Benzidine - Rotterdam Convention

Transcription

UNITED
NATIONS
RC
UNEP/FAO/RC/CRC.12/6/Add.2
Rotterdam Convention on the Prior
Informed Consent Procedure for
Certain Hazardous Chemicals and
Pesticides in International Trade
Distr.: General
21 June 2016
English only
Chemical Review Committee
Twelfth meeting
Rome, 14–16 September 2016
Item 4 (c) (ii) of the provisional agenda
Technical work: review of notifications of final
regulatory action: benzidine
Benzidine: supporting documentation provided by Canada
Note by the Secretariat
Addendum
As referred to in document UNEP/FAO/RC/CRC.12/6, the annex to the present note sets out
documentation received from Canada to support its notification of final regulatory action for
benzidine. The present note, including its annex, has not been formally edited.
* UNEP/FAO/RC/CRC.12/1.
K1606571
210616
Annex
Benzidine: supporting documentation provided by Canada
List of documents:
2
1.
Focussed summary outlining the regulatory action on benzidine in Canada
2.
Priority Substances List Assessment Report (Benzidine) – 1993
3.
Regulatory Impact Analysis Statement for the 2003 regulatory action
4.
1.
3
Focussed summary outlining the regulatory action on benzidine in Canada
Focussed Summary
Events that led to the regulatory action in Canada
In 1988, the Minister of the Environment and the Minister of Health established the first Expert Advisory
Panel, made up of representatives from various stakeholder groups including industry, environmental
groups, other levels of government and the academic community, to recommend a priority substance list.
The first Priority Substances List (PSL1) was published in 1989 and included 44 substances or groups of
substances. Benzidine was placed on the PSL1 and assessed on a priority basis to determine whether it
was toxic, as interpreted under the Canadian Environmental Protection Act, and posed a risk to the health
of Canadians or to the environment.
The Assessment Report for benzidine was completed and published following a critical review of relevant
identified data. The report concluded that the substance constitutes a danger to human life or health, but
does not have harmful effects on the environment. The Prohibition of Certain Toxic Substances
Regulations, 2003 was the regulatory tool used to protect the Canadian public from possible risks of
exposure to benzidine.
The Prohibition of Certain Toxic Substances, 2005 added a second schedule of toxic substances that
were subject to prohibitions related to concentration or use. The scope of the 2005 regulations included
new uses where the prohibition would not apply. This added flexibility over the 2003 regulations, which
had a single schedule and all toxic substances were subject to the same regulatory requirements.
Overview of Canada’s regulatory system
The Canadian Environmental Protection Act, 1999 (CEPA) is an important part of Canada’s federal
environmental legislation. CEPA requires the Minister of Environment and Climate Change and the
Minister of Health to assess certain substances and determine whether they are “toxic”.
Substances assessed as “toxic” may be placed on the List of Toxic Substances (Schedule 1 of CEPA).
Consideration can then be given to developing guidelines, codes of practice, pollution prevention plans or
regulations to control any aspect of their life cycle, from the research and development stage through
manufacture, use, storage, transport and ultimate disposal.
Significance of the regulatory action
Benzidine is not currently in Canadian commerce and was included in the 2003 Regulations as a
preventative measure.
Subsequent regulatory action through the Prohibition of Certain Toxic Substances, 2005 added flexibility
to the control of toxic substances. The use of benzidine and benzidine dihydrochloride were still severely
restricted, but new flexibilities in these regulations impacted the conditions under which these substances
might be legally used.
Scope of the regulatory action
Prohibition of Certain Toxic Substances Regulations, 2003
The 2003 Regulations prohibited the manufacture, use, sale, offer for sale and importation of benzidine
and benzidine dihydrochloride (benzidine salt) that have the molecular formulas C 12H12N2 and
C12H12N2·2HCl respectively. These Regulations did not apply to use:
• in a laboratory for scientific research;
• as a laboratory analytical standard;
• in staining for microscopic examination, such as immunoperoxidase staining, histochemical
staining or cytochemical staining;
• as a reagent for detecting blood in biological fluids;
• in niacin tests to detect some microorganisms; and,
• as a reagent for detecting chloralhydrate in biological fluids.
The regulatory action met the definition of “severely restricted” and a Notification of Final Regulatory
Action was provided to the Secretariat. This notification was considered at CRC-1 where it was
determined to meet all Annex I and Annex II criteria.
Prohibition of Certain Toxic Substances Regulations, 2005
The 2005 Regulations maintained the prohibition on manufacture, use, sale, offer for sale and importation
of benzidine and benzidine dihydrochloride, although the exemptions were changed to not apply to
benzidine and benzidine dihydrochloride:
• contained in a hazardous waste, hazardous recyclable material or non-hazardous waste to which
Division 8 of Part 7 of the Canadian Environmental Protection Act, 1999 applies;
• contained in a control product within the meaning of section 2 of the Pest Control Products Act;
• present as a contaminant in a chemical feedstock used in a process from which there are no
releases of the toxic substance and provided that the toxic substance is destroyed or completely
converted in that process to a substance that is not a toxic substance set out in either Schedule 1
or 2.
• used in a laboratory for analysis;
• used in scientific research;
• used as a laboratory analytical standard;
• used in staining for microscopic examination, such as immunoperoxidase staining, histochemical
staining or cytochemical staining;
• used as a reagent for detecting blood in biological fluids;
• used in niacin tests to detect some micro-organisms; and,
• used as a reagent for detecting chloralhydrate in biological fluids;
Reporting and record-keeping requirements were added for benzidine and benzidine dihydrochloride.
These requirements will help Environment and Climate Change Canada monitor these substances to
ensure they are used for permitted uses only. Moreover, it will ensure that the import, manufacture, and
use of these substances are subject to strict life-cycle controls designed to prevent/minimize exposure to
and/or the release of these substances into the environment.
The Regulations also specify a one-time notification requirement for all laboratory and scientific research
users of scheduled substances. This requirement will provide Environment and Climate Change Canada
with data on the use of toxic substances for scientific research and in laboratories.
In addition, the 2005 Regulations established a permitting system for temporarily exempting certain
applications of a substance listed under the Regulations. A permit may be granted only if the Minister of
the Environment and Climate Change is satisfied that there is no technically or economically feasible
alternative or substitute available for the substance. In addition, the Minister must be satisfied that
measures have been taken to minimize or eliminate any harmful effects of the substance on the
environment and human health. Finally, the applicant must provide an implementation plan that identifies
specific timelines for eliminating the substance. A permit lasts for 12 months and can be renewed only
twice.
Benzidine and benzidine dihydrochloride meet the definition of “severely restricted chemical” under the
Rotterdam Convention as a result of the Prohibition of Certain Toxic Substances Regulations, 2005.
Canada submitted a new Notification of Final Regulatory Action to replace its earlier notification and
describe the changes to regulatory controls that impacted benzidine and benzidine dihydrochloride.
Risk Evaluation
The risk evaluation conducted in 1993 which supported the earlier regulatory action to severely restrict
benzidine and benzidine dihydrochloride remains relevant to the 2005 Regulations. The evaluation
concluded that benzidine and benzidine dihydrochloride are toxic to human health as defined in Canadian
laws. (Canadian Environmental Protection Act Priority Substances List Assessment Report: Benzidine
(1993))
Risk assessment
The assessment for benzidine was based on the determination of whether it enters or is likely to enter the
Canadian environment in a concentration or quantities or under conditions that could lead to exposure of
humans or other biota to levels that could cause harmful effects.
Data relevant to the assessment of whether benzidine is “toxic” under CEPA were identified through
evaluation of existing review documents, as well as an unpublished review of the environmental
behaviour and health effects of this substance prepared under contract, supplemented with information
from published reference texts and literature identified through on-line searches of various databases. In
addition, a number of provincial authorities were requested to provide any available information on the
levels of benzidine in drinking water. Data relevant to the assessment of the effects of benzidine on the
environment and human health obtained after November 1992 and February 1993, respectively, were not
considered for inclusion. The assessment was further reviewed by experts outside of the review
committee. The final assessment was published in 1993.
Effect on the environment
Available data on the toxic effects of benzidine on aquatic organisms indicate that surface water
concentrations in the range of 0.1 mg/L would be required before adverse effects on fish would be
expected. Since benzidine is not currently produced or imported into Canada, and since its half-life in
environmental media is less than a few weeks, concentrations of benzidine in surface water in the range
of the estimated effect threshold are considered very unlikely. No information on the toxicity of benzidine
to wildlife was identified. However, due to the low accumulation of benzidine in aquatic organisms,
adverse effects on aquatic based wildlife due to decreased availability of prey are considered unlikely.
Effect on the environment on which human life depends
Due to its low volatility, and because it is expected to photo-oxidize rapidly in air, benzidine is not
expected to contribute to ozone depletion, global warming or the formation of ground-level ozone.
Effect on human life or health
Benzidine has been shown to cause cancer, particularly of the bladder (predominantly transitional cell
carcinoma), in occupationally exposed workers and experimental animals and is therefore considered to
be a “non-threshold” toxicant (i.e., a substance for which there is believed to be some chance of adverse
effect at any level of exposure). For such substances, where data permit, estimated exposure is
compared to quantitative estimates of cancer potency to characterize risk and provide guidance for
further action (i.e., analysis of options to reduce exposure). For benzidine, such values would be
expected to be low, owing to the lack of confirmed sources of exposure to the general population of
Canada to this substance.
Based on these considerations, the Ministers of the Environment and of Health concluded that benzidine
is not entering the environment in a quantity or concentration or under conditions that constitute a danger
to the environment or to the environment upon which human life depends. If benzidine were to enter the
Canadian environment as a consequence of its commercial use, however, it might constitute a danger to
human life and health. Therefore, benzidine is considered to be “toxic” as defined under CEPA.
Risk Reduction and Relevance to Other States
Uses
Benzidine is still used in specialty laboratory applications, including the analytical determination of various
inorganic cations and anions, in various organic analyses, in the determination of blood in forensic and
clinical medicine and as a stain in microscopy.
Production, importation and exportation
Benzidine and its salt are not produced in Canada, and the quantity imported into Canada was
approximately 60 grams per year in 1995 and 1996. These substances are currently used only in very
limited specialty laboratory applications, and for research and development purposes. Essential specialty
laboratory applications for which there are no substitutes are not targeted by the Regulations.
List of Supporting Documents
1. Canadian Environmental Protection Act Priority Substances List Assessment Report: Benzidine
• Relevance: This report establishes that benzidine and benzidine dihydrochloride meet
the criteria of “toxic” to human health. Originally supplied with the Notification of Final
Regulatory Action for the 2003 regulations, this report remains relevant to the Prohibition
of Certain Toxic Substances, 2005 since it summarizes the risks to Canadians and the
environment from these substances.
2. Regulatory Impact Analysis Statement, Prohibition of Certain Toxic Substances Regulations,
2003
• Relevance: Originally supplied with the Notification of Final Regulatory Action for the
2003 regulations, this document describes the impact of establishing a severe restriction
on benzidine and benzidine dihydrochloride.
3. Regulatory Impact Analysis Statement, Prohibition of Certain Toxic Substances Regulations,
2005
• Relevance: Specific to the Prohibition of Certain Toxic Substances Regulations, 2005,
this document describes the impact of the updated regulatory controls (including the
permitting mechanism for certain uses).
2.
Priority Substances List Assessment Report (Benzidine) – 1993
Canadian Environmental Protection Act
Priority Substances List
Assessment Report
Benzidine
Government of Canada
Health Canada
Environment Canada
Publié également en français sous le titre de :
Loi canadienne sur la protection de l’environnement
Liste des substances d’intérêt prioritaire
Rapport d’évaluation : Benzidine
CANADIAN CATALOGUING IN PUBLICATION DATA
Main entry under title:
Benzidine
(Priority substances list assessment report)
Issued also in French under title: Benzidine.
At head of title: Canadian Environmental
Protection Act.
Includes bibliographical references.
ISBN 0-662-20895-1
DSS cat. no. En40-215/20E
1. Benzidine — Toxicity testing — Canada.
2. Benzidine — Environmental aspects.
3. Benzidine dyes — Environmental aspects.
I. Canada. Environment Canada.
II. Canada. Health Canada.
III. Series.
TD195.T48B56 1993
363.73‘84
C93-099644-5
© Minister of Supply and Services Canada 1993
Canada Communication Group — Publishing
Ottawa, Canada K1A 0S9
Cat. No. En40-215/20E
ISBN 0-662-20895-1
Printed on recycled paper
Benzidine
Table of Contents
Synopsis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
v
1.0
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1
2.0
2.1
2.2
2.3
Summary of Information Critical to Assessment of “Toxic” .
Identity, Properties, Production and Uses . . . . . . . . . . . .
Entry into the Environment . . . . . . . . . . . . . . . . . . .
Exposure-related Information . . . . . . . . . . . . . . . . . .
2.3.1 Fate . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.3.2 Concentrations . . . . . . . . . . . . . . . . . . . . . .
Effects-related Information . . . . . . . . . . . . . . . . . . .
2.4.1 Experimental Animals and In Vitro . . . . . . . . . . .
2.4.2 Humans . . . . . . . . . . . . . . . . . . . . . . . . .
2.4.3 Ecotoxicology . . . . . . . . . . . . . . . . . . . . . .
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3.0
3.1
3.2
3.3
3.4
Assessment of “Toxic” under CEPA . . . . . . . . . . . .
CEPA 11(a): Environment . . . . . . . . . . . . . . . . . .
CEPA 11(b): Environment on Which Human Life Depends
CEPA 11(c): Human Life or Health . . . . . . . . . . . . .
Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . .
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4.0
Recommendations for Research . . . . . . . . . . . . . . . . . . . . . .
12
5.0
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
13
2.4
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iii
Benzidine
Synopsis
Benzidine has been used primarily as an intermediate in the manufacture of dyes and
pigments. It is not produced in Canada, and although it may have been imported in
small amounts between 1980 and 1987, there no longer appears to be any commercial
activity in Canada involving this substance. No conclusive information on the release
or occurrence of benzidine in the Canadian environment was identified. Based on
available data, benzidine is not expected to persist in the environment.
Available data on the toxic effects of benzidine on aquatic organisms indicate that
surface water concentrations in the range of 0.1 mg/L would be required before
adverse effects on fish would be expected. Since benzidine is not currently produced in
or imported into Canada, and since its half-life in environmental media is less than a
few weeks, concentrations of benzidine in surface water in the range of the estimated
effect threshold are considered very unlikely. No information on the toxicity of benzidine to wildlife was identified. However, due to the low accumulation of benzidine in
aquatic organisms, adverse effects on aquatic-based wildlife due to decreased
availability of prey are considered unlikely.
Due to its low volatility, and because it is expected to photooxidize rapidly in air,
benzidine is not expected to contribute to ozone depletion, global warming or the
formation of ground-level ozone.
Benzidine has been shown to cause cancer in occupationally exposed workers and
experimental animals and is therefore considered to be a “non-threshold toxicant” (i.e.,
a substance for which there is believed to be some chance of adverse effect at any level
of exposure). For such substances, where data permit, estimated exposure is compared
to quantitative estimates of cancer potency to characterize risk and provide guidance
for further action (i.e., analysis of options to reduce exposure). For benzidine, such
values would be expected to be low, owing to the lack of confirmed sources of
exposure of the general population of Canada to this substance.
Based on these considerations, the Ministers of the Environment and of Health
have concluded that benzidine is not entering the environment in a quantity or
concentration or under conditions that constitute a danger to the environment or
to the environment upon which human life depends. If benzidine were to enter
the Canadian environment (as a consequence of its commercial use), however, it
might constitute a danger to human life and health. Therefore, benzidine is considered to be “toxic” as defined under section 11 of the Canadian Environmental
Protection Act.
v
Benzidine
1.0 Introduction
The Canadian Environmental Protection Act (CEPA) requires the Ministers of the
Environment and of Health to prepare and publish a Priority Substances List that
identifies substances, including chemicals, groups of chemicals, effluents and wastes,
that may be harmful to the environment or constitute a danger to human health. The
Act also requires both Ministers to assess these substances and determine whether they
are “toxic” as interpreted in section 11 of the Act, which states:
“. . .a substance is toxic if it is entering or may enter the environment in
a quantity or concentration or under conditions
(a) having or that may have an immediate or long-term
harmful effect on the environment;
(b) constituting or that may constitute a danger to the
environment on which human life depends; or
(c) constituting or that may constitute a danger in Canada
to human life or health."
