Vol. 149, No. 16 — August 12, 2015

Registration

SOR/2015-206 July 31, 2015

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Order 2015-66-09-01 Amending the Domestic Substances List

Whereas, pursuant to subsection 66(1) of the Canadian Environmental Protection Act, 1999 (see footnote a), the Minister of the Environment is required to maintain the Domestic Substances List (see footnote b);

Therefore, the Minister of the Environment, pursuant to subsection 66(1) of the Canadian Environmental Protection Act, 1999 (see footnote c), makes the annexed Order 2015-66-09-01 Amending the Domestic Substances List.

Gatineau, July 27, 2015

LEONA AGLUKKAQ
Minister of the Environment

ORDER 2015-66-09-01 AMENDING THE DOMESTIC SUBSTANCES LIST

AMENDMENT

1. In column 1 of Part 2 of the Domestic Substances List (see footnote 1), the reference to “188627-10-03 N-S” is replaced by “188627-10-3 N-S”.

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 orders.)

Issues

Canadians depend on substances that are used in hundreds of goods, from medicines to computers, fabric and fuels. Under the Canadian Environmental Protection Act, 1999 (CEPA 1999), substances (i.e. chemicals, polymers, nanomaterials, and living organisms) “new” to Canada are subject to reporting requirements before they can be manufactured or imported. This limits market access until human health and environmental impacts associated with the new substances are assessed and managed where appropriate.

Environment Canada and Health Canada assessed the information on 21 new substances reported to the New Substances Program and determined that they meet the necessary criteria for their addition to the Domestic Substances List (DSL). Under CEPA 1999, the Minister of the Environment must add a substance to the DSL within 120 days after the criteria listed in section 87 or 112 have been met.

Environment Canada and Health Canada have determined that specific information regarding potential new activities associated with one substance (see footnote 2) must be provided to the Minister of the Environment prior to the commencement of any such activities. The significant new activity (SNAc) provisions of CEPA 1999 were originally applied to this substance pursuant to a notice published in Part I of the Canada Gazette. In order to maintain the SNAc reporting requirements, the Minister of the Environment is also applying the SNAc provisions of CEPA 1999 to this substance pursuant to the current amendments to the DSL.

A more accurate Chemical Abstracts Service Registry number (identifier) is available for one substance on the DSL. (see footnote 3) Therefore, the Minister of the Environment, keeping the current status of this substance in the DSL, will update the substance’s identifier on the DSL under section 66 of CEPA 1999.

Background

The Domestic Substances List

The DSL is a list of substances (chemicals, polymers, nanomaterials, and living organisms) that are considered “existing” in Canada for the purposes of CEPA 1999. “New” substances are not on the DSL and are subject to notification and assessment requirements before they can be manufactured in or imported into Canada. These requirements are set out in subsections 81(1) and 106(1) of CEPA 1999 as well as in the New Substances Notification Regulations (Chemicals and Polymers) and the New Substances Notification Regulations (Organisms).

The DSL was published in the Canada Gazette, Part II, in May 1994. (see footnote 4) The DSL is amended 10 times a year, on average; these amendments may add or remove substances or make corrections to the DSL.

The Non-domestic Substances List

The Non-domestic Substances List (NDSL) is a list of substances “new” to Canada that are subject to reduced notification and assessment requirements when manufactured in or imported into Canada in quantities above 1 000 kg per year. The NDSL only applies to chemicals and polymers.

The United States and Canada have similar new substances programs to assess new chemicals’ impact on human health and the environment prior to manufacture in or import into the country. Substances are eligible for listing on the United States Toxic Substances Control Act (TSCA) Inventory once they have undergone a new substances assessment in the United States. Substances that have been listed on the public portion of the TSCA Inventory for a minimum of one calendar year and that are not subject to risk management controls in either country are eligible for listing on the NDSL. On a semi-annual basis, Canada subsequently updates the NDSL based on amendments to the United States TSCA Inventory.

While chemicals and polymers on the DSL are not subject to the New Substances Notification Regulations (Chemicals and Polymers), those on the NDSL remain subject to them but with lesser reporting requirements, in recognition that they have undergone notification and assessment in the United States. This protects human health and the environment by ensuring that NDSL substances will undergo risk assessments in Canada, but leverages assessments conducted in the United States to lessen the reporting requirements imposed on industry.

Once substances are added to the DSL, they must be deleted from the NDSL, as a substance cannot be on both the DSL and NDSL simultaneously because these lists involve different regulatory requirements.

Addition and communication of SNAc requirements

The assessment of one of the substances in this package [ethanedioic acid, manganese(2++) salt (1:1), Chemical Abstracts Service Registry No. 640-67-5] identified potential environmental and human health concerns related to the use of the substance at the nano-scale. For this reason, the significant new activity provisions of CEPA 1999 were applied to this substance pursuant to a notice published in the Canada Gazette, Part I. SNAc provisions are being applied pursuant to the current amendments to maintain the reporting requirements on the substance. The required information will enable the Government of Canada to further assess the substance if it is engineered to contain particles of nano-scale size.

