scientific experimentation or
effective enforcement of the law.
analysis of a chemical substance.
CRS-35

.

Provision
15 U.S.C. 2601 et seq.
S. 3209
House Draft of April 16, 2010
Information submitted
Authorizes collection of information
The declaration must state: the chemical
Same as S. 3209.
including: trade name or common name,
identity and substance characteristics;
chemical identity, categories of use,
name and location of each facility where
amount of each chemical manufactured or
the substance is manufactured or
processed, byproducts resulting from such
processed or from which it is distributed;
manufacture or processing, “al existing
a list and copies of health and safety
data concerning the environmental and
studies that are reasonably ascertainable;
health effects,” number of individuals
and all other information not previously
exposed, and, in the initial report, the
submitted to EPA regarding the physical,
manner of disposal.
chemical, and toxicological properties of
the substance, the annual production
volume and known uses of, exposure and
fate information, and the name and
location of each facility to which the
substance is sent for processing,
distribution, or use. Or, the declaration
may say that al production, importation,
processing, and export of a substance has
ceased or will cease within 180 days.
Declarations must be updated and
submitted at least every 3 years, and
immediately when new information
becomes available regarding a physical,
chemical, or toxicological property or use
of, or exposure to the substance.
Inventory
TSCA 8(b) [15 U.S.C. 2607(b)] directs
Amended TSCA 8(c) is the same as TSCA
Similar to S. 3209 but applies also to
EPA to compile, keep current, and publish
8(b), but in addition, S. 3209 requires that
mixtures.
an inventory of each chemical
EPA publish in the Federal Register a list of
manufactured or processed in the United
all chemical substances distributed in
States. New chemicals are to be listed
commerce that categorizes the substances
when manufacture or processing begins.
based on existing information available
The list should exclude chemicals
into categories based on known health or
produced in smal quantities for purposes
environmental effects, exposure,
of scientific experimentation, analysis, or
insufficient data, or other category that
research. Authorizes EPA to list chemicals
EPA considers appropriate.
by category rather than individually.
Public access
No comparable provision.
Amended TSCA 8(d) directs EPA to
Same as S. 3209.
establish an electronic database of “al
significant decisions made by the
Administrator” under TSCA Title I.
CRS-36

.

Provision
15 U.S.C. 2601 et seq.
S. 3209
House Draft of April 16, 2010
Records of significant adverse
TSCA 8(c) [15 U.S.C. 2607(c)] requires al
Amended TSCA 8(e) is similar to TSCA
Similar to S. 3209 but requires submission
reactions
manufacturers and processors to keep
but also requires submission of such
to EPA annually, while current law and S.
records of all reports of significant adverse records to EPA.
3209 do not require reports at specific
reactions to health or the environment
times.
al eged to have resulted from exposure to
a chemical substance.
Information from other federal
No comparable provision.
Amended TSCA 8(f) requires each federal
Similar to S. 3209, but agencies are to
agencies
agency and institution to submit to EPA a
respond to a request from EPA, not to
synopsis of the data and records in its
submit reports every 3 years, and the bill
control that may be useful to EPA in
directs EPA to prescribe by order the
carrying out TSCA Title I. Such synopsis
format, content, and level of detail of the
shal be updated and resubmitted at least
requested report.
once every 3 years. On request by the
EPA Administrator, federal agencies are
directed to submit information relating to
hazard, use, exposure, or risk of a
chemical substance or mixture.
Health and safety studies
TSCA 8(d) [15 U.S.C. 2607(d)] directs
S. 3209 requires submission of such
Same as S. 3209.
EPA to require manufacturers, processors, studies as part of the declaration under
and distributors to submit lists and copies
amended TSCA 8(a).
of health and safety studies for each
chemical manufactured or processed.
Substantial risk notice
TSCA 8(e) [15 U.S.C. 2607(e)] requires
Amended TSCA 8(g) is the same as
Same as S. 3209.
manufacturers, processors, and
current law.
distributors who obtain information
“which reasonably supports the
conclusion” that a chemical substance or
mixture “presents a substantial risk of
injury to health or the environment” to
inform EPA.
CRS-37

.

