Proposed Amendments to the Toxic Substances Control Act (TSCA): Senate and House Bills Compared with Current Law

Proposed Amendments to the

Toxic Substances Control Act (TSCA):

Senate and House Bills Compared

with Current Law

(name redacted)

Specialist in Environmental Policy

August 12, 2010

Congressional Research Service

7-....

www.crs.gov

R41335

CRS Report for Congress

Prepared for Members and Committees of Congress

Proposed Amendments to the Toxic Substances Control Act

Summary

On April 15, 2010, Senator Lautenberg introduced legislation (S. 3209) to amend the core

provisions of the Toxic Substances Control Act (TSCA) Title I. Representatives Waxman and

Rush introduced comprehensive legislation to amend TSCA (H.R. 5820) on July 22, 2010. This

report compares key provisions of S. 3209, as introduced, H.R. 5820, as introduced, and current

law (15 U.S.C. 2601 et seq.).

Both bills would amend the 35-year-old law to shift the burden of demonstrating safety for

chemicals in commerce from the U.S. Environmental Protection Agency (EPA) to manufacturers

and processors of chemicals. Both bills also would prohibit manufacture, processing, and

distribution of any chemical substance or mixture for which safety has not been demonstrated.

Although they propose somewhat different safety standards for EPA to enforce, both bills 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 any regulation should control

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 bills also would add new sections to TSCA. Of particular significance is a section

authorizing actions that would allow U.S. implementation of three international agreements,

which the United States has signed but not yet ratified. Other new sections would provide

authority for EPA to support research in so-called “green” engineering and chemistry, promote

alternatives to toxicity testing on animals, encourage research on children’s environmental health,

and require biomonitoring of pregnant women and infants. A “hot spots” provision would require

EPA to identify locations where residents are disproportionately exposed to pollution and to

develop strategies for reducing their risks.

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 H.R. 5820. The

proposals also treat the identification of chemicals of highest concern differently. H.R. 5820

directs EPA to expedite action for 19 specified chemicals, 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.

Congressional Research Service

Proposed Amendments to the Toxic Substances Control Act

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 Toxic Chemicals Safety Act of

2010 (H.R. 5820), as Introduced...............................................................................................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 Toxic Chemicals Safety Act of 2010

(H.R. 5820), as Introduced ..................................................................................................... 13

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 Toxic Chemicals Safety Act of 2010

(H.R. 5820), as Introduced ..................................................................................................... 20

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 Toxic Chemicals Safety Act of 2010

(H.R. 5820), as Introduced ..................................................................................................... 30

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 Toxic Chemicals Safety

Act of 2010 (H.R. 5820), as Introduced .................................................................................. 39

Table 6. Other Selected Provisions of TSCA (15 U.S.C. 2601 et seq.), the Safe Chemicals

Act (S. 3209), as Introduced, and the Toxic Chemicals Safety Act of 2010 (H.R. 5820),

as Introduced ......................................................................................................................... 45

Contacts

Author Contact Information ...................................................................................................... 66

Congressional Research Service

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 On April 15, 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 was subjected to stakeholder comments and critiques in a

series of meetings during the spring. The proposal was revised and introduced July 22, 2010, as

H.R. 5820.

This report compares key provisions of S. 3209, as introduced, H.R. 5820, as introduced, 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 H.R. 5820, 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 substantial 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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Proposed Amendments to the Toxic Substances Control Act

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 H.R. 5820. 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. Both proposals also broaden the scope of environmental risks that

EPA may manage to include risks 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 H.R. 5820 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 that have entered into force for the United States. H.R. 5820 directs

EPA to ban activities only for specified 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 provides

that TSCA would not preempt laws relating to a chemical substance, mixture, or article unless

they were less stringent than federal law. H.R. 5820 provides that the act does not affect the right

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Proposed Amendments to the Toxic Substances Control Act

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 bills. 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 discussed here) and in several noteworthy

ways that are summarized in Tables 1 through 6. One significant difference is the length of time

each proposal 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. H.R. 5820 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. H.R. 5820 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

“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

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Proposed Amendments to the Toxic Substances Control Act

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. H.R. 5820

directs EPA to expedite action for 19 specified chemicals. 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 H.R. 5820 addresses “persistent, bioaccumulative, and toxic” chemicals (PBTs)

directly. The bill directs EPA to promulgate a rule establishing criteria for identifying PBTs and

requires listing of all PBTs within 18 months of enactment and every three years thereafter. EPA

is required to impose conditions on the manufacture, processing, distribution, use, and disposal of

PBTs to achieve the “greatest practicable reductions in exposure.” EPA then is required to

conduct the safety evaluation for all PBTs and to impose further risk management controls as

needed.

These and other similarities and differences are summarized in Tables 1 through 6.

Congressional Research Service

4

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 Toxic Chemicals Safety Act of 2010 (H.R. 5820), as Introduced

Provision

15 U.S.C. 2601 et seq.

S. 3209

H.R. 5820

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 alphabetical order

in section 3 (15 U.S.C. 2602.)

S. 3209 section 4 amends definitions in

TSCA section 3.

Section 3 of H.R. 5820 amends definitions

in TSCA section 3.

Chemical substance

“[A]ny organic or inorganic substance of a

particular molecular identity, including (i) any combination of such substances

occurring in whole or in part as a result of

a chemical reaction or occurring in nature

and (ii) any element or uncombined

radical.” The term does not include any

mixture, pesticide, tobacco, nuclear

material, firearms, shells or cartridges for

firearms, food, food additive, drug,

cosmetic, or devices regulated by other

specified federal laws. [TSCA 3(2)]

Amended TSCA 3(2) is the same as 15

U.S.C. 2602(2), but also includes in the

definition “any chemical substance

contained in or formed into an article.” In

addition, adds a new subparagraph to the

definition authorizing EPA to determine

that “a variant of a chemical substance is a

new chemical substance,” notwithstanding

molecular identity.

Amended TSCA 3(2) is the same as 15

U.S.C. 2602(2), but excludes alcoholic

beverages and does not exclude pesticides,

firearms, shells or cartridges for firearms,

foods, food additives, drugs, cosmetics, or

devices regulated under other federal

laws. Does not include articles. New

clause includes in the definition “any form

of a substance determined by the

Administrator to be a chemical substance

under subsection (b)(1)” which refers to a

new TSCA 3(b)(1).

Distribute in commerce /

Distribution in commerce

“[T]o sell, or the sale of the substance,

mixture, or article in commerce; to

introduce or deliver for introduction into

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.” [TSCA 3(4)]

Amends the TSCA 3(4) definition to

include “to export or offer for export the

substance, mixture, or article.”

Amended TSCA 3(4) is the same as S.

3209, but excepts export of a substance

“for demonstrated use solely as a

pesticide, … food, food additive, drug,

cosmetic, or device ...”

Environment

“[I]ncludes water, air, and land and the

interrelationship which exists among and

between water, air, and land and all living

things.” [TSCA 3(5)]

Amends the TSCA 3(5) definition to

include “ambient” and “indoor air.”

Amended TSCA 3(5) is the same as S.

3209.

CRS-5

Provision

15 U.S.C. 2601 et seq.

S. 3209

Health and safety study

“[S]tudy of any effect of a chemical

substance or mixture on health or the

environment or on both, including

underlying data and epidemiological

studies, studies of occupational exposure

to a chemical substance or mixture,

toxicological, clinical, and ecological

studies of a chemical substance or

mixture, and any test performed pursuant

to this chapter” [which corresponds to

TSCA]. [TSCA 3(6)]

Amends the TSCA 3(6) definition to

specifically include any test that relates to

a chemical substance or mixture or to a

specific chemical identity.

Same as S. 3209.

Manufacture

To import into the United States,

produce, or manufacture. [TSCA 3(7)]

Same as TSCA 3(7).

Amended TSCA 3(7) is the same as 15

U.S.C. 2602(7) “except for demonstrated

use solely as a pesticide, … food, food

additive, drug, cosmetic, or device …”

Mixture

“[A]ny combination of two or more

chemical substances if the combination

does not occur in nature and is not, in

whole or in part, the result of a chemical

reaction; except that such term does

include any combination which occurs, in

whole or in part, as a result of a chemical

reaction if none of the chemical substances

comprising the combination is 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.” [TSCA 3(8)]

Same as TSCA 3(8) [15 U.S.C. 2602(8)]

but amends the definition to include any

mixture contained in or formed into an

article.

H.R. 5820, section 10(a) amends TSCA

3(8) [15 U.S.C. 2602(8)] to authorize the

Administrator to determine different

mixtures comprised of the same chemical

substances to be the same mixture if the

substance characteristics of the mixtures

are identical.

New chemical substance

“[A]ny chemical substance which is not

included in the chemical substance list

compiled and published under section

2607(b) of this title, [corresponding to

TSCA section 6(b)].” [TSCA 3(9)]

Revises the definition of TSCA 3(9),

eliminating reference to listing under 15

U.S.C. 2607(b) and instead referring to any

chemical substance that does not have a

submitted declaration under amended

TSCA section 8(a).

Amended TSCA 3(9) is the same as S.

3209, “except that, with respect to the

first year after the date of enactment …

such term shall not include a chemical

substance distributed in commerce as of

such date of enactment.”

CRS-6

H.R. 5820

Provision

15 U.S.C. 2601 et seq.

S. 3209

H.R. 5820

Process

Preparation of a chemical, after its

manufacture, for distribution in

commerce. [TSCA 3(10)]

Same as TSCA 3(10).

Amended TSCA 3(10) is the same as 15

U.S.C. 2602(10) but excepts preparation

for use as a pesticide, food, food additive,

drug, cosmetic, or device. Also states that

relabeling, redistributing, or repackaging an

article does not constitute processing.

Standards for the development of

test data

A “prescription of (A) the - (i) health and

environmental effects, and (ii) information

relating to toxicity, persistence, and other

characteristics which affect health and the

environment, for which test data for a

chemical substance or mixture are to be

developed and any analysis that is to be

performed on such data, and (B) to the

extent necessary to assure that data

respecting such effects and characteristics

are reliable and adequate (i) the manner in

which such data are to be developed,

(ii) the specification of any test protocol

or methodology to be employed in the

development of such data, and (iii) such

other requirements as are necessary to

provide such assurance.” [TSCA 3(12)]

Eliminates this definition.

Same as S. 3209.

CRS-7

Provision

15 U.S.C. 2601 et seq.

S. 3209

H.R. 5820

New definitions

Adverse effect

No comparable definition.

“A biochemical change, anatomic change,

functional impairment, or pathological

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.” [Amended TSCA 3(14)]

Amended TSCA 3(14) is similar to S.

3209, except that the effect is one that

“has the potential to impair” rather than

one that “affects or alters” the

performance of an anatomic structure of a

vital system of an organism or progeny of

an organism. The definition does not

specify that it includes a “pathological

lesion.” Finally, H.R. 5820 authorizes the

Administrator to revise this definition, by

rule, to reflect the state of the science and

provide for equal or greater protection of

health and the environment.

Aggregate exposure

No comparable definition.

Total exposure to a chemical substance or

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. [Amended

TSCA 3(15)]

Amended TSCA 3(15) is similar to S.

3209, but omits mention of exposure from

mixtures and explicitly includes exposure

from contamination of food, air, water,

soil, house dust, and any other

environmental media from current or

prior uses or activity.

Bioaccumulative

No comparable definition.

As defined in the policy statement entitled

“Category for Persistent, Bioaccumulative,

and Toxic New Chemical Substances” (64

Federal Register 60194, Nov. 4, 1999). EPA

is authorized to revise this definition.

[Amended TSCA 3(16)]

Can significantly accumulate in biota, as

indicated through monitoring data, or is

highly likely to accumulate in biota. EPA is

authorized by rule to revise the definition

to reflect the state of the science and to

provide “equal or greater protection of

health and the environment.” [Amended

TSCA 3(16)]

CRS-8

Provision

15 U.S.C. 2601 et seq.

S. 3209

H.R. 5820

Chemical identity

No comparable definition.

Each common and trade name, the most

current internationally standardized name,

the Chemical Abstracts Service

registration number, and the molecular

structure of a chemical substance, and for

a mixture, the chemical identities and

proportions of the components.

[Amended TSCA 3(17)]

Amended TSCA 3(17) is similar to S.

3209, but refers to the 9th Collective

Index of the internationally standardized

name (rather than the most current index)

and the molecular identity, as well as the

molecular structure, and does not

specifically refer to chemical identities in a

mixture.

Cumulative exposure

No comparable definition.

The sum of aggregate exposure to each

chemical substance that is known or

suspected to contribute “appreciably to

the risk of an adverse effect,” and

mixtures containing those chemical

substances. [Amended TSCA 3(18)]

Amended TSCA 3(18) is similar to S.

3209, but exposure is cumulative across

chemical substances and mixtures that are

known or, “where supported by scientific

consensus, suspected to contribute

appreciably to the risk of the same

adverse effect.”

End consumer

No comparable definition.

An “individual or other entity that

purchases and uses or consumes a

chemical substance, mixture, or article.”

[Amended TSCA 3(19)]

No comparable definition.

Federal agency

No comparable definition.

“[A]ny department, agency, or other

independent agency or establishment of

the Federal Government including any

Government corporation, and the

Government Printing Office.” [Amended

TSCA 3(20)]

Amended TSCA 3(19) is similar to S.

3209, but also refers to any “other

instrumentality” of the Federal

Government.

Importer

No comparable definition.

No comparable definition.

