Vol. 145, No. 26 — December 21, 2011
SOR/2011-286 December 2, 2011
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
Order Adding a Toxic Substance to Schedule 1 to the Canadian Environmental Protection Act, 1999
P.C. 2011-1394 December 1, 2011
Whereas, pursuant to subsection 332(1) (see footnote a) of the Canadian Environmental Protection Act, 1999 (see footnote b), the Minister of the Environment published in the Canada Gazette, Part Ⅰ, on February 27, 2010, a copy of the proposed Order Adding a Toxic Substance to Schedule 1 to the Canadian Environmental Protection Act, 1999, substantially in the form set out in the annexed Order, 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;
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, His 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, 1999 (see footnote c), hereby makes the annexed Order Adding a Toxic Substance to Schedule 1 to the Canadian Environmental Protection Act, 1999.
ORDER ADDING A TOXIC SUBSTANCE TO SCHEDULE 1 TO THE CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
1. Schedule 1 to the Canadian Environmental Protection Act, 1999 (see footnote 1) is amended by adding the following in numerical order:
115. Benzene, (chloromethyl)-, which has the molecular formula C7H7Cl
COMING INTO FORCE
2. This Order comes into force on the day on which it is registered.
REGULATORY IMPACT ANALYSIS STATEMENT
(This statement is not part of the Order.)
Issue and objectives
Canadians depend on chemical substances that are used in the manufacturing of hundreds of goods, from medicines to computers, fabrics and fuels. Unfortunately, some chemical substances can have detrimental effects on the environment and/or human health when released in a certain quantity or concentration or under certain conditions in the environment. Scientific assessments of the impact of human and environmental exposure have determined that a number of these substances constitute or may constitute a danger to human health and to the environment as per the criteria set out under section 64 of the Canadian Environmental Protection Act, 1999 (CEPA 1999).
The objective of the Order Adding a Toxic Substance to Schedule 1 to the Canadian Environmental Protection Act, 1999 (hereinafter referred to as the Order), made pursuant to subsection 90(1) of CEPA 1999, is to add the following substance to the List of Toxic Substances in Schedule 1 of CEPA 1999, as per the recommendation of the screening assessment report:
- Benzene, (chloromethyl)- (Chemical Abstracts Service [CAS] (see footnote 2) Registry No. 100-44-7), hereafter referred to as “benzyl chloride.”
This addition enables the Minister of the Environment and the Minister of Health (the Ministers) to develop proposed regulations or instruments to manage human health and environmental risks posed by benzyl chloride under CEPA 1999. The Ministers may, however, choose to develop instruments outside of the purview of CEPA 1999 to manage these risks.
Description and rationale
Approximately 23 000 substances (often referred to as “existing” substances) were in use in Canada between January 1, 1984, and December 31, 1986. These substances are found on the Domestic Substances List (DSL), but many of them have never been assessed as to whether they meet any of the criteria set out in section 64 of CEPA 1999. Section 73 of the Act required that substances on the DSL be categorized to determine which of them pose the greatest potential for exposure to the general population. Categorization also determines which of these substances are persistent or bioaccumulative in accordance with the Regulations and inherently toxic to human beings or to non-human organisms. Pursuant to section 74 of the Act, substances that were flagged during the categorization process must undergo an assessment to determine whether they meet any of the criteria set out in section 64. Assessments may also be conducted under section 68 of the Act for substances identified as high priorities for action, but that do not meet the categorization criteria set out under section 73 of the Act.
The Ministers completed the categorization exercise in September 2006. Of the approximately 23 000 substances on the DSL, about 4 300 were identified as needing further attention.
As a result of categorization, the Chemicals Management Plan (the Plan) was launched on December 8, 2006, with the objective of improving the degree of protection from hazardous chemicals.
A key element of the first phase of the Plan is the collection of information on the properties and uses of approximately 200 substances identified as high priorities for action. This includes substances
- that were found to meet the categorization criteria for persistence, bioaccumulation potential and inherent toxicity to non-human organisms, and that are known to be in commerce, or of commercial interest, in Canada; these substances are considered to be high priorities for assessment of ecological risk; and/or
- that were found either to meet the categorization criteria for greatest potential for exposure or to present an intermediate potential for exposure, and were identified as posing a high hazard to human health based on available evidence on carcinogenicity, mutagenicity, developmental toxicity or reproductive toxicity; these substances are considered to be priorities for assessment of risk to human health.
