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entitled 'Chemical Regulation: Options Exist to Improve EPA's Ability
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Report to Congressional Requesters:
June 2005:
Chemical Regulation:
Options Exist to Improve EPA's Ability to Assess Health Risks and
Manage Its Chemical Review Program:
[Hyperlink, http://www.gao.gov/cgi-bin/getrpt?GAO-05-458]:
GAO Highlights:
Highlights of GAO-05-458, a report to congressional requesters:
Why GAO Did This Study:
Chemicals play an important role in everyday life, but some may be
harmful to human health and the environment. Chemicals are used to
produce items widely used throughout society, including consumer
products such as cleansers, paints, plastics, and fuels, as well as
industrial solvents and additives. However, some chemicals, such as
lead and mercury, are highly toxic at certain doses and need to be
regulated because of health and safety concerns. In 1976, the Congress
passed the Toxic Substances Control Act (TSCA) to authorize the
Environmental Protection Agency (EPA) to control chemicals that pose an
unreasonable risk to human health or the environment.
GAO reviewed EPA’s efforts to (1) control the risks of new chemicals
not yet in commerce, (2) assess the risks of existing chemicals used in
commerce, and (3) publicly disclose information provided by chemical
companies under TSCA.
What GAO Found:
EPA’s reviews of new chemicals provide limited assurance that health
and environmental risks are identified before the chemicals enter
commerce. Chemical companies are not required by TSCA, absent a test
rule, to test new chemicals before they are submitted for EPA’s review,
and companies generally do not voluntarily perform such testing. Given
limited test data, EPA predicts new chemicals’ toxicity by using models
that compare the new chemicals with chemicals of similar molecular
structures that have previously been tested. However, the use of the
models does not ensure that chemicals’ risks are fully assessed before
they enter commerce because the models are not always accurate in
predicting chemical properties and toxicity, especially in connection
with general health effects. Nevertheless, given the lack of test data
and health and safety information available to the agency, EPA believes
the models are generally useful as screening tools for identifying
potentially harmful chemicals and, in conjunction with other
information, such as the anticipated potential uses and exposures of
the new chemicals, provide a reasonable basis for reviewing new
chemicals. The agency recognizes, however, that obtaining additional
information would improve the predictive capabilities of its models.
EPA does not routinely assess the risks of all existing chemicals and
EPA faces challenges in obtaining the information necessary to do so.
TSCA’s authorities for collecting data on existing chemicals do not
facilitate EPA’s review process because they generally place the costly
and time-consuming burden of obtaining data on EPA. Partly because of a
lack of information on existing chemicals, EPA, in partnership with
industry and environmental groups, initiated the High Production Volume
(HPV) Challenge Program in 1998, under which chemical companies began
voluntarily providing information on the basic properties of chemicals
produced in large amounts. It is unclear whether the program will
produce sufficient information for EPA to determine chemicals’ risks to
human health and the environment.
EPA has limited ability to publicly share the information it receives
from chemical companies under TSCA. TSCA prohibits the disclosure of
confidential business information, and chemical companies claim much of
the data submitted as confidential. While EPA has the authority to
evaluate the appropriateness of these confidentiality claims, EPA
states that it does not have the resources to challenge large numbers
of claims. State environmental agencies and others are interested in
obtaining confidential business information for use in various
activities, such as developing contingency plans to alert emergency
response personnel of the presence of highly toxic substances at
manufacturing facilities. Chemical companies recently have expressed
interest in working with EPA to identify ways to enable other
organizations to use the information given the adoption of appropriate
safeguards.
What GAO Recommends:
GAO recommends that the Congress consider providing EPA additional
authorities under TSCA to improve its ability to assess chemical risks
and that the EPA Administrator take several actions to improve EPA’s
management of its chemical program. EPA did not disagree with GAO’s
recommendations but provided substantive comments.
www.gao.gov/cgi-bin/getrpt?GAO-05-458.
To view the full product, including the scope and methodology, click on
the link above. For more information, contact John Stephenson at (202)
512-6225 or stephensonj@gao.gov.
[End of section]
Contents:
Letter:
Results in Brief:
Background:
EPA Lacks Sufficient Data to Ensure That Potential Health and
Environmental Risks of New Chemicals Are Identified:
EPA Does Not Routinely Assess Existing Chemicals, Has Limited
Information on Their Health and Environmental Risks, and Has Issued Few
Regulations Controlling Such Chemicals:
EPA's Ability to Share Data Collected under TSCA Is Limited:
Conclusions:
Matters for Congressional Consideration:
Recommendations for Executive Action:
Agency Comments and Our Evaluation:
Appendixes:
Appendix I: EPA's Voluntary Programs:
Appendix II: Canadian and EU Chemical Legislation:
Appendix III: Additional Options for Strengthening EPA's Ability to
Assess and Regulate Chemicals under TSCA:
Appendix IV: Scope and Methodology:
Appendix V: Regulations Promulgated under Section 6 of TSCA:
Appendix VI: Comments From the Environmental Protection Agency:
Appendix VII: GAO Contact and Staff Acknowledgments:
Tables:
Table 1: TSCA's Major Sections for Chemical Data Collection and Control
Table 2: Regulation of Chemicals in the United States, Canada, and
European Union:
Abbreviations:
ACC: American Chemistry Council:
CCT: comfort cooling towers:
CEPA: Canadian Environmental Protection Act:
EPA: Environmental Protection Agency:
EC: European Commission:
EU: European Union:
FFDCA: Federal Food Drug and Cosmetic Act:
FIFRA: Federal Insecticide, Fungicide, and Rodenticide Act:
HPV: High Production Volume:
ITC: Interagency Testing Committee:
IUR: Inventory Update Rule:
NPPTAC: National Pollution Prevention and Toxics Advisory: Committee:
OECD: Organization for Economic Co-operation and Development:
PCBs: polychlorinated biphenyls:
PMN: pre-manufacture notice:
PPA: Pollution Prevention Act:
REACH: Registration, Evaluation and Authorization of Chemicals:
SAR: structure activity relationships:
SNUR: significant new use rule:
SOCMA: Synthetic Organic Chemical Manufacturers Association:
TCCD: tetrachlorodibenzo-p-dioxin:
TSCA: Toxic Substances Control Act:
VCCEP: Voluntary Children's Chemical Evaluation Program:
Letter June 13, 2005:
The Honorable James M. Jeffords:
Ranking Minority Member, Committee on Environment and Public Works:
United States Senate:
The Honorable Frank R. Lautenberg:
United States Senate:
The Honorable Patrick Leahy:
United States Senate:
Tens of thousands of chemicals are currently in commercial use in the
United States and, on average, over 700 new chemicals are introduced
into commerce each year. Many of these chemicals play an important role
in people's everyday lives. Consumers use products containing or made
from chemicals ranging from cleansers and paints to plastics and fuels.
In a wide variety of other products and industrial processes, companies
use chemicals as solvents and additives. Although chemicals are
important in producing goods and services, some may adversely affect
human health and the environment. For example, asbestos, which refers
to several minerals that typically separate into very tiny fibers, is a
known human carcinogen that can cause lung cancer and other diseases if
inhaled. Materials that contained asbestos were used widely for
fireproofing, thermal and acoustical insulation, and decoration in
building construction and renovation before the adverse effects of it
were known.
In 1976, the Congress passed the Toxic Substances Control Act (TSCA) to
provide the Environmental Protection Agency (EPA) with the authority to
obtain more information on chemicals and regulate those chemicals that
pose an unreasonable risk to human health or the environment. TSCA
addresses those chemicals manufactured, imported, processed,
distributed in commerce, used, or disposed of in the United States, but
excludes certain substances including, among other things, pesticides
that are regulated under the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA); and food; food additives; drugs; cosmetics or
devices that are regulated under the Federal Food, Drug and Cosmetic
Act (FFDCA).
TSCA authorizes EPA to assess chemicals before they enter commerce (new
chemicals) and review those chemicals already in commerce (existing
chemicals). EPA lists chemicals in commerce in the TSCA inventory. Of
the over 82,000 chemicals currently in the TSCA inventory, about 62,000
were already in commerce when EPA began reviewing chemicals in 1979.
Since then, EPA has reviewed more than 40,000 substances as new
chemical submissions, of which, approximately 20,000 were added to the
inventory after chemical companies began manufacturing them.
EPA has developed programs to assess, test, and manage identified
potential risks from new and existing chemicals. To assess risks, EPA
evaluates a chemical's potential exposure levels and adverse effects on
human health and the environment. For new chemicals, TSCA generally
requires a company to notify EPA at least 90 days before manufacturing
a new chemical by submitting a premanufacture notice. These notices are
to provide information on the chemical's identity, production process,
anticipated production volume, intended uses, potential exposure and
release levels, disposal, byproducts, test data possessed or controlled
by the chemical company, and a description of any other data concerning
the chemical's environmental or health effects known to or reasonably
ascertainable by the chemical company.
Information on chemical risks that EPA collects under TSCA is not
always available to state and local governments and the public. In
order to protect trade secrets and privileged or confidential
commercial or financial information, TSCA allows chemical companies to
designate information provided to EPA as confidential and, if it meets
certain criteria, EPA must protect this information from disclosure.
In response to your request, we reviewed EPA's efforts to (1) control
the risks of new chemicals not yet in commerce, (2) assess existing
chemicals used in commerce, and (3) publicly disclose information
provided by chemical companies under TSCA. In addressing these issues
we also obtained information on some of EPA's voluntary chemical
control programs designed to complement TSCA and on the chemical
control programs of Canada and the European Union (EU). In addition, we
identified some legislative options that we have noted in the past
could strengthen EPA's ability to assess and regulate chemicals under
TSCA. This information is presented in appendixes I, II, and III,
respectively.
To review the extent to which EPA has assessed the risks of new and
existing chemicals and has made information obtained under TSCA public,
we identified and analyzed EPA's policies and guidelines on how the
chemical review and control programs for new and existing chemicals
work, including the handling of confidential information, and
determined what actions EPA has taken to control chemicals. We also
gathered documentation on EPA's voluntary programs. These efforts were
augmented by interviews with EPA officials and representatives of the
American Chemistry Council (a national chemical manufacturers
association), Environmental Defense (a national, nonprofit,
environmental advocacy organization), and the Synthetic Organic
Chemical Manufacturer's Association (a national, specialty chemical
manufacturer's association). We also obtained and reviewed studies
conducted by EPA on the usefulness of confidential business information
to states. To identify potential options to strengthen EPA's ability to
assess and regulate chemical risks under TSCA, we (1) interviewed
officials at EPA, the American Chemistry Council, Environmental
Defense, EPA's National Pollution Prevention and Toxics Advisory
Committee, and the Synthetic Organic Chemical Manufacturer's
Association; (2) reviewed pertinent literature, including prior GAO
reports, case law, and congressional hearings on TSCA; (3) attended
various public meetings and conferences sponsored by EPA and others;
and (4) discussed chemical laws in Canada and the EU with their
representatives. A detailed description of our scope and methodology is
presented in appendix IV. We performed our work between July 2004 and
April 2005 in accordance with generally accepted government auditing
standards.
Results in Brief:
While TSCA authorizes EPA to promulgate rules requiring testing of
chemicals if EPA has made certain findings, TSCA does not require
chemical companies to test new chemicals for toxicity and to gauge
exposure levels before they are submitted for EPA's review and,
according to EPA officials, chemical companies typically do not
voluntarily perform such testing. In the absence of such data, EPA
predicts potential exposure levels and toxicity of new chemicals by
using scientific models and by comparing them with chemicals with
similar molecular structures (analogues) for which toxicity information
is available. However, the use of the models can present weaknesses in
the assessment because the models are not always accurate in predicting
physical chemical properties and the evaluation of general health
effects is contingent on the availability of suitable analogues.
Nevertheless, given the lack of test data in general, and health and
safety test data in particular available to the agency, EPA believes
that the models are generally useful as screening tools for identifying
potentially harmful chemicals and, in conjunction with other
information chemical companies provide in premanufacture notices, such
as the chemicals' estimated production volume and anticipated uses,
provide for a reasonable review of new chemicals. By enabling EPA to
screen chemicals for certain properties and characteristics, the models
allow the agency to perform more detailed reviews of those chemicals
that have properties and characteristics generally identified as posing
potential risks to people and the environment. EPA believes that, based
on limited validation studies, its models are more likely to identify a
false positive (where a chemical is determined to be of concern) than a
false negative (where a chemical is initially identified as a low
concern though on further analysis is actually of higher concern. EPA
recognizes, however, that obtaining additional information from
chemical companies could provide additional insight into chemical
toxicities and improve the predictive capabilities of its models.
Furthermore, the estimates of a chemicals' production volume and
anticipated uses provided in the premanufacture notice, which EPA uses
to assess exposure, can change substantially after EPA completes its
review and manufacturing begins. These estimates do not have to be
amended by companies unless EPA promulgates a rule determining that a
use of a chemical constitutes a significant new use, in which case a
significant new use notice would be required. EPA does this for only a
small percentage of new chemicals. However, the risk of exposure, and
thus the risk of injury to human health or the environment, may
increase when chemical companies increase production levels or expand
the uses of a chemical.
EPA does not routinely assess the human health and environmental risks
of existing chemicals and faces challenges in obtaining the information
necessary to do so. In this regard, TSCA authorizes EPA to require
chemical companies to develop test data only when the agency finds that
a chemical (1) may present an unreasonable risk of injury to health or
the environment or (2) is or will be produced in substantial quantities
and (a) there is or may be significant or substantial human exposure to
the chemical or (b) it enters or may reasonably be anticipated to enter
the environment in substantial quantities. EPA must also determine that
there are insufficient data to reasonably determine or predict the
effects of the chemical on health or the environment and that testing
is necessary to develop such data. EPA has used its authority to
require testing for fewer than 200 of the 62,000 chemicals in commerce
when EPA began reviewing chemicals under TSCA in 1979. In the late
1990s, in cooperation with chemical companies and environmental groups,
EPA implemented its High Production Volume (HPV) Challenge Program,
under which chemical companies have begun to voluntarily provide test
data on about 2,800 chemicals produced or imported in amounts of 1
million pounds or more a year. However, the chemical industry has not
agreed to provide testing for 300 chemicals originally identified in
the HPV Challenge Program, and EPA believes that some of the chemicals
produced in lesser quantities might potentially warrant testing.
Furthermore, even with the test data provided under the HPV Challenge
Program, EPA would need to demonstrate that chemicals pose unreasonable
risks in order to control their production or use under TSCA. While
TSCA does not define what risk is unreasonable, according to EPA
officials, the standard has been difficult to meet. In order to
withstand judicial scrutiny, a TSCA rule must be supported by
substantial evidence in the rulemaking record.
EPA has limited ability to publicly share the information it receives
under TSCA. TSCA generally prohibits disclosing to nonfederal officials
trade secrets and privileged or confidential commercial or financial
information protected under the Freedom of Information Act.In addition,
TSCA authorizes chemical companies to claim data as confidential
business information. According to EPA officials, about 95 percent of
the premanufacture notices for new chemicals submitted by chemical
companies contain some information that is claimed as confidential.
