United States Government Accountability Office

GAO Testimony before the Committee on 

Environment and Public Works, U.S. 

Senate

CHEMICAL REGULATION

Actions Are Needed to 

Improve the Effectiveness 

of EPA's Chemical Review 

Program 

Statement of John B. Stephenson, 

Director, Natural Resources and Environment 

For Release on Delivery

Expected at 9:30 a.m. EDT

Wednesday, August 2, 2006

 

GAO-06-1032T 
What GAO Found

United States Government Accountability Office

Why GAO Did This Study

Highlights

Accountability Integrity Reliability

August 2, 2006

CHEMICAL REGULATION 

Actions Are Needed to Improve the 

Effectiveness of EPA’s Chemical Review 

Program 

Highlights of GAO-06-1032T, testimony 

before the Committee on Environment and 

Public Works, U.S. Senate 

Chemicals play an important role in 

everyday life, but some may be 

harmful to human health and the 

environment. Chemicals are used

to produce items widely used 

throughout society, such as

cleansers and plastics as well as 

industrial solvents and additives. 

However, some chemicals, such as 

lead and mercury, are highly toxic

at certain doses and need to be

regulated because of health and 

safety concerns. In 1976, the 

Congress passed the Toxic 

Substances Control Act (TSCA) to

authorize the Environmental

Protection Agency (EPA) to control 

chemicals that pose an

unreasonable risk to human health 

or the environment.

This testimony is based on GAO’s 

June 2005 report, Chemical

Regulation: Options Exist to 

Improve EPA’s Ability to Assess 

Health Risks and Manage Its 

Chemical Review Program (GAO05-458). GAO’s report describes 

EPA’s efforts to (1) assess 

chemicals used in commerce, (2)

control the use of chemicals not yet 

in commerce, and (3) publicly 

disclose information provided by 

chemical companies under TSCA. 

GAO recommended that the 

Congress consider providing EPA 

additional authorities under TSCA 

to improve EPA’s ability to assess 

chemical risks, and that the EPA 

Administrator take several actions

to improve EPA’s management of

its chemical review program. EPA 

did not disagree with our findings

and is currently implementing 

some of our recommendations. 

EPA’s authority under TSCA to obtain the data needed to assess existing 

chemicals does not facilitate its review process because the costly and timeconsuming burden of obtaining the data is on EPA, rather than chemical

companies. Consequently, EPA has used its authorities to require testing of 

fewer than 200 of the 62,000 chemicals in commerce when EPA began 

reviewing chemicals under TSCA in 1979. To obtain more data on existing 

chemicals, EPA implemented its High Production Volume Challenge 

Program, under which chemical companies voluntarily provide test data on 

about 2,800 chemicals produced or imported in amounts of 1 million pounds 

or more a year. While the purpose of the program is laudable, several 

problems remain, including that the chemical industry has not agreed to 

provide test data for over 200 chemicals with high production volumes. 

Moreover, after obtaining test data, EPA is required under TSCA’s provisions 

to determine that a chemical poses an unreasonable risk before EPA can act 

to regulate its production or use. EPA officials say the act’s legal standards 

for demonstrating unreasonable risk are so high that they have generally

discouraged EPA from using its authorities to ban or restrict the 

manufacture or use of existing chemicals. Since Congress enacted TSCA in 

1976, EPA has issued regulations to ban or limit the production of only five 

existing chemicals or groups of chemicals. 

EPA’s reviews of new chemicals provide only limited assurance that health 

and environmental risks are identified because TSCA does not require

companies to test chemicals before they notify EPA of their intent to 

manufacture the chemicals. Because of a general lack of data on new 

chemicals, EPA has developed methods to predict their potential exposure 

and toxicity levels by using scientific models to compare the new chemicals 

with chemicals that have similar molecular structures and for which toxicity 

information is available. However, the use of these models can be

problematic because the models are not always accurate in predicting 

chemical properties and EPA’s evaluation of general health effects of the 

chemicals is contingent upon the availability of information on chemicals 

with similar molecular structures. Additionally, the estimates of a 

chemical’s production volume and anticipated uses, which EPA uses to 

assess exposure, can change substantially after EPA completes its review. 

Despite these limitations, EPA’s reviews have resulted in some action being 

taken to reduce the risks of over 3,600 new chemicals. 