Substances assessed as “toxic” according to section 11 may be placed on the List of
Toxic Substances (Schedule I of the Act). Consideration can then be given to developing guidelines, codes of practice, or regulations to control any aspect of their life cycle,
from the research and development stage through manufacture, use, storage, transport
and ultimate disposal.
The assessment of whether benzidine is “toxic”, as interpreted under CEPA, was based
on the determination of whether it enters or is likely to enter the Canadian environment in a concentration or quantities or under conditions that could lead to exposure
of humans or other biota to levels that could cause harmful effects.
Data relevant to the assessment of whether benzidine is “toxic” under CEPA were
identified through evaluation of existing review documents (ATSDR, 1989; U.S. EPA,
1980, 1986, 1987; IARC, 1982, 1987), as well as an unpublished review of the environmental behaviour and health effects of this substance prepared under contract by
Cambridge Environmental Inc. (Croy and DeVoto, 1990), supplemented with information from published reference texts and literature identified through on-line searches
(from 1965 to 1992) of various databases (HSDB, RTECS, IRIS, CCRIS, TOXLINE,
TOXLIT, MEDLINE, ENVIROLINE, CHEMICAL ABSTRACTS, BIOLOGICAL
ABSTRACTS, ELIAS, AQUAREF, MICROLOG, CODOC). In addition, a number of
1
CEPA Assessment Report
provincial authorities were requested to provide any available information on the
levels of benzidine in the drinking water in their provinces. The Quebec Ministry of
the Environment was requested to provide available quantitative data on potential
release of this substance from petrochemical facilities. Data relevant to the assessment
of the effects of benzidine on the environment and human health obtained after
November 1992 and February 1993, respectively, were not considered for inclusion.
Review articles were consulted where appropriate. However, all original studies that
form the basis for determining whether benzidine is “toxic” under CEPA have been
critically evaluated by the following staff of Health Canada (human exposure and
effects on human health) and Environment Canada (entry and environmental exposure
and effects):
R.G. Liteplo (Health Canada)
R.J. Maguire (Environment Canada)
M.E. Meek (Health Canada)
In this report, a summary of technical information critical to the assessment is presented in section 2. The assessment of whether benzidine is “toxic” is presented in
section 3. Supporting documentation that discusses the technical information in greater
detail has also been prepared and is available upon request.
The environmental sections of this report were reviewed by Drs. C.M. Auer and W.H.
Farland of the U.S. Environmental Protection Agency. Sections related to the assessment of effects on human health were approved by the Standards and Guidelines
Rulings Committee of the Bureau of Chemical Hazards of Health Canada. The entire
Assessment Report was reviewed and approved by the Environment Canada/Health
Canada CEPA Management Committee.
Copies of this Assessment Report and the supporting documentation are available
upon request from:
Environmental Health Centre
Health Canada
Room 104
Tunney’s Pasture
Ottawa, Ontario, Canada
K1A 0L2
2
Commercial Chemicals
Branch
Environment Canada
14th Floor
Place Vincent Massey
351 Saint-Joseph Boulevard
Hull, Quebec, Canada
K1A 0H3
Benzidine
2.0 Summary of Information Critical to
Assessment of “Toxic”
2.1
Identity, Properties, Production and Uses
Benzidine (Chemical Abstracts Service Registry Number 92-87-5) is a primary
aromatic amine with the molecular formula C12H12N2. Synonyms for benzidine
include 4,4’-bianiline, 4,4’-biphenyldiamine, 4,4’-diaminodiphenyl and 4,4’-diphenylenediamine (ATSDR, 1989; Croy and DeVoto, 1990). At room temperature, benzidine
is white or slightly red, and in the form of either crystals, powder or leaflets (Ferber,
1978). Benzidine has a vapour pressure of 6.6 × 10-2 Pa at 25oC (Mabey et al., 1982), a
water solubility of 500 mg/L at 25oC (Bowman et al., 1976) and a log n-octanol/water
partition coefficient of 1.34 (Lu et al., 1977).
The commercial manufacture of benzidine involves the alkaline reduction of nitrobenzene (Ferber, 1978). Currently, benzidine does not appear to be produced in or imported into Canada, since no company in Canada reported commercial activity
involving more than 10 kilograms of this substance in 1990 (Environment Canada,
1991a, 1991b). Available data indicate that benzidine has been sporadically imported
into Canada since 1980: 1980, 4 tonnes; 1981, 12 tonnes; 1982, 0.1 tonne; 1983,
0 tonne; 1984, 0 tonne; 1985, 0.3 tonne; 1986, 0 tonne; and 1987, 1.9 tonnes (Statistics
Canada, 1990).
Benzidine has been used primarily as an intermediate in the manufacture of dyes and
pigments, and may also be used in the analytical determination of various inorganic
cations and anions, in various organic analyses, in the determination of blood in forensic and clinical medicine and as a stain in microscopy (Ferber, 1978; Budavari, 1989).
2.2
Entry into the Environment
No conclusive data on the environmental release of benzidine in Canada were identified. It can enter the environment from any stage in the production, storage, transport,
use and disposal of benzidine itself or benzidine-containing materials (such as dyes
and pigments), or possibly by atmospheric and water-borne transport from other countries. In water, benzidine can be produced by the photodegradation of 3,3’-dichlorobenzidine (Banerjee et al., 1978). No information on the extent to which benzidine
may be formed and released into the environment by this mechanism was identified.
Approximately 100 tonnes of 3,3’-dichlorobenzidine were imported into Canada in
1989 (Statistics Canada, 1990). 3,3’-Dichlorobenzidine is on the CEPA Priority
Substances List.
3
2.3
Exposure-related Information
2.3.1
Fate
Oxidation, photochemical transformation, partitioning to sediment or soil, and microbial degradation are expected to be the main pathways of distribution and transformation of benzidine in the environment. Benzidine is not expected to persist in the
environment, with overall half-lives in water, soil and air of less than a few weeks. The
products formed by the degradation of this substance have not been well characterized.
Benzidine is expected to be slightly volatile (from water), based on its low Henry’s
law constant of 2.2 × 10-2 Pa m3/mol (Smith et al., 1980). In water, although oxidation
(by hydroperoxyl radical or molecular oxygen), biodegradation (Baird et al., 1977;
Tabak and Barth, 1978) and photolysis (Bilbo and Wyman, 1953; Larson and Zepp,
1988; Lu et al., 1977; Freitag et al., 1985) may be significant processes, the most
important process controlling the fate of benzidine appears to be oxidation by naturally
occurring metal cations; the half-life is approximately a few hours (Callahan et al.,
1979). Benzidine is quickly absorbed into clays and subsequently oxidized. Although
the environmental fate of such complexes is not known with certainty, it is assumed
that further oxidation would be facile (Callahan et al., 1979). Estimated half-lives for
the biodegradation of benzidine in surface water and groundwater are 31 to 192 h and
96 to 384 h, respectively (Syracuse Research Corp., 1989).
Benzidine is quickly bound in soils and sediments; however, information on the
bioavailability of such bound residues was not identified. Zierath et al. (1980) noted
that benzidine adsorption to soil or sediment was favoured by low pH, and highly
correlated with the surface area of the soil or sediment. In soil, benzidine is degraded
microbially (Graveel et al., 1985, 1986; Lu et al., 1977). The half-life of benzidine was
estimated to be 48 to 192 h for aerobic degradation (Lu et al., 1977).
In air, benzidine is expected to photooxidize moderately rapidly, with an estimated
half-life ranging from 0.3 to 3.2 h (Syracuse Research Corp., 1989).
4
Benzidine
2.3.2
Concentrations
Benzidine was not detected (detection limit = 2 µg/L) in 34 samples of raw and
1 015 samples of treated drinking water obtained in the province of Alberta between
1987 and 1991 (Alberta Environment, 1992). No other data on the concentrations of
benzidine within Canada in drinking water, surface water, groundwater, air, biota, soil
or sediment, foodstuffs or products containing dyes derived from this substance were
identified.
In the United States, benzidine was not detected in a survey of biota and sediment;
however, it was detected (but not quantitated) in 1.1% of 1 235 samples of industrial
effluent and 0.1% of 879 samples of natural water collected between 1980 and 1982
(Staples et al., 1985).
Benzidine accumulates only moderately in aquatic biota. Bioconcentration factors
(after 3 days) were 55 for mosquito fish (Gambusia affinis), 293 for Daphnia magna,
456 for mosquito larva (Culex pipiens quinquefasciatus), 645 for snail (Physa sp.) and
2 617 for a filamentous green alga (Oedogonium cardiacum) [Lu et al., 1977]. Freitag
et al. (1985) reported a 5-day bioaccumulation factor in activated sludge of 1 200, a
1-day bioaccumulation factor in algae (Chlorella fusca) of 850, and a 3-day bioaccumulation factor in fish (golden orfe, Leuciscus idus melanotus) of 83. While some of
the results may suggest some potential for the bioaccumulation of benzidine by predator organisms, none has been observed, nor would it be expected for a chemical with a
log octanol-water partition coefficient of 1.34.
2.4
Effects-related Information
2.4.1
Experimental Animals and In Vitro
Based on data derived from studies involving predominantly experimental animals, it
is apparent that benzidine may be metabolized via a number of metabolic routes
(reviewed in Hein, 1988; and Weber and Hein, 1985). One metabolic pathway involves
the acetylation of benzidine by cytosolic (acetyl-coenzyme A-dependent) N-acetyltransferase enzymes, which are present in many tissues. Humans (as well as some
animal species) may be classified as either “fast” or “slow” acetylators, based on the
extent to which they are able to acetylate a variety of chemical substances (Hein,
1988). Based on results of studies on individuals with and without bladder tumours,
it has been proposed that this “acetylation polymorphism” may be associated with the
development of bladder cancer in individuals exposed to aromatic amines—individuals with a “slow acetylator phenotype” may be more predisposed to develop bladder
cancer than individuals with a “fast acetylator phenotype” (Weber and Hein, 1985;
5
Hein, 1988; Peters et al., 1990 and references therein). Humans are capable of
metabolizing benzidine-based azo dyes to benzidine (Martin and Kennelly, 1985;
Gregory, 1984).
The carcinogenicity of benzidine has been assessed in a number of animal species. An
increased incidence of hepatocellular tumours (carcinomas, adenomas) has been
observed in mice exposed to benzidine (in drinking water or in the diet) compared to
unexposed controls (Littlefield et al., 1983, 1984; Nelson et al., 1982; Osanai, 1976;
Vesselinovitch et al., 1975). Rats administered benzidine (by gastric intubation of the
substance dissolved in sesame oil) had a greater incidence of mammary lesions (i.e.,
carcinomas, adenomas, fibromas and hyperplasia) compared to controls administered
vehicle alone (Griswold et al., 1968). The incidence of liver tumours (“hepatomas and
cholangiomas”) was increased in Syrian hamsters administered benzidine (in the diet),
compared to unexposed controls (Saffiotti et al., 1967). In a limited study, Spitz et al.
(1950, cited in ATSDR, 1989; and U.S. EPA, 1986) reported the development of bladder carcinomas in 3 of 7 dogs administered (orally) benzidine for a period of 5 years.
Benzidine is carcinogenic following injection (intraperitoneally; subcutaneously) in
rodents (i.e., rats, mice), although such routes of exposure are considered less relevant
to the assessment of risk than those by which humans are generally exposed (i.e., oral;
inhalation). Results of a limited study in mice indicate that benzidine may induce
tumours transplacentally (Vesselinovitch, 1983).
Though benzidine was not mutagenic nor did it bind covalently to DNA in some mammalian cells in vitro (Phillips et al., 1990; Oglesby et al., 1983; O’Brien et al., 1990),
the weight of evidence convincingly indicates that benzidine is mutagenic and genotoxic (reviewed in ATSDR, 1989; IARC, 1982; U.S. EPA, 1980, 1986; Beland et al.,
1983; Beland and Kadlubar, 1985). It is mutagenic in prokaryotic and eukaryotic cells,
has transformed a variety of rodent cells in in vitro assays, and increased sister chromatid exchange, unscheduled DNA synthesis and induced chromosomal aberrations in
eukaryotic cells in in vivo and in vitro assays. Benzidine induced DNA damage in
eukaryotic cells following in vitro or in vivo exposure, and the covalent binding of
benzidine (i.e., its metabolites) to DNA has been observed following the in vivo
exposure of experimental animals to this substance.
Mice administered drinking water containing benzidine dihydrochloride (20 to
160 mg/L) for their entire lifespan had vacuolation in the brain (Littlefield et al., 1983,
1984). Mice administered (by gavage) benzidine hydrochloride (10.8 to 43.2 mg/kg
bw/day) for 5 consecutive days had diminished immunological function (i.e., reduced
B- and T-cell mitogenic responses, reduced natural killer cell activity, delayed
hypersensitivity responses and reduced resistance to infection) [Luster et al., 1985].
Data on the reproductive and developmental effects of benzidine on experimental
animals were limited, and of little significance in assessing the toxicological effects of
this substance.
6
Benzidine
2.4.2
Humans
In case reports and series published since 1927 (cited in IARC, 1982, 1987), the
occurrence of bladder cancer in workers in Germany, Switzerland, Italy, England,
Japan, France and the United States who had been occupationally exposed to
benzidine has been reported.
You et al. (1990) reported a significant (p < 0.01) standardized incidence ratio
(SIR = 19.2) for bladder cancer (14 observed cases) in a group of males (n = 550)
employed for at least 6 months between 1946 and 1976 in 7 factories in Shanghai
producing benzidine-based dyes. The “standardized rate” for bladder cancer increased
with increasing duration of exposure to benzidine. The average periods of exposure to
benzidine and latency were 8 and 20 years, respectively.
Meigs et al. (1986) reported a significant (p < 0.01) SIR (3.4, 95% confidence limit
(CL) = 1.5 to 6.8) for cancer of the urinary bladder (8 observed cases/2.3 expected
cases) for a group of males (n = 830) employed for at least 1 day between 1945 and
1965 at a chemical plant in Connecticut producing benzidine and substituted benzidine
compounds. SIRs for bladder cancer of 1.8 (95% CL = 0.05 to 10.1; 1 observed/0.55
expected), 0 (95% CL = 0 to 4.7; 0 observed/0.79 expected), 1.9 (95% CL = 0.05 to
10.7; 1 observed/0.52 expected) and 13 (95% CL = 4.8 to 28.4; 6 observed/0.46
expected) were reported for males in the unexposed, low-, medium- and high-exposure
groups, (classified based on the duration of exposure to benzidine), respectively; however, a similar trend was not observed for “non-bladder” tumours. SIRs for bladder
cancer of 0 (95% CL = 0 to 3.2; 0 observed/1.15 expected), 3.4 (95% CL = 0.4 to 12.4;
2 observed/0.58 expected) and 10 (95% CL = 3.6 to 21.7; 6 observed/0.6 expected)
were reported for males employed at the plant from 0 to 1, 1 to 5 and more than
5 years, respectively. The SIR for bladder cancer (4 observed cases) for males occupationally exposed to benzidine between 1945 and 1949, was 9.8 (95% CL = 2.7 to 25),
while the SIR based on 1 observed case was 2.1 for workers employed between 1950
and 1954 (95% CL = 0.05 to 11.9). Measures to reduce the exposure of workers to
benzidine were introduced in 1950. The average latency period was approximately
20.9 years.
You et al. (1990) reported a significant (p < 0.01) standardized mortality ratio
(SMR = 14.7) for deaths due to bladder cancer (5 observed cases) in a group of males
(n = 550) employed for at least 6 months between 1946 and 1976 in 7 factories in
Shanghai producing benzidine-based dyes.
Morinaga et al. (1990) reported a significant (p < 0.01) SMR (14.3) for deaths due to
cancer of the “urinary organ” (3 observed deaths) in a group of males (n = 155)
occupationally exposed (between 1945 and 1971) to benzidine at two chemical plants
in Osaka, Japan.
7
Delzell et al. (1989) reported a significant (p < 0.05) SMR for bladder cancer
(SMR = 12.5; 2 observed/0.16 expected)1 in a group (n = 379) of hourly paid
"azo-dye" employees exposed to benzidine (in addition to other chemical compounds),
although the observed cases of bladder cancer occurred in men who had been previously exposed to benzidine and β-naphthylamine (former workers at the Cincinnati
Chemical Works). The azo-dye workers had been employed for at least 12 months
(between 1952 and 1985) at a chemical plant in New Jersey. Mortality in a subgroup
(n = 89) of males previously employed at the Cincinnati Chemical Works was also
assessed, and there was a significant (p < 0.05) increase in SMRs for deaths due to
cancer of the bladder (SMR = 12; 3 observed/0.25 expected), kidney (SMR = 9.5;
2 observed/0.21 expected) and central nervous system (SMR = 9.1; 2 observed/0.22
expected) [Delzell et al., 1989].
