Chemical Regulation: Options Exist to Improve EPA's Ability to
Assess Health Risks and Manage Its Chemical Review Program
(13-JUN-05, GAO-05-458).
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.
-------------------------Indexing Terms-------------------------
REPORTNUM: GAO-05-458
ACCNO: A26437
TITLE: Chemical Regulation: Options Exist to Improve EPA's
Ability to Assess Health Risks and Manage Its Chemical Review
Program
DATE: 06/13/2005
SUBJECT: Environmental law
Environmental monitoring
Federal regulations
Health hazards
Product evaluation
Safety regulation
Toxic substances
Chemicals
Public health
EPA High Production Volume Challenge
Program
******************************************************************
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GAO-05-458
United States Government Accountability Office
GAO 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
a
GAO-05-458
[IMG]
June 2005
CHEMICAL REGULATION
Options Exist to Improve EPA's Ability to Assess Health Risks and Manage Its
Chemical Review Program
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.
United States Government Accountability Office
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
1 3 6
10
18 31 34 36 37 37
Appendixes
Appendix I: EPA's Voluntary Programs 40
Appendix II: Canadian and EU Chemical Legislation 44
Additional Options for Strengthening EPA's
Appendix III: Ability to Assess
and Regulate Chemicals under TSCA 50
Appendix IV: Scope and Methodology 55
Appendix V: Regulations Promulgated under Section 6 of 58
TSCA
Appendix VI: Comments From the Environmental Protection 62
Agency
Appendix VII: GAO Contact and Staff Acknowledgments 64
Tables Table 1: TSCA's Major Sections for Chemical Data Collection and
Control 7
Table 2: Regulation of Chemicals in the United States, Canada,
and
European Union 48
Contents
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
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A
United States Government Accountability Office Washington, D.C. 20548
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.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
1Pub. L. No. 94-469, 90 Stat. 2003 (1976) (codified at 15 U.S.C. S:S:
2601-2692).
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 Purpose
Chemical testing
New chemical review and control and Significant new use rules
Chemical regulation
Industry reporting of chemical data
TSCA's relationship to other laws
Disclosure of chemical data
Source: GAO analysis of TSCA.
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.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
2Because the study was used for context purposes, we did not assess its
reliability.
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.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
3J. 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.
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.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.
4These 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.
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.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
5EPA 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.
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.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 risk7 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.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 1979.9
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
6TSCA does contain specific provisions regarding review of polychlorinated
biphenyls.
7EPA 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.
8If 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.
9As 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.
1 million pounds per year in 1990.10 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.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.12
Nevertheless, TSCA does provide EPA with the authority to obtain
information needed to assess chemicals by issuing rules under section 4 of
10The 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.
11Section 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.
12EPA 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.
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 Testing13 Committee
(ITC) under section 4(e) of TSCA.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.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
13The 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.
14Natural Resources Defense Council v. EPA, 595 F. Supp. 1255 (S.D.N.Y.
1984).
1551 Fed. Reg. 23706 (June 30, 1986).
needs.16 The regulations further require EPA to publish a notice in the
Federal Register when it decides to initiate negotiations.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,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
1640 C.F.R. S: 790.22(b). 1740 C.F.R. S:S: 790.22(b), 790.28(b). 1840
C.F.R. S: 790.24.
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.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
19Animal 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.
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
chemicals once they reach a substantial production volume, assuming EPA has also
determined that testing is necessary in order to obtain these data.
EPA Has Had Difficulty Proving That Chemicals Pose Unreasonable Risks and
Has Regulated Few Existing Chemicals under TSCA
Even when EPA has toxicity and exposure information on existing chemicals,
the agency stated that it has had difficulty demonstrating that harmful
chemicals pose an unreasonable risk and that they should be banned or have
limits placed on their production or use. Since the Congress enacted TSCA
in 1976, EPA has issued regulations under the act to ban or limit the
production or restrict the use of five existing chemicals or chemical
classes. The five chemicals or chemical classes are polychlorinated
biphenyls (PCB), fully halogenated chlorofluoroalkanes, dioxin, asbestos,
and hexavalent chromium. (See app. V for additional information on these
five chemicals). In addition, for 160 existing chemicals, EPA has required
chemical companies to submit notices of any significant new uses of the
chemical, providing EPA the opportunity to review the risks posed by the
new use.