EPA’s ability to provide the public with information on chemical production 

and risk is generally limited by the confidential business information 

provisions of TSCA. As a result, state agencies and foreign governments 

interested in obtaining this data for important purposes are denied access to 

the information. Recently, chemical companies have expressed interest in 

working with EPA to identify ways of enabling the agency to share 

confidential information with other organizations, provided that appropriate 

safeguards are adopted to prevent the unauthorized use of the information. 

www.gao.gov/cgi-bin/getrpt?GAO-06-1032T.

To view the full product, including the scope 

and methodology, click on the link above. 

For more information, contact John B. 

Stephenson at (202) 512-3841 or

stephensonj@gao.gov. 
Mr. Chairman and Members of the Committee: 

I am pleased to appear today before the Senate Committee on 

Environment and Public Works, to discuss our work on the Environmental 

Protection Agency’s (EPA) implementation of the Toxic Substances 

Control Act (TSCA). Tens of thousands of chemicals are currently in 

commercial use in the United States and, on average, over 700 new 

chemicals are introduced into commerce each year. Although these 

chemicals are an integral component in the production of important goods 

and services, some may be toxic and may adversely affect human health 

and/or the environment. It was in this context, that the Congress passed 

TSCA in 1976, authorizing EPA to obtain manufacturer information on the 

risks of chemicals and to control those that EPA determines will pose an 

unreasonable risk. 

TSCA addresses those chemicals manufactured, imported, processed, 

distributed in commerce, used, or disposed of in the United States, but 

excludes certain substances including pesticides regulated under the 

Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and food 

additives, drugs, and cosmetics regulated under the Federal Food, Drug, 

and Cosmetic Act (FFDCA). TSCA authorizes EPA to review those 

chemicals already in commerce – what are referred to as existing 

chemicals — and to assess chemicals before they enter commerce – socalled new chemicals. EPA lists chemicals currently in commerce in the

TSCA inventory. Of the over 82,000 chemicals currently in the TSCA 

inventory, about 62,000 were already in commerce when EPA began 

reviewing chemicals in 1979. Since then, approximately 20,000 new 

chemicals were added to the inventory and are now in use as existing 

chemicals. 

Prior to the passage of TSCA, chemical substances generally entered the 

marketplace without review or controls. Without government intervention, 

and often with little or no knowledge of their potential adverse health and 

environmental impacts, some of these chemicals were produced and used 

in high volumes. Earlier legislation on clean water and air had primarily 

addressed releases of chemicals into the environment. In contrast, TSCA 

authorized EPA to control the entire life cycle of chemicals from their 

production and distribution to their use and disposal—including options 

for the outright banning of chemical substances to mandating 

requirements for chemical testing or product labeling. Now, chemical 

companies are required to submit to EPA, 90 days before beginning to 

manufacture a new chemical, a premanufacture notice containing 

information including the chemical’s identity, categories of uses, estimated 

Page 1 GAO-06-1032T 
production volumes, and any test data possessed by the chemical 

company. 

My testimony today, which is based on our June 2005 report, Chemical 

Regulation: Options Exist to Improve EPA’s Ability to Assess Health 

Risks and Manage Its Chemical Review Program,

1

 describes EPA’s 

efforts to (1) assess existing chemicals used in commerce, (2) control the 

risks of new chemicals not yet in commerce, and (3) publicly disclose 

information provided by chemical companies under TSCA. 

In summary, EPA does not routinely assess the human health and 

environmental risks of existing chemicals and faces challenges in 

obtaining the information necessary to do so. TSCA’s authorities for 

collecting data on existing chemicals do not facilitate EPA’s review 

process because they generally place the costly and time-consuming 

burden of obtaining data on EPA, rather than requiring chemical 

companies to develop and submit such data to EPA. Consequently, EPA 

has used its authorities to require testing for fewer than 200 of the 62,000

chemicals in commerce when EPA began reviewing chemicals under 

TSCA in 1979. Recognizing the need for additional information on existing 

chemicals, in the late 1990s EPA implemented its High Production Volume 

(HPV) Challenge Program, under which chemical companies have begun 

to voluntarily provide test data on about 2,800 chemicals produced or 

imported in amounts of 1 million pounds or more a year. While the HPV 

Challenge Program is a laudable effort to develop data on these chemicals,

several problems remain, including that the chemical industry has not 

agreed to provide testing for over 200 chemicals originally identified in the 

HPV Challenge Program and that even with the test data provided under 

the program, EPA would need to demonstrate that the chemicals pose 

unreasonable risks in order to control their production or use under TSCA. 

