Canada Gazette, Part I, Volume 149, Number 31: GOVERNMENT NOTICES

August 1, 2015

DEPARTMENT OF THE ENVIRONMENT

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Notice with respect to microbeads in certain personal care applications

Pursuant to paragraph 71(1)(b) of the Canadian Environmental Protection Act, 1999, notice is hereby given that the Minister of the Environment requires, for the purpose of assessing whether to control, or the manner in which to control the substance, any person described in Schedule 2 to this notice who possesses or who may reasonably be expected to have access to the information required in Schedule 3 to this notice to provide that information no later than October 15, 2015, 5 p.m., Eastern Daylight Time.

Responses to this notice shall be submitted to the Minister of the Environment, to the attention of the Substances Management Coordinator, Chemicals Management Plan, Gatineau, Quebec K1A 0H3. Inquiries concerning the notice may be directed to the Substances Management Coordinator at the above-mentioned address, or at 1-800-567-1999 (toll-free in Canada), 819-938-3232 (outside of Canada) [telephone], 819-938-5212 (fax), or substances@ec.gc.ca (email).

Pursuant to section 313 of the Act, any person who provides information in response to this notice may submit a written request that the information or part of it be treated as confidential.

Pursuant to subsection 71(4) of the Act, the Minister of the Environment may, on request in writing from any person to whom this notice applies, extend the time or times within which the person shall comply with this notice. The person seeking such extension shall submit, prior to the deadline, a request in writing to the Minister of the Environment, to the attention of the Substances Management Coordinator, Gatineau, Quebec K1A 0H3 or at 819-938-5212 (fax), or substances@ec.gc.ca (email).

VIRGINIA POTER
Director General
Industrial Sectors, Chemicals and Waste Directorate

DAVID MORIN
Director General
Science and Risk Assessment Directorate
On behalf of the Minister of the Environment

SCHEDULE 1

Substance

1. This notice applies to synthetic polymer particles that, at the time of their manufacture, are greater than 0.1 μm and less than or equal to 5 mm in size.

SCHEDULE 2

Persons Required to Provide Information

1. This notice applies to any person who, during the 2014 calendar year, imported a total quantity greater than 10 kg of the substance set out in Schedule 1 to this notice, that is in a mixture or product intended to be applied to the human body for the purpose of exfoliating or cleansing, and the conditions of use are such that the substance may be released to water.

2. This notice applies to any person who, during the 2014 calendar year, exported a total quantity greater than 10 kg of the substance set out in Schedule 1 to this notice, that is in a mixture or product intended to be applied to the human body for the purpose of exfoliating or cleansing, and the conditions of use are such that the substance may be released to water.

3. This notice applies to any person who, during the 2014 calendar year, used a total quantity greater than 10 kg of the substance set out in Schedule 1 to this notice, in the manufacture of a mixture or product intended to be applied to the human body for the purpose of exfoliating or cleansing, and the conditions of use of the mixture or product are such that the substance may be released to water.

4. This notice does not apply to a substance set out in Schedule 1, whether alone, in a mixture or in a product that

SCHEDULE 3

Information Required

1. The definitions in this section apply in this notice.

“manufactured item” means an item that is formed into a specific physical shape or design during manufacture and has, for its final use, a function or functions dependent in whole or in part on its shape or design.

“mixture” means a combination of substances that does not produce a substance that is different from the substances that were combined, including a prepared formulation, hydrate, and reaction mixture that are characterized in terms of their constituents.

“product” excludes “mixture” and “manufactured item.”

“released to water” includes use in water, washing off or rinsing off with water.

2. If the person subject to the notice is a company that owns more than one facility, a single response to the notice shall be submitted. The single response shall amalgamate the information from all facilities owned by the company for each applicable question in the notice.

3. Where information required under sections 5, 6, and 7 of Schedule 3 to this notice has already been submitted to the Minister of the Environment or to the Minister of Health, it may be relied on as a response to this notice if

4. If a person submitted information for the substance in 2015 as part of a voluntary data submission, either directly or through a third party such as an association, a response from that person is not required under this notice if the Minister is satisfied with its completeness.

