The Toxic Substances Control Act (TSCA): Implementation and New Challenges
The Toxic Substances Control Act (TSCA):
Implementation and New Challenges
Updated September 18, 2008
Specialist in Environmental Policy
Resources, Science, and Industry Division
The Toxic Substances Control Act (TSCA):
Implementation and New Challenges
Title I of the Toxic Substances Control Act (TSCA)of 1976 has never been
amended, but recent legal, scientific, and technological changes are prompting some
policy makers to reexamine the law. H.R. 6100/S. 3040 would amend TSCA to
reshape risk assessment and management of industrial chemicals in U.S. commerce.
TSCA regulates potential risks based on three policies: (1) Chemical manufacturers
are responsible for testing chemicals to determine their potential effects on health and
the environment; (2) EPA should regulate chemicals that present an unreasonable
risk to health or the environment; and (3) EPA’s implementation of the law should
not create unnecessary economic barriers to technological innovation. Few have
expressed concern about the last TSCA purpose, but TSCA’s progress in achieving
the first two goals has been debated: where some see success, others see failure, and
both groups point to EPA’s history of implementation and voluntary initiatives in
support of their views. To date, EPA has compiled an inventory of roughly 82,000
chemicals that have been produced in, or imported into, the United States at some
time since 1976. The agency has promulgated regulations to restrict production or
use of five chemicals under TSCA.
Recently, many states and localities have acted to regulate chemicals not
regulated under TSCA using state or local authority. Some large chemical
manufacturers, processors, and distributors object to the emerging legal patchwork.
The U.S. Congress is considering legislation restricting use of specific chemicals. For
example, S. 742, as reported by the Senate Committee on Environment and Public
Works in the 110th Congress, and H.R. 6903, as introduced, would ban many
asbestos-containing materials from U.S. commerce. Multinational companies also
are faced with a variety of national laws restricting international commerce in
chemicals. International cooperation to harmonize regulations, and to eliminate
certain persistent pollutants, has led to several international agreements that aim to
ease the legal confusion, but amendments to TSCA would be required if the United
States is to fully implement the agreements. New laws in other nations also have
provided alternative models for chemical regulation, which some would prefer to
TSCA. Others defend the U.S. approach, arguing that TSCA is based on sound, risk-
based science. Recent changes in science and technology pose challenges to EPA
implementation of TSCA. Scientists now know that the timing and duration of
exposure to a chemical can determine its effects, as can the age, gender, and heritable
traits of people who are exposed. Biotechnology and nanotechnology have created
genetically modified organisms and nanomaterials, respectively, which EPA must
categorize as “existing” or “new” and manage as “chemical substances” under TSCA.
Faced with these challenges to TSCA, some analysts, and most in the regulated
community, nevertheless believe that TSCA has performed as intended, and they
support TSCA in its current form. They praise TSCA as a flexible, efficient, and
effective limit to over-regulation. Other legal commentators, analysts, and some
policy makers want to amend TSCA because they think that it has not accomplished
the tasks laid out for it by Congress, and is unlikely to do better in the future.
In troduction ......................................................1
Policies and Intent.............................................2
Pre-Manufacture Notices and Significant New Use Notices.............4
Regulatory Controls for Hazardous Chemicals.......................5
Chemical Production Inventory...................................6
Role of the States..............................................6
Review and Management of New Chemicals........................9
Review and Management of Chemicals on the Original Inventory.......11
Data Collection and Risk Assessment Authorized by TSCA.......11
Voluntary Initiatives to Gather Data..........................15
Impact of a 1991 Decision by the Fifth Circuit Court
on Section 6 Rulemaking...............................19
Recent Events and Trends..........................................20
State Laws and Local Ordinances................................20
International Agreements on Chemicals...........................22
New Chemical Laws in Other Nations ............................23
Scientific Developments and Issues...............................25
Technological Developments and Issues...........................28
Genetically Modified Organisms.............................28
Legislative and Administrative Initiatives..........................33
Appendix. A Key Court Case.......................................37
List of Tables
Table 1. Numbers of Chemicals in U.S. Commerce.......................8
The Toxic Substances Control Act (TSCA):
Implementation and New Challenges
Recent legal, scientific, and technological developments affecting chemicals in
U.S. commerce are prompting legislators to reexamine the Toxic Substances Control1
Act of 1976 (TSCA). This is a change from the situation that prevailed in most of
the previous thirty years since it was enacted; during that time, most legislators have
demonstrated little interest in amending the law, despite the long-standing concerns
of a few Members. The basic TSCA provisions in Title I have never been amended.2th
Companion bills in the 110 Congress, H.R. 6100 and S. 3040, would amend TSCA
to significantly reshape U.S. chemical assessment and management.
This report provides an overview of basic TSCA provisions, briefly examines
the history of TSCA implementation by the U.S. Environmental Protection Agency
(EPA), and describes the legal, scientific, and technological developments that are
being used to provide support to calls for TSCA reform. For more detailed
information about the provisions of TSCA Title I, particularly those that address
polychlorinated biphenyls, or for information about Titles II, III, IV, or V, which
concern asbestos, radon, lead, and school environments, respectively, see CRS
Report RL31905, The Toxic Substances Control Act: A Summary of the Act and Its
Major Requirements, by Linda-Jo Schierow.
Federal legislation to regulate U.S. commerce in chemical substances was
originally proposed in 1971 by the President’s Council on Environmental Quality
(CEQ). Its report, “Toxic Substances,” defined a need for comprehensive legislation
to identify and control chemicals whose manufacture, processing, distribution, use,
and/or disposal was potentially dangerous, and not adequately regulated under othernd
environmental statutes. The House and Senate each passed bills in both the 92 and
93rd Congresses (in 1972 and 1973, respectively), but controversies over the scope
of chemical screening prior to commercial production and distribution, level of costs,
and the relationship to other regulatory laws stalled final action. Episodes of
environmental contamination — including contamination of the Hudson River and
1 15 U.S.C. 2601-2692.
2 Four titles have been added to address specific concerns — asbestos in 1986 (Title II, P.L.
in 2007, school environments (Title V, P.L. 110-140).
other waterways by polychlorinated biphenyls (PCBs), the threat of stratospheric
ozone depletion from chlorofluorocarbon (CFC) emissions, and contamination of
agricultural produce by polybrominated biphenyls (PBBs) in the state of Michigan
— together with more exact estimates of the costs of imposing toxic substances
controls, opened the way for final passage of the legislation. President Ford signed
TSCA into law on October 11, 1976.
Title I contains the original, general provisions of TSCA, which are the subject
of this report.
Policies and Intent
TSCA established three general federal policies with respect to chemical
substances and mixtures in U.S. commerce, “ ... that —
![A]dequate data should be developed with respect to the effect of
chemical substances and mixtures on health and the environment and that
the development of such data should be the responsibility of those who
manufacture and those who process such chemical substances and
![A]dequate authority should exist to regulate chemical substances and
mixtures which present an unreasonable risk of injury to health or the
environment, and to take action with respect to chemical substances and
mixtures which are imminent hazards; and
![A]uthority over chemical substances and mixtures should be exercised in
such a manner as not to impede unduly or create unnecessary economic
barriers to technological innovation while fulfilling the primary purpose
of this act to assure that such innovation and commerce in such chemical
substances and mixtures do not present an unreasonable risk of injury to3
health or the environment.”
In addition, Congress expressed its intent in TSCA, Section2(c):
It is the intent of Congress that the Administrator shall carry out this Act in a
reasonable and prudent manner, and that the Administrator shall consider the
environmental, economic, and social impact of any action the Administrator
takes or proposes to take under this Act.
The scope of TSCA is very broad, covering all “chemical substances,” as
defined in Section 3(2).
... the term “chemical substance” means any organic or inorganic substance of
a particular molecular identity, including —
(i) any combination of such substances occurring in whole or in part as a result
of a chemical reaction or occurring in nature, and
(ii) any element or uncombined radical.
The law excludes from this definition substances that are otherwise regulated, such
as mixtures, pesticides, tobacco, nuclear material, substances subject to certain taxes
3 TSCA, Section2(b).
(e.g., alcohol), and food, drugs, cosmetics, and devices regulated under the Federal
Food, Drug, and Cosmetic Act.
To attain these policy goals, TSCA Section 4 directs EPA to require chemical
manufacturers and processors to conduct tests for existing chemicals if: (1) the
manufacture, distribution, processing, use, or disposal of the chemical “may present
an unreasonable risk” of injury to health or the environment; or (2) the chemical is
produced in very large volume and there is a potential for a substantial quantity to be
released into the environment or for substantial or significant human exposure.
Under either condition, EPA must issue a rule requiring tests (known as a test rule)
if: (a) existing data are insufficient, and (b) testing is necessary to develop the data.
Because there were roughly 61,000 chemicals covered by TSCA and in U.S.
commerce at the time EPA was to begin developing test rules, Congress established
a special interagency committee to help EPA determine which chemicals should be
considered first, and to coordinate testing needs and efforts among government
agencies.4 At least every six months the Interagency Testing Committee (ITC) must
consider candidate chemicals for inclusion on a list of substances that the ITC
recommends to EPA for development and promulgation of test rules.5 TSCA directs
the ITC to “designate” a subset of chemicals for EPA action within 12 months. In
response to a new listing on this Priority Testing List of chemicals designated for
testing, EPA is required to publish a Federal Register notice within 12 months either
to propose a test rule, or to provide reasons for not doing so.6 The Priority Testing
List can contain no more than 50 designated chemicals at any time.
EPA also is authorized under TSCA Section 8 to collect existing information
about chemicals to help evaluate the potential risks of exposure. Section 8(a) allows
EPA to issue rules requiring record keeping and reports by manufacturers and
importers for specified chemicals. Required elements of such reports may include
the chemical identity, molecular structure, and names; categories of use; amount
manufactured or processed and expected to be manufactured or processed;
description of any byproducts; existing environmental and health effect data; number
of individuals exposed occupationally and duration of exposure; and the manner of
4 The potential chemical universe (the universe of chemicals that could be synthesized and
those that exist but which have not yet been identified) has been described as “unimaginably
immense” (Christian Daughton, 2005, “‘Emerging’ Chemicals as Pollutants in thest
Environment: a 21 Century Perspective,” Renewable Resources Journal, v. 23, n. 4, p. 9).
The known universe of chemicals is a small fraction of that potential chemical universe: As
of February 16, 2007, the Chemical Abstract Service had indexed more than 30 million
organic and inorganic chemicals, 12 million of which it classifies as “in commerce”
worldwide, although it is not clear how this number is determined, and it is much larger than
would be expected based on the numbers in national inventories. Roughly 245,000
chemicals are regulated or inventoried. [http://www.cas.org/expertise/cascontent/regulated/].
5 TSCA Section 4(e).
6 Interagency Testing Committee homepage. [http://www.epa.gov/opptintr/itc/].
TSCA Section 8(c) requires chemical manufacturers, processors, and
distributors to maintain records of “significant adverse reactions to health or the
environment ... alleged to have been caused by the substance or mixture.” All records
must be maintained for five years, and records of employee allegations must be kept
for 30 years. Under Section 8(d), EPA must require that manufacturers submit lists
of unpublished health and safety studies known to have been conducted, and copies
of such studies. Finally, Section 8(e) requires that any commercial chemical
manufacturer, processor, or distributor who has information that “reasonably supports
the conclusion that such substance or mixture presents a substantial risk of injury to
health or the environment” must immediately inform EPA.
Other data may be collected through federal research programs. TSCA Section
development, and monitoring that is necessary to the purposes of the act. In addition,
TSCA Section 27 authorizes research and development of test methods for chemicals
by the Public Health Service in cooperation with EPA.
Pre-Manufacture Notices and Significant New Use Notices
EPA also is required to prevent future risks through pre-manufacture screening
and regulatory tracking of new chemical products. Section 5 of TSCA requires
manufacturers, importers, and processors to notify EPA at least 90 days prior to
producing or otherwise introducing a new chemical product into the United States.
At the same time, those submitting a Pre-Manufacture Notice (PMN) also must
submit any information or test data that are known to, reasonably ascertainable by,
or in possession of the notifier, and that might be useful to EPA in evaluating the
chemical’s potential adverse effects on human health or the environment.
