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United States Government Accountability Office: 
GAO: 

Report to the Chairman, Committee on Environment and Public Works, 

U.S. Senate: 

Toxic Substances: 

EPA Has Increased Efforts to Assess and Control Chemicals but Could 
Strengthen Its Approach: 

GAO-13-249: 

GAO Highlights: 

Highlights of GAO-13-249, a report to Chairman, Committee on 
Environment and Public Works, U.S. Senate. 

Why GAO Did This Study: 

In 1976, Congress passed TSCA to provide EPA with the authority to 
obtain more information on chemicals and to regulate those chemicals 
that EPA determines pose unreasonable risks of injury to human health 
or the environment. GAO has reported that EPA has found much of TSCA 
difficult to implement—hampering the agency’s ability to obtain 
certain chemical data or place limits on chemicals. Of the thousands 
of chemicals listed for commercial use in the United States, EPA has 
used its authority to limit or ban five chemicals since TSCA was 
enacted. In 2009, EPA announced TSCA reform principles to inform 
ongoing efforts in Congress to strengthen the act. At that time, EPA 
also initiated a new approach for managing toxic chemicals with the 
goal of ensuring chemicals’ safety using its existing authorities. 

GAO was asked to evaluate EPA’s efforts to strengthen its management 
of chemicals. This report determines the extent to which (1) EPA has 
made progress implementing its new approach and (2) EPA’s new approach 
positions it to achieve its goal of ensuring the safety of chemicals. 
GAO examined agency documents and TSCA rulemaking and interviewed 
agency officials and stakeholders from industry and environmental 
organizations. 

What GAO Found: 

Since 2009, the Environmental Protection Agency (EPA) has made 
progress implementing its new approach to managing toxic chemicals 
under its existing Toxic Substances Control Act (TSCA) authority; 
particularly by increasing efforts to obtain chemical toxicity and 
exposure data and initiating chemical risk assessments—which EPA uses, 
along with other information, to decide what regulatory or other 
actions, if any, are warranted. The results of EPA’s data collection 
activities, in most cases, have yet to be realized, and it may take 
several years before EPA obtains much of the data it is seeking. Also, 
EPA has not pursued some opportunities to obtain chemical data that 
companies submit to foreign governments or to obtain data from 
chemical processors that prepare chemical substances after their 
manufacture for distribution in commerce—some of which could help 
support the agency’s risk assessment activities. Of the 83 chemicals 
EPA has prioritized for risk assessment, it initiated 7 assessments in 
2012 and plans to start 18 additional assessments in 2013 and 2014. 
However, it may take several years to complete these initial risk 
assessments and, at the agency’s current pace, over a decade to 
complete all 83, especially as EPA does not have the toxicity and 
exposure data needed for 58 of the 83 chemicals prioritized for risk 
assessment. In addition to its risk assessment activity, EPA has 
initiated other actions—-such as increasing review of certain new uses 
of chemicals—-that may discourage the use of these chemicals, but it 
is too early to tell whether these actions will reduce chemical risks. 

It is unclear whether EPA’s new approach to managing chemicals within 
its existing TSCA authorities will position the agency to achieve its 
goal of ensuring the safety of chemicals. EPA officials said that the 
agency’s new approach, summarized in its 2012 Existing Chemicals 
Program Strategy, is intended to guide EPA’s efforts to assess and 
control chemicals in the coming years. However, EPA’s strategy, which 
largely focuses on describing activities EPA has already begun, does 
not include leading federal strategic planning practices that could 
help guide its effort. Specifically, EPA has not defined strategies 
that address challenges-—many of which are rooted in TSCA’s regulatory 
framework—-that may impede EPA’s ability to meet its long-term goal of 
ensuring chemical safety. Specifically, EPA has not clearly 
articulated how it will address challenges associated with obtaining 
toxicity and exposure data needed for risk assessments and placing 
limits on or banning chemicals under existing TSCA authorities. In 
addition, EPA’s strategy does not describe the resources needed to 
execute its new approach. For example, EPA’s strategy does not 
identify roles and responsibilities of key staff or offices or 
identify staffing levels or costs associated with conducting the 
activities under its new approach. Without a plan that incorporates 
leading strategic planning practices, EPA cannot be assured that its 
new approach to managing chemicals, as described in its Existing 
Chemicals Program Strategy, will provide a framework to effectively 
guide its effort. Consequently, EPA could be investing valuable 
resources, time, and effort without being certain that its efforts 
will bring the agency closer to achieving its goal of ensuring the 
safety of chemicals. 

What GAO Recommends: 

GAO recommends, among other things, that EPA develop strategies that 
address challenges impeding its ability to ensure chemical safety and 
the resources needed to so. 

View [hyperlink, http://www.gao.gov/products/GAO-13-249]. For more 
information, contact David Trimble at (202) 512-3841 or 
trimbled@gao.gov. 

Contents: 

Letter: 

Background: 

EPA Has Made Progress Implementing Its New Approach to Managing 
Chemicals, but, in Most Cases, Results Have Yet to Be Realized: 

It Is Unclear Whether EPA's New Approach Will Position the Agency to 
Achieve Its Goal of Ensuring the Safety of Chemicals: 

Conclusions: 

Recommendations for Executive Action: 

Agency Comments and Our Evaluation: 

Appendix I: Scope and Methodology: 

Appendix II: Comments from the Environmental Protection Agency: 

Appendix III: GAO Contact and Staff Acknowledgments: 

Related GAO Products: 

Table: 

Table 1: Purpose and Application of TSCA's Major Sections: 

Figure: 

Figure 1: Human Health Chemical Risk Assessment Model Used by EPA: 

Abbreviations: 

ADP: Action Development Process: 

ATO: antimony trioxide: 

BPA: bisphenol A: 

CAS: Chemical Abstracts Service: 

DCM: dichloromethane: 

EPA: Environmental Protection Agency: 

HHCB: 1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8,-hexamethylcyclopenta[g]-2-
benzopyran: 

HPV: High Production Volume: 

IUPAC: International Union of Pure and Applied Chemistry: 

IRIS: Integrated Risk Information System: 

NCEA: National Center for Environmental Assessment: 

NMP: n-methylpyrrolidone: 

OIRA: Office of Information and Regulatory Affairs: 

OMB: Office of Management and Budget: 

OPPT: Office of Pollution Prevention and Toxics: 

ORD: Office of Research and Development: 

OCSPP: Office of Chemical Safety and Pollution Prevention: 

PBDE: polybrominated diphenyl ether: 

PCB: polychlorinated biphenyls: 

PVC: plastics/rubber compounding: 

TCE: trichloroethylene: 

TSCA: Toxic Substances Control Act: 

[End of section] 

March 22, 2013: 

The Honorable Barbara Boxer: 
Chairman: 
Committee on Environment and Public Works: 
United States Senate: 

The Honorable Tom Udall: 
Chairman: 
Subcommittee on Superfund, Toxics and Environmental Health: 
Committee on Environment and Public Works: 
United States Senate: 

The Honorable Frank Lautenberg: 
United States Senate: 

Tens of thousands of chemicals are listed with the Environmental 
Protection Agency (EPA) for commercial use in the United States, with 
an average of 600 new chemicals listed each year. EPA's ability to 
effectively implement its mission of protecting public health and the 
environment depends on credible and timely assessments of the risks 
posed by toxic chemicals. In 1976, Congress passed the Toxic 
Substances Control Act (TSCA) to provide EPA with the authority to 
obtain more information on chemicals and to regulate those chemicals 
that EPA determines pose unreasonable risks to human health or the 
environment. TSCA authorizes EPA to review chemicals already in 
commerce (existing chemicals) and chemicals yet to enter commerce (new 
chemicals). The scope of TSCA includes those chemicals manufactured, 
imported, processed,[Footnote 1] distributed in commerce, used, or 
disposed of in the United States but excludes certain substances 
regulated under other laws.[Footnote 2] TSCA also specifies when EPA 
may publicly disclose chemical information it obtains from chemical 
companies and provides that chemical companies can claim certain 
information, such as data disclosing chemical processes, as 
confidential business information.[Footnote 3] 

We have reported in the past, among other things, that EPA has found 
many of the provisions of TSCA difficult to implement--which has 
hampered the agency's ability to obtain certain chemical data, place 
limits on chemicals, and manage company assertions of confidentiality. 
Specifically, EPA has found it difficult to obtain adequate 
information on chemical toxicity and exposure[Footnote 4] because TSCA 
does not require companies to provide this information and, instead, 
requires EPA to demonstrate that chemicals pose certain risks before 
it can ask for such information. Without adequate information on 
chemical toxicity and exposure, EPA is unable to assess the risks 
posed by many chemicals. 

Even when EPA has had adequate information on toxicity and exposure, 
the agency has had difficulty demonstrating, under the standards 
required by TSCA, that harmful chemicals pose an unreasonable risk 
and, therefore, should be banned or have limits placed on their 
production or use. Consequently, EPA has used its authority to limit 
or ban the use of five chemicals since TSCA was enacted in 1976. The 
agency last used this authority in 1990. In addition, while EPA has 
reported that 95 percent of information it receives on new chemicals 
contains assertions of confidentiality, EPA officials have stated that 
they have not had the resources that would be needed to investigate 
and, as appropriate, challenge such claims. 

In our past reports, we have suggested that Congress consider making 
statutory changes to strengthen EPA's authority to obtain toxicity 
information from the chemical industry and establish a framework for 
taking action that is less burdensome for EPA. In addition, we have 
identified a number of options that could strengthen EPA's ability to 
regulate harmful chemicals under TSCA.[Footnote 5] For the past 
several years, congressional committees annually have considered 
legislation aimed at reforming TSCA, but Congress has not passed such 
legislation. We have also made recommendations to EPA. In June 2005, 
we reported that EPA had not used its TSCA authority to obtain 
information that U.S. companies submit to foreign governments, which 
may contain important information on chemical toxicity, and we 
recommended that EPA promulgate a rule requiring that companies submit 
copies to the agency of any health and safety studies, as well as 
other information concerning the environmental and health effects of 
chemicals that they submit to foreign governments.[Footnote 6] We also 
recommended that the agency improve and validate its models for 
assessing and predicting the risks of chemicals and revise its 
regulations to require companies to reassert confidentiality claims 
within a certain period. EPA implemented our recommendation to improve 
its models. EPA did not disagree with our recommendations regarding 
obtaining health and safety studies and other information that 
companies submit to foreign governments and requiring companies to 
reassert confidentiality claims, but it provided substantive comments 
and has not fully implemented these recommendations. For this and 
other reasons, in 2009, we added EPA's processes for assessing and 
controlling toxic chemicals to our list of programs at high risk of 
waste, fraud, abuse, and mismanagement.[Footnote 7] 

Interest in reforming TSCA has heightened in recent years and, in 
2009, EPA announced principles for reforming TSCA to help inform 
efforts under way in Congress. These principles include, among other 
things, goals for reforming TSCA so that (1) EPA would have clear 
authority to establish safety standards that are based on scientific 
risk assessments; (2) manufacturers would be required to provide 
sufficient toxicity, exposure, and use data for a chemical to support 
a determination by EPA that the chemical meets the safety standard; 
(3) EPA would have clear authority to take regulatory or other actions 
when chemicals do not meet the safety standard, with flexibility to 
take into account a range of considerations, including children's 
health, economic costs, social benefits, and equity concerns; (4) EPA 
would have authority to set priorities for conducting safety reviews 
on existing chemicals based on relevant risk and exposure 
considerations; and (5) EPA would receive a sustained source of 
funding from manufacturers of chemicals to support the costs of agency 
implementation, including the review of information provided by 
manufacturers. 

