Proposed Reform of the Toxic Substances Control Act (TSCA) in the 112th Congress: S. 847 Compared with Current Law

Proposed Reform of the Toxic Substances

Control Act (TSCA) in the 112th Congress:

S. 847 Compared with Current Law

(name redacted)

Specialist in Environmental Policy

July 25, 2011

Congressional Research Service

7-....

www.crs.gov

R41937

CRS Report for Congress

Prepared for Members and Committees of Congress

Proposed Reform of the Toxic Substances Control Act (TSCA)

Summary

Thirty-five years of experience implementing and enforcing the Toxic Substances Control Act

(TSCA) have demonstrated the strengths and weaknesses of the law and led many to propose

legislative changes to TSCA’s core provisions. Stakeholders appear to agree that TSCA needs to

be updated, although there is disagreement about the extent and nature of any proposed revisions.

S. 847 in the 112th Congress legislation would amend core provisions of TSCA Title I. This report

compares key provisions of S. 847, as introduced, with current law (15 U.S.C. 2601 et seq.).

Generally, S. 847 would increase the amount of information about chemical toxicity and usage

that chemical manufacturers and processors would be required to submit to the U.S.

Environmental Protection Agency (EPA), and would facilitate EPA regulation of toxic chemicals.

The bill directs EPA to establish, by rule, varied or tiered minimum data set requirements for

different chemical substances or categories of substances. Data would be required from chemical

manufacturers and processors for all chemicals within five years of the date of enactment of S.

847, earlier for high-priority chemicals. All chemicals already in commerce are to be placed on a

list and prioritized by EPA into three groups based on the need for risk management. A chemical

must be included in the highest priority class if it “is, or is degraded and metabolized into, a

persistent, bioaccumulative, and toxic substance with the potential for widespread exposure to

humans or other organisms.” EPA is required to determine whether chemicals in the top two

priority classes, as well as all new chemicals, meet a stringent new safety standard, given the

imposition of any needed restrictions on manufacture, processing, distribution, use, or disposal.

The bill would prohibit any activities with respect to an evaluated chemical substance that the

EPA had not specifically allowed in the safety standard determination.

In contrast, current law authorizes data collection from manufacturers only if exposure is

expected to be substantial or if EPA determines that a chemical may pose an unreasonable risk.

TSCA as currently written allows all chemicals to enter and remain in commerce unless EPA can

show that a chemical poses “an unreasonable risk of injury to health or the environment.” EPA

then must regulate to control unreasonable risk, but only to the extent necessary using the “least

burdensome” means of available control. This TSCA standard has been interpreted to require

cost-benefit balancing.

S. 847 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.

Key provisions of S. 847 are compared with current law in Tables 1 through 6.

Congressional Research Service

Proposed Reform of the Toxic Substances Control Act (TSCA)

Contents

Introduction ................................................................................................................................1

Effects of the Proposed Legislation on Current Law ....................................................................1

Minimum Data Set Requirements..........................................................................................1

Prioritization of Chemicals....................................................................................................2

Safety Standard and Burden of Proof.....................................................................................2

EPA Authority to Manage Risks ............................................................................................3

State Preemption ...................................................................................................................3

Miscellaneous Provisions ......................................................................................................4

Tables

Table 1. Titles and Definitions in Selected Provisions of TSCA (15 U.S.C. 2601 et seq.)

and the Safe Chemicals Act (S. 847), as Introduced ..................................................................5

Table 2. Testing in Selected Provisions of TSCA (15 U.S.C. 2601 et seq.) and the Safe

Chemicals Act (S. 847), as Introduced ......................................................................................9

Table 3. Notices in Selected Provisions of TSCA (15 U.S.C. 2601 et seq.) and the Safe

Chemicals Act (S. 847), as Introduced .................................................................................... 14

Table 4. Restrictions in Selected Provisions of TSCA (15 U.S.C. 2601 et seq.) and the

Safe Chemicals Act (S. 847), as Introduced ............................................................................ 24

Table 5. Reporting Requirements in Selected Provisions of TSCA (15 U.S.C. 2601 et

seq.) and the Safe Chemicals Act (S. 847), as Introduced........................................................ 32

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

Chemicals Act (S. 847), as Introduced .................................................................................... 36

Contacts

Author Contact Information ...................................................................................................... 48

Congressional Research Service

Proposed Reform of the Toxic Substances Control Act (TSCA)

Introduction

In 1976, President Gerald R. Ford signed the Toxic Substances Control Act (15 U.S.C. 2601 et

seq.; TSCA), giving the U.S. Environmental Protection Agency (EPA) authority to regulate

production and use of industrial chemicals not otherwise regulated in U.S. commerce. 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 Based on hearing testimony, stakeholders generally agree that TSCA needs

to be updated, although there is disagreement about the extent and nature of any proposed

revisions.3 Democrats introduced legislation to amend TSCA Title I in the 111th Congress (S.

3209 and H.R. 5820), but Congress did not vote on either bill. Those previous bills proposed

generally similar changes to TSCA that were summarized in CRS Report R41335, Proposed

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

Current Law. On April 14, 2011, Senator Frank Lautenberg introduced similar, but not identical,

legislation (S. 847) in the 112th Congress. To date, no other legislation has been introduced that

would amend core provisions of TSCA Title I. Therefore, this report compares key provisions of

S. 847, as introduced, with provisions of TSCA Title I (15 U.S.C. 2601 et seq.) that would be

affected if S. 847 becomes law. These provisions are summarized in Tables 1 through 5. New

provisions that would be added to the end of TSCA Title I by S. 847—for example, those related

to reduced use of animals for toxicity testing—are summarized in Table 6.

Effects of the Proposed Legislation on Current Law

S. 847 would not affect Titles II through VI of TSCA, nor would it change the basic organization

of TSCA Title I. 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

changes to TSCA Title I that were enacted during the 110th Congress, such as a provision that

bans exports of elemental mercury.4 However, S. 847 would amend or delete most of the original

Title I provisions and would make substantial additions to current law. Some key changes are

summarized below.

Minimum Data Set Requirements

S. 847, as introduced, directs the EPA Administrator to establish varied or tiered minimum data

set requirements for different chemical substances or categories of substances. Manufacturers

would be given a specified period of time to produce and submit data meeting the minimum data

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.