Table 6. Other Selected Provisions of TSCA (15 U.S.C. 2601 et seq.), the Safe Chemicals Act (S. 3209), as Introduced, and the
House Draft (April 16, 2010) of the Toxic Chemicals Safety Act of 2010
Provision
15 U.S.C. 2601 et seq.
S. 3209
House Draft of April 16, 2010
Action under other EPA-administered
TSCA 9(b) [15 U.S.C. 2608(b)] directs
Same as current law.
Same as current law.
laws
EPA to coordinate actions taken under
TSCA with actions taken under other
federal laws administered by EPA.
Occupational safety and health
TSCA 9(c) states that any EPA exercise of
Same as current law. In addition, S. 3209
Same as current law.
authority under TSCA is deemed to be
directs EPA to ensure that any EPA actions
exercising statutory authority to prescribe
to address workplace exposures “are
or enforce standards or regulations
consistent with the industrial hygiene
affecting occupational safety and health.
hierarchy of controls.”
Coordination
TSCA 9(d) directs EPA to consult and
S. 3209 strikes the requirement that
Same as S. 3209.
coordinate with appropriate federal
coordination for the purpose of
agency heads to achieve “maximum
enforcement should impose the least
enforcement” “while imposing the least
burdens of duplicative requirements.
burdens of duplicative requirements” on
those being regulated.
CRS-39

.

Provision
15 U.S.C. 2601 et seq.
S. 3209
House Draft of April 16, 2010
Action under laws administered by
If EPA has a reasonable basis to conclude
Amended TSCA 9(a) is similar to current
Similar to S. 3209, but does not al ow EPA
other federal agencies
that activities with respect to a chemical
law, but the criterion for EPA action
action under TSCA 7 if EPA makes a
substance or mixture present or will
differs. If the Administrator determines
report and the other agency initiates
present an unreasonable risk, and EPA
“that the manufacture, processing,
action within the timeframe specified by
determines that such risk may be
distribution in commerce, use, or disposal
EPA.
prevented or reduced to a sufficient
of a chemical … either does not meet the
extent by action taken under a federal law
safety standard … or requires conditions
not administered by EPA, then TSCA 9(a)
or restrictions” to do so, and “that action
[15 U.S.C. 2608(a)] directs EPA to submit
may be taken under a Federal law not
to the agency which administers such law a administered by the Administrator to
report describing the risk and activities
address uses of, or aggregate and
that present such risks. The EPA report
cumulative exposure to, such chemical
must request that the other federal agency substance or mixture,” then EPA is
1) tel EPA whether the risk may be
directed to submit a report to the other
prevented or reduced under the law the
agency describing the activities that
agency administers, and 2) issue an order
prevent the chemical from meeting the
declaring whether the activities present a
safety standard or restrictions or
risk. If EPA makes a report and the other
conditions required to meet the safety
agency either 1) issues an order declaring
standard. The EPA report must request
that the activities do not present the risk ,
that the other agency 1) determine if the
or 2) initiates action to protect against
action may be taken under a law
such risk, then EPA may not take
administered by the agency, and if so, 2)
regulatory action under TSCA 6 or 7.
initiate such action and provide a timetable
for action, and 3) respond to EPA’s report.
If EPA makes a report and the other
agency initiates action within the
timeframe specified, EPA may not take
regulatory action, except under TSCA 7. If
EPA makes a report and the other agency
determines that action cannot be taken
under its authorities; does not initiate
action, or complete action within the
timeframe provided; or fails to respond,
then EPA may, by order, initiate action to
ensure compliance with the safety
standard.
CRS-40

.

Provision
15 U.S.C. 2601 et seq.
S. 3209
House Draft of April 16, 2010
Subpoenas and warrants
TSCA 11(c) [15 U.S.C. 2610(c)] authorizes Amended TSCA section 11(c) authorizes
Same as current law.
EPA to require by subpoena attendance
EPA to require attendance, testimony, and
and testimony of witnesses, production of
production of documents, items, answers
reports, documents, answers to questions, to questions and other information
and other information. Authorizes district
deemed necessary. In the event that
courts to order compliance in the event of “there is reason to believe that the
contumacy, failure, or refusal to obey.
provisions” of the law have been violated,
EPA is empowered to obtain and to
execute warrants authorizing entry,
inspection, and copying of records, or
seizures of any chemical in violation.
Inspections
TSCA 11 [15 U.S.C. 2610] authorizes EPA
Similar to TSCA but also applies to
Similar to TSCA, but also applies to
to inspect premises in which chemicals are premises and conveyances handling articles premises and conveyances related to
manufactured, processed, stored, or held
subject to TSCA, and S. 3209 does not
“articles containing such substances or
before or after distribution in commerce
limit inspections by requiring presentation
mixtures.”
and any conveyance used to transport
of credentials or provision of written
chemicals in commerce. Limits inspections
notice. Additional y authorizes EPA to
by requiring presentation of appropriate
inspect any place where records relating
credentials and written notice to the
to compliance with the law are held and to
person in charge of the premises or
inspect and obtain samples of any
conveyance to be inspected on each
chemicals, containers, or labeling. Does
occasion of inspection. Requires
not prohibit inspection of any data.
inspections to begin and end with
reasonable promptness and to “be
conducted at reasonable times, within
reasonable limits, and in a reasonable
manner.” Prohibits inspection of financial,
sales, pricing, personnel, or research data,
unless they are described specifically in the
required written notice.
CRS-41

.