Exemptions from these requirements are provided or allowed upon application under
For existing chemicals, a similar notification procedure may be required, if the
Administrator has determined by rule that new uses of a particular chemical may
produce significant changes in human and environmental exposures and therefore
require notification. The 90-day notice required by a Significant New Use Rule
(SNUR) provides EPA with the opportunity to evaluate the chemical use and, if
necessary, to prohibit or limit such activity before it occurs, to prevent unreasonable
risk of injury to human health or the environment.
EPA has 90 days after notification (or up to 180 days if it extends the period for
good cause) to evaluate the potential risk posed by the chemical that is the subject of
a PMN or SNUR. If EPA determines that there is a reasonable basis to conclude that
the substance presents or will present an unreasonable risk, the Administrator must
promulgate requirements to protect adequately against such risk.
EPA may determine that the proposed activity related to a chemical may present
an unreasonable risk based on the available scientific evidence with respect to
7 Exemptions are authorized at TSCA §5(h), §5(i), and §12. For EPA interpretations of
these authorities, see 40 CFR §§720.30, 720,36, and 720.38 and 723.
potential for exposure and adverse effects, or, when no data exist to document such
effects, on what is known about the effects of chemicals with similar chemical
structures. The latter method, known as structure-activity relationship analysis, often
is used to screen new chemicals.
If data are inadequate to make an informed judgment about inherent hazard and
potential for exposure, and (1) manufacture, processing, distribution in commerce,
use, or disposal may present an unreasonable risk, or (2) a chemical is to be produced
in substantial quantities, and the potential for environmental release or human
exposure is substantial or significant, EPA may issue a proposed order to prohibit or
limit such activities until sufficient data are submitted.
Although the legislative history of TSCA includes a presumption that testing of
new products would take place before they were widely used, either as the chemical
was developed, or as its markets grew, TSCA forbids promulgation of blanket testing
requirements for all new chemicals. This prohibition arose due to concern that
uniform testing requirements might stifle innovation in the chemical industry. Thus,
EPA must decide which chemicals, or categories of chemicals, warrant the costs of
Regulatory Controls for Hazardous Chemicals
TSCA Section 6 requires EPA to control unreasonable risks from existing
chemicals when they become known. Under TSCA Section 4(f), if EPA receives test
data in response to a test rule or in connection with a PMN or SNUR, or any other
information that indicates “there may be a reasonable basis to conclude that a
chemical substance or mixture presents or will present a significant risk of serious
or widespread harm to human beings from cancer, gene mutations, or birth defects,”
within 180 days of receiving such information EPA is required to initiate action to
prevent or reduce that risk, or to publish a finding that such risk is not unreasonable.
The decision to publish a finding (and not to initiate rulemaking) is subject to judicial
The law directs EPA to regulate manufacturing, processing, distribution in
commerce, use, or disposal under TSCA, if a chemical poses an unreasonable risk of
injury to health or the environment, and the risk cannot be reduced to a sufficient
degree under another federal law administered by EPA. (Alternatively, TSCA
Section 9 allows EPA to refer cases of chemical risk to other federal agencies that
have the authority to prevent or reduce the risk.) TSCA Section 6 provides various
regulatory alternatives. EPA has authority to:
!prohibit or limit the amount of production or distribution of a
substance in commerce;
!prohibit or limit the production or distribution of a substance for a
!limit the volume or concentration of the chemical produced;
!prohibit or regulate the manner or method of commercial use;
!require warning labels and/or instructions on containers or products;
!require notification of the risk of injury to distributors and, to the
extent possible, consumers;
!require record-keeping by producers;
!specify disposal methods; and
!require replacement or repurchase of products already distributed.
EPA also may impose any of these requirements in combination or for a specific
geographical region. However, EPA is required by TSCA to regulate only “to the
extent necessary to protect adequately” against a risk, and to use the “least
burdensome” regulatory approach in controlling unreasonable risks.
Chemical Production Inventory
Section 8(b) of TSCA requires EPA to gather and disseminate information about
chemical production, use, and possible adverse effects to human health and the
environment. It directs EPA to develop and maintain an inventory of all chemicals,
or categories of chemicals, manufactured or processed for commercial purposes in
the United States.
To aid EPA in its duties under TSCA, the agency was granted considerable
authority to collect information from industries. EPA may require maintenance of
records and reporting of: chemical identities, names, and molecular structures;
categories of use; amounts manufactured and processed for each category of use;
descriptions of byproducts resulting from manufacture, processing, use, and disposal;
environmental and health effects; number of individuals exposed; number of
employees exposed and the duration of exposure; and manner or method of chemical
TSCA provides broad protection of proprietary confidential information about
chemicals in commerce. Disclosure by EPA employees of such information
generally is not permitted, except to other federal employees, or when necessary to
protect health or the environment. However, data from health and safety studies of
chemicals is not protected from disclosure, unless it would reveal a chemical process
or chemical proportion in a mixture. Wrongful disclosure of confidential data by
federal employees may result in criminal penalties.
Role of the States
All of the mandates in Title I are federal: there is no provision for authorizing
state programs to implement Title I provisions. Neither does TSCA provide special
access for state officials to confidential business information that is reported to EPA.
TSCA Section 18(a) does not allow a state or local law to remain in effect if it
restricts the use of a chemical for which EPA has promulgated a rule or order under
Section 5 or 6, if the federal rule is intended to protect against a risk of injury to
health or the environment. State or local law is permitted only if it is identical to the
federal requirement, adopted under another federal law, or prohibits the use of such
substance or mixture within the relevant jurisdiction (except use in manufacture or
processing of other substances). TSCA Section 18(b) allows states or localities to
petition EPA to issue a rule exempting a state or local law, if compliance would not
cause a violation of federal law, it provides a significantly higher degree of protection
from such risk than the federal requirements, and does not unduly burden interstate
TSCA Section 19 authorizes any person to file a petition for judicial review of
specified rules within 60 days of issuance under TSCA. The court is directed to set
aside specified rules if they are not supported by “substantial evidence” in the
rulemaking record taken as a whole.
EPA efforts to implement TSCA include (1) developing and collecting data
relevant to risk assessment of chemicals under TSCA Sections 4 and 8, and (2)
regulating chemicals that pose an unreasonable risk under TSCA Sections 5 or 6 in
a manner that does not unduly oppress innovation and commerce. This section
summarizes available information relevant to EPA performance under TSCA so that
readers might have an objective basis for evaluating statements of opinion regarding
its effectiveness. A recently updated report for EPA’s Office of Pollution Prevention
and Toxics (OPPT) describes TSCA implementation in greater detail.8 A slightly
older report by the U.S. Government Accountability Office (GAO) also describes
EPA efforts to regulate chemicals under TSCA.9
TSCA directs EPA to establish requirements that would distinguish between
chemicals already in U.S. commerce and chemicals that would enter commerce after
enactment of TSCA. The first version of the inventory of existing chemicals was
compiled under TSCA Section 8(b) between 1978 and 1979. It identified
approximately 61,000 chemicals10 that manufacturers and importers reported had
been produced in, or imported into, the United States for commercial purposes after
January 1, 1975.11 This included naturally occurring as well as synthetic chemicals.
8 EPA, Office of Pollution Prevention and Toxics. Overview: Office of Pollution Prevention
and Toxics Programs. January 2007. [http://www.epa.gov/oppt/pubs/oppt101c2.pdf].
9 GAO. Chemical Regulation: Options Exist to Improve EPA’s Ability to Assess Health
Risks and Manage Its Chemical Review Program. June 2005. GAO-05-458.
10 U.S. EPA. 2007. Overview: Office of Pollution Prevention and Toxics Programs. p. 5.
[ h t t p : / / www.epa.go v/ oppt / pubs/ oppt 101c2.pdf ] .
11 42 Federal Register 64572.
Table 1. Numbers of Chemicals in U.S. Commerce
Original inventory in 197961,000
Added since 197920,700
Inventory in 200682,700
Reported in 2006 inventory update9,000
Note: Some chemicals on the 2006 Inventory may no longer
be in commerce. Also, chemicals need only be reported for an
inventory update if a facility produced or imported more than
10,000 pounds during the previous year (2005).
EPA has added new chemicals to the TSCA inventory whenever manufacturers
have submitted a Notice of Commencement (NOC) indicating that a chemical not on
the current inventory (for which a PMN was submitted) was about to be
manufactured and enter commerce.12 As of December 2006, roughly 20,700 new
chemical substances had entered U.S. commerce and been added to the inventory.13
A few chemicals have been removed from the inventory, generally because they were
reported in error and were not being produced commercially. (EPA does not list
chemicals if they are only produced in small quantities for purposes of
experimentation or research.) As of September 2006, EPA estimated that there were
82,700 chemical substances on the inventory, meaning that they had, at least for a
while, been in U.S. commerce after 1976.14 Included in this number were 50,200
organic substances that are not polymers, 29,500 polymers, and 3,200 inorganic
chemical substances.15 16
Beginning in 1986 and every four years thereafter, EPA has collected
information about the volume of chemicals produced and the locations of plants
where chemicals are produced or imported in amounts greater than 10,000 pounds
(5 tons) per year. In recent years, roughly 2,500 facilities (1,000 companies)
12 Although a NOC technically means the chemical has entered commerce, in fact it may or
may not ever be marketed, according to EPA (Charles Auer, personal communication,
August 5, 2007).
13 EPA Overview, p. 7.
14 The American Chemistry Council (ACC), a trade group for chemical manufacturers, has
a fact sheet, “TSCA Myth vs. Fact,” on their website that takes issue with statements
claiming that there are some 80,000 chemicals in commerce. The ACC argues that many
chemicals on the original inventory are no longer “in commerce.” [http://www.
americanchemistry.com/s_acc/bin.a sp?SID=1&DID=3384&CID=433&V ID=115&DOC=
15 EPA Overview, p. 6.
16 A polymer is a compound, usually large, composed of numerous copies of a much simpler
compound (known as the monomer) which form long chains. Many polymers are not toxic,
and therefore are of limited concern to EPA. Criteria for determining whether a polymer
is eligible for exemption from PMN requirements may be found at 40 CFR 723.250.
submitted inventory update reports for about 9,000 chemicals.17 18 The most recent
inventory update was conducted in 2006. The next update will be done in 2011,
because EPA amended the general rule governing inventory updates (issued under
TSCA Section 8(a), changing the frequency of future updates to once every five
years.19 EPA also amended the inventory update rule to require reporting for
inorganic chemicals (for which reporting has not been required in recent years), and
to raise the threshold for chemical production volume that triggers reporting.20 The
new rule requires reports from roughly 3,000 facilities that produce more than 25,000
pounds, as opposed to the old level of 10,000 pounds, of chemical per year.21 In
addition, information about the current uses and exposures of chemicals will be
required from facilities that produced or imported more than 300,000 pounds of a
chemical per year.22
Review and Management of New Chemicals
All chemicals not on the TSCA chemical inventory are, by definition, “new” and
subject to the Pre-Manufacture Notice (PMN) provisions of Section 5. However,
EPA rules under Section 5(h)(4) establish exemptions from providing a PMN for a
new chemical produced or imported at 10,000 kilograms (roughly 22,000 pounds) or
less annually; if the chemical releases to the environment and human exposure are
very low; or for certain polymers meeting specific requirements.23 EPA has received
approximately 40,000 PMNs since 1976, between 1,000 and 2,000 annually.24 EPA
protects from public disclosure the identities of as many as 90% of these new
chemicals due to formal assertions by manufacturers that the information is
confidential business information.25
17 ACC. Questions and Answers About Chemical Testing and Regulations. July 11, 2005.
18 68 Federal Register 884, January 7, 2003.
19 70 Federal Register 75059-75070, December 19, 2005.
20 68 Federal Register 847-906, January 7, 2003.
21 EPA, Office of Pollution Prevention and Toxics. “Economic analysis for the amended
inventory update final rule,” August 2002, pp. 3-11. This document is available through the
EPA docket (OPPT-2002-0054) for the rule, at [http://www.regulations.gov].
23 40 CFR 723.50.
24 EPA Overview, p. 10. The EPA report states that the total number of PMNs is 36,600,
but that is the same as the number that appeared in the 2003 version of the report. Adding
1,500 notices per year results in the 40,000 estimate, which also corresponds to the other
EPA statement that roughly half of PMN chemicals enter commerce, or some 20,000
25 Ibid., p. 10. That percentage drops to 65% for new chemicals that actually enter
Roughly 33% of PMN submissions include test data on the chemical properties.