This information is being used to make decisions regarding the best approaches to protect Canadians and their environment from the risks these substances might pose. This information-gathering initiative is known as the “Challenge.”
To facilitate the process, Environment Canada and Health Canada have organized the approximately 200 substances into 12 batches of approximately 15 substances. A batch is released every three months, and stakeholders are required to report information such as quantities imported, manufactured or used in Canada via a mandatory survey issued under section 71 of CEPA 1999. Affected parties are required to submit this information to better inform decision making, including determining whether a substance meets one or more of the criteria set out in section 64 of CEPA 1999 — that is to say, whether the substance is entering or may enter the environment in a quantity or concentration or under conditions that
- have or may have an immediate or long-term harmful effect on the environment or its biological diversity;
- constitute or may constitute a danger to the environment on which life depends; or
- constitute or may constitute a danger in Canada to human life or health.
Based on the information received and other available information, screening assessments are conducted in order to assess whether substances meet one or more of the criteria of section 64. The screening assessments are peer-reviewed and additional advice is also sought, as appropriate, through the Challenge Advisory Panel. The Panel, made up of experts from various fields such as chemical policy, chemical production, economics and environmental health, was formed to provide advice to Government on the application of precaution and weight of evidence to screening assessments in the Challenge. These screening assessments are then published on the Chemical Substances Web site at www.chemicalsubstanceschimiques.gc.ca/challenge-defi/ batch-lot-6/index-eng.php along with notices that are published in the Canada Gazette, Part Ⅰ, that signal the Ministers’ intent with regard to further risk management.
The Minister of the Environment is required under section 91 of CEPA 1999 to publish in the Canada Gazette a proposed regulation or instrument establishing preventive or control actions within two years of publishing a statement under paragraph 77(6)(b) of CEPA 1999 indicating that the measure the Ministers propose to take, as confirmed or amended, is a recommendation that the substance be added to the List of Toxic Substances in Schedule 1 of CEPA 1999. Section 92 then requires that the regulation or instrument be finalized and published within 18 months following the publication in the Canada Gazette, Part Ⅰ.
The addition of these substances to Schedule 1 of CEPA 1999 allows the Ministers to develop risk management instruments in order to meet these obligations. The Act enables the development of risk management instruments (such as regulations, guidelines or codes of practice) to protect the environment and human health. These instruments can be developed for any aspect of the substance’s life cycle, from the research and development stage through manufacture, use, storage, transport and ultimate disposal or recycling. Proposed Risk Management Approach documents, which provide an indication of where the Government will focus its risk management activities, have been prepared for Batch 6 substances and are available on the Chemical Substances Web site listed above.
Substance description, assessment summary and conclusion for Batch 6
Benzene, (chloromethyl)-, referred to throughout this document as “benzyl chloride,” is mainly used in the production of benzalkonium chloride, which is a chemical intermediate for the synthesis of other compounds found in numerous products (e.g. hard surface sanitizers, corrosion inhibitors, industrial and institutional cleaners, skin antiseptics, food packaging, and personal care products). The presence of benzyl chloride would only be as an impurity, residual or unreacted material, and would be present at very low to negligible concentrations (<0.01%). In accordance with information gathered from a survey conducted under section 71 of CEPA 1999, there is no indication that benzyl chloride was manufactured in Canada in quantities equal to or greater than the reporting threshold of 100 kg, in 2006. Based on the survey, benzyl chloride was imported into Canada in the range of 100 000 kg to 1 000 000 kg, in 2006.
Benzyl chloride was assessed as a high priority for further consideration on the basis of concern for potential risk to human health. The assessment has determined that a critical effect for assessment or risk to human health is carcinogenicity. This assessment is principally based on the weight-of-evidence classification of benzyl chloride by several international and other national agencies. The European Commission (1999) has classified benzyl chloride as a Category 2 carcinogenic substance (carcinogenic to humans), whereas the US Environmental Protection Agency (EPA) has classified it as a Group B2 carcinogen (probable human carcinogen) (US EPA 2008), and the International Agency for Research on Cancer (IARC 1999) has classified the chemical as a Group 2A carcinogen. These classifications were based principally on observation of increases in tumour incidences in long-term bioassays in rodents.
Foreign literature sources (see footnote 3) indicate that benzyl chloride may be released into the atmosphere from coal- and oil-fired power plants. However, recent Canadian measurement data of ambient (outdoor) and indoor air indicate that concentrations are low.
