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CEPA 1999 Annual Report : April 2003 to March 2004
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5 Controlling Toxic Substances (Part 5)
CEPA 1999 includes specific requirements for the assessment and management
of substances currently existing in commerce or being released to the
environment in Canada and substances that are new to Canada.
Determining a substance to be "toxic" under CEPA 1999 is a
function of its release or possible release into the environment, the
resulting concentrations in environmental media and its inherent toxicity.
Section 64 of CEPA 1999 defines a substance as "toxic" if it
is entering or may enter the environment in a quantity or concentration
or under conditions that:
- have or may have an immediate or long-term harmful effect on the
environment or its biological diversity;
- constitute or may constitute a danger to the environment on which
life depends; or
- constitute or may constitute a danger in Canada to human life or
health.
Part 5 sets specific timelines for taking preventive or control action
to manage the risks posed by toxic substances, including virtual elimination
from the environment for substances meeting certain criteria. CEPA 1999
allows for the setting of conditions and prohibitions on new substances.
Part 5 also provides for the development of regulations and interim orders
as well as the management of exports of substances.
5.1 Existing Substances
5.1.1 Risk Assessment
The three key risk assessment processes conducted under CEPA 1999
are:
- categorization and screening of the Domestic Substances List;
- assessment of the Priority Substances List; and
- review of other jurisdictions' decisions.
Other assessments may be triggered by information provided by other
programs, industry and scientific research. CEPA 1999 also allows for
the creation of a Virtual Elimination List and information gathering.
5.1.1.1 Categorization and Screening of the Domestic
Substances List
The Domestic Substances List includes substances that were in Canadian
commerce, between January 1, 1984, and December 31, 1986, or used for
manufacturing purposes, or manufactured in or imported into Canada in
a quantity of 100 kilograms or more in any calendar year. Currently, there
are approximately 23 000 substances on the Domestic Substances List. These
substances are referred to as "existing substances." Substances
not on the Domestic Substances List are considered to be "new substances"
and are subject to the New Substances Program (see Section
5.2).
Results on categorizing substances on the Domestic Substances List include:
- Categorization Decisions by Environment Canada — The
department collected and reviewed available information and produced
preliminary categorization decisions for 10 648 organic and 984 inorganic
substances on the Domestic Substances List. During the reporting period,
interested parties were invited to submit information to help improve
or refine these preliminary categorization decisions.
- Categorization for Inherent Toxicity to Humans — Health
Canada refined the approach for the initial categorization of organic
substances on the Domestic Substances List for "inherent toxicity
to humans" by considering 1352 organic substances and 642 inorganic
substances.
- Environment Canada Guidance Manual for the Categorization
of Organic and Inorganic Substances on Canada's Domestic Substances
List — Published in September 2003 for public comment, this
document provides the rationale and guidance that Environment Canada
uses to categorize organic substances, inorganic substances and organic
metal salts against the criteria of persistence, bioaccumulation and
potential and inherent toxicity to non-human organisms.
- Health Canada Proposal for Priority Setting for Existing Substances
on the Domestic Substances List under CEPA 1999: Greatest Potential
for Human Exposure — Released for public comment on January
16, 2004, this document outlines the approach for the initial categorization
of the 23 000 substances on the Domestic Substances List for their greatest
potential for human exposure (www.hc-sc.gc.ca/ewh-semt/alt_formats/hecs-sesc/pdf/contaminants/existsub/greatest_potential_human_exposure.pdf).