In order to regulate an existing chemical under section 6(a) of TSCA, EPA
must find 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. Before regulating a chemical, the EPA Administrator must
consider and publish a statement regarding
o the effects of the chemical on human health and the magnitude of human
exposure to the chemical;
o the effects of the chemical on the environment and the magnitude of the
environment's exposure to the chemical;
o the benefits of the chemical for various uses and the availability of
substitutes for those uses; and
o the reasonably ascertainable economic consequences of the rule, after
consideration of the effect on the national economy, small business,
technological innovation, the environment, and public health.
Further, the regulation must apply the least burdensome requirement that
will adequately protect against such risk. For example, if EPA finds that
it can adequately manage the unreasonable risk of a chemical through
requiring chemical companies to place warning labels on the chemical, EPA
could not ban or otherwise restrict the use of that chemical.
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."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.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.22
2015 U.S.C. S: 2618(c)(1).
2154 Fed. Reg. 29460 (July 12, 1989).
22Corrosion Proof Fittings v. EPA, 947 F.2d 1201 (5th Cir. 1991).
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."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 Canada and the EU have recently taken action to
prioritize and review Moving Toward Greater existing chemicals. The
Canadian legislation (CEPA), enacted in 1999, Control of Existing requires
the Minister of the Environment and the Minister of Health to
compile, and from time to time amend, a Priority Substances List
specifying
Chemicals 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
2315 U.S.C. S: 2601(c).
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.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.
24EPA 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.
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 study25 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
25Illinois EPA TSCA CBI Evaluation Final Report (May 31, 1996).
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 To improve EPA's ability to assess the health and
environmental risks of Congressional chemicals, the Congress should
consider amending TSCA to
Consideration o provide explicit authority for EPA to enter into
enforceable consent agreements under which chemical companies are required
to conduct testing;
o 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
o 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
o 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;
o 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;
o 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
o 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 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,
Our Evaluation 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
http://www.gao.gov.
If you have any questions about this report, please contact me at (202)
512-6225 or [email protected]. 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.
John B. Stephenson Director, Natural Resources and Environment
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).1
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
1IUR 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.
Appendix I
EPA's Voluntary Programs
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.2 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 2000.3 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
265 Fed. Reg. 81658 (Dec. 26, 2000). 365 Fed. Reg. 81700 (Dec. 26, 2000).
Appendix I
EPA's Voluntary Programs
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.4 Industry
participants in the program are offered (1) hands on training on some of
EPA's chemical
467 Fed. Reg. 76282 (Dec. 11, 2002).
Appendix I
EPA's Voluntary Programs
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.
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.
Appendix II
Canadian and EU Chemical Legislation
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
Appendix II
Canadian and EU Chemical Legislation
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
o the trade name of the substance,
o certain physicochemical data concerning the substance,
o possible ways of rendering the substance harmless,
o the interpretation of the toxicological and ecotoxicological tests and
the name of the body responsible for the tests, and
o 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:
o the trade name(s) of the substance; physicochemical data concerning the
substance and on pathways and environmental fate,
o the result of each toxicological and ecotoxicological study,
Appendix II
Canadian and EU Chemical Legislation
o 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,
o guidance on safe use, and
o 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:
o details of the full composition of a preparation,
o the precise use, function, or application of a substance or
preparation,
o the precise tonnage of the substance or preparation manufactured or
placed on the market, and
o 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.
Appendix II
Canadian and EU Chemical Legislation
Table 2: Regulation of Chemicals in the United States, Canada, and European
Union
United States Canada European Union
Name of Toxic Canadian Current EU EU proposed
Substances Environmental Regulation
chemical Control Act Protection Act, chemical Registration,
1999 (CEPA) Evaluation, and
Authorisation of
legislation legislationa Chemicals
(REACH)b
Approximate 62,000c 23,000d 100,000e Not applicablef
number of
chemicals in
commerce when
legislation was
passed
Companies notify According to a Companies Companies
Notifications EPA Canadian notify would
official, generally be
of new chemicals companies must the EU about required to
requirement by notify the new register
chemicals
Premanufacture government of a chemicals with a new
Notice new chemical that once the European
Chemicals
is not on the marketing Agency once
(PMN). Non-Domestic level production
or
Substances List import
(NDSL) before it reaches 10 reaches 1
metric ton
exceeds a (2,204.6
quantity of 20 kilograms. lbs).
kilograms
per year.g
No specific Tiered testing Tiered According to an EU
Testing tests are levels for new testing official,
levels
requirement required for chemicals based for new testing would be
registration on production chemicals required only
of new and importation based on when there is
chemicals. volume. insufficient
production information available
volume. and other
sources of
information are not
appropriate.