While TSCA does not define what risk is unreasonable, according to EPA 

officials the standard has been difficult to meet. In order to withstand 

judicial scrutiny, a TSCA rule must be supported by substantial evidence 

in the rulemaking record. In this regard, EPA officials say the act’s legal 

standards are so high that they have generally discouraged EPA from using 

its authorities to ban or restrict the manufacture or use of chemicals. Since 

Congress enacted TSCA in 1976, EPA has issued regulations under the act 

 1

 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). 

Page 2 GAO-06-1032T 
to ban or limit the production of only five existing chemicals or groups of 

chemicals. 

EPA’s reviews of new chemicals can provide only limited assurance that

health and environmental risks are identified before the chemicals enter 

commerce because TSCA does not require chemical companies to test 

new chemicals before notifying EPA of their intent to manufacture a 

chemical. Furthermore, chemical companies generally do not voluntarily 

perform such testing. Because of a general lack of data, EPA has 

developed sophisticated methods to predict the potential exposure and 

toxicity levels of new chemicals by using scientific models to compare 

them with chemicals with similar molecular structures for which toxicity 

information is available. However, the use of these models can present 

weaknesses in the assessment because the models are not always accurate

in predicting physical chemical properties and the evaluation of general

health effects is contingent on the availability of information on chemicals 

with similar molecular structures. Additionally, chemical company 

estimates of a chemical’s production volume and anticipated uses 

provided in the premanufacture notices that EPA uses to assess exposure, 

can change substantially after EPA completes its review and 

manufacturing begins. However, these estimates do not have to be 

amended by companies unless EPA promulgates a rule determining that a 

use of a chemical constitutes a significant new use, which EPA has done 

for only a small percentage of new chemicals. Despite limitations in the 

information available on new chemicals, EPA’s reviews have resulted in 

some action being taken to reduce the risks of over 3,600 new chemicals 

submitted for review. 

EPA’s ability to provide the public with information on chemical 

production and risk has also been hindered by strict confidential business 

information provisions of TSCA. TSCA generally prohibits the disclosure 

of confidential business information and, according to EPA officials, about 

95 percent of the premanufacture notices for new chemicals contain some 

information that is claimed as confidential. While EPA has the authority to

evaluate the appropriateness of confidentiality claims, these efforts are 

time and resource-intensive, and the agency does not have the resources 

to challenge a significant number of claims. State environmental agencies 

and others have expressed interest in obtaining information claimed as 

confidential business information for use in various activities, such as 

developing contingency plans to alert emergency response personnel to 

the presence of highly toxic substances at manufacturing facilities. 

Chemical companies recently have expressed interest in working with 

Page 3 GAO-06-1032T 
EPA to identify ways to enable other organizations to use the information 

given the adoption of appropriate safeguards. 

In our June 2005 report, we recommended that the Congress consider 

providing EPA additional authorities under TSCA to improve its ability to

assess chemical risks, such as providing the EPA Administrator the 

authority to require chemical companies develop test data when 

production volumes reach certain levels. We also recommended that the 

EPA Administrator take several actions to improve EPA’s management of 

its chemical program, including revising its regulations to require that 

companies reassert confidentiality claims under TSCA within a certain

time period after the information is initially claimed as confidential. EPA

did not disagree with the report’s findings and is in the process of 

implementing several of our recommendations. For example, EPA is 

currently launching a pilot project to review claims of confidentiality for 

data on certain older chemicals. 

Because chemical companies are generally not required to develop and 

submit toxicity information to EPA, when the agency decides to review 

existing chemicals, it generally has only limited information on the risks 

that the chemicals pose to human health and the environment. 

Furthermore, EPA’s authority under TSCA to require industry testing that 

would provide the information to review the chemicals is difficult to use, 

according to EPA officials. EPA has used its authority to require testing for 

fewer than 200 of the 62,000 chemicals in commerce when EPA began 

reviewing chemicals under TSCA in 1979. Furthermore, EPA has rarely 

banned, limited the production, or restricted the use of existing chemicals. 

