Chemical Regulation
Actions are Needed to Improve the Effectiveness of EPA's Chemical Review Program Gao ID: GAO-06-1032T August 2, 2006Chemicals 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, such as cleansers and plastics 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. This testimony is based on GAO's June 2005 report, Chemical Regulation: Options Exist to Improve EPA's Ability to Assess Health Risks and Manage Its Chemical Review Program (GAO-05-458). GAO's report describes EPA's efforts to (1) assess chemicals used in commerce, (2) control the use of chemicals not yet in commerce, and (3) publicly disclose information provided by chemical companies under TSCA. GAO recommended that the Congress consider providing EPA additional authorities under TSCA to improve EPA's ability to assess chemical risks, and that the EPA Administrator take several actions to improve EPA's management of its chemical review program. EPA did not disagree with our findings and is currently implementing some of our recommendations.
EPA's authority under TSCA to obtain the data needed to assess existing chemicals does not facilitate its review process because the costly and time-consuming burden of obtaining the data is on EPA, rather than chemical companies. Consequently, EPA has used its authorities to require testing of fewer than 200 of the 62,000 chemicals in commerce when EPA began reviewing chemicals under TSCA in 1979. To obtain more data on existing chemicals, EPA implemented its High Production Volume Challenge Program, under which chemical companies voluntarily provide test data on about 2,800 chemicals produced or imported in amounts of 1 million pounds or more a year. While the purpose of the program is laudable, several problems remain, including that the chemical industry has not agreed to provide test data for over 200 chemicals with high production volumes. Moreover, after obtaining test data, EPA is required under TSCA's provisions to determine that a chemical poses an unreasonable risk before EPA can act to regulate its production or use. EPA officials say the act's legal standards for demonstrating unreasonable risk are so high that they have generally discouraged EPA from using its authorities to ban or restrict the manufacture or use of existing chemicals. Since Congress enacted TSCA in 1976, EPA has issued regulations to ban or limit the production of only five existing chemicals or groups of chemicals. EPA's reviews of new chemicals provide only limited assurance that health and environmental risks are identified because TSCA does not require companies to test chemicals before they notify EPA of their intent to manufacture the chemicals. Because of a general lack of data on new chemicals, EPA has developed methods to predict their potential exposure and toxicity levels by using scientific models to compare the new chemicals with chemicals that have similar molecular structures and for which toxicity information is available. However, the use of these models can be problematic because the models are not always accurate in predicting chemical properties and EPA's evaluation of general health effects of the chemicals is contingent upon the availability of information on chemicals with similar molecular structures. Additionally, the estimates of a chemical's production volume and anticipated uses, which EPA uses to assess exposure, can change substantially after EPA completes its review. Despite these limitations, EPA's reviews have resulted in some action being taken to reduce the risks of over 3,600 new chemicals. EPA's ability to provide the public with information on chemical production and risk is generally limited by the confidential business information provisions of TSCA. As a result, state agencies and foreign governments interested in obtaining this data for important purposes are denied access to the information. Recently, chemical companies have expressed interest in working with EPA to identify ways of enabling the agency to share confidential information with other organizations, provided that appropriate safeguards are adopted to prevent the unauthorized use of the information.
GAO-06-1032T, Chemical Regulation: Actions are Needed to Improve the Effectiveness of EPA's Chemical Review Program
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Testimony before the Committee on Environment and Public Works, U.S.
Senate:
United States Government Accountability Office:
GAO:
For Release on Delivery Expected at 9:30 a.m. EDT:
Wednesday, August 2, 2006:
Chemical Regulation:
Actions Are Needed to Improve the Effectiveness of EPA's Chemical
Review Program:
Statement of John B. Stephenson, Director, Natural Resources and
Environment:
GAO-06-1032T:
GAO Highlights:
Highlights of GAO-06-1032T, testimony before the Committee on
Environment and Public Works, U.S. Senate
Why GAO Did This Study:
Chemicals play an important role in everyday life, but some may be
harmful to human health and the environment. Chemicals are used to
produce items widely used throughout society, such as cleansers and
plastics 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.
