Proposed Amendments to the Toxic Substances Control Act (TSCA) in the 114th Congress: H.R. 2576 Compared with the Senate Substitute Amendment
Congressional research reportMar 29, 2016
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Proposed Amendments to the Toxic
Substances Control Act (TSCA) in the 114th
Congress: H.R. 2576 Compared with the
Senate Substitute Amendment
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Legislative Attorney
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Congressional Research Service
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R44434
Proposed Amendments to the Toxic Substances Control Act (TSCA) in the 114 th Congress
Summary
This report compares H.R. 2576, the TSCA Modernization Act of 2015, as passed by the House
on June 23, 2015, and the Senate’s substitute amendment (S.Amdt. 2932) to H.R. 2576, the Frank
R. Lautenberg Chemical Safety for the 21st Century Act, as passed by the Senate on December 17,
2015. The Senate amendment is based, in part, on S. 697, as reported by the Senate Committee on
Environment and Public Works on April 28, 2015.
The House bill and the Senate amendment would amend Title I of the Toxic Substances Control
Act (TSCA). Enacted in 1976, TSCA is the primary federal law that authorizes the regulation of
commercial chemicals throughout their lifecycle from manufacture to disposal. TSCA authorizes
the Environmental Protection Agency (EPA) to determine whether regulation of a chemical is
necessary to provide protection against “unreasonable risk of injury to health or the
environment.” The Senate amendment, but not the House bill, would also amend the Mercury
Export Ban Act of 2008 and add a provision to the Public Health Service Act regarding potential
cancer clusters.
Over the 39-year history of TSCA, EPA, regulated entities, environmental and public health
groups and others have observed significant challenges in implementing the statute. For example,
concerns have been raised on whether the threshold to regulate a chemical under TSCA is too
difficult for EPA to demonstrate and whether the agency is unnecessarily constrained by the
requirement that it impose the “least burdensome requirement” to restrict a chemical. In addition,
EPA has argued that limits in requesting test information have constrained its ability to assess
risks of certain chemicals. Many have argued that these concerns have diminished public
confidence in the “safety” of chemicals in commerce. Additionally, regulated entities and right-toknow advocates have raised concerns about the appropriate balance between disclosures of
chemical information and confidentiality of business information submitted to EPA under TSCA.
Regulated entities have also raised concerns that state and local governments are adopting
different requirements with respect to particular chemicals and compliance may be difficult with
this growing “patchwork” of requirements. They argue that there should be uniform regulation
under TSCA nationally. However, certain states and others have expressed concerns regarding the
role of preemption in limiting states’ ability to regulate chemicals. Since 2005, these concerns and
others led to the introduction of legislation that would amend TSCA in each Congress.
The first section of the report provides a brief background on TSCA. The second section provides
a brief comparison between the House bill and the Senate amendment and also provides a
background discussion of seven issues:
Prioritization of chemicals for the evaluation of risks;
Regulatory threshold for restricting a chemical;
Regulatory options for restricting a chemical;
Requirements for the development of test information;
Preemption of state requirements;
Confidentiality and disclosures of information; and
Resources to administer TSCA.
Finally, Table 1 presents a side-by-side comparison of the provisions of existing law, the House
bill, and the Senate amendment. This report does not provide a comprehensive analysis of the
potential effect of particular provisions. Ultimately, the outcome, if either the House bill or the
Senate amendment were enacted, depends on implementation.
Congressional Research Service
Proposed Amendments to the Toxic Substances Control Act (TSCA) in the 114 th Congress
Contents
Introduction ..................................................................................................................................... 1
Title I of the Toxic Substances Control Act (TSCA) ....................................................................... 1
H.R. 2576 and the Senate Substitute Amendment ........................................................................... 3
Prioritization of Chemicals for the Evaluation of Risks............................................................ 4
Regulatory Threshold for Restricting a Chemical ..................................................................... 5
Regulatory Options for Restricting a Chemical ........................................................................ 6
Requirement for the Development of Test Information ............................................................ 7
Preemption of State Requirements ............................................................................................ 8
Confidentiality and Disclosures of Information ........................................................................ 9
Resources to Administer TSCA .............................................................................................. 10
Side-by-Side Comparison of Provisions by Topic.......................................................................... 11
Tables
Table 1. Side-by-Side Comparison of Existing Law, H.R. 2576 as Passed by the House,
and the Senate Substitute Amendment to H.R. 2576 as Passed by the Senate in the 114th
Congress ..................................................................................................................................... 12
Contacts
Author Contact Information .......................................................................................................... 59
Congressional Research Service
Proposed Amendments to the Toxic Substances Control Act (TSCA) in the 114 th Congress
Introduction
This report presents a side-by-side comparison of H.R. 2576, the TSCA Modernization Act of
2015, as passed by the House on June 23, 2015,1 and S.Amdt. 2932, the Frank R. Lautenberg
Chemical Safety for the 21st Century Act, as passed by the Senate on December 17, 2015, as a
substitute amendment to H.R. 2576.2 (Hereafter in this report, the House-passed bill H.R. 2576
will be referred to as the “House bill,” while the Senate amendment to H.R. 2576 will be referred
to as the “Senate amendment.”) Both the House bill and the Senate amendment would amend
Title I of the Toxic Substances Control Act (TSCA).3 The Senate amendment, but not the House
bill, would also amend the Mercury Export Ban Act of 20084 and add a provision to the Public
Health Service Act regarding potential cancer clusters.5
The first section of this report provides a brief background on Title I of TSCA. For a summary of
TSCA provisions and history, see CRS Report RL31905, The Toxic Substances Control Act
(TSCA): A Summary of the Act and Its Major Requirements, by (name redacted)
. The second section
describes differences between the House bill and the Senate amendment and also presents
background on selected issues that the legislation addresses. The final section includes Table 1,
which presents a side-by-side comparison of the provisions of existing law, the House bill, and
the Senate amendment.
Title I of the Toxic Substances Control Act (TSCA)
In 1976, President Ford signed into law the Toxic Substances Control Act, which authorizes 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.”6 Since 1976,
Congress has added five other titles to TSCA and has amended the original law, referred to as
Title I, to address specific chemical concerns.7 None of these additions and amendments has
altered the core program under Title I of TSCA. Neither the House bill nor the Senate amendment
would amend the other titles (i.e., Titles II through VI) of TSCA.
1
On June 3, 2015, the House Committee on Energy and Commerce reported the bill (H.Rept. 114-176).
The Senate amendment is based on S. 697, as reported by the Senate Committee on Environment and Public Works
on April 28, 2015, albeit with differences. On April 28, 2015, the Senate Committee on Environment and Public Works
ordered that the Frank R. Lautenberg Chemical Safety for the 21 st Century Act (S. 697) be reported for Senate floor
consideration. On June 18, 2015, the committee filed the report (S.Rept. 114-67).
3
P.L. 94-469 (1976), codified as amended at 15 U.S.C. 2601-2629.
4
P.L. 110-414 (2008), in part, amended TSCA, and Section 5 of the statute codified at 42 U.S.C. 6939f.
5
P.L. 78-410 (1944), codified as amended at 42 U.S.C. Chapter 6A.
6
TSCA Section 3(2) (15 U.S.C. 2602(2)) excludes certain chemical substances from regulation, including pesticides,
tobacco and tobacco products, certain radioactive materials, pistols, revolvers, firearms, shells, cartridges, food, food
additives (including food contact substances, such as container components, that may be indirect food additives), drugs,
cosmetics and personal care products, and medical devices. Additionally, TSCA Section 9 (15 U.S.C. 2608) limits
EPA’s authority to address unreasonable risks of chemical substances by directing the agency to determine, if
unreasonable risks are identified, whether other statutes administered by EPA or another federal agency may
adequately address such risks.
7
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). Title I was
amended by the Mercury Export Ban Act of 2008 to address elemental mercury. 15 U.S.C. 2605(f) and 2611(c).
2
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Proposed Amendments to the Toxic Substances Control Act (TSCA) in the 114 th Congress
Among other things, Title I of TSCA requires EPA to compile and maintain a list of chemical
substances manufactured or processed in the United States. This list is referred to as the TSCA
Chemical Substance Inventory (or TSCA Inventory). EPA’s initial compilation of the TSCA
Inventory included over 62,000 chemical substances.8 TSCA distinguishes between chemical
substances that are on the inventory and those that are not. Any chemical substance listed on the
inventory is considered by the agency as an “existing” chemical substance.9 The statute defines
any chemical substance not on the inventory as a “new chemical substance.” Since EPA’s
publication of the initial TSCA inventory, the agency has added over 23,000 new chemical
substances to the inventory.10 Once a chemical substance is added to the TSCA inventory, it
becomes an existing chemical substance for purposes of the statute.
In order to determine which chemicals warrant regulation under TSCA, EPA is authorized to
evaluate risks that may arise from the entire commercial life-cycle of chemicals, including their
manufacture,11 processing, distribution, use, and disposal. Pursuant to TSCA Section 6, EPA has
authority to pursue a range of regulatory options to address unreasonable risks from chemicals.
These options vary in severity from a complete ban to a requirement that manufacturers notify
distributors of unreasonable risks. Since the enactment of TSCA, EPA has regulated few
chemicals under TSCA Section 6, including:
chlorofluorocarbons used in aerosol propellants;12
nitrosamines used in metalworking fluids (40 C.F.R. Part 747);
hexavalent chromium used for certain water cooling towers (40 C.F.R. Part 749);
new uses of asbestos (40 C.F.R. Part 763, Subpart I);
dioxin-contaminated wastes;13 and
polychlorinated biphenyls (40 C.F.R. Part 761).
The agency has taken actions pursuant to other authorities in the statute. For example, EPA has:
collected information on the risks, uses, and volumes in commerce of various
chemicals to inform its evaluation of chemical risks (pursuant to TSCA Sections
4, 5, and 8);14
evaluated various chemicals for risks (pursuant to TSCA Section 6);15 and
promulgated rules to require notification for significant new uses of certain
chemical substances (pursuant to TSCA Section 5).16
8
EPA, “About the TSCA Chemical Substance Inventory,” updated October 26, 2015, http://www.epa.gov/tscainventory/about-tsca-chemical-substance-inventory.
9
15 U.S.C. 2602(9).
10
As of October 26, 2015, EPA states that the TSCA inventory lists over 85,000 chemicals. EPA, “About the TSCA
Chemical Substance Inventory,” updated October 26, 2015, http://www.epa.gov/tsca-inventory/about-tsca-chemicalsubstance-inventory.
11
TSCA Section 3(7) (15 U.S.C. 2602(7)) defines the term manufacture to include production and importation.
12
TSCA regulation of chlorofluorocarbons used in aerosol propellants was superseded by regulations promulgated
under the Clean Air Act.
13
TSCA regulation of dioxin-contaminated wastes was superseded by regulations promulgated under the Solid Waste
Disposal Act.
14
15 U.S.C. 2603, 2604, and 2607.
15
15 U.S.C. 2605.
16
15 U.S.C. 2604.
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Proposed Amendments to the Toxic Substances Control Act (TSCA) in the 114 th Congress
Since 2005, Members of Congress have introduced bills to revise the chemical evaluation process
for determining whether regulatory actions are warranted and to address other related purposes.17
Although the bills were not enacted, they generated debate on whether and how to amend the
evaluation process, regulatory criteria, and other elements of the law.18
H.R. 2576 and the Senate Substitute Amendment
The House bill would amend several provisions in TSCA, including:
the authority for EPA to require testing of chemicals under TSCA Section 4;19
the process by which EPA would evaluate risks of chemicals and regulate those
found to present unreasonable risks under TSCA Section 6;20
the procedures and standards under TSCA Section 14 for confidential treatment
of certain information submitted to EPA under TSCA;21
TSCA’s relationship to state laws regulating chemicals under TSCA Section 18;22
and
the authority for EPA to collect fees under TSCA Section 26.23
The Senate amendment would amend the same provisions of TSCA listed above, albeit with
differences. Additionally, the Senate amendment would amend:
the process by which EPA reviews new chemical substances or significant new
uses of chemicals under TSCA Section 5;24
the recordkeeping and reporting requirements under TSCA Section 8;25 and
various other provisions.
The following sections provide a brief discussion of seven issues that have received attention in
the debate to amend Title I of TSCA. The discussions include comparisons between how the
House bill and Senate amendment would address each issue. These issues include:
17
Legislation to revise the chemical evaluation process under TSCA and for certain other related purposes dates back at
least to the 109th Congress. S. 1391 and H.R. 4308, both introduced in 2005, are examples of such legislation.
18
For recent examples of debate, see U.S. Congress, House Committee on Energy and Commerce, Subcommittee on
Environment and the Economy, H.R. ___, the TSCA Modernization Act of 2015, 114th Cong., 1st sess., April 14, 2015,
(Washington: GPO, 2015), https://www.gpo.gov/fdsys/pkg/CHRG-114hhrg95937/pdf/CHRG-114hhrg95937.pdf
(hereinafter “House discussion draft hearing”); and U.S. Congress, Senate Committee on Environment and Public
Works, Legislative Hearing on the Frank R. Lautenberg Chemical Safety for the 21 st Century Act (S. 697), 114th Cong.,
1st sess., March 18, 2015, S. Hrg. 114-25 (Washington: GPO, 2015), https://www.gpo.gov/fdsys/pkg/CHRG114shrg94985/pdf/CHRG-114shrg94985.pdf (hereinafter “S. 697 hearing”).
19
15 U.S.C. 2603.
20
15 U.S.C. 2605.
21
15 U.S.C. 2613.
22
15 U.S.C. 2617. For more detailed information on preemption in TSCA, H.R. 2576 as passed by the House, and S.
697 as reported out of committee, see CRS Report R44066, Preemption in Proposed Amendments to the Toxic
Substances Control Act (TSCA): Side-by-Side Analysis of S. 697 and H.R. 2576, by (name redacted)
; and CRS
Legal Sidebar WSLG1269, Toxic Substances Control Act (TSCA) Preemption and State Chemical Regulations Under
Current Law, by (name redacted)
.
23
15 U.S.C. 2625.
24
15 U.S.C. 2604.
25
15 U.S.C. 2607.
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prioritization of existing chemical substances for the evaluation of risks;
regulatory threshold criteria under which EPA would be authorized to restrict a
chemical;
regulatory options available to EPA in restricting a chemical found to warrant
regulation;
EPA’s authority to require the development of new information regarding a
chemical;
preemption of state laws concerning the regulation of chemicals;
disclosure and protection from disclosure of information submitted to EPA; and
resources that may be available for EPA to administer the act.
Prioritization of Chemicals for Evaluation of Risks
Determining which chemicals EPA may select before others to evaluate risks has been a longstanding issue given that the agency has finite resources to evaluate over 85,000 chemical
substances listed on the TSCA inventory and continues to become aware of new chemical
substances. EPA’s evaluation of a chemical is intended to generate information that informs the
agency’s determination as to whether the regulatory threshold is met to restrict that chemical.
Under TSCA, EPA has discretion over which chemicals on the TSCA inventory to evaluate for
risks.26 In 2012, EPA identified, as part of the agency’s TSCA Work Plan, more than 1,200
substances that possibly warranted an evaluation based on certain prioritization criteria.27 These
substances were further screened based on hazard, exposure, and bioaccumulation potential,
which led EPA to prioritize 90 substances for an evaluation of risks to human health or the
environment.28 Of the 90 prioritized chemical substances, EPA has assessed five, three of which
were determined to present risks.29 EPA continues to evaluate the other 85 substances.
For new chemical substances, TSCA Section 5 requires manufacturers to submit a
premanufacture notice (PMN) to EPA 90 days prior to manufacturing the chemical substance,
subject to certain exemptions.30 During this time period, EPA has the opportunity to evaluate risks
26
The substances that EPA may evaluate for risks include those on the initial inventory of known chemical substances
reported to the agency under TSCA Section 8(a) after enactment of the law and those that manufacturers subsequently
report to the agency in premanufacture notices (PMNs) under TSCA Section 5. Combined, these substances currently
number more than 85,000. TSCA Section 3(7) (15 U.S.C. 2602(7)) defines the term manufacture to include production
and importation. PMNs are therefore required for chemical substances not on the TSCA inventory that are to be
imported into the United States. See EPA, “About the TSCA Chemical Substance Inventory,” updated October 26,
2015, http://www.epa.gov/tsca-inventory/about-tsca-chemical-substance-inventory.
27
EPA, Office of Pollution Prevention and Toxics, TSCA Work Plan for Chemical Assessments: 2014 Update, October
2014, p. 3, http://www.epa.gov/sites/production/files/2015-01/documents/tsca_work_plan_chemicals_2014_updatefinal.pdf.
28
Ibid.
29
EPA, “Assessments for TSCA Work Plan Chemicals,” updated March 3, 2016, http://www.epa.gov/assessing-andmanaging-chemicals-under-tsca/assessments-tsca-work-plan-chemicals. EPA completed assessments for Nmethylpyrrolidone (NMP) in paint and coating removal products; antimony trioxide (ATO) as a synergist in
halogenated flame retardants; 1,3,4,6,7,8-hexahydro-4,6,6,7,8,8-hexamethylcyclopenta[γ]-2-benzopyran as a fragrance
ingredient in commercial and consumer products; methylene chloride in paint and coating removal products; and
trichloroethylene (TCE) as a degreaser, a spot-cleaner in dry cleaning, and a spray-on protective coating. For NMP,
methylene chloride, and TCE, EPA has identified risks that have led the agency to consider pursuing a range of
possible voluntary and regulatory actions.