Since 1998, EPA has focused its efforts on obtaining information on 

existing chemicals through voluntary programs, such as the HPV 

Challenge Program. This program is intended to provide basic data on the 

characteristics of about 2,800 chemicals produced in excess of 1 million 

pounds a year. 

EPA Has Limited 

Information on the 

Health and 

Environmental Risks 

of Existing Chemicals 

and Has Issued Few 

Regulations 

Controlling Such 

Chemicals 

EPA Has Limited Toxicity 

and Exposure Data with 

Which to Review Existing 

Chemicals 

EPA’s toxicity and exposure data on existing chemicals is often 

incomplete and TSCA’s authority to require testing in support of the 

agency’s review process is difficult to use. While TSCA authorizes the 

review of existing chemicals, it generally provides no specific requirement, 

time frame, or methodology for doing so. Chemical companies are not 

required to develop and submit toxicity information to EPA unless the 

agency promulgates a testing rule, thus placing the burden for obtaining 

data on EPA. In addition, if chemical company testing shows that a 

Page 4 GAO-06-1032T 
chemical is not toxic, there is generally no standing requirement that the

chemical companies submit this data to EPA. Consequently, when EPA 

decides to review existing chemicals, it generally has only limited 

information on the risks of injury the chemicals pose to human health and

the environment. 

EPA officials told us that in cases where chemical companies do not 

voluntarily provide test data and health and safety studies in a complete 

and timely manner, requiring the testing of existing chemicals of 

concern—those chemicals for which some suspicion of harm exists—is 

the only practical way to ensure that the agency obtains the needed 

information. For example, there are currently over 200 high-productionvolume chemicals for which chemical companies have not agreed to 

provide the minimal test data that EPA believes are needed to initially 

assess their risks. Furthermore, many additional chemicals are likely to be

added to become high production chemicals because the specific 

chemicals used in commerce are constantly changing, as are their 

production volumes. Chemical industry representatives told us that TSCA 

provides EPA with adequate authority to issue rules requiring companies

to provide EPA with any test and exposure data possessed by the 

companies, and that EPA could use such authority to obtain company 

information on existing chemicals of concern. EPA could then use that 

information to determine whether additional rules should be issued to 

require companies to perform additional testing of the chemicals. 

However, EPA officials told us that it is time-consuming, costly, and 

inefficient for the agency to use a two-step process of (1) issuing rules 

under TSCA (which can take months or years to develop) to obtain 

exposure data or available test data that the chemical industry does not 

voluntarily provide to EPA and then (2) issuing additional rules requiring 

companies to perform specific tests necessary to ensure the safety of the 

chemicals tested. Officials also said that EPA’s authority under TSCA to 

issue rules requiring chemical companies to conduct tests on existing 

chemicals has been difficult to use because the agency must first make 

certain findings before it can require testing. Specifically, TSCA requires 

EPA to find that current data is insufficient; testing is necessary; and that

either (1) the chemical may present an unreasonable risk or (2) that the 

chemical is or will be produced in substantial quantities and that there is 

or may be substantial human or environmental exposure to the chemical.

Once EPA has made the required findings, the agency can issue a 

proposed rule for public comment, consider the comments it receives, and 

promulgate a final rule ordering chemical testing. EPA officials told us that 

Page 5 GAO-06-1032T 
finalizing rules can take from 2 to 10 years and require the expenditure of

substantial resources. Given the time and resources required, the agency 

has issued rules requiring testing for fewer than 200 chemicals. Because 

EPA has used authority to issue rules to require testing so sparingly, it has 

not continued to maintain information on the cost of implementing these 

rules. However, in our October 1994 report on TSCA,2

 we noted that EPA 

officials told us that issuing such a rule can cost hundreds of thousands of 

dollars. 

Given the difficulties involved in requiring testing, EPA officials do not 

believe that TSCA provides an effective means for testing a large number 

of existing chemicals. They believe that EPA could review substantially 

more chemicals in less time if they had the authority to require chemical 

companies to conduct testing and provide test data on chemicals once 

they reach a substantial production volume, assuming EPA had first 

determined that these data cannot be obtained without testing. We have 

long held a similar view based on our reviews involving TSCA, and in our 

in June 2005 report, we recommended that the Congress consider giving 

EPA the authority to require chemical manufacturers and processors to 

develop test data based on substantial production volume and the 

necessity for testing. 

