TOXIC SUBSTANCES

EPA Has Increased 

Efforts to Assess and 

Control Chemicals but 

Could Strengthen Its 

Approach

Report to Congressional Requesters

March 2013

GAO-13-249

United States Government Accountability Office

GAO
United States Government Accountability Office

Highlights of GAO-13-249, a report to 

congressional requesters 

March 2013 

TOXIC SUBSTANCES

EPA Has Increased Efforts to Assess and Control

Chemicals but Could Strengthen Its Approach

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 the safety of chemicals

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 Recommends

GAO recommends, among other 

things, that EPA develop strategies 

that address challenges impeding its

ability to ensure chemical safety and

identify the resources needed to so. 

EPA neither agreed nor disagreed with 

GAO’s recommendations.

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. 

View GAO-13-249. For more information, 

contact David Trimble at (202) 512-3841 or 

trimbled@gao.gov. 
Page i GAO-13-249 EPA Chemicals Management 

Letter 1 

Background 5

EPA Has Made Progress Implementing Its New Approach to 

Managing Chemicals, but, in Most Cases, Results Have Yet to Be 

Realized 12

It Is Unclear Whether EPA’s New Approach Will Position the 

Agency to Achieve Its Goal of Ensuring the Safety of Chemicals 25

Conclusions 28

Recommendations for Executive Action 30

Agency Comments and Our Evaluation 31

Appendix I Scope and Methodology 34

Appendix II Comments from the Environmental Protection Agency 38

Appendix III GAO Contact and Staff Acknowledgments 43

Related GAO Products 44

Table

Table 1: Purpose and Application of TSCA’s Major Sections 8

Figure

Figure 1: Human Health Chemical Risk Assessment Model 

Used by EPA 6

Contents 
Page ii GAO-13-249 EPA Chemicals Management 

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

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Page 1 GAO-13-249 EPA Chemicals Management 

United States Government Accountability Office 

Washington, DC 20548

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,1 distributed in commerce, used, or 

disposed of in the United States but excludes certain substances 

regulated under other laws.2

 

1

Processing refers to the preparation of a chemical substance or mixture, after its 

manufacture, for distribution in commerce.

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 

2

Excluded substances include certain nuclear materials, pesticides, food, food additives, 

tobacco, drugs, and cosmetics.

 
 

Page 2 GAO-13-249 EPA Chemicals Management 

data disclosing chemical processes, as confidential business 

information.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 exposure4

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.

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.

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 

 

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.
 

Page 3 GAO-13-249 EPA Chemicals Management 

regulate harmful chemicals under TSCA.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.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.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 

 

5

GAO, Toxic Substances Control Act: Legislative Changes Could Make the Act More 

Effective, 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, GAO-05-458 (Washington, D.C.: June 13, 2005).

6

GAO-05-458. 

7

GAO, High-Risk Series: An Update. GAO-09-271 (Washington, D.C.: Jan. 22, 2009).
 

Page 4 GAO-13-249 EPA Chemicals Management 

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 
 

Page 5 GAO-13-249 EPA Chemicals Management 

that the evidence obtained provides a reasonable basis for our findings 

and conclusions based on our audit objectives.

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.

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.

Background

Chemical Risk 

Assessments
 

Page 6 GAO-13-249 EPA Chemicals Management 

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

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.8

 

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.

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 
 

Page 7 GAO-13-249 EPA Chemicals Management 

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.

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.

TSCA’s Structure and Prior 

Findings on Challenges 

Posed by TSCA
 

Page 8 GAO-13-249 EPA Chemicals Management 

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

Section Purpose Provides EPA with a mechanism to:

4 Chemical testing Require companies to develop toxicity data 

under certain circumstances 

5 New chemical review and 

significant new use rules

Review existing information, including 

exposure and toxicity data for new 

chemicals and certain new uses of existing 

chemicals

6 Chemical regulation Limit or ban a chemical, among other 

controls

8 Industry reporting of chemical 

data

Obtain existing data, including exposure 

and toxicity data

14 Disclosure of chemical data Disclose certain data provided to or 

obtained by EPA while also protecting 

confidential business information

Source: GAO analysis of TSCA.

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.9

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 

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.

 

9

GAO-05-458. 
 

Page 9 GAO-13-249 EPA Chemicals Management 

(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.10

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.

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.

 

10Companies are not required to submit new notices if any information provided in the 

original notice changes.
 

Page 10 GAO-13-249 EPA Chemicals Management 

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 6.11 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.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,13

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 

 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.

 

11GAO-05-458. 

12Of 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.

13EPA came to this conclusion after reviewing over 100 studies of the health risks of 

asbestos, as well as public comments on the proposed rule.
 

Page 11 GAO-13-249 EPA Chemicals Management 

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.
 

Page 12 GAO-13-249 EPA Chemicals Management 

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.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 

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.

 

14Existing 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.

EPA’s New Approach to 

Managing Chemicals

EPA Has Made 

Progress 

Implementing Its New 

Approach to 

Managing Chemicals, 

but, in Most Cases, 

Results Have Yet to 

Be Realized
 

Page 13 GAO-13-249 EPA Chemicals Management 

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.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.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).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 1⁄2 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 

 

15Final 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). 