While significant amounts of benzyl chloride are used in the manufacture of other chemicals, industrial emissions are likely to be low. Several product exposure scenarios were also identified; however, exposures of the Canadian general population due to the use of products containing residual quantities of benzyl chloride are predicted to be low. The potential exposure of the general population in Canada was, therefore, considered to be limited. However, on the basis of the carcinogenicity of benzyl chloride, there may be a probability of harm at any level of exposure.
Final assessment conclusion
The final screening assessments for the sixth batch of the Challenge concluded that only one of the 18 substances, benzyl chloride, meets one or more of the criteria set out in section 64 of CEPA 1999.
On the basis of the carcinogenicity for which there is a probability of harm at any level of exposure, it is concluded that benzyl chloride may be entering the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health as set out in paragraph 64(c) of CEPA 1999. Benzyl chloride is thus proposed to be recommended for addition to Schedule 1 of CEPA 1999.
The final screening assessment report, the proposed risk management approach document and a summary of responses to comments received on this substance was published on November 28, 2009, and may be obtained from the Chemical Substances Web site listed above or from the Program Development and Engagement Division, Environment Canada, Gatineau, Quebec K1A 0H3, 819-953–7155 (fax) or by email at firstname.lastname@example.org.
The following measures can be taken after an assessment is conducted under section 74 of CEPA 1999:
- adding the substance to the Priority Substances List for further assessment (when additional information is required to determine whether or not a substance meets the criteria in section 64);
- taking no further action in respect of the substance; or
- recommending that the substance be added to the List of Toxic Substances in Schedule 1, and where applicable, recommending the implementation of virtual elimination.
It has been concluded in the final screening assessment report that benzyl chloride is entering, or may enter, the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health as set out in section 64 of CEPA 1999. Adding this substance to Schedule 1, which will enable the development of regulations or other risk management instruments, is therefore the best option.
Benefits and costs
This addition enables the Ministers to develop proposed regulations or instruments to manage risks posed by this substance under CEPA 1999. These include instruments such as pollution prevention plans. The Ministers may, however, choose to develop instruments outside of the purview of the Act to help protect human health and the environment. The ministers will undertake an assessment of the potential impacts, including an economic analysis, and consult with the public and other stakeholders during the development of these risk management proposals.
On May 30, 2009, the Ministers published a summary of the scientific assessments for the 18 substances in Batch 6 of the Challenge in the Canada Gazette, Part Ⅰ, for a 60-day public comment period. Risk management scope documents were also released on the same date, outlining the preliminary options being examined for the management of the substances proposed to be toxic under section 64 of CEPA 1999. Prior to this publication, Environment Canada and Health Canada have informed the governments of the provinces and territories through the CEPA National Advisory Committee (NAC) of the release of the Screening Assessment reports on the 18 substances, the risk management scope documents, and the public comment period mentioned above. No comments were received from CEPA NAC.
During the 60-day public comment period, a total of 11 submissions were received from 3 industry stakeholders, 3 industry associations and 5 non-governmental organisations (NGOs), on the scientific assessment and risk management scope documents. All comments were considered in developing the final screening assessments.
Comments received on the risk management scope document for benzyl chloride were considered when developing the proposed risk management approach document, which is also subject to a 60-day public comment period.
Below is a summary of comments received for all the Batch 6 assessments and new comments relevant to the overall process, as well as responses to these comments. In cases where comments have been made concerning whether or not a substance meets one of the criteria of section 64 of the Act due to lack of information or uncertainty, the Government will proceed to take action to protect the health of Canadians and their environment. The complete responses to comments received may be obtained from the Web site, address, fax number or email address listed above.
Summary of general comments and responses
- One environmental non-governmental organization suggested that the two departments should improve the assessment process to account for the exposure and release of substances (including breakdown products) throughout their life-cycle. In particular, exposure to humans and the environment from the recycling and disposal processes as well as recycled products should be considered.
Response: Information obtained in response to the Challenge, as well as from a range of other sources, is used to identify sources of exposure to a substance. Assessment of risk focuses on those sources that are most likely to be of concern. Regarding the disposal phase, assessments based on ecological concerns include an estimate of the quantity of the substance that may end up in landfills at the end of its life. Approaches are currently under development to identify substances for which monitoring of landfill leachates may be warranted to support risk management activities. Breakdown products are addressed in screening assessments if sufficient information is available and there is an indication that these products are hazardous.