Provision
15 U.S.C. 2601 et seq.
S. 3209
House Draft of April 16, 2010
Exports

Exclusion from requirements
TSCA 12(a) [15 U.S.C. 2611(a)] excludes
Eliminates the current exclusion from
Same as S. 3209.
chemical products manufactured for
requirements for chemicals manufactured,
export (other than elemental mercury)
processed, or distributed in commerce
from TSCA requirements except for
solely for the purpose of export.
reporting and record keeping
requirements in Section 8. This exclusion
applies as long as the products are labeled
for export only and their manufacture,
processing, and distribution do not pose
an unreasonable risk within the United
States. EPA may require testing to allow
assessment of the risk within the United
States.
Mercury
TSCA 12(c) [15 U.S.C. 2611(c)] prohibits
Same as current law.
Same as current law.
the export of elemental mercury (but not
of coal). Authorizes exemptions from this
prohibition for essential uses.
Notice
TSCA 12(b) [15 U.S.C. 2611(b)] requires
Amended TSCA 12(a) is similar to current
Similar to S. 3209, but requires exporters
anyone who exports or intends to export
law, but excludes from requirements those of substances contained in Annex III of the
a substance that is subject to a test rule or
who “intend” to export, and applies only
Rotterdam Convention on Prior Informed
order under section 4 or a proposed or
to exports of chemicals subject to data
Consent Procedure for Certain Hazardous
final rule under section 5 or 6, or for
submission requirements under amended
Chemicals and Pesticides in International
which action is pending or relief has been
TSCA 5 or 6(b), or for which action has
Trade (including any amendment or
granted under section 5 or 7, to notify
been taken under TSCA 6 or 7. Also, S.
protocol) to file notice of export at least
EPA of such exportation or intent, and
3209 al ows exporters 30 days from the
30 days prior to the date of exportation.
EPA must then notify the countries that
date of export for providing notice to
(Note that the United States has not yet
will be receiving the substance that data
EPA, and specifies that EPA must provide
ratified this treaty.)
are available or that restrictions are in
notice to countries “promptly thereafter.”
place in the United States for such
Requires exporters to notify EPA, and EPA
substance.
to notify receiving countries, of any change
in the status of a chemical. EPA also must
notify receiving countries that it has
received new data or if there is any change
in risk management action taken under
section 6 or 7. Requires EPA to maintain
copies of current notices provided to
other governments and to make them
available to the public electronically.
CRS-42

.

Provision
15 U.S.C. 2601 et seq.
S. 3209
House Draft of April 16, 2010
Imports
TSCA 13 [15 U.S.C. 2612] directs the
Similar to current law but transfers
Same as S. 3209.
Secretary of the Treasury to refuse entry
authority to the Secretary of the
into the United States of chemicals that fail Department of Homeland Security.
to comply with a rule under TSCA or that
are in violation of TSCA.
Risk information for workers
No comparable provision.
Amended TSCA 14 requires EPA to
Same as S. 3209.
provide standards for and facilitate sharing
with each certified or recognized
bargaining agent information regarding
chemical identity, safety standard
determination, and health and safety data
that pertains to substances that workers
may come into contact with or otherwise
be exposed to during the course of work.
Disclosure of data
TSCA 14 [15 U.S.C. 2613] provides broad
Amended TSCA 14 requires conformance
Amended TSCA 13 is similar to S. 3209,
protection of proprietary confidential
to the standards of the Freedom of
but directs EPA to release data from
information about chemicals in commerce.
Information Act (FOIA). Specifically directs health and safety studies of chemicals if it
Disclosure by EPA employees of such
EPA to disclose information upon request
is necessary to protect health or the
information generally is not permitted,
to a state, tribal, or municipal government. environment against “substantial” risk of
except to other federal employees, or
Directs EPA to release data from health
injury.
when necessary to protect health or the
and safety studies of chemicals if it is
environment against “an unreasonable risk
necessary to protect health or the
of injury” to health or the environment.
environment against “an imminent and
However, health and safety data are not
substantial endangerment” to health or the
protected for chemicals in commerce for
environment. Other data that are not
which testing is being required under
protected under amended TSCA 14
section 4, or for which notification is
include the identity of a chemical, any
required under section 5, unless data
safety standard determination and
disclosure would reveal a chemical process supporting information, information
or chemical proportion in a mixture.
“indicating the presence of a chemical in a
consumer article intended for use or
reasonably expected to be used by
children or to which children can
otherwise be reasonably expected to be
exposed.”
CRS-43

.