EPA Has Had Difficulty 

Proving That Chemicals 

Pose Unreasonable Risks 

and Has Regulated Few 

Existing Chemicals under 

TSCA 

Even when EPA has toxicity and exposure information on existing 

chemicals, the agency stated that it has had difficulty demonstrating that 

harmful chemicals pose an unreasonable risk and that they should be 

banned or have limits placed on their production or use. Indeed, EPA has 

rarely banned, limited the production, or restricted the use of existing 

chemicals. Since the Congress enacted TSCA in 1976, EPA has issued 

regulations under the act to ban or limit the production or restrict the use 

of only five existing chemicals or chemical classes. For an additional 173

existing chemicals, EPA has required chemical companies to submit 

notices of any significant new uses of the chemical, providing EPA the 

opportunity to review the risks posed by the new use. 

 2

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

Effective, GAO/RCED-94-103 (Washington, D.C.: September 26, 1994).

Page 6 GAO-06-1032T 
Facing difficulties obtaining information on existing chemicals, EPA took 

steps to address this shortcoming with the implementation of the HPV 

Challenge Program in 1998. According to EPA, the lack of information on 

existing chemicals and the relative difficulty of requiring testing under 

TSCA on the scale that would be necessary for the thousands of chemicals 

produced at high volumes, has led EPA, in cooperation with chemical 

companies, environmental groups, and other interested parties, to 

implement a voluntary program to obtain test data on high-productionvolume chemicals from chemical companies. The HPV Challenge Program 

focuses on obtaining chemical company “sponsors” to voluntarily provide 

data on the approximately 2,800 chemicals that chemical companies 

reported in 1990, that they produced at a high volume—generally over 1 

million pounds. 

EPA Implemented a 

Voluntary Program to 

Collect More Industry Data 

on Existing Chemicals 

Through this program, sponsors develop a minimum set of data on the 

chemicals, either by gathering available information, using models to 

predict the chemicals’ properties, or conducting testing of the chemicals. 

EPA plans to use the data collected under the program to prioritize highproduction chemicals for further assessment, but it has not yet adopted a 

methodology for prioritizing the chemicals or for determining those that 

require additional information. In our June 2005 report, we recommended 

that EPA develop and implement such a methodology for using 

information collected through the HVP Challenge Program to prioritize 

chemicals for further review and to identify and obtain additional 

information needed to assess their risks. At EPA’s request, a federal 

advisory group has proposed a methodology for prioritizing the HPV 

Challenge Program chemicals, and EPA anticipates that the agency will 

implement the proposal during 2006.

Nonetheless, other problems exist in the HPV Challenge Program. 

Chemical companies have not volunteered to provide data on all the 

chemicals currently in the HPV Program. In addition, despite the fact that

companies may begin raising the production volumes of other chemicals,

EPA has no mechanism for placing these chemicals on the HPV Challenge

Program list once they are produced in greater volume. We believe that 

action to implement our previously mentioned recommendation that the 

Congress consider giving EPA additional authority to require chemical 

testing could ameliorate such problems. 

Page 7 GAO-06-1032T 
EPA’s review of new chemicals provides only limited assurance that health 

and environmental risks are identified because the agency has limited 

information with which to review them. In the absence of chemical test 

data, EPA largely relies on scientific models that do not always accurately

determine chemicals’ properties or the full extent of their adverse effects.

Further, information that companies provide in the premanufacture 

notices that EPA uses to assess potential exposures to new chemicals are 

estimates that can change substantially once manufacturing begins. 

Despite limitations in the information available on new chemicals, EPA’s 

reviews have resulted in some action being taken to reduce the risks of 

over 3,600 new chemicals submitted for review. 

EPA Lacks Sufficient 

Data to Ensure That 

the Potential Health 

and Environmental 

Risks of New 

Chemicals Are 

Identified 

EPA Has Limited 

Information on New 

Chemicals and Relies on 

Modeling Tools to Assess 

the Health and 

Environmental Risks of 

New Chemicals 

TSCA generally requires chemical companies to notify EPA of their intent

to manufacture or import new chemicals and to provide any available test 

data. Yet EPA estimates that most premanufacture notices do not include 

test data of any type, and only about 15 percent include health or safety 

test data. Chemical companies do not have an incentive to conduct these 

tests because they may take over a year to complete, and some tests may 

cost hundreds of thousands of dollars. During a review of a new chemical, 

EPA evaluates risks by conducting a chemical analysis, searching the 

scientific literature, reviewing agency files (including files of related 

chemicals that have already been assessed by EPA), analyzing toxicity 

data on structurally similar chemicals, calculating potential releases of and 

exposures to the chemical, and identifying the chemical’s potential uses. 

