GAO-06-217R Chemical Regulation 

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. §§ 2601-2692). 
Page 2 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. § 2605. Unlike Canadian and European Union legislation, which subject chemical 

companies to notification requirements only after manufacturing has begun, and production or 

marketing of the chemical reaches a certain level, TSCA requires a premanufacture notice. 

 

3

15 U.S.C. § 2604. 

4

These chemicals reviewed do not include EPA’s review of the chemicals manufactured by companies 

that EPA exempted from the premanufacture notice requirements: 717 Test Marketing Exemption 

Applications; 7,888 Low Volume Exemptions; 35 Low Release/Low Exposure Exemptions; and 2,530 

Polymer Exemptions. EPA may exempt a chemical company from the premanufacture notice 

requirement, upon application from the company showing to EPA’s satisfaction that the chemical will 

not present any unreasonable risk of injury to human health or the environment. 
Page 3 GAO-06-217R Chemical Regulation 

 

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 legislation5 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. 
Page 4 GAO-06-217R Chemical Regulation 

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. 

 

9

GAO, Chemical Regulation: Options Exist to Improve EPA’s Ability to Assess Health Risks and 

Manage Its Chemical Review Program, GAO-05-458 (Washington, D.C.: June 13, 2005). 

10Corrosion Proof Fittings v. EPA, 947 F.2d 1201 (5th Cir. 1991). 
Page 5 GAO-06-217R Chemical Regulation 

 

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 

 

11Premanufacture 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. 

12EPA could also take these actions for a use of a chemical that EPA has determined by rule is a 

significant new use. 
Page 6 GAO-06-217R Chemical Regulation 

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. 

14The 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.
Page 7 GAO-06-217R Chemical Regulation 

 

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 

 

15This includes the initial TSCA Inventory as well as those new chemicals which commenced 

manufacturing and thus were added to the Inventory.
Page 8 GAO-06-217R Chemical Regulation 

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 

 

United States 

Toxic Substances 

Control Act (TSCA) 

Canadian 

Environmental 

Protection Act 

(CEPA) 

European Union 

Current 

Chemical 

Legislation 

European Union 

Proposed 

Regulation: 

Registration, 

Evaluation, 

Authorisation 

and 

Restriction of 

Chemicals 

(REACH) 

Are chemical 

companies 

generally required 

to develop basic 

data on the 

physical chemical 

properties of 

existing 

chemicals?a

No 

• Unless EPA 

promulgates a test 

rule to require the 

development of such 

data chemical 

companies are not 

required to develop 

physical chemical 

property data on 

chemicals.b

 

No 

• However, to 

assess whether a 

chemical is toxic 

or capable of 

becoming toxic, 

or to assess 

whether to control 

a chemical, the 

Ministers of 

Health and the 

Environment may 

publish a notice 

requiring the 

submission of 

existing 

information, 

including 

information on 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.

No 

• Chemical 

companies that 

produce or import 

more than 

1,000,000 

kilograms 

(2,204,623 

pounds) of a 

chemical in a year 

must submit 

physical chemical 

data. Companies 

must make all 

reasonable efforts 

to obtain existing 

data, but they are 

not bound to carry 

out further tests 

on animals in 

order to submit 

such data.c

 

Yes

• Chemical 

companies 

subject to the 

registration 

requirements that 

manufacture or 

import 1,000 

kilograms 

(2,204.6 pounds) 

or more of a 

chemical must 

provide physical 

chemical data 

and develop 

such data if 

necessary. 
Page 9 GAO-06-217R Chemical Regulation 

 

Are chemical 

companies 

generally required 

to develop basic 

health and 

ecological effects 

data for existing 

chemicals?d

No 

• Unless EPA 

promulgates a test 

rule, chemical 

companies are not 

required to develop 

and submit toxicity 

information to EPA.e

 

No 

• However, to 

assess whether a 

chemical is toxic 

or capable of 

becoming toxic, 

or to assess 

whether to control 

a chemical, the 

Ministers of 

Health and the 

Environment may 

publish a notice 

requiring the 

submission of 

existing 

information, 

including 

information on 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. 

