Chemical Regulation: Comparison of U.S. and Recently Enacted	 
European Union Approaches to Protect against the Risks of Toxic  
Chemicals (17-AUG-07, GAO-07-825).				 
                                                                 
Chemicals play an important role in everyday life. However, some 
chemicals are highly toxic and need to be regulated. 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, but some have questioned whether TSCA provides EPA  
with enough tools to protect against chemical risks. Like the	 
United States, the European Union (EU) has laws governing the	 
production and use of chemicals. The EU has recently revised its 
chemical control policy through legislation known as		 
Registration, Evaluation and Authorization of Chemicals (REACH)  
in order to better identify and mitigate risks from chemicals.	 
GAO was asked to review the approaches used under TSCA and REACH 
for (1) requiring chemical companies to develop information on	 
chemicals' effects, (2) controlling risks from chemicals, and (3)
making information on chemicals available to the public. To	 
review these issues, GAO analyzed applicable U.S. and EU laws and
regulations and interviewed U.S. and EU officials, industry	 
representatives, and environmental advocacy organizations. GAO is
making no recommendations.					 
-------------------------Indexing Terms------------------------- 
REPORTNUM:   GAO-07-825 					        
    ACCNO:   A74707						        
  TITLE:     Chemical Regulation: Comparison of U.S. and Recently     
Enacted European Union Approaches to Protect against the Risks of
Toxic Chemicals 						 
     DATE:   08/17/2007 
  SUBJECT:   Chemical industry					 
	     Chemical regulation				 
	     Comparative analysis				 
	     Data collection					 
	     Environmental law					 
	     Environmental monitoring				 
	     Hazardous substances				 
	     Health hazards					 
	     Information disclosure				 
	     Product evaluation 				 
	     Reporting requirements				 
	     Risk assessment					 
	     Toxic substances					 

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GAO-07-825

   

     * [1]Results in Brief
     * [2]Background
     * [3]REACH Requires Chemical Companies to Develop More Informatio

          * [4]TSCA Does Not Require Chemical Companies to Develop Informat
          * [5]TSCA Does Not Require Chemical Companies to Develop Hazard I
          * [6]REACH Requires Chemical Companies to Submit Hazard Informati

     * [7]TSCA Generally Requires EPA to Demonstrate That Chemicals Wi

          * [8]EPA Has Had Difficulty Proving That Chemicals Pose Unreasona
          * [9]TSCA's Section 5 Provides Limited Authority to Restrict New
          * [10]REACH Requires Chemical Companies to Request Authorization t

     * [11]Both TSCA and REACH Have Provisions to Make Certain Informat

          * [12]EPA's Ability to Share Data Collected under TSCA Is Limited
          * [13]REACH Has Provisions to Protect Confidential Business Inform

     * [14]Concluding Observations
     * [15]Agency Comments and GAO Response
     * [16]GAO Contact
     * [17]Staff Acknowledgments

          * [18]Order by Mail or Phone

Report to Congressional Requesters

United States Government Accountability Office

GAO

August 2007

CHEMICAL REGULATION

Comparison of U.S. and Recently Enacted European Union Approaches to
Protect against the Risks of Toxic Chemicals

GAO-07-825

Contents

Letter 1

Results in Brief 4
Background 5
REACH Requires Chemical Companies to Develop More Information than TSCA on
the Effects of Chemicals on Human Health and the Environment 7
TSCA Generally Requires EPA to Demonstrate That Chemicals Will Cause
Unreasonable Risk While REACH Requires Chemical Companies to Ensure No
Adverse Chemical Effects 18
Both TSCA and REACH Have Provisions to Make Certain Information Available
to the Public, but REACH Requires Greater Public Disclosure 25
Concluding Observations 29
Agency Comments and GAO Response 30
Appendix I Scope and Methodology 32
Appendix II Comparison of Selected Provisions of U.S. Toxic Substances
Control Act and the EU's Registration, Evaluation and Authorization of
Chemicals 34
Appendix III Additional Options For Strengthening EPA's Ability to Assess
and Regulate Chemicals under TSCA 41
Appendix IV Summary of Chemical Hazard Information Requirements under
REACH, TSCA, and the HPV Challenge Program by 43
Appendix V Comments from the Environmental Protection Agency 48
Appendix VI GAO Contact and Staff Acknowledgments 51

Tables

Table 1: Comparison of the Number of Chemical Tests Potentially Occurring
by Production Volume under TSCA, the HPV Challenge Program, and REACH
(shown in metric tons) 17
Table 2: Comparison of Chemical Information Requirements by Increasing
Production Volume for the EU and the United States (highlighted) 43

Abbreviations

CBI confidential business information
EINECS European Inventory of Existing Commercial Chemical Substances
EPA Environmental Protection Agency
EU European Union
HPV High Production Volume
IUR Inventory Update Rule
MTBE methyl-t-butyl ether
NPPTAC National Pollution Prevention and Toxics Advisory Committee
OECD Organization for Economic Cooperation and Development
OPPT Office of Pollution Prevention and Toxics
PBT persistent, bioaccumulative, and toxic PCB polychlorinated biphenyls
PMN premanufacture notice
REACH Registration, Evaluation and Authorization of Chemicals
SAR Structure Activity Relationship
SNUR significant new use rule
TSCA Toxic Substances Control Act
VCCEP Voluntary Children's Chemical Evaluation Program
vPvB very persistent, very bioaccumulative 

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United States Government Accountability Office
Washington, DC 20548

August 17, 2007

The Honorable Barbara Boxer
Chair, Committee on Environment and Public Works
United States Senate

The Honorable Frank R. Lautenberg
United States Senate

Each year thousands of chemicals are used by U.S. industries to produce
items widely used throughout society, including consumer products such as
cleansers, paints, plastics, and fuels as well as industrial solvents and
additives. While chemicals play an important role in people's everyday
lives, some may adversely affect human health and the environment and need
to be regulated to address health and safety risks. Because of concerns
that current legislation may not be adequate to protect human health and
the environment, congressional interest in revising chemical control laws
has heightened in recent years. Each year thousands of chemicals are used
by U.S. industries to produce items widely used throughout society,
including consumer products such as cleansers, paints, plastics, and fuels
as well as industrial solvents and additives. While chemicals play an
important role in people's everyday lives, some may adversely affect human
health and the environment and need to be regulated to address health and
safety risks. Because of concerns that current legislation may not be
adequate to protect human health and the environment, congressional
interest in revising chemical control laws has heightened in recent years.

In 1976, the Congress passed the Toxic Substances Control Act (TSCA),
which authorizes the Environmental Protection Agency (EPA) to obtain In
1976, the Congress passed the Toxic Substances Control Act (TSCA), which
authorizes the Environmental Protection Agency (EPA) to obtain existing
data from and require testing by chemical companies concerning the
environmental and health effects of chemical substances. TSCA authorizes
EPA to promulgate rules to regulate the manufacture, distribution, or use
of chemicals once EPA has determined the chemicals present an unreasonable
risk of injury to health or the environment. In promulgating a rule to
control activities based on a finding of unreasonable risk, EPA must
consider, among other things, (1) the chemical's effects on human health
and the environment and the magnitude of human and environmental exposure
to the chemical; (2) the benefits of the chemical for various uses and the
availability of substitutes for those uses; and (3) the reasonably
ascertainable consequences of the rule, after consideration of the effect
on the national economy, small businesses, technological innovation, the
environment, and public health.

TSCA addresses those chemicals manufactured or imported into the United
States, but it excludes certain substances because they are regulated
under other laws, such as pesticides that are regulated under the Federal
Insecticide, Fungicide, and Rodenticide Act, and pharmaceuticals that are
regulated under the Federal Food, Drug, and Cosmetics Act. Whereas other
environmental and occupational health and safety laws generally control
only disposal, environmental releases, or workplace exposures, under TSCA,
EPA can control the entire life cycle of chemicals from their production,
distribution in commerce, and use, to their disposal.

TSCA authorizes EPA to assess chemicals before they enter commerce (new
chemicals) and those chemicals already in commerce (existing chemicals).
EPA maintains a list of chemicals in commerce called 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, EPA has reviewed more than 45,000 new chemicals, of which
approximately 20,000 were added to the inventory after chemical companies
began manufacturing them.

To implement TSCA, EPA has developed programs to assess and require
testing of chemicals, and manage identified potential risks from new and
existing chemicals. To assess risks, EPA reviews information it obtains
from companies and other sources on a chemical's potential exposure levels
and its potential adverse effects on human health and the environment. If
EPA finds that a reasonable basis exists to conclude that a chemical
presents or will present an unreasonable risk to human health or the
environment, EPA can promulgate a rule to ban or restrict the chemical's
production, processing, distribution in commerce, use, or disposal, or to
require that warning labels be placed on the chemical.

Information about a chemical's effects on human health or the environment
are useful to the public in making informed decisions about the products
they use and the risks of chemicals that may be produced or used in nearby
facilities. Information about a chemical's hazards includes data on
physical properties (such as melting point or flammability) and health and
environmental effects (such as skin irritation, cancer, birth defects, or
toxicity to plants and animals). However, certain information, such as the
chemical's identity, that EPA collects under TSCA is not always available
to the public. In order to protect trade secrets and privileged or
confidential commercial or financial information, TSCA allows chemical
companies to designate information provided to EPA as confidential and, if
it meets certain criteria, EPA must protect this information from
disclosure.

Like the United States, the European Union (EU) has laws and regulations
governing the manufacturing and use of chemicals. However, the EU has
recently revised, but has not yet implemented, its chemical control policy
through legislation known as Registration, Evaluation and Authorization of
Chemicals (REACH). The purpose of REACH is to ensure a high level of
protection of human health and the environment while enhancing
competitiveness and innovation in the chemical industry. REACH went into
effect on June 1, 2007, and many of its provisions will be phased in over
an 11-year period. A newly created European Chemicals Agency that will
administer REACH is currently being organized and staffed.

In this context, you asked that we provide comparative information on TSCA
and REACH. Specifically, you asked that we compare the approaches used
under TSCA and REACH for (1) requiring chemical companies to develop
information on their chemicals' effects on human health and the
environment; (2) controlling risks from the production, distribution, or
use of chemicals; and (3) making information on chemicals available to the
public while protecting confidential business information (CBI). In
addressing these issues, we also obtained information on some of EPA's
voluntary chemical control programs designed to complement TSCA. In
addition, we identified some legislative revisions that we have reported
on in previous reports as options for strengthening EPA's ability to
assess and regulate chemicals under TSCA. Information on these revisions
is presented in appendix III.

To compare TSCA and REACH in their approaches to identifying chemicals
harmful to public health and the environment, controlling chemical risks,
and disclosing chemical data to the public while protecting confidential
business information, we identified and analyzed the policies and
guidelines of the United States and the EU on these issues. These efforts
were augmented by interviews with (1) EPA officials responsible for
implementing TSCA including the Director of EPA's Office of Pollution
Prevention and Toxics (OPPT), the EPA office with primary responsibility
for implementing TSCA, and (2) EU officials who helped develop and who
will be involved in implementing REACH, including the Environment
Counselor for the Delegation of the European Commission to the United
States. We also interviewed representatives of the American Chamber of
Commerce to the European Union, American Chemistry Council (a national
chemical manufacturers association), Environmental Defense (a national,
nonprofit environmental advocacy organization), the European Chemical
Industry Council (an EU chemical manufacturers' association), the European
Environmental Bureau (a federation of environmental advocacy organizations
based in the EU), and the Synthetic Organic Chemical Manufacturers
Association (a national, specialty chemical manufacturers' association).
We also gathered documentation on EPA's voluntary programs. A detailed
description of our scope and methodology is presented in appendix I. We
performed our work between January 2006 and May 2007 in accordance with
generally accepted government auditing standards.

Results in Brief

REACH generally requires chemical companies to develop and share with
government regulators information on the effects of the chemicals they
produce on human health and the environment, while TSCA generally does
not. For example, under REACH, chemical companies provide, and in some
cases develop, information on chemicals' physical/chemical properties and
health and environmental effects for both new and existing chemicals
produced over specified volumes. REACH also provides regulators the
general authority to require chemical companies to provide additional test
data and other information when necessary to evaluate a chemical's risk to
human health and the environment. In contrast, TSCA places the burden on
EPA to demonstrate that data on health and environmental effects are
needed before requiring chemical companies to develop the data. In this
regard, while TSCA requires chemical companies to notify EPA before
producing or importing a new chemical, it does not require chemical
companies to develop and provide data on health and environmental effects
unless EPA promulgates a rule requiring them to do so. In promulgating
such a rule, EPA must demonstrate that data already available are
insufficient and that either (1) the chemical may present an unreasonable
risk or (2) 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.