5. (1) For the substance set out in Schedule 1 that a person imported or exported during the 2014 calendar year, for which the criteria set out in Schedule 2 have been met, the person shall provide the following information:

5. (2) Where codes C563, C564 and C999 are applicable for paragraph (1)(a), a written description of the mixture or product must be provided.

6. (1) For the substance set out in Schedule 1 that a person used during the 2014 calendar year, for which the criteria set out in Schedule 2 have been met, the person shall provide the following information:

6. (2) Where codes C563, C564 and C999 are applicable for paragraph (1)(a), a written description of the mixture or product must be provided.

7. Persons to whom this notice applies shall provide the following information:

8. For the purpose of sections 5 and 6, the following tables set out the consumer and commercial codes and their corresponding descriptions.

Consumer and Commercial Codes and Corresponding Descriptions

Table 1: Substance in personal care
Consumer and commercial code Title Description
C108.01 Baby care Substances contained in products or mixtures labeled for use on infants up to 2 years old.
C108.02 Barrier cream or skin moisturizer or anti-wrinkle preparation or eye lotion Substances contained in products or mixtures which protect the hands from dirt, grease or solvents; to be applied to the skin to soften dry skin or maintain skin suppleness by reducing water loss or increasing the water content of the skin, such as emollients and humectants; to be applied to the face to mask or reduce the appearance of fine lines or wrinkles, such as makeup or moisturizer; for use as lotion in the area of the eye, such as lotions and moisturizers.
C108.03 Bath preparation Substances contained in products or mixtures added to the bath water, such as bath oils, tablets, salts or bubble baths.
C108.05 Dentifrice Substances contained in products or mixtures which clean or polish the teeth.
C108.10 Hair remover, hair bleach or dye and hair straightener or waving preparation Substances contained in products or mixtures used to facilitate the removal of hair by chemical or mechanical means, such as depilatory or depilatory products, and wax treatments.

Substances contained in products or mixtures used to bleach the hair or used to change the colour of hair.

Substances contained in products or mixtures which contain agents used to chemically soften the hair to facilitate straightening of the hair; or to chemically soften the hair to facilitate curling.
C108.11 Hair shampoo or conditioner Substances contained in products or mixtures to clean and condition the hair; or to increase the suppleness or body of the hair; to facilitate combing; or add gloss or texture to the hair.
C108.12 Manicure preparation Substances contained in products or mixtures to be applied to the nails, such as nail polishes, nail polish removers, nail creams and lotions, cuticle softeners and nail hardeners.
C108.13 Massage preparation Substances contained in products or mixtures used for massaging purposes, such as gels, creams and lotions.
C108.14 Mouthwash Substances contained in products or mixtures to freshen or deodorize the mouth and breath other than lozenges and gums, such as breath freshening drops, sprays, or strips.
C108.15 Shaving preparation Substances contained in products or mixtures for use in shaving, such as shaving cream, pre-shave lotion, after shave lotion, beard softener and shaving soap.
C108.16 Skin cleanser Substances contained in products or mixtures used to cleanse the skin, such as soap, adhesive removers, astringents, towelettes and exfolients.
C108.17 Tanning preparation Substances contained in products or mixtures which improve the appearance of a tan (e.g. by pigments). Excludes mixtures or products which protect the skin from the sun or enhance or accelerate the tanning process.
Table 2: Substance in items for food or health
Consumer and commercial code Title Description
C563 Drugs (specify) Substances contained in non-prescription drugs intended for humans. A written description of the mixture or product must be provided when using this code.
C564 Natural health (specify) Substances used in natural health products or mixtures intended for humans. A written description of the mixture or product must be provided when using this code.
Table 3: Substance in mixtures or products not described by other codes
Consumer and commercial code Title Description
C999 Other (specify) Substances contained in mixtures or products that are not described within any other consumer and commercial code. A written description of the mixture or product must be provided when using this code.

EXPLANATORY NOTE

(This note is not part of the notice.)

The House of Commons unanimously voted on March 24, 2015, to take immediate measures to add microbeads to the List of Toxic Substances managed by the Government under the Canadian Environmental Protection Act, 1999. The data that is being gathered via this notice is needed to identify uses and sources of microbeads used in certain personal care applications that may be released to water and to inform potential risk management.