Along with the announcement of these principles in 2009, EPA initiated 
a new approach to managing chemicals within the limits of existing 
authorities--which, according to agency documents, will transition the 
agency from an approach dominated by voluntary data submissions by 
industry to a more proactive approach in which EPA will use its data 
collection and other rulemaking authorities under TSCA to ensure 
chemical safety. In this context, you asked us to evaluate EPA's 
recent efforts to strengthen its management of chemicals. Our 
objectives were to determine the extent to which (1) EPA has made 
progress implementing its new approach to managing toxic chemicals 
under its existing TSCA authority and (2) EPA's new approach positions 
the agency to achieve its goal of ensuring the safety of chemicals. 

To address these objectives, we identified and reviewed EPA's efforts 
to obtain and analyze toxicity and exposure data, prioritize and 
perform risk assessments on chemicals, initiate regulatory and other 
actions to reduce risks; and make more chemical information--
particularly data classified as confidential business information--
available to the public. As part of this work, we reviewed EPA's TSCA 
rulemaking actions for the last 10 years and examined EPA's key 
policy, planning, and strategy documents. We interviewed officials 
from EPA's Office of Chemical Safety and Pollution Prevention, 
including its Office of Pollution Prevention and Toxics, regarding 
EPA's efforts to strengthen its management of chemicals. We 
interviewed officials from EPA's Office of Research and Development 
and Office of Policy relating to EPA's use of new analytical methods 
and tools and EPA's rulemaking process, respectively. We also 
interviewed representatives from stakeholder groups, such as industry 
associations and environmental organizations. A more detailed 
description of our scope and methodology can be found in appendix I. 

We conducted this performance audit from December 2011 to March 2013 
in accordance with generally accepted government auditing standards. 
Those standards require that we plan and perform the audit to obtain 
sufficient, appropriate evidence to provide a reasonable basis for our 
findings and conclusions based on our audit objectives. We believe 
that the evidence obtained provides a reasonable basis for our 
findings and conclusions based on our audit objectives. 

Background: 

This section discusses (1) chemical risk assessments, (2) the 
structure of TSCA and prior findings that have impeded EPA's ability 
to assess and control toxic chemicals, and (3) EPA's new approach to 
managing chemicals within the limits of existing authorities. 

Chemical Risk Assessments: 

EPA's ability to effectively implement its mission of protecting 
public health and the environment depends on credible and timely 
assessments of the risks posed by chemicals. EPA assesses the risks 
chemicals pose to human health (human health risk assessments) as well 
as to the environment (ecological risk assessments). 

The human health risk assessment model EPA uses (see fig. 1) includes 
steps to (1) identify a chemical's toxicity, or hazardous properties, 
which are the potential noncancer and cancer human health effects of 
exposure to a chemical; (2) assess the dose-response relationship 
between exposure to a chemical and the resultant health effects, which 
describes the magnitude of hazard for potential noncancer effects and 
increased cancer risk; (3) assess the extent of human exposure to the 
chemical; and (4) characterize risk by determining the probability 
that populations or individuals so exposed to the chemical will be 
harmed and to what degree. Such assessments are the cornerstone of 
scientifically sound environmental decisions, policies, and 
regulations under a variety of statutes, including TSCA. 

Figure 1: Human Health Chemical Risk Assessment Model Used by EPA: 

[Refer to PDF for image: illustration] 

Risk Characterization: consists of: 

Toxicity assessment: 
1. Hazard identification; 
2. Dose-response assessment. 

Exposure assessment. 

Source: GAO presentation of the risk assessment component of the 
National Academies' risk assessment model used by EPA 

[End of figure] 

For some, but not all, chemicals, EPA conducts the first two steps of 
its chemical risk assessment model--that is, the hazard identification 
and dose-response assessment--under its Integrated Risk Information 
System (IRIS) program.[Footnote 8] Taken together, these two steps are 
commonly referred to as toxicity assessments. EPA created the IRIS 
program in 1985 to help develop consensus opinions within the agency 
about the human health effects from chronic exposure to chemicals, and 
it is the only federal program that provides qualitative and 
quantitative assessments of both cancer risks and noncancer effects of 
chemicals. EPA's IRIS program--managed by EPA's National Center for 
Environmental Assessment (NCEA) within the Office of Research and 
Development (ORD)--develops new IRIS toxicity assessments and updates 
existing IRIS assessments if revisions are warranted on the basis of 
newly published peer-reviewed studies. For many chemicals, however, 
IRIS toxicity assessments are not available, current, or applicable to 
EPA's program offices--including the Office of Pollution Prevention 
and Toxics, which is responsible for implementing TSCA. Therefore, 
these offices, in some cases, prepare their own toxicity assessments. 

EPA program offices, including the Office of Pollution Prevention and 
Toxics, combine information from IRIS toxicity assessments or other 
toxicity assessments with the results from chemical exposure 
assessments to develop human health risk assessments, which 
characterize the risks posed by chemicals, and make risk management 
decisions. Risk management, as opposed to risk assessment, involves 
integrating the risk assessment information with other information--
such as economic information on the costs and benefits of mitigating a 
risk, technological information on the feasibility of managing the 
risk, and the concerns of various stakeholders--to determine whether 
the health risks identified in a chemical risk assessment warrant EPA 
taking regulatory or other risk management actions. 

In the case of EPA's ecological risk assessment model, EPA's 
guidelines suggest a three-step process consisting of (1) problem 
formulation, (2) analysis, and (3) risk characterization, rather than 
the four-step process used for human health risk assessments. While 
for a human health risk assessment EPA is primarily concerned with a 
chemical's toxicity to humans, for an ecological risk assessment, the 
agency might consider a range of adverse effects on natural resources 
(e.g., crops, livestock, commercial fisheries, and forests), wildlife 
(including plants), aesthetic values (e.g., clear air in a national 
park), and recreational opportunities. According to EPA's ecological 
risk assessment guidelines, an ecological risk assessment is a process 
that evaluates the likelihood that adverse ecological effects may 
occur or are occurring as a result of exposure to one or more 
environmental stressors, such as chemicals, disease, invasive species, 
and climate change, and one stressor or many stressors may be 
considered. EPA's guidance on ecological risk assessments focuses on 
stressors and adverse ecological effects generated or influenced by 
human activity that could be addressed by the agency's risk management 
decisions. 

TSCA's Structure and Prior Findings on Challenges Posed by TSCA: 

EPA's authority to ensure that chemicals in commerce do not present an 
unreasonable risk of injury to health or the environment is 
established in five major sections of TSCA. The purpose and 
application of these sections are shown in table 1 and described in 
further detail below. 

Table 1: Purpose and Application of TSCA's Major Sections: 

Section: 4; 
Purpose: Chemical testing; 
Provides EPA with a mechanism to: Require companies to develop 
toxicity data under certain circumstances. 

Section: 5; 
Purpose: New chemical review and significant new use rules; 
Provides EPA with a mechanism to: Review existing information, 
including exposure and toxicity data for new chemicals and certain new 
uses of existing chemicals. 

Section: 6; 
Purpose: Chemical regulation; 
Provides EPA with a mechanism to: Limit or ban a chemical, among other 
controls. 

Section: 8; 
Purpose: Industry reporting of chemical data; 
Provides EPA with a mechanism to: Obtain existing data, including 
exposure and toxicity data. 

Section: 14; 
Purpose: Disclosure of chemical data; 
Provides EPA with a mechanism to: Disclose certain data provided to 
EPA while also protecting confidential business information. 

Source: GAO analysis of TSCA. 

[End of table] 

Under the provisions for chemical testing in section 4 of TSCA, EPA 
can promulgate rules to require chemical companies to test potentially 
harmful chemicals for their health and environmental effects. However, 
EPA must first determine that testing is warranted based on some 
toxicity or exposure information. Specifically, to require such 
testing, EPA must find that a chemical (1) may present an unreasonable 
risk of injury to health or the environment or (2) is or will be 
produced in substantial quantities and that either (a) there is or may 
be significant or substantial human exposure to the chemical or (b) 
the chemical enters or may reasonably be anticipated to enter the 
environment in substantial quantities. EPA must also determine that 
there are insufficient data to reasonably determine or predict the 
effects of the chemical on health or the environment and that testing 
is necessary to develop such data. As we have previously reported, EPA 
has found this authority to be difficult, time-consuming, and costly 
to use.[Footnote 9] The structure of section 4 of the act 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. 

Under the provisions for new chemical review and significant new use 
rules in section 5 of TSCA, chemical companies are to notify EPA at 
least 90 days before beginning to manufacture a new chemical 
(premanufacture notice review). Section 5 also allows EPA to 
promulgate significant new use rules, which require companies to 
notify EPA at least 90 days before beginning to manufacture a chemical 
for certain new uses or in certain new ways (significant new use 
notice review). Such rules require existing chemicals to undergo the 
same type of review that new chemicals undergo. For example, EPA may 
issue a significant new use rule if it learns that a chemical that has 
previously been processed as a liquid is now being processed as a 
powder, which may change how workers are exposed to the chemical. For 
both new chemicals and significant new use reviews, the required 
notification to EPA must include certain information on chemical 
identity, use, production volume, and worker exposure, among other 
information. EPA has 90 days to review the information in the notice 
and identify potential risks. If EPA takes no action, manufacturing 
may commence.[Footnote 10] Section 5 of the act also authorizes EPA to 
maintain a list of chemicals--called the chemicals of concern list--
that present or may present an unreasonable risk of injury to health 
or the environment. 

Under the provisions for chemical regulation in section 6 of TSCA, EPA 
is to apply regulatory requirements to chemicals for which EPA finds a 
reasonable basis exists to conclude that the chemical presents or will 
present an unreasonable risk of injury to health or the environment. 
To adequately protect against a chemical's risk, EPA can promulgate a 
rule that bans or restricts the chemical's production, processing, 
distribution in commerce, disposal, or use or requires warning labels 
be placed on the chemical. Under TSCA, EPA must choose the least 
burdensome requirement that will adequately protect against the risk. 
In promulgating a rule, EPA must consider and publish a statement in 
the Federal Register regarding the following: (1) the effects of the 
chemical on health and the environment and the magnitude of human and 
environmental exposure; (2) the benefits of the chemical for various 
uses and the availability of substitutes for those uses; and (3) the 
reasonably ascertainable consequences of the rule, after consideration 
of the effect on the national economy, small businesses, technological 
innovation, the environment, and public health. 

As we have reported in the past, EPA has had difficulty demonstrating 
that chemicals should be banned or have limits placed on their 
production or use under section 6.[Footnote 11] Since Congress enacted 
TSCA in 1976, EPA has issued regulations under section 6 of the act to 
ban or limit the production or restrict the use of five existing 
chemicals or chemical classes out of tens of thousands of chemicals 
listed for commercial use on the agency's TSCA inventory--
polychlorinated biphenyls (PCB), fully halogenated 
chlorofluoroalkanes, dioxin, asbestos, and hexavalent chromium. 
[Footnote 12] EPA's 1989 asbestos rule illustrates the difficulties 
EPA has had in issuing regulations to control existing chemicals. In 
1979, EPA started considering rulemaking on asbestos. After concluding 
that asbestos was a potential carcinogen at all levels of exposure, 
[Footnote 13] EPA promulgated a rule in 1989 prohibiting the future 
manufacture, importation, processing, and distribution of asbestos in 
almost all products. 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 
1991, the Fifth Circuit Court of Appeals ruled for the manufacturers 
and returned parts of the rule to EPA for reconsideration. In reaching 
this conclusion, the court found that EPA did not consider all 
necessary evidence and failed to show that the control action it chose 
was the least burdensome reasonable regulation. The court further 
criticized EPA for banning a product for which no substitutes were 
currently available. EPA has not proposed a new section 6 rule since 
the court's ruling in 1991. 