16In addition to promulgating test rules, EPA told us that it has required testing for an 

additional 68 chemicals in enforceable consent agreements.

17Under 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. 

EPA Has Increased Efforts 

to Collect Data on Toxicity 

and Exposure, but It May 

Take Several Years to 

Produce Results
 

Page 14 GAO-13-249 EPA Chemicals Management 

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.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,19

 

18The 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.

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 

19For 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.
 

Page 15 GAO-13-249 EPA Chemicals Management 

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.20

EPA has also not used its authority to obtain exposure-related data from 

chemical processors that prepare chemical substances or mixtures, after 

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 publically 

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.

 

20The 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.
 

Page 16 GAO-13-249 EPA Chemicals Management 

their manufacture, for distribution in commerce.21

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.

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.

22

 

21EPA 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.

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 

22Section 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.
 

Page 17 GAO-13-249 EPA Chemicals Management 

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.

In February 2012, EPA announced a plan that identified 83 existing 

chemicals for risk assessment—known as the TSCA Work Plan.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 201224 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,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 2012.26

 

23In 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.

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 

24These 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.

25Prior to its effort under its TSCA Work Plan, EPA conducted two TSCA-related risk 

assessments since 2001.

2678 Fed. Reg. 1856 (Jan. 9, 2013).

EPA Has Begun Assessing 

Chemical Risks, but It Is 

Too Early to Tell What, If 

Any, Risk Management 

Actions Will Be Taken
 

Page 18 GAO-13-249 EPA Chemicals Management 

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 
 

Page 19 GAO-13-249 EPA Chemicals Management 

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.27

• 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.

The draft risk assessments indicate a “low concern for ecological 

health.” 

28

• 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.

The draft risk assessments identified “potential 

concern for human health under specific exposure scenarios for 

particular uses.” 

29

• 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.

The draft risk assessment identified “potential concern for 

human health under specific exposure scenarios for particular uses.” 

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 

 

27Antimony trioxide (ATO) as a synergist in halogenated flame retardants; and 1,3,4,6,7,8-

Hexahydro-4,6,6,7,8,8,-hexamethylcyclopenta-[γ]-2-benzopyran (HHCB) as a fragrance 

ingredient in commercial and consumer products.

28Methylene chloride or dichloromethane (DCM) and n-methylpyrrolidone (NMP) in paint 

stripper products.

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

30Medium and long chain chlorinated paraffins.
 

Page 20 GAO-13-249 EPA Chemicals Management 

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.31 However, 

as we have reported previously,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.33

 

31According 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 doseresponse 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.

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 

32GAO-08-440. 

33This 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.
 

Page 21 GAO-13-249 EPA Chemicals Management 

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.

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.

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.

 

34EPA Office of Research and Development, Human Health Risk Assessment Strategic 

Research Action Plan 2012-2016 (June 2012), 15.

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
 

Page 22 GAO-13-249 EPA Chemicals Management 

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.35

• 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.

These proposed actions include the 

following:

36 Although the period for 

OMB review is generally limited by executive order to 90 days,37

 

35Any 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.

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.

36These three groups are: (1) a category of eight phthalates, (2) a category of 

polybrominated diphenyl ether (PBDE), and (3) bisphenol A (BPA).

37Under 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.
 

Page 23 GAO-13-249 EPA Chemicals Management 

• 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.38

 

38In 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. 

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 
 

Page 24 GAO-13-249 EPA Chemicals Management 

to minimize exposure to potentially harmful chemicals by targeting 

chemicals in imports as part of consumer products.39

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.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.

41

 

39EPA 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.

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 

40Chemical 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). 

41EPA 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.

EPA Has Expanded Public 

Access to Some Chemical 

Information
 

Page 25 GAO-13-249 EPA Chemicals Management 

studies.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 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.

 

42The 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.

It Is Unclear Whether 

EPA’s New Approach 

Will Position the 

Agency to Achieve Its 

Goal of Ensuring the 

Safety of Chemicals
 

Page 26 GAO-13-249 EPA Chemicals Management 

• 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.43

• 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 

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.

 

43In August 2012, EPA provided us with an estimate that stated that it needed 17.5 fulltime 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.
 

Page 27 GAO-13-249 EPA Chemicals Management 

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 reported44 that, when developing new initiatives, 

agencies can benefit from following leading practices for federal strategic 

planning.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.46

 

44GAO, Environmental Justice: EPA Needs to Take Additional Actions to Help Ensure 

Effective Implementation, 

Without a plan that 

GAO-12-77 (Washington, D.C.: Oct. 6, 2011); GAO, 

Environmental Protection: EPA Should Develop a Strategic Plan for Its New Compliance 

Initiative, GAO-13-115 (Washington, D.C.: Dec. 10, 2012).

45Leading 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.