30
15 U.S.C. 2604. TSCA Section 5(h) authorizes certain exemptions from the requirements of all or parts of TSCA
(continued...)
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of the new chemical substance and determine whether regulation may be warranted based on the
PMN and any existing data concerning the environmental and health effects of the substance.
According to EPA, from July 1979 through September 2015, the agency has received more than
39,000 PMNs and more than 15,000 PMN exemption applications.31 EPA states that it has taken
regulatory action on approximately 10% of the PMNs submitted.
Both the House bill and the Senate amendment would establish a process and criteria for EPA to
prioritize existing chemical substances for evaluation, albeit with differences. The Senate
amendment, and not the House bill, would amend TSCA Section 5 with regard to the evaluation
of new chemical substances, although, in part, it would codify certain existing practices. For a
comparison among existing law, the House bill, and the Senate amendment on this topic, see
pages CRS-28 and CRS-36 in Table 1.
Regulatory Threshold for Restricting a Chemical
In order for EPA to restrict a chemical under TSCA, the agency must first determine that the
chemical presents or will present “an unreasonable risk of injury to [human] health or the
environment.” This phrase is used in multiple provisions of TSCA as the basis for whether certain
actions may be warranted. Some stakeholders have argued that the existing regulatory threshold
for restricting a chemical in TSCA—that the chemical presents or will present risks that are
unreasonable—is difficult for EPA to demonstrate. A recurring issue of concern in the TSCA
debate has been whether or how to amend the regulatory threshold to clarify the criteria and
factors to be considered for determining whether certain chemicals warrant regulatory control.
TSCA does not define the “unreasonable risk” standard.32 However, the “unreasonable risk”
standard of TSCA has been interpreted at the circuit court level as, essentially, a multi-factor
balancing test. In its 1991 decision, Corrosion Proof Fittings v. EPA, which struck down large
parts of an asbestos ban under TSCA, the Fifth Circuit stated 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.’”33 The court also quoted a Supreme Court case regarding
“unreasonable risk” language in general, saying that “‘unreasonable risk’ statutes require ‘a
generalized balancing of costs and benefits.’”34 The Fifth Circuit ruled that in its asbestos ban,
EPA had “basically ignored the cost side of the TSCA equation” and that potentially “spending
$200-$300 million to save approximately seven lives (approximately $30-$40 million per life)
over thirteen years” was not reasonable under the “unreasonable risk” standard.35 Thus, under
TSCA’s “unreasonable risk” standard, whether regulation of a chemical is warranted depends on
not only the hazards of the chemical and the extent or likelihood of exposure to the chemical but
(...continued)
Section 5.
31
EPA, “Statistics for the New Chemicals Review Program under TSCA,” updated October 19, 2015,
http://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/statistics-new-chemicalsreview.
32
The interpretation of “unreasonable risk” is also influenced by the regulatory conditions for restricting a chemical
substance, discussed below. In issuing rules to protect against unreasonable risk, EPA is directed to consider not only
the hazards and exposures but also the benefits of the chemical, available alternatives to the chemical and the economic
costs of restrictions. 15 U.S.C. 2605(c)(1).
33
947 F.2d 1201, 1222 (5th Cir. 1991) (quoting 15 U.S.C. 2601(c)).
34
Ibid. (quoting American Textile Mfrs. Inst. v. Donovan, 452 U.S. 490, 510 n.30 (1981)).
35
Ibid. at 1223.
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Proposed Amendments to the Toxic Substances Control Act (TSCA) in the 114 th Congress
also the costs of risk management and the benefits of various uses of the chemical. Since 1991,
EPA has not promulgated a rule to restrict a chemical under TSCA Section 6.
Both the House bill and the Senate amendment would amend the regulatory threshold for
restricting a chemical by modifying what constitutes “unreasonable risk.” As an example, both
the House bill and the Senate amendment would prohibit the consideration of cost and other nonrisk factors when determining whether there are unreasonable risks associated with a chemical.
However, whether more chemicals could be regulated under TSCA by amending the regulatory
threshold would ultimately depend on implementation. For a comparison among existing law, the
House bill, and the Senate amendment on this topic, see page CRS-31 in Table 1.
Regulatory Options for Restricting a Chemical
If EPA were to determine that a chemical presents or will present “an unreasonable risk of injury
to health or the environment,” TSCA Section 6 directs the agency to promulgate a requirement to
protect adequately against such risks using the “least burdensome requirement” while considering
certain other factors. These include, among other factors, the approximate costs of the proposed
regulation and the availability of alternatives to the chemical subject to regulatory control.36 EPA
may select the least burdensome requirement from options listed in the statute that vary in
severity from a complete ban to a requirement that manufacturers or processors notify
distributors, other people in possession of a chemical, and the general public of unreasonable
risks. This provision implements the concept of balancing costs and benefits when determining
what requirement to impose on a chemical determined to meet the regulatory threshold. Some
stakeholders have argued that the limit on EPA to choose the least burdensome regulatory
requirement that still adequately protects against unreasonable risk requires the agency to do
lengthy analyses and may result in the promulgation of a regulation that is inadequately protective
because of considerations of cost.
In Corrosion Proof Fittings v. EPA, the Fifth Circuit stated that EPA had not shown substantial
evidence37 that its total ban on most uses of asbestos was the least burdensome adequate
alternative for all circumstances and product categories.38 Thus, in practice, the “least
burdensome” requirement imposes an additional standard on EPA beyond that imposed by the
requirement that the agency conduct a cost-benefit analysis of the chosen alternative, because a
rule cannot be upheld based only on its benefits outweighing its costs. In order to reject a less
burdensome requirement in favor of a more burdensome one, the Fifth Circuit required EPA to
show that each less burdensome requirement would not adequately protect against the
unreasonable risk.39 Some environment and public health groups have argued that it is unlikely
another chemical could be regulated under TSCA if EPA was not able to regulate asbestos under
the statute.
36
15 U.S.C. 2605.
TSCA Section 19 (15 U.S.C. 2618(c)(1)(B)) provides that the standard of review for certain rules issued by EPA,
including restrictions on new or existing chemicals, is that a reviewing court shall set aside such rules if it finds that the
rule is not supported by substantial evidence in the rulemaking record. This standard applies in lieu of the standard
under the Administrative Procedure Act (APA), which provides that a reviewing court shall set aside agency action that
is arbitrary, capricious, an abuse of discretion, etc. (5 U.S.C. 706). Neither the House bill nor the Senate amendment
would substantively change this standard of review.
38
947 F.2d 1201 (5th Cir. 1991). The Fifth Circuit did not strike down restrictions on new uses of asbestos.
39
Ibid. at 1226, 1229. This interpretation of the “least burdensome” requirement has not been applied in other
significant TSCA litigation challenging risk management rules since Corrosion Proof Fittings v. EPA.
37
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Both the House bill and the Senate amendment would remove from TSCA the requirement that
EPA promulgate the “least burdensome requirement” in order to restrict a chemical demonstrated
by the agency to present unreasonable risks. In addition, the House bill and the Senate
amendment would amend the process that EPA would undertake to select a regulatory option that
would restrict a chemical determined to warrant regulation. For a comparison among existing law,
the House bill, and the Senate amendment on this topic, see page CRS-31 in Table 1.
Requirement for the Development of Test Information
EPA relies on scientific and technical information regarding chemical substances and mixtures to
evaluate risks and determine if any risks are unreasonable. In order to obtain such information,
TSCA Section 8 authorizes EPA to require reporting and recordkeeping of existing information on
chemical substances and mixtures by manufacturers, processors, and distributors of chemical
substances.40 If the risks are insufficiently known from existing information and testing is
necessary to develop new information about the risks, TSCA Section 4 mandates that EPA
promulgate a rule to require manufacturers and processors to conduct testing if the agency finds
(1) that the chemical substance may present unreasonable risks,41 or (2) that “substantial
quantities” are or will be produced either in a way that enters or may reasonably be anticipated to
enter the environment, or in a way that “there is or may be significant or substantial human
exposures.”42 To date, EPA has required additional testing for over 200 chemical substances.43
Some stakeholders have argued that limits on EPA’s authority under TSCA to require the
development of new information regarding the health and environmental effects of chemicals
have hindered EPA’s ability to assess the risks of chemicals.44 EPA has argued that finding a
chemical substance “may present an unreasonable risk of injury to health or the environment” in
order to require the development of new information to determine whether a chemical substance
presents an unreasonable risk is a “possible analytical catch-22.”45 Likely for this reason, EPA has
generally required further testing based on the production volume of a chemical and the
likelihood of exposure. Some stakeholders contend that the development of new information may
take a lengthy amount of time and be costly to those required to develop the information.
Both the House bill and the Senate amendment would expand EPA’s authority to require the
development of test data, albeit with differences in the extent of that authority. As an example, the
House bill would authorize EPA to require testing if the agency finds that testing of the chemical
40
15 U.S.C. 2607.
This threshold finding has been held to be met when EPA “finds a more-than-theoretical basis for suspecting that the
chemical substance in question presents an ‘unreasonable risk of injury….’” Chemical Mfrs. Ass’n v. U.S. EPA, 859
F.2d 977, 979 (D.C. Cir. 1988).
42
This threshold finding has been held to require EPA to “articulate the standards or criteria on the basis of which it
found the quantities of [a chemical] entering the environment … to be ‘substantial’ and the human exposure potentially
resulting to be ‘substantial’” on a general or case-specific basis. Chemical Mfrs. Ass’n v. EPA, 899 F.2d 344, 360 (5th
Cir. 1990). EPA thereafter published technical criteria that form the basis for EPA’s policy for making exposure-based
findings. EPA, “TSCA Section 4(a)(1)(B) Final Statement of Policy; Criteria for Evaluating Substantial Production,
Substantial Release, and Substantial or Significant Human Exposure,” 58 Federal Register 28736-28749, May 14,
1993.
43
Testimony of James Jones, EPA Assistant Administrator for the Office of Chemical Safety and Pollution Prevention,
in U.S. Congress, House Committee on Energy and Commerce, Subcommittee on Environment and the Economy, H.R.
___, the TSCA Modernization Act of 2015, 114th Cong., 1st sess., April 14, 2015, (Washington: GPO, 2015), pp. 5-6
(pp. 9-10 of PDF), https://www.gpo.gov/fdsys/pkg/CHRG-114hhrg95937/pdf/CHRG-114hhrg95937.pdf.
44
Ibid.
45
Ibid.
41
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Proposed Amendments to the Toxic Substances Control Act (TSCA) in the 114 th Congress
is necessary to evaluate risks to determine whether regulation is warranted under TSCA.
Compared to existing TSCA, this finding would be an additional finding that EPA could make to
require testing. As another example, the Senate amendment would give EPA discretion to require
testing that the agency determines is necessary for specific purposes related to evaluating risks of
chemicals. For a comparison among existing law, the House bill, and the Senate amendment on
this topic, see page CRS-18 in Table 1.
Preemption of State Requirements46
With an increasing number and diversity of state chemical regulations providing a backdrop for
TSCA amendment discussions at the federal level, the scope of TSCA preemption has been a
long-standing issue. Under the Supremacy Clause of the U.S. Constitution, conflicting state law
and policy must yield to the exercise of Congress’s enumerated powers.47 When it acts, Congress
can preempt state action within a field entirely, allow states to take different actions, or permit
state action to any degree in between. Current TSCA preemption is not at either end of the
spectrum; it gives EPA a primary role in management of chemicals but leaves states some ability
to set their own chemical requirements under certain circumstances.
Specifically, TSCA Section 18 provides that states are generally preempted from taking action to
manage risk from a chemical if EPA has taken action on a similar risk presented by that chemical,
although states may apply for waivers.48 For state requirements other than duplicative testing
requirements, a number of exceptions to preemption apply. State requirements that are identical to
federal requirements are not preempted, allowing states to co-enforce the federal requirements by
adopting them as their own law.49 States are also authorized to regulate disposal, establish or
continue in effect any chemical requirement adopted under the authority of any other federal law,
and prohibit use of a chemical within the state (except for its upstream use in manufacture or
processing of other chemicals).50
In the TSCA amendment context, advocates for broader federal preemption claim that a uniform
national regulatory framework with regard to chemicals can provide sufficient protection from
chemical risks. They assert that absent preemption, states may implement varying and even
conflicting regulations, leading to increased compliance costs, reduced economies of scale, and
economic repercussions across industry supply chains and throughout interstate commerce.51 On
the other hand, opponents of preemption argue that the federal regulation should set a minimum
standard but that states should be able to experiment with different policies and implement more
46
For more on this topic, see CRS Report R44066, Preemption in Proposed Amendments to the Toxic Substances
Control Act (TSCA): Side-by-Side Analysis of S. 697 and H.R. 2576, by (name redacted)
and CRS Legal Sidebar
WSLG1269, Toxic Substances Control Act (TSCA) Preemption and State Chemical Regulations Under Current Law,
by (name redacted)
.
47
U.S. Constitution, Article VI, clause 2. Note that local as well as state laws are subject to federal preemption. Also,
while this report discusses statutory preemption provisions, it should be noted that under the Supremacy Clause, state
law can be preempted either because the federal law is intended to be comprehensive and occupies the field or because
the state law conflicts with a federal law, even if the federal law does not expressly preempt the state law. Conflict
preemption could occur either because compliance with both the state rule and the federal rule would be impossible or
because the state rule would stand as an obstacle to the accomplishment and execution of the full purposes and
objectives of Congress. Whether a certain state action is preempted by federal law is a question of congressional intent.
48
15 U.S.C. 2617.
49
15 U.S.C. 2617(a)(2)(B).
50
Ibid.
51
See, for example, S. 697 hearing in footnote 16 above.
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Proposed Amendments to the Toxic Substances Control Act (TSCA) in the 114 th Congress
stringent requirements than those EPA sets in order to protect the safety and welfare of their
citizens.52
Both the House bill and the Senate amendment would retain the general structure of TSCA
preemption, in which certain EPA actions regarding a specific chemical will preempt state
chemical regulations for that same chemical, subject to exceptions and waivers. Both would add
some exceptions to preemption and would align the preempting EPA actions with the amended
regulatory framework but with some differences between their approaches. For a comparison
among existing law, the House bill, and the Senate amendment on this topic, see pages CRS-42
through CRS-46 in Table 1.
Confidentiality and Disclosures of Information
TSCA requires chemical manufacturers, processors, and distributors to submit certain information
to EPA regarding their chemicals.53 This information can include detailed chemical structures,
production volumes, and health and safety data. Thus, another issue of concern in amending
TSCA is how to balance the goals of, on the one hand, public access to chemical information and,
on the other, protection of information that if disclosed could compromise the submitter’s
competitiveness.
TSCA Section 14 prohibits disclosure of information reported to or obtained by EPA that is
exempt from disclosure under the Freedom of Information Act (FOIA) as “trade secrets and
commercial or financial information obtained from a person and privileged or confidential,”54
with certain exceptions.55 Under the terms of TSCA, wrongful disclosure by EPA employees or
contractors is a criminal act.56 Confidential business information (CBI) protection under TSCA
does not prohibit disclosure of any health and safety study, but any data within any such study
that would disclose manufacturing processes or proprietary mixture compositions would remain
protected.57
Many items of information—including chemical identities—have been protected by EPA as CBI
on the TSCA Inventory, in health and safety studies, and in other situations.58 TSCA Section 14
contains several exceptions requiring disclosure of CBI, including if EPA determines that
disclosure is “necessary to protect health or the environment against an unreasonable risk of
injury.”59 If EPA makes this determination, or if EPA finds that information that has been
designated as CBI does not meet the standard for protection, EPA must provide notice to the
information submitter prior to disclosing the information.60
52
Ibid.
See 15 U.S.C. 2604(d)(1), 2607(a)(2) (requiring information on new and existing chemicals to the extent such
information is known or reasonably ascertainable), 2607(d)-(e) (requiring submission to EPA of health and safety
studies and of substantial risk allegations), and 2603 (authorizing EPA to require development of new information).
54
5 U.S.C. 552(b)(4).
55
15 U.S.C. 2613.
56
15 U.S.C. 2613(d).
57
15 U.S.C. 2613(b).
58
EPA, “About Confidential Business Information (CBI) Claims and Their Reviews Under TSCA,” updated September
15, 2015, http://www.epa.gov/tsca-cbi/about-confidential-business-information-cbi-claims-and-their-reviews-undertsca.
59
15 U.S.C. 2613(a)(3).
60
15 U.S.C. 2613(c)(2).
53
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Proposed Amendments to the Toxic Substances Control Act (TSCA) in the 114 th Congress
Procedurally, to obtain CBI protection for information that the submitter believes is entitled to
confidential treatment, the submitter is required only to designate the information as CBI.61
Neither substantiation nor EPA review of confidentiality claims is expressly required under
current TSCA. CBI protection also continues indefinitely, unless EPA determines that the
information no longer qualifies for protection under the FOIA exemption and gives the submitter
the required prior notice.62 Since 2010, EPA has increased its review of confidentiality claims,
particularly relating to chemical identities in health and safety studies.63 The agency has also
issued a “CBI Declassification Challenge” asking industry to withdraw CBI claims voluntarily
and has engaged in other initiatives to increase public access to non-confidential information.64
Both the House bill and the Senate amendment would expand the requirements for substantiation
of confidentiality claims and add certain circumstances (such as emergencies) when confidential
information may be disclosed, with some differences. The House bill and the Senate amendment
also take somewhat differing approaches to protecting chemical identities in health and safety
studies. For a comparison among existing law, the House bill, and the Senate amendment on this
topic, see pages CRS-20 through CRS-27 in Table 1.
