Order Code RL34118
The Toxic Substances Control Act (TSCA):
Implementation and New Challenges
August 3, 2007
Linda-Jo Schierow
Specialist in Environmental Policy
Resources, Science, and Industry Division

The Toxic Substances Control Act (TSCA):
Implementation and New Challenges
Summary
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. TSCA regulates potential risks of industrial
chemicals in U.S. commerce, based on three policies: (1) Chemical manufacturers
and processors 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 of injury to health or the environment; and (3) EPA’s
implementation of the law should not “impede unduly or create unnecessary
economic barriers to technological innovation.”1 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 sides of the debate
point to EPA’s history of implementation 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.
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. For example, 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. New technologies have created
bioengineered plants, microbes, and nanoparticles, 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 and analysts 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.
1 TSCA, Section 2, 15 U.S.C. §2601.

Contents
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
TSCA Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Policies and Intent . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Chemical Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Pre-Manufacture Notices and Significant New Use Notices . . . . . . . . . . . . . 4
Regulatory Controls for Hazardous Chemicals . . . . . . . . . . . . . . . . . . . . . . . 5
Chemical Production Inventory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Role of the States . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Judicial Review . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Implementation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Chemical Inventory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Review and Management of New Chemicals . . . . . . . . . . . . . . . . . . . . . . . . 9
Review and Management of Chemicals on the Original Inventory . . . . . . . 10
Data Collection and Risk Assessment Authorized by TSCA . . . . . . . 10
Voluntary Initiatives to Gather Data . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Risk Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Impact of a 1991 Decision by the Fifth Circuit Court
on Section 6 Rulemaking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Recent Events and Trends
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
State Laws and Local Ordinances . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
International Agreements on Chemicals . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
New Chemical Laws in Other Nations . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Scientific Developments and Issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Toxicology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Computational Toxicology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Exposure Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Technological Developments and Issues . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Genetically Modified Organisms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Nanotechnology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Appendix. A Key Court Case . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
List of Tables
Table 1. Numbers of Chemicals in U.S. Commerce . . . . . . . . . . . . . . . . . . . . . . . 8

The Toxic Substances Control Act (TSCA):
Implementation and New Challenges
Introduction
Recent legal, scientific, and technological developments affecting chemicals in
U.S. commerce are prompting legislators to reexamine the Toxic Substances Control
Act of 1976 (TSCA).2 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.3
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, or IV which concern
asbestos, radon, or lead, respectively, see CRS Report RL31905, The Toxic
Substances Control Act: A Summary of the Act and Its Major Requirements
by
Linda-Jo Schierow.
TSCA Overview
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 other
environmental statutes. The House and Senate each passed bills in both the 92nd 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
other waterways by polychlorinated biphenyls (PCBs), the threat of stratospheric
ozone depletion from chlorofluorocarbon (CFC) emissions, and contamination of
2 15 U.S.C. 2601-2692.
3 Three titles have been added to address concerns about specific toxic substances —
asbestos in 1986 (Title II, P.L. 99-519), radon in 1988 (Title III, P.L. 100-551), and lead in
1992 (Title IV, P.L. 102-550).

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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 mixtures;
! [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 to health or the
environment.”4
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
4 TSCA, Section2(b).

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(e.g., alcohol), and food, drugs, cosmetics, and devices regulated under the Federal
Food, Drug, and Cosmetic Act.
Chemical Testing
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 to resolve the question of safety, 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.5 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.6 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.7 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
its disposal.
5 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 the
Environment: a 21st 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 are in commerce worldwide,
according to the Service. Of these, fewer than 245,000 are regulated or inventoried.
[http://www.cas.org/cgi-bin/regreport.pl].
6 TSCA Section 4(e).
7 Interagency Testing Committee homepage. [http://www.epa.gov/opptintr/itc/].

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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
10 directs EPA to conduct and coordinate among federal agencies research,
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
certain circumstances.8
For existing chemicals, a similar notification procedure may be required, if the
Administrator has determined by rule that new uses of a particular, potentially
dangerous, 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 45 days after notification (or up to 90 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.
Alternatively, EPA may determine that the proposed activity related to a
chemical does not present an unreasonable risk; this decision may be based on the
8 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.