Objectives

Adding 21 substances to the DSL

The objectives of the Order 2015-87-09-01 Amending the Domestic Substances List, and the Order 2015-112-09-01 Amending the Domestic Substances List are to comply with the requirements under CEPA 1999, and to facilitate access to and use of 21 substances by removing reporting requirements under the New Substances Program associated with their import or manufacture.

Applying the SNAc provisions of CEPA 1999 to ethanedioic acid, manganese(2++) salt (1:1)

Another objective of the Order 2015-87-09-01 Amending the Domestic Substances List is to contribute to the protection of human health and the environment by maintaining the reporting requirements for significant new activities associated with one substance, the ethanedioic acid, manganese(2++) salt (1:1), before they are undertaken. The information collected will enable the Government of Canada to assess the substance in relation to the significant new activity and to determine whether further risk management actions are necessary.

Amending the NDSL

As substances cannot be on both the DSL and the NDSL simultaneously, the Order 2015-87-09-02 Amending the Non-domestic Substances List will delete 2 of the 21 substances from the NDSL, as they meet the necessary criteria for addition to the DSL.

Modifying the DSL to change one substance’s identifier

Furthermore, the objective of the Order 2015-66-09-01 Amending the Domestic Substances List is to update the identifier of one substance currently on the DSL (Siloxanes and Silicones, di-Me, [[[3-[(2-aminoethyl)amino]-2-ethylpropyl] methoxymethylsilyl]oxy]- and (C13-15-alkyloxy), Chemical Abstracts Service Registry No. 188627-10-3) to better reflect the substance identity.

Description

The orders add 21 substances to the DSL. To protect confidential business information, 11 of the 21 substances will have masked names.

Additions to the Domestic Substances List

A substance must be added to the DSL under subsections 87(1), 87(5), or 112(1) of CEPA 1999 within 120 days once all of the following conditions are met

Addition of SNAc requirements associated with ethanedioic acid, manganese(2++) salt (1:1)

The Order 2015-87-09-01 Amending the Domestic Substances List adds the substance to Part 2 of the DSL and indicates that the substance is subject to the SNAc provisions of CEPA 1999. (see footnote 6) This Order has been registered and is now in force. It is therefore mandatory to meet all the requirements of this Order should a person wish to use the substance ethanedioic acid, manganese(2++) salt (1:1) for a significant new activity as defined in this Order.

Applicability of the SNAc requirements associated with ethanedioic acid, manganese(2++) salt (1:1)

The SNAc requirements apply to any person who intends to use the substance, for a significant new activity. Any person engaging in a significant new activity associated with ethanedioic acid, manganese(2++) salt (1:1) must submit a Significant New Activity Notification (SNAN) containing all of the information prescribed in the Order 2015-87-09-01 Amending the Domestic Substances List at least 90 days prior to the use of the substance for the significant new activity.

The activities associated with ethanedioic acid, manganese(2++) salt (1:1), requiring a SNAN submission involve any use where the substance is engineered to contain particles of particle size ranging from 1 to 100 nanometres in one or more dimensions, in a quantity that exceeds 10 kg per calendar year. These activities have not been identified as presently occurring in Canada.

Activities not subject to the SNAc requirements associated with ethanedioic acid, manganese(2++) salt (1:1)

The SNAc requirements do not apply to uses of the substance that are regulated under any of the following Acts of Parliament listed in Schedule 2 of CEPA 1999: the Pest Control Products Act, the Fertilizers Act and the Feeds Act. They also do not apply to transient reaction intermediates that are not isolated and are not likely released, impurities, contaminants or partially unreacted intermediates related to the preparation of a substance or in some circumstances to items such as wastes, mixtures or manufactured items. However, it should be noted that individual components of a mixture may be notifiable under the Order 2015-87-09-01 Amending the Domestic Substances List. See subsection 81(6) and section 3 of CEPA 1999, and section 3.2 of the Guidelines for the Notification and Testing of New Substances (Chemicals and Polymers) for additional details. (see footnote 7)

Information to be submitted associated with ethanedioic acid, manganese(2++) salt (1:1)

The Order 2015-87-09-01 Amending the Domestic Substances List sets out the information that must be provided to the Minister of the Environment 90 days before the day on which the substance ethanedioic acid, manganese(2++) salt (1:1) is used for a significant new activity. Environment Canada and Health Canada will use the information submitted in the SNAN to conduct human health and environmental assessments within 90 days after the complete information is received.

Some of the information requirements of this Order reference the New Substances Notification Regulations (Chemicals and Polymers) to describe the specific information being requested. (see footnote 8) Additional guidance on preparing a SNAN can be found in section 1.3 of the Guidelines for the Notification and Testing of New Substances (Chemicals and Polymers).