Resources to Administer TSCA
The level of resources and staffing available to EPA is one key factor that affects the pace and
thoroughness for evaluating chemicals under TSCA. An issue for Congress is whether to continue
funding EPA’s activities under TSCA through discretionary appropriations or to establish
dedicated sources of funding that are supplemental to and not subject to discretionary
appropriations.
Under TSCA Section 29, appropriations for Title I were authorized through FY1983. Congress
has continued to fund EPA’s implementation of TSCA through annual appropriations pursuant to
the program or “organic” authorities of TSCA that do not have a sunset date and do not expire
unless otherwise amended.65 Additionally, TSCA Section 26(b) authorizes EPA to assess fees on
chemical manufacturers (including importers) or processors.66 The authorization for EPA to assess
these fees does not have a sunset date. EPA’s authority to collect fees is statutorily limited to a
maximum of $2,500 for the following actions required under TSCA Section 5:
Each PMN that a manufacturer of a new chemical substance is required to submit
to EPA, and
Each notice that a manufacturer or processor is required to submit to EPA for a
significant new use of a chemical substance.67
TSCA Section 26(b) currently provides an exception for small businesses under which these fees
are limited to a maximum of $100. Furthermore, TSCA Section 26(b) authorizes EPA to assess
fees within these statutory caps for the costs of evaluating testing data that a manufacturer or
61
15 U.S.C. 2613(c)(1).
15 U.S.C. 2613(c)(2).
63
See footnote 58.
64
EPA, “Voluntary Challenge To Declassify Confidential Business Information (CBI),” updated September 15, 2015,
http://www.epa.gov/tsca-cbi/voluntary-challenge-declassify-confidential-business-information-cbi.
65
15 U.S.C. 2628.
66
15 U.S.C. 2625(b).
67
15 U.S.C. 2604.
62
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Proposed Amendments to the Toxic Substances Control Act (TSCA) in the 114 th Congress
processor of a chemical substance may be required to submit to the agency under TSCA Section
4.68 Under TSCA, there is no dedicated account for fees collected under Section 26(b). As such,
these fees are treated as miscellaneous receipts and deposited into the General Fund of the U.S.
Treasury as required by the Miscellaneous Receipts Act.69 The availability of fees collected under
TSCA for obligation by EPA is subject to annual appropriations.
Both the House bill and the Senate amendment would amend TSCA Section 26(b) with regard to
the authority to collect fees. The House bill and the Senate amendment differ in terms of what
activities EPA would be authorized to collect a fee from manufacturers or processors and certain
other limitations to overall fee collection authority. For either the House bill or the Senate
amendment, collected fees would only be made available to EPA subject to the discretionary
appropriations process. For a comparison among existing law, the House bill, and the Senate
amendment on this topic, see pages CRS-47 through CRS-48 in Table 1.
Side-by-Side Comparison of Provisions by Topic
Table 1 of this report presents a side-by-side comparison of existing law, the House bill, and the
Senate amendment. The table includes a discussion of each provision of the House bill and the
Senate amendment, although it does not provide comprehensive analysis of the potential effects
of particular provisions in the House bill or the Senate amendment. Existing law in the table is
presented to the extent that such law would be amended by either the House bill or the Senate
amendment. The table organizes the provisions of the House bill and the Senate amendment
under 10 subheadings selected by CRS that reflect the following elements of TSCA:
I.
II.
III.
IV.
V.
VI.
VII.
VIII.
IX.
X.
Short title, intent, and definitions (page CRS-12);
Policies, procedures, and guidance; and advisory committee (page CRS-13);
Recordkeeping, reporting, chemical inventory, and development of new
information (page CRS-15);
Confidential treatment and public disclosure of information (page CRS-20);
Addressing risks of existing chemical substances and mixtures (page CRS-28);
Addressing risks of new chemical substances and significant new uses of
chemical substances (page CRS-36);
Judicial review and enforcement (page CRS-39);
Relationship to state law (page CRS-42);
Resources to implement TSCA (page CRS-47); and
Other provisions (page CRS-49).
68
15 U.S.C. 2603. As a matter of implementation, the regulations that EPA has promulgated to assess fees under TSCA
apply to PMNs and notices of significant new uses required under TSCA Section 5 but not to the evaluation of testing
data that may be required under TSCA Section 4.
69
31 U.S.C. 3302(b).
Congressional Research Service
11
Table 1. Side-by-Side Comparison of Existing Law, H.R. 2576 as Passed by the House, and the Senate Substitute Amendment
to H.R. 2576 as Passed by the Senate in the 114th Congress
Purpose
Existing Law: the Toxic Substances Control
Act (TSCA) and Other Provisions
H.R. 2576, the TSCA Modernization Act of
2015, as Passed by the House
on Jun. 23, 2015 (“House bill”)
Senate Substitute Amendment to H.R.
2576, the Frank R. Lautenberg Chemical
Safety for the 21st Century Act,
as Passed by the Senate on Dec. 17, 2015
(“Senate amendment”)
I. Short title, intent, and definitions
Short title
Not applicable.
Section 1 of the House bill provides that it may
be cited as the “TSCA Modernization Act of
2015.”
Section 1 of the Senate amendment provides that
it may be cited as the “Frank R. Lautenberg
Chemical Safety for the 21st Century Act.”
Intent
TSCA Section 2(c) [15 U.S.C. 2601(c)] states the
intent of Congress that EPA shall carry out TSCA
in a reasonable and prudent manner, and consider
the environmental, economic, and social impact
of TSCA actions. These provisions, particularly
Section 2(c), have been used by courts in
interpreting other provisions of TSCA.a
TSCA Section 2 would not be amended.
Section 2 of the Senate amendment would add to
TSCA Section 2’s congressional intent statement
“as provided under this Act” language, reflecting
the new limitations the amendments would
impose on EPA’s consideration of the economic
and social impacts of certain TSCA actions.
Section 2 of the Senate amendment would also
add a new paragraph to TSCA Section 2(c)
specifying that (1) EPA shall protect various
populations and the environment from risks of
harmful exposures and shall ensure availability of
emergency response information, and (2) the
amendments shall not displace common law
rights and remedies. These additions are
mirrored in certain other provisions, as discussed
below.
Definitions
TSCA Section 3 [15 U.S.C. 2602] defines 14
terms for purposes of the statute: Administrator,
chemical substance, commerce, distribute in
commerce, environment, health and safety study,
manufacture, mixture, new chemical substance,
process, processor, standards for the
development of test data, state, and United
States.
Existing definitions in TSCA Section 3 would not
be amended. Section 2 of the House bill would
add definitions for two terms: “intended
conditions of use” and “potentially exposed
subpopulation.” These terms are discussed below
in the context of their uses in the House bill.
Existing definitions in TSCA Section 3 would not
be amended. Section 3 of the Senate amendment
would add definitions for five terms: “conditions
of use,” “potentially exposed or susceptible
population,” “safety assessment,” “safety
determination,” and “safety standard.” These
terms are discussed below in the context of their
uses in the Senate amendment.
CRS-12
Purpose
Existing Law: the Toxic Substances Control
Act (TSCA) and Other Provisions
H.R. 2576, the TSCA Modernization Act of
2015, as Passed by the House
on Jun. 23, 2015 (“House bill”)
Senate Substitute Amendment to H.R.
2576, the Frank R. Lautenberg Chemical
Safety for the 21st Century Act,
as Passed by the Senate on Dec. 17, 2015
(“Senate amendment”)
II. Policies, procedures, and guidance; and advisory committee
Scientific standards and
use of information
CRS-13
No comparable provision in TSCA.a
Section 8(3) of the House bill would add new
TSCA Section 26(h)-(i) to require EPA to
consider—when making decisions based on
science under amended TSCA Sections 4, 5, and
6—enumerated factors, as applicable. These
factors are (1) soundness of scientific and
technical methodology used to generate
information; (2) relevancy of information; (3)
clarity and completeness in documenting the
generation of information; (4) variability and
uncertainty in information; and (5) extent of
independent verification or peer review of the
information or of the methodology.b
Furthermore, EPA is required to make decisions
under amended TSCA Sections 4, 5, and 6 based
on the “weight of the scientific evidence.”
Amended TSCA Section 4 is discussed below
under subheading III, amended TSCA Section 5
under subheading VI, and amended TSCA Section
6 under subheading V.
Section 4 of the Senate amendment would add
new TSCA Section 3A(c) to direct that EPA
policies, procedures, and “guidance” on the use
of science in making decisions under amended
TSCA Section 4, 5, and 6 and new TSCA Section
4A “ensure” that EPA decisions (1) are based on
information and methodology that are consistent
with the “best available science;” (2) take into
account the extent to which there is clarity and
completeness in documenting the generation of
information, variability and uncertainty, and
independent verification and peer review; and (3)
are based on the “weight of the scientific
evidence.” Additionally, EPA policies, procedures,
and guidance are to “ensure” that funding sources
of information are clearly described and that, if
appropriate, the recommendations in reports of
the National Academy of Sciences relevant to
chemical risk assessment are considered.c For
purposes of new TSCA Section 3A, the term
“guidance” would be defined in new TSCA
Section 3A(a) to include any “significant” written
guidance of general applicability prepared by EPA.
Section 4 of the Senate amendment would also
add new TSCA Section 3A(f) to require EPA to
take into consideration various sources of
information relating to a chemical substance that
is reasonably available to the agency in carrying
out amended TSCA Sections 4, 5, and 6 and new
TSCA Section 4A.
Amended TSCA Section 4 is discussed below
under subheading III, amended TSCA Section 5
under subheading VI, and new TSCA Section 4A
and amended TSCA Section 6 under subheading
V.
Purpose
Development of
policies, procedures,
and guidance to
implement TSCA
CRS-14
Existing Law: the Toxic Substances Control
Act (TSCA) and Other Provisions
No comparable provision in TSCA.d
H.R. 2576, the TSCA Modernization Act of
2015, as Passed by the House
on Jun. 23, 2015 (“House bill”)
Section 8(3) of the House bill would add new
TSCA Section 26(k) to direct EPA to develop any
policies, procedures, and guidance for
implementing the new purposes of the bill within
two years of enactment. Within five years of
enactment and at least once every five years
thereafter, EPA would be directed to review the
adequacy of the policies, procedures, and
guidance, and, if necessary, revise them to reflect
new scientific developments or understandings.
Senate Substitute Amendment to H.R.
2576, the Frank R. Lautenberg Chemical
Safety for the 21st Century Act,
as Passed by the Senate on Dec. 17, 2015
(“Senate amendment”)
Section 4 of the Senate amendment would add
new TSCA Section 3A(b) to direct EPA, within
two years of enactment, to develop, with notice
and public comment, any policies, procedures,
and “guidance”—including those required by new
TSCA Section 3A—for implementing purposes of
amended TSCA Section 4, 5, and 6 and new
TSCA Section 4A. As discussed in the previous
row, the term “guidance” would be defined in
new TSCA Section 3A(a) to include certain
“significant” guidance. Section 4 of the Senate
amendment would add new TSCA Section 3A(d)
to direct that policies, procedures, and guidance
under new TSCA Section 3A(b) incorporate
existing relevant policies, procedures, and
guidance as appropriate. Section 4 of the Senate
amendment would add new TSCA Section 3A(e)
to direct EPA, within five years of enactment and
at least once every five years thereafter, to
review the adequacy of any policies, procedures,
and guidance developed under the section and, if
necessary, after notice and public comment,
revise them to reflect new scientific
developments or understandings.
Section 4 of the Senate amendment would add
new TSCA Section 3A(g) to require EPA to
establish policies, procedures, and guidance for
testing under amended TSCA Section 4.e Section
4 of the Senate amendment would also add new
TSCA Section 3(h) to require EPA, through
rulemaking, to establish policies and procedures
for implementing amended TSCA Section 6 that,
at a minimum, describe how EPA would gather,
receive, and evaluate information and require
certain content in each draft and final “safety
assessment” and “safety determination.”f Within
one year of enactment, EPA would also be
required to develop guidance to assist interested
persons in developing their own draft safety
assessments and other information for
consideration by EPA.
Purpose
Establishment of an EPA
advisory committee
Existing Law: the Toxic Substances Control
Act (TSCA) and Other Provisions
No comparable provision in TSCA.
However, Section 8 of the Environmental
Research, Development, and Demonstration
Authorization Act of 1978 (ERDDAA; 42 U.S.C.
4365) established a “science advisory board” that
may provide independent scientific and technical
advice to EPA regarding any proposed criteria
document, standard, limitation, or regulation of
the agency.g The Federal Advisory Committee
Act (FACA; 5 U.S.C. Appendix) generally governs
the operations of federal advisory committees,
including the EPA Science Advisory Board.h
H.R. 2576, the TSCA Modernization Act of
2015, as Passed by the House
on Jun. 23, 2015 (“House bill”)
No comparable provision.
Senate Substitute Amendment to H.R.
2576, the Frank R. Lautenberg Chemical
Safety for the 21st Century Act,
as Passed by the Senate on Dec. 17, 2015
(“Senate amendment”)
Section 4 of the Senate amendment would add
new TSCA Section 3A(j) to direct EPA to
establish, within one year of enactment, a Science
Advisory Committee on Chemicals with the sole
purpose of providing independent scientific and
technical advice regarding implementation of the
Senate amendment’s provisions. Section 4 of the
Senate amendment would establish certain
requirements for the committee’s membership
and frequency of meetings. FACA would govern
all proceedings and meetings of this committee,
and the Senate amendment would not amend
ERDDAA or FACA.
III. Recordkeeping, reporting, chemical inventory, and development of new information
Recordkeeping and
reporting requirements
under TSCA
CRS-15
TSCA Section 8(a) [15 U.S.C. 2607] directs EPA
to promulgate various recordkeeping and
reporting requirements for manufacturers and
processors of chemical substances and mixtures
for purposes of enforcing requirements under
TSCA.a EPA is prohibited from requiring
recordkeeping or reporting with respect to
changes in the proportions of mixture
components unless the agency finds that it is
necessary for enforcing requirements under
TSCA.
EPA has discretion to promulgate certain
recordkeeping and reporting requirements for
small manufacturers and processors of chemical
substances and mixtures that are found to
warrant additional testing or regulation.b EPA,
after consultation with the Small Business
Administration (SBA), is directed to promulgate a
rule establishing standards for determining
whether an entity qualifies as a small
manufacturer or processor for these purposes.
The standards are codified in 40 C.F.R. 704.3.
Section 9(e) of the House bill would make
conforming amendments to TSCA Section 8(a) to
reflect proposed changes elsewhere in the House
bill.
Section 10(1) of the Senate amendment would
amend TSCA Section 8(a) in two ways. First,
Section 10(1) of the Senate amendment would
direct EPA, after consultation with SBA, to
periodically review and, if necessary, after notice
and public comment, revise standards for
determining which entities qualify as a small
manufacturer or processor for purposes of
recordkeeping and reporting requirements. Initial
review of these standards would be directed
within 180 days of enactment and then at least
once every 10 years thereafter. Second, Section
10(1) of the Senate amendment would add a new
paragraph to TSCA Section 8(a) to direct EPA,
within two years of enactment, to promulgate
recordkeeping and reporting requirements for
manufacturers and processors for purposes of
implementing the amended TSCA. EPA would be
authorized to modify, as appropriate, rules
promulgated before the enactment of the Senate
amendment. EPA would also be authorized to
impose different recordkeeping and reporting
requirements on manufacturers and processors
and would be required to include the level of
detail necessary to be reported.
Purpose
Inventory of chemical
substances
CRS-16
Existing Law: the Toxic Substances Control
Act (TSCA) and Other Provisions
TSCA Section 8(b) [15 U.S.C. 2607(b)] directs
EPA to compile, keep current, and publish a list of
each non-exempt chemical substance
manufactured (defined to include imported) or
processed for commercial purposes in the United
States. This list is referred to as the TSCA
inventory. New chemical substances for which a
notice is received under TSCA Section 5 [15
U.S.C. 2604] are to be included on the inventory
when manufactured or processed in the United
States. EPA reports that the existing TSCA
inventory includes at least 85,000 chemical
substances.c EPA has also developed guidance on
nomenclature conventions for purposes of
identifying chemical substances.
H.R. 2576, the TSCA Modernization Act of
2015, as Passed by the House
on Jun. 23, 2015 (“House bill”)
TSCA Section 8(b) would not be amended.
Senate Substitute Amendment to H.R.
2576, the Frank R. Lautenberg Chemical
Safety for the 21st Century Act,
as Passed by the Senate on Dec. 17, 2015
(“Senate amendment”)
Section 10(2) of the Senate amendment would
add paragraphs to TSCA Section 8(b) to require
EPA to use certain nomenclature conventions
described in existing guidance for purposes of
identifying substances on the inventory.
