Chemical Regulation
Options for Enhancing the Effectiveness of the Toxic Substances Control Act Gao ID: GAO-09-428T February 26, 2009Congress passed the Toxic Substances Control Act (TSCA) in 1976, authorizing the Environmental Protection Agency (EPA) to obtain information on the risks of industrial chemicals and to control those that EPA determines pose an unreasonable risk. However, EPA does not have sufficient chemical assessment information to determine whether it should establish controls to limit public exposure to many chemicals that may pose substantial health risks. In reports on TSCA, GAO has recommended statutory changes to, among other things, provide EPA with additional authorities to obtain health and safety information from the chemical industry and to shift more of the burden to chemical companies for demonstrating the safety of their chemicals. The most important recommendations aimed at providing EPA with the information needed to support its assessments of industrial chemicals have not been implemented--a key factor leading GAO in January 2009 to add transforming EPA's process for assessing and controlling toxic chemicals to its list of high-risk areas warranting attention by Congress and the executive branch. This testimony, which is based on prior GAO work, addresses EPA's implementation of TSCA and options for (1) obtaining information on the risks posed by chemicals to human health and the environment, (2) controlling these risks, and (3) publicly disclosing information provided by chemical companies under TSCA.
TSCA generally places the burden of obtaining data on existing chemicals on EPA, rather than on the companies that produce the chemicals. For example, the act requires EPA to demonstrate certain health or environmental risks before it can require companies to further test their chemicals. As a result, EPA does not routinely assess the risks of the roughly 80,000 industrial chemicals in use. Moreover, TSCA does not require chemical companies to test the approximately 700 new chemicals introduced into commerce annually for their toxicity, and companies generally do not voluntarily perform such testing. Further, the procedures EPA must follow in obtaining test data from companies can take years to complete. In contrast, the European Union's chemical control legislation generally places the burden on companies to provide health effects data on the chemicals they produce. Giving EPA more authority to obtain data from the companies producing chemicals, as GAO has in the past recommended that Congress consider, remains a viable option for improving the effectiveness of TSCA. While TSCA authorizes EPA to issue regulations that may, among other things, ban existing toxic chemicals or place limits on their production or use, the statutory requirements EPA must meet present a legal threshold that has proven difficult for EPA and discourages the agency from using these authorities. For example, EPA must demonstrate "unreasonable risk," which EPA believes requires it to conduct extensive cost-benefit analyses to ban or limit chemical production. Since 1976, EPA has issued regulations to control only five existing chemicals determined to present an unreasonable risk. Further, its 1989 regulation phasing out most uses of asbestos was vacated by a federal appeals court in 1991 because it was not based on "substantial evidence." In contrast, the European Union and a number of other countries have largely banned asbestos, a known human carcinogen that can cause lung cancer and other diseases. GAO has previously recommended that Congress amend TSCA to reduce the evidentiary burden EPA must meet to control toxic substances and continues to believe such change warrants consideration. EPA has a limited ability to provide the public with information on chemical production and risk because of TSCA's prohibitions on the disclosure of confidential business information. About 95 percent of the notices companies have provided to EPA on new chemicals contain some information claimed as confidential. Evaluating the appropriateness of confidentiality claims is time- and resource-intensive, and EPA does not challenge most claims. State environmental agencies and others have said that information claimed as confidential would help them in such activities as developing contingency plans to alert emergency response personnel to the presence of highly toxic substances at manufacturing facilities. The European Union's chemical control legislation generally provides greater public access to the chemical information it receives, and GAO has previously recommended that Congress consider providing EPA additional authorities to make more chemical information publicly available.
GAO-09-428T, Chemical Regulation: Options for Enhancing the Effectiveness of the Toxic Substances Control Act
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Testimony:
Before the Subcommittee on Commerce, Trade, and Consumer Protection,
Committee on Energy and Commerce, House of Representatives:
United States Government Accountability Office:
GAO:
For Release on Delivery:
Expected at 10:00 a.m. EST:
Thursday, February 26, 2009:
Chemical Regulation:
Options for Enhancing the Effectiveness of the Toxic Substances Control
Act:
Statement of John Stephenson, Director:
Natural Resources and the Environment:
GAO-09-428T:
GAO Highlights:
Highlights of GAO-09-428T, a testimony before the Subcommittee on
Commerce, Trade, and Consumer Protection, Committee on Energy and
Commerce, House of Representatives.