Under EPA's regulations, information that is claimed as confidential
business information shall generally be treated as such. Exceptions
include if the information is required to be released by some federal
law or order of a court, if the company submitter voluntarily withdraws
its claim of confidentiality, or if EPA makes an administrative
determination that the information does not meet the regulatory
criteria substantiating a legal right to the claim. While TSCA
confidential business information can be provided to federal officials
and contractors, it generally cannot be provided to other organizations
responsible for assessing chemical risks, enforcing chemical control
laws, and performing other environmental activities, including state
regulatory agencies and foreign governments. However, some state
environmental regulators believe that toxicity information submitted
under TSCA would be useful in managing their environmental risk
programs, including developing contingency plans to alert emergency
response personnel to the presence of highly toxic substances at
manufacturing facilities. While EPA has the authority to evaluate the
appropriateness of confidentiality claims and can deny companies'
claims of confidentiality if they are found to be illegitimate, these
efforts are time and resource-intensive, and the agency does not have
the resources to challenge a significant large number of claims. EPA
has considered various changes in its regulations for TSCA
confidentiality claims, such as revising the regulations to require
chemical companies to more fully substantiate their claims. In
addition, the EPA Office of General Counsel led a comprehensive review
of EPA's agency wide confidential business information regulations,
which are referred to in the TSCA confidential business information
regulations, but this did not lead to any amendments to the general
agency-wide regulations.
In order to improve EPA's ability to assess the health and
environmental risks of chemicals, we are recommending that the Congress
consider amending TSCA to provide EPA additional authorities. We are
also making several recommendations to improve EPA's management of its
chemical review program.
Background:
In the last several decades, the Congress has passed legislation to
increase federal agencies' ability to determine the health and
environmental risks associated with toxic chemicals and to address such
risks. Some of these laws, such as the Clean Air Act, the Clean Water
Act; the Federal Food, Drug and Cosmetic Act; and the Federal
Insecticide, Fungicide, and Rodenticide Act; authorize the control of
hazardous chemicals in, among other things, the air, water, soil, food,
drugs, and pesticides. Other laws, such as the Occupational Safety and
Health Act and the Consumer Product Safety Act, can be used to protect
workers and consumers from unsafe exposures to chemicals in the
workplace and the home. These laws were generally enacted in or before
the early 1970s. Nonetheless, the Congress found that human beings and
the environment were being exposed to a large number of chemicals and
that some could pose an unreasonable risk of injury to health or the
environment. In 1976, the Congress passed TSCA to provide EPA with the
authority to obtain more information on chemicals and regulate those
chemicals that pose an unreasonable risk to human health or the
environment.[Footnote 1]
TSCA provides EPA with the authority, upon making certain
determinations, to collect information about the hazards posed by
chemical substances and to take action to control unreasonable risks by
either preventing dangerous chemicals from making their way into
commerce or otherwise regulating them, such as by placing restrictions
on those already in the marketplace. While other environmental and
occupational health laws generally only control the release of
chemicals in the environment, exposures in the workplace, or the
disposal of chemicals, TSCA allows EPA to control the entire life cycle
of chemicals from their production and distribution to their use and
disposal. However, the act does not apply to certain substances such as
nuclear material, firearms and ammunition, pesticides, food, food
additives, tobacco, drugs, and cosmetics.
TSCA's role in ensuring that chemicals in commerce do not present an
unreasonable risk of injury to health or the environment is established
in six major sections of the act, as shown in table 1.
Table 1: TSCA's Major Sections for Chemical Data Collection and
Control:
Section: 4;
Purpose: Chemical testing.
Section: 5;
Purpose: New chemical review and control and; Significant new use
rules.
Section: 6;
Purpose: Chemical regulation.
Section: 8;
Purpose: Industry reporting of chemical data.
Section: 9;
Purpose: TSCA's relationship to other laws.
Section: 14;
Purpose: Disclosure of chemical data.
Source: GAO analysis of TSCA.
[End of table]
Under section 4, EPA can promulgate rules to require chemical companies
to test potentially harmful chemicals for their health and
environmental effects. To require testing, EPA must find that a
chemical (1) may present an unreasonable risk of injury to human health
or the environment or (2) is or will be produced in substantial
quantities and that either (a) there is or may be significant or
substantial human exposure to the chemical or (b) the chemical enters
or may reasonably be anticipated to enter the environment in
substantial quantities. (For the remainder of this report, we will
refer to parts (a) and (b) of this second finding in abbreviated form
as a finding "that there is or may be substantial human or
environmental exposure to the chemical"). EPA must also determine that
there are insufficient data to reasonably determine or predict the
effects of the chemical on health or the environment and that testing
is necessary to develop such data.
Section 5 requires chemical companies to notify EPA at least 90 days
before beginning to manufacture a new chemical or before manufacturing
or processing a chemical for a use that EPA has determined by rule is a
significant new use. EPA has these 90 days to review the chemical
information in the premanufacture notice and identify the chemical's
potential risks. Under section 5(e), if EPA determines that there is
insufficient information available to permit a reasoned evaluation of
the health and environmental effects of a chemical and that (1), in
absence of such information, the chemical may present an unreasonable
risk of injury to health or the environment or (2) it is or will be
produced in substantial quantities and (a) it either enters or may
reasonably be anticipated to enter the environment in substantial
quantities or (b) there is or may be significant or substantial human
exposure to the substance, then EPA can issue a proposed order or seek
a court injunction to prohibit or limit the manufacture, processing,
distribution in commerce, use, or disposal of the chemical. Under
section 5(f), if EPA finds that the chemical will present an
unreasonable risk, EPA must act to protect against the risk. If EPA
finds that there is a reasonable basis to conclude that a new chemical
may pose an unreasonable risk before it can protect against such risk
by regulating it under section 6 of TSCA, EPA can (1) issue a proposed
rule, effective immediately, to require the chemical to be marked with
adequate warnings or instructions, to restrict its use, or to ban or
limit the production of the chemical or (2) seek a court injunction or
issue a proposed order to prohibit the manufacture, processing, or
distribution of the chemical.
Section 6 requires EPA to apply regulatory requirements to chemicals
for which EPA finds a reasonable basis exists to conclude that the
chemical presents or will present an unreasonable risk to human health
or the environment. To adequately protect against a chemical's risk,
EPA can promulgate a rule that bans or restricts the chemical's
production, processing, distribution in commerce, disposal or use, or
requires warning labels be placed on the chemical. Under TSCA, EPA must
choose the least burdensome requirement that will adequately protect
against the risk. In promulgating a rule, EPA must consider and publish
a statement regarding: the effects of the chemical on health and the
environment and the magnitude of human and environmental exposure; the
benefits of the chemical for various uses and the availability of
substitutes for those uses; and the reasonably ascertainable
consequences of the rule, after consideration of the effect on the
national economy, small businesses, technological innovation, the
environment, and public health. If another law would sufficiently
eliminate or reduce the risk of injury to health or the environment,
then EPA may not promulgate a TSCA rule unless it finds that it is in
the public interest to do so, considering all relevant aspects of the
risk, a comparison of the estimated costs of compliance under TSCA and
the other law and the relative efficiency of actions under TSCA and the
other law to protect against risk of injury.
Section 8 requires EPA to promulgate rules under which chemical
companies must maintain records and submit such information as the EPA
Administrator reasonably requires. This information can include, among
other things, chemical identity, categories of use, production levels,
by-products, existing data on adverse health and environmental effects,
and the number of workers exposed to the chemical. In addition, section
8 provides EPA with the authority to promulgate rules under which
chemical companies are required to submit lists or copies of any health
and safety studies to EPA. Finally, section 8 requires chemical
companies to report any information to EPA that reasonably supports a
conclusion that a chemical presents a substantial risk of injury to
health or the environment.
Section 9 establishes TSCA's relationship to other laws. The section
includes a mechanism for EPA to alert other federal agencies of a
possible need to take action if EPA has a reasonable basis to conclude
that an unreasonable chemical risk may be prevented or sufficiently
reduced by action under a federal law not administered by EPA. Section
9 also requires EPA to use authorities under other laws that it
administers if its Administrator finds that a risk to health or the
environment could be eliminated or sufficiently reduced under those
laws, or unless EPA determines that it is in the public interest to
protect against such risks under TSCA.
Section 14 details when EPA may disclose chemical information obtained
by the agency under TSCA. Chemical companies can claim certain
information, such as data disclosing chemical processes, as
confidential business information. EPA generally must protect
confidential business information against public disclosure unless
necessary to protect against an unreasonable risk of injury to health
or the environment. Other federal agencies and federal contractors can
obtain access to this confidential business information in order to
carry out their responsibilities. EPA may also disclose certain data
from health and safety studies.
EPA Lacks Sufficient Data to Ensure That Potential Health and
Environmental Risks of New Chemicals Are Identified:
While TSCA authorizes EPA to promulgate rules requiring chemical
companies to conduct tests on chemicals and submit the resulting data
to EPA, TSCA does not require chemical companies to test new chemicals
for their toxicity and exposures before they are submitted for EPA's
review and, according to EPA officials, chemical companies typically do
not voluntarily perform such testing. In the absence of chemical test
data, EPA largely relies on scientific models to screen new chemicals.
However, use of the models can present weaknesses in an assessment
because models do not always accurately determine the chemicals'
properties and the full extent of their adverse effects, especially
with regard to their general health effects. Nevertheless, EPA believes
that the models are useful as basic screening tools where actual test
data on health and environmental effects information is not available
from chemical companies. EPA believes that the models are an effective
tool that, in conjunction with other factors, such as premanufacture
notice information on the anticipated production levels and uses of a
chemical, supplies a reasonable basis for either dropping the chemical
from further review or subjecting it to more detailed review and
possible controls. EPA routinely updates database sources for models
with new data received through premanufacture notice submissions,
required testing from consent orders, substantial risk submissions, and
voluntary testing. EPA acknowledges, however, that future efforts to
obtain additional test data could enhance the models' usefulness by
providing a more robust database for their further development and
validation for regulatory purposes.
Furthermore, the information in premanufacture notices that EPA uses to
assess potential exposures to new chemicals, such as production volume
and anticipated uses, are estimates that can change substantially once
EPA completes its review and manufacturing begins. Although TSCA
authorizes EPA to require a manufacturer to submit a new notice under
certain conditions, the agency must first, after consideration of
relevant statutory factors, promulgate a significant new use rule in
which it identifies significant new uses or activities for which a new
notice is required.
EPA Has Limited Information on New Chemicals and Relies on Modeling
Tools to Assess the Health and Environmental Risks of New Chemicals:
EPA estimates that most premanufacture notices do not include test data
of any type, and only about 15 percent include health or safety test
data. Chemical companies do not have an incentive to conduct these
tests because they may take over a year to complete, and some tests may
cost hundreds of thousands of dollars. During a review of a new
chemical, EPA evaluates risks by conducting a chemical analysis,
searching the scientific literature, reviewing agency files (including
files of related chemicals that have already been assessed by EPA),
analyzing toxicity data on structurally similar chemicals, calculating
potential releases of and exposures to the chemical, and identifying
the chemical's potential uses. On the basis of this review, EPA makes a
decision to (1) take no action; (2) under section 5(e) of TSCA, require
controls on the use, manufacture, processing, distribution in commerce,
or disposal of the chemical pending development of test data; or (3)
ban or otherwise regulate the chemical pending the receipt and
evaluation of test studies performed by the chemical's manufacturer.
Because EPA generally does not have sufficient data on a chemical's
properties and effects when reviewing a new chemical, EPA uses a method
known as structure activity relationships analysis (SAR) to screen and
evaluate a chemical's toxicity. This method, also referred to as the
nearest analogue approach, involves using models to compare new
chemicals with chemicals with similar molecular structures for which
test data on health and environmental effects are available.
EPA applies models where actual test data in general, and health and
environmental effects test data in particular, are not available. EPA
officials said that the models make conservative predictions that the
agency believes result in erring on the side of protecting human health
and the environment in screening chemicals. EPA's own attempts to
determine the strength of these models shows them to be highly accurate
in predicting some chemical characteristics, but less accurate for
other characteristics. For example, in 1993, EPA and the EU jointly
conducted a study to compare EPA's predictions of individual physical
and chemical properties or health or environmental effects with those
identified by the EU based on test data submitted with EU
notifications.[Footnote 2] The joint evaluation showed that the
accuracy of EPA's predictions varied, depending on the effect or the
property being compared. For example, the study concluded that EPA
methods are likely to identify those substances that are not readily
biodegradable--in other words, slowly degrading chemicals. However, the
study concluded that EPA methods do not appear to work as well in
identifying chemicals that readily degrade as determined by the EU's
"ready biodegration" base set test. The model performance is explained
by recognizing that EPA's model does not focus on ready biodegration
but rather on ultimate biodegredation. Since the 1993 study, EPA and
others have conducted studies on selected aspects of some of its
models, such as a 2001 study conducted by PPG Industries on the
accuracy of aquatic toxicity predictions for different types of
polymers. This study showed mixed results in that the models proved to
be highly accurate for predicting the toxicity of the chemicals tested
on rainbow trout, but were in error for about 25 percent of the cases
in which the models' results were compared with actual test data for
determining the chemicals' effects on the growth of aquatic algae, an
important environmental end point.[Footnote 3]
EPA officials told us that, while the overall accuracy of the models
has not been validated for regulatory purposes, they are effective as
screening tools that allow EPA to focus its attention on the chemicals
of greatest concern--chemicals about which little is known other than
that they are structurally related to known harmful chemicals. By
applying approaches that make conservative predictions, EPA believes
that it is more likely to identify a false positive (where a chemical
is determined to be of concern, but on further analysis is found to be
of low concern) than a false negative (where a chemical is initially
viewed as a low concern though on further analysis is actually of
higher concern). According to EPA, only about 20 percent of the
premanufacture notices received annually go through the agency's more
detailed full-review process after they have been initially screened.
That is, according to EPA officials, the majority of new chemicals
submitted for review can be screened out as not requiring further
review because (1) EPA determines on the basis of its screening models
that a chemical has potential for low toxicity to human health or
environment or (2) on the basis of other information, such as the
anticipated uses, exposures, and releases of the chemicals, only
limited potential risks to people and the environment are expected. In
addition, using these models, EPA identifies for possible regulatory
action, those chemicals belonging to certain chemical categories that
based on its prior experience in reviewing new chemicals, are likely to
pose potential risks such that testing or controls are needed.
EPA officials told us that while they take efforts to improve and
validate their models for regulatory purposes where opportunities arise
(e.g., models are subjected to peer review when significant
modifications are introduced in their design or structure), they do not
have a specific program to do so. EPA officials stated that they
routinely use test data to improve the models as it becomes available
but TSCA does not require companies to routinely conduct tests and
submit such data to the agency. Unless EPA requires testing under
section 4 of TSCA, TSCA only requires chemical companies to provide
notice to EPA of information the companies obtain that reasonably
supports the conclusion that the chemical presents a substantial risk
of injury to health or the environment. Under section 4 of TSCA, EPA
may promulgate a rule requiring companies to conduct tests and submit
test data but may do so only if it first determines that current data
is insufficient; testing is necessary; and that either (1) the chemical
may present an unreasonable risk or (2) that the chemical is or will be
produced in substantial quantities and that there is or may be
substantial human or environmental exposure to the chemical. EPA
officials said that chemical companies may have test data that shows
that a chemical has low toxicity. These officials also said that such
data would be useful for helping to improve the accuracy of their
models. EPA has authority under section 8 of TSCA to promulgate rules
requiring companies to submit any existing test data concerning the
environmental and health effects of a chemical or copies of any health
and safety studies conducted or initiated by, or otherwise known by,
the chemical company.
EPA officials told us that other efforts are under way to validate
these models for regulatory purposes. Organization for Economic Co-
operation Development (OECD) member countries are undertaking
collaborative efforts to develop and harmonize SAR methods for
assessing chemical hazards. However, EPA is hampered in its ability to
provide supporting test data to aid OECD as part of this effort because
confidentiality provisions in TSCA do not allow EPA to share
confidential business information submitted by chemical companies with
foreign governments. EPA officials said that international efforts to
validate SAR models for regulatory purposes and to move toward
harmonized international chemical assessments would be improved if EPA
had the ability to share this information under appropriate procedures
to protect confidentiality. TSCA's provisions are in contrast to those
of the Canadian Environmental Protection Act (CEPA), for example, which
authorizes the Canadian Minister of the Environment to share
confidential business information with other governments under
agreements or arrangements where the government undertakes to keep the
information confidential.
