AT-A
GLANCE
A COMPARISON OF TSCA-LIKE
STATUTES
DECEMBER 1990
PREPARED BY:
OFFICE OF TOXIC SUBSTANCES
ENVIRONMENTAL ASSISTANCE DIVISION
OCT -3 1995
-------
World At*A*Glance
A Comparison of TSCA-Like Statutes
INDEX
PAGE(S)
i-iv
2
3
4 ,
5-6
7-9
10-15 -
16
17
18-19
20
21-25
26-27
28-29
30-32
33-35
36-41
42
43-55
56-57
58
SUBJECT
Summary
Introduction :
How the report is organized
What is covered
World structures Dealing with Industrial
Chemicals (Table 1)
European Community (EC)/ Organization for
Economic Cooperation and Development (OECD)
Countries (Table 2)
EC/OECD Facts (Table 3)
TSCA Comparison — EC (Table 4)
TSCA Comparison— OECD, Non-EC (Table 5)
TSCA Comparison — Eastern Europe (Table
6)
TSCA Comparison — Asia (Table 7)
TSCA Comparison — Central &
South America (Table 8)
TSCA Comparison — Africa (Table 9)
Dossiers on Some of the World's Most Advanced
TSCA-Like Statutes:
• Canada
• Germany
• Japan
• Netherlands
• Sweden
World Toxic Chemical Control Laws
Table (Table 10)
Top Ten Population Centers & Chemical
Regulation (Table 11)
OECD and OTS Activities (Appendix I)
References
Acknowledgments
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WORLD AT'A»GLANCE: A COMPARISON OF TSCA-LIKE STATUTES
SUMMARY
General Findings
1. Within the Organization for Economic cooperation and
Development (OECD) countries and the European Community (EC),
industrial chemicals are regulated by "command and control" type
statutes. The extent to which third world countries have legal
structures to regulate chemicals in the environment is the
subject of further investigation.
2. Chemical statutes of a country may include more than just what
the United States defines as TSCA chemicals. For example/ some
include pesticides (Germany) and hazardous wastes (Philippines).
3. New and existing chemical regulations in the EC predate TSCA,
and have been amended more frequently than TSCA. Nonetheless,
the proposed EC Existing Chemical regulation offers the first
relatively comprehensive authority to test, assess and control
chemicals at an EC level. The overriding characteristic in
OECD/EC chemical activities is to prevent non-tariff trade
barriers among its members.
4. Some new and existing chemical statutes include specific
regulation of chemicals in the workplace as well as the
environment and public health.
The following points reflect some of the generic comparisons
one is able to draw from this report. However, each statute has
its own distinct elements. Because this report is a summary in
structure, more specific comparisons are best made on a country
by country basis.
Existing Chemicals
1. The EC existing chemical inventory includes over 100,000
substances. The EC inventory does not include polymers. TSCA
has about 65,000, 20,000 of which are polymers. Under the EC
system, new chemicals are always considered new. Under TSCA, new
chemicals upon notice of manufacture are added to the existing
chemical inventory.
2. The EC does not presently have the authority to require
testing of existing chemicals. However, under the Screening
Information Data Sets (SIDS) program, OECD countries will be
testing a percentage of these chemicals. TSCA requires testing
of existing chemicals by rulemaking. The proposed EC regulation
will give some authority to require testing, however it is tied
to production volume and requires agreement among the EC
countries on priorities. It is not clear how this will work in
practice.
-------
3. Testing of existing chemicals in most OECO countries/ and
under the proposed EC regulation, will be determined by priority
lists. T8CA imposes a more complex "unreasonable risk" finding
which may include a number of confounding factors. However, TSCA
does provide greater latitude in requiring testing.
4. For proposed rules, TSCA has a lengthy rulemaking procedure
with notice and comment period with the rationale of the
rulemaking available. It is unclear how the EC will carry out
chemical specific test requirements and if they will make
rationales publicly available.
New Chemicals
1. In many of the OECD and EC countries, new chemical
notification is required before marketing the substance. Under
TSCA/ and a few other countries/ notice is required before
manufacture.
2. The U.S. has a 90 day review period; the EC and other
countries allow 45 days. Most countries have certain chemical
exemptions to full notifications.
3. In the EC, the manufacturer is required to test, evaluate,
classify and label new chemicals. (There is no PMN form, per se.)
Additional testing is required as marketing of the new chemical
expands.
Confidential Business Information
l. In the U.S., data on a new chemical are available to the
public in sanitized FMNs. Under TSCA, unless data are claimed as
CBI, the information is made available to the public. The EC
treats exposure information on a chemical as confidential. Other
data on physical/chemical data, toxicity, safety and handling
and items are generally available. Frequently, the data are only
available in summary form (such as Netherlands).
2. In Japan, all information on new chemicals is treated as
confidential and not released to the public. This reflects the
close industry-government relationship in Japan.
3. In some countries, such as Canada/ the government has the last
word on what is claimed CBI, or the notifier can withdraw the
claim. Certain statutes specify what may not be claimed
confidential in a new chemical notification.
4. Only a few countries have Freedom of Information kinds of laws
in place (U.S., Sweden).
ii
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Chemical Information Gathering
1. Chemical information can be gathered more easily under other
statutes (such as Canada) because a number of statutes allow
broad government authority to directly obtain information from
industry. Under TSCA, information gathering on a chemical is
subject to rulemaking procedures.
2. some statutes (such as Japan, Netherlands) require automatic
annual reporting on chemicals that reach certain manufacturing
threshold amounts.
3. The EC proposed regulation will implement a process whereby
information on a specified list of high volume existing chemicals
must be provided within a specified time frame. This information
will be used to confirm classification /labeling on chemicals and
subsequently to establish priorities for testing/ assessment and
control measures.
The following section lists some of the features found in
statutes of the five countries (described in greater detail in
each country's dossier) that are different from TSCA.
Novel Features
CANADA—Biotechnology is defined and covered in the act.
CANADA—Citizen Petition provides for citizen's input. Citizens
may petition for chemicals to be added to the Priority Substance
list (quite like Emergency Planning and Community Right-to-Know
Act, section 313).
CANADA—Mandatory Product Recall The Minister of the
Environment may order a company to replace a product believed to
be a threat to human health or the environment, or if there is a
contravention of any part of CEPA, Part II.
GERMANY—Mandatory Product labeling Germany requires proper
warning labels on all chemical products. In the event that a
substance has not been fully tested, the label must indicate such
information.
JAPAN—On-the-Spot Inspections This provision gives the
government agency broad authority to examine chemical
manufacturing records, take samples, "within the limits necessary
for enforcing this law," for information gathering purposes.
JAPAN—Conforming to standards Japan may set technical
standards on how to manufacture the chemical.
NETHERLANDS—General Duty The onus is on industry to take
responsible measures for knowing a chemical is dangerous to the
environment and health, and to take measures to restrict the
danger as much as possible.
iii
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NETHERLANDS—Microorganisms are defined and covered by its law.
NETHERLANDS—Labeling provisions New or existing chemicals must
be labelled if the chemical comes under one or more of the 14
danger categories. Labeling is applied to the whole life cycle
and users of the chemical.
NETHERLANDS—Registration of chemical substances in circulation
NETHERLANDS—Temporary Regulations The minister may issue
temporary regulations himself instead of going through the
procedures of the General Administrative Order.