46The 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, GAO/GGD-96-118 (Washington, D.C.: June 1, 1996); GAO, 

Tax Administration: IRS Needs to Further Refine Its Tax Filing Season Performance 

Measures, GAO-03-143 (Washington, D.C.: Nov. 22, 2002); and GAO, Managing for 

Results: Strengthening Regulatory Agencies’ Performance Management Practices, 

GAO/GGD-00-10 (Washington, D.C.: Oct. 28, 1999).
 

Page 28 GAO-13-249 EPA Chemicals Management 

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.

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 exposurerelated 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 

Conclusions
 

Page 29 GAO-13-249 EPA Chemicals Management 

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 
 

Page 30 GAO-13-249 EPA Chemicals Management 

current effort to help bring the agency closer to achieving its goal of 

ensuring the safety of chemicals.

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.

Recommendations for 

Executive Action
 

Page 31 GAO-13-249 EPA Chemicals Management 

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 exposurerelated 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 

Agency Comments 

and Our Evaluation
 

Page 32 GAO-13-249 EPA Chemicals Management 

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.
 

Page 33 GAO-13-249 EPA Chemicals Management 

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 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.

David C. Trimble

Director, Natural Resources and Environment
Appendix I: Scope and Methodology

Page 34 GAO-13-249 EPA Chemicals Management 

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 

Appendix I: Scope and Methodology
Appendix I: Scope and Methodology

Page 35 GAO-13-249 EPA Chemicals Management 

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.1

For both objectives, we interviewed officials with EPA’s Office of 

Chemical Safety and Pollution Prevention, including its Office of Pollution 

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 

indentified in its TSCA Work Plan. We reviewed EPA estimates on the 

costs and staff levels for performing such risk assessments.

 

1

GAO-12-77 and GAO-13-115. 
Appendix I: Scope and Methodology

Page 36 GAO-13-249 EPA Chemicals Management 

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.2

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 

We sought to achieve a 

balance of perspectives between groups representing industry and those

representing the environment.

 

2

GAO-05-458 and GAO, EPA Should Focus Its Chemical Use Inventory on Suspected 

Harmful Substances, GAO/RCED-95-165 (Washington, D.C.: July 7, 1995).
Appendix I: Scope and Methodology

Page 37 GAO-13-249 EPA Chemicals Management 

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.
Appendix II: Comments from the 

Environmental Protection Agency

Page 38 GAO-13-249 EPA Chemicals Management 

Appendix II: Comments from the 

Environmental Protection Agency

Note: GAO comments 

supplementing those in 

the report text appear at 

the end of this appendix.

See comment 1.
Appendix II: Comments from the 

Environmental Protection Agency

Page 39 GAO-13-249 EPA Chemicals Management 

See comment 3.

See comment 2.
Appendix II: Comments from the 

Environmental Protection Agency

Page 40 GAO-13-249 EPA Chemicals Management 
Appendix II: Comments from the 

Environmental Protection Agency

Page 41 GAO-13-249 EPA Chemicals Management 

The following are GAO’s comments on the letter from the Environmental 

Protection Agency dated March 13, 2013. 

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 publically 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.

GAO comments
Appendix II: Comments from the 

Environmental Protection Agency

Page 42 GAO-13-249 EPA Chemicals Management 

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.
Appendix III: GAO Contact and Staff 

Acknowledgments

Page 43 GAO-13-249 EPA Chemicals Management 

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

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.

Appendix III: GAO Contact and Staff 

Acknowledgments 

GAO Contact

Staff 

Acknowledgments
Related GAO Products

Page 44 GAO-13-249 EPA Chemicals Management 

Chemical Regulation: Observations on Improving the Toxic Substances 

Control Act. GAO-10-292T. Washington, D.C.: December 2, 2009. 

Chemical Regulation: Options for Enhancing the Effectiveness of the 

Toxic Substances Control Act. GAO-09-428T. Washington, D.C.: 

February 26, 2009.

High-Risk Series: An Update. 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.

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. GAO-07-825. Washington, D.C.: August 17, 2007.

Chemical Regulation: Actions Are Needed to Improve the Effectiveness of 

EPA’s Chemical Review Program. GAO-06-1032T. Washington, D.C.: 

August 2, 2006.

Chemical Regulation: Approaches in the United States, Canada, and the 

European Union. 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. GAO-05-458. 

Washington, D.C.: June 13, 2005.

Toxic Substances: EPA Should Focus Its Chemical Use Inventory on 

Suspected Harmful Substances. GAO/RCED-95-165. Washington, D.C.: 

July 7, 1995.

Toxic Substances Control Act: Legislative Changes Could Make the Act 

More Effective. GAO/RCED-94-103. Washington, D.C.: 

September 26, 1994.

Toxic Substances: EPA’s Chemical Testing Program Has Not Resolved 

Safety Concern. GAO/RCED-91-136. Washington, D.C.: June 19, 1991.

Toxic Substances: EPA’s Chemical Testing Program Has Made Little 

Progress. GAO/RCED-90-112. Washington, D.C.: April 25, 1990.

EPA’s Efforts To Identify and Control Harmful Chemicals in Use.

GAO/RCED-84-100. Washington, D.C.: June 13, 1984.

Related GAO Products

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