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available scientific evidence with respect to potential for exposure and subsequent
adverse effects, or, when no data exist to document such effects, on what is known
about the effects of chemicals in commerce with similar chemical structures and used
in similar ways. 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
pre-market testing.
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
review.
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. 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
particular use;
! 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;

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! 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.
TSCA Section 9 also allows EPA to refer cases of chemical risk to other federal
agencies that have the authority to prevent or reduce the risk.
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
disposal.
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.
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

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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
commerce.
Judicial Review
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.
Implementation
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.9 A slightly
older report by the U.S. Government Accountability Office (GAO) also describes
EPA efforts to regulate chemicals under TSCA.10
Chemical Inventory
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 chemicals11 that manufacturers and importers reported had
been produced in, or imported into, the United States for commercial purposes after
January 1, 1975.12 This included naturally occurring as well as synthetic chemicals.
9 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].
10 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.
11 U.S. EPA. 2007. Overview: Office of Pollution Prevention and Toxics Programs. p. 5.
[http://www.epa.gov/oppt/pubs/oppt101c2.pdf].
12 42 Federal Register 64572.

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Table 1. Numbers of Chemicals in U.S. Commercea
Original inventory in 1979
61,000
Added since 1979
20,700
Inventory in 2006
82,700
Reported in 2006 inventory update
9,000
a. Note that 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 enter U.S.
commerce. 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)
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, in consultation with the President’s Office of Management and Budget
(OMB) amended the general rule governing inventory updates (issued under TSCA
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.asp?SID=1&DID=3384&CID=433&VID=115&DOC
=File.PDF].
15 EPA Overview, p. 6.
16 A polymer is a compound, usually large, composed of numerous copies of a much simpler
compound which form long chains. Many polymers are not toxic, and therefore are of
limited concern to EPA. Criteria for determining whether a polymer is exempt from
requirements may be found at 40 CFR 723.250.
17 ACC. Questions and Answers About Chemical Testing and Regulations. July 11, 2005.
18 68 Federal Register 884, January 7, 2003.

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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 intended uses 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 exempt facilities from providing a PMN for a new chemical if they
produce or import certain polymers, or 10,000 kilograms (roughly 22,000 pounds)
or less of a chemical annually; or if chemical releases to the environment and human
exposure are very low.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
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
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].
22 Ibid.
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
chemicals.
25 Ibid., p. 10. That percentage drops to 65% for new chemicals that actually enter
commerce.
26 Ibid., p. 8.
27 EPA. “Economic analysis for the amended inventory update final rule,” August 2002, pp.
2-5.

CRS-10
and human health. Such models usually are referred to as structure-activity
relationships (SARs), or sometimes quantitative structure-activity relationships
(QSARs).
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),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
tests.
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
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.
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/

CRS-11
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
States.
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 the agency can safely ignore.35 Of these, about 3,000 were produced
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
32 (...continued)
itc/pubs/faq.htm].
33 Walker, personal communication. Updated information requested from EPA but not
provided.
34 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. 136.
35 EPA, Overview, p. 15.
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
others.

CRS-12
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
50,000 studies.43
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
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
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.
43 Ibid.
44 EPA. Interagency Testing Committee. Substantial Risk Information. TSCA Section 8(e).
[http://www.epa.gov/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
(continued...)

CRS-13
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
170 chemicals covered by final test rules.49
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
45 (...continued)
3, 2003), and brought in as many as 10,000 notices. [http://www.epa.gov/opptintr/
tsca8e/pubs/basicinformation.htm].
46 EPA. Toxic Substances Control Act Section 8(e) Notices. [http://www.epa.gov/oppt/
tsca8e/pubs/basicinformation.htm#pacess].
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
2004. The database available through Scorecard was last updated May 18, 2000.
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].
50 U.S. Congress. Senate. Committee on Environment and Public Works, Subcomittee 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.

CRS-14
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.
Settlement negotiations are still underway for those.53
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 industrial
chemicals in the united States has not progressed much over the last 20 years.54
The current head of OPPTS has a different opinion. According to Assistant
Administrator James Gulliford, “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.”55
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
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 Ibid., 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.
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.

CRS-15
categories of chemicals. Several High Production Volume (HPV) testing programs
are examples of the latter type.57
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.58 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
substances.59
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
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.60
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.
Environmental Defense, an advocacy group that helped to design the program, has
issued three reports on the status of the HPV program to date.61
57 Overview, pp. 30-33.
58 Organisation for Economic Co-operation and Development. Description of OECD work
on investigation of high production volume chemicals. [http://www.oecd.org/document/
21/0,2340,en_2649_201185_1939669_1_1_1_1,00.html].
59 EPA. OECD SIDS voluntary testing program for international high production volume
chemicals. [http://www.epa.gov/oppt/chemtest/pubs/oecdsids.htm].
60 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.
61 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.