3

U.S. Congress, Senate, Committee on Environment and Public Works, Subcommittee on Superfund, Toxics and

Environmental Health, Hearing, “Assessing the Effectiveness of U.S. Chemical Safety Laws.” February 3, 2011,

http://epw.senate.gov/public/index.cfm?FuseAction=Hearings.Hearing&Hearing_ID=cd4fd6b9-802a-23ad-4d18eac94d1414b3.

4

S. 906, which became P.L. 110-414.

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Proposed Reform of the Toxic Substances Control Act (TSCA)

requirements for chemicals that are already in commerce and for any new chemicals that they

propose to manufacture. Data sets would have to be submitted within five years of the date of

enactment of S. 847.

Current law does not routinely require submission of data for chemicals, but EPA has the

authority to require data submission if it promulgates a rule based on a finding that a chemical

“may present an unreasonable risk of injury to health or the environment” and the agency

demonstrates a data need.

Prioritization of Chemicals

S. 847 directs the EPA Administrator to prioritize all chemicals already in commerce for

evaluation and risk management by establishing a list that “contains the names of the chemical

substances that … warrant placement within 1 of 3 priority classes … and identifies the priority

class to which each listed chemical substance or category of chemical substance has been

assigned by the Administrator.” Priority class 1 chemicals would be defined as those “... that the

Administrator determines require immediate risk management.” The Administrator would be

required to place between 20 and 30 chemicals in this category, and the data set for a high-priority

chemical would have to be submitted within 18 months of its placement on the priority class 1

list. Priority class 2 chemicals would be defined as those “that the Administrator determines

require safety standard determinations … based on any more-than-theoretical concern, that there

is uncertainty as to whether a chemical substance would satisfy the safety standard.” Priority class

3 chemicals would be defined as those “that the Administrator determines require no immediate

action.”

Chemicals are not prioritized under current law.

Safety Standard and Burden of Proof

The Senate bill would establish a health-based safety standard for chemical use that protects

vulnerable populations: manufacturers would be required to produce scientific data demonstrating

“there is a reasonable certainty that no harm will result to human health or the environment from

aggregate exposure to the chemical substance.” S. 847 would prohibit manufacture, processing,

and distribution of any chemical substance for any use that had not been included in the safety

determination issued for that chemical. Moreover, an exemption from a prohibition would be

allowed for a particular use only if: it were “in the paramount interest of national security”; lack

of the chemical use “would cause significant disruption in the national economy”; the use were

essential or critical and there were no safer feasible alternative; or the chemical use, relative to

alternatives, provided a benefit to health, the environment, or public safety.

In contrast, current law allows manufacture of and commerce in a chemical unless EPA

promulgates a rule including a finding that a chemical presents or will present an “unreasonable

risk” to human health or the environment. If EPA demonstrates that a risk associated with a

chemical is unreasonable (relative to the benefits provided by the chemical and the estimated

risks and benefits of any alternatives), the Agency is required to regulate, but only to the extent

necessary to reduce that risk to a reasonable level and using “the least burdensome” restriction.

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Proposed Reform of the Toxic Substances Control Act (TSCA)

EPA Authority to Manage Risks

S. 847 would expedite regulatory action, relative to the process under current law, by authorizing

EPA in some cases 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. 847. As introduced, the bill includes

language that allows EPA to define various distinct forms of substances that are the same in terms

of molecular identity but differ in structure and function, such as manufactured nanoscale forms

of carbon and silver. The introduced bill also broadens 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. S. 847 also would appear to more clearly authorize EPA

control of risks posed by articles containing a substance.

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.

S. 847 would authorize EPA activities not currently authorized under TSCA to allow

implementation of three international agreements pertaining to persistent organic pollutants and

other hazardous chemicals. For example, the proposal would authorize EPA to regulate chemicals

manufactured solely for export. The authority provided by the bill would be specific to three

international agreements, rather than more generally authorizing regulatory activity to implement

any ratified international agreement concerning chemicals. The bill would prohibit production

and use of chemicals when it was inconsistent with U.S. obligations under any of the three

international agreements after they had entered into force for the United States. For more

information about these agreements, see CRS Report RS22379, Persistent Organic Pollutants

(POPs): Fact Sheet on Three International Agreements.

State Preemption

The effect of TSCA on state and local chemical laws would be modified by S. 847, as introduced.

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.” S. 847 would simplify this section of TSCA. An amended TSCA would not preempt

laws relating to a chemical substance, mixture, or article unless compliance with both federal and

the state or local law were impossible.

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Proposed Reform of the Toxic Substances Control Act (TSCA)

Miscellaneous Provisions

Several new provisions are included in S. 847. 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.”

EPA would be required to establish 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. The program would be required to expedite review of a new chemical

substance if an alternatives analysis indicated it was a safer alternative, and to recognize a

substance or product determined by EPA to be a safer alternative.

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 had indicated may be present in human biological substances and that may have adverse

effects on human development in fact was present in pregnant women and infants. If the chemical

were found to be present, manufacturers and processors would have to disclose to EPA,

commercial customers, consumers, and the general public all known uses of the chemical and all

articles in which the chemical was expected to be present.

Children’s environmental health also is addressed by the bill. It 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.

S. 847, as introduced, also establishes 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, S. 847 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.

This provision aims to expedite development of so-called “alternative testing methods,” which

have been under development for many years, but remain a minor component of toxicity testing

programs.

Tables 1 through 6 summarize these and other selected provisions of S. 847.

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Table 1.Titles and Definitions in Selected Provisions of TSCA (15 U.S.C. 2601 et

seq.) and the Safe Chemicals Act (S. 847), as Introduced

Provision

15 U.S.C. 2601 et seq.

S. 847

Title

Toxic Substances Control Act (TSCA)

Safe Chemicals Act of 2011 (SCA)

Revised definitions

TSCA definitions are in alphabetical

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

S. 847 section 4 would amend

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)]

Proposed TSCA 3(5) is the same as

15 U.S.C. 2602(2), but also authorizes

EPA to determine that “a variant of a

chemical substance is a new chemical

substance,” notwithstanding molecular

identity.

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)]

Would amend the TSCA 3(8)

definition to include “to export or

offer for export the substance,

mixture, or article.”

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)]

Would amend the TSCA 3(10)

definition to include “ambient” and

“indoor air.”

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)]

Proposed TSCA 3(15) revises the

definition, 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 Proposed

TSCA section 8(a).

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Proposed Reform of the Toxic Substances Control Act (TSCA)

Provision

15 U.S.C. 2601 et seq.

S. 847

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)]

This definition would be eliminated.

Aggregate exposure

No comparable definition.