Only about 15% of submissions include data on health effects.26 Due to the paucity
of data for most new chemicals, EPA has developed databases and models to
estimate physical-chemical properties, environmental fate, and human and
environmental effects associated with more than 55 classes of chemicals.27 These
models are based on relationships the agency has observed between molecular
structures and properties of chemicals that determine their impact on the environment
and human health. Such models usually are referred to as structure-activity
relationships (SARs), or sometimes quantitative structure-activity relationships
As of September 30, 2005, EPA reported it had taken 3,899 regulatory or
voluntary actions to gather data or restrict use of roughly 10% of all PMNs.28 EPA
issued 1,320 Consent Orders under Section 5(e), subjected 575 new chemicals to
SNUR requirements without an accompanying 5(e) order,29 took four actions to
protect against unreasonable risks under Section 5(f), and received information
gathered through voluntary testing for at least 300 chemicals. In addition, 1,705
PMNs were “withdrawn often in face of action.”
EPA also has acted proactively to encourage the development of chemicals that
are likely to be less hazardous. To that end, the agency has shared a set of its models,
known as the P2 Framework, with chemical manufacturers so that they may avoid
designing or developing chemicals that are likely to raise concerns and prompt
requests for additional data.30 For example, one of the models in the set, EPI Suite™
evaluates chemical structures and estimates the melting and boiling points, vapor
pressure, and other physical and chemical characteristics of new chemicals. Another
model, the Cancer Expert System, which is registered under the trademark
OncoLogic™, analyzes chemical structures to determine the likelihood that they
might cause cancer.31 By using EPA’s models, some manufacturers have been able
to design “greener” products that do not require investments in extensive toxicity
26 Ibid., p. 8.
27 EPA. “Economic analysis for the amended inventory update final rule,” August 2002, pp.
28 Ibid., p. 10.
29 Because consent orders only bind the PMN submitter, EPA sometimes issues a Significant
New Use Rule under Section 5(e) to ensure that other producers or processors must adhere
to the same restrictions that were imposed on the PMN submitter. According to EPA
(Overview, p. 11), 734 Consent Orders for PMN chemicals were accompanied by SNURs
through September 30, 2005.
30 EPA. Sustainable futures — Voluntary pilot project under the TSCA new chemicals
program; Notice. December 11, 2002, 67 Federal Register pp. 76285-86286.
31 EPA Overview, Appendix B-50.
Review and Management of Chemicals
on the Original Inventory
Data Collection and Risk Assessment Authorized by TSCA. The
TSCA Interagency Testing Committee (ITC), which was established under TSCA
Section 4(e) to assist EPA in setting priorities among chemicals, has reviewed more
than 40,000 chemicals and submitted 59 reports to EPA. The committee has selected
for reporting or testing about 4,500 chemicals for which it had concerns about
toxicity or exposure and for which there were few or no data on ecological effects,
environmental fate, or health effects.32 These substances were added to a Priority
Chemicals List. In response to ITC recommendations, EPA must promulgate rules
adding these chemicals to a list in the Code of Federal Regulations for which
reporting is required under the TSCA 8(a) PAIR rule and TSCA Section 8(d), the
Health and Safety Data Reporting rule. The ITC has reviewed more than 10,200
studies submitted in response to 8(d) rules.
In addition, the ITC may “designate” up to 50 substances per year for testing
under TSCA §4(e). The ITC reviewed roughly 2,000 to 6,000 chemicals before 1999
for possible addition to the Priority Testing List, and 1,000 to 2,000 were in fact
added to the Priority Testing List.33
EPA has addressed its responsibilities for screening and managing the 61,000
“existing” chemicals (on the original inventory) by categorizing them according to
relative risk, based primarily on the information reported by manufacturers between
1975 and 1979.34 Many chemicals have been assigned a low priority for evaluation
and management, because they are thought to pose no risk or a relatively small risk
of harm, generally because they are produced in quantities less than 10,000 pounds
per year, per site, or because they are polymers. EPA has not required reporting for
such chemicals under the TSCA 8(a) inventory update rule. As a result, it is not
known whether many of them still are produced and distributed within the United
EPA has estimated that roughly 15,000 organic and inorganic chemicals are
produced at significant volumes (more than 10,000 pounds per year) and are not
polymers that are generally of less concern.35 Of these, about 3,000 were produced
32 John D. Walker, Director, TSCA Interagency Testing Committee. Personal
communication. October 6, 1999. Updated information requested from EPA but not
provided. ITC website, Frequently Asked Questions. [http://www.epa.gov/opptintr/
33 Walker, personal communication. Updated information requested from EPA but not
34 U.S. Congress. Senate. Committee on Environment and Public Works, Subcommittee on
Toxic Substances, Research and Development. Hearing held July 13, 1994, “Reauthorization
of the Toxic Substances Control Act.” S. Hrg. 103-776. Statement of Lynn R. Goldman.
U.S. Govt. Print. Off. Washington, DC, p. 136.
35 EPA Overview, p. 15.
in volumes of one million pounds or more annually, across all U.S. companies.36
These are known as High Production Volume (HPV) chemicals. HPV chemicals
generally have received greater EPA scrutiny, because of the presumption that they
have a relatively high potential for human and environmental exposure. Many of
these HPV substances are considered likely to be benign. Others have risks that,
while considerable, are well understood. (Chlorine gas or hydrogen peroxide are
examples.) For most HPV chemicals, however, basic information about chemical
properties is lacking.
When EPA becomes concerned that a chemical may pose an unreasonable risk,
the agency first gathers data that is already available by using record keeping and
reporting rules. For example, under TSCA Section 8(a), in addition to the inventory
update rule, EPA has promulgated Preliminary Assessment Information Reporting
(PAIR) rules.37 They direct manufacturers to report within 90 days on the quantities
of specified chemicals produced and released, and the extent of worker exposure.
Such information is useful for determining whether exposure is sufficient to pose an
unreasonable risk. Through September 2006, EPA had issued 33 PAIR rules,
requiring reporting for about 1,200 chemicals.38
In addition, under the authority of TSCA Section 8(c), EPA has promulgated
rules requiring manufacturers, processors, and distributors of chemicals to keep
records of allegations of significant adverse reactions to chemical exposure.39
Through 2006, EPA had issued two reporting rules to collect such records for two
chemicals and two chemical categories.40
EPA rules under TSCA Section 8(d) require manufacturers to submit lists and
copies of unpublished health and safety studies.41 As of September 2006, EPA had
issued 51 reporting rules for 1,200 chemicals.42 In response, EPA received more than
Under TSCA Section 8(e), which requires submission of information that
“reasonably supports the conclusion that such substance or mixture presents a
substantial risk of injury to health or the environment,” EPA has received and
36 The estimated number of such chemicals, roughly 3,000, has not changed since the late
1970s, but chemical identities have changed: some chemicals produced in high volumes at
that time no longer are produced at such high levels, while others are being produced at high
volumes now that were not then. Moreover, some chemicals qualify intermittently as high-
production volume, being produced in greater volumes in some years and lesser volumes in
37 40 CFR 712.
38 EPA Overview, p. 16.
39 40 CFR 717.
40 EPA Overview, p. 16.
41 40 CFR 716.
42 EPA Overview, p. 16.
reviewed more than 16,500 initial notices and 7,750 supplemental or follow-up
notices since 1977. These notices contained data concerning serious adverse health
effects, ecotoxicological effects, and exposures.44 EPA receives roughly 200 new
8(e) submissions and 100 supplemental submissions each year.45 EPA has
established lists of these studies and made the studies themselves available to the
public,46 but the internet links provided on EPA’s webpages are to databases that
have not been updated in recent years.47 Moreover, the value of the studies, or the
lists of studies, is greatly reduced by the confidentiality claims of the submitters: in
most cases, the identity of the chemical is concealed.
To track testing, production, uses, and regulations of all TSCA inventory
chemicals (the so-called “existing chemicals”), EPA began using a “Master Testing
List” (MTL) in 1990. The MTL presents a consolidated listing of OPPT’s priorities
for testing, as well as those brought forward to OPPT by other EPA Program Offices,
other Federal agencies, the ITC, and international organizations such as the
Organization for Economic Cooperation and Development (OECD). However,
EPA’s online Master Testing List is from 1996, and has not been updated.48
When reporting rules fail to generate data that EPA believes are needed to assess
risks, EPA has used its authority under TSCA Section 4 to require data generation
(or submission, if data are in company files). EPA has issued test rules under Section
4 for approximately 254 existing chemicals: 60 chemicals using Enforceable Consent
Agreements (ECAs), 24 chemicals under negotiated testing agreements, and about
44 EPA. Interagency Testing Committee. Substantial Risk Information. TSCA Section 8(e).
[http://www.epa.go v/ oppt/itc/pubs/sect8e.htm] .
45 EPA Overview, p. 17. The apparent inconsistency between EPA’s annual and total
numbers is a result of the voluntary Compliance Audit Program (CAP) which allowed
manufacturers to file overdue notices and pay pre-set penalties of up to one million dollars.
CAP began in 1991 (56 FR 4128, February 1), ended on May 15, 1996 (68 FR 33131, June
46 EPA. Toxic Substances Control Act Section 8(e) Notices. [http://www.epa.gov/oppt/
47 The link to the TSCATS database through the National Library of Medicine’s Toxline is
at least two years out of date. Information in EPA’s own online database is current only
through 2005. Syracuse Research Corporation’s website includes submissions through
48 EPA. 1996 Master Testing List. [http://www.epa.gov/opptintr/chemtest/pubs/mtl.htm].
Schweer, Greg (Chief of the Chemical Information and Testing Branch in OPPT.) Personal
communication. July 27, 2007.
49 Although the EPA Overview states on page 15 that test data have been generated for about
200 chemicals, that number was not updated from the 2003 draft. It omits the 51 chemicals
addressed in test rules published March 16, 2006 (71 FR 13707-13735) and April 26, 2004
(69 FR 22402-22441). [http://www.epa.gov/opptintr/chemtest/pubs/4final.htm].
EPA Assistant Administrators for OPPTS sometimes have criticized TSCA
provisions concerning data collection. For example, former Assistant Administrator
Lynn Goldman testified in 1994 that “Our available tools for gathering testing data
about these chemicals are cumbersome.”50 She later explained that under the
provisions of TSCA Section 4, “It’s almost as if ... we have to, first, prove that
chemicals are risky before we can have the testing done to show whether or not the
chemicals are risky.”51 This situation results in high transaction costs due to legal
challenges when test rules are promulgated: the regulated community generally can
argue that there is insufficient evidence supporting the agency’s determination that
a rule is needed.52 Goldman testified:
For example, in July 1993 we promulgated a TSCA section 4 multi-chemical
toxicity end point test rule covering 10 chemicals. In October 1993, however, we
were sued by the Chemical Manufacturers Association [now the American
Chemistry Council]. Settlement was only reached earlier this month [May 1994].
We also promulgated a final TSCA section 4 test rule on October of 1993 on four
chemicals, and were sued by the manufacturers for two of those four chemicals.53
Settlement negotiations are still underway for those.
In a recent report on federal requirements for toxicity testing, the National
Research Council agreed with Dr. Goldman and noted that,
TSCA authorizes EPA to review existing chemicals, but toxicity and exposure
information on them is typically so incomplete that it does not support the review
process. EPA can require testing if it determines that a chemical meets a specific
set of criteria; however, in vitro and whole-animal tests are rarely required.
Thus, the basis for establishing priorities and requiring testing for industrial54
chemicals in the united States has not progressed much over the last 20 years.
The current head of OPPTS has a different opinion. According to Assistant
Administrator James Gulliford, who testified before the Senate Committee on
Environment and Public Works in August 2006:
50 U.S. Congress. Senate. Committee on Environment and Public Works, Subcommittee on
Toxic Substances, Research and Development. Hearing held May 17, 1994,
“Reauthorization of the Toxic Substances Control Act.” S. Hrg. 103-776. Statement of
Lynn R. Goldman. U.S. Govt. Print. Off. Washington, DC, p. 6.