This testimony is based on GAO‘s June 2005 report, Chemical Regulation:
Options Exist to Improve EPA‘s Ability to Assess Health Risks and
Manage Its Chemical Review Program (GAO-05-458). GAO‘s report describes
EPA‘s efforts to (1) assess chemicals used in commerce, (2) control the
use of chemicals not yet in commerce, and (3) publicly disclose
information provided by chemical companies under TSCA. GAO recommended
that the Congress consider providing EPA additional authorities under
TSCA to improve EPA‘s ability to assess chemical risks, and that the
EPA Administrator take several actions to improve EPA‘s management of
its chemical review program. EPA did not disagree with our findings and
is currently implementing some of our recommendations.
What GAO Found:
EPA‘s authority under TSCA to obtain the data needed to assess existing
chemicals does not facilitate its review process because the costly and
time-consuming burden of obtaining the data is on EPA, rather than
chemical companies. Consequently, EPA has used its authorities to
require testing of fewer than 200 of the 62,000 chemicals in commerce
when EPA began reviewing chemicals under TSCA in 1979. To obtain more
data on existing chemicals, EPA implemented its High Production Volume
Challenge Program, under which chemical companies voluntarily provide
test data on about 2,800 chemicals produced or imported in amounts of 1
million pounds or more a year. While the purpose of the program is
laudable, several problems remain, including that the chemical industry
has not agreed to provide test data for over 200 chemicals with high
production volumes. Moreover, after obtaining test data, EPA is
required under TSCA‘s provisions to determine that a chemical poses an
unreasonable risk before EPA can act to regulate its production or use.
EPA officials say the act‘s legal standards for demonstrating
unreasonable risk are so high that they have generally discouraged EPA
from using its authorities to ban or restrict the manufacture or use of
existing chemicals. Since Congress enacted TSCA in 1976, EPA has issued
regulations to ban or limit the production of only five existing
chemicals or groups of chemicals.
EPA‘s reviews of new chemicals provide only limited assurance that
health and environmental risks are identified because TSCA does not
require companies to test chemicals before they notify EPA of their
intent to manufacture the chemicals. Because of a general lack of data
on new chemicals, EPA has developed methods to predict their potential
exposure and toxicity levels by using scientific models to compare the
new chemicals with chemicals that have similar molecular structures and
for which toxicity information is available. However, the use of these
models can be problematic because the models are not always accurate in
predicting chemical properties and EPA‘s evaluation of general health
effects of the chemicals is contingent upon the availability of
information on chemicals with similar molecular structures.
Additionally, the estimates of a chemical‘s production volume and
anticipated uses, which EPA uses to assess exposure, can change
substantially after EPA completes its review. Despite these
limitations, EPA‘s reviews have resulted in some action being taken to
reduce the risks of over 3,600 new chemicals.
EPA‘s ability to provide the public with information on chemical
production and risk is generally limited by the confidential business
information provisions of TSCA. As a result, state agencies and foreign
governments interested in obtaining this data for important purposes
are denied access to the information. Recently, chemical companies have
expressed interest in working with EPA to identify ways of enabling the
agency to share confidential information with other organizations,
provided that appropriate safeguards are adopted to prevent the
unauthorized use of the information.
[Hyperlink, http://www.gao.gov/cgi-bin/getrpt?GAO-06-1032T].
To view the full product, including the scope and methodology, click on
the link above.
For more information, contact John B. Stephenson at (202) 512-3841 or
stephensonj@gao.gov.