Rubino et al. (1982) reported a significant (p < 0.001) SMR (83.3; 5 observed/0.06
expected) for deaths due to bladder cancer in a group of males (n = 65) employed for
at least 1 month between 1922 and 1970 at a dyestuff factory in Northern Italy, who
had been exposed to benzidine during its manufacture. The mean latency period was
23.4 years.
Case et al. (1954) identified 10 deaths due to bladder cancer from 1921 to 1952 in a
group (number not specified) of male workers employed in the chemical industry in
Britain who had been occupationally exposed to benzidine; the expected number of
deaths due to bladder cancer was 0.72.
2.4.3
Ecotoxicology
Limited data on the acute toxicity of benzidine in aquatic organisms were identified.
For the red shiner (Notropis lutrensis), a 72- and 96-h LC50 of 2.5 mg/L has been
reported (Jones, 1980), while for the sheepshead minnow (Cyprinodon variegatus),
the 96-h LC50 was 64 mg/L (Martin, 1982).
Baird et al. (1977) reported that benzidine (20 mg/L) had some (unquantified) inhibitory effect on the respiration of organisms in activated sludge while this substance was
being degraded, suggesting that a metabolite or metabolites may be responsible for the
observed toxicity.
No data on the toxicity of benzidine to wild mammals, birds, sediment or soil biota
were identified. Because of the low accumulation of benzidine by aquatic organisms,
adverse effects on aquatic-based wildlife due to decreased availability of prey are
considered unlikely.
1.
8
SMRs for death due to all cancers (SMR = 1.9; 16 observed/8.3 expected), cancer of the stomach
(SMR = 9.7; 3 observed/0.31 expected), and central nervous system (SMR = 9.1; 3 observed/0.33
expected) were also significantly (p < 0.05) increased.
Benzidine
3.0 Assessment of “Toxic” under CEPA
3.1
CEPA 11(a): Environment
The most sensitive species of fish identified is the red shiner (Notropis lutrensis) with
a 72- and 96-hour LC50 of 2.5 mg/L. This concentration was divided by a factor of 20
to convert it to a chronic no-observed-effect-level, to account for interspecies differences and to extrapolate laboratory results to the field. This yielded an estimated effect
threshold of 0.13 mg/L. Since benzidine is not currently produced in or imported into
Canada, and since its half-life in environmental media is less than a few weeks, concentrations of benzidine in surface water in the range of the estimated effect threshold
are considered very unlikely.
Therefore, on the basis of the limited available data, benzidine is not considered
to be “toxic” as interpreted under paragraph 11(a) of CEPA.
3.2
CEPA 11(b): Environment on Which Human Life Depends
Benzidine is expected to be slightly volatile and to photooxidize rapidly in air. Therefore, this substance is not expected to contribute to ozone depletion, global warming or
the formation of ground-level ozone.
Therefore, on the basis of available data, benzidine is not considered to be “toxic”
as interpreted under paragraph 11(b) of CEPA.
3.3
CEPA 11(c): Human Life or Health
Population Exposure
Quantitative data on the concentrations of benzidine in air, drinking water, soil or foodstuffs within Canada (or elsewhere) were not identified. Consequently, the available
data are inadequate to estimate the exposure of the general population of Canada to
benzidine.
9
Effects
The results of a number of analytical epidemiological studies as well as supporting
data from case reports and series of workers occupationally exposed to benzidine have
provided clear evidence for the carcinogenicity of this substance in humans. Indeed,
the observed association between the occurrence of bladder carcinoma and occupational exposure to benzidine fulfils the traditional criteria (consistency, strength, specificity, temporal relationship, exposure-response relationship and plausibility) for
assessment of causality in epidemiological studies.
The observed associations have been very specific, in that occupational exposure to
benzidine has been associated with an increased incidence of, or death due to, cancer
of the bladder—almost exclusively, transitional cell carcinoma. The results have been
remarkably consistent, with an association between occupational exposure to benzidine and an increased incidence of, or mortality due to, bladder cancer observed in all
the analytical epidemiological studies (Meigs et al., 1986; You et al., 1990; Morinaga
et al., 1990; Delzell et al., 1989; Rubino et al., 1982; Case et al., 1954) in which these
relationships were examined.
The association between the increased incidence of, or mortality due to, bladder carcinoma is strong. Reported standardized incidence ratios (SIRs) for bladder cancer in
occupationally exposed workers are 3.4 (Meigs et al., 1986) and 19.2 (You et al.,
1990). Reported standardized mortality ratios (SMRs) for death due to bladder cancer
in occupationally exposed workers range from 12 (Delzell et al., 1989) to 83.3
(Rubino et al., 1982).
Although quantitative information on exposure to benzidine was not assessed in any of
the available analytical epidemiological studies, a relationship between qualitative
measures of exposure and an increased incidence of bladder cancer was reported in
two studies (You et al., 1990; Meigs et al., 1986). Although the data are limited, there
is evidence indicating that a reduction in the (occupational) exposure to benzidine was
associated with a decrease in the incidence of bladder carcinoma (Meigs et al., 1986).
The carcinogenicity of benzidine in humans is plausible, based on the overwhelming
evidence of the genotoxicity of this substance. Moreover, the carcinogenicity of
benzidine in experimental animals (i.e., rats, mice, hamsters) has been well
documented.
Since the observed association of bladder cancer (predominantly transitional cell carcinoma) with occupational exposure to benzidine fulfils the traditional criteria for assessment of causality in epidemiological studies, on the basis of the available data,
10
Benzidine
benzidine has been classified in Group I (Carcinogenic to Humans) of the classification scheme developed for the determination of “toxic” under paragraph 11(c) of
CEPA (EHD, 1992).
For such substances, where possible, estimated total daily intake by the general population in Canada is compared to quantitative estimates of carcinogenic potency to characterize risk and provide guidance for further action (i.e., analysis of options to reduce
exposure). Owing to the lack of available information on concentrations of benzidine
in environmental media to which humans are exposed, it is not possible to quantitatively estimate the total daily intake of this substance by the general population of
Canada. Consequently, estimates of total daily intake have not been compared to quantitative estimates of cancer potency, although such values would be expected to be low
owing to the lack of reported use of this substance in Canada.
Benzidine has been classified as being “Carcinogenic to Humans”, and is therefore considered to be “toxic” under paragraph 11(c) of CEPA.
This approach is consistent with the objective that exposure to non-threshold toxicants
should be reduced wherever possible, and obviates the need to establish an arbitrary
de minimis level of risk for determination of “toxic” under CEPA.
3.4
Conclusion
Based on the available data, benzidine is not considered to be “toxic” as defined
under paragraphs 11(a) or 11(b) of CEPA. Benzidine is considered to be “toxic” as
defined under paragraph 11(c) of CEPA.
11
4.0 Recommendations for Research
Although a number of data gaps on the effects of benzidine on the environment and human health were identified, because of the negligible exposure of biota and the general
population of Canada to this substance the priority for additional research is considered to be low.
12
Benzidine
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Environmental Protection, Ottawa.
Ferber, K.H. 1978. Benzidine and related biphenyldiamines. In: H.F. Mark,
D.F. Othmer, C.G. Overberger, and G.T. Seaborg, eds. Kirk-Othmer Encyclopaedia of
Chemical Technology, 3rd ed., Volume 3. John Wiley and Sons, Toronto: 772–777.
Freitag, D., L. Ballhorn, H. Geyer, and F. Korte. 1985. Environmental hazard profile
for organic chemicals. An experimental method for the assessment of the behaviour of
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Graveel, J.G., L.E. Sommers, and D.W. Nelson. 1986. Decomposition of benzidine,
α-naphthylamine and p-toluidine in soils. J. Environ. Qual. 15: 53–59.
Graveel, J.G., L.E. Sommers, and D.W. Nelson. 1985. Sites of benzidine, α-naphthylamine and p-toluidine retention in soils. Environ. Toxicol. Chem. 4: 607–613.
Gregory, A.R. 1984. The carcinogenic potential of benzidine-based dyes. J. Environ.
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Griswold, D.P., A.E. Casey, E.K. Weisburger, and J.H. Weisburger. 1968. The carcinogenicity of multiple intragastric doses of aromatic and heterocyclic nitro or amino
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Evaluation of Carcinogenic Risks to Humans. Some Industrial Chemicals and
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14
Benzidine
IARC (International Agency for Research on Cancer). 1987. IARC Monographs on the
Evaluation of Carcinogenic Risks to Humans. Overall Evaluation of Carcinogenicity:
An Updating of IARC Monographs Volumes 1 to 42, Supplement 7. Lyon, France:
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Jones, T.C. 1980. Risk assessment, phase 1: benzidine, its congeners and their derivative dyes and pigments. U.S. Environmental Protection Agency, Washington. EPA
560/11-80-019.
Larson, R.A., and R.G. Zepp. 1988. Reactivity of the carbonate radical with aniline
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Littlefield, N.A., C.J. Nelson, and C.H. Frith. 1983. Benzidine dihydrochloride: Toxicological assessment in mice during chronic exposures. J. Toxicol. Environ. Health
12: 671–685.
Littlefield, N.A., C.J. Nelson, and D.W. Gaylor. 1984. Benzidine dihydrochloride:
Risk assessment. Fund. Appl. Toxicol. 4: 69–80.
Lu, P.-Y., R.L. Metcalf, N. Plummer, and D. Mandel. 1977. The environmental fate of
three carcinogens: benzo(a)pyrene, benzidine and vinyl chloride evaluated in laboratory model ecosystems. Arch. Environ. Contam. Toxicol. 6: 129–142.
Luster, M.I., A.N. Tucker, H.T. Hayes, O.J. Pung, T. Burka, R. McMillan, and T. Eling.
1985. Immunosuppressive effects of benzidine in mice: evidence of alterations in
arachidonic acid metabolism. J. Immunol. 135: 2754–2761.
Mabey, W.R., J.H. Smith, R.T. Podoll, H.L. Johnson, T. Mill, T.-W. Chou, J. Gates,
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15
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17
3.
2003-04-09
Canada Gazette Part II, Vol. 137, No. 8
Gazette du Canada Partie II, Vol. 137, no 8 SOR/DORS/2003-99
REGULATORY IMPACT
ANALYSIS STATEMENT
RÉSUMÉ DE L’ÉTUDE D’IMPACT
DE LA RÉGLEMENTATION
(This statement is not part of the Regulations.)
(Ce résumé ne fait pas partie du règlement.)
Description
Description
The Prohibition of Certain Toxic Substances Regulations, 2003
(hereafter referred to as the Regulations) feature a schedule listing
toxic substances subjected to prohibition for manufacture, use,
sale, offer for sale and import. The Regulations have been
amended in two respects. First, two substances were added to the
Schedule in the Regulations: benzidine and its salt (benzidine
dihydrochloride) and hexachlorobenzene (HCB). Second, the
Regulations include conditions specific to one substance, HCB.
These Regulations replace the Prohibition of Certain Toxic
Substances Regulations.
Le Règlement sur certaines substances interdites (2003), ciaprès appelé le règlement, comprend une annexe énumérant les
substances toxiques dont la fabrication, l’utilisation, la vente, la
mise en vente et l’importation sont interdites. On a apporté deux
modifications au règlement. Premièrement, deux substances ont
été ajoutées à l’annexe : la benzidine et son sel (le dihydrochlorate de benzidine), et l’hexachlorobenzène (HCB). Deuxièmement, des conditions particulières à la substance hexachlorobenzène ont été incluses.
Les inscriptions pour la benzidine et le mirex dans l’annexe 1
de la Loi canadienne sur la protection de l’environnement (1999)
[LCPE (1999)] ont été modifiées avant la publication du règlement. Le dihydrochlorate de benzidine a été ajouté à l’annexe 1
pour clarifier l’inclusion du sel de la benzidine. Les inscriptions
pour le mirex dans l’annexe 1 et la partie 1 de l’annexe 3 de
la LCPE (1999) n’étaient pas uniformes. Pour éviter la confusion,
la même terminologie est maintenant utilisée dans les deux annexes ainsi que dans la Liste des substances toxiques interdites du
règlement.
Le règlement remplace le Règlement sur certaines substances
toxiques interdites.
Benzidine
Benzidine
In 1994, benzidine was found to be carcinogenic to humans and
declared toxic under paragraph 11(c) of CEPA 1988 (now paragraph 64(c) of CEPA 1999). The goal is to minimize the health
risks associated with benzidine by reducing exposure to and/or
release of the substance, to the greatest extent possible. Benzidine
salt is also being addressed, as it dissociates in water into benzidine.
Benzidine and its salt are not produced in Canada, and the
quantity imported into Canada was approximately 60 grams per
year in 1995 and 1996. These substances are currently used only
in very limited specialty laboratory applications, and for research
and development purposes. Essential specialty laboratory applications for which there are no substitutes are not targeted by the
Regulations. Such applications include the following uses of benzidine: to detect certain micro-organisms by means of the niacin
test; to detect chloralhydrate in biological fluids; as a reagent for
detecting blood in biological fluids; as staining for microscopic
examination.
En 1994, la benzidine a été jugée cancérogène pour les humains et déclarée toxique au sens de l’alinéa 11c) de
la (LCPE 1988) (maintenant l’alinéa 64c) de la LCPE (1999). Le
but consiste à réduire au minimum les risques pour la santé liés à
la benzidine en diminuant le plus possible l’exposition à cette
substance et son rejet. Le sel de la benzidine est aussi visé parce
qu’il se dissocie dans l’eau pour donner de la benzidine.
La benzidine et son sel ne sont pas produits au Canada, et la
quantité importée annuellement au pays était d’environ 60 grammes en 1995 et 1996. Ces substances sont actuellement utilisées
seulement dans certaines applications spécialisées de laboratoire
très limitées ainsi qu’à des fins de recherche et de développement.
Les applications essentielles des laboratoires spécialisés pour
lesquelles il n’existe pas de substituts ne sont pas visées par le
règlement. Ces applications comprennent les utilisations suivantes
de la benzidine : la détection de certains micro-organismes en
effectuant un test à la niacine, la détection de l’hydrate de chloral
dans les liquides biologiques, comme réactif pour la détection du
sang dans les liquides biologiques, et l’emploi de la substance
comme colorant pour l’examen au microscope.
Hexachlorobenzene
Hexachlorobenzène
In 1994, HCB was declared toxic under paragraphs 11(a)
and (c) of CEPA 1988 (now paragraphs 64(a) and (c) of CEPA
1999), based on the conclusion that the concentrations of HCB
present in the Canadian environment may constitute a danger to
the environment and to human life and health. As this substance
meets the criteria of persistence, bioaccumulation and toxicity,
releases of HCB are targeted for virtual elimination.
En 1994, l’hexachlorobenzène (HCB) a été déclaré toxique au
sens des alinéas 11a) et c) de la (LCPE 1988) (maintenant les
alinéas 64a) et c) de la LCPE (1999) parce qu’on a conclu que les
concentrations de HCB dans l’environnement canadien pouvaient
constituer un danger pour l’environnement ainsi que pour la vie et
la santé humaine. Comme cette substance satisfait aux critères de
persistance, de bioaccumulation et de toxicité, la quasiélimination des rejets de HCB est visée.
Le HCB a été introduit au Canada en 1940 en vue de son utilisation dans le traitement des semences de blé, d’orge, d’avoine et
The benzidine and Mirex entries were amended in Schedule 1 to the Canadian Environmental Protection Act, 1999
(CEPA 1999) prior to publication of the Regulations. Benzidine
salt (benzidine dihydrochloride) has been added to Schedule 1,
to clarify the inclusion of the salt compound of benzidine. The
entries for Mirex in Schedule 1 and in Part 1 of Schedule 3
to CEPA 1999 were not consistent. To avoid confusion, the same
terminology is now used in both schedules, as well as in the List
of Prohibited Toxic Substances of the Regulations.
HCB was introduced in Canada in 1940, for use as seed dressing for wheat, barley, oats, and rye, in order to prevent fungal
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disease. However, the use of HCB in fungicides was discontinued
in 1972, due to concerns about adverse effects on the environment
and human health. In industry, HCB was used directly in the
manufacture of pyrotechnics, tracer bullets, and as a fluxing agent
in the manufacture of aluminum. It was also used as a woodpreservative agent, a porosity-control agent in the manufacture of
granite anodes, and as a peptizing agent in the production of nitroso compounds and rubber for tires. Since 1980, the production
and use of HCB as a commercial chemical in Canada has ceased.
