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Registration

SOR/2013-66 April 16, 2013

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Order 2013-87-05-01 Amending the Domestic Substances List

Whereas the substance set out in the annexed Order is specified on the Domestic Substances List (see footnote a);

Whereas the Minister of the Environment and the Minister of Health have conducted a screening assessment of the substance under section 74 of the Canadian Environmental Protection Act, 1999 (see footnote b);

Whereas the Ministers are satisfied that the substance is not being manufactured in Canada by any person in a quantity of more than 100 kg in any one calendar year and is only being imported into Canada by any person in that quantity in any one calendar year for a limited number of uses;

And whereas the Ministers suspect that the information concerning a significant new activity in relation to the substance may contribute to determining the circumstances in which the substance is toxic or capable of becoming toxic within the meaning of section 64 of the Canadian Environmental Protection Act, 1999;

Therefore, the Minister of the Environment, pursuant to subsection 87(3) of the Canadian Environmental Protection Act, 1999 (see footnote c), makes the annexed Order 2013-87-05-01 Amending the Domestic Substances List.

Gatineau, April 11, 2013

PETER KENT
Minister of the Environment

ORDER 2013-87-05-01 AMENDING THE DOMESTIC SUBSTANCES LIST

AMENDMENTS

1. Part 1 of the Domestic Substances List (see footnote 1) is amended by deleting the following:

100-44-7

2. Part 2 of the List is amended by adding the following in numerical order:

Column 1


S
ubstance

Column 2

Significant New Activity for which substance is subject to subsection 81(3) of the Act

100-44-7 S′

  1. Any activity involving, in any one calendar year, more than 100 kg of the substance benzene, (chloromethyl)-, other than an activity related to
    • (a) its use as a chemical intermediate in the manufacture of quaternary ammonium compounds; or
    • (b) its use in an activity that is regulated under the Pest Control Products Act.
  2. For each proposed significant new activity, the following information must be provided to the Minister at least 180 days before the day on which the quantity of the substance exceeds 100 kg in any one calendar year:
    • (a) a description of the significant new activity in relation to the substance;
    • (b) the annual quantity of the substance anticipated to be used;
    • (c) if known, the three sites in Canada where the greatest quantity of the substance is anticipated to be used or processed and the estimated quantity by site;
    • (d) the information specified in items 3 to 7 of Schedule 4 to the New Substances Notification Regulations (Chemicals and Polymers);
    • (e) the information specified in paragraphs 2(d) to (f) and 8(a) to (g) of Schedule 5 to those Regulations;
    • (f) the information specified in item 11 of Schedule 6 to those Regulations;
    • (g) a summary of all other information or test data in respect of the substance that are in the possession of the person proposing the significant new activity, or to which they have access, and that are relevant to identifying hazards to the environment and human health and the degree of environmental and public exposure to the substance;
    • (h) the identification of every government department or government agency, either outside or within Canada, to which the person proposing the significant new activity has provided information regarding the use of the substance and, if known, the department’s or agency’s file number and, if any, the outcome of the department’s or agency’s assessment and the risk management actions in relation to the substance imposed by the department or agency;
    • (i) the name, civic and postal addresses and telephone number and, if any, the fax number and email address of the person proposing the significant new activity and of the person authorized to act on behalf of that person, if any; and
    • (j) a certification stating that the information is accurate and complete, dated and signed by the person proposing the significant new activity, if they are resident in Canada or, if not, by the person authorized to act on their behalf.
  3. The above information will be assessed within 180 days after the day on which it is received by the Minister.

COMING INTO FORCE

3. 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

The screening assessment conducted on benzene, (chloromethyl)- [hereafter referred to as “benzyl chloride”] concluded that this substance is harmful to human life or health based on its carcinogenicity. (see footnote 2)Current activities associated with benzyl chloride are being managed through existing risk management actions. As a result, current levels of exposure to Canadians are expected to be low and current activities are not expected to pose a risk to the health of Canadians. However, should new activities associated with benzyl chloride commence, the substance may pose a risk to human health.

Background

On December 8, 2006, the Chemicals Management Plan (CMP) was announced by the Government of Canada to assess and manage chemicals that may be harmful to human health or the environment. A key element of the CMP is the Challenge initiative, which collected information on the properties and uses of the approximately 200 high priority chemical substances. These 200 chemicals were divided into 12 batches of 10 to 20 chemicals each. Benzyl chloride is among the 18 chemicals in batch six of the Challenge.