Why GAO Did This Study:
Congress passed the Toxic Substances Control Act (TSCA) in 1976,
authorizing the Environmental Protection Agency (EPA) to obtain
information on the risks of industrial chemicals and to control those
that EPA determines pose an unreasonable risk. However, EPA does not
have sufficient chemical assessment information to determine whether it
should establish controls to limit public exposure to many chemicals
that may pose substantial health risks. In reports on TSCA, GAO has
recommended statutory changes to, among other things, provide EPA with
additional authorities to obtain health and safety information from the
chemical industry and to shift more of the burden to chemical companies
for demonstrating the safety of their chemicals. The most important
recommendations aimed at providing EPA with the information needed to
support its assessments of industrial chemicals have not been
implemented”a key factor leading GAO in January 2009 to add
transforming EPA‘s process for assessing and controlling toxic
chemicals to its list of high-risk areas warranting attention by
Congress and the executive branch.
This testimony, which is based on prior GAO work, addresses EPA‘s
implementation of TSCA and options for (1) obtaining information on the
risks posed by chemicals to human health and the environment, (2)
controlling these risks, and (3) publicly disclosing information
provided by chemical companies under TSCA.
What GAO Found:
TSCA generally places the burden of obtaining data on existing
chemicals on EPA, rather than on the companies that produce the
chemicals. For example, the act requires EPA to demonstrate certain
health or environmental risks before it can require companies to
further test their chemicals. As a result, EPA does not routinely
assess the risks of the roughly 80,000 industrial chemicals in use.
Moreover, TSCA does not require chemical companies to test the
approximately 700 new chemicals introduced into commerce annually for
their toxicity, and companies generally do not voluntarily perform such
testing. Further, the procedures EPA must follow in obtaining test data
from companies can take years to complete. In contrast, the European
Union‘s chemical control legislation generally places the burden on
companies to provide health effects data on the chemicals they produce.
Giving EPA more authority to obtain data from the companies producing
chemicals, as GAO has in the past recommended that Congress consider,
remains a viable option for improving the effectiveness of TSCA.
While TSCA authorizes EPA to issue regulations that may, among other
things, ban existing toxic chemicals or place limits on their
production or use, the statutory requirements EPA must meet present a
legal threshold that has proven difficult for EPA and discourages the
agency from using these authorities. For example, EPA must demonstrate
’unreasonable risk,“ which EPA believes requires it to conduct
extensive cost-benefit analyses to ban or limit chemical production.
Since 1976, EPA has issued regulations to control only five existing
chemicals determined to present an unreasonable risk. Further, its 1989
regulation phasing out most uses of asbestos was vacated by a federal
appeals court in 1991 because it was not based on ’substantial
evidence.“ In contrast, the European Union and a number of other
countries have largely banned asbestos, a known human carcinogen that
can cause lung cancer and other diseases. GAO has previously
recommended that Congress amend TSCA to reduce the evidentiary burden
EPA must meet to control toxic substances and continues to believe such
change warrants consideration.
EPA has a limited ability to provide the public with information on
chemical production and risk because of TSCA‘s prohibitions on the
disclosure of confidential business information. About 95 percent of
the notices companies have provided to EPA on new chemicals contain
some information claimed as confidential. Evaluating the
appropriateness of confidentiality claims is time- and resource-
intensive, and EPA does not challenge most claims. State environmental
agencies and others have said that information claimed as confidential
would help them in such activities as developing contingency plans to
alert emergency response personnel to the presence of highly toxic
substances at manufacturing facilities. The European Union‘s chemical
control legislation generally provides greater public access to the
chemical information it receives, and GAO has previously recommended
that Congress consider providing EPA additional authorities to make
more chemical information publicly available.
To view the full product, including the scope and methodology, click on
[hyperlink, http://www.gao.gov/products/GAO-09-428T]. For more
information, contact John B. Stephenson at (202) 512-3841 or
stephensonj@gao.gov.
[End of section]
Mr. Chairman and Members of the Subcommittee:
I am pleased to appear today before the Subcommittee on Commerce,
Trade, and Consumer Protection, House Committee on Energy and Commerce,
to discuss our work on the need to improve the Toxic Substances Control
Act (TSCA). As you know, tens of thousands of chemicals are currently
in commercial use in the United States and hundreds of new chemicals
are introduced into commerce each year--some of which may be toxic and
adversely affect human health or the environment. The Congress passed
TSCA in 1976 to enable the Environmental Protection Agency (EPA) to
obtain information on the risks of commercially used chemicals and to
control those that EPA determines may pose unreasonable risks. However,
TSCA generally places the burden of obtaining information about the
roughly 80,000 chemicals already on the U.S. market on EPA, rather than
on the companies that produce the chemicals. The act requires EPA to
demonstrate certain health or environmental risks before it can require
companies to further test their chemicals. As a result, EPA does not
routinely assess the risks of the industrial chemicals that are already
in use. Further, for the approximately 700 new chemicals introduced
into commerce annually, chemical companies are required to provide EPA
with certain information in "premanufacture notices," and EPA can ban
or limit a chemical's use if it finds, among other things, that this
information is insufficient to allow evaluation of the chemical's
health and environmental effects. Although 85 percent of the notices
lack any health or safety test data, EPA does not often use its
authority to obtain more information.