No 

• While chemical 

companies that 

produce more 

than 1,000,000 

kilograms 

(2,204,623 

pounds) of a 

chemical must 

make all 

reasonable efforts 

to obtain existing 

toxicological and 

health effects 

data, they are not 

bound to conduct 

tests on animals in 

order to submit 

such data.

Yes 

• Chemical 

companies that 

manufacture or 

import 10,000 

kilograms 

(22,046 pounds) 

or more of a 

chemical subject 

to registration 

requirements 

must provide 

basic data, and 

develop such 

data if 

necessary, on 

toxicity and 

mutagenicity. 

Is there a 

requirement to 

systematically 

prioritize and 

assess existing 

chemicals? 

No 

• TSCA does not 

require EPA to 

systematically 

prioritize and assess 

existing chemicals, 

and EPA estimates 

it has assessed 

about 200 of the 

60,000 chemicals in 

the initial TSCA 

Inventory not 

reviewed through 

the new chemical 

review program. 

TSCA established 

an Interagency 

Testing Committee 

(ITC) to recommend, 

on behalf of member 

Federal Agencies, 

chemicals that EPA 

should give priority 

consideration to in 

promulgating test 

rules. EPA must 

either initiate 

rulemaking or 

publish its reasons 

for not doing so. 

Yes 

• CEPA requires 

the systematic 

categorization 

and screening 

assessment of all 

existing 

chemicals.f

No 

• However, the 

European 

Commission, in 

consultation with 

the member states 

must regularly 

draw up lists of 

priority chemicals 

requiring 

immediate 

attention because 

of their potential 

effects on human 

health or the 

environment. For 

chemicals on the 

list, manufacturers 

and importers 

must submit all 

relevant available 

information but do 

not have to 

develop this 

information. 

Yes 

• REACH would 

require the 

proposed 

European 

Chemicals 

Agency to

develop criteria 

for prioritizing all 

registered 

chemicals for 

further review 

based on a riskbased approach. 

Criteria for 

evaluation would 

include 

consideration of 

hazard data, 

exposure data 

and production 

volume and 

whether the 

registrant 

submits a plan 

for animal 

testing.g

 
Page 10 GAO-06-217R Chemical Regulation 

Are chemical 

companies 

generally required 

to notify regulators 

of significant 

changes in the 

uses of existing 

chemicals?

No 

• Companies are not 

required to notify 

EPA of changes in 

the uses of existing 

chemicals unless 

EPA promulgates a 

significant new use 

rule. In 2006, 

chemical companies 

will begin reporting 

use information 

under revised 

inventory update 

rules promulgated 

by EPA.h

No 

• Chemical 

companies 

generally are not 

required to notify 

regulatory 

agencies of new 

uses unless the 

chemical is 

specified on the 

Domestic 

Substances List 

as a chemical for 

which notification 

of a significant 

new activity is 

required.

Yes 

• Chemical 

companies 

manufacturing or 

importing more 

than 10,000 

kilograms (22,046 

pounds) of a 

chemical per year 

must submit new 

uses of the 

chemical that 

substantially 

change the type, 

form, magnitude, 

or duration of 

exposure to the 

chemical. 

Yes 

• Chemical 

companies must 

immediately 

inform the 

proposed 

European 

Chemicals 

Agency in writing 

of new uses of 

chemicals for 

which the 

company may be 

reasonably 

aware of and, 

according to an 

EU official, may 

be required to 

update the 

registration file.

Can regulators 

require pollution 

prevention plans 

for toxic 

chemicals? 

No 

• TSCA does not 

authorize EPA to 

require chemical 

companies to 

prepare pollution 

prevention plans for 

chemicals.i

 

Yes 

• The Minister of 

Environment shall 

issue 

environmental 

quality objectives 

that specify goals 

or purposes for 

pollution 

prevention or 

environmental 

control, including 

goals or purposes 

stated in 

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. 

