Title I of the Toxic Substances Control Act (TSCA): A Summary of the Statute

April 4, 2018 – July 20, 2021 R45149

Title I of the Toxic Substances Control Act
July 20, 2021
(TSCA): A Summary of the Statute
Jerry H. Yen
In 1976, Congress enacted the Toxic Substances Control Act (TSCA; P.L. 94-469) to direct the
Analyst in Environmental
U.S. Environmental Protection Agency (EPA) to evaluate the lifecycle (i.e., manufacture,
Policy
importation, processing, distribution, use, and disposal) of industrial and commercial chemicals

for “unreasonable risks” and, if warranted, to regulate such chemicals. In 2016, Congress enacted
Kate R. Bowers
the Frank R. Lautenberg Chemical Safety for the 21st Century Act (LCSA; P.L. 114-182) to
Legislative Attorney
amend Title I of TSCA due, in part, to long-standing concerns that EPA lacked sufficient

authority to obtain information and regulate chemicals that present unreasonable risks.

TSCA, as amended, requires EPA to gather existing information from chemical manufacturers,
processors, and distributors about risks that industrial and commercial chemicals may present to human health or the
environment. Prior to introducing a new chemical into commerce, its manufacturer must notify EPA to allow the agency to
evaluate the chemical for unreasonable risks. Similar notification requirements apply to existing chemicals proposed for uses
determined by EPA to be “significant new uses.”
If EPA has inadequate information about a chemical to determine whether it presents unreasonable risks, the agency may
require the manufacturer to develop new information necessary to evaluate risks. TSCA establishes a framework to protect
from disclosure submitted information that warrants confidential treatment.
To identify which chemicals may warrant regulation, TSCA requires EPA to systematically prioritize chemicals for risk
evaluation. Based on the evaluation, EPA must regulate those chemicals that present unreasonable risks to ensure they no
longer do so. Regulatory options available to EPA range from labeling requirements to an outright ban on manufacturing.
TSCA directs EPA to take expedited action on chemicals that exhibit characteristics known to present greater risks.
Additionally, TSCA authorizes EPA to expedite review of chemicals that present significant risk of serious or widespread
harm and initiate enforcement actions against imminently hazardous chemicals.
Requirements for chemicals regulated under TSCA apply to chemicals manufactured in the United States and imported into
the United States. TSCA establishes additional procedures for handling imports of chemicals for which EPA has promulgated
requirements under the act. Chemicals marked for export only are subject to recordkeeping and reporting requirements unless
EPA has required the development of new information or established a requirement to protect against unreasonable risk.
TSCA authorizes citizen petitions and citizen suits to challenge EPA’s implementation of the act and enforce certain
requirements under the act through litigation. Additionally, TSCA includes enforcement provisions and establishes civil and
criminal penalties for violations.
TSCA does not allow chemical evaluation and restriction to be delegated to states. While states may evaluate and regulate
chemicals under their own authorities, TSCA provides an explicit, though limited, preemption of state requirements for
chemicals that EPA has evaluated and either determined to present no unreasonable risks or regulated to protect against
unreasonable risks. TSCA generally preserves long-standing state requirements and allows preemption waivers under certain
circumstances.
Congress funds TSCA activities through annual discretionary appropriations. TSCA also authorizes EPA to collect fees from
chemical manufacturers and processors to partially defray costs that the agency may incur from implementing the statute.
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Contacts
Author Information ........................................................................................................................ 33

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Title I of the Toxic Substances Control Act (TSCA): A Summary of the Statute

Introduction
In 1976, President Ford signed into law the Toxic Substances Control Act (TSCA), which
requires the U.S. Environmental Protection Agency (EPA) to identify and regulate chemicals in
U.S. commerce that present an “unreasonable risk of injury to health or the environment” or an
imminent hazard.1 In proposing the legislative framework for TSCA, the Council on
Environmental Quality (CEQ) of President Nixon’s Administration highlighted concerns with
risks from metals (e.g., lead, cadmium, mercury, and vanadium), metal compounds, and synthetic
organic chemicals (e.g., polychlorinated biphenyls, nitrilotriacetic acid, orthonitrochlorobenzene).
CEQ noted that pollution control and consumer or occupational safety statutes in effect at the
time limited the federal government to controlling pollution at the end of the chemical lifecycle or
restricting chemicals that have specific uses (e.g., pesticides, food).2
Since TSCA was originally enacted, Congress has added five other titles to TSCA to address
specific chemical concerns.3 The original 1976 act is referred to as Title I, which is the focus of
this report. The additional titles did not amend the core chemical evaluation and regulatory
program under Title I and therefore are not discussed in this report.
To determine which chemicals warrant regulation under TSCA, EPA requires chemical
manufacturers, importers, and processors to provide certain information about the manufacture,
importation, and processing of chemicals to the agency. When EPA determines that it does not
have adequate information to evaluate risks of a particular chemical, the agency may require
chemical manufacturers and processors to develop new information necessary to evaluate risks.
Based on the evaluation of information available to the agency, EPA has restricted few chemicals
reported to have been in commerce prior to 1976. EPA has promulgated regulations to prohibit or
restrict the following chemicals under TSCA:
 chlorofluorocarbons used in aerosol propellants;
 nitrosamines in metalworking fluids;4
 hexavalent chromium used in certain water cooling towers;5
 certain uses of asbestos in paper products and any proposed new use of asbestos
after 1990;6
 dioxin-contaminated wastes;
 polychlorinated biphenyls not used in a totally enclosed manner;7
 methylene chloride for certain consumer uses;8 and
 certain persistent, bioaccumulative, and toxic chemicals.9

1 P.L. 94-469. TSCA, as amended, is codified at 15 U.S.C. §2601 et seq.
2 CEQ, Toxic Substances, 1971.
3 The other specific chemical concerns include asbestos (Title II), indoor radon (Title III), lead-based paint (Title IV),
environmental exposures in schools (Title V), and formaldehyde in composite wood products (Title VI).
4 40 C.F.R. Part 747.
5 40 C.F.R. Part 749.
6 40 C.F.R. Part 763, Subpart I.
7 40 C.F.R. Part 761.
8 40 C.F.R. Part 751, Subpart B.
9 40 C.F.R. Part 751, Subpart E. Bioaccumulation generally refers to the retention of a chemical in an organism at ever-
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Title I of the Toxic Substances Control Act (TSCA): A Summary of the Statute

Regulations that pertain to chlorofluorocarbons and dioxin-contaminated wastes under TSCA
were later superseded by regulations promulgated under other environmental statutes.
For chemicals introduced into commerce after 1976, EPA established a program to identify which
of those chemicals warranted regulation.10 Through that program, EPA has taken regulatory action
to restrict a subset of such chemicals based on an evaluation of available risk information.11 Over
time, environmental and public health organizations began to question whether the agency had
sufficient information to evaluate risks from chemicals and whether the threshold for regulating a
chemical was attainable.12 To address these issues and other concerns, several Members
introduced proposals to amend TSCA beginning in the 109th Congress.13
On June 22, 2016, President Obama signed into law the Frank R. Lautenberg Chemical Safety for
the 21st Century Act (LCSA; P.L. 114-182), which amended Title I of TSCA.14 The LCSA broadly
amended EPA’s information gathering, chemical evaluation, and regulatory authorities under
TSCA and provided additional procedures and standards for confidential treatment or disclosure
of information submitted to EPA under TSCA. To supplement funding provided for TSCA
implementation, the LCSA expanded EPA’s authority to collect fees from chemical
manufacturers and processors to partially defray the costs of conducting risk evaluations.
In broad terms, TSCA, as amended, establishes a multistep prioritization and review process for
existing chemicals. Under this revised process, EPA must
1. identify chemicals to prioritize for evaluation;
2. establish the scope of the risk evaluation for each selected chemical substance;
3. conduct risk evaluations for each selected chemical substance; and
4. implement regulations to restrict or prohibit the manufacture, processing,
distribution, or use of the chemical substances as appropriate.15
TSCA also generally prohibits specific state and local actions, and it restricts the reach of those
prohibitions through limitations, exceptions, and waivers.16 As originally enacted, TSCA

increasing levels.
10 To implement TSCA Section 5 (15 U.S.C. §2604), EPA established a program to evaluate chemicals introduced into
commerce after 1976 (i.e., new chemicals). EPA, “Toxic Substances Control Act; Premanufacturing Notification
Requirements and Review Procedure; Statement of Interim Policy,” 44 Federal Register 28564, May 15, 1979.
11 See “Statistics Prior to June 22, 2016” tab at EPA, “Statistics for the New Chemicals Review Program under TSCA,”
last updated June 11, 2021, https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/
statistics-new-chemicals-review.
12 For at least a decade prior to the enactment of amendments to TSCA in 2016, several congressional committees held
hearings that offered the opportunity for different stakeholders, including environmental and public health
organizations, to present their perspectives on the implementation of TSCA. For example, see testimony from U.S.
Congress, Senate Committee on Environment and Public Works, Strengthening Public Health Protections by
Addressing Toxic Chemical Threats, 113th Cong., 1st sess., July 31, 2013, S. Hrg. 113-724 (Washington: GPO, 2015).
13 In the 109th Congress, the Kid Safe Chemicals Act (S. 1391, H.R. 4308) would have amended TSCA for various
purposes. Between the 109th and 114th Congresses, at least one bill that would amend TSCA was introduced in each
Congress.
14 For committee reports of bills reported to the House and Senate that resulted in the LCSA, see U.S. Congress, House
Committee on Energy and Commerce, TSCA Modernization Act of 2015, report to accompany H.R. 2576, 114th Cong.,
1st sess., June 23, 2015, H.Rept. 114-176 (Washington: GPO, 2015); and U.S. Congress, Senate Committee on
Environment and Public Works, Frank R. Lautenberg Chemical Safety for the 21st Century Act, report together with
minority views to accompany S. 697, 114th Cong., 1st sess., June 18, 2015, S.Rept. 114-67 (Washington: GPO, 2015).
15 15 U.S.C. §2605.
16 15 U.S.C. §2617.
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contained a preemption provision; the 2016 amendments established additional conditions in
which TSCA requirements would or would not preempt state chemical regulatory requirements.
This report summarizes the major authorities of TSCA through the following topics:
1. the overall scope and applicability of authorities under TSCA;
2. the information gathering authorities;
3. the confidentiality and disclosure of information submitted to EPA under the act;
4. the framework for prioritizing chemicals for evaluation, evaluating risks, and
regulating those chemicals that present unreasonable or imminent risks;
5. the applicability of the act to chemical imports;
6. the requirements for chemical export notification;
7. the process of filing citizen petitions and bringing citizen suits;
8. the enforcement of the act;
9. the federal and state roles under the act; and
10. the resources to administer the act.
In some cases, the discussion of certain topics may align with a specific section of TSCA, but
other topics involve multiple sections or subsections of TSCA.
Chemicals Covered by TSCA and Limitations on
Authority
TSCA applies to “chemical substances,” which the statute defines broadly to include substances
that have a “particular molecular identity.”17 To avoid redundancy with other federal pollution
control and public health laws, Congress generally excluded from regulation under TSCA groups
of chemicals where the risks were considered sufficiently addressed under such other laws.18
Congress also specifically excluded the following substances without regard to their regulation
under other laws:
 pesticides;
 tobacco and tobacco products;
 certain radioactive materials;
 firearms (including pistols and revolvers), shells, cartridges, and their
components;19
 food (including poultry, meat, and eggs), food additives (including food contact
substances), drugs, cosmetics, and medical devices; and
 mixtures.20

17 15 U.S.C. §2602(2).
18 15 U.S.C. §2608. See infra “Unreasonable Risk” Threshold and Relationship with Other Federal Laws.”
19 Relatedly, Section 108 of America’s Conservation Enhancement Act (P.L. 116-188) prohibits EPA from taking any
action to regulate lead content of sport fishing equipment or sport fishing equipment components under TSCA for five
years after enactment (i.e., until October 30, 2025). This provision is codified as a note to 15 U.S.C. §2601.
20 15 U.S.C. §2602(2). TSCA Section 3(10) (15 U.S.C. §2602(10)) defines “mixtures” as combinations of chemical
substances not resulting from a chemical reaction.
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Title I of the Toxic Substances Control Act (TSCA): A Summary of the Statute

Since these exclusions are generally framed based on the intended uses of a chemical substance
(e.g., a pesticide), the same chemical substance may be subject to TSCA and other federal
pollution control and public health laws depending on the intended use. For example, EPA has
examined the risks of bisphenol A under TSCA with regard to its use in manufacturing
polycarbonate plastics and epoxy resins.21 However, the use of bisphenol A as a food contact
substance is not covered by TSCA based on the statutory exclusion.
Although the definition of a chemical substance excludes mixtures, multiple TSCA provisions
apply to mixtures. References hereinafter to “chemicals” in the report collectively refer to
chemical substances and mixtures. Provisions that apply only to chemical substances or mixtures
are noted accordingly.
Generally, a mixture is subject to requirements under TSCA if the requirements that pertain to its
constituent chemical substances will not result in adequate evaluation or control of the risks
anticipated from the mixture.22 Additionally, as a practical matter, articles (i.e., manufactured
items) that contain chemical substances subject to TSCA may be regulated by the act to the extent
that those chemical substances present an unreasonable risk or meet other criteria.
“Unreasonable Risk” Threshold and Relationship with Other
Federal Laws
In addition to excluding groups of chemicals from the scope of chemicals covered under TSCA,
Congress generally limited the extent to which EPA may regulate a chemical. For example, EPA
must make an unreasonable risk finding or determination before requiring information on, or
regulating, a chemical.23 TSCA does not explicitly define what constitutes an unreasonable risk.
In 1991, the U.S. Court of Appeals for the Fifth Circuit held that the “unreasonable risk” standard
as originally set forth in TSCA meant that “[i]n evaluating what is ‘unreasonable,’ the EPA is
required to consider the costs of any proposed actions and to ‘carry out this chapter in a
reasonable and prudent manner [after considering] the environmental, economic, and social
impact of any action.’”24 This interpretation led the court to vacate parts of the 1989 EPA rule that
regulated various asbestos uses.
Though the LCSA did not amend TSCA to explicitly define unreasonable risk, it prohibited EPA
from considering cost or nonrisk factors when evaluating risks.25 However, EPA must consider
“reasonably ascertainable economic consequences” and other nonrisk factors when restricting
uses of a chemical.26 Additionally, the LCSA codified existing agency practice to consider risks
for “potentially exposed or susceptible subpopulations” when evaluating the risks of a chemical.27