On the basis of this review, EPA makes a decision to (1) take no action; (2) 

require controls on the use, manufacture, processing, distribution in 

commerce, or disposal of the chemical pending development of test data; 

or (3) ban or otherwise regulate the chemical pending the receipt and 

evaluation of test studies performed by the chemical’s manufacturer. 

Because EPA generally does not have sufficient data on a chemical’s 

properties and effects when reviewing a new chemical, EPA uses a method

known as structure activity relationships analysis to screen and evaluate a 

chemical’s toxicity. This method, also referred to as the nearest analogue 

approach, involves using models to compare new chemicals with 

chemicals with similar molecular structures for which test data on health 

and environmental effects are available. 

EPA officials told us that, while the overall accuracy of the models has not 

been validated for regulatory purposes, they are effective as screening 

tools that allow EPA to focus its attention on the chemicals of greatest 

concern—chemicals about which little is known other than that they are 

structurally related to known harmful chemicals. By applying approaches 

Page 8 GAO-06-1032T 
that make conservative predictions, EPA believes that it is more likely to 

identify a false positive (where a chemical is determined to be of concern, 

but on further analysis is found to be of low concern) than a false negative 

(where a chemical is initially viewed as a low concern though on further 

analysis is actually of higher concern). According to EPA, only about 20 

percent of the premanufacture notices received annually go through the 

agency’s more detailed full-review process after they have been initially 

screened. That is, according to EPA officials, the majority of new 

chemicals submitted for review can be screened out as not requiring 

further review because (1) EPA determines on the basis of its screening 

models that a chemical has low potential to harm human health or the 

environment or (2) on the basis of other information, such as the 

anticipated uses, exposures, and releases of the chemicals, only limited 

potential risks to people and the environment are expected. In addition, 

using these models, EPA identifies for possible regulatory action, those 

chemicals belonging to certain chemical categories that based on its prior 

experience in reviewing new chemicals are likely to pose potential risks 

such that testing or controls are needed. In our June 2005 report, we 

recommended that the EPA Administrator develop a strategy for 

improving and validating, for regulatory purposes, the models that EPA 

uses to assess and predict the risks of chemicals and to inform regulatory 

decisions on the production, use, and disposal of the chemicals. 

Estimates of Exposures 

and Other Information 

Provided in 

Premanufacturing Notices 

Can Change after 

Manufacturing Begins 

EPA bases its exposure estimates for new chemicals on information 

contained in premanufacture notices. However, the anticipated production 

volume, uses, exposure levels, and release estimates outlined in these 

notices generally do not have to be amended once manufacturing begins. 

That is, once EPA completes its review and production begins, chemical 

companies are not 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. However, the 

potential risk of injury to human health or the environment may increase 

when chemical companies increase production levels or expand the uses

of a chemical. To address this potential, TSCA authorizes EPA to 

promulgate a rule specifying that a particular use of a chemical would be a 

significant new use. EPA has infrequently issued such rules, which require 

manufacturers, importers, and processors of the chemical for the new use

to notify EPA at least 90 days before beginning manufacturing or 

processing the chemical for that use.

Page 9 GAO-06-1032T 
When EPA’s assessment of a new chemical identifies health and safety 

problems, EPA can issue a proposed rule to prevent chemical companies 

from manufacturing or distributing the chemical in commerce, or to 

otherwise restrict the chemical’s production or use, if the agency believes

the new chemical may present an unreasonable risk before EPA can 

regulate the chemical under the relevant provisions of TSCA. Despite 

limitations in the information available on new chemicals, EPA’s reviews 

have resulted in some action being taken to reduce the risks of over 3,600 

new chemicals that chemical companies have submitted for review. These 

actions ranged from chemical companies voluntarily withdrawing their 

notices of intent to manufacture new chemicals, chemical companies 

entering into consent orders with EPA to produce a chemical under 

specified conditions, and EPA promulgating significant new use rules 

requiring chemical companies to notify EPA of their intent to manufacture 

or process a chemical for new uses. 