Total exposure to a chemical

substance regardless of the source of

exposure, including activities involved

in the manufacture, processing,

distribution, use, or disposal of

chemicals; contamination of food, air,

water, soil, and house dust from

current or prior uses or activity;

accidental releases; permitted sources

of pollution; nonpoint sources of

pollution; documented background

levels from natural and anthropogenic

sources; and a mixture or article

containing that chemical substance.

The term would include exposure

from a chemical substance that is not

considered a chemical substance

under TSCA solely because of its use

as, or in, food, cosmetics, or medical

devices. [Proposed TSCA 3(2)]

Bioaccumulative

No comparable definition.

As determined by the EPA

Administrator, the ability to

significantly accumulate in biota, or

highly likely to accumulate in biota.

[Proposed TSCA 3(3)]

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.

[Proposed TSCA 3(4)]

Standards for the development

of test data

New definitions

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Proposed Reform of the Toxic Substances Control Act (TSCA)

Provision

15 U.S.C. 2601 et seq.

S. 847

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 the same

or a similar adverse effect.” [Proposed

TSCA 3(7)]

End consumer

No comparable definition.

An “individual or other entity that

purchases and uses or consumes a

chemical substance (or mixture or

article containing that chemical

substance).” [Proposed TSCA 3(9)]

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.”

[Proposed TSCA 3(11]

Persistent

No comparable definition.

Determined by the EPA

Administrator to significantly persist

in one or more environmental media.

[Proposed TSCA 3(16)]

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.” Includes “each

Federal agency and any officer, agent,

or employee of a Federal agency.”

[Proposed TSCA 3(17)]

Special substance characteristics

No comparable definition.

Defines “special substance

characteristic” to mean “such physical,

chemical, or biological characteristic,

other than molecular identity, that the

Administrator determines, by order

or rule, may significantly affect the

risks posed by substances exhibiting

that characteristic.” Allows

consideration of size, shape, reactivity,

and any other properties that may

significantly affect risks posed.

[Proposed TSCA 3(20)]

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Proposed Reform of the Toxic Substances Control Act (TSCA)

Provision

15 U.S.C. 2601 et seq.

S. 847

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.”

[Proposed TSCA 3(22)]

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.” [Proposed TSCA 3(23)]

Vulnerable human population

No comparable definition.

A “human population that is subject

to a disproportionate exposure to, or

the 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.” [Proposed TSCA

3(25)]

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Table 2.Testing in Selected Provisions of TSCA (15 U.S.C. 2601 et seq.) and the Safe

Chemicals Act (S. 847), as Introduced

Provision

Testing authorities and

requirements

15 U.S.C. 2601 et seq.

S. 847

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. 847, section 5, amends TSCA 4.

Proposed TSCA 4(a) directs the EPA

Administrator within one year of

enactment of S. 847 to promulgate a

rule establishing varied or tiered

minimum data sets for different

chemical substances or categories of

substances. Data sets must encourage

and facilitate use of alternative testing

methods and strategies in accordance

with section 30 and must include “the

minimum amount of information

necessary“ for the conduct of a

screening-level risk assessment of the

substance or category of substances.

The rule must require submission to

EPA of such data by each

manufacturer and processor of a new

chemical substance and each

manufacturer and processor of an

existing chemical. Also requires

updates of minimum data set

submissions.

Proposed TSCA 4(b) authorizes EPA

to require, by rule or 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.

Test rule requirements

Congressional Research Service

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.

Proposed TSCA 4(c) is similar to 15

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

EPA orders as well as rules.

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Proposed Reform of the Toxic Substances Control Act (TSCA)

Provision

15 U.S.C. 2601 et seq.

S. 847

Deadlines for initial data

submission

No comparable provision.

Proposed TSCA 4(a) requires

submission to EPA of the minimum

data set for an existing chemical

within 18 months of the date that EPA

assigns the chemical to a priority class

under section 6(a) or 5 years of the

date of enactment of the SCA,

whichever is earlier. Submission of the

minimum data set is required for a

new chemical at the time notice is

provided to EPA [under revised TSCA

section 5(a)] that a new chemical will

be manufactured.

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.

Proposed 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

Failure to submit data

No comparable provision.

Proposed TSCA 4(a)(3) and 4(b)(3)

authorize EPA to, by order, take any

regulatory action authorized under

section 6(c) if a manufacturer or

processor fails to submit required

data or a required chemical sample.

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.

Proposed 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 EPA Administrator’s

order to reimburse is a final agency

action for the purpose of judicial

review.

Cessation of manufacture or

processing

No comparable provision.

Proposed 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.

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Provision

15 U.S.C. 2601 et seq.

S. 847

Contents of minimum data set

No comparable provision.

Proposed TSCA 4(a) directs EPA to

include in the minimum data set

information on characteristics,

toxicological properties, exposure,

and use of a chemical substance,

information that the EPA anticipates

will be necessary for the conduct of a

screening-level risk assessment of the

chemical. Allows EPA to provide for

varied or tiered testing for different

chemicals or categories of chemicals.

Prescribed data needs

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

authorizes 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.

Proposed TSCA 4(c) authorizes EPA

to prescribe data development

standards for health and

environmental information, including

information pertaining to: any effect

that may be considered in a safety

standard determination; exposure,

including presence in human tissues

and fluids; and any characteristic of a

chemical 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).

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.

This provision would be eliminated.

Alternatives to animal testing

No comparable provision.a

Requires that animal tests are

consistent with provisions of

Proposed TSCA section 30,

promoting alternatives to animal

testing.

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.

Proposed TSCA 4(c)(3)(C) changes

the interval between required reviews

and revisions, if necessary, from one

to 3 years.

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

EPA Administrator must publish

findings required by TSCA 4(a)(1)(A)

or (B).

Proposed TSCA 4(c) omits TSCA

requirements for rulemaking that go

beyond the notice and comment

requirements of 5 U.S.C. 553.

Proposed TSCA 4(b) authorizes EPA

to issue orders in lieu of rules.

Congressional Research Service

11

Proposed Reform of the Toxic Substances Control Act (TSCA)

Provision

15 U.S.C. 2601 et seq.

S. 847

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).

Proposed 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 a publicly accessible Internet site.”

Interagency testing committee

(ITC)

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

establishes the ITC to advise the EPA

Administrator regarding chemicals

that should receive priority

consideration for promulgation of a

test rule [under subsection (a)].

Proposed TSCA 6(a)(5) establishes

the Interagency Prioritization and

Testing Committee, which is similar

to the ITC in composition.