21 EPA, “Risk Management for Bisphenol A (BPA),” last updated March 4, 2021, https://www.epa.gov/assessing-and-
managing-chemicals-under-tsca/risk-management-bisphenol-bpa.
22 For example, see 15 U.S.C. §§2603(a)(1)(B), 2607(a)(1)(B).
23 For example, see 15 U.S.C. §2603(a)(1)(A)(i)(I), §2604(f), and §2605(a).
24 Corrosion Proof Fittings v. EPA, 947 F.2d 1201, 1222 (5th Cir. 1991) (quoting prior version of 15 U.S.C. §2601(c)).
25 For example, see P.L. 114-182 §§5(1)(B), 6(3) (amending TSCA to add Sections 5(a)(3) and 6(b)(4) and specifying
that risk evaluations and unreasonable risk determinations are “without consideration of costs or other nonrisk
factors”).
26 For example, see P.L. 114-182 §6(4) (adding Section 6(c)(2) to TSCA to require the consideration of various factors
in promulgating a rule to restrict a chemical).
27 A list of risk assessment guidelines is available at EPA, “Risk Assessment Guidelines,” last updated February 2,
2021, https://www.epa.gov/risk/risk-assessment-guidelines. Several guidelines discuss evaluating risks for potentially
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Title I of the Toxic Substances Control Act (TSCA): A Summary of the Statute

Even if EPA concludes under TSCA that a chemical presents an unreasonable risk, TSCA
provides that other federal laws supersede EPA’s authority under TSCA to address unreasonable
risks. If EPA determines that a risk associated with a chemical may be sufficiently eliminated or
reduced by actions taken under other federal laws that the agency administers, Section 9(b)
requires the agency to use those authorities to protect against the risk unless the agency
determines that it is in the public interest to take action under TSCA.28
If EPA determines that a chemical presents an unreasonable risk that may be sufficiently
prevented or reduced by action taken under a federal law a different federal agency administers,
Section 9(a) directs EPA to submit to that other agency a report describing the risk and a request
for a response.29 A federal agency that receives such a report from EPA must respond within 90
days (or a shorter period if specified by EPA). If that federal agency issues an order disagreeing
with EPA about the unreasonable risk or initiates action to protect against such risk, then EPA
may not regulate the chemical under TSCA.30
Use of Scientific and Technical Information
Under TSCA, EPA relies on scientific and technical information about a chemical to evaluate
risks associated with the chemical and determine whether to regulate the chemical. The chemical
industry and environmental and public health organizations have contested on occasion the
quality of scientific and technical information that EPA has relied upon to make regulatory
decisions under TSCA.31 To that end, the LCSA added various provisions specifying how EPA is
to use scientific and technical information to carry out the act.
In determining whether to require development of new information about a chemical or whether
to regulate a chemical that presents unreasonable risks, EPA must consider the “best available
science” and any applicable factors generally used to assess the quality of scientific information.32

exposed or susceptible subpopulations such as children. For example, see EPA, “Guidelines for Exposure Assessment,”
EPA/600/Z-92/001, May 1992. Section 3(4) of the LCSA added Section 3(12) to TSCA to define “potentially exposed
or susceptible subpopulation,” which is referenced in various provisions relevant to evaluating risks, added by the
LCSA to TSCA.
28 15 U.S.C. §2608(b)(1). EPA administers various federal pollution control laws, such as the Clean Air Act, Clean
Water Act, Safe Drinking Water Act, Solid Waste Disposal Act, and Federal Insecticide, Fungicide, and Rodenticide
Act.
29 15 U.S.C. §2608(a). For example, in 1985, EPA referred 1,3-butadiene to the Occupational Safety and Health
Administration (OSHA) of the Department of Labor. EPA, “1,3-Butadiene; Decision to Report to the Occupational
Safety and Health Administration,” 50 Federal Register 41393, October 10, 1985. In February 1986, EPA and the
Department of Labor entered into a memorandum of understanding that established a process for notification and
consultation for TSCA Section 9(a) reports intended for submission to OSHA. EPA and the Department of Labor,
Memorandum of Understanding Between the Environmental Protection Agency and the Department of Labor, EPA
Agreement No. PW 16931704-01-1, February 6, 1986, https://www.osha.gov/laws-regs/mou/1986-02-06.
30 For example, in 1986, OSHA announced initiation of a regulatory action on 1,3,-butadiene to address unreasonable
risks that EPA had identified and referred to OSHA. OSHA, “Occupational Exposure to 1,3-Butadiene,” 51 Federal
Register 35003, October 1, 1986.
31 See, for example, Corrosion Proof Fittings v. EPA, 947 F.2d 1201, 1211 (5th Cir. 1991); Opening Briefs for
Petitioners Neighbors for Environmental Justice et al. and for Petitioners State of New York et al., Neighbors for Env’t
Justice v. EPA, No. 20-72091, Doc. Nos. 39 at 52-55, 42 at 49-56 (9th Cir. Jan. 25, 2021).
32 15 U.S.C. §2625(h).
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Title I of the Toxic Substances Control Act (TSCA): A Summary of the Statute

EPA must also consider “reasonably available information” that relates to chemicals’ conditions
of use33 and make decisions based on the “weight of the scientific evidence.”34
More generally, EPA must develop policies, procedures, and “guidance” necessary to carry out
the amendments to TSCA made by the LCSA.35 EPA must periodically review these policies,
procedures, and guidance for their adequacy in carrying out the law and revise them if necessary
to reflect new scientific developments or understandings.
Related to the requirements on the use of scientific and technical information, the LCSA directs
EPA to establish a Science Advisory Committee on Chemicals (SACC) to provide nonbinding,
independent scientific and technical advice to the agency regarding implementation of the act.36
SACC held its first in-person meeting in June 2019 to discuss EPA’s draft risk evaluation for C.I.
Pigment Violet 29.37 Since then, SACC has convened multiple times to provide scientific review
to other EPA draft risk evaluations.
Recordkeeping and Reporting Requirements and
Confidentiality or Disclosure of Information
The information gathering framework under TSCA uses various recordkeeping and reporting
requirements to provide EPA with sufficient information to evaluate chemical risks, while
prohibiting EPA from disclosing information that, if disclosed, may harm commercial interests.
Through the reporting requirements, EPA receives from chemical manufacturers, processors, and
distributors existing information on (1) chemicals already being manufactured or processed for
commercial purposes, (2) new chemicals, and (3) chemicals proposed for uses determined by EPA
to be significant new uses. If EPA determines that the information available to the agency is
insufficient to evaluate a chemical’s risks and determines that additional information is necessary,
EPA may require chemical manufacturers, processors, and distributors to develop new
information.
Because information that EPA obtains may contain material that, if disclosed, would harm
commercial interests, TSCA prohibits the disclosure of submitted information for which the
submitter has claimed and justified the need for confidentiality. EPA regulations establish
procedures to protect such confidential business information from public disclosure.

33 Section 3(4) of TSCA defines “conditions of use” as “the circumstances, as determined by the Administrator, under
which a chemical substance is intended, known, or reasonably foreseen to be manufactured, processed, distributed in
commerce, used, or disposed of.” 15 U.S.C. §2602(4).
34 15 U.S.C. §2625(i) and (k).
35 15 U.S.C. §2625(l). For purposes of TSCA, Section 3(6) (15 U.S.C. §2602(6)) defines the term guidance to mean
any “significant” written guidance of general applicability prepared by EPA.
36 15 U.S.C. §2625(o). As a federal advisory committee, the Science Advisory Committee on Chemicals is subject to
Federal Advisory Committee Act (FACA) requirements in addition to relevant TSCA requirements. For more
information on FACA requirements, see CRS Report R44253, Federal Advisory Committees: An Introduction and
Overview, by Meghan M. Stuessy.
37 For more information on the SACC and its activities, see EPA, “TSCA Scientific Peer Review Committees,” last
updated October 1, 2020, https://www.epa.gov/tsca-peer-review.
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Title I of the Toxic Substances Control Act (TSCA): A Summary of the Statute

Existing Information Regarding Chemical Risks
Section 8 directs EPA to promulgate rules that require chemical manufacturers and processors
(other than small manufacturers and processors) to maintain records pertaining to the chemicals
they use.38 EPA may require these records to include information such as chemical identity, uses,
volumes produced, byproducts, health and environmental effects, exposure, and disposal
methods.39 EPA may also require chemical manufacturers and processors to report such records to
the agency.40 For small manufacturers and processors, EPA may promulgate recordkeeping and
reporting requirements only for chemicals for which the agency has already required the
development of new information or that are already regulated under the act.41
Based on information gathered by EPA, the agency must maintain a list of chemical substances
manufactured or processed for commercial purposes in the United States.42 EPA refers to this list
as the TSCA Inventory. The list includes approximately 60,000 chemical substances that were
reported to the agency soon after the original enactment of TSCA.43 EPA refers to these
substances as “existing” substances.44 New chemical substances are to be listed on the inventory
upon their manufacture in the United States.45 The list excludes substances that are manufactured
or processed in small quantities for research and development, and chemicals that were not
manufactured or processed in the United States within three years before the effective date of
EPA’s recordkeeping rules.46 Since the original enactment of TSCA, more than 26,000 chemical
substances have been added to the TSCA Inventory as new chemical substances. The LCSA
amended TSCA Section 8 to require EPA to divide the TSCA Inventory into “active substances”
and “inactive substances,” depending on whether or not the substance was manufactured or
processed between June 2006 and June 2016.47 Based on reporting from chemical manufacturers
and processors, EPA determined that over 41,000 chemical substances on the TSCA Inventory
met the criteria for designation as “active substances.”48

38 15 U.S.C. §2607(a)(1).
39 15 U.S.C. §2607(a)(2).
40 15 U.S.C. §2607(a). EPA regulations establishing recordkeeping and reporting requirements under TSCA are
codified at 40 C.F.R. Parts 704, 711, and 712. Reporting may be required for exceeding certain manufacturing or
processing volume thresholds at a single site or for specific chemicals, such as nanoscale materials.
41 15 U.S.C. §2607(a)(3). For purposes of defining small manufacturers and processors subject to recordkeeping and
reporting requirements, EPA, after consultation with the Small Business Administration, must promulgate standards for
determining whether an entity qualifies as a small manufacturer or processor. EPA established general small
manufacturer standards (40 C.F.R. §704.3), but the agency has also codified variations of the general standards for
specific recordkeeping and reporting requirements (e.g., 40 C.F.R. §704.45).
42 15 U.S.C. §2607(b).
43 EPA, “About the TSCA Chemical Substance Inventory,” last updated July 20, 2021, https://www.epa.gov/tsca-
inventory/about-tsca-chemical-substance-inventory.
44 Ibid.
45 15 U.S.C. §2607(b). See also EPA, “Toxic Substances Control Act; Premanufacturing Notification Requirements and
Review Procedure; Statement of Interim Policy,” 44 Federal Register 28564, May 15, 1979; and EPA,
“Premanufacture Notification Requirements and Review Procedures,” final rule and notice form, 48 Federal Register
21722, May 13, 1983.
46 15 U.S.C. §2607(b)(1).
47 Pursuant to TSCA Section 8, EPA promulgated regulations that require chemical manufacturers and processors to
submit commercial activity notifications identifying the chemicals that were manufactured or processed between June
2006 and June 2016. These regulations are codified at 40 C.F.R. Part 710, Subpart B.
48 To access the TSCA Inventory, see EPA, “How to Access the TSCA Inventory,” last updated February 25, 2021,
https://www.epa.gov/tsca-inventory/how-access-tsca-inventory.
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Section 8 also authorizes EPA to require reporting of information documenting “significant
adverse reactions” to human health or the environment alleged to have been caused by a
chemical, as well as lists and copies of available health and safety studies.49 Additionally, Section
8 requires chemical manufacturers or processors to report to EPA any evidence of “substantial
risk” of injury to human health or the environment with regard to a chemical.50
For a specific group of chemicals—per- and polyfluoroalkyl substances (PFAS)—that has
received heightened attention for potential risks to human health and the environment, Congress
has required EPA to gather more information about such chemicals.51 Section 7351 of the
National Defense Authorization Act for FY2020 (P.L. 116-92) amended TSCA Section 8(a) to
require EPA to issue a data call among manufacturers of PFAS by January 1, 2023, to collect
additional information on the potential health and environmental risks of these chemicals in
commerce. On June 28, 2021, EPA proposed reporting and recordkeeping requirements for PFAS
under TSCA Section 8(a).52
New Chemical Substance and Significant New Use Notifications
Under Section 5, chemical manufacturers must submit a notice to EPA at least 90 days prior to the
initial commercial manufacture of a new chemical substance, unless the chemical substance
meets certain criteria for an exemption from notification.53 This notification is known as a
premanufacture notice (PMN).54 According to EPA, the agency has received more than 40,000
PMNs since the enactment of TSCA in 1976.55
Chemical manufacturers and processors must also submit a notice to EPA before manufacturing
or processing a chemical for a use that EPA has determined to be significant and new. EPA
determines significant new uses through rulemakings on a chemical-by-chemical basis after