No 

• Chemical 

legislation does 

not authorize the 

European Union 

environmental 

agency to require 

chemical 

companies to 

prepare pollution 

prevention plans 

for the chemicals 

they manufacture 

or import.j

No 

• The REACH 

legislation would 

not authorize the 

European Union 

environmental 

agency to require 

chemical 

companies to 

prepare pollution 

prevention plans 

for the chemicals 

they manufacture 

or import. j

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. 
Page 11 GAO-06-217R Chemical Regulation 

 

b

EPA in cooperation with industry, environmental groups, and other interested parties launched the High 

Production Volume Challenge Program to voluntarily gather information and ensure that a minimum set of basic 

data on approximately 2,800 high-production volume chemicals—those produced at 1 million pounds or more per 

year—would be available to EPA. Chemical companies were invited to voluntarily sponsor these chemicals and 

submit data summaries of existing information along with a test plan that proposes a strategy to fill data gaps for 

either an individual chemical or for a category of chemicals. EPA intends to use these data to prioritize these 

chemicals for additional review and testing. 

c

Council Regulation (EEC) No 793/93 requires chemical companies to update this information if they obtain new 

data on physico-chemical properties, toxicological, or ecotoxicological effects where it is likely to be relevant to 

the evaluation of the risk posed by the chemical. 

 

d

The OECD SIDS is the minimum amount of data required for making an initial hazard assessment of High 

Production Volume chemicals agreed upon by OECD. 

 

e

However, if the company obtains information that reasonably supports the conclusion that the chemical presents 

a substantial risk to human health or the environment, TSCA requires that the company immediately notify EPA 

about this information. 

f

The Ministers of Health and Environment are to categorize chemicals on the Domestic Substances List to 

identify those that (1) may present to individuals in Canada the greatest potential for exposure or (2) are 

persistent or bioaccumulative in accordance with the regulations and inherently toxic to human beings or to 

nonhuman organisms. Once categorization has been completed, the Ministers shall conduct screening 

assessments for such chemicals to determine whether they are toxic or capable of becoming toxic. 

g

According to a European Union official—under REACH—as originally proposed all registrations of chemicals 

including a plan for animal testing, will be evaluated. Furthermore, for other registered substances, member 

states could use these criteria to include chemicals they believe present a risk to health or the environment in a 

plan for evaluation. The European Parliament Committee on the Environment, Public Health and Food Safety 

recently proposed an amendment to REACH, yet to be confirmed by the European Parliament in plenary 

session, that instead proposes giving the European Chemicals Agency the task of compiling the list and giving 

the agency a greater role in the decision making procedure for chemical evaluation. 

h

In 2003, EPA amended its TSCA Inventory Update Rule (IUR), which is primarily used to gather certain 

information on chemicals produced at more than a basic threshold volume in the year reported. Among other 

things, EPA raised the basic production volume reporting threshold from 10,000 to 25,000 pounds; required 

chemical companies producing or importing chemicals at a site at or above this threshold to report the number of 

workers reasonably likely to be exposed to the chemical at each site; and added a reporting threshold of 300,000 

pounds per site at or above which chemical companies must report readily obtainable exposure-related use and 

processing information. 

i

According to EPA, the United States has considerable experience utilizing tools and incentives to facilitate the 

entry into market safer chemicals or use of safer processes as demonstrated with the Green Chemistry and 

Design for the Environment Programs and the utilization by industry of the P2 Framework tools prior to 

submitting new chemicals for consideration. In addition, section 6602 (b) of the Pollution Prevention Act of 1990 

states that it is the policy of the United States that “pollution should be prevented or reduced at the source 

whenever feasible." The act required EPA to establish an office to carry out the functions of the EPA 

Administrator under the act, including the development and implementation of a strategy to promote source 

reduction. The act also requires many owners and operators of manufacturing facilities to report annually on 

source reduction and recycling activities. 

