Chemical Regulation
Observations on Improving the Toxic Substances Control Act Gao ID: GAO-10-292T December 2, 2009The Environmental Protection Agency (EPA) is authorized under the Toxic Substances Control Act (TSCA) to obtain information on the risks of chemicals and to control those that it determines to pose an unreasonable risk. EPA also conducts assessments of chemicals under its Integrated Risk Information System (IRIS) program. Nonetheless, EPA does not have sufficient information to determine whether it should establish controls to limit public exposure to many chemicals that may pose substantial health risks. The Government Accountability Office (GAO) has recommended statutory changes to TSCA to, among other things, provide EPA with additional authorities to obtain health and safety information from the chemical industry and to shift more of the burden to chemical companies for demonstrating the safety of their chemicals. GAO has also recommended that EPA adopt a streamlined, more transparent IRIS assessment process to address significant productivity and credibility issues. Problems with TSCA and IRIS led GAO to add transforming EPA's processes for assessing and controlling toxic chemicals to its list of high-risk areas warranting attention by Congress and the executive branch This testimony, based on prior GAO work, addresses EPA's implementation of TSCA and IRIS and options for (1) obtaining more information on chemical risks, (2) controlling these risks, and (3) sharing more of the information collected under TSCA.
EPA lacks adequate scientific information on the toxicity of many chemicals. One major reason is that TSCA generally places the burden of obtaining data about existing chemicals on EPA rather than on chemical companies. For example, the act requires EPA to demonstrate certain health or environmental risks before it can require companies to further test their chemicals. As a result, EPA does not routinely assess the risks of the over 83,000 chemicals already in use. Moreover, TSCA does not require chemical companies to test the approximately 700 new chemicals introduced into commerce each year for toxicity, and companies generally do not voluntarily perform such testing. Furthermore, the procedures EPA must follow to obtain test data from companies can take years. Regarding IRIS, in 2008, GAO reported that this significant chemical assessment program--which provides EPA's scientific position on the potential human health effects of exposure to more than 540 chemicals--is at serious risk of becoming obsolete because the agency has not been able to complete timely, credible assessments. In May 2009, EPA announced reforms to its IRIS assessment process, citing GAO's conclusions and its high-risk designation. Overall, GAO believes that, if the reforms are effectively implemented, they will address GAO's recommendations and provide a sound framework for conducting IRIS assessments. However, given the number of obstacles that can impede the progress of IRIS assessments, the viability of this program will depend on effective and sustained management. While TSCA authorizes EPA to ban, limit, or otherwise regulate existing toxic chemicals, EPA must meet a high legal threshold, which has proven difficult. For example, EPA must demonstrate "unreasonable risk" to ban or limit chemical production, which EPA believes requires it to conduct extensive cost-benefit analyses that can take many years to complete. Since 1976, EPA has issued regulations to control only five existing chemicals. Furthermore, its 1989 regulation phasing out most uses of asbestos was largely vacated by a federal appeals court in 1991 because it was not based on "substantial evidence." In contrast, the European Union and a number of other countries have largely banned asbestos, a known human carcinogen that can cause lung cancer and other diseases. GAO previously suggested that Congress amend TSCA to reduce the evidentiary burden EPA must meet to control toxic substances and continues to believe such change warrants consideration. Because of TSCA's prohibitions on the disclosure of confidential business information, EPA has limited ability to share information on chemical production and risk. According to EPA officials, about 95 percent of the notices companies have provided to EPA on new chemicals contain some information claimed as confidential. Evaluating the appropriateness of confidentiality claims is time- and resource-intensive, and EPA does not challenge most claims. GAO previously suggested that Congress, among other things, consider amending TSCA to authorize EPA to share the confidential business information that chemical companies provide to EPA with states.
GAO-10-292T, Chemical Regulation: Observations on Improving the Toxic Substances Control Act
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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 2:30 p.m. EST:
Wednesday, December 2, 2009:
Chemical Regulation:
Observations on Improving the Toxic Substances Control Act:
Statement of John Stephenson, Director:
Natural Resources and Environment:
GAO-10-292T:
GAO Highlights:
Highlights of GAO-10-292T, a testimony before the Committee on
Environment and Public Works, U.S. Senate.