49 Regulations that govern reporting of “significant adverse reactions” alleged to have been caused by a chemical are
codified at 40 C.F.R. Part 717. Regulations that govern reporting of health and safety studies are codified at 40 C.F.R.
Part 716.
50 In 1978, EPA issued its statement of interpretation and enforcement policy for the notification of substantial risks.
EPA, “Notification of Substantial Risk under Section 8(e),” statement of interpretation and enforcement policy, 43
Federal Register 11110, March 16, 1978. For additional EPA guidance on reporting substantial risk notification, see
EPA, “Reporting a TSCA Chemical Substantial Risk Notice,” last updated January 21, 2021, https://www.epa.gov/
assessing-and-managing-chemicals-under-tsca/reporting-tsca-chemical-substantial-risk-notice.
51 For more information on PFAS, including actions taken by EPA under TSCA, see CRS Report R45986, Federal
Role in Responding to Potential Risks of Per- and Polyfluoroalkyl Substances (PFAS), coordinated by David M.
Bearden.
52 EPA, “TSCA Section 8(a)(7) Reporting and Recordkeeping Requirements for Perfluoroalkyl and Polyfluoroalkyl
Substances,” 86 Federal Register 33926-33966, June 28, 2021.
53 15 U.S.C. §2604(a). EPA regulations governing the notification requirements for new chemical substances are
codified at 40 C.F.R. Part 720. EPA has also promulgated regulations to require notice for new intergeneric
microorganisms (i.e., microorganisms formed by the deliberate combination of genetic material from species that do
not belong to the same genus classification) produced for commercial purposes. These EPA regulations are codified at
40 C.F.R. Part 725.
54 A sample PMN form is available at EPA, “Sample Premanufacture Notification (PMN) Form,” OMB No. 2070-
0012, approval expires December 31, 2022, https://www.epa.gov/sites/production/files/2020-02/documents/
section_5_main_form_updated_omb_and_expiration_01142020.pdf.
55 EPA, “Reviewing New Chemicals under the Toxic Substances Control Act (TSCA), Statistics for the New
Chemicals Review Program Under TSCA,” last updated June 11, 2021, https://www.epa.gov/reviewing-new-
chemicals-under-toxic-substances-control-act-tsca/statistics-new-chemicals-review. For discussion of EPA’s regulation
of new chemical substances and significant new uses, see “Regulation of New Chemical Substances and Significant
New Uses” section.
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considering all relevant factors, including projected volumes of manufacture and processing and
changes in the manufacture, processing, distribution, use, or disposal that may increase exposure
to the chemical. These rules are known as significant new use rules (SNURs), and notifications
submitted under a SNUR are known as significant new use notices (SNUNs).56 Although EPA
promulgates multiple SNURs per year, the agency does not receive, and generally does not
expect, many SNUN submissions per year, based on prior experience.57
Although most significant new use determinations are associated with new chemicals,58 EPA has
determined that certain non-ongoing uses (i.e., discontinued uses) are new uses for specific
existing chemicals.59 EPA generally determines that a discontinued use of an existing chemical is
a significant new use for which notification is required when a manufacturer or processor seeks to
reintroduce such discontinued use of the existing chemical into commerce. This notification is
intended to give the agency an opportunity to prevent the reintroduction of a discontinued use of
an existing chemical if such a reintroduction would pose unreasonable risks. As an example, in
April 2019, EPA determined that “any discontinued uses of asbestos cannot re-enter the
marketplace without EPA review.”60
Promulgation of a SNUR does not imply EPA would approve the significant new uses of a
chemical reported in a SNUN if the agency were to receive one. Receipt of a SNUN triggers EPA
review of the risks associated with the SNUN and a determination of whether such risks warrant
control. SNURs are intended to allow EPA the opportunity to review specific significant new uses
proposed in a SNUN on a case-by-case basis before such uses of the chemical enter commerce.
EPA does not predetermine the outcome of a SNUN review when promulgating a SNUR. EPA
review of a SNUN puts the agency in the position of reviewing the risks of specific significant
new uses only when introduction into commerce is imminent.
The LCSA amended TSCA Section 5 to direct EPA to review a PMN or a SNUN within 90 days
of receipt to determine if regulatory action is warranted.61 EPA may extend the review period up
to 90 days with appropriate justification.62 Regulatory authorities for new chemical substances
and significant new uses of chemical substances are discussed in “Regulation of New Chemical
Substances and Significant New Uses.”
Under Section 5(h), EPA may exempt a chemical manufacturer or processor from submitting a
PMN or a SNUN when the agency determines that the use of a chemical substance would not

56 SNURs are codified at 40 C.F.R. Part 721. The sample PMN form referenced in footnote 54 is also the sample form
for submitting a SNUN.
57 EPA, Supporting Statement for a Request for OMB Review Under the Paperwork Reduction Act: Premanufacture
Review Reporting and Exemption Requirements for New Chemical Substances and Significant New Use Reporting
Requirements for Chemical Substances, October 16, 2019, https://www.reginfo.gov/public/do/DownloadDocument?
objectID=87850802.
58 See “Statistics Prior to June 22, 2016” tab at EPA, “Statistics for the New Chemicals Review Program under TSCA,”
last updated June 11, 2021, https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/
statistics-new-chemicals-review.
59 For example, EPA, “PBBs and Tris; Significant New Uses of Chemical Substances,” final rule, 52 Federal Register,
2699, January 26, 1987; and EPA, “Perfluoroalkyl Sulfonates; Significant New Use Rule,” final rule, 67 Federal
Register 11008, March 11, 2002.
60 EPA, “Restrictions on the Discontinued Uses of Asbestos; Significant New Use Rule,” final rule, 84 Federal
Register 17345, April 25, 2019.
61 Prior to the enactment of the LCSA, EPA had discretion on whether to review PMNs and SNUNs submitted to the
agency.
62 15 U.S.C. §2604(c).
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pose an unreasonable risk, or when the agency already has information about the chemical
substance.63 In some circumstances, EPA may not grant an exemption unless an entity applies for
one.64 For exemptions that require an application, EPA must grant or deny the exemption within
45 days of receiving the application.65 According to EPA, the agency has received over 14,000
exemption applications since the enactment of TSCA in 1976.66
Development of New Information Regarding Chemicals
Section 4(a) authorizes EPA to require any person (e.g., chemical manufacturers or processors) to
develop new information necessary to evaluate the risks of a chemical if
1. available information on the chemical is insufficient for the agency to evaluate
risks associated with the chemical;
2. testing is necessary to develop such information; and
3. either there may be unreasonable risk associated with the chemical, or the
chemical is or will be produced in substantial quantities and may enter the
environment in substantial quantities or result in substantial human exposure.67
EPA may require the development of new information through a rulemaking, administrative
order, or consent agreement. If EPA issues an administrative order, the agency must justify that
the order is needed over a rule or a consent agreement.68
Generally, EPA must justify the need for the new information (e.g., to assess a new chemical
substance or significant new use, prioritize chemicals for risk evaluation, or conduct a risk
evaluation) to require its development.69 A requirement to develop new information for
prioritizing chemicals for risk evaluation is limited to information necessary to meet that
objective.70 EPA may not establish a broadly applicable “minimum information requirement” for
purposes of prioritizing chemicals for risk evaluation.71

63 15 U.S.C. §2604(h). EPA regulations implementing the process for granting or denying exemption applications from
PMN and SNUN requirements are codified at 40 C.F.R. Parts 720 and 723. EPA has established several exemptions,
including for specified low volumes and certain types of polymers. The sample PMN form referenced in footnote 54 is
also the sample form for submitting a request for an exemption from PMN or SNUN requirements.
64 15 U.S.C. §2604(h)(1), (2), (4), and (5).
65 15 U.S.C. §2605(h)(6).
66 EPA, “Statistics for the New Chemicals Review Program under TSCA,” last updated June 11, 2021,
https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/statistics-new-chemicals-
review.
67 15 U.S.C. §2603(a). Regulations that govern procedures for entering into consent agreements or promulgating a rule
to require the development of new information for chemicals are codified at 40 C.F.R. Part 790. Additionally,
regulations that establish “good laboratory practice” standards and testing guidelines are codified at 40 C.F.R. Parts
792, 795, 796, 797, and 798. Rules requiring the development of new information for specific chemicals (also known
as test rules) are codified at 40 C.F.R. Part 799.
68 Prior to the LCSA, TSCA Section 4 authorized EPA to require the development of new information on a chemical
through rulemaking. Under Section 4, EPA promulgated regulations that permitted the agency to enter into enforceable
consent agreements with a chemical manufacturer or processor to develop new information on a chemical. The LCSA
codified this authority and also authorized EPA to issue orders for the same purpose.
69 15 U.S.C. §2603(a)(3).
70 15 U.S.C. §2603(a)(2)(B).
71 A minimum information requirement generally refers to a predetermined set of information about a chemical that is
required to be submitted without the review of available information to determine whether subsets of the predetermined
information may not be necessary for the evaluation of risks. In contrast, EPA must use a tiered approach that requires
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Upon application, EPA may provide exemptions from requirements to develop new information
for a chemical when the requested information has already been developed or is being developed
by another entity.72 TSCA establishes a process for exempt entities to reimburse testing costs to
the entity that developed or is developing the required information.73
Section 4(d) requires EPA to publish a notice in the Federal Register of the receipt of any new
information required to be developed within 15 days of its receipt.74 Unless the submitted new
information warrants confidential treatment in accordance with Section 14 (as discussed in
“Confidentiality and Disclosures of Information”), EPA must make this information available for
examination by any person upon request.
Interagency Testing Committee
TSCA establishes an interagency committee to make nonbinding recommendations to EPA
regarding which chemicals the agency should prioritize when requiring the development of new
information.75 Section 4(e) further directs the committee to designate chemicals that warrant the
development of new information within 12 months of designation; up to 50 chemicals may be
designated for priority testing at any one time.76 The committee must review its recommendations
and designations at least once every six months to determine if revisions are necessary. In April
2021, the TSCA interagency testing committee added 39 chemicals to the list of recommended
chemicals for the development of new information.77 None of these designated chemicals were
recommended for expedited priority testing.
Strategy to Minimize Animal Testing
Generally, the development of new information on chemicals relies on animal testing, unless an
alternative approach is shown to reliably produce information suitable for evaluating risks.
Stakeholders have disagreed about whether animal testing is necessary to develop new
information on chemicals, particularly with respect to the usefulness of any new information and
whether alternative testing methods can reliably produce information that traditionally has been
produced through animal testing. The LCSA added Section 4(h) to TSCA to require EPA to
develop a strategic plan to minimize, to the extent practicable, the use of vertebrate animals when
requiring the development of new information pertaining to a chemical.78 EPA published the
strategic plan in June 2018.79

the agency to first review available information about a chemical then determine what additional information is needed
for the evaluation of risks.
72 15 U.S.C. §2603(c).
73 15 U.S.C. §2603(c)(3). Regulations that govern the process for reimbursement of costs associated with required
testing of chemical substances are codified at 40 C.F.R. Part 791.
74 15 U.S.C. §2603(d).
75 15 U.S.C. §2603(e).
76 15 U.S.C. §2603(e)(1)(A).
77 EPA, “Seventy-Fourth Report of the TSCA Interagency Testing Committee to the Administrator of the
Environmental Protection Agency; Receipt of Report and Request for Comments,” 86 Federal Register 22414, April
28, 2021. For more information on prior meetings of the TSCA interagency testing committee, see EPA, “Interagency
Testing Committee (ITC) Reports,” last updated April 28, 2021, https://www.epa.gov/assessing-and-managing-
chemicals-under-tsca/interagency-testing-committee-itc-reports.
78 15 U.S.C. §2603(h).
79 EPA, “Final Strategic Plan to Promote the Development and Implementation of Alternative Test Methods Supporting
the Toxic Substances Control Act (TSCA); Notice of Availability,” 83 Federal Register 30167, June 27, 2018. For
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Research, Development, and Monitoring Activities
Section 10 directs EPA, in consultation and cooperation with other federal agencies, to conduct
basic and applied research, development, and monitoring activities, such as toxicological
screening and environmental monitoring, for purposes of carrying out the act.80 Generally, these
research, development, and monitoring activities are not focused on a specific chemical but on
scientific methods or technologies to better understand risks from chemicals more generally. EPA
may also enter into contracts and award grants for these purposes. Additionally, EPA must
develop information systems for the collection, dissemination, and use of information submitted
to the agency under TSCA and for federal, state, and local entities to exchange relevant research
and development information.
Confidentiality and Disclosures of Information
Some of the information chemical manufacturers and processors submit to EPA under TSCA is
proprietary. To balance the objectives of protecting sensitive or proprietary information from
public disclosure and maintaining the public’s right of access to information about the agency’s
activities, Section 14 of TSCA protects information from disclosure under certain conditions.
TSCA builds upon protections from disclosure set forth in the Freedom of Information Act
(FOIA).81 FOIA generally requires federal agencies to disclose information requested by any
person unless the information falls under one of nine exemptions. Section 14 of TSCA requires
EPA to withhold from disclosure information that meets the criteria under FOIA Exemption 4 for
which a confidentiality claim has been properly asserted.82 FOIA Exemption 4 protects “trade
secrets and commercial or financial information obtained from a person and privileged or
confidential.”83 Knowing and willful disclosure of such information is subject to a criminal
penalty under TSCA.84
Section 14(b) also provides that certain categories of information are not protected from
disclosure. In particular, information from “health and safety studies” is not protected, unless
disclosure would reveal specific manufacturing and processing information or a mixture’s
chemical proportions.85 The LCSA also established a presumption that information can be
released when it pertains to chemicals that EPA has banned or phased out.86 For specific chemical
identities determined to warrant confidential treatment, the LCSA amended TSCA Section 14 to