Chemical industry representatives told us that the industry also sees
benefits in allowing countries to share information in order to
harmonize chemical assessments among developed countries and improve
chemical risk assessment methods by allowing countries to cooperate in
improving models used to predict chemical toxicity. The chemical
industry is concerned, however, that the confidential information
shared be protected from inappropriate disclosure. These chemical
industry representatives told us that some countries currently do not
have stringent enough procedures for protecting confidential business
information. However, they suggested that the policies and procedures
EPA currently uses to protect confidential information are appropriate.
Accordingly, they said that the chemical industry would not object to
TSCA revisions allowing EPA to share confidential information with
foreign countries and organizations, provided that such revisions
contain specific reference to safeguards that EPA would establish and
enforce to ensure that those receiving the information have stringent
policies and procedures to protect it. In this regard, chemical
industry representatives stated that such policies and procedures
should include provisions such as requiring that those who handle
confidential information be briefed on the importance of not disclosing
the information to those without the proper clearance and keeping such
information in locked storage.
EPA officials told us that, in addition to assisting international
efforts to enhance modeling tools and harmonize international chemical
assessments, the ability to share confidential business information
with foreign governments would be beneficial for developing a strategy
to identify the resources needed to develop and validate new models for
regulatory purposes--a measure that is especially important given the
continuing central role of scientific models in EPA's assessment
program for new chemicals. These officials also suggested that it would
be productive to explore regulatory and voluntary approaches that could
be used to obtain additional information from chemical companies on
chemical properties and characteristics, including "negative" studies-
-i.e., evidence that a chemical is not harmful. According to EPA, such
information is useful for understanding the chemical and thus for
developing and validating models for regulatory purposes. Under TSCA,
companies submitting a premanufacture notice must, at the same time,
submit data such as anticipated production volume, manufacturing
process, and any test data in their possession and a description of any
other reasonably ascertainable data concerning the environmental and
health effects of the chemical. If EPA feels it needs more information
on these chemicals, it could explore promulgating a test rule under
section 4 or issuing a proposed order pending the development of
information under section 5(e). In addition, as noted above, EPA has
authority under section 8 of TSCA to promulgate rules requiring
companies to submit any existing test data concerning the environmental
and health effects of a chemical or copies of any health and safety
studies conducted or initiated by, or otherwise known by, the chemical
company.
Chemical industry representatives with whom we spoke told us that they
see much merit in working toward a strategy that would give EPA data
that could help the agency improve its models. They believe that it is
to everyone's benefit to have approaches that produce models that are
useful for identifying both safe and problematic chemicals. This is
especially true for enabling industry to make timely decisions--
especially for chemicals having short life spans and requiring quick
production decisions essential to innovation. These chemical industry
representatives also said that a comprehensive strategy for improving
models would be particularly beneficial to developing countries lacking
extensive experience in manufacturing chemicals because it would enable
them to speed their progress toward developing chemicals that are safe
and effective.
Estimates of Exposures and Other Information Provided in Premanufacture
Notices Can Change after Manufacturing Begins:
Chemical companies are generally required to submit to EPA, 90 days
before beginning to manufacture a new chemical, a premanufacture notice
containing information including the chemical's identity, its
production process, categories of uses, estimated production volumes,
potential exposure levels and releases, any test data in the possession
or control of the chemical company, and a description of any other data
concerning the environmental or health effects known to or reasonably
ascertainable by the chemical company. EPA bases its exposure estimates
for new chemicals on information contained in premanufacture notices.
However, the anticipated production volume, uses, exposure levels, and
release estimates outlined in the premanufacture notice do not have to
be amended once manufacturing begins. That is, once EPA completes its
review and production begins, absent any requirement imposed by EPA
such as a significant new use rule, chemical companies are not required
under TSCA to limit the production of a chemical or its uses to those
specified in the premanufacture notice or to submit another
premanufacture notice if changes occur. However, the potential risk of
injury to human health or the environment may increase when chemical
companies increase production levels or expand the uses of a chemical.
To address this potential TSCA authorizes EPA to promulgate such a rule
specifying that a particular use of a chemical would be a "significant
new use." The manufacturers, importers, and processors of the chemical
for that use would then be required to notify EPA at least 90 days
before beginning manufacturing or processing the chemical for that use.
EPA Reviews of New Chemicals Have Resulted in Numerous Control Actions:
When EPA's assessment of new chemicals identifies health and safety
problems, EPA can issue a proposed rule to prevent chemical companies
from manufacturing or distributing the chemical in commerce, or to
otherwise restrict the chemical's production or use, if the agency
believes the new chemical may present an unreasonable risk before EPA
can regulate the chemical under section 6 of TSCA. Despite limitations
in the information available on new chemicals, EPA's reviews have
resulted in some action being taken to reduce the risks of over 3,500
of the 32,000 new chemicals that chemical companies have submitted for
review.[Footnote 4] These actions ranged from chemical companies
voluntarily withdrawing their notices of intent to manufacture new
chemicals, chemical companies entering into consent orders with EPA to
produce a chemical under specified conditions, and EPA promulgating
significant new use rules requiring chemical companies to notify EPA of
their intent to manufacture or process certain chemicals for new uses
prior to manufacturing or processing the chemicals for such uses.
For over 1,600 chemicals, companies withdrew their premanufacture
notices, sometimes after EPA officials indicated that the agency
planned to initiate the process for placing controls on the chemical,
such as requiring testing or prohibiting the production or certain uses
of the chemical. EPA officials told us that after EPA screened the
chemical or performed a more detailed analysis of it, chemical
companies often drop their plans to market a new chemical when the
chemical's niche in the marketplace is uncertain and EPA requests that
the company develop and submit test data. According to an EPA official,
companies may be uncertain that they will recoup the costs of testing
and prefer instead to withdraw their premanufacture notice.
For over 1,200 chemicals, EPA has issued orders requiring chemical
companies to implement workplace controls or practices during
manufacturing pending the development of information, and/or perform
toxicity testing when the chemical's production volumes reached certain
levels. EPA may issue these proposed orders to control the production,
distribution, use, or disposal of a new chemical when there is
insufficient information available to EPA to reasonably evaluate the
human health or environmental effects of a chemical and when the
chemical (1) may present an unreasonable risk to human health or the
environment or (2) it is or will be produced in substantial quantities
and (a) it either enters or may reasonably be anticipated to enter the
environment in substantial quantities or (b) there is or may be
significant or substantial human exposure to the substance. Under
section 5 of TSCA, EPA cannot require that chemical companies develop
this information, but TSCA authorizes EPA to control the manufacturing
and processing of the chemical until EPA has sufficient data to
determine if the chemical will pose a risk.
For about 570 of the 32,000 new chemicals submitted for review, EPA
required chemical companies to submit premanufacture notices for any
significant new uses of the chemical, providing EPA the opportunity to
review the risks of injury to human health or the environment before
new uses had begun. For example, in 2003, EPA promulgated a significant
new use rule requiring chemical companies to submit a notice for the
manufacture or processing of substituted benzenesulfonic acid salt for
any use other than as described in the premanufacture notice.
Finally, in 1984, EPA issued proposed rules that were effective upon
publication to impose certain controls on four new chemicals the agency
determined would pose an unreasonable risk to human health or the
environment.[Footnote 5] The rules--which remain in effect today--
prohibit adding any nitrosating agent, including nitrites, to metal
working fluids that contain these substances. According to EPA, adding
nitrites or other nitrosating agents to the substances causes the
formation of a substance known to cause cancer in laboratory animals.
See appendix V for more information on the rules issued to control
these four chemicals.
EPA Does Not Routinely Assess Existing Chemicals, Has Limited
Information on Their Health and Environmental Risks, and Has Issued Few
Regulations Controlling Such Chemicals:
TSCA authorizes but does not specifically require EPA to review the
risks of existing chemicals. Further, EPA cannot require chemical
companies to test the safety of existing chemicals and provide the
resulting test data to the agency, unless EPA first determines on the
basis of risk or production and exposure information that the chemicals
warrant such testing. EPA has used its authority to require testing for
fewer than 200 of the 62,000 chemicals in commerce when EPA began
reviewing chemicals under TSCA in 1979. Furthermore, according to EPA,
in part because it is costly and labor-intensive for EPA to require the
development of toxicity and exposure data, the agency has performed
internal reviews of only an estimated 2 percent of the chemicals that
were in the TSCA inventory when EPA began chemical reviews in 1979.
Additionally, EPA has rarely banned, limited the production, or
restricted the use of existing chemicals. Only five chemical substances
or groups of chemical substances have been regulated under section 6,
and the last final action EPA took to control existing chemicals under
section 6 was published in 1990. Since 1998, EPA has focused its
efforts on obtaining information on existing chemicals through
voluntary programs, such as the HPV Challenge Program. This program
will provide basic data on the characteristics of about 2,800 chemicals
produced in excess of 1 million pounds a year. However, while EPA has
received recommendations from the NPPTAC on a process for screening
these chemicals, the agency has not yet implemented guidelines for
reviewing the data so that the chemicals can be prioritized and more
detailed information can be obtained to further assess their risks to
human health and the environment. Canada and the EU have recently taken
action--passing legislation and proposing a new regulation,
respectively--to further regulate or assess existing chemicals. When
implemented, these actions may require U.S. chemical companies to
submit information on some chemicals manufactured or processed in or
exported to Canada and the EU. EPA has authority under section 8 of
TSCA to require that copies of such data for chemicals manufactured or
processed by chemical companies in the United States be made available
to EPA.
EPA Has Limited Toxicity and Exposure Data with Which to Review
Existing Chemicals:
According to EPA officials, EPA's toxicity and exposure data on
existing chemicals is often incomplete and TSCA's authority to require
testing is difficult to use in support of the agency's review process.
While TSCA authorizes the review of existing chemicals, it generally
provides no specific requirement, time frame, or methodology for doing
so.[Footnote 6] Instead, EPA conducts initial reviews after it receives
information from the public or chemical companies that a chemical may
pose a risk. For example, if a chemical company voluntarily tests a
chemical or otherwise obtains information about a chemical that
reasonably supports the conclusion that the chemical presents a
substantial risk[Footnote 7] to human health or the environment, TSCA
requires that the chemical company immediately notify EPA about this
information. EPA then reviews the information to determine the need for
additional testing or risk management. However, chemical companies are
not required to develop and submit toxicity information to EPA unless
EPA promulgates a testing rule, thus placing the burden for obtaining
or requiring industry development of data on the agency. In addition,
if chemical company testing shows that a chemical is not toxic, there
is generally no standing requirement that the chemical companies submit
this data to EPA.[Footnote 8] Consequently, when EPA decides to review
existing chemicals, it generally has only limited information on the
risks of injury the chemicals pose to human health and the environment.
Facing difficulties obtaining such information, as noted above, EPA has
made little progress in reviewing existing chemicals since EPA began
reviewing chemicals under TSCA in 1979.[Footnote 9]
The limited amount of information available to EPA on existing
chemicals' toxicity was illustrated in a 1998 EPA report of publicly
available data on 2,863 high-production-volume chemicals produced and/
or imported at over 1 million pounds per year in 1990.[Footnote 10] For
each of these chemicals, EPA examined the readily available data
corresponding to six basic end points that have been internationally
agreed to as necessary for a screening level assessment of a chemical's
toxicity and environmental fate. EPA estimated that only about 7
percent of the 2,863 chemicals had information on all six basic end
points, 50 percent had information for one to five of the end points,
and 43 percent had no information for any of the end points. According
to EPA officials, the agency has access to even less information for
chemicals not considered high-production-volume chemicals.
Furthermore, EPA has limited information on how existing chemicals are
used and how they come into contact with people or the environment. To
gather more exposure information, in 2003, EPA amended its TSCA
Inventory Update Rule (IUR), which is primarily used to gather certain
information on chemicals produced at more than a basic threshold volume
in the year reported.[Footnote 11] Among other things, EPA raised the
basic production volume reporting threshold from 10,000 to 25,000
pounds, required chemical companies producing or importing chemicals at
a site at or above this threshold to report the number of workers
reasonably likely to be exposed to the chemical at each site, and added
a reporting threshold of 300,000 pounds per site at or above which
chemical companies must report readily obtainable exposure-related use
and processing information.[Footnote 12]
Nevertheless, TSCA does provide EPA with the authority to obtain
information needed to assess chemicals by issuing rules under section 4
of TSCA requiring chemical companies to test chemicals and submit the
test data to EPA. However, because promulgating test rules to obtain
test data on chemicals can be time consuming, EPA has negotiated
agreements with chemical companies to conduct testing. In 1979, EPA
instituted a process to negotiate with chemical companies and reach
voluntary agreements to test the safety of certain chemicals. However,
in 1984, the United States District Court for the Southern District of
New York found that EPA had failed to discharge its obligations under
TSCA by negotiating such voluntary agreements instead of initiating
rulemaking with respect to chemicals designated for testing by the
Interagency Testing[Footnote 13] Committee (ITC) under section 4(e) of
TSCA.[Footnote 14] The court determined that EPA had made de facto
findings that testing of the ITC-designated chemicals was necessary.
The court noted that the very negotiation and acceptance of voluntary
testing agreements demonstrated EPA's belief that additional data on
the particular chemicals at issue needed to be developed. Upon making
such findings, the court stated that it is EPA's duty under TSCA to
make the mandatory choice between initiating rulemaking proceedings or
publishing its reasons for not doing so and that EPA had not done this.
The court found no support either in TSCA or "on some vague assertion
of agency discretion" for EPA's use of the negotiated testing
agreements instead of rulemaking proceedings. The court also found
that, in addition to violating the test rule promulgation process set
forth in TSCA, EPA's failure to use the rulemaking process bypassed
several other important provisions within the statutory framework of
TSCA. The court stated that it was not EPA's prerogative to "substitute
for this intricate framework a number of haphazard and informal
purported equivalents" and that negotiated testing programs without
rulemaking cannot be sanctioned under TSCA.
In order to address the concerns raised by the court, EPA promulgated a
rule in 1986, revising its procedures and providing for its current use
of enforceable consent agreements, which EPA believes bind the
companies signing them to perform the testing they agree to
perform.[Footnote 15] EPA regulations state that when EPA believes
testing is necessary, it will explore whether a consent agreement can
be negotiated that satisfies those testing needs.[Footnote 16] The
regulations further require EPA to publish a notice in the Federal
Register when it decides to initiate negotiations.[Footnote 17] EPA
will meet with manufacturers, processors, and other interested parties
(those responding to EPA's Federal Register notice) to attempt
negotiation of a consent agreement. All negotiating meetings are open
to the public, and EPA is to prepare meeting minutes and make them--as
well as testing proposals, correspondence, and other relevant material-
-available to the public. When EPA prepares a draft consent agreement,
it is circulated for comment to all interested parties, who have 4
weeks to submit comments or written objections. Where consensus exists
on the draft consent agreement, as determined under the criteria listed
in EPA's regulations,[Footnote 18] the draft will be circulated to EPA
management and interested parties for final approval and signature. EPA
will then publish another Federal Register notice summarizing the
consent agreement and listing the name of the chemical to be tested in
its regulations.
According to EPA, these agreements allow greater flexibility in the
design of the testing program because test methods can be negotiated.