Provision
15 U.S.C. 2601 et seq.
S. 3209
House Draft of April 16, 2010
Designation of confidential data
Al ows data submitters to designate data
Similar to current law, but specifies that
Same as S. 3209.
believed to be entitled to confidential
submitters must include justification for
treatment and to request that EPA treat
each claim, certification that the
the data as such.
information is not otherwise publicly
available, and separate copies of al
submitted information, one with and the
other excluding the designated confidential
information.
Directs EPA by order to develop and
make publicly available standards that
specify acceptable bases for confidentiality
claims and the documentation that must
accompany requests for confidentiality.
Requires EPA to review requests and to
decide whether to approve or deny each
request no later than 90 days after
receiving it. If such request is denied, the
information must be made available to the
public, but if the request is approved, EPA
must specify a time period of less than 5
years for which the information shall be
kept confidential.
Prohibited Acts
TSCA 15 [15 U.S.C. 2614] prohibits any
Amended TSCA 15 is similar to current
Similar to S. 3209, but also prohibits failing
person from failing or refusing to comply
law and prohibits all the same actions, but
or refusing to permit access to or copying
with rules, orders, or other requirements
also prohibits manufacturing, processing,
of records.
of TSCA, using for commercial purposes a
distributing in commerce, or disposing of a
chemical substance or mixture that was
chemical or article or using an article that
known to be manufactured, processed, or
was known to have been manufactured,
distributed in commerce in violation of the processed, or distributed in commerce in
law, failing or refusing to establish and
violation of the law. S. 3209 also prohibits
maintain records, submit reports, notices,
failing or refusing to establish and maintain
or other information, or to permit access
“accurate and complete” records, reports,
to or copying of records, or failing or
notices, information, disclosures,
refusing to permit entry or inspection.
declarations, certifications, or other
information. Prohibits submitting
information “that is materially false, in
whole or in part,” or falsifying or
concealing “any material fact.” Prohibits
taking any action prohibited by amended
TSCA.
CRS-44

.

Provision
15 U.S.C. 2601 et seq.
S. 3209
House Draft of April 16, 2010
Penalties
TSCA 16 [15 U.S.C. 2615] authorizes civil
Amended TSCA 16 increases the
Similar to S. 3209 for civil penalties and
penalties, not to exceed $25,000 per
maximum per violation per day civil
criminal penalties, but as in current law,
violation per day, and affords the
penalty to $37,500 and authorizes EPA to
criminal penalties apply to persons who
defendant an opportunity to request a
commence a civil action in an appropriate
“knowingly or willfully” violate the act.
hearing before an order is issued and to
U.S. district court to assess penalties.
petition for judicial review of an order
Changes the court in which a person may
after it is issued with the U.S. Court of
file a petition for judicial review to
Appeals for the District of Columbia
eliminate jurisdiction in any federal circuit
circuit or for any other circuit in which
court, instead vesting jurisdiction in the
the person resides or transacts business.
appropriate district court for the district
in which the person resides or transacts
Criminal penalties of up to $25,000 per
business.
day of violation or up to one year of
imprisonment, or both, also are
Removes criminal sanctions for “willfully”
authorized for knowing or willful
violating any provision of TSCA, as
violations.
amended, but increases the maximum
penalty for “knowing” violations to
$50,000 per day of violation or up to 5
years of imprisonment, or both. Adds a
provision that any person who knowingly
violates any provision of the law and “who
knows at the time that he thereby places
another person in imminent danger of
death or serious bodily injury to any
person shal upon conviction be subject to
a fine of not more than $250,000 or
imprisonment of not more than 15 years,
or both.” A person who is not an
individual is subject to a fine of not more
than $1,000,000.
Seizure
Makes substances produced in violation of
Similar to current law but in addition to
Same as S. 3209.
Title IV (Lead Exposure Reduction) liable
substances and mixtures, S. 3209 applies
to be proceeded against, by process of
to “articles” rather than “products” and to
libel, for seizure and condemnation in any
any such items that are subject to any title
district where the substance is found.
of TSCA.
CRS-45

.