Health Canada and Environment Canada conducted screening assessments to determine whether any of the substances in batch six are harmful to the environment or human health as defined under section 64 of the Canadian Environmental Protection Act, 1999 (CEPA 1999). According to the summary of the final screening assessments, published in the Canada Gazette, Part I, on November 28, 2009, benzyl chloride met the criteria set out in paragraph 64(c) of CEPA 1999 based on its carcinogenicity. (see footnote 3) An order adding this substance to Schedule 1 of CEPA 1999 was published in the Canada Gazette, Part II, on December 21, 2011, to enable the development of risk management instruments to manage risks associated with this substance. (see footnote 4)

Significant new activity (SNAc) provisions of CEPA 1999

Given that benzyl chloride is listed on the Domestic Substances List (DSL), activities associated with this substance can be conducted by industry without obligation to notify the Government of Canada. When the Government of Canada is concerned that any significant new activity in relation to a substance may result in an increased risk to human health or the environment, the Minister of the Environment (the Minister) may impose notification requirements on future activities in relation to the substance.As benzyl chloride has been determined to be harmful to human health, new activities involving this substance may be a source of potential concern. (see footnote 5) Therefore, the Minister published a Notice of Intent in the Canada Gazette, Part I, on November 26, 2011, to inform stakeholders of the Minister’s intent of applying the SNAc provisions of CEPA 1999 to benzyl chloride. (see footnote 6)

Current industry activities

Benzyl chloride is mainly used as a chemical intermediate for the manufacturing of quaternary ammonium compounds. End-use applications of these chemical compounds include their use as an active ingredient in pest control products, as a surface-active agent (surfactant) in industrial and commercial products, and as a surfactant or bactericide in personal care products.

According to data gathered from a mandatory survey published under section 71 of CEPA 1999, benzyl chloride was not manufactured in quantities above 100 kg (the minimum threshold for reporting) in Canada during the 2006 calendar year. In the same year, between 100 000 and 1 000 000 kg of benzyl chloride were imported into Canada.

Current risk management actions

Benzyl chloride is currently managed both directly and indirectly by regulations issued under various federal acts. Regulations that help limit releases and exposure to benzyl chloride include the Transport of Dangerous Goods Regulations,the Export and Import of Hazardous Waste and Hazardous Recyclable Material Regulations under CEPA 1999, the Vessel Pollution and Dangerous Chemicals Regulations under the Canada Shipping Act, 2001, and the Controlled Products Regulations under the Hazardous Products Act.

Benzyl chloride is on Health Canada’s Cosmetic Ingredient Hotlist. It is also on List 2 of the Pest Management Regulatory Agency (PMRA) List of Formulants, a list of formulants of potential concern with high priority for reassessment. (see footnote 7) Benzyl chloride is also subject to reporting under the National Pollutant Release Inventory as well as the Airborne Contaminant Discharge Monitoring and Reporting Regulation of Ontario.

Risk management actions in other jurisdictions

Benzyl chloride is subject to various risk management actions internationally. In Japan, benzyl chloride is listed as a hazardous air pollutant under the Air Pollution Control Law. In the European Union, the substance is subject to the Transport of Dangerous Goods directive, and is prohibited in cosmetic products. (see footnote 8) In the United States, the substance is subject to the Resource and Conservation and Recovery Act, requiring federal or state regulations for the management of the waste of benzyl chloride; releases of benzyl chloride are subject to the Emergency Planning and Community Right-to-Know Act and the Comprehensive Environmental Response, Compensation, and Liability Act; and this substance is on List II of the Controlled Substances Act.

Objectives

The objective of the Order is to contribute to the protection of human health by collecting information on significant new activities associated with benzyl chloride. This will allow the Government of Canada to assess the substance associated with the new activities and to determine whether further risk management on benzyl chloride is necessary.

Description

The Order deletes benzyl chloride from Part 1 of the DSL, by removing its Chemical Abstracts Service (CAS) Registry Number, adds it to Part 2 of the DSL, and indicates, by the addition of the letter S′ following the CAS Registry Number, that benzyl chloride is subject to the SNAc provisions of CEPA 1999.

The Order requires any person that intends to import, use, or manufacture benzyl chloride in the manner and quantity defined in the Order to provide a notice to the Minister 180 days in advance of the intended activity. The Order outlines the information requirements.

Environment Canada and Health Canada will use the submitted information to conduct human health and environmental assessments within 180 days after the information is received and will determine if such activity requires further risk management consideration. Activities which are determined to be adequately managed by existing risk management actions or are of low concern are therefore exempted from the notification requirements. These exemptions are described in the Order.

The Order complements the existing risk management actions and will assist in managing potential risks associated with new activities related with benzyl chloride.

The Order comes into force on the day on which it is registered.

Consultation

On November 26, 2011, a Notice of Intent to amend the Domestic Substances List was published for a 60-day public comment period in the Canada Gazette, Part I. (see footnote 9)No comments from stakeholders were received during the 60-day public comment period.

The National Advisory Committee of CEPA 1999 (CEPA NAC) was given the opportunity to advise the Minister of Health and the Minister of the Environment (the ministers) on the Notice of Intent. No comments were received from CEPA NAC.

“One-for-One” Rule

The “One-for-One” Rule is not applicable to the Order. Current activities involving benzyl chloride are exempted by the Order and there is no indication that industry’s current activity pattern associated with benzyl chloride may change in the future. Therefore, no incremental administrative costs are expected to be incurred by businesses.

Small business lens

The small business lens does not apply to this Order as there are no expected impacts on industry or small businesses based on current and anticipated practices. Canadian companies that are currently using benzyl chloride are not captured by the Order and there is no indication that current industrial activity patterns associated with the substance will change in the future.