Committee recommendations for

testing

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

the ITC to establish a prioritized list

of chemicals for the EPA

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.”

Proposed TSCA 6(a)(5) changes the

directive to the interagency

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.”

The committee also is to make

recommendations for prioritization of

chemical substances for risk

assessment and management using the

criteria established for each priority

class under proposed TSCA

6(a)(2)(B), 6(a)(3)(B), and 6(a)(4)(B).

Recommendations are to be updated

annually, if necessary. The EPA

Administrator is directed to provide

reasonable opportunity to any

interested person to file written

comments on the recommendations.

The Administrator is required to

consider any comments received and

to make them available to the public.

Prohibition of judicial review for

committee recommendations

No comparable provision.

Proposed TSCA 6(a)(5) protects from

judicial review recommendations by

the Interagency Prioritization and

Testing Committee.

Congressional Research Service

12

Proposed Reform of the Toxic Substances Control Act (TSCA)

Provision

15 U.S.C. 2601 et seq.

S. 847

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.

This provision would be eliminated,

but proposed TSCA 6(a)(2) directs

the Administrator to assign a chemical

substance to priority class 1 if “the

chemical substance is, or is degraded

and metabolized into, a persistent,

bioaccumulative, and toxic substance

with the potential for widespread

exposure to humans or other

organisms.” “As soon as practicable,

but not later than 18 months after the

date on which a chemical substance is

assigned to priority class 1,” EPA must

impose conditions on its

manufacturing, processing, use,

distribution in commerce, and disposal

that are determined to be necessary

to achieve “the greatest practicable

reductions in human or environmental

exposure” to the chemical substance.

Proposed TSCA 6(a)(2)(E) directs

EPA to promptly revise the priority 1

list of chemicals whenever the

addition or removal of a chemical

substance from the list is warranted.

Requests from other federal

agencies

No comparable provision.

Proposed 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 within 60 days to

collect and provide such information

to the requesting agency, collect

information under TSCA 8, issue a

rule or order to develop the data, or

publish in the Federal Register the

reason for not taking any of these

actions.

Certification of data submitted

No comparable provision.

Proposed 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.

a.

However, EPA has stated that it “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).

Congressional Research Service

13

Proposed Reform of the Toxic Substances Control Act (TSCA)

Table 3. Notices in Selected Provisions of TSCA (15 U.S.C. 2601 et seq.) and the Safe

Chemicals Act (S. 847), as Introduced

Provision

Notices concerning new

chemicals or uses

15 U.S.C. 2601 et seq.

S. 847

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.

Proposed TSCA 5(a)(1)-(3) treats new

chemicals in a similar manner to

current law, but also requires notice

prior to processing for a new

chemical. For an existing chemical that

has met the safety standard, requires

notice prior to manufacture or

processing for a new use, at new

production volume, or in a manner

other than specified in the safety

determination.

No notice is required for an existing

chemical for which EPA has not yet

made a safety determination, when

manufacture or process would be for

a new use or at a significantly

increased volume, but in such cases,

proposed TSCA 5(a)(2) requires

submission of a new or updated

declaration as required under

proposed TSCA 8(a).

New use determination

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.”

Prior to a safety standard

determination for an existing

chemical, proposed TSCA 5(a)

designates a use to be a new use if at

the time of enactment of S. 847 that

use was not ongoing, or if

manufacture or processing of the

substance would be at a significantly

increased volume. After a safety

standard determination has been

made for an existing chemical, a new

use is any use, production volume, or

manner other than those the EPA

Administrator specified in the safety

standard determination.

Special substance characteristics

No comparable provision.

Proposed TSCA 5(a)(6) directs the

EPA 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 proposed

TSCA 3(20)] is a new use or a new

chemical substance.

Congressional Research Service

14

Proposed Reform of the Toxic Substances Control Act (TSCA)

Provision

15 U.S.C. 2601 et seq.

S. 847

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.]

Proposed TSCA 5(c) requires a notice

to include the declaration made under

proposed TSCA 8(a)(2), the minimum

data set established under TSCA 4(a),

and a statement that the chemical will

meet the applicable safety standard.

Certification

No comparable provision.

Proposed 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.

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 EPA 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.”

At the time a manufacturer or

processor notifies EPA that it plans to

manufacture or process a chemical

substance that is new, proposed

TSCA 5(b) requires submission of: any

data required for that chemical

substance under a section 4(b) test

rule or order; the section 8(a)

declaration; and the minimum data set

established under proposed section

4(a).

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.

Proposed TSCA 5(b)(2) requires EPA

to make data available on a publicly

accessible Internet site, subject to

proposed TSCA 14.

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.

Proposed 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 proposed TSCA

section 6(b).

Congressional Research Service

When providing notice to EPA

regarding a new use of a chemical for

which the EPA 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 proposed TSCA

8(a).

15

Proposed Reform of the Toxic Substances Control Act (TSCA)

Provision

15 U.S.C. 2601 et seq.

S. 847

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.”

Authorizes EPA to extend the

determination deadline for periods

not to exceed one year.

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.

Proposed TSCA 5(b)(3)-(4) is similar

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

specifies that EPA must make notices

available on a publicly accessible

Internet site and requires disclosure

of the availability of the minimum data

set. In addition, requires EPA to make

available on the internet monthly a list

of chemical substances for which

notice has been received. [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.

Proposed TSCA 5(f) provides the

same definition as current law.

Congressional Research Service

16

Proposed Reform of the Toxic Substances Control Act (TSCA)

Provision

Safety determination for new

chemical or new use

15 U.S.C. 2601 et seq.

S. 847

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.

Proposed TSCA 5(a) prohibits

manufacture and processing of a

chemical for which notice is required

unless the EPA 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.

With respect to a new use of a

chemical for which the EPA

Administrator previously has made

the safety determination,

manufacturers must provide evidence

that permits the EPA Administrator to

amend the safety determination.

With respect to a new use of a

chemical for which the EPA

Administrator has not yet made a

safety standard determination,

manufacturers must provide the

declaration described in proposed

8(a).

Congressional Research Service

17

Proposed Reform of the Toxic Substances Control Act (TSCA)

Provision

15 U.S.C. 2601 et seq.

S. 847

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 EPA Administrator issues a

proposed rule, it is effective on the

date it is issued.

This provision would be eliminated. S.

847 requires risk management prior

to production and distribution.

Regulation pending development

of information

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

authorizes the EPA 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 EPA 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 would be eliminated.