Why GAO Did This Study:
The Environmental Protection Agency (EPA) is authorized under the Toxic
Substances Control Act (TSCA) to obtain information on the risks of
chemicals and to control those that it determines to pose an
unreasonable risk. EPA also conducts assessments of chemicals under its
Integrated Risk Information System (IRIS) program. Nonetheless, EPA
does not have sufficient information to determine whether it should
establish controls to limit public exposure to many chemicals that may
pose substantial health risks. GAO has recommended statutory changes to
TSCA to, among other things, provide EPA with additional authorities to
obtain health and safety information from the chemical industry and to
shift more of the burden to chemical companies for demonstrating the
safety of their chemicals. GAO has also recommended that EPA adopt a
streamlined, more transparent IRIS assessment process to address
significant productivity and credibility issues. Problems with TSCA and
IRIS led GAO to add transforming EPA‘s processes for assessing and
controlling toxic chemicals to its list of high-risk areas warranting
attention by Congress and the executive branch
This testimony, based on prior GAO work, addresses EPA‘s implementation
of TSCA and IRIS and options for (1) obtaining more information on
chemical risks, (2) controlling these risks, and (3) sharing more of
the information collected under TSCA.
What GAO Found:
EPA lacks adequate scientific information on the toxicity of many
chemicals. One major reason is that TSCA generally places the burden of
obtaining data about existing chemicals on EPA rather than on chemical
companies. For example, the act requires EPA to demonstrate certain
health or environmental risks before it can require companies to
further test their chemicals. As a result, EPA does not routinely
assess the risks of the over 83,000 chemicals already in use. Moreover,
TSCA does not require chemical companies to test the approximately 700
new chemicals introduced into commerce each year for toxicity, and
companies generally do not voluntarily perform such testing.
Furthermore, the procedures EPA must follow to obtain test data from
companies can take years. Regarding IRIS, in 2008, GAO reported that
this significant chemical assessment program”which provides EPA‘s
scientific position on the potential human health effects of exposure
to more than 540 chemicals”is at serious risk of becoming obsolete
because the agency has not been able to complete timely, credible
assessments. In May 2009, EPA announced reforms to its IRIS assessment
process, citing GAO‘s conclusions and its high-risk designation.
Overall, GAO believes that, if the reforms are effectively implemented,
they will address GAO‘s recommendations and provide a sound framework
for conducting IRIS assessments. However, given the number of obstacles
that can impede the progress of IRIS assessments, the viability of this
program will depend on effective and sustained management.
While TSCA authorizes EPA to ban, limit, or otherwise regulate existing
toxic chemicals, EPA must meet a high legal threshold, which has proven
difficult. For example, EPA must demonstrate ’unreasonable risk“ to ban
or limit chemical production, which EPA believes requires it to conduct
extensive cost-benefit analyses that can take many years to complete.
Since 1976, EPA has issued regulations to control only five existing
chemicals. Furthermore, its 1989 regulation phasing out most uses of
asbestos was largely vacated by a federal appeals court in 1991 because
it was not based on ’substantial evidence.“ In contrast, the European
Union and a number of other countries have largely banned asbestos, a
known human carcinogen that can cause lung cancer and other diseases.
GAO previously suggested that Congress amend TSCA to reduce the
evidentiary burden EPA must meet to control toxic substances and
continues to believe such change warrants consideration.
Because of TSCA‘s prohibitions on the disclosure of confidential
business information, EPA has limited ability to share information on
chemical production and risk. According to EPA officials, about 95
percent of the notices companies have provided to EPA on new chemicals
contain some information claimed as confidential. Evaluating the
appropriateness of confidentiality claims is time- and resource-
intensive, and EPA does not challenge most claims. GAO previously
suggested that Congress, among other things, consider amending TSCA to
authorize EPA to share the confidential business information that
chemical companies provide to EPA with states.
View GAO-10-292T or key components. For more information, contact John
Stephenson at (202) 512-3841 or stephensonj@gao.gov.