Additionally, Section 10(2) of the Senate
amendment would establish a process for EPA to
divide substances on the TSCA inventory into
those that are “active substances” or “inactive
substances,” which would both be new terms
defined in TSCA Section 8(f). In order to inform
EPA’s division of the inventory, the agency would
be directed, within one year of enactment, to
promulgate a rule that requires manufacturers
and processors to notify EPA, within 180 days
after the rule is promulgated, which chemical
substances on the inventory have been
manufactured or processed during the timeframe
within 10 years prior to enactment. EPA would
be required to designate chemical substances for
which a notice was received as active substances
on the TSCA inventory. EPA would also be
required to designate chemical substances for
which no notice was received as inactive
substances on the TSCA inventory. EPA would
also be required to maintain and keep current
designations of active substances and inactive
substances on the TSCA inventory. Any person
who intends to manufacture or process a
chemical substance that is designated as an
inactive substance would be required to notify
EPA of this intention, and the agency would be
required to redesignate this chemical substance
as an active substance. Additionally, EPA would
be required to designate chemical substances that
were most recently reported under 40 C.F.R.
Part 711 prior to enactment as the interim list of
active substances for purposes of prioritization
under new TSCA Section 4A.
Purpose
Existing Law: the Toxic Substances Control
Act (TSCA) and Other Provisions
H.R. 2576, the TSCA Modernization Act of
2015, as Passed by the House
on Jun. 23, 2015 (“House bill”)
Senate Substitute Amendment to H.R.
2576, the Frank R. Lautenberg Chemical
Safety for the 21st Century Act,
as Passed by the Senate on Dec. 17, 2015
(“Senate amendment”)
Confidential inventory
The inventory required under TSCA Section 8(b),
as described above, includes a portion in which
the confidentiality of certain chemical identities is
maintained in accordance with procedures for
protecting confidential information (40 C.F.R.
Part 2).
No comparable provision.
As part of the overall process to divide
substances on the TSCA inventory as “active”
and “inactive,” Section 10(2) of the Senate
amendment would add paragraphs to TSCA
Section 8(b) to require manufacturers and
processors submitting active substance notices to
indicate whether they seek to maintain any
existing claim for confidentiality protection of
specific chemical identities and to substantiate
such claims (unless recently substantiated). The
certifications would differ somewhat from the
data-related confidentiality certifications (see
below, subheading VI). Section 10(2) of the
Senate amendment would require EPA to
establish, by rule, a plan and a timeline for
reviewing all such claims within five to seven
years—and to review claims when an inactive
substance changes to active status—as well as to
“encourage” withdrawal or substantiation of
claims for inactive substances.
Substantial risk
notification requirement
under TSCA
TSCA Section 8(e) [15 U.S.C. 2607(e)] requires
any manufacturer, processor, or distributor of a
chemical substance or mixture to notify EPA
immediately of information obtained that
reasonably supports the conclusion that such
chemical substance or mixture presents a
substantial risk of injury to health or the
environment unless the notifier has knowledge
that the agency has been adequately informed of
such information.d
TSCA Section 8(e) would not be amended.
Section 10(3) of the Senate amendment would
add new provisions to TSCA Section 8(e) to
explicitly authorize any person to submit to EPA
information that reasonably supports the
conclusion that a chemical substance or mixture
presents, will present, or does not present
substantial risks. Section 10(3) of the Senate
amendment would not amend the requirement
for manufacturers, importers, processors, and
distributors to notify EPA immediately of
substantial risk information.
CRS-17
Purpose
Authority to require
testing of chemical
substances and mixtures
to evaluate risks
CRS-18
Existing Law: the Toxic Substances Control
Act (TSCA) and Other Provisions
TSCA Section 4(a) [15 U.S.C. 2603(a)] directs
EPA to require manufacturers or processors of a
chemical substance or mixture to test for
whether there may be adverse health or
environmental effects from that substance or
mixture if the agency makes certain findings. In
order to require testing, the agency may find that
(1) there may be unreasonable risks from a
substance or mixture and that the risks are
insufficiently known or (2) substantial quantities
of a chemical substance or mixture are being or
will be produced in a way that either substantial
quantities may enter the environment or there
may be “significant or substantial human
exposure” for which the risks are also
insufficiently known. Additionally, EPA may
require testing of mixtures if effects cannot be
determined by the testing of substances that
comprise the mixture. Section 4 authorizes EPA
to require testing through rulemaking that is
subject to the Administrative Procedure Act (5
U.S.C. 553) and additional requirements specified
in TSCA Section 4. Exceptions from testing
requirements are provided for instances when
the information requested has already been
developed or is being developed by another
entity. Section 4(c) establishes a process for
determining reimbursement of testing costs to
the entity developing the required information by
those for which an exception from testing
requirements is made. EPA regulations
establishing the procedures for test rules are
codified in 40 C.F.R. Part 790. These regulations
also provide for enforceable consent agreements,
but Section 4 does not explicitly address such
agreements. EPA regulation treats violations of
enforceable consent agreements as subject to
enforcement of orders (40 C.F.R. 790.65).
H.R. 2576, the TSCA Modernization Act of
2015, as Passed by the House
on Jun. 23, 2015 (“House bill”)
Section 3 of the House bill would generally retain
the current framework under TSCA Section 4(a)
for EPA to require testing based on the same
findings as current law. In addition to the findings
under current law, EPA would also be authorized
to require testing if the agency finds that testing
of a chemical substance is necessary to conduct a
risk evaluation to determine whether regulation
is warranted under TSCA. In addition to existing
authority for EPA to promulgate a rule to require
testing, EPA would also be expressly authorized
to issue administrative orders and enter into
consent agreements for purposes of requiring
testing.
Section 9(a) of the House bill would make
conforming amendments to TSCA Section 4 to
reflect proposed changes elsewhere in the bill.
Senate Substitute Amendment to H.R.
2576, the Frank R. Lautenberg Chemical
Safety for the 21st Century Act,
as Passed by the Senate on Dec. 17, 2015
(“Senate amendment”)
Section 5 of the Senate amendment would
generally amend and restructure TSCA Section
4(a)-(e) and strike Section 4(g) (relating to certain
petitions).e Section 5 of the Senate amendment
would eliminate TSCA’s current requirements for
certain findings in order to require testing.
Section 5 would amend TSCA Section 4(a) to
give EPA discretion to require testing that the
agency determines is necessary for specific
purposes. The purposes include (1) prioritization
of existing chemical substances for evaluation
under new TSCA Section 4A (with certain
limitations); (2) evaluation of existing and new
chemical substances under amended TSCA
Sections 5 and 6; (3) implementation of a
requirement imposed in a consent agreement or
order that prohibits or restricts a new chemical
substance under new TSCA Section 5(c)(4) and
6(d)(3); (4) evaluation of chemical substances,
mixtures, and articles manufactured or processed
solely for export under amended TSCA Section
12; or (5) response to requests by another
“implementing authority” under another federal
law, to meet that authority’s regulatory testing
needs. In addition to existing authority for EPA to
promulgate a rule to require testing, EPA would
also be expressly authorized to issue
administrative orders and enter into consent
agreements for purposes of requiring testing,
subject to certain requirements and procedures
as would be amended by the bill, including certain
explanatory statements. Section 5 of the Senate
amendment would also amend TSCA Section 4(d)
regarding procedures for determining fair and
equitable reimbursement among entities required
to conduct testing.
Purpose
Existing Law: the Toxic Substances Control
Act (TSCA) and Other Provisions
H.R. 2576, the TSCA Modernization Act of
2015, as Passed by the House
on Jun. 23, 2015 (“House bill”)
Senate Substitute Amendment to H.R.
2576, the Frank R. Lautenberg Chemical
Safety for the 21st Century Act,
as Passed by the Senate on Dec. 17, 2015
(“Senate amendment”)
Interagency committee
for purposes of
recommending testing
of priority chemical
substances and mixtures
TSCA Section 4(e) [15 U.S.C. 2603(e)] authorizes
EPA to establish an interagency committee for
purposes of recommending a list of priority
chemical substances and mixtures to EPA for the
agency to determine whether promulgation of a
test rule is warranted.f The committee is
authorized to designate a subset of chemical
substances and mixtures, no more than 50 at any
one time, from this list that warrant higher
priority for testing. Such designation identifies
those chemical substances and mixtures for
which EPA is to determine whether the agency
may find that a test rule is required under Section
4(a) within 12 months of its designation. EPA is
required to publish reasons for not initiating a
rulemaking for those designated chemical
substances and mixtures that the agency does not
find to require testing. The recommendations of
the committee are not binding on EPA.
TSCA Section 4(e) would not be amended.
Section 5 of the Senate amendment would amend
TSCA Section 4(e) with new language, thereby
repealing the establishment of the interagency
committee. As discussed above, under amended
TSCA Section 4(a), EPA may require testing that
the agency determines to be necessary for
purposes of “implementing authority” requests
under another federal law, to meet the regulatory
testing needs of that authority.
Use of vertebrate
animals for testing
chemical substances and
mixtures under TSCA
No comparable provision in TSCA.
However, the ICCVAM Authorization Act of
2000 (42 U.S.C. 285l-2 et seq.) directs the
National Institute of Environmental Health
Sciences to establish the Interagency
Coordinating Committee on the Validation of
Alternative Methods (ICCVAM) for purposes of
establishing guidelines, recommendations, and
regulations that promote the use of new or
revised scientifically valid toxicological tests while
reducing, refining, or replacing animal tests.g EPA
is a member of ICCVAM.
No comparable provision.
Section 5 of the Senate amendment would amend
TSCA Section 4(c) to direct EPA to minimize, to
the extent practicable, the use of vertebrate
animals when requiring the development of new
information under TSCA. Within two years of
enactment, EPA would be directed to develop a
strategic plan to promote alternative testing
methods not based on vertebrate animals and
fund research that is intended to help minimize
the use of vertebrate animals in testing. EPA
would be authorized to adapt or waive testing
requirements based on certain considerations
regarding the use of vertebrate animals.
Additionally, Section 5 of the Senate amendment
would address the use of vertebrate animals in
voluntary testing for purposes of TSCA. The
ICCVAM Authorization Act of 2000 would not
be amended.
CRS-19
Purpose
Existing Law: the Toxic Substances Control
Act (TSCA) and Other Provisions
H.R. 2576, the TSCA Modernization Act of
2015, as Passed by the House
on Jun. 23, 2015 (“House bill”)
Senate Substitute Amendment to H.R.
2576, the Frank R. Lautenberg Chemical
Safety for the 21st Century Act,
as Passed by the Senate on Dec. 17, 2015
(“Senate amendment”)
IV. Confidential treatment and public disclosure of information
Information protected
from disclosure
CRS-20
TSCA Section 14 [15 U.S.C. 2613(a)] operates in
conjunction with the Freedom of Information Act
(FOIA; 5 U.S.C. 552). TSCA Section 14(a) clarifies
that information reported to or obtained by EPA
under TSCA that is exempt from the public
disclosure requirements of FOIA as “trade
secrets and commercial or financial information
obtained from a person and privileged or
confidential” (5 U.S.C. 552(b)(4)) cannot be
disclosed by EPA or any representative of EPA,
with certain exceptions described below.
EPA’s general regulations on public information
and confidential business information (40 C.F.R.
Part 2) generally apply to information submitted
under TSCA (40 C.F.R. 2.306).
Section 6 of the House bill would maintain TSCA
Section 14(a) confidentiality protections for trade
secrets and confidential business information.
Section 14 of the Senate amendment would
maintain TSCA Section 14(a) confidentiality
protections for trade secrets and confidential
business information, slightly rearranged, “so long
as the requirements of subsection (d) [of
amended TSCA Section 14; for example, required
certifications] are met.”a Section 14 of the Senate
amendment would also amend TSCA Section
14(b) to list categories of information “presumed
to be protected from disclosure.” These would
include, for example, specific information
describing manufacturing or processing,
marketing and sales information, and, in general,
the specific chemical identity of a new chemical
substance claimed as confidential before it is first
offered for commercial distribution. Time limits
on protection (see below) would not apply to
TSCA Section 14(b) information.
Purpose
Procedures and
standards for
designating or asserting
confidentiality
CRS-21
Existing Law: the Toxic Substances Control
Act (TSCA) and Other Provisions
TSCA Section 14(c)(1) [15 U.S.C. 2613(c)(1)]
allows but does not require a manufacturer,
processor, or distributor, when submitting
information under TSCA to EPA, to designate in
writing the information the submitter believes is
entitled to confidential treatment.
H.R. 2576, the TSCA Modernization Act of
2015, as Passed by the House
on Jun. 23, 2015 (“House bill”)
Section 6 of the House bill would amend TSCA
Section 14(c)(1)(A) to require a manufacturer,
processor, or distributor, when submitting
information under TSCA to EPA, to designate in
writing the information the submitter believes is
entitled to confidential treatment. It would
require each designation to include a justification
and a certification by the submitter that the
information is not otherwise publicly available.
Senate Substitute Amendment to H.R.
2576, the Frank R. Lautenberg Chemical
Safety for the 21st Century Act,
as Passed by the Senate on Dec. 17, 2015
(“Senate amendment”)
Section 14 of the Senate amendment would
amend TSCA Section 14(d) to require any person
seeking to protect from disclosure any
information submitted under TSCA to EPA to
assert a confidentiality claim at the time of
submission. It would require each assertion to
include a certification, by an authorized official of
the submitter, that certain statements of
justification and supporting information required
to assert or substantiate a confidentiality claim
are true. Section 14 of the Senate amendment
would also require claims for protection of
specific chemical identity of substances to include
“structurally descriptive generic names” for the
substances meeting certain conditions. EPA
would be tasked with assigning a “unique
identifier” to each generically named substance.
For submitted information not presumed to be
protected from disclosure under amended TSCA
Section 14(b), Section 14 of the Senate
amendment would require the submitter to
provide further substantiation for confidentiality
claims, pursuant to rules and guidance to be
developed by EPA.
Purpose
Penalties for wrongful
disclosure of
confidential information
CRS-22
Existing Law: the Toxic Substances Control
Act (TSCA) and Other Provisions
TSCA Section 14(d) [15 U.S.C. 2613(d)] sets
forth criminal penalties for wrongful disclosure of
information by current or former federal officers
or employees, or contractors or their employees.
Knowing and willful disclosure of protected
information to any person not entitled to receive
it is a misdemeanor. TSCA Section 14(d) provides
that a person who commits such a misdemeanor
shall be subject to a fine of up to $5,000 and/or
imprisonment for up to one year. However,
under the Sentencing Reform Act of 1984, as
amended by the Criminal Fines Improvement Act
of 1987 (18 U.S.C. 3571), all criminal fines are
subject to certain uniform levels, modifying all
fines imposed in the U.S. Code, including those
imposed by TSCA. As a result of those two laws,
the current maximum fine for an individual who
has committed a misdemeanor under TSCA
Section 14(d) is $100,000. TSCA Section 14(d)
also provides that the penalties apply in lieu of 18
U.S.C. 1905 (which also requires removal from
employment for public officers/employees).
H.R. 2576, the TSCA Modernization Act of
2015, as Passed by the House
on Jun. 23, 2015 (“House bill”)
TSCA Section 14(d) would not be amended.
Section 6 of the House bill would add new TSCA
Section 14(f) prohibiting any person receiving
information under one of the TSCA Section 14(a)
exceptions (as discussed below) from using the
information for any purpose not specified in the
exception and from disclosing the information to
any unauthorized person.
Senate Substitute Amendment to H.R.
2576, the Frank R. Lautenberg Chemical
Safety for the 21st Century Act,
as Passed by the Senate on Dec. 17, 2015
(“Senate amendment”)
Section 14 of the Senate amendment would
amend the penalties in a new TSCA Section
14(h), changing the fine from “not more than
$5,000” to “fined under title 18.” 18 U.S.C. 3571
applies higher fines for misdemeanors that result
in death and for violations by organizations. 18
U.S.C. 3571 also provides for alternative fines
based on pecuniary gain by the offender or
pecuniary loss by another person caused by the
violation.
Purpose
EPA review of
confidentiality claims;
time limits on
protection from
disclosure and renewal
of claims
CRS-23
Existing Law: the Toxic Substances Control
Act (TSCA) and Other Provisions
There are no provisions in TSCA requiring a
confidentiality designation to include any
justification of the designation or providing for
the expiration of the information’s confidentiality
protection.b
H.R. 2576, the TSCA Modernization Act of
2015, as Passed by the House
on Jun. 23, 2015 (“House bill”)
The House bill would not modify EPA’s review of
confidentiality claims; it appears that EPA could
continue to apply its current policy authorizing
review of business information confidentiality
under certain circumstances.
Section 6 of the House bill would amend TSCA
Section 14(c)(1)(B) to provide that designations
of confidentiality made after enactment of the
House bill would expire after 10 years, after
which EPA would make the information public—
unless the submitter had reasserted the claim in
writing, including (at least) all of the elements
required for the initial designation. Section 6 of
the House bill would add new TSCA Section
14(c)(1)(C) to require EPA to notify the
submitter at least 60 days prior to such
expiration. It is uncertain from the bill’s language
whether this renewal would be one time only or
would be required every 10 years.
Senate Substitute Amendment to H.R.