Currently there is no production of HCB in most countries
worldwide. However, it is still being generated incidentally as a
by-product and/or impurity in several chemical processes.
For example, HCB is found as a contaminant in some chlorinated solvents, such as carbon tetrachloride, trichloroethylene (TCE) and perchloroethylene (PERC). The production of
PERC and TCE ceased in Canada in 1992, while production of
carbon tetrachloride ceased in 1995. Therefore, only the use of
these chlorinated solvents, mostly in the dry cleaning and solvent
degreasing sectors, contributes to possible HCB releases into the
environment. The concentration of HCB measured in chlorinated
solvents is currently below 20 parts per billion (ppb). The emission of HCB through the use of chlorinated solvents is estimated
to be up to 280 grams per year.
de seigle pour prévenir les maladies fongiques. Toutefois,
l’utilisation du HCB dans les agents fongicides a été abandonnée
en 1972 en raison des préoccupations exprimées au sujet de ses
effets nocifs sur l’environnement et la santé humaine. Dans
l’industrie, le HCB a été utilisé directement pour la fabrication de
pièces pyrotechniques et de balles traçantes et comme agent
fluxant dans la fabrication de l’aluminium. Il a aussi été utilisé
comme agent de préservation du bois, agent de contrôle de la
porosité dans la fabrication des anodes de graphite, et agent peptisant dans la fabrication de composés nitreux et de caoutchouc
pour les pneus. Depuis 1980, la production et l’utilisation de HCB
comme produit chimique commercial au Canada ont cessé. Actuellement, la plupart des pays du monde ne produisent plus
de HCB. Cependant, cette substance est encore produite de façon
fortuite comme sous-produit ou impureté dans plusieurs procédés
chimiques.
Par exemple, le HCB contamine certains solvants chlorés,
comme le tétrachlorure de carbone, le trichloroéthylène (TCE) et
le perchloroéthylène (PERC). La production de TCE et de PERC
a cessé en 1992 au Canada et celle de tétrachlorure de carbone,
en 1995. Par conséquent, seule la consommation de ces solvants
chlorés, surtout utilisés dans les secteurs du nettoyage à sec et du
dégraissage, contribue aux rejets possibles de HCB dans
l’environnement. La concentration de HCB mesurée dans les solvants chlorés est actuellement inférieure à 20 parties par milliard (ppb). On estime que les émissions de HCB dues à
l’utilisation de solvants chlorés peuvent atteindre 280 grammes
par année.
HCB is also found in some ferric and ferrous chloride products. HCB concentrations reported to Environment Canada in
1999 were between 100 ppb and 210 ppb. However, since then,
manufacturing processes have been improved and HCB concentrations have been reduced.
On retrouve également du HCB dans les chlorures ferrique et
ferreux. Les concentrations de HCB déclarées au ministère de
l’Environnement en 1999 variaient entre 100 et 210 ppb. Toutefois, les procédés de fabrication ont été améliorés depuis et les
concentrations de HCB ont été réduites.
After the pre-publication of the proposed Regulations in the
Canada Gazette, Part I, on September 29, 2001, it was reported
that HCB is also incidentally produced by the magnesium industry. It is estimated that 200 grams per year of HCB could be released from the use of products containing HCB as a contaminant,
which are by-products of the production of magnesium. The HCB
concentrations in those products are below 20 ppb.
Après la publication préalable du règlement proposé dans la
Gazette du Canada Partie I le 29 septembre 2001, il a été rapporté
que le HCB est aussi produit fortuitement par l’industrie du magnésium. Ainsi, l’utilisation de produits contenant du HCB
comme contaminant, qui sont des sous-produits de la production
du magnésium, pourrait donner lieu à des émissions
de 200 grammes de HCB annuellement. Les concentrations
de HCB dans ces produits sont inférieures à 20 ppb.
Sources of HCB emissions addressed by these Regulations are
relatively small compared to the principal sources, which were
identified in the Strategic Options Report for Hexachlorobenzene
as being the application of chlorinated pesticides containing HCB
as a contaminant, and the incineration of wastes. Sources not addressed by these Regulations are subject to various initiatives
contributing to the reduction of HCB releases. For instance, the
Pest Management Regulatory Agency (PMRA) of Health Canada
is committed to establishing a Risk Management plan for HCB.
The PMRA has identified the pesticides containing HCB as a
contaminant, and has requested that the concerned registrants take
steps toward virtual elimination. Also, since HCB is released in
many instances from the same sources that are releasing dioxins
and furans, the Federal/Provincial Task Force on Dioxins and
Furans of the Canadian Council of the Ministers of the Environment accepted the addition of HCB to its mandate. Therefore,
releases of HCB are addressed through actions to be carried out
for dioxins and furans.
Les sources d’émission de HCB visées par le règlement sont
relativement minimes si on les compare aux principales sources
d’émission de HCB identifiées dans le Rapport sur les options
stratégiques pour l’hexachlorobenzène, soit l’épandage de pesticides chlorés contenant du HCB comme contaminant et
l’incinération des déchets. Les sources qui ne sont pas visées par
le règlement font l’objet de diverses initiatives contribuant à la
réduction des rejets de HCB. Par exemple, l’Agence de réglementation de la lutte antiparasitaire (ARLA) de Santé Canada s’est
engagée à établir un plan de gestion du risque pour le HCB. Ainsi, l’ARLA a identifié les pesticides contenant du HCB comme
contaminant et a par la suite demandé aux compagnies visées de
prendre les mesures nécessaires qui mèneront vers la quasiélimination. De plus, puisque les rejets de HCB proviennent souvent des mêmes sources qui rejettent des dioxines et des furannes,
le groupe de travail fédéral-provincial du Conseil canadien des
ministres de l’environnement (CCME) a accepté d’ajouter
le HCB à son mandat. Par conséquent, les actions entreprises pour
les dioxines et les furannes seront aussi utilisées pour les rejets
de HCB.
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More information on overall sources of HCB releases can be
obtained from the Strategic Options Report at www.ec.gc.ca/sop/
en/index.cfm.
Pour de plus amples informations sur les sources d’émission de
HCB, veuillez consulter le Rapport sur les options stratégiques à
l’adresse suivante : www.ec.gc.ca/sop/fr/index.cfm.
Scope of the Regulations
Portée du règlement
The Regulations add benzidine and its salt, as well as HCB, to
the existing list of prohibited substances. The Regulations prohibit the manufacture, use, sale, offering for sale and import of
these substances into Canada.
With respect to HCB incidentally present in the manufacture of
a product, the Regulations exempt products containing HCB as a
contaminant at a concentration of 20 ppb or less. In addition, the
Regulations do not apply to the use of benzidine and HCB in research laboratories or as a laboratory analytical standard, because
of the limited quantity that is used and their essential role in laboratories for research and non-research purposes. Applications
requiring analytical standards are necessary for testing purposes.
The Regulations also exempt selective uses of benzidine for specific applications, as mentioned above. Furthermore, the Regulations do not apply to pesticides containing HCB as a contaminant,
as these are already controlled by the PMRA under the federal
Pest Control Products Act.
The Regulations will come into force on the date of their registration by the Clerk of the Privy Council.
Le règlement ajoute la benzidine et son sel ainsi que le HCB à
la liste existante des substances interdites. Il interdit la fabrication, l’utilisation, la vente, la mise en vente et l’importation de ces
substances au Canada.
En ce qui concerne la présence fortuite de HCB au cours de la
fabrication d’un produit, le règlement comporte une dérogation à
l’égard des produits contenant cette substance comme contaminant lorsque sa concentration est inférieure à 20 ppb. En outre, le
règlement ne s’applique pas à l’utilisation de la benzidine et
du HCB dans les laboratoires de recherche ou comme étalons
pour les analyses de laboratoire, en raison des faibles quantités
utilisées et de leur rôle essentiel dans les laboratoires pour des
fins de recherche et à d’autres fins. Les applications qui exigent
des étalons analytiques sont nécessaires aux fins d’expérimentation. Le règlement comporte aussi des dérogations à l’égard de
certaines utilisations de la benzidine pour les applications susmentionnées. De plus, le règlement ne s’applique pas aux pesticides contaminés par le HCB parce qu’ils sont déjà contrôlés par
l’Agence de réglementation de la lutte antiparasitaire en vertu de
la Loi sur les produits antiparasitaires.
Le règlement entrera en vigueur à la date de son enregistrement
par le greffier du Conseil privé.
Alternatives
Solutions envisagées
Benzidine
Benzidine
Stakeholders discussed the full range of options for managing
benzidine, including command and control instruments, market
based options, voluntary options, and the status quo through an
issue table that was part of the Strategic Options Process to address the management of substances declared toxic
under CEPA 1988. There was a consensus among stakeholders
that the management of benzidine could best be achieved by directly controlling the import, manufacture and use of benzidine
and its salt. Environment Canada subsequently determined that
the Prohibition of Certain Toxic Substances Regulations, 2003,
incorporating exemptions for specific essential applications,
would be the most efficient way of implementing the recommendations. As benzidine is used only by hospitals, universities and
other research institutions where laboratory practices are already
subject to stringent controls, no guidelines or codes of practice are
required for implementing exposure and/or release controls.
Les intervenants participant à une table de concertation dans le
cadre de ce processus ont discuté de toutes les options en matière
de gestion de la benzidine, y compris les instruments réglementaires, les options reposant sur les mécanismes du marché, les mesures volontaires et le statu quo. Le processus sur les options stratégiques visait la gestion des substances déclarées toxiques en vertu
de la LCPE (1988). Il y avait consensus parmi les intervenants au
sujet de la gestion de la benzidine qui se ferait mieux en réglementant directement l’importation, la fabrication et l’utilisation
de la benzidine et de son sel. Environnement Canada a par la suite
conclu que le Règlement sur certaines substances toxiques interdites (2003), avec des dérogations à l’égard de certaines applications essentielles, serait le moyen le plus efficace de donner suite
aux recommandations. En outre, comme la benzidine est utilisée
seulement par les hôpitaux, les universités et d’autres établissements de recherche où les méthodes de laboratoire sont déjà assujetties à de rigoureux contrôles, il n’y a pas lieu d’établir des directives ou des codes de pratique pour la mise en place des
contrôles de l’exposition et des rejets.
Hexachlorobenzene
Hexachlorobenzène
Various options were considered by stakeholders to address the
management of HCB through a separate consultation process. The
status quo and voluntary measures were both rejected. The status
quo was not acceptable due to the result of the toxicity assessment
that confirmed that HCB is toxic, persistent and bioaccumulative.
Under the legislation, its releases to the environment have to be
virtually eliminated. Voluntary measures cannot ensure that the
objective of virtual elimination of releases will be achieved.
Diverses solutions ont été envisagées pour la gestion de l’HCB
dans le cadre d’un processus de consultation auprès des intervenants. Le statu quo et les mesures volontaires ont tous deux été
rejetés. Le statu quo n’était pas acceptable parce que le résultat de
l’évaluation de la toxicité a confirmé que le HCB était toxique,
persistant et bioaccumulable. En vertu de la Loi, ces rejets dans
l’environnement devraient donc être quasi-éliminés. Quant aux
mesures volontaires, elles ne peuvent assurer que l’objectif de la
quasi-élimination des rejets soit atteint.
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Market-based instruments were also rejected. Taxes, for example, would not ensure the virtual elimination of HCB, because
some potential users might be willing to pay the tax and continue
using HCB. Thus, this measure would not reduce the release
of HCB below the level of quantification on a long term basis as
set out in subsection 65(3) and subsection 77(4) of CEPA 1999,
and the objective of prohibiting the supply of HCB in most of its
uses would not be achieved.
A regulation prohibiting the manufacture, use, sale, offering for
sale and import into Canada is the only option capable of ensuring
that the expected environmental objectives are achieved, as it
specifies where the prohibition applies. Consequently, this option
has been selected.
Les instruments reposant sur les mécanismes du marché ont
aussi été rejetés. Les taxes, par exemple, n’assureraient pas la
quasi-élimination car quelques utilisateurs potentiels pourraient
être prêts à payer la taxe pour continuer d’utiliser le HCB. Par
conséquent, cette mesure ne réduirait pas, à long terme, les rejets
de HCB à un niveau inférieur à celui qui peut être décelé, tel que
le spécifient les paragraphes 65(3) et 77(4) de la LCPE (1999), et
l’objectif consistant à interdire l’approvisionnement en HCB pour
la plupart de ses utilisations ne serait pas atteint.
Un règlement interdisant la fabrication, l’utilisation, la vente, la
mise en vente et l’importation au Canada est la seule solution
permettant d’assurer que les objectifs environnementaux prévus
soient atteints puisqu’il spécifie les cas où l’interdiction
s’applique. Cette solution a donc été choisie.
Benefits and Costs
Avantages et coûts
Benzidine
Benzidine
Current levels of use of benzidine in Canada do not pose a
threat to human health and the environment. The Regulations will
protect the health of Canadians and ecosystems by ensuring that
future production, importation and use of benzidine is prohibited,
with very limited exemptions.
Les quantités de benzidine actuellement utilisées au Canada ne
causent pas de danger pour la santé humaine et l’environnement.
Toutefois, le règlement assurera la protection de la santé des Canadiens et des écosystèmes puisque la production, l’importation et
l’utilisation de la benzidine seront maintenant interdites, sauf pour
certaines utilisations très restreintes.
En raison des utilisations limitées de la benzidine et de son sel,
l’interdiction entraînera donc des coûts de conformité négligeables pour le secteur privé. En outre, il n’y aura qu’une augmentation négligeable des frais de conformité associés à la mise en
place des contrôles de l’exposition et des rejets car les entreprises
touchées (les hôpitaux, les universités et les laboratoires privés)
mettent déjà en application de telles mesures de contrôle en tant
que bonnes pratiques de laboratoire.
Given the limited use of benzidine and its salt, the prohibition
will result in negligible compliance costs to the private sector.
Incremental compliance costs associated with implementing exposure and/or release controls for exempted uses are also expected to be negligible since affected firms (hospitals, universities
and private laboratories) are already implementing such controls
as part of good laboratory practices.
Hexachlorobenzene
Hexachlorobenzène
The reduction and eventual virtual elimination of HCB releases
will contribute to reducing the health risk to the Canadian population, and to protecting the Canadian environment.
In 1996, a notice, pursuant to subsection 16(1) of CEPA 1988,
was published in the Canada Gazette, Part I, requiring persons
using HCB alone or as an HCB compound to provide Environment Canada with the volume they use and the purpose for which
it has been used. The resulting information indicated that there
were no individuals using more that ten (10) kilograms of HCB
alone or as a compound in 1995. As HCB is not used as a commercial chemical in Canada, the compliance cost to the private
sector will be negligible.
La réduction et, éventuellement, la quasi-élimination des rejets
de HCB contribueront à réduire le risque pour la santé de la population canadienne et à protéger l’environnement canadien.
En 1996, conformément au paragraphe 16(1) de la LCPE
(1988) (Loi précédant la LCPE (1999)), un avis a été publié dans
la Gazette du Canada Partie I enjoignant quiconque utilisant
du HCB seul ou dans un mélange de déclarer à Environnement
Canada la quantité utilisée et le but de l’utilisation. Les renseignements obtenus ont indiqué que personne n’utilisait plus de dix
kilogrammes de HCB seul ou dans un mélange en 1995. Comme
le HCB n’est pas utilisé comme produit chimique commercial au
Canada, le coût lié à la conformité au règlement par le secteur
privé sera négligeable.
Le Rapport d’évaluation du HCB publié en 1994 a indiqué que,
depuis 1980, de faibles quantités de HCB avaient été importées et
ultérieurement exportées; il s’agissait de formulations antiparasitaires ou de composé mère. Il est à noter que l’ARLA a la responsabilité de ces activités et que ces dernières ne sont donc pas visées par le règlement. Par conséquent, le règlement n’entraîne pas
de coûts supplémentaires pour ce secteur.
La concentration de HCB dans les chlorures ferrique et ferreux
est inférieure à 20 ppb. Tel qu’il est indiqué plus haut, l’industrie
prend déjà des mesures afin de réduire les concentrations
de HCB, et c’est pourquoi le règlement n’entraînera pas de coûts
supplémentaires.