REACH is based on the principle that chemical companies have the
responsibility to demonstrate that the chemicals they place in the market,
distribute, or use do not adversely affect human health or the
environment, while TSCA generally requires EPA to demonstrate that
chemicals pose risks to human health or the environment prior to
controlling risks related to their production, distribution, or use. Under
REACH, chemical companies must obtain authorization to continue to use a
chemical of very high concern, such as a chemical for which there is
scientific evidence of probable serious health or environmental effects.
Generally, to obtain such authorization, each chemical company needs to
demonstrate that it can adequately control risks posed by the chemical,
such as by requiring that workers wear safety equipment when working with
the chemical or otherwise ensuring that the chemical is produced under
safe conditions. If the chemical company cannot provide evidence of
adequate control, authorization would be granted only if the socioeconomic
advantages of a specific use of the chemical are greater than its
potential risks, and if there are no suitable alternatives or
technologies. Under TSCA, EPA has differing authorities to control the
risks posed by new and existing chemicals. For new chemicals, EPA can
restrict a chemical's production or use if the agency determines that
insufficient information exists to permit a reasoned evaluation of the
health and environmental effects of the chemical and that, in the absence
of such information, the chemical may present an unreasonable risk to
human health or the environment; the chemical is or will be produced in
substantial quantities and either enters or may reasonably be anticipated
to enter the environment in substantial quantities; or there is or may be
significant or substantial human exposure to the substance. For existing
chemicals, EPA may regulate those chemicals for which it finds a
reasonable basis exists to conclude that they present or will present an
unreasonable risk to human health or the environment. In this regard, EPA
can promulgate a rule that bans or restricts the chemical's production,
processing, distribution in commerce, use, or disposal, or that requires
warning labels be placed on the chemical. However, TSCA requires EPA to
choose the least burdensome requirement on the chemical industry that will
adequately protect against the risk.

TSCA and REACH both have provisions to protect information claimed by
chemical companies as confidential or sensitive business information;
however, REACH requires greater public disclosure of certain information,
including information about (1) basic chemical properties such as melting
and boiling points and (2) analytical methods that make it possible to
detect a dangerous substance when discharged into the environment and to
determine the effects of direct exposure to humans. In addition, REACH
places greater restrictions on the kinds of information companies may
claim as confidential or sensitive. For example, REACH generally does not
allow confidentiality claims to apply to the chemical's trade name, it and
does not allow such claims to apply to guidance on the chemical's safe
use.

Background

In the last several decades, Congress has passed various legislation to
increase federal agencies' abilities to identify and address the health
and environmental risks associated with toxic chemicals and to address
such risks. Some of these laws, such as the Clean Air Act; the Clean Water
Act; the Federal Food, Drug and Cosmetic Act; and the Federal Insecticide,
Fungicide, and Rodenticide Act authorize the control of hazardous
chemicals in, among other things, the air, water, and soil and in food,
drugs, and pesticides. Other laws, such as the Occupational Safety and
Health Act and the Consumer Product Safety Act, can be used to protect
workers and consumers from unsafe exposures to chemicals in the workplace
and the home. Nonetheless, the Congress found that human beings and the
environment were being exposed to a large number of chemicals and that
some could pose an unreasonable risk of injury to health or the
environment. In 1976, the Congress passed TSCA to provide EPA with the
authority to obtain information on chemicals and regulate those substances
that pose an unreasonable risk to human health or the environment.^1 While
other environmental and occupational health laws generally control only
the release of chemicals in the environment, exposures in the workplace,
or the disposal of chemicals, TSCA allows EPA to control the entire life
cycle of chemicals from their production and distribution to their use and
disposal.^2

In October 2003, the European Commission^3 presented a proposal for a new
EU regulatory system for chemicals. REACH was proposed because the
Commission believed that the current legislative framework for chemicals
in the EU did not produce sufficient information about the effects of
chemicals on human health and the environment. In addition, the risk
assessment process was slow and resource-intensive and did not allow the
regulatory system to work efficiently and effectively. Under REACH,
authority exists to establish restrictions for any chemical that poses
unacceptable risks and to require authorization for the use of chemicals
identified as being of very high concern. These restrictions could include
banning uses in certain products, banning uses by consumers, or even
completely banning the chemical. Authorization will be granted if a given
manufacturer can demonstrate that the risks from a given use of the
chemical can be adequately controlled if a threshold can be determined for
the chemical. Or, if no threshold can be determined, the manufacturer has
to demonstrate that the socioeconomic benefits outweigh the risks
associated with continued use and that there are no suitable alternatives
or technologies available. In addition, a key aspect of REACH is that it
places the burden on manufacturers, importers, and downstream users to
ensure that they manufacture, place on the market, or use such substances
that do not adversely affect human health or the environment. Its
provisions are underpinned by the precautionary principle.^4 REACH was
approved in December 2006 and went into effect in June 2007. To avoid
overloading regulators and companies with the work arising from the
registration process, full implementation of all the provisions of REACH
will be phased in over an 11-year period (or by 2018).

^1Pub. L. No. 94-469, 90 Stat. 2003 (1976) (codified at 15 U.S.C. SS
2601-2692).

^2TSCA does not apply to certain substances such as nuclear material,
firearms and ammunition, pesticides, food, food additives, tobacco, drugs,
and cosmetics.

^3The European Commission is one of the three primary institutions
governing the EU. One of the primary roles of the European Commission is
to propose and implement legislation for the EU. The other two governing
bodies are the European Parliament and the Council of the European Union.
Among other responsibilities, the Parliament and the Council jointly adopt
new European laws in many policy areas.

REACH Requires Chemical Companies to Develop More Information than TSCA on the
Effects of Chemicals on Human Health and the Environment

TSCA does not require companies to develop information for either new or
existing chemicals, whereas REACH generally requires companies to submit
and, in some circumstances, requires companies to develop such information
for both kinds of chemicals. For new chemicals, TSCA requires companies to
submit to EPA any available human health and environmental data, but
companies do not have to develop additional information unless EPA
requires additional test data through a test rule or other EPA action. For
existing chemicals, companies do not have to develop such information
unless EPA requires them to do so. In contrast, companies generally are
required under REACH to provide and develop where needed the European
Chemicals Agency with health and environmental data. The extent of such
data depends on the annual production volume of the chemical.

TSCA Does Not Require Chemical Companies to Develop Information on the Hazards
of New Chemicals

TSCA does not require chemical companies to test new chemicals for their
effect on human health or the environment, but it requires companies to
submit such information if it already exists when they submit a
premanufacture notice (PMN) notifying EPA of their intent to manufacture a
new chemical. This notice provides, among other things, certain
information on the chemical's intended uses and potential exposure. TSCA
also requires chemical companies to submit data and other information on
the physical/chemical properties, fate, or health and environmental
effects of a chemical, which we refer to in this report as "hazard
information," that the companies possesses or is reasonably ascertainable
by them when they submit a PMN to EPA. In part because TSCA does not
require chemical companies to develop hazard information before submitting
a PMN, EPA employs several other approaches for assessing hazards,
including using models that compare new chemicals with existing chemicals
with similar molecular structures for which test data on health and
environmental effects are available. In June 2005, we recommended that EPA
develop a strategy for improving and validating the models that EPA uses
to assess and predict the hazards of chemicals.^5 EPA is currently
devising such a strategy, according to agency officials.

^4In general, the precautionary principle means that where there are
threats of serious or irreversible damage, lack of full scientific
certainty shall not be used as a reason for postponing cost-effective
measures to reduce risks to human health and the environment.

EPA receives approximately 1,500 new chemical notices each year, half of
which are exemption requests,^6 and has reviewed more than 45,000 from
1979 through 2005.^7 PMNs include information such as specific chemical
identity estimated maximum production volume for 12 months of production a
description of how the chemical will be processed and used and estimates
of how many workers may be exposed to the chemical. Additionally, EPA
requires that the following information be submitted with a PMN: all
existing health and environmental data in the possession of the submitter,
parent company, or affiliates, and a description of any existing data
known to or reasonably ascertainable by the submitter. EPA estimates that
most PMNs do not include test data of any type, and only about 15 percent
include health and safety data--such as acute toxicity or skin and eye
irritation data.

In some cases, EPA may determine during the review process that more data
are needed for an analysis of a chemical's potential risks and often will
negotiate an agreement with the chemical company to conduct health hazard
or environmental effects testing. According to EPA, more than 300 testing
agreements have been issued since EPA began reviewing new chemicals in
1979. In some cases, however, the chemical company may voluntarily
withdraw the PMN rather than incur the costs of hazard testing requested
by EPA, or for other reasons. EPA does not maintain records as to how many
PMNs chemical companies have withdrawn because of potential EPA action.

^5GAO, Chemical Regulation: Options Exist to Improve EPA's Ability to
Assess Health Risks and Manage Its Chemical Review Program, [19]GAO-05-458
( Washington, D.C.: June13,2005).

^6EPA may exempt a chemical company from the PMN requirement upon
application from the company showing to EPA's satisfaction that the
chemical will not present any unreasonable risk of injury to human health
or the environment and under such restrictions as EPA deems appropriate.
EPA regulations relating to premanufacture notice exemptions, including
the restrictions applicable to specific exemptions, appear at 40 C.F.R.
part 723.

^7According to EPA, about half of the premanufacture notices the agency
receives from chemical companies are for new chemicals that, for various
reasons, never enter the marketplace. These chemicals are not listed on
the TSCA inventory.

TSCA Does Not Require Chemical Companies to Develop Hazard Information for
Existing Chemicals, and EPA Uses Regulatory and Voluntary Programs to Gather
Such Information for Certain Chemicals

While TSCA does not require chemical companies to develop information on
the harmful effects of existing chemicals on human health or the
environment, TSCA provides that EPA, by issuing a test rule, can require
such information on a case-by-case basis. Before promulgating such a rule
EPA must find, among other things, that current data are insufficient,
testing is necessary, and that either (1) the chemical may present an
unreasonable risk or (2) 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. EPA officials responsible for
administering the act said that TSCA's test rule provision and
data-gathering authorities can be burdensome and too time consuming for
EPA to administer. Because EPA has limited information on existing
chemicals and the difficulty in promulgating test rules, EPA uses
voluntary programs to help gather more data to assess risks on certain
chemicals.

While TSCA authorizes EPA to require testing of existing chemicals, the
act does not authorize the agency to do so unless EPA first determines on
the basis of risk or exposure information that the chemicals warrant such
testing. TSCA provides EPA the authority to obtain hazard information
needed to assess chemicals by issuing rules under Section 4 of TSCA
requiring chemical companies to test to determine the health and
environmental effects of chemicals and submit the test data to EPA.
However, in order for EPA to issue a test rule, the agency must determine
that a chemical (1) may present an unreasonable risk of injury to health
or the environment or (2) is or will be produced in substantial quantities
and (a) there is or may be significant or substantial human exposure to
the chemical or (b) it 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. Once EPA has made the required determination, the
agency can issue a proposed rule for public comment, consider the comments
it receives, and promulgate a final rule ordering chemical testing. OPPT
officials responsible for implementing TSCA told us that finalizing rules
under Section 4 of TSCA can take from 2 to 10 years and require the
expenditure of substantial resources. EPA has used its authority to
require testing for about 200 existing chemicals since the agency began
reviewing chemicals under TSCA in 1979. EPA does not maintain estimates of
the cost of implementing these rules. However, in our September 1994
report on TSCA, we noted that EPA officials told us that issuing a rule
under Section 4 can cost up to a $234,000.^8 Given the difficulties and
cost of requiring testing, EPA could review substantially more chemicals
in less time if it had authority to require chemical companies to conduct
testing and provide test data on chemicals once they reach a substantial
production volume. In June, 2005, we stated that Congress may wish to
consider amending TSCA to provide EPA such authority.^9

As an alternative to formal rule making, EPA asserts that Section 4 of
TSCA provides EPA implied authority to enter into "enforceable consent
agreements" with chemical companies that would require them to conduct
testing when there is insufficient data available to assess a chemical's
risk. EPA uses enforceable consent agreements to accomplish testing where
a consensus exists among EPA, affected manufacturers and/or processors,
and interested members of the public concerning the need for and scope of
testing. According to EPA, these agreements allow greater flexibility in
the design of the testing program and negotiating these agreements is
generally less costly and time consuming than promulgating test rules. EPA
has entered into consent agreements with chemical companies to develop
tests for about 60 chemicals where the agency determined additional data
were needed to assess the chemical's risk.

Under Section 8 of TSCA, EPA promulgates rules directing chemical
companies to 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 health and environmental effects,
and the number of workers exposed to the chemical. Section 8(d) authorizes
EPA to promulgate rules under which chemical companies are required to
submit lists or copies of any health and safety studies to EPA. Finally,
Section 8 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.

According to EPA, the agency has issued about 50 Section 8(d) rules
covering approximately 1,000 chemicals. As a result of these rules, EPA
has received nearly 50,000 studies covering environmental fate, human
health effects, and environmental effects. However, TSCA Section 8(d) only
applies to existing studies and does not require companies to develop new
studies.

^8GAO, Toxic Substances Control Act: Legislative Changes Could Make the
Act More Effective, [20]GAO/RCED-94-103 (Washington, D.C.: Sept. 26,
1994).

^9 [21]GAO-05-458.

