Chemical Regulation: Approaches in the United States, Canada, and
the European Union (04-NOV-05, GAO-06-217R).
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.
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.
-------------------------Indexing Terms-------------------------
REPORTNUM: GAO-06-217R
ACCNO: A41117
TITLE: Chemical Regulation: Approaches in the United States,
Canada, and the European Union
DATE: 11/04/2005
SUBJECT: Environmental law
Environmental monitoring
Federal regulations
Foreign governments
Hazardous substances
Health hazards
Manufacturing industry
Regulatory agencies
Reporting requirements
Toxic substances
Chemical agents
Risk assessment
Comparative analysis
Confidential information
Canada
European Union
******************************************************************
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GAO-06-217R
* Approaches to Controlling Chemical Risks
* Scope and Methodology
* Agency Comments and Our Evaluation
* PDF6-Ordering Information.pdf
* Order by Mail or Phone
United States Government Accountability Office Washington, DC 20548
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. 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.
1
Pub. L. No. 94-469, 40 Stat. 2003 (1976) (codified at 15 U.S.C. S:S:
2601-2692).
GAO-06-217R Chemical Regulation
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. 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. 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.
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
2
15 U.S.C. S: 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. S: 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.
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 5 generally
requires chemical companies to notify a member state regulatory agency
once the marketing level of a new chemical reaches 10 kilograms. 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. 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. 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
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.
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. 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. 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.
GAO, ChemicalRegulation: Options ExisttoImproveEPA's AbilitytoAssess
HealthRisks and Manage Its ChemicalReview Program, GAO-05-458 (
Washington, D.C.: June 13, 2005).
10Corrosion ProofFiingsv.EPA, 947 F.2d 1201 (5th Cir. 1991).
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. 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. 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
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.
least burdensome requirement that will adequately protect against the
risk. As we noted in our earlier report, 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. 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
13GAO-05-458.
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.
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 timelimited 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. 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
This includes the initial TSCA Inventory as well as those new chemicals
which commenced manufacturing and thus were added to the Inventory.
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
European Union
Proposed
Regulation:
Registration,
Evaluation,
Authorisation
Canadian European and Restriction
United States Environmental Union Current of
Toxic Protection Act Chemical Chemicals
Substances
Control Act (CEPA) Legislation (REACH)
(TSCA)
Are chemical No No No Yes
companies o Unless EPA o However, to o Chemical o Chemical
generally promulgates a assess whether companies companies
required test a that
to develop rule to chemical is produce or subject to the
basic require the toxic import
data on the development of or capable of more than registration
such
physical data chemical becoming toxic, 1,000,000 requirements
chemical companies are or to assess kilograms that
properties of not required whether to (2,204,623 manufacture or
existing to develop control a pounds) of a import 1,000
chemicals?a physical chemical, the kilograms
chemical
property data Ministers of chemical in a (2,204.6
on chemicals. Health and the year must pounds) or more
b submit of a
Environment may physical chemical must
chemical
publish a data. provide
notice Companies physical
requiring the must make all chemical data
submission of reasonable and develop
efforts
existing to obtain such data if
existing
information, data, but necessary.
they are
including not bound to
carry
information on out further
the tests
composition of on animals in
the chemical. order to
If submit
the Ministers such data. c
have reason to
suspect, or it
has
been determined
under CEPA,
that
the chemical is
toxic or
capable
of becoming
toxic, then
they
may send the
company a
notice
requiring
testing.
Are chemical No No No Yes
companies o Unless EPA o However, to o While o Chemical
chemical
generally promulgates a assess whether companies companies
required test a that that
to develop rule, chemical chemical is produce more manufacture
basic toxic or
health and companies are or capable of than import 10,000
not 1,000,000
required to becoming kilograms kilograms
ecological develop and toxic, or to (2,204,623 (22,046
effects data submit toxicity assess whether pounds) of a pounds) or
for existing information to to control more of a
chemicals?d EPA.e
a chemical, chemical must chemical
the subject
Ministers of make all to
registration
Health and the reasonable requirements
efforts
Environment to obtain must provide
may existing
publish a toxicological basic data,
notice and and
requiring the health develop such
effects
submission of data, they data if
are not
existing bound to necessary, on
conduct
information, tests on toxicity and
animals in
including order to mutagenicity.
submit
information on such data.
the
composition of
the chemical.
If
the Ministers
have reason to
suspect, or it
has
been
determined
under CEPA,
that
the chemical
is
toxic or
capable
of becoming
toxic, then
they
may send the
company a
notice
requiring
testing.
Is there a No Yes No Yes
requirement to o TSCA does o CEPA o However, o REACH
not requires the would
systematically require EPA to the systematic European require the
prioritize and systematically categorization Commission, proposed
assess existing prioritize and and screening in European
chemicals? assess existing assessment of consultation Chemicals
chemicals, all with the
member states
and EPA existing must Agency to
estimates it chemicals. f regularly develop
has assessed draw up lists criteria
of
about 200 of priority for
the chemicals prioritizing
all
60,000 requiring registered
chemicals in
the initial immediate chemicals for
TSCA
Inventory not attention further
because review
reviewed of their based on a
through potential risk
the new effects on based
chemical human approach.
review program. health or the Criteria for
TSCA environment. evaluation
established For would
an Interagency chemicals on include
the
Testing list, consideration
Committee manufacturers of
(ITC) to and importers hazard data,
recommend,
on behalf of must submit exposure data
member all
Federal relevant and
Agencies, available production
chemicals that information volume and
EPA but do
should give not have to whether the
priority
consideration develop this registrant
to in
promulgating information. submits a
test plan
rules. EPA must for animal
either initiate testing.g
rulemaking or
publish its
reasons
for not doing
so.
