CHEMICAL REGULATION

Observations on the Toxic 

Substances Control Act and 

EPA Implementation

Statement of Alfredo Gomez, Director

Natural Resources and Environment

Testimony 

Before the Subcommittee on 

Environment and the Economy, 

Committee on Energy and Commerce, 

House of Representatives

For Release on Delivery 

Expected at 10:15 a.m. EDT

Thursday, June 13, 2013

GAO-13-696T

United States Government Accountability Office
United States Government Accountability Office

Highlights of GAO-13-696T, a testimony 

before the Subcommittee on Environment and 

the Economy, Committee on Energy and 

Commerce, House of Representatives 

June 13, 2013 

CHEMICAL REGULATION

Observations on the Toxic Substances Control Act 

and EPA Implementation

Why GAO Did This Study

In 1976, Congress passed TSCA to 

give EPA the authority to obtain more 

health and safety information on 

chemicals and to regulate chemicals it 

determines pose unreasonable risks of 

injury to human health or the 

environment. GAO has reported that 

EPA has found many of TSCA’s 

provisions difficult to implement. 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 

using its existing TSCA authorities. 

This testimony summarizes GAO’s 

past work describing: (1) challenges 

EPA has faced historically in regulating 

chemicals and (2) the extent to which 

EPA has made progress implementing 

its new approach, and challenges, if 

any, which persist. This statement is 

based on GAO reports issued between 

1994 and 2013.

GAO is not making new 

recommendations in this testimony. In 

prior reports, GAO suggested that 

Congress consider statutory changes 

to TSCA to give EPA additional 

authorities to obtain information from 

the chemical industry and shift more of 

the burden to chemical companies for 

demonstrating the safety of their 

chemicals. In these reports, among 

other things, GAO recommended that 

EPA require companies to provide 

chemical data they submitted to foreign 

governments, require companies to 

reassert confidentiality claims, and 

develop strategies for addressing 

challenges that impeded EPA’s ability 

to ensure chemical safety. EPA’s 

responses to these recommendations 

have varied.

What GAO Found

GAO reported in June 2005 that EPA has historically faced the following 

challenges in implementing the provisions of the Toxic Substances Control Act 

(TSCA): 

• Obtaining adequate information on chemical toxicity and exposure. EPA has

found it difficult to obtain such information because TSCA does not require 

companies to provide it; instead, TSCA requires EPA to demonstrate that 

chemicals pose certain risks before it can ask for such information.

• Banning or limiting chemicals. EPA has had difficulty demonstrating that 

chemicals should be banned or have limits placed on their production or use

under section 6—provisions for controlling chemicals. The agency issued

regulations to ban or limit production or use of five existing chemicals, or 

chemical classes, out of tens of thousands of chemicals listed for commercial 

use. A court reversal of EPA’s 1989 asbestos rule illustrates the difficulties 

EPA has had in issuing regulations to control existing chemicals. 

• Disclosing data and managing assertions of confidentiality. EPA has not 

routinely challenged companies’ assertions that data they provide are 

confidential business information and cannot be disclosed. As a result, the 

extent to which companies’ confidentiality claims are warranted is unknown.

GAO reported in March 2013 that EPA has made progress implementing its new 

approach to managing toxic chemicals under its existing TSCA authority but, in 

most cases, results have yet to be realized. Examples are as follows:

• EPA has increased efforts to collect toxicity and exposure data through the 

rulemaking process, but because rules can take 3 to 5 years to finalize and 2 

to 2 1⁄2 years for companies to execute, these efforts may take several years 

to produce results. Specifically, since 2009, EPA has (1) required companies 

to test 34 chemicals and provide EPA with the resulting toxicity and other 

data, and (2) announced, but has not yet finalized, plans to require testing for 

23 additional chemicals.

• EPA has increased efforts to assess chemical risks, but because EPA does 

not have the data necessary to conduct all risk assessments, it is too early to 

tell what, if any, risk management actions will be taken. In February 2012, 

EPA announced a plan that identified and prioritized 83 existing chemicals 

for risk assessment; the agency initiated assessments for 7 chemicals in 

2012 and announced plans to start 18 additional assessments during 2013 

and 2014. At its current pace, it would take EPA at least 10 years to 

complete risk assessments for the 83 chemicals. 