Implementation, enforcement and service standards associated with the substance ethanedioic acid, manganese(2++) salt (1:1)
Compliance

When assessing whether or not a particular SNAc applies, a person is expected to make use of information in their possession or to which they ought to have access. (see footnote 9) The phrase “to which they ought to have access” means information in any of the company’s offices worldwide or other locations where the notifier can reasonably have access to the information. For example, manufacturers are expected to have access to their formulations, while importers or users of a substance, mixture, or product, are expected to have access to import records, usage information and the relevant Safety Data Sheet (SDS).

Although an SDS is an important source of information on the composition of a purchased product, it should be noted that the goal of the SDS is to protect the health of workers in the workplace from specific hazards of chemical products. Therefore, an SDS may not list all product ingredients that may be subject to SNAc provisions due to public health or environmental concerns. Any person requiring more detailed information on product composition is encouraged to contact his or her supplier.

If any information becomes available that reasonably supports the conclusion that ethanedioic acid, manganese(2++) salt (1:1) is toxic or capable of becoming toxic, the person in possession of or that has knowledge of the information and is involved in activities with the substance is obligated, under section 70 of CEPA 1999, to provide that information to the Minister of the Environment without delay.

A company can submit a SNAN on behalf of its clients. For example, in cases where individuals receive possession and control of ethanedioic acid, manganese(2++) salt (1:1) from another person, they may not be required to submit a SNAN, under certain conditions, if their activities were covered by the original SNAN. The Substances Management Advisory Note, Clarification in relation to the submission of Significant New Activity Notifications in application of the Canadian Environmental Protection Act, 1999 provides more detail on this subject. (see footnote 10)

A pre-notification consultation (PNC) is recommended for notifiers who wish to consult with the New Substances Program during the planning or preparation of their SNAN to discuss any questions or concerns they have about the prescribed information and test plans.

Where individuals have questions concerning their obligations to comply with the Order 2015-87-09-01 Amending the Domestic Substances List or believe they may be out of compliance, or, would like to request a PNC, they are encouraged to contact the Substances Management Information Line. (see footnote 11) The Program will work with the person to help them comply with the Order.

CEPA 1999 is enforced in accordance with the publically available Compliance and Enforcement Policy. (see footnote 12) In instances of non-compliance, consideration is given to factors, such as the nature of the alleged violation, potential harm, intent and history of compliance.

Further modifications to the Domestic Substances List

The Order 2015-66-09-01 Amending the Domestic Substances List modifies the identifier of one substance in Part 2 of the DSL to make the information reflected by this identifier more accurate.

Publication of masked names

The Order 2015-87-09-01 Amending the Domestic Substances List and the Order 2015-112-09-01 Amending the Domestic Substances List mask the chemical name of 11 of the 21 substances being added to the DSL. Masked names are allowed by CEPA 1999 if the publication of the explicit chemical or biological name of a substance would result in the release of confidential business information. The procedure to be followed for creating a masked name is set out in the Masked Name Regulations under CEPA 1999. Substances with a masked name are added under the confidential portion of the DSL. Anyone who wishes to determine if a substance is on the confidential portion of the DSL must file a Notice of Bona Fide Intent to Manufacture or Import with the New Substances Program.

“One-for-One” Rule and small business lens

The orders do not trigger the “One-for-One” Rule, as they do not add any additional costs to business. Also, the small business lens does not apply to these orders, as they do not add any administrative or compliance burden to small businesses. Rather, the orders provide industry with better access to the 21 substances being added to the DSL.

Consultation

As the orders are administrative in nature and do not contain any information that would be subject to comment or objection by the general public, no consultation is required.

Rationale

Twenty-one substances have met the necessary conditions for addition to the DSL. The orders add these substances to the DSL to exempt them from assessment and reporting requirements under subsection 81(1) of CEPA 1999.

The orders will benefit Canadians by enabling industry to use these substances in larger quantities. The orders will also benefit industry by reducing the administrative burden associated with the current regulatory status of these substances. As a result, it is expected that there will be no incremental costs to the public, industry or governments associated with the orders. However, the Government of Canada may still decide to assess any substance on the DSL under the existing substances provisions of CEPA 1999 (section 68 or 74) should an assessment be deemed necessary.

Implementation, enforcement and service standards

The DSL identifies substances that, for the purposes of CEPA 1999, are not subject to the requirements of the New Substances Notification Regulations (Chemicals and Polymers) or the New Substances Notification Regulations (Organisms). As the orders only add substances to the DSL, developing an implementation plan or a compliance strategy or establishing a service standard is not required.

Contact

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)
819-938-3232 (outside of Canada)
Fax: 819-938-3231
Email: substances@ec.gc.ca