2576, the Frank R. Lautenberg Chemical
Safety for the 21st Century Act,
as Passed by the Senate on Dec. 17, 2015
(“Senate amendment”)
Section 14 of the Senate amendment would add
new TSCA Section 14(g) to require EPA to
review a data submitter’s confidentiality claim
within 90 days of the submission and give reasons
for denial or modification of the claim. The
“failure of [EPA] to make a decision regarding a
claim” by the deadline would not be a basis for
denying or eliminating the claim. EPA would have
to review all claims for confidential treatment of
the identity of chemical substances offered for
commercial distribution and at least 25% of other
confidentiality claims.
Section 14 of the Senate amendment would add
new TSCA Section 14(f)(1) to require EPA to
protect from disclosure confidential information
submitted after enactment of the Senate
amendment (other than information presumed to
be protected under amended TSCA Section
14(b)) for 10 years and to notify the submitter 60
days before the expiration of that period. Certain
procedures would apply to extension requests.
The number of confidentiality extensions would
be unlimited.
Section 14 of the Senate amendment would add
new TSCA Section 14(f)(2) to authorize EPA, in
its discretion, to require a submitter claiming
protection to withdraw, reassert, or
resubstantiate confidentiality claims in limited
circumstances. Section 14 of the Senate
amendment would require EPA to review
confidentiality claims (1) if it had a reasonable
basis to believe the information does not qualify,
(2) in connection with FOIA requests, or (3) for
any chemical substance found not to meet the
safety standard. Approval after review would
begin a 10-year protection period. A savings
clause would bar EPA from requiring
substantiation except as provided.
Purpose
Circumstances when
confidential information
may be disclosed
CRS-24
Existing Law: the Toxic Substances Control
Act (TSCA) and Other Provisions
TSCA Section 14(a) [15 U.S.C. 2613(a)] sets forth
exceptions to protection from disclosure, the
first three of which are mandatory. Information is
to be made available (1) to any officer or
employee of the United States, in connection
with official duties for the protection of health or
the environment or specific law enforcement
purposes; (2) to federal contractors and their
employees for work in connection with TSCA,
under certain conditions; (3) when EPA
determines it “necessary to protect health or the
environment against an unreasonable risk of
injury”; or (4) at EPA’s discretion, in any
proceeding under TSCA, preserving
confidentiality to the extent practicable.
TSCA Section 14(e) clarifies that all information
obtained by EPA under TSCA shall be made
available upon written request to any duly
authorized congressional committee.
H.R. 2576, the TSCA Modernization Act of
2015, as Passed by the House
on Jun. 23, 2015 (“House bill”)
Section 6 of the House bill would retain TSCA
Section 14(a)’s four current exceptions to
protection from disclosure and also (1) authorize
disclosure to a state, local, or tribal government
official upon their request for the purpose of
administration or enforcement (but not
development) of a law; and (2) mandate
disclosure upon request to a health or
environmental professional employed by a federal
or state agency in response to an environmental
release or to a treating physician or other health
care professional to assist in individuals’ diagnoses
or treatments. Rather than requiring
confidentiality agreements in specific situations,
Section 6 of the House bill would prohibit
recipients from using the information for any
purpose not specified in the exception and from
disclosing the information to any unauthorized
person, as noted above.
TSCA Section 14(e) would not be amended.
Senate Substitute Amendment to H.R.
2576, the Frank R. Lautenberg Chemical
Safety for the 21st Century Act,
as Passed by the Senate on Dec. 17, 2015
(“Senate amendment”)
Section 14 of the Senate amendment would
restructure and expand the exceptions to
protection from disclosure by replacing TSCA
Section 14(e). It would generally maintain the
current exceptions and would add the following
mandatory disclosures:
(1) To a state or locality—tribes are not
mentioned—upon their request for the purpose
of development, administration, or enforcement
of a law, subject to confidentiality agreements
meeting certain criteria;
(2) To a health or environmental professional
employed by a federal or state agency or treating
health care professional in a non-emergency
situation, upon a written statement of need and
agreement to sign a confidentiality agreement,
subject to certain conditions;
(3) In emergencies, upon request, to a treating
health care or poison control professional, public
health or environmental official, or first
responder, subject to certain conditions, including
a statement of need and signed confidentiality
agreement (not necessarily prior to disclosure);
(4) Similar to current TSCA Section 14(e), for
requests from any duly authorized congressional
committees; and
(5) If required to be made public under any other
provision of federal law.
For disclosures to a health or environmental
professional or in an emergency, as described in
(2) and (3) above, EPA would be required to
consult with the Centers for Disease Control and
Prevention (CDC) on an access system for the
information disclosed.
Purpose
Procedures for
disclosure of
information designated
as confidential
CRS-25
Existing Law: the Toxic Substances Control
Act (TSCA) and Other Provisions
TSCA Section 14(c)(2) [15 U.S.C. 2613(c)(2)]
sets forth notice procedures if EPA proposes to
release information designated as confidential
(other than health and safety studies, as discussed
below). EPA may not release such information
until 30 days after the information’s submitter has
received notice, in writing by certified mail, of
EPA’s intended release. This notice period is
shortened to 15 days if EPA deems disclosure
“necessary to protect health or the environment
against an unreasonable risk” (or 24 hours if the
risk is imminent). Notice requirements generally
do not apply to disclosures to federal employees
or contractors, or to disclosures in proceedings
under TSCA.
H.R. 2576, the TSCA Modernization Act of
2015, as Passed by the House
on Jun. 23, 2015 (“House bill”)
The House bill would not make substantive
changes to the proposed release notice
procedures of TSCA Section 14(c)(2) except to
clarify that (1) they are distinct from the notice
required before expiration of the 10-year
protection period, and (2) the procedures do not
apply to disclosures to government health or
environmental professionals or treating health
care professionals who are provided information
upon their request under the circumstances
described above.
Section 6 of the House bill would add new TSCA
Section 14(g) savings clause clarifying that nothing
in amended TSCA Section 14 shall be construed
to affect the applicability of state or federal rules
of evidence or procedures in any judicial
proceeding. This is similar to the savings clause in
the preemption provisions in amended TSCA
Section 18 (see below).
Senate Substitute Amendment to H.R.
2576, the Frank R. Lautenberg Chemical
Safety for the 21st Century Act,
as Passed by the Senate on Dec. 17, 2015
(“Senate amendment”)
Section 14 of the Senate amendment would
generally prohibit EPA from releasing information
asserted as confidential (other than, e.g., to EPA
employees and contractors) until 30 days after
the submitter has received notice, in writing by
certified mail, of EPA’s intended release. This
notice period would be shortened to 15 days for
congressional requests or if EPA deems it
necessary to protect health or the environment
against an unreasonable risk (no prior notification
is required if the release is to protect against
imminent and substantial harm). EPA would be
required to notify “as soon as practicable” after
disclosure to a health or environmental
professional or in an emergency under the
circumstances set forth, respectively, in
exceptions (2) and (3) in the preceding row. For
chemical substances subject to a ban or phase-out
under TSCA, Section 14 of the Senate
amendment would authorize requests for
nondisclosure, with “a rebuttable presumption
that the public interest in [disclosure] outweighs
the proprietary interest in maintaining the
protection,” subject to certain conditions for EPA
determinations and appeals.
Purpose
Information that may be
disclosed; health and
safety studies
CRS-26
Existing Law: the Toxic Substances Control
Act (TSCA) and Other Provisions
TSCA Section 14(b) [15 U.S.C. 2613(b)] provides
that TSCA’s confidentiality protections do not
extend to health and safety studies or related
data submitted to EPA under TSCA for chemical
substances and mixtures that have been offered
for commercial distribution or in certain other
circumstances. However, this exclusion does not
authorize “the release of any data which discloses
processes used in the manufacturing or
processing of a chemical substance or mixture or,
in the case of a mixture, … the portion of the
mixture comprised by any of the chemical
substances in the mixture.” Some chemical
identities in health and safety studies have been
protected as confidential under this exclusion.c
There is no specific provision regarding other
information that may be disclosed, but
information that is outside the FOIA (b)(4) [5
U.S.C. 552(b)(4)] exemption for trade secrets
and confidential business information is outside
the scope of protection from disclosure under
TSCA Section 14. (Other FOIA exemptions could
still apply.)
H.R. 2576, the TSCA Modernization Act of
2015, as Passed by the House
on Jun. 23, 2015 (“House bill”)
Section 6(2) of the House bill would retain TSCA
Section 14(b)’s provision that TSCA’s
confidentiality protections do not extend to
health and safety studies or related data but
expands the exception to this provision: In
addition to protecting data disclosing processes
or mixture portions, Section 6(2) of the House
bill would also protect “data that disclose
formulas (including molecular structures) of a
chemical substance or mixture” if otherwise
confidential. This provision could include
confidential chemical identities.
There would continue to be no specific provision
regarding other information that may be
disclosed.
Senate Substitute Amendment to H.R.
2576, the Frank R. Lautenberg Chemical
Safety for the 21st Century Act,
as Passed by the Senate on Dec. 17, 2015
(“Senate amendment”)
Section 14 of the Senate amendment would
amend TSCA Section 14(c) to expressly articulate
information not protected from disclosure
pursuant to TSCA. Amended TSCA Section 14(c)
would retain without substantive change TSCA’s
provision that confidentiality protections do not
extend to health and safety studies or related
data. It would address chemical identities,
whether in health and safety studies or not, in a
separate paragraph on “other information not
protected from disclosure.” For information
submitted after enactment, information not
protected from disclosure would include “the
specific identity of a chemical substance as of the
date on which the chemical substance is first
offered for commercial distribution” unless the
person submitting the information meets the
substantiation and other requirements of
amended TSCA Section 14(d). Information not
protected from disclosure would also include
safety assessments, safety determinations, and
certain types of general information. If EPA
promulgates a rule establishing a ban or phaseout of a chemical substance, then any
confidentiality protection for information on that
chemical substance would no longer apply,
subject to applicable notification and appeal
provisions.
Purpose
Requirements for public
disclosure
CRS-27
Existing Law: the Toxic Substances Control
Act (TSCA) and Other Provisions
TSCA has no general requirement for public
disclosure or dissemination of non-confidential
information.d
H.R. 2576, the TSCA Modernization Act of
2015, as Passed by the House
on Jun. 23, 2015 (“House bill”)
Section 6 of the House bill would amend TSCA
Section 14(c)(1)(B) to require EPA to make public
all information submitted to the agency for which
the 10-year protection period (described above)
has expired without renewal.
Additionally, Section 8 of the House bill would
add new TSCA Section 26(j) to require EPA to
make available to the public all EPA notices,
determinations, findings, rules, and orders under
TSCA.
Senate Substitute Amendment to H.R.
2576, the Frank R. Lautenberg Chemical
Safety for the 21st Century Act,
as Passed by the Senate on Dec. 17, 2015
(“Senate amendment”)
Sections 4, 5, and 7 of the Senate amendment
contain provisions that would require EPA to
make available to the public certain information
relating to safety assessments and safety
determinations, testing or other information
submitted or orders or agreements issued under
amended TSCA Section 4, and new chemical
information submitted or issued under amended
TSCA Section 5, subject to the protections of
TSCA amended Section 14. Information from
states on state chemical restrictions would also
have to be made publicly available, subject to
amended TSCA Section 14 and any applicable
state law. Section 14 of the Senate amendment
would also require EPA to promptly make public
information for which a claim for confidentiality is
withdrawn or information on a chemical
substance subject to a ban or phase-out rule if
EPA determines the information is not protected
from disclosure.
Purpose
Existing Law: the Toxic Substances Control
Act (TSCA) and Other Provisions
H.R. 2576, the TSCA Modernization Act of
2015, as Passed by the House
on Jun. 23, 2015 (“House bill”)
Senate Substitute Amendment to H.R.
2576, the Frank R. Lautenberg Chemical
Safety for the 21st Century Act,
as Passed by the Senate on Dec. 17, 2015
(“Senate amendment”)
V. Addressing risks of existing chemical substances and mixtures
Prioritization of existing
chemical substances and
mixtures for evaluation
of risks
CRS-28
No comparable provision in TSCA.
As a practical matter, EPA has discretion
regarding which chemical substances and
mixtures to prioritize for the evaluation of risks
to determine whether regulation is warranted.a
Section 4 of the House bill would add new TSCA
Section 6(b)(3) to establish three principal
mechanisms to select existing chemical
substances for risk evaluation.b Section 4 of the
House bill would require EPA to conduct and
publish risk evaluations on chemical substances
(1) that the agency has determined may present
an unreasonable risk because of potential hazard
and potential route of exposure under the
“intended conditions of use” (defined in Section 2
of the House bill), or (2) for which a
manufacturer has requested a risk evaluation,
subject to fees (discussed below under
subheading IX). Third, EPA would be authorized
and not required to conduct risk evaluations for
substances listed in EPA’s TSCA Work Planc on
the date of enactment without having to make a
determination regarding potential hazard and
potential route of exposure, as discussed above.
Section 4 of the House bill also sets forth
separate provisions in new TSCA Section 6(i) to
address chemical substances that are “persistent,
bioaccumulative, and toxic.” These provisions are
discussed below under this subheading.
Section 6 of the bill would add new TSCA Section
4A to establish a risk-based screening process for
EPA to prioritize existing chemical substances on
the TSCA inventory for evaluation to determine
whether regulation is warranted. EPA would be
directed to promulgate a rule to establish the
process and criteria for prioritization within one
year of enactment. The rule would be required to
contain a number of procedures (including
various public notice and certain public comment
requirements), preferences, and criteria.d For
example, EPA would have to prioritize at a
specified rate all substances identified by EPA on
the TSCA Work Plane; to use certain approaches
for certain substances, such as metalsf or inactive
substances; and to consider state input. (States
would be required to notify EPA of their
proposed restrictions on chemical substances not
prioritized.) EPA would also be required to
prioritize a chemical substance within 90 days
after receiving information on that substance
required under TSCA Section 4. Based on the
process, preferences, and criteria, chemical
substances would be listed as high priority or low
priority for evaluation or needing additional
information for prioritization. Chemical
substances would be removed from the high
priority list as their evaluations are completed
and replaced on the list by at least one other
chemical. EPA would have to make “every effort”
to prioritize all active substances “in a timely
manner.”
The process would also include input from
manufacturers or processors who may request
EPA to evaluate a particular chemical substance
as an “additional priority,” subject to fees. Such
requests would be subject to notice and public
comment, and EPA would be required to grant or
deny them within 180 days under set criteria and
limits.
Purpose
Evaluation of existing
chemical substances and
mixtures
CRS-29
Existing Law: the Toxic Substances Control
Act (TSCA) and Other Provisions
TSCA Section 6 [15 U.S.C. 2605] authorizes EPA
to evaluate chemical substances or mixtures to
find whether regulation is warranted. EPA is
authorized to make a finding that there is a
reasonable basis to conclude that the
manufacture, processing, distribution, use, or
disposal of a chemical substance or mixture
presents or will present an unreasonable risk of
injury to health or the environment.
“Unreasonable risk” has been interpreted by the
Fifth Circuit Court of Appeals to encompass
economic and practical considerations.g
Additionally, TSCA Section 4(f) [15 U.S.C.
2603(f)] requires EPA to initiate “appropriate”
action under TSCA Sections 5, 6, or 7 to reduce
risk from a chemical substance or mixture for
which test data or other information indicates
there may be a reasonable basis to conclude that
the chemical substance or mixture presents a
significant risk of serious or widespread harm
from cancer, gene mutations, or birth defects or
to publish reasons for finding that such risk is not
unreasonable. EPA is required to initiate the
action or publish the reasons within 180 days
after receiving the information; EPA may extend
this deadline up to 90 days for good cause.
H.R. 2576, the TSCA Modernization Act of
2015, as Passed by the House
on Jun. 23, 2015 (“House bill”)
Section 4(b) of the House bill would amend
TSCA Section 6(b) to require EPA to conduct
risk evaluations “without consideration of cost or
other non-risk factors” to determine whether a
chemical substanceh presents or will present an
unreasonable risk under amended TSCA Section
6(a). EPA would be directed to evaluate chemical
substances that meet criteria described in the
row above to determine whether they present
unreasonable risk under their “intended
conditions of use” and thus whether regulation is
warranted.
Sections 4 and 8 of the House bill would direct
EPA to conduct risk evaluations in accordance
with certain requirements that pertain to timing,
use of science, and consideration of risks to
“potentially exposed subpopulations” (defined in
Section 2 of the House bill).
Relatedly, Section 4(e) of the House bill would
add new TSCA Section 6(g) to prohibit EPA from
considering costs or other non-risk factors when
deciding whether to initiate a rulemaking under
amended TSCA Section 6(a).
TSCA Section 4(f) would not be amended.
Senate Substitute Amendment to H.R.
2576, the Frank R. Lautenberg Chemical
Safety for the 21st Century Act,
as Passed by the Senate on Dec. 17, 2015
(“Senate amendment”)
Section 3 of the Senate amendment would add
several new definitions to TSCA Section 3 that
would effectively prohibit EPA from considering
cost or other non-risk factors in making a “safety
determination” as to whether a chemical
substance meets the “safety standard.” Section 3
would also define “safety standard” as a standard
that “ensures, without taking into consideration
cost or other non-risk factors,” no “unreasonable
risk.”