In previous reports on TSCA, we have recommended both statutory and
regulatory changes to, among other things, strengthen EPA's authority
to obtain additional 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. In part because the most
important recommendations aimed at providing EPA with the information
needed to support its assessments of industrial chemicals have not been
implemented, in January 2009, we added transforming EPA's processes for
assessing and controlling toxic chemicals to our list of areas at "high-
risk" for waste, fraud, abuse and mismanagement or in need of broad-
based transformation.[Footnote 1]
My testimony today is largely based on our prior work involving TSCA
that identified the challenges associated with implementing the act and
some of the legislative options available to address these challenges.
Specifically, my statement addresses EPA's implementation of TSCA and
options for (1) obtaining information on the risks posed by chemicals
to human health and the environment, (2) controlling these risks, and
(3) publicly disclosing information provided by chemical companies
under TSCA. In addition, my testimony will also highlight the results
of our 2007 report assessing the key differences between the approach
to chemical regulation under TSCA and the chemical control policy the
European Union adopted in 2006 under legislation known as Registration,
Evaluation and Authorization of Chemicals (REACH). (See Related GAO
Products following this statement.)
In summary, EPA lacks adequate scientific information on the toxicity
of many chemicals in the environment. TSCA generally places the burden
of obtaining data on chemicals on EPA, rather than on the companies
that produce the chemicals. This approach requires that EPA demonstrate
certain health or environmental risks before it can require companies
to further test their chemicals. As a result, EPA has only limited
information on the health and environmental risks posed by these
chemicals. In previous reports on TSCA, we have identified for
Congressional consideration statutory changes to strengthen EPA's
authority to obtain information from the chemical industry. In our
view, these changes remain viable options for improving the
effectiveness of TSCA and thereby enhancing EPA's ability to protect
public health and the environment.
While TSCA authorizes EPA to issue regulations that may, among other
things, ban existing toxic chemicals or place limits on their
production or use, the statutory requirements EPA must meet to do so
present a legal threshold that has proven difficult for EPA and
discouraged agency action. For example, EPA has long concluded that
asbestos is a known human carcinogen that can cause lung cancer and
other diseases. Although EPA spent 10 years developing a rule to phase
out the use of nearly all products containing asbestos under its TSCA
authority, a federal appeals court largely vacated the rule because it
was not based on "substantial evidence." In contrast to the United
States, the European Union and a number of other countries have
essentially banned asbestos and asbestos-containing products. Since
EPA's asbestos rule was rejected in 1991, the agency has not completed
any actions to ban or limit toxic chemicals under section 6. The
options for enhancing the effectiveness of TSCA that we have identified
in prior reports include amendments to reduce the evidentiary burden
that EPA must meet to enable EPA to better protect the public health
and the environment.
EPA's ability to provide the public with information on chemical
production and risk has been hindered by strict confidential business
information provisions of TSCA, which generally prohibits the
disclosure of confidential business information. State environmental
agencies and others have expressed interest in obtaining information
claimed as confidential business information for use in various
activities, such as developing contingency plans to alert emergency
response personnel to the presence of highly toxic substances at
manufacturing facilities. In previous reports, we have identified
options for statutory changes to improve EPA's ability to make more
chemical information publicly available.