 

j

According to a European Union official, while a pollution prevention plan is not required under European Union 

chemical legislation, it is obligatory under the Integrated Pollution Prevention and Control Directive. 

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 
Page 12 GAO-06-217R Chemical Regulation 

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.

 

16For additional information on EPA’s use of models, see our report GAO-05-458. 

17New chemicals that are accepted as being in commercial use internationally are listed on the NonDomestic 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. 
Page 13 GAO-06-217R Chemical Regulation 

 

Table 2: Regulation of New Chemicals in the United States, Canada, European Union 

 

United States Toxic 

Substances 

Control Act (TSCA) 

Canadian 

Environmental 

Protection Act 

(CEPA) 

European Union 

Current Chemical 

Legislation 

European Union 

Proposed 

Regulation: 

Registration, 

Evaluation, 

Authorisation, and 

Restriction of 

Chemicals 

(REACH) 

Are chemical 

companies 

generally required 

to develop basic 

data on the 

physical chemical 

properties of new 

chemicals?a

No 

• Chemical 

companies are not 

required to test new 

chemicals before 

they are submitted to 

EPA for review 

unless EPA 

promulgates a test 

rule.b

Yes 

• Under the New 

Substances 

Notification 

Regulations 

chemical companies 

are required to 

provide certain 

basic physical 

chemical data for 

new chemicals 

produced or 

imported above 

1,000 kilograms 

(2,204.6 pounds) in 

a calendar year.c

 

Yes 

• Chemical 

companies that are 

subject to the 

notification 

requirements must 

submit certain basic 

physical chemical 

data. The extent of 

information and 

testing required 

varies, based on 

production or 

importation volume.

Yes

• Chemical 

companies subject to 

the registration 

requirements that 

manufacture or 

import 1,000 

kilograms (2,204.6 

pounds) or more 

must provide certain 

basic physical 

chemical data. 

Are chemical 

companies 

generally required 

to develop basic 

health and 

ecological effects 

data for new 

chemicals?d

 

No 

• Chemical 

companies are not 

required to develop 

basic toxicological 

and health effects 

data for new 

chemicals before 

they are submitted to 

EPA for review 

unless EPA 

promulgates a test 

rule.e

Yes 

• Under the New 

Substances 

Notification 

Regulations,

chemical companies 

must provide basic 

data on toxicity and 

health effects data 

for chemicals 

produced or 

imported above 

1,000 kilograms 

(2,204.6 pounds) in 

a calendar year.f

 

Yes 

• Chemical 

companies that are 

subject to the 

notification 

requirements must 

submit certain basic 

toxicological data. 

The extent of 

information and 

testing required 

varies, based on 

production or 

importation volume. 

Yes 

• Chemical 

companies subject to 

the registration 

requirements that 

produce 10,000 

kilograms (22,046 

pounds) or more of a 

chemical must 

develop and provide 

basic data on toxicity 

and mutagenicity. 
Page 14 GAO-06-217R Chemical Regulation 

Is there a 

requirement for the 

annual disclosure 

of production 

quantities of 

chemicals? 

No 

• Chemical 

companies must 

provide EPA a 

reasonable estimate 

of the total 

production volume of 

a new chemical with 

the premanufacture 

notice. After EPA’s 

review of the new 

chemical and 

chemical companies 

have notified EPA 

that production of the 

chemical has begun, 

EPA places the 

chemical on the 

TSCA Inventory and 

the chemical is 

subject to existing 

chemical regulations, 

including the 

Inventory Update 

Rule. 

No 

• However, under 

the New 

Substances 

Notification 

Regulations,

chemical companies 

manufacturing or 

importing more than 

1,000 kilograms 

(2,204.6 pounds) in 

any calendar year of 

a chemical that is 

not on Canada’s 

Non-Domestic 

Substances List 

(NDSL) must 

provide an estimate 

of the quantity to be 

manufactured or 

imported annually.f

No 

• However, chemical 

companies that are 

subject to the

notification 

requirements must

submit a technical 

dossier, which 

includes an estimate 

of overall production 

and/or import volume 

per year. Chemical 

companies must 

notify regulators of 

changes in the 

annual or total 

quantities placed on 

the European Union 

Community Market, 

but are not otherwise 

required to annually 

disclose production 

quantities. 