The Assessment Report on HCB (published in 1994) indicated
that, since 1980, small quantities of HCB have been imported and
subsequently exported, either in pesticide formulations or as the
parent compound. It should be noted that these activities are under the responsibility of the PMRA and, hence, are not covered by
the Regulations. Therefore, the Regulations impose no additional
costs on this sector.
For ferric and ferrous chloride, the concentration of HCB is below 20 ppb. As indicated above, initiatives are being undertaken
by industry to reduce HCB concentrations. Given that industry is
already taking steps to reduce HCB concentrations in this sector,
the Regulations will not impose any additional costs.
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The by-products generated and sold by the magnesium industry
also have a concentration of HCB below 20 ppb. As a result, the
Regulations will not impose any additional costs on this sector.
La concentration de HCB dans les sous-produits générés et
vendus par l’industrie du magnésium est inférieure à 20 ppb.
C’est pourquoi le règlement n’entraînera pas de coûts supplémentaires pour ce secteur.
Costs to the Government
Coûts pour le gouvernement
For the Government, the enforcement of the Regulations is expected to require between 0.5 to 1 full-time equivalent (FTE)
annually. The major task will be to ensure that benzidine, its salt
and HCB are not imported into Canada, except for benzidine
laboratory uses set out in the Regulations and for products containing HCB as a contaminant with a concentration of 20 ppb or
less. The enforcement costs are expected to be in the range
of $36,000 to $72,000 per year.
Pour le gouvernement, il est prévu que l’exécution du règlement nécessitera de 0,5 à 1 équivalent temps plein (ÉTP) annuellement. La principale tâche consistera à assurer que la benzidine,
son sel et le HCB ne soient pas importés au Canada, sauf pour les
utilisations en laboratoire de la benzidine qui sont spécifiées dans
le règlement et dans les produits où les concentrations de HCB
sont inférieures à 20 ppb. Les coûts de l’exécution seront compris
entre 36 000 et 72 000 dollars par année.
•
•
•
•
•
•
Basic salary (0.5 FTE to 1 FTE)
Benefits (20% )
TOTAL
$30,000 to $60,000
$ 6,000 to $12,000
$36,000 to $72,000
Traitement de base (0,5 à 1 ÉTP)
Avantages (20 % )
TOTAL
30 000 $ à 60 000 $
_6 000 $ à 12 000 $_
36 000 $ à 72 000 $
Consultation
Consultations
Benzidine
Benzidine
As part of the Strategic Options Process, which aimed to
address the management of substances declared toxic
under CEPA 1988 (now CEPA 1999), an Issue Table was formed
in 1994, consisting of government, industry and environmental
groups. It was established to consider how benzidine should be
managed in Canada. The Issue Table recommended that the essential specialty laboratory applications for which there are no
substitutes should be allowed. Applications that should be allowed include the following uses of benzidine: to detect certain
micro-organisms by means of the niacin test; to detect chloralhydrate in biological fluids; as a reagent for detecting blood in biological fluids; as staining for microscopic examination.
Dans le cadre du Processus sur les options stratégiques, qui a
pour but d’examiner la gestion des substances déclarées toxiques
en vertu de la LCPE (1988) (maintenant la LCPE (1999)), une
Table de concertation, formée de représentants du gouvernement,
de l’industrie et de groupes environnementaux, a été formée
en 1994 afin d’examiner les moyens à prendre pour gérer la benzidine au Canada. La Table a recommandé que les applications
spécialisées de laboratoire qui sont essentielles et pour lesquelles
il n’existe pas de substituts soient permises. Les applications
permises comprennent les utilisations suivantes de la benzidine :
la détection de certains micro-organismes en effectuant un test à
la niacine, la détection de l’hydrate de chloral dans les liquides
biologiques, comme réactif pour la détection du sang dans les
liquides biologiques, et l’emploi de la substance comme colorant
pour l’examen au microscope.
La Table de concertation a également recommandé que
l’utilisation de la benzidine soit assujettie à des contrôles convenables de rejet dans l’environnement. Comme la benzidine est
utilisée seulement par les hôpitaux, les universités et d’autres
établissements de recherche où les méthodes de laboratoire font
déjà l’objet de contrôles rigoureux, des directives ou des codes de
pratique ne sont pas nécessaires. Le rapport sur les consultations
avec les intervenants, intitulé Options stratégiques pour la gestion
des substances toxiques : Benzidine et 3,3′ -Dichlorobenzidine
(février 1997) a été largement diffusé et peut être consulté à
l’adresse www.ec.gc.ca/sop/fr/index.cfm. Aucun commentaire
négatif n’a été reçu.
The Issue Table also recommended that when benzidine is
used, it must be subject to appropriate environmental release controls. Since benzidine is used only by hospitals, universities and
other research institutions where laboratory practices are already
subject to stringent controls, no guidelines or codes of practice are
required. The report of the stakeholder consultations, entitled
Strategic Options for the Management of Toxic Substances: Benzidine and 3,3′ -Dichlorobenzidine (February 1997), has been
widely circulated and can be found at www.ec.gc.ca/sop/en/
index. cfm. No negative comments have been received.
Hexachlorobenzene
Hexachlorobenzène
Given that HCB is no longer in commerce in Canada, no formal Strategic Options Process was held. However, Environment
Canada sent a letter to companies/associations that could potentially be affected by HCB controls, informing them that a regulation prohibiting the manufacture, use, offer for sale and import
of HCB into Canada would be proposed in the Canada Gazette,
Part I.
Comme le HCB n’est plus commercialisé au Canada, aucun
processus sur les options stratégiques n’a été établi de façon officielle. Toutefois, Environnement Canada a fait parvenir une lettre
aux entreprises et associations pouvant être touchées par les mesures de contrôle du HCB. Cette lettre les informait qu’un règlement interdisant la fabrication, l’utilisation, la mise en vente et
l’importation du HCB au Canada serait proposé dans la Gazette
du Canada Partie I.
Par la suite, un document de travail portant sur le HCB utilisé
comme produit chimique commercial et sur la contamination par
Following this letter, a discussion paper addressing HCB as a
commercial chemical, and HCB contamination in products such
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as chlorinated solvents, was sent to stakeholders in March 1999.
It provided information on the proposed HCB controls, and was
forwarded to companies/associations that could be affected in
order to obtain their views and comments. The discussion paper
included recommendations to the Ministers on control actions
with respect to HCB as a commercial chemical, and summarized
the actions taken to address HCB contamination in products such
as chlorinated solvents as well as HCB emissions from different
processes. This report can be found at www.ec.gc.ca/sop/en/
index.cfm.
During the consultation with industry in 1999, Environment
Canada received information indicating that ferric chloride and
ferrous chloride could also be contaminated with the substance HCB. Therefore, a notice was sent in July 1999 to companies involved in the ferrous/ferric chloride market. The purpose of
this notice was to obtain the quantities of ferric/ferrous chloride
used in Canada in order to determine the quantity of HCB released into the environment.
Because HCB concentrations in ferric/ferrous chloride could
not be provided by the companies, Environment Canada published a second notice pursuant to section 16 of CEPA 1988, in
order to obtain samples of ferric/ferrous chloride used in Canada.
This notice was published in the Canada Gazette, Part I, on October 30, 1999.
The samples were analyzed by Environment Canada’s laboratory in December 1999. The results of the analysis showed
that HCB concentrations in ferric/ferrous chloride were well
below 20 ppb for the majority of samples.
Prior to publication of the Regulations in the Canada Gazette,
Part I, the Minister’s National Advisory Committee and the Joint
Environment Canada/Health Canada CEPA Management Committee were informed of the Regulations, and approved the action
taken with respect to HCB as a commercial chemical and HCBcontamination in products.
The Regulations were pre-published in the Canada Gazette,
Part I, on September 29, 2001, under the title Prohibition of Certain Toxic Substances Regulations, 2001. The PMRA expressed
its concern that the Regulations might create regulatory redundancy with respect to certain pesticides contaminated with HCB.
Hence, an exemption was added in paragraph 4(b) to exclude
these substances from the Regulations.
In addition, one company expressed concern that the Regulations could impact intermediates containing HCB. However, intermediates were not intended to be covered under the Regulations. Section 2 and subsection 3(2) were amended to reflect this.
Estimates of enforcement costs were revised to better reflect
the actual cost of enforcing the Regulations.
cette substance de produits comme les solvants chlorés a été envoyé aux intervenants en mars 1999. Il contenait des renseignements sur les mesures proposées de réglementation du HCB et a
été transmis aux entreprises et associations pouvant être touchées
afin d’obtenir leur opinion et leurs commentaires. Le document
présentait les recommandations formulées aux ministres au sujet
des mesures de contrôle du HCB utilisé comme produit chimique
commercial et résumait les mesures prises pour réduire la contamination par le HCB dans les produits comme les solvants chlorés ainsi que les émissions de HCB produites par différents procédés. Le document est disponible à l’adresse www.ec.gc.ca/sop/
fr/index.cfm.
Au cours des consultations qui ont eu lieu en 1999 avec
l’industrie, Environnement Canada a reçu des renseignements à
l’effet que les chlorures ferrique et ferreux pourraient aussi être
contaminés par le HCB. En juillet 1999, un avis a donc été envoyé aux entreprises qui faisaient le commerce des chlorures ferrique et ferreux afin de connaître les quantités de ces composés
utilisées au Canada et les rejets de HCB dans l’environnement.
Comme ces entreprises ne pouvaient fournir les concentrations
de HCB dans les chlorures ferrique et ferreux, Environnement
Canada a publié dans la Gazette du Canada Partie I le 30 octobre 1999, un deuxième avis en vertu de l’article 16 de
la LCPE (1988) afin d’obtenir des échantillons des chlorures ferrique et ferreux utilisés au Canada.
Les échantillons ont été analysés par le laboratoire
d’Environnement Canada en décembre 1999. Les résultats de
l’analyse ont démontré que les concentrations de HCB dans la
majorité des échantillons de chlorures ferrique et ferreux étaient
bien inférieures à 20 ppb.
Préalablement à la publication du règlement dans la Gazette du
Canada Partie I, le Comité consultatif national du ministre et le
Comité mixte de gestion de la LCPE d’Environnement Canada et
de Santé Canada ont été informés du règlement et ont approuvé
les mesures prises concernant l’utilisation du HCB comme produit chimique commercial et la contamination des produits par
cette substance.
Le règlement a été préalablement publié dans la Gazette du
Canada Partie I le 29 septembre 2001, sous le titre Règlement sur
certaines substances toxiques interdites (2001). L’ARLA a affirmé craindre que le règlement pourrait être redondant en ce qui
concerne certains pesticides contaminés par le HCB. Une dérogation a donc été ajoutée à l’alinéa 4b) pour exclure ces substances
du règlement.
En outre, une entreprise s’est demandée si le règlement pouvait
s’appliquer aux intermédiaires contenant du HCB. Comme les
intermédiaires n’étaient pas visés par le règlement, l’article 2 et le
paragraphe 3(2) ont été modifiés en conséquence.
Les estimations des coûts de la mise en application ont été révisées pour mieux tenir compte du coût actuel de l’application du
règlement.
Compliance and Enforcement
Respect et exécution
As the Regulations would be promulgated under CEPA 1999,
the Compliance and Enforcement Policy implemented under the
Act will be applied by CEPA 1999 enforcement officers. The
policy outlines measures designed to promote compliance, including education, information, promotion of technology development, and consultation on the development of the regulations.
Puisque le règlement sera pris en vertu de la LCPE (1999), les
agents de l’autorité appliqueront la Politique d’observation et
d’application mise en oeuvre en vertu de cette loi. Leurs activités
de promotion de la conformité sont limitées à la distribution de la
Loi, des règlements et de la Politique d’observation et d’application de la LCPE (1999). La Politique indique les mesures à
1007
2003-04-09
When verifying compliance with these Regulations, CEPA enforcement officers will abide by the Compliance and Enforcement
Policy, which also sets out the range of possible responses to violations: warnings, directions and environmental protection compliance orders issued by enforcement officers, ticketing, ministerial orders, injunctions, and prosecution. In addition, CEPA 1999
provides for environmental protection alternative measures,
which are an alternative to a court trial after the laying of charges
for a CEPA 1999 offense. Furthermore, the policy explains when
Environment Canada will resort to civil suits by the Crown for
costs recovery.
If, following an inspection, investigation or the report of a suspected violation, a CEPA enforcement officer has reasonable
grounds to believe that a violation has been committed, the enforcement officer will select the appropriate response to the alleged violation, based on the following criteria:
• Nature of the alleged violation: this includes consideration of
the damage, the intent of the alleged violator, whether it is a
repeat violation, and whether an attempt has been made to
conceal information or otherwise subvert the objectives and
requirements of the Act.
•
•
Effectiveness in achieving the desired result with the alleged
violator: the desired result is compliance within the shortest
possible time and with no further repetition of the violation.
Factors to be considered include the violator’s history of
compliance with the Act, willingness to co-operate with
enforcement officials, and evidence of corrective action
already taken.
Consistency: enforcement officers will consider how similar
situations have been handled in determining the measures to
be taken to enforce the Act.
Contacts
Bernard Madé
National Office of Pollution Prevention
Toxics Pollution Prevention Directorate
Environment Canada
Hull, Quebec
K1A 0H3
Telephone: (819) 994-3648
FAX: (819) 994-0007
E-mail: [email protected]
Céline Labossière
Regulatory and Economic Analysis Branch
Economic and Regulatory Affairs Directorate
Environment Canada
Hull, Quebec
K1A 0H3
Telephone: (819) 997-2377
FAX: (819) 997-2769
Published by the Queen’s Printer for Canada, 2003
1008
prendre par les scientifiques et les ingénieurs pour promouvoir
l’application de la Loi, ce qui comprend l’éducation, l’information et la consultation sur l’élaboration des règlements.
La Politique décrit toute une gamme de mesures à prendre en
cas d’infractions présumées : avertissements, ordres en cas de
rejet, ordres d’exécution en matière de protection de
l’environnement, contraventions, ordres ministériels, injonctions,
poursuites pénales et mesures de rechange en matière de protection de l’environnement (lesquelles peuvent remplacer une poursuite pénale, une fois que des accusations ont été portées pour une
infraction présumée à la LCPE (1999). De plus, la politique explique quand Environnement Canada aura recours à des poursuites civiles intentées par la Couronne pour recouvrer ses frais.
Lorsque, à la suite d’une inspection ou d’une enquête, un agent
de l’autorité arrive à la conclusion qu’il y a eu infraction présumée, l’agent se basera sur les critères suivants pour décider de la
mesure à prendre :
•
•
•
La nature de l’infraction présumée : il convient notamment de
déterminer la gravité des dommages réels ou potentiels causés
à l’environnement, s’il y a eu action délibérée de la part du
contrevenant, s’il s’agit d’une récidive et s’il y a eu tentative
de dissimuler de l’information ou de contourner, d’une façon
ou d’une autre, les objectifs ou exigences de la Loi.
L’efficacité du moyen employé pour obliger le contrevenant à
obtempérer : le but visé est de faire respecter la Loi dans les
meilleurs délais tout en empêchant les récidives. Il sera tenu
compte, notamment, du dossier du contrevenant pour l’observation de la Loi, de sa volonté de coopérer avec les agents de
l’autorité et de la preuve que des correctifs ont été apportés.
La cohérence dans l’application : les agents de l’autorité
tiendront compte de ce qui a été fait dans des cas semblables
pour décider de la mesure à prendre pour appliquer la Loi.
Personnes-ressources
Bernard Madé
Bureau national de la prévention de la pollution
Direction générale de la prévention de la pollution par
les toxiques
Environnement Canada
Hull (Québec)
K1A 0H3
Téléphone : (819) 994-3648
TÉLÉCOPIEUR : (819) 994-0007
Courriel : [email protected]
Céline Labossière
Direction des analyses réglementaires et économiques
Direction générale des affaires économiques
et réglementaires
Hull (Québec)
K1A 0H3
Téléphone : (819) 997-2377
TÉLÉCOPIEUR : (819) 997-2769
Publié par l’Imprimeur de la Reine pour le Canada, 2003
4.