more information, see EPA, “Alternative Test Methods and Strategies to Reduce Vertebrate Animal Testing,” February
5, 2021, https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/alternative-test-methods-and-strategies-
reduce.
80 15 U.S.C. §2609.
81 5 U.S.C. §552. EPA’s FOIA regulations are codified at 40 C.F.R. Part 2. Special rules governing confidentiality or
disclosure of information obtained under TSCA are codified at 40 C.F.R. §2.306. For further discussion of FOIA, see
CRS Report R46238, The Freedom of Information Act (FOIA): A Legal Overview, by Daniel J. Sheffner.
82 15 U.S.C. §2613(a). TSCA Section 14 cross-references 5 U.S.C. §552(b)(4), commonly known as FOIA Exemption
4. For more information on FOIA Exemption 4, see U.S. Department of Justice, “Exemption 4,” The United States
Department of Justice Guide to the Freedom of Information Act, last updated August 10, 2009,
https://www.justice.gov/oip/foia_guide09/exemption4.pdf. See also CRS Report R46238, The Freedom of Information
Act (FOIA): A Legal Overview, by Daniel J. Sheffner, p. 27.
83 5 U.S.C. §552(b)(4).
84 15 U.S.C. §2613(h).
85 15 U.S.C. §2613(b)(2).
86 15 U.S.C. §2613(b)(4).
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require the use of unique generic identifiers when disclosing the chemical names may provide
information about the structure and identity of a chemical substance.87
In several ways, TSCA generally favors disclosure over confidentiality, placing the burden of
demonstrating that confidentiality is warranted on the person seeking to protect information from
disclosure. A person seeking to protect information from disclosure must file a confidentiality
claim when submitting the information to EPA.88 The submitter must substantiate the
confidentiality claim unless the information falls into one of the categories of information
explicitly exempt from disclosure.89 The LCSA amended TSCA Section 14 to require further
substantiation for claims regarding a specific chemical identity.90 The LCSA also limited the
duration of any substantiation to 10 years (though the submitter may renew the substantiation
before its expiration).91 There are circumstances in which EPA may require a submitter to reassert
and resubstantiate a confidentiality claim for information that has previously been protected:
when chemicals are designated as an active substance (i.e., those reported as having been
manufactured in the United States between 2006 and 2016),92 when chemicals are newly
designated as a high-priority substance for risk evaluation under Section 6(b),93 or if the agency
determines that disclosure of protected information would be important in conducting risk
evaluations or promulgating rules.94 There are also circumstances in which EPA must require a
submitter to reassert and resubstantiate a confidentiality claim: as necessary to determine whether
the protected information is exempt from disclosure in connection with a pending FOIA request
that seeks the protected information, if the agency has a reasonable basis to believe the
information does not qualify for protection from disclosure, or when EPA makes an unreasonable
risk determination about a chemical.95 EPA must also review all claims or renewals for specific
chemical identities, as well as a representative subset of confidentiality claims or renewals subject
to substantiation requirements.96
Even when information warrants confidential treatment, Section 14 establishes circumstances in
which such information may or must be disclosed.97 For instance, such information must be

87 15 U.S.C. §2613(g)(4). In June 2018, EPA issued its policy on assigning unique generic identifiers and applying such
identifiers to nonconfidential information related to the chemical. EPA, “TSCA Chemical Structure; Unique Identified
Assignment and Application Policy; Notice of Availability,” 83 Federal Register 30168, June 27, 2018. EPA also
issued a guidance document on creating generic names. EPA, “Guidance for Creating Generic Names for Confidential
Chemical Substance Identity Reporting under the Toxic Substances Control Act; Notice of Availability,” 83 Federal
Register 30173, June 27, 2018.
88 15 U.S.C. §2613(c).
89 15 U.S.C. §2613(c)(3). Section 14(c)(2) generally exempts from disclosure (1) information describing the steps to
manufacture or process a chemical; (2) marketing and sales information; (3) information identifying a supplier or
customer; (4) mixture composition details; (5) specific information regarding a chemical’s use, function, or application
in a process, mixture, or article; (6) production or import volumes; and (7) a chemical’s specific chemical identity
before it is first offered for commercial distribution, if the identity was claimed as confidential when it was submitted in
a PMN or a SNUN. 15 U.S.C. §2613(c)(2).
90 15 U.S.C. §2613(c).
91 15 U.S.C. §2613(e).
92 See “Existing Information Regarding Chemical Risks” section for provision on dividing the TSCA inventory into
“active substances” and “inactive substances.”
93 See “Prioritization of Chemicals for Evaluation of Risks” section.
94 15 U.S.C. §2613(f)(1).
95 15 U.S.C. §2613(f)(2).
96 15 U.S.C. §2613(f)-(g).
97 15 U.S.C. §2613(d).
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disclosed for certain law enforcement purposes, or to states, localities, tribes, and health or
environmental professionals if EPA determines that disclosure is necessary to protect health or the
environment against an unreasonable risk.98 In June 2018, EPA published guidance on expanded
access to confidential business information under certain conditions.99
Federal Chemical Evaluation and Regulatory
Authorities
EPA evaluates chemicals under TSCA to determine whether they meet the unreasonable risk
threshold for regulation, and to determine how to regulate chemicals that meet that threshold.
Section 6 of TSCA establishes a framework for EPA to prioritize which existing chemicals to
evaluate for risks. It directs EPA to take expedited actions for the following chemicals and
chemical categories:
 polychlorinated biphenyls;
 certain persistent, bioaccumulative, and toxic (PBT) chemical substances;
 imminently hazardous chemicals;
 chemicals that present significant risks; and
 new chemical substances and significant new uses of chemical substances.
The process by which EPA determines which chemicals to evaluate has been a long-standing
issue for Congress and stakeholders, particularly in light of the finite resources the agency can
dedicate to evaluating both chemicals already in commerce and new chemical substances.100
Related to concerns about the risk evaluation prioritization process is how long EPA takes to
complete a risk evaluation.

98 Ibid.
99 EPA, “Guidance on Expanded Access to TSCA Confidential Business Information; Notice of Availability,” 83
Federal Register 30171, June 27, 2018.
100 U.S. Congress, Senate Committee on Environment and Public Works, Frank L. Lautenberg Chemical Safety for the
21st Century Act, report to accompany S. 697, 114th Cong., 1st sess, S.Rept. 114-67 (Washington, DC: GPO, 2015), pp.
4, 13; see U.S. Congress, House Committee on Energy and Commerce, TSCA Modernization Act of 2015, report to
accompany H.R. 2576, 114th Cong., 1st sess., June 23, 2015, H.Rept. 114-176 (Washington: GPO, 2015), p. 13; also see
statement of Rep. Henry A. Waxman, Testimony of Beth D. Bosley, Responses to Additional Questions for the Record
from Jeanne Rizzo, in U.S. Congress, House Committee on Energy and Commerce, Subcommittee on Environment and
the Economy, Title I of the Toxic Substances Control Act: Understanding its History and Reviewing its Impact, hearing,
113rd Cong., 1st sess., June 13, 2013 (Washington: GPO, 2013).
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Prioritization of Chemicals for Evaluation of Risks
Prior to the enactment of the LCSA, EPA had
Initial 10 Chemicals for Risk
discretion in selecting which chemicals to evaluate
Evaluation
under TSCA.101 The LCSA amended TSCA Section 6

1,4-Dioxane
to establish a framework and a timetable for

1-Bromopropane
prioritizing chemicals for risk evaluation.102 Section 6

directed EPA to select 10 chemicals for risk evaluation

Asbestos
from a list of chemicals that the agency identified in

Carbon tetrachloride
2014 as warranting risk assessment, and to begin

Cyclic aliphatic bromide cluster (i.e.,
conducting risk evaluations for those chemicals by
hexabromocyclododecane or HBCD)
December 2016.103 In December 2016, EPA published

Methylene chloride
its selection of the initial 10 chemicals for risk

N-methylpyrrolidone
evaluation.104 Table 1 presents a list of chemicals that

C.I. Pigment Violet 29
EPA subsequently designated as high- or low-priority

Tetrachloroethylene (also known as
for risk evaluation.
perchloroethylene)

The 2016 act also directed EPA to promulgate a rule

Trichloroethylene
establishing a risk-based screening process for
Source: EPA, “Designation of Ten Chemical
Substances for Initial Risk Evaluations Under
designating chemicals as either high-priority or low-
the Toxic Substances Control Act,” 81
priority for risk evaluations.105 The screening process
Federal Register 91927, December 19, 2016.
must give preference to chemicals previously judged to
present a greater level of risk (e.g., acute toxicity, carcinogenic, persistent and bioaccumulative)
and consider the chemical substance’s hazard and exposure potential, conditions of use, and
volume manufactured or processed.106
Based on this screening process, if EPA concludes that a chemical may present unreasonable
risks, then the agency must designate the chemical as high-priority for risk evaluation and initiate
a risk evaluation on the chemical.107 If EPA concludes, based on sufficient information, that a
chemical does not present an unreasonable risk, the agency must designate the chemical as low-
priority for risk evaluation, though the agency has discretion to revise the designation based on
subsequent available information.108 If EPA has insufficient information to prioritize the chemical,
the agency must require the development of new information from the chemical’s manufacturer
or processor and prioritize the chemical within 90 days of receiving the required information.109

101 Prior to the enactment of the LCSA, TSCA did not include provisions prescribing criteria or a process for EPA to
select chemicals to evaluate.
102 15 U.S.C. §2605(b)(1).
103 15 U.S.C. §2605(b)(2)(A).
104 EPA, “Designation of Ten Chemical Substances for Initial Risk Evaluations Under the Toxic Substances Control
Act,” 81 Federal Register 91927, December 19, 2016.
105 15 U.S.C. §2605(b)(1). EPA regulations establishing procedures for prioritization of chemicals for risk evaluation
are codified at 40 C.F.R. Part 702, Subpart A.
106 15 U.S.C. §2605(b)(1)(i)(B)(i), (b)(2)(D).
107 15 U.S.C. §2605(b)(1)(B)(i), (b)(3)(A).
108 15 U.S.C. §2605(b)(1)(B)(ii).
109 15 U.S.C. §2603(a)(2)(B).
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In October 2018, EPA published its approach for selecting potential chemicals to prioritize for
risk evaluation.110
Table 1. EPA High-Priority and Low-Priority Chemicals for Risk Evaluation Under
the Amended Toxic Substances Control Act (TSCA)
High-Priority Chemicals
Low-Priority Chemicals
1,3-Butadiene
1-Butanol, 3-methoxy-, 1-acetate
Butyl benzyl phthalate (BBP) (1,2-Benzenedicarboxylic
D-gluco-Heptonic acid, sodium salt (1:1), (2.xi.)-
acid, 1-butyl 2-(phenylmethyl) ester)
Dibutyl phthalate (DBP) (1,2-Benzenedicarboxylic acid,
D-Gluconic acid
1,2-dibutyl ester)
1,1-Dichloroethane
D-Gluconic acid, calcium salt (2:1)
1,2-Dichloroethane
D-Gluconic acid, .delta.-lactone
1,2-Dichloropropane
D-Gluconic acid, potassium salt (1:1)
Dicyclohexyl phthalate (1,2-Benzenedicarboxylic acid,
D-Gluconic acid, sodium salt (1:1)
1,2-dicyclohexyl ester)
Di-ethylhexyl phthalate (DEHP) (1,2-
Decanedioic acid, 1,10-dibutyl ester
Benzenedicarboxylic acid, 1,2-bis(2-ethylhexyl) ester)
Di-isobutyl phthalate (DIBP) (1,2-Benzenedicarboxylic
1-Docosanol
acid, 1,2-bis(2-methylpropyl) ester)
Ethylene dibromide
1-Eicosanol
Formaldehdye
1,2-Hexanediol
1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-hexamethylcyclopenta 1-Octadecanol
[g]-2-benzopyran (HHCB)
4,4′-(1-Methylethylidene)bis[2, 6-dibromophenol]
Propanol, [2-(2-butoxymethylethoxy)methylethoxy]-
(TBBPA)
o-Dichlorobenzene (Benzene, 1,2-dichloro-)
Propanedioic acid,1,3-diethyl ester
p-Dichlorobenzene (Benzene, 1,4-dichloro-)
Propanedioic acid,1,3-dimethyl ester
Phosphoric acid, triphenyl ester (TPP)
Propanol, 1(or 2)-(2-methoxymethylethoxy)-, acetate
Phthalic anhydride (1,3-Isobenzofurandione)
Propanol, [(1-methyl-1,2-ethanediyl)bis(oxy)]bis-
trans-1,2- Dichloroethylene (Ethene, 1,2-dichloro-,
2-Propanol, 1,1′-oxybis-
(1E)-)
1,1,2-Trichloroethane
Propanol, oxybis-
Tris(2-chloroethyl) phosphate (TCEP) (Ethanol, 2-
Tetracosane, 2,6,10,15,19,23-hexamethyl-
chloro-, 1,1′,1″-phosphate)
Source: EPA, “High-Priority Substance Designations Under the Toxic Substances Control Act (TSCA) and
Initiation of Risk Evaluation on High-Priority Substances; Notice of Availability,” 84 Federal Register 71924,
December 30, 2019; EPA, “Final Designation of Low-Priority Substances Under the Toxic Substances Control
Act (TSCA); Notice of Availability,” notice, 85 Federal Register 11069, February 26, 2020; and EPA, TSCA Work
Plan for Chemical Assessments: 2014 Update, October 2014, at https://www.epa.gov/sites/production/files/2015-01/
documents/tsca_work_plan_chemicals_2014_update-final.pdf.