In addition, it is unclear whether EPA’s new approach to managing chemicals will 

position the agency to achieve its goal of ensuring the safety of chemicals. EPA’s 

Existing Chemicals Program Strategy, which is intended to guide EPA’s efforts to 

assess and control chemicals in the coming years, does not discuss how EPA 

will address identified challenges. 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-13-696T. For more information, 

contact Alfredo Gomez at (202) 512-3841 or 

gomezj@gao.gov. 
Page 1 GAO-13-696T 

441 G St. N.W.

Washington, DC 20548

Chairman Shimkus, Ranking Member Tonko, and Members of the 

Subcommittee:

I am pleased to be here today to discuss the Environmental Protection 

Agency’s (EPA) efforts to assess and control toxic chemicals. Tens of 

thousands of chemicals are listed with 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).1

We have reported in the past that EPA has found many of the provisions 

of TSCA difficult to implement. 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. 

We have also made several recommendations to better position EPA to 

collect chemical toxicity and exposure-related data and ensure chemical 

safety under existing TSCA authority. Among other recommendations, in 

June 2005,2 we recommended that EPA strengthen its ability to regulate 

harmful chemicals under TSCA by, for example, promulgating a rule 

requiring that companies submit copies to EPA 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.3

 

1

Existing chemicals are composed of those that were in commerce in 1979 when EPA 

began reviewing chemicals, as well as those listed for commercial use after that time.

In 

2

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).

3

Throughout this testimony, the phrase “chemical companies” refers 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, the type of company to which I am referring is 

specified.

 
 

Page 2 GAO-13-696T 

that report, we also recommended that EPA improve and validate its 

models for assessing and predicting the risks of chemicals and revise its 

regulations to require chemical companies to reassert confidentiality 

claims within a certain period.4

In 2009, EPA announced principles for reforming TSCA to help inform 

efforts under way in Congress. These principles include 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’ data on toxicity, exposure,

EPA implemented our 2005 

recommendation to improve its models. EPA did not disagree with our 

2005 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.

5

Along with the announcement of these principles in 2009, EPA initiated a 

new approach to managing chemicals within the limits of existing 

authorities that focuses largely on existing chemicals. According to 

agency documents, EPA will transition from an approach dominated by 

voluntary data submissions by industry to a more proactive approach in 

which the agency will use its data collection and other rulemaking 

and use for chemicals would 

be required at sufficient levels so that EPA could support a determination 

that a 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 the flexibility to take into account a range of 

considerations, including children’s health, economic costs, social 

benefits, and equity concerns; (4) EPA would have authority to set 

priorities for conducting safety reviews on existing chemicals based on 

relevant risk and exposure considerations; and (5) EPA would receive a 

sustained source of funding from manufacturers of chemicals to support 

the costs of agency implementation, including the review of information 

provided by manufacturers.

 

4

As described later in this testimony, TSCA contains provisions for governing the 

disclosure of chemical data. Chemical companies can claim certain information, such as 

data disclosing chemical processes, as confidential business information.

5

In this testimony, exposure represents the magnitude, frequency, and duration of contact 

with a chemical. Toxicity represents the degree to which a chemical is harmful. In this 

testimony, the terms toxicity and hazard are used synonymously.
 

Page 3 GAO-13-696T 

authorities under TSCA to ensure chemical safety. 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 the following 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.

In our most recent report in March 2013, we reported on the extent to 

which EPA had made progress implementing its new approach.6 We 

recommended, among other things, that EPA consider promulgating a 

rule requiring chemical companies to report exposure-related data from 

processors to EPA. EPA stated in its comments that downstream 

chemical processors have little exposure-relevant data—which suggests 

that it does not intend to implement that recommendation.7

 Because EPA 

has not developed sufficient chemical assessment information to limit 

exposure to many chemicals that may pose substantial health risks, 

among 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.8

My testimony today is based on our prior work on EPA’s processes for 

assessing and controlling toxic chemicals. Specifically, my statement 

today discusses: (1) challenges EPA has faced historically in regulating 

chemicals and (2) the extent to which EPA has made progress 

implementing its new approach, and challenges, if any, which persist. 

