Chemical Regulation
Approaches in the United States, Canada, and the European Union Gao ID: GAO-06-217R November 4, 2005Chemicals are used 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 everyday life, some may be harmful to human health and the environment. Some chemicals, such as lead and mercury, are highly toxic at certain doses and need to be regulated because of health and safety concerns. In 1976, the Congress passed the Toxic Substances Control Act (TSCA) in part to authorize the Environmental Protection Agency (EPA) to regulate chemicals that pose an unreasonable risk to human health or the environment. TSCA addresses chemicals that are manufactured, imported, processed, distributed in commerce, used, or disposed of in the United States and authorizes EPA to assess chemicals before they enter commerce (new chemicals) and review those already in commerce (existing chemicals). TSCA excludes certain chemical substances, including among other things pesticides that are regulated under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA); and food; food additives; drugs; cosmetics or devices that are regulated under the Federal Food, Drug and Cosmetic Act (FFDCA). In this context, Congress asked that we provide comparative information on the following chemical control laws: TSCA, Canadian Environmental Protection Agency (CEPA), the current European Union legislation, and the Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH) as proposed. Specifically, Congress asked that we provide information on the approaches of (1) controlling chemical risks, (2) reviewing existing chemicals used in commerce, (3) assessing new chemicals, and (4) handling confidential business information.
TSCA authorizes EPA to take a number of control actions with regard to new chemicals or uses of chemicals that EPA has determined by rule are significant new uses. To control existing chemicals under TSCA, EPA must present substantial evidence that a reasonable basis exists to conclude that the chemical presents or will present an unreasonable risk to human health or the environment. The United States Court of Appeals for the Fifth Circuit has stated that EPA must consider the costs of any proposed action in evaluating what risks are unreasonable. EPA must also apply the least burdensome regulatory requirement. In contrast, under Canadian and European Union legislation the costs of various controls are to be considered in deciding the particular control action to be taken, but these costs are not factors in determining whether to control a chemical. Under TSCA, EPA is not required to systematically prioritize existing chemicals for purposes of determining their risks, although EPA relies upon mechanisms such as voluntary testing programs and advice from federal advisory groups to help ensure that it gives priority to the chemicals posing the greatest risks. Both CEPA and the proposed REACH legislation contain requirements for systematically prioritizing and reviewing existing chemicals. For new chemicals, TSCA requires that chemical companies submit for EPA's review any data already in their possession on the chemicals' health and ecological effects, potential exposures and on their physical chemical properties, with the premanufacture notice (PMN) generally required before chemical companies may manufacture the chemicals. Chemical companies generally do not have such data at the time they submit the PMN for the chemicals and are not required to develop the data unless EPA promulgates a test rule. Under REACH, chemical companies would be required to develop and submit data on the physical properties and health and ecological effects of new chemicals with the initial notification and, subsequently before the chemicals reach certain levels of production. Regarding the protection of confidential business information that is provided to the regulatory agencies, TSCA, CEPA, and the European Union current and proposed legislation have provisions for protecting such information from inappropriate disclosures, although the specifics of the protection varies. One of the objectives of the proposed REACH legislation is to make information on chemicals more widely available to the public.
GAO-06-217R, Chemical Regulation: Approaches in the United States, Canada, and the European Union
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November 4, 2005:
The Honorable James M. Jeffords:
Ranking Minority Member:
Committee on Environment and Public Works:
United States Senate:
The Honorable Frank R. Lautenberg:
United States Senate:
The Honorable Patrick Leahy:
United States Senate:
Subject: Chemical Regulation: Approaches in the United States, Canada,
and the European Union.
Chemicals are used 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 everyday life, some may be harmful to human
health and the environment. Some chemicals, such as lead and mercury,
are highly toxic at certain doses and need to be regulated because of
health and safety concerns. In 1976, the Congress passed the Toxic
Substances Control Act (TSCA) in part to authorize the Environmental
Protection Agency (EPA) to regulate chemicals that pose an unreasonable
risk to human health or the environment.[Footnote 1] TSCA addresses
chemicals that are manufactured, imported, processed, distributed in
commerce, used, or disposed of in the United States and authorizes EPA
to assess chemicals before they enter commerce (new chemicals) and
review those already in commerce (existing chemicals). TSCA excludes
certain chemical substances, including among other things pesticides
that are regulated under the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA); and food; food additives; drugs; cosmetics or
devices that are regulated under the Federal Food, Drug and Cosmetic
Act (FFDCA).
For existing chemicals, TSCA authorizes, but does not specifically
require, EPA to review the risks of chemicals included in TSCA's
inventory of existing chemicals. Using its authority under TSCA, EPA
has required testing for less than 200 of the over 62,000 chemicals
that were already in commerce when EPA began reviewing chemicals in
1979. Since then, upon receiving notice of commencement that the
company has begun manufacturing a chemical, EPA has added another
20,000 chemicals to its inventory after reviewing them under its new
chemical review program. 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, TSCA generally requires EPA to
impose regulatory requirements. When doing so, EPA must apply the least
burdensome regulatory requirement to adequately protect against a
chemical's risk.[Footnote 2] EPA can promulgate a rule that bans or
restricts the chemical's production, processing, distribution in
commerce, disposal or use, or that requires warning labels be placed on
the chemical. Canada and the European Union also maintain inventories
of existing chemicals.
