Vol. 144, No. 9 — February 27, 2010

Order Adding a Toxic Substance to Schedule 1 to the Canadian Environmental Protection Act, 1999

Statutory authority

Canadian Environmental Protection Act, 1999

Sponsoring departments

Department of the Environment and Department of Health

REGULATORY IMPACT
ANALYSIS STATEMENT

(This statement is not part of the Order.)

Issue and objectives

Canadians depend on chemical substances that are used in hundreds of goods, from medicines to computers, fabrics, and fuels. Unfortunately, some chemical substances can negatively affect our health and environment when released in a certain quantity or concentration in the environment. A scientific assessment of the impact of human and environmental exposure to Benzene, (chloromethyl)-, hereinafter referred to as “benzyl chloride,” has determined that it constitutes or may constitute a danger in Canada to human life or health as set out under paragraph 64(c) of the Canadian Environmental Protection Act, 1999 (CEPA 1999).

The objective of the proposed Order Adding a Toxic Substance to Schedule 1 to the Canadian Environmental Protection Act, 1999 (hereinafter referred to as the proposed Order) to be made under subsection 90(1) of CEPA 1999 is to add benzyl chloride to the List of Toxic Substances in Schedule 1 of the Act. This addition would enable the development of measures (which could include regulatory and non-regulatory instruments) under CEPA 1999 to manage human health risks posed by this substance.

Description and rationale

Background

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), many of which have never been assessed as to whether they meet any of the toxicity criteria set out in section 64 of CEPA 1999. Section 73 of the Act requires that substances on the DSL be “categorized” to determine which of them pose the greatest potential for exposure to the general population as well as those that are persistent or bioaccumulative and inherently toxic to human beings or non-human organisms. Pursuant to section 74 of the Act, substances that are “categorized in” must undergo an assessment to determine whether they meet any of the toxicity 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 specific criteria set out under section 73 of the Act.

The Minister of the Environment and the Minister of Health (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, of which around 200 were identified as high priorities for action.

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 Plan is the collection of information on the properties and uses of the approximately 200 substances identified as high priorities for action mentioned above. 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 12 to 20 substances, and every three months a batch is released, 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 if 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 any of the criteria set out in section 64. The screening assessments are peer-reviewed and additional advice is also sought, as appropriate, through the Challenge Advisory Panel. The Panel, comprised of experts from various fields such as chemical policy, chemical production, economics and environmental health, was formed to provide advice to the Ministers pertaining to the application of precaution and/or weight of evidence in screening assessments in the Challenge. These screening assessments are then published on the Chemical Substances Web site at www.chemicalsubstances.gc.ca along with notices that are published in the Canada Gazette, Part I, which signal the Ministers’ intent with regards to further risk management.

The addition of this particular substance on Schedule 1 of CEPA 1999 allows the Ministers to develop risk management instruments. 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. A “risk management approach” document, which provides an indication of where the Government will focus its risk management activities, has been prepared for benzyl chloride and is available on the Chemical Substances Web site listed above.

The draft screening assessments for the sixth batch of the Challenge comprising 18 substances were published on the Chemical Substances Web site (www.chemicalsubstanceschimiques.gc.ca/challenge-defi/batch-lot-6/index-eng.php). It has been concluded that benzyl chloride meets the criteria set out in paragraph 64(c) of CEPA 1999. The substance constitutes or may constitute a danger in Canada to human life or health. The statement recommending addition to Schedule 1 for benzyl chloride was published in the Canada Gazette, Part I, on May 30, 2009, for a 60-day comment period.

The assessment summary, the conclusion and an overview of the public comments received during the public comment period for this substance are presented below.

Substance description, assessment summary and conclusion

Benzyl chloride

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). Therefore, benzyl chloride may be present as a residual in these products. In accordance with information gathered from a survey conducted under section 71 of CEPA 1999, there is no indication that any company manufactured benzyl chloride in Canada at 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 U.S. Environmental Protection Agency (EPA) has classified it as a Group B2 carcinogen (probable human carcinogen) [U.S. 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 1) indicate that benzyl chloride may be released into the atmosphere from facilities of 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.

Assessment conclusion

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 section 64 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 at www.chemicalsubstances.gc.ca or from the Program Development and Engagement Division, Gatineau, Quebec K1A 0H3, 819-953-7155 (fax), Existing.Substances.Existantes@ec.gc.ca (email).

Alternatives

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 if a substance meets the criteria in section 64 or not);
• 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, 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.

This substance meets one or more of the criteria under 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

Adding benzyl chloride onto Schedule 1 enables the Ministers to develop risk management proposals for this substance under CEPA 1999, which may be both regulatory and non-regulatory, to help protect human health and the environment. The Ministers will assess costs and benefits and consult with the public and other stakeholders during the development of these risk management proposals.

Consultation

In accordance with the Act, 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 organizations (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 Batch 6 assessments and new comments relevant to the overall process, as well as responses to these. 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 Ministers 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 its 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.
  
  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.
  
  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.
  
  The two 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.”
  
  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.
  
  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 non-governmental organizations commented on the absence of the substance residue or releases from its use as an intermediate and its presence in industrial waste.
  
  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.

Implementation, enforcement and service standards

The proposed Order would add benzyl chloride to Schedule 1 of CEPA 1999, thereby allowing the Minister of the Environment to meet his statutory duty to publish proposed regulations or other 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.

Contacts

Mark Burgham
Program Development and Engagement Division
Environment Canada
Gatineau, Quebec
K1A 0H3
Telephone: 819-956-9313
Fax: 819-953-7155
Email: Existing.substances.existantes@ec.gc.ca

Arthur Sheffield
Risk Management Bureau
Health Canada
Ottawa, Ontario
K1A 0K9
Telephone: 613-957-8166
Fax: 613-952-8857
Email : Arthur_Sheffield@hc-sc.gc.ca

PROPOSED REGULATORY TEXT

Notice is hereby given, pursuant to subsection 332(1) (see footnote a) of the Canadian Environmental Protection Act, 1999 (see footnote b), that the Governor in Council, on the recommendation of the Minister of the Environment and the Minister of Health, pursuant to subsection 90(1) of that Act, proposes to make the annexed Order Adding a Toxic Substance to Schedule 1 to the Canadian Environmental Protection Act, 1999.

Any person may, within 60 days after the date of publication of this notice, file with the Minister of the Environment comments with respect to the proposed Order or a notice of objection requesting that a board of review be established under section 333 of that Act and stating the reasons for the objection. All comments and notices must cite the Canada Gazette, Part I, and the date of publication of this notice, and be sent to the Executive Director, Program Development and Engagement Division, Environment Canada, Gatineau, Quebec K1A 0H3 (fax: 819-953-7155; e-mail: Existing.Substances.Existantes@ec.gc.ca).

A person who provides the Minister of the Environment with information may submit it with a request for confidentiality under section 313 of that Act.

Ottawa, February 23, 2010

JURICA ČAPKUN
Assistant Clerk of the Privy Council

ORDER ADDING A TOXIC SUBSTANCE TO SCHEDULE 1 TO THE CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

AMENDMENT

1. Schedule 1 to the Canadian Environmental Protection Act, 1999 (see footnote 2) is amended by adding the following:

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.

[9-1-o]

Footnote 1
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), www.epa.gov/ttn/chief/ap42/ch01/final/c01s01.pdf.

Footnote 2
S.C. 1999, c. 33

Footnote a
S.C. 2004, c. 15, s. 31

Footnote b
S.C. 1999, c. 33

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