Provision
15 U.S.C. 2601 et seq.
S. 3209
House Draft of April 16, 2010
Enforcement
TSCA 17 [15 U.S.C. 2616] provides
Authorizes the EPA Administrator to
Same as S. 3209.
jurisdiction to district courts over civil
commence a civil action in the appropriate
actions to restrain any violation or any
district court to compel compliance of any
person from taking any action prohibited,
person with any provision of TSCA or any
to compel the taking of any action
rule or order promulgated pursuant to it.
required, or to direct any manufacturer or Authorizes EPA to seek civil or criminal
processor in violation of section 5 or 6 or
penalties, enjoin any violation, or order
of Title IV (or a rule or order under those
compliance, through an administrative
provisions): to give notice to distributors
proceeding, with any provision of TSCA or
and to others in possession of the
with any rule or order issued under it.
substance, to give public notice of risk, and
to replace or repurchase the substance.
Gives district courts jurisdiction over civil
actions to seek penalties or enjoin
Authorizes civil actions brought in the U.S. violations in the U.S. district court for the
district court for the judicial district
judicial district wherein any violation
wherein any violation occurred or where
occurred or where the defendant is found
the defendant is found or transacts
or transacts business. Gives jurisdiction
business.
over civil actions ordering compliance to
the U.S. district court for the judicial
district where the defendant is found or
transacts business.
Preemption of state law
TSCA 18 [15 U.S.C. 2617] does not
Amended TSCA 18 would not preempt
Amended TSCA 18 provides that the act
preempt state laws with two exceptions:
laws relating to a chemical substance,
does not affect the right of a state or
1) when EPA requires testing of a chemical mixture, or article of states or political
political subdivision to adopt or enforce its
under section 4, no state may require
subdivisions unless they were less
own laws or requirements with regard to
testing of the same substance for similar
stringent than federal law.
a chemical unless compliance with both
purposes; and 2) if EPA prescribes a rule
the requirement and TSCA is
or order under section 5 or 6 to protect
“impossible.”
against a risk, no state or political
subdivision may have a requirement for
such substance to protect against such risk
unless it is identical to the EPA
requirement, is adopted under authority of
the Clean Air Act or another federal law,
or prohibits the use of such substance in
such state or political subdivision (other
than use in manufacture or processing of
other substances or mixtures).
CRS-46

.

Provision
15 U.S.C. 2601 et seq.
S. 3209
House Draft of April 16, 2010
Exemption from preemption
TSCA 18 [15 U.S.C. 2617] authorizes EPA, No comparable provision. (Since state
Same as S. 3209.
upon application by a state or political
laws are not preempted, there is no need
subdivision, by rule to exempt a law in
for an exemption.)
effect in the state or political subdivision, if
compliance with the requirement would
not cause activities involving the substance
to be in violation of the EPA requirement,
and the requirement of the state or
political subdivision provides a significantly
higher degree of protection from the risk
than the EPA requirement does and does
not “unduly burden interstate commerce.”
Judicial review
TSCA 19 [15 U.S.C. 2618] authorizes any
Similar to current law, but TSCA 19, as
Same as S. 3209.
person to file a petition with the U.S.
amended, authorizes filing a petition for
Court of Appeals for the District of
judicial review of any rule or order issued
Columbia Circuit or for the circuit in
under TSCA, as amended, rather than only
which such person resides or in which the
specified rules, and eliminates the directive
person’s principal place of business is
in current law to the court (to set aside a
located, for judicial review of rules
rule not supported by substantial evidence
promulgated under TSCA sections 4(a),
in the rulemaking record taken as a
5(a)(2), 5(b)(4), 6(a), 6(e), or 8. within 60
whole).
days of issuance. The appropriate district
court is directed to set aside specified
rules if they are not supported by
“substantial evidence in the rulemaking
record … taken as a whole” which is
defined in TSCA 19(a)(3).
Citizen suits
TSCA 20 [15 U.S.C. 2619] authorizes civil
Similar to current law, but authorizes suits
Same as S. 3209.
suits by any person against any person in
against any person in violation of rules or
violation of TSCA or rules or orders
orders promulgated under any provision
promulgated under specified sections of
of TSCA, as amended.
TSCA. It also authorizes suits against EPA
to compel performance of
nondiscretionary actions under TSCA.
Citizen petitions
TSCA 21 [15 U.S.C. 2620] provides the
Similar to current law but authorizes
Same as S. 3209.
public with the right to petition EPA to
petitions for EPA to initiate any action
initiate rulemaking or repeal of specified
authorized under the law.
rules. Requires the Administrator to grant
or deny the petition within 90 days of its
filing.
CRS-47

.