TSCA generally requires chemical companies to notify EPA at least 90
days before beginning production, manufacture, or import of a new
chemical--or before manufacturing or processing a chemical for a use
that EPA has determined by rule is a significant new use--by submitting
a premanufacture notice.[Footnote 3] Such notices are to provide
information on the chemical's identity, production process, anticipated
production volume, intended uses, potential exposure and release
levels, disposal, and byproducts. A premanufacture notice is required
for all levels of production or import. In addition, companies are
required to provide EPA any test data that they possess or control
related to the chemical's effect on health or the environment and a
description of any other data concerning the chemical's environmental
or health effects known to or reasonably ascertainable by the
companies. EPA has these 90 days to review the chemical information in
the premanufacture notice and identify the chemical's potential risks.
On the basis of this review, EPA makes a decision to (1) take no
action; (2) after making certain findings under TSCA, require controls
on the use, manufacture, processing, distribution in commerce, or
disposal of the chemical pending development of test data; or (3) ban
or otherwise regulate the chemical pending the receipt and evaluation
of test studies performed by the chemical's manufacturer. As of June
2005, EPA's reviews resulted in some action being taken to reduce the
risks of over 3,500 of the 32,000 new chemicals that companies had
submitted for review.[Footnote 4]
Under Canadian Environmental Protection Act (CEPA) regulations,
companies must submit certain information and test data to the
government when production or importation volumes reach certain levels.
Under CEPA, the Ministers of Health and the Environment must assess the
information provided on a new chemical to determine whether it is toxic
or capable of becoming toxic. Canada defines new chemicals as those
that are not on Canada's Domestic Substances List--a list of all known
chemicals that (1) were in commercial use in Canada between January 1,
1984, and December 31, 1986; (2) were manufactured in or imported into
Canada by any person in a quantity of 100 kilograms or more in any
calendar year during that period; or that (3) have subsequently been
fully assessed under CEPA. According to Canadian officials, a new
chemical is generally added to the existing chemicals inventory only
after a certain level of production or importation has been reached and
specified testing for that level has been performed without conditions
being placed on the chemical's manufacture or importation.
The European Union's current chemical control legislation[Footnote 5]
generally requires chemical companies to notify a member state
regulatory agency once the marketing level of a new chemical reaches 10
kilograms.[Footnote 6] The European Union maintains a new chemicals
inventory--separate from the one for existing chemicals--and the
chemicals in this inventory are subject to additional testing by the
chemical company and review by the authorities when the annual amount
marketed reaches certain levels.[Footnote 7] Furthermore, the European
Union is currently considering revising its chemical control
legislation through proposed legislation known as Registration,
Evaluation, Authorisation, and Restriction of Chemicals (REACH) that
would largely eliminate the distinction between new and existing
chemicals and would require chemical companies to submit certain basic
information on chemicals produced over certain volumes.[Footnote 8]
In this context, you asked that we provide comparative information on
the following chemical control laws: TSCA, CEPA, the current European
Union legislation, and REACH as proposed. Specifically, you asked that
we provide information on the approaches of (1) controlling chemical
risks, (2) reviewing existing chemicals used in commerce, (3) assessing
new chemicals, and (4) handling confidential business information. The
laws and regulations discussed in this letter are sometimes augmented
by various other mechanisms for controlling chemicals. For example, in
the United States, this includes programs implemented under other
environmental 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, as well as programs in which the
chemical industry voluntarily participates. Details on some of these
other chemical control mechanisms are discussed in our June 2005 report
on options that exist to control harmful chemicals.[Footnote 9] For
purposes of this report, we have focused on TSCA, CEPA, and current and
proposed European Union chemical control legislation. It is important
to note that the manner in which new and existing chemicals are defined
under these pieces of legislation varies and, as EPA notes in its
comments, may make for some imperfect comparisons. To the extent
possible, we have attempted to highlight such differences when
comparing various legislative provisions.
To respond to your request, we reviewed EPA's policies and guidelines
on the chemical review and control programs for new and existing
chemicals. We also obtained information from and discussed chemical
laws with chemical control agency representatives of Canada and the
European Union. These efforts were augmented by interviews with EPA
officials. We performed our work between July 2005 and October 2005 in
accordance with generally accepted government auditing standards.
In summary, TSCA authorizes EPA to take a number of control actions
with regard to new chemicals or uses of chemicals that EPA has
determined by rule are significant new uses. To control existing
chemicals under TSCA, EPA must present substantial evidence that a
reasonable basis exists to conclude that the chemical presents or will
present an unreasonable risk to human health or the environment. The
United States Court of Appeals for the Fifth Circuit has stated that
EPA must consider the costs of any proposed action in evaluating what
risks are unreasonable.[Footnote 10] EPA must also apply the least
burdensome regulatory requirement. In contrast, under Canadian and
European Union legislation the costs of various controls are to be
considered in deciding the particular control action to be taken, but
these costs are not factors in determining whether to control a
chemical.
Under TSCA, EPA is not required to systematically prioritize existing
chemicals for purposes of determining their risks, although EPA relies
upon mechanisms such as voluntary testing programs and advice from
federal advisory groups to help ensure that it gives priority to the
chemicals posing the greatest risks. Both CEPA and the proposed REACH
legislation contain requirements for systematically prioritizing and
reviewing existing chemicals.
For new chemicals, TSCA requires that chemical companies submit for
EPA's review any data already in their possession on the chemicals'
health and ecological effects, potential exposures and on their
physical chemical properties, with the premanufacture notice (PMN)
generally required before chemical companies may manufacture the
chemicals.[Footnote 11] Chemical companies generally do not have such
data at the time they submit the PMN for the chemicals and are not
required to develop the data unless EPA promulgates a test rule. Under
REACH, chemical companies would be required to develop and submit data
on the physical properties and health and ecological effects of new
chemicals with the initial notification and, subsequently before the
chemicals reach certain levels of production.