The TSCA Inventory Update Rule (IUR),^10 currently requires chemical
companies to report every 5 years to EPA the site and manufacturing
information for chemicals in the TSCA inventory that they manufacture or
import in amounts of 25,000 pounds or greater at a single site. For the
most current reporting cycle and for subsequent reporting cycles, chemical
companies must report additional information--such as uses, the types of
consumer products the chemical will be used in--including those intended
for use by children, and the number of workers who could potentially be
exposed--for chemicals manufactured or imported in amounts of 300,000
pounds or more at a single site.^11

In response to the lack of information on existing chemicals and the
relative difficulty the agency faces in requiring companies to conduct
additional testing under TSCA, EPA has taken efforts to increase the
amount of the information it can access on chemicals by implementing a
voluntary program called the High Production Volume (HPV) Challenge
Program. The HPV Challenge Program focuses on obtaining chemical company
sponsors to voluntarily provide data on approximately 2,800 chemicals that
chemical companies reported in 1990 were domestically produced or imported
at a high volume--over 1 million pounds. Through this program, sponsors
develop a basic set of screening level information on the chemicals either
by gathering available data, using models to predict the chemicals'
properties, or conducting testing of the chemicals. The six data endpoints
collected under the HPV Challenge Program are acute toxicity, repeat dose
toxicity, developmental and reproductive toxicity, mutagenicity,
ecotoxicity, and environmental fate.^12 EPA believes that these basic data
are needed to make an informed, preliminary judgment about the hazards of
HPV chemicals. In June 2005, we recommended that EPA develop a methodology
for using information collected through the HPV Challenge Program to
prioritize chemicals for further review.^13 EPA's Director of OPPT told us
the agency developed such a methodology as data from chemical companies
became available and are currently applying the methodology to assess HPV
chemicals. The methodology was developed based on input received from an
advisory committee, the National Pollution Prevention and Toxics Advisory
Committee (NPPTAC).^14

^10In 1977, EPA promulgated a rule under TSCA, Section 8(a), to compile and
keep current an inventory of chemicals in commerce in the United States.
This inventory is called the TSCA Chemical Substance Inventory or TSCA
Inventory. In 1986, EPA promulgated the Inventory Update Reporting (IUR)
regulation to facilitate the periodic updating of the TSCA Inventory and
to support activities associated with implementing TSCA. The 1986
regulation required chemical companies to report to EPA every 4 years the
identity of and basic manufacturing information for organic chemicals
produced annually in quantities of 10,000 pounds or greater at each plant
site they own or control. In 2003, EPA amended the IUR, expanding the
range of chemicals (inorganic chemicals are now included as well as
organic chemicals) and plant sites reporting, expanding the types of
exposure and use data reported, and raising the production volume
threshold that triggers reporting. EPA published additional changes in the
TSCA Inventory Update Reporting Revisions in 2005, including changing the
reporting frequency from every 4 years to every 5 years.

^11The reporting for 2005 data--the most current cycle--ended in March
2007.

Despite these promising voluntary efforts regarding high-production-volume
chemicals, several difficulties remain, as we have noted in our prior
work.^15 For example, (1) chemical companies have not agreed to test
approximately 300 chemicals identified by EPA as high-production-volume
chemicals; (2) additional chemicals will become high-production chemicals
in the constantly changing commercial chemical marketplace; and (3)
chemicals without a particularly high-production volume may also warrant
testing, based on their toxicity and the nature of exposure to them. In
addition, this program may not provide enough information for EPA to use
in making risk-assessment decisions. While the data in the HPV Challenge
Program and the new exposure and use reporting under the IUR may help EPA
prioritize chemicals of concern, the data may not provide sufficient
evidence for EPA to determine whether a reasonable basis exists to
conclude that the chemical presents an unreasonable risk of injury to
health or the environment and that regulatory action is necessary.
Although the chemical industry may be willing to take action, even before
EPA has the evidence required for rule making under TSCA, the industry is
nonetheless large and diverse, and it is uncertain that all companies will
always take action voluntarily.

^12An endpoint is the chemical or biological effect that is assessed by a
test method.

^13 [22]GAO-05-458.

^14NPPTAC is a national advisory body chartered under the Federal Advisory
Committee Act to provide advice, information and recommendations on the
overall policy and operation of programs managed by EPA's Office of
Pollution Prevention and Toxics in performing its duties and
responsibilities under TSCA and the Pollution Prevention Act. EPA has not
held a NPPTAC meeting since the resignation of three NPPTAC members in
October 2006, which resulted in an imbalance in representation on the
Committee. EPA is evaluating options for NPPTAC's future.

^15 [23]GAO-05-458.

To ensure that adequate data are made publicly available to assess the
special impact that industrial chemicals may have on children, EPA
launched the Voluntary Children's Chemical Evaluation Program (VCCEP). In
December 2000, EPA implemented VCCEP first as a pilot program. EPA's goal
is to learn from this pilot program before a final VCCEP process is
determined and before additional chemicals are selected. For the VCCEP
pilot, EPA identified 23 commercial chemicals to which children have a
high likelihood of exposure and the information needed to assess the risks
to children from these chemicals. Recently, EPA requested comments on the
implementation of the pilot program from stakeholders and other interested
parties but has not yet responded to the comments or evaluated the program
for its effectiveness.

EPA is running a pilot of the VCCEP so it can gain insight into how best
to design and implement the VCCEP in order to effectively provide the
agency and the public with the means to understand the potential health
risks to children associated with exposure to these and ultimately other
chemicals to which children may be exposed. EPA intends the pilot to be
the means of identifying efficiencies that can be applied to any
subsequent implementation of the VCCEP. Another purpose for running the
pilot is the opportunity it will offer to test the performance of the peer
consultation process. For the VCCEP pilot, the purpose of the peer
consultation process is to provide a forum for scientists and relevant
experts from various stakeholder groups to exchange scientific views on
the chemical sponsor's data submissions and in particular on the
recommended data needs.

Under the VCCEP pilot, EPA is pursuing a three-tiered approach for
gathering information, with tier 3 involving more detailed toxicology and
exposure studies than tier 2, and tier 2 involving more detailed
toxicology and exposure studies than tier 1. EPA asked companies that
produce and/or import 23 specific chemicals to volunteer to sponsor their
chemical in the first tier of the VCCEP pilot. EPA selected these 23
chemicals because the agency believed them to be especially relevant to
children's chemical exposures, such as the presence of the chemical in
human tissue or blood, in food and water children eat and drink, and in
air children breathe. In addition, many of these chemicals were known to
be relatively "data rich" in that chemical data were already available.
Chemical companies have volunteered to sponsor 20 of the 23 chemicals in
the VCCEP. EPA believes that these 20 chemicals provide an adequate basis
for evaluating the VCCEP pilot.

Chemical companies volunteering to sponsor a chemical under the program
have agreed to make chemical-specific public commitments to make certain
hazard, exposure, and risk assessment data and analyses publicly
available. For toxicity data, specific types of studies have been assigned
to each of the three tiers. For exposure data, the depth of exposure
information increases with each tier. If data needs are identified through
the peer consultation process, the sponsor will choose whether to
volunteer for any additional data generation or testing and whether to
provide additional assessments in subsequent tiers. However, company
sponsors are under no obligation to volunteer for tiers 2 and 3, even if
EPA determines additional information is needed. After the submission of
tier 1 information and its review by the peer consultation
group--consisting of scientific experts with extensive and broad
experience in toxicity testing and exposure evaluations--EPA reviews the
sponsor's assessment and develops a response, focusing primarily on
whether any additional information is needed to adequately evaluate the
potential risks to children. If additional information is needed, EPA will
indicate what information should be provided in tier 2. Companies will
then be given an opportunity to sponsor chemicals at tier 2. EPA plans to
repeat this process to determine whether tier 3 information is needed.
Information from all three tiers may not always be necessary to adequately
evaluate the risk to children.

According to EPA officials, since the program's inception, sponsors have
submitted 15 of the 20 assessments on chemicals to EPA and the peer
consultation group. The peer consultation group has issued reports on 13
of the 15 chemical submissions. EPA has issued Data Needs Decisions on 11
of these 13 chemicals for which EPA determined that 5 chemicals needed
additional data. One of the sponsors agreed to commit to tier 2 and to
provide the additional data to EPA. The sponsor of two other chemicals
declined to commit to tier 2 since it had ceased manufacturing the
chemicals in 2004. The sponsor of the other 2 chemicals told EPA it will
decide whether to commit to the additional testing by the end of July
2007.

In November 2006, EPA requested comments on the implementation of the
pilot program from stakeholders and interested parties. As part of its
request for comments, EPA included a list of questions that the agency
believed would be helpful in its evaluation of the pilot program. The
questions ranged from asking about the sufficiency of the hazard,
exposure, and risk assessments provided by the chemical sponsors; to the
effectiveness and efficiency of the peer review panel; to the timeliness
of the VCCEP pilot in providing data. EPA received comments from 11
interested parties, including from industry representatives, environmental
organizations, children's health advocacy groups, and other interested
parties. Generally, the industry groups provided positive comments about
the pilot while the children's health advocacy and environmental groups
provided negative comments about VCCEP. For example, the American
Chemistry Council commented that the pilot is proceeding well, the current
tiered approach is sound, and that only minimal improvements are needed.
One of the improvements the chemistry council suggested is that EPA should
make the data generated under the pilot more accessible to the public,
other EPA program offices, and to other federal and state agencies.
Conversely, the American Academy of Pediatrics^16 commented that the VCCEP
pilot is failing in its goal to provide timely or useful information on
chemical exposures and their implications to the public or to health care
providers. EPA plans to prepare a comments document summarizing the
comments received from the stakeholders and publish it on the VCCEP Web
site.^17 In addition, EPA plans to have a final evaluation of the
effectiveness of the VCCEP pilot in late 2007.

REACH Requires Chemical Companies to Submit Hazard Information for New and
Existing Chemicals That Meet Specified Production and Toxicity Levels

REACH created a single system for the regulation of new and existing
chemicals and, once implemented, will generally require chemical companies
to register chemicals produced or imported at 1 ton or more per producer
or importer per year with a newly created European Chemicals Agency.^18
Information requirements with registration will vary according to the
production volume and suspected toxicity of the chemical.

For chemicals produced at 1 ton or more per producer or importer per year,
chemical companies subject to registration will be required to submit
information for the chemical, such as the chemical's identity; how it will
be produced; how it will be used; guidance on its safe use; exposure
information; and study summaries of physical/chemical properties and their
effects on human health or the environment. REACH specifies the amount of
information to be included in the study summaries based on the chemical's
production volume, i.e., how much of the chemical will be produced or
imported each year. The information requirements may be met through a
variety of methods, including existing data, scientific modeling, or
testing. REACH separates the production volume information requirements
into four metric tonnage bands--1 ton or more, 10 tons or more, 100 tons
or more, and 1,000 tons or more. Hazard information must be submitted for
each tonnage band with each higher band requiring the information for the
lower bands in addition to the ones specified for that band.^19 For
example, at the one or more tonnage band, REACH requires information on
environmental effects that include short-term toxicity on invertebrates,
toxicity to algae, and ready biodegradability. At the 10 or more tonnage
band, REACH requires such information in addition to a chemical safety
assessment, which includes an assessment of the chemical's human health
and environmental hazards; a physiochemical hazard assessment; an
environmental hazard assessment; and an assessment of the chemical's
potential to be a persistent, bioaccumulative, and toxic pollutant, which
are chemicals that create pollutants that persist in the environment,
bioaccumulate in food chains, and are toxic.

^16The Academy is a nonprofit organization of primary care pediatricians
and pediatric specialists dedicated to the health, safety, and well-being
of infants, children, adolescents, and young adults.

^17The program's Web site address is [24]http://www.epa.gov/chemrtk/vccep
.

^18Existing chemicals will be registered during an 11 year phase-in
period, while new chemicals will be registered prior to production above 1
metric ton or their introduction to the marketplace.

Table 1 shows the total number of chemical endpoints--the chemical or
biological effect that is assessed by a test method--required for
chemicals produced at various production volumes, where applicable, for
TSCA, the HPV Challenge Program, and REACH. While industry participation
in the EPA's HPV Challenge Program is voluntary, we have included
information on the number of endpoints to be produced for chemicals in the
program for comparison purposes. As the table shows, companies will
provide a greater number of endpoints on chemicals under REACH than TSCA
or the HPV Challenge Program. Additionally, appendix IV provides a listing
of specific information requirements or endpoints for three testing
categories: physical/chemical, human health, and environmental
effects/fates.

^19According to the Environment Counselor for the Delegation of the
European Commission to the U.S., REACH places the onus on industry to
provide adequate information but testing under REACH is to be a last
resort from an ethical point of view and from a cost-effectiveness point
of view. It is industry's responsibility to present a satisfactory level
and quantity of information to comply with the requirements set out in the
annexes of REACH which could include using scientific models to estimate
chemical effects, using existing test data, or conducting new testing if
needed.

Table 1: Comparison of the Number of Chemical Tests Potentially Occurring
by Production Volume under TSCA, the HPV Challenge Program, and REACH
(shown in metric tons)

                         U.S. TSCA                                             
                         chemicals                                             
                                         U.S. HPV         
                                        Challenge         
                      New^a Existing^b    Program           EU REACH
                        100                                   10    100  1,000 
                     metric                   454       1 metric metric metric 
                       tons                metric  metric   tons   tons   tons 
                         or               tons or  ton or     or     or     or 
                       more                more^b  more^c   more   more   more 
Physical/chemical      1          0          5      14     17     17     17 
Human health           4          0          6       5     12     15     16 
Environmental                                                               
effects/fate           9          0          7       3      7     16     21 

Source: GAO analysis of TSCA, HPV Challenge Program, and REACH data.