“[A]ny person who imports a chemical

substance or mixture, or any article

containing a chemical substance or

mixture, for distribution in commerce.”

[Amended TSCA 3(20)]

Persistent

No comparable definition.

As defined in the policy statement entitled

“Category for Persistent, Bioaccumulative,

and Toxic New Chemical Substances” (64

Federal Register 60194, Nov. 4, 1999).

Authorizes EPA to revise this definition by

rule. [Amended TSCA 3(21)]

Significantly persists in one or more

environmental media, as indicated by

monitoring data or other evidence.

Authorizes EPA to revise the definition by

rule to reflect the state of the science and

provide for equal or greater protection of

health and the environment. [Amended

TSCA 3(21)]

CRS-9

Provision

15 U.S.C. 2601 et seq.

S. 3209

H.R. 5820

Person

No comparable definition.

An “individual, trust, firm, joint stock

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.” [Amended TSCA

3(22)]

No comparable definition.

Reasonable certainty of no harm

No comparable definition.

“[I]n establishing whether a chemical

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 …”[Amended TSCA 3(23)]

No comparable definition.

Special substance characteristics

No comparable definition.

Defines “special substance characteristics”

to mean “such physical, chemical, or

biological characteristics, other than

molecular identity, that the Administrator

determines, by order or rule, may

significantly affect the risks posed by

substances exhibiting those

characteristics.” Allows consideration of

size, shape, reactivity, and any other

properties that may significantly affect

risks posed. [Amended TSCA 3(24)]

Defines “substance characteristic” as “the

physical and chemical characteristics that

may vary for such substance, and whose

variation may bear on the toxicological

properties or the exposure potential of

the chemical substance.” Includes

structure and composition, size, shape,

surface structure, reactivity, and “other

characteristics that may bear on

toxicological properties.” [Amended

TSCA 3(22)]

CRS-10

Provision

15 U.S.C. 2601 et seq.

S. 3209

H.R. 5820

Toxic

No comparable definition.

Satisfies one of the following conditions:

has a toxicological property meeting

criteria for Category 1 or 2 for any

toxicity endpoint established by the

Globally Harmonized System for the

Classification and Labeling of Hazardous

Substances; “causes an adverse effect that

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.” [Amended TSCA

3(25)]

Similar to S. 3209, but includes a

metabolite or degradation product of a

substance or mixture and omits the first

condition—that is, it does not define the

term by reference to the categories of the

Globally Harmonized System for the

Classification and Labeling of Hazardous

Substances. Also, the word “exposed” is

omitted from the third defining condition.

[Amended TSCA 3(23)]

Toxicological property

No comparable definition.

“[A]ctual or potential toxicity or other

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.” [Amended TSCA

3(26)]

Amended TSCA 3(24) is similar to S. 3209

but includes established precursors to

such toxicity or adverse effects and

explicitly includes effects on genetics,

including mutagenicity, genotoxicity, and

epigenetics.

Use

No comparable definition.

No comparable definition.

Any utilization of a chemical substance or

mixture that is not otherwise covered by

the terms manufacture or process, such as

“any composition of the chemical

substance with other chemical substances”

or any group of utilizations determined by

EPA to be a single use under new TSCA

3(b)(2). [Amended TSCA 3(25)]

CRS-11

Provision

15 U.S.C. 2601 et seq.

S. 3209

H.R. 5820

Vulnerable population

No comparable definition.

A “population that is subject to a

disproportionate exposure to, or potential

for a disproportionate adverse effect from

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.” [Amended TSCA 3(27)]

Amended TSCA 3(26) is similar to S.

3209, except that workers are included in

the definition without regard to their

work with chemicals and effects on

pregnant women include effects on fetal

development. Other appropriate

populations may be identified based on

consideration of socioeconomic status,

racial or ethnic background, cultural

practices, or similar factors identified by

the Administrator.

EPA authority to define

No comparable provision.

No comparable provision.

Adds a new subsection (b) to TSCA

section 3 (15 U.S.C. 2602). New TSCA

3(b)(1) authorizes the Administrator to

determine different forms of a chemical

substance with a particular molecular

identity to be different chemical

substances for purposes of the act based

on variations in the substance

characteristics. Such distinct substances

are to be considered new chemical

substances. New TSCA 3(b)(2) authorizes

the Administrator to determine different

uses of a chemical substance or mixture to

be the same use for purposes of the act,

based on industry classification systems or

factors determined by the Administrator

to indicate similarity in use and exposure.

CRS-12

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 Toxic Chemicals Safety Act of 2010 (H.R. 5820), as Introduced

Provision

15 U.S.C. 2601 et seq.

S. 3209

H.R. 5820

Testing authorities and requirements

TSCA 4(a) [15 U.S.C. 2603(a)] directs the

EPA Administrator to promulgate a rule

requiring that testing be conducted on a

substance or mixture to develop health

and environmental effects data if: (1) the

manufacture, processing, distribution, use,

or disposal of the chemical “may present

an unreasonable risk of injury to health or

the environment,” or (2) the chemical is

produced in very large volume and there is

a potential for a substantial quantity to be

released into the environment or for

substantial or significant human exposure.

In either case, EPA also must find that (a)

existing data are insufficient to resolve the

question of safety, and (b) testing is

necessary to develop the data.

S. 3209, section 5, amends TSCA 4.

Amended TSCA 4(a) directs the EPA

Administrator within one year of

enactment of S. 3209 to promulgate a rule

establishing a minimum data set and

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.

H.R. 5820, section 4, amends TSCA 4.

Similar to S. 3209, but amended TSCA 4(a)

requires manufacturers and processors to

submit a minimum data set for mixtures as

well as chemical substances. In addition,

the Administrator is required to update

the rule establishing the minimum data set

at least once every 5 years. Amended

TSCA 4(a)(3) excepts several categories of

chemical substances (see Exemptions

below). Amended TSCA 4(b) explicitly

authorizes EPA to issue a rule or order,

after notice and opportunity for comment,

for collection of data in addition to the

minimum data set, but the bill does not

authorize chemical sample collection

(except for enforcement purposes under

amended TSCA 11).

TSCA 4(b) [15 U.S.C. 2603(b)] requires

EPA in any test rule to identify the

chemical substance or mixture for which

testing is required, specify standards for

the development of test data, and specify

the period during which test results must

be submitted.

Amended TSCA 4(c) is similar to 15

U.S.C. 2603(b), but is applicable to EPA

orders as well as rules.

Test rule requirements

CRS-13

Amended TSCA 4(b) authorizes EPA to

require, by rule or by order, testing and

submission of test results by a specified

date “as necessary for making any

determination or carrying out any

provision” of TSCA. Authorizes EPA to

require submission of a sample of any

chemical for the purpose of conducting

tests and making a determination or

carrying out any provision of the act.

Like S. 3209 in applying to orders as well

as rules, but EPA is authorized rather than

required to specify test protocols and

methodology, and the bill does not refer

to “standards for the development of test

data.”

Provision

15 U.S.C. 2601 et seq.

S. 3209

H.R. 5820

Deadlines for data submission

No comparable provision.

Amended TSCA 4(a) requires submission

to EPA of the minimum data set within 18

months of the date that EPA places a

chemical on the chemical substance

priority list, or at the time notice is

provided to EPA [under revised TSCA

section 5(a)] that a new chemical will be

manufactured. Amended TSCA 6(b)(2)

requires submission of the minimum data

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.

Amended TSCA 4(a) requires minimum

data set submission within 18 months of

the date that EPA places a chemical or

mixture on the chemical substance priority

list; at the time notice is provided to EPA

that a new chemical will be manufactured;

or, for existing chemicals (but not

mixtures) not placed on the priority list,

within 3 years of the date of enactment of

H.R. 5820 for high production volume

chemicals, within 4 years for chemicals

produced in moderate volumes, and within

5 years for chemicals produced in low

volumes, as determined by the

Administrator.

Persons required to submit data

TSCA 4(b) [15 U.S.C. 2603(b)] requires

manufacturers and processors to conduct

tests in response to a rule issued by EPA,

but allows EPA to permit such persons to

designate one person or a qualified third

party to conduct such tests and submit

data on their behalf.

Amended TSCA 4(c) directs EPA to

specify in any rule or order persons

required to conduct tests and submit data,

but allows designation of a single data

provider, as is allowed under current law.

In the event that a single data provider is

designated, all parties remain individually

liable for testing requirements

Amended TSCA 4(b)(5) is the same as S.

3209.

Failure to submit data

No comparable provision.

Amended TSCA 4(b)(3) authorizes EPA

to, by order, prohibit manufacture,

processing, or distribution in commerce

for a chemical if a manufacturer or

processor fails to submit required data.

Amended TSCA 4(a)(4) authorizes

penalties for noncompliance as provided in

amended TSCA section 16, or imposition

of conditions, by order, including

prohibitions on the manufacture,

processing, or distribution in commerce of

the chemical substance, mixture or article

containing the substance. Failure to submit

required information is grounds for

determining that the chemical substance

or mixture does not meet the safety

standard under amended TSCA

6(b)(3)(D).

CRS-14

Provision

15 U.S.C. 2601 et seq.

S. 3209

H.R. 5820

Data exemption

TSCA 4(c) [15 U.S.C. 2603(c)] allows

manufacturers and processors to request

an exemption, and directs EPA to grant an

exemption if data would be 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.

Amended TSCA 4(d) would have the same

effect as TSCA, except exemptions could

apply to orders as well as rules, and the

bill does not provide that the

Administrator’s order to reimburse is a

final agency action for the purpose of

judicial review.

Similar to 15 U.S.C. 2603(c), but amended

TSCA 4(c) applies to orders as well as

rules. In addition, amended TSCA 4(a)(3)

exempts from data requirements: (1)

chemicals for which EPA first is required

to make a safety determination under

amended TSCA 6(a)(1)(A); (2) chemicals

determined by the Administrator to be

persistent, bioaccumulative, and toxic and

to which people are exposed; (3)

chemicals EPA exempts because, due to

their intrinsic properties, they do not pose

any risk of injury to health or the

environment; and (4) chemicals that EPA

determines are safer substitutes for

chemicals already in commerce.

Cessation of manufacture or

processing

No comparable provision.

Amended TSCA 4(b)(4) explicitly exempts

from requirements any manufacturer or

processor who has submitted a

declaration of cessation of manufacture or

processing of a chemical substance.

Amended TSCA 4(b)(5) is the same as S.

3209, but only if the declaration is of

permanent cessation.

Contents of minimum data set

No comparable provision.

Amended TSCA 4(a) directs EPA to

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.

Similar to S. 3209, but amended TSCA

4(b)(3) also requires that the set include

information on chemical identity; biological

and environmental fate and transport;

toxicological properties; volume

manufactured, processed, or imported;

intended uses; and “exposures from all

stages of the chemical substance or

mixture’s lifecycle that are known or

reasonably foreseeable to the party

submitting the data set.”

CRS-15

Provision

15 U.S.C. 2601 et seq.

S. 3209

H.R. 5820

Prescribed data needs

TSCA 4(b) [15 U.S.C. 2603(b)] authorizes

EPA to prescribe data development

standards for effects which may present an

unreasonable risk of injury to health or the

environment and for characteristics of

chemical substances and mixtures which

may present such a risk, as well as for

methodologies including epidemiological

studies, serial or hierarchical tests, in vitro

tests, and whole animal tests.

Amended TSCA 4(c) authorizes EPA to

prescribe data development standards for

effects which may be considered in a safety

determination, assessing exposure,

including presence in human tissues and

fluids, and characteristics of chemicals that

may present an adverse effect. Also

authorizes EPA to prescribe biomonitoring

studies, in addition to methodologies

already permitted under 15 U.S.C.

2603(b).

Similar to 15 U.S.C. 2603(b) but amended

TSCA 4(b)(4)(A) does not refer to test

standards, and it provides broad authority

to prescribe testing for “any toxicological

property and any other adverse effect

which may be considered in a safety

standard determination under [amended

TSCA] section 6(b).” Specifies exposure

information for which testing may be

prescribed, and explicitly authorizes

testing for bioaccumulation, biomonitoring

studies, and in amended TSCA 4(b)(4)(B),

industrial hygiene surveys.

Petition for standards for

development of test data

TSCA 4(g) [15 U.S.C. 2603(g)] authorizes

manufacturers to petition EPA to

prescribe standards for the development

of test data for a new chemical.

Eliminates this provision.

Same as S. 3209.

Alternatives to animal testing

No comparable provision.3

Requires that animal tests are consistent

with provisions of amended TSCA section

31, promoting alternatives to animal

testing.

Amended TSCA 4(b)(4)(B) requires that

whole animal studies be consistent with

amended TSCA section 34.

Biomonitoring by the Centers for

Disease Control and Prevention

No comparable provision.

No comparable provision.

New TSCA 4(b)(6) requires that any

biomonitoring study of the public

regarding a chemical substance or any

metabolite or degradation byproduct be

conducted by the Director of the Centers

for Disease Control and Prevention in

collaboration with the Administrator at

the expense of the manufacturers and

processors of the substance.

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-16

Provision

15 U.S.C. 2601 et seq.

S. 3209

H.R. 5820

Review and revision of data needs

TSCA 4(b) [15 U.S.C. 2603(b)]requires

annual review and revision, if necessary, of

standards for the development of data.

Changes the interval between required

reviews and revisions, if necessary, from

one to 3 years.

Similar to 15 U.S.C. 2603(b), but amended

TSCA 4(b)(4)(C) refers to “methodology”

rather than “standards for the

development of test data.”