Section 8 of the Senate amendment would amend
TSCA Section 6(a) and (c) to direct EPA to
conduct a “safety assessment” (also defined by
Section 3 of the Senate amendment) and make a
safety determination of high-priority substances
to determine whether regulation is warranted.i
For each safety determination, EPA would be
required to determine whether a chemical
substance meets or does not meet the safety
standard or whether additional information is
necessary to make such determination. The
scope of the safety determination would be
limited to the “conditions of use” and risks that
would be evaluated include those to “potentially
exposed or susceptible populations,” defined in
Section 3 of the Senate amendment. Section 8 of
the Senate amendment would amend TSCA
Section 6(b) to encourage continuation of priorinitiated assessments and policies and use of
existing information. Other considerations
pertaining to use of science and other topics
would be guided by policies and guidance
required to be issued by EPA under new TSCA
Section 3A. A determination that a substance
meets the safety standard would be required to
be issued by order and would be a final agency
action subject to judicial review.
Section 5 of the Senate amendment would amend
TSCA Section 4(f) to encompass any serious or
widespread harm and make certain other
conforming changes.
Purpose
Pace of prioritization
and evaluation of
existing chemical
substances and mixtures
CRS-30
Existing Law: the Toxic Substances Control
Act (TSCA) and Other Provisions
No comparable provision in TSCA.
H.R. 2576, the TSCA Modernization Act of
2015, as Passed by the House
on Jun. 23, 2015 (“House bill”)
Section 4 of the House bill would add new
paragraphs to TSCA Section 6(b) to require EPA
to initiate 10 or more risk evaluations in each
fiscal year (excluding requests from
manufacturers) subject to the availability of
appropriations.
EPA would also be required to conduct and
publish risk evaluations that the agency initiates
within three years of determining that the
chemical substance warrants evaluation. The
agency would be required to complete
manufacturer-requested evaluations within two
years after granting the request. These deadlines
would be subject to extension if EPA determines
additional information is necessary to make a risk
evaluation determination up to 90 days after
receipt of the required information or two years
after the deadline being extended. Additionally,
EPA would be required to publish a preliminary
determination of no unreasonable risk at least 30
days prior to finalizing such determination. The
final determination would be considered a final
agency action subject to judicial review.
Senate Substitute Amendment to H.R.
2576, the Frank R. Lautenberg Chemical
Safety for the 21st Century Act,
as Passed by the Senate on Dec. 17, 2015
(“Senate amendment”)
Section 6 of the Senate amendment would add
new TSCA Section 4A(a) directing EPA to publish
an initial list of at least 10 high-priority substances
and at least 10 low-priority substances within 180
days after enactment (that is, prior to the
deadline for EPA’s publication of a rule to
establish the process and criteria for subsequent
prioritization). Section 6 of the Senate
amendment would require EPA to add chemical
substances to the priority lists described above
sufficient to have initiated at least 20 safety
assessments of high-priority substances by three
years after enactment (and to have listed 20 lowpriority chemical substances) and at least 25 by
five years after enactment. Generally at least half
of high-priority substances would be drawn from
the TSCA Work Plan until all Work Plan
chemical substances were designated. EPA would
also be required to designate high-priority
substances consistent with the agency’s ability to
complete safety assessments and safety
determinations in accordance with the statutory
deadlines and to publish an annual goal for
prioritization.
Section 8 of the Senate amendment would amend
TSCA Section 6(a) to require EPA to complete
risk assessments within three years of
prioritization, subject to limited extension up to
one year where required information has not
been received. Manufacturer- or processorrequested risk assessments could not be
expedited or otherwise favored. Section 4 of the
Senate amendment would add new TSCA Section
3A(h) to require EPA to publish an annual plan,
including certain mandatory elements, for safety
assessments and safety determinations.
Purpose
Regulatory actions to
address unreasonable
risks
CRS-31
Existing Law: the Toxic Substances Control
Act (TSCA) and Other Provisions
If EPA were to find that a chemical substance or
mixture warranted regulation due to
unreasonable risks, TSCA Section 6(a) [15 U.S.C.
2605] directs the agency to promulgate a rule
using the “least burdensome” requirement to
adequately address such risks pursuant to certain
procedures and requirements in rulemaking.j
TSCA Section 6 identifies seven regulatory
options that range in severity from a labeling
requirement to an outright ban.
EPA is required to consider the effects and
exposure of the chemical substance found to
warrant regulation, benefits of the substance, and
any consequences from regulation. Additionally,
EPA is required to determine whether another
federal law may adequately address the identified
risks (see discussion below on “Relationship to
other federal laws not administered by EPA” and
“Relationship to other federal laws administered
by EPA”).
TSCA Section 6(b) authorizes EPA to issue
quality control orders under certain conditions.
TSCA Section 6(c) sets forth required statements
and procedures, including informal hearings.
TSCA Section 6(d) addresses effective dates for
rules under TSCA Section 6(a).
H.R. 2576, the TSCA Modernization Act of
2015, as Passed by the House
on Jun. 23, 2015 (“House bill”)
If EPA were to determine that a chemical
substance or mixture presented an unreasonable
risk based on the evaluation of risks, TSCA
Section 6(a), as would be amended by Section 4
of the House bill, would require EPA to
promulgate, by rule, a restriction on the
substance or mixture so that it would no longer
present unreasonable risks, including those risks
to “potentially exposed subpopulations.” Section
4(a) of the House bill would strike language
requiring EPA to protect against unreasonable
risks using the “least burdensome requirement.”
EPA would be required to determine that the
restrictions are “cost effective” unless the agency
was to determine that additional or different
requirements were necessary to protect against
the identified risks. Section 4 of the House bill
would require EPA to make a determination on
the availability of alternatives as a substitute to
the chemical substance subject to the proposed
restriction. EPA would be required to apply
restrictions to articles containing a chemical
substance that are subject to a proposed
restriction only to the extent necessary to
protect against the risks being addressed. The
deadline for the final rule would be two years
after the publication of the risk evaluation. Any
restriction would be required to have a
reasonable transition period. Additionally, Section
4 of the House bill would repeal the authority of
EPA to issue quality control orders under TSCA
Section 6(b) and the provisions on informal
hearings under TSCA Section 6(c).
Section 9(c) of the House bill would make
conforming amendments to TSCA Section 6 to
reflect proposed changes elsewhere in the bill.
Senate Substitute Amendment to H.R.
2576, the Frank R. Lautenberg Chemical
Safety for the 21st Century Act,
as Passed by the Senate on Dec. 17, 2015
(“Senate amendment”)
If EPA were to find that a chemical substance
warranted regulation based on a safety
determination, TSCA Section 6, as would be
amended by Section 8 of the Senate amendment,
would require EPA to promulgate, by rule, a
restriction on the substance so that the safety
standard (defined to include no unreasonable
risks to “potentially exposed or susceptible
subpopulations”) would be met. Section 8 of the
Senate amendment would slightly reword the
regulatory options and add specific requirements
for a ban or phase-out. Restrictions would no
longer need to be the least burdensome
requirement. EPA would have discretion in
determining whether restrictions would apply to
mixtures containing a substance found to warrant
regulation. There would be certain rulemaking
requirements and mandatory considerations, such
as alternatives to the chemical substance that
warrants regulation. EPA would be required to
apply restrictions to articles containing a chemical
substance subject to a proposed restriction, only
to the extent necessary to address risks from
exposure to that substance in articles. The
deadline for the final rule would be two years
after the safety determination, subject to
extension up to two years and the condition that
the aggregate length of all extensions of deadlines
for the safety assessment and safety
determination for a chemical substance does not
exceed two years. Rules would have to include
dates by which compliance is mandatory, as soon
as practicable but generally within four years.
Additionally, Section 8 of the Senate amendment
would repeal EPA authority to issue quality
control orders under TSCA Section 6(b) and the
provisions on informal hearings.
Purpose
Existing Law: the Toxic Substances Control
Act (TSCA) and Other Provisions
H.R. 2576, the TSCA Modernization Act of
2015, as Passed by the House
on Jun. 23, 2015 (“House bill”)
Senate Substitute Amendment to H.R.
2576, the Frank R. Lautenberg Chemical
Safety for the 21st Century Act,
as Passed by the Senate on Dec. 17, 2015
(“Senate amendment”)
Exemptions from
regulatory actions
No comparable provision in TSCA.
Section 4(c) of the House bill would amend
TSCA Section 6(c) to require EPA to exempt
“replacement parts” designed prior to the
publication of the rule unless the agency finds that
such parts contribute significantly to the risks
being addressed.k
Additionally, Section 4(e) of the House bill would
add new TSCA Section 6(h) giving EPA discretion
to exempt critical uses from any restriction
pursuant to certain procedures and
requirements.
Section 8 of the Senate amendment would direct
EPA to exempt “replacement parts” that are
manufactured prior to the publication of the rule,
unless the agency finds that such parts contribute
significantly to the risks being addressed.l
EPA would have discretion to exempt from
regulation, by rule, certain uses that the agency
determines would compromise national security,
disrupt the national economy, or provide
substantial benefit or public safety over an
alternative, although there would be additional
considerations and conditions for any proposed
exemption to a ban or a phase-out.
Chemical substances
that are persistent,
bioaccumulative, and
toxic (PBT)
No comparable provision in TSCA.
Section 4 of the House bill would add TSCA
Section 6(i) to require expedited action for
chemical substances that are “persistent,
bioaccumulative, and toxic” (PBT) and not metals,
metal compounds, or polychlorinated biphenyls
(PCBs) subject to TSCA Section 6(e). EPA would
be directed to publish an initial list of PBTs within
nine months after enactment; within two years
after enactment, EPA would be required to
confirm and designate as PBT chemicals of
concern those that, with respect to persistence
and bioaccumulation, score high for one and
either high or moderate for the other, pursuant
to EPA’s February 2012 “TSCA Work Plan
Chemicals Method Document”m and for which
exposure is likely to the general population or to
a “potentially exposed subpopulation” identified
by EPA. Upon such designation, EPA would be
directed to promulgate a rule within two years to
reduce likely exposure to the designated
substance to the extent practicable. However, if,
within 90 days after EPA publishes the initial list
of PBTs, the agency were to make a finding that a
risk evaluation is warranted or a manufacturer
were to request a risk evaluation for a chemical
substance, these provisions would not apply to
that chemical substance.
Section 6 of the Senate amendment would, in
new TSCA Section 4A, direct EPA to give
preference in prioritization to (among others)
chemical substances that, with respect to
persistence and bioaccumulation, score high for
one and either high or moderate for the other,
pursuant to EPA’s February 2012 “TSCA Work
Plan Chemicals Methods Document.”n
For such substances, Section 7 of the Senate
amendment would add new TSCA Section
5(d)(4)(D), and Section 8 of the Senate
amendment would amend TSCA 6(d)(2)(B) to
direct EPA, in selecting among regulatory actions
to address unreasonable risk, to reduce exposure
to the maximum extent practicable.
CRS-32
Purpose
Regulatory actions to
address imminently
hazardous chemical
substances and mixtures
CRS-33
Existing Law: the Toxic Substances Control
Act (TSCA) and Other Provisions
TSCA Section 7 [15 U.S.C. 2606] authorizes EPA
to file a civil action in a federal district court to
address an “imminently hazardous chemical
substance or mixture,” which is defined in Section
7(f) as a chemical substance or mixture that
presents an “imminent and unreasonable risk of
substantial or widespread injury to health or the
environment.” Imminent risks are considered as
those risks that are likely to result in serious or
widespread injury before a Section 6 rule may be
promulgated to protect against such risk. EPA
may file for seizure of such substance, mixture, or
article containing such substance or mixture or
for other relief.
H.R. 2576, the TSCA Modernization Act of
2015, as Passed by the House
on Jun. 23, 2015 (“House bill”)
Section 9(d) of the House bill would make
conforming amendments to TSCA Section 7 to
reflect proposed changes elsewhere in the bill.
Senate Substitute Amendment to H.R.
2576, the Frank R. Lautenberg Chemical
Safety for the 21st Century Act,
as Passed by the Senate on Dec. 17, 2015
(“Senate amendment”)
Section 9 of the Senate amendment would amend
TSCA Section 7 to authorize EPA to file a civil
action to address a chemical substance or
mixture for which risks are imminent but not
necessarily unreasonable and make certain
conforming amendments.
Purpose
Relationship to other
federal laws not
administered by EPA
CRS-34
Existing Law: the Toxic Substances Control
Act (TSCA) and Other Provisions
TSCA Section 9(a) [15 U.S.C. 2608] directs EPA
to take certain actions if the agency has
reasonable basis to conclude that the
manufacture, processing, distribution, use or
disposal of a chemical substance or mixture
presents or may present unreasonable risk and
determines that such risk may be prevented or
reduced to a sufficient extent by action taken
under a federal law not administered by the
agency. If such determination were made, EPA is
directed to report (1) a description of the
unreasonable risk and (2) activities that EPA
believes to present such risk to the federal
agency that administers the other federal law.
Additionally, EPA is required to request that the
other federal agency determine if the risk may be
addressed to a sufficient extent by action taken
under other federal law and to issue an order
declaring whether or not the activities described
by EPA present such risk within an amount of
time that EPA specifies in the request, although
the amount of time may not be less than 90 days
from when the request was made. EPA is
prohibited from taking action under TSCA
Section 6 or 7 with respect to the unreasonable
risk reported to the other federal agency if such
agency issues an order declaring that activities
described by EPA do not present unreasonable
risk or initiates action under another federal law
to protect against such risk described by the
report. If EPA has already initiated action under
TSCA Section 6 or 7 with respect to an
unreasonable risk reported to another federal
agency, that agency is required to consult with
EPA before taking action under other federal law
for the purpose of avoiding duplication of federal
action against such risk.
H.R. 2576, the TSCA Modernization Act of
2015, as Passed by the House
on Jun. 23, 2015 (“House bill”)
Section 9(f) of the House bill would make
conforming amendments to TSCA Section 9(a) to
reflect proposed changes elsewhere in the bill.
Senate Substitute Amendment to H.R.
2576, the Frank R. Lautenberg Chemical
Safety for the 21st Century Act,
as Passed by the Senate on Dec. 17, 2015
(“Senate amendment”)
Section 11 of the Senate amendment would
amend TSCA Section 9 to direct EPA to take
certain actions if (1) EPA were to report to
another federal agency that administers other
federal law regarding unreasonable risks and (2)
that agency does not respond or take action
within an amount of time that EPA specifies in its
request. If the aforementioned conditions are
met, EPA would be required to (1) complete the
safety assessment and safety determination for
the chemical substance that is the subject of the
report under amended TSCA Section 6 if such
assessment and determination has not been
completed, (2) initiate action under amended
TSCA Section 6(d) with respect to the risk if the
chemical substance that is the subject of the
report is determined not to meet the safety
standard, or (3) take any action authorized or
required under amended TSCA Section 7, as
appropriate. Section 11 of the Senate amendment
further clarifies that EPA would not be relieved of
any obligation to complete a safety assessment
and safety determination or take any required
action under amended TSCA Section 6(d) or 7 to
address risks that are not identified in a report
issued by the agency.
Additionally, Section 11 of the Senate amendment
would add new TSCA Section 9(e) to direct EPA
to make information related to exposures or
releases of a chemical substance that may be
prevented or reduced under another federal law
to the relevant federal agency or EPA office.
Purpose
Relationship to other
federal laws
administered by EPA
CRS-35
Existing Law: the Toxic Substances Control
Act (TSCA) and Other Provisions
TSCA Section 9(b) [15 U.S.C. 2608(b)] requires
EPA to coordinate actions taken under TSCA
with actions taken under other federal laws
administered by the agency. If EPA determines
that a risk associated with a chemical substance
or mixture could be eliminated or reduced to a
sufficient extent by actions taken under other
federal law, EPA is required to take action under
that other federal law unless the agency
determines it is in the public interest to take
action under TSCA.
H.R. 2576, the TSCA Modernization Act of
2015, as Passed by the House
on Jun. 23, 2015 (“House bill”)
Section 5 of the House bill would add a new
paragraph to TSCA Section 9(b) to require EPA
to consider the relevant risks, and compare the
estimated costs and efficiencies, of an EPA action
under TSCA and an action taken under another
federal law that the agency administers if the
agency has determined that it is in the public
interest to take action under TSCA.
Senate Substitute Amendment to H.R.
2576, the Frank R. Lautenberg Chemical
Safety for the 21st Century Act,
as Passed by the Senate on Dec. 17, 2015
(“Senate amendment”)
TSCA Section 9(b) would not be amended.
Purpose
Existing Law: the Toxic Substances Control
Act (TSCA) and Other Provisions
H.R. 2576, the TSCA Modernization Act of
2015, as Passed by the House
on Jun. 23, 2015 (“House bill”)
Senate Substitute Amendment to H.R.
2576, the Frank R. Lautenberg Chemical
Safety for the 21st Century Act,
as Passed by the Senate on Dec. 17, 2015
(“Senate amendment”)
VI. Addressing risks of new chemical substances and significant new uses of chemical substances
Premanufacture notices
(PMNs) of new
chemical substances and
significant new use
notices (SNUNs) of
chemical substances
CRS-36
TSCA Section 5 [15 U.S.C. 2604] establishes a
framework in which EPA is authorized to evaluate
new chemical substances and “significant new
uses” of a chemical substance to determine
whether regulation may be warranted prior to
such substances and uses entering commerce.