The relationship between EPA and the chemical industry is typically
nonadversarial, and it usually takes less than a year for testing to
begin on chemicals subject to enforceable consent agreements. According
to EPA, negotiating these agreements is generally less costly and time-
consuming than promulgating test rules because EPA does not have to
determine that (1) a chemical poses or may pose an unreasonable risk or
(2) a significant or substantial potential may exist for human exposure
to the chemical. However, chemical companies must be willing to
participate in such negotiations. EPA has entered into consent
agreements with chemical companies to develop tests for about 60
chemicals. EPA officials told us that, for an additional 250 chemicals,
EPA issued formal decisions not to test. In a number of these cases,
EPA had initiated the process to either require testing or to negotiate
consent agreements but prior to finalizing the rules or agreements
chemical companies or other organizations had met EPA's need for the
data.
While it appears that EPA's enforceable consent procedures have been a
good mechanism for acquiring needed test data, as the United States
District Court for the Southern District of New York noted, "[i]t is
not an agency's prerogative to alter a statutory scheme even if its
assertion is as good or better than the congressional one." In this
regard, it is not clear whether EPA's current use of enforceable
consent agreements would fare better than its previous use of voluntary
agreements if challenged in court. EPA's regulations require
enforceable consent agreements to address many of the provisions of
TSCA triggered by test rules that the court found were lacking in EPA's
earlier voluntary agreements. However, some important differences
remain between the TSCA framework for testing rules and EPA's
regulations for enforceable consent agreements. First, the enforceable
consent agreement regulations would not account for some of the TSCA
provisions that would be triggered by a test rule. For example, the
regulations do not require the submission of test data along with the
premanufacture notices for new chemicals. The regulations also neither
preempt state or local testing rules, as a TSCA test rule would, nor do
they have the same reporting and recordkeeping requirements. Second,
unlike a testing rule, which would trigger TSCA requirements for all
manufacturers and processors of a particular chemical, the consent
agreement would generally only trigger such requirements for those
manufacturers and processors that sign the agreement. While EPA
regulations state that any person exporting or intending to export a
chemical that is the subject of an enforceable consent agreement must
notify EPA, it is unclear how EPA would enforce this provision if the
person had not signed the agreement. Despite EPA's attempts to
incorporate a number of the test rule-triggered TSCA provisions into
its enforceable consent agreements, its efforts may still fall short.
Like EPA's earlier use of voluntary agreements, its use of enforceable
consent agreements is not explicitly authorized under TSCA, and, if a
court determined that EPA's use of enforceable consent agreements
equated to a de facto finding that testing was necessary, a court could
again find that EPA lacked discretion to require testing other than
through promulgation of a test rule.
EPA officials believe that the agency's revised procedures address the
court's findings, and that, while TSCA does not specifically authorize
the use of consent agreements to obtain test data, a sound legal basis
exists for invoking TSCA's enforcement provisions against chemical
companies that violate such agreements. Representatives of the American
Chemistry Council (ACC) also told us that they have always considered
the consent agreements to be enforceable and binding on the chemical
companies signing them. Bolstering these views somewhat is the fact
that EPA has been using the enforceable consent agreement process since
establishing it by rule in 1986--nearly two decades ago. Nevertheless,
an EPA legal memorandum states that although EPA could reasonably take
the position that it is authorized to enter into enforceable consent
agreements requiring testing--ultimately concluding that enforceable
consent agreements could be enforced by EPA and would be upheld by the
courts--"the matter is not free from doubt." EPA officials have stated
that revising TSCA to explicitly provide authority to enter enforceable
consent agreements would be beneficial for clarifying when EPA has
authority to enter into such agreements. Chemical industry
representatives agreed with EPA that explicit authorization could be
useful.
Finally, according to EPA, the lack of information on existing
chemicals and the relative difficulty in requiring testing under TSCA
on such a large scale as would be required for the more than 2,000
chemicals produced at high volumes, has led EPA, in cooperation with
chemical companies, environmental groups, and other interested parties,
to implement a voluntary program to obtain test data on high-
production-volume chemicals from chemical companies. The HPV Challenge
Program focuses on obtaining chemical company "sponsors" to voluntarily
provide data on the approximately 2,800 chemicals that chemical
companies reported in 1990, that they produced at a high volume--
generally over 1 million pounds. Through this program, sponsors develop
a minimum set of information on the chemicals, either by gathering
available data, using models to predict the chemicals' properties, or
conducting testing of the chemicals.[Footnote 19]
EPA plans to use the data collected under the HPV Challenge Program to
prioritize high-production chemicals for further assessment. However,
EPA has not yet adopted a methodology for prioritizing the chemicals or
determining those that require additional information. At EPA's request
in 2005, a federal advisory group has proposed a methodology for
prioritizing the HPV Challenge Program chemicals. EPA anticipates
implementing the recommendation and beginning screening in early 2006.
While EPA will soon be collecting limited exposure information on
chemicals produced at or above 25,000 pounds per year, the agency does
not regularly collect exposure information on lower volume chemicals.
EPA officials stated, based on the success of the HPV Challenge
Program, there may be promise in a future effort to develop an
appropriate level of information for lower volume chemicals, although
given the demands of current efforts by EPA, industry, and others on
HPV chemicals, no steps have been taken in this regard. Furthermore,
EPA has no voluntary or test rule program in place for obtaining test
data on chemicals that are currently produced in low volumes but which
may be produced at high volumes in the future. While chemical industry
organizations have said that they will voluntarily provide a basic set
of test data on certain high-production-volume chemicals that are not
part of the HPV Challenge Program, it is unclear that their efforts
will produce information sufficient for EPA to make determinations of a
chemical's risk to human health or the environment or provide the
information in a timely manner.
EPA officials told us that, in cases where chemical companies do not
voluntarily provide needed test data and health and safety studies in a
complete and timely manner, requiring testing of existing chemicals of
concern is the only practical way to ensure that needed information is
obtained by the agency. For example, there are currently over 300 high-
production-volume chemicals for which chemical companies have not
agreed to provide the minimal test data that EPA believes are needed to
initially assess their risks. Furthermore, many additional chemicals
are likely to be added to this number in the future because the
specific chemicals used in commerce are constantly changing, as are
their production volumes. Chemical industry representatives told us
that TSCA (under section 8) provides EPA with adequate authority to
issue rules requiring companies to provide EPA with any test and
exposure data possessed by the companies, and that EPA could use such
authority to obtain company information on existing chemicals of
concern. EPA could then use that information to determine whether
additional rules should be issued under section 4 of TSCA to require
companies to perform additional testing of the chemicals.
However, EPA officials told us that it is time-consuming, costly, and
inefficient for the agency to use a two-step process of (1) issuing
rules under section 8 of TSCA (which can take months or years to
develop) to obtain exposure data or available test date that the
chemical industry does not voluntarily provide to EPA and then (2)
issuing additional rules under section 4 of TSCA requiring companies to
perform specific tests necessary to ensure the safety of the chemicals
tested. They also said that EPA's authority to issue rules requiring
chemical companies to conduct tests on existing chemicals under section
4 of TSCA has been difficult to use because of the findings the agency
must first make before EPA can require testing. Section 4 of TSCA
requires EPA to find that current data is insufficient; testing is
necessary; and that either (1) the chemical may present an unreasonable
risk or (2) that the chemical is or will be produced in substantial
quantities and that there is or may be substantial human or
environmental exposure to the chemical.
For example, if EPA wanted to issue a test rule on the basis of a
chemical's production volume, it would still need to make the other
requisite findings. In this regard, according to EPA officials,
obtaining exposure information needed for rulemaking is particularly
difficult. To fully assess human exposure to a chemical, EPA needs to
know how many workers, consumers and others are exposed; whether the
exposure occurs through inhalation or other means, such as skin
absorption; and the amount and duration of the exposure. For
environmental exposure, EPA needs to know such things as whether the
chemical is being released in the air, water or land; how much is being
released; and the extent of the area affected. Another important factor
in environmental exposure is chemical fate, that is, how the chemical
acts and is ultimately disposed of in the environment. EPA must rely on
its estimates for most of this information because actual measurements
of exposure in the environment, workplace, and home, for the thousands
of chemicals in use are not practicable because of the monitoring
equipment and staff resources that would be required.
Once EPA has made the required findings, the agency can issue a
proposed rule for public comment, consider the comments it receives,
and promulgate a final rule ordering chemical testing. EPA officials
told us that finalizing rules under section 4 of TSCA can take from 2
to 10 years and require the expenditure of substantial resources. Given
the time and resources required, the agency has issued rules requiring
testing for only 185 of the approximately 82,000 chemicals in the TSCA
inventory. Because EPA has used section 4 so sparingly, it has not
continued to maintain information on the cost of implementing test
rules. However, in our October 1994 report on TSCA, we noted that EPA
officials told us that issuing a rule under section 4 can cost between
about $68,500 and $234,000.
Given the difficulties involved in requiring testing, EPA officials do
not believe that TSCA's authorities under section 4 provide an
effective means for testing a large number of chemicals. They believe
that EPA could review substantially more chemicals in less time if they
had authority to require chemical companies to conduct testing and
provide test data on Additionally, if the EPA Administrator determines
that a risk of injury to health or the environment could be eliminated
or sufficiently reduced by actions under another federal law, then TSCA
prohibits EPA from promulgating a rule under section 6(a) of TSCA,
unless EPA finds that it is in the public interest considering all
aspects of the risk, the estimated costs of compliance, and the
relative efficiency of such action to protect against risk of injury.
According to EPA, it has found it difficult to meet all of these
requirements for rulemaking.
Finally, EPA must also develop substantial evidence in the rulemaking
record in order to withstand judicial review. Under TSCA, a court
reviewing a TSCA rule "shall hold [it] unlawful and set [it] aside…if
the court finds that the rule is not supported by substantial evidence
in the rulemaking record."[Footnote 20] According to EPA officials, the
economic costs of regulating a chemical are usually more easily
documented than the risks of the chemical or the benefits associated
with controlling those risks, and it is difficult to show by
substantial evidence that EPA is promulgating the least burdensome
requirement.
EPA's 1989 asbestos rule illustrates the evidentiary requirements that
TSCA places on EPA to control existing chemicals. In 1979, EPA began
exploring rulemaking under TSCA to reduce the risks posed by exposure
to asbestos. Based upon its review of over 100 studies of the health
risks of asbestos as well as public comments on the proposed rule, EPA
concluded that asbestos was a potential carcinogen at all levels of
exposure. In 1989, EPA promulgated a rule under TSCA section 6
prohibiting the future manufacture, importation, processing, and
distribution of asbestos in almost all products.[Footnote 21] Some
manufacturers of asbestos products filed suit against EPA, arguing, in
part, that the rule was not promulgated on the basis of substantial
evidence regarding unreasonable risk. In October 1991, the U.S. Court
of Appeals for the Fifth Circuit agreed with the chemical companies,
concluding that EPA had failed to muster substantial evidence to
justify its asbestos ban and returning parts of the rule to EPA for
reconsideration.[Footnote 22]
In its ruling, the court concluded that EPA did not present sufficient
evidence to justify the ban on asbestos because it did not consider all
necessary evidence and failed to show that the control action it chose
was the least burdensome regulation required to adequately protect
human health or the environment. EPA had not calculated the risk levels
for intermediate levels of regulation, as it believed there was no
asbestos exposure level for which the risk of injury or death was zero.
As articulated by the court, the proper course of action for EPA, after
an initial showing of product danger, would have been to consider each
regulatory option, beginning with the least burdensome, and the costs
and benefits of each option. The court further criticized EPA's ban of
products for which no substitutes were currently available stating
that, in such cases, EPA "bears a tough burden" to demonstrate, as TSCA
requires, that a ban is the least burdensome alternative. Since the
court's 1989 decision, EPA has only exercised its authority to ban or
limit the production or use of an existing chemical once (for
hexavalent chromium). However, EPA officials said that they had started
the process for promulgating the rule for hexavalent chromium years
prior to the asbestos decision.
As the court noted, TSCA is not a zero-risk statute. EPA generally is
required to choose the least burdensome regulatory action and the
Congress has indicated its intent that EPA carry out TSCA "in a
reasonable and prudent manner [after considering] the environmental,
economic, and social impact of any action."[Footnote 23] While concerns
about the potential economic and social impacts of EPA's regulations
are legitimate, according to EPA officials, requiring EPA to satisfy
before taking regulatory action that the regulation uses the least
burdensome approach to mitigate unreasonable risks and that its
rulemaking is supported by substantial evidence has proven difficult
for EPA to meet.
Canada and the EU Are Moving Toward Greater Control of Existing
Chemicals:
Canada and the EU have recently taken action to prioritize and review
existing chemicals. The Canadian legislation (CEPA), enacted in 1999,
requires the Minister of the Environment and the Minister of Health to
compile, and from time to time amend, a Priority Substances List
specifying those substances that the ministers believe should be given
priority for assessing whether they are toxic or capable of becoming
toxic. Within 7 years of the act, the ministers are to categorize
existing chemicals for the purpose of identifying substances that, in
their opinion, and on the basis of available information, (1) may
present to individuals in Canada the greatest potential for exposure or
(2) are persistent or bioaccumulative in accordance with the
regulations, and inherently toxic to human beings or to nonhuman
organisms, as determined by laboratory or other studies. The ministers
shall then conduct screening assessments for such chemicals. The EU is
currently considering a proposed regulation that, among other things,
would require chemical companies to register and submit information on
chemicals produced or imported in volumes of 1 metric ton or more per
year, and would require submission of a chemical safety report
documenting an assessment of chemicals manufactured or processed in
quantities of 10 metric tons or more per year.
Under CEPA and the proposed EU regulation, U.S. chemical companies may
be required to provide information on some existing chemicals that are
manufactured or processed in, or exported to, Canada and the EU. Under
current EPA regulations, these U.S. chemical companies generally would
not be required to submit the same information to EPA, although section
8 of TSCA provides the EPA Administrator authority to promulgate rules
requiring chemical companies to submit such existing information on
chemicals manufactured in or imported into the United States. While EPA
officials told us that they are aware of the agency's authority to
require the submission of at least some of the types of information
that U.S. chemical companies may be required to submit to Canada and
the EU, they have not decided whether or when to use such authority.
For example, these officials said that while the concept of obtaining
copies of the information that U.S. chemical companies submit to
foreign countries has merit, they might be able to obtain the
information through voluntary arrangements with the foreign
governments. Furthermore, EPA officials told us that any requirement
for chemical companies to provide EPA a copy of the information they
submit to Canada and the EU would have to meet the requirements under
the Paperwork Reduction Act of 1995. Under this act, federal agencies
must, among other things, conduct a review of the proposed information
collection and obtain Office of Management and Budget approval before
requesting most types of information from the public.
EPA officials acknowledged that exchanging information through
voluntary arrangements with foreign governments would have limitations,
such as EPA's inability to provide other countries with confidential
business information. EPA officials also acknowledged that requiring
copies of the submissions directly from the companies would produce a
substantial amount of information that EPA could use to improve its
models for assessing and predicting chemical risks. They told us that,
given the recency of the Canadian chemical control changes and the
pending nature of the EU regulation, EPA has not assessed all options
or decided on a preferred approach for obtaining the data that U.S.
chemical companies may be required to submit to foreign governments.
EPA officials told us that the agency does not currently have a
strategy or milestones for identifying resource needs and making
decisions regarding future agency efforts to obtain such data.
Chemical industry representatives told us that the industry would have
no objections to EPA using its authority to require that chemical
companies submit to EPA the same information that they provide to
Canada, the EU, or other foreign governments. They indicated that few
additional costs would be incurred by providing this information, but
that companies could face additional burdens depending on the specific
requirements governing the submission of data. For example, it would be
easier for the chemical companies to provide the information
periodically, such as annually, rather than concurrently along with the
submissions to foreign governments.