2005-03-09
Registration
SOR/2005-40 February 15, 2005
Enregistrement
DORS/2005-40
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
LOI CANADIENNE SUR LA PROTECTION DE
L’ENVIRONNEMENT (1999)
Order Adding a Toxic Substance to Schedule 1 to
the Canadian Environmental Protection Act, 1999
Décret d’inscription d’une substance toxique à
l’annexe 1 de la Loi canadienne sur la protection
de l’environnement (1999)
P.C. 2005-186
C.P. 2005-186
February 15, 2005
a
Le 15 février 2005
Le 15 février 2005
And whereas, pursuant to subsection 90(1) of that Act, the
Governor in Council is satisfied that the substance set out in the
annexed Order is a toxic substance;
Therefore, Her Excellency the Governor General in Council,
on the recommendation of the Minister of the Environment and
the Minister of Health, pursuant to subsection 90(1) of the Canadian Environmental Protection Act, 1999b, hereby makes the annexed Order Adding a Toxic Substance to Schedule 1 to the Canadian Environmental Protection Act, 1999.
Attendu que, conformément au paragraphe 332(1)a de la Loi
canadienne sur la protection de l’environnement (1999)b, le
ministre de l’Environnement a fait publier dans la Gazette du
Canada Partie I, le 3 avril 2004, le projet de décret intitulé Décret
d’inscription d’une substance toxique à l’annexe 1 de la Loi canadienne sur la protection de l’environnement (1999), conforme
en substance au texte ci-après, et que les intéressés ont ainsi eu la
possibilité de présenter leurs observations à cet égard ou un avis
d’opposition motivé demandant la constitution d’une commission
de révision;
Attendu que, conformément au paragraphe 90(1) de cette loi, la
gouverneure en conseil est convaincue que la substance visée par
le décret ci-après est une substance toxique,
À ces causes, sur recommandation du ministre de l’Environnement et du ministre de la Santé et en vertu du paragraphe 90(1) de
la Loi canadienne sur la protection de l’environnement (1999)b,
Son Excellence la Gouverneure générale en conseil prend le Décret d’inscription d’une substance toxique à l’annexe 1 de la Loi
canadienne sur la protection de l’environnement (1999), ci-après.
ORDER ADDING A TOXIC SUBSTANCE TO
SCHEDULE 1 TO THE CANADIAN ENVIRONMENTAL
PROTECTION ACT, 1999
DÉCRET D’INSCRIPTION D’UNE SUBSTANCE
TOXIQUE À L’ANNEXE 1 DE LA LOI CANADIENNE
SUR LA PROTECTION DE L’ENVIRONNEMENT (1999)
AMENDMENT
MODIFICATION
1. Schedule 1 to the Canadian Environmental Protection Act,
19991 is amended by adding the following after item 68:
69. Dichlorodiphenyltrichloroethane (DDT), which has the molecular formula C14H9Cl5
1. L’annexe 1 de la Loi canadienne sur la protection de
l’environnement (1999)1 est modifiée par adjonction, après
l’article 68, de ce qui suit :
69. Dichlorodiphényltrichloroéthane (DDT), dont la formule
moléculaire est C14H9Cl5
COMING INTO FORCE
ENTRÉE EN VIGUEUR
2. This Order comes into force on the day on which it is
registered.
2. Le présent décret entre en vigueur à la date de son enregistrement.
REGULATORY IMPACT
ANALYSIS STATEMENT
RÉSUMÉ DE L’ÉTUDE D’IMPACT
DE LA RÉGLEMENTATION
(This statement is not part of neither the Order nor the Regulations.)
(Ce résumé ne fait pas partie ni du décret ni du règlement.)
Whereas, pursuant to subsection 332(1) of the Canadian Environmental Protection Act, 1999b, the Minister of the Environment
published in the Canada Gazette, Part I, on April 3, 2004, a copy
of the proposed Order Adding a Toxic Substance to Schedule 1 to
the Canadian Environmental Protection Act, 1999, substantially
in the annexed form, and persons were given an opportunity to
file comments with respect to the proposed Order or to file a notice of objection requesting that a board of review be established
and stating the reasons for the objection;
Description
Description
The Prohibition of Certain Toxic Substances Regulations, 2005
(hereafter referred to as the Regulations) are made pursuant
Le Règlement sur certaines substances toxiques interdites
(2005) (ci-après appelé le « règlement ») a été établi en vertu du
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a
a
b
1
S.C. 2004, c. 15, s. 31
S.C. 1999, c. 33
S.C. 1999, c. 33
306
b
1
L.C. 2004, ch. 15, art. 31
L.C. 1999, ch. 33
L.C. 1999, ch. 33
2005-03-09
to subsection 93(1) of the Canadian Environmental Protection
Act, 1999 (CEPA 1999). The Regulations repeal the Prohibition
of Certain Toxic Substances Regulations, 2003 (hereafter referred
to as the 2003 Regulations).
The Regulations prohibit the manufacture, use, sale, offer for
sale and import of the toxic substances listed in Schedules 1 and 2
to the Regulations. Schedule 1 lists prohibited toxic substances
subject to total prohibition, with the exception of incidental presence. Schedule 2 includes toxic substances that are subject to
prohibitions related to concentration or use. The 2003 Regulations
included only one schedule that subjected all listed toxic substances to the same regulatory requirements. As such, the restructured Regulations facilitate more flexible management of the
scheduled toxic substances, by providing more targeted regulatory controls. They also facilitate the addition of new toxic substances to the two Schedules in the future.
Prior to being listed on a Schedule of these Regulations, a
substance must be added to the List of Toxic Substances
under CEPA 1999. As such, an Order to add DDT to the List of
Toxic Substances under CEPA 1999 is included with these Regulations.
The Regulations will come into force three months after the
day on which they are registered. The Order will come into force
the day on which it is registered.
paragraphe 93(1) de la Loi canadienne sur la protection de
l’environnement (1999) [(LCPE (1999)]. Ce règlement abroge le
Règlement sur certaines substances toxiques interdites (2003) (ciaprès appelé le « règlement 2003 »).
Le règlement interdit la fabrication, l’utilisation, la vente, la
mise en vente et l’importation des substances toxiques figurant
dans ses annexes 1 et 2. L’annexe 1 énumère les substances toxiques qui sont assujetties à une interdiction complète, à l’exception
d’une présence fortuite. L’annexe 2 comprend les substances
toxiques pour lesquelles l’interdiction est reliée à la concentration
ou l’utilisation de la substance. Le règlement 2003 comprenait
une seule annexe qui assujettissait toutes les substances toxiques
aux mêmes exigences réglementaires. Ainsi, la restructuration du
règlement facilite la voie pour une gestion plus souple des substances toxiques répertoriées en permettant des contrôles réglementaires mieux ciblés. De plus, ce remaniement facilitera à
l’avenir l’ajout de nouvelles substances toxiques aux deux annexes.
En outre, les modifications ont pour effet :
• d’inscrire l’hexachlorobutadiène (HCBD), la N-nitrosodiméthylamine (NDMA) et le dichlorodiphényltrichloroéthane (DDT) à l’annexe 1 du règlement;
• d’introduire de nouvelles exigences en matière de soumission
de rapports et de tenue de registres pour l’hexachlorobenzène (HCB), la benzidine et le dihydrochlorate de benzidine;
• d’introduire une exigence de fournir un avis lorsqu’une substance énumérée à l’annexe 1 ou 2 est utilisée en laboratoire ou
pour des fins de recherche scientifique;
• de créer un régime de permis pour accorder des dérogations
temporaires aux interdictions lorsqu’une période de transition
sera jugée nécessaire afin de trouver ou de mettre en œuvre
des solutions de rechange pour des substances toxiques;
• d’associer plus étroitement la limite établie pour la présence
fortuite de HCB à des produits ou à des mélanges où sa présence a été détectée et des décisions ont été prises pour la
contrôler;
• d’aider le Canada à respecter ses obligations internationales
relatives au DDT en vertu de la Convention de Stockholm sur
les polluants organiques persistants.
Une condition préalable pour qu’une substance soit répertoriée
dans l’annexe du règlement est son ajout à la Liste des substances
toxiques de la LCPE (1999). Pour ce faire, un décret d’inscription
du DDT à l’annexe 1 de la LCPE (1999) est inclus avec ce règlement.
Le règlement entrera en vigueur trois mois après sa date
d’enregistrement. Quant au décret, il entrera en vigueur à la date
de son enregistrement.
Addition of New Substances to the Regulations
Ajout de nouvelles substances au règlement
The addition of HCBD, NDMA, and DDT, currently not present in the Canadian marketplace, to the Prohibited Toxic Substances List (Schedule 1) of the Regulations, is intended to prevent their re-introduction to the Canadian market.
Prior to being added to the Prohibited Toxic Substances List, a
substance must be present in the List of Toxic Substances (Schedule 1) of CEPA 1999.
HCBD was added to Schedule 1 of CEPA 1999 in July 2003.
The substance meets the criteria for persistence and bioaccumulation, as established by the Persistence and Bioaccumulation
L’ajout du HCBD, de la NDMA et du DDT, actuellement absent du marché canadien, à la Liste de substances toxiques interdites (annexe 1) du règlement préviendra la réintroduction de ces
substances sur le marché canadien.
Avant son inscription à la liste de substances toxiques interdites, une substance doit être inscrite à la Liste des substances toxiques de l’annexe 1 de la LCPE (1999).
Le HCBD a été ajouté à l’annexe 1 de la LCPE (1999) en juillet 2003. Le HCBD remplit les critères de persistance et de bioaccumulation comme cela est établi dans le Règlement sur la
•
•
•
•
•
•
In addition, the restructured Regulations:
list hexachlorobutadiene (HCBD), N-nitrosodimethylamine
(NDMA) and dichlorodiphenyltrichloroethane (DDT) in
Schedule 1;
introduce new reporting and record-keeping requirements
with respect to hexachlorobenzene (HCB), benzidine and benzidine dihydrochloride;
introduce a notification requirement for the use of Schedule 1
and 2 substances in a laboratory setting or for the purposes of
scientific research;
create a permit system for granting temporary exemptions to
prohibitions, where it is identified that a transition period will
be required to find or implement alternatives to toxic substances;
more tightly associate the limit established for the incidental
presence of HCB to products or mixtures where its presence
has been detected, and control decisions have been taken;
assist Canada in meeting its international obligations respecting DDT under the Stockholm Convention on Persistent Organic Pollutants (POPs).
307
2005-03-09
Regulations made under CEPA 1999. It is not naturally occurring,
and may be present in the environment only as a result of human
activity. Therefore, the implementation of the virtual elimination of HCBD was proposed pursuant to subsection 77(4)
of CEPA 1999, in the publication of the summaries of the draft
and final Priority Substances Assessment Reports for HCBD.
An Order adding HCBD to the Virtual Elimination List
of CEPA 1999 was pre-published in the Canada Gazette, Part I
for public comment, on August 16, 2003. Virtual elimination
involves reducing releases of a substance below those levels that
can be measured with routine but sensitive tests. To do so, it is
necessary to prohibit the sale, manufacture, use, and import
of HCBD. Not imposing such prohibitions on HCBD would undermine the intent of virtual elimination.
NDMA was added to Schedule 1 of CEPA 1999 in May 2003.
Although NDMA is not slated for virtual elimination, it is likely
carcinogenic to humans at low levels of exposure.
An Environment Canada review of the physical, chemical, and
toxicity properties of DDT was conducted in the 1990s. The ministers of the Environment and Health used a summary of this review to justify a decision that DDT meets the criteria for management as a Track 11 substance under the federal Toxic Substances Management Policy. Accordingly, an Order adding DDT
to Schedule 1 of CEPA 1999 was made with the Regulations.
DDT was first registered as a pesticide in the 1940s, and although it was never manufactured in Canada, it was widely used
in pest control products until the 1960s. In response to increasing
environmental and safety concerns, most uses of DDT in Canada
were phased out by the mid-1970s. Registration of all uses
of DDT was discontinued in 1985, with the understanding that
existing stocks would be sold, used or disposed of by December 31, 1990. The sale or use of DDT in Canada today constitutes
a violation of the Pest Control Products Act.
DDT is an internationally acknowledged POP that is covered
by the Stockholm Convention on Persistent Organic Pollutants.
The Convention seeks to control, reduce, or eliminate discharges,
emissions, and losses of POPs to the environment. The substance
is also subject to the Prior Informed Consent (PIC) procedure
under the Rotterdam Convention on the Prior Informed Consent
Procedure for Certain Hazardous Chemicals and Pesticides in
International Trade, which requires notification or the consent of
the country of destination before the substance is exported from
Canada. Due to its characteristics and effects, DDT has already
been banned or severely restricted in several jurisdictions.
persistance et la bioaccumulation, en vertu de la LCPE (1999). Il
n’existe pas de sources naturelles de cette substance dans
l’environnement et il peut être présent dans l’environnement surtout en raison de l’activité humaine. La quasi-élimination
du HCBD a donc été proposée, en vertu du paragraphe 77(4) de
la LCPE (1999), dans la publication des résumés de l’ébauche et
de la version finale des rapports d’évaluation des substances
d’intérêt prioritaire pour le HCBD.
Un décret visant à ajouter le HCBD à la liste de quasiélimination de la LCPE (1999) a été publié au préalable dans la
Gazette du Canada Partie I le 16 août 2003, pour commentaires.
La quasi-élimination consiste à réduire les rejets d’une substance
à un niveau inférieur aux concentrations qui peuvent être mesurées par des méthodes d’analyses courantes mais sensibles. Pour
ce faire, il est nécessaire que la vente, la fabrication, l’utilisation
et l’importation du HCBD soient interdites. Ne pas imposer de
telles interdictions sur le HCBD irait à l’encontre du but de la
quasi-élimination.
La NDMA a été ajouté à l’annexe 1 de la LCPE (1999) en
mai 2003. Bien que la NDMA ne soit pas désignée pour la quasiélimination, elle est, selon toute probabilité, cancérogène pour les
humains à des niveaux d’exposition relativement faibles.
Au cours des années 1990, Environnement Canada a procédé
à un examen des propriétés physiques, chimiques et toxiques
du DDT. Le ministre de l’Environnement et le ministre de la Santé ont utilisé un résumé de cet examen pour décider que le DDT
remplit les critères pour être géré comme une substance de la
voie 11 en vertu de la Politique sur la gestion des substances toxiques. Par conséquent, ce règlement comprend aussi un décret
visant à ajouter le DDT à la Liste des substances toxiques de
l’annexe 1 de la LCPE (1999).
C’est dans les années 1940 que le DDT a été enregistré pour la
première fois comme un pesticide, et bien qu’il n’ait jamais été
fabriqué au Canada, il a été largement utilisé dans les produits
antiparasitaires jusqu’aux années 1960. Pour donner suite aux
préoccupations croissantes exprimées au sujet de l’environnement
et de la sécurité, la plupart des utilisations canadiennes du DDT
ont été progressivement éliminées vers le milieu des années 1970.
L’enregistrement de toutes les utilisations du DDT a été supprimé
en 1985 à condition que les stocks existants soient vendus, utilisés
ou éliminés au plus tard le 31 décembre 1990. Depuis lors, la
vente ou l’utilisation du DDT au Canada constitue une infraction
à la Loi sur les produits antiparasitaires.
Le DDT est un polluant organique persistant reconnu internationalement qui est visé par la Convention de Stockholm sur les
polluants organiques persistants. Celle-ci vise essentiellement à
contrôler, à réduire ou à éliminer les rejets, les émissions et les
pertes de polluants organiques persistants dans l’environnement.
Cette substance est aussi assujettie à la procédure de consentement préalable en vertu de la Convention de Rotterdam sur la
procédure de consentement préalable en connaissance de cause
applicable dans le cas de certains produits chimiques et pesticides
dangereux qui font l’objet du commerce international. Cette
convention exige l’avis ou le consentement du pays de destination
avant que la substance soit exportée du Canada. En raison de ses
caractéristiques et de ses effets, le DDT a déjà été interdit ou considérablement restreint dans plusieurs compétences.
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1
1
Track 1 substances are persistent, bioaccumulative, and result predominantly
from human activity. These substances are slated for virtual elimination from the
environment.
308
Une substance de la voie 1 est persistante, bioaccumulative et sa présence dans
l’environnement est due principalement à l’activité humaine. Ces substances sont
visées par la quasi-élimination de leur rejet dans l’environnement.
2005-03-09
The prohibition of DDT under the Regulations applies only to
non-pesticidal uses, as the Pest Control Products Act continues to
regulate pesticidal uses.
L’interdiction en vertu du règlement s’applique seulement à
l’utilisation du DDT à des fins autres que la lutte antiparasitaire,
puisque la Loi sur les produits antiparasitaires continue à réglementer l’utilisation de cette substance comme pesticide.