EPA evaluations are based on required
notification from (1) manufacturers of new
chemical substances and (2) manufacturers and
processors of chemical substances that are
intended for a use that the agency has
determined, through a significant new use rule
(SNUR), to be a significant new use. Notification
for a new chemical substance is commonly
referred to as a PMN, whereas notification for a
significant new use is commonly referred to as a
SNUN. PMNs and SNUNs are required to be
submitted at least 90 days prior to the new
chemical substance entering commerce or the
manufacture or processing of a chemical
substance for a significant new use, respectively,
subject to extension by EPA for good cause.
Section 5(b) addresses testing for new chemical
substances and significant new uses and
authorizes EPA to compile a list of chemical
substances that present or may present
unreasonable risk. Section 5(h) provides certain
exemptions from notification for circumstances in
which there is likely to be less risk. Existing EPA
regulation generally does not require notification
for importation of an article that contains a new
chemical substance or a chemical substance that
would otherwise require notification by a SNUR
(40 C.F.R. 720.22).a
Section 9(b) of the House bill would make
conforming amendments to TSCA Section 5 to
reflect proposed changes elsewhere in the bill.
Section 7 of the Senate amendment would
restructure TSCA Section 5.b Section 7 of the
Senate amendment would amend TSCA Section
5(b) to authorize EPA to require notification for
importing or processing of a chemical substance
as part of an article or category of articles that
would otherwise require notification based on a
SNUR if the agency makes a finding in the SNUR
that there is “reasonable potential for exposure”
from importation and processing that warrants
notification.
Section 7 of the Senate amendment would also
amend TSCA Section 5(c) to codify existing EPA
regulations (40 C.F.R. 720.45 and 720.50)
regarding the content required in a PMN or
SNUN and require that such notices include all
known or reasonably ascertainable information
regarding conditions of use and reasonably
anticipated exposures.
Additionally, Section 7 of the Senate amendment
would make certain conforming amendments to
TSCA Section 5(h) to reflect proposed changes
elsewhere in the Senate amendment.
Purpose
Review of PMNs and
SNUNs
CRS-37
Existing Law: the Toxic Substances Control
Act (TSCA) and Other Provisions
Under TSCA Section 5 [15 U.S.C. 2604], EPA is
not required to review the information required
in PMNs or SNUNs. In practice, the agency
prioritizes its reviews based on the likelihood of
unreasonable risk to determine if regulation may
be warranted. If EPA does not take regulatory
action on a chemical substance that is the subject
of a notice, the manufacturer or processor
submitting that notice may initiate manufacture or
processing of that chemical substance.
H.R. 2576, the TSCA Modernization Act of
2015, as Passed by the House
on Jun. 23, 2015 (“House bill”)
Section 9(b) of the House bill would make
conforming amendments to TSCA Section 5 to
reflect proposed changes elsewhere in the bill.
Senate Substitute Amendment to H.R.
2576, the Frank R. Lautenberg Chemical
Safety for the 21st Century Act,
as Passed by the Senate on Dec. 17, 2015
(“Senate amendment”)
Section 7 of the Senate amendment would amend
TSCA Section 5(d) to direct EPA to conduct
initial reviews of PMNs and SNUNs that are
submitted to the agency within 90 days of receipt
of the notice and make a determination on
whether regulation would be warranted or that
additional information is necessary to make such
determination. Regulation would be warranted if
the substance or significant new use is “not likely
to meet the safety standard.” (Section 3 of the
Senate amendment would define “safety
standard” as a standard that “ensures, without
taking into consideration cost or other non-risk
factors” no “unreasonable risk.”) Generally, EPA
would be authorized to extend the review period
by an additional 90 days. If EPA were to find that
a new chemical substance or significant new use
was “likely to meet the safety standard,”
manufacturing of the new chemical substance or
manufacturing or processing of the chemical
substance for the significant new use could
commence before the end of the 90-day review
period.
Purpose
Existing Law: the Toxic Substances Control
Act (TSCA) and Other Provisions
H.R. 2576, the TSCA Modernization Act of
2015, as Passed by the House
on Jun. 23, 2015 (“House bill”)
Senate Substitute Amendment to H.R.
2576, the Frank R. Lautenberg Chemical
Safety for the 21st Century Act,
as Passed by the Senate on Dec. 17, 2015
(“Senate amendment”)
Regulatory action to
address unreasonable
risks of new chemical
substances and
significant new uses of
chemical substances
TSCA Section 5 [15 U.S.C. 2604] provides three
mechanisms through which EPA can take
regulatory action to address unreasonable risks of
a new chemical substance or a significant new use
of a chemical substance. These mechanisms
include administrative orders, rulemakings, and
judicial orders. Section 5(e) authorizes EPA to
issue an administrative order based on
determinations that (1) there may be
unreasonable risks from a substance and that the
risks are insufficiently known, or (2) substantial
quantities of a chemical substance are being or
will be produced in a way that either substantial
quantities may enter the environment or there
may be “significant or substantial human
exposure” for which the risks are also
insufficiently known. In practice, such orders are
generally negotiated as a consent order with the
manufacturer or processor and are sometimes
followed by SNURs. Section 5(e) also authorizes
EPA to apply for a judicial order under certain
conditions. Additionally, Section 5(f) authorizes
EPA to issue an administrative order, pursue
rulemaking under Section 6, or apply for a judicial
order to address unreasonable risks.
TSCA Section 5(e) and (f) would not be
amended. Section 4 of the House bill would
amend TSCA Section 6, as discussed above.
Section 7 of the Senate amendment would amend
TSCA Section 5(d) to authorize EPA to issue an
administrative order or enter into a consent
agreement to restrict new chemical substances or
significant new uses of chemical substances that
EPA determines not to meet the “safety
standard” or determines that additional
information would be necessary to make a
determination. (Section 3 of the Senate
amendment would define “safety standard” as a
standard that “ensures, without taking into
consideration cost or other non-risk factors” no
“unreasonable risk.”) Section 7 of the Senate
amendment would also require EPA, within 90
days after a consent agreement or order under
TSCA Section 5 as would be amended, to
consider whether to promulgate a SNUR and
initiate rulemaking or publish reasons for not
doing so.
Notice of
commencement
Pursuant to TSCA Section 8(b) [15 U.S.C.
2607(b)], new chemical substances for which a
notice is received under TSCA Section 5 [15
U.S.C. 2604] are to be included on the TSCA
inventory by EPA when manufactured or
processed for commercial purposes in the United
States, as discussed above under subheading III.c
No comparable provision.
Section 7 of the Senate amendment would amend
TSCA Section 5(e) to codify existing EPA
regulation that requires manufacturers to submit
a SNUN within 30 days after commencing
manufacture of a new chemical substance.
Section 7 of the Senate amendment would amend
TSCA Section 5(f) to authorize EPA to prioritize
chemical substances for evaluation of risks under
new TSCA Section 4A any time after a notice of
commencement or new information has been
received by the agency.
CRS-38
Purpose
Existing Law: the Toxic Substances Control
Act (TSCA) and Other Provisions
H.R. 2576, the TSCA Modernization Act of
2015, as Passed by the House
on Jun. 23, 2015 (“House bill”)
Senate Substitute Amendment to H.R.
2576, the Frank R. Lautenberg Chemical
Safety for the 21st Century Act,
as Passed by the Senate on Dec. 17, 2015
(“Senate amendment”)
VII. Judicial review and enforcement
Judicial review of EPA
actions
CRS-39
TSCA Section 19(a) [15 U.S.C. 2618(a)] allows
any person to file a petition for judicial review of
a rule to require testing under Section 4, a SNUR
under Section 5, risk protection requirements
under Section 6(a) or 6(e), or a reporting or
recordkeeping rule under Section 8 (or rules
under other titles of TSCA). Petitions must be
filed in a federal court of appeals within 60 days
after the rule’s promulgation. Section 19(a) also
provides for judicial review of quality control
orders under Section 6(b)(1) in federal courts of
appeals. Section 19(a) incorporates 28 U.S.C.
2112 procedural requirements relating to filing
the rulemaking record and defines “rulemaking
record.” TSCA Section 19(b) governs applications
for additional submissions and presentations.
Under TSCA Section 19(c), the standard of
review for rules other than SNURs is that “the
court shall hold unlawful and set aside such rule if
the court finds that the rule is not supported by
substantial evidence in the rulemaking record (as
defined …) taken as a whole,” rather than the
usual “arbitrary or capricious” standard under the
Administrative Procedure Act (APA; 5 U.S.C.
706(2)(E)). Section 19(c) also offers grounds for
striking down a Section 6 rule based on certain
deficiencies in informal hearings. The APA
otherwise applies.
TSCA Section 4(f) also provides that a finding by
EPA that a risk is not unreasonable, after the
receipt of certain “significant risk of serious or
widespread harm” information under that
subsection, is “an agency action for purposes of
judicial review.”
Section 9(j) of the House bill would expand
TSCA Section 19(a) to authorize challenges to
testing orders (in addition to rules) under
amended TSCA Section 4 and amend TSCA
Section 19(b)-(c) to reflect the addition of such
orders to TSCA Section 19(a). The House bill
would not amend the standard of review, except
to make a conforming amendment to extend the
application of the “substantial evidence” standard
to challenges to testing orders as well as to
testing rules.
Additionally, Section 9(j) of the House bill would
make conforming amendments to TSCA Section
19 to reflect proposed changes elsewhere in the
bill.
Section 18 of the Senate amendment would
amend TSCA Section 19(a) to authorize
challenges to safety determination orders under
amended TSCA Section 6(c)(1)(A) finding a
chemical substance to meet the safety standard. It
would not authorize challenges to testing orders.
However, Section 18 of the Senate amendment
would also state that except as otherwise
provided, federal courts of appeals shall have
exclusive jurisdiction of any action to obtain
judicial review of any order (other than in
enforcement proceedings) issued under Title I of
TSCA if any federal district court would have had
jurisdiction. This could potentially include testing
orders. Section 18 of the Senate amendment
would change TSCA Section 19(a)’s references to
rules under specific provisions of Sections 4, 5, 6,
or 8 to “a rule under this title.”
Section 18 of the Senate amendment would add a
paragraph to TSCA Section 19(a) dealing
specifically with civil actions to challenge lowpriority decisions. The implications of the use of
the term “civil action” rather than “petition” are
not entirely clear.
Section 18 of the Senate amendment would
remove the definition of “rulemaking record” and
slightly reword the standard of review under
TSCA Section 19(c) to read that “… if the court
finds that the rule is not supported by substantial
evidence (including any matter) in the rulemaking
record, taken as a whole.” Section 18 of the
Senate amendment would make certain
conforming and streamlining revisions but would
not update TSCA Section 19(b)-(c) to reference
orders in addition to rules, except that the safety
standard would apply to positive safety
determination orders under amended TSCA
Section 6(c)(1)(A).
Purpose
Penalties
CRS-40
Existing Law: the Toxic Substances Control
Act (TSCA) and Other Provisions
Under TSCA Section 16(a) [15 U.S.C. 2615(a)],
any person who violates Section 15 or 409 (in
TSCA Title IV) shall be liable for a civil penalty up
to $25,000 per violation. Each day a violation
continues is a separate violation. Section 16(a)
provides procedures for notice, hearing, judicial
review, and recovery for non-payment. (The
Federal Civil Penalties Inflation Adjustment Act of
1990 (28 U.S.C. 2461 note and 31 U.S.C. 3701
note) requires agencies to issue regulations
adjusting for inflation the statutory civil monetary
penalty limits under the laws they administer. The
adjusted limit for civil penalties under TSCA is
$37,500 per violation (40 C.F.R. 19.4).
TSCA Section 16(b) sets forth criminal penalties
for knowing or willful violations, providing that in
addition to or in lieu of any civil penalty, such a
violator shall be subject, upon conviction, to a
fine of up to $25,000 for each day of violation
and/or imprisonment for up to one year.
However, under the Sentencing Reform Act of
1984, as amended by the Criminal Fines
Improvement Act of 1987 (18 U.S.C. 3571), all
criminal fines are subject to certain uniform
levels, modifying all fines imposed in the U.S. Code,
including those imposed by TSCA. As a result of
those two laws, the current maximum fine for an
individual who has committed a TSCA
misdemeanor that does not result in death is
$100,000, and an individual who has committed a
TSCA misdemeanor that does result in death or a
TSCA felony could be subject to a fine of up to
$250,000. Likewise, under current law, an
organization could be forced to pay a maximum
fine of $200,000 if guilty of a TSCA misdemeanor
and a maximum fine of $500,000 for a TSCA
misdemeanor resulting in death or a TSCA
felony.
H.R. 2576, the TSCA Modernization Act of
2015, as Passed by the House
on Jun. 23, 2015 (“House bill”)
TSCA Section 16 would not be amended.
Senate Substitute Amendment to H.R.
2576, the Frank R. Lautenberg Chemical
Safety for the 21st Century Act,
as Passed by the Senate on Dec. 17, 2015
(“Senate amendment”)
Section 16 of the Senate amendment would
increase the civil penalty cap under TSCA Section
16(a) from $25,000 to $37,500, reflecting the
current adjusted civil monetary penalty cap, and
change “violation of section 15 or 409’’ to
‘‘violation of this Act.”
Section 16 of the Senate amendment would also
double the criminal penalty cap under TSCA
Section 16(b) from $25,000 per day to $50,000
per day. Section 16 of the Senate amendment
would add a new paragraph to TSCA Section
16(b) regarding knowing or willful criminal
violations placing an individual in imminent danger
of death or serious bodily injury. In such cases, an
individual violator would be subject on conviction
to a fine of not more than $250,000 total and/or
imprisonment for not more than 15 years, and an
organization would be subject on conviction to a
fine of up to $1 million per violation.a For
prosecution of these violations, Section 16 of the
Senate amendment would incorporate various
procedural and definitional provisions in Clean
Air Act Section 113(c)(5) [42 U.S.C.
7413(c)(5)]—for example, regarding affirmative
defenses and what constitutes knowledge and
“serious” injury.b
Purpose
Existing Law: the Toxic Substances Control
Act (TSCA) and Other Provisions
H.R. 2576, the TSCA Modernization Act of
2015, as Passed by the House
on Jun. 23, 2015 (“House bill”)
Senate Substitute Amendment to H.R.
2576, the Frank R. Lautenberg Chemical
Safety for the 21st Century Act,
as Passed by the Senate on Dec. 17, 2015
(“Senate amendment”)
Citizen civil actions
TSCA Section 20 [15 U.S.C. 2619] allows any
person to commence a civil action in certain
federal district courts (1) to restrain alleged
TSCA violations, or (2) to compel EPA to
perform a nondiscretionary duty under TSCA.
Section 20 also sets forth certain other provisions
governing such civil actions, including certain
requirements to give notice to EPA and, if
applicable, to the alleged violator prior to
commencing action.
Section 9(k) of the House bill would make
conforming amendments to TSCA Section 20 to
reflect proposed changes elsewhere in the bill.
Section 19 of the Senate amendment would make
certain conforming amendments to TSCA Section
20.
Citizen petitions
TSCA Section 21 [15 U.S.C. 2620] allows any
person to petition EPA to initiate a proceeding
for issuance, amendment, or repeal of certain
rules or orders and sets forth certain procedures.
Section 9(l) of the House bill would make
conforming amendments to TSCA Section 21 to
reflect proposed changes elsewhere in the bill.
Section 20 of the Senate amendment would make
certain conforming amendments to TSCA Section
21.
CRS-41
Purpose
Existing Law: the Toxic Substances Control
Act (TSCA) and Other Provisions
H.R. 2576, the TSCA Modernization Act of
2015, as Passed by the House
on Jun. 23, 2015 (“House bill”)
Senate Substitute Amendment to H.R.
2576, the Frank R. Lautenberg Chemical
Safety for the 21st Century Act,
as Passed by the Senate on Dec. 17, 2015
(“Senate amendment”)
VIII. Relationship to state law
Preemption general
framework
CRS-42
Under the Supremacy Clause of the U.S.
Constitution,a state or local (hereinafter “state”
will be used to refer collectively to both state and
local) law and policy must yield to the exercise of
Congress’s powers if Congress so intends.b
Under TSCA Section 18(a)(1) [15 U.S.C.
2617(a)(1)], there is no preemption of state
regulation of chemical substances, mixtures, or
articles containing chemical substances or
mixtures unless EPA takes certain preemptive
actions described in Section 18(a)(2). Where EPA
has taken such actions, any preemption is
chemical-specific. Exceptions to preemption may
apply, or EPA may grant waivers by rule.
Section 18(a)(2) provides for preemption of state
requirements as follows:
(A) An EPA test rule under Section 4 will
preempt a state testing requirement for the same
chemical substance or mixture for similar
purposes.
(B) An EPA rule or order under Section 5 or 6
(other than a regulation of disposal of a chemical
substance or mixture) that is designed to protect
against a risk of injury to health or the
environment associated with a chemical
substance or mixture will preempt a non-identical
state requirement that is applicable to that
chemical substance or mixture and is designed to
protect against the same risk.
There has been little preemption of state law
under TSCA, in part because EPA has issued few
Section 6 rules.c
The House bill would retain TSCA’s general
framework whereby enumerated EPA actions
preempt state chemical requirements for
particular chemical substances or mixtures unless
an exception or waiver applies.
Section 7 of the House bill would modify and add
to the circumstances in which state requirements
are preempted (unless an exception or waiver
applies):
(A) An EPA order or consent agreement, as well
as rule, under TSCA Section 4 would preempt a
state testing requirement for the same chemical
substance or mixture for similar purposes.