EPA's Ability to Share Data Collected under TSCA Is Limited:
EPA's ability to make publicly available the information that it
collects under TSCA is limited. Chemical companies may claim some of
the information they provide to EPA under TSCA as confidential business
information. EPA is required under the act to protect trade secrets and
privileged or confidential commercial or financial information against
unauthorized disclosures, and this information generally cannot be
shared with others, such as state health and environmental officials
and foreign governments.[Footnote 24] However, some state officials
believe this information would be useful for informing and managing
their environmental risk programs. While EPA believes that some claims
of confidential business information may be unwarranted, challenging
the claims is resource-intensive. Lacking the resources needed to
challenge claims on a wide basis, EPA identified several possible
changes aimed at discouraging the submission of unwarranted claims of
confidential business information under TSCA, but few were adopted.
When companies submit information to EPA through premanufacture
notices, many claim a large portion of the information as confidential.
According to EPA, about 95 percent of premanufacture notices contain
some information that chemical companies claim as confidential. Under
EPA regulations, information that is claimed as confidential shall
generally be treated as such if no statute specifically requires
disclosure. Exceptions include if the information is required to be
released by some other federal law or order of a court, if the company
submitter voluntarily withdraws its confidential claim, or if the EPA
Office of General Counsel makes a final administrative determination
that the information does not meet the regulatory criteria
substantiating a legal right to the claim. Officials who have various
responsibilities for protecting public health and the environment from
the dangers posed by chemicals believe that having access to
confidential TSCA information would allow them to examine information
on chemical properties and processes that they currently do not possess
and could enable them to better control potential risks from harmful
chemicals. For example, on the basis of a study[Footnote 25] performed
by the state of Illinois with the cooperation of chemical companies and
EPA, Illinois regulators found that toxicity information submitted
under TSCA was useful in identifying chemical substances that should be
included in contingency plans in order to alert emergency response and
planning personnel to the presence of highly toxic substances at
facilities. Additionally, the availability of this information could
assist the states with environmental monitoring and enforcement. For
instance, using TSCA data, Illinois regulators identified potential
violations of state environmental regulations, such as cases where
companies had submitted information to EPA under TSCA but failed to
submit such information to the states as required.
Likewise, the general public may also find information provided under
TSCA useful. Individual citizens or community groups may have a
specific interest in information on the risks of chemicals that are
produced or used in nearby facilities. For example, neighborhood
organizations can use such information to engage in dialogues with
chemical companies about reducing chemical risks, preventing accidents,
and limiting chemical exposures.
EPA has not performed any recent studies of the appropriateness of
confidentiality claims, although a 1992 EPA study indicated that
problems with inappropriate claims were extensive. This study examined
the extent to which companies made confidential business information
claims, the validity of the claims, and the impact of inappropriate
claims on the usefulness of TSCA data to the public. While EPA may
suspect that some chemical companies' confidentiality claims are
unwarranted, they have no data on the number of inappropriate claims.
EPA officials also told us that the agency does not have the resources
that would be needed to investigate and, as appropriate, challenge
claims to determine the number that are inappropriate. Consequently,
EPA focuses on investigating primarily those claims that it believes
may be both inappropriate and among the most potentially important--
that is, claims relating to health and safety studies performed by the
chemical companies involving chemicals currently used in commerce. The
EPA official responsible for initiating challenges to confidentiality
claims told us that EPA challenges about 14 such claims each year, and
that the chemical companies withdraw nearly all of the claims
challenged.
During the early 1990s, the EPA Office of General Counsel led an agency
wide review of EPA's confidential business information regulations, but
this review did not lead to substantial changes. Subsequent to this
effort, EPA developed a plan involving various voluntary and regulatory
measures to reduce industry's use of TSCA confidentiality claims. These
measures included exploring ways to make confidential information
available to states, having senior corporate officials certify that the
information claimed as confidential meets applicable statutory and
regulatory requirements, and requiring companies to reassert their
claims at a future date when confidentiality may no longer be
necessary. While most of these changes were not implemented, EPA
officials said they did make some changes to TSCA confidential business
information regulations as a result of this review such as requiring up-
front substantiation requirements for claiming plant site identity as
confidential. EPA serves as an intermediary between chemical companies
and state agencies that wish to have access to TSCA confidential
information and, according to EPA, in recent years, state agencies have
not been very aggressive in requesting such information. EPA believes,
based on informal discussions with state officials, that obtaining such
information may no longer be a high priority of the states, although
the agency has not fully analyzed this issue. In addition, EPA
officials said that chemical companies had expressed concerns about the
costs of changing confidentiality procedures and have suggested that
providing this information to states could increase the risk that some
confidential information could be revealed to competitors.
However, as noted previously, chemical industry representatives told us
that chemical companies would not object to revising TSCA to enable
states to obtain access to the confidential business information that
companies provide to EPA--provided that adequate safeguards exist to
ensure that the information would be used only for legitimate reasons
and would be protected from inappropriate disclosures. EPA would need
to ensure that the states receiving confidential information have
policies and procedures similar to those that EPA uses to protect
confidential information from improper disclosures. For example, when
EPA provides confidential TSCA information to other federal agencies as
permitted under the act, EPA ensures that the agencies have policies
and procedures for protecting the information. In this regard, among
other things, the agencies provide security briefings to those handling
the confidential information, take steps to prevent the information
from being stored on electronic systems open to the Internet, and
require that such information is kept locked away when not in use.
Chemical company representatives also told us that, in principle, they
have no concerns about revising TSCA or EPA regulations to require that
confidentiality claims be reasserted at a future date. They said that
chemical companies make bona fide claims at the time the information is
submitted to EPA, but this information may not need to be kept
confidential after a certain date because confidentiality may no longer
be necessary in order to protect trade secrets. However, EPA has no
mechanism for determining when information no longer needs to be
protected as confidential. Chemical company representatives said that
companies sometimes choose to inform EPA that the information is no
longer confidential, but neither TSCA nor EPA regulations require them
to do so. Chemical industry representatives said that a requirement to
reassert claims of confidentially at some later date would not be
disruptive to the industry if the effective date of the requirement
occurred after a considerable period had passed, such as 5 years or
more after the information was initially claimed as confidential.
Conclusions:
While TSCA allows EPA to require the testing of existing chemicals
through the rulemaking process, EPA has found it difficult and costly
to make the findings necessary to promulgate rules, including findings
that a chemical may pose unreasonable risks or that the chemical will
be produced in substantial quantities, and that there is or may be
substantial human or environmental exposure to the chemical.
Consequently, to obtain the test information needed on existing
chemicals, EPA relies extensively on the chemical industry to perform
specific tests of certain chemicals under (1) consent agreements
negotiated with chemical companies and (2) voluntary industry efforts
under the HPV Challenge Program. Although the agency believes that the
negotiated agreements are enforceable and consistent with EPA's
authority under TSCA section 4, the enforceable consent agreements have
never been tested in court, and EPA believes that explicit reference to
the agreements in TSCA would be beneficial.
Chemical companies have begun voluntarily providing some test data that
EPA needs to assess chemical risks through the HPV program. However, in
cases where the industry does not agree to voluntarily perform testing
in an adequate and timely manner, EPA believes that requiring such
testing is the only practical way to ensure that testing is performed.
In this regard, while the chemical industry believes that EPA can use
its existing authority under TSCA to promulgate testing rules and
require testing as needed on a case-by-case basis, EPA notes its
relative lack of experience in promulgating large multichemical test
rules and that the testing authorities may prove difficult to implement
on a large number of chemicals. For example, EPA has pointed out that,
despite notable voluntary efforts regarding high-production-volume
chemicals, (1) chemical companies have not agreed to test 300 chemicals
identified by EPA as high-production-volume chemicals, (2) additional
chemicals will become high-production chemicals in the constantly
changing commercial chemical marketplace, and (3) chemicals without a
particularly high-production volume may also warrant testing based on
their toxicity and the nature of exposure to them. Furthermore,
although the chemical industry may be willing to take action even
before EPA has the evidence required for rulemaking under TSCA, the
industry is nonetheless large and diverse, and it is uncertain that all
companies will always take action voluntarily.
While the protection of confidential business information is obviously
a legitimate concern, TSCA currently prohibits EPA from disclosing much
of this data for useful and important purposes such as providing
complete information to state environmental management agencies and
assisting international efforts to develop and validate, for regulatory
purposes, SAR models or to harmonize chemical assessment approaches by
sharing information with foreign governments--a goal generally shared
by government and industry. Both EPA and the chemical industry believe
that revising TSCA to allow the sharing of such information would be
beneficial and appropriate provided that EPA ensures that recipients
have in place policies and procedures designed to prevent inappropriate
disclosures of the information. In addition, EPA and the chemical
industry agree that the need to protect industry data often diminishes
over time, and thus it would be appropriate to revise TSCA regulations
to require companies to periodically reassert the confidentiality of
business information.
Largely because of limitations in the amounts and types of test data
provided with new chemical notifications, over the past decades EPA has
moved toward innovative approaches to assessing new chemicals and to
obtaining test data needed to assess chemicals. Most notably, these
approaches include the development and extensive use of models to
assess new chemicals and voluntary chemical testing approaches to
obtain test data needed to assess some existing chemicals. While of
many of EPA's models have not been validated for regulatory purposes,
EPA believes that they are useful screening tools that have supported
EPA's actions to control the production or use of about 3,500 of the
more than 32,000 new chemicals reviewed under TSCA. Nonetheless, EPA
recognizes that, given the central role that these models play in the
chemical review process, the agency needs a multifaceted strategy for
improving the models, which includes obtaining additional information
on chemical properties necessary to further develop and validate the
models for regulatory purposes.
Likewise, EPA is encouraged by the early results of the HPV voluntary
chemical testing program for existing chemicals, which has already
produced substantial amounts of basic test data. The agency has moved
toward, but has not yet implemented, a methodology necessary for using
the data to prioritize chemicals for further review and identify the
specific additional data needed to determine whether and what controls
should be placed on their production or use. The impact of EPA's
programs could be substantially enhanced as a result of additional
information that companies may be required to provide to Canada and the
EU. By promulgating a rule requiring U.S. companies and their
subsidiaries to submit to EPA the same information that they submit to
foreign governments, the agency could acquire substantial additional
basic test data and health and safety studies, at little, if any,
additional cost to the chemical companies.
Matters for Congressional Consideration:
To improve EPA's ability to assess the health and environmental risks
of chemicals, the Congress should consider amending TSCA to:
* provide explicit authority for EPA to enter into enforceable consent
agreements under which chemical companies are required to conduct
testing;
* give EPA, in addition to its current authorities under section 4 of
TSCA, the authority to require chemical substance manufacturers and
processors to develop test data based on substantial production volume
and the necessity for testing; and:
* authorize EPA to share with the states and foreign governments the
confidential business information that chemical companies provide to
EPA, subject to regulations to be established by EPA in consultation
with the chemical industry and other interested parties, that would set
forth the procedures to be followed by all recipients of the
information in order to protect the information from unauthorized
disclosures.
Recommendations for Executive Action:
To improve EPA's management of its chemical review program, we
recommend the EPA Administrator:
* develop and implement a methodology for using information collected
through the HPV Challenge Program to prioritize chemicals for further
review and to identify and obtain additional information needed to
assess their risks;
* promulgate a rule under section 8 of TSCA requiring chemical
companies to submit to EPA copies of any health and safety studies, as
well as other information concerning the environmental and health
effects of chemicals, that they submit to foreign governments on
chemicals that the companies manufacture or process in, or import to,
the United States;
* develop a strategy for improving and validating, for regulatory
purposes, the models that EPA uses to assess and predict the risks of
chemicals and to inform regulatory decisions on the production, use,
and disposal of the chemicals; and:
* revise its regulations to require that companies reassert claims of
confidentiality submitted to EPA under TSCA within a certain time
period after the information is initially claimed as confidential.
Agency Comments and Our Evaluation:
We provided EPA a draft of this report for its review and comment. EPA
did not disagree with the report's findings and recommendations. EPA,
however, offered two substantive comments. Regarding our recommendation
to the Administrator to promulgate a Section 8 rule to obtain data
submitted by chemical manufacturers to foreign governments, EPA
commented that, while such a reporting rule may bring useful
information, other targeted approaches for collecting information which
are directed at EPA's domestic priorities, rather than foreign
government mandates, may be more prudent. We believe that having access
to the information submitted to foreign governments would provide EPA
with an important source of information that would be useful for
assessing the risks of existing chemicals and improving the models that
EPA uses to assess new chemicals. EPA could tailor this rule more
narrowly, however, if it saw good reason to do so, such as to avoid
duplication of information it already possesses. Regarding the matter
for Congressional consideration that Congress consider amending TSCA to
explicitly recognize enforceable consent agreements, EPA stated that it
believes that there is currently strong legal authority for these
agreements. As we noted in our report, TSCA does not explicitly
authorize EPA to enter into these agreements and a court could find
that EPA lacked discretion to require testing other than through
promulgation of a test rule. EPA's comments are reproduced in appendix
VI.
As agreed with your offices, unless you publicly announce the contents
of this report earlier, we plan no further distribution until 30 days
from the report date. At that time, we will send copies of this report
to the congressional committees with jurisdiction over EPA and its
activities; the Administrator, EPA; and the Director, Office of
Management and Budget. We also will make copies available to others
upon request. In addition, the report will be available at no charge on
the GAO Web site at [Hyperlink, http://www.gao.gov].
If you have any questions about this report, please contact me at (202)
512-6225 or [Hyperlink, stephensonj@gao.gov]. Contact points for our
Offices of Congressional Relations and Public Affairs may be found on
the last page of this report. Key contributors to this report are
listed in appendix VII.
Signed by:
John B. Stephenson:
Director, Natural Resources and Environment:
[End of section]
Appendixes:
Appendix I: EPA's Voluntary Programs:
The Environmental Protection Agency (EPA) has initiated voluntary
programs to help gather data to assess chemical risks and to promote
the use of more environmentally safe chemicals. The following
information does not offer an exhaustive account of EPA's voluntary
programs but rather a discussion of three specific programs that are
designed to complement EPA's efforts to assess and control chemicals
under the Toxic Substances Control Act (TSCA) and to encourage
pollution prevention under the Pollution Prevention Act (PPA).
High Production Volume Challenge Program:
In response to several studies that showed that there were relatively
few U.S. High-Production-Volume (HPV) chemicals for which an
internationally agreed upon set of hazard screening data was available
to the public, EPA, in cooperation with industry, environmental groups,
and other interested parties, officially launched the HPV Challenge
Program in late 1998. The program was created to ensure that a baseline
set of data on approximately 2,800 high-production-volume-chemicals
would be made available to the public. HPV chemicals are manufactured
or imported in amounts equal to or greater than 1 million pounds per
year and were identified for this program through data reported under
TSCA Inventory Update Rule (IUR).[Footnote 26] Under the HPV Challenge
Program, EPA invited chemical companies to voluntarily sponsor the
approximately 2,800 chemicals. As part of their commitment to the HPV
Challenge Program, sponsors submit data summaries of existing
information along with a test plan that proposes a strategy to fill
data gaps for either individual chemicals or for a category of
chemicals. Sponsors could fill data gaps by (1) using existing
scientifically adequate data, (2) using an estimation technique such as
Structured Activity Analyses (SAR), or (3) proposing new testing.
Testing will only be conducted when there are inadequate existing data
or when other approaches, such as SAR, are not adequate to meet the
need. EPA requested that companies perform a self-assessment on the
quality of information they are providing to EPA.