Note: The number of tests shown is approximate and represents high-end
estimates as many of the tests are conditional and may not need to be
conducted if the data or endpoints can be obtained from other sources such
as existing data or modeling, or are not relevant for the applicable
chemical.

^aFor TSCA, we have included test data for new chemicals that chemical
companies plan to produce at high volumes within a few years of
introducing the chemical to the marketplace. While TSCA does not require
companies to produce or provide this information, EPA officials said that
companies generally produce and provide this information if EPA requests
it or if required to under the terms of a TSCA Section 5(e) order.

^bUnder TSCA, existing chemicals have no test/endpoint data requirements.

^cThe production volume for the HPV Challenge Program of 1 million pounds
was converted to metric tons for comparison purposes.

TSCA Generally Requires EPA to Demonstrate That Chemicals Will Cause
Unreasonable Risk While REACH Requires Chemical Companies to Ensure No Adverse
Chemical Effects

Both TSCA and REACH provide regulators with authorities to control
chemical risks by restricting the production or use of both new and
existing chemicals. Under TSCA, EPA must generally compile data needed to
assess the potential risks of chemicals and must also develop substantial
evidence in the rule-making record in order to withstand judicial review.
However, REACH is based on the principle that chemical
companies--manufacturers, importers, and downstream users^20--should
ensure that the chemicals they manufacture, place on the market, or use do
not adversely affect human health or the environment.

EPA Has Had Difficulty Proving That Chemicals Pose Unreasonable Risks and Has
Regulated Few Existing Chemicals under Section 6 of TSCA

Even when EPA has toxicity and exposure information on existing chemicals,
the agency has had difficulty demonstrating that chemicals present or will
present an unreasonable risk and that they should have limits placed on
their production or use. Since the Congress enacted TSCA in 1976, EPA has
issued regulations under Section 6 of the act to limit the production or
restrict the use of five existing chemicals or chemical classes. The five
chemicals or chemical classes are polychlorinated biphenyls (PCB), fully
halogenated chlorofluoroalkanes, dioxin, asbestos, and hexavalent
chromium. In addition, under Section 5(a)(2) of TSCA, for 160 existing
chemicals, EPA issued significant new use rules that require chemical
companies to submit notices to EPA prior to commencing the manufacture,
import, or processing of the substance for a significant new use.

In order to regulate an existing chemical under Section 6(a) of TSCA, EPA
must find that there is a reasonable basis to conclude that the chemical
presents or will present an unreasonable risk of injury to health or the
environment. Before regulating a chemical under Section 6(a), the EPA
Administrator must consider and publish a statement regarding

^20Under REACH, a downstream user is an entity within the supply chain,
other than the manufacturer or importer, who uses a substance, either on
its own or in a preparation.

           o the effects of the chemical on human health and the magnitude of
           human exposure to the chemical;

           o the effects of the chemical on the environment and the magnitude
           of the environment's exposure to the chemical;

           o the benefits of the chemical for various uses and the
           availability of substitutes for those uses; and

           o the reasonably ascertainable economic consequences of the rule,
           after consideration of the effect on the national economy, small
           business, technological innovation, the environment, and public
           health.

           Further, the regulation must apply the least burdensome
           requirement that will adequately protect against such risk. For
           example, if EPA finds that it can adequately manage the
           unreasonable risk of a chemical through requiring chemical
           companies to place warning labels on the chemical, EPA could not
           ban or otherwise restrict the use of that chemical.

           Additionally, if the EPA Administrator determines that a risk of
           injury to health or the environment could be eliminated or
           sufficiently reduced by actions under another federal law, then
           TSCA prohibits EPA from promulgating a rule under Section 6(a) of
           TSCA, unless EPA finds that it is in the public interest
           considering all aspects of the risk, the estimated costs of
           compliance, and the relative efficiency of such action to protect
           against risk of injury.

           Finally, EPA must also develop substantial evidence in the
           rule-making record in order to withstand judicial review. Under
           TSCA, a court reviewing a TSCA rule "shall hold [it] unlawful and
           set [it] aside...if the court finds that the rule is not supported
           by substantial evidence in the rule-making record." According to
           EPA officials responsible for administering TSCA, the economic
           costs of regulating a chemical are usually more easily documented
           than the risks of the chemical or the benefits associated with
           controlling those risks, and it is difficult to show by
           substantial evidence that EPA is promulgating the least burdensome
           requirement.

           According to EPA officials in OPPT who are responsible for
           implementing TSCA, the use of Section 6(a) has presented
           challenges as the agency must, in effect, perform a cost-benefit
           analysis, considering the economic and societal costs of placing
           controls on the chemical. Specifically, these officials say that
           EPA must take into account the benefits provided by the various
           uses of the chemical, the availability of substitutes, and the
           reasonably ascertainable economic consequences of regulating the
           chemical after considering the effects of such regulation on the
           national economy, small business, technological innovation, the
           environment, and public health.

           EPA's 1989 asbestos rule illustrates the evidentiary requirements
           that TSCA places on EPA to control chemicals under TSCA Section
           6(a). The rule prohibited the future manufacture, importation,
           processing, and distribution of asbestos in almost all products.
           Some of the manufacturers of these asbestos products filed suit
           against EPA, arguing that the rule was not promulgated on the
           basis of substantial evidence regarding unreasonable risk. In
           October 1991, the U.S. Court of Appeals for the Fifth Circuit
           agreed with the manufacturers, concluding that EPA had failed to
           muster substantial evidence to justify its asbestos ban and
           returning parts of the rule to EPA for reconsideration.

           In reaching this conclusion, the court found that EPA did not
           consider all necessary evidence and failed to show that the
           control action it chose was the least burdensome reasonable
           regulation required to adequately protect human health or the
           environment. As articulated by the court, the proper course of
           action for EPA, after an initial showing of product danger, would
           have been to consider the costs and benefits of each regulatory
           option available under Section 6, starting with the less
           restrictive options, such as product labeling, and working up
           through a partial ban to a complete ban. The court further
           criticized EPA's ban of asbestos in products for which no
           substitutes were currently available stating that, in such cases,
           EPA "bears a tough burden" to demonstrate, as TSCA requires, that
           a ban is the least burdensome alternative.

           The court's decision on the asbestos rule is especially revealing
           about Section 6 because EPA spent 10 years preparing the rule. In
           addition, asbestos is generally regarded as one of the substances
           for which EPA has the most scientific evidence or documentation of
           substantial adverse health effects. Since the U.S. Court of
           Appeals for the Fifth Circuit's ruling in October 1991, EPA has
           not used TSCA Section 6 to restrict any chemicals. However, EPA
           has used Section 6 to issue a proposed ban on certain grouts,
           which was later withdrawn when industry agreed to use personal
           protection equipment to address worker exposure issues, and issue
           an Advance Notice of Proposed Rule Making for methyl-t-butyl
           ether^21 because of widespread drinking water contamination.
           Although TSCA's Section 6 has been used infrequently, the Director
           of OPPT and other EPA officials responsible for implementing TSCA
           told us that they believe that taking action under this section
           remains a practicable option for the agency.
			  
           TSCA's Section 5 Provides Limited Authority to Restrict New Chemicals			  

           Section 5(a)(2) requires chemical companies to notify EPA at least
           90 days before beginning to manufacture or process a chemical for
           a use that EPA has determined by rule is a significant new use.
           EPA has these 90 days to review the chemical information in the
           premanufacture notice and identify the chemical's potential risks.
           Under Section 5(e), if EPA determines that there is insufficient
           information available to permit a reasoned evaluation of the
           health and environmental effects of a chemical and that (1), in
           absence of such information, the chemical may present an
           unreasonable risk of injury to health or the environment or (2) it
           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, then EPA can issue a
           proposed order or seek a court injunction to prohibit or limit the
           manufacture, processing, distribution in commerce, use, or
           disposal of the chemical. Under Section 5(f), if EPA finds that
           the chemical will present an unreasonable risk, EPA must act to
           protect against the risk. If EPA finds that there is a reasonable
           basis to conclude that a new chemical may pose an unreasonable
           risk before it can protect against such risk by regulating it
           under Section 6 of TSCA, EPA can (1) issue a proposed rule,
           effective immediately, to require the chemical to be marked with
           adequate warnings or instructions, to restrict its use, or to ban
           or limit the production of the chemical or (2) seek a court
           injunction or issue a proposed order to prohibit the manufacture,
           processing, or distribution of the chemical. According to the
           Director of OPPT, it is less difficult for the agency to
           demonstrate that a chemical "may present" an unreasonable risk
           than it is to show that a chemical "will present" such a risk.
           Thus, EPA has found it easier to impose controls on new chemicals
           when warranted.

           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 3,800 of the 33,000 new chemicals that chemical
           companies have submitted for review since 1979.^22 These actions
           included, among other things, chemical companies voluntarily
           withdrawing their notices of intent to manufacture new chemicals,
           and entering into consent orders with EPA to produce a chemical
           only under specified conditions. In addition, EPA has promulgated
           significant new use rules requiring chemical companies to notify
           EPA of their intent to manufacture or process certain chemicals
           for any uses that EPA has determined to be a "significant new
           use."

^21Methyl-t-butyl ether (MTBE) is a chemical compound that is used as a
fuel additive in gasoline. 65 Federal Register 16094, Mar. 24, 2000.

           For over 1,700 chemicals, companies withdrew their PMNs sometimes
           after EPA officials indicated that the agency planned to initiate
           the process for placing controls on the chemicals, such as
           requiring testing or prohibiting the production or certain uses of
           the chemical. The Director of OPPT told us that after EPA has
           screened a new chemical or performed a detailed analysis of it,
           chemical companies may drop their plans to market the chemical
           when the chemical's niche in the marketplace is uncertain and EPA
           requests that the company develop and submit test data or apply
           exposure controls. According to EPA officials, companies may be
           uncertain that they will recoup costs associated with the test
           data and controls and prefer to withdraw their PMN. In addition,
           for over 1,300 chemicals, EPA issued orders requiring chemical
           companies to implement workplace controls or practices during
           manufacturing pending the development of information on the risks
           posed by the chemicals and/or to perform toxicity testing if the
           chemicals' production volumes reached certain levels.

           For over 570 of the 33,000 new chemicals submitted for review, EPA
           required chemical companies to submit 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 begin. For example, in 2003, EPA promulgated a significant
           new use rule requiring chemical companies to submit a notice for
           the manufacture or processing of substituted benzenesulfonic acid
           salt for any use other than as described in the PMN.

^22The 33,000 new chemicals do not include those that EPA has exempted
from the PMN requirements, such as low volume chemicals and polymers. EPA
may exempt a chemical company from the PMN requirement upon application
from the company showing to EPA's satisfaction that the chemical will not
present any unreasonable risk of injury to human health or the
environment. Following EPA's approval of an exemption request, the company
must manufacture and use the chemical in accordance with the terms of the
exemption. Thus, all exemption chemicals are subject to controls per the
terms of the exemption request and relevant exemption regulations.

           REACH Requires Chemical Companies to Request Authorization to Use
			  Certain Hazardous Chemicals and Search for Safer Substitutes

           To control chemical risks, REACH provides procedures for both
           authorizing and restricting the use of chemicals. Authorization
           procedures under REACH have three major steps. First, the European
           Chemicals Agency will publish a list of chemicals--known as the
           candidate list--that potentially need authorization before they
           can be used. The chemical agency will determine which chemicals to
           place on the candidate list after it has reviewed the information
           that chemical companies submit to the agency at the time the
           chemicals are registered under REACH and after considering the
           input provided by individual EU member states and the European
           Commission. In making this determination, the agency is to use
           criteria set forth in REACH, covering issues such as
           bioaccumulation, carcinogenicity, and reproductive toxicity.
           Secondly, the European Commission will determine which chemicals
           on the candidate list will require authorization and which will be
           exempted from the authorization requirements. According to the
           Environment Counselor for the Delegation of the European
           Commission to the United States, some chemicals may be exempted
           from authorization requirements because, so far, sufficient
           controls established by other legislation are already in place.
           Finally, once a chemical has been deemed to require authorization,
           a chemical company will have to apply to the European Commission
           for an authorization for each use of the chemical.

           The application for authorization must include an analysis of the
           technical and economic feasibility of using safer substitutes and,
           if appropriate, information about any relevant research and
           development activities by the applicant. If such an analysis shows
           that suitable alternatives are available for any use of the
           chemical, then the application must also include a plan for how
           the company plans to substitute the safer chemical for the
           chemical of concern in that particular use. The European
           Commission is generally required to grant an authorization if the
           applicant meets the burden of demonstrating that the risks from
           the manufacture, use, or disposal of the chemical can be
           adequately controlled, except for (1) PBTs; (2) very persistent,
           very bioaccumulative chemicals (vPvBs); and (3) certain other
           chemicals including those that are carcinogenic or reproductive
           toxins.^23 However, even these chemicals may receive authorization
           if a chemical company can demonstrate that social and economic
           benefits outweigh the risks. In addition, 6 years after REACH goes
           into effect (or in 2013), the European Commission will review
           whether endocrine disrupters^24 should also be excluded from
           authorization unless chemical companies can demonstrate that the
           social and economic benefits outweigh their risks.
			  