SWEDEN—Product Stewardship The onus is on industry to see to
it/ through its own investigations or in another manner/ that
satisfactory research is carried out to determine what health or
environmental injuries the product may cause.
SWEDEN—Permits Certain extremely dangerous chemicals may be
permitted for certain professional use.
SWEDEN—Risk Reduction In 1989, the Swedes published a list of
13 chemicals to reduce or eliminate by 2000.
IV
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The purpose of this report is to examine the laws of other
countries that are in part similar to the Toxic Substances
Control Act (TSCA) . TSCA was enacted in 1976, when regulating
chemicals in the environment was a relatively new process.
During the 1980s, other countries have chosen different methods
for controlling chemicals in the environment..
This report is organized using TSCA as the primary reference
point. Four topical categories are used to compare the statutes:
1) existing chemicals; 2) new chemicals; 3) confidential business
information; and 4) chemical information gathering. Summary
tables are grouped by European Community (EC) countries, non-EC,
Organization for Economic Cooperation and Development (OECD)
countries, and other geographical regions. Th® tables are a
partial listing of the world's countries.
As part of the overview, tables are provided to explain the world
structures involved in chemical control, how the EC's unique
supranational structure and the OECD work, and to provide a
review of control laws organized by major population centers.
This report also contains country dossiers, which go into more
detail than the comparison tables. Dossiers were developed only
if a country provided an English translation of its statute. The
dossier was then reviewed by an official of the country for
technical accuracy. The country dossiers, in addition to
elaborating on the four categories listed above, also mention
novel features not found in TSCA. The comparisons and listing of
novel features are by no means exhaustive. For example, other
features, such as import/ export, or enforcement provisions could
be compared at a later date. This report looks only at the major
parts of a country's TSCA-like laws and lists the major novel
features.
Chemical laws can only be fully understood within the framework
of the national legislation of a country. Socio-economic
characteristics of w*t for differences and idiosyncrasies of national
efforts at ehdmical control.
As more information becomes available about a country, a dossier
will be developed".
"P" in the tables or dossiers indicates pending or missing
information.
—Jamie Walters
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WORLD STRUCTURES DEALING WITH
INDUSTRIAL CHEMICALS ~
OECD
GATT
UNITED
NATIONS
Directorates
GATT
Secretariat
UNEP
WHO
IRPTC
Environment
Directorate
IPCS
Chemicals
Group
Accidents
Group
Biotechnology
Group
GATT General Agreement on Trade and Tariffs
IPCS International Program for Chemical Safety
IRPTC International Registry of Potentially Toxic Chemicals
OECD Organization for Economic Cooperation and Development
UNEP United Nations Environmental Programs
WHO World Health Organization
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TABLE 2
EUROPEAN
COMMUNITY (EC or EEC)
(12 member countries)
Belgium
Denmark
France
Germany
Greece
Ireland
Italy
Luxembourg
Netherlands
Portugal
Spain
United Kingdom
ORGANIZATION FOR
ECONOMIC COOPERATION
AND DEVELOPMENT (OECD)
(24 member countries )
ALL EC COUNTRIES ARE ALSO
MEMBERS OF THE OECD
Austria
Australia
Canada
Iceland
Finland
Japan
New Zealand
Norway
Sweden
Switzerland
Turkey
United States
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EC FACTS - Table 3
Single European Treaty (1987) made laws binding on member
countries, providing a supranational structure
Article VII establishes the environment as an area for
common laws
Directives are legally binding on members
If a member has no "state laws," the EC Directive becomes
the law to follow.
"State laws" may be stricter that EC directives
The Commission (executive and administrative roles)
initiates and drafts proposals
The European Parliament (elected by citizens of the EC)
considers and comments on proposals
The Council (composed of representatives of member states at
the ministerial level) adopts proposal, which becomes law.
In .some cases, the Commission may do this also.
TYPES OF EC MEASURES
Regulations a law that is binding and applicable to all member
states without any implementing legislation [The current proposal
for EC Existing Chemicals will become a regulation]
Directives are binding: they require members to meet an EC
Standard but leave the legal path to individual authorities.
The law requires that a particular result must be achieved, but
the choice of method to achieve that result is up to the member
state [The EC New Chemical process is a directive.]
Decisions a decision is binding on those to whom it is
addressed. No national implementing legislation is required.
have no binding affect.
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OECD FACTS — TABLE 3 (cont.)
o
The U.S. State Department has the lead responsibility for
coordinating U.S. participation in the OECD
Since the late 1970s, OTS has been an active participant in
OECD's Chemicals Group
Set up as a forum for industrialized powers to discuss
issues of common interest and to coordinate and harmonize
their national policies
Directives are not binding legally on countries
TYPES OF OECO MEASURES
Council Decisions binding, once member countries have met their
individual national requirements
Council Reco™™?nflfl*;i7nff no^ binding, but carry moral obligations
for members to follow
MAJOR OECD PROGRAMS
Recommendation on the Assessment of the Potential
Environmental Effects of Chemicals (1974)
Recommendation on the Guidelines in respect of Procedures
and requirements for Anticipating the Effects of Chemicals
on Man and in the Environment (1977)
Decision on the Mutual Acceptance of Data in the Assessment
of Chemicals (1981)
Decision on the Minimum Pre-Marketing Set of Data in the
Assessment of Chemicals (1982)
Recommendation on the Mutual Recognition of Compliance with
Good Laboratory Practice (1983)
Recommendation concerning information exchange related to
export of banned or severely restricted chemicals (1984)
(SEE APPENDIX 1 FOR CURRENT OECD/OTS EFFORTS)
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EUROPEAN COMMUNITY (EC) -- TABLE 4
COUNTRY
BC
-
Belgium
TOXICS
LAW (8)
(Y/n)
yes
yes
EXISTING
CHEMICALS
Regulation
Tasting
• Proposal
regulation
stage
• Will require
testing of
chemicals
based on
production
volume;
• Highest
volume
chemicals
require more
test data than
lower
• Establishes
a list of
chemicals
exceeding 1000
tonnes for
testing & data
submission
no regs.
NEW
CHEMICALS
• Directive in
place
• premarket
notice
• notice
requires a
technical
dossier. with
test data;
negative effects
associated with
use ; proposed
classification
for labeling;
and safety
precautions
• stricter
testing is
required as
market exceeds
1000 tonnes per
year or a total
of 5000 tonnes.
• Standards in
place
CONFIDENTIAL
BUSINESS
INFORMATION
Existing
Chemicals
• Allowed, but
specifies
criteria for
that which
cannot be •
claimed as CBI
New Chemicals
• all exposure
data submitted
is CBI
• interpretation
of tox. and
ecotox. data is
publicly
available.