No 

• However, chemical 

companies subject to 

the registration 

requirement must 

include information 

on the overall 

manufacture or 

import of a chemical 

in metric tons per

year in a technical 

dossier with their 

registration. 

Chemical companies 

must immediately 

report any significant 

changes in the 

annual or total 

quantities 

manufactured or 

imported, but are not 

otherwise required to 

annually 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. 

d

SIDS is the minimum amount of data required for making an initial hazard assessment of High Production 

Volume Chemicals agreed upon by OECD. CEPA, current European Union legislation and proposed REACH all 

require at least three toxicological properties, including acute toxicity, repeated dose toxicity, and genetic toxicity 

for new chemicals produced over certain volumes. Current European Union legislation and proposed REACH 

also require reproductive toxicity once reporting thresholds have been met. 

e

Testing is not required for new chemicals unless the EPA promulgates a test rule, but companies must submit 

(1) any test data in the possession or control of the company related to the chemicals effect on health or the 

environment and (2) a description of any other data concerning the environmental and health affects that is 

known or reasonably ascertainable by the company. Companies must also inform EPA if they obtain information 

that reasonably supports the conclusion that a chemical presents a substantial risk of injury to health or the 

environment. 

f

For chemicals listed on the NDSL, the threshold is 10,000 kilograms (22,046 pounds) in a calendar year. 
Page 15 GAO-06-217R Chemical Regulation 

 

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. 

 

1815 U.S.C. § 2613. 
Page 16 GAO-06-217R Chemical Regulation 

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 
Page 17 GAO-06-217R Chemical Regulation 

 

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. 
Page 18 GAO-06-217R Chemical Regulation 

With regard to EPA’s comments regarding additional points that the report should 

address, we agree that such additional information could be useful, but given time 

constraints we were not able to add this information into this report. Given the short 

period available to complete our work, we agreed with the requesters of our report to 

primarily rely upon the work we had previously performed regarding TSCA and the 

other countries, as supplemented by appropriate and necessary follow-up work. We 

have generally attempted, given the information available to us, to present a similar 

amount of detail for the United States, Canadian, and European Union legislation. In 

some cases, the amount of detail presented in this report varies because some laws 

contain more detail than others. With regard to EPA’s suggestion that the report 

would benefit from a discussion of enforcement activities, we did not perform the 

work that would enable us to address enforcement activities in this report. Such 

activities, however, are an important part of our ongoing work in the area of chemical 

regulation in the United States, Canada, and the European Union. 

EPA’s comments are reproduced in the enclosure. 

---------------------------- 

As agreed with your office, unless you publicly announce the contents of this report 

earlier, we plan no further distribution until 30 days from the report date. At that 

time, we will send copies of this report to the congressional committees with 

jurisdiction over EPA and its activities; the Administrator, EPA; and the Director, 

Office of Management and Budget. We also will make copies available to others upon 

request. In addition, the report will be available at no charge on the GAO Web site at 

http://www.gao.gov. 

If you have any questions about this report, please contact me at (202) 512-3841 or 

stephensonj@gao.gov. Contact points for our Offices of Congressional Relations and 

Public Affairs may be found on the last page of this report. Ed Kratzer, Assistant 

Director; David Bennett; John Delicath; Aaron Kaminsky; and Amy Webbink made 

key contributions to this report. 

John B. Stephenson 

Director, Natural Resources 

and Environment 

Enclosure 
Page 19 GAO-06-217R Chemical Regulation 

 

Enclosure 

Comments from the Environmental Protection Agency 
Page 20 GAO-06-217R Chemical Regulation 
Page 21 GAO-06-217R Chemical Regulation 

 

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