^23Substances classified as PBTs are chemicals that can persist in the
environment, bioaccumulate in food chains, and are toxic. Substances
classified as vPvBs are chemicals that are very persistent and very
bioaccumulative, but not necessarily toxic.

           Eventually, all chemicals granted authorizations under REACH will
           be reviewed to ensure that they can be safely manufactured, used,
           and disposed. The time frame for such reviews will be determined
           on a case-by-case basis that takes into account information such
           as the risks posed by the chemical, the availability of safer
           alternatives, and the social and economic benefits of the use of
           the chemical. For example, if suitable substitutes become
           available, the authorization may be amended or withdrawn, even if
           the chemical company granted the authorization has demonstrated
           that the chemical can be safely controlled.

           In addition to such authorization procedures, REACH provides
           procedures for placing restrictions on chemicals that pose an
           unacceptable risk to health or the environment. The restriction
           may completely ban a chemical or limit its use by consumers or by
           manufacturers of certain products. REACH's restrictions procedures
           enable the EU to regulate communitywide^25 conditions for the
           manufacture, marketing, or use of certain chemicals where there is
           an unacceptable risk to health or the environment. Proposals for
           restrictions will be prepared by either a Member State or by the
           European Chemicals Agency at the request of the European
           Commission. The proposal must demonstrate that there is a risk to
           human health or the environment that needs to be addressed at the
           communitywide level and to identify the most appropriate set of
           risk reduction measures. Interested parties will have an
           opportunity to comment on the restriction proposal. However, the
           final determination on the restriction proposal will be made by
           the European Commission. Because no chemicals have undergone
           REACH's authorization and restriction procedures, it is not
           possible to comment on the ability of these procedures to control
           the risks of chemicals to human health or the environment.

^24Endocrine disputing chemicals can alter the endocrine system and may
cause adverse health effects such as cancer. The endocrine system is a
complex system consisting of glands that produce hormones, including the
thyroid in the throat and the pituitary gland in the brain that helps
guide the development, growth, and reproduction of humans and animals.

^25Communitywide refers to the EU's member states. As of January 2007, the
EU had 27 member states. The member states are Austria, Belgium, Bulgaria,
Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany,
Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden,
and the United Kingdom.

           Both TSCA and REACH Have Provisions to Make Certain Information
			  Available to the Public, but REACH Requires Greater Public Disclosure

           TSCA and REACH require public disclosure of certain information on
           chemicals and both laws protect confidential or sensitive business
           information, although the extent to which information can be
           claimed as confidential or sensitive varies under the two laws. In
           this regard, one of the objectives of REACH is to make information
           on chemicals more widely available to the public. Accordingly,
           REACH places greater limitations on the kinds of information that
           companies may claim as confidential or sensitive.
			  
			  EPA's Ability to Share Data Collected under TSCA Is Limited

           TSCA has provisions to protect information claimed by chemical
           companies as confidential or sensitive business information, such
           as information on chemical production volumes and trade secret
           formulas. Health and safety studies, however, generally cannot be
           considered confidential business information, and TSCA has
           provisions for making such studies available to the public.
           Additionally, EPA can disclose confidential business information
           when it determines such disclosure is necessary to protect human
           health or the environment from an unreasonable risk. EPA
           interprets the term health and safety study broadly and, as such,
           it may include but is not limited to epidemiological, occupational
           exposure, toxicological, and ecological studies.

           However, TSCA generally allows chemical companies to claim any
           information provided to EPA, other than health and safety studies,
           as confidential. TSCA requires EPA to protect the information from
           unauthorized disclosure. More specifically, TSCA restricts EPA's
           ability to share certain information it collects from chemical
           companies, such as information about the company (including its
           identity); the chemical's identity; or the site of operation,
           including with state officials or with officials of foreign
           governments. If a request is made for disclosure of the
           confidential information, EPA regulations require the chemical
           company to substantiate the claims by providing the agency
           information on a number of issues, such as whether the identity of
           the chemical had been kept confidential from competitors and what
           harmful effects to the company's competitive position would result
           from publication of the chemical on the TSCA inventory. State
           environmental agencies and others are interested in obtaining
           chemical information, including that claimed as confidential, for
           use in various activities, such as developing contingency plans to
           alert emergency response personnel of the presence of highly toxic
           substances at local manufacturing facilities. Likewise, the
           general public may find information collected under TSCA useful to
           engage in dialogues with chemical companies about reducing
           chemical risks and limiting chemical exposures at nearby
           facilities that produce or use toxic chemicals.

           While EPA believes that some claims of confidential business
           information may be unwarranted, challenging the claims is
           resource-intensive. According to a 1992 EPA study, the latest
           performed by the agency, problems with inappropriate claims were
           extensive. This study examined the extent to which companies made
           confidential business information claims, the validity of the
           claims, and the impact of inappropriate claims on the usefulness
           of TSCA data to the public. The study found that many of the
           confidentiality claims submitted under TSCA were not appropriate,
           particularly for health and safety data. For example, between
           September 1990 and May 1991, EPA reviewed 351 health and safety
           studies that chemical companies submitted with a claim of
           confidentiality. EPA challenged the confidentiality claimed for
           77, or 22 percent of the studies and, in each case, the submitter
           amended the confidentiality claim when challenged by EPA.
           Currently, while EPA may suspect that some chemical companies'
           confidentiality claims are unwarranted, the agency does not have
           data on the number of inappropriate claims.

           As we reported in June 2005, EPA focuses on investigating
           primarily those claims that it believes may be both inappropriate
           and among the most potentially important--that is, claims relating
           to health and safety studies performed by chemical companies.^26
           According to the EPA official responsible for initiating
           challenges to confidentiality claims, the agency challenges about
           14 such claims each year, and the chemical companies withdraw
           nearly all of the claims challenged.

           Chemical companies have expressed interest in working with EPA to
           identify ways to enable other organizations to use the information
           given the adoption of appropriate safeguards. In addition,
           chemical company representatives told us that, in principle, they
           have no concerns about revising TSCA or EPA regulations to require
           that confidentiality claims be periodically reasserted and
           reviewed. However, neither TSCA nor EPA regulations require
           periodic reviews to determine when information no longer needs to
           be protected as confidential. In our June 2005 report, we
           recommended that EPA revise its regulations to require that
           companies reassert claims of confidentiality submitted to EPA
           under TSCA within a certain time period after the information is
           initially claimed as confidential.^27 In July 2006, EPA responded
           to Congress that the agency planned to initiate a pilot process,
           using its existing authorities, to review selected older
           submissions containing CBI claims. According to EPA officials, the
           agency is examining PMNs and notices of commencements submitted to
           EPA from fiscal years 1993 thorough March 2007 and plans to
           compile statistics on the numbers and percentages of submissions
           and the types of CBI claims made. Based on the agency's review,
           and in light of its other regulatory priorities, EPA will consider
           whether rule making is appropriate to maximize the benefits of a
           reassertion program, including benefits to the public. However, no
           completion date has been determined for the pilot.
			  
^26 [26]GAO-05-458.			

           REACH Has Provisions to Protect Confidential Business Information
			  but Allows Greater Public Access to Chemical Information than TSCA

           Similar to TSCA, REACH has provisions to protect information
           claimed by chemical companies as confidential or sensitive,
           including trade secret formulas and production volumes. In
           addition, REACH treats some information as confidential, including
           the following, even if a company did not claim it as confidential:
           (1) details of the full composition of the chemical's preparation;
           (2) the precise use, function, or application of the chemical or
           its preparation; (3) the precise tonnage or volume of the chemical
           manufactured or placed on the market; or (4) relationships between
           manufacturers/importers and downstream users. In exceptional cases
           where there are immediate risks to human health and safety or to
           the environment, REACH authorizes the European Chemicals Agency to
           publicly disclose this information.

           Furthermore, unlike TSCA, REACH places substantial restrictions on
           the types of data that chemical companies may claim as
           confidential. Consistent with one of the key objectives of REACH,
           the legislation makes information on hazardous chemicals widely
           available to the public by limiting the types of hazard
           information that chemical companies may claim as confidential, and
           generally does not allow confidentiality claims related to, among
           other things, guidance on the chemical's safe use, and the
           chemical's physical chemical properties, such as melting and
           boiling points, and results of toxicological and ecotoxicological
           studies, including analytical methods that make it possible to
           detect a dangerous substance when discharged into the environment
           and to determine the effects of direct exposure to humans. In
           addition, other information, such as study summaries and tonnage
           band information will be available unless the chemical companies
           justify that disclosing the information will be harmful to its
           commercial interests.

^27 [27]GAO-05-458.

           REACH also requires that safety data sheets for PBTs and vPvBs and
           other chemicals classified as dangerous be provided to ensure that
           commercial users--known as downstream users and distributors of a
           chemical, as well as chemical manufacturers and importers, have
           the information they need to safely use chemicals.^28 The data
           sheets, which chemical companies are required to prepare, include
           information on health, safety, and environmental properties, and
           risks and risk management measures.^29

           Similar to TSCA, REACH requires public disclosure of health and
           safety information and has provisions for making information
           available to the public. REACH also includes a provision for
           public access to basic chemical information, including brief
           profiles of hazardous properties, labeling requirements,
           authorized uses, and risk management measures. The European
           Union's rules regarding the public's access to information combine
           a variety of ways that the interests of the public's right to know
           is balanced with the need to keep certain information
           confidential. As such, nonconfidential information will be
           published on the chemical agency's Web site. However, some types
           of information are always to be treated as confidential under
           REACH, such as precise production volume.

           REACH also includes a provision under which confidential
           information can generally be shared with government authorities of
           other countries or international organizations under an agreement
           between the parties provided that the following conditions are
           met: (1) the purpose of the agreement is cooperation on
           implementation or the management of legislation concerning the
           chemicals covered by REACH and (2) the foreign government or
           international organization protects the confidential information
           as mutually agreed. In our June 2005 report, we suggested that
           Congress should consider amending TSCA to authorize EPA to share
           with the states and foreign governments the confidential business
           information that chemical companies provide to the agency, 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.Furthermore, chemical industry representatives told us
           that chemical companies would not object to Congress revising TSCA
           to allow those with a legitimate reason to obtain access to the
           confidential business information provided that adequate
           safeguards exist to protect the information from inappropriate
           disclosures. In addition, EPA officials said that harmonized
           international chemical assessments would be improved if the agency
           had the ability to share this information under appropriate
           procedures to protect confidentiality. ^30

^28Substances classified as PBTs are chemicals that can persist in the
environment, bioaccumulate in food chains, and are toxic. Substances
classified as vPvBs are chemicals that are very persistent and very
bioaccumulative, but not necessarily toxic.

^29Commercially sensitive information will not be required to be
exchanged.

^30 [28]GAO-05-458.

           Concluding Observations

           Substantial differences exist between TSCA and REACH in their
           approaches to obtaining the information needed to identify
           chemical risks; controlling the manufacture, distribution, and use
           of chemicals; and providing the public with information on harmful
           chemicals. Assuming that the EU has the ability to review chemical
           information in a timely manner, specific provisions under REACH
           provide a means for addressing long-standing difficulties
           experienced both under TSCA and previous European chemicals
           legislation in (1) obtaining information on chemicals' potentially
           harmful characteristics and their potential exposure to people and
           the environment and (2) making the chemical industry more
           accountable for ensuring the safety of their products.
           Furthermore, REACH is structured to provide a broader range of
           data about chemicals that could enable people to make more
           informed decisions about the products they use in their everyday
           lives.

           We have identified, in our previous reports on TSCA, various
           potential revisions to the act that could strengthen TSCA to
           obtain additional chemical information from the chemical industry,
           shift more of the burden to chemical companies for demonstrating
           the safety of their chemicals, and enhance the public's
           understanding of the risks of chemicals to which they may be
           exposed.
			  
			  Agency Comments and GAO Response

           We provided EPA and the Environment Counselor for the Delegation
           of the European Commission to the United States a draft of this
           report for review and comment. Both EPA and the Environment
           Counselor for the Delegation of the European Commission provided
           technical comments, which we have incorporated into this report as
           appropriate. EPA also provided written comments. EPA highlighted
           the regulatory actions it has taken under TSCA and noted that TSCA
           is a "fully implemented statute that has withstood the test of
           time" and that, in contrast, "REACH is not yet in force, and there
           is no practical experience with any aspect of its implementation."
           Furthermore, while EPA agreed that it is possible to compare the
           approaches used to protect against the risks of toxic chemicals
           under TSCA and REACH, "it is not yet possible to evaluate or
           compare the effectiveness of the different chemical management
           approaches or requirements." EPA's written comments are presented
           in appendix V.