CRS-16
Through November 2006, chemical manufacturers had committed to providing
EPA basic information on roughly 1,400 chemicals produced in high volumes.62
Data sets still were incomplete for 575 of the HPV chemicals on the original list, as
of December 2006. No manufacturer had committed to providing information for
about 265 chemicals on that list.63 Before the end of 2006, EPA had entered data
received for almost 900 chemicals into its new High Production Volume Information
System.64
More than 500 chemicals not on the original list now qualify as HPV chemicals;
232 of these are being sponsored by manufacturers through an Extended HPV
Program.65 On the other hand, about 250 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 2002.66 EPA plans a final report on
the HPV Challenge Program in 2008.
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 851
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.67
The American Chemistry Council points out that 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]).68
However, this basic screening information is provided only for about 2,000 chemicals
62 Denison, Richard A. “U.S. HPV Challenge and Beyond.” Presentation to the First U.S.
Conference on Characterizing Chemicals in Commerce: Using Data on High Production
Volume (HPV) Chemicals, Austin, Texas, December 12-14, 2006.
63 Denison, 2006.
64 Knobeloch, Lynda, and Henry Anderson, 2006, Use of the HPVIS to identify chemicals
that may pose a threat to the Great Lakes fishery, Final report. Presentation to the First U.S.
Conference on Characterizing Chemicals in Commerce: Using Data on High Production
Volume (HPV) Chemicals, Austin, Texas, December 12-14, 2006.
65 Denison, 2006.
66 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.
67 EPA Overview, p. 34.
68 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=
3384&CID=433&VID=115&DOC=File.PDF].

CRS-17
covered by the HPV Challenge Program.69 Thus, most existing chemicals lack
toxicity data relevant to risk assessment.70,71 Data on production volume and use,
which are critical for determining the potential for human and environmental
exposure and for setting priorities for EPA action, are also lacking.72 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.73
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
adverse health impacts, but not requiring testing to determine whether such impacts
might occur.74
Risk Management. EPA has used its Section 6 authority on eight occasions
to restrict manufacture or use of six chemicals.75 Two of these regulations were later
superseded by regulations under other environmental laws.76 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.77 Regulation of PCBs is required
explicitly by TSCA Section 6(e).
69 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.
70 EPA, Office of Pollution Prevention and Toxics. 1998. Chemical Hazard Data
Availability Study.
EPA, Washington, DC.
71 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.
141- 165.
72 EPA, Office of Pollution Prevention and Toxics. “Economic analysis for the amended
inventory update final rule,” August 2002, pp. 2-8.
73 EPA Overview, p. 8.
74 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.
75 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.
76 EPA Overview, p. 20.
77 EPA Overview, p. 20. Also see 40 CFR Parts 747, 749, 761, and 763, respectively.

CRS-18
In four instances, EPA has 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).78 In 1990, EPA sent a 9(a)
report to the Food and Drug Administration (FDA) on dioxins and furans in wood
and paper products.79 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
Section 9] has proven burdensome to EPA and cumbersome as a mechanism for
obtaining prompt consideration by applicable agencies.”80
Impact of a 1991 Decision by the Fifth Circuit Court on Section 6
Rulemaking.81 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,
importation, processing, and distribution of asbestos in almost all products.82 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 be
expected.83 As explained by Robert B. Haemer, Corrosion Proof Fittings “may have
done the most damage to EPA’s ability to regulate chemical substances.” He
continues:
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
78 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,
1986)
79 55 FR 53047, December 26, 1990.
80 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.
81 This section of the report was written chiefly by Robert Meltz, Legislative Attorney, CRS
American Law Division.
82 Corrosion Proof Fittings v. EPA, 947 F.2d 1201 (5th Cir. 1991).
83 See, for example, Thomas O. McGarrity, Professor Sunstein’s Fuzzy Math, 90 Geo. L. J.
2341, 2376 (2002); Thomas Sullivan (ed.), ENVIRONMENTAL LAW HANDBOOK 573 (16th
ed.) (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).

CRS-19
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 to
surmount an overly restrictive interpretation of reasonable risk....84
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
under TSCA leaves EPA almost paralyzed to take action to regulate toxic
substances.85
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’s
requirements for promulgating a single rule after a decade’s effort.”86
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 prevent
inefficient and wasteful regulation of toxic substances.87
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 appear to be increasing legislative interest
and are discussed below.
84 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-
119.
85 Id. at 126.
86 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.
87 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.