Environment Canada and Health Canada strive to take into consideration recycling activities and resulting potential releases to the Canadian environment during the risk assessment process.
- Two environmental non-governmental organizations recommended that the screening assessment reports should identify the levels of chemicals that result from incineration, if applicable. Chemicals that are harmful to human health such as dioxins, furans and heavy metals result from incineration and the lack of information on incineration practices hinders the complete understanding of a chemical’s fate.
Response: Environment Canada and Health Canada recognize that other potentially toxic substances may be present or formed during processing, use and disposal of products. Assessments of substances in the Challenge on the basis of ecological concerns include an estimate of the quantity of the substance that may end up in landfills or incinerators at the end of its life. Breakdown products are addressed in screening assessments if sufficient information is available and there is an indication that these products are hazardous. Consequently, risks posed by breakdown products can influence the conclusion on whether the subject substance meets the “toxic” criteria under section 64 of CEPA 1999.
- Two environmental non-governmental organizations suggested that the draft/final screening assessment reports have not addressed issues raised in the past by the public on the limitations observed in the screening assessment reports.
Response: The departments are committed to continuing and improving dialogue with all stakeholders so that risks posed by substances being assessed under the Challenge are reduced and managed to protect the health of Canadians and the environment. The departments will continue to consider all comments received on risk assessment and management scope documents.
Summary of comments and responses specific to benzyl chloride
- Two non-governmental organizations suggested that there were gaps in the information currently available on human exposure and health effects, but given the current scientific knowledge they agreed that the substance should be designated as “toxic.”
Response: The screening assessment is based on the information currently available for determination of critical health effects from published literature in scientific journals as well as international reviews and information collected under section 71 of CEPA 1999. The Ministers have stated that the absence of new information does not preclude from issuing a decision that safeguards human health and the environment.
- Three non-governmental organizations suggested that the scope of the assessment be expanded to include other media of exposure such as food and products containing residual amounts of the substance, the effects of the exposure on vulnerable sub-group populations and long-range transportation impacts.
Response: Exposure of the general population through environmental media was considered in developing the screening assessment. The substance was not identified in any other food contact application except for use in the production of a specific type of coating for fruit packaging. Consequently, the exposure from food would be negligible.
Because the substance is only moderately persistent in the air and presents a low risk to aquatic organisms; long-range transportation does not represent a concern.
- Two NGOs commented on the absence of the substance residue or releases from its use as an intermediate and its presence in industrial waste.
Response: The substance is not an ingredient directly added in any consumer application. Due to its use as an intermediate in closed systems and its readily reactive nature, residues and releases are expected to be minimal. This has been confirmed by data collected at industrial facilities.
Comments received following publication of the proposed Order in the Canada Gazette, Part Ⅰ
On February 27, 2010, the Ministers published a proposed Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999 in the Canada Gazette, Part Ⅰ. No comments were received during the 60-day public comment period.
Implementation, enforcement and service standards
The Order adds benzyl chloride to Schedule 1 of CEPA 1999, thereby allowing the Ministers to develop and publish proposed regulations or instruments no later than November 28, 2011, and finalize them no later than May 28, 2013. Developing an implementation plan, a compliance strategy or establishing service standards are not considered necessary without any specific risk management proposals. An appropriate assessment of implementation, compliance and enforcement will be undertaken during the development of a proposed regulation or control instrument(s) respecting preventive or control actions for this substance.
Program Development and Engagement Division
Substances Management Information Line:
1-800-567-1999 (toll free in Canada)
Risk Management Bureau
S.C. 2004, c. 15, s. 31
S.C. 1999, c. 33
S.C. 1999, c. 33
S.C. 1999, c. 33
The Chemical Abstracts Service Registry Number (CAS RN) is the property of the American Chemical Society and any use or redistribution, except as required in supporting regulatory requirements and/or for reports to the government when the information and the reports are required by law or administrative policy, is not permitted without the prior, written permission of the American Chemical Society.
United States Environmental Protection Agency, Bituminous and subbituminous coal combustion. In Emission factor documentation for AP 42. Washington (DC): U.S. EPA, Office of Air Quality Planning and Standards (1993). Available from www.epa.gov/ttn/chief/ap42/ch01/final/c01s01.pdf.