However, raw
data may be
claimed CBI
P
CHEMICAL
INFORMATION
GATHERING
• European
Inventory of
Exixting
Commercial
Chemical
Substances
(EINECS) is
EC's existing
chemical
inventory (with
over 100,000
chemicals)
• Data supplied
from producers
from 1/71 to
9/81 compose
the inventory
• All chemicals
after 1981 are
always
considered
"new" and not
added to EINECS
P
-------
CD
COUNTRY
Denmark
France
Germany
Oreece
Ireland
Italy
TOXICS
LAW(S)
(Y/n)
yes
yes
yes
no
no
yes
EXISTING
CHEMICALS
Regulation
Testing
P
P
• Develops
priority lists
• regulates
based on
exposure or
hazard
follows EC
follows EC
no regulations
NEW
CHEMICALS
• Standards in
place for new
chemicals. Some
revisions in
1989
• standards in
place
• separate law
in place
• Standards in
place
CONFIDENTIAL
BUSINESS
INFORMATION
P
P
no provision or
not specified in
the law
P
CHEMICAL
INFORMATION
GATHERING
P
P
P
Italy has a
National
Inventory of
2000 existing
chemical
substances
which have been
evaluated for
risk. A data
sheet exists
for each
substance.
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COUNTRY
Luxem-
bourg
Mather-
lands
Portugal
Spain
United
Kingdom
TOXICS
LAW (8)
(y/»)
no
yes
yes
yes
yes
EXISTING
CHEMICALS
Regulation
Testing
follows EC
Chemicals
tested are
listed on
priority lists
by production
volume
p
no regs. in
place
P
NEW
CHEMICALS
• has standards
• premanufacture
notice and
premarket notice
• has
notification
procedures
covers new
chemicals
has notification
procedures
CONFIDENTIAL
BUSINESS
INFORMATION
• specifies
criteria for
that which
cannot be
claimed CB1
P
P
P
CHEMICAL
INFORMATION
GATHERING
Section 29
registration of
all existing
chemicals and
annual
reporting
p
P
P
vo
-------
COUNTRY
TOXICS
LAW(8)
(y/n)
EXISTING
CHEMICALS
Regulation
Tasting
MEW
CHEMICALS
CONFIDENTIAL
BUSINESS
INFORMATION
CHEMICAL
INFORMATION
GATHERING
OBCD COOMTRIB8 MOT IN THE EUROPEAN COMMUNITY — TABLE 5
Australia
yes
• regulations
currently being
developed
• OECD
guidelines on
non-CBI material
apply
• is compiling
an inventory of
new substances
(AICS)
• existing
chemical
inventory of
30,000
chemicals in
Australia from
1977-1988
Austria
yes
• covers new
chemicals only
• premarket
notice
• exposure data
claimed CBI
• inventory
includes EINECS
plus market
chemicals in
Austria between
1982-89
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COUNTRY
Canada
TOXICS
LAW (8)
-------
COUNTRY
Finland
Japan
Norway
TOXICS
LAW (8)
(y/n)
yes
yes
no
EXISTING
CHEMICALS
Regulation
Tasting
• covers
pesticides and
wood
preservatives
• follows EC
regulation on
labeling
P
NEW
CHEMICALS
• is developing
a new chemicals
notification
statute
• law in place
regarding new
chemicals
• premanuf acture
notice
no regulations
CONFIDENTIAL
BUSINESS
INFORMATION
P
• exposure data
claimed CBI
• physical
/chemical data
claimed CBI
• ecotoxicity
data claimed CBI
• safe handling,
storage,
transport and
disposal is
claimed as CBI
CHEMICAL
INFORMATION
GATHERING
• is planning
to use EINECS
in order to
differentiate
between new and
existing
chemicals
• has an
inventory of
substances
• initial
inventory had
about 45,000
chemicals in
1979
• as chemicals
are notified,
they are added
to the
inventory
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COUNTRY
Sweden
Switzer-
land
Turkey
TOXICS
LAW(8)
(Y/n)
yes
yes
yes
EXISTING
CHEMICALS
Regulation
Testing
covers
existing
chemicals
p
P
*
NEW
CHEMICALS
• covers new
chemicals
• EINECS
chemicals
exempted from
notification
• premanufacture
notice
• covers new
chemicals
• premarket
notice
• regulations on
do not cover all
new chemicals,
only certain
classes
(including
genetically
modified
organisms)
• premanufacture
and premarket
notice
CONFIDENTIAL
BUSINESS
INFORMATION
P
P
• exposure data
claimed CBI
• physical
/chemical data
claimed CBI
• ecotoxicity
data claimed CBI
CHEMICAL
INFORMATION
GATHERING
• EINECS plus
Toxic list I
(1985) (about
10,000
chemicals)
• no inventory
-------
COUNTRY
United
States
TOXICS
LAW(S)
(Y/n)
yes
EXISTING
CHEMICALS
Regulation
Testing
Regulation
• 8(e)
submissions
trigger
chemicals to
be screened
• TRI
chemicals also
feed the
process
(section 6)
• unreasonable
risk criteria
need to be
met; range of
control
options from
ban to labels
• section 9
referrals
Testing
• Section 4
test rules
issued based
on ITC list
NEW
CHEMICALS
• premanufacture
review
• may require
restrictions
under 5(e)
• limited test
data available
• EPA may issue
handling
controls under
5(e) or an
outright ban
CONFIDENTIAL
BUSINESS
INFORMATION
• Any item may
be claimed CBI
if it would
affect the
competitive
position of the
company
• Case law
decisions have
made more data
available, to
limit CBI claims
CHEMICAL
INFORMATION
GATHERING
• TSCA
Inventory of
about 68,000
chemicals
• New chemicals
manufactured
are added to
the inventory
• TSCA provides
for issuance of
reporting rules
for chemicals
(sections 8A,
8D, include
PAIR and CAIR
rules)
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COUNTRY
United
States
(oont.)
Yugo-
slavia
TOXICS
LAW (8)
(Y/n)
>;i
yes
EXISTING
CHEMICALS
Regulation
, Testing
• Master
Testing list
• Candidate
list for
testing of
chemicals
• covers new
chemicals
• premarket
notice
NEW
CHEMICALS
P
CONFIDENTIAL
BUSINESS
INFORMATION
P
CHEMICAL
INFORMATION
GATHERING
no inventory
-------
COUNTRY
TOXICS
LAW(S)
(Y/n)
EXISTING
CHEMICALS
Regulation
Testing
NEW
CHEMICALS
CONFIDENTIAL
BUSINESS
INFORMATION
CHEMICAL
INFORMATION
GATHERING
EASTERN EUROPE — TABLE 6
Albania
Bulgaria
Czecho-
slovakia
Hungary
Poland
Romania
soviet
Union
p
P
yes
no
P
P
yes,
under
more
than
one
law
• includes
notification
of poisons,
narcotics and
corrosive
agents
P
• includes a
preroanu f acture
provision
• must include
composition of
the substance
and results of
toxicologic
tests
P
P
P
• has an
inventory of
substances
subject to the
provision
P
-------
COUNTRY
TOXICS
LAW(S)
(Y/n)
EXISTING
CHEMICALS
Regulation
Testing
NEW
CHEHICALS
.