Background:
The Toxic Substances Control Act was enacted in 1976 to provide EPA
with the authority, upon making certain determinations, to collect
information about the hazards posed by chemical substances and to take
action to control unreasonable risks by either preventing dangerous
chemicals from making their way into use or placing restrictions on
those already in commerce. TSCA authorizes EPA to review chemicals
already in commerce (existing chemicals) and chemicals yet to enter
commerce (new chemicals). EPA lists chemicals in commerce in the TSCA
inventory. Of the over 83,000 chemicals currently in the TSCA
inventory, about 62,000 were already in commerce when EPA began
reviewing chemicals in 1979. Since then, over 21,000 new chemicals were
added to the inventory and are now in use as existing chemicals. To
assess risks, EPA examines a chemical's toxicity or potential adverse
effects and the amount of human and environmental exposures. TSCA
generally requires the industry to notify EPA at least 90 days before
producing or importing a new chemical. These notices contain
information, such as the chemical's molecular structure and intended
uses that EPA uses to evaluate the chemical's potential risks. TSCA
also authorizes EPA to promulgate rules to require manufacturers to
perform tests on chemicals in certain circumstances or provide other
data, such as production volumes, on existing chemicals. In addition,
TSCA requires chemical companies to report to EPA any data that
reasonably support a conclusion that a chemical presents a substantial
risk. If EPA finds that a chemical's risks are unreasonable, it can
prohibit or limit its production, processing, distribution, use, and
disposal or take other action, such as requiring warning labels on the
substance. While TSCA authorizes EPA to release chemical information
obtained by the agency under the act, TSCA provides that certain
information, such as data disclosing chemical processes, can be claimed
as confidential business information by chemical manufacturers and
processors. EPA generally must protect such information against public
disclosure unless such disclosure is necessary to protect against an
unreasonable risk of injury to health or the environment.
Like the United States, the European Union has laws and regulations
governing the manufacturing and use of chemicals. However, the EU has
recently revised its chemical control policy through legislation known
as Registration, Evaluation and Authorization of Chemicals (REACH).
REACH went into effect in June 2007, but full implementation of all the
provisions of REACH will be phased in over an 11-year period. 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 manufacturer can demonstrate that the risks from a use
of the chemical can be adequately controlled or that the socioeconomic
benefits outweigh the risks and that there are no suitable
alternatives. 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. In 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 Lacks Adequate Information on Potential Health and Environmental
Risks of Toxic Chemicals:
While TSCA authorizes EPA to review existing chemicals, it generally
provides no specific requirement, time frame, or methodology for doing
so. Significantly, chemical companies are not required to develop and
submit toxicity information to EPA on existing chemicals unless the
agency finds that a chemical may present an unreasonable risk of injury
to human health or the environment or is or will be produced in
substantial quantities and that either (a) there is or may be
significant or substantial human exposure to the chemical or (b) the
chemical enters the environment in substantial quantities. EPA must
also determine there are insufficient data to reasonably determine the
effects on health or the environment and that testing is necessary to
develop such data before it can require a company to test its chemicals
for harmful effects. This structure places the burden on EPA to
demonstrate a need for data on a chemical's toxicity rather than on a
company to demonstrate that a chemical is safe. As a result, EPA does
not routinely assess the risks of the roughly 80,000 industrial
chemicals in use.
EPA has begun to rely on voluntary programs for data, such as the High
Production Volume Challenge program, where companies voluntarily agree
to provide EPA certain data on high-production volume chemicals.
However, these programs may not provide EPA with complete data in a
timely manner. For example, there are currently over 200 high-
production-volume chemicals for which chemical companies have not
voluntarily agreed to provide the minimal test data that EPA believes
are needed to initially assess their risks. EPA officials told us that
in cases where chemical companies do not voluntarily provide test data
and health and safety studies in a complete and timely manner,
requiring the testing of existing chemicals of concern--those chemicals
for which some suspicion of harm exists--is the only practical way to
ensure that the agency obtains the needed information. Furthermore,
many additional chemicals are likely to become high production
chemicals because the specific chemicals used in commerce are
constantly changing, as are their production volumes.
However, EPA officials told us that it is time-consuming, costly, and
inefficient for the agency to use TSCA's two-step process of (1)
issuing rules under TSCA (which can take months or years to develop) to
obtain exposure data or available test data that the chemical industry
does not voluntarily provide to EPA and then (2) issuing additional
rules requiring companies to perform specific tests necessary to ensure
the safety of the chemicals tested. Officials also said that EPA's
authority under TSCA to issue rules requiring chemical companies to
conduct tests on existing chemicals has been difficult to use because
the agency must first make certain findings before it can require
testing. Specifically, TSCA requires EPA to find that current data is
insufficient; testing is necessary; and that either (1) the chemical
may present an unreasonable risk or (2) that the chemical is or will be
produced in substantial quantities and that there is or may be
substantial human or environmental exposure to the chemical.