           As agreed with your offices, unless you publicly announce the
           contents of this report earlier, we plan no further distribution
           until 30 days from the report date. At that time, we will send
           copies of this report to the congressional committees with
           jurisdiction over EPA and its activities; the Administrator, EPA;
           and the Director, Office of Management and Budget. We also will
           make copies available to others upon request. In addition, the
           report will be available at no charge on the GAO Web site at
           [25]http://www.gao.gov .

           If you have any questions about this report, please contact me at
           (202) 512-3841 or [email protected]. Contact points for our
           Offices of Congressional Relations and Public Affairs may be found
           on the last page of this report. Key contributors to this report
           are listed in appendix VI.

           John B. Stephenson
           Director, Natural Resources and Environment
			  
			  Appendix I: Scope and Methodology

           Our objectives were to describe how Toxic Substances Control Act
           (TSCA) compares with Registration, Evaluation and Authorization of
           Chemicals (REACH) in its approaches to (1) identifying chemicals
           harmful to public health and the environment, (2) controlling
           chemical risks, and (3) disclosing chemical data to the public
           while protecting confidential business information. In addressing
           these issues, we also obtained information on Environmental
           Protection Agency's (EPA) voluntary chemical control programs that
           complement TSCA. We reviewed the relevant provisions of TSCA,
           identified and analyzed EPA's regulations on how the new and
           existing chemical review and control programs work, including the
           handling of confidential information, and determined the extent of
           actions taken by EPA to control chemicals. These efforts were
           augmented by interviews with EPA officials in the agency's Office
           of Pollution Prevention and Toxics (OPPT), the EPA office with
           primary responsibility for implementing TSCA, the High Production
           Volume (HPV) Challenge Program, and the Voluntary Children's
           Chemical Evaluation Program (VCCEP) pilot. In addition, we
           interviewed representatives of the American Chemistry Council (a
           national chemical manufacturers association), Environmental
           Defense (a national, nonprofit, environmental advocacy
           organization), and the Synthetic Organic Chemical Manufacturers
           Association (a national, specialty chemical manufacturer's
           association). We also attended meetings of EPA's National
           Pollution Prevention and Toxics Advisory Committee (NPPTAC)^1 and
           attended various conferences sponsored by EPA and others. We
           selected the industry and environmental experts we interviewed
           based on discussions with NPPTAC representatives and based on our
           prior work on TSCA. Finally, we obtained and reviewed EPA
           documents related to its chemical program.

           For reviewing REACH, we obtained laws, technical literature, and
           government documents that describe the European Union's (EU)
           chemical control program. We also interviewed EU officials who
           helped develop and who will be involved in implementing REACH,
           including the Environment Counselor for the Delegation of the
           European Commission to the United States and representatives from
           the European Commission and the European Parliament. Our
           descriptions of these laws are based on interviews with government
           officials and written materials they provided. In addition, we
           interviewed representatives of the American Chamber of Commerce to
           the EU, American Chemistry Council (a national chemical
           manufacturers association), Environmental Defense (a national,
           nonprofit environmental advocacy organization), the European
           Chemical Industry Council (an EU chemical manufacturers
           association), the European Environmental Bureau (a federation
           environmental advocacy organization based in the EU Member
           States),^2 and the Synthetic Organic Chemical Manufacturers
           Association (a national, specialty chemical manufacturer's
           association). Furthermore, we interviewed staff from the U.S.
           Mission to the EU. Finally, for the purposes of this report, we
           compared TSCA to the REACH legislation that was approved in
           December 2006, as the basis for analysis.

^1NPPTAC is a national advisory body chartered under the Federal Advisory
Committee Act to provide advice, information and recommendations on the
overall policy and operation of programs managed by EPA's Office of
Pollution Prevention and Toxics in performing its duties and
responsibilities under TSCA and the Pollution Prevention Act. EPA has not
held a NPPTAC meeting since the resignation of three NPPTAC members in
October 2006, which resulted in an imbalance in representation on the
Committee. EPA is evaluating options for NPPTAC's future.

           Our review was performed between January 2006 and May 2007 in
           accordance with generally accepted government auditing standards.
			  
^2As of January 2007, the EU consists of 27 member states. The member
states are Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark,
Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy,
Lativa, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, and the United Kingdom.

Appendix II: Comparison of Selected Provisions of U.S. Toxic Substances
Control Act and the EU's Registration, Evaluation and Authorization of
Chemicals


                 TSCA                                                REACH            
Enactment date   1976                                                Approved in      
                                                                     December 2006    
                                                                     and entered into 
                                                                     force June 2007  
Definition of    New chemicals are those not on the TSCA inventory.  REACH creates a  
new and existing                                                     single system so 
chemicals        Existing chemicals are those listed in the TSCA     that there will  
                 Inventory.                                          be virtually no  
                                                                     distinction      
                                                                     between new and  
                                                                     existing         
                                                                     chemicals.^a     
Approximate      Originally 62,000. Of the more than 82,000          EU officials     
number of        chemicals currently in the TSCA inventory,          estimated the    
chemicals        approximately 20,000 were added to the inventory    number of        
covered by       since EPA began reviewing chemicals in 1979.^b      chemicals with   
legislation                                                          production or    
                                                                     import levels of 
                                                                     at least 1       
                                                                     metric ton       
                                                                     (2,205 pounds)   
                                                                     to be about      
                                                                     30,000. Chemical 
                                                                     registration     
                                                                     will be phased   
                                                                     in over 11 years 
                                                                     after enactment  
                                                                     of REACH.^c      
Notification     New chemicals:     Existing chemicals:              In general,      
requirement                                                          REACH treats new 
                 Companies are      TSCA generally does not require  and existing     
                 required to notify chemical companies to notify EPA chemicals the    
                 EPA prior to       of changes in use or production  same. Chemical   
                 manufacturing a    volume. However, every 5 years   companies        
                 new chemical.      companies are required to update register         
                 Companies notify   EPA on information such as the   chemicals with   
                 EPA of its intent  processing, use, and production  the European     
                 to manufacture a   volume of chemicals produced at  Chemicals Agency 
                 new chemical       over 25,000 pounds.              once production  
                 through submission                                  or import of a   
                 of a               Companies must also notify EPA   chemical reaches 
                 Premanufacture     if the company obtains           1 metric ton     

                 Notice (PMN) or of information that reasonably      (2,205 pounds).  
                 an application for supports the conclusion that the                  
                 exemption. After   chemical presents a substantial  After            
                 the PMN review     risk to human health or the      registration,    
                 period has expired environment.                     companies are    
                 and within 30 days                                  required to      
                 of the chemical's                                   immediately      
                 manufacture,                                        notify the       
                 companies submit a                                  European         
                 Notice of                                           Chemicals Agency 
                 Commencement of                                     of significant   
                 Manufacture or                                      changes in use   
                 Import to EPA. The                                  or production    
                 chemical is then                                    volumes of the   
                 added to the TSCA                                   registered       
                 Inventory, and the                                  chemical.        
                 chemical is                                                          
                 classified as an                                                     
                 existing chemical.                                                   
Method used to   New chemicals:     Existing chemicals:              The European     
prioritize                                                           Chemicals Agency 
chemicals for    Based on           TSCA does not require EPA to     will develop the 
further review   information        systematically prioritize and    criteria for     
                 compiled through a assess existing chemicals.       prioritizing     
                 series of steps,                                    chemicals for    
                 including a        However, TSCA established an     further review   
                 chemical review    Interagency Testing              based on, among  
                 strategy meeting,  Committee--an advisory committee other things,    
                 structure-activity created to identify chemicals    hazard data,     
                 relationship       for which there are suspicions   exposure data,   
                 analysis, and      of toxicity or exposure and for  and production   
                 exposure-based     which there are few, if any      volume.          
                 reviews, EPA makes ecological effects,                               
                 a decision ranging environmental fate, or           Member states    
                 from "dropping" a  health-effects testing data--to  may use these    
                 chemical for       recommend chemicals to which EPA criteria when    
                 further review to  should give priority             developing their 
                 banning a chemical consideration in promulgating    list of          
                 pending further    test rules.                      chemicals to be  
                 information.                                        reviewed.        
                                    EPA also plans to use the High                    
                                    Production Volume (HPV)                           
                                    Challenge Program and the                         
                                    information under the Inventory                   
                                    Update Rule to help the agency                    
                                    prioritize the chemicals it will                  
                                    review.^d                                         
Notification of  New chemicals:     Existing chemicals:              Chemical         
significant                                                          companies must   
changes in uses  New chemicals once Chemical companies report use    immediately      
of existing      they have          information once every 5 years   inform the       
chemicals        commenced          under TSCA's Inventory Update    European         
                 manufacture are    Rule (IUR),^e which is primarily Chemicals Agency 
                 added to the TSCA  used to gather certain           in writing of    
                 Inventory. Such    information on chemicals         new uses of the  
                 former new         produced at the threshold of     chemical about   
                 chemicals can be   25,000 pounds or more.           which the        
                 subject to                                          company may      
                 significant new    However, in the absence of a     reasonably be    
                 use rules (SNUR)   SNUR on a particular chemical,   expected to have 
                 or restrictions on there is no requirement for      become aware.    
                 the manufacture,   chemical companies to notify EPA                  
                 processing,        of significant new uses of                        
                 distribution in    existing chemicals in the                         
                 commerce, use, or  intervening years or for                          
                 disposal of the    chemicals produced at less than                   
                 chemical under     25,000 pounds.                                    
                 TSCA 5(e) consent                                                    
                 orders.            Manufacturers and processors of                   
                                    existing chemicals subject to a                   
                                    SNUR must notify EPA 90 days                      
                                    before manufacture of or                          
                                    processing for significant new                    
                                    use.                                              
Requirement for  New chemicals:     Existing chemicals:              Chemical         
chemical                                                             companies must   
companies to     Chemical companies Chemical companies are not       conduct a risk   
complete risk    are not required   required to complete assessments assessment in    
assessments      to perform risk    on the risks of existing         addition to      
                 assessments on the chemicals.                       European         
                 risks of new                                        Chemicals Agency 
                 chemicals.         However, TSCA requires chemical  review for all   
                 However, if a      companies to notify EPA          chemicals        
                 company has        immediately of new unpublished   produced at a    
                 voluntarily        information on chemicals that    level of 1 ton   
                 performed risk     reasonably supports a conclusion or more per      
                 assessments, they  of substantial risk.             year.            
                 must submit these                                   Additionally,    
                 data with the PMN.                                  chemical         
                                                                     companies must   
                                                                     conduct a        
                                                                     chemical safety  
                                                                     assessment for   
                                                                     all chemicals    
                                                                     produced at a    
                                                                     level of 10 tons 
                                                                     or more per      
                                                                     year.            
Encourages       New chemicals:     Existing chemicals:              REACH states     
minimizing                                                           that testing on  
animal testing   TSCA contains no   No specific language relating to vertebrate       
                 specific language  reducing animal testing.         animals for the  
                 relating to        However, under the HPV Challenge purposes of      
                 reducing animal    Program, EPA encourages          regulation shall 
                 testing. However,  companies to consider            be undertaken as 
                 according to EPA   approaches, such as using        a last resort.   
                 officials, TSCA's  existing data, sharing data, and To reduce the    
                 approach of not    using SAR and read across        amount of animal 
                 requiring          approaches that would reduce the testing, REACH   
                 companies to test  amount of animal testing needed. encourages the   
                 new chemicals for  Further, EPA does not require    sharing and      
                 health hazards or  retesting for chemicals with     joint submission 
                 environmental      adequate Screening Information   of information.  
                 effects absent EPA Data Sets data. EPA has          REACH            
                 action, combined   expressed its commitment to      implementation   
                 with EPA's use of  examining alternate test methods guidance         
                 Structure Activity that reduce the number of        encourages the   
                 Relationship (SAR) animals needed for testing, that use of SAR and   
                 analysis reduces   reduce pain and suffering to     read across      
                 the need for       test animals or that replaces    approaches.      
                 animal testing     test animals with validated in   Further,         
                 compared with      vitro (nonanimal) test systems.  registrants may  
                 requiring a base                                    use any study    
                 set of data        In addition, under the Voluntary summaries or     
                 without the use of Children's Chemical Evaluation   robust study     
                 SAR analysis.      Program (VCCEP), EPA encouraged  summaries        
                                    participating companies to       performed within 
                                    reduce or eliminate animal       the 12 previous  
                                    testing.                         years by another 
                                                                     manufacturer or  
                                                                     importer to      
                                                                     register after   
                                                                     due compensation 
                                                                     of the costs to  
                                                                     the owner of the 
                                                                     data.^f          
Requirement for  New chemicals:     Existing chemicals:              Chemical         
the disclosure                                                       companies must   
of production    Chemical companies Chemical companies report        include          
quantities       must provide EPA a production quantities every 5    information on   
                 reasonable third   years for those chemicals on the the overall      
                 year estimate of   TSCA inventory and produced at   manufacture or   
                 the total          quantities of 25,000 pounds or   import of a      
                 production volume  more through the Inventory       chemical in      
                 of a new chemical  Update Rule (IUR).               metric tons per  
                 at the time a PMN                                   year in a        
                 is submitted.                                       technical        
                                                                     dossier with     
                                                                     their            
                                                                     registration.    
                                                                     Chemical         
                                                                     companies must   
                                                                     immediately      
                                                                     report any       
                                                                     significant      
                                                                     changes in the   
                                                                     annual or total  
                                                                     quantities       
                                                                     manufactured or  
                                                                     imported.        
Downstream user  New chemicals:     Existing chemicals:              Downstream users 
responsibilities                                                     are required to: 
                 No specific        No specific requirement relating                  
                 requirement        to downstream users.             Assemble and     
                 relating to                                         keep available   
                 downstream users.                                   all information  
                                                                     required to      
                                                                     carry out duties 
                                                                     under REACH for  
                                                                     a period of at   
                                                                     least 10 years   
                                                                     after the        
                                                                     substance has    
                                                                     been used.       
                                                                     Prepare a        
                                                                     chemical safety  
                                                                     report for any   
                                                                     use outside the  
                                                                     conditions       
                                                                     described in an  
                                                                     exposure         
                                                                     scenario or if   
                                                                     appropriate use  
                                                                     and exposure     
                                                                     category         
                                                                     described in a   
                                                                     safety data      
                                                                     sheet or for any 
                                                                     use the supplier 
                                                                     advises against. 
                                                                                      