This statement is based on our extensive body of work on TSCA and 

EPA’s programs to assess and control chemicals, including reports 

issued from September 1994 to March 2013. Detailed information on our 

scope and methodology is available in each issued product. We 

 

6

GAO, Toxic Substances: EPA Has Increased Efforts to Assess and Control Chemicals 

but Could Strengthen Its Approach, GAO-13-249 (Washington, D.C.: Mar. 22, 2013).

7

This position, however, conflicts with 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 have said that data from downstream 

processors would provide the agency with a better understanding of potential exposure to 

chemicals, for example, chemical exposure from consumer products such as those 

designed for children.

8

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

Page 4 GAO-13-696T 

conducted this work in accordance with generally accepted government 

auditing standards.

Federal laws have been enacted over the years to determine the health 

and environmental hazards associated with toxic chemicals and to 

address these problems. Even with the existence of media-specific 

environmental laws enacted in the early 1970s, such as the Clean Air Act 

and the Clean Water Act, problems with toxic chemicals continued to 

occur. In addition, Congress became increasingly concerned about the 

long-term effects of substantial amounts of chemicals entering the 

environment.

TSCA was enacted to authorize EPA to collect information about the 

hazards posed by chemical substances and to take action to control 

unreasonable risks by either preventing dangerous chemicals from 

making their way into use or placing restrictions on those already in 

commerce. Under the act, EPA can control the entire life cycle of 

chemicals from their production, distribution in commerce, and use to 

their disposal. Other environmental and occupational health laws 

generally control only disposal or release to the environment, or 

exposures in the workplace. The scope of TSCA includes those 

chemicals manufactured, imported, processed,9 distributed in commerce, 

used, or disposed of in the United States but excludes certain substances 

regulated under other laws.10

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 also specifies when EPA may 

publicly disclose chemical information it obtains from chemical companies 

and provides that chemical companies can claim certain information, such 

as data disclosing chemical processes, as confidential business 

information.

 

9

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

manufacture, for distribution in commerce.

10Excluded substances include certain nuclear materials, pesticides, food, food additives, 

tobacco, drugs, and cosmetics.

Background
 

Page 5 GAO-13-696T 

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 Control of 

chemicals

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 human 

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.

Under the provisions for new chemical review and significant new use 

rules in section 5 of TSCA, chemical companies are to notify EPA at least 

90 days before beginning to manufacture a new chemical 

(premanufacture notice review). Section 5 also allows EPA to promulgate 

significant new use rules, which require companies to notify EPA at least 

90 days before beginning to manufacture a chemical for certain new uses 

or in certain new ways (significant new use notice review). Such rules 

require existing chemicals to undergo the same type of review that new 

chemicals undergo. For example, EPA may issue a significant new use 

rule if it learns that a chemical that has previously been processed as a 

liquid is now being processed as a powder, which may change how 

workers are exposed to the chemical. Section 5 of the act also authorizes 

EPA to maintain a list of chemicals—called the chemicals of concern 
 

Page 6 GAO-13-696T 

list—that present or may present an unreasonable risk of injury to health 

or the environment.

Under the provisions for chemical regulation in section 6 of TSCA, EPA is 

to apply regulatory requirements to chemicals for which EPA finds a 

reasonable basis exists to conclude that the chemical presents or will 

present an unreasonable risk of injury to health or the environment. To 

adequately protect against a chemical’s risk, EPA can promulgate a rule 

that bans or restricts the chemical’s production, processing, distribution in 

commerce, disposal, or use or requires warning labels be placed on the 

chemical. Under TSCA, EPA must choose the least burdensome 

requirement that will adequately protect against the risk.