Pursuant to subsection 71(3) of the Canadian Environmental Protection Act, 1999 (hereinafter referred to as the “Act”), every person to whom this notice applies is required to comply with this notice within the time specified in the notice. The deadline specified in this notice is October 15, 2015, 5 p.m., Eastern Daylight Time.

Persons not subject to this notice who have a current or future interest in the substance set out in Schedule 1 to this notice may identify themselves as a “stakeholder” by completing the voluntary Declaration of Stakeholder Interest using the online reporting system via Environment Canada's Single Window. The person may be contacted for further information regarding their interest in the substance. The online reporting system is available from the Chemical Substances Web site at www.chemicalsubstanceschimiques.gc.ca.

Persons who do not meet the requirements to respond and have no commercial interest in the substance covered by this notice may submit a Declaration of Non-Engagement for the notice using the online reporting system via Environment Canada's Single Window. The online reporting system is available from the Chemical Substances Web site at www.chemicalsubstanceschimiques.gc.ca.

The Minister of the Environment and the Minister of Health are also inviting interested stakeholders to submit additional information that is deemed beneficial. Organizations that may be interested in submitting additional information in response to this invitation include those that manufacture, import, export or use this substance whether alone, in a mixture or in a product.

Compliance with the Act is mandatory pursuant to subsections 272(1) and 272.1(1) of the Act. Amendments to the fine scheme of the Act came into force on June 20, 2012. Subsections 272(2), (3) and (4) and 272.1(2), (3) and (4) of the Act set the penalties for persons who commit an offence under the Act. Offences include failing to comply with an obligation arising from the Act and providing false or misleading information. Penalties for offences can result, upon conviction (either summary conviction or indictment), of fines of not more than $12 million, imprisonment for a term of not more than three years, or both.

The current text of the Act, including the most recent amendments, is available on the Department of Justice Canada's Web site at http://laws-lois.justice.gc.ca/eng/acts/C-15.31/.

The Act is enforced in accordance with the Compliance and Enforcement Policy for the Canadian Environmental Protection Act, 1999 available at www.ec.gc.ca/lcpe-cepa/default.asp?lang=En&n=5082BFBE-1. Suspected violations under the Act can be reported to the Enforcement Branch by email at environmental.enforcement@ec.gc.ca.

Responses to the notice must be provided no later than October 15, 2015, 5 p.m., Eastern Daylight Time, using the online reporting system available through Environment Canada's Single Window, or to the attention of the Substances Management Coordinator, Chemicals Management Plan, Gatineau, Quebec K1A 0H3, substances@ec.gc.ca (email), 819-938-5212 (fax).

An electronic copy of this notice is available at the following Web site: www.chemicalsubstanceschimiques.gc.ca.

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DEPARTMENT OF THE ENVIRONMENT

DEPARTMENT OF HEALTH

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Notice of intent to develop microbeads regulations and publication of a science summary report on microbeads

Whereas the Government of Canada has prioritized the review of microbeads;

Whereas the synopsis of a science summary report conducted on microbeads is annexed hereby;

And whereas it is recommended that this substance be considered to meet one or more of the criteria set out in section 64 of the Canadian Environmental Protection Act, 1999 (CEPA 1999),

Notice, therefore, is hereby given that the Minister of the Environment and the Minister of Health propose to recommend to His Excellency the Governor in Council that this substance be added to Schedule 1 to the Act.

Notice is furthermore given that, on this basis, the Department of the Environment is initiating the development of proposed regulations under CEPA 1999 to prohibit the manufacture, import, sale and offer for sale of microbead-containing personal care products (see footnote 1) that are used to exfoliate or cleanse. The proposed controls would apply to the microbeads that are recommended for addition to Schedule 1 to CEPA 1999. Proposed regulations are intended to be developed for prepublication in the Canada Gazette, Part I, in 2016.

This process will include consultations with representatives of provincial and territorial governments, industry, non-governmental organizations, the public and other stakeholders. Input received during these consultations will be considered during the development of the regulations. A statutory consultation period will follow, during which interested parties will have an opportunity to make written comments specific to regulatory proposals.