CONFIDENTIAL
BUSINESS
INFORMATION
CHEMICAL
INFORMATION
GATHERING
ASIA — TABLE 7
Bangla-
desh
China
India
Israel
Korea
Nepal
Pakistan
Philli-
pines
p
yes
P
no
P
P
P
yes
P
• controls
industrial
chemicals and
nuclear and
hazardous
wastes
• unreasonable
risk test,
similar to
TSCA
• may require
testing
P
• contains a
preraanufacture
and preimport
requirements
P
• provides for
public access to
records and
reports
P
• establishes
an inventory of
chemicals
-------
COUNTRY
TOXICS
LAW(S)
(y/n)
t
»•
EXISTING
CHEMICALS
Regulation
Testing
NEW
CHEMICALS
CONFIDENTIAL
BUSINESS
INFORMATION
CHEMICAL
INFORMATION
GATHERING
CENTRAL AND SOUTH AMERICA — TABLE 8
Argentina
Belize
Bolivia
Brazil
Chile
Columbia
Costa
Rica
Ecuador
Mexico
Nicaragua
Panama
P
P
P
P
P
P
P
P
yes
P
P
a broad
environmental
statute
includes
regulations in
general
not specified
•
not specified
not specified
CD
-------
COUNTRY
Paraguay
Peru
Uruguay
Venezuela
TOXICS
LAW (8)
(y/»)
p
p
p
p
EXISTING
CHEMICALS
Regulation
Tasting
NEW
CHEMICALS
CONFIDENTIAL
BUSINESS
INFORMATION
CHEMICAL
INFORMATION
GATHERING
VO
-------
COUNTRY
TOXICS
LAW(S)
(y/»)
: ••.
EXISTING
CHEMICALS
Regulation
Testing
NEW
CHEMICALS
CONFIDENTIAL
BUSINESS
INFORMATION
CHEMICAL
INFORMATION
GATHERING
AFRICA — TABLE 9
Algeria
Chad
Egypt
Kenya
Morocco
Nigeria
South
Africa
Sudan
Uganda
Zambia
P
P
P
P
P
yes
P
P
P
P
• has a broad
environmental
policy which
includes the
control of
chemicals
P
P
.
P
rv>
o
-------
CANADA
Background
The Canadian Environmental Protection Act (CEPA, 1988) is a
consolidation and updating of several environmental laws
developed in Canada since the 1970s, administered by Environment
Canada. In particular, Part II of CEPA deals with the
environmental management of toxic substances. CEPA regulations
made on other substances prior to passage of CEPA are rolled over
under the new law. Next to the United States, Canada is one of
the world's largest manufacturers, importers, exporters and users
of chemicals.
Existing Chemicals
Regulation CEPA section 12 required Canada to establish a
Priority Substances List (PSL). The government convened a panel
of industry, environmentalists, provincial representative and
government experts to make recommendations for candidates to be
included on the list. Published in February 1989, the PSL lists
44 substances. CEPA requires that a scientific assessment be
completed on each chemical on the PSL list. If Canada determines
that the substance is toxic based on the assessment, the chemical
is added to Schedule I. Subsequently, it will be determined if
further controls are necessary* Chemicals are prioritized by the
ability to complete the assessment based on the complexity of the
data needs. If a chemical is found to be toxic, a control
options paper is developed which looks at safe concentration
levels, best available technology, etc. A proposed regulation
and a regulatory impact analysis examines the economic
implications of the control options. All of these documents are
published in the Canada Gazette (a Federal Register equivalent)
and subject to a 60-day review period by the public. A draft
regulation is then published and reviewed in the same manner.
Section 34 spells out a range of control actions that can be
taken. Environment Canada estimates that this process will take
two-three years, from assessment to final regulation.
For example, dioxins and furans were the first PSL
chemicals to have a completed assessment. These chemicals are
now in th* control options stage. The next assessments to be
completed •£• effluents from pulp and paper mills using
bleaching, feanzene, chlorobenzene, and MTBE. Canada has
prohibitions on other chemicals including PCBs, PBBs, Mirex, and
CFCs in certain applications. (Prohibitions are comparable to
TSCA section 6 ban on PCBs and asbestos.) Under section 35,
there is an interim order provision, which can control a
substance not on the PSL list if there is significant danger.
This provision was used on several occasions. Action is
implemented in a few days.
21
-------
Canada, p.2
Canada has received requests to add chemicals to the PSL
list. Environment Canada will convene a public consultation
panel. The next PSL will be published in 1994 and every three
years thereafter. Candidates may also come from Canada's program
work with OECD or from the public advisory panel itself.
Testing Unlike TSCA which has an ITC Chemicals list that
triggers chemical testing candidates, the PSL establishes the
list which may involve testing of chemicals in the process of
preparing the required assessment. If the Minister of the
Environment has reason to believe that a substance is toxic or is
capable of being toxic (whether on the PSL or not), under section
18(l)(c) the Minister may require companies to test a substance
(among other communication options.) This provision has not been
used under CEPA.
New Chemicals
CEPA covers new chemicals as well as existing chemicals. Unlike
TSCA, which does not require much up front data, and relies
heavily on structure activity relationships (SAR) to evaluate new
chemicals, Canada will require tests of new chemicals before they
are manufactured [section 29(c)]. The law provides for a 90-day
review (as does TSCA). CEPA may extend the review period to 180
days if appropriate.
A substance is considered new if'it is not found on the Domestic
Substances List (DSL), the non-DSL, or the TSCA Inventory. New
chemicals require full reporting. The DSL contains all chemicals
manufactured or imported in Canada at a specified threshold
quantity between November 1, 1984 to December 31, 1986. If the
substance is listed on the non-domestic substances list (NDSL), a
lower threshold of reporting is required. Canada will be
publishing the DSL and NDSL on January 26, 1991.
Canada is preparing a premanufacture notice regulation (in
Canada, referred to as New Substances Notifications (NSN)). The
government will not exempt R & D chemicals, for example, as does
TSCA. The NSN regulation is expected to be published during
1991.
Confidential Business Information
Under CEPA section 19, any person providing information may
request information be treated as confidential, except in a
medical emergency. A CBI claim must be substantiated. Section
20 (6) gives the Minister latitude in the disclosure of data to
the public. Section 20 specifies the information that cannot be
protected under the CBI provisions. The following information
may be disclosed: a) general data on uses of a substances; b)
safe handling precautions; c) methods for disposal; d) safety
22
-------
Canada, p.3
measures in the event of accidents; e) physical and chemical
information that do not reveal the identity of a substance; f)
various summaries of health and safety data, epidemiology
studies, occupational exposure, toxicologic, clinical or
ecological test; g) any tests performed under CEPA, or other
tests done by the Canadian government. This is similar to the
provisions of TSCA section 14.
Chemical Information Gathering
The procedure for collecting information under CEPA from industry
is simpler than TSCA. Under CEPA section 16, the program
director (equivalent to the OTS-Office Director or Division
Director) -may send an interrogatory to companies requesting a
broad range of information including chemical production volume,
use, etc. This may be in the form of a letter or publication in
the Canada Gazette. The government sets its own reporting
deadlines (usually 30 days). The whole process takes about 6
weeks to obtain the information. Under TSCA, there is a
rulemaking procedure for gathering information (Section 8(a),
8(d)), may take up to 18 months to be published and get results.
After rulemaking, EPA rules are subject to OMB oversight, adding
additional time to a reporting rule to be finalized. Canada does
not have an OMB equivalent, although the Canadian Department of
Justice, Privy Council Office and Parliament have regulatory
oversight. Environment Canada (as well as other Ministries)
operates independently.
Novel Features of CEPA
Biotechnology (section 3) is defined in the act and such
chemicals are treated like other new chemicals under review.
Biotechnology was not around at the time of TSCA's passage.