Under the provisions for industry reporting of chemical data in section 

8(a), EPA is to promulgate rules under which chemical companies must 

maintain records and submit such information as the EPA Administrator 

reasonably requires. This information can include, among other things, 

chemical identity, categories of use, production levels, by-products, 

existing data on adverse human health and environmental effects, and 

the number of workers exposed to the chemical, to the extent such 

information is known or reasonably ascertainable. Under section 8(a), 

EPA issues rules to update the TSCA inventory. 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. 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) generally 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.

Under the provisions for disclosure of chemical data in section 14, EPA 

may disclose chemical information it obtains under TSCA under certain 

conditions. 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 
 

Page 7 GAO-13-696T 

information to carry out their responsibilities. EPA may also disclose 

certain data from health and safety studies.

We have previously reported that EPA has historically faced challenges 

implementing many of the provisions of TSCA, in particular (1) obtaining 

adequate information on chemical toxicity and exposure through testing 

provisions; (2) banning or limiting chemicals; and (3) disclosing chemical 

data and managing company assertions of confidentiality.

EPA has found it difficult to obtain adequate information on chemical 

toxicity and exposure 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.

Specifically, we reported in 2005 that under section 4—provisions for 

chemical testing—EPA has found its authority to be difficult, timeconsuming, and costly to use.11

In addition, we reported in June 2005 that under section 5—provisions for 

new chemical review—TSCA generally requires chemical companies to 

submit a notice to EPA (known as a “premanufacture notice”) before they 

manufacture or import new chemicals and to provide any available test 

The structure of this section places the 

burden on EPA to demonstrate certain health or environmental risks 

before it can require companies to further test their chemicals. While 

TSCA authorizes EPA to review existing chemicals, it generally provides 

no specific requirement, time frame, or methodology for doing so. Instead, 

EPA conducts initial reviews after it receives information from the public 

or chemical companies that a chemical may pose a risk. As a result, EPA 

has only limited information on the health and environmental risks posed 

by these chemicals. In our June 2005 report, we suggested that Congress 

consider amending TSCA to provide explicit authority for EPA to enter 

into enforceable consent agreements under which chemical companies 

are required to conduct testing, and give EPA, in addition to its current 

authorities under section 4 of TSCA, the authority to require chemical 

substance manufacturers and processors to develop test data based on 

substantial production volume and the necessity for testing.

 

11GAO-05-458. 

Historical Challenges 

EPA Has Faced 

Regulating Chemicals 

under TSCA

Obtaining Adequate 

Information on Chemical 

Toxicity and Exposure
 

Page 8 GAO-13-696T 

data. EPA estimated that most notices do not include any test data and 

that about 15 percent of them included health or safety test data. These 

tests may take over a year to complete and cost hundreds of thousands 

of dollars, and chemical companies usually do not perform them 

voluntarily. However, chemical companies are not generally required 

under TSCA to limit the production of a chemical or its uses to those 

specified in the premanufacture notice or to submit another 

premanufacture notice if changes occur. For example, companies may 

increase production levels or expand the uses of a chemical, potentially 

increasing the risk of injury to human health or the environment.

EPA has had difficulty demonstrating that chemicals should be banned or 

have limits placed on their production or use under section 6—provisions 

for controlling chemicals. Specifically, we reported, in June 2005, that 

since Congress enacted TSCA in 1976,12 EPA has issued regulations 

under section 6 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.13

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,14

 

12

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 

GAO-05-458. 

13TSCA requires EPA to compile, keep current, and publish a list of each chemical 

substance that is manufactured or processed in the United States, which is called the 

TSCA inventory. Of the over 84,000 chemicals currently on the TSCA inventory, 

approximately 8,000 chemicals are produced at annual volumes of 25,000 pounds or 

greater.