                                                                     Downstream users 
                                                                     may also provide 
                                                                     information to   
                                                                     assist in the    
                                                                     preparation of a 
                                                                     registration.    
Regulation of    New chemicals:     Existing chemicals:              Chemicals may be 
hazardous                                                            regulated under  
chemicals        EPA can issue a    TSCA requires EPA to apply       provisions known 
                 proposed order or  regulatory requirements to       as authorization 
                 seek a court       chemicals for which EPA finds a  and restriction. 
                 injunction to      reasonable basis to conclude                      
                 prohibit or limit  that the chemical presents or    Authorization is 
                 the manufacture,   will present an unreasonable     required for the 
                 processing,        risk to human health or the      use of           
                 distribution in    environment. To adequately       substances of    
                 commerce, use, or  protect against a chemical's     very high        
                 disposal of a      risk, EPA can promulgate a rule  concern.^g This  
                 chemical if EPA    that bans or restricts the       includes         
                 determines that    chemical's production,           substances that  
                 there is           processing, distribution in      are (1)          
                 insufficient       commerce, use or disposal, or    carcinogenic,    
                 information        requires warning labels be       mutagenic, or    
                 available to       placed on the chemical.          toxic for        
                 permit a reasoned                                   reproduction;    
                 evaluation of the  Section 6(a) authorizes EPA to   (2) persistent,  
                 health and         regulate existing chemicals,     bioaccumulative, 
                 environmental      including restriction or         and toxic or     
                 effects of a       prohibition. EPA is required to  very persistent  
                 chemical and that  apply the least burdensome       and very         
                 (1) in the absence requirement and the rule must be bioaccumulative; 
                 of such            supported by substantial         or (3)           
                 information, the   evidence in the rule-making      identified as    
                 chemical may       record.                          causing serious  
                 present an                                          and irreversible 
                 unreasonable risk                                   effects to       
                 of injury to                                        humans or the    
                 health or the                                       environment,     
                 environment or (2)                                  such as          
                 it is or will be                                    endocrine        
                 produced in                                         disrupters.      
                 substantial                                                          
                 quantities and (a)                                  Restrictions on  
                 it either enters                                    substances       
                 or may reasonably                                   relating to its  
                 be anticipated to                                   manufacture,     
                 enter the                                           marketplace, or  
                 environment in                                      use, including   
                 substantial                                         banning, may be  
                 quantities or (b)                                   required where   
                 there is or may be                                  there is an      
                 significant or                                      unacceptable     
                 substantial human                                   risk to health   
                 exposure to the                                     or the           
                 substance.                                          environment.     
Enforcement      New chemicals:     Existing chemicals:              Reach requires   
mechanisms                                                           EU Member States 
                 EPA maintains      EPA maintains compliance         to monitor       
                 compliance         officials to monitor compliance  compliance with  
                 officials to       with TSCA.                       provisions of    
                 monitor compliance                                  REACH.           
                 with TSCA.                                                           
Substitution     New chemicals:     Existing chemicals:              Authorization    
requirement                                                          applications     
                 No specific        No specific language relating to (for chemicals   
                 language relating  substitution or finding safer    of very high     
                 to substitution or alternatives.                    concern) require 
                 finding safer                                       an analysis of   
                 alternatives.                                       possible         
                                                                     alternatives or  
                                                                     substitutes.     
Protection of    New chemicals:     Existing chemicals:              REACH allows     
Confidential                                                         chemical         
Business         TSCA allows        TSCA allows companies to make    companies to     
Information      companies to make  confidentiality claims on nearly make             
(CBI)            confidentiality    all information it provides to   confidentiality  
                 claims on nearly   EPA.                             claims; however, 
                 all information it                                  it places        
                 provides EPA.                                       restrictions on  
                                                                     what kinds of    
                                                                     information      
                                                                     companies may    
                                                                     claim as         
                                                                     confidential.    
Public           New chemicals:     Existing chemicals:              REACH requires   
availability of                                                      public           
chemical         TSCA requires that TSCA requires that existing      disclosure of    
information      existing health    health and safety-related        information such 
                 and safety-related information must be made         as the trade     
                 information must   available to the public.         name of the      
                 be made available                                   substance,       
                 to the public.     EPA uses its HPV Challenge       certain          
                                    Program to voluntarily gather    physicochemical  
                                    information from industry and    data, guidance   
                                    ensure that a minimum set of     on safe use, and 
                                    basic data on approximately      all health and   
                                    2,800                            safety-related   
                                    high-production-volume-chemicals information.     
                                    is available to the public.                       
Requirements     New chemicals:     Existing chemicals:              No specific      
addressing                                                           language         
children's       No specific        No specific language relating to relating to      
health           language relating  children's health. However,      children's       
                 to children's      under the TSCA Inventory Update  health.          
                 health.            Reporting Regulation of December                  
                                    2005, manufacturers of chemicals                  
                                    in volumes of 300,000 pounds or                   
                                    more must report use in or on                     
                                    products intended for use by                      
                                    children.                                         
           
			  Source: GAO analysis of U.S. TSCA New Chemicals and HPV Programs
           and EU REACH regulation.
			  
           Note: This table is not meant for purposes of legal comparison but
           only to provide some basic information to compare the U.S. and EU
           approaches to regulating chemicals.

           ^aUnder REACH, chemical substances are now described as
           nonphase-in (i.e., those not produced or marketed prior to the
           enactment of REACH) and phase-in (i.e., those substances listed in
           the European Inventory of Existing Commercial Chemical
           Substances--EINECS , or those that have been manufactured
           (produced) but not placed on the European market prior to the
           enactment of REACH).

           ^bThe TSCA Inventory contains about 82,000 chemicals; however, EPA
           officials say that the majority of the listed chemicals are either
           (1) not produced at all, (2) are produced in small quantities
           (less than 10,000 lbs. per year) or (3) are polymers.

           ^cAll chemicals (approximately 100,000) reported as being on the
           European market between January 1, 1971, and September 18, 1981
           (those listed in the European Inventory of Existing Commercial
           Chemical Substances--EINECS--or those manufactured but not placed
           on the European market in the last 15 years) were classified as
           existing chemicals, and all chemicals (over 3,800) introduced
           after 1981 were termed new chemicals prior to the enactment of
           REACH and need not be registered under REACH unless a change in
           volume produced or marketed occurs.

           ^d EPA invited chemical companies to voluntarily sponsor these
           chemicals and submit data summaries of existing information along
           with a test plan proposing a strategy to fill data gaps for either
           an individual chemical or for a category of chemicals.

           ^eThe TSCA IUR is primarily used to gather certain information on
           chemicals produced at more than a basic threshold volume in the
           year reported. Among other things, chemical companies that produce
           or import chemicals at or above the 25,000 pound per site
           threshold are to report the number of workers reasonably likely to
           be exposed to the chemical at each site and has a reporting
           threshold of 300,000 pounds per site at or above which chemical
           companies must report readily obtainable exposure-related use and
           processing information.

           ^fData older than 12 years is regarded as public domain.

           ^gApplicants for authorization must demonstrate that risks
           associated with the use of the chemical are adequately controlled,
           that socioeconomic benefits outweigh the risks to human health and
           the environment, and that no suitable alternatives exist. All
           applications must be accompanied by an analysis of potential
           substitutes.
			  
			  Appendix III: Additional Options For Strengthening EPA's Ability
			  to Assess and Regulate Chemicals under TSCA

           As requested, we identified a number of options that could
           strengthen EPA's ability under the TSCA to assess chemicals and
           control those found to be harmful. These options have been
           previously identified in earlier GAO reports^1 on ways to make
           TSCA more effective. Representatives of environmental
           organizations and subject matter experts subsequently concurred
           with a number of these options and commented on them in
           congressional testimony. These options are not meant to be
           comprehensive but illustrate actions that the Congress could take
           to strengthen EPA's ability to regulate chemicals under TSCA.

           The Congress may wish to consider revising TSCA to place more of
           the burden on industry to demonstrate that new chemicals are safe.
           Some of the burden could be shifted by requiring industry to test
           new chemicals based on substantial production volume and the
           necessity for testing, and to notify EPA of significant increases
           in production, releases, and exposures or of significant changes
           in manufacturing processes and uses after new chemicals are
           marketed.

           To put existing chemicals on a more equal footing with new
           chemicals, the Congress could consider revising TSCA to set
           specific deadlines or targets for the review of existing
           chemicals. These deadlines or targets would help EPA to establish
           priorities for reviewing those chemicals that, on the basis of
           their toxicity, production volumes, and potential exposure,
           present the highest risk to health and the environment. The
           Congress could also consider revising TSCA to shift more of the
           burden for reviewing existing chemicals to industry. If more of
           the responsibility for assessing existing chemicals was shared by
           industry, EPA could review more chemicals with current resources.
           In deciding how much of the burden to shift to industry, the
           Congress would need to consider the extent to which providing data
           to show that chemicals are safe should be a cost of doing business
           for the chemical industry.

           To ensure that EPA can implement its initiatives without having to
           face legal challenges and delays, the Congress may wish to
           consider revising TSCA to
			  
^1 [29]GAO/RCED-94-103 and [30]GAO-05-458.

           o provide explicit authority for EPA to enter into enforceable
           consent agreements under which chemical companies are required to
           conduct testing,
           o clarify that health and safety data cannot be claimed as
           confidential business information,
           o require substantiation of confidentiality claims at the time
           that the claims are submitted to EPA,
           o limit the length of time for which information may be claimed as
           confidential without reaffirming the need for confidentiality,
           o establish penalties for the false filing of confidentiality
           claims, and
           o authorize states and foreign governments to have access to
           confidential business information when they can demonstrate to EPA
           that they have a legitimate need for the information and can
           adequately protect it against unauthorized disclosure.
			  
			  Appendix IV: Summary of Chemical Hazard Information Requirements under
           REACH and TSCA by Production Volume

           In general, TSCA does not require chemical companies to test the
           chemicals they produce for their hazardous effects on human health
           and the environment absent EPA rule making, whereas REACH requires
           chemical companies to develop such data based on the production
           volume of the chemical. Table 2 provides information on the total
           number and types of data on chemical hazards required for
           chemicals produced at various production volumes, where
           applicable, for REACH, TSCA, and the HPV Challenge Program. While
           TSCA does not require chemical companies to develop data on
           chemicals' effects on human health or the environment, absent EPA
           action, we have included data requirements for new chemicals that
           chemical companies plan to produce at high volumes within a few
           years of introducing the chemical to the marketplace. While TSCA
           does not require companies to provide this information, EPA says
           that companies generally agree to provide this information through
           negotiated consent orders. In addition, while industry
           participation in EPA's HPV Challenge Program is voluntary, we have
           included information on the number of tests likely to be produced
           for chemicals in the program.