Provision
15 U.S.C. 2601 et seq.
S. 3209
House Draft of April 16, 2010
Employment effects
TSCA 24 [15 U.S.C. 2623] directs the
Similar to current law, but directs the
Same as S. 3209.
Administrator to continual y evaluate the
Administrator to evaluate potential effects
potential effects of specified rules, orders,
of the law as a whole, rather than specific
and requirements under specified TSCA
provisions, and periodically, rather than
provisions on employment.
continually.
Administration
TSCA 26(a) [15 U.S.C. 2625(a)] authorizes Similar to current law, except for
Same as S. 3209.
federal agencies, upon request from EPA,
subsection (b) and a new subsection (h).
to provide services, personnel, facilities,
and information to EPA to assist in
Amended TSCA 26(b) authorizes
implementation of TSCA.
collection of fees from data submitters to
defray the cost of administering TSCA, as
TSCA 26(b) [15 U.S.C. 2625(b)]
amended. It removes the restrictions in
authorizes collection of fees for EPA
the original TSCA 26(b) on the amount of
processing of data submitted in response
such fees.
to an order under Section 4 or 5.
New TSCA 26(h) authorizes the
TSCA 26(c) [15 U.S.C. 2625(c)] authorizes Administrator to issue orders and
EPA to impose regulatory controls on
prescribe regulations as necessary to carry
categories of chemicals, rather than on a
out the law.
case-by-case basis. Prohibits regulation of
a group based solely on the fact that it
consists of new chemical substances.
TSCA 26(d) [15 U.S.C. 2625(d)] directs
EPA to establish an office to assist the
regulated community.
TSCA 26(e) [15 U.S.C. 2625(e)] requires
that EPA establish a procedure to ensure
disclosure of financial interests in the
regulated community by EPA employees.
TSCA 26(f) [15 U.S.C. 2625(f)] provides
that final orders issued under TSCA must
contain a statement of basis and purpose.
TSCA 26(g) [15 U.S.C. 2625(g)] requires
appointment of an Assistant Administrator
for Toxic Substances.
CRS-48

.

Provision
15 U.S.C. 2601 et seq.
S. 3209
House Draft of April 16, 2010
State programs
TSCA 28 [15 U.S.C. 2627] authorizes
Similar to current law, but grants are
Same as S. 3209.
grants to states to establish and operate
authorized to prevent or eliminate any
programs to prevent or eliminate
risks that EPA has not addressed. In
unreasonable risks to health or the
addition, EPA is directed to establish a
environment which EPA is unable or is not process to coordinate with the states “to
likely to address under TSCA.
share data and priorities relating to the
management of chemical substances”
under TSCA, as amended, and under state
programs.
Chemicals of highest concern
No comparable provision.
Amended TSCA 29 directs the
Amended TSCA 33 directs the
Administrator to “act quickly to manage
Administrator to expedite action for 31
risks from chemical substances that clearly
specified chemicals and chemical groups.
pose the highest risks to human health or
According to the House draft, these are
the environment.”
chemicals “for which risk to health and the
environment have been well documented
yet sufficient risk management actions
have not been taken.” Within 6 months,
manufacturers and processors of these
chemicals must submit the declaration
required by amended TSCA 8(a)(2), but
they need not submit the minimum data
set. Within 12 months of enactment of the
House draft, EPA must determine whether
the manufacturers and processors of these
chemicals have established that the
substances meet the safety standard, and
then must take appropriate action to
ensure that activities with respect to those
chemicals meet the safety standard. New
uses of these chemicals are prohibited
unless they meet the requirements for a
critical use exemption under amended
TSCA 6(e).
CRS-49

.

Provision
15 U.S.C. 2601 et seq.
S. 3209
House Draft of April 16, 2010
Monitoring exposures
No comparable provision.
Amended TSCA 30 directs the
Same as S. 3209.
Administrator to coordinate with the
Secretary of Health and Human Services
(HHS) to conduct a biomonitoring study
to determine the presence of a chemical in
human biological media in pregnant
women and infants if research has
indicated that it may be present and may
have adverse effects on development.
Study results must be published. If the
study finds that the chemical is present in
human biological media, manufacturers and
processors must disclose to EPA,
commercial customers, consumers, and
the public all known uses of the chemical
and all articles in which the chemical is
expected to be present.
Children’s environmental health
No comparable provision.
Amended TSCA 30 establishes a
Same as S. 3209.
research
Children’s Environmental Health Research
Program at EPA and authorizes the
Administrator to enter into contracts and
make grants to “further understanding of
the vulnerability of children to chemical
substances and mixtures.” Establishes an
Interagency Science Advisory Board on
Children’s Health Research subject to the
Federal Advisory Committee Act to
provide independent advice upon request
of the Administrator or Congress relating
to the implementation of the amended
TSCA “with respect to protecting
children’s health and research.” The
committee members would include
representatives of the National Institute of
Environmental Health Sciences, the
Centers for Disease Control and
Prevention, the National Toxicology
Program, the National Cancer Institute,
the National Tribal Science Council, and
not fewer than 3 centers of children’s
health at leading universities.
CRS-50

.