Once EPA has made the required findings, the agency can issue a
proposed rule for public comment, consider the comments it receives,
and promulgate a final rule ordering chemical testing. EPA officials
told us that finalizing rules can take from 2 to 10 years and require
the expenditure of substantial resources. Given the time and resources
required, the agency has issued rules requiring testing for only about
200 chemicals. Because EPA has used authority to issue rules to require
testing so sparingly, it has not continued to maintain information on
the cost of implementing these rules. However, in our October 1994
report on TSCA, we noted that EPA officials told us that issuing such a
rule can cost hundreds of thousands of dollars. Given the difficulties
involved in requiring testing, EPA officials do not believe that TSCA
provides an effective means for testing a large number of existing
chemicals. They believe that EPA could review substantially more
chemicals in less time if they had the authority to require chemical
companies to conduct testing and provide test data on chemicals once
they reach a substantial production volume, assuming EPA had first
determined that these data cannot be obtained without testing. We have
long held a similar view based on our reviews involving TSCA. For
example, in our in June 2005 report,[Footnote 2] we recommended that
the Congress consider giving EPA the authority to require chemical
manufacturers and processors to develop test data based on substantial
production volume and the necessity for testing. We continue to believe
that providing EPA with more authority to obtain test data from
companies would enhance the effectiveness of TSCA.
In contrast with TSCA's provisions for obtaining information on
chemicals, we found that REACH, the legislation through which the
European Union has recently revised its chemical control policy,
requires chemical companies to develop more information than TSCA on
the effects of chemicals on human health and the environment. REACH
generally requires that chemical companies provide to, and in some
cases develop for, government regulators information on chemicals'
effects on human health and the environment, while TSCA generally does
not. For example, under REACH, chemical companies provide information
on chemicals' properties and health and environmental effects for
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.
Regarding new chemicals, TSCA generally requires chemical companies to
notify EPA of their intent to manufacture or import new chemicals and
to provide any available test data. Yet EPA estimates that most
premanufacture notices do not include test data of any type, and only
about 15 percent include health or safety test data. Chemical companies
do not have an incentive to conduct these tests because they may take
over a year to complete, and some tests may cost hundreds of thousands
of dollars. Because EPA generally does not have sufficient data on a
chemical's properties and effects when reviewing a new chemical, EPA
uses models to compare new chemicals with chemicals with similar
molecular structures for which test data on health and environmental
effects are available.
EPA bases its exposure estimates for new chemicals on information
contained in premanufacture notices. However, the anticipated
production volume, uses, exposure levels, and release estimates
outlined in these notices generally do not have to be amended once
manufacturing begins. That is, once EPA completes its review and
production begins, chemical companies are not required under TSCA to
limit the production of a chemical or its uses to those specified in
the premanufacture notice or to submit another premanufacture notice if
changes occur. However, the potential risk of injury to human health or
the environment may increase when chemical companies increase
production levels or expand the uses of a chemical. TSCA addresses
expanded uses of chemicals by authorizing EPA to promulgate a rule
specifying that a particular use of a chemical would be a significant
new use. However, EPA has infrequently issued such rules, which require
manufacturers, importers, and processors of the chemical for the new
use to notify EPA at least 90 days before beginning manufacturing or
processing the chemical for that use.
An option that could make TSCA more effective would be to revise the
act to require companies to test their chemicals and submit the results
to EPA with their premanufacture notices. Currently, such a step is
required only if EPA makes the necessary findings and promulgates a
testing rule. A major drawback to testing is its cost to chemical
companies, possibly resulting in a reduced willingness to perform
chemical research and innovation. To ameliorate such costs, or to delay
them until the new chemicals are produced in large enough quantity to
offset the cost of testing, requirements for testing could be based on
production volume. For example, in Canada and the European Union,
testing requirements for low-volume chemicals are less extensive and
complex than for those for high-volume chemicals. Congress could give
EPA, in addition to its current authorities under section 4 of TSCA,
the authority to require chemical substance manufacturers and
processors to develop test data based on, for example, substantial
production volume and the necessity for testing.
Another option would be to provide EPA with greater authority to
require testing targeted to those areas in which EPA's analysis models
do not adequately predict toxicity. For example, EPA could be
authorized to require such testing if it finds that it cannot be
confident of the results of its analysis (e.g., when it does not have
sufficient toxicity data on chemicals with molecular structures similar
to those of the new chemicals submitted by chemical companies.) Under
such an option, EPA could establish a minimal set of tests for new
chemicals to be submitted at the time a chemical company submits a
premanufacture notice for the chemical for EPA's review. Additional and
more complex and costly testing could be required as the new chemical's
potential risks increase, based on, for example, production or
environmental release levels.
According to some chemical companies, the cost of initial testing could
be reduced by amending TSCA to require EPA to review new chemicals
before they are marketed, rather than before they are manufactured. In
this regard, according 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. Thus, requiring
companies to conduct tests and submit the resulting test data only for
chemicals that are actually marketed would be substantially less
expensive than requiring them to test all new chemicals submitted for
EPA's review.