51 Ibid., p. 8.
52 As explained in an earlier section, the provisions of Section 4 authorize test rules only if
EPA determines that a chemical “may present an unreasonable risk,” or that there is a
potential for a substantial quantity to be released into the environment or for substantial or
significant human exposure.
53 U.S. Congress. Senate. Committee on Environment and Public Works, Subcommittee on
Toxic Substances, Research and Development. Hearing held May 17, 1994,
“Reauthorization of the Toxic Substances Control Act.” S. Hrg. 103-776. Statement of
Lynn R. Goldman. U.S. Govt. Print. Off. Washington, DC, p. 6.
54 National Research Council. 2006. Toxicity Testing for Assessment of Environmental
Agents: Interim Report. The National Academies Press, Washington, DC, pp. 100, 112.
TSCA provides the agency with the necessary authority to ensure that new
chemicals are adequately reviewed, that EPA can require reporting or
development of information needed to assess existing chemicals, and that those
chemicals that pose an unreasonable risk can be effectively controlled. Using
TSCA as the foundation for our efforts, EPA has, over the decades, developed
a wide array of regulatory and voluntary approaches and tools to assist us in our
goal to protect both human health and the environment. Using the strengths of
both regulatory and partnership approaches we have ensured effective, timely55
chemical management decisions.
Some of those voluntary approaches and tools are described below.
Voluntary Initiatives to Gather Data. EPA also obtains data about
chemical properties through various voluntary programs, some aimed at particular
chemical groups (such as certain fluorinated compounds),56 and others aimed at entire
categories of chemicals. Several High Production Volume (HPV) testing programs
are examples of the latter type.57 The regulated community considers the flexibility
of TSCA that permits such voluntary programs to be one of the TSCA’s greatest
EPA efforts to develop toxicity data on HPV chemicals date back to the late
1980s. At that time, the Organization for Economic Cooperation and Development
(OECD), an intergovernmental organization consisting of 29 developed countries,
including the United States, began developing a voluntary program to develop basic
toxicity information for chemicals produced in volumes greater than 2.2 million
pounds per year in at least one member country or in the European Union.59 As of
2004, the OECD had listed 4,843 such HPV chemicals. In 1990, OECD countries
agreed to generate and gather data sufficient to allow an informed judgment with
respect to the hazard potential of certain of these high production volume chemicals.
The necessary data elements are referred to as the Screening Information Data Set,
or SIDS. A SIDS has been, or is being, compiled for approximately 600 of these
EPA’s HPV Challenge Program began in 1998, when Vice President Gore and
EPA Administrator Browner called on the chemical industry to produce health and
55 U.S. Congress. Senate. Committee on Environment and Public Works. Hearing held
August 2, 2006, “Oversight on the Toxic Substances Control Act and the Chemicals
Management Program at EPA.” Submitted testimony of James B. Gulliford.
56 EPA Overview, p. 17.
57 Overview, pp. 30-33.
58 Roberts, Kathleen M. (Senior Director, Regulatory and Technical Affairs, American
Chemistry Council.) Personal correspondence, September 5, 2007.
59 Organisation for Economic Co-operation and Development. Description of OECD work
on investigation of high production volume chemicals. [http://www.oecd.org/document/
60 EPA. OECD SIDS voluntary testing program for international high production volume
environmental effects data for approximately 2,782 chemicals produced in, or
imported to, the United States in amounts greater than one million pounds per year,
according to reports filed under the 1990 TSCA Inventory Update Rule. That
challenge was prompted by studies conducted during the late 1990s that documented
a lack of basic health and safety data for most chemicals in U.S. commerce.61
According to the original program goals, all basic data were to be submitted by the
end of 2004 and made public by the end of 2005. EPA plans to make all the data it
receives as a result of the HPV program available to the general public, consistent
with a recommendation of the National Pollution and Prevention Toxics Advisory
Environmental Defense, an advocacy group that helped to design the program,
has issued three reports on the status of the HPV program to date.62 According to
Richard Denison, senior scientist with Environmental Defense who has been tracking
the HPV chemicals, through July 2007, chemical manufacturers had committed to
providing EPA information on roughly 1,300 chemicals produced in high volumes.63
Data sets still were incomplete for 536 of the HPV chemicals on the original list, as
of July 2007, according to Denison. Furthermore, he said that no manufacturer had
committed to providing information for about 265 chemicals on that list.64 By April
2007, EPA had entered data received for 873 chemicals into its new High Production
Volume Information System, Denison reported.65
More than 500 chemicals not on the original list now qualify as HPV chemicals;
231 of these are being sponsored by manufacturers through an Extended HPV
Program, according to Denison.66 On the other hand, about 327 of the chemicals on
the original list are no longer produced in such high volumes, according to the most
recent reports filed in response to inventory update rules in 1998 and 2002.6768 EPA
plans a final report on the HPV Challenge Program in 2008.
61 Roe, David, William Pease, Karen Florini, and Ellen Silbergeld. 1997. Toxic Ignorance.
Environmental Defense Fund, Washington, DC. EPA, Office of Pollution Prevention and
Toxics. 1998, Chemical Hazard Data Availability Study. EPA, Washington, DC.
62 Denison, Richard A. and Karen Florini. 2003. Facing the Challenge: A Status Report on
the U.S. HPV Challenge Program. Environmental Defense, Washington, DC. Denison,
Richard A. 2004. Orphan Chemicals in the HPV Challenge: A Status Report.
Environmental Defense, Washington, DC. Denison, Richard A. 2007. High Hopes, Low
Marks: A Final Report Card on the High Production Volume Chemical Challenge.
Environmental Defense, Washington, DC.
63 Denison, Richard A. 2007. High Hopes, Low Marks. Environmental Defense.
Washington, DC. p. 11-12.
64 Ibid., p. 11.
65 Ibid., p. 21.
66 Ibid, p. 23.
67 Ibid., p. 11.
68 Willis, Jim. High Production Volume (HPV) Challenge Program — Future Directions.
Presentation to the First U.S. Conference on Characterizing Chemicals in Commerce: Using
Data on High Production Volume (HPV) Chemicals, Austin, Texas, December 13, 2006.
The U.S. HPV Challenge Program is similar to an international program
organized by chemical trade groups known as the International Council of Chemical
Associations (ICCA). The ICCA initiative aims to test and assess an additional 734
chemicals produced in volumes greater than 22 million pounds annually.
Another, much smaller, U.S. initiative is the Voluntary Children’s Chemical
Evaluation Program (VCCEP). It aims to provide detailed information about risks
to children potentially posed by a small group of 23 chemicals. Manufacturers have
volunteered to conduct basic tests for 20 of these chemicals.69
The American Chemistry Council has noted that through the HPV program (and
related OECD program), the chemical industry has developed and submitted to EPA
data for “more than 95% of all chemicals in commerce today, by volume,” and the
public has electronic access to these data through EPA’s High Production Volume
website ([http://www.epa.gov/hpv]).70 However, the HPV program only collected
information for about 2,000 chemicals.71 The MPV program will address another
Despite the noteworthy progress being made through these voluntary programs,
which is greater than under any previous TSCA initiative, most existing chemicals
still lack toxicity data relevant to hazard assessment.72 73 Data also are lacking on
production volume and use, which are critical for determining the potential for
human and environmental exposure and for risk assessments that would permit
priority setting for EPA action.74 Moreover, with respect to new chemicals, roughly
two-thirds of PMN submissions do not include test data on chemical properties, and
almost 85% of PMN submissions provide no data on health effects.75
Some lawyers argue that TSCA acts as a disincentive to data production, and
therefore to data submission, by punishing any failure to report information about
69 EPA Overview, p. 34.
70 American Chemistry Council. 2006. “TSCA Myth vs. Fact.” Note, that this percentage
refers to the volume of HPV chemicals produced, rather than to the number of different
chemicals in commerce. [http://www.americanchemistry.com/s_acc/bin.asp?SID=1&DID=
71 The basic screening data being collected includes data for four health-related endpoints
(acute toxicity, chronic toxicity, mutagenicity, and reproductive effects/developmental
toxicity), ecological effects, and environmental fate endpoints.
72 EPA, Office of Pollution Prevention and Toxics. 1998. Chemical Hazard Data
Availability Study. EPA, Washington, DC.
73 Physicians’ Committee for Responsible Medicine. “The Availability of HPV Chemical
Data” at [http://www.pcrm.org/resch/anexp/hpv_report.html]. Conrad, James W. Jr. 2006.
Open Secrets: The Widespread Availability of Information about the Health and
Environmental Effects of Chemicals. Law & Contemporary Problems, v. 69 (Summer) pp.
74 EPA, Office of Pollution Prevention and Toxics. “Economic analysis for the amended
inventory update final rule,” August 2002, pp. 2-8.
75 EPA Overview, p. 8.
adverse health impacts, but not requiring testing to determine whether such impacts
Risk Management. EPA has used its Section 6 authority on eight occasions77
to restrict manufacture or use of six chemicals. Two of these regulations were later
superseded by regulations under other environmental laws.78 Four chemicals remain
regulated to some extent under TSCA Section 6: metalworking fluids, hexavalent
chromium use to treat water in comfort cooling systems (that is, cooling towers
dedicated exclusively to heating, ventilation, and air conditioning or refrigeration
systems), PCBs, and new uses of asbestos.79 Regulation of PCBs is required
explicitly by TSCA Section 6(e).
According to Ed Brooks, of EPA’s Chemical Control Division, EPA used
Section 6 authority sparingly because “With respect to the unreasonable risk issue,
... the Agency came to view Section 6 rulemaking as an inherently large and complex
undertaking that offered little prospect of resulting in success.”80
In four instances, EPA \referred chemicals for regulation to another federal
agency. In 1983 and 1984, EPA referred six chemicals to the Occupational Safety
and Health Administration under TSCA Section 9(a).81 In 1990, EPA sent a 9(a)
report to the Food and Drug Administration (FDA) on dioxins and furans in wood
and paper products.82 In testimony before the Senate Committee on Environment and
Public Works, Subcommittee on Toxic Substances, Research and Development,
Lynn R. Goldman, then Assistant Administrator of EPA’s Office of Pesticides,
Prevention, and Toxic Substances, testified that “the formal referral mechanism [of
76 Wagner, Wendy E. 2004. Commons ignorance: The failure of environmental law to
produce needed information on health and the environment. Duke Law Journal, v. 53, pp.
1619-1745. Case, David. W. 2005. The EPA’s HPV Challenge Program: A toxic tort
liability trap? Washington & Lee Law Review, v. 62, pp. 147-206.
77 EPA Overview, p. 20. EPA also devotes significant resources to so-called “national
program chemicals,” which include dioxin, mercury, and the chemicals addressed explicitly
by TSCA Section 6(e) and Titles II through IV, PCBs, asbestos, radon, and lead,
respectively. With respect to these chemicals, EPA coordinates federal activities as well as
international efforts to reduce risks.
78 EPA Overview, p. 20.
79 EPA Overview, p. 20. Also see 40 CFR Parts 747, 749, 761, and 763, respectively.
80 Brooks, Ed. 1996. Evolution of Risk Management of Existing Chemicals Under TSCA.
In: TSCA at Twenty, Chemicals in the Environment: Public Access Information, Issue 4
(Fall). EPA 749-R-96-001. EPA, Washington, DC.
81 The chemicals were 4,4-Methylenedianiline (48 FR 42898, September 20, 1983), 1,3-
Butadiene (48 FR 20524, May 15, 1984), and four glycol ethers (51 FR 18488, May 20,
82 55 FR 53047, December 26, 1990.
Section 9] has proven burdensome to EPA and cumbersome as a mechanism for
obtaining prompt consideration by applicable agencies.”83
Impact of a 1991 Decision by the Fifth Circuit Court on Section 684
Rulemaking. In 1991, the U.S. Court of Appeals for the Fifth Circuit vacated and
remanded an EPA rule promulgated under Section 6 that prohibited the manufacture,85
importation, processing, and distribution of asbestos in almost all products. The
substantive heart of the Corrosion Proof decision was its conclusion that EPA had
insufficiently justified its ban. The ruling is described in more detail in the Appendix
to this report.