Rulemaking process

TSCA 4(b) [15 U.S.C. 2603(b)] directs

EPA to issue test rules pursuant to 5

U.S.C. 553 (Administrative Procedure Act,

procedures for informal notice and

comment rulemaking). In addition, persons

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).

Amended TSCA 4(c) omits TSCA

requirements for rulemaking that go

beyond the requirements of 5 U.S.C. 553.

Amended TSCA 4(b) authorizes EPA to

issue orders in lieu of rules.

Amended TSCA 4(b)(8) is the same as S.

3209.

Interagency testing committee

TSCA 4(e) [15 U.S.C. 2603(e)] establishes

the Interagency Testing Committee (ITC)

to advise the Administrator regarding

chemicals that should receive priority

consideration for promulgation of a test

rule [under subsection (a)].

Amended TSCA 6(a)(3) establishes the

Interagency Prioritization and Testing

Committee, which is similar to the ITC in

composition.

Amended TSCA 4(e) is similar to current

law, but amended TSCA 4(e) directs the

ITC also to make recommendations for

listing chemical substances and mixtures

under amended TSCA 6(a)(1). The bill

raises the number of committee members

from 8 to 10, including a representative of

the Food and Drug Administration and

one from the Consumer Product Safety

Commission.

CRS-17

Provision

15 U.S.C. 2601 et seq.

S. 3209

H.R. 5820

Committee recommendations for

testing

TSCA 4(e) [15 U.S.C. 2603(e)] directs the

interagency testing committee to establish

a prioritized list of chemicals for the

Administrator to consider testing and to

designate up to 50 chemicals on the list as

the highest priority. In selecting chemicals,

the committee is authorized to consider

all relevant factors, including “the extent

to which the substance or mixture is

closely related to a chemical substance or

mixture which is known to present an

unreasonable risk of injury to health or the

environment.” Priority attention is to be

given to chemicals “known to cause or

contribute to or which are suspected of

causing or contributing to cancer, gene

mutations, or birth defects.”

Amended TSCA 6(a)(3) changes the

directive to the committee with respect to

the basis for recommendations for

issuance of test rules or orders. The

committee is directed to make

recommendations for issuance of test

rules or orders based on “all factors

relevant to risk” including presence in

biological and environmental media, use,

production volume, toxicity, persistence,

or bioaccumulation. The committee also is

to make recommendations for placement

of chemical substances on the priority list

based on criteria identified pursuant to

amended TSCA 6(a)(1). Recommendations

are to be in the form of one or more lists

of chemical substances and mixtures and

are to be updated annually, if necessary.

The Administrator is directed to provide

reasonable opportunity to any interested

person to file written comments on the

recommendations.

Amended TSCA 4(e) is similar to 15

U.S.C. 2603(e), but authorizes

consideration of chemicals posing a

“substantial risk” rather than those posing

“an unreasonable risk” of injury to health

or the environment, and directs the

committee to provide priority attention to

chemicals suspected of causing or

contributing to “adverse effects on health

or the environment” rather than those

that might cause or contribute to cancer,

gene mutations, or birth defects. The

requirement that the list of chemicals

designated for testing should remain less

than 50 is eliminated. The chemicals listed

are to be those that should be subject to

test rules or orders, in the view of the

committee.

Public notice of receipt of data

TSCA 4(d) [15 U.S.C. 2603(d)] requires

that EPA provide public notice of receipt

of data and make data available for

examination by any person (subject to

section 14).

Amended TSCA 4(e) is similar to 15

U.S.C. 2603(d) in requiring public notice of

the receipt of data, but applies also to data

submitted in accord with an EPA order,

and requires that data be made available

on the internet.

Similar to 15 U.S.C. 2603(d), but amended

TSCA 4(d) applies also to data submitted

in accord with an EPA order and requires

that notices be added to the public

database established in amended TSCA

8(d).

Judicial review prohibited for

committee recommendations

No comparable provision.

Amended TSCA 6(a)(4) protects from

judicial review recommendations by the

Interagency Prioritization and Testing

Committee.

No comparable provision.

CRS-18

Provision

15 U.S.C. 2601 et seq.

S. 3209

H.R. 5820

Required agency actions

TSCA 4(f) [15 U.S.C. 2603(f)] requires the

EPA Administrator to respond within 180

days to new information indicating “that

there may be a reasonable basis to

conclude that a chemical substance or

mixture presents or will present a

significant risk of serious or widespread

harm to human beings from cancer, gene

mutations, or birth defects.” Requires EPA

to “initiate appropriate action under

section 5, 6, or 7 to prevent or reduce to

a sufficient extent such risk or publish in

the Federal Register a finding that such risk

is not unreasonable.” A finding that a risk

is not unreasonable is a final agency action

for purposes of judicial review.

Eliminates this provision, but TSCA 4(a)

as amended requires EPA, within 180 days

of receipt of a data submission, to

determine, by order, whether the

manufacturers and processors of the

substance have established that the

substance meets the safety standard. If

data are not submitted, S. 3209 authorizes

EPA to prohibit, by order, manufacture,

processing, or distribution in commerce of

the substance, mixture, or article

containing the substance.

Eliminates this provision, but amended

TSCA 6(b)(3)(D) requires that the

Administrator complete and publish the

safety standard determination within 30

months of the date on which the chemical

substance or mixture is placed on the

priority list, or, within 18 months of the

date of enactment of H.R. 5820 for

chemicals listed in amended TSCA

6(a)(1)(A). However, if additional

information is needed, the determination

must be completed and published within

12 months after submission of all required

information.

Requests from other federal agencies

No comparable provision.

Amended TSCA 4(f) authorizes any federal

agency to request that EPA seek

information unavailable to that 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.

Amended TSCA 4(f) is the same as S.

3209.

Certification of data submitted

No comparable provision.

Amended TSCA 4(g) requires that each

submission of information under a rule or

order be accompanied by a 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.

Amended TSCA 4(a)(2)and 8(i) require

each submission of a minimum data set to

be accompanied by a 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-19

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 Toxic Chemicals Safety Act of 2010 (H.R. 5820), as Introduced

Provision

15 U.S.C. 2601 et seq.

S. 3209

H.R. 5820

Notices concerning new chemicals or

uses

TSCA 5(a)(1) [15 U.S.C. 2604(a)(1)]

prohibits manufacture of a new chemical

and prohibits manufacture or processing of

any chemical for a use which is a significant

new use unless notice is submitted to EPA

90 days prior to such manufacture or

processing.

Amended TSCA 5(a)(1)-(3) is similar to

current law, but it also requires notice

prior to processing of a new chemical

substance or mixture. Requires notice

prior to manufacture or processing of an

existing chemical that has met the safety

standard for a use, at a production

volume, or in a manner other than

specified in the safety determination.

Amended TSCA 5(a) is similar to S. 3209

in that it prohibits manufacturing and

processing of new chemical substances and

mixtures unless notice is provided to EPA.

H.R. 5820 also requires notice prior to

manufacture or processing of a new

mixture or an existing chemical or mixture

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.

New use determination

CRS-20

TSCA 5(a)(2) [15 U.S.C. 2604(a)(2)]directs

EPA to designate a significant new use of

an existing chemical by promulgating a rule

after considering “all relevant factors,

including—(A) the projected volume of

manufacturing and processing of a

chemical substance, (B) the extent to

which a use changes the type or form of

exposure of human beings or the

environment to a chemical substance, (C)

the extent to which a use increases the

magnitude and duration of exposure of

human beings or the environment to a

chemical substance, and (D) the

reasonably anticipated manner and

methods of manufacturing, processing,

distribution in commerce, and disposal of a

chemical substance.”

Amended TSCA 5(a)(2) and (3) designate

use of an existing chemical as new if at the

time of enactment of S. 3209—such use

was not ongoing, use would be at a

significantly increased volume, or the

person who would be manufacturing or

processing the chemical had not previously

done so.

Amended TSCA 5(a)(2) designates a use as

new if—1) the substance or mixture

already received a safety standard

determination which did not include the

use; or (2) the proposed use will result in

manufacturing or processing of the

chemical substance or mixture at a

significantly increased volume from that

previously considered in the safety

determination made under amended

TSCA 6(b).

Provision

15 U.S.C. 2601 et seq.

S. 3209

H.R. 5820

Special substance characteristics

No comparable provision.

Amended TSCA 5(a)(6) directs

Administrator to determine by 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.

No comparable provision.

Notice content

TSCA 5(d) [15 U.S.C. 2604(d)] requires

that notices contain the information

required by TSCA 8(a)(2)(A)-(D), (F), and

(G). [See “Reporting and record keeping”

below.]

Amended TSCA 5(c) requires a notice to

include the declaration made under

amended TSCA 8(a)(2), the minimum data

set, and a statement that the chemical will

meet the safety standard.

Amended TSCA 5(c) is similar to S. 3209,

but the statement required is that the

chemical is “reasonably anticipated to

meet the safety standard under section

6(b),” and H.R. 5820 requires a

justification for such statement.

Certification

No comparable provision.

Amended TSCA 5(e) requires that each

submission of information under a rule or

order be accompanied by a 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.

Amended TSCA 8(i) requires each

submission of information that is required

pursuant to “this title” to be accompanied

by a 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-21

Provision

15 U.S.C. 2601 et seq.

S. 3209

H.R. 5820

Submission of test data with notice

TSCA 5(b) [15 U.S.C. 2604(b)] requires

persons who propose to manufacture a

new chemical or to manufacture or

process a chemical for a significant new

use to submit with such notice any test

data that are required by rule under TSCA

4(a). If no test data are required under

TSCA 4(a), but the chemical has been

listed under TSCA 5(b)(4), indicating that

the Administrator has determined that it

“presents or may present an unreasonable

risk,” manufacturers and processors must

submit data showing that manufacture,

processing, distribution in commerce, use,

and disposal (in the case of a new chemical

or mixture), or the new use (in the case of

a significant new use), “will not present an

unreasonable risk of injury to health or the

environment.”

Amended TSCA 5(b) requires submission

to EPA of any data required for a chemical

under a test rule or order, as well as the

declaration and minimum data set at the

time notice is provided to EPA.

Amended TSCA 5(b) is similar to S. 3209

in requiring data submission for chemicals

subject to test rules or orders at the time

notice is provided, but requires submission

for new mixtures as well as new chemical

substances. H.R. 5820 also requires

submission of the declaration and

minimum data set when notice is provided

regarding production of a chemical

substance or mixture.

Public availability of data

TSCA 5(b)(3) [15 U.S.C. 2604(b)(3)]

directs EPA to make such data publicly

available, subject to protections for

confidential business information in section

14.

Amended TSCA 5(b)(2) requires EPA to

make data available on the internet,

subject to amended TSCA 14.

Requires EPA to publish each new

chemical and new use pre-manufacture

notice. Also requires that EPA publish

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.

EPA’s response to notice

No comparable provision, but EPA has 90

days to decide whether the chemical or

chemical use may present an unreasonable

risk of injury to health or the environment.

Amended TSCA 5(a)(4) requires EPA to

determine within 180 days after receiving

notice and data whether it has been

established that the chemical substance or

mixture meets the safety standard under

amended TSCA section 6(b).

Requires EPA to determine within 90 days

after receiving notice and data whether

the use is a critical use or whether a safety

standard determination is required by

amended TSCA 5(a)(1)(B). Within 9

months of that determination, the

Administrator is required to “complete

any such required safety standard

determination.”

CRS-22

With respect to a new use of a chemical

for which the Administrator previously has

made the safety determination,

manufacturers must provide an update for

the minimum data set.

With respect to a new use of a chemical

which has not been evaluated for safety,

manufacturers must submit to EPA a new

or updated declaration under amended

TSCA 8(a) and comply with amended

TSCA 5(b).

Also requires that any chemical substance

subject to a Significant New Use Rule as of

the date of enactment of H.R. 5820 remain

subject to that rule until it receives a

safety standard determination and any

conditions are imposed.

Provision

15 U.S.C. 2601 et seq.

S. 3209

H.R. 5820

Extension of the notice period

TSCA 5(c) [15 U.S.C. 2604(c)] authorizes

EPA to extend the period between notice

and manufacture for additional periods of

up to a total of 90 days “for good cause.”

Eliminates this provision.

Same as S. 3209.

Publication of notice

TSCA 5(d) [15 U.S.C. 2604(d)(1)] requires

notice to be available for examination by

interested persons, subject to disclosure

restrictions at TSCA 14 [15 U.S.C. 2613].

[See “Disclosure of data” section below.]

Directs EPA to publish a notice identifying

the chemical, listing the intended uses, and

describing the nature of tests performed

and data that were developed pursuant to

a rule.

Amended TSCA 5(b)(3)-(4) is similar to

current law [TSCA 5(d)(1)], but specifies

that EPA must make notices available on

the internet and requires disclosure of the

availability of the minimum data set. In

addition, requires EPA to make available

on the internet a list of chemical

substances for which notice has been

received monthly. [Also, see “Disclosure

of data” section below.]

Amended TSCA 5(c)(3) is similar to

current TSCA 5(d), but H.R. 5820 specifies

that data must be placed in the public

database established pursuant to amended

TSCA 8(d). Eliminates specific content

requirements for published notices. [Also,

see “Disclosure of data” section below.]

“Manufacture” and “process”

TSCA 5(i) [15 U.S.C. 2604(i)] defines

“manufacture” and “process” as used in

TSCA section 5 to mean manufacturing

and processing for commercial purposes.

Amended TSCA 5(f) provides the same

definition as current law.