110 EPA, “A Working Approach for Identifying Potential Candidate Chemicals for Prioritization; Notice of
Availability,” 83 Federal Register 50366, October 5, 2018.
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Note: All 20 high-priority chemicals are among the 90 chemicals identified by EPA in the 2014 update of the
TSCA Work Plan for Chemical Assessments.
Section 6 establishes a process for chemical manufacturers to request that EPA conduct a risk
evaluation on a specific chemical, provided the manufacturer pays the requisite fee, discussed
later in the “Resources and Fees to Administer TSCA” section of the report.111 However,
manufacturer requests for risk evaluation of a chemical identified in 2014 by EPA to warrant risk
assessment are not subject to fees.112 EPA has discretion to grant or deny requests for risk
evaluation.113 In December 2019, EPA granted manufacturer-submitted requests to conduct risk
evaluations for two phthalate chemicals—di-isononyl phthalate and di-isodecyl phthalate.114
Risk Evaluation Process
When Congress enacted TSCA in 1976, it directed EPA to regulate the lifecycle of chemicals that
present unreasonable risks but did not specify how the agency should evaluate risks. Over time,
EPA has developed guidelines to assess risks from chemicals.115 Generally, risk evaluation
involves identifying the adverse health or environmental effects that exposure to a chemical may
cause and the extent to which exposure may occur based on how the chemical is used. Ultimately,
a risk assessor makes a risk determination by integrating and evaluating the scientific and
technical information relevant to the chemical. The risk assessor may also rely on precedence
established from the evaluation of similar chemicals, when appropriate.
The LCSA amended TSCA Section 6 to require EPA to promulgate a rule establishing a process
for conducting risk evaluations to determine whether a chemical presents unreasonable risks.116 It
also provided that EPA must conduct the risk evaluation without consideration of cost and other
nonrisk factors.117
Timing of Risk Evaluations
Prior to the 2016 amendments, stakeholders expressed concerns about the low volume and slow
pace of EPA’s risk evaluations under TSCA.118 To address these concerns, the LCSA imposed

111 15 U.S.C. §2605(b)(4)(C)(ii), (b)(4)(E)(ii). See also 15 U.S.C. §2625(b).
112 15 U.S.C. §2605(b)(4)(E)(iv)(II).
113 15 U.S.C. §2605(b)(4)(E)(iii).
114 EPA, “List of Manufacturer-Requested Risk Evaluations under TSCA Section 6,” last updated April 1, 2021,
https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/list-manufacturer-requested-risk-evaluations-
under-tsca.
115 For example, EPA, “Guidelines for Exposure Assessment,” 57 Federal Register 22888, May 29, 1992. A list of risk
assessment guidelines is available at EPA, “Risk Assessment Guidelines,” last updated February 2, 2021,
https://www.epa.gov/risk/risk-assessment-guidelines. Several of these guidelines are also used to implement other
environmental statutes administered by the agency.
116 15 U.S.C. §2605(b)(1)(A). EPA’s regulations establishing procedures for chemical risk evaluations are codified at
40 C.F.R. Part 702, Subpart B. In November 2019, the U.S. Court of Appeals for the Ninth Circuit struck down a
portion of EPA’s risk evaluation rule. Safer Chemicals, Healthy Families v. EPA, 943 F.3d 397 (9th Cir. 2019). The
court held that TSCA required EPA, when considering a chemical’s conditions of use in conducting a risk evaluation,
to evaluate “legacy uses,” or the use of chemicals not currently or prospectively manufactured or distributed in
commerce for that use, and disposals from such uses. Id. at 425.
117 15 U.S.C. §2605(b)(4)(A).
118 See, for example, testimony in U.S. Congress, House Committee on Energy and Commerce, Subcommittee on
Environment and the Economy, Title I of the Toxic Substances Control Act: Understanding its History and Reviewing
its Impact, hearing, 113rd Cong., 1st sess., June 13, 2013 (Washington: GPO, 2013).
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deadlines for EPA to initiate and complete risk evaluations. As described above, EPA must initiate
a risk evaluation when it designates a chemical as high-priority. In addition to requiring EPA to
begin risk evaluations for the initial list of 10 chemicals by December 2016, Section 6 required
EPA to begin conducting risk evaluations for at least 20 high-priority chemicals by the end of
2019.119
No later than six months after initiating a risk evaluation, EPA must publish the scope of the risk
evaluation to be conducted.120 EPA must complete a risk evaluation “as soon as practicable” but
not later than three years after initiating the risk evaluation, though the agency may extend this
time frame up to six months.121 Additionally, the LCSA added Section 26(n) to TSCA to require
EPA to identify annually which chemical risk evaluations the agency intends to initiate or
complete in the upcoming year.122
EPA must continue to designate chemicals as high-priority for risk evaluation and conduct such
evaluations at a pace consistent with the agency’s ability to complete the evaluations, though
TSCA also establishes the minimum number of risk evaluations that EPA must ensure are
ongoing at given time frames.123 When EPA completes a risk evaluation, the agency must
designate at least one other chemical as high-priority for risk evaluation and begin the risk
evaluation process for that chemical.124
On January 14, 2021, EPA finalized its evaluation of C.I. Pigment Violet 29, marking the
completion of EPA’s first 10 risk evaluations.125 All of the first 10 risk evaluations identified
unreasonable risks associated with particular conditions of use that warrant proceeding to a
rulemaking to address such risks (as discussed below).126 On February 5, 2021, EPA announced
that it would review the 10 risk evaluations in light of statutory obligations and policy objectives
related to use of the best available science and protection of human health and the environment,
in accordance with the executive orders and other direction provided by the Biden
Administration.127 Additionally, on February 16, 2021, EPA announced that the agency would
change its approach to selecting and reviewing scientific studies used to inform its risk
evaluations as a response to recommendations from a National Academies of Sciences,
Engineering, and Medicine study requested by the agency.128 On June 30, 2021, EPA announced
policy changes that the agency would apply to future risk evaluations and to the reconsideration

119 15 U.S.C. §2605(b)(2)(A)-(B).
120 15 U.S.C. §2605(b)(4)(D).
121 15 U.S.C. §2605(b)(4)(G).
122 15 U.S.C. §2625. EPA issued its most recent annual report on risk evaluation in May 2020. EPA, 2020 Annual Plan
for Chemical Risk Evaluations under TSCA, May 13, 2020, https://www.epa.gov/sites/production/files/2020-05/
documents/annual_plan_for_chemical_risk_evaluations_under_tsca_2020.pdf.
123 15 U.S.C. §2605(b)(2)(B)-(C).
124 15 U.S.C. §2605(b)(3)(C).
125 EPA, “C.I. Pigment Violet 29; Final Toxic Substances Control Act (TSCA) Risk Evaluation; Notice of
Availability,” 86 Federal Register 6322, January 21, 2021.
126 For more information on unreasonable risk determinations in EPA’s final risk evaluations, see entries for individual
chemicals on EPA, “Chemicals Undergoing Risk Evaluation under TSCA,” last updated July 19, 2021,
https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/chemicals-undergoing-risk-evaluation-under-tsca.
127 EPA, “Updates on Chemical Safety Actions,” last updated February 5, 2021, https://www.epa.gov/chemicals-under-
tsca/updates-chemical-safety-actions.
128 EPA, “EPA Commits to Strengthening Science Used in Chemical Risk Evaluations,” last updated February 16,
2021, https://www.epa.gov/newsreleases/epa-commits-strengthening-science-used-chemical-risk-evaluations. For more
general discussion of the process by which agencies may alter or rescind legislative rules, see CRS Report R46673,
Agency Rescissions of Legislative Rules, by Kate R. Bowers and Daniel J. Sheffner.
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of some of the 10 risk evaluations, including changes relating to consideration of exposure
pathways, assumptions regarding the use of personal protective equipment, and the use of a
whole-chemical approach instead of making separate unreasonable risk determinations for every
condition of use of a chemical.129
Rulemaking Procedures to Regulate Chemicals That Present
Unreasonable Risks
If EPA determines that a chemical presents unreasonable risk based on a risk evaluation, Section
6 requires the agency to promulgate a rule to eliminate the unreasonable risk.130 EPA may select
among seven different regulatory options to regulate a chemical found to present unreasonable
risk, which may be applied in combination or only to specific geographic areas. The seven
regulatory options are as follows:
1. prohibition or restriction on manufacturing, processing, or distribution of the
chemical;
2. prohibition or restriction on manufacturing, processing, or distribution of the
chemical for particular uses;
3. requirement that the chemical (including as part of a mixture or an article) be
marked with or accompanied by clear and adequate minimum warnings and
instructions with respect to its use, distribution, or disposal;
4. requirement to keep records on, or monitor, processes used to manufacture or
process the chemical to assure compliance with the rule;
5. prohibition or regulation of the manner or method of commercial use of the
chemical;
6. prohibition or regulation of the manner or method of disposal of the chemical
(including as part of a mixture or an article); or
7. requirement that manufacturers or processors of the chemical notify
distributors—and, to the extent reasonably ascertainable, downstream entities—
and the public of the agency’s determination of unreasonable risks and replace or
repurchase the chemical upon request.131
As amended by the LCSA, TSCA Section 6(g) authorizes EPA to grant exemptions from rules
promulgated under Section 6(a).132 EPA may grant an exemption if it finds that doing so would be
necessary to (1) maintain critical or essential uses of a chemical or (2) avoid significant disruption
to the national economy, security, or critical infrastructure; or if (3) a specific condition of use
provides substantial benefits to health, environment, or public safety despite risks associated with
the chemical.133 Additionally, EPA must exempt replacement parts for “complex durable goods”
and “complex consumer goods” designed prior to a rule’s publication in the Federal Register
unless the agency finds that such replacement parts contribute significantly to unreasonable risks

129 EPA, “EPA Announces Path Forward for TSCA Chemical Risk Evaluations,” press release, June 30, 2021,
https://www.epa.gov/newsreleases/epa-announces-path-forward-tsca-chemical-risk-evaluations.
130 15 U.S.C. §2605(a), (c). EPA’s regulation establishing procedures for rulemaking to address a chemical found to
present unreasonable risk is codified at 40 C.F.R. Part 750.
131 15 U.S.C. §2605(a)(1)-(7).
132 15 U.S.C. §2605(g).
133 15 U.S.C. §2605(g)(1).
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identified in a risk evaluation.134 When EPA grants an exemption, it must publish its analysis of
the need for the exemption,135 and also must establish a time limit on the exemption.136
Section 6 directs EPA to promulgate one or more of the seven regulatory requirements in
accordance with the Administrative Procedure Act’s (APA’s) provisions governing agency
rulemaking.137 Section 6 also imposes additional procedural requirements, such as considering the
chemical’s risks and benefits, “reasonably ascertainable economic consequences” of the
requirements on the chemical, and alternative regulatory actions.138
Under Section 6, as amended by the LCSA, EPA must propose a rule not later than one year after
publishing the final risk evaluation and finalize the rule not later than two years after publishing
the final risk evaluation.139 However, EPA may extend these time frames up to two years for
chemicals the agency has not already identified as persistent and bioaccumulative.140
Section 6 also includes requirements regarding the effective date and compliance dates for rules
issued under that section.141 EPA must establish mandatory compliance dates that are as soon as
practicable but not later than five years after promulgation of the rule, except for uses being
exempted.142 EPA may vary the mandatory compliance dates for different affected persons (e.g.,
chemical manufacturers, processors, and distributors).143 Section 6 rules must provide for a
reasonable transition period before the mandatory compliance dates become effective.144 If,
however, EPA determines that the manufacture, processing, distribution, use, or disposal of a
chemical is likely to present an unreasonable risk before the effective date, EPA may declare a
proposed rule to be effective to protect the public interest, in which case compliance with the
proposed requirements is mandatory upon the proposed rule’s publication in the Federal Register
until the proposed rule is finalized or revoked.145
Since the enactment of the LCSA in 2016, EPA has issued one final rule under TSCA Section 6 to
prohibit the manufacture, processing, and distribution of a chemical. In March 2019, EPA issued a
final rule to prohibit the manufacture, processing, and distribution of methylene chloride in all
paint and coating removers for consumer use.146 Although EPA had proposed to regulate

134 15 U.S.C. §2605(c)(2)(D). For purposes of exempting replacement parts, the terms complex consumer goods and
complex durable goods are generally defined by the number of components making up the product, the intended useful
lifetime of the product, and whether the product is typically reused. For example, automotive products may contain
chemical substances subject to TSCA and be replaceable throughout the lifetime of the automobile.
135 15 U.S.C. §2605(g)(2).
136 15 U.S.C. §2605(g)(3).
137 15 U.S.C. §2605(c)(3). See also 5 U.S.C. §553. For more information on the APA, see CRS Report RL32240, The
Federal Rulemaking Process: An Overview, coordinated by Maeve P. Carey; and CRS Report R41546, A Brief
Overview of Rulemaking and Judicial Review, by Todd Garvey.
138 15 U.S.C. §2605(c)(3).
139 15 U.S.C. §2605(c)(1)(A)-(B).
140 15 U.S.C. §2605(c)(1)(C).
141 15 U.S.C. §2605(d).
142 15 U.S.C. §2605(d)(1)(B).
143 15 U.S.C. §2605(d)(2).
144 15 U.S.C. §2605(d)(1)(E).
145 15 U.S.C. §2605(d)(3).
146 EPA, “Methylene Chloride; Regulation of Paint and Coating Removal for Consumer Use Under TSCA Section
6(a),” 84 Federal Register 11420, March 27, 2019. EPA based its rule on a 2014 risk assessment. TSCA Section
26(l)(4) (15 U.S.C. §2624(l)(4)) authorizes EPA to propose and finalize rules under Section 6(a) for chemicals listed in
the 2014 update to the TSCA Work Plan for Chemical Assessments for which EPA has published a completed risk
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methylene chloride for other commercial paint and coating removal uses, the agency decided to
further evaluate the risks from such uses to inform the development of an appropriate regulatory
risk management approach.147 Separate from the 2019 rule, EPA selected methylene chloride as
one of the first 10 chemicals to undergo risk evaluation to examine risks posed by conditions of
use not addressed by the rule. In June 2020, EPA concluded that certain conditions of use of
methylene chloride presented unreasonable risks that warranted proceeding to rulemaking to
address such risks.148
Special Regulatory Authority for Certain Chemicals
In addition to the general provisions for evaluating chemicals for unreasonable risks and
regulating those chemicals that present such risks, TSCA also authorizes EPA to take regulatory
action with respect to the risks posed by specific categories of chemicals.
Polychlorinated Biphenyls (PCBs)
PCBs are a group of synthetic chemicals that were widely used as coolants and lubricants in
electrical equipment until the late 1970s. Due primarily to certain characteristics and experience
with PCBs (e.g., they bioaccumulate, do not readily break down in the environment, and have
been associated with a variety of adverse health effects), Congress in 1976 included a provision in
TSCA that directed EPA to prescribe methods for the disposal of PCBs and to require clear and
adequate warnings and instructions with respect to their processing, distribution, use, and
disposal.149 Furthermore, TSCA made it unlawful to manufacture, process, and distribute PCBs
after 1979 unless EPA grants, by rule, a petition for an exemption.150 Exemptions are limited to
one year and subject to terms and conditions that EPA may prescribe.