Risk Public According to Public Manufacturers
authorities officials, public authorities and importers
perform a authorities are would be
assessment 90-day risk responsible for perform risk responsible for
using
assessment on performing risk knowledge on
new assessments on assessments on properties of
the
chemicals. new and existing existing substances they
chemicals, but chemicals. manufacture or
industry will Industry import to ensure
provide the provides responsible
majority of
Public testing and and
authorities the test data. risk well-informed
management
concentrate information on of the risks
risk new those substances
assessment chemicals. may present. For
efforts on all substances
high-volume subject to
existing registration
that are
chemicals. 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.
aThe 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.
bThe 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
Appendix II
Canadian and EU Chemical Legislation
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.
cSince EPA began its review program for new chemicals, approximately
20,000 new chemicals have been added to the list of chemicals in commerce.
dBecause the data from Canada was used for context purposes, we did not
assess the reliability of the data.
eBecause the data from the EU was used for context purposes, we did not
assess the reliability of the data.
fIf 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.
gAccording 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.
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 report1 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."2 Several options are available to amend this standard. For
example:
o 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
1GAO, Toxic Substances Control Act: Legislative Changes Could Make the Act
More Effective, GAO/RCED-94-103 (September 1994).
215 U.S.C. S: 2605(a).
Appendix III
Additional Options for Strengthening EPA's
Ability to Assess and Regulate Chemicals
under TSCA
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.3
o 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.4 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.5 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
3The 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).
442 U.S.C. S: 2618(c)(1)(B)(i).
5See 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).
Appendix III
Additional Options for Strengthening EPA's
Ability to Assess and Regulate Chemicals
under TSCA
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."6 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.
6Statement 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.
Appendix III
Additional Options for Strengthening EPA's
Ability to Assess and Regulate Chemicals
under TSCA
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
Appendix III
Additional Options for Strengthening EPA's
Ability to Assess and Regulate Chemicals
under TSCA
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.
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
Appendix IV Scope and Methodology
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
Appendix IV Scope and Methodology
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.
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 In 1978, EPA banned nonessential uses of fully
halogenated
Chlorofluoroalkanes chlorofluoroalkanes as propellants in aerosol spray
containers. EPA took this action because of concerns that these chemicals
were destroying the
Appendix V Regulations Promulgated under Section 6 of TSCA
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.1
Dioxin In 1980, EPA promulgated a rule prohibiting Vertac Chemical
Company and others from removing for disposal certain wastes containing
2,3,7,8tetrachlorodibenzo-p-dioxin (TCDD) stored at Vertac's Jacksonville,
Arkansas, facility.2 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.3
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,
160 Fed. Reg. 31917 (June 19, 1995). 245 Fed. Reg. 32676 (May 19, 1980).
350 Fed. Reg. 2003 (Jan. 14, 1985).
Appendix V Regulations Promulgated under Section 6 of TSCA
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 1989.4 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.5 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,6 (2)
triethanolamine salts of a substituted organic acid,7 (3) triethanolanime
salt of tricarboxylic acid, and (4) tricarboxylic acid.8 The agency
determined these chemicals would pose an unreasonable risk to human health
or the
4EPA 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.
555 Fed. Reg. 222 (Jan. 3, 1990).
649 Fed. Reg. 36846 (Sep. 20, 1984).
749 Fed. Reg. 24658 (Sep. 20, 1984).
849 Fed. Reg. 2762 (Jan. 23, 1984).
Appendix V Regulations Promulgated under Section 6 of TSCA
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.
Appendix VI
Comments From the Environmental Protection Agency
Appendix VI
Comments From the Environmental
Protection Agency
Appendix VII
GAO Contact and Staff Acknowledgments
GAO Contact John B. Stephenson, (202) 512-3841
Staff In addition to the individual named above, David Bennett, John
Delicath, Richard Frankel, Ed Kratzer, Malissa Livingston, Jean McSween,
Marcella
Acknowledgments Phelps, and Amy Webbink made key contributions to this
report.
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