Same as current law [TSCA 5(i)].

CRS-23

Provision

15 U.S.C. 2601 et seq.

S. 3209

H.R. 5820

Safety determination for new chemical

or new use

No specific provision, but TSCA requires

an EPA finding that manufacture,

processing, distribution in commerce, use,

and disposal of a chemical “may present an

unreasonable risk of injury to health or the

environment,” when the agency issues a

test rule under TSCA 4(a). Similarly, EPA

must find that a chemical substance

“presents an unreasonable risk” before

EPA can issue a rule to ensure that risks

are adequately regulated.

Amended TSCA 5(a) prohibits

manufacture and processing of a chemical

for which notice is required unless the

Administrator finds either: (1) that the

manufacturers and processors have

established that the chemical meets the

safety standard under proposed TSCA

6(b), or (2) that the new chemical

substance or its metabolite or degradation

product is not, and is not expected to

be—manufactured in a volume of more

than one million pounds annually or

released into the environment in a volume

of more than 100,000 pounds annually; a

known, 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

naturally 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

naturally present at the level commonly

found in that medium.

Amended TSCA 5(a) imposes an additional

condition on any new chemical or use:

manufacture or processing is permitted

only if the Administrator finds—the use is

a critical use as determined pursuant to

amended TSCA 6(e), or the substance or

mixture meets the safety standard for all

intended uses under amended TSCA 6(b).

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-24

Provision

15 U.S.C. 2601 et seq.

Protection against unreasonable risks

TSCA 5(f) [15 U.S.C. 2604(f)] directs EPA

to control an unreasonable risk posed by a

new chemical or a significant new use of a

chemical in the interim between the

expiration of the notification period and

the effective date of a rule that is being

developed to control such risk. EPA is

directed to issue a proposed rule or an

order. If the Administrator issues a

proposed rule, it is effective on the date it

is issued.

This provision is eliminated. S. 3209

requires risk management prior to

production and distribution.

Same as S. 3209.

Regulation pending development of

information

TSCA 5(e) [15 U.S.C. 2604(e)] authorizes

the Administrator to issue a proposed

order to prohibit or limit manufacture,

processing, distribution in commerce, use,

or disposal of a new chemical or significant

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.

This provision is eliminated. Amended

TSCA 5(a) requires submission of data and

a safety determination prior to production

and distribution of a new chemical or of an

existing chemical for a new use.

Same as S. 3209.

CRS-25

S. 3209

H.R. 5820

Provision

15 U.S.C. 2601 et seq.

S. 3209

H.R. 5820

Statement of reasons for not taking

action

If EPA does not take action with respect

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.

This provision is eliminated.

This provision is eliminated.

General authority

TSCA 5(h)(4) [15 U.S.C. 2604(h)(4)]

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).

Eliminates this provision.

Same as S. 3209, but amended TSCA 39(d)

directs EPA to review existing exemptions

granted under TSCA 5(h)(4) within a year

of enactment of H.R. 5820 to determine

whether chemicals exempted under

current law meet the “intrinsic properties”

requirements to qualify for an exemption

under amended TSCA 39(d).

Intermediate production chemicals

TSCA 5(h)(5) [15 U.S.C. 2604(h)(5)]

authorizes exemptions upon application

for production-related (temporary, socalled “intermediate”) chemicals when no

human or environmental exposure will

occur.

Amended TSCA 5(d)(4) is the same as

current law.

Same as current law.

Test marketing

TSCA 5(h)(1) [15 U.S.C. 2604(h)(1)]

authorizes EPA to exempt any person

from notification or data requirements so

as to permit manufacture or processing

for test marketing purposes, if the person

applies for such exemption and

demonstrates the chemical will not

present an “unreasonable risk.”

Amended TSCA 5(d)(1) is similar to

current law but a person must show that

it “will not endanger the health [sic] or the

environment.”

Amended TSCA 5(d)(1) is similar to

current law but specifies that exemptions

are made “by order,” authorizes

exemptions for mixtures as well as

chemical substances, and requires that the

applicant show the chemical or mixture

will not present “a substantial” risk.

Exemptions from notice requirements

CRS-26

“Test marketing” is defined in amended

TSCA 5(f) to exclude provision of a

chemical or article containing a chemical

to an end consumer.

Provision

15 U.S.C. 2601 et seq.

S. 3209

H.R. 5820

Equivalent chemicals and duplicative

data

TSCA 5(h)(2) [15 U.S.C. 2604(h)(2)]

allows manufacturers and processors of

new chemicals or chemicals with significant

new uses that are on the priority list but

are not subject to a section 2603 data

submission requirement to request from

EPA an exemption from the requirement

in 2604(b)(2) that they submit data

showing that manufacture, processing,

distribution in commerce, use, and

disposal of the chemical substance, or the

significant new use, will not present an

unreasonable risk. Directs EPA to grant

such exemption if the chemical is

equivalent to a substances for which data

has been submitted and data would be

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.

Amended TSCA 5(d)(2) allows

manufacturers and processors of new

chemicals or chemicals with new uses to

request, and EPA to grant, full or partial

exemption from data submission

requirements if the chemical is equivalent

to a chemical substance for which data

have been submitted and submission

would be duplicative of data previously

submitted to EPA. Provides for

reimbursement by the exempted persons

to those who collected and submitted data

in the same manner as current law.

Amended TSCA 5(d)(2) concerns any new

use of a chemical substance or mixture

subject to a data collection rule or order

under section 4. H.R. 5820 directs the

Administrator upon application to exempt

the manufacturer or processor of such a

chemical or mixture from the amended

TSCA 5 requirement to submit data along

with the required new use notice, if the

chemical is equivalent to a substance for

which data have been submitted previously

and submission would be duplicative.

Provides for reimbursement by the

exempted persons to those who collected

and submitted data in the same manner as

current law.

Small quantities

TSCA 5(h)(3) [15 U.S.C. 2604(h)(3)]

exempts from notification and data

requirements manufacturing and

processing of small quantities for purposes

of scientific experimentation or chemical

research on, or analysis of, such

substances or another substance, including

product development.

Amended TSCA 5(d)(3) is the same as

current law.

Amended TSCA 5(d)(3) is similar to

current law, but it also applies to mixtures.

EPA response to exemption

requests

TSCA 5(h)(6) [15 U.S.C. 2604(h)(6)]

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.

Amended TSCA 5(d)(5) is the same as

current law.

Same as current law.

CRS-27

Provision

Safer chemical substances or

mixtures

CRS-28

15 U.S.C. 2601 et seq.

No comparable provision.

S. 3209

No comparable provision.

H.R. 5820

Amended TSCA 5(d)(1) exempts from

section 5 requirements any new chemical

substance or mixture approved pursuant

to amended TSCA 35 as a safer

alternative. Amended TSCA 5(d)(2)

authorizes the Administrator to exempt

any new chemical substance or new use of

a chemical substance or mixture from the

requirements of amended TSCA section 5

pursuant to section 39, based on intrinsic

properties which render the substance

harmless.

Provision

15 U.S.C. 2601 et seq.

S. 3209

H.R. 5820

Chemicals of concern list (priority list)

TSCA 5(b)(4) [15 U.S.C. 2604(b)(4)]

authorizes EPA to “by rule, compile and

keep current a list of chemical substances

with respect to which the Administrator

finds that the manufacture, processing,

distribution in commerce, use, or disposal,

or any combination of such activities,

presents or may present an unreasonable

risk of injury to health or the

environment.” In listing decisions the

Administrator is directed to consider “all

relevant factors, including—(I) the effects

of the chemical substance to health and

the magnitude of human exposure to such

substance; and (II) the effects of the

chemical substance on the environment

and the magnitude of environmental

exposure to such substance.” Any rule

listing a chemical must identify “uses that

the Administrator determines, by rule

under subsection (a)(2), would constitute

a significant new use of such substance.”

Amended TSCA 6(a) directs EPA by order

to develop and publish a priority list of not

less than 300 chemical substances “for

which safety standard determinations shall

first be made” within 18 months of S. 3209

enactment. 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.

Amended TSCA 6(a) establishes a list of

19 specified chemical substances for which

safety standards must first be made.

Twelve months after H.R. 5820 is enacted,

the Administrator must update the list to

consist of at least 300 chemical substances.

Listing is at the Administrator’s discretion,

“based on available scientific evidence and

consideration of their hazard, exposure, or

risk relative to other chemical substances,

aggregate or cumulative exposure,

evidence of exposure to humans including

presence in human or animal biological and

environmental media including in the

workplace, use, volume of manufacture,

toxicological properties, persistence,

bioaccumulation, or other properties

indicating risk.” Otherwise similar to S.

3209, but does not require the list to be

developed and published “by order” and

may include mixtures. H.R. 5820 also does

not explicitly require that EPA consider

listing recommendations provided by the

Interagency Prioritization and Testing

Committee.

Any rulemaking under this provision must

be promulgated pursuant to the

procedures specified in 5 U.S.C. 553 and

must provide opportunity for oral and

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-29

Chemicals must be selected based on:

available scientific evidence, relative risk,

presence in biological and environmental

media, use, production volume, toxicity,

persistence, bioaccumulation, “or other

properties indicating risk.” Requires

removal of a substance from the list only

after a safety standard determination has

been made for it. Requires EPA to add

chemical substances or mixtures

periodically to keep the number greater

than 300 at all times until all substances

and mixtures distributed in commerce

have had a safety standard determination.

EPA must give due consideration in listing

decisions to recommendations provided

by the Interagency Prioritization and

Testing Committee which is to base its

recommendations on the criteria listed

(above) in amended TSCA 6(a).

Amended TSCA 6(a)(4) protects from

judicial review EPA’s decisions about

whether to place particular chemicals on

the priority list, including any EPA

response to a petition to list a particular

chemical substance.

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 Toxic Chemicals Safety Act of 2010 (H.R. 5820), as Introduced

Provision

Regulation

15 U.S.C. 2601 et seq.

S. 3209

H.R. 5820

TSCA 6(a) [15 U.S.C. 2605(a)] directs EPA by

rule to apply one or more requirements “to

the extent necessary to protect adequately

against” an “unreasonable risk” “using the

least burdensome requirements,” if EPA finds

that “there is a reasonable basis to conclude

that the manufacture, processing, distribution

in commerce, use, or disposal of a chemical

substance or mixture … presents or will

present an unreasonable risk of injury to

health or the environment.” Specifies various

regulatory options. Authorizes regulations

to—prohibit or limit the amount of substance

manufactured, processed, or distributed in

commerce, generally or for a specific use;

require labeling, recordkeeping, provision of

notice to distributors and to the public of

unreasonable risk of injury, or replacement or

repurchase of a substance; and specify

methods of disposal.

S. 3209 does not require rulemaking, but

section 7 amends TSCA 6(b) and (c) to

authorize EPA to specify allowed uses of

any substance that meets the safety

standard and to impose conditions on its

manufacture, processing, use, distribution

in commerce, or disposal to “ensure the

safety standard is met.” Many of the

conditions that EPA is authorized to

impose are the same as the regulatory

options listed in current law, but S. 3209

also authorizes EPA to impose a

requirement that the manufacturers and

processors of a chemical substance or

mixture or article containing it develop a

risk reduction management plan to achieve

a risk reduction specified by the

Administrator. The bill does not authorize

the option of requiring manufacturers or

processors to give notice of unreasonable

risk of injury to distributors or the public

or to replace or repurchase a substance.

Amended TSCA 6(c)(2) is similar to S.

3209, but the bill authorizes prescription

for specific control measures to reduce

occupational exposures and requires that

any such measures must reflect the

industrial hygiene hierarchy of controls.

Any warnings or instructions required

must be consistent with the Globally

Harmonized System of Labeling and

Classification of Chemicals. In determining

the conditions necessary to ensure the

substance or mixture meets the safety

standard, the Administrator must

“consider human health and the

environment as the primary and

paramount concern, and shall also

consider the technological feasibility of

compliance, the economic impact of

compliance, and benefits of earlier

compliance, and other relevant

considerations.”

TSCA 6(c) [15 U.S.C. 2605(c)] specifies

procedures for rulemaking that allow for

informal hearings and requires EPA to publish

a statement describing the health and

environmental effects, level of exposure,

benefits of the substance, and “reasonably

ascertainable economic consequences of the

rule, after consideration of the effect on the

national economy, small business,

technological innovation, the environment,

and public health.” Requires that EPA’s

decisions be based on the rulemaking record.

Directs EPA to promulgate needed rules

under other environmental laws, unless it is in

the public interest to issue rules under TSCA.

CRS-30

In addition, S. 3209 differs from current

law in that the bill does not authorize

limiting conditions to specified geographic

areas, nor does it prohibit requiring a

person to take an action that would be in

violation of a law or requirement of a state

or political subdivision.

Provision

General process for safety

determinations

15 U.S.C. 2601 et seq.

No comparable provision.

S. 3209

H.R. 5820

Amended TSCA 6(b)(1) requires that EPA

produce a risk assessment addressing

health and environmental impacts using

“the best available science” in support of

any determination that a manufacturer or

processor of a chemical substance has met

the burden of proof. Risk assessments

must be transparent and understandable

to the public and to risk managers.

Amended TSCA 6(b)(1) requires the

Administrator to apply a safety standard

that “takes into account aggregate

exposure to a chemical substance or

mixture and ensures that, for all intended

uses—(i) with regard to public health,

there is a reasonable certainty that no

harm will result, including to vulnerable

populations; and (ii) the public welfare is

protected.” The Administrator is required

to consider the lifecycle of the substance

or mixture and “available information

concerning the cumulative effects of

exposure to chemical substances or

mixtures.”