New Reporting, Record-keeping, and Notification Requirements
Nouvelles exigences en matière de soumission de rapports, de
tenue de registres et d’avis
New reporting and record-keeping requirements apply to benzidine, benzidine dihydrochloride and hexachlorobenzene (HCB).
They are necessary to promote compliance and facilitate enforcement. In the case of HCB, these requirements will provide
Environment Canada with information on the presence of HCB in
products or mixtures used in the Canadian market, which is critical to effectively implementing virtual elimination of this substance.
With respect to benzidine and benzidine dihydrochloride, these
requirements will help Environment Canada monitor these substances to ensure they are used for permitted uses only. Moreover,
it will ensure that the import, manufacture, and use of these substances are subject to strict life-cycle controls designed to prevent/minimize exposure to and/or the release of these substances
into the environment.
Les nouvelles exigences en matière de soumission de rapports
et de tenue de registres s’appliquent à la benzidine, au dihydrochlorate de benzidine ainsi qu’au HCB, et sont nécessaires pour
faciliter l’application du règlement et promouvoir la conformité à
ce dernier. En outre, ces exigences fourniront à Environnement
Canada des données concernant l’utilisation du HCB sur le marché, ce qui est essentiel à la mise en œuvre efficace de la quasiélimination de cette substance.
Pour ce qui est de la benzidine et du dihydrochlorate de benzidine, les exigences en matière de soumission de rapports et de
tenue de registres aideront Environnement Canada à surveiller ces
substances afin d’assurer qu’elles sont utilisées seulement aux
fins permises. De plus, cela assurera que leur importation, leur
fabrication et leur utilisation font l’objet de rigoureux contrôles
du cycle de vie afin de prévenir ou de réduire au minimum l’exposition à ces substances et/ou leur rejet dans l’environnement.
Un seuil de déclenchement quantitatif pour fin de rapport (par
exemple, la limite de concentration) s’applique maintenant à tous
les rapports soumis ainsi qu’aux avis. Ce seuil de déclenchement
quantitatif permettra d’éviter la soumission de rapports ou de
préavis pour de très faibles quantités à aviser ou à déclarer.
Le règlement contient également une exigence de fournir un
avis unique lorsqu’une substance toxique interdite est utilisée en
laboratoire ou pour des fins de recherche scientifique. Le règlement permettra à Environnement Canada d’obtenir des données
sur l’utilisation de substances toxiques en laboratoire et pour des
fins de recherche scientifique.
A quantity (e.g., concentration limit) trigger is now applied to
all reporting and notification. This trigger limit will circumvent
having very small quantities notified or reported.
The Regulations also specify a one-time notification requirement for all laboratory and scientific research users of scheduled
substances. This requirement will provide Environment Canada
with data on the use of toxic substances for scientific research and
in laboratories.
New Permit System
Nouveau régime de permis
The Regulations establish a permit system intended to provide
a mechanism for temporarily exempting certain applications of a
prohibited substance. A permit may be granted only if the Minister of the Environment is satisfied that there is no technically and
economically feasible alternative or substitute available for the
prohibited substance. In addition, the Minister must be satisfied
that measures have been taken to minimize or eliminate any
harmful effects of the toxic substance on the environment and
human health. Finally, the applicant must provide an implementation plan that identifies specific timelines for eliminating the toxic
substance. Each permit lasts for 12 months, and can be renewed
only twice. This system is similar to the one used in the Ozonedepleting Substances Regulations, 1998.
Le règlement établit un régime de permis qui a pour but de
fournir un mécanisme permettant d’exempter temporairement
certaines applications d’une substance interdite. Un permis peut
être octroyé seulement si le ministre de l’Environnement juge
qu’il n’est pas techniquement ou économiquement viable
d’utiliser un produit de remplacement ou un substitut autre qu’une
substance toxique. De plus, le ministre doit s’assurer que des mesures ont aussi été prises afin d’éliminer ou de réduire au minimum les effets nuisibles de la substance toxique sur l’environnement et la santé humaine. Enfin, le demandeur doit fournir un
plan de mise en œuvre identifiant des délais précis pour
l’élimination de la substance toxique en cause. La durée d’un
permis est de douze mois et il ne pourra être renouvelé que deux
fois. Cette formule est semblable à celle utilisée dans le Règlement sur les substances appauvrissant la couche d’ozone (1998).
Ce régime de permis aidera à réaliser l’interdiction de certaines
substances toxiques visées par le règlement tout en accordant à
l’industrie le temps pour identifier et mettre en œuvre des solutions de rechange qui ne sont pas excessivement onéreuses ou
coûteuses.
This permit system will assist in achieving the prohibitions
placed on toxic substances covered by the Regulations, while
allowing industry time to identify and implement alternatives in a
manner that is not excessively onerous or costly.
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Alternatives
Solutions envisagées
Restructuring the Regulations
Remaniement du règlement
The restructuring of the 2003 Regulations was necessary to
provide greater flexibility in imposing prohibitions on the use,
sale, offer for sale, and import of toxic substances (e.g., ability to
impose partial bans). The restructuring simplifies the process of
adding new substances to the Regulations. As these issues all
relate to the structure and language of the text itself, a regulatory
change was the only viable option. As such, the repeal and replacement of the 2003 Regulations was considered to be the best
solution.
Le remaniement du règlement 2003 était nécessaire pour offrir
plus de flexibilité quant à l’imposition d’interdictions sur l’utilisation, la vente, la mise en vente et l’importation des substances
toxiques (p.ex., la capacité d’imposer des interdictions partielles)
et la simplification du processus de l’ajout de nouvelles substances au règlement. Puisque ces questions se rattachent toutes à la
structure et à la terminologie du texte lui-même, un changement
réglementaire était la seule solution valable. Ainsi, la meilleure
solution consiste à abroger et à remplacer le règlement 2003.
Addition of New Substances to the Regulations
Ajout de nouvelles substances au règlement
It was assessed that both HCBD and NDMA are toxic pursuant
to CEPA 1999. Both substances pose risks either to the health or
environment of Canadians. Currently, neither substance is used,
sold, produced, imported, or exported in Canada. The only way to
ensure that neither substance is introduced into the Canadian
market is through a ban, which can only be effected through these
Regulations.
Le HCBD et la NDMA ont été évalués comme étant tous deux
toxiques conformément à la LCPE (1999). Ces deux substances
posent de graves risques soit pour la santé des Canadiennes et des
Canadiens ou leur environnement. Actuellement, aucune de ces
substances n’est utilisée, vendue, fabriquée, importée ou exportée
au Canada. L’unique moyen d’assurer que ces substances ne
soient pas introduites sur le marché canadien consiste à les interdire, ce que seul le règlement permet de faire.
En outre, dans le cas du HCBD, le gouvernement a proposé que
cette substance soit sujette aux dispositions de la quasiélimination sous la LCPE (1999). L’interdiction de fabrication,
d’utilisation, de vente, de mise en vente ou d’importation de cette
substance œuvrera pour l’atteinte de l’objectif de la quasiélimination.
À l’échelle internationale, le DDT est reconnu comme un polluant organique persistant qui fait déjà l’objet d’importantes restrictions dans la plupart des juridictions. La Loi sur les produits
antiparasitaires interdit actuellement d’utiliser le DDT comme
pesticide, et le règlement est le seul moyen permettant d’interdire
l’utilisation industrielle de cette substance.
Si les interdictions ne sont pas mises en place à travers ce règlement, ces substances pourraient être introduites sur le marché
canadien comme des produits chimiques industriels. Puisque
l’industrie canadienne ne commercialise pas actuellement ces
substances ou ne les utilise pas délibérément, l’introduction de
ces produits chimiques représenterait une importante augmentation du risque pour la santé des Canadiennes et des Canadiens
et pour leur environnement, si ces substances étaient rejetées
dans l’environnement. En outre, l’introduction du HCBD et de
la NDMA sur le marché saperait les mesures de gestion des risques visant à contrôler les rejets nationaux de ces substances
toxiques. Une interdiction réglementaire est la seule façon
d’assurer que ces substances ne soient pas réintroduites sur notre
marché.
Furthermore, in the case of HCBD, the federal government has
proposed that the substance be subject to virtual elimination provisions of CEPA 1999. The prohibition on manufacture, use, sale,
offer for sale, or import of the substance will work towards the
objective of virtual elimination.
DDT is globally acknowledged to be a persistent organic pollutant, and it is already the subject of severe restrictions in most
jurisdictions. The Pest Control Products Act bans pesticidal use
of DDT, and these Regulations are the only manner in which a
prohibition on industrial use of DDT can be implemented.
If prohibitions are not implemented through these Regulations,
these substances could be introduced to the Canadian marketplace
as industrial chemicals. As Canadian industry does not currently
trade in or deliberately use these substances, introduction of these
chemicals could represent an increase in risk to Canadians’ health
and environment, if these chemicals were released to the environment. Furthermore, in the case of HCBD and NDMA, such an
introduction would undermine risk management measures aimed
at controlling domestic releases of these toxic substances. A regulatory ban is the only way to ensure that these substances do not
enter the Canadian marketplace.
Benefits and Costs
Avantages et coûts
Benefits
Avantages
HCBD and NDMA are included in Schedule 1 of CEPA 1999.
Risk management strategies have been developed to manage the
risks associated with each substance. For these strategies to succeed, it is critical that these substances, which are not deliberately
used in Canada, do not enter widespread use which could increase
health and environmental risks to Canadians. The prohibitions in
the Regulations would fulfill that objective and maximize the
benefits derived from risk management measures implemented by
domestic industry.
Le HCBD et la NDMA sont répertoriés dans l’annexe 1 de
la LCPE (1999). Des stratégies concernant la gestion des risques
pour chaque substance ont été élaborées afin de gérer les risques
posés par ces substances. La réussite de ces stratégies assurerait
que ces substances, qui ne sont pas utilisées délibérément au
Canada, ne deviennent pas largement utilisées à l’avenir, ce qui
augmenterait les risques pour la population canadienne. Les interdictions du règlement permettraient d’atteindre cet objectif et de
maximiser les avantages résultant des mesures de gestion des
risques mises en œuvre par l’industrie nationale.
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Restructuring the 2003 Regulations to have greater variation in
the controls placed on individual substances allows for more
flexible management of toxic substances. In addition, the Regulations facilitate the addition of new toxic substances in the future,
which will result in reduced costs to government.
Le remaniement du règlement 2003, pour une plus grande variation des contrôles imposés sur chacune des substances, permet
d’assouplir la gestion des substances toxiques et de faciliter
l’ajout de nouvelles substances toxiques à l’avenir, ce qui réduira
les coûts encourus par le gouvernement.
Costs
Given that the Regulations prohibit the manufacture, use, sale,
offer for sale, and import of three additional substances that are
not currently manufactured, used, sold, offered for sale, or imported, there should be no significant impact on industry and
compliance costs are expected to be minimal.
Incremental costs to government resulting from the Regulations, including administrative and enforcement costs, are
expected to be minimal. It is estimated that enforcement activeties associated with the Regulations will require an annual budget
of $58,600. Inspections will verify, among other things,
that HCBD, NDMA, and DDT are not being imported or produced and that reports submitted under the Regulations are true
and accurate.
The addition of the permit system to these Regulations will imply negligible administrative costs as the number of applications
is expected to be minimal (i.e. not more than one application per
year per applicant). It is expected that the additional enforcement
related to permits can be accommodated through existing resources.
On balance, it is expected that the benefits accruing from the
regulatory changes will exceed the costs.
Coûts
Étant donné que le règlement interdit la fabrication, l’utilisation, la vente, la mise en vente et l’importation de trois substances
supplémentaires qui ne sont pas actuellement fabriquées, utilisées,
vendues, mises en vente ou importées, il ne devrait pas en résulter
de conséquences importantes pour l’industrie. D’autre part, il est
prévu que les coûts d’observation du règlement seront réduits au
minimum.
Les exigences en matière de soumission de rapports annuels
du HCB, de la benzidine et du dihydrochlorate de benzidine et
l’unique avis pour les utilisations en laboratoire et pour fins de
recherche scientifique entraîneront des coûts minimums pour la
soumission de rapports et la tenue des registres. Ceci est particulièrement vrai dû au nouveau seuil de déclenchement quantitatif
ajouté dans le cas de soumission de rapports.
Il est prévu que les coûts additionnels découlant de ce règlement pour le gouvernement, y compris les frais d’administration
et les coûts d’application du règlement, seront réduits au minimum. Les coûts de l’application du règlement, sont estimés à
environ 58 600 dollars annuellement. Les inspections permettront
de vérifier, entre autres, que le HCBD, la NDMA et le DDT ne
soient pas importés ou fabriqués et que les rapports soumis en
vertu du règlement soient vrais et exacts.
L’ajout du régime de permis au règlement entraînera des frais
d’administration négligeables puisque le nombre de demandes
sera probablement minime, soit pas plus d’une demande par année par requérant. Il est prévu que les coûts additionnels d’application du règlement reliés aux permis pourront être payés à même
les ressources existantes.
Finalement, il est prévu que les avantages résultant des changements réglementaires seront supérieurs aux coûts.
Consultation
Consultations
Addition of HCBD
On December 9, 2002, a multi-stakeholder consultation was
held, in Ottawa, to discuss a proposed management approach for
reducing and virtually eliminating releases of HCBD, and to discuss analytical approaches for testing for HCBD contamination in
various products. A second stakeholder consultation was also held
in Ottawa, on September 29, 2003, to review and discuss the draft
Regulations. In addition, all stakeholders were invited to provide
written comments to Environment Canada by October 31, 2003.
Ajout du HCBD
Le 9 décembre 2002, une consultation multilatérale a eu lieu à
Ottawa afin de discuter, d’une part, d’une proposition de mode de
gestion visant à réduire et à quasi-éliminer les rejets de HCBD et,
d’autre part, des démarches analytiques à employer pour tester si
divers produits sont contaminés par le HCBD. Une seconde consultation a eu lieu à Ottawa le 29 septembre 2003 dans le but
d’examiner et de discuter de l’ébauche du règlement. En outre,
tous les intervenants ont été invités à formuler par écrit leurs
commentaires à Environnement Canada au plus tard le 31 octobre 2003.
Au cours de cette période, 11 réponses écrites provenant de
l’industrie, d’organisations non gouvernementales environnementales (ONGE) et du gouvernement ont été reçues. La principale
préoccupation exprimée par les intervenants, durant la période de
consultation, avait trait à la limite de contamination proposée
pour le HCBD. Les intervenants ont demandé que la limite proposée dans l’ébauche du règlement soit recalculée. Selon les ONGE,
cette limite était trop élevée, tandis que l’industrie a demandé
d’incorporer un certain tamponnage dans la fixation de la limite
de concentration en raison des fluctuations naturelles se produisant dans les procédés industriels.
The annual reporting requirements for HCB, benzidine and
benzidine dihydrochloride, and the one-time notification requirement for laboratories and scientific research facilities, imply
minimal reporting and record-keeping costs. This is particularly
true due to the new quantity trigger added for reporting.
Eleven written responses from industry, environmental nongovernmental organizations (ENGOs) and government were received during this period. The primary concern expressed by
stakeholders, throughout the consultation period, was related to
the proposed contamination limit for HCBD. Stakeholders asked
that the proposed contamination limit in the draft Regulations be
recalculated. The ENGOs suggested that the proposed level was
too high, while industry asked that some buffering be incorporated in setting the concentration limit, because of naturally occurring fluctuations in industrial processes.
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Some stakeholders also indicated that Environment Canada
should not unnecessarily burden commercial sectors where the
contamination level in products is very low and close to the
method detection limit, by requiring that these sectors monitor
and report their level of contamination.
After a review of the risks, it was decided to remove the proposed contamination limit for HCBD from the draft Regulations.
Instead, guidelines will be developed to complement these Regulations, where acceptable contamination levels of HCBD would
be set. This approach would significantly reduce the administrative burden of both industry and Environment Canada, without
compromising the environmental objective.
A detailed review of public comments received during the consultation for the draft Regulations, and responses to these comments, as well as comments received for other consultations, may
be obtained from Environment Canada’s National Office of Pollution Prevention Web site at http://www.ec.gc.ca/NOPP/
Consultations/en/consult.cfm.
Certains intervenants ont aussi mentionné qu’Environnement
Canada ne devrait pas imposer inutilement de fardeau aux secteurs commerciaux lorsque le niveau de contamination dans les
produits est très faible et près de la limite de détection de la méthode, en exigeant que ces secteurs examinent et déclarent leur
niveau de contamination.