With very limited exception, legal commentators have viewed TSCA section 6,
particularly as construed in Corrosion Proof Fittings, as imposing high evidentiary
hurdles on EPA regulators, so that little regulation under its authority may be86
expected. As explained by Robert B. Haemer, Corrosion Proof Fittings “may have
done the most damage to EPA’s ability to regulate chemical substances.” He
The fact that the court found ten years of rulemaking and a 45,000 page record
inadequate to support a ban on asbestos makes it appear that EPA management
has good reason to avoid rulemaking altogether. Requiring EPA to use the
balancing approach recommended by the Corrosion Proof court would result in
the agency making tough policy choices that cannot be resolved solely by
science. .... The time and effort required to flawlessly follow rulemaking
procedures affects [sic] EPA’s decisions about whether to pursue section 6
rulemakings, especially considering that more procedure may not necessarily
produce better administrative decisions. It is even more difficult for EPA to87
surmount an overly restrictive interpretation of reasonable risk....
The court’s remand of the asbestos rule in Corrosion Proof Fittings indicates that
TSCA’s failure is tied to its structure, not the lack of need for the statute itself.
The balancing of risks in the face of a very high hurdle of scientific uncertainty
83 U.S. Congress. Senate. Committee on Environment and Public Works, Subcomittee on
Toxic Substances, Research and Development. Hearing held July 13, 1994, “Reauthorization
of the Toxic Substances Control Act.” S. Hrg. 103-776. Statement of Lynn R. Goldman.
U.S. Govt. Print. Off. Washington, DC. p. 140.
84 This section of the report was written chiefly by Robert Meltz, Legislative Attorney, CRS
American Law Division.
85 Corrosion Proof Fittings v. EPA, 947 F.2d 1201 (5th Cir. 1991).
86 See, for example, Thomas O. McGarrity, Professor Sunstein’s Fuzzy Math, 90 Geo. L. J.
(2001); Robert B. Haemer, Reform of the Toxic Substances Control Act: Achieving Balance
in the Regulation of Toxic Substances, 6 Envtl. Lawyer 99, 115 (1999); and Joyce Merritt,
Comment, Standard of Review Under the Toxic Substances Control Act: Corrosion Proof
Fittings v. EPA, 8 J. Nat. Res. & Envtl. L. 167, 176 (1992/1993).
87 Haemer, Robert B. 1999. Reform of the Toxic Substances Control Act: Achieving
balance in the regulation of toxic substances. Environmental Lawyer, v. 6, n. 99, pp. 118-
under TSCA leaves EPA almost paralyzed to take action to regulate toxic88
A 1993 study by the Carnegie Commission on Science, Technology, and
Government, Risk and the Environment: Improving Regulatory Decision Making,
concluded, “Regardless of whether the statute, the courts, the agency, or others
should be faulted in this case, it is unsettling that EPA could not satisfy TSCA’s89
requirements for promulgating a single rule after a decade’s effort.”
The only favorable comment by a legal scholar regarding TSCA and Corrosion
Proof Fittings, as revealed by CRS research, was the following statement by the
current EPA Assistant Administrator for Enforcement and Compliance Assurance —
Contrary to the criticisms of those who would rewrite toxic substance control
statutes, or restrict the scope of judicial review under these statutes, Corrosion
Proof Fittings illustrates the importance of the substantive protections accorded
private parties under the current toxic substances regulatory statutes. ...
Corrosion Proof Fittings is a case study in how judicial review can prevent90
inefficient and wasteful regulation of toxic substances.
Recent Events and Trends
Few legislators have expressed much interest in TSCA during its thirty-year
history: Congress has held few oversight hearings on its implementation, and the
basic TSCA provisions in Title I have never been amended. However, recent legal,
scientific, and technological developments, which appear to be increasing legislative
interest, are discussed below. Recent Congressional and Administrative initiatives
that address the purported weaknesses of TSCA also are summarized.
State Laws and Local Ordinances
Many states and localities have enacted laws in recent years restricting the sale
or use of various chemicals91 or categories of substances that are federally managed
88 Id. at 126.
89 Carnegie Commission on Science, Technology, and Government. 1993. Risk and the
Environment: Improving Regulatory Decision Making. Carnegie Commission on Science,
Technology, and Government, New York.
90 Nakayama, Granta. 1992. Corrosion Proof Fittings v. EPA: No Death Penalty for Asbestos
Under TSCA. George Mason Independent Law Review, v. 1, pp. 99-101.
91 A general compendium of information about state chemical policies is provided
electronically by the University of Massachusetts, Lowell, at [http://www.chemicalspolicy.
org/usstatelevel.shtml], visited June 27, 2007. Recent restrictions include a total ban on
decabrominated diphenyl ether in Washington and restrictions on formaldehyde emissions
from certain wood products by the California Air Resources Board. “Washington state
passes PBDE ban. Policy news.” April 27, 2007. Environmental Science & Technology,
v. 41, n. 9, online edition. [http://pubs.acs.org/subscribe/journals/esthag-w/2007/apr/policy/
under TSCA. For example, numerous state and even local governments have enacted
laws regulating bioengineered organisms, although EPA treats such organisms as
“new chemical substances” (see below).92 Those promoting revisions to TSCA argue
that state laws and local ordinances restricting chemicals are evidence that TSCA is
not effective in controlling chemicals in the marketplace, and that citizens have lost
confidence in the ability of the act to adequately protect public health and the
environment.93 Some California legislators have been modeling proposals based on
the laws of other nations. For example, a law recently enacted in California that
restricts formaldehyde emissions from certain wood products is similar to a law in
the European Union. Other bills in the California Assembly or Senate have
specifically referenced Canadian or Dutch law.94
A number of California’s legislative proposals derive from a University of
California (Berkeley) report commissioned in January 2004 by Members of the
California legislature.95 That report concluded that the cause of the chemical
challenges facing California is the failure of TSCA to provide an effective vehicle to
motivate chemical producers to generate and distribute adequate information on the
toxicity of their products. This “information deficit,” the report continues, makes it
“difficult for businesses and consumers to choose safer chemicals” and has
“undermined the efficient operation of the market.” As a result, the market is driven
by the function and price of chemicals more than by their toxic properties, according
to the report’s principal author.96 The report also suggested that the process is self-
sustaining: because the market is driven by knowledge of what chemicals can do and
what they cost, the report claims that new graduates with PhD’s in chemistry from
major universities can lack even a rudimentary understanding of toxicology.97 The
nl_PBDEs.html]. Whetzel, Carolyn. 2007. “California Adopts Emission Standards For
Formaldehyde From Wood Products.” Daily Environment Reporter, May 2, 2007, p. A-2.
[ h t t p : / / www.ar b.ca.go v/ r e gact / 2007/ comp wood07/ comp wood07.ht m] .
92 National Conference of State Legislatures. Agriculture: Biotechnology Statutes Chart.
[http://www.ncsl.org/ programs /agr i/biotchlg.htm] .
93 Ditz, Daryl. 2006. “Cloudy Skies, Chance of Sun: A Forecast for U.S. Reform of
Chemicals Policy.” Center for International Environmental Law: Washington, DC. Watson,
Traci. States and cities move to curb toxic substances the EPA hasn’t,” USA Today, May
94 Rau, Jordan. “Legislature Targets Toxic Risks in Products,” Los Angeles Times, May 30,
2005. [http://www.safecosmetics.org/newsroom/la_times_5_30_05.cfm]. California Senate
bill SB 973, Chemicals of Concern. Introduced February 23, 2007. [http://www.leginfo.
ca.gov/ pub/07-08/bill/sen/sb_0951-1000/ sb_973_bill_20070223_introduced.html ].
95 Wilson, Michael P. 2006. Green Chemistry in California: A Framework for Leadership
in Chemicals Policy and Innovation. California Policy Research Center, University of
California, Berkeley. Hereafter cited as Wilson, Green Chemistry. [http://coeh.berkeley.edu/
97 “Stakeholders mull need for strategy to address emerging chemical issues.” Special
solution for California, the report concludes, is for it to take a leadership role in
As the number of state and local restrictions on chemicals increases, compliance
becomes more difficult and costly for chemical manufacturers and distributors who
operate in multiple states.99 The emerging legal patchwork may also be less firmly
based on sound science. For these reasons, some large chemical makers might lean
toward TSCA reform to preempt state and local regulatory action. TSCA currently
does not prevent state and local regulation of chemicals, unless they are already
regulated under the act.100
International Agreements on Chemicals
Globalization of commerce in chemicals also is forcing some reconsideration
of TSCA. International commerce in chemicals has grown significantly during the
thirty years of TSCA’s existence, and most of the largest chemical manufacturers,
processors, and distributors now operate internationally. This means that they must
adjust their business practices to accommodate the expectations of diverse
governments, labor forces, and customers. Proliferating and sometimes conflicting
obligations with respect to the chemical industry have prompted some multinational
firms to advocate for international harmonization of regulations.101
The Executive Branch, working through the State Department and EPA, has
sought to smooth the way for American businesses abroad (at the same time that it
reduces its own burden for data collection and chemical risk assessments), through
informal agreements and formal treaties. Business interests and other non-
governmental organizations often have participated in negotiations. Domestic
implementation of such agreements, however, is constrained by U.S. environmental
Between 1998 and 2001, the United States signed two international treaties and
one executive agreement to ban or strictly regulate certain toxic chemicals that persist
and bioaccumulate in the environment. The agreements apply to all production,
report. April 30, 2007. Daily Environment Report. p. B-1.
98 Wilson, Michael P. Testimony before the California Senate Environmental Quality
Committee, June 28, 2006, Sacramento, CA.
99 Phibbs-Rizzuto, Pat. 2007. “State efforts to restrict chemicals rising, speakers at global
chemical conference say,” Daily Environment Report, March 12, 2007. p. A-4.
100 TSCA Section 18 preempts state and local actions that establish or continue in effect
requirements applicable to a chemical substance or mixture that is regulated federally under
TSCA Section 5 or 6, unless a state requirement is identical to the federal requirement,
implements another federal law, or prohibits use of the substance or mixture within the state.
Section 18 allows a state to ask EPA to allow a state requirement that provides a
significantly higher degree of protection from risk than does the federal requirement.
101 American Electronics Association. AeA International Environment Overview. Issues
import, export, use, and disposal of the listed chemicals. But TSCA Section 12(a)
explicitly excludes chemicals intended solely for export from regulation under
TSCA, deferring to the authority of the importing nations to impose any necessary
restrictions on chemical imports or uses. To implement the international agreements,
TSCA would have to be amended to permit regulation of chemical production for
export, at least in the case of the chemicals specified in the treaties.
Although there is broad U.S. support for all three international agreements,
stakeholders and policy makers have not been able to agree on implementing
legislation targeted specifically to the necessary TSCA changes. Legislators appear
preoccupied by the larger issues that surround TSCA specifically (discussed in the
following section of this report) and chemical regulation more generally. Until these
larger issues are resolved, implementing legislation seems unlikely to be enacted.
Meanwhile, multinational chemical company representatives and international
environmental protection groups can be expected to continue pushing for legislative
action. For more information about these international agreements, see CRS Report
RS22379, Persistent Organic Pollutants (POPs): Fact Sheet on Three International
Agreements, by Linda-Jo Schierow.
New Chemical Laws in Other Nations
Recent legislation in the European Union (EU) addressed many of the broader
questions about how chemicals should be regulated. The legislation
!is based on the EU version of the precautionary principle;102
!requires data production and reporting for most chemicals in
!shifts responsibility for demonstrating a chemical’s safety from
regulators to chemical makers and processors;
!reverses the default status for certain chemicals without data from
safe to unsafe; and
!requires reduced use of specified toxic chemicals when safer
substitutes are available.
Adopted in December 2006, the new law for the Registration, Evaluation, and
Authorization of Chemicals, known as REACH, is heralded by some as a model for
other countries that are striving to develop sustainable economies based on the
precautionary principle. Others are concerned about the potential negative effect of
REACH on the European economy and international commerce.
102 Generally, the European Commission describes the precautionary principle as a risk
management strategy used when “there are reasonable grounds for concern that potential
hazards may affect the environment or human, animal or plant health, and when at the same
time the available data preclude a detailed risk evaluation.” In applying the precautionary
principle, the EU strives to achieve a high level of protection by taking protective action
before all relevant scientific knowledge is available. The EU definition of the precautionary
principle is being refined over time by case law and through the diverse contexts in which
it is employed. For a thorough discussion of the precautionary principle see the
Communication from the Commission of the European Communities which was issued in
the year 2000. [http://ec.europa.eu/dgs/health_consumer/library/pub/pub07_en.pdf].