Under the provisions for industry reporting of chemical data in 
section 8(a), EPA is to promulgate rules under which chemical 
companies must maintain records and submit such information as the EPA 
Administrator reasonably requires. This information can include, among 
other things, chemical identity, categories of use, production levels, 
by-products, existing data on adverse human health and environmental 
effects, and the number of workers exposed to the chemical, to the 
extent such information is known or reasonably ascertainable. Under 
section 8(a), EPA issues rules to collect additional or updated 
information on certain TSCA inventory chemicals. For example, in 
August 2011, EPA finalized its TSCA Chemical Data Reporting rule 
(previously referred to as the Inventory Update Reporting 
Modifications Rule); the rule requires companies to report, among 
other things, exposure-related information, such as production volume 
and use data, on chemicals manufactured or imported over a certain 
volume per year. EPA uses production volume and use data reported by 
companies as a proxy to estimate the extent of human exposure to the 
chemicals. In addition, section 8(d) provides EPA with the authority 
to promulgate rules under which chemical companies are required to 
submit lists or copies of existing health and safety studies to EPA. 
Section 8(e) requires chemical companies to report any information to 
EPA that reasonably supports a conclusion that a chemical presents a 
substantial risk of injury to health or the environment, unless the 
company has actual knowledge that EPA already has the information. 

The provisions for disclosure of chemical data in section 14 of the 
act specify when EPA may disclose chemical information it obtains 
under TSCA. Chemical companies can claim certain information, such as 
data disclosing chemical processes, as confidential business 
information. EPA generally must protect confidential business 
information against public disclosure unless necessary to protect 
against an unreasonable risk of injury to health or the environment. 
Other federal agencies and federal contractors can obtain access to 
this confidential business information in order to carry out their 
responsibilities. EPA may also disclose certain data from health and 
safety studies. Over the years, companies have classified much of the 
information they submitted to EPA as confidential business 
information, and, prior to 2009, EPA did not routinely challenge their 
assertions, citing resource constraints. As a result, the extent to 
which companies' confidentiality claims were warranted was unknown. 

EPA's New Approach to Managing Chemicals: 

In September 2009, EPA initiated a new approach to managing chemicals 
that focuses largely on existing chemicals--that is, the approximately 
84,000 chemicals already on the TSCA inventory.[Footnote 14] EPA's new 
approach has evolved over time and includes a variety of different 
activities and initiatives. In February 2012, EPA summarized many of 
the activities it had initiated under its new approach in the agency's 
Existing Chemicals Program Strategy. Collectively, these activities 
address four areas: (1) collecting toxicity and exposure data, (2) 
conducting risk assessments, (3) discouraging the use of some 
chemicals, and (4) expanding public access to some chemical data. 

EPA Has Made Progress Implementing Its New Approach to Managing 
Chemicals, but, in Most Cases, Results Have Yet to Be Realized: 

EPA has made progress implementing its new approach to managing toxic 
chemicals under its existing TSCA authority--particularly by 
increasing efforts to (1) obtain toxicity and exposure data, (2) 
assess risks posed by chemicals, (3) discourage the use of some 
chemicals, and (4) expand public access to some chemical information. 
However, the results of EPA's activities, in most cases, have yet to 
be realized. 

EPA Has Increased Efforts to Collect Data on Toxicity and Exposure, 
but It May Take Several Years to Produce Results: 

Since 2009, EPA has increased its efforts to collect toxicity and 
exposure data. Specifically, since 2009, EPA has required companies to 
test 34 chemicals and provide EPA with the resulting toxicity and 
other data. In addition, in 2011, EPA announced, but has yet to 
finalize, plans to require testing for 23 additional chemicals. 
[Footnote 15] By comparison, EPA promulgated test rules for 197 
chemicals from the time TSCA was enacted in 1976 until 2009 when the 
agency undertook its new approach to managing chemicals.[Footnote 16] 
The 57 chemicals that are part of EPA's current and proposed testing 
requirements were identified but not sponsored as part of the 
agency's1998 voluntary effort to obtain testing data from companies on 
chemicals produced or imported at high volumes (i.e., amounts of 1 
million pounds or more a year).[Footnote 17] 

Due to requirements under TSCA that place the burden of developing 
toxicity data on EPA, rather than on industry, and because EPA's past 
efforts to obtain these data voluntarily were not successful, EPA 
proposed or promulgated rules to require chemical companies to test 
these 57 chemicals. However, because rules can take years to finalize 
and additional time for companies to execute, EPA has yet to obtain 
much of the information it has been seeking. According to EPA 
officials, it can take, on average, 3 to 5 years for the agency to 
promulgate a test rule and an additional 2 to 2 ½ years for the 
companies to provide the data once EPA has requested them. 

In addition, toxicity data eventually obtained on the 57 chemicals may 
not, in all cases, be sufficient for EPA to conduct a risk assessment 
(i.e., characterize risk by determining the probability that 
populations or individuals so exposed to a chemical will be harmed and 
to what degree). EPA officials told us that much of the chemical 
toxicity information obtained previously through its 1998 voluntary 
effort to obtain testing data from companies is considered "screening 
level" information. That is, the information was collected to identify 
a chemical's potential hazards to human health and the environment, 
but it was not intended to be the basis for assessing whether a 
chemical poses an unreasonable risk of injury to human health or the 
environment, according to agency documents describing the program. 
EPA's efforts since 2009 to require companies to test chemicals is 
based on testing parameters similar to those used under its voluntary 
effort and thus may produce similar basic screening level 
data.[Footnote 18] 

With regard to exposure data, in August 2011, EPA revised its periodic 
chemical data reporting requirements to obtain exposure-related 
information for a greater number of chemicals. Under the revised 
requirements, EPA (1) lowered the reporting thresholds, in some cases, 
[Footnote 19] which will allow it to look at exposure scenarios for a 
larger number of chemicals than in the past and (2) shortened the 
reporting cycle from every 5 years to every 4 years. In addition, 
starting in 2016, the revised requirements for reporting will be 
triggered when companies exceed applicable production thresholds in 
any year during the 4-year reporting cycle. Previously, the reporting 
requirement was triggered only if production levels were exceeded 
during the reporting year. According to EPA officials, this change was 
important because, under the previous requirement, production volumes 
of chemical substances fluctuated above and below reporting thresholds 
in different reporting periods, resulting in a change of approximately 
30 percent in the composition of the chemical substances reported as 
being produced from one reporting period to the next. EPA received the 
first batch of exposure-related data under the new reporting 
requirements for approximately 8,000 chemicals in August 2012, and EPA 
officials told us they expect to begin analyzing these data in the 
coming months. After receiving and analyzing these exposure-related 
data, according to agency documents, EPA plans to determine how to use 
the information to identify additional data collection needs or 
identify chemicals that may warrant further review or risk assessment. 

Even with the steps it has taken since 2009 to increase the toxicity 
and exposure data it collects, EPA has not pursued all opportunities 
to obtain chemical data. In particular, EPA has not broadly sought 
toxicity and exposure data that companies submit to the European 
Chemicals Agency on chemicals that the companies manufacture or 
process in, or import to, the United States.[Footnote 20] Under the 
European Union's chemicals legislation, the European Chemicals Agency 
may share information it receives from chemical companies with foreign 
governments in accordance with a formal agreement concluded between 
the European Community and the foreign government, but EPA has not 
pursued such an agreement. According to EPA, it has an informal 
agreement, or Statement of Intent, for cooperation and sharing of 
information with European Chemicals Agency, and had hoped that such an 
agreement would allow for the sharing of detailed studies, beyond the 
summaries made publicly available by European Chemicals Agency. In 
addition, EPA has not issued a rule under section 8 of TSCA requiring 
companies to provide EPA with the information provided to the European 
Chemicals Agency. EPA officials told us that the agency has not sought 
to obtain chemical data--from either the European Chemicals Agency or 
companies directly--because it does not believe that this would be the 
best use of EPA or industry resources. They also said that it is 
unclear whether these data would be useful to EPA. EPA officials 
believe it is a more effective use of resources to gain access to 
data, as needed, on a case-by-case basis from chemical companies. 

EPA has also not used its authority to obtain exposure-related data 
from chemical processors that prepare chemical substances or mixtures, 
after their manufacture, for distribution in commerce.[Footnote 21] 
Specifically, EPA has not issued a rule under section 8 of TSCA to 
extend its periodic chemical data reporting requirements to chemical 
processors. EPA's chemical data reporting requirements apply only to 
chemical manufacturers and importers. However, chemical processors are 
often the downstream users of chemical substances produced by chemical 
manufacturers and, therefore, may be in a better position to 
understand end users' exposure scenarios. EPA's principles for TSCA 
reform stress the importance of these data, stating that, "EPA's 
authority to require submission of use and exposure information should 
extend to downstream processors…" In addition, EPA officials told us 
that data from processors would provide the agency with a better 
understanding of potential exposure to chemicals, for example, from 
consumer products such as those designed for children, and that these 
data are necessary to conduct chemical risk assessments and make risk 
management decisions on potentially harmful chemicals. Nonetheless, 
the same EPA officials told us that the agency has not sought to 
collect such data from all processors because the agency does not 
currently have the resources to receive, store, and analyze the 
additional data. Instead, according to EPA officials, the agency has 
worked on a case-by-case basis with processors and processor 
associations to ask them to voluntarily submit data. 

With regard to obtaining toxicity and exposure data submitted to the 
European Chemicals Agency and exposure-related data from chemical 
processors, EPA officials told us that they have considered using 
EPA's subpoena authority under TSCA section 11(c) to obtain the 
information if they are unable to obtain it voluntarily--which is an 
approach EPA has not frequently used before.[Footnote 22] EPA 
officials said that they recognized that rules under section 8 of TSCA 
could be fashioned in such a way as to establish general access to 
information while also providing EPA with the flexibility to request 
the information as needed. However, according to EPA officials, TSCA 
section 11(c) authority may be appropriate in situations where EPA is 
seeking specific data and information from a specific entity, rather 
than a more general unknown population where rulemaking might be more 
appropriate. EPA has yet to take such action under its new approach to 
managing chemicals, however, and it is unclear whether such an 
approach would provide the agency with timely access to needed 
information. Without access to the data that companies have submitted 
to the European Chemicals Agency and by not pursuing exposure-related 
data from processors, regardless of the mechanism used, EPA is missing 
an opportunity to collect data that it has identified as an essential 
part of assessing chemical risk and future chemical regulation. 

EPA Has Begun Assessing Chemical Risks, but It Is Too Early to Tell 
What, If Any, Risk Management Actions Will Be Taken: 

In February 2012, EPA announced a plan that identified 83 existing 
chemicals for risk assessment--known as the TSCA Work Plan.[Footnote 
23] From this list of 83 chemicals, EPA's Office of Pollution 
Prevention and Toxics--the office responsible for implementing TSCA--
initiated risk assessments for 7 chemicals in 2012[Footnote 24] and 
announced plans to start risk assessments during 2013 and 2014 for 18 
additional chemicals. While EPA's effort to initiate TSCA-related risk 
assessments represents a significant increase in risk assessment 
activity,[Footnote 25] it may be years before EPA initiates risk 
management actions to reduce any chemical risks identified in these 
assessments. In January 2013, EPA released 5 draft risk assessments 
for public comment; from the 7 chemicals for which it initiated risk 
assessments in 2012.[Footnote 26] The two remaining assessments are to 
be released for public comment at a later date, according to EPA's 
website. EPA officials told us that, upon completion of the public 
comment periods and its external peer-review process, all 7 risk 
assessments will be finalized early in 2014. After EPA completes each 
risk assessment, according to EPA documents, the agency plans to 
determine what risk management actions, if any, are warranted to 
address identified risks. As discussed previously, before EPA can 
determine whether regulatory or other risk management action is 
warranted, the agency would need to consider other factors--such as 
economic information on the costs and benefits of mitigating the risk, 
technological information on the feasibility of managing the risk, and 
the concerns of various stakeholders such as industry and 
environmental organizations--which could require additional time and 
resources beyond completing risk assessments. Moreover, assuming EPA 
meets its target for completing these assessments and initiating new 
assessments, at its current pace, it would take EPA at least 10 years 
to complete risk assessments for the 83 chemicals in the TSCA Work 
Plan. 