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State Laws and Local Ordinances
Many states and localities have enacted laws in recent years restricting the sale
or use of various chemicals88 or categories of substances that are federally managed
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).89 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.90 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.91
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.92 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
88 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/
nl_PBDEs.html]. Whetzel, Carolyn. 2007. “California Adopts Emission Standards For
Formaldehyde From Wood Products.” Daily Environment Reporter, May 2, 2007, p. A-2.
[http://www.arb.ca.gov/regact/2007/compwood07/compwood07.htm].
89 National Conference of State Legislatures. Agriculture: Biotechnology Statutes Chart.
[http://www.ncsl.org/programs/agri/biotchlg.htm].
90 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
5, 2007, online version. [http://www.usatoday.com/news/washington/2007-05-07-epa-
chemicals_N.htm?csp=34].
91 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].
92 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/
news/06_wilson_policy.htm].

CRS-21
“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.93 He also suggested that the process is self-
sustaining: because the market is driven by knowledge of what chemicals can do and
what they cost, he claims that new graduates with Ph.D.s in chemistry from major
universities can lack even a rudimentary understanding of toxicology.94 The solution
for California, the report concludes, is for it to take a leadership role in chemicals
policy.95
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.96 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.97
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.98
The Executive Branch, working through the State Department and EPA, has
sought to smooth the way for American businesses abroad, through informal
agreements and formal treaties. Business interests and other non-governmental
93 Ibid.
94 “Stakeholders mull need for strategy to address emerging chemical issues.” Special
report. April 30, 2007. Daily Environment Report. p. B-1.
95 Wilson, Michael P. Testimony before the California Senate Environmental Quality
Committee, June 28, 2006, Sacramento, CA.
96 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.
97 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.
98 American Electronics Association. AeA International Environment Overview. Issues
Summary. [http://aeanet.org/GovernmentAffairs/gamb_EnvOverview.asp].

CRS-22
organizations often have participated in negotiations. Domestic implementation of
such agreements, however, is constrained by U.S. environmental statutes.
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,
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;99
! requires data production and reporting for most chemicals in
commerce;
! 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.
99 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].

CRS-23
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.
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
environmental policy.100
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.101 As stated in an American Chemistry Council
(ACC) factsheet:
The United States chemical management regulatory system is based on the use
of credible scientific information and embodies several layers of precaution that
are protective of human health and the environment.102
Implementation of REACH will provide the world 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.
100 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.
101 ACC. Registration, Evaluation, and Authorization of Chemicals. [http://www.
americanchemistry.com/s_acc/sec_policyissues.asp?CID=621&DID=2217].
102 ACC. TSCA Fact Sheet. August 2, 2006. [http://www.americanchemistry.com/s_acc/
bin.asp?SID=1&DID=2766&CID=433&VID=115&DOC=File.PDF].

CRS-24
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 toxicology
was published in 1972.103 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 in
toxicology and regulation” since TSCA was enacted.104
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;105
! ability of chemicals to disrupt the functioning of endocrine
systems;106
! exposure from a variety of sources and environmental media (for
example, drinking water as well as workplace air);107 and
! cumulative exposure from different chemicals that have similar
effects on the body.108
103 Casarett, Louis J. and John Doull (Eds.). 1975. Toxicology: The Basic Science of Poisons.
New York: Macmillan.
104 Commission on Risk Assessment and Risk Management. 1997. Risk Assessment and
Risk Management in Regulatory Decision-Making
. Final Report, Vol. 2. p. 126.
105 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).
106 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.
107 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).
108 Ibid.

CRS-25
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
TSCA.109
Computational Toxicology. The most recent innovation with respect to
toxicology emerged in the late 1990s and is developing rapidly: computational
toxicology.110 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.111
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.112 Such data 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.
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
109 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%
20&%20Vccep/Child%20Safe%20Chemicals%20Statement%20of%20Principles.htm].
110 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
living organisms.
111 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.
112 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.

CRS-26
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 reliable predictors of
chemical properties, the question may arise whether QSAR is a sufficient basis for
an unreasonable risk determination. EPA may make this decision on its own
authority, but Congress also might wish to weigh in on that decision. According to
one former EPA Assistant Administrator:
There is not a lot of empirical basis for SAR, and the one major empirical
examination of its validity found that it was moderately accurate for some effects
but not at all accurate for others (U.S. EPA, 1993). For example, it was correct
only 57% of the time when predicting systemic toxicity (ibid. p. 49).
Furthermore, it consistently tended to underestimate health effects (ibid. p. 50).
However, SAR has allowed both EPA and the chemical industry to defend the
TSCA program and to claim that it adequately protects the public.113
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 cumulative
exposure to different chemicals with similar modes of action.114 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
particular periods, for example, before or after mating, during the gestation period,
or soon after birth.115
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. Amendments to TSCA might address such issues.
113 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].
114 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.
115 Ibid.