U.S. chemical exporters, and even manufacturers whose products contain certain
chemicals, will have to meet REACH requirements, which are to be phased in over
the next 11 years. Many U.S. environmentalists hope that REACH implementation
in the EU will demonstrate the feasibility of its approach to chemical regulation, and
show the way to TSCA reform. Some argue further that failing to amend TSCA in
the near term will reduce (or further reduce) U.S. stature as a leader in global
Others reject the approach taken by REACH and defend TSCA, arguing that the
U.S. approach continues to provide the leading example of chemical regulation
based on sound, risk-based science.104 As stated in an American Chemistry Council
The United States chemical management regulatory system is based on the use
of credible scientific information and embodies several layers of precaution that105
are protective of human health and the environment.
Moreover, the trilateral Montebello Agreement reportedly is seen by some as an
American alternative to REACH that will focus resources efficiently on chemicals
of greatest concern.106
Implementation of REACH will provide the world with evidence regarding the
pros and cons of its approach to chemicals policy. These lessons will probably
influence the debate about future U.S. chemical policy generally, and TSCA in
particular. In addition, REACH will force multinational firms to produce toxicity
and exposure data in order to market their products in Europe. Once reported to the
EU, those data might become public or might be provided to EPA. For more
information about REACH, see CRS Report RS22673, Chemical Regulation in the
European Union: Registration, Evaluation, and Authorization of Chemicals, by
Linda-Jo Schierow. For comparisons of REACH and TSCA, see Government
Accountability Office report GAO-07-825, Chemical Regulation: Comparison of
U.S. and Recently Enacted European Union Approaches to Protect against the Risks
of Toxic Chemicals, or Richard Denison’s 2007 report Not That Innocent.107
Denison’s report also compares REACH and TSCA to the Canadian Environmental
Protection Act of 1999.
103 Purvis, Meghan. 2006. “EU: Burden of proof shifted to chemical maker,” The Forum:
Who’s Ahead In Environmental Protection: The United States or the European Union? The
Environmental Forum, (March/April), p. 50.
104 ACC. Registration, Evaluation, and Authorization of Chemicals. [http://www.american
chemistry.com/ s_acc/sec_policyi ssues.asp?CID=621&DID=2217].
105 ACC. TSCA Fact Sheet. August 2, 2006. [http://www.americanchemistry.com/s_acc/
106 Rizzuto, Pat. Canadian, U.S. Trade Associations Praise Trilateral Agreement on
Chemical Reviews. Daily Environment Report, August 22, 2007. p. A-2.
107 Denison, Richard A. 2007. Not That Innocent. Environmental Defense, Washington,
Scientific Developments and Issues
Toxicology. Toxicology is the study of how chemicals adversely affect the
health of individuals. It is an ancient area of study, but its modern form emerged
only recently, largely during the 1960s and 1970s. The first textbook of toxicology108
was published in 1972. Since that time, the science has grown and developed
rapidly. The Presidential/Congressional Commission on Risk Assessment and Risk
Management, which was established by Congress in the Clean Air Act Amendments
of 1990, recommended in 1997 that TSCA “be updated to reflect advances in109
toxicology and regulation” since TSCA was enacted.
TSCA reflects the concerns of the early days of toxicology, and the knowledge
and methods of that first toxicology book. At the time TSCA became law, concerns
focused on acute effects, birth defects, or cancer due to accidental poisoning
incidents, pharmaceutical drugs, or occupational exposures. Thus, TSCA addresses
individual chemicals and does not account for the variety of metabolic processes
leading to toxicity, vast individual differences in sensitivity and vulnerability to toxic
effects (and consequently, the inherent difficulty of proving that an individual case
or group of cases of disease resulted from a particular exposure), or for effects on
neurological development, reproduction, the immune system, or endocrine systems.
In recent years, Congress has directed EPA to conduct its risk assessment taking
into account potential:
!vulnerability and sensitivity of developing human embryos and
children, as well as other major identifiable subgroups of consumers,
to toxic chemicals;110
!ability of chemicals to disrupt the functioning of endocrine
!exposure from a variety of sources and environmental media (for
example, drinking water as well as workplace air);112 and
!cumulative exposure from different chemicals that have similar
effects on the body.113
108 Casarett, Louis J. and John Doull (Eds.). 1975. Toxicology: The Basic Science of Poisons.
New York: Macmillan.
109 Commission on Risk Assessment and Risk Management. 1997. Risk Assessment and
Risk Management in Regulatory Decision-Making. Final Report, Vol. 2. p. 126.
110 Food Quality Protection Act of 1976, P.L. 104-170, Section 405, which amended the
Federal Food, Drug, and Cosmetic Act, Section 408(b)(2)(C) and (D).
111 Food Quality Protection Act of 1976, P.L. 104-170, Section 405, which amended the
Federal Food, Drug, and Cosmetic Act, Section 408 by adding subsection (p). Safe Drinking
Water Act, 42 USC Sections 300F-300j-26.
112 Food Quality Protection Act of 1976, P.L. 104-170, Section 405, which amended the
Federal Food, Drug, and Cosmetic Act, Section 408(b)(2)(D).
Although such factors are not excluded as considerations under TSCA, public health
advocates have argued that they do not influence decisions enough, given the
uncertainties of the toxicology and the need to balance risks and benefits under
Computational Toxicology. The most recent innovation with respect to
toxicology emerged in the late 1990s and is developing rapidly: computational
toxicology.115 Computational toxicology refers to computer-assisted techniques for
estimating risks to human health or the environment based on mathematical models
that link scientific knowledge about various chemicals, environmental media (air,
water, land, etc.), and the biology of human and other potentially affected organisms.
Computational toxicology is particularly valuable for comparing and analyzing large
amounts of very detailed biological data, for example on the molecular structure of
the human genome and the functions of its parts. This has allowed scientists to
identify genetic variations that may make some individuals more or less vulnerable
to damage from exposure to certain chemicals. For more information about these
emerging techniques, see the interim report by the National Research Council’s
Committee on Toxicity Testing and Assessment of Environmental Agents.116
Computational toxicology also is expected to improve the scientific basis for
EPA’s decisions about whether to require data collection or to regulate particular
chemicals for which data are lacking. Data can be easily and relatively quickly
collected on the identities of proteins produced within living cells as they respond to
different chemicals or other stressors.117 Such data indicating biological effects of
exposure are generated using rapid, so-called “high-throughput” biochemical tests
and recorded in vast databases. The databases then are analyzed for patterns, which
may be used to inform models intended to predict the environmental and toxicity
characteristics of chemicals not yet tested. By matching this information on the
biological response to toxic substances with genomic information, scientists can
identify genetic variations more or less susceptible to toxic effects of exposure. A
114 Children’s Environmental Health Network. April 2005. In Support of Child-Safe U.S.
Chemical Policies: Statement of Principles. [http://www.cehn.org/cehn/chemicals%
115 Computational toxicology also is referred to as in silico toxicology, as opposed to in vitro
toxicology, which refers to toxicology based on experiments using tissues grown in
laboratory glassware, or in vivo toxicology, referring to toxicology based on observation of
116 Committee on Toxicity Testing and Assessment of Environmental Agents, National
Research Council. 2006. Toxicity Testing for Assessment of Environmental Agents, Interim
Report. Washington, DC: The National Academies Press. pp. 194-221.
117 The application of computers to analyze biological information is known as
bioinformatics. When the biological information being studied is the proteins being
manufactured within the cells of a particular tissue at a particular time, the field of study is
known as proteomics. When the focus is on the function of various portions of a genome
(human or otherwise), the field is called genomics. When the focus is on how genomes are
affected by exposure to toxic substances, the field is called toxicogenomics.
recent report calls for amendments to TSCA that would require such tests, with the
aim of more rapidly developing these tools for toxicity assessment.118
As mentioned previously, EPA already relies heavily on its quantitative
structure-activity relationship (QSAR) models for setting priorities and conducting
screening-level risk assessments. These models quantitatively correlate what is
known about particular chemical structures and the biological activity or chemical
reactivity of the chemicals in which such structures are found. The correlations then
are used to predict the activity or reactivity of other chemicals with similar structures
but for which data are lacking.
If these models become even more reliable predictors of chemical properties,
the question may arise whether QSAR is a sufficient basis for an unreasonable risk
determination.119 EPA may make this decision on its own authority, but Congress
also might wish to weigh in on that decision. One former EPA Assistant
Administrator argues that the empirical basis for SAR is weak, and that “SAR has
allowed both EPA and the chemical industry to defend the TSCA program and to
claim that it adequately protects the public.”120 The empirical basis for SAR is
expected to strengthen over time, however, and many scientists see SAR positively,
as a potentially powerful tool that, in the long term, may reduce costs for the
regulated community and reduce the need to require some animal-based toxicity tests.
Exposure Data. When TSCA was enacted, risk assessment was a primitive
tool based on simple toxicological models, usually of a single incident of exposure
to a single chemical, followed (usually relatively quickly) by an obvious health effect.
Multiple, low-level, episodic, or chronic exposures to multiple chemicals were
thought to be too complex to model. Today EPA routinely models long-term, low-
level exposure through multiple pathways, and sometimes looks at cumulative121
exposure to different chemicals with similar modes of action. Such complex
exposure assessment was mandated by the Food Quality Protection Act of 1996 and
is conducted routinely for pesticides.
Research also has determined that the timing of an exposure can be important,
especially to a developing fetus or a young child. Thus, if there are data indicating
that exposure to a chemical is likely to adversely affect fetal or infant development,
rat or mouse experiments may be conducted in which exposure is restricted to
118 Snir, Reut. 2007. Applying Toxicogenomics Data in Chemical Regulation. Foresight
and Governance Project, Woodrow Wilson International Center for Scholars, Washington,
DC. 29 pp.
119 No one has argued to date that QSAR is suitable for any purpose other than screening.
120 Davies, J. Clarence. EPA and Nanotechnology: Oversight for the 21st Century. 2007.
Woodrow Wilson International Center for Scholars, Project on Emerging Nanotechnologies.
Washington, DC, p. 18. [http://www.nanotechproject.org].
121 For a description of modern techniques for toxicity testing, see Chapter 2 in Toxicity
Testing for Assessment of Environmental Agents, Interim Report, by the Committee on
Toxicity Testing and Assessment of Environmental Agents, National Research Council,
published in 2006 by the National Academies Press in Washington, DC.
particular periods, for example, before or after mating, during the gestation period,
or soon after birth.122
TSCA does not prevent consideration of aggregate or cumulative exposure or
of its timing, but neither does it require them. TSCA also does not provide guidance
with respect to the use of such information in regulatory decisions. For example, if
an unreasonable risk results from exposure to two or more chemicals, it is not clear
whether TSCA authorizes EPA to control the individual chemicals contributing to
the risk.123 Amendments to TSCA might address such issues.
Technological Developments and Issues
Advances in science and technology also are raising some concerns about
TSCA, particularly with respect to whether and how EPA’s procedures for
identifying and managing unreasonable risks might be applied to new forms of
chemical substances like genetically modified organisms or nanoparticles.
Genetically Modified Organisms. Soon after TSCA was enacted,
entrepreneurs began applying new technologies for cutting, copying, and pasting
pieces of genetic material obtained from one organism into another. The resulting
genetically modified organisms (GMOs) are useful for various purposes. For
example, some could produce specialty enzymes for use by industry or proteins that
control plant pests, while others could break down pollutants in the environment.
These products of recombined DNA could not have occurred as a result of normal
reproduction, but instead required significant human intervention.
Public concerns about the possible human health or environmental effects of
GMO products led federal agencies to adopt in 1986 a “Coordinated Framework for
Regulation of Biotechnology.” The Framework established a federal policy in favor
of regulating GMOs that are not naturally occurring and combine genetic material
from different genera,124 or that are capable of causing disease (that is, “pathogens”).
In accord with the policy, federal agencies regulate GMOs according to their
properties and intended uses under existing statutory authority.125 For example, EPA
123 However, there may be a precedent for EPA action based on potential effects due to
combinations of chemicals. According to EPA, metal working fluids were regulated
because they could combine with nitrates or nitrites to form carcinogenic nitrosamines
(Charles Auer, personal communication, August 5, 2007).