Proposed 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.

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

EPA Administrator to publish a

statement of reasons for not taking

action.

This provision would be eliminated.

Congressional Research Service

18

Proposed Reform of the Toxic Substances Control Act (TSCA)

Provision

15 U.S.C. 2601 et seq.

S. 847

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 EPA 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).

This provision would be eliminated.

Intermediate production

chemicals

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

authorizes exemptions upon

application for production-related

(temporary, so-called “intermediate”)

chemicals when no human or

environmental exposure will occur.

Proposed TSCA 5(d)(4) is the 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.”

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

current law but a person must show

that it “will not endanger human

health or the environment.”

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

TSCA 4(b) data submission

requirement to request from EPA an

exemption from the TSCA 5(b)

requirement 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 substance

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.

Proposed 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.

Exemptions from notice requirements

Equivalent chemicals and

duplicative data

Congressional Research Service

“Test marketing” is defined in

proposed TSCA 5(f) to exclude

provision of a chemical or article

containing a chemical to an end

consumer.

19

Proposed Reform of the Toxic Substances Control Act (TSCA)

Provision

15 U.S.C. 2601 et seq.

S. 847

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.

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

current law.

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.

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

current law.

Congressional Research Service

20

Proposed Reform of the Toxic Substances Control Act (TSCA)

Provision

15 U.S.C. 2601 et seq.

S. 847

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

EPA 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 EPA 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.”

This provision would be eliminated,

but proposed TSCA 6(a) directs EPA

by order to establish a list that

“contains the names of the chemical

substances that … warrant placement

within 1 of 3 priority classes … and

identifies the priority class to which

each listed chemical substance or

category of chemical substance has

been assigned by the EPA

Administrator.”

EPA must give due consideration in

listing decisions to recommendations

provided by the Interagency

Prioritization and Testing Committee.

Proposed TSCA 6(a)(6) prohibits

judicial review of EPA’s decisions

about listing, including any EPA

response to a petition to list a

particular chemical substance.

Any rulemaking under this provision

must be promulgated pursuant to the

procedures specified in the

Administrative Procedure Act (5

U.S.C. 553) providing for notice and

public comment, 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 EPA 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.”

Congressional Research Service

21

Proposed Reform of the Toxic Substances Control Act (TSCA)

Provision

15 U.S.C. 2601 et seq.

S. 847

Priority class 1

No comparable provision.

Priority class 1 chemicals are those

“that the Administrator determines

require immediate risk management.”

A chemical must be assigned to

priority class 1 if it “is, or is degraded

and metabolized into, a persistent,

bioaccumulative, and toxic substance

with the potential for widespread

exposure to humans or other

organisms.” Proposed TSCA

6(a)(2)(C) requires that at least 20 but

no more than 30 chemicals be

assigned to priority class 1 within one

year of enactment of S. 847. Proposed

TSCA 6(a)(2)(E) directs the EPA

Administrator to revise the list

whenever the EPA Administrator

determines that addition or removal

of a chemical substance is warranted,

but a substance only may be removed

“if the Administrator finds that such

substance meets the safety standard

under subsection (b).”

Priority class 2

No comparable provision.

Priority class 2 chemicals are those

“that the Administrator determines

require safety standard

determinations … based on any

more-than-theoretical concern, that

there is uncertainty as to whether a

chemical substance would satisfy the

safety standard in a determination

made under “ proposed TSCA 6(b).

The timing of additions to the priority

class 2 list of chemicals should be

“expeditious” but “shall not exceed

the rate at which the Administrator

reasonably anticipates completing

safety determinations under

subsection (b).” The EPA

Administrator is required to first

assign to priority class 2 those

chemicals “that present the greater

risks to human health or the

environment.” Proposed TSCA

6(a)(3)(C) prohibits removal of a

chemical from the list until the EPA

Administrator has made a safety

determination for that chemical.

Congressional Research Service

22

Proposed Reform of the Toxic Substances Control Act (TSCA)

Provision

Priority class 3

Congressional Research Service

15 U.S.C. 2601 et seq.

No comparable provision.

S. 847

Priority class 3 chemicals are those

“that the Administrator determines

require no immediate action.” A

chemical is to be assigned to this list if

it has intrinsic properties that pose no

risk of adverse effects to human

health or the environment under

existing, proposed, or anticipated

levels of exposure or production or

patterns of use. The EPA

Administrator is directed to

“promptly revise the list under

paragraph (1) whenever the

Administrator determines that the

addition or removal of a chemical

substance from priority class 3 is

warranted.”

23

Proposed Reform of the Toxic Substances Control Act (TSCA)

Table 4. Restrictions in Selected Provisions of TSCA (15 U.S.C. 2601 et seq.) and the

Safe Chemicals Act (S. 847), as Introduced

Provision

Regulation

15 U.S.C. 2601 et seq.

S. 847

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. 847 does not require rulemaking,

but section 7 would 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.

847 also would authorize 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 EPA

Administrator. The bill, as introduced,

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.

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.

Congressional Research Service

In addition, S. 847 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. [Proposed TSCA 6(b) and

(c)]

24

Proposed Reform of the Toxic Substances Control Act (TSCA)

Provision

15 U.S.C. 2601 et seq.

S. 847

Safety standard

No comparable provision, but in general

terms, the standard embedded in TSCA

is that EPA should protect against

“unreasonable risk,” a standard that

appears to require risk assessment but

allows balancing of risks and benefits.

Proposed TSCA 6(b)(1)(C) directs the

EPA Administrator to base a

determination of whether a chemical

meets its safety standard ”solely on

considerations of human health and

the environment, including the health

of vulnerable human populations.” To

the extent practicable, the EPA

Administrator is required to

incorporate “any available scientific

information relating to the effect of

cumulative exposure … on human

health and the environment.” For a

chemical to meet the safety standard,

the EPA Administrator must find that

“there is a reasonable certainty that

no harm will result to human health

or the environment from aggregate

exposure to the chemical substance.”

General process for safety

determinations

No comparable provision.

Proposed TSCA 6(b)(1) requires that

EPA produce a risk assessment

addressing health and environmental

impacts in support of any

determination that a manufacturer or

processor of a chemical substance has

met the applicable safety standard.

Risk assessments must be transparent

and understandable to the public and

to risk managers.

No risk assessment is required when

EPA determines that the safety

standard has not been met, and such

determination is not subject to judicial

review.