Regarding the protection of confidential business information that is
provided to the regulatory agencies, TSCA, CEPA, and the European Union
current and proposed legislation have provisions for protecting such
information from inappropriate disclosures, although the specifics of
the protection varies. One of the objectives of the proposed REACH
legislation is to make information on chemicals more widely available
to the public.
Approaches to Controlling Chemical Risks:
TSCA authorizes EPA to take a number of control actions with regard to
new chemicals.[Footnote 12] 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 chemical, 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. In
addition, 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 risks by otherwise regulating the chemical under 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.
In addition, under TSCA, EPA generally must apply regulatory
requirements--banning or restricting the chemical's production,
processing, distribution in commerce, disposal or use, or requiring a
warning label--to chemicals for which EPA finds a reasonable basis
exists to conclude that the chemical presents or will present an
unreasonable risk to human health or the environment. EPA must choose
the least burdensome requirement that will adequately protect against
the risk. As we noted in our earlier report,[Footnote 13] this presents
a high evidentiary burden for EPA in regulating chemicals. When
reviewing EPA's asbestos rule, the United States Court of Appeals for
the Fifth Circuit 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. EPA must also consider
and publish a statement regarding the effects of the chemical on health
and the environment and the magnitude of human and environmental
exposure; the benefits of the chemical for various uses and the
availability of substitutes for those uses; and 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. If another law would
sufficiently eliminate or reduce the risk of injury to health or the
environment, then EPA may not promulgate a TSCA rule unless it finds
that it is in the public interest to do so, considering all relevant
aspects of the risk, a comparison of the estimated costs of compliance
under TSCA and the other law, and the relative efficiency of actions
under TSCA and the other law to protect against risk of injury.
Under CEPA, regulators are authorized to control chemicals that are (1)
determined to be toxic on the basis of a screening assessment and (2)
where the Ministers of Health and the Environment have made certain
determinations.[Footnote 14] A chemical may not be regulated under CEPA
to the extent that it is regulated by or under another act that, in the
opinion of the Governor in Council, provides sufficient protection to
the environment and human health. In general, the costs and benefits of
control actions are not factors in determining the risk posed by a
chemical nor are they determinative of whether any control action
should be taken. Rather, they may be factors in deciding what control
action to take. Moreover, Canadian regulators are not required to
choose the "least burdensome" regulatory requirements.
Under current chemical control legislation in the European Union,
member states take the lead on assessing the risks of chemicals. For
existing chemicals, once a health and environmental risk assessment is
completed, the lead member state makes a draft risk assessment,
including risk reduction measures, which is submitted to a committee
established by the existing chemicals regulation that has
representatives of all member states and the Commission. The committee
decides if more information is needed and what types of risk reduction
measures are needed. Between 1993 and October 2003 only 140 high volume
existing chemicals had been singled out for risk assessment and a
limited number have completed the process. According to the European
Commission, decisions on further testing of substances can only be
taken via a lengthy committee procedure and can only be requested from
industry after authorities have proven that a substance may present a
serious risk.
The proposed REACH legislation would generally require chemical
companies to register all chemicals produced or imported in quantities
over 1,000 kilograms (2,204.6 pounds) per manufacturer or importer per
year. For certain uses of registered chemicals of very high concern,
chemical companies are required to seek authorization for those uses.
These chemicals of very high concern are those that are carcinogenic,
mutagenic, or toxic for reproduction; persistent, bioaccumulative and
toxic or very persistent and very bioaccumulative; and those that cause
serious and irreversible effects to humans or the environment, such as
endocrine disrupters. Companies using such chemicals or placing them on
the market would need to apply for an authorization for each use of the
chemical, and an authorization would be granted if the risk to human
health or the environment from the use of the substance is adequately
controlled. Even if the risks cannot be adequately controlled, a time-
limited authorization could also be granted if it was shown that the
socioeconomic benefits outweigh the risks and if there were no suitable
alternative substances or technologies. In this case, it is recommended
that the applicant submit a plan to develop alternative substances or
technologies. Downstream users could use a substance for an authorized
use provided that they obtained the substance from a company to which
an authorization has been granted and that they meet the conditions of
that authorization. Such downstream users also would be required to
notify the chemical control agency that they are using an authorized
substance.
Approaches to Reviewing Existing Chemicals:
TSCA, CEPA, and the current European Union chemical control legislation
generally do not require chemical companies to develop test data for
existing chemicals, unless the regulatory agencies first make certain
findings and take regulatory action. Unlike CEPA, which provides for
the systematic categorization and review of existing chemicals, TSCA
does not require EPA to prioritize and review existing chemicals.
For existing chemicals, REACH would require chemical companies subject
to registration requirements that import or manufacture above a certain
quantity to provide test data to regulatory authorities on the
chemical's physical properties, and ecological and health effects. Both
the current European Union legislation and REACH provide for (1) the
regulatory agencies' prioritization of existing chemicals for
assessment and (2) chemical companies' notification to regulatory
agencies of new uses of existing chemicals (under current legislation
if manufactured or imported at a level of 10,000 kilograms (22,046
pounds) or more per year) so that regulators may assess the potential
risk of the new use of the chemical.
Existing chemicals are defined differently under each country's
chemical control legislation. In the United States, existing chemicals
are defined as those chemicals on the TSCA Inventory.[Footnote 15] In
Canada, existing chemicals are those chemicals on the Domestic
Substances List, including chemicals that--between January 1, 1984, and
December 31, 1986--were in commercial use in Canada, used for
commercial manufacturing practices, or manufactured or imported into
Canada in a quantity of 100 kilograms or more in any calendar year. The
list is regularly amended to include additional substances that have
been notified and assessed under the new substances provisions of CEPA.