Likewise, TSCA's chemical review provisions could be strengthened by
requiring the systematic review of existing chemicals. In requiring
that EPA review premanufacture notices within 90 days, TSCA established
a firm requirement for reviewing new chemicals, but the act contains no
similar requirement for existing chemicals unless EPA determines by
rule that they are being put to a significant new use. TSCA could be
amended to establish a time frame for the review of existing chemicals,
putting existing chemicals on a more equal footing with new chemicals.
However, because of the large number of existing chemicals, EPA would
need the flexibility to identify which chemicals should be given
priority. TSCA could be amended to require individual chemical
companies or the industry as a whole to compile and submit chemical
data, such as that included in EPA's High Production Volume (HPV)
Challenge Program, for example, as a condition of manufacture or import
above some specified volume.
TSCA's Regulatory Framework Impedes EPA's Efforts to Control Toxic
Chemicals:
While TSCA authorizes EPA to issue regulations that may, among other
things, ban existing toxic chemicals or place limits on their
production or use, the statutory requirements EPA must meet to do so
present a legal threshold that has proven to be difficult for EPA.
Specifically, in order to regulate an existing chemical under section 6
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. EPA officials believe that
demonstrating an unreasonable risk is a more stringent requirement than
demonstrating, for example, a significant risk, and that a finding of
unreasonable risk requires an extensive cost-benefit analysis. In
addition, before regulating a chemical under section 6, the EPA
Administrator must consider and publish a statement regarding:
* the effects of the chemical on human health and the magnitude of
human exposure to the chemical;
* the effects of the chemical on the environment and the magnitude of
the environment's exposure to the chemical;
* the benefits of the chemical for various uses and the availability of
substitutes for those uses; and:
* 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.
Moreover, while TSCA offers EPA a range of control options when
regulating existing chemicals--ban or restrict a chemical's production,
processing, distribution in commerce, or disposal or use, or require
warning labels on the chemicals--EPA is required to choose the least
burdensome requirement that will be adequately protective. For example,
if EPA finds that it can adequately manage the unreasonable risk of a
chemical by requiring chemical companies to place warning labels on the
chemical, EPA may not ban or otherwise restrict the use of that
chemical. EPA must also develop substantial evidence in the rulemaking
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 rulemaking record." As several courts have noted, the
substantial evidence standard is more rigorous than the arbitrary and
capricious standard normally applied to rulemaking under the
Administrative Procedure Act. Further, according to EPA officials, 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 substantial
evidence that EPA is promulgating the least burdensome requirement.
EPA has had difficulty demonstrating that harmful chemicals pose an
unreasonable risk and consequently should be banned or have limits
placed on their production or use. In fact, since Congress passed TSCA
nearly 33 years ago, EPA has issued regulations under the act to ban or
limit or restrict the production or use of only five existing chemicals
or chemical classes.[Footnote 3] Significantly, in 1991, EPA's 1989
regulation broadly banning asbestos was largely vacated by a federal
appeals court decision that cited EPA's failure to meet statutory
requirements.[Footnote 4] In contrast to the United States, the
European Union, as well as a number of other countries, has banned all,
or almost all, asbestos and asbestos-containing products.
Asbestos, which refers to several minerals that typically separate into
very tiny fibers, is a known human carcinogen that can cause lung
cancer and other diseases if inhaled. Asbestos has been used widely in
products such as fireproofing, thermal insulation, and friction
products, including brake linings. EPA invested 10 years in exploring
the need for the asbestos ban and in developing the regulation. Based
on its review of over 100 studies of the health risks of asbestos as
well as public comments on the proposed rule, EPA determined that
asbestos is a potential carcinogen at all levels of exposure--that is,
that it had no known safe exposure level. EPA's 1989 rule under TSCA
section 6 prohibited the future manufacture, importation, processing,
and distribution of asbestos in almost all products. In response, some
manufacturers of asbestos products filed suit against EPA arguing, in
part, that the rule was not promulgated on the basis of substantial
evidence regarding unreasonable risk. In October 1991, the U.S. Court
of Appeals for the Fifth Circuit agreed with the chemical companies,
concluding that EPA had failed to muster substantial evidence to
justify its asbestos ban and returning parts of the rule to EPA for
reconsideration.
Specifically, the court concluded that EPA did not present sufficient
evidence to justify the ban on asbestos because it did not consider all
necessary evidence and failed to show that the control action it chose
was the least burdensome regulation required to adequately protect
human health or the environment. EPA had not calculated the risk levels
for intermediate levels of regulation because it believed there was no
asbestos exposure level for which the risk of injury or death was zero.