[End of section]
Madam Chairman, Ranking Member and Members of the Committee:
I am pleased to appear here today to discuss the need to transform
EPA's processes for assessing and controlling toxic chemicals. The
Environmental Protection Agency's (EPA) ability to effectively
implement its mission of protecting public health and the environment
is critically dependent on credible and timely assessments of the risks
posed by toxic chemicals. Such assessments are the cornerstone of
scientifically sound environmental decisions, regulations, and
policies. In previous reports, we have recommended both statutory and
regulatory changes to, among other things, strengthen EPA's authority
to obtain additional information from the chemical industry, shift more
of the burden to chemical companies for demonstrating the safety of
their chemicals, and enhance the public's understanding of the risks of
chemicals to which they may be exposed. In 2009, we added transforming
EPA's processes for assessing and controlling toxic chemicals to our
list of areas at high risk for waste, fraud, abuse, and mismanagement
because EPA has failed to develop sufficient chemical assessment
information on the toxicity of many chemicals that may be found in the
environment and tens of thousands of chemicals used commercially in the
United States.[Footnote 1] We reported that the lack of this
information significantly limits the agency's ability to limit public
exposure to many chemicals that may pose substantial health risks in
fulfillment of its mission of protecting human health and the
environment.
The Toxic Substances Control Act (TSCA) was enacted in 1976 to
authorize EPA to obtain information on the risks of chemicals and to
control those chemicals that EPA determines to pose unreasonable risks.
TSCA authorizes EPA to review chemicals already in commerce (existing
chemicals) and chemicals yet to enter commerce (new chemicals). TSCA
also provides that certain information, such as data disclosing
chemical processes, can be claimed as confidential business information
by chemical manufacturers and processors. EPA's ability to provide the
public with information on chemical production and risk has been
limited by TSCA' s strict confidential business information provisions,
which generally prohibit the disclosure of such information. In
addition to its authorities under TSCA, EPA conducts assessments of
toxic chemicals in the environment under its Integrated Risk
Information System (IRIS) program. EPA's IRIS database provides the
agency's scientific position on the potential health effects that may
result from exposure to more than 540 chemicals in the environment.
IRIS toxicity assessments constitute critical steps of the risk
assessment process and provide the basic information EPA needs to
determine whether it should establish controls to protect the public
from exposure to toxic chemicals in the air and water and at hazardous
waste sites, among other things.
My testimony today is based on our prior work on EPA's processes for
assessing and controlling toxic chemicals, in which we identified
challenges associated with implementing TSCA and some of the
legislative options available to address these challenges.
Specifically, my statement addresses EPA's implementation of TSCA and
options for (1) obtaining more information on the risks posed by
chemicals, (2) controlling these risks, and (3) sharing more of the
information gathered under TSCA.
Background:
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 use or
placing restrictions on those already in commerce. Of the over 83,000
chemicals currently in the TSCA inventory, about 62,000 were already in
commerce when EPA began reviewing chemicals in 1979. Since then, over
21,000 new chemicals--about 700 each year, on average--have been added
to the inventory and are now in use as existing chemicals. To assess a
chemical's risks, EPA examines its toxicity or potential adverse
effects and the amount of human and environmental exposures.
TSCA generally requires the industry to notify EPA at least 90 days
before producing or importing a new chemical. These notices are to
contain such information as the chemical's molecular structure and
intended uses, which EPA uses to evaluate the chemical's potential
risks. TSCA also authorizes EPA to promulgate rules to require
manufacturers to perform tests on chemicals in certain circumstances or
to provide other data, such as production volumes, on existing
chemicals. In addition, TSCA requires chemical companies to report to
EPA any data that reasonably support a conclusion that a chemical
presents a substantial risk. If EPA finds that a chemical's risks are
unreasonable, it can prohibit or limit the chemical's production,
processing, distribution, use, and disposal or take other action, such
as requiring warning labels on the substance. While TSCA authorizes EPA
to release some chemical information obtained by the agency under the
act, it allows chemical companies to claim certain information, such as
data disclosing chemical processes, as confidential business
information. EPA generally must not disclose such information unless
such disclosure is necessary to protect against an unreasonable risk of
injury to health or the environment. Evaluating the appropriateness of
confidentiality claims is time-and resource-intensive, and EPA does not
challenge most 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. In previous
reports, we have identified options for statutory changes to improve
EPA's ability to make more chemical information publicly available.