EPA officials believe that the early results of the HPV Challenge
Program are promising. Nonetheless, several problems remain. While
chemical companies collectively have agreed to sponsor, or provide data
for, most of the chemicals that are produced at a high-production-
volume, about 300 chemicals, called, "orphans," have not been sponsored
by any chemical company. EPA has issued a proposed rule under section 4
of TSCA requiring chemical companies to conduct tests on and provide
data for 37 orphan chemicals in 2000, but has not yet finalized these
rules.[Footnote 27] According to EPA officials, due in part to the
difficulty and cost in developing and issuing such rules, EPA has not
determined how to proceed on obtaining data on the remaining orphan
chemicals. EPA officials do not know if they can make the findings
necessary to issue test rules for the additional unsponsored chemicals.
In addition, since 1990, other chemicals are produced at or above the
high-production-volume threshold. Although EPA has not developed a plan
to address these new HPV chemicals, several chemical associations have
announced a joint initiative to extend industry's work to chemicals
that meet the HPV threshold as of 2002 and to provide use and exposure
information for chemicals sponsored through EPA's and industry's
programs. Finally, while the HPV Challenge Program looks promising in
that, if successful, it will provide EPA and the public with
information not previously available on the properties of chemicals
produced at large volumes in the United States, this program may not
provide enough information for EPA to use in making risk assessment
decisions. While the data in the HPV Challenge Program may help EPA
prioritize chemicals of concern, the data may not present sufficient
evidence for EPA to determine whether a reasonable basis exists to
conclude that the chemical presents an unreasonable risk of injury to
health or the environment and that regulatory action is necessary.
Voluntary Children's Chemical Evaluation Program:
The Voluntary Children's Chemical Evaluation Program (VCCEP) is a pilot
program developed by EPA to ensure that there is adequate publicly
available toxicity and exposure information to assess the potential
risks to children posed by 23 specific chemicals. The pilot VCCEP was
announced in a Federal Register notice in December 2000.[Footnote 28]
EPA is running a pilot of the VCCEP in order to gain insight into how
best to design and implement the program in order to effectively
provide the agency and the public with the means to understand the
potential health risk to children associated with certain chemical
exposures. EPA intends the pilot to be the means of identifying
efficiencies that can be implemented in future VCCEPs. EPA asked
companies that produce and/or import 23 specific chemicals to volunteer
to sponsor their chemical in the first phase of a pilot of the VCCEP.
Chemical companies have volunteered to sponsor 20 of the 23 chemicals
in the VCCEP.
Chemical companies volunteering to sponsor a chemical under the program
make chemical-specific public commitments to make certain hazard,
exposure, and risk assessment data and analyses publicly available. EPA
is pursuing a three-tiered approach for gathering information, with
Tier 3 conducting more detailed toxicology and exposure studies than
Tier 2, and Tier 2 conducting more detailed toxicology and exposure
studies than Tier 1. After the submission of Tier 1 information and its
review by a peer consultation group consisting of scientific experts
with extensive and broad experience in toxicity testing and exposure
evaluations, EPA reviews the sponsor's assessment and develops a
response focusing primarily on whether any additional information is
needed to adequately evaluate the potential risks to children. If
additional information is needed to assess a chemical's risk to
children, EPA will indicate what information should be provided in Tier
2. Companies will then be given an opportunity to sponsor chemicals at
Tier 2. EPA plans to repeat this process for determining if Tier 3
information is needed. Information from all three tiers may not always
be necessary to adequately evaluate the risk to children.
According to EPA officials, since the program's inception, sponsors
have submitted six assessments on chemicals to EPA and the consultation
group. EPA officials believe that they will collect Tier I data for all
20 sponsored chemicals within the next 4 to 5 years. According to EPA
officials, as of December 2004, three assessments are in the peer
consultation stage, and industry has indicated that three or four
assessments will be ready for peer consultation in 2005. Although EPA
has not currently assessed the effectiveness of VCCEP, it plans to have
an interim evaluation in 2005, and a final evaluation in 2007.
Sustainable Futures:
In December 2002, EPA announced the Sustainable Futures Program, a
voluntary program designed to help industry develop new chemicals that
are sustainable economically and environmentally.[Footnote 29] Industry
participants in the program are offered (1) hands on training on some
of EPA's chemical risk screening models, (2) regulatory relief in the
form of expedited review, (3) small business assistance, (4) technical
assistance, and (5) public recognition. In Sustainable Futures, EPA has
sought to reduce the likelihood of harmful new chemicals entering into
commerce by making its screening tools available to chemical companies.
EPA provides companies training for and access to the same chemical
risk screening models that EPA uses in screening and evaluating the
risks of new chemicals. Use of these tools may enhance companies'
ability to identify concerns and halt or redirect work on a potentially
risky chemical early in the research and development phase. This
approach can save a company the resources it might otherwise invest in
a chemical that ultimately may encounter problems during EPA's review
process for new chemicals. By getting early feedback on the potential
hazards of a new chemical, a company can reduce regulatory uncertainty,
lower development and production costs, and make production decisions
that consider a broader array of factors other than the potential
profitability of a new chemical. Additionally, by using these screening
tools, companies may choose not to produce chemicals that could be
regulated by EPA, thus, potentially reducing EPA's regulatory burden.
[End of section]
Appendix II: Canadian and EU Chemical Legislation:
Canada and the European Union (EU) have inventories of chemicals
already in the marketplace and require chemical companies to notify
regulators about the manufacture or importation of new chemicals.
Officials we spoke with identified several notable aspects of the
Canadian and EU chemical legislation that differ from the Toxic
Substances Control Act (TSCA). First, in the EU, chemical companies
must notify regulators prior to marketing new chemicals, which is after
production has already begun. Second, Canadian law requires chemical
companies to conduct testing of new chemicals based on production or
import volume, while EU legislation requires testing based on marketed
volume. Finally, the EU is considering changes to its basic chemical
legislation that would require chemical companies to submit testing
information on existing, as well as new, chemicals. A chart generally
describing some of the provisions of TSCA and chemical control
legislation in the EU and Canada, along with the proposed EU
Registration, Evaluation and Authorization of Chemicals (REACH)
regulation, is provided in table 2.
Canadian and EU Processes for Assessing the Health and Environmental
Risks of Chemicals:
Canadian Environmental Protection Act (CEPA) regulations and EU
legislation require chemical companies to submit certain test data on
new chemicals before they enter commerce. Canada defines new chemicals
as those chemicals that are not on Canada's Domestic Substances List--
a list of all known substances that were in commercial use in Canada
between January 1, 1984, and December 31, 1986, were manufactured in or
imported into Canada by any person in a quantity of 100 kilograms or
more in any calendar year during that period, or that have subsequently
been fully notified and assessed under CEPA. Under CEPA regulations,
chemical companies must submit certain information and test data to the
government when production or importation volumes reach specified
levels. The information required for new chemicals differs depending on
whether the new chemical is listed on the Non-Domestic Substances List-
-a list that is based on the TSCA Chemical Substances Inventory.
Chemicals that are on the Non-Domestic Substances List are subject to
notification requirements at higher volume thresholds than are
applicable to other new chemicals and are exempt from certain
information submission requirements. In addition, the requirements to
submit test data for low volume chemicals are less extensive and
complex than those for high volume chemicals. According to Canadian
officials, a new chemical is generally not added to the existing
chemical inventory until a certain level of production or import has
been reached, and specified testing for that level has been performed
without conditions being placed on the chemical's manufacture or
import.
The EU currently maintains a separate inventory for new chemicals,
which are subject to additional testing and review before they are
marketed in volumes starting at 10 kilograms. Existing chemicals are
not subject to the same testing requirements. However, under the
proposed EU REACH chemical regulation, according to officials, this
distinction between new and existing chemicals would largely be
eliminated. All chemical companies would generally be required to
register substances they produce or import in volumes of 1 metric ton
or more per year. REACH would require chemical companies to gather and
submit information on the properties of their substances and where
necessary perform tests to generate health and safety data. For all
substances subject to registration manufactured or imported by the
registrant in quantities of 10 metric tons or more per year, REACH
would require submission of a chemical safety report, documenting a
chemical safety assessment including, among other things, human health
and environmental health hazard assessments. Substances would not be
allowed to be manufactured or imported in the European community unless
they met the registration requirements. Thus, according to EU
officials, REACH would reverse the burden of proof that is now placed
on public authorities to manage the risks and uses of particular
existing chemicals.
Confidentiality Claims:
CEPA and EU legislation allow chemical companies to make
confidentiality claims. However, according to officials we spoke with,
these countries place some greater restrictions than TSCA does on the
types of data that may be claimed as confidential.
In Canada, information that companies request be treated as
confidential is not to be disclosed except in certain circumstances.
The Minister of the Environment may disclose certain information upon
giving 24 hours notice to the company, if (a) the disclosure is in the
interest of public health, public safety or the protection of the
environment and (b) the public interest in the disclosure (1) outweighs
in importance any material financial loss or prejudice to the
competitive position of the person who provided the information or on
whose behalf it was provided and (2) any damage to the privacy,
reputation or human dignity of any individual that may result from
disclosure. However, CEPA maintains certain protections for information
protected under Canada's Privacy Act, Access to Information Act, and
Hazardous Materials Information Review Act.
EU legislation also allows chemical companies to make confidentiality
claims. However, according to an EU official we spoke with, the EU
places some greater restrictions on the types of data that may be
claimed as confidential than TSCA does. In the EU, a company may
indicate that information is commercially sensitive and that disclosure
may be harmful to the company industrially and commercially and,
therefore, that the company wishes to keep the information secret from
all persons other than the competent authorities and the European
Commission. Secrecy, however, shall not apply to:
* the trade name of the substance,
* certain physicochemical data concerning the substance,
* possible ways of rendering the substance harmless,
* the interpretation of the toxicological and ecotoxicological tests
and the name of the body responsible for the tests, and:
* certain recommended methods and precautions and emergency measures.
The authority receiving the information is to decide on its own
responsibility what information is covered by commercial and industrial
secrecy. The company can go to court and appeal the authority's
decision.
Under REACH, as currently proposed, one of the objectives of the new
system for the management of industrial chemicals would be to make
information on chemicals more widely available. Whenever a request for
access to documents held by the proposed European Chemicals Agency is
made, the agency would be required to inform the registrant of the
chemical or other party concerned of the request. That party would have
30 days to submit a declaration identifying information considered to
be commercially sensitive and disclosure of which might harm the party
commercially that the party wishes to be kept confidential. The agency
would consider the information and decide whether to accept the
declaration. The party could appeal this decision. The following
information would be among the types of information that would not be
treated as confidential:
* the trade name(s) of the substance; physicochemical data concerning
the substance and on pathways and environmental fate,
* the result of each toxicological and ecotoxicological study,
* if essential to classification and labeling, the degree of purity of
the substance and the identity of impurities and/or additives which are
known to be dangerous,
* guidance on safe use, and:
* information contained in the safety data sheet (except for the name
of the company or otherwise accepted as confidential in REACH).
The following information would be treated as confidential, even if the
company did not claim it as confidential:
* details of the full composition of a preparation,
* the precise use, function, or application of a substance or
preparation,
* the precise tonnage of the substance or preparation manufactured or
placed on the market, and:
* links between a manufacturer or importer and his downstream users.
However, in exceptional cases where there are immediate risks to human
health, safety or the environment, REACH would authorize the proposed
European Chemicals Agency to disclose this information.
Table 2: Regulation of Chemicals in the United States, Canada, and
European Union:
Name of chemical legislation;
United States: Toxic Substances Control Act;
Canada: Canadian Environmental Protection Act, 1999 (CEPA);
European Union: Current EU chemical legislation[A];
European Union: EU proposed Regulation Registration, Evaluation, and
Authorisation of Chemicals (REACH)[B].
Approximate number of chemicals in commerce when legislation was
passed;
United States: 62,000[C];
Canada: 23,000[D];
European Union: 100,000[E];
European Union: Not applicable[F].
Notifications requirement;
United States: Companies notify EPA of new chemicals by Premanufacture
Notice (PMN);
Canada: According to a Canadian official, companies must notify the
government of a new chemical that is not on the Non-Domestic Substances
List (NDSL) before it exceeds a quantity of 20 kilograms per year[G];
European Union: Companies notify the EU about new chemicals once the
marketing level reaches 10 kilograms;
European Union: Companies would generally be required to register
chemicals with a new European Chemicals Agency once production or
import reaches 1 metric ton (2,204.6 lbs).
Testing requirement;
United States: No specific tests are required for registration of new
chemicals;
Canada: Tiered testing levels for new chemicals based on production and
importation volume;
European Union: Tiered testing levels for new chemicals based on
production volume;
European Union: According to an EU official, testing would be required
only when there is insufficient information available and other sources
of information are not appropriate.
Risk assessment;
United States: Public authorities perform a 90-day risk assessment on
new chemicals; Public authorities concentrate risk assessment efforts
on high-volume existing chemicals;
Canada: According to officials, public authorities are responsible for
performing risk assessments on new and existing chemicals, but industry
will provide the majority of the test data;
European Union: Public authorities perform risk assessments on existing
chemicals. Industry provides testing and risk information on new
chemicals;
European Union: Manufacturers and importers would be responsible for
using knowledge on properties of the substances they manufacture or
import to ensure responsible and well-informed management of the risks
those substances may present. For all substances subject to
registration that are manufactured or imported at a level of more than
10 metric tons per year, a chemical safety assessment would be
required.
Source: GAO.
Note: This table is not meant for purposes of legal comparison but only
to provide some basic information about the countries' regulation of
chemicals.
[A] The current EU chemical legislation consists of 4 major pieces of
legislation with adaptations to technical progress over the years:
Council Directive 67/548/EEC: "Classification, Packaging and Labeling
of Dangerous Substances", Council Directive 76/769/EEC: "Marketing and
Restrictions", Council Regulation 793/93: "Existing Substances
Evaluation", and Council Directive 88/379/EEC as replaced by 99/45/EC:
"Preparations" as well as a number of other directives.
[B] The EU is currently considering a proposal known as REACH. COM 2003
0644 (03), Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF
THE COUNCIL concerning the Registration, Evaluation, Authorisation and
Restriction of Chemicals (REACH), establishing a European Chemicals
Agency and amending Directive 1999/45/EC and Regulation (EC) {on
Persistent Organic Pollutants} Proposal for a DIRECTIVE OF THE EUROPEAN
PARLIAMENT AND OF THE COUNCIL amending Council Directive 67/548/EEC in
order to adapt it to Regulation (EC) of the European Parliament and of
the Council concerning the registration, evaluation, authorisation and
restriction of chemicals. An EU representative estimates that the
earliest possible implementation of REACH, if adopted, is 2006 with the
first registrations arriving in 2009.
[C] Since EPA began its review program for new chemicals, approximately
20,000 new chemicals have been added to the list of chemicals in
commerce.
[D] Because the data from Canada was used for context purposes, we did
not assess the reliability of the data.
[E] Because the data from the EU was used for context purposes, we did
not assess the reliability of the data.
[F] If the REACH regulation is passed, an EU representative estimates
that over 30,000 chemicals currently in commerce or production in the
EU will qualify as existing chemicals because their production or
import exceeds 1 metric ton (2,204.6 lbs) per producer, or importer per
year. At this time, the proposed regulation has not been passed.
[G] According to a Canadian official, a revised notification regulation
is expected to be finalized in the summer of 2005. Once the New
Substances Notification Regulation is published and enforced, the
volume thresholds will be under 100 kilograms per year for a new
chemical that is not on the Non-Domestic Substances List. For chemicals
that are listed on the NDSL, the notification level will be 1,000
kilogram per year. The Non-domestic Substances List (NDSL) specifies
substances that are not on the Domestic Substances List but are in
commercial use in the United States. The Domestic Substances List (DSL)
is the sole basis for determining whether a substance is new for the
purposes of the Canadian Environmental Protection Act, 1999 (CEPA,
1999). The DSL contains 23,000 substances that were existing substances
at the time CEPA, 1999 was enacted.