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.

Amended TSCA 6(b)(1) also establishes

that manufacturers and processors of a

chemical substance are responsible for

proving that the substance meets the

applicable safety standard, and that the

EPA Administrator has the responsibility

of determining within 180 days of data

submission whether the manufacturers

and processors have met the burden of

proof.

H.R. 5820 is similar to S. 3209 in that

amended TSCA 6(b)(2) assigns the burden

of proving that a chemical meets the safety

standard to manufacturers and processors.

Amended TSCA 6(b)(3) requires the

Administrator to “determine whether the

chemical substance or mixture meets the

safety standard, taking into account any

existing conditions or controls already in

effect, or can be made to meet the safety

standard through the imposition of

additional conditions … and whether

intended uses that do not meet the safety

standard are critical.” A safety

determination must be completed and

published not later than 30 months after

the date on which a chemical is placed on

the priority list, or within 18 months of

the date of enactment for the 19 chemicals

listed in amended TSCA 6(a)(1)(A).

The determinations must be made in

keeping with “standards for assessment”

developed by the Administrator under

amended TSCA 6(b)(4).

CRS-31

Provision

15 U.S.C. 2601 et seq.

S. 3209

H.R. 5820

Scientific standards for data

assessment

No comparable provision.

Amended TSCA 6(b)(1)(C) requires The

Administrator to “use the best available

science” in conducting a risk assessment

considering the most recent

recommendations of the National

Academy of Sciences “on ways to better

protect people, including pregnant women,

infants, children and other vulnerable

populations from harm by exposure to

toxic substances when assessing such

potential risks.”

Within 18 months of the date of

enactment of H.R. 5820, amended TSCA

6(b)(4) directs the Administrator, after

providing for notice and opportunity for

comment, to develop and publish guidance

regarding the use of science in making

safety determinations. Requires that the

Administrator rely on the

recommendations of the National

Academy of Sciences report entitled

Science and Decisions. Such guidance must

be reviewed and may be revised to reflect

new scientific developments or

understanding at least once every 5 years.

Safety of chemicals for export

No comparable provision.

Directs EPA to consider risks that a

chemical manufactured for export may

pose in the United States during

production and distribution in commerce,

including in imported products containing

the substance.

No comparable provision.

No comparable provision.

Within 180 days of receipt of a data

submission, EPA is directed to determine,

by order, whether the manufacturers and

processors of the substance have

established that the substance meets the

safety standard.

Amended TSCA 6(b)(3)(D) requires that

the Administrator complete and publish

the safety standard determination within

30 months of the date on which the

chemical substance or mixture is placed

on the priority list, or, within 18 months

of the date of enactment of H.R. 5820 for

chemicals listed in amended TSCA

6(a)(1)(A). However, if additional

information is needed, the determination

must be completed and published within

12 months after submission of all required

information.

Safety determinations for existing

chemicals

EPA’s determination

CRS-32

Provision

15 U.S.C. 2601 et seq.

S. 3209

H.R. 5820

Failure to submit data

No comparable provision.

If data are not submitted, amended TSCA

6(b)(2) authorizes EPA to prohibit, by

order, manufacture, processing, or

distribution in commerce of the substance,

mixture, or article containing the

substance.

Amended TSCA 6(b)(3) provides that

failure to submit required information is

grounds for determining that the chemical

substance or mixture does not meet the

safety standard.

Failure by EPA

No comparable provision.

If EPA fails to meet the deadline for a

safety determination, amended TSCA

6(b)(2) provides that manufacturers and

processors are required to notify EPA, the

public, their employees, and customers

written notice that a determination by

EPA of the safety of the chemical is

pending.

Amended TSCA 6(b)(7) requires EPA

promptly to publish notice of a failure to

publish or renew a determination by the

applicable deadline. Directs the

Administrator to prohibit new

manufacturers or processors or new uses

of the chemical substance or mixture until

the determination is published and

requires manufacturers and processors to

provide written notice to the public, their

employees, and their commercial

customers that a safety standard

determination is pending.

Resubmission

No comparable provision.

Amended TSCA 6(b)(2) provides that at

least every 15 years, manufacturers and

processors of each chemical substance

must submit the minimum dataset and

indicate whether the substance and

specified uses meet the safety standard.

Amended TSCA 6(b)(6) provides that a

safety determination remains in effect for

up to 15 years, if no new use or

information warrants a redetermination.

Redetermination

No comparable provision.

EPA may initiate a redetermination of

whether the chemical meets the safety

standard if new information raises a

question in that regard, on the receipt of a

renewal submission, or 15-years following

the previous determination.

The Administrator may renew a

determination for additional 15 year

periods but the burden of proof for

renewal remains with the manufacturers

and processors.

Petition for redetermination

No comparable provision.

Authorizes any person to petition the

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.

No comparable provision.

CRS-33

Provision

15 U.S.C. 2601 et seq.

S. 3209

H.R. 5820

Restrictions on substances that do

not meet the safety standard

No comparable provision, but TSCA 6(a)

directs EPA by rule to apply one or more

requirements (such as labeling or banning

particular uses) “to the extent necessary to

protect adequately against” an “unreasonable

risk” “using the least burdensome

requirements,” if the Administrator finds that

“there is a reasonable basis to conclude that

the manufacture, processing, distribution in

commerce, use, or disposal of a chemical

substance or mixture, or that any combination

of such activities, presents or will present an

unreasonable risk of injury to health or the

environment.”

Amended TSCA 6(b)(3) prohibits

manufacture, processing, and distribution

in commerce of a chemical substance,

mixture, or article if EPA makes a safety

determination and does not determine

that a substance meets the safety standard.

Such prohibition is effective immediately

for a new chemical or after one year for

any other chemical.

Amended TSCA 6(c)(3) is similar to S.

3209 but also immediately prohibits

activities with respect to a new use of an

existing substance, mixture, or article if

EPA determines that the manufacturers

and processors have not shown that the

use meets the safety standard.

Unrestricted distribution in

commerce

No comparable provision, but current law

allows unrestricted distribution in commerce

of chemicals and mixtures unless EPA

determines that a substance presents an

unreasonable risk and then promulgates a rule

to regulate it.

No comparable provision. If EPA

determines that the substance meets the

safety standard, the allowed uses of the

substance must be specified as well as any

conditions on those specified uses to

ensure that the safety standard is met. S.

3209 prohibits manufacture, processing,

and distribution in commerce of a

chemical substance, mixture, or article for

uses not specified in the safety

determination.

Amended TSCA 6(c)(1) authorizes

manufacture, processing, and distribution

in commerce for any chemical substance

or mixture that EPA determines meets the

safety standard without imposition of

conditions for uses identified and included

in the safety standard determination. EPA

is authorized to make the determination

contingent on the continuation of

conditions or controls already in effect.

Uses restricted for substances

meeting the safety standard

No comparable provision.

Amended TSCA 6(b) prohibits

manufacture, processing, and distribution

in commerce of a chemical substance,

mixture, or article for any use not

specified in the safety determination if EPA

determines that the chemical and its

specified uses meet the safety standard.

Amended TSCA 6(c)(2) requires EPA to

impose conditions on manufacture,

processing, use, distribution in commerce,

or disposal of a chemical substance or

mixture to ensure that it meets the safety

standard. Such conditions must “be

identified in a manner that ensures

effective and efficient protection of health

and the environment.”

CRS-34

Provision

15 U.S.C. 2601 et seq.

S. 3209

H.R. 5820

Effective date of Section 6 rules

TSCA 6(d) [15 U.S.C. 2605(d)] directs EPA to

make such rules effective “as soon as feasible,”

and allows EPA to make a proposed rule

effective upon publication until the effective

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.

Amended TSCA 6(i) directs EPA to specify

a date on which a rule or order shall take

effect and that such date should be “as

soon as feasible.”

Amended TSCA 6(c)(2)(H) requires that

conditions be met within one year after

publication of the determination, or as

quickly as feasible and in no case later than

3 years after publication. Prohibits

activities with respect to a chemical if such

conditions are not met by the applicable

deadline.

Quality control

TSCA 6(b) [15 U.S.C. 2605(b)] authorizes

EPA to review and regulate a manufacturer’s

or processor’s quality control procedures if

there is “a reasonable basis to conclude” that

the manner of manufacturing or processing

“unintentionally causes a chemical … to

present or which will cause it to present an

unreasonable risk of injury to health or the

environment.” EPA also is authorized to order

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.

Amended TSCA 6(d) is similar to current

law but applies when there is “a

reasonable basis to conclude” that the

manner of manufacturing or processing

“may present a substantial endangerment

to health or the environment.” Does not

require such determination to be made on

the record after opportunity for hearing.

Amended TSCA 6(d) is similar to current

law but applies when there is a reasonable

basis to conclude that the manner of

manufacturing or processing “causes the

chemical substance or mixture to present

or which will cause it to present a

significant risk of injury to health or the

environment.”

Resale of used articles

No comparable provision.

Restrictions established under sections

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.

No comparable provision.

CRS-35

Provision

15 U.S.C. 2601 et seq.

S. 3209

H.R. 5820

Delay of effective date of

restrictions

No comparable provision.

Authorizes EPA to order delay in the

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.

No comparable provision, but conditions

may be imposed up to 3 years after they

are established (see above “Effective date

of Section 6 rules”).

Exemptions from prohibitions and

other restrictions

No comparable provision.

Amended TSCA 6(e) authorizes EPA to

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.

Amended TSCA 6(e) authorizes

manufacturers and processors to request

exemptions from restrictions under

amended TSCA 6(c) for a specific use by a

manufacturer or processor. The

procedure for granting exemptions is the

same as under S. 3209, but H.R. 5820

requires that EPA impose conditions on

any use receiving an exemption “to reduce

risk from the chemical substance or

mixture to the greatest extent feasible.”

CRS-36

Provision

15 U.S.C. 2601 et seq.

S. 3209

H.R. 5820

Certification of the quality of

submitted information

No comparable provision.

Amended TSCA 6(h) requires that each

submission of information under a rule or

order be accompanied by a 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.

Amended TSCA 8(i) requires each

submission of information that is required

pursuant to “this title” or pursuant to a

rule or order issued under this title to be

accompanied by a 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

from conveying, selling, or distributing

elemental mercury to any federal agency, state

or local government, or private entity, except

to facilitate storage at a federal agency.

Amended TSCA 6(g) is the same as

current law.

Amended TSCA 6(g) is the same as

current law.

Polychlorinated biphenyls (PCBs)

TSCA 6(e) [15 U.S.C. 2605(e)] directs EPA to

prescribe methods of disposal for PCBs and

to require PCBs to be marked with clear and

adequate warnings and instructions regarding

processing, distribution in commerce, use, or

disposal. Prohibits use of any PCB other than

“in a totally enclosed manner,” unless EPA

finds that such activity “will not present an

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).

Amended TSCA 6(f) is similar to existing

law but authorizes the Administrator to

act by order or rule, and to grant

exemptions from the general prohibitions

when the activities “will not present a

substantial endangerment to health or the

environment” rather than when activities

“will not present an unreasonable risk.”

Amended TSCA 6(f) is similar to current

law, but authorizes EPA to grant

exemptions if activities will not “present a

substantial risk to health or the

environment” and will comply with section

37 (concerning data quality).

CRS-37

Provision

15 U.S.C. 2601 et seq.

S. 3209

H.R. 5820

Relief

Authorizes an appropriate district court to

grant relief necessary to protect health or the

environment from unreasonable risk.

Similar to current law, but authorizes

court to grant relief necessary to protect

health or the environment from “the risk

associated with the activity involved in the

action.”

Similar to current law, but authorizes

court to grant relief necessary to protect

health or the environment from “imminent

and substantial endangerment.”

Civil actions

TSCA 7(a) [15 U.S.C. 2606(a)] authorizes EPA

to begin a civil action: for seizure of “an

imminently hazardous” chemical substance,

mixture, or article; for relief against any

person who manufactures, processes,

distributes in commerce, or uses, or disposes

of such chemical or article; or for both

seizure and relief. Requires EPA to commence

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.”

Similar to current law, but authorizes EPA

action against a person when a chemical,

mixture, or article “may present an

imminent and substantial endangerment to

health or the environment.” S. 3209 does

not require EPA to commence action if

the agency has not made a rule effective

immediately concerning the chemical. S.

3209 also authorizes EPA to issue orders

to protect health or the environment from

a chemical substance or mixture or article

containing such substance or mixture that

may present an imminent and substantial

endangerment to health or the

environment.

Amended TSCA 7 is similar to S. 3209, but

amended TSCA 7(d) directs the

Administrator, as appropriate,

concurrently with the filing of an action

under amended TSCA 7(a)(1), to add the

chemical substance or mixture to the

priority list under amended TSCA 6(a) or

to initiate a redetermination of whether

the substance meets the safety standard

under amended TSCA 6(b).

Imminent hazards

CRS-38

Eliminates authority concurrently to

initiate a proceeding for the promulgation

of a rule under TSCA 6(a) [15 U.S.C.

2605(a)]. Also eliminates the definition for

“imminently hazardous chemical substance

or mixture.”

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 Toxic Chemicals Safety Act of 2010 (H.R. 5820), as Introduced

Provision

Reporting and record keeping

(declaration)

15 U.S.C. 2601 et seq.

S. 3209

H.R. 5820

TSCA 8(a) [15 U.S.C. 2607(a)] authorizes

EPA, to the extent necessary for the

effective enforcement of the law, to

promulgate rules requiring maintenance of

records and submission of reports to EPA

by persons who manufacture or process

or who propose to manufacture or

process a chemical substance. Prohibits a

rule requiring maintenance of records or

submission of reports with respect to

changes in the proportions of the

components of a mixture unless necessary

for effective enforcement.