As articulated by the court, the proper course of action for EPA, after
an initial showing of product danger, would have been to consider each
regulatory option listed in TSCA, beginning with the least burdensome,
and the costs and benefits of each option. The court further criticized
EPA's ban of 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. In
addition, the court stated that in evaluating what risks are
unreasonable, EPA must consider the costs of any proposed actions;
moreover, the court noted that TSCA's requirement that EPA impose the
least burdensome regulation reinforces the view that EPA must balance
the costs of its regulations against their benefits. After completing
the 1989 asbestos rule, EPA has completed only one regulation to ban or
limit the production or use of an existing chemical (for hexavalent
chromium in 1990). Further, EPA has not completed any actions to ban or
limit toxic chemicals under section 6 since the court rejected its
asbestos rule in 1991.
With EPA's limited actions to control toxic chemicals under TSCA, state
and federal actions have established controls for some toxic chemicals.
For example, a California statute enacted in 2007 prohibits the
manufacture, sale, or distribution of certain toys and child care
articles after January 1, 2009, if the products contain concentrations
of phthalates exceeding 0.1 percent.[Footnote 5] In 2008, Congress took
similar action. California has also enacted limits on formaldehyde in
pressed wood. In response to a petition asking EPA to use section 6 of
TSCA to adopt the California formaldehyde regulation, EPA recently
issued an advance notice of proposed rulemaking suggesting several
regulatory options the agency could pursue under its TSCA section 6
authority to limit exposure to formaldehyde. However, because of the
legal hurdles the agency would face in regulating formaldehyde under
TSCA, some stakeholders have recommended that EPA pursue legislation to
control formaldehyde.
In our previous reports on TSCA, we identified a number of options that
could strengthen EPA's ability to regulate harmful chemicals under TSCA
and enhance EPA's ability to protect public health and the environment.
Potential changes to TSCA include reducing the evidentiary burden that
EPA must meet to take regulatory action under the act by amending the
(1) unreasonable risk standard that EPA must meet to regulate existing
chemicals under section 6 of TSCA, (2) standard for judicial review
that currently requires a court to hold a TSCA rule unlawful and set it
aside unless it is supported by substantial evidence in the rulemaking
record, and (3) requirement that EPA choose the least burdensome
regulatory requirement. We have previously recommended that the
Congress amend TSCA to reduce the evidentiary burden that EPA must
meet.[Footnote 6]
Alternatively, the European Union's recently enacted chemical control
legislation, REACH, represents a regulatory model that differs from the
TSCA framework in key ways. For example, 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. In addition, 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, the 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. This process substantially differs from
TSCA's section 6 requirements as discussed above.
EPA's Ability to Share Information Under TSCA's Confidential Business
Information Provisions Are Limited:
EPA's ability to make publicly available the information that it
collects under TSCA is limited. Chemical companies may claim some of
the information they provide to EPA under TSCA as confidential business
information. EPA is required under the act to protect trade secrets and
privileged or confidential commercial or financial information against
unauthorized disclosures, and this information generally cannot be
shared with others, including state health and environmental officials
and foreign governments. However, some state officials believe this
information would be useful for informing and managing their
environmental risk programs. Furthermore, while EPA believes that some
claims of confidential business information may be unwarranted,
challenging the claims is resource-intensive.
EPA has not performed any recent studies of the appropriateness of
confidentiality claims, but a 1992 EPA study indicated that 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. While EPA may
suspect that some chemical companies' confidentiality claims are
unwarranted, the agency does not have data on the number of
inappropriate claims. According to EPA, about 95 percent of
premanufacture notices contain some information that chemical companies
claim as confidential. EPA officials also told us that the agency does
not have the resources that would be needed to investigate and, as
appropriate, challenge claims to determine the number that are
inappropriate. Consequently, EPA focuses on investigating primarily
those claims that it believes may be both inappropriate and among the
most potentially important--that is, claims relating to health and
safety studies performed by the chemical companies involving chemicals
currently used in commerce. The EPA official responsible for initiating
challenges to confidentiality claims told us that EPA challenges about
14 such claims each year and that the chemical companies withdraw
nearly all of the claims challenged.
Officials who have various responsibilities for protecting public
health and the environment from the dangers posed by chemicals believe
that having access to confidential TSCA information would allow them to
examine information on chemical properties and processes that they
currently do not possess and could enable them to better control the
risks of potentially harmful chemicals. Likewise, the general public
may also find information provided under TSCA useful. Individual
citizens or community groups may have a specific interest in
information on the risks of chemicals that are produced or used in
nearby facilities. For example, neighborhood organizations can use such
information to engage in dialogue with chemical companies about
reducing chemical risks, preventing accidents, and limiting chemical
exposures.