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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,116 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.117 For example, EPA
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.118,119
(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
116 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].
117 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.
[http://www.icsu-scope.org/downloadpubs/scope44/chapter14.html].
118 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/].
119 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,
U.S. EPA.

CRS-28
microbes under TSCA Section 5.120 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” and
warrant review.121
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 fall
within this definition.”122 A 2004 report by the Pew Initiative on Food and
Biotechnology raised the same point.123 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.124 At least eight microorganism PMNs have been
received by OPPT, according to EPA.125 OPPT has reviewed bacteria for degradation
of hazardous wastes, enhanced nitrogen fixation in plants, and for closed system
production of enzymes.126
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.127 They raise the question, are cloned
mammals or the substances they produce also “new chemical substances” under
120 Ibid.
121 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].
122 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.
123 Pew Initiative on Food and Biotechnology. 2004. Issues in the Regulation of Genetically
Engineered Plants and Animals. Executive Summary. p. 9. [http://pewagbiotech.org/
research/regulation/].
124 40 CRF §725.3.
125 EPA Overview, p. 12.
126 EPA Overview, Appendix, p. B-11.
127 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/
research/regulation/].

CRS-29
TSCA? Investment in developing markets for such bioengineered livestock and
products reportedly is suffering from a lack of clear federal rules.128
On the other hand, many support the current regulatory framework, arguing that
the dangers of genetically modified organisms are adequately controlled.129 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.”130
Nanotechnology. More recently, scientists and engineers have begun to
examine, design, and manipulate materials at the molecular level, or nanoscale.131
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,
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.132 There is scientific evidence that some nanoparticles may be hazardous.
128 Pollack, Andrew. Without U.S. rules, biotech food lacks investors. New York Times,
July 30, 2007. Online edition. [http://www.nytimes.com/].
129 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,
U.S. EPA.
130 Grace, Eric S. 2006. Biotechnology Unzipped: Promises and Realities, Revised 2nd
edition. Washington DC: Joseph Henry Press. p. 216.
131 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 —
06 at [http://www.astm.org].
132 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.org/documents/4857_ACC-ED_nanotech.pdf].

CRS-30
For example, certain nanoparticles are known to be toxic to microbes,133 and EPA has
reported studies that have found nanoparticles generally (but not always) are more
toxic than larger particles of identical chemical composition.134 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.135
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.”136 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.137 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
the public and workers.138 One analyst has suggested that EPA regulation should
focus on the specific products of nanotechnology, rather than on more generic
nanomaterials.139 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.”140
133 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 C fullerenes to bacteria in water under laboratory conditions (Fortner, J.D., D.Y.
60
Lyon, C.M. Sayes, et al. “C60 in water: Nanocrystal formation and microbial response,”
Environmental Science & Technology, v. 39, (2005), pp. 4307-4316.)
134 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,
p. 54.
135 Naturally occurring nanoparticles exist, and some (for example particles in exhaust from
diesel fuel) have been studied for years.
136 EPA Fact Sheet for Nanotechnology under the Toxic Substances Control Act.
[http://www.epa.gov/oppt/nano/nano-facts.htm#usf].
137 Balbus, John, Richard Denison, Karen Florini, and Scott Walsh. 2005. “Getting
Nanotechnology Right the First Time,” Issues in Science and Technology, Summer, pp. 65-
71.
138 Natural Resources Defense Council. 2006. “Health facts: Nanotechnology’s invisible
threat: Small science, big consequences.” December. [http://www.nrdc.org/health/
science/nano/fnano.pdf].
139 Davies, p. 23.
140 Rizzuto, Pat. 2006. “EPA Reviews 15 New Nanoscale Chemicals,” Daily Environment
Report
, v. 158, (August 16), p. A-7.

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Recently, EPA released a document outlining its historical approach to
determining whether a chemical is “new” to the TSCA inventory.141 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.
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.”142
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.143 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
chemicals.
Conclusion
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
141 EPA. 2007. TSCA Inventory Status of Nanoscale Substances — General Approach.
[http://www.regulations.gov/fdmspublic/component/main?main=DocumentDetail&d=
EPA-HQ-OPPT-2004-0122-0057].
142 Davies, p. 5.
143 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.

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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
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.144
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, would ban many asbestos-containing products. 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.145 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.
144 Wilson, Green Chemistry, p. 16.
145 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
, Linda-Jo
Schierow.

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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,
importation, processing, and distribution of asbestos in almost all products.146 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 costs
and benefits of regulation under each option.”147 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 and
consumers.”148 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.
146 Corrosion Proof Fittings v. EPA, 947 F.2d 1201 (5th Cir. 1991).
147 Id. at 1217.
148 Id. at 1222.