www.ec.gc.ca/substances/ese/eng/dsl/dslprog.cfm
www.hc-sc.gc.ca/ewh-semt/contaminants/existsub/screen-eval_e.html
Environment Canada and Health Canada conducted various screening assessments
and refined their screening assessment approaches and processes. Progress
with the screening assessments included:
- the continuing assessments of 25 substances, including those representing
categories or classes of related chemicals, as well as a variety of
persistent, bioaccumulative substances, or substances that pose great
potential for human exposure;
- the completion of the first environmental and health screening assessment
of polybrominated diphenyl ethers (a notice was published on May 8,
2004, proposing to add seven of these substances to the List of Toxic
Substances with the goal of virtual elimination of three of them);
- the commencement of a second screening assessment on tetrabromobisphenol
A and two derivative compounds, ethoxylated tetrabromobisphenol A and
tetrabromobisphenol A allyl ether;
- Health Canada's review of the basis for decisions of other jurisdictions
to prohibit or restrict 16 substances for health reasons identified
in preparation for implementation of Section 75 of CEPA 1999; and
- internal reviews of draft screening health assessments on the following
compounds (perfluorooctanoic acid and its salts; quinoline; biphenyl;
2-methyl-4,6-dinitrophenol; 2,2'-methylenebis[6-(1,1-dimethylethyl)-4-methylphenol];
1,1-dichloroethylene; ethylene dibromide; hexachloroethane; 4,4'-methylenebis[2-chloro-benzenamine];
acetone; hydrogen sulfide; ethylbenzene; tetrabromobisphenol A and derivatives)
by senior staff members of the Existing Substances Division of Health
Canada, and externally (quinoline; biphenyl; ethylene dibromide; 2-methyl-4,6-
dinitrophenol; 4,4'-methylenebis[2-chloro-benzenamine]; 2,2'-methylenebis[6-(1,1-dimethylethyl)-4-methylphenol])
by outside experts.
www.ec.gc.ca/substances/ese/eng/dsl/dslprog.cfm
5.1.1.2 First Priority Substances List
Updates were completed on six Priority Substances List compounds (aniline,
bis(2-chloroethyl) ether, 3,5-dimethylaniline, di-n-octyl phthalate,
non-pesticidal organotin compounds, 1,1,2,2-tetrachloroethane) for which
data were considered insufficient to conclude whether they were "toxic"
under Paragraph 11(c) of the 1988 Canadian Environmental Protection
Act. Environment Canada and Health Canada released one follow-up assessment
report for public comment and published four final decisions for substances
from the first Priority Substances List for which there was originally
insufficient information to conclude whether they were "toxic"
under the 1988 Canadian Environmental Protection Act. Used crankcase
oils were proposed to be considered toxic under CEPA 1999, and four substances
(styrene, tetrachloroethane, di-n-octyl phthalate, non-pesticidal
organotin compounds) were found not to be toxic under CEPA 1999.
www.ec.gc.ca/substances/ese/eng/psap/PSL1_IIC.cfm
5.1.1.3 Second Priority Substances List
Results in 2003-04 include the following:
- Six substances were added to the List of Toxic Substances: ethylene
oxide, formaldehyde, N-nitrosodimethylamine, hexachlorobutadiene,
particulate matter containing metals that is released in emissions from
copper smelters or refineries, or from both, and particulate matter
containing metals that is released in emissions from zinc plants.
- Two substances were proposed to be added to the List of Toxic Substances:
2-butoxyethanol and 2-methoxyethanol.
- One substance was found not to be toxic: 2-ethoxyethanol.
Health Canada continued to work with an Expert Steering Committee to
refine design parameters for a study on the neurological effects of aluminum.
The department also held discussions with representatives of the primary
aluminum industry in Canada on how the study should be carried out.
Health Canada worked with representatives of the American Chemistry Council
to finalize the protocol for industry-sponsored studies to address uncertainty
concerning the progression of renal lesions in male rats following exposure
to ethylene glycol.
www.ec.gc.ca/substances/ese/eng/psap/final/main.cfm
5.1.1.4 List of Toxic Substances
When a substance is assessed and found to be CEPA toxic, it is added
to the List of Toxic Substances in Schedule 1 of CEPA 1999. By adding
substances to Schedule 1 of CEPA 1999, the federal government has the
authority to take action, including making regulations or requiring the
preparation of pollution prevention plans or environmental emergency plans.
Table 2 : Substances Assessed and Added to the List of Toxic Substances
(Schedule 1) in 2003-04 and Substances Being Considered for Addition to
the List
Substance |
Proposed Order adding to Schedule 1
– date |
Final Order adding to Schedule 1
– date |
Sectors/Sources involved |
2-methoxyethanol and 2-Butoxyethanol |
October 25, 2003 |
|
2-methoxyethanol is not commercially produced in Canada.