IRIS was created in 1985 to help EPA develop consensus opinions within
the agency about the health effects from chronic exposure to chemicals.
Its importance has increased over time. EPA, state and local
environmental programs, international regulatory bodies, academia,
industry, and others now rely heavily on the IRIS database to support
risk-based decision making to protect public health and the
environment. A typical IRIS assessment contains a qualitative
description of the hazard posed by a chemical and a quantitative
assessment of the relationship between exposure and the likelihood and
severity of adverse health effects. The focus of IRIS toxicity
assessments is on the potential health effects of long-term (chronic)
exposure to chemicals. According to the Office of Management and Budget
(OMB), EPA is the only federal agency that develops qualitative and
quantitative assessments of both cancer and noncancer risks of exposure
to chemicals, and EPA does so largely under the IRIS program. The
quantitative estimates of potency that EPA provides are particularly
important, as they are required to conduct quantitative risk
assessments. EPA uses risk assessments developed with IRIS toxicity
data to determine whether the identified health risks warrant
regulatory or other actions. Examples of subsequent decisions that
could stem from a determination that action is necessary to protect
public health include how much of a chemical a company may discharge
into a river, which substances may be stored at a hazardous waste
facility, the extent to which a hazardous waste site must be cleaned
up, levels for air emissions, and allowable levels of contamination in
drinking water.
EPA Lacks Adequate Information on Potential Health and Environmental
Risks of Chemicals:
EPA lacks adequate scientific information on the toxicity of many
chemicals that are or may be found in the environment. For existing
chemicals, TSCA generally places the burden of obtaining data on EPA,
rather than on the companies that produce the chemicals. This approach
requires that EPA demonstrate certain health or environmental risks
before it can require companies to further test their chemicals. As a
result, EPA has only limited information on the health and
environmental risks posed by these chemicals. Furthermore, while TSCA
authorizes EPA to review existing chemicals, it generally provides no
specific requirement, time frame, or methodology for doing so.
Significantly, chemical companies are not required to develop and
submit toxicity information to EPA on existing chemicals unless the
agency finds that a chemical may present an unreasonable risk of injury
to human health or the environment or 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 the environment in substantial quantities. EPA must
also determine there are insufficient data on a chemical to reasonably
determine its effects on health or the environment and that testing is
necessary to develop such data before the agency can require a company
to test its chemicals for harmful effects. This structure places the
burden on EPA to demonstrate a need for data on a chemical's toxicity
rather than on a company to demonstrate that a chemical is safe. As a
result, EPA does not routinely assess the risks of the more than 83,000
commercial chemicals in use.
As we have previously reported,[Footnote 2] TSCA's chemical review
provisions could be strengthened by requiring EPA's systematic review
of existing chemicals. 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 as a condition of manufacture
or import above some specified volume or other criteria.
Regarding new chemicals, TSCA generally requires chemical companies to
submit a premanufacture notice to EPA before they manufacture or import
new chemicals and to provide any available test data. Yet EPA estimates
that most premanufacture notices do not include any test data, and only
about 15 percent include health or safety test data. These tests may
take over a year to complete and cost hundreds of thousands of dollars,
and chemical companies usually do not perform them voluntarily. Because
EPA generally does not have sufficient data on a chemical's properties
and effects when reviewing a new chemical, EPA uses models to compare
new chemicals with chemicals that have similar molecular structures and
for which test data on health and environmental effects are available,
which can take years. Furthermore, EPA bases its exposure estimates for
new chemicals on information contained in premanufacture notices--
information that chemical companies generally are not bound by and that
may change without notice. For example, companies may increase
production levels or expand the uses of a chemical, potentially
increasing the risk of injury to human health or the environment.