EPA Reviews of New 

Chemicals Have Resulted 

in Some Control Actions 

For over 1,700 chemicals, companies withdrew their premanufacture 

notices, sometimes after EPA indicated that the agency planned to initiate

the process for placing controls on the chemical, such as requiring testing 

or prohibiting the production or certain uses of the chemical. EPA officials 

told us that after EPA screens a chemical or performs a more detailed 

analysis of it, chemical companies often drop their plans to market a new 

chemical when the chemical’s niche in the marketplace is uncertain and 

EPA requests that the company develop and submit test data. 

For over 1,300 chemicals, EPA has issued orders requiring chemical 

companies to implement workplace controls or practices during 

manufacturing (pending the development of information), and/or perform 

toxicity testing when the chemical’s production volumes reached certain

levels. EPA may issue these proposed orders to control the production, 

distribution, use, or disposal of a new chemical when there is insufficient 

information available to reasonably evaluate the human health or 

environmental effects of a chemical and when the chemical (1) may 

present an unreasonable risk to human health or the environment or (2) is 

or will be produced in substantial quantities and (a) it either enters or may 

reasonably be anticipated to enter the environment in substantial 

quantities or (b) there is or may be significant or substantial human 

exposure to the substance. While TSCA does not authorize EPA to require 

that chemical companies develop this information, the act does allow EPA 

to control the manufacturing and processing of the chemical until EPA has 

sufficient data to determine if the chemical will pose a risk. 

Page 10 GAO-06-1032T 
For over 570 new chemicals submitted for review, EPA required chemical 

companies to submit premanufacture notices for any significant new uses 

of the chemical, providing EPA the opportunity to review the risks of 

injury to human health or the environment before new uses had begun. 

EPA’s ability to make publicly available the information that it collects 

under TSCA is limited. Chemical companies may claim the information 

they provide to EPA under TSCA as confidential business information. 

While EPA believes that some claims of confidential business information 

may be unwarranted, challenging the claims is resource-intensive. 

EPA’s Ability to Share 

Data Collected Under 

TSCA Is Limited 

When companies submit information to EPA through premanufacture 

notices, many claim a large portion of the information as confidential. 

According to EPA, about 95 percent of premanufacture notices contain 

some information that chemical companies claim as confidential. Under 

EPA regulations, information that is claimed as confidential shall generally 

be treated as such if no statute specifically requires disclosure. Exceptions 

include if the information is required to be released by some other federal 

law or court order, if the company voluntarily withdraws its confidential 

claim, or if the EPA Office of General Counsel makes a final administrative 

determination that the information does not meet the regulatory criteria 

substantiating a legal right to the claim. EPA has not performed any recent 

studies of the appropriateness of confidentiality claims, although a 1992 

EPA study indicated that problems with inappropriate claims were 

extensive. That study examined the extent to which companies made 

confidential business information claims, the validity of the claims, and the 

impact of inappropriate claims on the usefulness of TSCA data to the 

public. While EPA may suspect that some chemical companies’ 

confidentiality claims are unwarranted, they have no data on the number 

of inappropriate claims. 

EPA officials told us that the agency does not have the resources 

necessary to investigate and, where appropriate, challenge claims that it 

believes are inappropriate. Consequently, EPA focuses on investigating 

primarily those claims that it believes may be both inappropriate and 

among the most potentially important—that is, confidentiality claims 

relating to health and safety studies performed by the chemical companies 

involving chemicals currently in commerce. The EPA official responsible 

for initiating challenges to confidentiality claims told us that EPA 

challenges about 14 such claims each year, and that the chemical 

companies withdraw nearly all of the claims when challenged. 

Page 11 GAO-06-1032T 
Officials who have various responsibilities for protecting public health and 

the environment from the dangers posed by chemicals believe that having 

access to confidential TSCA information would allow them to examine 

information on chemical properties and processes that they currently do 

not possess and could enable them to better control the risks of 

potentially harmful chemicals. For example, on the basis of a study 

performed by the state of Illinois with the cooperation of chemical 

companies and EPA, Illinois regulators found that toxicity information 

submitted under TSCA was useful in identifying chemical substances that 

should be included in contingency plans in order to alert emergency 

response and planning personnel to the presence of highly toxic 

substances at facilities. Additionally, the availability of this information 

could assist the states with environmental monitoring and enforcement. 