Current European Union legislation defines existing chemicals as those
listed on the European Inventory of Existing Commercial Chemical
Substances (EINECS)--those chemicals deemed to be in the community
market on September 18, 1981. The proposed REACH would largely
eliminate the distinction between existing and new chemicals. Table 1
provides additional information on the treatment of existing chemicals
in the United States, Canada, and the European Union.
Table 1: Regulation of Existing Chemicals in the United States, Canada,
European Union:
[See PDF for image]
Source: GAO analysis of selected legislation.
[A] For existing chemicals, we are defining basic physical chemical
properties as including properties identified on the Organization for
Economic Co-operation and Development's (OECD) Screening Information
Data Set (SIDS), such as melting point, boiling point, relative
density, vapor pressure, partition co-efficient: n-Octanol/Water, and
water solubility. The octanol-water partition coefficient is the ratio
of the concentration of a chemical in octanol and in water at
equilibrium and at a specified temperature. This test is used in many
environmental studies to help determine the fate of chemicals in the
environment.
[B] EPA in cooperation with industry, environmental groups, and other
interested parties launched the High Production Volume Challenge
Program to voluntarily gather information and ensure that a minimum set
of basic data on approximately 2,800 high-production volume chemicals-
-those produced at 1 million pounds or more per year--would be
available to EPA. Chemical companies were invited to voluntarily
sponsor these chemicals and submit data summaries of existing
information along with a test plan that proposes a strategy to fill
data gaps for either an individual chemical or for a category of
chemicals. EPA intends to use these data to prioritize these chemicals
for additional review and testing.
[C] Council Regulation (EEC) No 793/93 requires chemical companies to
update this information if they obtain new data on physico-chemical
properties, toxicological, or ecotoxicological effects where it is
likely to be relevant to the evaluation of the risk posed by the
chemical.
[D] The OECD SIDS is the minimum amount of data required for making an
initial hazard assessment of High Production Volume chemicals agreed
upon by OECD.
[E] However, if the company obtains information that reasonably
supports the conclusion that the chemical presents a substantial risk
to human health or the environment, TSCA requires that the company
immediately notify EPA about this information.
[F] The Ministers of Health and Environment are to categorize chemicals
on the Domestic Substances List to identify those that (1) may present
to individuals in Canada the greatest potential for exposure or (2) are
persistent or bioaccumulative in accordance with the regulations and
inherently toxic to human beings or to nonhuman organisms. Once
categorization has been completed, the Ministers shall conduct
screening assessments for such chemicals to determine whether they are
toxic or capable of becoming toxic.
[G] According to a European Union official--under REACH--as originally
proposed all registrations of chemicals including a plan for animal
testing, will be evaluated. Furthermore, for other registered
substances, member states could use these criteria to include chemicals
they believe present a risk to health or the environment in a plan for
evaluation. The European Parliament Committee on the Environment,
Public Health and Food Safety recently proposed an amendment to REACH,
yet to be confirmed by the European Parliament in plenary session, that
instead proposes giving the European Chemicals Agency the task of
compiling the list and giving the agency a greater role in the decision
making procedure for chemical evaluation.
[H] In 2003, EPA amended its TSCA Inventory Update Rule (IUR), which is
primarily used to gather certain information on chemicals produced at
more than a basic threshold volume in the year reported. Among other
things, EPA raised the basic production volume reporting threshold from
10,000 to 25,000 pounds; required chemical companies producing or
importing chemicals at a site at or above this threshold to report the
number of workers reasonably likely to be exposed to the chemical at
each site; and added 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.
[I] According to EPA, the United States has considerable experience
utilizing tools and incentives to facilitate the entry into market
safer chemicals or use of safer processes as demonstrated with the
Green Chemistry and Design for the Environment Programs and the
utilization by industry of the P2 Framework tools prior to submitting
new chemicals for consideration. In addition, section 6602 (b) of the
Pollution Prevention Act of 1990 states that it is the policy of the
United States that "pollution should be prevented or reduced at the
source whenever feasible." The act required EPA to establish an office
to carry out the functions of the EPA Administrator under the act,
including the development and implementation of a strategy to promote
source reduction. The act also requires many owners and operators of
manufacturing facilities to report annually on source reduction and
recycling activities.
[J] According to a European Union official, while a pollution
prevention plan is not required under European Union chemical
legislation, it is obligatory under the Integrated Pollution Prevention
and Control Directive.
[End of table]
Approaches to Reviewing New Chemicals:
The United States, Canadian, and European Union regulatory authorities
review the risks of new chemicals, although they do so at different
times. For example, TSCA requires chemical companies to notify EPA
before beginning manufacture of new chemicals, while CEPA and both
current European Union legislation and the proposed REACH require
chemical companies to notify regulatory authorities only after the new
chemical has reached certain levels of manufacture or importation. In
addition, depending on production volumes, Canada and the European
Union require chemical companies to develop and submit data to the
government on the physical chemical properties, as well as basic
toxicological and health effects data, for new chemicals along with
their notifications or registrations. In contrast, TSCA only requires
chemical companies to submit data already in their possession on the
physical properties and on the chemicals' health and ecological effects
and exposures. Companies generally do not have such data at the time
new chemicals are submitted for EPA's review, and TSCA does not require
them to develop test data unless EPA promulgates a test rule. In the
absence of test data obtained from chemical companies, the burden of
developing data to assess the risks of new chemicals primarily falls on
EPA, which uses scientific models to predict a new chemical's
properties and toxicity based on comparisons with other chemicals of
similar molecular structures that have previously been tested.[Footnote
16] EPA also takes into account the information that chemical companies
provide on the anticipated potential uses and estimated exposures of
the new chemicals.