assessment prior to the enactment of the LCSA if the rule is consistent with the scope of the completed risk assessment
and other applicable requirements under Section 6.
147 EPA, “Methylene Chloride; Regulation of Paint and Coating Removal for Consumer Use Under TSCA Section
6(a),” 84 Federal Register 11420, March 27, 2019.
148 EPA, “Methylene Chloride (MC); Final Toxic Substances Control Act (TSCA) Risk Evaluation; Notice of
Availability,” 85 Federal Register 37942, June 24, 2020. Environmental groups and a coalition of 11 states and 2 city
governments filed lawsuits challenging EPA’s risk evaluation. See Neighbors for Env’t Justice v. EPA, No. 20-72091
(9th Cir.). The groups argue that EPA unlawfully analyzed the chemical’s risks on a use-by-use basis rather than
comprehensively and holistically, failed to consider certain aspects of the risks posed by the chemical, improperly
considered regulatory protections provided by other statutes, and did not support its risk evaluation with substantial
evidence or appropriate data. Opening Briefs for Petitioners Neighbors for Environmental Justice et al. and for
Petitioners State of New York et al., Neighbors for Env’t Justice v. EPA, Doc. Nos. 39, 42. On May 13, 2021, EPA
requested that the Ninth Circuit Court of Appeals remand the risk evaluation to allow the agency to reconsider it,
consistent with an executive order directing agencies to review actions (including the methylene chloride risk
evaluation) for consistency with the Biden Administration’s scientific policies. Respondents’ Motion for Voluntary
Remand, Neighbors for Env’t Justice v. EPA, Doc. No. 51. See also Executive Order 13990, “Protecting Public Health
and the Environment and Restoring Science to Tackle the Climate Crisis,” 86 Federal Register 7037 (2021); The White
House Briefing Room, “Fact Sheet: List of Agency Actions for Review” (Jan. 20, 2021), https://www.whitehouse.gov/
briefing-room/statements-releases/2021/01/20/fact-sheet-list-of-agency-actions-for-review/. On July 14, 2021, the court
granted EPA’s motion and remanded the risk evaluation “for the limited purpose of permitting the agency to reconsider
the challenged no-unreasonable-risk determinations.” Order, Neighbors for Env’t Justice v. EPA, Doc. No. 80.
149 15 U.S.C. §2605(e). EPA regulations concerning PCB manufacture, processing, distribution, use, and disposal are
codified at 40 C.F.R. Part 761. For more information on PCBs, see Agency for Toxic Substances Disease Registry,
Toxicological Profile for Polychlorinated Biphenyls (PCBs), November 2000.
150 Exemptions for the manufacture, processing, and distribution of PCBs are codified at 40 C.F.R. §761.80.
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Certain Persistent, Bioaccumulative, and Toxic Chemical Substances
The LCSA added Section 6(h) to TSCA to provide a pathway for regulating chemicals that EPA
identified as persistent, bioaccumulative, and toxic (PBT) in 2014 and that also meet certain other
criteria.151 Congress directed EPA to propose rules pursuant to Section 6(a) by June 2019 to
address unreasonable risks presented by those chemicals.152 EPA must issue a final rule, which
must reduce exposure to the extent practicable, on an expedited basis no later than 18 months
after issuing a proposed rule.153 EPA is not required to conduct a risk evaluation when
undertaking a rulemaking under Section 6(h).154 In January 2021, EPA finalized rules to prohibit
or restrict the manufacture, processing, and distribution of five PBT chemicals for many
industrial and commercial uses.155
Imminently Hazardous Chemicals and Chemicals That Present Significant
Risk of Serious or Widespread Harm
TSCA establishes procedures for addressing imminently hazardous chemicals and chemicals that
present significant risk of serious or widespread harm. Section 7(f) defines an “imminently
hazardous chemical substance or mixture” as a chemical that “presents an imminent and
unreasonable risk of serious or widespread injury to health or the environment.”156 Under Section
7, EPA may commence a civil action in U.S. district court to protect against an imminently
hazardous chemical through seizure or other relief before promulgating a rule to regulate the
chemical.157 When appropriate, EPA must initiate promulgation of a rule for an imminently
hazardous chemical at the same time as commencing the civil action or as soon as practicable
thereafter.158
Additionally, if EPA receives information indicating a chemical may present significant risk of
serious or widespread harm to humans, Section 4(f) requires the agency to either initiate an action
to prevent or reduce to a sufficient extent such risk or publish a finding that the risk is not

151 15 U.S.C. §2605(h).
152 15 U.S.C. §2605(h)(1).
153 15 U.S.C. §2605(h)(3), (4).
154 15 U.S.C. §2605(h)(2).
155 EPA, “2,4,6-tris(tert-butyl)phenol (2,4,6-TTBP); Regulation of Persistent, Bioaccumulative, and Toxic Chemicals
Under TSCA Section 6(h),” final rule, 86 Federal Register 866, January 6, 2021; EPA, “EPA, “Decabromodiphenyl
Ether (DecaBDE); Regulation of Persistent, Bioaccumulative, and Toxic Chemicals Under TSCA Section 6(h),” final
rule, 86 Federal Register 880, January 6, 2021; EPA, “Phenol, Isopropylated Phosphate (3:1) (PIP 3:1); Regulation of
Persistent, Bioaccumulative, and Toxic Chemicals Under TSCA Section 6(h),” final rule, 86 Federal Register 894,
January 6, 2021; EPA, “Pentachlorothiophenol (PCTP); Regulation of Persistent, Bioaccumulative, and Toxic
Chemicals Under TSCA Section 6(h),” final rule, 86 Federal Register 911, January 6, 2021; and EPA,
“Hexachlorobutadiene (HCBD); Regulation of Persistent, Bioaccumulative, and Toxic Chemicals Under TSCA Section
6(h),” final rule, 86 Federal Register 922, January 6, 2021. For more information, see EPA, “Persistent,
Bioaccumulative, and Toxic (PBT) Chemicals under TSCA Section 6(h),” last updated June 17, 2021,
https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/persistent-bioaccumulative-and-toxic-pbt-
chemicals-under.
156 15 U.S.C. §2606(f).
157 15 U.S.C. §2606.
158 In 1984, EPA alleged that dielectric fluid containing PCBs from transformers and capacitors were an “imminently
hazardous chemical substance” under TSCA Section 7. U.S. v. Com. Edison Co., 620 F. Supp. 1404, 1410 (N.D. Ill.
1985).
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unreasonable in the Federal Register within 180 days of receiving the information.159 EPA may
extend the 180-day deadline by an additional 90 days for good cause.
Regulation of New Chemical Substances and Significant New Uses
If EPA finds that a new chemical substance subject to a PMN or a significant new use of a
chemical substance subject to a SNUN presents an unreasonable risk,160 Section 5(f) directs the
agency to either (1) propose a rule imposing one or more of the requirements specified in Section
6(a) to the extent necessary to protect against such risk, or (2) issue an order to prohibit or limit
the manufacture, processing, or distribution of the chemical.161 If EPA issues a proposed rule
under Section 5(f), the requirements in the proposed rule become effective upon its publication in
the Federal Register, and EPA must, as expeditiously as possible, either finalize the rule (with or
without modification) or revoke it.162 An issued order becomes effective at the end of the review
period, which is 90 days unless extended with good cause.163 Though more than 40,000 PMNs
have been submitted to EPA, the agency has promulgated regulations under Section 5(f) for three
chemical substances (i.e., certain nitrosating agents in metalworking fluids).164
If EPA finds that available information is insufficient to evaluate risks of a new chemical
substance or significant new use, Section 5(e) requires EPA to issue an administrative order to
prohibit or otherwise restrict manufacture, processing, distribution, use, or disposal to the extent
necessary to protect against unreasonable risks pending the development of further
information.165 An issued order becomes effective at the end of the review period. The submitter
of the PMN or SNUN must comply with the order while the required information is being
developed.166 For new chemical substances or significant new uses for which information is
insufficient to evaluate risks while Section 5(e) orders apply to the PMN or SNUN submitter,
EPA may in practice also promulgate a SNUR to apply the restrictions outlined in an order to
other manufacturers and processors.167 Prior to June 2016, EPA reported that the agency had

159 15 U.S.C. §2603(f). As an example, in 1983, EPA initiated a 180-day review of 4,4’-methylenedianiline under
TSCA Section 4(f). EPA, “4,4’-Methylenedianiline; Initiation of Review,” 48 Federal Register 19078, April 27, 1983.
160 See “New Chemical Substance and Significant New Use Notifications” section.
161 15 U.S.C. §2604(f).
162 15 U.S.C. §§2604(f)(2), 2605(d)(3)(B).
163 15 U.S.C. §2604(f)(3), (i)(3).
164 EPA, “Prohibition of Nitrites in Metalworking Fluids,” 49 Federal Register 2762, January 23, 1984; EPA,
“Triethanolamine Salt of a Substituted Organic Acid Restrictions on Use in Metalworking Fluids,” 49 Federal Register
24658, June 14, 1984; and EPA, “Mixed Mono and Diamides of an Organic Acid Restrictions on Use in Metalworking
Fluids,” 49 Federal Register 36846, September 20, 1984. See also EPA, “Substance Registry Services (SRS): TSCA
5(f) Orders,” updated January 23, 2021, https://sor.epa.gov/sor_internet/registry/substreg/searchandretrieve/
searchbylist/search.do?search=&searchCriteria.substanceList=155&searchCriteria.substanceType=-1.
165 15 U.S.C. §2604(e).
166 Ibid.
167 See, for example, EPA, “Significant New Uses of Chemical Substances; Certain Chemicals,” 49 Federal Register
35011, September 5, 1984. Also see EPA, “Reviewing New Chemicals under the Toxic Substances Control Act
(TSCA); Actions under TSCA Section 5,” last updated June 17, 2021, https://www.epa.gov/reviewing-new-chemicals-
under-toxic-substances-control-act-tsca/actions-under-tsca-section-5. EPA states that “TSCA section 5(e) or 5(f) Orders
are only binding on the original PMN submitter for that substance. Consequently, after issuing a section 5 Order, EPA
generally promulgates a SNUR that requires notice to EPA by any manufacturer or processor who wishes to
manufacture or process the chemical in a way other than described in the terms and conditions contained in the Order.”
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issued 1,729 Section 5(e) orders.168 Among the Section 5(e) orders, more than 760 were
associated with SNURs.
For substances subject to PMN and SNUN restrictions that EPA subsequently finds are not likely
to present unreasonable risk, the submitter of the notice may commence manufacture of the
substance for the uses described in the notice after the agency publishes a statement of its
finding.169
Chemical Imports and Exports
Import Certification
Under TSCA, requirements that apply to the manufacture of chemicals also apply to their
importation, because the statutory definition of manufacture includes importation.170 Section 13
establishes a process for handling chemicals (including mixtures and articles that contain
chemicals) imported into the United States that are subject to TSCA requirements.171 Pursuant to
Section 13, U.S. Customs and Border Protection (CBP), an agency of the Department of
Homeland Security, has promulgated regulations requiring certification of chemical imports as to
whether TSCA requirements apply.172
Export Notification
Section 12 provides that most of TSCA’s requirements do not apply to chemicals manufactured
or processed solely for export unless EPA has required the development of new information or
promulgated requirements to address unreasonable risks presented by the chemical.173 Generally,
only recordkeeping and reporting requirements apply to chemicals (including mixtures and
articles that contain chemicals) manufactured or processed for export only and marked as such.174
If EPA has required the development of new information or has established requirements to
prevent unreasonable risk for a chemical solely for export, the exporter must notify the agency of
the export activity. In turn, EPA must notify the country receiving the chemical export of the
TSCA requirements applicable to the chemical being exported.175

168 EPA, “Reviewing New Chemicals Under the Toxic Substances Control Act, Statistics for the New Chemicals
Review Program under TSCA,” last updated June 11, 2021, https://www.epa.gov/reviewing-new-chemicals-under-
toxic-substances-control-act-tsca/statistics-new-chemicals-review.
169 15 U.S.C. §2604(g).
170 15 U.S.C. §2602(9).
171 15 U.S.C. §2612. Regulations governing importation of chemicals are codified at 19 C.F.R. §§12.118 through
12.127 and 127.28, and 40 C.F.R. Part 707. For general information on regulation of imports, see CRS Report R43014,
U.S. Customs and Border Protection: Trade Facilitation, Enforcement, and Security, by Vivian C. Jones and Audrey
Singer.
172 U.S. Customs and Border Protection, Department of Homeland Security, and Department of the Treasury, “Toxic
Substance Control Act Chemical Substance Import Certification Process Revisions,” December 27, 2016, 81 Federal
Register 94980. CBP estimates that it receives approximately 2.8 million TSCA import certifications each year.
173 15 U.S.C. §2611.
174 15 U.S.C. §2611(b). EPA regulations governing export notification requirements are codified at 40 C.F.R. Part 707,
Subpart D. For more information, see EPA, “TSCA Requirements for Exporting Chemicals,” last updated July 19,
2021, https://www.epa.gov/tsca-import-export-requirements/tsca-requirements-exporting-chemicals.
175 15 U.S.C. §2611(b).
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Mercury Export Ban Act
Congress enacted the Mercury Export Ban Act (MEBA; P.L. 110-414) in 2008 to reduce the
availability of mercury in domestic and international markets. Mercury and mercury compounds
may be used to manufacture chemicals and electrical equipment, although their use has declined
due in part to concerns about human health and environmental effects from exposure.176 MEBA
added Section 12(c) to TSCA, which prohibits the export of elemental mercury unless EPA issues
an exemption for a specified use as an “essential use” through a petition and rulemaking process,
or unless the export involves coal.177 Essential use exemptions may not exceed three years in
duration or 10 metric tons of elemental mercury and are subject to other terms and conditions
specified by EPA. To date, EPA has not granted any essential use exemptions. The LCSA further
amended TSCA Section 12(c) to make it unlawful to export specific mercury compounds after
January 1, 2020, and to require EPA to report to Congress on the status of mercury compound
exports and disposal.178
Other TSCA provisions complement the mercury export provision. MEBA added Section 6(f) to
TSCA to make it unlawful for a federal agency to convey, sell, and distribute elemental mercury
under its jurisdiction unless the transfer of elemental mercury facilitates its storage or involves
coal.179 Prior to MEBA’s enactment, the policy of the U.S. Department of Energy (DOE) and
Department of Defense was to store, not sell, mercury stocks.180 MEBA codified this existing
policy in TSCA and also directed DOE to establish a program for long-term management and
storage of elemental mercury generated within the United States.181 The LCSA amended MEBA
with regard to the long-term storage of mercury.
The LCSA also added Section 8(b)(10) to TSCA to direct EPA to gather information regarding the
supply, use, and trade of elemental mercury and mercury compounds in the United States and
periodically publish such information in the Federal Register.182 In 2017, EPA published its initial
report on the inventory of mercury supply, use, and trade in the United States.183