An option that we have previously reported could make TSCA more
effective and provide EPA with adequate information on chemicals is
revising the act to require companies to test their chemicals and
submit the results to EPA with their premanufacture notices.[Footnote
3] Currently, such a step is required only if EPA makes the necessary
findings and promulgates a testing rule. A major drawback to testing is
its cost to chemical companies, which may reduce their willingness to
perform chemical research and invest in innovation. To reduce such
costs or to delay them until production is sufficient to offset them,
requirements for testing could be based on production volume. For
example, in Canada and the European Union, testing requirements for low-
volume chemicals are less extensive and complex than for high-volume
chemicals. We previously reported that Congress could 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, for example, substantial production volume
and the necessity for testing.[Footnote 4]
Another option we reported was to provide EPA with greater authority to
require additional testing in areas where EPA's analysis models do not
adequately predict toxicity. [Footnote 5] Under such an option, EPA
could establish a minimal set of tests for new chemicals to be
submitted with premanufacture notices. Additional and more complex and
costly testing could be required as a new chemical's potential risks
increase, based on, for example, production or environmental release
levels. According to some chemical companies, the cost of initial
testing could be reduced by amending TSCA to require EPA to review new
chemicals before they are marketed, rather than before they are
manufactured. This could substantially reduce the expense of testing
because, 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.
In addition to TSCA, EPA assesses chemicals under its IRIS program. We
reported in March 2008 that this key program was at serious risk of
becoming obsolete because the agency has not been able to keep its
existing assessments current; decrease its backlog of 70 assessments;
or complete assessments of key chemicals of concern, such as dioxin,
formaldehyde, and trichloroethylene (TCE).[Footnote 6] Among other
things, we found that EPA's efforts to finalize IRIS assessments were
impeded by a combination of factors, including OMB's requiring two
additional reviews of IRIS assessments by OMB and other federal
agencies with an interest in the assessments, such as the Department of
Defense. Moreover, the two interagency reviews involved other federal
agencies in EPA's IRIS assessment process in a manner that hindered
EPA's ability to manage its assessments and limited their credibility
and transparency. For example, the input these agencies provided to EPA
was treated as "deliberative" and was not released to the public. As a
result, we recommended that EPA adopt a streamlined, more transparent
assessment process. A revised process that EPA subsequently adopted in
2008 did not incorporate our recommendations and actually exacerbated
the concerns we identified about productivity and credibility. As a
result, we included the IRIS program along with TSCA in our high-risk
designation on assessing and controlling toxic chemicals.
However, in May 2009, EPA again announced comprehensive reforms to its
IRIS assessment process, citing our designation of this program as high
risk as well as key conclusions from our reports. We reviewed EPA's
reforms and testified that overall, if implemented effectively, these
reforms will address our recommendations and provide a sound framework
for conducting IRIS assessments and significantly improve the IRIS
process.[Footnote 7] For example, under the new process, EPA is to
manage the entire assessment process, including the interagency
reviews. Under EPA's prior process, these reviews were required and
managed by OMB--and at various stages, EPA was not allowed to proceed
with assessments until OMB notified EPA that it had sufficiently
responded to comments from OMB and other agencies. The independence
restored to EPA under the new process will be critical to ensuring that
EPA has the ability to develop transparent, credible IRIS chemical
assessments. While the broad reforms provide a sound general framework
for conducting IRIS assessments, the manner in which EPA implements the
new process will determine whether the agency will be able to overcome
its long-standing productivity problems and complete credible and
transparent assessments. Specifically, certain aspects of the new
process are incomplete or lack clarity and thus warrant management
attention. For example, EPA has likely understated the time required to
complete an assessment because its estimated time frames do not include
the time required to complete two key steps. Overall, the viability of
the IRIS program will depend on effective and sustained management,
given the number of factors that can impede the progress of IRIS
assessments--even one delay can have a domino effect, requiring the
process to essentially be repeated to incorporate changing science. We
note that, unlike some other EPA programs with statutory deadlines for
completing various activities, the IRIS program is discretionary. As we
have previously stated, we believe the absence of statutory deadlines
in completing assessments may contribute to EPA's failure to complete
timely IRIS assessments.[Footnote 8]
TSCA's Regulatory Framework Impedes EPA's Efforts to Control Risks
Posed by Chemicals:
While TSCA authorizes EPA to issue regulations that may ban, limit, or
otherwise regulate the production or use of existing toxic chemicals,
EPA must meet a high legal threshold, which has proven to be difficult.