2-methoxyethanol is imported for limited use mainly as industrial
coating, chemical intermediate and military applications.2-Butoxyethanol
is not commercially produced in Canada, but it is imported for use
mainly as a solvent for formulations in paints and coatings, inks
and cleaning products. It is also used to a much lesser extent as
an additive to hydraulic fluids, and in the chemical processing for
plasticizers and other compounds. |
Ethylene oxide |
April 27, 2002 |
June 4, 2003 |
Use as a process reactant, as a sterilizer of health care materials
and heat-sensitive products. |
Formaldehyde |
April 27, 2002 |
June 4, 2003 |
Automotive and other fuel combustion, industrial on-site sources,
and natural sources (including forest fires). |
Gaseous ammonia |
July 27, 2002 |
June 2, 2003 |
Natural sources include waste product of animal, fish and microbial
mechanism, whereas anthropogenic sources include industry and agriculture. |
Hexachlorobutadiene |
June 1, 2002 |
August 13, 2003 |
No industrial or commercial uses in Canada. It is released as by-product
and contaminant from various industries. |
Nitric oxide and
nitrogen dioxide |
July 27, 2002 |
June 12, 2003 |
The main anthropogenic sources are from combustion in transportation,
industry and the electric power generating sector. The natural sources
are mainly forest fires, lightning and soil microbial activity. |
N-Nitrosodimethylamine |
April 27, 2002 |
June 4, 2003 |
There are no industrial or commercial uses of this substance in
Canada; released as by-product and contaminant from various industries,
and municipal wastewater treatment plants. Major releases have been
from the manufacture of pesticides, rubber tires, alkylamines, and
dye manufacture. |
Ozone |
July 27, 2002 |
June 12, 2003 |
Ozone is produced in the atmosphere from precursors, primarily nitrogen
oxides and volatile organic compounds. These precursor gases are emitted
from combustion processes often associated with industry and the transportation
sector, and from various commercial and industrial processes and solvent
use. |
Particulate matter containing metals that is released in emissions
from copper smelters or refineries, or from both |
November 2, 2002 |
August 13, 2003 |
Copper smelters and refineries. |
Particulate matter containing metals that is released in emissions
from zinc plants |
November 2, 2002 |
August 13, 2003 |
Zinc plant operations. |
Sulphur dioxide |
July 27, 2002 |
June 2, 2003 |
Sulphur dioxide is the main precursor that contributes to the formation
of fine particulate matter in the summer months in eastern Canada.
Emissions occur from copper and zinc smelters and refineries. |
Tetrachlorobenzenes and pentachlorobenzene |
April 24, 2004 |
|
Not produced or used in their pure form in Canada. They may be formed
and released to the environment as a result of waste incineration
and barrel burning of household waste, dielectric fluids, pesticides,
municipal solid waste. Possible sources of release may include dielectric
PCB material still in use, some pesticides and a wood preservation
chemical. |
Used crankcase oils |
June 21, 2003 |
|
New information on exposure and effects from leakage of waste crankcase
oil (WCO) from the crankcases of vehicles was found in the literature.
Studies on roadway runoff provide a link between release of WCO from
vehicles and effects on benthic organisms, which also include changes
in the biodiversity of sediment fauna. Various components of WCO are
listed on the List of Toxic Substances (Schedule1), including arsenic
and its compounds, benzene, cadmium, chromium and its compounds, acidic,
sulfidic and soluble inorganic nickel, polycyclic aromatic hydrocarbons
(PAHs) and lead. |
Volatile organic compounds as listed in the Order |
July 27, 2002 |
June 12, 2003 |
Anthropogenic sources include combustion and evaporation processes
associated with transportation, the industrial sector, applications
of surface coatings (e.g., paints), general solvent use and other
miscellaneous sources. |
5.1.1.5 Information Gathering
CEPA 1999 provides several authorities to request any person to provide
or generate data for the purpose of assessing whether a substance is toxic
or capable of becoming toxic or for assessing whether to control, or the
manner in which to control, a substance. In 2003-04, information-gathering
notices were published for five substances in order to assess whether
to control them and/or the manner in which to control them:
- methyl bromide (February 14, 2004);
- hexachlorobutadiene in certain chlorinated substances (May 24, 2003);
- submitting samples for the determination of hexachlorobutadiene in
certain chlorinated substances (May 24, 2003);
- certain halons (June 21, 2003); and
- dichloromethane (methylene chloride) (February 28, 2004).