176 U.S. Geological Survey, “Mercury,” Mineral Commodity Summaries, January 2021, https://pubs.usgs.gov/
periodicals/mcs2021/mcs2021-mercury.pdf; and Agency for Toxic Substances and Disease Registry, Toxicological
Profile for Mercury, March 1999, https://www.atsdr.cdc.gov/ToxProfiles/tp46.pdf.
177 15 U.S.C. §2611(c)(4), (c)(6).
178 15 U.S.C. §2611(c)(7).
179 15 U.S.C. §2605(f).
180 U.S. Department of Defense, Defense Logistics Agency, “Record of Decision for the Final Mercury Management
Environmental Impact Statement; Notice,” 69 Federal Register 23733, April 30, 2004.
181 Section 3 of MEBA added Section 6(f) (15 U.S.C. §2605(f)) to TSCA, and Section 5 of MEBA is codified at 42
U.S.C. §6939f. For more information, see DOE, “Long-Term Management and Storage of Elemental Mercury,”
https://energy.gov/em/services/waste-management/waste-and-materials-disposition-information/long-term-
management-and.
182 15 U.S.C. §2607(b)(10). Regulations governing the reporting of mercury supply, use, and trade are codified at 40
C.F.R. Part 713.
183 EPA, “Mercury; Initial Inventory Report of Supply, Use, and Trade,” 82 Federal Register 15522, March 29, 2017.
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Enforcement, Citizens’ Petitions, Citizens’ Suits,
and Judicial Review
Several TSCA provisions (Sections 11, 15, 16, and 17) relate to enforcement of the statute.184 To
enforce TSCA rules, orders, and consent agreements, the act provides EPA with inspection and
administrative subpoena authority,185 and provides the agency with administrative and judicial
mechanisms to restrain violations and apply civil or criminal penalties to violators.186
Administrative civil penalties are capped and further limited if a state undertakes enforcement for
the same violation under its own law.187 Separately, Section 22 authorizes the President through
EPA to waive compliance with any TSCA requirement for national defense purposes.188
Additionally, like many other environmental statutes, TSCA establishes a process by which
citizens can request that EPA reexamine certain agency actions under the act or challenge EPA’s
implementation of the act. Under Section 21, any person may petition EPA to issue, amend, or
repeal certain TSCA rules or orders.189 EPA must either grant or deny a citizen petition within 90
days after the petition is filed.190 If EPA denies a petition, the petitioner may file a lawsuit in
federal district court to compel the agency to undertake the requested action.191
Under Section 20, any person may file a lawsuit (commonly called a citizen suit) against EPA to
compel it to perform a nondiscretionary duty or against any other person (including government
entities) alleged to be in violation of certain types of TSCA rules or orders.192 Section 20
generally requires a citizen suit plaintiff to give 60 days’ notice of the claims to the EPA

184 15 U.S.C. §§2610, 2614, 2615, 2616. For background on the enforcement of federal pollution control laws more
generally, see CRS Report RL34384, Federal Pollution Control Laws: How Are They Enforced?, by Robert Esworthy.
See also EPA, “Compliance Monitoring Strategy for the Toxic Substances Control Act (TSCA),” last updated March
15, 2017, https://www.epa.gov/compliance/compliance-monitoring-strategy-toxic-substances-control-act-tsca.
185 15 U.S.C. §2610.
186 15 U.S.C. §§2615, 2616.
187 Statutory civil penalties, as adjusted for inflation, for various environmental statutes, including TSCA, are codified
at 40 C.F.R. §19.4. See “Coenforcement” for discussion of the relationship between federal civil enforcement and state
enforcement for the same violation under TSCA.
188 15 U.S.C. §2621.
189 15 U.S.C. §2620. EPA’s website includes a list of the more than 20 TSCA Section 21 petitions filed with the agency
since September 2007. EPA, “TSCA Section 21,” last updated July 12, 2021, https://www.epa.gov/assessing-and-
managing-chemicals-under-tsca/tsca-section-21.
190 15 U.S.C. §2620(b)(3).
191 15 U.S.C. §2620(b)(4). Section 21 provides that courts shall review the denial of a petition seeking issuance of a
new rule in a de novo proceeding, but does not specify the standard of review for petitions seeking the amendment or
repeal of existing rules. Courts have applied a more deferential standard to the latter category of petitions. See Asbestos
Disease Awareness Org. v. Wheeler, No. 19-cv-00871, 2019 WL 6050752, *7 (N.D. Cal. Nov. 15, 2019); Env’t Def.
Fund v. Reilly, 909 F.2d 1497, 1505 (D.C. Cir. 1990).
Since the enactment of the LCSA, groups have challenged EPA’s denial of TSCA Section 21 petitions. See Food &
Water Watch, Inc. v. EPA, No. 3:17-cv-02162 (N.D. Cal.) (challenging denial of petition to issue rule pursuant to
Section 6 banning fluoridation of drinking water); Order Granting Plaintiffs’ Motion for Summary Judgment and
Denying Defendant’s Cross-Motion for Summary Judgment, Asbestos Disease Awareness Org. v. EPA, No. 19-cv-
00871, 2020 WL 7625445 (N.D. Cal. Dec. 22, 2020) (ordering EPA to amend its Chemical Data Reporting rule to
require additional information-gathering on the production, importation, and processing of asbestos, in response to
lawsuit challenging agency denial of petition to amend rule).
192 15 U.S.C. §2619. Regulations governing citizen suits under TSCA Section 20 are codified at 40 C.F.R. Part 702,
Subpart C.
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Administrator and the alleged violator, if applicable, prior to filing the suit.193 A citizen suit may
not proceed if EPA or the Department of Justice is already “diligently prosecuting” an
administrative or judicial proceeding against the alleged violator.194 However, the citizen who has
given notice of the claims may intervene as a matter of right in the enforcement proceeding if it is
initiated after notice is given.195 If a citizen suit is successful, the court may require the violator to
take actions to correct a violation and may impose civil penalties on the violator.
TSCA Section 19 governs judicial review of various EPA actions under the act.196 In general,
Section 19 requires that petitions for judicial review of certain rules and orders under TSCA, and
civil actions challenging low-priority designations,197 be filed within 60 days after EPA finalizes
the action.198 The federal courts of appeals have exclusive jurisdiction over challenges to rules
and orders issued under TSCA.199 For civil actions challenging low-priority designations,
jurisdiction is limited specifically to the U.S. Court of Appeals for the District of Columbia
Circuit.200 Review is presumptively limited to the administrative record.201 Courts review EPA
rules and orders under TSCA pursuant to a specific standard of review set forth in Section 19,
rather than the more common (and more deferential) “arbitrary and capricious” standard of
review under the Administrative Procedure Act.202 Specifically, Section 19 provides that courts
must “hold unlawful and set aside” such actions “if the court finds that the rule is not supported
by substantial evidence in the rulemaking record taken as a whole.”203
TSCA includes provisions intended to protect employees of regulated entities from retaliation for
participating in a proceeding under the act or from potential effects on employment because of
economic costs in implementing the act. Section 23 authorizes the Department of Labor (DOL) to
investigate alleged retaliations and provides DOL with administrative and judicial mechanisms to
resolve such allegations.204 Section 24 directs EPA to investigate allegations of potential effects
on employment resulting from a TSCA requirement and to prepare recommendations based on
the investigation.205

193 15 U.S.C. §2619(b).
194 15 U.S.C. §2619(b)(1)(B).
195 Ibid. Intervention allows an entity that was not originally a party to ongoing litigation to join the case and present
legal arguments to the court.
196 15 U.S.C. §2618.
197 For a discussion of low-priority designations, see “Prioritization of Chemicals for Evaluation of Risks.”
198 15 U.S.C. §2618(a)(1). The implications of the act’s use of the term civil action rather than petition for low-priority
designation challenges are not entirely clear.
199 15 U.S.C. §2618(a)(1)(A).
200 15 U.S.C. §2618(a)(1)(C)(ii).
201 15 U.S.C. §2618(b).
202 5 U.S.C. §706(2)(E). See also Corrosion Proof Fittings v. EPA, 947 F.2d 1201, 1213-14 (5th Cir. 1991) (“The
substantial evidence standard mandated by [TSCA] is generally considered to be more rigorous than the arbitrary and
capricious standard normally applied to informal rulemaking,’ and ‘afford[s] a considerably more generous judicial
review’ than the arbitrary and capricious test.”) (quoting Env’t Def. Fund, Inc. v. EPA, 636 F.2d 1267, 1277 (D.C. Cir.
1980), and Abbot Labs. v. Gardner, 387 U.S. 136, 143 (1967)).
203 15 U.S.C. §2618(c)(1)(B)(i).
204 15 U.S.C. §2622. Regulations that govern the handling of retaliation complaints under TSCA Section 23 and other
environmental statutes are codified at 29 C.F.R. Part 24.
205 15 U.S.C. §2623. Recommendations may include amending or repealing a rule or order, but the Administrator’s
recommendations under this section are not binding.
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Federal and State Relationship
To avoid potential conflict between federal requirements under TSCA and state requirements or
restrictions on chemicals, TSCA identifies circumstances in which a federal requirement for a
specific chemical under the act would preempt state requirements that apply to the same chemical
unless exempted or waived.206 On the other hand, TSCA does not preempt states from requiring
the development of new information or regulating a chemical for which EPA has not taken action
under TSCA.207 Additionally, TSCA authorizes EPA to award grants to states to take action to
address unreasonable risk associated with a chemical that the agency is unable or not likely to
address.208
Preemption of State Requirements
Under the Supremacy Clause of the U.S. Constitution, state law and policy must yield to the
exercise of Congress’s powers if Congress so intends.209 As Congress debated whether to expand
EPA authority to regulate chemicals under TSCA leading up to the enactment of the LCSA,
federal preemption of state requirements was a key issue. As enacted in 1976, TSCA preempted
state and local requirements only for specific chemicals. Some states and localities enacted their
own laws or promulgated regulations pertaining to other chemicals in response to concerns
regarding the risks of commercial chemicals and the absence of federal regulatory action. The
chemical industry and associated entities (e.g., retailers) expressed concern over regulatory
requirements that differed from one state to another.210
The LCSA revised TSCA’s preemption provisions. In broad terms, Section 18 as it is currently in
effect prohibits specific state and local actions, and then restricts the reach of those prohibitions
through limitations, exceptions, and waivers.211 Any preemption is chemical-specific, and EPA
must take specific actions under TSCA in order to trigger the preemption of state regulation of
chemicals.212 Exceptions to preemption may apply under certain conditions, and EPA may grant
preemption waivers by rule.213
As amended, Section 18 contains two preemption sections that prohibit different kinds of state or
local regulations corresponding to different stages in EPA’s review process under TSCA. The
prohibitions in Section 18(b) apply while EPA is conducting its risk evaluation of a particular
chemical, beginning on the date EPA determines the scope of its risk evaluation and ending either
on the deadline for completion of the risk evaluation or when EPA publishes the risk evaluation,

206 15 U.S.C. §2617.
207 Ibid. As discussed below, preemption under TSCA is specific to individual chemicals for which EPA has taken
regulatory action, so consideration of whether a requirement or restriction is preempted under TSCA requires a
chemical-specific analysis. As a general matter, however, TSCA’s grandfathering exceptions, which are also discussed
below, allow for certain laws, such as California’s Proposition 65 and Massachusetts Toxics Use Reduction Act and
their associated regulations, to remain in place. See Cal. Health & Safety Code §25249.5 et seq.; Mass. Gen. Laws ch.
21I.
208 15 U.S.C. §2627.
209 U.S. Const. art. VI, cl. 2.
210 U.S. Congress, Senate Committee on Environment and Public Works, Frank L. Lautenberg Chemical Safety for the
21st Century Act, report to accompany S. 697, 114th Cong., 1st sess, S.Rept. 114-67 (Washington, DC: GPO, 2015), p. 6.
211 15 U.S.C. §2617.
212 15 U.S.C. §2617(a)-(c).
213 15 U.S.C. §2617(d)-(g).
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whichever is earlier.214 Section 18(b) imposes a temporary prohibition on states from establishing
any new prohibition or restriction on a chemical designated by EPA as a high-priority substance
for risk evaluation. States are preempted from regulating only the hazards, exposures, risks, and
uses included in the scope of EPA’s risk evaluation.215
The prohibitions in Section 18(a) apply once EPA implements information requirements,
notification of significant new use requirements, or restrictions or prohibitions based on its risk
evaluation for the particular chemical.216 Under Section 18(a), once EPA has acted to regulate a
chemical, no state may establish or continue to enforce any of the following, subject to
exemptions and potential waivers:217
 A statute or administrative action that requires the development of information on
a chemical that would be “reasonably likely” to be the same as information
required under an existing EPA rule, order, or consent agreement under the act.
 A statute, criminal penalty, or administrative action to prohibit or otherwise
restrict the manufacture, processing, or distribution in commerce or use of a
chemical for which EPA has either (1) issued an order finding the chemical not to
present an unreasonable risk or (2) found the chemical to present an unreasonable
risk and promulgated a final rule to address the unreasonable risk after the
effective date of the rule.
 A statute or administrative action requiring the notification of a use of a chemical
for which EPA has already determined that notification as a significant new use is
required.218
Section 18 provides exceptions that, in effect, preserve state chemical requirements that otherwise
would be preempted. States and localities may continue to enforce any chemical substance
prohibitions or restrictions that were in effect before April 22, 2016.219 States and localities also
may adopt new regulations and other actions pursuant to any laws in effect on August 31, 2003.220
TSCA also leaves in place the “cooperative federalism” structure of several other federal
environmental laws, under which states administer programs that either meet or exceed minimum
federal requirements. Thus, it does not preempt a state from adopting or enforcing any rule,
standard of performance, risk evaluation, scientific assessment, or any other protection for public
health or the environment that (1) is adopted under the authority of or to satisfy any other federal
law; (2) implements a reporting, monitoring, disclosure, or other information obligation not
otherwise required by EPA under TSCA or required under other federal law; or (3) is generally
adopted under a state law related to water quality, air quality, or waste treatment or disposal, with
certain exceptions.221