Canadian chemical control laws and those in effect and proposed in the
European Union require, to varying degrees, that chemical companies
develop and submit for review test data on the physical chemical
properties and toxicological characteristics and health effects of
exposures to new chemicals. The testing required depends on the
importation or production volume of the chemical.
New chemicals are defined differently under each country's chemical
control legislation. In the United States, new chemicals are defined as
those not on the TSCA Inventory. In Canada, new chemicals are those not
on Canada's Domestic Substances List. [Footnote 17] Current European
Union legislation defines new chemicals as those not listed on EINECS.
The proposed REACH would largely eliminate the distinction between
existing and new chemicals. Table 2 provides information on the
treatment of new chemicals in the United States, Canada, and the
European Union.
Table 2: Regulation of New Chemicals in the United States, Canada,
European Union:
[See PDF for image]
Source: GAO analysis of selected legislation.
[A] Such data could include any of the information required in the
Screening Information Data Set (SIDS), which is the minimum amount of
data required for making an initial hazard assessment of High
Production Volume Chemicals agreed upon by the Organization for
Economic Co-operation and Development (OECD). CEPA, Current European
Union legislation and the proposed REACH legislation all require at
least six physical chemical properties identified in the SIDS,
including melting point, boiling point, relative density, vapor
pressure, partition co-efficient: n-Octanol/Water, and water
solubility--CEPA only requires this be reported in the water solubility
is 10-6 g/L or greater--for new chemicals produced over certain
volumes. The remaining two properties dissociation constant and
oxidation reduction potential are required by some legislation, but not
all. Oxidation-reduction potential is not required under CEPA, and
current European Union legislation and REACH do not require
dissociation constant.
[B] Testing is not required for new chemicals unless the EPA
promulgates a test rule, but companies must submit (1) any test data in
the possession or control of the company related to the chemicals
effect on health or the environment and (2) a description of any other
data concerning the environmental and health affects that is known or
reasonably ascertainable by the company. Companies must also inform EPA
if they obtain information, which reasonably supports the conclusion
that a chemical presents a substantial risk of injury to health or the
environment.
[C] For chemicals listed on the Non-Domestic Substances List (NDSL),
the threshold is 10,000 kilograms (22,046 pounds) in a calendar year.
[D] SIDS is the minimum amount of data required for making an initial
hazard assessment of High Production Volume Chemicals agreed upon by
OECD. CEPA, current European Union legislation and proposed REACH all
require at least three toxicological properties, including acute
toxicity, repeated dose toxicity, and genetic toxicity for new
chemicals produced over certain volumes. Current European Union
legislation and proposed REACH also require reproductive toxicity once
reporting thresholds have been met.
[E] Testing is not required for new chemicals unless the EPA
promulgates a test rule, but companies must submit (1) any test data in
the possession or control of the company related to the chemicals
effect on health or the environment and (2) a description of any other
data concerning the environmental and health affects that is known or
reasonably ascertainable by the company. Companies must also inform EPA
if they obtain information that reasonably supports the conclusion that
a chemical presents a substantial risk of injury to health or the
environment.
[F] For chemicals listed on the NDSL, the threshold is 10,000 kilograms
(22,046 pounds) in a calendar year.
[End of table]
Approaches to Confidential Business Information:
TSCA, CEPA, current European Union legislation, and REACH all provide
for chemical companies to claim certain information as confidential,
but they vary in their treatment of such information. For example, TSCA
does not allow EPA to share confidential business information with
foreign governments in efforts toward developing and harmonizing
methods for assessing chemical hazards. CEPA, however, provides for the
sharing of confidential information with foreign governments under
agreements or arrangements where the foreign government keeps the
information confidential. REACH contains similar provisions, also
allowing for disclosure to international organizations under agreements
where they protect confidential information.
EPA's ability to make publicly available the information that it
collects under TSCA is limited. 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, such as state
health and environmental officials and foreign governments.[Footnote
18] Other federal agencies and federal contractors can obtain access to
this confidential business information in order to carry out their
responsibilities. TSCA does not treat health and safety data as
confidential and EPA can also disclose other information that it
determines is necessary to disclose in order to protect health or the
environment from an unreasonable risk.
In Canada, information that companies request to be treated as
confidential is not to be disclosed, except in certain circumstances.
The Canadian Minister of the Environment may disclose certain
information upon giving 24 hours notice to the company, if (1) the
disclosure is in the interest of public health, public safety or the
protection of the environment and (2) the public interest in the
disclosure (a) outweighs in importance any material financial loss or
prejudice to the competitive position of the person who provided the
information or on whose behalf it was provided and (b) any damage to
the privacy, reputation, or human dignity of any individual that may
result from disclosure.
European Union legislation also allows chemical companies to make
confidentiality claims. In the European Union, a company may indicate
that information is commercially sensitive and that disclosure may be
harmful to the company industrially and commercially and, therefore,
that the company wishes to keep the information secret from all persons
other than the competent authorities and the European Commission.
Secrecy, however, does not apply to the trade name of the substance,
certain physicochemical data concerning the substance, possible ways of
rendering the substance harmless, the interpretation of the
toxicological and ecotoxicological tests and the name of the body
responsible for the tests, and certain recommended methods and
precautions and emergency measures. The authority receiving the
information is to decide on its own responsibility what information is
covered by commercial and industrial secrecy. The chemical company can
go to court and appeal the authority's decision.