[End of table]
[End of section]
Appendix III: Additional Options for Strengthening EPA's Ability to
Assess and Regulate Chemicals under TSCA:
As requested, we identified a number of options that could strengthen
the Environmental Protection Agency's (EPA) ability under the Toxic
Substances Control Act (TSCA) to assess chemicals and control those
found to be harmful. These options are those that we previously
identified in an earlier GAO report[Footnote 30] on ways to make TSCA
more effective. Representatives of environmental organizations and
subject matter experts subsequently concurred with a number of these
options and commented on them in congressional testimony. These options
are not meant to be comprehensive but illustrate actions that the
Congress could take to strengthen EPA's ability to regulate chemicals
under TSCA.
Options to Reduce EPA's Evidentiary Burden to Take Action under TSCA:
The Congress could amend TSCA to reduce the evidentiary burden that EPA
must meet to take regulatory action under the act by (1) amending the
unreasonable risk standard that EPA must meet to regulate existing
chemicals under section 6 of TSCA, (2) amending the standard for
judicial review that currently requires a court to hold a TSCA rule
unlawful and set it aside unless it is supported by substantial
evidence in the rulemaking record, or (3) amending the requirement that
EPA must choose the least burdensome regulatory requirement.
Currently, under TSCA section 6, EPA may only regulate existing
chemicals if it finds that there is a reasonable basis to conclude that
the chemical "presents or will present an unreasonable risk of injury
to health or the environment."[Footnote 31] Several options are
available to amend this standard. For example:
* The Congress could authorize EPA to regulate existing chemicals when
it identifies "significant," rather than "unreasonable," risks of
injury to health or the environment. "Significant risk" is the standard
under TSCA section 4(f) by which EPA is to identify chemicals for
priority review. EPA officials view the term "significant risk" as a
very high threshold for action. However, they believe that
demonstrating significant risk would be less demanding than
demonstrating unreasonable risk. While "significant risk" implies a
finding that the risks are substantial or serious, EPA believes that a
finding of "unreasonable" risk requires an extensive cost-benefit
analysis. When reviewing EPA's asbestos rule, the United States Court
of Appeals for the Fifth Circuit stated that in evaluating what risks
are unreasonable EPA must consider the costs of any proposed actions;
moreover, the court noted that TSCA's requirement that EPA impose the
least burdensome regulation reinforces the view that EPA must balance
the costs of its regulations against their benefits.[Footnote 32]
* The Congress could amend TSCA to require that EPA demonstrate that a
chemical "may present" an unreasonable risk, rather than requiring a
demonstration that a chemical "presents or will present" an
unreasonable risk. Such a change would still require EPA to develop
documentation of evidence supporting its assessment, although to a
lesser extent than is currently required under TSCA.
In addition, TSCA currently requires a court to hold unlawful and set
aside a TSCA rule if it finds that the rule is not supported by
substantial evidence in the rulemaking record.[Footnote 33] As several
courts have noted, the substantial evidence standard is more rigorous
than the arbitrary and capricious standard normally applied to
rulemaking under the Administrative Procedure Act.[Footnote 34] The
Congress could amend the standard for judicial review to instead
reflect a rational basis test to prevent arbitrary and capricious
administrative decisions.
Finally, TSCA currently requires that EPA choose the least burdensome
requirement when regulating existing chemicals. As we noted earlier, in
its ruling that EPA had failed to muster substantial evidence to
justify its asbestos ban, the United States. Court of Appeals for the
Fifth Circuit concluded that EPA did not present sufficient evidence to
justify the ban on asbestos because it did not consider all necessary
evidence and failed to show that the control action it chose was the
least burdensome regulation required to adequately protect human health
or the environment. EPA had not calculated the risk levels for
intermediate levels of regulation, as it believed there was no asbestos
exposure level for which the risk of injury or death was zero. As
articulated by the court, the proper course of action for EPA, after an
initial showing of product danger, would have been to consider each
regulatory option, beginning with the least burdensome, and the costs
and benefits of each option. Congressional testimony has indicated
that, under this court decision, the process "is not merely onerous; it
may well be impossible."[Footnote 35] The Congress could amend or
repeal this requirement.
Options for Requiring Chemical Companies to Provide Additional
Information on New Chemicals:
TSCA could be revised to require companies to test their chemicals and
submit the results to EPA with their premanufacture notices. Currently,
such a step is only required if EPA makes the necessary findings and
promulgates a testing rule. A major drawback to testing is its cost to
chemical companies, possibly resulting in a reduced willingness to
perform chemical research and innovation. To ameliorate such costs, or
to delay them until the new chemicals are produced in large enough
quantity to offset the cost of testing, requirements for testing could
be based on production volume. For example, in Canada and the EU,
testing requirements for low-volume chemicals are less extensive and
complex than for those for high-volume chemicals.
Another option would be to provide EPA with greater authority to
require testing targeted to those areas in which EPA's structure
activity relationship (SAR) analysis does not adequately predict
toxicity. For example, EPA could be authorized to require such testing
if it finds that it cannot be confident of the results of its SAR
analysis (e.g., when it does not have sufficient toxicity data on
chemicals with molecular structures similar to those of the new
chemicals submitted by chemical companies.) Under such an option, EPA
could establish a minimal set of tests for new chemicals to be
submitted at the time a chemical company submits a premanufacture
notice for the chemical for EPA's review. Additional and more complex
and costly testing could be required as the new chemical's potential
risks increase, based on production or environmental release levels.
According to some chemical companies, the cost of initial testing could
be reduced by amending TSCA to require EPA to review new chemicals
before they are marketed, rather than before they are manufactured. In
this regard, according to EPA, about half of the premanufacture notices
the agency receives from chemical companies are for new chemicals that,
for various reasons, never enter the marketplace. Thus, requiring
companies to conduct tests and submit the resulting test data only for
chemicals that are actually marketed would be substantially less
expensive than requiring them to test all new chemicals submitted for
EPA's review.
Options for Requiring the Systematic Testing of Existing Chemicals:
TSCA's chemical review provisions could be strengthened by requiring
the systematic review of existing chemicals. In requiring that EPA
review premanufacture notices within 90 days, TSCA established a firm
requirement for reviewing new chemicals, but the act contains no
similar requirement for existing chemicals unless EPA determines by
rule that they are being put to a significant new use. TSCA could be
amended to establish a time frame for the review of existing chemicals,
putting existing chemicals on a more equal footing with new chemicals.
However, because of the large number of existing chemicals, EPA would
need the flexibility to identify which chemicals should be given
priority. TSCA could be amended to require individual chemical
companies or the industry as a whole to compile and submit chemical
data, such as that included in the HPV Challenge Program to EPA, for
example, as a condition of manufacture or import above some specified
volume.
Options for Reducing Risks through Chemical Use Reduction:
Given the thousands of chemicals in use and the many ways that
exposures and releases to the environment can occur, TSCA's chemical-
by-chemical approach means that the act is unlikely to address more
than the most serious chemical risks. The process of collecting
information on chemical effects and exposures to support regulatory
actions under TSCA is a resource intensive and time-consuming process.
A different approach would be to set goals for reducing the use of
toxic chemicals overall. Under this approach, legislation could
establish national goals for reductions in the use of toxic chemicals
and provide EPA with various tools, such as pollution taxes and other
economic incentives to encourage chemical companies to engage in risk
reduction activities. This approach differs from a command-and-control
approach in which the regulator specifies how pollution must be reduced
or what pollution control technology must be used. An approach
employing economic incentives gives companies more flexibility in
choosing how to reduce pollution and could lead to more cost-effective
solutions to pollution problems. An approach employing economic
incentives can take several forms, including systems under which firms
can buy and sell emission reduction credits and pollution taxes. A
pollution tax is a tax on the emissions of a pollutant or on harmful
products or substances. Such a tax would have to be carefully designed
and implemented to be effective in achieving environmental and economic
benefits.
Because of their inherently greater flexibility, market-based
incentives may be both a less costly and a more effective means of
controlling pollution. More chemicals could also be addressed under
TSCA if the Congress were to amend TSCA to expand the types of
circumstances under which EPA could take action under the act to
specifically include situations in which (1) it identifies pollution
prevention opportunities, such as when safer chemical substitutes can
be shown to exist at a reasonable cost, or (2) the use of a toxic
chemical cannot be shown to pose a current problem, but its continued
use could be a long-term problem because it persists in the environment
or accumulates in plant or animal tissue. To better support EPA's
pollution prevention initiatives, TSCA could also be amended to expand
the range of regulatory control options available to EPA to reduce
chemical risks. Such additional options could include the authority to
require the use of safer chemical substitutes or manufacturing
processes that result in less exposure or fewer environmental releases.
[End of section]
Appendix IV: Scope and Methodology:
Our objectives were to review the Environmental Protection Agency's
(EPA) efforts to (1) control the risks of new chemicals not yet in
commerce, (2) assess existing chemicals used in commerce, and (3)
publicly disclose information provided by chemical companies under the
Toxic Substances Control Act (TSCA). In addressing these issues we also
obtained information on EPA's voluntary chemical control programs that
complement TSCA, the chemical control programs of Canada and the
European Union (EU), and identified some legislative options that GAO
and others have previously noted could strengthen EPA's authority to
assess and regulate chemicals under TSCA.
To review the extent to which EPA has assessed the risks of new and
existing chemicals and has made information obtained under TSCA public,
we reviewed the relevant provisions of TSCA, identified and analyzed
EPA's regulations on how the new and existing chemical review and
control programs work, including the handling of confidential
information, and determined the extent of actions taken by EPA to
control chemicals. These efforts were augmented by interviews with EPA
officials and representatives of the American Chemistry Council (a
national chemical manufacturers association), Environmental Defense (a
national, nonprofit, environmental advocacy organization), and the
Synthetic Organic Chemical Manufacturer's Association (a national,
specialty chemical manufacturer's association). We also obtained and
reviewed documentation provide to EPA by the states on the usefulness
of confidential business information to states. We interviewed several
EPA officials to assess the reliability of data related to assessment
and control of new chemicals. We determined the data were sufficiently
reliable for the purposes of this report.
To understand efforts EPA has taken to assess and control the risks of
new and existing chemicals, we identified several voluntary programs
designed to promote environmentally safer chemicals and to gather
information to assess the risks of chemicals, in particular, EPA's
Sustainable Futures Program, Voluntary Children's Chemical Evaluation
Program (VCCEP), and the High Production Volume (HPV) Challenge
Program. We selected Sustainable Futures because it is a risk
assessment tool used to complement EPA's other pollution prevention
programs. Sustainable Futures represents a pollution prevention program
that impacts manufacturer's chemical decision-making process for
chemicals not yet in commerce; while other pollution prevention
programs focus on chemicals already in commerce. We selected the HPV
Challenge Program and VCCEP because they represent significant data
collection efforts to provide information for EPA's assessment of
existing chemicals. To enhance our understanding, we interviewed EPA
officials and representatives at American Chemistry Council,
Environmental Defense, and the Synthetic Organic Chemical
Manufacturer's Association; we also attended EPA's National Toxic and
Pollution Prevention Advisory Committee meetings. Finally, we obtained
and reviewed agency documents related to these programs.
To understand other chemical control regulation, we collected
documentation and interviewed individuals knowledgeable about (1) the
Toxic Substances Control Act and (2) foreign chemical control laws or
proposed legislation: (a) the Canadian Environmental Protection Act
1999 and (b) the European Union's Chemical Directives and proposed
Registration, Evaluation and Authorization of Chemicals. The EU and
Canada were chosen because they have recently taken action to revise
their chemical legislation. In 1999, Canada revised its chemical
control law and in 2003, the EU proposed a new regulation. The EU and
Canada were also selected because they have characteristics that are
similar to those of the United States: Canada and the EU member
countries are industrialized nations and have extensive experience with
the review and control of chemical substances. In addition, Canada and
the EU produce a considerable amount of chemicals. Furthermore, EPA
officials and chemical industry representatives recommended these
countries for comparison with TSCA. For each of the countries, we
obtained laws, technical literature, and government documents that
describe their chemical control programs. We also interviewed foreign
officials responsible for implementing the chemical substances control
laws in Canada and for representing the European Commission in the
United States. Our descriptions of these countries' laws are based on
interviews with government officials and written materials they
provided.
To identify potential options to strengthen EPA's ability to assess and
regulate chemical risks under TSCA, we (1) interviewed officials at
EPA, the American Chemistry Council, Environmental Defense, EPA's
National Toxic and Pollution Prevention Advisory Committee, and the
Synthetic Organic Chemical Manufacturer's Association; (2) reviewed
pertinent literature, including prior GAO reports and congressional
hearings on TSCA; (3) attended various public meetings and conferences
sponsored by EPA and others; and (4) reviewed chemical legislation in
Canada and and proposed legislation in the EU. This report does not
discuss all possible options for revising TSCA. Those options that are
discussed were selected because they have been identified as addressing
constraints in EPA's authority under the act. Our selection of these
options reflects (1) our knowledge of EPA's implementation of TSCA
obtained during this and previous reviews of the agency's toxics
programs, (2) foreign countries' approaches to reviewing and
controlling harmful chemicals, and (3) views provided by U.S.
government officials and representatives of the chemical industry and
environmental groups.
Our review was performed between June 2004 and April 2005 in accordance
with generally accepted government auditing standards.
[End of section]
Appendix V: Regulations Promulgated under Section 6 of TSCA:
The Environmental Protection Agency (EPA) has promulgated rules under
section 6 of the Toxic Substances Control Act (TSCA) to place
restrictions on five existing chemicals or chemical categories and four
new chemicals. The five existing chemicals/chemical categories are
polychlorinated biphenyls (PCB), fully halogenated chlorofluoroalkanes,
dioxin, asbestos and hexavalent chromium. The four new chemicals are
all used in metal working fluids that, when combined with nitrites,
could cause the formation of a cancer causing substance. EPA's rules
for the four new chemicals were immediately effective, unlike EPA's
rules for existing chemicals, which required a comment period.
Existing Chemicals:
Polychlorinated Biphenyls:
Because the Congress believed that PCBs posed a significant risk to
public health and the environment, section 6(e) of TSCA prohibited the
manufacture, processing, distribution in commerce, or use of PCBs other
than in a totally enclosed manner after January 1, 1978, unless
otherwise authorized by EPA rule. Under TSCA, EPA may, by rule,
authorize the manufacture, processing, distribution in commerce or use
of any PCB in a manner other than a totally enclosed manner if EPA
finds that it will not present an unreasonable risk of injury to health
or the environment. EPA was also required by July 1977 to promulgate
rules to (1) prescribe methods for PCB disposal and (2) require PCBs to
be marked with clear and adequate warnings and instructions with
respect to their processing, distribution in commerce, use, or
disposal. EPA has issued various rules to implement these statutory
requirements and provide for some exemptions to the PCB prohibitions.
About 50 percent of PCBs were used in electrical, heat transfer, and
hydraulic equipment. PCBs were also used in numerous other
applications, including plasticizers and fire retardants. Approximately
half of the PCBs manufactured were disposed of or released into the
environment prior to EPA promulgating rules for the disposal
requirements under TSCA. PCBs are toxic and very persistent in the
environment. When released into the environment, they decompose very
slowly and can accumulate in plants, animals, and human tissue.
Laboratory tests show that they cause cancer in rats and mice and that
they have adverse effects on fish and wildlife.