Specifically, in order to regulate an existing chemical under section 6
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. EPA officials have said that this
requires an extensive cost-benefit analysis. In addition, before
regulating a chemical under section 6, the EPA Administrator must
consider and publish a statement regarding the following:
* the effects of the chemical on human health and the magnitude of
human exposure to the chemical;
* the effects of the chemical on the environment and the magnitude of
the environment's exposure to the chemical;
* the benefits of the chemical for various uses and the availability of
substitutes for those uses; and:
* 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.
Moreover, while TSCA offers EPA a range of control options when
regulating existing chemicals, the agency must choose the least
burdensome regulation that will be adequately protective. For example,
if EPA finds that it can adequately manage the risk of a chemical by
requiring chemical companies to place warning labels on the chemical,
EPA may not ban or otherwise restrict its use. EPA must also develop
substantial evidence in support of the action it proposes to take in
order to withstand judicial review. Under TSCA, a court reviewing a
TSCA rule must set it aside if such evidence is lacking.[Footnote 9] As
several courts have noted, this standard is more rigorous than the
"arbitrary and capricious" standard normally applied to rulemaking.
Furthermore, 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 substantial evidence that EPA is
promulgating the least burdensome requirement.
EPA has had difficulty demonstrating that harmful chemicals pose an
unreasonable risk and consequently should be regulated. In fact, since
Congress passed TSCA in 1976--over 33 years ago--EPA has issued TSCA
regulations on only five existing chemicals or chemical classes. In
1991, one of these regulations--the 1989 regulation banning most uses
of asbestos--was largely vacated by a federal appeals court decision
that cited EPA's failure to meet statutory requirements. In contrast to
the United States, the European Union and a number of other countries
have banned all, or almost all, asbestos and asbestos-containing
products. Asbestos is a known human carcinogen that can cause lung
cancer and other diseases if inhaled. Asbestos has been used widely in
products such as fireproofing; thermal insulation; and friction
products, including brake linings.
EPA spent 10 years exploring the need for the asbestos ban and
developing the regulation. On the basis of its review of over 100
studies of the health risks of asbestos as well as public comments on
the proposed rule, EPA determined that asbestos is a potential
carcinogen at all levels of exposure--that is, that it has no known
safe exposure level. EPA's 1989 rule under TSCA section 6 prohibited
the future manufacture, importation, processing, and distribution of
asbestos in almost all products. In response, 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 manufacturers, concluding that EPA had
failed to muster substantial evidence to justify its asbestos ban.
Specifically, the court concluded that EPA did not consider all
necessary evidence and failed to show that the control action it chose
was the least burdensome regulation that would adequately protect human
health or the environment. EPA had not calculated the risk levels for
intermediate levels of regulation because 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 would
have been to consider each regulatory option listed in TSCA, beginning
with the least burdensome, and the costs and benefits of each option.
Since completing the 1989 asbestos rule, EPA has completed only one
regulation to ban or limit the production or use of an existing
chemical (for hexavalent chromium in 1990).
With EPA's limited actions to control toxic chemicals under TSCA, state
and federal actions have filled the void by establishing controls for
some toxic chemicals. For example, a California statute enacted in 2007
prohibits the manufacture, sale, or distribution of certain toys and
child care articles after January 1, 2009, if the products contain
concentrations of phthalates exceeding 0.1 percent. In 2008, Congress
took similar action. California has also enacted limits on formaldehyde
in pressed wood. In response to a petition asking EPA to use section 6
of TSCA to adopt the California formaldehyde regulation, EPA recently
issued an advance notice of proposed rulemaking suggesting several
regulatory options the agency could pursue under its TSCA section 6
authority to limit exposure to formaldehyde. However, because of the
legal hurdles the agency would face in regulating formaldehyde under
TSCA, some stakeholders have recommended that EPA pursue legislation
instead.
In our previous reports, we identified a number of options that could
strengthen EPA's ability to regulate harmful chemicals under TSCA.
[Footnote 10] Potential changes to TSCA include reducing the
evidentiary burden that EPA must meet to take regulatory action under
the act by amending (1) the unreasonable risk standard; (2) the
standard for judicial review, which requires substantial evidence in
the rulemaking record; and (3) the requirement that EPA choose the
least burdensome regulatory requirement.