The NSN regulation recently proposed contains provision for
biotechnology review.
Citizen Petition TSCA has section 21; CEPA has a potential
for stronger citizen's input in very specific areas. For
example, it. the government has failed to complete the assessment
on a chemiSal on the PSL in five years, an independent board
reviews the case. Citizens may petition for chemicals to be
added to the list (quite like Emergency Planning and Community
Right-to-Know Act, section 313).
Mandatory Product Recall (section 40) The Minister of the
Environment may order a company to replace a product believed to
be a threat to human health or the environment, or if there is a
contravention of any part of CEPA, Part II. TSCA's section 7
(imminent hazard provision) has only been used in the regions in
regard to certain PCB-related hazards.
23
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OVERVIEW SUMMARY FOR THE ASSESSMENT OF PRIORITY SUBSTANCES
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SUMMARY OF WORKPLANS FOR THE ASSESSMENT OF PRIORITY SUBSTANCES
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OCT. 22. IMO
-------
GERMANY
Background
Chemicals are controlled in Germany under the Protection Against
Dangerous Substances Act (PADSA, 1980, revised in 1986 and 1990).
Under the terms of the reunified Germany, all environmental
regulations in West Germany apply nationwide. As a -member of the
EC, Germany must follow directorates and regulations issued by
the EC. References to the EC regulations are contained in the
national legislation. The regulation covers all pesticides and
toxic substances.
Existing Chemicals
Regulation PADSA may regulate existing chemicals, that is, apply
a general screening and registration of a chemical, provided
there is "factual evidence" of hazardous properties and
screening. The action is limited to those properties to which
the evidence points. Since the serious evidence finding is
relatively rare, the government has not made use of this
provision. There are some specific prohibitions on certain
chemicals. (For example, there are specific prohibitions on PCBs
and vinyl chloride.)
Section 16c requires annual reporting of existing chemicals
exceeding 10 tonnes imported or manufactured into the- country.
Testing Germany has agreements with industry to test chemicals
on which data are inadequate. The government prepared a list of
126 chemicals on which data is inadequate, and a priority ranking
for testing. In addition, based on submissions from several
German government agencies, a Federal List was developed
containing over 500 chemicals, which were to be prioritized for
testing.
New Chemicals
PADSA requires that any new substances meet a screening and
registration requirement. The premarket notification must occur
45 days before marketing. The notice must include some basic
test information on health effects, and safe handling and safe
disposal instructions. If no bans or restrictions are placed on
a new chemical, the chemical may be marketed. The German
government then notifies the EC that a new chemical is on the
market. The government has a tiered testing approach based on
production volume. After notification, certain test information
is required for quantities reaching 100 tonnes annually or 500
tonnes since commencement (level 1) and additional tests for
chemicals reaching 1000 tonnes or 5000 tonnes cumulatively (level
2) .
26
-------
Germany, p. 2
Confidential Business Information
Section 22 (paragraph 2) allows for industry to make and defend
claims of confidentiality. However certain information may not
be claimed confidential. This generally includes the trade name,
the chemical properties of the substance and most of the test
information. PADSA does not specify if this information is
available to the public.
Chemical Information Gathering
The European Inventory of Existing Commercial Chemical Substances
(EINECS) is the basis for the existing chemicals inventory.
Safety Sheets (similar to Material Safety Data Sheets) are
available on 261 chemicals. The Chemical Industry was to develop
a list of chemicals and determine (in 1985) production and import
volumes on EINECS chemicals exceeding 10 tons/year. The Chemical
Industry was also responsible for compiling rough toxicological
and ecotoxicological data, use, and exposure information for
substances exceeding 1000 tons/year. PADSA requires annual
reporting on existing chemicals on these lists exceeding 10
tonnes per year.
Novel Features of PADSA
• Mandatory Product labeling Section 13 requires proper warning
labels on all chemical products. The government has the power to
classify substances as well as precautionary measures. In the
event that a substance has not been fully tested, the label must
indicate such information.
• Restrictions on certain poisonous animals and plants (Section
18)
• Occupational Measures (section 19) This section includes
information that must be made available to workers handling
hazardous chemicals, how health hazards are to be reported and
monitored
• Pesticide* are treated the same as any other new or existing
chemical.
27
-------
JAPAN
Background
The Japanese Chemical Substances Control Law (JCSCL) is
administered by three government organizations, the Ministry of
International Trade (MITI), the Ministry"of Health and Welfare
(MHW), and by the Environment Agency (EA). When MITI is referred
to below, it also includes the joint authority of MHW and EA.
The Japanese law requires a considerable amount of government
oversight at most stages in the classification, notification,
registration and labeling of a new chemical.
Existing Chemicals
Regulation The focus of JCSCL is new chemicals. There is a
listing for an existing chemical inventory. The law is not clear
on what actions can be taken on existing chemicals.
Testing MITI may order a manufacturer to test Class II (see
below) chemicals. The government may also reguire testing of any
chemical on the Existing Chemical Inventory.
New Chemicals
The law outlines two classes of chemicals of concern. Class I
chemicals include those found to bioaccumulate in organisms and
cause harm to humans when ingested, or those that change chemical
form easily. Class II chemicals change form less easily and may
be harmful to humans when ingested. MITI is responsible for the
designation of the class of a chemical submitted for 90-day
review. The company may not manufacture a substance until
classification by MITI. A Class I substance is registered with
MITI, but
Class I substances are exempt from registration if used for
testing and research. Class I chemicals may not be imported into
Japan unless used for R & D. (article 11). MITI must also be
notified by a submitter when the chemical is being used. The
manufacturer must keep records on the manufacture which are
subject to MITI review. A manufacturer must also notify MITI
when the substance is discontinued (article 20). There is a
broad provision for restricting the chemical to the extent
necessary (as seen fit by MITI) and a product recall provision
(article 22.)
28
-------
Japan, p. 2
Class II chemicals must be reported annually regarding the
previous year's manufacturing and importing volumes. if human
health questions arise over a substance, MITI may order the
manufacture to test for the health effects. (The law does not
specify MITI criteria for requiring tests, nor industry
requirement to submit data in this regard.) Testing expenses can
be allocated to several groups by MITI. Class II chemicals can
only be produced up to the levels stated by the manufacturer.
The manufacturer must file a notification of production change if
the previous limits are passed. Handling procedures (similar to
TSCA 5(e) orders may issued if necessary (article 27). MITI
establishes labeling requirements for manufacturers and
determines filing fees (article -35).
Confidential Business Information
There are no provisions which specify what may be claimed CBI by
industry. JCSCL treats all data reported as secret and reveals
nothing to the public.
Chemical Information Gathering
JCSCL has an automatic annual reporting (production information)
provision for all registered chemicals. All new chemicals that
enter the marketplace are then tracked until use is discontinued.
Novel Features of the JCSCL
• On-the-spot inspections (article 33) This provision gives the
government agency broad authority to examine chemical
manufacturing records, take samples, "within the limits necessary
for enforcing this law," for information gathering purposes.
TSCA is weaker.
• Conforming to standards (article 17) MITI may set technical
standards on how to manufacture the chemical. There is no
counterpart in TSCA.
• Success!** (article 16) Perhaps because of the unique nature
of JapanM* culture and business, the succession provision
requires procedures to take place in the event of a merger or
inheritance, in order to continue necessary reporting
requirements of a given chemical and continuity.