14EPA came to this conclusion after reviewing over 100 studies of the health risks of 

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

Banning or Limiting 

Chemicals
 

Page 9 GAO-13-696T 

necessary evidence and failed to show that the control action it chose 

was the least burdensome reasonable regulation required to adequately 

protect human health or the environment. Since the court’s 1989 decision, 

EPA has only exercised its authority to ban or limit the production or use

of an existing chemical once—for hexavalent chromium, a known human 

carcinogen widely used in industrial cooling towers—in 1990.15

EPA has limited ability to publicly share the information it receives from 

chemical companies under TSCA. Specifically, as we reported in 2005, 

EPA has not routinely challenged companies’ assertions that the 

chemical data they disclose to EPA under section 14—disclosure of 

chemical data—are confidential business information, citing resource 

constraints. TSCA requires EPA to protect trade secrets and privileged or 

confidential commercial or financial information against unauthorized 

disclosures. When information is claimed as confidential business 

information, it limits EPA’s ability to expand public access to this 

information—such as sharing it with state environmental agencies and 

foreign governments, which potentially limits the effectiveness of these 

organizations’ environmental risk programs.

Because EPA has not routinely challenged these assertions, the extent to 

which companies’ confidentiality claims are warranted is unknown. We 

recommended, in June 2005, that EPA revise its regulations to require 

that companies periodically reassert claims of confidentiality.16 EPA did 

not disagree with our recommendation but has not revised its regulations. 

EPA has explored ways to reduce the number of inappropriate and overbroad claims of confidentiality by companies that submit data to EPA.

 

15However, EPA officials said that they had started the process for promulgating the rule 

for hexavalent chromium years prior to the asbestos decision.

16GAO-05-458. 

Disclosure of Chemical 

Data
 

Page 10 GAO-13-696T 

In March 2013, we reported on progress EPA has made implementing its 

new approach to manage toxic chemicals under its existing TSCA 

authority—particularly by increasing efforts to (1) obtain toxicity and 

exposure data, (2) assess risks posed by chemicals, and (3) discourage 

the use of some chemicals.17 However, the results of EPA’s activities, in 

most cases, have yet to be realized. We also reported that it is unclear 

whether EPA’s new approach will position the agency to achieve its goal 

of ensuring the safety of chemicals.

EPA has increased its efforts to collect toxicity and exposure data, but 

because rules can take years to finalize and additional time for 

companies to execute, these efforts may take several years to produce 

results. Even with these efforts, EPA has not pursued all opportunities to 

obtain chemical data.

We reported, in March 2013, that EPA has made progress by taking the 

following actions but continues to face challenges in collecting such data, 

specifically:

• Since 2009, EPA has proposed or promulgated rules to require 

chemical companies to test 57 chemicals. Specifically, EPA has 

required companies to test 34 chemicals and provide EPA with the 

resulting toxicity and other data. In addition, EPA announced, but has 

yet to finalize,18 plans to require testing for 23 additional chemicals.19

 

17

However, requirements under TSCA place the burden of developing 

toxicity data on EPA. Because rulemaking can take years, 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 

GAO-13-249. 

18Final 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).

19By comparison, EPA required testing for fewer than 200 chemicals from the time TSCA 

was enacted in 1976 until 2009 when the agency undertook its new approach to managing 

chemicals. The 57 chemicals that are part of EPA’s current and proposed testing 

requirements were identified but not sponsored as part of the agency’s 1998 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).

EPA Has Made 

Progress to 

Implement Its New 

Approach to 

Managing Chemicals, 

but Some Challenges 

Persist

EPA Has Increased Efforts 

to Collect Data on Toxicity 

and Exposure, but It May 

Take Several Years to 

Produce Results
 

Page 11 GAO-13-696T 

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, the toxicity data eventually obtained on the 57 chemicals 

may not 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). Specifically, EPA may obtain data that are considered to be 

“screening level” information. Screening level information is 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.

• 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,20 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.21

Even with the increased efforts EPA has taken to collect toxicity and 

exposure data, in March 2013, we reported that EPA has not pursued all 

opportunities to obtain such data. For example, EPA has not sought 

toxicity and exposure data that companies submit to the European 

Chemicals Agency on chemicals that the companies manufacture or 

 

20For 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.

21Previously, 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.
 

Page 12 GAO-13-696T 

process in, or import to, the United States.22 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. 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. As a result, we recommended that EPA 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. In its written comments on a draft of our March 2013 

report, EPA stated that it intends to pursue data submitted to the 

European Chemicals Agency from U.S. companies using voluntary or 

regulatory means as necessary but did 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.