In addition, it is not clear that EPA can maintain its current pace 
given that it currently does not have the toxicity and exposure data 
it will need to conduct risk assessments for all of the 83 chemicals 
in its TSCA Work Plan, and it is unclear how or when EPA will obtain 
these data. According to EPA officials and agency documents, of the 83 
chemicals identified in its TSCA Work Plan, the agency has started or 
plans to start risk assessments on the 25 chemicals for which it has 
well-characterized toxicity and exposure data. Before EPA can initiate 
risk assessments for the remaining 58 chemicals, the agency will need 
to identify the toxicity and exposure data it needs and then obtain 
them. According to agency officials, to obtain the toxicity data 
needed, EPA may need to promulgate rules to require companies to 
perform additional testing on some of these chemicals. However, EPA 
has not clearly articulated how or when it plans to obtain these 
needed data. Moreover, without exposure-related data, such as those 
potentially available from chemical processors, EPA may still be 
missing the data necessary to conduct risk assessments. 

The type and scope of each of EPA's planned risk assessments are also 
unclear. For the 76 risk assessments in the TSCA Work Plan that EPA 
has yet to initiate, it is not clear what type of risk assessment EPA 
will perform. That is, whether a risk assessment will focus on human 
health, ecological hazards, or both--or how broadly or narrowly 
focused a risk assessment will be in terms of assessing exposure 
scenarios. The type and scope of a risk assessment will, in part, 
affect the risk management options available to EPA--which can include 
a number of alternatives such as requiring special labeling and 
banning or limiting the use of a chemical. More is known about the 
type and scope of the 7 risk assessments EPA has initiated--
particularly the 5 draft assessments released in January 2013. 
Examples are as follows: 

* For two chemicals, EPA produced draft risk assessments that were 
focused on potential ecological hazards from specific chemical uses. 
[Footnote 27] The draft risk assessments indicate a "low concern for 
ecological health." 

* For two chemicals, EPA produced draft risk assessments that were 
focused on the human health hazards to consumers, including bystanders 
and workers, when exposed to these chemicals during paint 
stripping.[Footnote 28] The draft risk assessments identified 
"potential concern for human health under specific exposure scenarios 
for particular uses." 

* For one chemical, EPA produced a draft risk assessment focused on 
human health hazards to consumers, including bystanders and workers, 
from inhalation exposures when the chemical is used as a degreaser or 
a "clear protective coating spray" in the arts and crafts 
field.[Footnote 29] The draft risk assessment identified "potential 
concern for human health under specific exposure scenarios for 
particular uses." 

* For the two chemicals for which EPA has yet to release draft risk 
assessments, EPA plans to focus primarily on releases to the 
environment from the processing and use from metalworking fluids and 
plastics/rubber (PVC) compounding.[Footnote 30] 

It is also not clear where EPA will obtain and who will develop the 
toxicity assessments needed to support its planned risk assessments--
for example, whether IRIS toxicity assessments will be used, in whole 
or in part, or if some other type of assessment will be developed or 
used. According to EPA officials with the Office of Pollution 
Prevention and Toxics, they plan to incorporate information from IRIS 
toxicity assessments to the extent such information is available, 
recent, and relevant. For example, two of the three draft risk 
assessments discussed above that focused on human health hazards 
incorporated information from IRIS toxicity assessments, according to 
agency officials.[Footnote 31] However, as we have reported 
previously,[Footnote 32] IRIS toxicity assessments are not available 
or current for many chemicals, including many of the remaining 
chemicals in the TSCA Work Plan. Officials with the Office of 
Pollution Prevention and Toxics have not requested IRIS assessments 
through the formal IRIS nomination process for any of the 83 chemicals 
prioritized for risk assessment in the TSCA Work Plan but, according 
to IRIS program officials, they are working to find other options for 
assessing toxicity when IRIS assessments are not available, recent, or 
applicable. According to officials with the Office of Pollution 
Prevention and Toxics, they have not requested IRIS assessments for 
these 83 chemicals because IRIS toxicity assessments often take years 
to complete, among other reasons. In addition, these officials noted 
that IRIS assessments are generally used to estimate risks associated 
with continuous exposures to a pollutant in the air or water rather 
than the intermittent exposures that workers and consumers are subject 
to from chemicals contained in products.[Footnote 33] While IRIS 
toxicity assessments are not essential for conducting a risk 
assessment, EPA officials have described IRIS assessments as the 
premier national and international source for qualitative and 
quantitative chemical risk information. In addition, no other federal 
toxicity assessment program has internal and external peer-review 
processes that are as rigorous according to EPA's recent Human Health 
Risk Assessment Strategic Research Action Plan.[Footnote 34] The rigor 
associated with an IRIS assessment may be an important consideration 
in defending regulations that ban or limit the use of a chemical. 

EPA Has Taken Actions That May Discourage the Use of Certain 
Chemicals, but It Is Too Early to Tell Whether These Actions Will 
Reduce Chemical Risk: 

Given the difficulty that EPA has faced in the past using section 6 of 
TSCA to ban existing toxic chemicals or place limits on their 
production or use, EPA officials told us that the agency generally 
considers section 6 authority only after exhausting all other 
available options. As such, since 2009, EPA has taken other actions 
that may discourage the use of certain chemicals by (1) making greater 
use of significant new use rules under section 5 and (2) proposing 
actions that use its TSCA authority in new ways. However, it is too 
early to tell whether some of these actions will reduce chemical risks. 

Our analysis of TSCA rulemaking from 2009 to 2012 shows that EPA has 
quadrupled its issuance of significant new use rules since 2009. From 
2009 to 2012, EPA issued significant new use rules affecting about 540 
chemicals, about 25 percent of all 2,180 chemicals subject to 
significant new use rules issued by EPA since 1976. According to EPA 
officials, for chemicals subject to significant new use rules, EPA 
typically recommends that companies submit testing information when 
they notify EPA of their intent to manufacture or process chemicals 
subject to such rules, which enables EPA to better evaluate the 
potential risks associated with the new use. According to EPA 
officials, this approach allows the agency to "chip away" at chemicals 
that may pose risks to human health and the environment. Such 
recommendations may discourage companies from pursuing new uses of 
existing chemicals that may pose health or environmental risks either 
because testing itself can be expensive, or because the testing 
recommendation suggests that the agency may consider banning or 
limiting the manufacture or production of the chemical on the basis of 
that testing. One industry stakeholder told us that while EPA has not 
directly regulated chemicals through significant new use rules, EPA's 
use of these rules has deterred companies from pursuing new uses of 
these chemicals. 

EPA has also proposed actions that use its TSCA authority in new ways 
and that, according to agency officials, are intended to discourage 
the use of certain chemicals that may pose health or environmental 
risks. However, it is too early to assess the impact of EPA's proposed 
actions because they have yet to be finalized. In addition, in some 
cases, the Office of Management and Budget (OMB) has not met the 
established 90-day time for reviewing EPA's proposed actions--which 
has increased the time frames for finalizing them.[Footnote 35] These 
proposed actions include the following: 

* Creating "Chemicals of concern" list. In May 2010, EPA announced 
that it intended to create a list of chemicals that present or may 
present ''an unreasonable risk of injury to health or the 
environment.'' EPA has had the authority to create such a list under 
section 5 of TSCA since its enactment in 1976 but has never attempted 
to use this authority. EPA submitted the list, which consists of three 
groups of chemicals, for review by OMB in May 2010.[Footnote 36] 
Although the period for OMB review is generally limited by executive 
order to 90 days,[Footnote 37] as of December 2012, EPA's proposed 
"chemicals of concern" list has been under review at OMB for over 900 
days. Stakeholders we interviewed had differing perspectives on EPA's 
proposed use of this list. One said that EPA did not assert clear 
criteria for a chemical's inclusion on the list and that being on the 
list has the effect of blacklisting a chemical and negatively 
impacting the market. Alternatively, another stakeholder we spoke with 
said that the list is analogous to the European Union's candidate 
list, which acts to provide companies sufficient time to respond to 
possible future regulation. The list thus gets the market moving to 
either defend the safety of the chemical or to get the chemical out of 
production. 

* Pairing of test and significant new use rules. In December 2010, EPA 
submitted to OMB for review a proposal to pair testing rules with 
significant new use rules for the first time. Specifically, EPA has 
proposed single rules that combine provisions requiring companies to 
develop toxicity and other data with provisions requiring companies to 
provide data for new uses of chemicals. EPA has proposed using this 
approach in two cases. In one case, for example, EPA proposed this 
approach for certain Polybrominated Diphenyl Ethers (PBDE)--flame 
retardants that are being voluntarily phased out, effective December 
2013. Under the proposed rule, any new use of the chemical after it 
has been phased out would qualify as a significant new use, triggering 
a testing requirement. According to EPA officials, the pairing of 
these types of rules is intended to discourage new uses of certain 
chemicals that may pose a risk to human health or the environment and 
create a disincentive for companies to continue current use of the 
chemical--something EPA has not done before. OMB's review of this 
proposal took 422 days and was completed on February 15, 2012. As of 
January 2013, this rule has yet to be finalized. 

* Extending significant new use rules to articles. Since 2009, EPA has 
made increasing use of its ability to subject chemicals contained in 
certain products, or "articles," such as furniture, textiles, and 
electronics, to significant new use rules. Generally, those who import 
or process a substance as part of a product are exempted from 
compliance with a significant new use rule. EPA's proposals would 
eliminate this exemption for certain chemicals.[Footnote 38] Some 
stakeholders stated that the move to eliminate the article exemption 
for certain chemicals represents an attempt by EPA to regulate 
consumer products, not just the chemical substances they contain. 
Other stakeholders noted that EPA's ability to regulate potentially 
harmful chemicals is diminishing given their increased production 
outside of the United States, and that an increasing focus on articles 
allows EPA to minimize exposure to potentially harmful chemicals by 
targeting chemicals in imports as part of consumer products.[Footnote 
39] 

EPA Has Expanded Public Access to Some Chemical Information: 

EPA has made progress in expanding public access to some chemical 
information--which according to EPA documents is an important 
underpinning of a credible chemical management program. When 
information is claimed as confidential business information, it limits 
EPA's ability to share it with state environmental agencies and 
foreign governments, which potentially limits the effectiveness of 
these organizations' environmental risk programs. Since 2009, EPA has 
made 617 formerly confidential chemical identities public.[Footnote 
40] By reviewing past claims of confidentiality and comparing them 
with more current reporting--such as reporting of periodic production 
and use data--EPA was able to identify chemicals for which companies 
were no longer making confidentiality claims. Since 2009, EPA has also 
made 783 previously unavailable health and safety filings available to 
the public after reviewing approximately 15,500 such filings.[Footnote 
41] In addition, EPA issued new policies regarding how it handles 
confidentiality claims and, according to EPA officials, has begun 
reviewing and challenging new confidentiality claims--including claims 
associated with chemical identity information listed on the TSCA 
inventory and in health and safety studies.[Footnote 42] Further, as 
part of the 2011 Chemical Data Reporting rule, EPA included new 
upfront substantiation requirements for CBI claims related to 
processing and use information. According to EPA, the change has 
resulted in significantly decreased CBI claims for those data. 