(B) An EPA final determination under amended
TSCA Section 6(b) that a chemical substance will
not present an unreasonable risk under the
“intended condition of use” would preempt a
state requirement designed to protect against
exposure to the chemical substance under those
intended conditions of use.
(C) An EPA rule or order under TSCA Section 5
or 6, designed to protect against a risk of injury
to health or the environment associated with a
chemical substance or mixture, would preempt,
from its effective date, a state requirement that
applies to that substance or mixture (or to an
article because the article contains the substance)
and is (i) designed to protect against exposure to
the substance under either the intended
conditions of use considered by EPA in its risk
evaluation or uses identified in a PMN or SNUN,
or (ii) for an EPA requirement under new TSCA
Section 6(i) (i.e., expedited action for chemical
substances that are persistent, bioaccumulative,
and toxic, designed to protect against a risk
considered by EPA in imposing such requirement.
The Senate amendment would retain TSCA’s
general framework whereby enumerated EPA
actions preempt state chemical requirements for
particular chemicals unless an exception or
waiver applies, but it would generally restructure
TSCA Section 18.d
Section 17 of the Senate amendment would
modify and add to the circumstances in which
state requirements would be preempted (from
the effective date of the EPA action in each case):
(A) An EPA order or consent agreement, as well
as rule, under TSCA Section 4 would preempt a
state information development requirement for
the same chemical substance reasonably likely to
produce the same information.
(B)(i) An EPA safety determination finding a
chemical substance to meet the safety standard,
or (ii) an EPA rule issued under amended TSCA
Section 6(d) on the basis of an EPA safety
determination, finding the chemical not to meet
the safety standard, would preempt a state
chemical restriction to the extent of the scope of
the safety assessment and determination.
(C) A SNUR for a chemical would preempt a
state requirement for the notification of the uses
in the SNUR.
Section 17 would also set forth temporary
preemption of new state requirements. While a
high-priority (not manufacturer-requested
“additional priority”) substance is under
evaluation—from scoping until either publication
of the determination or the deadline for such
publication, whichever is earlier—states would be
preempted from establishing a new prohibition or
restriction on the manufacture, processing,
distribution in commerce, or use of that
substance.
Purpose
Exceptions to
preemption based on
nature of state
requirement
CRS-43
Existing Law: the Toxic Substances Control
Act (TSCA) and Other Provisions
TSCA Section 18 [15 U.S.C. 2617] does not
provide exceptions to preemption by EPA test
rules, but there are several exceptions to
preemption by EPA rules or orders under
Sections 5 or 6:
(i) state requirements identical to those
prescribed by EPA;
(ii) state requirements adopted under the
authority of the Clean Air Act or any other
federal law; or
(iii) prohibitions on the use of a chemical
substance or mixture in the state (other than its
use in the manufacture or processing of other
substances or mixtures).
A parenthetical provides that Section 6 rules
imposing disposal requirements will not preempt
state disposal-related requirements.
H.R. 2576, the TSCA Modernization Act of
2015, as Passed by the House
on Jun. 23, 2015 (“House bill”)
Section 7 of the House bill would generally
expand the exceptions to preemption but would
not add exceptions to preemption by EPA test
rules. For chemical substances or mixtures found
to not present an unreasonable risk or for which
EPA has issued a risk protection rule or order
under amended TSCA Section 5 or 6, exceptions
would include state requirements:
(i) adopted under the authority of a federal law;
(ii) adopted to protect air or water quality or
related to waste treatment or disposal, except if
an EPA action under TSCA “actually conflicts”
with the state requirement; and
(iii) identical to those prescribed by EPA, for EPA
rules under TSCA Section 5 or 6. A state could
not assess a penalty for a violation for which EPA
had assessed a penalty under TSCA. If a state
assessed a penalty, EPA could not assess a penalty
for that violation in an amount that would cause
the total penalties assessed to exceed TSCA’s
penalty caps.
Senate Substitute Amendment to H.R.
2576, the Frank R. Lautenberg Chemical
Safety for the 21st Century Act,
as Passed by the Senate on Dec. 17, 2015
(“Senate amendment”)
Section 17 of the Senate amendment would set
forth exceptions to preemption in new
subsections (d) and (e) of TSCA Section 18. For
all bases of preemption, exceptions would include
state requirements, standards, determinations,
etc.:
(i) adopted or authorized under the authority of,
or adopted to satisfy or obtain authorization or
approval under, any other federal law;
(ii) implementing a reporting, monitoring,
disclosure, or other information obligation not
otherwise required by EPA or under any other
federal law;
(iii) adopted under a state or local law related to
water quality, air quality, or waste treatment or
disposal, except to the extent that the state or
local action or requirement imposes a restriction
and either (a) addresses the same hazards and
exposures, under the same conditions of use, as
EPA included in the chemical’s safety
determination, but is inconsistent with the EPA
action, or (b) would cause a violation of (i.e.,
narrower than “conflicts with”) the applicable
EPA action; or
(iv) identical to a requirement prescribed by EPA.
The state could not have more stringent penalties
or sanctions than EPA for the requirement and
could not assess a penalty for a violation for
which EPA had assessed an “adequate” penalty
under TSCA. If a state assessed a penalty, EPA
could not assess a penalty for that violation in an
amount that would cause the total penalties to
exceed TSCA’s penalty caps.
Purpose
Exceptions to
preemption to preserve
certain existing state
requirements
CRS-44
Existing Law: the Toxic Substances Control
Act (TSCA) and Other Provisions
Not applicable.
H.R. 2576, the TSCA Modernization Act of
2015, as Passed by the House
on Jun. 23, 2015 (“House bill”)
Section 7 of the House bill would add new TSCA
Section 18(c)(1) allowing a state to continue to
enforce (A) any action taken, or requirement that
has taken effect, before August 1, 2015, under the
authority of a state (not local) chemical
restriction law; and (B) any action taken, or
requirement that has taken effect, pursuant to a
state law that was in effect on August 31, 2003.
Exception (B) in this subsection appears not to
include, for example, future actions or
requirements under California’s Proposition 65
or existing state green chemistry laws. Neither
(A) nor (B) would apply if an EPA action or
determination under TSCA “actually conflicts
with the [state] action.…”
Senate Substitute Amendment to H.R.
2576, the Frank R. Lautenberg Chemical
Safety for the 21st Century Act,
as Passed by the Senate on Dec. 17, 2015
(“Senate amendment”)
Section 17 of the Senate amendment would
amend TSCA Section 18(e) to allow a state (A)
to continue to enforce any action taken before
August 1, 2015, under the authority of a state or
local chemical restriction law; and (B) to proceed
without preemption with any action taken,
without time limitation, pursuant to a state law
that was in effect on August 31, 2003. Exception
(B) appears to preserve, for example, future
actions or requirements under California’s
Proposition 65 but not later state green
chemistry laws. Nothing in amended TSCA
Section 18 could be construed as modifying the
preemptive effect of any EPA rules or orders
existing before enactment of the Senate
amendment. For the few chemical substances for
which Section 6 rules have been issued, current
TSCA Section 18 would govern unless and until
the chemical substance is designated as highpriority or an additional priority.
Purpose
Waivers or exemptions
from preemption
CRS-45
Existing Law: the Toxic Substances Control
Act (TSCA) and Other Provisions
Under TSCA Section 18(b) [15 U.S.C. 2617(b)],
EPA has discretion to grant, by rule, an
application of a state to exempt a state
requirement from preemption by an EPA rule or
order under TSCA Sections 5 or 6 if certain
conditions are met:
(1) compliance with the state requirement would
not cause a violation of the otherwise preempting
EPA requirement;
(2) the state requirement provides a significantly
higher degree of protection from the risk than
the EPA requirement; and
(3) the state requirement does not unduly burden
interstate commerce through difficulties in
marketing, distribution, or other factors.
EPA could impose conditions in the rule. There
are no specific provisions for judicial review, so
presumably the APA would apply. (It appears that
no TSCA preemption waivers have been issued.)
H.R. 2576, the TSCA Modernization Act of
2015, as Passed by the House
on Jun. 23, 2015 (“House bill”)
TSCA Section 18(b) would not be amended.
Senate Substitute Amendment to H.R.
2576, the Frank R. Lautenberg Chemical
Safety for the 21st Century Act,
as Passed by the Senate on Dec. 17, 2015
(“Senate amendment”)
Section 17 of the Senate amendment sets forth
two types of waivers from preemption in new
TSCA Section 18(f). First, the EPA Administrator
(non-delegable) would have discretion to grant,
by rule, an application of a state to exempt a state
statute or administrative action from preemption
if he or she determines that (A) compelling
conditions warrant the waiver to protect health
or the environment; (B) compliance with the
state requirement would not unduly burden
interstate commerce or cause a violation of any
federal requirement; and (C) the state
requirement is designed to address a chemical
risk, under the conditions of use that (in the
Administrator’s judgment) the state identified
consistent with various scientific and evidentiary
standards. EPA could impose conditions on the
waivers. Second, the Administrator would be
required to grant an application of a state to
exempt, from the temporary preemption
applicable during EPA’s evaluation, a new state
statute or action relating to the effects of
exposure to a chemical under the conditions of
use if he or she determines the state “has a
concern about the chemical … based in peerreviewed science” and meets conditions similar
to (B) above.
New TSCA Section 18(f) would require the
Administrator to make a determination on a
discretionary waiver within 180 days and on a
required waiver within 110 days. For the latter, if
the Administrator missed the deadline, the
application would be automatically approved.
Notice and public comment would be required
for all waiver applications, except those for
required waivers that had been automatically
approved. Decision on waiver applications would
be considered final agency action, subject to
judicial review. Amended TSCA Section 19 would
add expediting provisions for actions brought to
compel a decision by EPA on required waivers.
Purpose
Existing Law: the Toxic Substances Control
Act (TSCA) and Other Provisions
H.R. 2576, the TSCA Modernization Act of
2015, as Passed by the House
on Jun. 23, 2015 (“House bill”)
Senate Substitute Amendment to H.R.
2576, the Frank R. Lautenberg Chemical
Safety for the 21st Century Act,
as Passed by the Senate on Dec. 17, 2015
(“Senate amendment”)
Preemption savings
clauses: limitations on
effects of TSCA on
common law and other
actions
No comparable provision in TSCA.
TSCA does not restrict evidentiary uses of EPA
actions under TSCA, although the relevance or
evidentiary weight—if any—of EPA actions in a
particular case would depend on applicable law
and on the facts of that case.
TSCA Section 18 also does not expressly
preempt or affect lawsuits regarding chemical
exposures under common law. Nonetheless,
courts could interpret preempted “requirements”
to include state common law.e
Section 7 of the House bill would add new
paragraphs in TSCA Section 18(c) to provide that
nothing in TSCA Title I as amended, nor any risk
evaluation or requirement under that title, shall
be construed to “preempt or otherwise affect”
federal or state tort law or law governing the
interpretation of contracts of any state. This
would include any statutory or common law
remedy for civil relief, including for civil damages,
as well as any cause of action for injury based on
any legal theory relating to tort law.f
New TSCA Section 18(c) would also state the
intent of Congress that nothing in amended
TSCA, and no requirement under that title (this
provision does not expressly address risk
evaluations), be interpreted as influencing the
disposition of any civil action for damages in a
state court or the authority of any court to make
a determination in an adjudicatory proceeding
under applicable state law on the admissibility of
evidence unless a provision of this title actually
conflicts with the state court action. For
purposes of TSCA Title I, the term
“requirements” would not include civil tort
actions for damages under state law.
Section 17 of the Senate amendment would add
new TSCA Section 18(g)(1) to provide that
nothing in TSCA as amended—and no scientific
assessment, safety determination, or requirement
under it—shall be construed to “preempt,
displace, or supplant” federal or state common
law rights or statutes creating a remedy for civil
relief, including for civil damages, or a penalty for
criminal conduct. Nothing in amended TSCA
would preempt or preclude any cause of action
for injury based on any legal theory of liability
under any state law, maritime law, or federal
common law or statutory theory.g
TSCA Section 18(g)(2) would also provide that
nothing in amended TSCA—no safety
determination, scientific assessment, or
requirement pursuant to amended TSCA—shall
be interpreted as dispositive in any civil action.
Amended TSCA would also not affect the
authority of any court to make a determination in
an adjudicatory proceeding under applicable state
or federal law with respect to the admission into
evidence, or any other use, of amended TSCA
and any safety determination, scientific
assessment, or requirement thereunder.
Preemptive effect of
pre-enactment EPA
actions
Not applicable.
Section 7(c) of the House bill would state that
nothing in the House bill shall be construed as
changing the preemptive effect of a rule
promulgated or order issued by EPA under TSCA
either prior to enactment of the House bill or at
any time under TSCA Section 6(e) [15 U.S.C.
2605(e)] (regarding polychlorinated biphenyls
(PCBs)).
Section 17 of the Senate amendment would state
that nothing in amended TSCA Section 18 shall
be construed as changing the preemptive effect of
any rule promulgated or order issued under
TSCA prior to the enactment of the Senate
amendment. For chemicals for which any rule or
order was promulgated under TSCA Section 6
prior to enactment of the Senate amendment
(including Section 6(e) regarding PCBs), the preamendment version of TSCA Section 18 would
govern the preemptive effect of any additional
rule or order after that date as well, unless the
latter rule or order follows a designation of that
chemical as a high-priority substance or as an
additional priority.
CRS-46
Purpose
Grants to states
addressing unreasonable
risks not being
addressed by EPA
Existing Law: the Toxic Substances Control
Act (TSCA) and Other Provisions
TSCA Section 28 [15 U.S.C. 2627] authorizes
EPA to award grants to states that have programs
approved by the agency to address unreasonable
risks associated with a chemical substance or
mixture that the agency is unable or is not likely
to address. Grant awards are limited to 75% of
the establishment and operation costs of a state
program. Section 28 provides criteria for EPA
approval of a state program and authorizes states
to use such grants only for the establishment and
operation of such program. Section 28
established an annual reporting requirement on
EPA to report to Congress grant awards to
states for fiscal years that have since passed.
Section 28 also authorized appropriations of $1.5
million for the purpose of awarding grants most
recently for FY1982 and FY1983. Although
authorization of such appropriations has expired,
Congress has continued to provide TSCA grant
funding to states through annual discretionary
appropriations.h
H.R. 2576, the TSCA Modernization Act of
2015, as Passed by the House
on Jun. 23, 2015 (“House bill”)
Senate Substitute Amendment to H.R.
2576, the Frank R. Lautenberg Chemical
Safety for the 21st Century Act,
as Passed by the Senate on Dec. 17, 2015
(“Senate amendment”)
TSCA Section 28 would not be amended.
Section 25 of the Senate amendment would
repeal the annual reporting requirement and the
authorization of appropriations for awarding
grants for fiscal years that have since expired.
EPA authority to award grants to states under
TSCA Section 28 would be retained.
TSCA Section 29 would not be amended.
Section 26 of the Senate amendment would
repeal TSCA Section 29.
IX. Resources to implement TSCA
Authorization of
appropriations
CRS-47
TSCA Section 29 [15 U.S.C. 2628] authorized
appropriations ($58.65 million for FY1982 and
$62.00 million for FY1983) for the
implementation of TSCA not including
development and evaluation of test methods
under TSCA Section 27, grants to state programs
under TSCA Section 28, and certain research,
development, and monitoring authorities under
TSCA Section 10. Although authorization of
appropriations has expired, Congress has
continued to fund EPA’s implementation of TSCA
through annual discretionary appropriations.a
Purpose
Fees
Existing Law: the Toxic Substances Control
Act (TSCA) and Other Provisions
TSCA Section 26(b) [15 U.S.C. 2625(b)]
authorizes EPA to assess fees for the following
actions. EPA may assess fees for the costs of
evaluating (1) each PMN under TSCA Section 5,
(2) each SNUN under TSCA Section 5, and (3)
testing data that a manufacturer or processor of a
chemical substance or mixture may be required
to submit to the agency under TSCA Section 4.
Fees are limited to a maximum of $2,500, and an
exception is provided for a “small business
concern” up to a maximum of $100. EPA, after
consultation with the Small Business
Administration, is directed by rule to prescribe
standards for determining a small business
concern for purposes of collecting fees under
TSCA. The standard is codified in 40 C.F.R.
700.43. The availability of fees collected under
TSCA for obligation by EPA are subject to annual
discretionary appropriations. Fees without a
dedicated account, such as these TSCA fees, are
generally treated as miscellaneous receipts and
deposited into the General Fund of the U.S.
Treasury as required by the Miscellaneous
Receipts Act (31 U.S.C. 3302(b)).b
CRS-48
H.R. 2576, the TSCA Modernization Act of
2015, as Passed by the House
on Jun. 23, 2015 (“House bill”)
Section 8(1) of the House bill would amend
TSCA Section 26(b) to strike the existing
statutory caps on fees that EPA may assess. The
agency would be limited to assessing fees that are
“sufficient and not more than reasonably
necessary.” In addition to the same notices and
testing data for which EPA may assess fees under
TSCA Section 4 and 5, the agency would be
authorized to assess fees from manufacturers
who request the agency to conduct a risk
evaluation of a chemical substance. Section 8(2)
of the House
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