TSCA Limits EPA's Ability to Share Information:
TSCA' s confidential business information provisions limit EPA's
ability to make the information that it collects under the act
available to outside entities if chemical companies designate such
information 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, including
state health and environmental officials and foreign governments that
may have legitimate needs for the information. For example, some state
officials said this information would be useful for informing and
managing their environmental risk programs.
EPA officials told us that some claims of confidential business
information may be unwarranted, but challenging the claims is resource-
intensive. EPA has not performed any recent studies of the
appropriateness of confidentiality claims, but a 1992 EPA study
indicated that problems with inappropriate claims were extensive. This
study examined the extent to which companies made confidential business
information claims, the validity of the claims, and the impact of
inappropriate claims on the usefulness of TSCA data to the public.
While EPA may suspect that some chemical companies' confidentiality
claims are unwarranted, the agency does not have data on the number of
inappropriate claims. According to EPA officials, about 95 percent of
premanufacture notices contain some information that chemical companies
claim as confidential. EPA officials also told us that the agency does
not have the resources that would be needed to investigate and
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.
As we have previously reported, state officials who have various
responsibilities for protecting public health and the environment from
the dangers posed by chemicals have said that having access to
confidential TSCA information would allow them to examine information
on chemical properties and processes that they currently do not
possess, which could enable them to better control the risks of
potentially harmful chemicals.[Footnote 11] 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 could use such information to
engage in dialogue with chemical companies about reducing chemical
risks, preventing accidents, and limiting chemical exposures.
In our June 2005 report, we suggested that Congress consider amending
TSCA to authorize EPA to share the confidential business information
that chemical companies provide to EPA with states and foreign
governments.[Footnote 12] This amendment would be subject to
regulations to be established by EPA in consultation with the chemical
industry and other interested parties, which would protect the
information from unauthorized disclosures. In our September 1994
report, we recommended that Congress consider limiting the length of
time for which information may be claimed as confidential without
resubstantiation of the need for confidentiality.[Footnote 13]
Concluding Observations:
Although we have identified significant shortcomings with TSCA in
numerous reports and made recommendations to remedy them, EPA still
does not have the authority to develop sufficient information to
support critical decisions regarding how to protect human health and
the environment from toxic chemicals. In our previous reports on TSCA,
we have recommended both statutory and regulatory changes to (1)
strengthen EPA's authority to obtain additional information from the
chemical industry, (2) shift more of the burden to chemical companies
for demonstrating the safety of their chemicals, and (3) enhance the
public's understanding of the risks of chemicals to which they may be
exposed, among other things. With regard to IRIS, it is too soon to
know if EPA's new IRIS assessment process will enable the agency to
develop timely and credible assessments of chemicals of concern.
Without greater attention to EPA's efforts to assess toxic chemicals,
the nation lacks assurance that human health and the environment are
adequately protected.
Madam Chairman, Ranking Member, this concludes my prepared statement. I
would be happy to respond to any questions that you or other Members of
the Committee may have at this time.
GAO Contact and Staff Acknowledgments:
For further information about this testimony, please contact John B.
Stephenson at (202) 512-3841 or stephensonj@gao.gov. Contact points for
our Offices of Congressional Relations and Public Affairs may be found
on the last page of this statement. Contributors to this testimony
include David Bennett, Ben Shouse, Antoinette Capaccio, Christine
Fishkin, and Ed Kratzer.
[End of section]
Related GAO Products:
EPA Chemical Assessment: Process Reforms Offer the Potential to Address
Key Problems. [hyperlink, http://www.gao.gov/products/GAO-09-774T].
Washington, D.C.: June 11, 2009.
Scientific Integrity: EPA's Efforts to Enhance the Credibility and
Transparency of Its Scientific Processes. [hyperlink,
http://www.gao.gov/products/GAO-09-773T]. Washington, D.C.: June 9,
2009.
Biomonitoring: EPA Needs to Coordinate Its Research Strategy and
Clarify Its Authority to Obtain Biomonitoring Data. [hyperlink,
http://www.gao.gov/products/GAO-09-353]. Washington, D.C.: April 30,
2009.
Chemical Regulation: Options for Enhancing the Effectiveness of the
Toxic Substances Control Act. [hyperlink,
http://www.gao.gov/products/GAO-09-428T]. Washington, D.C.: February
26, 2009.