29
-------
Background
The Netherlands (ML) Chemical Substances Act (NCSA) became law in
1986. The regulations incorporate the EC's notification
requirements (sixth amendment). Unlike some of the other EC
members, NCSA covers new and existing chemicals„ As in the US,
NL has separate statutes for pesticides and.medicines.
Existing Chemicals
NCSA section 32 requires a registration of all
chemicals used in the country. NCSA has a list of 126 substances
that "require special attention'-' (NSCA section 22) . NCSA section
24 outlines the regulatory measures that may be taken. Under
NCSA section 40 , the Minister can take immediate action to
restrict use (similar to TSCA section 7). Restrictions exist for
PCBs, genetically modified organisms, detergents, asbestos, the
organic halogen content in fuels, and cadmium (effective April
1991).
Tosfeiag. The minister may request additional testing of new
chemicals. The Minister may request tests (NCSA section 23) to
be made by companies using a chemical on the "special attention
list" and establish deadlines for data to be submitted. If more
than one company is using a chemical, test costs are allocated by
agreement. Use of the substance is not restricted during the
testing period.
New Chemicals
A manufacturer must submit a baseset of data to the NL Minister
of Environment. NCSA requires a premanufacture notice as well as
a premarket notice. The premarket notice review period is 45
days. Once manufacture begins, the company must report any
changes or new information about the chemical to the Minister
(NSCA section 13). If a chemical reaches a certain threshold
quantity (100 tonnes produced; or 500 tonnes imported), the
Minister say notify the company to perform additional tests. A
draft tegfe j?al© for the new chemical is published for a 30 day
public TQt&C3° Stringency of the test required increases with
the quant^S^ef the substance in circulation. NCSA specifies
certain s\aJbcr£anc
-------
Netherlands, p. 2
Confidential Business Information
NCSA Section 56 covers confidentiality. While a company may
request data to be declared CBI, NSCA specifies that the a) trade
name; b) physico-chemical properties; c) summary of toxicological
and ecotoxicological tests; d) the name of the research
institution(s); e) precautionary measures for handling, transport
and storage; and f) recommended emergency measures in the event
of an accident may not be claimed CBI. PMNs are not released to
the public, so their content is automatically confidential.
Information on registered chemicals may be claimed CBI.
Chemical Information Gathering
NSCA has an automatic reporting provision on new chemicals that
exceed certain thresholds (10/100/1000 tonnes per year;
50/500/5000 tonnes accumulated over a number of years). There
is an automatic registration of any existing chemical used in the
country. NCSA specifies what data must be registered. The
registration is not considered a burden to industry and generally
contains information shared among importers and manufacturers.
Registration data include: a) the trade name or names; b) the
chemical name; c) the quantity which is being produced, imported
or marketed; d) the name and address of clients; e) for
preparations: the chemical names and the percentage weights of
the principal substance they contain, up to a total of 95 percent
of the weight of the preparation; f) the chemical names of the
substances which constitute the remaining five percent of the
weight of the preparation. There are certain exemptions to the
registration requirement (NSCA-excluded chemicals) and only the
total annual quantities need to be registered for chemicals.
Novel Features of the NCSA
NCSA section 2 "general duty clause" Puts the onus on industry
to take responsible measures for knowing a chemical is dangerous
to the environment and health, and to take measures to restrict
the danger mm much as possible. OTS is considering a "product
stewardship" rule which would require similar kinds of industry
responsibilities in this area. Several provisions mention
industry responsibility which tend to hold the stewardship of
industry accountable for chemical safety stronger. No comparable
authority exists under TSCA.
Microorganisms defined and covered by NCSA
31
-------
Netherlands, p.3
Labeling provisions (NCSA section 34-39). New or existing
chemicals must be labelled if the chemical comes under one or
more of the 14 danger categories. Labeling is applied to the
whole life cycle and users of the chemical. NL is in the process
of revising its labeling regulations. Other than PCBs, there
have been no labeling regulations under TSCA.
Registration of Chemical Substances in Circulation. NSCA section
32 provides for automatic information gathering for all chemicals
in commerce. This provides baseline information on chemical
production and the ability to track users in the event a chemical
is found to be dangerous to health and the environment. No
comparable authority exists under TSCA.
Temporary Regulations (section 31) The minister may issue
temportary reulgations himself instead of going through the
procedures of the General Administrative Order. This provision
has been used on new chemicals.
32
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SWEDEN
Background
The Act on Chemical Products (ACP, 1986) is Sweden's chemical
control statute. A number of industry sources report Sweden has
one of the strictest laws in the world regarding chemicals. The
law covers review of chemicals, labeling, safety measures,
substitution for hazardous chemicals with less risky chemicals,
and safe handling procedures. The ACP establishes the framework
for regulation of chemicals, with a series of ordinances which
cover specific substances and products in more detail. The
ordinances also cover pesticide production and use, and hazardous
waste. Tobacco and Pharmaceuticals are covered by other laws.
Existing Chemicals
Regulation All chemical products must be registered with KEMI
(Sweden's National Chemicals Inspectorate). The registration of
existing chemicals, however is not an approval for the use of the
chemical. It is a tracking mechanism. Pesticides are covered by
the Act.and must be registered and approved for use. There are
ordinances that cover the regulation of PCBs, gasoline (lead free
content levels), and cadmium.
An ordinance restricts certain products form to be hazardous to
health and the environment, including certain phosphorus
containing matches, certain lye-containing cleansers, and certain
automotive and motor fluids containing methanol. Section 9 of
this ordinance also bans the manufacture and import of aerosol
packages with CFCs. This ordinance also restricts sale or
transfer of certain chemically treated products such as medical
or sanitary supplies, garments and materials for garments, toys,
household ware. Lime spreading is restricted as well as
chemicals Used to contain escaping oil in the event of a spill.
In all the ordinances, the government has the option to waive
certain restrictions. Sweden has labelling provisions for all
new and existing chemicals.
Sweden ha* published a list of 13 undesirable chemicals that it
wants to M« eliminated or reduced by the year 2000. (See Table
later in this dossier).
Testing Under ACP section 6, the government is empowered to
require testing or other research need on a chemical product (new
or used) as it deems necessary. The industry is obliged to test
existing chemicals of concern.
33
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Sweden, p.2
New Chemicals
ACP section 10 establishes a " prior notification " provision for
new chemicals. The government is considering an ordinance to
add a "pre-notification of new substances." The new ordinance
will be essentially the same as the European Community's sixth
amendment.
Confidential Business Information
Data may be claimed confidential (for up to 20 years). The
government may release CBI if it is in the public interest to do
so. ACP section 23 has strict provisions for government
officials who improperly disclose professional secrets or CBI.
Chemical Information Gathering
All existing chemicals are registered. The government has broad
authority to collect additional data from industry as it deems
necessary.
All chemicals must be registered in Sweden (section 12-13) unless
a company manufactures or imports less than 100 kg. of a
chemical product annually. There is a product inventory of
chemical categories which must be registered.
Also chemical products must be properly labeled if they fall into
one of the four danger classes. There is a separate, detailed
ordinance on the labeling of chemical products.
