FEDERAL REG

SOR/2016-243: Domestic Substances List — Order 2016-112-09-01 Amending Canadian Environmental Protection Act, 1999

REGISTRATION OF FEDERAL REGULATION - VIA PART II OF THE GAZETTE

Registered
September 10, 2016


REGULATORY IMPACT ANALYSIS STATEMENT (This statement is not part of the orders.) Issues The Government of Canada (the Government) amended the Domestic Substances List (DSL) by adding 19 chemicals and polymers under the Order 2016-87-09-01 Amending the Domestic Substances List; and adding one living organism under the Order 2016-112-09-01 Amending the Domestic Substances List. Background Canadians... (Click for more)


Published on September 10, 2016

Bill Summary

SOR/2016-243: Domestic Substances List — Order 2016-112-09-01 Amending Canadian Environmental Protection Act, 1999

REGULATORY IMPACT ANALYSIS STATEMENT (This statement is not part of the orders.) Issues The Government of Canada (the Government) amended the Domestic Substances List (DSL) by adding 19 chemicals and polymers under the Order 2016-87-09-01 Amending the Domestic Substances List; and adding one living organism under the Order 2016-112-09-01 Amending the Domestic Substances List. Background Canadians depend on substances that are used in hundreds of goods from medicines, computers, fabric to fuels. Under the Canadian Environmental Protection Act, 1999 (CEPA), 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. The DSL is an inventory of substances in the Canadian marketplace. Substances that are not on the DSL are considered new to Canada 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 as well as in the New Substances Notification Regulations (Chemicals and Polymers) and the New Substances Notification Regulations (Organisms). These requirements do not apply to substances listed on the DSL. The DSL was published in the Canada Gazette, Part II, in May 1994 (see footnote 2) and is amended on average 10 times a year to add or delete substances. A substance must be added to the DSL under subsection 87(1), 87(5) or 112(1) of CEPA within 120 days once all of the following conditions are met: the Minister of the Environment has been provided with information regarding the substance; (see footnote 3) the Minister of the Environment and the Minister of Health are satisfied that the substance has already been manufactured in or imported into Canada under the conditions set out in section 87 or 112 of CEPA by the person who provided the information; the period prescribed for the assessment of the information submitted for the substance has expired; and the substance is not subject to any conditions imposed pursuant to paragraph 84(1)a) or 109(1)a) of CEPA on its import or manufacture. 1. Order 2016-87-09-01 Amending the Domestic Substances List The Government assessed information on 19 new chemicals and polymers reported to the New Substances Program and determined that they meet the conditions for their addition to the DSL. These substances have therefore been added to the DSL under this Order. Objective The objective of this Order is to comply with the requirements under subsection 87(5) of CEPA by adding 19 substances to the DSL, making them no longer subject to the notification and assessment requirements as set out in subsection 81(1) of CEPA and in the New Substances Notification Regulations (Chemicals and Polymers). Description This Order adds a total of 19 substances to the DSL: 9 substances are added to Part 1 of the DSL and 10 substances, to Part 3 of the DSL. To protect confidential business information, 10 of the 19 substances have masked chemical names. (see footnote 4) 2. Order 2016-112-09-01 Amending the Domestic Substances List The Government assessed information on one new living organism reported to the New Substances Program and determined that it meets the conditions for its addition to the DSL. This living organism has therefore been added to the DSL under this Order. Objective The objective of this Order is to comply with the requirements under subsection 112(1) of CEPA by adding one living organism to the DSL, making it no longer subject to the notification and assessment requirements as set out in subsection 106(1) of CEPA and in the New Substances Notification Regulations (Organism). Description This Order adds one living organism identified as Bacillus amyloliquefaciens to Part 5 of the DSL. Consultation As the two orders do not contain any information expected to generate comments or objections by stakeholders, no consultation is deemed necessary. Rationale The Government assessed information on 19 chemicals and polymers and one living organism reported to the New Substances Program and determined that they met the conditions for their addition to the DSL. These substances have therefore been added to the DSL. The two orders will benefit Canadians by enabling industry to have better access to larger quantities of these substances, which is expected to reduce costs associated with products consumed by Canadians. It is expected that there will be no incremental costs to the public, industry or governments associated with the two orders. “One-for-One” Rule and small business lens The two 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 the two orders, as they do not add any administrative or compliance burden to small businesses. Implementation, enforcement and service standards The DSL identifies substances that, for the purposes of CEPA, are not subject to the requirements of the New Substances Notification Regulations (Chemicals and Polymers) or the New Substances Notification Regulations (Organisms). Developing an implementation plan or a compliance strategy, or establishing a service standard is not required when adding substances to the DSL. Contact Greg Carreau Executive Director Program Development and Engagement Division Department of the Environment Gatineau, Quebec K1A 0H3 Substances Management Information Line: 1-800-567-1999 (toll-free in Canada) 819-938-3232 (outside of Canada) Fax: 819-938-5212 Email: [email protected] Footnote a S.C. 1999, c. 33 Footnote b SOR/94-311 Footnote c SOR/2005-248 Footnote d S.C. 1999, c. 33 Footnote 1 SOR/94-311 Footnote 2 The Order 2001-87-04-01 Amending the Domestic Substances List (SOR/2001-214), published in the Canada Gazette, Part II, in July 2001, establishes the structure of the DSL. For more information, please visit http://publications.gc.ca/gazette/archives/p2/2001/2001-07-04/pdf/g2-13514.pdf. Footnote 3 The most comprehensive package depends on the class of a substance. The information requirements are set out in the New Substances Notification Regulations (Chemicals and Polymers) and the New Substances Notification Regulations (Organisms) made under CEPA. Footnote 4 Masked names are allowed by CEPA to protect confidential business information. The procedure for creating a masked name is set out in the Masked Name Regulations. Anyone who wishes to determine if a substance is on the DSL under a masked name must file a Notice of Bona Fide Intent to Manufacture or Import with the New Substances Program.

This Bill does not amend any statutes.

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