www.ec.gc.ca/Ceparegistry/notices
5.1.2 Risk Management
CEPA 1999 requires that preventive or control actions be established
to manage the risks posed by substances assessed as toxic under the Act
within strict legislated timelines. Risk management tools that are substance
specific, apply to groups of substances or apply to sector(s) are developed
through the Toxics Management Process. Central to the process are the
development and implementation of a risk management strategy that communicates
what will be done to prevent or control the uses or releases from the
sources/sectors of the toxic substance. Under this process, Environment
Canada and Health Canada ensure that risk management instruments are developed
in a way that provide efficient and effective consultations with industry
and public stakeholders and that the obligations to protect the environment
and human health set out in CEPA 1999 are met.
A variety of risk management measures are available to risk managers
to reduce risk associated with the use and/or release of toxic substances.
These risk management measures may be used to control any aspect of the
substance's life cycle - from the design and development stage to its
manufacture, use, storage, transport and ultimate disposal. They include
instruments that are developed pursuant to a specific provision in CEPA
1999, such as regulations, pollution prevention plans, guidelines and
codes of practice, and those that are developed outside of CEPA 1999 such
as environmental performance agreements (referred to as tools). Under
certain conditions, risk management actions can also be applied through
other federal acts or provincial and territorial legislation.
Appendix A contains a list of the risk management
measures proposed or finalized in 2003-04.
5.1.2.1 Regulations
In 2003-04, four final regulations (see Appendix A) were published under
Part 5 of CEPA 1999 related to existing substances:
- Prohibition of Certain Toxic Substances Regulations, 2003
(April 9, 2003) — The regulations feature a schedule, listing
toxic substances subject to prohibition for manufacture, use, sale,
offer for sale and import. The amendments include the addition of two
substances to the Schedule in the regulations (benzidine and its salt
(benzidine dihydrochloride) and hexachlorobenzene) and the application
of conditions on one of them (hexachlorobenzene).
- Regulations Amending the Benzene in Gasoline Regulations (October
8, 2003) — The amendments are of a minor technical nature and
do not alter the intent of the regulations.
- Regulations Amending the Sulphur in Gasoline Regulations (October
8, 2003) — The regulations limit the level of sulphur in gasoline
to an average of 150 parts per million and further reduce the limit
to 30 parts per million starting in 2005. The amendments provide for
a more accurate measurement of sulphur at low levels. At the same time,
a number of other minor changes were made to update the regulations,
clarify some provisions and make the regulations more consistent with
other federal fuels regulations.
- Solvent Degreasing Regulations (August 13, 2003) —
These regulations will implement a three-year freeze in the consumption
of trichloroethylene and tetrachloroethylene, followed by a 65% reduction
in consumption for the subsequent years. The regulations will apply
to persons involved in degreasing operations (vapour and cold degreasing)
who use more than 1000 kilograms of these solvents during a calendar
year.
In 2003-04, two proposed regulations were published:
- Regulations Amending the Benzene in Gasoline Regulations (Miscellaneous
Program) (November 22, 2003) — The regulations correct inconsistencies
between French and English versions of the regulations.
- Virtual Elimination List Regulations (August 16, 2003) —
Environment Canada proposed the addition of the first substance to the
Virtual Elimination List: hexachlorobutadiene with a 0.06 nanogram per
millilitre level of quantification in a chlorinated solvent. Hexachlorobutadiene
is incidentally present in certain chlorinated solvents and chemicals
such as ferric chloride and may be released to the environment upon
their use. Other possible releases could be from hazardous landfill
leachates and hazardous waste incineration.
www.ec.gc.ca/CEPARegistry/regulations
5.1.2.2 Environmental Performance Agreements
An environmental performance agreement is a voluntary agreement negotiated
among parties to achieve specified environmental results. While it is
not considered an instrument under CEPA 1999, it is an additional risk
management tool that can be used to achieve environmental objectives for
toxic substances and other substances of concern.