Under REACH, as originally proposed, one of the objectives of the new
system for the management of industrial chemicals would be to make
information on chemicals more widely available. According to a European
Union official, the proposed legislation has precise provisions on the
issue of disclosure of information. Certain information will always be
regarded as available to the public, where other information is always
confidential, even if a producer does not make the claim. For the
remaining information categories, chemical companies may claim
confidentiality. Whenever a request for access to documents held by the
proposed European Chemicals Agency is made, the agency would be
required to inform the registrant of the chemical or other party
concerned of the request. That party would have 30 days to submit a
declaration identifying information that it wishes to remain
confidential because the information is considered commercially
sensitive and disclosing it might harm the party commercially. The
agency would consider the information and decide whether to accept the
declaration. The party could appeal this decision. The following
information would be among the types of information that would not be
treated as confidential: the trade name(s) of the substance;
physicochemical data on the substance and on pathways and environmental
fate; the result of each toxicological and ecotoxicological study; if
essential to classification and labeling, the degree of purity of the
substance and the identity of impurities and/or additives that are
known to be dangerous; guidance on safe use; and information contained
in the safety data sheet (except for the name of the company or other
information accepted as confidential in REACH). Recent amendments to
REACH proposed by the European Parliament Committee on the Environment,
Public Health, and Food Safety, still to be confirmed by the European
Parliament in plenary session, would reintroduce provisions of current
European Union legislation requiring industry to justify
confidentiality. The European Chemicals Agency would only have to
inform parties other than the registrant of a request where
appropriate.
The following information would be treated as confidential, even if the
company did not claim it as confidential: details of the full
composition of a preparation, the precise use, function, or application
of a substance or preparation, the precise tonnage of the substance or
preparation manufactured or placed on the market, and links between a
manufacturer or importer and its downstream users. However, in
exceptional cases where there are immediate risks to human health,
safety, or the environment, REACH would authorize the proposed European
Chemicals Agency to disclose this information.
Scope and Methodology:
This report describes the approaches the United States, Canada and the
European Union have taken in regulating chemicals in commerce. In
addressing these issues, we obtained information on EPA's
implementation of TSCA and the chemical control programs of Canada and
the European Union. To understand other chemical control regulation, we
collected documentation and interviewed individuals knowledgeable about
(1) the Toxic Substances Control Act and (2) foreign chemical control
laws or proposed legislation: (a) the Canadian Environmental Protection
Act, 1999 and (b) the European Union's chemical control legislation and
proposed Registration, Evaluation, Authorisation and Restriction of
Chemicals. The European Union and Canada were chosen because they have
recently taken action to revise their chemical legislation. In 1999,
Canada revised its chemical control law and in 2003, the European Union
proposed a new regulation. The European Union and Canada were also
selected because they have characteristics that are similar to those of
the United States: Canada and the European Union member countries are
industrialized nations and have extensive experience with the review
and control of chemical substances. In addition, Canada and the
European Union produce a considerable amount of chemicals. Furthermore,
EPA officials and chemical industry representatives recommended these
countries for comparison with TSCA. Our descriptions of Canadian and
European Union legislation are based on our review of the laws,
technical literature, government documents describing their chemical
control programs, and follow-up discussions with government officials.
Given the time frames available to complete our work, we relied
primarily upon work previously performed for our report issued in June
2005, as supplemented by additional interviews and document review.
Our review was performed between July 2005 and October 2005 in
accordance with generally accepted government auditing standards.
Agency Comments and Our Evaluation:
EPA provided comments on the information included in a draft of our
report on November 1, 2005. EPA said that our report (1) attempts to
compare functions that are fundamentally different due to varying
definitions of "new" and "existing" chemicals under TSCA, CEPA, and the
European Union legislation; (2) does not reflect the range of
regulatory options that exist for existing and new chemicals, focusing
almost exclusively on sections 4 and 6 of TSCA; (3) should offer the
same level of information across the four regulatory approaches of
TSCA, CEPA, EU current legislation, and proposed REACH; and (4) should
address enforcement activities.
We agree that it is important to note the differing definitions of
"new" and "existing" chemicals under TSCA, CEPA, and the European Union
legislation in comparing these laws. Where possible, we have attempted
to highlight the impact of such differences when comparing various
legislative provisions. We added additional language to the beginning
of the report to draw attention to this point. Despite the different
definitions of new and existing chemicals, we believe that it is
possible to draw some useful comparisons between the legislative
provisions and chemical control functions under those provisions.
Likewise, we agree with EPA's comment that our draft report would
benefit from a more complete discussion of regulatory tools available
under TSCA. In response to EPA's comments, we have added a discussion
of section 5(e) and section 5(f) of TSCA to the final report. We have
also added references to EPA's utilization of modeling tools and to our
June 2005 report that more fully discusses actions that EPA has taken
under TSCA. Moreover, as we stated in our draft report and as this
final report states, the laws and regulations discussed in this letter
are sometimes augmented by various other mechanisms for controlling
chemicals, such as programs under other environmental laws and
voluntary programs. Again, we refer readers to our June 2005 report for
more information.
With regard to EPA's comments regarding additional points that the
report should address, we agree that such additional information could
be useful, but given time constraints we were not able to add this
information into this report. Given the short period available to
complete our work, we agreed with the requesters of our report to
primarily rely upon the work we had previously performed regarding TSCA
and the other countries, as supplemented by appropriate and necessary
follow-up work. We have generally attempted, given the information
available to us, to present a similar amount of detail for the United
States, Canadian, and European Union legislation. In some cases, the
amount of detail presented in this report varies because some laws
contain more detail than others. With regard to EPA's suggestion that
the report would benefit from a discussion of enforcement activities,
we did not perform the work that would enable us to address enforcement
activities in this report. Such activities, however, are an important
part of our ongoing work in the area of chemical regulation in the
United States, Canada, and the European Union.
EPA's comments are reproduced in the enclosure.