Novel Features of ACP
• Classification registration, and labelling of chemical
substances (explained above)
• Product Stewardship (section 5-6) ACP clearly places the onus
on industry to see to it that through its own investigations or
in another manner, that satisfactory research is carried out to
determine what health or environmental injuries the product may
cause.
• Permits (section 17) Under ACP, certain extremely dangerous
chemicals may be permitted for certain professional use.
34
-------
Sweden, p.3
SWEDEN TOP 13 CHEMICALS LIST
In December 1989, the Swedish Government asked KEMI and the
Environmental Protection Agency (SNV) to draw up an action
program (risk reduction activity) to curb the use of substances
harmful to health or the environment. The result was the
following list of 13 substances, the use of which should be
reduced or banned altogether by the year 2000.
Methylene Chloride
Trichloroethylene
Tetrachloroethylene
Lead
Organotin compounds
Chlorparaffins
Diethyl hexyl phthalate (DEHP)
Konyl phenol ethoxylates
Arsenic
Creosote
Cadmium
Mercury -
Brominated Flame Retardants
ACT ON CHEMICAL PRODUCTS AND RELATED ORDINANCES
Act of Chemical Products (1985)
Ordinance on Chemical Products (1985)
Ordinance on Pesticides (1985)
Ordinance on PCBs (1985)
Ordinance on Motor Gasoline (Petrol) (1985)
Ordinance on Cadmium (1985)
Ordinance of Certain Products Hazardous to Health and to the
Environment (1985)
Ordinance on the Spreading of Pesticides over Forestland (1985)
Ordinance on Levies for Financing of the Activities of the
Chemicals Inspectorate (1986)
35
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WORLD TOXIC CHEMICAL CONTROL LAWS — TABLE 10
COUNTRY
STATUTE
(name, year, chemicals
covered)
STATUS/COMMENTS
Argentina
Australia
Industrial Chemicals Lav
(1989), covers new
chemicals
proposal stage
Austria
Protection of Man and
the Environment against
Chemical Substances
(1987), covers new
chemicals
Bangladesh
Belgium
Regulation regarding
substances found to be,
dangerous to man and the
environment (1982),
covers new chemicals
Brazil
Bulgaria
Canada
Canadian Environmental
Protection Act (1988),
covers new and existing
chemicals
• in 1991, will
publish Domestic
Substances List
(DSL) and Non-DSL
• in 1992, will
reconvene a public
meeting to add or
delete chemicals to
the PSL (4 new
substances
proposed)
China
Directive on Applying
Environmental Management
to Rural and
Neighborhood Enterprises
(1984), covers ... P
• has been
developing policies
over all since the
1970's as the
country began to
rapidly
industrialize
• has pollution
control policies
over a number of
different
environmental media
36
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COUNTRY
STATUTE
(name/ y«**/ chemicals
covered)
STATUS/COMMENTS
Denmark
Statutory Order on
Notification of Chemical
Substances (1989),
covers new chemicals
European
Community (EC)
• Council Directive
79/831/EEC (6th
Amendment) (1979),
covers new chemicals
• (90/C 276/01) Proposed
Regulation on the the
Evaluation and the
Control of the
Environmental Risks of
Existing Substances
(1990), will cover
existing chemicals
Finland
• Toxic Substances Act
(1969) covers all
industrial chemicals and
pesticides
• follows EC labelling
regs.
• new chemical
regulations under
development
France
Law on Chemicals,
Article L. 231-7 Labor
Law and Code (1977),
covers new chemicals
Germany
Ordinance on Hazardous
Substances (1986),
covers new and existing
chemicals, workplace
chemicals
Greece
• Expected to follow EC
regulations on new
chemicals
• no existing chemical
regulations
37
-------
COUNTRY
Hungary
Iceland
Israel .
Italy
India
Indonesia
Ireland
Japan
Korea
STATUTE
(name/ year, chemicals
covered)
none
Expected to follow EC
regulations on new
chemicals
• no existing chemical
regulations
no
Decree of the President
of the Republic DPR
927/1981 (1981), covers
new chemicals
P
P
• Expected to follow EC
regulations on new
chemicals
• no existing chemical
regulations
Chemical Substances
Control Law (1987) ,
covers new chemicals
P
STATUS/COMMENTS
• in 1987,
reorganized how to
handle enviromental
matters
• EPA has opened a
Regional
Environmental
Center in Budapest
to help develop
various
environmental
program areas.
• environmental
policies in place
• developing
regulations on
industrial
chemicals
38
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COUNTRY
Luxembourg
Mexico
Netherlands
New Zealand
Nicaragua
Nigeria
Norway
Panama
Peru
STATUTE
(name/ year/ chemicals
covered)
Expected to follow EC
regulations on new
chemicals
• no existing chemical
regulations
• Federal Environmental
Protection Act (1987) ,
covers chemicals in a
general way
• no new chemical
provision
• provides for
restrictions or bans of
chemicals if found to
harm health and the
environment P
• Netherlands Chemical ,
Substances Act (1986) ,
covers new and existing
chemicals
• Toxic Substances
Regulations (19.83), with
amendments through 1988,
covers existing
chemicals and pesticides
• no new chemical review
provision
P
• National Policy on the
Environment (1989) ,
covers chemicals broadly
• needs implementing
regulations for new and
existing chemical
not at present
P
P
STATUS/COMMENTS
• new chemical
regulations under
development
39
-------
COUNTRY
Phillipines
Poland
Portugal
Romania
South Africa
Spain
Sweden
Switzerland
Syria
Thailand .
Turkey ^
USSR
STATUTE
(name/ year/ chemicals
covered)
Toxic Substances and
Hazardous and Nuclear
Wastes Control Act
(1990)
• covers new and
existing chemicals,
pesticides, and nuclear
and hazardous chemical
wastes
P
Expected to follow EC
regulations on new
chemicals
• no existing chemical
regulations
P
P
Royal Decree 2216/1985
(1985) , covers new
chemicals
Swedish Chemical
Substances Act (1986),
covers new and existing
chemicals
Ordinance relating to
Environmentally
Hazardous Substances
(19 P ) , covers new
chemicals
P
P
• several laws cover
specific new chemical
products; no single law
covering new or existing
'chemicals
P
STATUS/COMMENTS
recently passed
legislation
P
• undergoing
complete revamping
of ministries
handling
environmental
matters
40
-------
COUNTRY
United Kingdom
USA
Uruguay
Venezuela
Viet Mam
Yugoslavia
STATUTE
(name, year, chemicals
covered)
Health and Safety at
Work Act (1974) ,The
Notification of New
Substances (1982), and
Amendments (1986),
covers new chemicals
Toxic Substances Control
Act (TSCA 1976, 1986
Title II)
p
p
p
Poisons Marketing Act
(19 P ) , covers new
chemicals
STATUS/COMMENTS
P
41
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TOP TEN POPULATION CENTERS 6 CHEMICAL REGULATION
TABLE 11
COUNTRY
CHINA
INDIA
EUROPEAN
COMMUNITY
SOVIET UNION
UNITED STATES
INDONESIA
BRAZIL
JAPAN
BANGLADESH
NIGERIA
POPULATION
(in mil.)