Table 2: Comparison of Chemical Information Requirements by Increasing
Production Volume for the EU and the United States (highlighted)

                               EU           U.S. TSCA                               
                            REACH                 New                               
                            1 ton  EU REACH Chemicals  EU REACH  U.S. HPV  EU REACH 
                               or   10 tons  100 tons  100 tons Challenge 1000 tons 
                           more^a   or more or more^b or more^c Program^d or more^c 
Weight range in pounds per  2,205                                                   
year                           or 22,046 or   220,460   220,460 1,000,000 2,204,600 
                             more      more   or more   or more   or more   or more 
Weight range in metric       1 or     10 or    100 or    100 or    454 or  1,000 or 
tons per year                more      more      more      more      more      more 
Approximate number of                 5,800               3,000     2,800     3,700 
chemicals per category       ^a   chemicals    ^e     chemicals chemicals chemicals 
Physical/Chemical                                                                   
properties tests                                                                    
Boiling point                  0M        0M        0M        0M        0M           
Dissociation constant                    0M        0M                               
Explosive properties           0M        0M        0M        0M                     
Flammability                   0M        0M        0M        0M                     
Flash point                    0M        0M        0M        0M                     
Granulometry                   0M        0M        0M        0M                     
Melting/freezing point         0M        0M        0M        0M        0M           
Oxidizing properties           0M        0M        0M        0M                     
Partition coefficient:                                                              
n-octanol/water                0M        0M        0M        0M        0M           
Relative density               0M        0M                  0M                  0M 
Self-ignition temperature      0M        0M                  0M                  0M 
Stability in organic                                                                
solvents and identity of                                                            
relevant degradation                                                                
products                                                     0M                  0M 
State of the substance at                                                           
20DEGC                         0M        0M                  0M                  0M 
Surface tension                0M        0M                  0M                  0M 
Vapor pressure                 0M        0M                  0M        0M        0M 
Viscosity                                                    0M                  0M 
Water solubility               0M        0M        0M        0M        0M        0M 
Total tests for                                                                     
physical/chemical                                                                   
properties                     14        14         1        17         5        17 
Human health effects tests                                                          
Acute toxicity (by oral                                                             
route, inhalation, dermal                                                           
route)^f                       0M        0M        0M        0M        0M        0M 
Carcinogenicity                                                                  0M 
Eye irritation (in vitro)      0M        0M                  0M                  0M 
Eye irritation (in vivo)                 0M                  0M                  0M 
Genetic toxicity: In vitro                                                          
cytogenecity in mammalian                                                           
cells or in vitro                                                                   
micronucleus study                       0M        0M        0M        0M        0M 
Genetic toxicity: In vitro                                                          
gene mutation study in                                                              
bacteria                       0M        0M        0M        0M        0M        0M 
Genetic toxicity: In vitro                                                          
gene mutation study in                                                              
mammalian cells                          0M                  0M                  0M 
Repeated dose toxicity                                                              
short term                               0M        0M        0M        0M        0M 
Repeated dose toxicity                                                              
subchronic                                                   0M                  0M 
Reproductive toxicity:                                                              
Prenatal development                                                                
toxicity                                       ^g            0M        0M        0M 
Reproductive toxicity:                                                              
Reproductive/developmental                                                          
toxicity testing                         0M     g            0M        0M        0M 
Reproductive toxicity:                                                              
two-generation                                                                      
reproductive toxicity                                                               
testing                                                      0M                  0M 
Skin irritation (in vivo)                0M                  0M                  0M 
Skin irritation or skin                                                             
corrosion (in vitro)           0M        0M                  0M                  0M 
Skin sensitization             0M        0M                  0M                  0M 
Toxicokinetics                           0M                  0M                  0M 
Total tests for human                                                               
health effects                  5        12         4        15         6        16 
Environmental effects                                                               
tests                                                                               
Abiotic degradation:                                                                
Stability in water                                                                  
(hydrolysis)                             0M        0M        0M        0M        0M 
Activated sludge                                                                    
respiration                              0M        0M        0M                  0M 
Aquatic toxicity:                                                                   
Long-term/chronic toxicity                                                          
testing on fish                                              0M                  0M 
Aquatic toxicity:                                                                   
Long-term/chronic toxicity                                                          
testing on invertebrates                                     0M                  0M 
Aquatic toxicity: Short-                                                            
term/acute toxicity                                                                 
testing on fish                          0M        0M        0M        0M        0M 
Aquatic toxicity: Short-                                                            
term/acute toxicity                                                                 
testing on invertebrates       0M        0M        0M        0M        0M        0M 
Aquatic toxicity: Toxicity                                                          
to aquatic plants (algae)/                                                          
Growth inhibition              0M        0M        0M        0M        0M        0M 
Biotic degradation:                                                                 
Anaerobic biodegradation                           0M                               
Biotic degradation: Ready                                                           
biodegradability               0M        0M        0M        0M        0M        0M 
Biotic degradation:                                                                 
Further biotic degradation                                                          
testing^h                                                    0M                  0M 
Identification of                                                                   
degradation products                                         0M                  0M 
Soil biodegradation                                0M                               
Environmental fate                                                                  
Adsorption/desorption                                                               
screening                                0M                  0M                  0M 
Adsorption/desorption,                                                              
further information                                          0M                  0M 
Bioaccumulation in aquatic                                                          
species                                                      0M                  0M 
Birds: long-term or                                                                 
reproductive toxicity                                                            0M 
Further information on                                                              
environmental fate and                                                              
behavior                                                                         0M 
Photodegradation                                   0M                  0M           
Sediment organisms:                                                                 
long-term toxicity                                                               0M 
Terrestrial organisms                                                               
effects: Effects on soil                                                            
micro-organisms                                              0M                  0M 
Terrestrial organisms                                                               
effects: Long-term                                                                  
toxicity testing on                                                                 
invertebrates                                                                    0M 
Terrestrial organisms                                                               
effects: Long-term                                                                  
toxicity testing on plants                                                       0M 
Terrestrial organisms                                                               
effects: Short-term                                                                 
toxicity to invertebrates                                    0M                  0M 
Terrestrial organisms                                                               
effects: Short-term                                                                 
toxicity to plants                                           0M                  0M 
Transport/Distribution                                                              
between environmental                                                               
compartments                                                           0M           
Total tests for                                                                     
environmental effects/fate      3         7         9        16         7        21 

Source: GAO analysis of U.S. TSCA New Chemicals and HPV Programs and EU
REACH regulation.

Note: Not all of the tests/data requirements listed necessarily have to be
conducted. In some cases, certain tests are not appropriate for the
chemical in question or it is not technically feasible to carry them out.
In other cases, required information may be replaced by other information,
adapted in another way, or inferred from other information.

^aUnder REACH, for chemicals produced in the one to ten ton range, only
chemicals that are likely to be classified as carcinogenic, mutagenic, or
toxic for reproduction will require human health and environmental effects
data. All chemicals in this range will require physical/chemical
properties and any available human health and environmental effects data.

^bEPA may require human health or environmental hazard testing through a
TSCA Section 5(e) Consent Order either based on risk criteria or exposure
criteria under EPA's TSCA Section 5(e) Exposure Based Policy for chemicals
produced at 100 tons or more. However, not all tests under this policy are
required for all chemicals produced at 100 tons or above. Chemicals that
meet human exposure criteria may require some or all of the health effects
tests listed by EPA; chemicals that meet substantial environmental release
criterion (exposure criteria) may require some or all of the environmental
effects tests listed by EPA; chemicals that meet the drinking water,
ground water, total release to environment media, or total release to
surface water exposure-based policy criteria may require some or all of
the environmental fate tests listed by EPA.

^cFor the 100 ton level and the 1,000 ton level, the chemical company
should submit a testing proposal if they do not already possess the
required information. Since tests might be costly and might involve
testing on vertebrate animals, the necessity for and the quality of the
testing proposal will be checked by the European Chemicals Agency, in
coordination with the Member States, in the evaluation process.

^dThe HPV Challenge Program is a voluntary program aimed at developing and
making publicly available screening level health and environmental effects
information on chemicals manufactured in or imported into the United
States in quantities of one million pounds or more per year. Health and
environmental effects tests are based on the Organization for Economic
Cooperation and Development's (OECD) Screening Information Data Sets. The
OECD is a forum where the governments of 30 countries work together to
address economic, social, and environmental issues and is recognized as
the largest and most reliable source of comparable statistical, economic,
and social data. The Screening Information Data Sets is the OECD's program
under which data on HPV chemicals are collected and shared.

^eOnce a company begins production of a chemical, it is placed on the TSCA
Inventory and is classified as an existing chemical.

^fFor the HPV Challenge Program, only one of the three tests of oral
route, inhalation, or dermal route are required. For REACH, the oral route
test is the only one required at one ton or above and all three (oral,
inhalation, and dermal) are required at 10 tons or above.

^gThese tests may be required at production volumes of 1 million pounds
(about 454 tons) or more.

^hThree biotic degradation tests are specified: simulation testing on
ultimate degradation in surface water; soil simulation testing (for
substances with a high potential for adsorption to soil); and sediment
simulation testing (for substances with a high potential for adsorption to
sediment). The choice of the appropriate test(s) depends on the results of
the chemical safety assessment.

Appendix V: Comments from the Environmental Protection Agency

Appendix VI: GAO Contact and Staff Acknowledgments

GAO Contact

John B. Stephenson, (202) 512-3841

Staff Acknowledgments

In addition to the individual named above, David Bennett, John Delicath,
Richard Johnson, Valerie Kasindi, Ed Kratzer, and Tyra Thompson made key
contributions to this report.

(360656)

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Highlights of [38]GAO-07-825 , a report to congressional requesters

August2007

CHEMICAL REGULATION

Comparison of U.S. and Recently Enacted European Union Approaches to
Protect against the Risks of Toxic Chemicals

Chemicals play an important role in everyday life. However, some chemicals
are highly toxic and need to be regulated. 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, but some have questioned whether
TSCA provides EPA with enough tools to protect against chemical risks.
Like the United States, the European Union (EU) has laws governing the
production and use of chemicals. The EU has recently revised its chemical
control policy through legislation known as Registration, Evaluation and
Authorization of Chemicals (REACH) in order to better identify and
mitigate risks from chemicals.

GAO was asked to review the approaches used under TSCA and REACH for (1)
requiring chemical companies to develop information on chemicals' effects,
(2) controlling risks from chemicals, and (3) making information on
chemicals available to the public. To review these issues, GAO analyzed
applicable U.S. and EU laws and regulations and interviewed U.S. and EU
officials, industry representatives, and environmental advocacy
organizations.

GAO is making no recommendations.

REACH requires companies to develop information on chemicals' effects on
human health and the environment, while TSCA does not require companies to
develop such information absent EPA rule-making requiring them to do so.
While TSCA does not require companies to develop information on chemicals
before they enter commerce (new chemicals), companies are required to
provide EPA any information that may already exist on a chemical's impact
on human health or the environment. Companies do not have to develop
information on the health or environmental impacts of chemicals already in
commerce (existing chemicals) unless EPA formally promulgates a rule
requiring them to do so. Partly because of the resources and difficulties
the agency faces in order to require testing to develop information on
existing chemicals, EPA has moved toward using voluntary programs as an
alternative means of gathering information from chemical companies in
order to assess and control the chemicals under TSCA. While these programs
are noteworthy, data collection has been slow in some cases,and it is
unclear if the programs will provide EPA enough information to identify
and control chemical risks.

TSCA places the burden of proof on EPA to demonstrate that a chemical
poses a risk to human health or the environment before EPA can regulate
its production or use, while REACH generally places a burden on chemical
companies to ensure that chemicals do not pose such risks or that measures
are identified for handling chemicals safely. In addition, TSCA provides
EPA with differing authorities for controlling risks, depending on whether
the risks are posed by new or existing chemicals. For new chemicals, EPA
can restrict a chemical's production or use if the agency determines that
insufficient information exists to permit a reasoned evaluation of the
health and environmental effects of the chemical and that, in the absence
of such information, the chemical may present an unreasonable risk. For
existing chemicals, EPA may regulate a chemical for which it finds a
reasonable basis exists to conclude that it presents or will present an
unreasonable risk. Further, TSCA requires EPA to choose the regulatory
action that is least burdensome in mitigating the unreasonable risk.
However, EPA has found it difficult to promulgate rules under this
standard. Under REACH, chemical companies must obtain authorization to use
chemicals that are listed as chemicals of very high concern. Generally, to
obtain such authorization, chemical companies need to demonstrate that
they can adequately control risks posed by the chemical or otherwise
ensure that the chemical is used safely.

TSCA and REACH both have provisions to protect information claimed by
chemical companies as confidential or sensitive business information but
REACH requires greater public disclosure of certain information, such as
basic chemical properties, including melting and boiling points. In
addition, REACH places greater restrictions on the kinds of information
chemical companies may claim as confidential.

References

Visible links
  19. http://www.gao.gov/cgi-bin/getrpt?GAO-05-458
  20. http://www.gao.gov/cgi-bin/getrpt?GAO/RCED-94-103
  21. http://www.gao.gov/cgi-bin/getrpt?GAO-05-458
  22. http://www.gao.gov/cgi-bin/getrpt?GAO-05-458
  23. http://www.gao.gov/cgi-bin/getrpt?GAO-05-458
  24. http://www.epa.gov/chemrtk/vccep
  25. http://www.gao.gov/
  26. http://www.gao.gov/cgi-bin/getrpt?GAO-05-458
  27. http://www.gao.gov/cgi-bin/getrpt?GAO-05-458
  28. http://www.gao.gov/cgi-bin/getrpt?GAO-05-458
  29. http://www.gao.gov/cgi-bin/getrpt?GAO/RCED-94-103
  30. http://www.gao.gov/cgi-bin/getrpt?GAO-05-458
  31. http://www.gao.gov/
  32. http://www.gao.gov/
  33. http://www.gao.gov/fraudnet/fraudnet.htm
  34. mailto:[email protected]
  35. mailto:[email protected]
  36. mailto:[email protected]
  37. http://www.gao.gov/cgi-bin/getrpt?GAO-07-825
  38. http://www.gao.gov/cgi-bin/getrpt?GAO-07-825
*** End of document. ***