In 2003-04, one agreement was signed with the Specialty Graphic Imaging
Association and participating facilities in Ontario (see Appendix
A). Facilities participating in this agreement will develop targets
and timelines to achieve verifiable reductions in the use, generation
and release of specified priority substances, develop and implement plans
to minimize and eliminate volatile organic compounds using pollution prevention
activities and best available technology that is economically achievable,
and implement an environmental management system.
www.ec.gc.ca/epa-epe
5.2 New Substances
Substances that are not on the Domestic Substances List are considered
to be new to Canada. These cannot be manufactured or imported until:
- the Minister has been notified prior to manufacturing or importation
of the substance;
- relevant information needed for an assessment of its potential
toxicity has been provided by the notifier; and
- the period for assessing the information (as set out in regulations)
has expired.
When the assessment process identifies a new substance that may pose
a risk to human health or the environment, the Act empowers Environment
Canada to intervene by requiring a risk management measure, placing restrictions
or prohibiting the substance from import or manufacture in Canada.
When Environment Canada and Health Canada suspect that a significant
new activity in relation to a new substance that had been previously assessed
and found not to be toxic may result in the substance becoming toxic,
a Significant New Activity Notice is issued to ensure
that adequate additional information is provided to the Minister by the
notifier or any other proponent who wishes to manufacture, import or use
the organism for activities not specified by the notice. The additional
information allows Environment Canada and Health Canada to assess the
potential environmental and human health risks associated with the new
activities.
CEPA 1999 requirements apply to new substances (chemicals and polymers)
that are manufactured or imported unless other applicable Acts provide
for notice and assessment and are specifically identified on Schedule
2 of the Act.
5.2.1 Risk Assessment
During 2003-04, the New Substances Program (composed of Environment Canada
and Health Canada officials) received 757 new substance notifications
under CEPA 1999. Additionally, the New Substances Notification Regulations
under CEPA 1999 currently apply to substances in products regulated under
the Food and Drugs Act, which is administered by Health Canada.
During 2003-04, Health Canada received 85 submissions for new substances
under the Food and Drugs Act, of which 78 were accepted and 7 were
withdrawn or rejected due to, among other reasons, the submission of incomplete
applications.
5.2.2 Risk Management
Of the 757 substances assessed under the New Substances Program, Environment
Canada issued 10 Significant New Activity Notices and 6 conditions related
to some of these substances.
www.ec.gc.ca/substances/nsb/eng/pub_e.htm
5.2.3 Regulations
The revised New Substances Notification Regulations were published
on June 18, 2003 (see Appendix A). These revisions to the chemicals and
polymers portion of the regulations were based on the recommendations
received during the public consultations (see Section 5.2.5) and are expected
to improve and streamline the regulations while not compromising Environment
Canada's and Health Canada's abilities to protect human health and the
environment.
www.ec.gc.ca/CEPARegistry/regulations
5.2.4 Additions to the Domestic Substances List
Substances regulated under the Food and Drugs Act are eligible
to be added to the Domestic Substances List provided that the Environment
Minister is satisfied that these substances, between 1984 and 1986, were
manufactured in or imported into Canada by a person in a quantity of not
less than 100 kilograms in any one calendar year or used in Canadian commerce
or used for commercial manufacturing purposes in Canada.
Health Canada nominated 1226 substances listed in the Food and Drugs
Act for addition to the Domestic Substances List. Of these 1226 substances:
- 2 were already on the Domestic Substances List;
- 623 were added to the Domestic Substances List on February 11, 2004
(these substances will now be subject to the categorization and screening
program); and
- 601 submissions required further investigation and data collection
by Health Canada.
Three hundred and fifty-five substances regulated under the New Substances
Notification Regulations were also added to the Domestic Substances
List between April 2003 and March 2004.