It Is Unclear Whether EPA's New Approach Will Position the Agency to 
Achieve Its Goal of Ensuring the Safety of Chemicals: 

It is unclear whether EPA's new approach to managing chemicals within 
its existing TSCA authorities will position the agency to achieve its 
goal of ensuring the safety of chemicals. EPA officials have said that 
the agency's new approach, initiated in 2009 and summarized in its 
2012 Existing Chemicals Program Strategy, is intended to guide EPA's 
efforts to assess and control chemicals in the coming years. However, 
EPA's strategy, which largely focuses on describing activities EPA has 
already begun, does not discuss how it will address challenges that 
might impede its goal of ensuring chemical safety. Specifically, and 
as detailed in the list that follows, EPA's strategy does not discuss 
challenges associated with (1) obtaining toxicity and exposure data; 
(2) identifying the resources needed to execute EPA's new approach; 
and (3) banning or limiting the use of chemicals, given the agency's 
past difficulties with taking such actions. 

* Obtaining toxicity and exposure data. EPA's strategy does not 
discuss how the agency will meet the challenge of obtaining the 
toxicity and exposure data it will need for conducting risk 
assessments for all 83 chemicals in its TSCA Work Plan. As discussed 
previously, EPA has not broadly sought toxicity and exposure data that 
companies submit to the European Chemicals Agency or exposure-related 
data from chemical processors and instead plans to obtain these data, 
as needed, on a case-by-case basis from chemical companies. However, 
the agency's strategy does not discuss how EPA would execute these 
plans or how the data obtained would be used to inform its ongoing or 
future risk assessment activities, if at all. 

* Identifying the resources needed. EPA's strategy does not include a 
description of the resources needed to meet its goal of ensuring 
chemical safety. For example, EPA's strategy does not include a 
description of the resources needed to carry out risk assessment 
activities, even though risk assessment is a central part of EPA's 
effort to manage chemicals under its new approach. Specifically, EPA 
does not identify roles and responsibilities of key staff or offices--
for example which office within EPA will develop the toxicity 
assessments needed to support its planned risk assessments--or 
identify staffing levels or cost associated with conducting its risk 
assessment activities. In response to our questions regarding 
resources, EPA officials provided us with an estimate of the staffing 
levels and contract support costs needed to conduct its first 7 risk 
assessments; however, EPA does not include this or any other 
information regarding staffing levels or cost in its strategy. 
[Footnote 43] As discussed previously, at its current pace--which it 
may not be able to sustain--it will take more than a decade for EPA to 
complete the 83 risk assessments it has identified in its TSCA Work 
Plan. However, EPA officials were unable to tell us--and EPA strategy 
does not discuss--whether the agency has the capacity to accelerate 
the pace of its risk assessment activities. Further, the plan does not 
discuss how EPA will keep pace with the introduction of approximately 
600 new chemicals each year, some of which may require risk 
assessments to determine whether they pose risks to health or the 
environment. Without a clear understanding of the resources needed to 
complete risk assessments and other activities identified in its 
strategy, EPA cannot be certain that its current funding and staffing 
levels are sufficient to execute its new approach to managing 
chemicals under existing TSCA authorities. 

* Banning or limiting the use of chemicals. EPA's strategy also does 
not discuss how it will address specific regulatory challenges that 
might impede the agency's ability to meet its goal of ensuring 
chemical safety. According to EPA officials, to demonstrate that a 
chemical presents or will present an unreasonable risk of injury to 
health or the environment--which would be required before EPA could 
ban or limit the chemical under section 6 of TSCA--EPA must develop or 
obtain toxicity and exposure data and then conduct a risk assessment. 
However, EPA officials told us that, even if EPA has substantial 
toxicity and exposure data and wants to protect the public against 
known risks, the agency is challenged in meeting the statutory 
requirement under TSCA to limit or ban chemicals. While agency 
planning documents related to EPA's new approach state that it would 
consider using its authority under section 6 of TSCA to limit or ban 
the use of some chemicals, EPA has yet to publicly take steps toward 
that end and has not articulated, in its strategy or elsewhere, how it 
would overcome the regulatory challenges it experienced in the past. 
As discussed previously, EPA officials told us that they would 
consider using the agency's authority under section 6 only after 
exhausting all other available options, but EPA's strategy does not 
discuss what other options the agency plans to pursue--for example, 
whether it plans to continue to rely on significant new use rules 
under section 5 of TSCA to discourage the use of certain chemicals. As 
a result, EPA cannot be assured that its new approach best positions 
the agency to ensure the safety of chemicals. 

We have previously reported[Footnote 44] that, when developing new 
initiatives, agencies can benefit from following leading practices for 
federal strategic planning.[Footnote 45] Of these leading practices, 
it is particularly important for agencies to define strategies that 
address management challenges that threaten their ability to meet long-
term goals.[Footnote 46] Without a plan that incorporates leading 
strategic planning practices--particularly a plan that clearly 
articulates how EPA will address management challenges--EPA cannot be 
assured that it its new approach to managing chemicals, as described 
in its Existing Chemicals Program Strategy, will provide a framework 
to effectively guide its efforts. Consequently, EPA could be investing 
valuable resources, time, and effort without being certain that its 
efforts will bring the agency closer to achieving its goal of ensuring 
the safety of chemicals. 

Conclusions: 

Since 2009, EPA has made progress implementing its new approach to 
managing toxic chemicals under its existing TSCA authority--
particularly by increasing efforts to obtain toxicity and exposure 
data. However, due to requirements under TSCA that place the burden of 
developing toxicity data on EPA, rather than industry, and because 
promulgating the rules needed to obtain toxicity data from companies 
can take years to finalize, and additional time for companies to 
execute, EPA has yet to obtain much of the toxicity data it has been 
seeking. Also, EPA is in the process of analyzing exposure-related 
data it received in August 2012 and, therefore, is not yet in a 
position to use them to identify additional data collection needs or 
identify chemicals that may warrant further review or risk assessment. 
Moreover, while EPA's toxicity and exposure data collection efforts 
may be useful for identifying chemicals that are potentially harmful, 
it is unclear whether these data will be sufficient for conducting a 
risk assessment. According to EPA officials, EPA needs both toxicity 
and exposure data to conduct a risk assessment in order to demonstrate 
that a chemical presents or will present an unreasonable risk of 
injury to health or the environment--which would be required before 
EPA could ban or limit the use of a chemical under TSCA. 

Even with the steps it has taken since 2009 to increase the toxicity 
and exposure data it collects, EPA has not pursued all opportunities 
to obtain chemical data. In particular, EPA has not sought (1) 
toxicity and exposure data that companies submit to the European 
Chemicals Agency or (2) generally pursued exposure-related data from 
chemical processors. That is, EPA has not pursued a formal agreement 
with the European Community or used its authority to promulgate rules 
under TSCA section 8 to require chemical companies to report chemical 
toxicity and exposure-related data they have submitted to the European 
Chemicals Agency. EPA has also not promulgated rules under TSCA 
section 8 to require chemical companies to report exposure-related 
data from processors to EPA. EPA officials said that they recognized 
that rules under section 8 of TSCA could be fashioned in such a way as 
to establish general access to information while also providing EPA 
with the flexibility to request the information as needed--but were 
considering a different approach. Agency officials told us that they 
have considered using EPA's subpoena authority under TSCA section 
11(c) to obtain the information--which is an approach EPA has not 
frequently used before. Regardless of the mechanism used, without 
access to the data that companies have submitted to the European 
Chemicals Agency and by not pursuing exposure-related data from 
processors, EPA is missing an opportunity to collect data that it has 
identified as an essential part of assessing chemical risk and future 
chemical regulation. 

It is unclear whether EPA's new approach to managing chemicals within 
its existing TSCA authorities will position the agency to achieve its 
goal of ensuring the safety of chemicals because EPA has not clearly 
articulated how its strategy will address challenges that threaten an 
agency's ability to meet its goal--particularly, challenges associated 
with obtaining toxicity and exposure data needed for risk assessments 
and with EPA's ability to ban or limit the use of chemicals, given the 
agency's past difficulties with taking such actions. EPA officials 
have said that the agency's approach, summarized in its 2012 Existing 
Chemicals Program Strategy, is intended to guide EPA's efforts to 
assess and control chemicals in the coming years. However, EPA's 
strategy does not include leading federal strategic planning 
practices, such as defining strategies for addressing management 
challenges that might help the agency achieve its goal of ensuring the 
safety of chemicals. For example, EPA's strategy does not address 
challenges associated with (1) obtaining toxicity and exposure data 
for the 58 TSCA Work Plan chemicals for which it currently needs such 
data, (2) gaining access to toxicity and exposure data provided to the 
European Chemicals Agency, (3) working with processors and processor 
associations to obtain exposure-related data, (4) addressing specific 
regulatory challenges with banning or limiting the use of chemicals 
under section 6 of TSCA, and (5) identifying the resources needed to 
achieve its goal. 

It is worth noting that many of the challenges that EPA faces are 
rooted in TSCA's regulatory framework. In our past reports, we have 
suggested that Congress consider making statutory changes to 
strengthen EPA's authority to obtain toxicity information from the 
chemical industry and establish a framework for taking action that is 
less burdensome for EPA; in addition, we have identified a number of 
options that could strengthen EPA's ability to regulate harmful 
chemicals under TSCA. Until Congress passes any such legislation, 
however, EPA can do more to improve its current effort to help bring 
the agency closer to achieving its goal of ensuring the safety of 
chemicals. 

Recommendations for Executive Action: 

To better position EPA to collect chemical toxicity and exposure-
related data and ensure chemical safety under existing TSCA authority, 
while balancing its workload, we are recommending that the 
Administrator of EPA take the following three actions: 

* Consider promulgating a rule under TSCA section 8, or take action 
under another section, as appropriate, to require chemical companies 
to report chemical toxicity and exposure-related data they have 
submitted to the European Chemicals Agency. 

* Consider promulgating a rule under TSCA section 8, or take action 
under another section, as appropriate, to require chemical companies 
to report exposure-related data from processors to EPA. 

* To better position EPA to ensure chemical safety under existing TSCA 
authority, direct the appropriate offices to develop strategies for 
addressing challenges that impede the agency's ability to meet its 
goal of ensuring chemical safety. At a minimum, the strategies should 
address challenges associated with: 

* obtaining toxicity and exposure data needed to conduct ongoing and 
future TSCA Work Plan risk assessments, 

* gaining access to toxicity and exposure data provided to the 
European Chemicals Agency, 

* working with processors and processor associations to obtain 
exposure-related data, 

* banning or limiting the use of chemicals under section 6 of TSCA and 
planned actions for overcoming these challenges--including a 
description of other actions the agency plans to pursue in lieu of 
banning or limiting the use of chemicals, and: 

* identifying the resources needed to conduct risk assessments and 
implement risk management decisions in order to meet its goal of 
ensuring chemical safety. 

Agency Comments and Our Evaluation: 

We provided a draft of this report to the Environmental Protection 
Agency for their review and comment. We received written comments from 
the Acting Assistant Administrator of EPA's Office of Chemical Safety 
and Pollution Prevention. These comments and our detailed response to 
them are presented in appendix II. EPA also provided technical 
comments, which we incorporated into the report as appropriate. 