[End of Section]
Mr. Chairman and Members of the Committee:
I am pleased to appear today before the Senate Committee on Environment
and Public Works, to discuss our work on the Environmental Protection
Agency's (EPA) implementation of the Toxic Substances Control Act
(TSCA). 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. Although these chemicals are an
integral component in the production of important goods and services,
some may be toxic and may adversely affect human health and/or the
environment. It was in this context, that the Congress passed TSCA in
1976, authorizing EPA to obtain manufacturer information on the risks
of chemicals and to control those that EPA determines will pose an
unreasonable risk.
TSCA addresses those chemicals manufactured, imported, processed,
distributed in commerce, used, or disposed of in the United States, but
excludes certain substances including pesticides regulated under the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and food
additives, drugs, and cosmetics regulated under the Federal Food, Drug,
and Cosmetic Act (FFDCA). TSCA authorizes EPA to review those chemicals
already in commerce - what are referred to as existing chemicals --and
to assess chemicals before they enter commerce - so-called new
chemicals. EPA lists chemicals currently 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, approximately 20,000 new
chemicals were added to the inventory and are now in use as existing
chemicals.
Prior to the passage of TSCA, chemical substances generally entered the
marketplace without review or controls. Without government
intervention, and often with little or no knowledge of their potential
adverse health and environmental impacts, some of these chemicals were
produced and used in high volumes. Earlier legislation on clean water
and air had primarily addressed releases of chemicals into the
environment. In contrast, TSCA authorized EPA to control the entire
life cycle of chemicals from their production and distribution to their
use and disposal--including options for the outright banning of
chemical substances to mandating requirements for chemical testing or
product labeling. Now, chemical companies are required to submit to
EPA, 90 days before beginning to manufacture a new chemical, a
premanufacture notice containing information including the chemical's
identity, categories of uses, estimated production volumes, and any
test data possessed by the chemical company.
My testimony today, which is based on our June 2005 report, Chemical
Regulation: Options Exist to Improve EPA's Ability to Assess Health
Risks and Manage Its Chemical Review Program,[Footnote 1] describes
EPA's efforts to (1) assess existing chemicals used in commerce, (2)
control the risks of new chemicals not yet in commerce, and (3)
publicly disclose information provided by chemical companies under
TSCA.
In summary, 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. 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, rather than requiring chemical
companies to develop and submit such data to EPA. Consequently, EPA has
used its authorities to require testing for fewer than 200 of the
62,000 chemicals in commerce when EPA began reviewing chemicals under
TSCA in 1979. Recognizing the need for additional information on
existing chemicals, in the late 1990s 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. While the HPV Challenge Program is a laudable effort to develop
data on these chemicals, several problems remain, including that the
chemical industry has not agreed to provide testing for over 200
chemicals originally identified in the HPV Challenge Program and that
even with the test data provided under the program, EPA would need to
demonstrate that the 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. In this regard, EPA officials say the act's legal standards are
so high that they have generally discouraged EPA from using its
authorities to ban or restrict the manufacture or use of chemicals.
Since Congress enacted TSCA in 1976, EPA has issued regulations under
the act to ban or limit the production of only five existing chemicals
or groups of chemicals.
EPA's reviews of new chemicals can provide only limited assurance that
health and environmental risks are identified before the chemicals
enter commerce because TSCA does not require chemical companies to test
new chemicals before notifying EPA of their intent to manufacture a
chemical. Furthermore, chemical companies generally do not voluntarily
perform such testing. Because of a general lack of data, EPA has
developed sophisticated methods to predict the potential exposure and
toxicity levels of new chemicals by using scientific models to compare
them with chemicals with similar molecular structures for which
toxicity information is available. However, the use of these 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
information on chemicals with similar molecular structures.
Additionally, chemical company estimates of a chemical's production
volume and anticipated uses provided in the premanufacture notices that
EPA uses to assess exposure, can change substantially after EPA
completes its review and manufacturing begins. However, 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,
which EPA has done for only a small percentage of new chemicals.
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 3,600 new chemicals submitted for review.