Proposed TSCA 6(b)(1) also

establishes that manufacturers and

processors of a chemical substance

are responsible for providing sufficient

information for the EPA

Administrator to determine whether

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 applicable safety standard.

Congressional Research Service

25

Proposed Reform of the Toxic Substances Control Act (TSCA)

Provision

15 U.S.C. 2601 et seq.

S. 847

Scientific standards for data

assessment

No comparable provision.

Proposed TSCA 6(b)(1)(C) requires

the EPA Administrator to “use the

best available science” in conducting a

risk assessment considering the

recommendations of the National

Academy of Sciences in the report

entitled “Science and Decisions.”

Every 5 years, the EPA Administrator

is required to review the

methodology and may revise it “to

reflect new scientific developments or

understandings.”

Safety of chemicals for export

No comparable provision.

Proposed TSCA directs EPA to

consider risks that a chemical

manufactured in whole or in part for

export may pose in the United States

during production and distribution in

commerce, including in imported

products containing the substance.

EPA’s determination

No comparable provision.

Within 1 year after 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.

Failure to submit data

No comparable provision.

If data are not submitted, proposed

TSCA 6(b)(2) authorizes EPA to take

any action authorized under

subsection (c).

Failure by EPA to meet

required deadline

No comparable provision.

If EPA fails to meet the deadline for a

safety determination, proposed TSCA

6(b)(2) provides that manufacturers

and processors are required to

provide to EPA, the public, their

employees, and customers written

notice that a determination by EPA of

the safety of the chemical is pending.

Resubmission

No comparable provision.

Proposed TSCA 6(b)(2) provides that

within 30 months of assignment of a

chemical to priority class 2 under

proposed TSCA 6(a), manufacturers

must submit updated information for

any previously submitted minimum

dataset. In addition, requires that at

least every 15 years, manufacturers

and processors of each chemical

substance submit an updated

minimum dataset and indicate

whether the substance and specified

uses meet the safety standard.

Safety determinations for

existing chemicals

Congressional Research Service

26

Proposed Reform of the Toxic Substances Control Act (TSCA)

Provision

15 U.S.C. 2601 et seq.

S. 847

Redetermination

No comparable provision.

EPA may initiate a redetermination of

whether a 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.

Petition for redetermination

No comparable provision.

Authorizes any person to petition the

EPA Administrator for a

redetermination. The Administrator

must decide whether to make the

requested redetermination and

publish the decision and its basis in

the Federal Register within 180 days.

Restrictions on substances that

do 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 EPA

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.”

Proposed 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.

Use restrictions for substances

meeting the safety standard

No comparable provision.

Proposed 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.

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.

Proposed 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.”

Congressional Research Service

27

Proposed Reform of the Toxic Substances Control Act (TSCA)

Provision

15 U.S.C. 2601 et seq.

S. 847

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.

Proposed 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 human health or the

environment.” Does not require such

determination to be made on the

record after opportunity for hearing.

Resale of used articles

No comparable provision.

Proposed TSCA 6(e)(3) provides that

restrictions established under sections

4(a)(3), 4(b)(3), 6(b)(2)(A)(iv), 6(b)(3),

8(b)(6), or 8(c)(3) do not apply to

resale of an article subject to a

restriction under proposed TSCA

6(b) if the article has previously been

used.

Delay of effective date of

restrictions

No comparable provision.

Proposed TSCA 6(e)(4) 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 proposed TSCA section 8.

Congressional Research Service

28

Proposed Reform of the Toxic Substances Control Act (TSCA)

Provision

15 U.S.C. 2601 et seq.

S. 847

Exemptions from prohibitions

and other restrictions

No comparable provision.

Proposed TSCA 6(e) authorizes EPA

to grant, by order, exemptions (and

renewals of exemptions) to

restrictions proposed to be

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

for which there is no safer feasible

alternative, or the specified use

compared to available alternatives

provides a net benefit to human

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.

Certification of the quality of

submitted information

No comparable provision.

Proposed 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.

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.

Proposed TSCA 6(g) is the same as

current law.

Congressional Research Service

29

Proposed Reform of the Toxic Substances Control Act (TSCA)

Provision

Polychlorinated biphenyls

(PCBs)

15 U.S.C. 2601 et seq.

S. 847

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).

Proposed TSCA 6(f) is similar to

existing law but authorizes the EPA

Administrator to act by order or rule,

and to grant exemptions from the

general prohibitions on manufacturing,

processing, distribution in commerce,

or use when such activities “will not

present a substantial endangerment to

health or the environment” rather

than when activities “will not present

an unreasonable risk.”

Authorizes an appropriate district court

to grant relief necessary to protect health

or the environment from unreasonable

risk.

Similar to current law, but authorizes

district court to grant relief necessary

to protect health or the environment

from “the risk associated with the

activity involved in the civil action.”

Imminent hazards

Relief

Congressional Research Service

30

Proposed Reform of the Toxic Substances Control Act (TSCA)

Provision

Civil actions

15 U.S.C. 2601 et seq.

S. 847

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 civil action against a person who

manufactures, processes, distributes in

commerce, uses, or disposes of a

chemical substance or mixture, or any

article containing a chemical substance

or mixture, or who contributes to any

of those activities, when a chemical,

mixture, or article “may present an

imminent and substantial

endangerment to health or the

environment, as determined by the

Administrator.” Does not require EPA

to commence action if the agency has

not made a rule effective immediately

concerning the chemical. 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.

Would eliminate authority

concurrently to initiate a proceeding

for the promulgation of a rule under

TSCA 6(a) [15 U.S.C. 2605(a)]. Also

would eliminate the definition for

“imminently hazardous chemical

substance or mixture.”

Congressional Research Service

31

Proposed Reform of the Toxic Substances Control Act (TSCA)

Table 5. Reporting Requirements in Selected Provisions of TSCA (15 U.S.C. 2601 et

seq.) and the Safe Chemicals Act (S. 847), as Introduced

Provision

15 U.S.C. 2601 et seq.

S. 847

EPA authority to require

reporting and record keeping

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.

Proposed 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 to

maintain records of and report any

information that would assist the EPA

Administrator in administering TSCA.

Declaration

No comparable provision

Proposed 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. Each declaration must be

accompanied by certification of its

accuracy, reliability, and

comprehensiveness.

Failure to submit declaration

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 a declaration.

Congressional Research Service

32

Proposed Reform of the Toxic Substances Control Act (TSCA)

Provision

Information required to be

submitted

15 U.S.C. 2601 et seq.

S. 847

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.