1119.6
831.9
360.0*
291.3
248.0
178.4
150.4
122.7
115.2
113.3
CHEMICAL
CONTROLS
(yes/no)
yes
P
yes
P
yes
P
P
yes
P
P
STATUS/COMMENT
P
P
6th Amendment- new
chemicals
Proposed regulation
for existing
chemicals
P
TSCA
P
P
P
P
Statistics: 1990 World Almanac
1990 U.S. Census (est.)
* EC estimate includes reunified Germany
42
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APPENDIX I
43
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SCREENING INFORMATION DATA SET (SIDS)
Background
To date 14 OECD member countries have agreed to participate in
the SIDS program. Participation by U.S. industry is voluntary.
The total U.S. responsibility will be to provide information on
25 percent of the chemicals, though presently we are looking at
only nine. Testing using OECD guidelines is to begin shortly and
be completed by May 1992. Following completion of testing,
participating countries will assess the data, evaluate risks, and
judge the priority for additional, more detailed testing. The
second phase of the SIDS effort is to begin in 1991.
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SIDS/HPV PILOT PHASE
1
i
A
rN t»-r
V
United Kingdom i3>
Switzerland (4)
United States (9)
45
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SIDS Data Elements
Chemical Identity
-> CAS number
•> N7ame
^ Synonyms (as available)
£ Empirical formula
$ Structural formula
$ Purity, known impurities
46
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SIDS Data Elements
Physi cal—Chem.i cal Do to.
~> Melting Point
* Boiling Point
*> Vapor Pressure
r> Partition coefficient
* Water solubility
£ Flash point
& Flammability
* pH
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SIDS Data Elements
Environmental Effects
ft Toxicity to fish
ft Toxicity to daphnids
ft Toxicity to algae
ft Toxicity to other aquatic organisms
& Toxicity to bacteria
ft Toxicity to terrestrial organisms
ft Biological Effects Monitoring
ft Biotransformation and kinetics
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SIDS Data Elements
Health Effects
ft Acute toxicity
ft Corrosiveness/Irritation
ft Sensitization
ft Repeated dose toxicity
ft Genetic toxicity
ft Carcinogenicity
ft Reproductive toxicity
•£ Specific toxicity
It Mechanisms of toxicity
& Biotransformation and kinetics
ft Toxicity via other routes
ft Effects of Accidental or Occupational Exposure
ft Epidemiology
& Biological effects monitoring
49
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SIDS Data. Elements
Environm. en to I Fa te a, n d Path u a ys
-> Degradability
•> Bioaccumulation
-> Transport and distribution between
compartments
r> Monitoring data
50
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i—r
SIDS Data Elements
Sources of Exposure
* Production
ft Processes
ft Uses
ft Presence in Food
51
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OECD RISK REDUCTION PROGRAM
Background
In March 1990, the OECD's Chemicals Group decided to initiate a
pilot risk reduction program on five chemicals (see next page for
lead country and chemicals). Additional discussion on this topic
is likely at the upcoming meeting of Environmental Ministers in
January 1991.
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OECD RISK REDUCTION PROGRAM
(Chemicals and lead countries)
United States
Methylene
Chloride
Commission
of the
European
Communities
Brominated
Flame
Retardants
Netherlands
53
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OECD CLEARINGHOUSES
Background
Following are examples of chemicals that various countries have
the lead on for collecting information about production, use, and
health effects data.
54
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ONGOING OECD CLEARINGHOUSE
OECD CLEARINGHOUSES
(Some Examples)
Chemical
Noriylphenol
Tributyltin Oxide
1.2 -Dichloroethane
White Spirits (Naphtha)
Diethyl Phthalate
Lead Country
Sweden
United States
United Kingdom
Denmark
Netherlands
55
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REFERENCES
"The Organization for Economic Cooperation and Development (OECD)
Chemicals Programme," OECD, 1988
"A Survey of New Chemicals Notification Procedures in OECD
Countries," OECD Environmental Monographs, 1990
"The Global Concern for Toxics Risk Reduction," a speech by Linda
Fisher, AA for OPTS before CMA, Oct. 3, 1990
"Protection Against Chemical Hazards," by Mohan A. Prabhu,
Canadian Department of Justice, January 1988
"Directory of Country Environmental Studies," Center for
International Development and Environment, World Resources
Institute, 1990
"Environmental Data Report," United Nations Environmental
Programme (UNEP), 1987
"The State of the Environment," UNEP, 1987
"Chemical Risk Control in the European Community," Commission on
European Communities (CEC), 1987
"International Register of Potentially Toxic Chemicals (IRPTC)
Legal File 1986," UNEP, 1987
"Proposal for a Council Regulation (EEC) on the evaluation and
control of the environmental risks of existing substances," CEC,
1990
"Council Directive amending for the sixth time ... regulations
and administrative provision relating to the classification,
packaging and labelling of dangerous substances (Sixth
Amendment), CEC, 1979
"Environmental Policy in the European Community," CEC, 1990
"Canadian Invironmental Protection Act," Environment Canada, 1988
"Controlling Toxic Substances and Enforcing the Controls: The
American and Canadian Way," by James Michael Thunder, Chemical
Regulation Reporter. Nov. 13, 1987
"Environmental Policy in China," by Lester Ross, Indiana
University Press,. 1988
"Environmental Policies in Finland," OECD, 1988
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"Federal Government [GERMANY] Concept on the Systematic Listing
and Evaluation of Existing Chemicals under the Chemicals Act,"
Federal Ministry of the Environment, 1988
"Protection Against Dangerous Substances Act, amended 1990" [un
official TRANSLATION of Germany's Law]
"State of the Hungarian Environment," Hungarian Academy of
Sciences, et al. 1987
"The Environment in Israel," State of Israel, Ministry of the
Interior, Environmental Protection Service, 1979
"The Law Concerning Examination and Regulation of Manufacture,
etc. of Chemical Substances" [TRANSLATION of Japan's law], 1989
"General Law on Ecological Balance and Environmental Protection,"
[TRANSLATION of Mexico's environmental law], 1990
"Netherlands Chemical Substances Act," [TRANSLATION of
Netherland's Law], 1987
"Act on Chemical Products," [TRANSLATION of Sweden's Law], 1986
"Toxic Substances Regulations [New Zealand]," and amendments,
1988
"National Policy on the Environment, Federal Republic of Nigeria,
Federal Environmental Protection Agency, 1989
"Toxic Substances and Hazardous and Nuclear Wastes Control Act of
1990" [English version of Phillipine's law]
"Ecology & Perestroika: Environmental Protection in the Soviet
Union," by Eric Green, The American Committee on U.S.-Soviet
Relations, 1990
"Swedish Environmental Legislation," Ministry of the Environment,
1990
"Environmental Policies in Yugoslavia," OECD, 1986
57
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ACKNOWLEDGMENTS
I want to thank OTS staff who provided guidance on the
development of this report: Charlie Auer, Diane Beal and Barbara
Ostrow.
For international toxics contacts and obtaining certain foreign
technical reports, I owe thanks to David Ogden of EPA's Office of
International Activities.
For technical assistance in the physical production of the
report, I thank Susan Galliher of the Policy Staff and Michael
Brem of Unisys for preparing certain graphics in the report, and
the WIC for PC support. Karen Boswell of ECAD provided the
graphics in Appendix I.
For editorial assistance, I want to thank Joe Boyle and Steve
Young.
—Jamie Walters
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