Are chemical No No Yes Yes
companies o Companies o Chemical o Chemical o Chemical
are not
generally required to companies companies companies must
required notify
to notify EPA of generally are manufacturing immediately
regulators changes in not or
of the uses of required to importing more inform the
significant existing notify than 10,000 proposed
changes in chemicals regulatory kilograms European
the uses of unless EPA agencies of new (22,046 pounds) Chemicals
existing promulgates a uses unless the of a
chemicals? significant
new use
rule. In chemical is chemical per Agency in
2006, year writing
chemical specified on must submit new of new uses of
companies the
will begin Domestic uses of the chemicals for
reporting
use Substances List chemical that which the
information
under revised as a chemical substantially company may be
for
inventory which change the reasonably
update notification type,
rules of a form, aware of and,
promulgated significant new magnitude, or according to
by EPA.h activity is duration of an
required. exposure to the EU official,
may
chemical. be required to
update the
registration
file.
Can No Yes No No
regulators
require o TSCA does o The Minister o Chemical o The REACH
pollution not of
prevention authorize EPA Environment legislation legislation
plans to shall does would
for toxic require issue not authorize not authorize
chemical the the
chemicals? companies to environmental European Union European Union
prepare quality environmental environmental
pollution objectives
prevention that specify agency to agency to
plans for goals or require require
chemicals. i purposes for chemical chemical
pollution companies to companies to
prevention or prepare prepare
pollution pollution
environmental prevention prevention
plans plans
control, for the for the
including chemicals chemicals
goals or they they
purposes stated manufacture or manufacture or
in import.j import. j
quantitative or
qualitative
terms
for carrying
out
CEPA's mandate
related to
preserving the
quality of the
environment.
The agency may
also issue a
notice
requiring
companies to
prepare and
implement
pollution
prevention
plans
for chemicals
on
Canada's List
of
Toxic
Substances.
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.
dThe 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.
fThe 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.
gAccording 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.
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. 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. 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.
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.
Table 2: Regulation of New Chemicals in the United States, Canada, European
Union
European Union
Proposed
Regulation:
Registration,
Evaluation,
Canadian Authorisation,
and
United States Environmental European Union Restriction of
Toxic Protection Act Current Chemicals
Substances Chemical
Control Act (CEPA) Legislation (REACH)
(TSCA)
Are chemical No Yes Yes Yes
companies o Chemical o Under the o Chemical o Chemical
New
generally companies are Substances companies that companies
required not are subject to
to develop required to Notification subject to the the
basic test new registration
data on the chemicals Regulations notification requirements
before that
physical they are chemical requirements manufacture or
chemical submitted to companies are must submit import 1,000
properties of EPA for review required to certain basic kilograms
new unless EPA provide physical (2,204.6
chemicals?a certain chemical
promulgates a basic physical data. The pounds) or more
test rule.b chemical data extent of must provide
for information certain
and
new chemicals testing basic physical
required
produced or varies, based chemical data.
on
imported above production or
1,000 importation
kilograms volume.
(2,204.6
pounds) in
a calendar
year. c
Are chemical No Yes Yes Yes
companies o Chemical o Under the o Chemical o Chemical
New
generally companies are Substances companies that companies
required not are subject to
to develop required to Notification subject to the the
basic develop registration
health and basic Regulations, notification requirements
toxicological that
ecological and health chemical requirements produce 10,000
effects data effects data companies must must submit kilograms
for new for new provide basic certain basic (22,046
chemicals?d chemicals data on toxicological pounds) or more
before toxicity and data. of a
they are health effects The extent of chemical must
submitted to data
EPA for review for chemicals information develop and
and provide
unless EPA produced or testing basic data on
required toxicity
promulgates a imported above varies, based and
test on mutagenicity.
rule.e 1,000 production or
kilograms
(2,204.6 importation
pounds) in a volume.
calendar year.
f
Is there a No o Chemical No o No o No o
requirement companies must However, under However, However,
for the provide EPA a the New chemical chemical
annual reasonable Substances companies companies
disclosure of estimate of the Notification that are subject to the
production total production Regulations, subject to registration
quantities of volume of a new chemical the requirement
chemicals? chemical with companies notification must include
the manufacturing requirements information on
premanufacture or importing must submit a the overall
notice. After more than technical manufacture or
EPA's review of 1,000 dossier, import of a
the new chemical kilograms which chemical in
and chemical (2,204.6 includes an metric tons
companies have pounds) in any estimate of per year in a
notified EPA calendar year overall technical
that production of a chemical production dossier with
of the chemical that is not on and/or import their
has begun, EPA Canada's volume per registration.
places the Non-Domestic year. Chemical
chemical on the Substances Chemical companies must
TSCA Inventory List (NDSL) companies immediately
and the chemical must provide must notify report any
is subject to an estimate of regulators of significant
existing the quantity changes in changes in the
chemical to be the annual or annual or
regulations, manufactured total total
including the or imported quantities quantities
Inventory Update annually.f placed on the manufactured
Rule. European or imported,
Union but are not
Community otherwise
Market, but required to
are not annually
otherwise disclose
required to production
annually quantities.
disclose
production
quantities.
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.
Oxidationreduction 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.
dSIDS 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.
fFor chemicals listed on the NDSL, the threshold is 10,000 kilograms
(22,046 pounds) in a calendar year.
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. 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.
15 U.S.C. S: 2613.
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 [email protected] . 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.
John B. Stephenson Director, Natural Resources and Environment
Enclosure Enclosure
Comments from the Environmental Protection Agency
(360615)
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