The Government recognizes the importance of regulatory alignment between Canada and the United States and of ensuring a level playing field for Canadian and U.S. companies and enterprises. Canada will, therefore, endeavour to align measures for microbeads in personal care products with those of the United States, to the extent possible, and will work toward an approach that takes both our environment and our economy into account.

As part of an open and transparent process, interested parties will be invited to participate in consultation sessions in the fall of 2015. Additional information will be available on the following Web page: www.ec.gc.ca/CEPARegistry. As a first step in the consultation process, interested parties may submit comments on the approach set out above by mail or email before August 31, 2015, to

Director
Products Division
Environment Canada
Place-Vincent-Massey
351 Saint-Joseph Boulevard, 9th Floor
Gatineau, Quebec
K1A 0H3
Fax: 819-938-4218
Email: products.produits@ec.gc.ca

LEONA AGLUKKAQ
Minister of the Environment
RONA AMBROSE
Minister of Health

ANNEX I

Synopsis of the science summary

Microbeads are synthetic polymer particles that, at the time of their manufacture, are greater than 0.1 μm and less than or equal to 5 mm in size, which can vary in chemical composition, size, shape, density and function. Microbeads are manufactured for specific purposes, including for use in personal care products (such as scrubs, bath products, facial cleansers and toothpastes). They may also be used in other consumer uses, including cleaning products and printer toners, in industrial products such as abrasive media (e.g. plastic blasting) and in other plastic products (e.g. anti-slip, anti-blocking applications), as well as in medical applications and industry (e.g. oil and gas exploration, textile printing and automotive molding).

Microbeads from “down the drain” products will likely be released into the aquatic environment after wastewater treatment. Studies have shown that microplastics, including microbeads, are present in the environment and that they can reside in the environment for a long time. Microbeads have been shown to elicit both short- and long-term effects in laboratory organisms.

Proposed conclusion

Based on the available information, it is recommended that microbeads be considered toxic under paragraph 64(a) of the Canadian Environmental Protection Act, 1999. This would enable appropriate preventative measures to be taken to reduce the release of microbeads into the environment. As a precautionary next step, the Government of Canada is proposing to add microbeads to the List of Toxic Substances under the Act.

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DEPARTMENT OF THE ENVIRONMENT

DEPARTMENT OF HEALTH

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Publication of final decision after screening assessment of a living organism — Escherichia hermannii (E. hermannii) strain ATCC (see footnote 2) 700368 — specified on the Domestic Substances List (subsection 77(6) of the Canadian Environmental Protection Act, 1999)

Whereas E. hermannii strain ATCC 700368 is a living organism on the Domestic Substances List identified under subsection 105(1) of the Canadian Environmental Protection Act, 1999;

Whereas a summary of the Screening Assessment conducted on this living organism pursuant to paragraph 74(b) of the Act is annexed hereby;

Whereas it is concluded that this living organism does not meet any of the criteria set out in section 64 of the Act,

Notice therefore is hereby given that the Minister of the Environment and the Minister of Health propose to take no further action on this living organism at this time under section 77 of the Act.

LEONA AGLUKKAQ
Minister of the Environment
RONA AMBROSE
Minister of Health

ANNEX

Summary of the Screening Assessment of E. hermannii Strain ATCC 700368

Pursuant to paragraph 74(b) of the Canadian Environmental Protection Act, 1999 (CEPA 1999), the Minister of the Environment and the Minister of Health have conducted a screening assessment of E. hermannii strain ATCC 700368.

E. hermannii strain ATCC 700368 is a non-spore-forming Gram-negative bacterium. Reports of isolation of E. hermannii are rare but include a range of sources, including humans, raw and processed food, animals and their food products, plants, and terrestrial, aquatic and marine environments. E. hermannii plays a role in the nitrogen and sulphur cycle and can tolerate environments contaminated with toxic hydrocarbons and metals. These properties make it of possible commercial interest. Potential uses of E. hermannii strain ATCC 700368 reported in the public domain include bioremediation, biodegradation, industrial effluent treatment, municipal wastewater treatment (particularly oil and grease traps as well as sewage sludge), odour control, organic waste treatment, and composting.