Provision
15 U.S.C. 2601 et seq.
S. 3209
House Draft of April 16, 2010
Animal-based testing
No comparable provision.4
Amended TSCA 31 directs the
Similar to S. 3209, but does not require
Administrator to minimize the use of
EPA to fund and carry out research,
animals in testing of chemical substances
development, performance assessment,
or mixtures. Establishes an Interagency
and translational studies to accelerate
Science Advisory Board on Alternative
development of test methods and
Testing Methods subject to FACA. The
strategies.
Board is directed to provide independent
advice and peer review to the
Administrator and Congress and to
publish a list of testing methods that
reduce the use of animals in testing under
amended TSCA 4. Directs the
Administrator in consultation with the
Board to develop a strategic plan,
biennial y report to Congress on progress
in implementing this section, and fund and
carry out research, development,
performance assessment, and translational
studies to accelerate the development of
test methods and strategies for use in
safety standard determinations under
amended TSCA 6(b). Authorizes the
Administrator, on request of a
manufacturer or processor, to adapt or
waive animal-based testing of a chemical
substance or mixture under specific
conditions.

4 However, EPA “is committed to examining alternative test methods that reduce the number of animals needed for testing, reduce pain and suffering of test animals, and whenever
possible, replace animals in testing with validated in vitro (non-animal) test systems. EPA has released guidance on this issue …” U.S. EPA, “Fact Sheet on Animal Welfare,”
April 2001, EPA 745-F-99-003, http://www.epa.gov/HPV/pubs/general/anfacs.pdf.
CRS-51

.

Provision
15 U.S.C. 2601 et seq.
S. 3209
House Draft of April 16, 2010
Safer alternatives and green chemistry
No comparable provision.
Amended TSCA 32 establishes a program
Similar to S. 3209, but omits directive to
and engineering
to create market incentives for the
develop a workforce education and
development of safer alternatives to
training program, and subjects other
existing chemical substances that reduce
requirements “to amounts made available
or avoid the use and generation of
in advance in appropriations Acts.”
hazardous substances. Establishes a
network of at least four green chemistry
and engineering centers in various U.S.
regions. Directs EPA to make grants to
promote and support research,
development, and adoption of safer
alternatives. Creates a program to
facilitate the development of a workforce
that produces safer alternatives to existing
chemical substances.
Reliable information and advice
No comparable provision.
Amended TSCA 34 directs EPA by order
Similar to S. 3209, but does not direct EPA
to establish and implement procedures to
to establish a registry of health and safety
ensure data reliability by annually
studies.
inspecting laboratories and performing an
annual data audit. Requires that EPA
establish a registry of studies. Provides the
Administrator with access to all records of
health and safety studies initiated in
response to requirements of Title I, and
requires each submitter of a research
study conducted by a third party to
disclose the sources of any funding used to
conduct or publish the study.
CRS-52

.

Provision
15 U.S.C. 2601 et seq.
S. 3209
House Draft of April 16, 2010
Hot spots
No comparable provision.
Amended TSCA 35 requires that EPA
Similar to S. 3209, but does not address
promulgate a rule to establish criteria to
judicial review or state that listing is a
identify any locality that is
nondiscretionary duty.
disproportionately exposed. Defines
“disproportionate exposure” to mean
residential population exposure to one or
more toxic chemical substances and
mixtures at levels that are significantly
greater than the average exposure in the
United States. Directs EPA, within 120
days of promulgation of the rule, to
identify localities subject to such exposure
using data in EPA’s National Air Toxic
Assessment Database and other available
data, and providing an opportunity for
public nominations of localities. Requires
EPA to publish a list of such localities, and
to update it at least once every 5 years.
The list is not subject to judicial review.
Publication of a list is a nondiscretionary
duty and subject to judicial review.
Requires the Administrator to develop and
publish an action plan that includes an
identification of the chemicals that
contribute to the disproportionate
exposure, and a description of actions to
be taken to reduce exposure. Directs EPA
to report annual y to Congress.

CRS-53

.