High-Risk Series: An Update. [hyperlink,
http://www.gao.gov/products/GAO-09-271]. Washington, D.C.: January 22,
2009.
EPA Science: New Assessment Process Further Limits the Credibility and
Timeliness of EPA's Assessments of Toxic Chemicals. [hyperlink,
http://www.gao.gov/products/GAO-08-1168T]. Washington, D.C.: September
18, 2008.
Chemical Assessments: EPA's New Assessment Process Will Further Limit
the Productivity and Credibility of Its Integrated Risk Information
System. [hyperlink, http://www.gao.gov/products/GAO-08-810T].
Washington, D.C.: May 21, 2008.
Toxic Chemicals: EPA's New Assessment Process Will Increase Challenges
EPA Faces in Evaluating and Regulating Chemicals. [hyperlink,
http://www.gao.gov/products/GAO-08-743T]. Washington, D.C.: April 29,
2008.
Chemical Assessments: Low Productivity and New Interagency Review
Process Limit the Usefulness and Credibility of EPA's Integrated Risk
Information System. [hyperlink,
http://www.gao.gov/products/GAO-08-440]. March 7, 2008.
Chemical Regulation: Comparison of U.S. and Recently Enacted European
Union Approaches to Protect against the Risks of Toxic Chemicals.
[hyperlink, http://www.gao.gov/products/GAO-07-825]. Washington, D.C.:
August 17, 2007.
Chemical Regulation: Actions Are Needed to Improve the Effectiveness of
EPA's Chemical Review Program. [hyperlink,
http://www.gao.gov/products/GAO-06-1032T]. Washington, D.C.: August 2,
2006.
Chemical Regulation: Options Exist to Improve EPA's Ability to Assess
Health Risks and Manage Its Chemical Review Program. [hyperlink,
http://www.gao.gov/products/GAO-05-458]. Washington, D.C.: June 13,
2005.
Toxic Substances Control Act: Legislative Changes Could Make the Act
More Effective. [hyperlink,
http://www.gao.gov/products/GAO/RCED-94-103]. Washington, D.C.:
September 26, 1994.
[End of section]
Footnotes:
[1] GAO, High-Risk Series: An Update, [hyperlink,
http://www.gao.gov/products/GAO-09-271] (Washington, D.C.: Jan. 22,
2009).
[2] GAO, Chemical Regulation: Options Exist to Improve EPA's Ability to
Assess Health Risks and Manage Its Chemical Review Program, [hyperlink,
http://www.gao.gov/products/GAO-05-458] (Washington, D.C.: June 13,
2005).
[3] [hyperlink, http://www.gao.gov/products/GAO-05-458].
[4] [hyperlink, http://www.gao.gov/products/GAO-05-458].
[5] [hyperlink, http://www.gao.gov/products/GAO-05-458].
[6] GAO, Chemical Assessments: Low Productivity and New Interagency
Review Process Limit the Usefulness and Credibility of EPA's Integrated
Risk Information System, [hyperlink,
http://www.gao.gov/products/GAO-08-440] (Washington D.C.: Mar.7, 2008).
[7] GAO, Scientific Integrity: EPA's Efforts to Enhance the Credibility
and Transparency of Its Scientific Processes, [hyperlink,
http://www.gao.gov/products/GAO-09-773T] (Washington, D.C.: June 9,
2009).
[8] GAO, EPA Chemical Assessment: Process Reforms Offer the Potential
to Address Key Problems, [hyperlink,
http://www.gao.gov/products/GAO-09-774T] (Washington, D.C.: June 11,
2009).
[9] Specifically, a court reviewing a 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." 15 U.S.C.A. §
2618(c)(1)(B)(i).
[10] [hyperlink, http://www.gao.gov/products/GAO/RCED-94-103] and
[hyperlink, http://www.gao.gov/products/GAO-05-458].
[11] [hyperlink, http://www.gao.gov/products/GAO-05-458].
[12] [hyperlink, http://www.gao.gov/products/GAO-05-458].
[13] GAO, Toxic Substances Control Act: Legislative Changes Could Make
the Act More Effective, [hyperlink,
http://www.gao.gov/products/GAO/RCED-94-103] (Washington, D.C.: Sept.
26, 1994).
[End of section]
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