Amended TSCA 8(a) requires each

manufacturer and processor of a chemical

substance to submit a declaration of

current manufacturing or processing for

each substance, mixture, or article

manufactured or processed containing

information that will assist the

Administrator in making a safety

determination or otherwise in

administering the law. Each declaration

must be accompanied by certification of its

accuracy, reliability, and

comprehensiveness.

Amended TSCA 8(a) is the same as S.

3209, but in addition authorizes EPA to

require submission of a declaration by

manufacturers and processors of mixtures,

when the Administrator determines that

the substance characteristics of the

mixture are different from those of the

constituent chemical substances, “in kind

or in degree.”

Amended TSCA 8(b) is similar to S. 3209.

Amended TSCA 8(b) 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

CRS-39

No comparable provision.

EPA may by order prohibit manufacture,

processing, or distribution of any

substance if a manufacturer or processor

violates EPA requirements for submitting

or updating declarations.

Amended TSCA 8(a)(6) authorizes the

Administrator to impose penalties

pursuant to section 16 or, by order,

prohibit, or otherwise impose conditions

under amended TSCA 6(c) on a

manufacturer or processor in violation of

an 8(a) reporting requirement.

Provision

Information submitted

CRS-40

15 U.S.C. 2601 et seq.

S. 3209

H.R. 5820

TSCA 8(a) authorizes collection of

information including: trade name or

common name, chemical identity,

categories of use, amount of each chemical

manufactured or processed, byproducts

resulting from such manufacture or

processing, “all existing data concerning

the environmental and health effects,”

number of individuals exposed, and, in the

initial report, the manner of disposal.

Amended TSCA 8(a) requires the

declaration to state: the chemical identity

and substance characteristics; name and

location of each facility where the

substance is manufactured or processed

or from which it is distributed; a list and

copies of health and safety studies that are

reasonably ascertainable; and all other

information not previously submitted to

EPA regarding the physical, 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 all 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.

Similar to S. 3209, but also requires

information regarding the number of

individuals exposed, classification of the

toxicity of the chemical, categories of

intended use of the substance or mixture,

total amount of substance and mixture

manufactured or processed, byproducts

resulting from manufacture, processing,

use, or disposal, exposure information, any

condition currently placed on the

substance or mixture due to regulation

under any federal law or due to voluntary

action, and for a processor of a chemical

substance, information indicating that the

mixture has substance characteristics that

are different from the characteristics of

the individual substances. Updates are

required when the Administrator receives

information “indicating a new potential

adverse effect of the chemical substance

or mixture, suggesting an adverse effect at

a lower dose than previously

demonstrated, or otherwise reasonably

relevant to an analysis of whether the

chemical substance or mixture meets the

safety standard under section 6.”

Provision

15 U.S.C. 2601 et seq.

S. 3209

H.R. 5820

Inventory

TSCA 8(b) [15 U.S.C. 2607(b)] directs

EPA to compile, keep current, and publish

an inventory of each chemical

manufactured or processed in the United

States. New chemicals are to be listed

when manufacture or processing begins.

The list should exclude chemicals

produced in small quantities for purposes

of scientific experimentation, analysis, or

research. Authorizes EPA to list chemicals

by category rather than individually.

Amended TSCA 8(c) is the same as TSCA

8(b), except that it omits the authority in

current law to list chemicals by category

rather than individually. In addition, S.

3209 requires that EPA publish in the

Federal Register a list of all chemical

substances distributed in commerce that

categorizes the substances based on

existing information available into

categories based on known health or

environmental effects, exposure,

insufficient data, or other category that

EPA considers appropriate.

Amended TSCA 8(c)(1) directs the

Administrator to compile, keep current,

publish and enter into the public database

established under amended TSCA 8(d) a

list of each chemical substance and

mixture for which a declaration (under

amended TSCA 8(a)) is received which is

manufactured or processed in the United

States. Omits the authority in current law

to list chemicals by category rather than

individually. The list shall not include any

chemical substance or mixture for which

all manufacturers and processors have

submitted declarations of permanent

cessation. Also requires the categorization

of substances as in S. 3209, but includes

mixtures.

Small quantities for research and

development

TSCA 8(a)(3) [15 U.S.C. 2607(a)(3)]

explicitly authorizes EPA to require by

rule reporting from small manufacturers

and processors of chemicals substances or

mixtures subject to a rule proposed or

promulgated under TSCA 4, 5(b)(4), or 6

or an order under TSCA 5(e) or with

respect to which relief has been granted

under TSCA 5 or 6. Reporting also may be

required once under TSCA 8(b) for the

original inventory (see below) from

processors and manufacturers who are

small (as determined by the Administrator

after consultation with the Small Business

Administration). TSCA 8(b) [15 U.S.C.

2607(b)]directs EPA to limit record

keeping and reporting requirements for

those who manufacture or process a

chemical in small quantities solely for

purposes of scientific experimentation or

analysis of a chemical substance.

Amended TSCA 8(b)(2) authorizes EPA by

rule to define manufacture, processing,

distribution in commerce, use, or disposal

of a chemical substance in small quantities

solely for purposes of research, and to

issue a rule or order under this subsection

only if EPA determines maintenance of

records or submission of reports is

necessary for effective enforcement of the

law.

Amended TSCA 8(b)(2) is the same as S.

3209.

CRS-41

Provision

15 U.S.C. 2601 et seq.

S. 3209

H.R. 5820

Public access

No comparable provision.

Amended TSCA 8(d) directs EPA to

establish an electronic database of

information relating to the toxicity and use

of and exposure to chemical substances. It

is required to include descriptions of “all

significant decisions made by the

Administrator” and significant information

submitted under TSCA Title I.

Same as S. 3209.

Records of significant adverse

reactions

TSCA 8(c) [15 U.S.C. 2607(c)] requires all

manufacturers and processors to keep

records of all reports of significant adverse

reactions to health or the environment

alleged to have resulted from exposure to

a chemical substance.

Amended TSCA 8(e) is similar to TSCA

but also requires submission of such

records to EPA.

Similar to S. 3209 but requires submission

to EPA annually or immediately upon

request by the Administrator, while

current law and S. 3209 do not require

reports at specific times.

Disclosure to commercial purchasers

No comparable provision.

No comparable provision.

Amended TSCA 8(f) requires all

manufacturers and processors of chemical

substances and mixtures to provide to all

known commercial purchasers, with

shipment or promptly thereafter, and by

request, a disclosure, subject to amended

TSCA 14 (which protects confidential

business information), of the chemical

identity of the substances or mixture

ingredients, their toxicological properties,

health and safety studies submitted to

EPA, and records of significant adverse

reactions submitted under amended TSCA

8(e).

CRS-42

Provision

15 U.S.C. 2601 et seq.

S. 3209

H.R. 5820

Information from other federal

agencies

No comparable provision.

Amended TSCA 8(f) requires each federal

agency and institution to submit to EPA a

synopsis of the data and records in its

control that may be useful to EPA in

carrying out TSCA Title I. Such synopsis

shall be updated and resubmitted at least

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.

Similar to S. 3209, but agencies are to

respond to a request from EPA, not to

submit reports every 3 years, and the bill

directs EPA to prescribe by order the

format, content, and level of detail of the

requested report. Also directs the

Administrator to make such a request

from each federal agency which the

Administrator reasonably expects may

have information on chemical substances

or mixtures that would assist in making a

safety standard determination. Requests

must be issued no more than 12 months

after a substance or mixture is added to

the priority list under amended TSCA 6(a)

or within 12 months of enactment of H.R.

5820 for substances listed in amended

TSCA 6(a)(1)(A).

Health and safety studies

TSCA 8(d) [15 U.S.C. 2607(d)] directs

EPA to require manufacturers, processors,

and distributors to submit lists and copies

of health and safety studies for each

chemical manufactured or processed.

S. 3209 requires submission of such

studies as part of the declaration under

amended TSCA 8(a).

Same as S. 3209.

Substantial risk notice

TSCA 8(e) [15 U.S.C. 2607(e)] requires

manufacturers, processors, and

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.

Amended TSCA 8(g) is the same as

current law.

Amended TSCA 8(h) is the same as

current law.

CRS-43

Provision

15 U.S.C. 2601 et seq.

S. 3209

H.R. 5820

Certification

No comparable provision.

Amended TSCA 8(h) requires that each

submission of information under a rule or

order be accompanied by a 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.

Amended TSCA 8(i) requires each

submission of information that is required

pursuant to “this title” or pursuant to a

rule or order issued under this title, other

than a submission under section 8(g)

(relating to submissions from federal

agencies), to be accompanied by a

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.

“Manufacture” and “process”

TSCA 8(f) [15 U.S.C. 2607(f)] defines

“manufacture” and “process” to mean

manufacture or process for commercial

purposes.

Amended TSCA 8(i) is the same as

current law.

Amended TSCA 8(j) is the same as

current law.

CRS-44

Table 6. Other Selected Provisions of TSCA (15 U.S.C. 2601 et seq.), the Safe Chemicals Act (S. 3209), as Introduced, and the

Toxic Chemicals Safety Act of 2010 (H.R. 5820), as Introduced

Provision

15 U.S.C. 2601 et seq.

S. 3209

H.R. 5820

Action under laws administered

by other federal agencies

If EPA has a reasonable basis to conclude

that activities with respect to a chemical

substance or mixture present or will

present an unreasonable risk, and EPA

determines that such risk may be prevented

or reduced to a sufficient extent by action

taken under a federal law not administered

by EPA, then TSCA 9(a) [15 U.S.C. 2608(a)]

directs EPA to submit to the agency which

administers such law a report describing the

risk and activities that present such risks.

The EPA report must request that the other

federal agency (1) tell EPA whether the risk

may be prevented or reduced under the law

the agency administers, and (2) issue an

order declaring whether the activities

present a risk. If EPA makes a report and

the other agency either (1) issues an order

declaring that the activities do not present

the risk, or (2) initiates action to protect

against such risk, then EPA may not take

regulatory action under TSCA 6 or 7.

Amended TSCA 9(a) is similar to current

law, but the criterion for EPA action differs.

If the Administrator determines “that the

manufacture, processing, distribution in

commerce, use, or disposal of a chemical …

either does not meet the safety standard …

or requires conditions or restrictions” to do

so, and “that action may be taken under a

Federal law not administered by the

Administrator” then EPA must submit a

report to the other agency describing the

activities that prevent the chemical from

meeting the safety standard or restrictions

or conditions required to meet the safety

standard. The report must request that the

other agency (1) determine if the action may

be taken under a law administered by the

agency, and if so, (2) initiate such action and

provide a timetable for action, and (3)

respond to EPA’s report. If the other agency

initiates action within the timeframe

specified, EPA may not take regulatory

action, except under TSCA 7. If 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.

Similar to current law, except that EPA must

submit a report to another agency if “the

Administrator has reasonable basis to

conclude that a chemical substance or

mixture does not meet the safety standard

under section 6(b).” Also, information that is

to be published in the Federal Register must

be entered into the public database

established in amended TSCA 8(d).

Action under other EPAadministered laws

TSCA 9(b) [15 U.S.C. 2608(b)] directs EPA

to coordinate actions taken under TSCA

with actions taken under other federal laws

administered by EPA.

Same as current law.

Same as current law.

Occupational safety and health

TSCA 9(c) states that any EPA exercise of

authority under TSCA is deemed to be

exercising statutory authority to prescribe

or enforce standards or regulations affecting

occupational safety and health.

Same as current law. In addition, S. 3209

directs EPA to ensure that any EPA actions

to address workplace exposures “are

consistent with the industrial hygiene

hierarchy of controls.”

Same as current law.

CRS-45

Provision

15 U.S.C. 2601 et seq.

S. 3209

H.R. 5820

Coordination

TSCA 9(d) directs EPA to consult and

coordinate with appropriate federal agency

heads to achieve “maximum enforcement”

“while imposing the least burdens of

duplicative requirements” on those being

regulated.

S. 3209 strikes the requirement that

coordination for the purpose of

enforcement should impose the least

burdens of duplicative requirements.

Same as S. 3209.

Mixture survey

No comparable provision.

No comparable provision.

Amended TSCA 8(c)(3) directs EPA to

characterize the number of mixtures

introduced into commerce and the number

of such mixtures that may have different

substance characteristics from the

constituent chemical substances. Such

survey shall be based on declarations and a

survey of processors. The characterization of

mixtures in commerce must be published in

the Federal Register and entered into the

public database established in amended

TSCA 8(d).

Subpoenas and warrants

TSCA 11(c) [15 U.S.C. 2610(c)] authorizes

EPA to require by subpoena attendance and

testimony of witnesses, production of

reports, documents, answers to questions,

and other information. Authorizes district

courts to order compliance in the event of

contumacy, failure, or refusal to obey.

Amended TSCA section 11(c) authorizes

EPA to require attendance, testimony, and

production of documents, items, answers to

questions and other information deemed

necessary. In the event that “there is reason

to believe that the 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.

Amended TSCA 11 is the same as current

law.