Proposed 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, its annual production

volume and known uses, 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.

Inventory

Congressional Research Service

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.

Proposed 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.

33

Proposed Reform of the Toxic Substances Control Act (TSCA)

Provision

15 U.S.C. 2601 et seq.

S. 847

Small quantities for research and

development

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

explicitly authorizes EPA to require

reporting from small manufacturers

and processors of chemical 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 above)

from processors and manufacturers

who are small (as determined by the

EPA 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.

Proposed TSCA 8(b)(2) authorizes

EPA to define by rule 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.

Public access

No comparable provision.

Proposed 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.

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 or mixture.

Proposed TSCA 8(e) is similar to

TSCA but does not apply to mixtures.

For chemical substances, it also

requires submission of such records

to EPA.

Information from other federal

agencies

No comparable provision.

Proposed 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 or article containing that

chemical substance).

Congressional Research Service

34

Proposed Reform of the Toxic Substances Control Act (TSCA)

Provision

15 U.S.C. 2601 et seq.

S. 847

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.

Requires submission of such studies as

part of the declaration under

proposed TSCA 8(a).

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.

Proposed TSCA 8(g) is the same as

current TSCA 8(e).

Certification

No comparable provision.

Proposed 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.

“Manufacture” and “process”

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

“manufacture” and “process” to mean

manufacture or process for

commercial purposes.

Proposed TSCA 8(i) is the same as

current TSCA 8(f).

Congressional Research Service

35

Proposed Reform of the Toxic Substances Control Act (TSCA)

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

Chemicals Act (S. 847), as Introduced

Provision

15 U.S.C. 2601 et seq.

S. 847

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.

Proposed TSCA 9(a) is similar to current

law, but does not apply to mixtures and the

criterion for EPA action differs. If the EPA

Administrator determines “that the

manufacture, processing, distribution in

commerce, use, or disposal of a chemical …

does not meet a 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 whether action

may be taken under a Federal 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 civil action under

Federal law within 90 days or a shorter

timeframe specified in the report, EPA may

not take action under proposed TSCA with

respect to the civil 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 a safety

standard.

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. 847

directs EPA to ensure that any EPA actions

to address workplace exposures “are

consistent with the industrial hygiene

hierarchy of controls.”

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.

Strikes the requirement that coordination

for the purpose of enforcement should

impose the least burdens of duplicative

requirements.

Congressional Research Service

36

Proposed Reform of the Toxic Substances Control Act (TSCA)

Provision

15 U.S.C. 2601 et seq.

S. 847

Inspections

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.

Proposed TSCA 11(a) and (b) are similar to

current TSCA 11 but also apply to premises

and conveyances handling articles subject to

TSCA. Inspections are not limited by

requiring presentation of credentials or

provision of written notice. 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.

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.

Proposed TSCA 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, proposed TSCA 11(d)

empowers EPA to obtain and to execute

warrants authorizing entry, inspection, and

copying of records, or seizures of any

chemical in violation.

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.

Proposed TSCA 12 would eliminate the

current exclusion from requirements for

chemicals manufactured, processed, or

distributed in commerce solely for the

purpose of export.

Mercury

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

the export of elemental mercury (but not

of coal containing mercury). Authorizes

exemptions from this prohibition for

essential uses.

Same as current law.

Exports

Congressional Research Service

37

Proposed Reform of the Toxic Substances Control Act (TSCA)

Provision

Notice of export

Imports

15 U.S.C. 2601 et seq.

S. 847

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.

Proposed TSCA 12(a) is similar to current

TSCA 12(b), but excludes from requirements

those who “intend” to export, and applies

only to exports of chemicals subject to data

submission requirements under proposed

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

been taken under TSCA 6 or 7. Also, S. 847

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.

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.

Proposed TSCA 13 is similar to current law

but transfers authority to the Secretary of

the Department of Homeland Security. In

addition, a new paragraph (3) in proposed

TSCA 13(a) explicitly subjects to TSCA

requirements chemical substances and

mixtures imported as part of an article,

except “as the Administrator may provide by

rule under this Act, or as the Secretary of

Homeland Security may provide by rule.”

Congressional Research Service

38

Proposed Reform of the Toxic Substances Control Act (TSCA)

Provision

15 U.S.C. 2601 et seq.

S. 847

Disclosure of data

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 EPA

Administrator must notify the

manufacturer, processor, or distributor

who designated the data.

Proposed TSCA 14 requires conformance to

the standards of the Freedom of Information

Act (FOIA). Like current law, S. 847

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 proposed

TSCA 14 and 40 CFR 350.19, which directs

EPA to provide confidential information to

states if EPA receives a written request from

a governor and the state agrees to safeguard

the information with procedures equivalent

to those used by EPA and the governor

agrees to disclose the information only to

employees. 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 EPA

Administrator is required to by order

develop standards for justifying claims and

necessary documentation and within one

year of enactment, to identify by rule the

types of information for which EPA shall not

specify prospectively the term of

confidentiality. Requests must be reviewed

by EPA within 90 days. If approved,

submitted information will be protected

from disclosure for up to 5 years.

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.

Proposed TSCA 14 specifies data that are

not to be protected, including the health and

safety data allowed to be disclosed by

current law, 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.”

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.

Proposed TSCA 14(f) is the same as current

TSCA 14(d).

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39

Proposed Reform of the Toxic Substances Control Act (TSCA)

Provision

15 U.S.C. 2601 et seq.

S. 847

Risk information for workers

No comparable provision.

Proposed 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.

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.

Proposed 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. 847 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

proposed TSCA.

Penalties

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.

Proposed TSCA 16 increases the maximum

civil penalty per violation per day 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.

Congressional Research Service

Removes criminal sanctions for “willfully”

violating any provision of TSCA, as

proposed, 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.

40

Proposed Reform of the Toxic Substances Control Act (TSCA)

Provision

15 U.S.C. 2601 et seq.

S. 847

Seizure

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.

Proposed TSCA 17 is similar to current law

but S. 847 applies to “articles” rather than

“products” and to any articles, substances, or

mixtures, that are subject to any title of

TSCA.

Enforcement

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.

Proposed 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 TSCA. 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

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).

Congressional Research Service

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.

Proposed TSCA 18 does not preempt laws

of states or political subdivisions relating to a

chemical substance, mixture, or article unless

compliance with both the law of the state or

political subdivision and federal law is

impossible.