5.2.5 Consultation on the New Substances Program
Spanning two years, the consultations on the New Substances Program began
in June 1999 and resulted in 76 recommendations to amend the New Substances
Notification Regulations and the New Substances Program. In November
2003, Environment Canada and Health Canada reported on the progress in
implementing the recommendations in the document Consultations on the
CEPA New Substances Notification Regulations and New Substances Program
(Chemicals and Polymers Portion) - Report on Progress: Implementing the
Consultation Recommendations for Period Ending October 2003.
www.ec.gc.ca/substances/nsb/eng/consul_e.htm
5.2.6 International Actions
5.2.6.1 Four Corners Arrangement
The Four Corners Arrangement was revised in November 2003 and signed
in January 2004 by Environment Canada, Health Canada, the United States
Environmental Protection Agency, the American Chemical Council and the
Industry Coordinating Group from Canada. The overall objective of the
revised arrangement is to work towards achieving efficiency of resources
for all parties for the introduction of new substances to the North American
marketplace, while continuing to protect human health and the environment.
During 2003-04, four substances were submitted and reviewed under this
Agreement. Two of these substances were recommended for addition to the
Non-Domestic Substances List. The Non-Domestic Substances List contains
those substances that, while new to Canada, are already in commerce in
the United States. Substances on the Non-Domestic Substances List are
still subject to notification requirements in Canada, but face less onerous
information requirements under the New Substances Notification Regulations.
5.2.6.2 Canada Australia Arrangement
The Cooperative Arrangement among the National Industrial Chemicals
Notification and Assessment Scheme of Australia, Environment Canada and
Health Canada allows both the sharing of information on new industrial
chemicals and the harmonizing of national new industrial chemicals schemes.
In 2003-04, 15 notification requests were processed under the Arrangement.
Assessment reports on 10 substances were shared with Australia following
requests by industry. Canada and Australia continued work on comparing
assessment approaches and methodologies for six polymers and three chemicals.
A draft report describing "lessons learned" for polymers was
completed, and a similar report for chemicals was in progress.
5.2.6.3 New Chemicals Task Force
The Organisation for Economic Co-operation and Development (OECD) New
Chemicals Task Force was established to manage a work program aimed at
improving information and work sharing associated with notification and
assessment of new industrial chemicals. A retrospective document in the
area of bilateral/ multilateral arrangements was prepared by Environment
Canada and Health Canada and presented at the 7th Meeting of the Organisation's
Task Force on New Chemicals. This document was presented to senior officials
for endorsement in November 2004.
5.2.6.4 Good Laboratory Practice
The OECD principles of good laboratory practice set out managerial concepts
covering the organization of test facilities and the conditions under
which preclinical safety studies are executed. Their purpose is to ensure
the generation of high-quality and reliable test data (in vitro
and in vivo) related to the safety of chemicals and analytical
procedures in the framework of the Mutual Acceptance of Data.
In 2003-04, work on the New Substance Notification Good Laboratory Practice
compliance monitoring program included:
- maintaining and updating the OECD Canadian database;
- providing technical advice during the revision of good laboratory
practice aspects of the New Substances Notification Regulations;
- representing Environment Canada on the OECD Steering and Working
Groups on Good Laboratory Practices; and
- providing information on data quality to new substances evaluators.
www.etc-cte.ec.gc.ca/organization/spd_e.html
5.3 Export of Substances
The authorities in the Act allow the Minister to establish an Export
Control List containing substances whose export is controlled because
their manufacture, import and/or use in Canada are prohibited or severely
restricted or because Canada has accepted, through an international agreement,
such as the Rotterdam Convention, to control their export. The authorities
also allow the Minister to make regulations in relation to substances
specified on the Export Control List.
5.3.1 Export Control List
The Export Control List Notification Regulations require exporters
to provide notice to the Minister of the Environment of the proposed export
of substances on the Export Control List and to submit annual reports.
In 2003-04, eight notifications of export were received, and no additional
substances were added to the Export Control List (Schedule 3).
www.ec.gc.ca/CEPARegistry/subs_list/ECLNRExLst2003.cfm
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