In its written comments, EPA neither agreed nor disagreed with our 
findings and recommendations and instead stated that it appreciated 
the intent of our recommendations and will consider them as it further 
develops and implements the TSCA program. However, based on the 
comments the agency provided, it is unclear whether EPA intends to 
take any action toward implementing our recommendations. Specifically, 
it is unclear whether EPA plans to address our recommendations that 
the agency consider promulgating rules under TSCA section 8, or take 
action under another section, as appropriate, to require chemical 
companies (1) to report chemical toxicity and exposure-related data 
they have submitted to the European Chemicals Agency and (2) to report 
exposure-related data from processors to EPA. In its written comments, 
EPA states that it intends to pursue data submitted to the European 
Chemicals Agency from U.S. companies using voluntary or regulatory 
means as necessary but does not provide information on its planned 
approach to pursue such data. Consequently, the extent to which EPA 
plans to continue to rely on voluntary efforts to obtain the needed 
data is unclear. For example, it is not clear whether EPA intends to 
first ask companies to voluntarily comply with their data request and 
then, if that does not yield data, pursue regulatory action. In 
addition, it is unclear whether continuing to rely on voluntary 
efforts will provide the agency with timely access to needed data. As 
we noted in our report, EPA officials have recognized that rules under 
section 8 of TSCA could be fashioned in such a way as to establish 
general access to information while providing EPA with the flexibility 
to request the information as needed. 

In addition, with regard to obtaining data from chemical processors, 
in its written comments, EPA states that downstream chemical 
processors have little exposure-relevant data--which suggests that it 
does not intend to implement that recommendation. This position, 
however, conflicts with previous statements by EPA officials and EPA's 
principles for TSCA reform, which state that, "EPA's authority to 
require submission of use and exposure information should extend to 
downstream processors…" In addition, EPA officials told us that data 
from downstream processors would provide the agency with a better 
understanding of potential exposure to chemicals, for example, 
chemical exposure from consumer products such as those designed for 
children. EPA officials also told us that these data are necessary to 
conduct chemical risk assessments and make risk management decisions 
on potentially harmful chemicals. In its written comments, EPA also 
states that the use of section 8 requires a lengthy and resource 
intensive rulemaking process. However, as previously noted, EPA 
officials have recognized that a rule under section 8 of TSCA could be 
promulgated to require chemical companies to report exposure-related 
data while also providing EPA with the flexibility to request the data 
as needed. In this way, should EPA identify a need for information 
from downstream processors, EPA would not have to go through the 
lengthy rulemaking process multiple times. 

Regarding our recommendation to develop strategies for addressing 
challenges associated with obtaining toxicity and exposure data needed 
for risk assessments, and with EPA's ability to meet its goal of 
ensuring chemical safety, it is also unclear what action, if any, EPA 
intends to pursue. In its written comments, the agency states that it 
will not be able to meet the goal of ensuring chemical safety now and 
into the future without legislative reform and, until then, EPA plans 
to utilize its Existing Chemicals Program Strategy. However, as 
discussed in this report, EPA's Existing Chemicals Program Strategy, 
which largely focuses on describing activities the agency is already 
undertaking and is therefore backward-looking, does not provide the 
framework needed to guide EPA's efforts into the future. We recognize 
that many of the challenges that EPA faces are rooted in TSCA but 
continue to believe that, without a plan that incorporates leading 
strategic planning practices--particularly a plan that clearly 
articulates how EPA will address management challenges--EPA cannot be 
assured that it its new approach to managing chemicals will provide a 
framework to effectively guide its efforts. Consequently, EPA could be 
investing valuable resources, time, and effort without being certain 
that its investments will bring the agency closer to achieving its 
goal of ensuring the safety of chemicals. 

As agreed with your offices, unless you publicly announce the contents 
of this report earlier, we plan no further distribution until 30 days 
from the report date. At that time, we will send copies to the 
Administrator of EPA, the appropriate congressional committees, and 
other interested parties. In addition, the report will be available at 
no charge on the GAO website at [hyperlink, http://www.gao.gov]. 

If you or your staff members have questions regarding this report, 
please contact me at (202) 512-3841 or trimbled@gao.gov. Contact 
points for our Offices of Congressional Relations and Public Affairs 
may be found on the last page of this report. GAO staff who made major 
contributions to this report are listed in appendix III. 

Signed by: 

David C. Trimble 
Director, Natural Resources and Environment: 

[End of section] 

Appendix I: Scope and Methodology: 

This report focuses on the Environmental Protection Agency's (EPA) 
management of chemicals within the limits of its existing authorities 
under the Toxic Substances Control Act (TSCA). Our objectives were to 
determine the extent to which (1) EPA has made progress implementing 
its new approach to managing toxic chemicals under its existing TSCA 
authority, and (2) EPA's new approach positions the agency to achieve 
its goal of ensuring the safety of chemicals. 

To determine the extent to which EPA has made progress implementing 
its new approach to managing toxic chemicals under its existing TSCA 
authority, we focused on EPA's new initiatives to manage chemicals 
beginning in September 2009.This was the date that EPA's Administrator 
announced that the agency was pursuing a comprehensive approach to 
enhance EPA's current chemicals management program within the limits 
of existing authorities. We identified and reviewed documents 
associated with activities that EPA identified as being part of its 
new approach, including the agency's Chemical Action Plans for 10 
chemicals or chemical categories, its February 2012 Existing Chemicals 
Program Strategy, and March 2012 TSCA Work Plan and associated TSCA 
Work Plan Methods document. We also reviewed documents, including 
Federal Register Notices, and interviewed agency officials, with 
respect to EPA's efforts to obtain test data for High Production 
Volume Challenge chemicals. We reviewed applicable legislation, 
including the relevant sections of TSCA; relevant federal regulations; 
and EPA's policies and procedures on EPA's existing and new chemical 
programs. We analyzed TSCA rulemaking trends from January 2001 through 
October 2012. We selected this time frame to include a time period 
prior to and after the announcement of EPA's new approach to managing 
chemicals to see how rulemaking changed over this time period. In our 
report, we only present findings from 2009 to 2012 when the majority 
of the rulemaking activity took place. To identify TSCA rules that 
were issued, we searched online sources, including Federal Register 
Notices and the information available from the Office of Management 
and Budget (OMB), Office of Information and Regulatory Affairs (OIRA). 
We then analyzed proposed, final, and direct final rules exclusive of 
rule revocations, technical modifications, and withdrawals for 
rulemakings deriving from the implementation of Title I of TSCA. We 
excluded rules deriving from the implementation of other titles of 
TSCA from this rulemaking analysis as they derive from separate 
provisions or later amendments to TSCA; they are chemical-specific 
provisions that have specific rulemaking requirements and deadlines. 
From the list of identified TSCA rules, we determined frequencies of 
TSCA rulemaking by TSCA section; for example, we determined the number 
of proposed and final significant new use rules under TSCA section 5, 
as well as the number of chemicals subject to these rules. We also 
analyzed such frequencies before and after 2009, which was when EPA 
announced its new approach to managing chemicals. As part of our 
rulemaking analysis, we also examined EPA's Action Development Process 
(ADP) and interviewed officials from EPA's Office of Policy, Office of 
Chemical Safety and Pollution Prevention (OCSPP), and Office of 
Pollution Prevention and Toxics (OPPT) on how individual TSCA rules 
are developed. We obtained and reviewed EPA's regulatory plans and 
agendas from 2011, to determine if TSCA rules were expected to be 
issued in proposed or final form during this period. We also reviewed 
Executive Order 12866 to characterize EPA's and OMB's processes for 
submitting and reviewing TSCA rules, respectively. In addition, we 
reviewed EPA's efforts, through discussions with EPA officials, and by 
reviewing recently issued policies, on confidential business 
information claims. 

To determine the extent to which EPA's new approach positions the 
agency to achieve its goal of ensuring the safety of chemicals, we 
reviewed EPA's Existing Chemical Program Strategy , which EPA 
identified as the document that it intends to use to guide its current 
and future efforts, and compared it against leading practices in 
federal strategic planning, which include practices such as developing 
strategies to address challenges that may threaten the agency ability 
to achieve its goal including identifying the resources needed to 
achieve agency goals.[Footnote 47] To further characterize how EPA is 
positioning itself to assess and control chemicals, we asked EPA 
officials to describe expected outcomes from EPA's recent rulemakings, 
for example, the extent to which TSCA rules would position EPA to 
obtain chemical data and reduce chemical risks. We also obtained 
documents and interviewed EPA officials on the agency's processes for 
screening existing chemicals to identify those requiring further 
review or a risk assessment. We also requested and obtained 
information on EPA's resource levels to carry out this work--
particularly related to the resources required to conduct risk 
assessments identified in its TSCA Work Plan. We reviewed EPA 
estimates on the costs and staff levels for performing such risk 
assessments. 

For both objectives, we interviewed officials with EPA's Office of 
Chemical Safety and Pollution Prevention, including its Office of 
Pollution Prevention and Toxics (OPPT), the office with primary 
responsibility for implementing TSCA, regarding EPA's efforts to 
manage chemicals. Specifically, we interviewed officials across OPPT's 
divisions about how EPA obtains chemical data, analyzes existing 
chemicals, and conducts risk assessments, as well as agency reviews of 
new chemicals and new uses of existing chemicals, reviews of claims of 
confidential business information, and the process of promulgating 
rules under TSCA. We also interviewed officials from EPA's Office of 
Research and Development relating to EPA's development and use of new 
analytical methods and tools. In addition, we interviewed 
representatives from industry, including the American Chemistry 
Council (a national chemical manufacturers association); the Society 
of Chemical Manufacturers and Affiliates (a national, specialty 
chemical manufacturers association); American Fuel & Petrochemical 
Manufacturers (a trade association representing high-tech American 
fuel manufacturers); Consumer Specialty Products Association (a trade 
association representing companies manufacturing various cleaning 
products); Bergeson & Campbell, P.C. (a law firm that represents 
chemical manufacturers); and Greenwood Environmental Counsel (a law 
firm). We also interviewed other stakeholder groups, including the 
Environmental Defense Fund (a national, nonprofit environmental 
advocacy organization); Safer Chemicals, Healthy Families (a coalition 
of individuals, health professionals, advocates for people with 
learning and developmental disabilities, reproductive health 
advocates, environmentalists and businesses); and the Environmental 
Law Institute (a nonpartisan research and education center working to 
strengthen environmental protection by improving law and governance 
worldwide. We selected these stakeholder groups based on discussions 
with other stakeholders and our prior work on TSCA.[Footnote 48] We 
sought to achieve a balance of perspectives between groups 
representing industry and those representing the environment. 

To assess the reliability of EPA's data related to the types and 
numbers of TSCA rules promulgated, data from EPA on rules under OMB 
review over 90 days, and data on the number of chemicals regulated 
under TSCA and the number of chemicals under assessment, we reviewed 
relevant documents and interviewed knowledgeable agency officials. We 
worked with the EPA to ensure that we had the most updated data and, 
in consultation with the EPA officials, revised the numbers of 
chemicals listed for commercial use under TSCA and the numbers of 
filings to reflect the most updated numbers. Based on this review and 
our discussions with the EPA officials, we concluded that the data 
were sufficiently reliable for the purposes of reporting on rulemaking 
trends and the numbers of chemicals listed with EPA for commercial use 
as authorized under TSCA. 

We conducted this performance audit from December 2011 to March 2013 
in accordance with generally accepted government auditing standards. 
Those standards require that we plan and perform the audit to obtain 
sufficient, appropriate evidence to provide a reasonable basis for our 
findings and conclusions based on our audit objectives. We believe 
that the evidence obtained provides a reasonable basis for our 
findings and conclusions based on our audit objectives. 