As agreed with your office, 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 http://www.gao.gov.
If you have any questions about this report, please contact me at (202)
512-3841 or stephensonj@gao.gov. Contact points for our Offices of
Congressional Relations and Public Affairs may be found on the last
page of this report. Ed Kratzer, Assistant Director; David Bennett;
John Delicath; Aaron Kaminsky; and Amy Webbink made key contributions
to this report.
Signed by:
John B. Stephenson:
Director, Natural Resources and Environment:
Enclosure:
Enclosure: Comments from the Environmental Protection Agency:
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY:
OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES:
WASHINGTON, D.C. 20460:
NOV 1 2005:
Mr. John Stephenson:
Director:
Natural Resources and Environment:
Government Accountability Office:
Washington, DC 20548:
Dear Mr. Stephenson:
Thank you for the opportunity to review and comment on the proposed
draft Government Accountability Office (GAO) report entitled "Chemical
Regulation: Approaches in the United States, Canada, and the European
Union" (GAO-06-217R). The Report provides comparative information on
the United States (U.S.) Toxic Substances Control Act (TSCA), the
Canadian Environmental Protection Act (CEPA), the European Union's (EU)
current and proposed chemical control legislation in relation to the
approaches of (1) controlling chemical risks, (2) reviewing existing
chemicals used in commerce, (3) assessing new chemicals not yet in
commerce, and (4) handling confidential business information.
Chemicals are an integral part of modern society which provide benefits
and may present risks. TSCA recognizes that the benefits of chemicals
to society and their risks must be taken into account in considering
whether and what regulatory controls are appropriate in a given
circumstance. EPA is proud of the progress we have made in protecting
human health and the environment. To date, TSCA authority has provided
the Agency the ability to review more than 40,000 new chemicals prior
to introduction into the marketplace and we have restricted or
otherwise regulated over 1,600 of these chemicals while a similar
number have been withdrawn by the manufacturer, often in the face of
EPA action. TSCA provides a wide array of tools available to protect
against risks and facilitate the assessment of risks. These tools,
[discussed in your June 2005 Report on the Agency's chemical regulation
efforts (GAO 05-458)] include, among an array of other regulatory and
non-regulatory approaches, TSCA section 5(e) which allows EPA to
regulate based on risk or exposure concerns "pending the development of
information" that is needed to assess the chemical's risks, and TSCA
section 5(a)(2) significant new use rules that require persons to
notify EPA in advance of manufacture, import, or processing for a
designated new use so that EPA can assess and regulate the use if
appropriate before it begins. The Agency utilizes a variety of tools
including modeling such as the Structural Activity Relationship (SAR),
voluntary and innovative approaches, and information gathering and
dissemination to ensure that we have the ability to make informed
decisions prior to chemical production at any level and to -facilitate
the entry into the market of safer chemicals and substitutes.
The Agency also works to target chemical data development, information
collection and risk management on chemicals already in commerce,
including aggressively obtaining data on a key set of chemicals on the
TSCA Inventory. EPA's "numerous control actions" noted in your June
2005 detailed report on the Agency's chemical regulation efforts (GAO
05-458) speak to the range of approaches applied by the Agency in the
chemical review program.
In this reply to GAO's request for comment, EPA has focused its
comments on information as it relates to descriptions of the U.S.
authorities and certain critical distinctions among the various
authorities compared. While EPA appreciates the observations and
comparisons, there are a few comments for your consideration. -
Technical comments are provided in the enclosed attachment.
The Report attempts to compare functions that are fundamentally
different -due to variations in definitions applied to "new" versus
"existing" chemicals under each government's chemical control
legislation. In the U.S., a key concept is "commerce" or "commercial
purposes." Under TSCA, a "new chemical substance" means any chemical
substance that is not included in the chemical substance list compiled
and published under TSCA section 8(b), i.e., it not on the TSCA
Inventory and generally has not been manufactured or processed for
commercial purposes in the United States since three years before the
passage of TSCA. Conversely, an "existing chemical" is generally one
that is on the TSCA Inventory and is or has been (since the
establishment of the Inventory) in commerce. As both Canada and the EU
approaches are somewhat different as to what delineates a "new" versus
"existing" chemical, the comparisons are often awkward and in some
cases not appropriate. The definitions are fundamental to understanding
the approaches and establish key differences not accounted for in the
Report and more specifically in the two comparison tables. While the
footnotes attempt to correct the problem, the questions in the table
which are the focus of the points under consideration are often not
aligned with the U.S. definitions and, therefore, approaches. For
example, in the new chemicals table, the third question asks about an
annual requirement for the disclosure of production quantities of new
chemicals. . Given the U.S. definition of new chemicals (generally not
in commerce), the answer is an automatic no without regard to the fact
that these substances would be considered an "existing" chemical if in
production. One approach to deal with this is to use language such as
"new chemicals or, in the case of the U.S., former new chemicals." This
point should be explained the first time it appears.
The Report does not reflect the range of regulatory options for new and
existing chemicals, instead focusing on the most restrictive of the
TSCA options, setting-up an awkward and inappropriate comparison with
the other governments' authorities. With regard to TSCA authority, the
Report focuses almost exclusively on sections 4 and 6, which suggests
that they are the only mechanisms available to facilitate the
development of data and reduction of risks in the statute. As reflected
in your earlier detailed report GAO 05-458, this is clearly not the
case and therefore sets the stage for an inaccurate comparison with the
other governments' authorities. In addition, it should be noted, the
framework of options in the U.S. for controlling chemical risks
identified under the authorities of TSCA is larger than this one
statute. This point is also generally true for Canadian and EU systems.