124 That is, the covered organism has genetic material from two organisms that would not be
joined in nature because they are not of the same species. “Genera” is plural for genus, “a
level in a classification system based on the relatedness of organisms” as defined in the EPA
fact sheet at [http://www.epa.gov/oppt/biotech/pubs/pdf/fs-002.pdf].
125 Kingsbury, David T. 1990. Regulation of Biotechnology: A. Perspective on the US
‘Coordinated Framework,’ Chapter 14. In: SCOPE 44 Introduction of Genetically Designed
Organisms into the Environment, H.A. Mooney & G. Bernardi eds., Wiley, U.K.
[ h t t p : / / www.i c su-s cope.or g/ downl oadpubs/ s cope44/ chapt e r 14.ht ml ] .
regulates GMOs that produce or contain pesticides under the Federal Insecticide,
Fungicide, and Rodenticide Act.
EPA regulates GMOs that are not pesticides as new chemical substances under
TSCA, unless they are outside the TSCA definition of a chemical substance.126 127
(For example, a GMO that is food or that produces pharmaceuticals would be
regulated by the Food and Drug Administration under the Federal Food, Drug, and
Cosmetic Act.) EPA also oversees significant new commercial uses of existing
microbes under TSCA Section 5.128 EPA policy with respect to bioengineered
organisms is based on its 1986 interpretation of what constitutes a “new”
microorganism, as explained in an EPA Fact Sheet:
New microorganisms are those microorganisms formed by combining genetic
material from organisms in different genera (intergeneric). A genus (pl. genera)
is a level in a classification system based on the relatedness of organisms. EPA
believes that intergeneric microorganisms have a sufficiently high likelihood of
expressing new traits or new combinations of traits to be termed “new” and129
Some have criticized this interpretation and the resulting regulatory
arrangement. For example, a critic noted in 1988, “The first difficulty is that the
TSCA gives the EPA authority to regulate “chemical substances,” and there is some
question as to whether living microorganisms developed for deliberate release fall130
within this definition.” A 2004 report by the Pew Initiative on Food and
Biotechnology raised the same point.131 The definition of “chemical substances”
subject to TSCA is described above, in the subsection “Policies and Intent” of the
section “TSCA Overview.” Nevertheless, EPA includes microorganisms that are not
intergeneric on the inventory of existing “chemical substances” and requires PMNs
for intergeneric microorganisms.132 At least eight microorganism PMNs have been
126 Rules for products of biotechnology may be found in the Code of Federal Regulations,
Title 40, Part 725. The rules also are posted online at [http://www.epa.gov/biotech_rule/].
127 U.S. Congress. House of Representatives. Hearing before the Committee on Agriculture,
Subcommittee on Conservation, Credit, and Research, June 17, 2003. Testimony of Stephen
Johnson, Assistant Administrator, Office of Prevention, Pesticides, and Toxic Substances,
129 EPA. Microbial products of biotechnology: Final regulations under the Toxic Substances
Control Act summary (fact sheet). [http://www.epa.gov/biotech_rule/pubs/fs-001.htm].
130 Marchant, Gary. 1988. Modified Rules for Modified Bugs: Balancing Safety and
Efficiency in the Regulation of Deliberate Release of Genetically Engineered
Microorganisms. Harvard Journal of Law and Technology, v. 1, (Spring), pp. 163-208.
131 Pew Initiative on Food and Biotechnology. 2004. Issues in the Regulation of Genetically
Engineered Plants and Animals. Executive Summary. p. 9. [http://pewagbiotech.org/
132 40 CRF §725.3.
received by OPPT, according to EPA.133 OPPT has reviewed bacteria for degradation
of hazardous wastes, enhanced nitrogen fixation in plants, and for closed system
production of enzymes.134
Other critics of the current federal Framework believe that the policy (if not the
underlying statutes) is dated, particularly in light of the recent use of biotechnology
to engineer large animals for various purposes.135 They raise the question, are cloned
mammals or the substances they produce also “new chemical substances” under
TSCA? Investment in developing markets for such bioengineered livestock and
products reportedly is suffering from a lack of clear federal rules.136
On the other hand, many support the current regulatory framework, arguing that
the dangers of genetically modified organisms are adequately controlled.137 Although
they admit that there is a possibility that a dangerous new microbe might be created
inadvertently, they maintain that the risk is small, and, “Now that genetically altered
bacteria have been handled for more than 20 years without disaster, earlier anxieties
about mutant germs have diminished.”138
Nanotechnology. More recently, scientists and engineers have begun to
examine, design, and manipulate materials at the molecular level, or nanoscale.139
At this scale, particles have chemical, physical, and biological properties that vary,
depending on particle size and shape, even when particles are made of the same
elements. Recent work in biochemistry, physical chemistry, and materials science
has advanced to the point that a rapid increase in commercial applications of
nanomaterials is expected. Many patents for commercial applications of
nanotechnology already are pending, and hundreds of products are being marketed,
133 EPA Overview, p. 12.
134 EPA Overview, Appendix, p. B-11.
135 Pew Initiative on Food and Biotechnology. 2004. Issues in the Regulation of Genetically
Engineered Plants and Animals. Executive Summary. pp. 6-7. [http://pewagbiotech.org/
136 Pollack, Andrew. Without U.S. rules, biotech food lacks investors. New York Times,
July 30, 2007. Online edition. [http://www.nytimes.com/].
137 U.S. Congress. House of Representatives. Hearing before the Committee on Agriculture,
Subcommittee on Conservation, Credit, and Research, June 17, 2003. Testimony of Stephen
Johnson, Assistant Administrator, Office of Prevention, Pesticides, and Toxic Substances,
138 Grace, Eric S. 2006. Biotechnology Unzipped: Promises and Realities, Revised 2nd
edition. Washington DC: Joseph Henry Press. p. 216.
139 A nanometer is one-billionth of a meter, which is about 1/75,000 of a human hair or the
width of ten hydrogen atoms in a line. A bacterium is a few hundred nanometers across.
Nanoscience may be defined as the study of the fundamental principles of molecules and
other structures with at least one dimension roughly between 1 and 100 nanometers. For a
more detailed explanation of nanotechnology, see Nanotechnology: A Gentle Introduction
to the Next Big Idea, by Mark and Daniel Ratner (2003; Prentice Hall: Upper Saddle River,
NJ). For standard terminology relevant to nanotechnology, see ASTM Standard E 2456 —
including many cosmetics, sunscreen, tennis balls, food additives, clothes washers,
and odor-free clothing.
While the potential economic gains and beneficial uses for nanotechnology are
exciting prospects, the potential risks associated with nanoparticles are a concern for
some scientists, policy makers, and industrial trade, consumer, and environmental
groups.140 There is scientific evidence that some nanoparticles may be hazardous.
For example, certain nanoparticles are known to be toxic to microbes,141 and EPA has
reported studies that have found nanoparticles generally (but not always) are more
toxic than larger particles of identical chemical composition.142 Yet, such studies are
rare, and nanoparticles are diverse, so that one study with one kind of particle may
not be informative with respect to the properties of other kinds of particles. Research
into the inherent properties and behaviors of various nanoparticles in living
organisms or ecosystems is only beginning.143
According to EPA, despite the scientific uncertainties surrounding
nanoparticles, “EPA has the obligation and mandate to protect human health and
safeguard the environment by better understanding and addressing potential risks
from exposure to these nanoscale materials and products containing nanoscale
materials.”144 Different stakeholders have different views about which TSCA
provisions they would like to see used for nanomaterials. Some environmental
groups have argued that all products of nanotechnology are new and should be
subject to PMN requirements.145 Others would prohibit uses of nanomaterials that
were untested or unsafe, require a “full lifecycle environmental, health, and safety
impact assessments and robust testing prior to commercialization of a
nanotechnology-based product,” and ensure “full and meaningful participation” by
140 Environmental Defense and American Chemistry Council. Nanotechnology Panel Joint
Statement of Principles. Comments on EPA’s Notice of a Public Meeting on Nanoscale
Materials, 70 Federal Register 24574, June 23, 2005. [http://www.environmentaldefense.
141 Silver, for example, is toxic, and some product manufacturers have made antibacterial
claims for their products containing nanosilver. In addition, research has demonstrated the
toxicity of C60 fullerenes to bacteria in water under laboratory conditions (Fortner, J.D., D.Y.
Lyon, C.M. Sayes, et al. “C60 in water: Nanocrystal formation and microbial response,”
Environmental Science & Technology, v. 39, (2005), pp. 4307-4316.)
142 Science Policy Council. 2007. U.S. Environmental Protection Agency’s Nanotechnology
White Paper, EPA 100/B-07/001. U.S. Environmental Protection Agency, Washington, DC,
143 Naturally occurring nanoparticles exist, and some (for example particles in exhaust from
diesel fuel) have been studied for years.
144 EPA Fact Sheet for Nanotechnology under the Toxic Substances Control Act.
[ ht t p: / / www.epa.gov/ oppt / nano/ nano-f a ct s.ht m#usf ] .
145 Balbus, John, Richard Denison, Karen Florini, and Scott Walsh. 2005. “Getting
Nanotechnology Right the First Time,” Issues in Science and Technology, Summer, pp. 65-
the public and workers.146 One analyst has suggested that EPA regulation should
focus on the specific products of nanotechnology, rather than on more generic
nanomaterials.147 Another view is that the relevant TSCA authority for regulating
nanomaterials depends on each material’s properties: If the nanomaterial has unique
properties that would not be predictable based on the properties of larger forms of the
same chemical, then it might be considered “new.”148
Recently, EPA released a document outlining its historical approach to
determining whether a chemical is “new” to the TSCA inventory.149 According to
that document, EPA intends to continue to apply this current approach to
nanomaterials on a case-by-case basis. On July 12, EPA asked for public comments
on the approach. With respect to “existing” nanomaterials, to date, EPA has not
issued a rule directing manufacturers to notify the Agency if new nanoscale uses are
proposed for an existing chemical substance. The question that arises then is whether
EPA is even notified about the existence of most commercially produced
nanomaterials, and if so, whether the agency is evaluating them for hazard potential
prior to entry to the U.S. market.
It is clear, however, that EPA has been working to become informed about new
nanotechnologies, and conferring with stakeholders, as well as counterpart agencies
in other nations, about how best to address nanomaterials. The agency is more
formally gathering data about nanotechnologies through a voluntary stewardship
program known as the Nanoscale Materials Stewardship Program (NMSP). Formally
announced October 18, 2006, the program was launched January 28, 2008.150
Stakeholders were asked to respond within six months. As of August 22, 2008, EPA
reported that 22 organizations have submitted information and 10 more have
promised to submit information for the basic program. Three organizations have
agreed to participate in the “in-depth” part of the program.151
146 Natural Resources Defense Council. 2006. “Health facts: Nanotechnology’s invisible
threat: Small science, big consequences.” December. [http://www.nrdc.org/health/science/
147 Davies, p. 23.
148 Rizzuto, Pat. 2006. “EPA Reviews 15 New Nanoscale Chemicals,” Daily Environment
Report, v. 158, (August 16), p. A-7.
149 EPA. 2007. TSCA Inventory Status of Nanoscale Substances — General Approach.
[ h t t p : / / www. r e gu l a t i o n s . gov/fdmspublic/component/main?ma i n = D o c u me n t D e t a i l & d =
150 EPA. Nanotechnology under the Toxic Substances Control Act. [http://www.epa.gov/
151 EPA. Nanoscale Materials Stewardship Program. [http://www.epa.gov/oppt/nano/
stewardship.htm], visited September 18, 2008.
J. Clarence Davies, who was EPA Assistant Administrator for Policy, Planning
and Evaluation during the administration of President George Herbert Walker Bush,
and who helped author the original legislative proposal that became TSCA, recently
evaluated the law as a means of regulating nanotechnology. His report concluded
that the law “is extremely deficient in many respects and needs to be amended.”152
In the absence of federal regulation, at least one city has acted to regulate
nanotechnology. Berkeley, California issued an ordinance December 13, 2006,
which requires facilities that handle engineered nanoscale materials to disclose
information to the city about the amounts of materials they handle, uses of such
material, and benefits and toxicity of the materials.153 If toxicity and exposure data
are unavailable, nanomaterials will be considered by the city to be “toxic” and
therefore subject to the same requirements for risk management as other toxic
For more information about engineered nanomaterials and some challenges
associated with regulating nanotechnology, see CRS Report RL34332, Engineered
Nanoscale Materials and Derivative Products: Regulatory Challenges or CRS
Report RL34511, Nanotechnology: A Policy Primer.