EPA's ability to provide the public with information on chemical
production and risk has also been hindered by strict confidential
business information provisions of TSCA. TSCA generally prohibits the
disclosure of confidential business information and, according to EPA
officials, about 95 percent of the premanufacture notices for new
chemicals contain some information that is claimed as confidential.
While EPA has the authority to evaluate the appropriateness of
confidentiality claims, these efforts are time and resource-intensive,
and the agency does not have the resources to challenge a significant
number of claims. State environmental agencies and others have
expressed interest in obtaining information claimed as confidential
business information for use in various activities, such as developing
contingency plans to alert emergency response personnel to 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.
In our June 2005 report, we recommended that the Congress consider
providing EPA additional authorities under TSCA to improve its ability
to assess chemical risks, such as providing the EPA Administrator the
authority to require chemical companies develop test data when
production volumes reach certain levels. We also recommended that the
EPA Administrator take several actions to improve EPA's management of
its chemical program, including revising its regulations to require
that companies reassert confidentiality claims under TSCA within a
certain time period after the information is initially claimed as
confidential. EPA did not disagree with the report's findings and is in
the process of implementing several of our recommendations. For
example, EPA is currently launching a pilot project to review claims of
confidentiality for data on certain older chemicals.
EPA Has Limited Information on the Health and Environmental Risks of
Existing Chemicals and Has Issued Few Regulations Controlling Such
Chemicals:
Because chemical companies are generally not required to develop and
submit toxicity information to EPA, when the agency decides to review
existing chemicals, it generally has only limited information on the
risks that the chemicals pose to human health and the environment.
Furthermore, EPA's authority under TSCA to require industry testing
that would provide the information to review the chemicals is difficult
to use, according to EPA officials. 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, EPA
has rarely banned, limited the production, or restricted the use of
existing chemicals. Since 1998, EPA has focused its efforts on
obtaining information on existing chemicals through voluntary programs,
such as the HPV Challenge Program. This program is intended to provide
basic data on the characteristics of about 2,800 chemicals produced in
excess of 1 million pounds a year.
EPA Has Limited Toxicity and Exposure Data with Which to Review
Existing Chemicals:
EPA's toxicity and exposure data on existing chemicals is often
incomplete and TSCA's authority to require testing in support of the
agency's review process is difficult to use. While TSCA authorizes the
review of existing chemicals, it generally provides no specific
requirement, time frame, or methodology for doing so. Chemical
companies are not required to develop and submit toxicity information
to EPA unless the agency promulgates a testing rule, thus placing the
burden for obtaining data on EPA. 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. 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.
EPA officials told us that in cases where chemical companies do not
voluntarily provide test data and health and safety studies in a
complete and timely manner, requiring the testing of existing chemicals
of concern--those chemicals for which some suspicion of harm exists--is
the only practical way to ensure that the agency obtains the needed
information. For example, there are currently over 200 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 become high production chemicals because the specific
chemicals used in commerce are constantly changing, as are their
production volumes. Chemical industry representatives told us that TSCA
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 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 TSCA (which can take months or years to develop) to obtain
exposure data or available test data that the chemical industry does
not voluntarily provide to EPA and then (2) issuing additional rules
requiring companies to perform specific tests necessary to ensure the
safety of the chemicals tested. Officials also said that EPA's
authority under TSCA to issue rules requiring chemical companies to
conduct tests on existing chemicals has been difficult to use because
the agency must first make certain findings before it can require
testing. Specifically, 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.
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 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 fewer than
200 chemicals. Because EPA has used authority to issue rules to require
testing so sparingly, it has not continued to maintain information on
the cost of implementing these rules. However, in our October 1994
report on TSCA,[Footnote 2] we noted that EPA officials told us that
issuing such a rule can cost hundreds of thousands of dollars.