41

Proposed Reform of the Toxic Substances Control Act (TSCA)

Provision

15 U.S.C. 2601 et seq.

S. 847

Exemption from state or local

law 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.)

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

proposed, authorizes filing a petition for

judicial review of any rule or order issued

under TSCA, as proposed, rather than only

specified rules, and would eliminate 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).

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.

Proposed 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 proposed.

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 EPA Administrator to

grant or deny the petition within 90 days

of its filing.

Proposed TSCA 21 is similar to current law,

but authorizes petitions for EPA to initiate

any action authorized under the law.

Employment effects

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

EPA Administrator to continually

evaluate the potential effects of specified

rules, orders, and requirements under

specified TSCA provisions on

employment.

Proposed TSCA 24 is similar to current law,

but directs the EPA Administrator to

evaluate potential effects of the law as a

whole, rather than specific provisions, and

reporting is to be “periodic,” rather than

continual.

Congressional Research Service

42

Proposed Reform of the Toxic Substances Control Act (TSCA)

Provision

Administration

15 U.S.C. 2601 et seq.

S. 847

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.

Proposed TSCA 26 is similar to current law,

except for proposed subsections (b) and (c)

and a new subsection (h).

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

authorizes EPA to collect fees from

persons required to submit data under

section 4 or 5 to defray the cost to EPA

of administering the Act. Such fees may

not exceed $2,500, or in the case of a

small business $100.

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.

TSCA 26(d) [15 U.S.C. 2625(d)] directs

EPA to establish an office to assist the

regulated community.

Proposed TSCA 26(b) authorizes collection

of fees from any data submitter (not just

those submitting under section 4 or 5) to

defray the cost of administering TSCA. It

removes the restrictions in the original

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

Proposed TSCA 26(c) also authorizes the

EPA Administrator to take an action with

respect to a mixture if such action is

authorized or required under any provision

of the Act with respect to a chemical

substance, if the Administrator determines it

is “reasonable and efficient” to do so.

New TSCA 26(h) authorizes the EPA

Administrator to issue orders and prescribe

regulations as necessary to carry out the law.

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

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.

Congressional Research Service

Proposed 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 proposed, and under state

programs.

43

Proposed Reform of the Toxic Substances Control Act (TSCA)

Provision

15 U.S.C. 2601 et seq.

S. 847

Children’s environmental

health research

No comparable provision.

New TSCA 29(a) would establish a

Children’s Environmental Health Research

Program at EPA and authorize the EPA

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.” Proposed TSCA 29(b) establishes

an Interagency Science Advisory Board on

Children’s Health Research and makes it

subject to the Administrative Procedure Act

and Chapter 7 of Title 5 of the U.S. Code,

which pertains to judicial review. The

purpose of the Board is to provide

independent advice upon request of the EPA

Administrator or Congress relating to the

implementation of the proposed 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 institutions of higher education.

Monitoring exposures

No comparable provision.

New TSCA 29(c) would direct 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.

Congressional Research Service

44

Proposed Reform of the Toxic Substances Control Act (TSCA)

Provision

15 U.S.C. 2601 et seq.

S. 847

Animal-based testing

No comparable provision.a

New TSCA 30 would direct the EPA

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 Title 5, Chapter 5, Subchapter 11

and Chapter 7. The Board is directed to

provide independent advice and peer review

to the EPA Administrator and Congress and

to publish a list of testing methods that

reduce the use of animals in testing under

proposed TSCA 4. Directs the EPA

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 proposed TSCA 6(b). Authorizes the

EPA Administrator, on request of a

manufacturer or processor, to adapt or

waive animal-based testing of a chemical

substance or mixture under specific

conditions.

Safer alternatives

No comparable provision.b

New TSCA 31(a) would establish 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.

Green chemistry and green

engineering

No comparable provision.b

New TSCA 31(b) would direct the EPA

Administrator to establish a network of at

least four green chemistry and engineering

centers in various U.S. regions. New TSCA

31(c) would direct EPA to make grants to

promote and support research,

development, and adoption of safer

alternatives. New TSCA 31(d) would create

a program to facilitate the development of a

workforce that produces safer alternatives

to existing chemical substances.

Congressional Research Service

45

Proposed Reform of the Toxic Substances Control Act (TSCA)

Provision

15 U.S.C. 2601 et seq.

S. 847

International cooperation

No comparable provision.

New TSCA 32 would direct the EPA

Administrator to cooperate with the

Secretary of State and the head of any other

appropriate federal agency “with

international efforts as appropriate” to

develop a common protocol or electronic

database relating to chemical substances or

to develop safer alternatives for chemical

substances.

Reliable information and

advice

No comparable provision.

New TSCA 33 would direct 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 EPA 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.

Hot spots

No comparable provision.

As proposed, a new TSCA 34 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

EPA 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.

Congressional Research Service

46

Proposed Reform of the Toxic Substances Control Act (TSCA)

Provision

Federal agencies subject to

TSCA

15 U.S.C. 2601 et seq.

No comparable provision.

S. 847

New TSCA 35 would provide that all federal

agencies are subject to the provisions of

TSCA, as proposed, and expressly waive 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 proposed TSCA. The

President is authorized to grant an

exemption for any federal agency from

compliance with any requirement of TSCA,

as proposed, 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.

Authorizes enforcement action against any

federal agency, as well as voluntary

resolution or settlement set forth in a

consent order.

International agreements

No comparable provision

Congressional Research Service

New TSCA 36 would provide 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 EPA Administrator to implement

and support implementation of the

provisions of the three agreements that have

entered into force for the United States.

Prohibits manufacture, processing,

distribution in commerce, use, disposal, or

any other action with respect to a covered

chemical, mixture, or substance that is part

of an article 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.

47

Proposed Reform of the Toxic Substances Control Act (TSCA)

Provision

15 U.S.C. 2601 et seq.

S. 847

Authorizes the EPA 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 proposed TSCA 6.

Authorization of

appropriations

TSCA 29 [15 U.S.C. 2628] authorizes

appropriations for implementation of

specific TSCA provisions for 1982 and

1983. Prohibits expenditures of

appropriated funds to construct

laboratories.

New TSCA 39 (but identified as section 38 in

the new Table of Contents) would authorize

“such sums as are necessary” to carry out

the law for 2011 through 2018, with no

restriction on how those funds might be

used.

a.

However, EPA has stated that it “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.

b.

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.

Author Contact Information

(name redacted)

Specialist in Environmental Policy

/redacted/@crs.loc.gov, 7-....

Congressional Research Service

48

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