Legislative and Administrative Initiatives
Legislation. Companion bills in the 110th Congress, H.R. 6100 and S. 3040,
would amend TSCA, adding a new title to the end of the act, to significantly reshape
U.S. chemical assessment and management. Known as the “Kid-Safe Chemicals Act
of 2008,” H.R. 6100/S. 3040 aims to “eliminate the exposure of all children,
workers, consumers, and sensitive subgroups to harmful chemicals distributed in
commerce by calendar year 2020.” To that end, the bill would establish a safety
standard for chemicals in commerce that —
(A) provides a reasonable certainty that no harm will be caused by aggregate
exposure of a fetus, infant, child, worker, or member of other sensitive subgroup
to the chemical substance; and
(B) is requisite to protect the public welfare from any known or anticipated
adverse effects associated with the chemical substance.
Chemical manufacturers would be required to submit to EPA: 1) a statement that
each chemical they manufacture or import meets the safety standard, or that there are
insufficient data to determine whether that is the case, and 2) “all reasonably
available information” regarding chemical properties, uses, production volume,
exposure, and fate. Based on all available information, EPA then would be required
to categorize all chemicals in commerce based on criteria relating to human exposure,
known health effects, and persistence in the environment, and to identify at least 300
high-priority chemicals. The bills would direct EPA to evaluate manufacturers’ safety
and data statements for those 300 chemicals within four and a half years of
152 Davies, p. 5.
153 Phibbs-Rizzuto, Pat. “Toxic substances makers, users of nanomaterials in Berkeley must
provide certain data to city by June,” Daily Environment Report, v. 86, May 4, 2007, p. A-3.
enactment of the Kid-Safe Chemicals Act. H.R. 6100/S. 3040 would require EPA
to evaluate statements within 15 years for all chemicals in commerce as of the date
of enactment. No new chemical would be permitted to enter U.S. commerce unless
EPA found that the manufacturer had demonstrated conformance with the safety
standard. If manufacturers failed to submit required statements or data for a chemical,
or if the EPA Administrator determined that a chemical failed to meet the safety
standard, then manufacture, importation, and distribution of that chemical in the
United States would be prohibited. EPA would be authorized to prohibit or permit
H.R. 6100/S. 3040 establishes an incentive for manufacturers to conduct studies
to determine the level of risk posed by their chemicals by changing the regulatory
default status for chemicals lacking toxicity and exposure data from generally
permitted to generally banned. EPA would no longer have to prove that an
unreasonable risk may exist in order to require data to be developed. Manufacturers
who failed to produce and submit required safety data would lose the right to market
their chemicals in the United States. The bill’s requirements for proving safety before
marketing, together with its establishment of new programs to inform the public
about chemical hazards and uses, and to fund development of “safer” or “greener”
chemicals and processes, would be likely to reduce use over time of the more toxic
chemicals in commerce. Reduced use of toxic chemicals has long been a goal of
H.R. 6100/S. 3040 has the strong support of environmental and public health
advocacy groups,154 but is opposed or supported only with reservations by trade
groups representing the chemical industry.155
EPA’s Initiatives. In August 2007, EPA announced that the United States,
Mexico, and Canada had reached an agreement at Montebello, Quebec, at the
Security and Prosperity Partnership of North America (SPP) Leaders’ Summit.156,157
The three countries committed to coordinate efforts to assess and manage risks of
approximately 9,000 chemicals produced or imported in quantities greater than
25,000 pounds per year. The EPA commitments under the SPP are being fulfilled
by the Chemical Assessment and Management Program (ChAMP). EPA will apply
the results of EPA’s work on HPV chemicals and extend its efforts to moderate
154 For example, see the comparison of current law and law as it would exist under H.R.
155 For example, see the May 21, 2008, press release of the American Chemistry Council.
[ h t t p : / / www.a me r i c a n c h e mi s t r y. c o m/ ne ws r oom] .
156 EPA. EPA Newsroom. U.S., Canada and Mexico Take Lead to Manage Industrial
Chemicals. August 21, 2007. [http://yosemite.epa.gov/opa/admpress.nsf/d0cf6618525a
November 1, 2007.
157 Regulatory Cooperation in the Area of Chemicals. 2007 Joint Statement: Prime Minister
Harper, President Bush and President Calderón. North American Leaders’ Summit, August
pdf/spp_reg_coop_chemicals.pdf], visited June 25, 2008.
production volume (MPV) chemicals, relying in part on work completed by Canada’s
Chemical Management Program. That program was announced by the Canadian
government on December 8, 2006,158 but Canada has been screening and categorizing
all 23,000 chemicals on its Domestic Substances List, its equivalent of the TSCA
Inventory, since 1999.159 The Canadian approach to prioritizing chemicals for review,
assessment, and management has resulted in new data reporting requirements for the
chemicals of highest priority.160 “EPA plans to use the Canadian results as a starting
point for U.S. efforts to assess the hazards of moderate-volume chemicals, using
available data and hazard estimation approaches to prepare initial scientific
assessments.”161 No new U.S. data will be collected. However, EPA plans to
summarize available data and make it available to the public. The first hazard
characterizations for HPV chemicals have been posted online.162 As of September
2008, EPA has developed and posted risk-based prioritizations for 102 HPV
chem i cal s. 163
It is widely agreed that the regulation of chemicals in U.S. commerce should be
based on sound science, cost-benefit analysis, and relative risks, that stakeholders
should be involved in developing and evaluating risk-reduction measures, and that
chemicals posing unreasonable risks to the environment or public health should be
adequately controlled. Congress enacted the Toxic Substances Control Act in 1976
to generate scientific information needed for chemical risk assessment, and to
regulate chemicals in a way that would balance public health and environmental risks
with economic costs and benefits.
Analysts and policy makers currently are evaluating TSCA performance over
the past 30 years and considering how the law is likely to perform in the future.
Some analysts, and most in the regulated community, believe that TSCA has
performed as intended, and they support TSCA in its current form. They praise
TSCA as a flexible, efficient, and effective limit to over-regulation. Other policy
analysts and legal commentators want to amend TSCA, because they think that it has
158 Government of Canada. Chemical Substances. [http://www.chemicalsubstances
chimiques.gc.ca/en/], visited September 18, 2008.
159 Environment Canada. Existing Substances Evaluation, CEPA Registry, Domestic
Substances List Categorization and Screening Program. [http://www.ec.gc.ca/substances/
ese/eng/dsl/dslprog.cfm], visited September 18, 2008.
160 Denison, Richard A. 2007. Not That Innocent. Environmental Defense, Washington,
DC. p. IV-3.
161 EPA. Press release. August 21, 2007.
162 EPA. HPV Chemical Hazard Characterizations. [http://iaspub.epa.gov/oppthpv/hpv_
hc_characterization.get_report], visited September 18, 2008.
163 EPA. About HPV Chemical Risk-Based Prioritizations. [http://www.epa.gov/chemrtk/
hpvis/aboutrbd.htm], visited September 18, 2008.
not accomplished the tasks laid out for it by Congress and is unlikely to do better in
the future, given recent and emerging changes in science and technology.164
The available evidence indicates that EPA has had limited success using TSCA
to gather information about new chemicals, but has demonstrated creativity and
expertise in making use of available information to categorize such chemicals based
on hazard potential, thereby reducing risks potentially associated with exposure to
chemicals entering U.S. commerce. The agency has had some success in gathering
information about existing chemicals, but has regulated only a handful. Based on a
lack of expressed concern by stakeholders and the competitive strength of the U.S.
chemical industry, EPA also appears to have avoided imposing a regulatory burden
that unduly oppresses innovation and commerce.
Whether the amount of chemical regulation in the United States adequately
controls unreasonable risks is a key policy question. However, it is clear that a few
chemicals posed risks that Congress found unreasonable and TSCA (Title I) failed
to control: Congress amended TSCA on three occasions to control risks associated
with asbestos, lead, and radon. Some remain dissatisfied with TSCA. For example,
S. 742, as reported by the Senate Committee on Environment and Public Works in
the 110th Congress, and H.R. 6903, as introduced, would ban many asbestos-
containing materials. Numerous states also have acted to control risks from
chemicals that are not regulated under TSCA. In addition, many nations have joined
together to regulate persistent, organic, pollutants and persistent, bioaccumulative
toxic substances in ways that the United States cannot under the current provisions
of TSCA.165 The European Union recently adopted a new law, REACH, that takes
a new approach to the regulation of chemicals, eliminating the distinction between
new and existing chemicals and requiring manufacturers to identify hazards and
manage risks for all uses of their chemicals. Multinational companies, therefore, may
have to comply with multiple, possibly redundant or conflicting regulations.
Even if one concludes that TSCA has performed successfully in the past, it may
be reasonable to question the adequacy of a 1976 chemical law in the light of thirty
years of scientific and technological advances. In particular, nanotechnology and
GMO advances pose new challenges that many feel require clarified and possibly
augmented authority under TSCA, to protect human health and the environment.
164 Wilson, Green Chemistry, p. 16.
165 However, the United States does regulate these chemicals. For more on these
international agreements and issues related to them, see CRS Report RS22379, Persistent
Organic Pollutants (POPs): Fact Sheet on Three International Agreements, by Linda-Jo
Appendix. A Key Court Case
In 1991, the U.S. Court of Appeals for the Fifth Circuit vacated and remanded
an EPA rule promulgated under Section 6 that prohibited the manufacture,166
importation, processing, and distribution of asbestos in almost all products. The
substantive heart of the Corrosion Proof decision was its conclusion that EPA had
insufficiently justified its ban. This conclusion was based on two grounds. First, the
court said that EPA failed to give adequate weight to Section 6(a) insistence that the
regulatory approach chosen by EPA be the “least burdensome” to achieve the agency-
determined acceptable level of (non-zero) risk. EPA’s burden was especially difficult
here, because the court noted that in imposing an asbestos ban, EPA chose the most
burdensome of the options afforded by Section 6(a). By analyzing only two scenarios
— the ban and no TSCA regulation at all — the court held that EPA failed to show,
as TSCA requires, that there was not some intermediate regulation that would
achieve the acceptable risk level. “[T]he proper course for the EPA to follow is to
consider each regulatory option, beginning with the least burdensome, and the costs167
and benefits of regulation under each option.” Only such an exercise assures that
the agency has not skipped a less-burdensome alternative.
Second, the court said EPA also must present a stronger case for a ban of
products for which substitutes are not now available (as describes some of the
asbestos products covered by the ban here), than of products for which substitutes are
available. This it did not do. As to asbestos products for which substitutes are now
available, EPA declined to consider the harm from a probable substitute’s increased
use, even where it is a known carcinogen, the court added. Thus, EPA cannot assure
that its ban will increase workplace safety, depriving the ban of a reasonable basis.
To be sure, EPA need not seek out and test every possible substitute, but where
interested parties introduce evidence showing the toxicity or decreased safety of
probable substitutes, EPA must consider the comparative toxic costs of each — that
is, whether its chosen section 6(a) option is increasing workplace safety at all.
As another facet of this insufficient evidence issue, the court determined that
EPA failed to consider adequately the costs imposed by its ban. Under section 6(a),
EPA may regulate only to address “unreasonable risk” — that is, whether “the
severity of the injury that may result from the product, factored by the likelihood of
the injury, offsets the harm the regulation itself imposes upon manufacturers and168
consumers.” The high costs imposed on industry by the asbestos ban, compared to
the small number of lives predicted to be saved, suggested to the court that EPA
could not have given the former serious consideration.
Finally, the court examined both the failure to examine intermediate options
(first ground above) and the insufficiency of evidence (second ground above) as these
issues affected specific asbestos products covered by the ban, spelling out the
deficiencies in greater detail. For example, in the case of friction products, EPA
failed to study the effects of non-asbestos brakes on automotive safety, despite
evidence that non-asbestos brakes could increase the number of highway fatalities.
166 Corrosion Proof Fittings v. EPA, 947 F.2d 1201 (5th Cir. 1991).
167 Id. at 1217.
168 Id. at 1222.