CRS-46

Provision

15 U.S.C. 2601 et seq.

S. 3209

H.R. 5820

TSCA 11 [15 U.S.C. 2610] authorizes EPA

to inspect premises in which chemicals are

manufactured, processed, stored, or held

before or after distribution in commerce

and any conveyance used to transport

chemicals in commerce. Limits inspections

by requiring presentation of appropriate

credentials and written notice to the person

in charge of the premises or conveyance to

be inspected on each occasion of inspection.

Requires 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.

Similar to TSCA but also applies to premises

and conveyances handling articles subject to

TSCA, and S. 3209 does not limit

inspections by requiring presentation of

credentials or provision of written notice.

Additionally authorizes EPA to inspect any

place where records relating to compliance

with the law are held and to inspect and

obtain samples of any chemicals, containers,

or labeling. Does not prohibit inspection of

any data.

Amended TSCA 11 is similar to current law,

but also applies to commercial premises in

which articles containing such substances or

mixtures are manufactured, processed,

stored, or held, and to any place where

records relating to such substances or

mixtures or articles are held. Like S. 3209,

authorizes EPA to inspect and obtain

samples. The bill also authorizes EPA to

collect containers and labeling of substances,

mixtures, products, or articles.

Exclusion from requirements

TSCA 12(a) [15 U.S.C. 2611(a)] excludes

chemical products manufactured for export

(other than elemental mercury) from TSCA

requirements except for 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.

Amended TSCA 12 eliminates the current

exclusion from requirements for chemicals

manufactured, processed, or distributed in

commerce solely for the purpose of export.

Same as S. 3209.

Mercury

TSCA 12(c) [15 U.S.C. 2611(c)] prohibits

the export of elemental mercury (but not of

coal). Authorizes exemptions from this

prohibition for essential uses.

Same as current law.

Same as current law.

Inspections

Exports

CRS-47

Provision

Notice of export

Imports

CRS-48

15 U.S.C. 2601 et seq.

S. 3209

H.R. 5820

TSCA 12(b) [15 U.S.C. 2611(b)] requires

anyone who exports or intends to export a

substance that is subject to a test rule or

order under section 4 or a proposed or

final rule under section 5 or 6, or for which

action is pending or relief has been granted

under section 5 or 7, to notify EPA of such

exportation or intent, and EPA must then

notify the countries that will be receiving

the substance that data are available or that

restrictions are in place in the United States

for such substance.

Amended TSCA 12(a) is similar to current

law, but excludes from requirements those

who “intend” to export, and applies only to

exports of chemicals subject to data

submission requirements under amended

TSCA 5 or 6(b), or for which action has

been taken under TSCA 6 or 7. Also, S.

3209 allows exporters 30 days from the

date of export for providing notice to EPA,

and specifies that EPA must provide notice

to countries “promptly thereafter.”

Requires exporters to notify EPA, and EPA

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.

Similar to S. 3209, but requires exporters of

substances contained in Annex III of the

Rotterdam Convention on Prior Informed

Consent Procedure for Certain Hazardous

Chemicals and Pesticides in International

Trade (including any amendment or

protocol) to file notice of export at least 30

days prior to the date of exportation. (Note

that the United States has not yet ratified

this treaty.)

TSCA 13 [15 U.S.C. 2612] directs the

Secretary of the Treasury to refuse entry

into the United States of chemicals that fail

to comply with a rule under TSCA or that

are in violation of TSCA.

Amended TSCA 13 is similar to current law

but transfers authority to the Secretary of

the Department of Homeland Security.

Amended TSCA 13 is similar to S. 3209, but

requires importers of substances, mixtures,

or articles to satisfy all requirements under

amended TSCA 4, 5, 6, and 8.

Provision

Disclosure of data

CRS-49

15 U.S.C. 2601 et seq.

S. 3209

H.R. 5820

TSCA 14 [15 U.S.C. 2613] provides broad

protection of proprietary confidential

information about chemicals in commerce.

Disclosure by EPA employees of such

information generally is not permitted,

except to other federal employees or when

relevant in any proceeding under TSCA.

Disclosure of information is required when

“necessary to protect health or the

environment against an unreasonable risk of

injury to health or the environment.”

Manufacturers, processors, or distributors

in commerce may designate data that they

believe is entitled to confidential treatment.

If EPA proposes to release such data the

Administrator must notify the manufacturer,

processor, or distributor who designated

the data.

Amended TSCA 14 requires conformance

to the standards of the Freedom of

Information Act (FOIA). Like current law, S.

3209 prohibits disclosure of proprietary

confidential information by EPA employees

except to other federal agencies and EPA

contractors, but it specifically directs EPA to

disclose information upon request to a state,

tribal, or municipal government for the

purpose of administration or enforcement

of a law if an agreement ensures that the

recipient government will take appropriate

steps to maintain the confidentiality of the

information in accordance with amended

TSCA 14 and 40 CFR 350.27, which refers

to the substantiation form to accompany

claims of trade secrecy under the

Emergency Planning and Community Rightto-Know Act. Directs EPA to release

information if it is necessary to protect

health or the environment against “an

imminent and substantial endangerment” to

health or the environment. Requires those

designating data as confidential to justify

such claims and to certify that the

information is not otherwise publicly

available. The Administrator is required to

by order develop standards for justifying

claims and necessary documentation.

Requests must be reviewed by EPA within

90 days. If approved, submitted information

will be protected from disclosure for up to

5 years.

Amended TSCA 14 is similar to S. 3209 in

that it requires conformance to the

standards of the FOIA and allows disclosure

to state, tribal, and municipal governments. It

also generally prohibits disclosure by EPA

employees, but only if the designation is not

determined to be inappropriate. Like S. 3209,

H.R. 5820 provides for disclosure to state,

tribal, and municipal governments. Directs

EPA to release information if it is necessary

to protect health and the environment from

a “substantial” risk of injury. The procedure

in amended TSCA 14(f) for requesting and

receiving designation of information as

confidential is similar to that in S. 3209, but

submitters must pay a fee, and the

Administrator is not required to approve

each request. Rather the Administrator is

required to review and approve a

representative sample of requests.

Provision

15 U.S.C. 2601 et seq.

S. 3209

H.R. 5820

Health and safety information

Disclosure of health and safety information

is not prohibited when it relates to a

chemical which has been offered for

commercial distribution, or for which

testing is being required under section 4, or

for which notification is required under

section 5, unless data disclosure would

reveal a chemical process or chemical

proportion in a mixture.

Amended TSCA 14 specifies data that are

not to be protected, including the identity of

a chemical, any safety standard

determination, and information “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.”

Similar to S. 3209. In addition, H.R. 5820

denies protection for information about the

components of a mixture, when included in a

health and safety study, safety standard

determination, or information indicating

presence in a consumer article intended for

use or reasonably expected to be used by

children or indicating exposure to the

mixture in children. Any other information

indicating exposure to a chemical substance

or mixture in children also is denied

disclosure protection.

Penalties for disclosure and

inappropriate designation

TSCA 14(d) provides that knowing and

willful disclosure of protected information

by a federal employee may result in a fine of

up to $5,000 or imprisonment for up to one

year, or both.

Amended TSCA 14(f) is the same as current

law.

Amended TSCA 14(g) retains the penalties

for disclosure in current law. In addition, it

authorizes administrative penalties for a

manufacturer or processor whose

designation of information is found not to

have met the criteria for protection.

Knowing and willful designation of

information that does not meet the criteria

may result in a fine of not more than $5,000

or imprisonment for up to one year, or both.

Fees for designating information

confidential

No comparable provision.

No comparable provision.

Amended TSCA 14(i) authorizes the

Administrator, by rule, to require payment of

a reasonable fee from any person designating

information for protection or seeking to

renew such designation.

CRS-50

Provision

15 U.S.C. 2601 et seq.

S. 3209

H.R. 5820

Risk information for workers

No comparable provision.

Amended TSCA 14(h) requires EPA to

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.

Amended TSCA 14(j) is the same as S. 3209.

Prohibited Acts

TSCA 15 [15 U.S.C. 2614] prohibits any

person from failing or refusing to comply

with rules, orders, or other requirements of

TSCA, using for commercial purposes a

chemical substance or mixture that was

known to be manufactured, processed, or

distributed in commerce in violation of the

law, failing or refusing to establish and

maintain records, submit reports, notices,

or other information, or to permit access to

or copying of records, or failing or refusing

to permit entry or inspection.

Amended TSCA 15 is similar to current law

and prohibits all the same actions, but also

prohibits manufacturing, processing,

distributing in commerce, or disposing of a

chemical or article or using an article that

was known to have been manufactured,

processed, or distributed in commerce in

violation of the law. S. 3209 also prohibits

failing or refusing to establish and maintain

“accurate and complete” records, reports,

notices, information, disclosures,

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.

Similar to S. 3209, but also prohibits failing or

refusing to permit access to or copying of

records and introducing or knowingly

distributing in commerce a substance or

mixture, or an article containing a substance

or mixture, that lacks or fails to comply with

labeling requirements, or that has misleading

advertising or labeling. It also prohibits

making or employing without proper

authority any identification device authorized

or required under TSCA.

CRS-51

Provision

Penalties

15 U.S.C. 2601 et seq.

S. 3209

TSCA 16 [15 U.S.C. 2615] authorizes civil

penalties, not to exceed $25,000 per

violation per day, and affords the defendant

an opportunity to request a hearing before

an order is issued and to petition for judicial

review of an order after it is issued with the

U.S. Court of Appeals for the District of

Columbia circuit or for any other circuit in

which the person resides or transacts

business.

Amended TSCA 16 increases the maximum

per violation per day civil penalty to $37,500

and authorizes EPA to commence a civil

action in an appropriate U.S. district court

to assess penalties. Changes the court in

which a person may file a petition for judicial

review to eliminate jurisdiction in any

federal circuit court, instead vesting

jurisdiction in the appropriate district court

for the district in which the person resides

or transacts business.

Criminal penalties of up to $25,000 per day

of violation or up to one year of

imprisonment, or both, also are authorized

for knowing or willful violations.

Seizure

CRS-52

TSCA 17 [15 U.S.C. 2616] makes

substances produced in violation of Title IV

(Lead Exposure Reduction) liable to be

proceeded against, by process of libel, for

seizure and condemnation in any district

where the substance is found.

H.R. 5820

Similar to S. 3209 for civil penalties and

criminal penalties, but as in current law,

criminal penalties apply to persons who

“knowingly or willfully” violate the act.

Removes criminal sanctions for “willfully”

violating any provision of TSCA, as

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 shall 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.

Amended TSCA 17 is similar to current law

but in addition to substances and mixtures,

S. 3209 applies to “articles” rather than

“products” and to any such items that are

subject to any title of TSCA.

Same as S. 3209.

Provision

Enforcement

15 U.S.C. 2601 et seq.

S. 3209

TSCA 17 [15 U.S.C. 2616] provides

jurisdiction to district courts over civil

actions to restrain any violation or any

person from taking any action prohibited, to

compel the taking of any action required, or

to direct any manufacturer or processor in

violation of section 5 or 6 or of Title IV (or

a rule or order under those provisions): to

give notice to distributors and to others in

possession of the substance, to give public

notice of risk, and to replace or repurchase

the substance.

Amended TSCA 17 authorizes the EPA

Administrator to commence a civil action in

the appropriate district court to compel

compliance of any person with any provision

of TSCA or any rule or order promulgated

pursuant to it. Authorizes EPA to seek civil

or criminal penalties, enjoin any violation, or

order compliance, through an administrative

proceeding, with any provision of TSCA or

with any rule or order issued under it.

Authorizes civil actions brought in the U.S.

district court for the judicial district wherein

any violation occurred or where the

defendant is found or transacts business.

Preemption of state law

CRS-53

TSCA 18 [15 U.S.C. 2617] does not

preempt state laws with two exceptions: (1)

when EPA requires testing of a chemical

under section 4, no state may require

testing of the same substance for similar

purposes; and (2) if EPA prescribes a rule or

order under section 5 or 6 to protect

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).

H.R. 5820

Same as S. 3209.

Gives district courts jurisdiction over civil

actions to seek penalties or enjoin violations

in the U.S. district court for the judicial

district wherein any violation occurred or

where the defendant is found or transacts

business. Gives jurisdiction over civil actions

ordering compliance to the U.S. district

court for the judicial district where the

defendant is found or transacts business.

Amended TSCA 18 would not preempt laws

relating to a chemical substance, mixture, or

article of states or political subdivisions

unless they were less stringent than federal

law.

Amended TSCA 18 provides that the act

does not affect the right of a state or political

subdivision to adopt or enforce its own laws

or requirements with regard to a chemical

unless compliance with both the requirement

and TSCA is “impossible.”

Provision

15 U.S.C. 2601 et seq.

S. 3209

Exemption from preemption

TSCA 18 [15 U.S.C. 2617] authorizes EPA,

upon application by a state or political

subdivision, by rule to exempt a law in 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.”

No comparable provision. (Since state laws

are not preempted, there is no need for an

exemption.)

Same as S. 3209.

Standard for judicial review

TSCA 19 [15 U.S.C. 2618] authorizes any

person to file a petition with the U.S. Court

of Appeals for the District of Columbia

Circuit or for the circuit in which such

person resides or in which the person’s

principal place of business is located, for

judicial review of rules promulgated under

TSCA sections 4(a), 5(a)(2), 5(b)(4), 6(a),

6(e), or 8. within 60 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).

Similar to current law, but TSCA 19, as

amended, authorizes filing a petition for

judicial review of any rule or order issued

under TSCA, as amended, rather than only

specified rules, and eliminates the directive

in current law to the court (to set aside a

rule not supported by substantial evidence

in the rulemaking record taken as a whole).

