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
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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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