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
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