There is no evidence in the scientific literature to suggest that E. hermannii strain ATCC 700368 is likely to have adverse effects on animal or plant populations in the environment. However, because E. hermannii has been only rarely isolated, there may not have been sufficient exposure of environmental species to E. hermannii strains in nature to observe or document an ability to cause disease in plants or animals. Therefore, there is some uncertainty about the pathogenic potential of E. hermannii strain ATCC 700368 and its effects on the environment.

Although E. hermannii has occasionally been described as an opportunistic human pathogen, and there is evidence in the literature to demonstrate that some strains contain determinants of pathogenicity, there are no reports linking E. hermannii to the production of known toxins. Infections involving E. hermannii as the putative primary pathogen are very rare and occur in individuals predisposed to infection or involve a significant breach in normal barriers against infection. Like most micro-organisms, E. hermannii can cause adverse effects if introduced into normally sterile body compartments. The majority of case reports involving E. hermannii were polymicrobial, and the other micro-organisms involved were considered to be the primary pathogens. E. hermannii has also been isolated from diarrheal stools, although rarely so, but has never been demonstrated to be the cause of disease.

This assessment considers the aforementioned characteristics of E. hermannii strain ATCC 700368 with respect to environmental and human health effects associated with product use and industrial processes subject to CEPA 1999, including releases to the environment through waste streams and incidental human exposure through environmental media. To update information about current uses, the Government launched a mandatory information-gathering survey under section 71 of CEPA 1999, published in the Canada Gazette, Part I, on October 3, 2009. Information submitted in response to the notice, as well as the latest available information, indicates that E. hermannii strain ATCC 700368 is not imported into or manufactured in Canada.

Considering all available lines of evidence presented in the Screening Assessment, there is a low risk of harm to organisms and the broader integrity of the environment from E. hermannii strain ATCC 700368. It is concluded that E. hermannii strain ATCC 700368 does not meet the criteria under paragraph 64(a) or (b) of CEPA 1999, as it is not entering 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 or that constitute or may constitute a danger to the environment on which life depends.

Also, based on the information presented in the Screening Assessment, it is concluded that E. hermannii strain ATCC 700368 does not meet the criterion under paragraph 64(c) of CEPA 1999, as it is not 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.

Conclusion

It is concluded that E. hermannii strain ATCC 700368 does not meet any of the criteria set out under section 64 of CEPA 1999.

The Screening Assessment for this living organism is available on the Government of Canada's Chemical Substances Web site (www.chemicalsubstances.gc.ca).

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DEPARTMENT OF THE ENVIRONMENT

DEPARTMENT OF HEALTH

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Publication of final decision after screening assessment of living organisms — Bacillus amyloliquefaciens 13563-0, (see footnote 3) Bacillus atrophaeus 18250-7, Bacillus licheniformis ATCC (see footnote 4) 12713, Bacillus subtilis ATCC 6051A, Bacillus subtilis ATCC 55405, Bacillus subtilis subspecies subtilis ATCC 6051, Bacillus subtilis subspecies inaquosorum ATCC 55406, Bacillus species 16970-5, Bacillus species 2 18118-1, Bacillus species 4 18121-4 and Bacillus species 7 18129-3 — specified on the Domestic Substances List (subsection 77(6) of the Canadian Environmental Protection Act, 1999)

Whereas Bacillus amyloliquefaciens 13563-0, Bacillus atrophaeus 18250-7, Bacillus licheniformis ATCC 12713, Bacillus subtilis ATCC 6051A, Bacillus subtilis ATCC 55405, Bacillus subtilis subspecies subtilis ATCC 6051, Bacillus subtilis subspecies inaquosorum ATCC 55406, Bacillus species 16970-5, Bacillus species 2 18118-1, Bacillus species 4 18121-4 and Bacillus species 7 18129-3 are living organisms on the Domestic Substances List (DSL) identified under subsection 105(1) of the Canadian Environmental Protection Act, 1999;

Whereas a summary of the Screening Assessment conducted on these living organisms pursuant to paragraph 74(b) of the Act is annexed hereby;

Whereas it is concluded that these living organisms do not meet any of the criteria set out in section 64 of the Act,

Notice therefore is hereby given that the Minister of the Environment and the Minister of Health propose to take no further action on these living organisms at this time under section 77 of the Act.

