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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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