While both TSCA and REACH have provisions to protect information
claimed by chemical companies as confidential, REACH requires greater
public disclosure of certain information, such as basic chemical
properties. Furthermore, REACH places greater restrictions on the kinds
of information chemical companies may claim as confidential. For
example, REACH includes a provision for public access to basic chemical
information, including brief profiles of hazardous properties and
authorized uses. The European Union's approach to public's access to
information combines 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. 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
certain conditions are met.
In previous reports, we recommended that the Congress consider
providing EPA additional authorities under TSCA to improve its ability
to make more chemical information publicly available. For example, in
our June 2005 report,[Footnote 7] we recommended that the Congress
consider amending TSCA to authorize EPA to share with the states and
foreign governments the confidential business information that chemical
companies provide to EPA, subject to regulations to be established by
EPA in consultation with the chemical industry and other interested
parties that would set forth the procedures to be followed by all
recipients of the information in order to protect the information from
unauthorized disclosures. In our September 1994 report,[Footnote 8] we
recommended that the Congress consider limiting the length of time for
which information may be claimed as confidential without
resubstantiation of the need for confidentiality.
Mr. Chairman, this concludes my prepared statement. I would be happy to
respond to any questions that you or Members of the Subcommittee may
have.
Contacts and Acknowledgments:
For further information about this testimony, please contact John
Stephenson at (202) 512-3841 or stephensonj@gao.gov. Key contributors
to this testimony were David Bennett, Antoinette Capaccio, Nancy
Crothers, Christine Fishkin, Richard Johnson, and Ed Kratzer.
[End of section]
Related GAO Products:
High-Risk Series: An Update. [hyperlink,
http://www.gao.gov/products/GAO-09-271]. Washington, D.C.: January 22,
2009.
Chemical Regulation: Comparison of U.S. and Recently Enacted European
Union Approaches to Protect against the Risks of Toxic Chemicals.
[hyperlink, http://www.gao.gov/products/GAO-07-825]. Washington, D.C.:
August 17 2007.
Chemical Regulation: Actions are Needed to Improve the Effectiveness of
EPA's Chemical Review Program. [hyperlink,
http://www.gao.gov/products/GAO-06-1032T]. Washington, D.C.: August 2,
2006.
Chemical Regulation: Options Exist to Improve EPA's Ability to Assess
Health Risks and Manage Its Chemical Review Program. [hyperlink,
http://www.gao.gov/products/GAO-05-458]. Washington, D.C.: June 13,
2005.
Toxic Substances Control Act: Legislative Changes Could Make the Act
More Effective. [hyperlink,
http://www.gao.gov/products/GAO/RCED-94-103]. Washington, D.C.:
September 26, 1994.
[End of section]
Footnotes:
[1] High Risk Series: An Update. [hyperlink,
http://www.gao.gov/products/GAO-09-271]. Washington, D.C.: Jan. 22,
2009.
[2] GAO, Chemical Regulation: Options Exist to Improve EPA's Ability to
Assess Health Risks and Manage Its Chemical Review Program. [hyperlink,
http://www.gao.gov/products/GAO-05-458]. Washington, D.C.: June 13,
2005
[3] EPA has placed controls on four new chemicals under section 5(f).
[4] The court vacated most of the rule but continued the rule's ban on
asbestos products no longer in commerce.
[5] This statute, as well as restrictions in place by the European
Union, covers several phthalates, including dibutyl phthalate. In 2000,
the Department of Health and Human Services' National Toxicology
Program concluded that dibutyl phthalate may adversely affect human
reproduction or development if exposures are sufficiently high.
[6] GAO, Toxic Substances Control Act: Legislative Changes Could Make
the Act More Effective. [hyperlink,
http://www.gao.gov/products/GAO/RCED-94-103]. Washington, D.C.:
September 26, 1994
[7] GAO, Chemical Regulation: Options Exist to Improve EPA's Ability to
Assess Health Risks and Manage Its Chemical Review Program. [hyperlink,
http://www.gao.gov/products/GAO-05-458]. Washington, D.C.: June 13,
2005.
[8] GAO, Toxic Substances Control Act: Legislative Changes Could Make
the Act More Effective. [hyperlink,
http://www.gao.gov/products/GAO/RCED-94-103]. Washington, D.C.:
September 26, 1994.
[End of section]
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