Provision
15 U.S.C. 2601 et seq.
S. 3209
House Draft of April 16, 2010
Federal agencies
No comparable provision.
Amended TSCA 36 provides that all
Same as S. 3209.
federal agencies are subject to the
provisions of TSCA, as amended, and
expressly waives any immunity otherwise
applicable to the United States. However,
no agent, employee, or officer of the
United States is personally liable for any
civil penalty under TSCA with respect to
any act or omission within the scope of
the official duties of that person. Such
persons are subject to any criminal
sanction under amended TSCA. The
President is authorized to grant an
exemption for any federal agency from
compliance with any requirement of
amended TSCA if “the President
determines it is in the paramount interest
of the United States.” An exemption may
be granted due to lack of appropriation if
the President specifically requested such
appropriation and Congress failed to make
available such requested appropriation.
Directs the President annually to report to
Congress al exemptions granted during
the previous year.
Authorizes enforcement action against any
federal agency, as well as voluntary
resolution or settlement set forth in a
consent order.
International cooperation
No comparable provision.
Amended TSCA 33 directs the
Similar to S. 3209, but directs the
Administrator to cooperate with the
Administrator to develop “safer
Secretary of State and the head of any
alternatives for chemical substances and
other appropriate federal agency with
mixtures that the Administrator
international efforts to develop a common
determines has [sic] broad international
protocol or electronic database relating to support and a reasonable expectation of
chemical substances or to develop safer
success.”
alternatives for chemical substances.
CRS-54

.

Provision
15 U.S.C. 2601 et seq.
S. 3209
House Draft of April 16, 2010
International agreements
No comparable provision
Amended TSCA 37 provides authority for
Amended TSCA 37 directs the
EPA to implement three international
Administrator to implement international
agreements: the Stockholm Convention
agreements and subsequent amendments
on Persistent Organic Pollutants
to which the United States becomes a
(Stockholm Convention), the Aarhus
party related to chemical substances.
Protocol to the Convention on Long-
Range Transboundary Air Pol ution
It directs the Administrator to prohibit
(LRTAP Protocol), and the Rotterdam
manufacture, processing, distribution in
Convention on the Prior Informed
commerce, use, and disposal of specified
Consent Procedure for Certain Hazardous chemical substances and mixtures (some
Chemicals and Pesticides in International
of which are listed in an annex to the
Trade (PIC Convention). Directs the
Stockholm Convention and/or the LRTAP
Administrator to implement and support
Protocol) within 5 years of enactment, but
implementation of the provisions of the
excepts use of such chemicals for critical
three agreements that have entered into
uses.
force for the United States.
Requires the Administrator, in
Prohibits manufacture, processing,
consultation with the Secretary of State,
distribution in commerce, use, disposal, or
to publish in the Federal Register a notice of
any other action with respect to a covered the chemical substances or mixtures
chemical in a manner inconsistent with
subject to the Stockholm Convention, the
applicable international obligations.
PIC Convention, and the LRTAP Protocol.
Directs EPA to provide timely public
Requires that any chemical listed under an
notice and opportunity to comment on: a
international agreement to which the
chemical proposed for listing, a
United States is a party must be added to
recommendation made to list a chemical
the priority list under amended TSCA
on any Annex in advance of any meeting of 6(a), unless it already is subject to risk
the Parties at which the recommendation
management under amended TSCA 6(c).
is to be considered, and any decision by
Directs EPA to provide timely public
the Meeting of the Parties to list a
notice and opportunity to comment at
chemical.
various stages of the process of listing or
Authorizes the Administrator to prescribe
delisting chemicals, as required in
regulations to carry out provisions of the
agreements to which the United States is a
three agreements or to ensure compliance party.
with obligations under them. Prohibitions
Authorizes the Administrator to prescribe
and other requirements shal be enforced
regulations as necessary to cooperate with
in the same way as final rules or orders
international efforts and to implement
under amended TSCA 6.
international agreements to which the
United States is a party.
CRS-55

.

Provision
15 U.S.C. 2601 et seq.
S. 3209
House Draft of April 16, 2010
Persistent, bioaccumulative, toxic
No comparable provision.
No comparable provision.
Amended TSCA 32 directs the
substances (PBTs)
Administrator to promulgate a rule
establishing methodology for evaluation of
risk from chemical substances and
mixtures determined to be persistent and
bioaccumulative. Requires use of this
methodology for PBTs on the priority list
and risk management to ensure safety.
Authorization of appropriations
TSCA 29 [15 U.S.C. 2628] authorizes
Amended TSCA 39 authorizes “such sums
Same as S. 3209.
appropriations for implementation of
as may be necessary” to carry out the law
specific TSCA provisions in 1982 and
for 2011 through 2018, with no restriction
1983. Prohibits expenditures of
on how those funds might be used.
appropriated funds to construct
laboratories.

CRS-56

.
Proposed Amendments to the Toxic Substances Control Act

Author Contact Information

Linda-Jo Schierow

Specialist in Environmental Policy
lschierow@crs.loc.gov, 7-7279

Congressional Research Service
57