The Report does not offer the same level of information across the four
regulatory approaches of TSCA, CEPA, EU current chemical legislation
and proposed REACH. A more complete description of the parameters at
play in CEPA and the EU current and proposed authorities would offer a
more balanced observation. For example, on page 7, the first paragraph
describes the EU assessment process. In the last sentence there is
reference to a determination if more information is needed and risk
reduction measure decisions. While with the U.S. description there is
more specific detailed information on "findings" that trigger these
actions, there is no discussion with regards to the findings or factors
that are considered within the EU before regulating a chemical. It
seems appropriate that the CEPA and EU legislative authorities be given
similar treatment as the U.S. authority so that more fully-informed
comparisons can be made.
In addition, the Report does not address enforcement, an important
component of any chemical regulation scheme. The U.S. has specific
enforcement authorities to support chemical review and control
regulations. The Report would benefit from a discussion of the various
enforcement capabilities across the various schemes of U.S., Canada and
the EU compared in the document.
Thank you for this opportunity to review and comment on the report GAO-
06-217R, "Chemical Regulation: Approaches in the United States, Canada,
and the European Union. " We look forward to continuing to work with.
the General Accountability Office and Congress on our efforts to ensure
chemical safety and protection of human health and the environment.
Sincerely,
Signed for:
Charles M. Auer:
Director:
Office of Pollution Prevention and Toxics:
Attachment:
(360615):
FOOTNOTES
[1] Pub. L. No. 94-469, 40 Stat. 2003 (1976) (codified at 15 U.S.C. §§
2601-2692).
[2] 15 U.S.C. § 2605. Unlike Canadian and European Union legislation,
which subject chemical companies to notification requirements only
after manufacturing has begun, and production or marketing of the
chemical reaches a certain level, TSCA requires a premanufacture
notice.
[3] 15 U.S.C. § 2604.
[4] These chemicals reviewed do not include EPA's review of the
chemicals manufactured by companies that EPA exempted from the
premanufacture notice requirements: 717 Test Marketing Exemption
Applications; 7,888 Low Volume Exemptions; 35 Low Release/Low Exposure
Exemptions; and 2,530 Polymer Exemptions. EPA may exempt a chemical
company from the premanufacture notice 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.
[5] The current European Union chemical legislation consists of four
major pieces of legislation with adaptations to technical progress over
the years: Council Directive 67/548/EEC: "Classification, Packaging and
Labeling of Dangerous Substances," Council Directive 76/769/EEC:
"Marketing and Restrictions," Council Regulation 793/93: "Existing
Substances Evaluation," and Council Directive 88/379/EEC, as replaced
by 99/45/EC: "Preparations" as well as a number of other directives. In
general, a European Union directive is a binding collective decision
made by the member states, acting through their national Government
Ministers in the Council of the European Union and the Parliament.
[6] According to a European Union official, the competent authority
acts on behalf of all member states and informs these agencies of the
notification. Normally, the applicant must wait 60 days for a reaction
to this notification before marketing a chemical. The amount of test
data required, increases with the volume marketed.
[7] New chemicals are identified as those not listed on the European
Inventory of Existing Commercial Chemical Substances (EINECS), a list
of approximately 100,000 chemicals deemed to be on the European
Community market on September 18, 1981.
[8] The European Union is currently considering a proposal known as
REACH. COM 2003 0644 (03), Proposal for a Regulation of the European
Parliament and of the Council concerning the Registration, Evaluation,
Authorisation and Restriction of Chemicals (REACH), establishing a
European Chemicals Agency and amending Directive 1999/45/EC and
Regulation (EC) {on Persistent Organic Pollutants} Proposal for a
Directive of the European Parliament and of the Council amending
Council Directive 67/548/EEC in order to adapt it to Regulation (EC) of
the European Parliament and of the Council concerning the registration,
evaluation, authorisation, and restriction of chemicals. A European
Union representative estimates that the earliest possible adoption of
REACH is the end of 2006 with the first registrations arriving in 2010.
[9] GAO, Chemical Regulation: Options Exist to Improve EPA's Ability to
Assess Health Risks and Manage Its Chemical Review Program, GAO-05-458
(Washington, D.C.: June 13, 2005).
[10] Corrosion Proof Fittings v. EPA, 947 F.2d 1201 (5th Cir. 1991).
[11] Premanufacture notices are also generally required for new uses of
an existing chemical if EPA promulgates a rule determining that the use
of the chemical constitutes a significant new use.
[12] EPA could also take these actions for a use of a chemical that EPA
has determined by rule is a significant new use.
[13] GAO-05-458.
[14] The Ministers must be satisfied that (a) the chemical may have a
long-term harmful effect on the environment and is (i) persistent and
bioaccumulative in accordance with the regulations, and (ii) inherently
toxic to human beings or non-human organisms, as determined by
laboratory or other studies, and (b) the presence of the chemical in
the environment results primarily from human activity. A substance is
toxic if it is entering or may enter the environment in a quantity or
concentration or under conditions that (a) have or may have an
immediate or long-term harmful effect on the environment or its
biological diversity; (b) constitute or may constitute a danger to the
environment on which life depends; or (c) constitute or may constitute
a danger in Canada to human life or health.
[15] This includes the initial TSCA Inventory as well as those new
chemicals which commenced manufacturing and thus were added to the
Inventory.
[16] For additional information on EPA's use of models, see our report
GAO-05-458.
[17] New chemicals that are accepted as being in commercial use
internationally are listed on the Non-Domestic Substances List--which
is based on the TSCA Inventory--and are subject to lesser requirements.
Unless otherwise noted below, we are referring to new chemicals that
are not on the Non-Domestic Substances List.
[18] 15 U.S.C. § 2613.