[End of section] 

Appendix II: Comments from the Environmental Protection Agency: 

Note: GAO comments supplementing those in the report text appear at 
the end of this appendix. 

United States Environmental Protection Agency: 
Office of Chemical Safety and Pollution Prevention: 
Washington, DC 20460: 

March 13, 2013: 

Mr. David C. Trimble: 
Director, Natural Resources and Environment: 
Government Accountability Office:
Washington, DC 20548: 

Dear Mr. Trimble: 

Thank you for the opportunity to comment on the draft report entitled 
"EPA Has Increased Efforts to Address and Control Chemicals but Could 
Strengthen Its Approach (GAO-13-249)." Our comments include input from 
other relevant parts of the Environmental Protection Agency (EPA). 
Below are our general comments on the report and its recommendations. 
Our technical comments will be sent via email to your staff. 

We appreciate the significant amount of time GAO staff spent on this 
audit, and their efforts to learn the intricacies of the Toxic 
Substances Control Act (TSCA) and the associated EPA program that 
implements the statute. The report, in general, does a good job of 
reflecting the challenges EPA faces in implementing TSCA. We also 
appreciate that the report recognizes the Agency's efforts over the 
past few years to strengthen our existing chemicals program and make 
information on chemicals more readily available. As the report 
indicates, it may take some time before the results of our efforts 
come into fruition and can truly be evaluated. 

EPA appreciates the intent of GAO's recommendations with respect to 
improving the chemicals program under the current TSCA legislative 
framework, and we will consider them as we further develop and 
implement the program. We must emphasize, however, that EPA cannot be 
fully successful in ensuring the safety of chemicals absent statutory 
reform, for reasons discussed by GAO in previous reports and as 
addressed by the Administration's principles for TSCA reform. 

Recommendations: 

(EPA should) Consider promulgating a rule under TSCA Section 8, or 
take action under another section, as appropriate, to require chemical 
companies to report chemical toxicity and exposure-related data they 
have submitted to the European Chemicals Agency, The EPA agrees that 
duplicative testing of chemicals should be avoided and existing, valid 
data be reviewed and used whenever possible. As our technical comments 
reflect, we do not believe the report adequately addresses the efforts 
EPA has made to work with the European Chemicals Agency to receive 
chemical data, or the challenges that we have faced in doing so. I 
assure you that as the EPA identifies needs for REACH-generated data 
(e.g., for use in risk assessments, for use in screening and 
prioritization), the Agency intends to pursue obtaining these data 
from U.S. companies using voluntary or regulatory means as necessary. 
[See comment 1] 

(EPA should) Consider promulgating a rule under TSCA section 8, or 
take action under another section, as appropriate, to require chemical 
companies to report exposure-related data from processors to EPA. 

The EPA agrees that obtaining current, valid information on the use 
of, and exposure to, chemicals "downstream" from chemical 
manufacturers and processors is a significant challenge. While TSCA 
does provide EPA with the authority to require data from processors, 
these entities are not always the end users of chemicals or those 
which incorporate them into commercial or consumer products. Those 
companies that are end users of chemicals or incorporate them into 
products often have little exposure-relevant data. Also, as with other 
data gathering authorities under TSCA, use of section 8 requires a 
lengthy and resource intensive rule-making process. The EPA is, 
nonetheless, committed to working toward improving the quality and 
quantity of use and exposure information available to it for chemical 
assessment and, as specific needs are identified, will consider both 
voluntary and regulatory means as necessary. Earlier this year, EPA 
made public the 2012 Chemical Data Reporting (CDR) information that 
contains comprehensive use and exposure information on more than 7500 
of the most widely used chemicals in the U.S. Companies are now 
required to provide information on chemicals used in children's and 
other consumer products, along with reports on commercial applications 
and industrial uses of chemicals. This information will help EPA and 
others better assess chemicals, evaluate potential exposures and use, 
and expand efforts to encourage the use of safer chemicals. [See 
comment 2] 

To better position EPA to ensure chemical safety under existing TSCA 
authority, direct the appropriate offices to develop strategies for 
addressing challenges that impede the agency's ability to meet its 
goal of ensuring chemical safety. 

As the report notes, "many of the challenges that EPA faces are rooted 
in TSCA's regulatory framework" and, in past reports, GAO has 
suggested that Congress consider making statutory changes to 
strengthen EPA's authority to obtain information from the chemical 
industry and establish a framework for taking action that is less 
burdensome for EPA. It is EPA's position that, absent such statutory 
changes, the Agency will not be able to successfully meet the goal of 
ensuring chemical safety now and into the future. The Administration's 
principles for TSCA reform reflect the basic changes that we believe 
are necessary to a fully successful program. Change is needed in every 
significant aspect of the program which GAO has addressed in this and 
previous reports. Strategic planning is a useful exercise, but cannot 
substitute for the basic authorities needed for a modem, effective 
chemicals program. However, until legislative reform takes place, EPA 
developed and is utilizing an Existing Chemicals Strategy that 
outlines the Agency's comprehensive approach for prioritizing 
chemicals for risk assessment and risk reduction, increasing the 
public's access to chemical data and information, and advancing 
innovation for safer products and green chemistry. This effort 
includes the development of a TSCA Work Plan of chemicals for risk 
assessment development over the coming years, further targeting the 
agency's efforts on existing chemicals. Following stakeholder 
engagement, EPA released the Work Plan in March 2012, and identified 
seven chemicals for risk assessment in 2012. In June, 2012, the agency 
identified 18 chemicals slated for risk assessment in 2013 and 2014. 
[See comment 3] 

The Agency remains committed to continuing improvement of the TSCA 
program implemented under the current statutory framework and will 
continue to develop and implement the most effective approaches 
possible given our current statutory and resource limitations. If you 
have any questions or concerns regarding our comments, we would be 
pleased to meet with you prior to GAO finalizing this report. Please 
feel free to contact me or Janet Weiner of my staff at 202564-2309 if 
there is any additional follow up required. 

Sincerely, 

Signed by: 
Louise P. Wise, for: 
James J. Jones: 
Acting Assistant Administrator: 

The following are GAO’s comments on the letter from the Environmental 
Protection Agency dated March 13, 2013. 

GAO Comments: 

1. According to EPA officials, EPA has an agreement for cooperation 
and sharing of information (referred to as a Statement of Intent) with 
the European Chemicals Agency. EPA had hoped that this agreement would 
allow for the sharing of detailed studies beyond the summaries that 
the European Chemicals Agency makes publicly available. However, the 
European Union’s chemicals legislation requires a formal agreement be 
concluded between the European Community and the foreign government 
before the European Chemicals Agency may share information it receives 
from chemical companies, and EPA has not pursued such an agreement. 
While EPA has stated that the agency intends to pursue these data from 
U.S. companies using voluntary or regulatory means, as necessary, and 
notes that it has solicited and received some such data, EPA has yet 
to pursue comprehensive action. As we noted in our report, EPA 
officials have recognized that rules under section 8 of TSCA could be 
fashioned in such a way as to establish general access to information 
while also providing EPA with the flexibility to request the 
information as needed. 

2. We recognize that rulemaking is a long and resource-intensive 
process but as previously noted, EPA officials have recognized that 
EPA could promulgate rules under section 8 of TSCA to require chemical 
companies to report exposure-related data while also providing EPA 
with the flexibility to request the information as needed. In this 
way, EPA would not have to go through the lengthy rulemaking process 
each time it identifies a need for information from downstream 
processors. In addition, it is unclear why EPA has stated that 
downstream chemical processors have little exposure-relevant data. 
This position conflicts with previous statements by EPA officials and 
EPA’s principles for TSCA reform, which state that, “EPA’s authority 
to require submission of use and exposure information should extend to 
downstream processors...” In addition, EPA officials told us that data 
from downstream processors would provide the agency with a better 
understanding of potential exposure to chemicals, for example, from 
consumer products such as those designed for children. EPA officials 
also told us that these data are necessary to conduct chemical risk 
assessments and make risk management decisions on potentially harmful 
chemicals. 

3. We do not believe that EPA’s Existing Chemicals Program Strategy, 
which largely focuses on describing activities EPA has already begun 
and is therefore backward-looking, provides the framework needed to 
guide EPA’s efforts into the future. We recognize that many of the 
challenges that EPA faces are rooted in TSCA but continue to believe 
that, without a plan that incorporates leading strategic planning 
practices—particularly a plan that clearly articulates how EPA will 
address management challenges—EPA cannot be assured that it its new 
approach to managing chemicals will provide a framework to effectively 
guide its efforts. Consequently, EPA could be investing valuable 
resources, time, and effort without being certain that its efforts 
will bring the agency closer to achieving its goal of ensuring the 
safety of chemicals. 

[End of section] 

Appendix III: GAO Contact and Staff Acknowledgments: 

GAO Contact: 

David C. Trimble, (202) 512-3841 or trimbled@gao.gov: 

Staff Acknowledgments: 

In addition to the individual named above, Diane LoFaro, Assistant 
Director; Antoinette Capaccio; Irina Carnevale; Pamela Davidson; Les 
Mahagan; Alison O'Neill; Aaron Shiffrin; and Kiki Theodoropoulos made 
key contributions to this report. Richard Johnson also made important 
contributions. 

[End of section] 

Related GAO Products: 

Chemical Regulation: Observations on Improving the Toxic Substances 
Control Act. [hyperlink, http://www.gao.gov/products/GAO-10-292T]. 
Washington, D.C.: December 2, 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. 

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 Regulation: Comparison of U.S. and Recently Enacted European 
Union Approaches to Protect against the Risks of Toxic Chemical. 
[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: Approaches in the United States, Canada, and the 
European Union. [hyperlink, http://www.gao.gov/products/GAO-06-217R]. 
Washington, D.C.: November 4, 2005. 

Chemical Regulation: Options Exist to Improve EPA's Ability to Assess 
Health Risks and Manage Its Chemical Review Program. [hyperlink, 
http://www.gao.gov/products/GAO-05-458]. Washington, D.C.: June 13, 
2005. 

Toxic Substances: EPA Should Focus Its Chemical Use Inventory on 
Suspected Harmful Substances. [hyperlink, 
http://www.gao.gov/products/GAO/RCED-95-165]. Washington, D.C.: July 
7, 1995. 

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. 

Toxic Substances: EPA's Chemical Testing Program Has Not Resolved 
Safety Concern. [hyperlink, 
http://www.gao.gov/products/GAO/RCED-91-136]. Washington, D.C.: June 
19, 1991. 

Toxic Substances: EPA's Chemical Testing Program Has Made Little 
Progress. [hyperlink, http://www.gao.gov/products/GAO/RCED-90-112]. 
Washington, D.C.: April 25, 1990. 

EPA's Efforts To Identify and Control Harmful Chemicals in Use. 
[hyperlink, http://www.gao.gov/products/GAO/RCED-84-100]. Washington, 
D.C.: June 13, 1984. 

[End of section] 

Footnotes: 

[1] Processing refers to the preparation of a chemical substance or 
mixture, after its manufacture, for distribution in commerce. 

[2] Excluded substances include certain nuclear materials, pesticides, 
food, food additives, tobacco, drugs, and cosmetics. 

[3] Throughout this report, we use the phrase "chemical companies" to 
refer generally to companies that manufacture, import, process, 
distribute in commerce, use, or dispose of chemicals regulated under 
TSCA. When it is important to differentiate between, for example, 
manufacturers and processors, we specify the type of company to which 
we are referring. 