Given the difficulties involved in requiring testing, EPA officials do
not believe that TSCA provides an effective means for testing a large
number of existing chemicals. They believe that EPA could review
substantially more chemicals in less time if they had the authority to
require chemical companies to conduct testing and provide test data on
chemicals once they reach a substantial production volume, assuming EPA
had first determined that these data cannot be obtained without
testing. We have long held a similar view based on our reviews
involving TSCA, and in our in June 2005 report, we recommended that the
Congress consider giving EPA the authority to require chemical
manufacturers and processors to develop test data based on substantial
production volume and the necessity for testing.
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. Indeed, EPA
has rarely banned, limited the production, or restricted the use of
existing chemicals. 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 only five existing chemicals or chemical classes.
For an additional 173 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.
EPA Implemented a Voluntary Program to Collect More Industry Data on
Existing Chemicals:
Facing difficulties obtaining information on existing chemicals, EPA
took steps to address this shortcoming with the implementation of the
HPV Challenge Program in 1998. According to EPA, the lack of
information on existing chemicals and the relative difficulty of
requiring testing under TSCA on the scale that would be necessary for
the thousands of 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 data on the
chemicals, either by gathering available information, using models to
predict the chemicals' properties, or conducting testing of the
chemicals. EPA plans to use the data collected under the program to
prioritize high-production chemicals for further assessment, but it has
not yet adopted a methodology for prioritizing the chemicals or for
determining those that require additional information. In our June 2005
report, we recommended that EPA develop and implement such a
methodology for using information collected through the HVP Challenge
Program to prioritize chemicals for further review and to identify and
obtain additional information needed to assess their risks. At EPA's
request, a federal advisory group has proposed a methodology for
prioritizing the HPV Challenge Program chemicals, and EPA anticipates
that the agency will implement the proposal during 2006.
Nonetheless, other problems exist in the HPV Challenge Program.
Chemical companies have not volunteered to provide data on all the
chemicals currently in the HPV Program. In addition, despite the fact
that companies may begin raising the production volumes of other
chemicals, EPA has no mechanism for placing these chemicals on the HPV
Challenge Program list once they are produced in greater volume. We
believe that action to implement our previously mentioned
recommendation that the Congress consider giving EPA additional
authority to require chemical testing could ameliorate such problems.
EPA Lacks Sufficient Data to Ensure That the Potential Health and
Environmental Risks of New Chemicals Are Identified:
EPA's review of new chemicals provides only limited assurance that
health and environmental risks are identified because the agency has
limited information with which to review them. In the absence of
chemical test data, EPA largely relies on scientific models that do not
always accurately determine chemicals' properties or the full extent of
their adverse effects. Further, information that companies provide in
the premanufacture notices that EPA uses to assess potential exposures
to new chemicals are estimates that can change substantially once
manufacturing begins. 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 3,600 new chemicals submitted for
review.
EPA Has Limited Information on New Chemicals and Relies on Modeling
Tools to Assess the Health and Environmental Risks of New Chemicals:
TSCA generally requires chemical companies to notify EPA of their
intent to manufacture or import new chemicals and to provide any
available test data. Yet 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) 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 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 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 low potential to harm human health or the
environment or (2) on the basis of other information, such as the
anticipated uses, exposures, and releases of the chemicals, only
limited potential risks to people and the environment are expected. In
addition, using these models, EPA identifies for possible regulatory
action, those chemicals belonging to certain chemical categories that
based on its prior experience in reviewing new chemicals are likely to
pose potential risks such that testing or controls are needed. In our
June 2005 report, we recommended that the EPA Administrator 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.
Estimates of Exposures and Other Information Provided in
Premanufacturing Notices Can Change after Manufacturing Begins:
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 these notices generally do not have to be amended once
manufacturing begins. That is, once EPA completes its review and
production begins, 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 a rule specifying that a
particular use of a chemical would be a significant new use. EPA has
infrequently issued such rules, which require manufacturers, importers,
and processors of the chemical for the new use 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 Some Control Actions:
When EPA's assessment of a new chemical 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 the relevant provisions 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 3,600 new chemicals that chemical companies have
submitted for review. 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 a chemical for new uses.