Après une évaluation des risques, il a été décidé d’éliminer la
limite de contamination proposée pour le HCBD de l’ébauche du
règlement. En revanche, des lignes directrices seront élaborées, en
complément au règlement, établissant des limites de contaminations acceptables. Cette approche permettrait de réduire considérablement le fardeau administratif imposé à la fois à l’industrie et
à Environnement Canada sans pour autant compromettre l’objectif environnemental.
Il est possible de prendre connaissance de tous les commentaires formulés par le public au cours de la consultation sur
l’ébauche du règlement ainsi que des réponses à ces commentaires, de même que les commentaires reçus pour d’autres consultations, en visitant le site Internet du Bureau national de la prévention de la pollution d’Environnement Canada à l’adresse suivante :
www.ec.gc.ca/NOPP/Consultations/FR/consult.cfm.
Addition of NDMA
Ajout de la NDMA
Stakeholders were invited to review and provide written comments on the draft Regulations in October 2003. The following
documents were provided as additional sources of information,
through a mail-out and Web site postings: a synopsis of the assessment report for NDMA; and a fact sheet containing information regarding NDMA, its uses and potential exposure sources.
An electronic version of all consultation documents pertaining
to NDMA was posted on Environment Canada’s National Office
of Pollution Prevention Web site at http://www.ec.gc.ca/NOPP/
En octobre 2003, les intervenants ont été invités à examiner
l’ébauche du projet de règlement et à formuler par écrit des commentaires à ce sujet. Les documents suivants ont été envoyés par
la poste et affichés sur le site Web dans le but de fournir des sources supplémentaires d’information : un résumé du rapport
d’évaluation de la NDMA et une fiche de renseignements contenant des informations sur la NDMA, ses utilisations et les sources
possibles d’exposition à cette substance. Une version électronique
de tous les documents de consultation se rapportant à la NDMA a
été affichée sur le site Internet du Bureau national de la prévention de la pollution d’Environnement Canada, à www.ec.gc.ca/
NOPP/Consultations/FR/consult.cfm.
Un intervenant a demandé pourquoi il était proposé que
la NDMA, une substance identifiée comme devant être gérée
durant tout son cycle de vie, soit ajoutée au règlement. Cette substance n’est pas actuellement utilisée commercialement au Canada.
Néanmoins, son ajout au règlement préviendra sa réintroduction
dans le commerce canadien. Aucun autre commentaire n’a été
reçu.
One stakeholder questioned why NDMA, a substance identified for management through its life cycle, is added to the proposed Regulations. NDMA is not currently used in commerce in
Canada. Nevertheless, the addition of this substance to the Regulations will prevent its reintroduction in Canadian commerce. No
other comments were received.
Addition of DDT
Ajout du DDT
Stakeholders were invited to review and provide written comments on the draft Regulations in October 2003. A fact sheet containing information related to DDT, its characteristics and potential exposure sources, was provided as an additional source of
information through a mail-out and Web site postings. An electronic version of all consultation documents pertaining to DDT
was posted on Environment Canada’s National Office of Pollution Prevention Web site at http://www.ec.gc.ca/NOPP/
En octobre 2003, les intervenants ont été invités à examiner
l’ébauche du règlement et à formuler par écrit des observations à
ce sujet. Une fiche de renseignements contenant des informations
sur le DDT, ses caractéristiques et les sources possibles
d’exposition à cette substance a été envoyée par la poste et affichée sur le site Web dans le but de fournir des sources supplémentaires d’information. Une version électronique de tous les
documents de consultation se rapportant au DDT a été affichée
sur le site Internet du Bureau national de la prévention de la pollution d’Environnement Canada à l’adresse suivante : www.ec.
gc.ca/NOPP/Consultations/FR/consult.cfm.
Un intervenant a demandé si certaines utilisations avantageuses
reconnues internationalement ne devraient pas être permises dans
l’ébauche du règlement. Conformément à la Convention de
Stockholm sur les polluants organiques persistants, ratifiée par
le Canada, l’utilisation continue du DDT est permise pour la
lutte antivectorielle jusqu’à ce que des solutions de rechange
One stakeholder questioned whether some internationally recognized beneficial uses should be allowed in the draft Regulations. Under the Stockholm Convention on Persistent Organic
Pollutants, which Canada has ratified, continued use of DDT is
allowed for vector control until safe, affordable and effective
alternatives are in place. These Regulations do not address the use
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of DDT if registered as a pesticide under the Pest Control Products Act; therefore, an exemption is not necessary. The other
comments received for DDT during the consultation period did
not result in changes to the text of the proposed Regulations.
sécuritaires, abordables et efficaces soient mises en place.
Comme le règlement ne porte pas sur l’utilisation du DDT si cette
substance est enregistrée comme pesticide en vertu de la Loi sur
les produits antiparasitaires, une exemption n’est pas nécessaire.
Les autres commentaires reçus au sujet du DDT, durant la période
de consultation, n’ont pas occasionné de changements dans le
texte du projet de règlement.
Record-keeping and Reporting Requirements
Exigences en matière de tenue de registres et de soumission de
rapports
Provisions for keeping records and reporting of certain information related to HCB, HCBD, benzidine and benzidine dihydrochloride were included in the proposed Regulations. Stakeholders
were invited to review and provide written comments on the draft
Regulations, in October 2003. An electronic version of all consultation documents pertaining to HCB, HCBD, benzidine and benzidine dihydrochloride was posted on Environment Canada’s
National Office of Pollution Prevention Web site at http://www.
ec.gc.ca/NOPP/Consultations/en/consult.cfm.
Des dispositions relatives à la tenue de registres et à la soumission de certains renseignements se rapportant à l’HCB, au HCBD,
à la benzidine et au dihydrochlorate de benzidine ont été incluses
dans le projet de règlement. En octobre 2003, les intervenants ont
été invités à examiner l’ébauche du règlement et à formuler
par écrit des commentaires à ce sujet. Une version électronique
de tous les documents de consultation se rapportant au HCB,
au HCBD, à la benzidine et au dihydrochlorate de benzidine a été
affichée sur le site Internet du Bureau national de prévention de la
pollution d’Environnement Canada, à www.ec.gc.ca/NOPP/
Consultations/FR/consult.cfm.
Il a été proposé que soit l’Inventaire national des rejets de polluants ou l’ébauche du règlement soit utilisé à des fins de soumission de rapports. Des opinions contradictoires ont été émises : si
une liste de produits exigeant une soumission de rapports devrait
être ajoutée dans l’ébauche du règlement ou si des limites bien
définies déclenchant une déclaration obligatoire, devraient être
établies. Pour régler cette question, une liste de produits ou mélanges pour lesquelles une limite de concentration est requise, a
été ajoutée à la partie 1 de l’annexe 2.
It was suggested that either National Pollutant Release Inventory or the draft Regulations be used for reporting purposes. Opposing views were expressed on whether a list of products for
which reporting is required should be added in the draft Regulations, or whether well-defined limits that trigger reporting requirements should be identified. A list of products or mixtures for
which the contamination limit is required was added to Schedule 2, Part 1 to address this issue.
CEPA 1999 National Advisory Committee
Comité consultatif national de la LCPE
Prior to pre-publication in the Canada Gazette, Part I, members
of the CEPA National Advisory Committee were provided a formal opportunity to advise on the draft Total, Partial or Conditional Prohibition of Certain Toxic Substances Regulations, as
well as on the proposed addition of DDT to Schedule 1 of CEPA
1999. No objections were received, and comments were considered during the drafting of the Regulations.
Avant la publication dans la Gazette du Canada Partie I les
membres du Comité consultatif national de la LCPE ont été officiellement priés de donner leur avis sur l’ébauche du Règlement
sur l’interdiction totale, partielle ou conditionnelle de certaines
substances toxiques de même que sur l’ajout proposé du DDT à
l’annexe 1 de la LCPE (1999). Aucune objection n’a été reçue et
les commentaires ont été pris en compte durant l’élaboration du
règlement.
Comments Following Pre-Publication in the Canada Gazette,
Part I, on April 3, 2004
Commentaires suivant la publication au préalable dans la Gazette
du Canada Partie I le 3 avril 2004
The Regulations were pre-published in the Canada Gazette,
Part I, under the title Total, Partial or Conditional Prohibition of
Certain Toxic Substances Regulations. During the 60-day comment period, a total of eleven representations were submitted
from stakeholders. The majority of comments received were of
either a technical or administrative nature.
Le règlement a été publié au préalable dans la Gazette du
Canada Partie I sous le titre Règlement sur l’interdiction totale,
partielle ou conditionnelle de certaines substances toxiques. Pendant la période de commentaires de 60 jours, un total de 11 représentations a été soumis par les intervenants. La plupart de ces
commentaires étaient soit de nature technique ou soit de nature
administrative.
Neuf des soumissions provenaient du secteur privé, incluant
une association industrielle et cinq laboratoires. Les laboratoires
ont recommandé l’ajout d’un seuil de déclenchement quantitatif
pour la soumission des rapports. De plus, la communauté réglementée a recommandé l’ajout d’un seuil de déclenchement quantitatif pour la soumission de rapports pour le HCB, la benzidine et
le dihydrochlorate de benzidine. À la suite de la révision de ces
recommandations, des seuils de déclenchement quantitatif ont été
ajoutés aux exigences de soumission de rapports pour les laboratoires ainsi que pour les fabricants et les importateurs des deux
substances toxiques énumérées dans l’annexe 2, partie 3.
Nine submissions came from private industry, including one
industry association and five laboratories. Laboratories recommended the addition of a quantity trigger reporting standard. In
addition, the regulated community recommended the addition of
quantity triggers for the reporting of HCB, benzidine, and benzidine dihydrochloride. After a review of these proposals, quantity triggers were added to the reporting requirements for laboratories, as well as manufacturers and importers of the two toxic
substances in Schedule 2, Part 3.
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Private industry also recommended that Environment Canada
consider exempting destructive or consumptive uses of toxic substances where there is no to minimal risk. After a review of the
risks, an exemption has been added for non-emissive and destructive chemical feedstock uses, where the toxic substance is destroyed or completely converted to another substance.
Concern was expressed that fertilizers being potentially contaminated with a toxic substance will not be regulated for toxic
contaminants to the same degree as other products or mixtures,
including those regulated under other enforced Acts that will be
subjected to these Regulations. Hence, the exemption for fertilizers within the meaning of section 2 of the Fertilizers Act has been
removed.
A detailed review of public comments received during the consultation period for the proposed Regulations, and responses to
these comments, as well as comments received for other consultations, may be obtained from Environment Canada’s National
Office of Pollution Prevention Web site at http://www.ec.gc.ca/
NOPP.
Le secteur privé a également recommandé qu’Environnement
Canada considère exempter les usages destructeurs et non rationnels des substances toxiques où le risque est nul à minime. Après
un examen des risques, une exemption a été ajoutée lors de
l’utilisation d’une matière première chimique qui contient la substance toxique en tant que contaminant. Cette exemption s’applique au cours d’un processus n’occasionnant aucun rejet de la
substance toxique, pourvu que celle-ci soit détruite ou totalement
convertie au cours de ce processus en une autre substance.
Des préoccupations ont été exprimées à l’effet que certains engrais pouvaient être potentiellement contaminés par une substance
toxique. Dans ce cas, la substance toxique ne serait pas réglementée au même degré qu’une substance toxique contenue dans tout
autre produit ou mélange, incluant celles réglementées par
d’autres lois en vigueur qui seront assujetties à ce règlement.
D’où le retrait de l’exemption pour les engrais au sens de l’article 2 de la Loi sur les engrais.
Il est possible de prendre connaissance de tous les commentaires formulés par le public au cours de la période de commentaires
pour le projet de règlement ainsi que les réponses à ces commentaires, de même que les commentaires reçus pour d’autres consultations, en visitant le site Internet du Bureau national de la prévention de la pollution d’Environnement Canada à l’adresse
suivante : www.ec.gc.ca/NOPP/Consultations/FR/consult.cfm.
Compliance and Enforcement
Respect et exécution
As the Regulations will be promulgated under CEPA 1999, enforcement officers will, when verifying compliance with the
Regulations, apply the Compliance and Enforcement Policy implemented under that Act. The Policy outlines measures designed
to promote compliance, including education, information, promoting of technology development and consultation on the development of the Regulations. It also sets out the range of possible
responses to alleged violations: warnings, directions, environmental protection compliance orders, ticketing, ministerial orders,
injunctions, prosecution, and environmental protection alternative
measures (which are an alternative to a court trial after the laying
of charges for a violation under the Act). In addition, the Policy
explains when Environment Canada will resort to civil suits by
the Crown for cost recovery.
Puisque le règlement sera promulgué en vertu de
la LCPE (1999), les agents de l’autorité appliqueront, lors de la
vérification de la conformité aux règlements, la Politique
d’observation et d’application mise en œuvre en vertu de cette loi.
La Politique indique les mesures à prendre pour promouvoir la
conformité, ce qui comprend l’éducation, l’information, la promotion du développement de la technologie et la consultation sur
l’élaboration des règlements. La Politique décrit aussi toute une
gamme de mesures à prendre en cas de violations alléguées :
avertissements, ordres en cas de rejet, ordres d’exécution en matière de protection de l’environnement, contraventions, ordres
ministériels, injonctions, poursuites pénales et mesures de rechange en matière de protection de l’environnement (qui peuvent
remplacer une poursuite pénale, une fois que des accusations ont
été portées pour une infraction présumée à la Loi). De plus, la
Politique explique quand Environnement Canada aura recours à
des poursuites civiles intentées par la Couronne pour recouvrer
ses frais.
Lorsque, à la suite d’une inspection ou d’une enquête, un agent
de l’autorité arrive à la conclusion qu’il y a eu violation alléguée,
l’agent se basera sur les critères suivants pour décider de la mesure à prendre :
• La nature de la violation alléguée : Il convient notamment de
déterminer la gravité des dommages réels ou potentiels causés
à l’environnement, s’il y a eu action délibérée de la part du
contrevenant, s’il s’agit d’une récidive et s’il y a eu tentative
de dissimuler de l’information ou de contourner, d’une façon
ou d’une autre, les objectifs ou exigences de la Loi.
• L’efficacité du moyen employé pour obliger le contrevenant à
obtempérer : Le but visé est de faire respecter la Loi dans les
meilleurs délais tout en empêchant les récidives. Les facteurs
à être considérés sont entre autres le dossier du contrevenant
pour l’observation de la Loi, sa volonté de coopérer avec les
agents de l’autorité et la preuve que des mesures correctives
ont été apportées.
When, following an inspection or an investigation, an enforcement officer discovers an alleged violation, the officer will
choose the appropriate enforcement action based on the following
criteria:
• Nature of the alleged violation: This includes consideration of
the seriousness of the harm or potential harm to the environment, the intent of the alleged violator, whether it is a repeat
violation, and whether an attempt has been made to conceal
information or otherwise subvert the objectives and requirements of the Act.
• Effectiveness in achieving the desired result with the alleged
violator: The desired result is compliance with the Act within
the shortest possible time and with no further repetition of the
violation. Factors to be considered include the violator’s history of compliance with the Act, willingness to co-operate
with enforcement officers, and evidence of corrective action
already taken.
314
2005-03-09
•
Consistency in enforcement: Enforcement officers will consider how similar situations have been handled in determining
the measures to be taken to enforce the Act.
Contacts
Josée Trudel
Head
Toxics Control Section
Chemical Controls Branch
Environment Canada
Gatineau, Quebec
K1A 0H3
Telephone: (819) 953-6118
Céline Labossière
Policy Manager
Regulatory and Economic Analysis
Economic and Regulatory Affairs Directorate
Environment Canada
Gatineau, Quebec
K1A 0H3
Telephone: (819) 997-2377
Published by the Queen’s Printer for Canada, 2005
•
La cohérence dans l’application : Les agents de l’autorité
tiendront compte de ce qui a été fait dans des cas semblables
pour décider de la mesure à prendre pour appliquer la Loi.
Personnes-ressources
Josée Trudel
Chef
Section du contrôle des substances toxiques
Direction du contrôle des produits chimiques
Gatineau (Québec)
K1A 0H3
Téléphone : (819) 953-6118
Céline Labossière
Gestionnaire des politiques
Direction des analyses réglementaires et économiques
Direction générale des affaires économiques et réglementaire
Gatineau (Québec)
K1A 0H3
Téléphone : (819) 997-2377
Publié par l’Imprimeur de la Reine pour le Canada, 2005
315
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Benzidine - Rotterdam Convention

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