[4] Toxicity represents the degree to which a chemical is harmful. In 
this report, the terms toxicity and hazard are used synonymously. 
Exposure represents the magnitude, frequency, and duration of contact 
with a chemical. 

[5] 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), 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). 

[6] [hyperlink, http://www.gao.gov/products/GAO-05-458]. 

[7] GAO, High-Risk Series: An Update. [hyperlink, 
http://www.gao.gov/products/GAO-09-271] (Washington, D.C.: Jan. 22, 
2009). 

[8] We have reported on EPA's difficulty producing timely, credible 
IRIS assessments, which contributed to our decision in 2009 to add 
EPA's processes for assessing and controlling chemicals to our list of 
areas at high risk for waste, fraud, abuse, and mismanagement or in 
need of broad-based transformation. 

[9] [hyperlink, http://www.gao.gov/products/GAO-05-458]. 

[10] Companies are not required to submit new notices if any 
information provided in the original notice changes. 

[11] [hyperlink, http://www.gao.gov/products/GAO-05-458]. 

[12] Of the over 84,000 chemicals currently on the TSCA inventory, 
approximately 8,000 chemicals are produced at annual volumes of 25,000 
pounds or greater. TSCA requires EPA to compile, keep current, and 
publish a list of each chemical substance that is manufactured or 
processed in the United States. 

[13] EPA came to this conclusion after reviewing over 100 studies of 
the health risks of asbestos, as well as public comments on the 
proposed rule. 

[14] Existing chemicals listed on the TSCA inventory are composed of 
approximately 62,000 that were in commerce in 1979 when EPA began 
reviewing chemicals and 22,000 chemicals that were listed for 
commercial use after 1979. Under EPA's periodic chemical data 
reporting rules, approximately 8,000 chemicals are reported as being 
produced or imported at annual volumes of 25,000 pounds or greater 
but, for the remaining 76,000 chemicals on the inventory, EPA does not 
know how many are currently in commerce. 

[15] Final rules are located at 40 C.F.R. §§ 799.5087 and 799.5089 
(2012). The proposed rule is located at 76 Fed. Reg. 65580 (Oct. 21, 
2011). 

[16] In addition to promulgating test rules, EPA told us that it has 
required testing for an additional 68 chemicals in enforceable consent 
agreements. 

[17] Under the 1998 High Production Volume (HPV) challenge program, 
EPA asked chemical companies to sponsor chemicals that were 
manufactured in or imported into the United States in quantities 
greater than 1 million pounds per year--at the time, 2,800 chemicals--
and voluntarily provide existing toxicity data and, if data did not 
exist, conduct testing and provide EPA with the resulting data. 
Companies sponsored more than 2,200 HPV chemicals. 

[18] The data set sought by EPA is known as the Screening Information 
Data Set, and was developed by the Organization for Economic 
Cooperation and Development. The data set provides an internationally 
agreed upon set of test data for screening high-production volume 
chemicals for human and environmental hazards, and it is intended to 
allow the EPA and others to make an informed, preliminary judgment 
about the hazards of HPV chemicals. The data set is not intended to 
describe a chemical thoroughly, but rather it is intended to provide 
enough information to support an initial (or screening level) 
assessment and to assign a priority for further work, if necessary. 

[19] For example, the production threshold for providing processing 
and use information went from 300,000 pounds or more to 100,000 pounds 
or more in 2012 and will be reduced to 25,000 pounds thereafter. 

[20] The European Chemicals Agency implements the European Union's 
chemicals legislation. The European Union's chemicals legislation 
requires companies to develop information on chemicals' effects on 
human health and the environment before entering commerce, while TSCA 
does not require companies to develop such information absent EPA 
rulemaking requiring them to do so. 

[21] EPA identifies a broad range of activities that may cause a 
person or entity to be considered a chemical processor. Examples of 
chemical processors include, but are not limited to, producers of 
paint, automotive products, specialty cleaners, rubber, and plastics; 
or tire manufacturers, tanneries, textile mills, and metal coating 
facilities. 

[22] Section 11(c) of TSCA gives EPA the authority, in carrying out 
the provisions of TSCA, to use a subpoena to require the attendance 
and testimony of witnesses and the production of reports, papers, 
documents, answers to questions, and other information that the EPA 
Administrator deems necessary. 

[23] In 2011, EPA convened a stakeholder meeting to discuss proposed 
screening criteria and data sources and took public comment over a 35-
day period. Based on the input received, EPA devised and executed a 
protocol that used a combination of risk factors and other criteria. 
Using this protocol, EPA winnowed an initial group of 1,235 chemicals 
down to 83. 

[24] These chemicals are: antimony and antimony compounds, HHCB 
(1,3,4,6,7,8-hexahydro-4,6,6,7,8,8,-hexamethylcyclopenta[g]-2-
benzopyran), long-chain chlorinated paraffins, medium-chain 
chlorinated paraffins, methylene chloride, n-methylpyrrolidone, and 
trichloroethylene. 

[25] Prior to its effort under its TSCA Work Plan, EPA conducted two 
TSCA-related risk assessments since 2001. 

[26] 78 Fed. Reg. 1856 (Jan. 9, 2013). 

[27] Antimony trioxide (ATO) as a synergist in halogenated flame 
retardants; and 1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8,-
hexamethylcyclopenta-[ã]-2-benzopyran (HHCB) as a fragrance ingredient 
in commercial and consumer products. 

[28] Methylene chloride or dichloromethane (DCM) and n-
methylpyrrolidone (NMP) in paint stripper products. 

[29] Trichloroethylene (TCE) as a degreaser and a spray-on protective 
coating. 

[30] Medium and long chain chlorinated paraffins. 

[31] According to EPA officials, the IRIS program is charged with 
evaluating chronic hazard potential including hazard identification 
and dose response information for cancer and noncancer outcomes. Many 
of the chemical uses and particularly the consumer uses are acute and 
short term in nature. In most cases, the information used to develop 
the dose-response assessments is based on intermittent exposures to 
workers or animals in a controlled environment. IRIS assessments 
include an adjustment to continuous exposure in the derivation of 
toxicity values. Often data are available in IRIS for shorter term 
exposures scenarios that have long-lasting/persistent effects (e.g., 
development toxicity). In these cases, evaluation of hazard and dose 
response information described in an IRIS assessment is useful. 

[32] [hyperlink, http://www.gao.gov/products/GAO-08-440]. 

[33] This focus is consistent with the fact that media-specific 
environmental laws such as the Clean Air Act and Clean Water Act are 
available to limit the concentration of contaminants in water or the 
ambient air, and TSCA generally requires EPA to defer action to such 
other laws. However, information on such continuous exposures is still 
critical for regulation under TSCA. For example, to promulgate a rule 
under section 6 of TSCA, EPA must establish the effects of a chemical 
on health and the environment and the magnitude of the exposure of 
human beings and the environment to such a chemical. 

[34] EPA Office of Research and Development, Human Health Risk 
Assessment Strategic Research Action Plan 2012-2016 (June 2012), 15. 

[35] Any rules that EPA plans to issue under TSCA that are considered 
significant regulatory actions, as defined by Executive Order 12866, 
are subject to review by the Office of Information and Regulatory 
Affairs, an office within OMB, prior to being proposed in the Federal 
Register. Among other things, a significant regulatory action may have 
an annual effect on the economy of $100 million or more or raise novel 
legal or policy issues. 

[36] These three groups are: (1) a category of eight phthalates, (2) a 
category of polybrominated diphenyl ether (PBDE), and (3) bisphenol A 
(BPA). 

[37] Under Executive Order 12866, the review period may be extended by 
the head of the rulemaking agency, and the OMB Director may extend the 
review period once for no more than 30 days. 

[38] In spring 2012, EPA proposed three significant new use rules that 
would require companies to report new uses of five groups of 
chemicals, including in domestic and imported articles. 

[39] EPA has used this approach before but infrequently. EPA first 
eliminated the article exemption for a chemical substance in 1991, 
when it promulgated a significant new use rule for erionite fiber, and 
it used the same approach for a significant new use rule pertaining to 
the use of elemental mercury in certain switches in 2007. 

[40] Chemical identity is a name that uniquely identifies a chemical. 
This can be a name in accordance with the nomenclature systems of, for 
example, the International Union of Pure and Applied Chemistry (IUPAC) 
or the Chemical Abstracts Service (CAS). 

[41] EPA determined that many of the identified health and safety 
filings (1) were misidentified as having confidentiality claims for 
the chemical name or as being or containing health and safety studies, 
(2) had valid confidentiality claims for the chemical name, or (3) 
contained claims that were considered invalid under the law. 

[42] The first policy, published in January 2010, involves 
confidentiality claims related to chemical identities included in 
health and safety studies submitted under section 8(e) of TSCA. Under 
this policy, when the agency receives a health and safety study for a 
chemical already listed on the public portion of the TSCA inventory, 
it will not accept a claim that the identity of the chemical is 
confidential. The second policy, published in May 2010, involves 
confidentiality claims related to chemical identities and data 
included in health and safety studies more generally. Under this 
policy, EPA does not extend confidential treatment to health and 
safety studies or data contained in health and safety studies unless 
the studies or data reveal (1) processes used in making the chemical 
or (2) the portion of the chemical in a mixture. 

[43] In August 2012, EPA provided us with an estimate that stated that 
it needed 17.5 full-time EPA staff and about $800,000 in contractor 
support to prepare the 7 risk assessments; it needed an additional 
$160,000 per chemical to support contractor peer reviews. According to 
EPA officials, they will be in a better position to provide an 
accounting of expenditures toward the end of fiscal year 2013. 

[44] GAO, Environmental Justice: EPA Needs to Take Additional Actions 
to Help Ensure Effective Implementation, [hyperlink, 
http://www.gao.gov/products/GAO-12-77] (Washington, D.C.: Oct. 6, 
2011); GAO, Environmental Protection: EPA Should Develop a Strategic 
Plan for Its New Compliance Initiative, [hyperlink, 
http://www.gao.gov/products/GAO-13-115] (Washington, D.C.: Dec. 10, 
2012). 

[45] Leading practices in federal strategic planning include defining 
mission and goals, involving leadership and stakeholders, developing 
performance measures, and developing strategies to address management 
challenges and resources needed, among others. 

[46] The strategic planning elements established under the Government 
Performance and Results Act (GPRA) of 1993 and associated OMB guidance 
and practices we identified, taken together, can serve as leading 
practices for strategic planning at lower levels within federal 
agencies, such as planning for individual divisions, programs, or 
initiatives. For example, see GAO, Executive Guide: Effectively 
Implementing the Government Performance and Results Act, [hyperlink, 
http://www.gao.gov/products/GAO/GGD-96-118] (Washington, D.C.: June 1, 
1996); GAO, Tax Administration: IRS Needs to Further Refine Its Tax 
Filing Season Performance Measures, [hyperlink, 
http://www.gao.gov/products/GAO-03-143] (Washington, D.C.: Nov. 22, 
2002); and GAO, Managing for Results: Strengthening Regulatory 
Agencies' Performance Management Practices, [hyperlink, 
http://www.gao.gov/products/GAO/GGD-00-10] (Washington, D.C.: Oct. 28, 
1999). 

[47] [hyperlink, http://www.gao.gov/products/GAO-12-77] and 
[hyperlink, http://www.gao.gov/products/GAO-13-115]. 

[48] [hyperlink, http://www.gao.gov/products/GAO-05-458] and GAO, EPA 
Should Focus Its Chemical Use Inventory on Suspected Harmful 
Substances, [hyperlink, http://www.gao.gov/products/GAO/RCED-95-165] 
(Washington, D.C.: July 7, 1995). 

[End of section] 

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