EPA has increased its efforts to assess chemical risks, but because EPA 

does not have the data necessary to conduct all risk assessments, it is 

too early to tell what, if any, risk management actions will be taken. Even 

with these efforts, it is unclear how EPA is going to obtain the data 

necessary to continue to conduct all risk assessments.

We reported, in March 2013, that EPA has made progress to assess 

chemical risks by taking the following actions but continues to face 

 

22The 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.

EPA Has Begun Assessing 

Chemical Risks, but It Is 

Too Early to Tell What, If 

Any, Risk Management 

Actions Will Be Taken
 

Page 13 GAO-13-696T 

challenges. Specifically, in February 2012, EPA announced a plan that 

identified and prioritized 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 

2012—5 of which were released for public comment—and announced 

plans to start risk assessments during 2013 and 2014 for 18 additional 

chemicals.24

As we reported, in March 2013, even with these increased efforts, it is 

unclear whether 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. According 

to EPA officials and agency documents, the agency has started or plans 

to start risk assessments on the 25 chemicals for which it has wellcharacterized toxicity and exposure data. However, before EPA can 

initiate risk assessments for the remaining 58 chemicals, the agency will 

need to identify and obtain toxicity and exposure data. 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 

EPA officials told us that they expect that all 7 risk 

assessments will be finalized early in 2014. However, it may be years 

before EPA initiates regulatory or other risk management actions to 

reduce any chemical risks identified in these assessments. Before EPA 

can determine such actions are warranted, the agency would need to 

consider other factors—such as costs and benefits of mitigating the risk, 

technological information, and the concerns of stakeholders—which could 

require additional time and resources. Moreover, assuming EPA meets its 

2014 target for completing these 7 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.

 

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.

2478 Fed. Reg. 1856 (Jan. 9, 2013).
 

Page 14 GAO-13-696T 

assessments. To better position EPA to ensure chemical safety under 

existing TSCA authority, in our March 2013 report we recommended that 

EPA develop strategies for addressing challenges associated with 

obtaining toxicity and exposure data needed for risk assessments. 

However, based on EPA’s written response to a draft of our 2013 report, 

it is unclear what action, if any, EPA intends to pursue.

EPA has taken actions that may discourage the use of certain chemicals, 

but because many of these actions have yet to be finalized, it is too early 

to tell whether they will reduce chemical risk. We reported in March 2013 

that, 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, the agency generally considers using this authority only after 

exhausting all other available options. Since 2009, EPA has made 

progress by increasing its use of certain options, including (1) making 

greater use of significant new use rules under section 5 and (2) proposing 

actions that use its TSCA authority in new ways as follows:

• EPA is making greater use of significant new use rules under section 

5 to control new uses of existing chemicals. 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. EPA officials told us that EPA 

typically recommends that companies submit testing information when 

they notify EPA of their intent to manufacture or process chemicals, 

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.

• EPA has also proposed actions that use its TSCA authority in new 

ways including the following:

• Creating “chemicals of concern” list. In May 2010, EPA 

announced that it intended to create a list of chemicals that 

present or may present ‘‘an unreasonable risk of injury to health or 

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 15 GAO-13-696T 

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 the 

Office of Management and Budget (OMB) in May 2010, and as of 

May 2013, EPA’s proposed “chemicals of concern” list has been 

under review at OMB for over 1,000 days and remains listed as 

pending review by OMB.25

• 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 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.

• 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 

 

25These three groups are: (1) a category of eight phthalates, (2) a category of 

polybrominated diphenylethers (PBDE), and (3) bisphenol A (BPA). 
 