214 15 U.S.C. §2617(b).
215 15 U.S.C. §2617(b).
216 15 U.S.C. §2617(a).
217 15 U.S.C. §2617(f).
218 15 U.S.C. §2617(a)(1).
219 15 U.S.C. §2617(e)(1)(A).
220 15 U.S.C. §2617(e)(1)(B). For example, California’s Safe Drinking Water and Toxic Enforcement Act of 1986
(California Health and Safety Code §§25249.5-25249.13), commonly known as Proposition 65, makes it unlawful
within the state of California for a business to “knowingly and intentionally expose any individual to a chemical known
to the state to cause cancer or reproductive toxicity without first giving clear and reasonable warning to such
individual.”
221 15 U.S.C. §2617(d).
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In addition to these exemptions from preemption, TSCA sets forth “savings clauses,” providing
that the act’s requirements do not preempt penalties for criminal conduct or common law rights or
statutes creating remedies for civil relief—such as damages—under any legal theory of
liability.222 TSCA also provides that determinations, such as risk assessments, made pursuant to
the statute are not definitive proof in court for private actions.223
In addition to the specific statutory exemptions, Section 18 allows the EPA Administrator the
discretion to exempt from preemption a state requirement under certain circumstances.224 If the
state submits an application for the exemption, the Administrator may grant the exemption if he
or she determines that compelling conditions warrant granting the waiver to protect health or the
environment, that compliance with the requirement would not unduly burden interstate commerce
and would not cause a violation of federal requirements, and that the risk identified by the state is
based on sufficiently strong science.225
The Administrator must exempt from preemption new state requirements established during
EPA’s risk evaluation period for a chemical if either (1) the state requirement is enacted within 18
months of EPA’s prioritization of the chemical for review; or (2) the Administrator determines
that compliance with the requirement would not unduly burden interstate commerce or cause a
violation of federal requirements, and that the state’s concern about the chemical is based on
peer-reviewed science.226 The Administrator must act on a required exemption application within
110 days after an application is submitted.227 All waiver applications are subject to public notice
and comment requirements, and decisions regarding such applications are final agency actions
subject to judicial review.228
Coenforcement
Section 18 also establishes parameters for states that adopt and enforce requirements under their
own laws that are identical to TSCA’s requirements.229 Penalties and other sanctions that are
applicable to violations under state law must not be more stringent than those available under
TSCA.230 Additionally, a state may not assess a penalty for a violation under its own law if EPA
has already assessed an adequate penalty for the same violation under TSCA.231 If a state has
already assessed a penalty for a specific violation under state law, TSCA limits the penalty EPA
may assess for the same violation so that the combined total penalty amount would not exceed the
maximum penalty amount allowed under the act.232 Under this scheme, regulated entities may
face enforcement by either state or federal regulators.

222 15 U.S.C. §2617(g). TSCA’s savings clauses also specify that TSCA does not preempt the availability of specific
tort causes of action for personal injury. 15 U.S.C. §2617(g)(1)(B). Lawsuits alleging one of those causes of action—
for example, products liability—thus may be available even if a manufacturer has complied with TSCA.
223 15 U.S.C. §2617(g)(2).
224 15 U.S.C. §2617(f).
225 15 U.S.C. §2617(f)(1).
226 15 U.S.C. §2617(f)(2).
227 15 U.S.C. §2617(f)(3).
228 15 U.S.C. §2617(f)(5)-(6).
229 15 U.S.C. §2617(d)(1)(B).
230 15 U.S.C. §2617(d)(1)(B).
231 15 U.S.C. §2617(d)(1)(B)(ii)(I).
232 15 U.S.C. §2617(d)(1)(B)(ii)(II).
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State Grants
TSCA Section 28 authorizes EPA to award grants to states to establish and operate programs
intended to prevent or eliminate unreasonable risks associated with chemicals for which the
agency “is unable or is not likely to take action” under the act.233 Section 28 limits grant awards
to 75% of the establishment and operation costs of the program. The LCSA repealed the
authorization of appropriations for state grants but not the program authority, and Congress has
continued to provide TSCA grant funding to states through annual discretionary appropriations.234
Resources and Fees to Administer TSCA
Resource and staffing levels available to EPA to evaluate chemicals may affect the pace and
thoroughness of evaluations and, in turn, whether chemicals are regulated under TSCA or the
timing of when new chemicals may be introduced into commerce. Although the authorization of
appropriations to carry out TSCA expired after FY1983, Congress has continued to fund the
statute’s activities through annual discretionary appropriations.235
As originally enacted, TSCA Section 26(b) authorized EPA to collect fees from chemical
manufacturers and processors for submissions of new information required by the agency or
PMNs or SNUNs.236 Because there was no dedicated account in which to deposit fee receipts,
however, the Miscellaneous Receipts Act required those receipts to be deposited in the U.S.
Treasury as miscellaneous receipts, instead of being directly used to implement TSCA.237
The LCSA amended TSCA Section 26(b) to authorize the collection of fees from chemical
manufacturers and processors to defray certain costs of administering TSCA programs.238 EPA
may collect fees in a given fiscal year if appropriations for a related EPA “program project”
match or exceed the level appropriated in FY2014.239 Fee collections are limited to 25% of EPA’s
annual costs of administering TSCA activities and are not to exceed $25 million per year.240
Section 26 requires the deposit of collected fees into the “TSCA Service Fee Fund” in the U.S.
Treasury, and the fees are available to EPA, subject to the annual discretionary appropriations
process, to partially defray the costs of activities to implement Title I of TSCA, including
conducting chemical risk evaluations. This authority to collect fees expires in June 2026.
In 2018, EPA finalized a rule to collect fees from those required to submit information, such as
test data or notices for new chemicals or significant new uses of chemicals, and those who

233 15 U.S.C. §2627. Regulations that govern the Toxic Substances Compliance Monitoring grant program are codified
at 40 C.F.R. §§35.310-35.318 for states and 40 C.F.R. §§35.710-35.718 for tribes.
234 Although authorization of appropriations for these grants expired after FY1983, Congress has continued to provide
TSCA state grant funding through annual discretionary appropriations. Congress appropriates funding for TSCA state
grants through the “Categorical Grants: Toxic Substances Compliance” subaccount within EPA’s State and Tribal
Assistance Grant account in the Department of the Interior, Environment, and Related Agencies appropriations acts.
For EPA guidance on this grant, see EPA, Toxic Substances Compliance Monitoring Grant Guidance for Fiscal Year
2021, April 2021, https://www.epa.gov/sites/production/files/2021-04/documents/2021tscagrant.pdf.
235 15 U.S.C. §2628.
236 15 U.S.C. §2625(b).
237 31 U.S.C. §3302(b).
238 15 U.S.C. §2625(b).
239 15 U.S.C. §2625(b)(5).
240 15 U.S.C. §2625(b)(4)(B).
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manufacture chemicals subject to an agency risk evaluation under the amended TSCA.241 The rule
establishes different fee amounts depending on the type of information being submitted to EPA or
whether the risk evaluation was initiated by EPA or requested by a manufacturer.242 The rule
establishes fee amounts only for FY2019, FY2020, and FY2021. EPA states that the agency
intends to adjust the fees for inflation and other factors once every three years. For FY2020, EPA
reported total TSCA fee revenues of $5.5 million.243 These fee revenues were primarily associated
with PMN submissions. For FY2021, EPA expects total TSCA fee revenues of $30.0 million, as
the agency identifies chemical manufacturers and processors to assess fees to cover some of the
costs of ongoing risk evaluations.244
Section 26(m) requires EPA to provide a report to Congress at least once every five years with
estimates on the agency’s capacity to complete the required number of chemical risk evaluations,
including those requested by chemical manufacturers, and to promulgate rules to regulate
chemicals that present unreasonable risks.245
Concluding Discussion
TSCA establishes a framework for EPA to obtain information about a vast and growing body of
industrial and commercial chemicals to assess risks to human health and the environment. TSCA
authorizes EPA to regulate any stage of the lifecycle of a chemical through rulemaking if the
agency finds an unreasonable risk associated with that chemical. The statute’s framework applies
to a wide variety of chemicals and directs EPA to consider, when evaluating the risk of chemicals,
different chemical characteristics, intended uses, exposure scenarios, and potential health effects
associated with exposure. Due to limited staffing and resources to implement TSCA, EPA
generally focuses on chemicals that are more likely to present greater risks than others.
EPA risk evaluations are intended to provide the agency with sufficient evidence to regulate a
chemical. A risk evaluation involves characterizing potential health effects from exposure to a
chemical and the likely exposure scenarios based on the use of a chemical. Whether EPA has
sufficient information to evaluate the risks of a chemical depends in part on whether that
information is already available to the agency or whether the agency has authority under TSCA to
require the development of new information by manufacturers or processors. Various
environmental and public health organizations and the chemical industry have differing

241 EPA, “Fees for the Administration of the Toxic Substances Control Act,” 83 Federal Register 52694, October 17,
2018. Regulations governing the collection of TSCA fees are codified in various sections of 40 C.F.R. Parts 700, 720,
723, 725, 790, and 791.
242 For more information on TSCA administration fees, see EPA, “Toxic Substances Control Act (TSCA)
Administration Fees,” last updated June 3, 2021, https://www.epa.gov/tsca-fees.
243 EPA, Fiscal Year 2022 Justification of Appropriation Estimates for the Committee on Appropriations, EPA-190-R-
21-002, May 2021, pp. 792-793 (pp. 824-825 of the PDF), https://www.epa.gov/sites/production/files/2021-05/
documents/fy-2022-congressional-justification-all-tabs.pdf.
244 EPA, Fiscal Year 2022 Justification of Appropriation Estimates for the Committee on Appropriations, EPA-190-R-
21-002, May 2021, pp. 389 and 793 (pp. 410 and 825 of the PDF), https://www.epa.gov/sites/production/files/2021-05/
documents/fy-2022-congressional-justification-all-tabs.pdf.
245 15 U.S.C. §2625(m). In January 2017, EPA submitted its initial report to Congress on its capacity to conduct risk
evaluations under TSCA. EPA, Initial Report to Congress on EPA’s Capacity to Implement Certain Provisions of the
Frank R. Lautenberg Chemical Safety for the 21st Century Act, January 2017, https://www.epa.gov/sites/production/
files/2017-01/documents/tsca_report_to_congress.pdf.
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perspectives on what types of information are necessary for EPA to evaluate the risks of a
chemical.246
The scientific understanding of a chemical’s risks is generally not static but evolves over time.
Additional studies may generate a better understanding of the risks of a chemical. Some studies
may suggest or demonstrate that a chemical presents more risk than previously thought, while
other studies may suggest or demonstrate the opposite view. Ultimately, EPA exercises
professional judgment in characterizing the body of scientific information with regard to the risks
a chemical may present.
Even if EPA finds that a chemical presents unreasonable risks that warrant regulatory control, the
agency must consider costs and other factors when selecting the appropriate regulatory
requirement, potentially leading to disagreements about EPA’s analysis and findings (e.g., the
availability of alternatives to a chemical for a particular use). Furthermore, even if stakeholders
concur with EPA’s assessment of risks, they may hold different perspectives on whether the
regulatory requirement selected by EPA adequately addresses the identified unreasonable risk and
meets the statutory requirements. Such disagreements may result in litigation.247
Ultimately, the pace at which EPA can evaluate chemicals and promulgate regulations for
chemicals that present unreasonable risks under TSCA could largely depend on resources,
staffing, and the availability of relevant scientific and technical information that supports a
finding of unreasonable risks. EPA authority to regulate a chemical under TSCA also depends on
whether another law may be used to regulate that chemical for the identified unreasonable risk.
Since the enactment of the LCSA in 2016, EPA has continued to evaluate chemicals for
unreasonable risk, subject to applicable statutory time frames. With regard to EPA’s findings of
unreasonable risk, it generally remains to be seen whether the agency’s findings are defensible
from a scientific standpoint, what requirements might EPA propose to address such risks, and
whether such proposals, if promulgated, are also found to be defensible.

Author Information

Jerry H. Yen
Kate R. Bowers
Analyst in Environmental Policy
Legislative Attorney

246 See, for example, testimony in U.S. Congress, House Committee on Energy and Commerce, Subcommittee on
Environment and the Economy, Testing of Chemicals and Reporting and Retention of Information under TSCA
Sections 4 and 8, hearing, 113rd Cong., 2nd sess., February 4, 2014 (Washington: GPO, 2013).
247 See footnote 148.
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