Same as S. 3209.

CRS-54

H.R. 5820

Provision

15 U.S.C. 2601 et seq.

S. 3209

Citizen suits

TSCA 20 [15 U.S.C. 2619] authorizes civil

suits by any person against any person in

violation of TSCA or rules or orders

promulgated under specified sections of

TSCA. It also authorizes suits against EPA to

compel performance of nondiscretionary

actions under TSCA.

Amended TSCA 20 is similar to current law,

but authorizes suits against any person in

violation of rules or orders promulgated

under any provision of TSCA, as amended.

Same as S. 3209.

Citizen petitions

TSCA 21 [15 U.S.C. 2620] provides the

public with the right to petition EPA to

initiate rulemaking or repeal of specified

rules. Requires the Administrator to grant

or deny the petition within 90 days of its

filing.

Amended TSCA 21 is similar to current law,

but authorizes petitions for EPA to initiate

any action authorized under the law.

Amended TSCA 21 is the same as S. 3209.

Employee protection

TSCA 23 [15 U.S.C. 2622] prohibits

employers from discriminating against an

employee because the employee has acted

or is about to act in a way that would

further the purposes of TSCA. Authorizes

filing of complaints by employees who

believe they have been discriminated against.

Describes remedies, procedures, and

enforcement.

Same as current law.

H.R. 5820, section 22 amends TSCA 23 to

elaborate the procedures, authorize

protection for employees who refuse to

violate TSCA or who share information

about violations of TSCA with government

officials, shorten the time between the filing

of a complaint and issuance of a preliminary

order by the Secretary of Labor, and

describe the criteria that are to be used by

the Secretary to deal with complaints.

Employment effects

TSCA 24 [15 U.S.C. 2623] directs the

Administrator to continually evaluate the

potential effects of specified rules, orders,

and requirements under specified TSCA

provisions on employment.

Amended TSCA 24 is similar to current law,

but directs the Administrator to evaluate

potential effects of the law as a whole,

rather than specific provisions, and

reporting is to be “periodic,” rather than

continual.

Same as S. 3209.

CRS-55

H.R. 5820

Provision

Administration

15 U.S.C. 2601 et seq.

S. 3209

H.R. 5820

TSCA 26(a) [15 U.S.C. 2625(a)] authorizes

federal agencies, upon request from EPA, to

provide services, personnel, facilities, and

information to EPA to assist in

implementation of TSCA.

Amended TSCA 26 is similar to current law,

except for subsection (b) and a new

subsection (h).

H.R. 5820, section 24 is similar to current

law, except that it amends TSCA 26(b) in the

same way as S. 3209.

Amended TSCA 26(b) authorizes collection

of fees from data submitters to defray the

cost of administering TSCA, as amended. It

removes the restrictions in the original

TSCA 26(b) on the amount of such fees.

In addition, the bill amends TSCA 26(d) to

direct the Administrator to take actions by

order when the action applies to a single

chemical substance or single category of

chemical substances.

New TSCA 26(h) authorizes the

Administrator to issue orders and prescribe

regulations as necessary to carry out the

law.

Amended TSCA 26(e) also provides that no

action will apply to articles already

introduced or delivered for introduction into

commerce, unless the action is taken to

address an imminent hazard and is necessary

to protect health or the environment.

TSCA 26(b) [15 U.S.C. 2625(b)] authorizes

collection of fees for EPA processing of data

submitted in response to an order under

Section 4 or 5.

TSCA 26(c) [15 U.S.C. 2625(c)] authorizes

EPA to impose regulatory controls on

categories of chemicals, rather than on a

case-by-case basis. Prohibits regulation of a

group based solely on the fact that it

consists of new chemical substances.

Finally, amended TSCA 26(j) authorizes the

Administrator to prescribe regulations as are

necessary to carry out the act.

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.

State programs

CRS-56

TSCA 28 [15 U.S.C. 2627] authorizes grants

to states to establish and operate programs

to prevent or eliminate unreasonable risks

to health or the environment which EPA is

unable or is not likely to address under

TSCA.

Amended TSCA 28 is similar to current law,

but grants are authorized to prevent or

eliminate any risks that EPA has not

addressed. In addition, EPA is directed to

establish a process to coordinate with the

states “to share data and priorities relating

to the management of chemical substances”

under TSCA, as amended, and under state

programs.

Amended TSCA 28 is similar to S. 3209

except that tribes are eligible for grants, and

the specific reference to “cancer, birth

defects, and gene mutations” is eliminated.

Amended TSCA 28(b) also specifies the

areas for coordination.

Provision

15 U.S.C. 2601 et seq.

S. 3209

H.R. 5820

Children’s environmental health

research

No comparable provision.

New TSCA 30 establishes a Children’s

Environmental Health Research Program at

EPA and authorizes the Administrator to

enter into contracts and make grants to

conduct research that will “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 (FACA) 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.

New TSCA 33 is similar to S. 3209, but does

not establish a research program at EPA. It

does direct the Administrator to enter into

contracts and make grants, subject to

amounts made available in advance in

appropriations acts. Establishes the Science

Advisory Board on Children’s Health and

Toxic Substances, an advisory committee

subject to FACA, to consult with the

Administrator on the scientific and technical

aspects of issues relating to the

implementation of the amended TSCA.

Membership is the same as for the

interagency committee established by S.

3209. The appointment process for members

of the committee is to be publicly disclosed.

A transcript or audio or video recording of

each advisory committee meeting must be

made available electronically on the EPA

website within 30 days of the meeting.

Monitoring exposures

No comparable provision.

New TSCA 30 directs EPA 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.

New TSCA 33(c) is similar to S. 3209,

except that a study need not be conducted if

the Administrator determines that the

substance already is subject to equivalent

testing or meets the safety standard, or a

safety standard determination is pending and

a study is not required to complete the

determination.

CRS-57

Provision

Animal-based testing

15 U.S.C. 2601 et seq.

No comparable provision.4

S. 3209

H.R. 5820

New TSCA 31 directs the Administrator to

minimize the use of animals in testing of

chemical substances or mixtures. Establishes

an Interagency Science Advisory Board on

Alternative Testing Methods subject to

FACA. The 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,

biennially 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.

New TSCA 34 is similar to S. 3209, but does

not require EPA to fund and carry out

research, development, performance

assessment, and translational studies to

accelerate development of test methods and

strategies. H.R. 5820 also does not establish

a new interagency advisory board, instead

directing EPA to consult with the Interagency

Coordinating Committee on the Validation

of Alternative Methods, which already is

established (P.L. 106-545, 42 U.S.C. 285l-3).

Specifies that a waiver of animal-based

testing does not waive the duty of the

manufacturer or processor to demonstrate

that the substance or mixture meets the

safety standard.

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-58

Provision

Safer alternatives

5

15 U.S.C. 2601 et seq.

No comparable provision.5

S. 3209

H.R. 5820

New TSCA 32 establishes a program to

create market incentives for the

development of safer alternatives to existing

chemical substances that reduce or avoid

the use and generation of hazardous

substances. Requires that the program

include expedited review of new chemical

substances for which an alternatives analysis

indicates it is a safer alternative, and

recognition for a substance or product

determined by EPA to be a safer alternative.

New TSCA 35 is similar to S. 3209, except

that it: requires the program to apply to

mixtures as well as chemical substances;

requires the Administrator to provide notice

and an opportunity for public comment prior

to establishment of the program; and omits

the requirement that the program include

expedited review of new chemical substances

that may be safer alternatives. Also, the

Administrator is directed to establish by rule

the data that constitute a safer alternative

data set to be used in seeking approval for

designation as a safer alternative for a

particular use. Requires inclusion of specified

information. Directs the Administrator to

approve an applicant alternative for a

proposed use if the manufacturer or

processor shows that the product is effective

and provides a reasonable certainty of no

harm from aggregate exposure through

intended uses, protects the public welfare,

and reduces the potential for harm relative

to the substance it is meant to replace. Such

safer alternatives are exempt for 15 years

from requirements of amended TSCA 4, 5,

and 6 for the uses approved.

Although there is no explicit authority in TSCA, EPA does promote green chemistry (http://www.epa.gov/greenchemistry/), safer products (http://www.epa.gov/dfe/

product_label_consumer.html), green engineering (http://www.epa.gov/oppt/greenengineering/pubs/whats_ge.html) and other “green” initiatives.

CRS-59

Provision

Green chemistry and green

engineering

Reliable information and advice

6

Ibid.

CRS-60

15 U.S.C. 2601 et seq.

No comparable provision.6

No comparable provision.

S. 3209

H.R. 5820

Directs the Administrator to establish 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.

Similar to S. 3209, but directs the

Administrator within 2 years of the date of

enactment of H.R. 5820 to establish an

interdisciplinary network of an unspecified

number of regional centers to support

research, development, and adoption of safer

alternatives.

New TSCA 34 directs EPA by order to

establish and implement procedures to

ensure data reliability by annually 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.

New TSCA 37 is similar to S. 3209, but does

not direct EPA to establish a registry of

health and safety studies and requires notice

and an opportunity to comment on

procedures to ensure data reliability.

All these requirements are made subject “to

amounts made available in advance in

appropriations Acts.”

Provision

Hot spots

CRS-61

15 U.S.C. 2601 et seq.

No comparable provision.

S. 3209

H.R. 5820

New TSCA 35 requires that EPA

promulgate a rule to establish criteria to

identify any locality that is

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 locations

on the list are 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 annually to

Congress.

New TSCA 38 is similar to S. 3209, but does

not address judicial review or state that

listing is a nondiscretionary duty. Requires

EPA to initially identify at least 20 localities.

Provision

Federal agencies subject to

TSCA

15 U.S.C. 2601 et seq.

No comparable provision.

S. 3209

New TSCA 36 provides that all 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 all

exemptions granted during the previous

year.

H.R. 5820

New TSCA 40 is the same as S. 3209.

Authorizes enforcement action against any

federal agency, as well as voluntary

resolution or settlement set forth in a

consent order.

International cooperation

CRS-62

No comparable provision.

New TSCA 33 directs the Administrator to

cooperate with the Secretary of State and

the head of any other appropriate federal

agency with international efforts to develop

a common protocol or electronic database

relating to chemical substances or to

develop safer alternatives for chemical

substances.

New TSCA 36 is similar to S. 3209, but

directs the Administrator to cooperate with

any international effort that “the

Administrator determines has broad

international support and a reasonable

expectation of success” to develop “safer

alternatives for chemical substances and

mixtures.”

Provision

International agreements

15 U.S.C. 2601 et seq.

No comparable provision.

S. 3209

H.R. 5820

New TSCA 37 provides authority for EPA

to implement three international

agreements: the Stockholm Convention on

Persistent Organic Pollutants (Stockholm

Convention), the Aarhus Protocol to the

Convention on Long-Range Transboundary

Air Pollution (LRTAP Protocol), and the

Rotterdam Convention on the Prior

Informed Consent Procedure for Certain

Hazardous Chemicals and Pesticides in

International Trade (PIC Convention).

Directs the Administrator to implement and

support implementation of the provisions of

the three agreements that have entered into

force for the United States.

New TSCA 36 directs the Administrator to

implement international agreements related

to chemical substances and subsequent

amendments to which the United States

becomes a party. It directs the Administrator

to prohibit manufacture, processing,

distribution in commerce, use, and disposal

of specified chemical substances and

mixtures (some of which are listed in an

annex to the Stockholm Convention and/or

the LRTAP Protocol) within 3 years of

enactment or in accord with requirements of

the Stockholm Convention, the PIC

Convention, or the LRTAP Protocol if the

United States deposits its instrument of

ratification before the prohibition has taken

effect. Excepts use of such chemicals for

critical uses.

Prohibits manufacture, processing,

distribution in commerce, use, disposal, or

any other action with respect to a covered

chemical in a manner inconsistent with

applicable international obligations.

Directs EPA to provide timely public notice

and opportunity to comment on: a chemical

proposed for listing, a recommendation

made to list a chemical on any Annex in

advance of any meeting of the Parties at

which the recommendation is to be

considered, and any decision by the Meeting

of the Parties to list a chemical.

Authorizes the Administrator to prescribe

regulations to carry out provisions of the

three agreements or to ensure compliance

with obligations under them. Prohibitions

and other requirements shall be enforced in

the same way as final rules or orders under

amended TSCA 6.

CRS-63

Requires the Administrator, in consultation

with the Secretary of State, to publish in the

Federal Register a notice of the chemical

substances or mixtures subject to the

Stockholm Convention, the PIC Convention,

and the LRTAP Protocol. Directs EPA to

provide timely public notice and opportunity

to comment at various stages of the process

of listing or delisting chemicals, as required in

agreements to which the United States is a

party.

Requires that any chemical listed under an

international agreement to which the United

States is a party must be added to the

priority list under amended TSCA 6(a),

unless it already is subject to risk

management under amended TSCA 6(c).

Authorizes the Administrator to prescribe

regulations as necessary to cooperate with

international efforts and to implement

international agreements to which the

United States is a party.

Provision

Persistent, bioaccumulative,

toxic substances (PBTs)

CRS-64

15 U.S.C. 2601 et seq.

No comparable provision.

S. 3209

No comparable provision.

H.R. 5820

New TSCA 32 directs the Administrator

within one year of enactment of H.R. 5820

to establish criteria by rule to identify

chemical substances and mixtures that are

persistent, bioaccumulative, and toxic,

(PBTs), or are degraded or metabolized into

PBTs, and for which there is documented

evidence of exposure to humans or the

environment. With

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