Fully Halogenated Chlorofluoroalkanes:
In 1978, EPA banned nonessential uses of fully halogenated
chlorofluoroalkanes as propellants in aerosol spray containers. EPA
took this action because of concerns that these chemicals were
destroying the upper atmosphere's ozone layer, which shields the earth
from ultraviolet radiation. Increased exposure to ultraviolet radiation
has been linked to increased skin cancer. Depletion of the ozone layer
is also thought to lead to climate changes and other adverse effects.
Chlorofluorocarbons, halons, and other fully halogenated
chlorofluoroalkanes have been relied upon for applications including
air conditioning, refrigeration, fire suppression, insulation, and
solvent cleaning. According to EPA officials, in advance of its
obligations under the Montreal Protocol, the United States began
phasing out production of the most potent ozone depleting chemicals in
1994 and is now gradually phasing out hydrofluorocarbon production as
well. According to EPA officials, other industrialized countries have
followed the U.S. lead, and developing countries with assistance from
the Multilateral Fund are now complying with the protocol phase out
requirements. The regulation of fully halogenated chlorofluoroalkanes
was eliminated in 1995 by an EPA final rule because EPA had banned such
chlorofluorocarbons propellants under the Clean Air Act, making the
TSCA rule obsolete.[Footnote 36]
Dioxin:
In 1980, EPA promulgated a rule prohibiting Vertac Chemical Company and
others from removing for disposal certain wastes containing 2,3,7,8-
tetrachlorodibenzo-p-dioxin (TCDD) stored at Vertac's Jacksonville,
Arkansas, facility.[Footnote 37] The rule also required any persons
planning to dispose of TCCD contaminated wastes to notify EPA 60 days
before their intended disposal. TCDD, one of the most toxic of the
about 75 dioxins in existence and an animal carcinogen, is a
contaminant or waste product formed during the manufacture of certain
substances. EPA concluded that it was likely to result in adverse human
health effects. This TSCA action was superseded by a 1985 Resource
Conservation and Recovery Act regulation.[Footnote 38]
Asbestos:
Asbestos, which refers to several minerals that typically separate into
very tiny fibers, is a known human carcinogen that can cause lung
cancer and other diseases if inhaled. Asbestos containing materials
were used widely for fireproofing, thermal and acoustical insulation,
and decoration in building construction and renovation before the
adverse effects of asbestos were known. Asbestos also has numerous
other applications, for example, in friction products such as brake
linings. After initially regulating asbestos under the Clean Air Act in
the early 1970s, EPA issued a final rule under TSCA to ban the
manufacturing, importing, and processing of nearly all asbestos
products in July 1989.[Footnote 39] The rule was to begin phasing out
asbestos-containing products in August 1990, and complete the phaseout
by 1997. EPA's rule was challenged in federal court by asbestos product
manufacturers, and in October 1991, the United States Court of Appeals
for the Fifth Circuit vacated most of the rule--the rule continued to
apply to asbestos products no longer in commerce--and remanded it to
the agency for further consideration.
Hexavalent Chromium:
In 1990, EPA banned the use of hexavalent chromium-based water
treatment chemicals in comfort cooling towers (CCT) and the
distribution of them in commerce for use in CCTs on the basis of health
risks associated with human exposure to air emissions.[Footnote 40]
According to EPA, hexavalent chromium was being released from a large
number of unidentified cooling towers. At the time, hexavalent chromium
was a known human carcinogen. EPA could have issued an emissions
standard under the Clean Air Act. However, the agency believed that
regulation under TSCA would be more efficient and effective because the
act could be used to regulate use and distribution of hexavalent
chromium-based water treatment chemicals.
New Chemicals:
EPA issued proposed rules to impose certain controls on four new
chemicals: (1) mixed mono and diamides of an organic acid,[Footnote 41]
(2) triethanolamine salts of a substituted organic acid,[Footnote 42]
(3) triethanolanime salt of tricarboxylic acid, and (4) tricarboxylic
acid.[Footnote 43] The agency determined these chemicals would pose an
unreasonable risk to human health or the environment. According to EPA,
adding nitrites or other nitrosating agents to the substances causes
the formation of a substance known to cause cancer in laboratory
animals. EPA promulgated the rules regulating these chemicals in 1984
to prohibit adding any nitrosating agent, including nitrites, to metal
working fluids that contain these substances. EPA promulgated the rules
under TSCA section 5(f). Under this section of TSCA, if EPA determines
that there is a reasonable basis to conclude that the manufacturing,
processing, distribution in commerce, or disposal of a new chemical
presents or will present an unreasonable risk of injury to health or
the environment before EPA can promulgate a rule under TSCA section 6,
EPA may limit the amount or impose other restrictions via an
immediately effective proposed rule. The restrictions on these
chemicals remain in place today.
[End of section]
Appendix VI: Comments From the Environmental Protection Agency:
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY:
OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES:
WASHINGTON, D.C. 20460:
MAY 26 2005:
Mr. John Stephenson:
Director:
Natural Resources and Environment:
Government Accountability Office:
Washington, DC 20548:
Dear Mr. Stephenson:
Thank you for the opportunity to review and comment on the proposed
draft Government Accountability Office (GAO) report entitled "Chemical
Regulation: Actions Needed to Improve EPA's Ability to Assess Health
Risks and Manage its Chemical Review Program" (GAO-05-458). The Report
examines the Environmental Protection Agency's (EPA's) efforts to (1)
control the risks of new chemicals not yet in commerce, (2) assess the
risks of existing chemicals used in commerce, and (3) publicly disclose
information provided by chemical companies under the Toxics Substances
Control Act (TSCA).
EPA is proud of the progress that we have made in protecting human
health and the environment. There are over 82,000 chemicals currently
on the TSCA inventory and approximately 1,500 new chemical notices are
reviewed each year in EPA's New Chemicals Program. To date, TSCA
authority has provided the Agency the ability to review more than
40,000 new chemicals prior to introduction into the marketplace and we
have restricted or otherwise regulated over 1,600 of these chemicals
while a similar number have been withdrawn by the manufacturer, often
in the face of EPA action. In addition, the Agency has issued rules
requiring Agency review of significant new uses of more than 700
chemicals. The Agency utilizes a variety of tools including modeling,
voluntary and innovative approaches, international coordination, and
information gathering and dissemination to ensure that we have the
ability to make informed decisions and that there is transparency for a
wide range of stakeholders and the public.
The Agency also works to target chemical data development and
information collection and appreciates GAO's recognition of the need to
balance this against external expectations and regulated community
burdens. We also appreciate GAO bringing these considerations into the
dialogue at various points throughout the report. This balance is, in
part, evidenced by the interviews your staff conducted with the
American Chemistry Council, Environmental Defense, the Synthetic
Organic Chemical Manufacturers Association and members of EPA's
National Pollution Prevention and Toxics Advisory Committee. GAO
recognizes EPA's "numerous control actions" resulting from reviews of
new chemicals and efforts under the High Production Volume Chemicals
Challenge Program to aggressively obtain data on a key set of chemicals
on the TSCA Inventory. EPA's "numerous control actions" speak to the
range of traditional and innovative approaches applied by the Agency in
the chemical review program.
While EPA appreciates the observations and suggestions for the
chemicals management program, there are two substantive comments that
we would like to provide. Technical and editorial comments are provided
in the enclosed Appendices.
EPA has concerns regarding GAO's recommendation to the Administrator to
promulgate a Section 8 rule to obtain data submitted to foreign
governments. The Report recommends a rule that would require chemical
companies to submit to EPA copies of any health and safety studies and
related information that the companies submit to foreign governments on
chemicals manufactured, processed, or imported in the United States.
The recommendation suggests a potentially broad-ranging information
collection. While such a reporting rule may bring useful information,
other more targeted approaches for collecting information which are
directed at EPA's domestic priorities, rather than foreign government
mandates, may be more prudent.
In another recommendation for Congressional consideration, GAO
recommends that TSCA be amended to explicitly recognize enforceable
consent agreements (ECAs). As we have stated throughout the discussions
on this report, EPA believes that there is currently strong legal
authority for ECAs under which chemical companies are required to
conduct testing.
Thank you for this opportunity to review and comment on the report GAO-
05-458, "Chemical Regulation: Actions Needed to Improve EPA's Ability
to Assess Health Risks and Manage its Chemical Review Program. " We
look forward to continuing to work with the General Accountability
Office and Congress on our efforts to ensure chemical safety and
protection of human health and the environment.
Sincerely,
Signed for:
Susan B. Hazen:
Principal Deputy Assistant Administrator:
Enclosures:
[End of section]
Appendix VII: GAO Contact and Staff Acknowledgments:
GAO Contact:
John B. Stephenson, (202) 512-3841:
Staff Acknowledgments:
In addition to the individual named above, David Bennett, John
Delicath, Richard Frankel, Ed Kratzer, Malissa Livingston, Jean
McSween, Marcella Phelps, and Amy Webbink made key contributions to
this report.
(360493):
FOOTNOTES
[1] Pub. L. No. 94-469, 90 Stat. 2003 (1976) (codified at 15 U.S.C. §§
2601-2692).
[2] Because the study was used for context purposes, we did not assess
its reliability.
[3] J. Chun, V. Nabholz, and M. Wilson. 2001. "Comparison of measured
aquatic toxicity data with EPA, OPPT SAR Predictions." Poster
presentations by J. Chun, PPG Industries at the March 2001 meeting of
the Society of Toxicology in San Francisco, Calif., and the November
2002 meeting of the Society of Environmental Toxicology and Chemistry.
[4] These chemicals reviewed do not include EPA's review of the
chemicals manufactured by companies that EPA has exempted from the
premanufacture notice requirements: 717 Test Marketing Exemption
Applications; 7,888 Low Volume Exemptions; 35 Low Release/Low Exposure
Exemptions; and 2,530 Polymer Exemptions. EPA may exempt a chemical
company from the premanufacture notice requirement, upon application
from the company showing to EPA's satisfaction that the chemical will
not present any unreasonable risk of injury to human health or the
environment.
[5] EPA has limited the uses of four new chemicals: (1) mixed mono and
diamides of an organic acid, (2) triethanolamine salts of a substituted
organic acid, (3) triethanolanime salt of tricarboxylic acid, and (4)
tricarboxylic acid.
[6] TSCA does contain specific provisions regarding review of
polychlorinated biphenyls.
[7] EPA guidance states that manufacturers are to consider (1) the
seriousness of the adverse effect and (2) the probability of the
effect's occurrence in determining if information qualifies as
substantial risk information. This information need not establish
conclusively that a substantial risk exists.
[8] If the company must submit a notice as the result of a significant
new use rule, then TSCA would require the company to submit this
information.
[9] As discussed later in this section of the report, however, EPA took
steps to address this shortcoming with the implementation of the HPV
Challenge Program in 1989.
[10] The 2,863 HPV chemicals included in the study consist of a subset
of chemicals found in the United States. They are defined by production
within the United States of a volume of 1 million pounds or more per
year and the legal definitions established in TSCA. This study
represents EPA's most recent study to assess the number of publicly
available data for these HPV chemicals.
[11] Section 8(b) of TSCA requires EPA to compile, keep current, and
publish a list of each chemical manufactured or processed in the United
States. EPA promulgates inventory update rules under section 8(a) of
TSCA, which requires EPA to promulgate rules under which chemical
companies are required to maintain certain records and submit certain
reports to EPA.
[12] EPA also added inorganic chemicals for which basic information at
a 25,000-pound threshold will be provided in 2006. Inorganics are
exempted from additional use and processing information at the 300,000-
pound threshold in the 2006 reporting cycle. This information will be
required for higher volume inorganic chemicals in the next IUR
reporting cycle.
[13] The ITC is an independent advisory committee to EPA created to
identify chemicals regulated by TSCA for which there are suspicions of
toxicity or exposure and for which there are few, if any, ecological
effects, environmental fate or health effects testing data.
[14] Natural Resources Defense Council v. EPA, 595 F. Supp. 1255
(S.D.N.Y. 1984).
[15] 51 Fed. Reg. 23706 (June 30, 1986).
[16] 40 C.F.R. § 790.22(b).
[17] 40 C.F.R. §§ 790.22(b), 790.28(b).
[18] 40 C.F.R. § 790.24.
[19] Animal welfare groups filed a lawsuit alleging that EPA violated
TSCA by developing and implementing the HPV Challenge Program, rather
than promulgating formal test rules. The United States District Court
held that EPA's use of the HPV Challenge Program was not in violation
of TSCA and that EPA was not required to initiate rulemaking.
Physicians Committee for Responsible Medicine v. Leavitt, 331 F. Supp.
2d 204 (S.D.N.Y. 2004). This case is currently on appeal.
[20] 15 U.S.C. § 2618(c)(1).
[21] 54 Fed. Reg. 29460 (July 12, 1989).
[22] Corrosion Proof Fittings v. EPA, 947 F.2d 1201 (5th Cir. 1991).
[23] 15 U.S.C. § 2601(c).
[24] EPA can disclose certain health and safety data, as well as
information that it determines is necessary to disclose in order to
protect health or the environment from an unreasonable risk.
[25] Illinois EPA TSCA CBI Evaluation Final Report (May 31, 1996).
[26] IUR requires certain manufacturers and importers of chemical
substances included on the TSCA inventory to report, among other
things, current data on the production volume of these substances. The
HPV program generally uses information from the 1990 IUR reporting
period to determine HPV chemicals.
[27] 65 Fed. Reg. 81658 (Dec. 26, 2000).
[28] 65 Fed. Reg. 81700 (Dec. 26, 2000).
[29] 67 Fed. Reg. 76282 (Dec. 11, 2002).
[30] GAO, Toxic Substances Control Act: Legislative Changes Could Make
the Act More Effective, GAO/RCED-94-103 (September 1994).
[31] 15 U.S.C. § 2605(a).
[32] The Supreme Court has stated that the Congress, in a number of
statutes has used the phrase "unreasonable risk" to "signify a
generalized balancing of costs and benefits." American Textile
Manufacturers Inst. v. Donovan, 452 U.S. 490, 512 (1981).
[33] 42 U.S.C. § 2618(c)(1)(B)(i).
[34] See Corrosion Proof Fittings v. EPA, 947 F.2d 1201, 1213-14 (5th
Cir. 1991); Environmental Defense Fund v. EPA, 636 F.2d 1267, 1277
(D.C. Cir. 1980).
[35] Statement of Lisa Heinzerling, Professor of Law, Georgetown
University Law Center before the Committee on House Energy and
Commerce, Subcommittee on Environment and Hazardous Materials (July 13,
2004). David Monsma, Toxics Project, referred to this standard in his
July 13, 1994, testimony as an "arduous standard" and stated that "TSCA
can be restored to a functional state by articulating, as a general
purpose of the Act, its pollution prevention purposes and by removing
the regulatory trap created by the" least burdensome alternative"
language.
[36] 60 Fed. Reg. 31917 (June 19, 1995).
[37] 45 Fed. Reg. 32676 (May 19, 1980).
[38] 50 Fed. Reg. 2003 (Jan. 14, 1985).
[39] EPA first regulated asbestos in the early 1970s as a hazardous air
pollutant under the Clean Air Act by prescribing, among other things,
work practices to prevent or minimize the release of asbestos into the
air during the demolition or renovation of buildings containing
asbestos. In 1982, EPA issued a rule requiring all public and private
elementary and secondary schools to inspect for friable (easily
crumbled into powder) asbestos-containing materials.
[40] 55 Fed. Reg. 222 (Jan. 3, 1990).
[41] 49 Fed. Reg. 36846 (Sep. 20, 1984).
[42] 49 Fed. Reg. 24658 (Sep. 20, 1984).
[43] 49 Fed. Reg. 2762 (Jan. 23, 1984).
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