Rationale

Benzyl chloride has the potential to be harmful to human health as determined by the screening assessment, and had been added to Schedule 1 of CEPA 1999. Sections 91 and 92 of CEPA 1999 require the Minister to propose and publish in the Canada Gazette a risk management instrument in relation to substances listed on Schedule 1 of CEPA 1999.

Current activities associated with benzyl chloride are being managed by existing risk management actions. However, as the substance is listed on Part 1 of the DSL, notification to the Minister of activities involving it is not required. Given the hazardous nature of benzyl chloride, future activities may pose a risk to human health. Therefore, maintaining the status quo as a risk management option has been rejected.

Modifying the DSL to apply the SNAc provisions allows the Minister to be informed of new activities of benzyl chloride. The submitted information will assist the Government of Canada in conducting both health and environmental assessments on these activities and would allow the ministers to take appropriate risk management actions in relation to those activities. For these reasons, it was determined that applying the SNAc provisions to benzyl chloride is the preferred option.

The Order contributes to the protection of human health by assessing significant new activities prior to their introduction. The permitted activities, as set out in the Order, are expected to result in a low to negligible exposure to the substance. Therefore, the Order allows these activities to continue while ensuring that the Government is notified of any significant new activities.

Based on their current business practices, companies that are currently using or importing benzyl chloride will not be captured by the Order. Should significant new activities involving the substance occur, costs would be incurred by industry for generating data and other information to be supplied to the Minister. However, it is not expected that current industrial activity patterns will change in the future, and industry did not provide any indications to the contrary following the publication of the Notice of Intent. Therefore, the Order is not expected to impact industry.

In the event of notification, the Government of Canada will incur costs for processing the information in relation to the SNAc and for conducting health and environmental assessments. Furthermore, the Government of Canada will incur costs to verify compliance with the Order by conducting compliance promotion and enforcement activities. Costs associated with these activities are expected to be low.

In conclusion, although it was not possible to quantitatively estimate the benefits and costs, the overall impact of the Order is expected to be positive.

Implementation, enforcement and service standards

Implementation

The Order comes into force on the day on which it is registered. The compliance promotion activities to be conducted as part of the implementation of the Order includes developing and distributing promotional material, responding to inquiries from stakeholders and undertaking activities to raise industry stakeholders’ awareness of the requirements of the Order.

Enforcement

The Order is made under the authority of CEPA 1999. When verifying compliance with the Order, enforcement officers will apply the Compliance and Enforcement Policy implemented under CEPA 1999. The Compliance and Enforcement Policy sets out the range of possible responses to violations, including 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 CEPA 1999 violation). In addition, the Policy explains when Environment Canada will resort to civil suits by the Crown for cost recovery.

When an enforcement officer discovers an alleged violation following an inspection or an investigation, the officer will choose the appropriate enforcement action based on the following factors:

  • 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 CEPA 1999.
  • 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 CEPA 1999, willingness to co-operate with enforcement officers, 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 CEPA 1999.
Service standards

Environment Canada and Health Canada will assess all information submitted as part of the SNAc notification and will communicate the result to the notifier 180 days after the information is received.

Contacts

  • Greg Carreau
    Executive Director
    Program Development and Engagement Division
    Environment Canada
    Gatineau, Quebec
    K1A 0H3
    Substances Management Information Line:
    1-800-567-1999 (toll-free in Canada)
    819-953-7156 (outside of Canada)
    Fax: 819-953-7155
    Email: substances@ec.gc.ca

  • Michael Donohue
    Risk Management Bureau
    Safe Environments Directorate
    Healthy Environments and Consumer Safety Branch
    Health Canada
    Ottawa, Ontario
    K1A 0K9
    Telephone: 613-957-8166
    Fax: 613-952-8857
    Email: michael.donohue@hc-sc.gc.ca

  • Footnote a
    SOR/94-311
  • Footnote b
    S.C. 1999, c. 33
  • Footnote c
    SOR/94-311
  • Footnote 1
    SOR/94-311
  • Footnote 2
    The Chemical Abstracts Service Registry Number of benzyl chloride is 100-44-7.
  • Footnote 3
    The final screening assessments for all batch six substances can be found at: www.chemicalsubstanceschimiques.gc.ca/challenge-defi/batch-lot-6/index-eng.php.
  • Footnote 4
    The Order adding benzyl chloride to Schedule 1 of CEPA 1999 can be found at www.gazette.gc.ca/rp-pr/p2/2011/2011-12-21/html/sor-dors286-eng.html.
  • Footnote 5
    For more information on CEPA 1999 SNAc provisions, please visit: www.ec.gc.ca/lcpe-cepa/default.asp?lang=En&n=24374285-1&offset=6&toc=show#e.
  • Footnote 6
    The Notice of Intent can be found at www.gazette.gc.ca/rp-pr/p1/2011/2011-11-26/html/notice-avis-eng.html#d109.
  • Footnote 7
    A formulant is a component of a pest control product that is intentionally added without being an active ingredient.
  • Footnote 8
    This is a prohibition under the European Commission Directive 2004/93/EC.
  • Footnote 9
    The notice of Intent can be found at www.gazette.gc.ca/rp-pr/p1/2011/2011-04-02/html/notice-avis-eng.html#d110.