Page 16 GAO-13-696T 

exempted from compliance with a significant new use rule. EPA’s 

proposals would eliminate this exemption for certain chemicals.26

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, OMB 

has not met the established 90-day time for reviewing EPA’s proposed 

actions—which has increased the time frames for formally proposing and 

finalizing them.27 In particular, the period for OMB review is generally 

limited by executive order to 90 days, although it can be extended. 28

As we reported in March 2013, 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 discussed earlier associated with obtaining toxicity and 

exposure data and banning or limiting the use of chemicals as follows:

• Obtaining toxicity and exposure data. EPA’s strategy does not discuss 

how the agency will meet the challenge we described related to 

obtaining the toxicity and exposure data it will need to conduct all risk 

assessments. In particular, as discussed previously, EPA has not 

broadly sought toxicity and exposure data that companies submit to 

foreign governments; instead EPA plans to obtain these data on a 

 

26In 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. EPA has used this approach before but infrequently. EPA first 

eliminated the article exemption for a chemical substance in 1991, when it promulgated a 

significant new use rule for erionite fiber, and it used the same approach for a significant 

new use rule pertaining to the use of elemental mercury in certain switches in 2007.

27Any 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.

28Under 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.

It Is Unclear Whether 

EPA’s New Approach Will 

Position the Agency to 

Achieve Its Goal of 

Ensuring the Safety of 

Chemicals
 

Page 17 GAO-13-696T 

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 the agency’s ongoing or 

future risk assessment activities, if at all.

• Banning or limiting the use of chemicals. EPA’s strategy does not 

articulate how the agency would overcome the regulatory challenges 

it experienced in the past. In particular, EPA officials told us that, even 

if EPA has substantial toxicity and exposure data, the agency is 

challenged in meeting the statutory requirement under section 6 of 

TSCA to limit or ban chemicals.

Further, EPA’s strategy does not identify the resources needed to meet 

its goal of ensuring chemical safety. For example, EPA’s strategy does 

not identify 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. 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.

When developing new initiatives, agencies can benefit from following 

leading practices for federal strategic planning.29 Of these leading 

practices, it is particularly important for agencies to define strategies that 

address management challenges that threaten their ability to meet longterm goals. In our March 2013 report,30

 

29The 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. 

Leading practices in federal strategic planning include defining mission and goals, 

involving leadership and stakeholders, developing performance measures, and developing 

strategies to address management challenges and resources needed, among others. See 

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

Effective Implementation, 

we stated that without a plan that 

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

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

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

30GAO-13-249. 
 

Page 18 GAO-13-696T 

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. As a result, we recommended that the EPA 

Administrator direct the appropriate offices to develop strategies for 

addressing challenges that impede the agency’s ability to meet its goal of 

ensuring chemical safety to better position EPA to ensure chemical safety 

under its existing TSCA authority. In its written response to our March 

2013 report,31 EPA’s Acting Assistant Administrator stated that change is 

needed in every significant aspect of the program, and, while strategic 

planning is a useful exercise it cannot substitute for the basic authorities 

needed for a modern, effective chemicals program. Moreover, the Acting 

Assistant Administrator stated that it is EPA’s position that, absent 

statutory changes to TSCA, the agency will not be able to successfully 

meet the goal of ensuring chemical safety now and into the future.

Chairman Shimkus, Ranking Member Tonko, and Members of the 

Subcommittee, this concludes my prepared statement. I would be happy 

to respond to any questions that you or Members of the Subcommittee 

may have at this time.

If you or your staff members have any questions about this testimony, 

please contact me at (202) 512-3841 or gomezj@gao.gov. Contact points 

for our Offices of Congressional Relations and Public Affairs may be 

found on the last page of this statement. Other individuals who made key 

contributions include Diane LoFaro, Assistant Director; Diane Raynes, 

Assistant Director; Elizabeth Beardsley; Richard Johnson; Alison O’Neill; 

and Aaron Shiffrin.

 

31GAO-13-249. 

GAO Contact and 

Staff 

Acknowledgments
Related GAO Products

Page 19 GAO-13-696T 

Toxic Substances: EPA Has Increased Efforts to Assess and Control

Chemicals but Could Strengthen Its Approach, GAO-13-249 (Washington, 

D.C.: Mar. 22, 2013).

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.

Related GAO Products
Related GAO Products

Page 20 GAO-13-696T 

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.

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