For instance, using TSCA data, Illinois regulators identified potential 

violations of state environmental regulations, such as cases where 

companies had submitted information to EPA under TSCA but failed to 

submit such information to the states as required.

Likewise, the general public may also find information provided under 

TSCA useful. Individual citizens or community groups may have a specific 

interest in information on the risks of chemicals that are produced or used

in nearby facilities. For example, neighborhood organizations can use such 

information to engage in dialogue with chemical companies about 

reducing chemical risks, preventing accidents, and limiting chemical 

exposures. 

TSCA’s provisions are in contrast to those of some foreign governments’ 

environmental laws, such as Canada, which authorizes its environmental 

agency to share confidential business information with other governments 

under agreements or arrangements where the government undertakes to

keep the information confidential. Chemical industry representatives told

us that the industry also sees benefits in allowing EPA to share 

information with other countries in order to harmonize chemical 

assessments among developed countries and improve chemical risk 

assessment methods by allowing cooperation on improving models used 

to predict chemical toxicity. The chemical industry is concerned, however, 

that confidential information be protected from inappropriate disclosure.

These chemical industry representatives told us that some countries 

currently do not have adequate procedures for protecting confidential 

business information. However, they suggested that the policies and 

procedures EPA currently uses to protect confidential information are 

appropriate. Accordingly, they said that the chemical industry would not 

object to TSCA revisions allowing EPA to share confidential information 

Page 12 GAO-06-1032T 
with foreign countries and organizations, provided that such revisions 

contain specific reference to safeguards that EPA would establish and 

enforce to ensure that those receiving the information have stringent 

policies and procedures to protect it.

Our June 2005 report included two recommendations for addressing the 

problems we identified related to the confidential business information 

provisions of TSCA. We recommended that EPA revise its regulations to 

require companies to reassert claims of confidentiality within a certain

period after the information is initially claimed as confidential. We also 

recommended that the Congress consider amending TSCA to authorize 

EPA to share with the states and foreign governments the confidential 

business information that chemical companies provide to EPA, subject to

regulations to be established by EPA in consultation with the chemical 

industry and other interested parties that would set forth the procedures 

to be followed by all recipients of the information in order to protect the 

information from unauthorized disclosures. EPA did not disagree with the 

report’s findings and is in the process of implementing several of our 

recommendations. For example, EPA is currently launching a pilot project 

to review claims of confidentiality for data on certain older chemicals. 

Mr. Chairman, EPA’s efforts to encourage companies to voluntarily 

provide data on existing chemicals is commendable. However, the 

fundamental and historical problems the agency has experienced with 

utilizing its authorities under TSCA continue to limit EPA’s ability to 

manage its chemical review program and assess chemical risks. In this 

respect, EPA faces considerable difficulties using its authorities to require 

testing of existing chemicals, which prevents the agency from reviewing 

substantially more chemicals in less time than it could if it had the 

authority to require chemical companies to provide test data on chemicals 

once they have reached a substantial production volume. Moreover, EPA’s 

ability to provide the public with information on chemical production and 

risks is hampered by the strict confidential business information 

provisions of TSCA. While protecting such information is a legitimate 

concern, TSCA currently prohibits EPA from disclosing much data for 

important purposes such as assisting state agencies in carrying out their

environmental management responsibilities and foreign governments in 

harmonizing international chemical assessment approaches—a goal 

generally shared by these governments and the chemical industry. We 

believe the actions that we have recommended to both the Congress and 

EPA would go a long way in addressing the challenges EPA faces in 

exercising its authorities under TSCA. 

Concluding 

Observations 

Page 13 GAO-06-1032T 
Mr. Chairman, this concludes my prepared statement. I would be happy to

respond to any questions that you or Members of the Committee may 

have. 

For further information about this testimony, please contact me Mr. John

B. Stephenson at (202) 512-3841. David Bennett, John Delicath, Tyra 

DiPalma-Vigil, Richard Johnson, Valerie Kasindi, and Ed Kratzer made key 

contributions to this statement. 

Page 14 GAO-06-1032T 

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