For over 1,700 chemicals, companies withdrew their premanufacture
notices, sometimes after EPA 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 screens a chemical or
performs 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.
For over 1,300 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 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) 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. While TSCA does not
authorize EPA to require that chemical companies develop this
information, the act does allow 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 over 570 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.
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 the
information they provide to EPA under TSCA as confidential business
information. While EPA believes that some claims of confidential
business information may be unwarranted, challenging the claims is
resource-intensive.
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 court order, if the company
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. EPA has not performed any recent studies of
the appropriateness of confidentiality claims, although a 1992 EPA
study indicated that problems with inappropriate claims were extensive.
That 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 told us that the agency does not have the resources
necessary to investigate and, where appropriate, challenge claims that
it believes 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,
confidentiality claims relating to health and safety studies performed
by the chemical companies involving chemicals currently 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 when challenged.
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 the
risks of potentially harmful chemicals. For example, on the basis of a
study 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 dialogue with
chemical companies about reducing chemical risks, preventing accidents,
and limiting chemical exposures.
TSCA's provisions are in contrast to those of some foreign governments'
environmental laws, such as Canada, which authorizes its environmental
agency 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 EPA to share information with other countries in order to
harmonize chemical assessments among developed countries and improve
chemical risk assessment methods by allowing cooperation on improving
models used to predict chemical toxicity. The chemical industry is
concerned, however, that confidential information be protected from
inappropriate disclosure. These chemical industry representatives told
us that some countries currently do not have adequate 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.
Our June 2005 report included two recommendations for addressing the
problems we identified related to the confidential business information
provisions of TSCA. We recommended that EPA revise its regulations to
require companies to reassert claims of confidentiality within a
certain period after the information is initially claimed as
confidential. We also recommended that the Congress consider amending
TSCA to 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. EPA did not disagree with the report's findings and is in
the process of implementing several of our recommendations. For
example, EPA is currently launching a pilot project to review claims of
confidentiality for data on certain older chemicals.
Concluding Observations:
Mr. Chairman, EPA's efforts to encourage companies to voluntarily
provide data on existing chemicals is commendable. However, the
fundamental and historical problems the agency has experienced with
utilizing its authorities under TSCA continue to limit EPA's ability to
manage its chemical review program and assess chemical risks. In this
respect, EPA faces considerable difficulties using its authorities to
require testing of existing chemicals, which prevents the agency from
reviewing substantially more chemicals in less time than it could if it
had the authority to require chemical companies to provide test data on
chemicals once they have reached a substantial production volume.
Moreover, EPA's ability to provide the public with information on
chemical production and risks is hampered by the strict confidential
business information provisions of TSCA. While protecting such
information is a legitimate concern, TSCA currently prohibits EPA from
disclosing much data for important purposes such as assisting state
agencies in carrying out their environmental management
responsibilities and foreign governments in harmonizing international
chemical assessment approaches--a goal generally shared by these
governments and the chemical industry. We believe the actions that we
have recommended to both the Congress and EPA would go a long way in
addressing the challenges EPA faces in exercising its authorities under
TSCA.
Mr. Chairman, this concludes my prepared statement. I would be happy to
respond to any questions that you or Members of the Committee may have.
Contacts and Acknowledgments:
For further information about this testimony, please contact me Mr.
John B. Stephenson at (202) 512-3841. David Bennett, John Delicath,
Tyra DiPalma-Vigil, Richard Johnson, Valerie Kasindi, and Ed Kratzer
made key contributions to this statement.
FOOTNOTES
[1] GAO, Chemical Regulation: Options Exist to Improve EPA's Ability to
Assess Health Risks and Manage Its Chemical Review Program, GAO-05-458
(Washington, D.C.: June 13, 2005).
[2] GAO, Toxic Substances Control Act: Legislative Changes Could Make
the Act More Effective, GAO/RCED-94-103 (Washington, D.C.: September
26, 1994).
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