LEONA AGLUKKAQ
Minister of the Environment
RONA AMBROSE
Minister of Health

ANNEX

Summary of the Screening Assessment of the Domestic Substances List Bacillus licheniformis/subtilis group strains

Pursuant to paragraph 74(b) of the Canadian Environmental Protection Act, 1999 (CEPA 1999), the Minister of the Environment and the Minister of Health have conducted a screening assessment of the following living organism strains that are listed on the DSL:

For the purposes of this assessment, the DSL micro-organisms listed above will collectively be referred to as the “DSL Bacillus licheniformis/subtilis group” (B. licheniformis/subtilis group). The term “Bacillus subtilis complex” will denote information that is not specific to these DSL strains, but relates to the broader group of species that includes the DSL strains.

Under the Masked Name Regulations pursuant to section 113 of CEPA 1999, Environment Canada assigned masked names and accession numbers to Bacillus species 16970-5, Bacillus species 2 18118-1, Bacillus species 4 18121-4 and Bacillus species 7 18129-3 in place of these organisms' explicit biological names, which are considered confidential and must not be publicly disclosed.

Members of the broader Bacillus subtilis (B. subtilis) complex have the ability to adapt to and thrive in many terrestrial and aquatic habitats. They may be contaminants in food and aviation fuel and transient members of bowel microflora. Some members of the B. subtilis complex are used in the fermentation of foods. They form endospores that permit survival in suboptimal environmental conditions. Numerous physiological variants exist in nature, indicating that members of this complex establish themselves successfully in nearly every environment. Various characteristics of the DSL B. licheniformis/subtilis group make the organisms suitable for use as active ingredients in commercial and consumer products.

Certain strains of Bacillus licheniformis (B. licheniformis) can cause bovine, porcine and ovine abortion as well as mastitis in cattle, but the overall impact of B. licheniformis disease in livestock is low. Members of the DSL B. licheniformis/subtilis group are susceptible to veterinary antibiotics; therefore, in the case of livestock infection, effective treatment options are available. Negative effects in aquatic and terrestrial invertebrates exposed to strains of B. subtilis and B. licheniformis have been reported. One report implicated an isolate of B. licheniformis as the causative agent of pistachio dieback. B. subtilis complex strains also have antimicrobial properties and can promote growth in both plants and animals.

Certain members of the B. subtilis complex are occasionally reported to cause disease in susceptible humans, including those with debilitating disease or compromised immunity, young infants and the elderly, but do so rarely in the general population. Some produce extracellular enzymes and toxins that could cause food poisoning. In laboratory analyses done by scientists at Health Canada, the DSL B. licheniformis/subtilis group strains did not produce these food poisoning toxins.

This assessment considers the aforementioned characteristics of these strains with respect to environmental and human health effects associated with product use and industrial processes subject to CEPA 1999, including releases to the environment through waste streams and incidental human exposure through environmental media. To update information about current uses, the Government launched a mandatory information-gathering survey under section 71 of CEPA 1999, published in the Canada Gazette, Part I, on October 3, 2009. Information submitted in response to the notice indicates that the DSL B. licheniformis/subtilis group strains were used in biodegradation and bioremediation; products for surface and drain cleaning, degreasing and deodorizing; enzyme and chemical production; and waste and wastewater treatment.

Considering all available lines of evidence presented in the Screening Assessment, there is low risk of harm to organisms and the broader integrity of the environment from the DSL B. licheniformis/subtilis group strains. It is concluded that Bacillus amyloliquefaciens 13563-0, Bacillus atrophaeus 18250-7, Bacillus licheniformis ATCC 12713, Bacillus subtilis ATCC 6051A, Bacillus subtilis ATCC 55405, Bacillus subtilis subsp. subtilis ATCC 6051, Bacillus subtilis subsp. inaquosorum ATCC 55406, Bacillus species 16970-5, Bacillus species 2 18118-1, Bacillus species 4 18121-4 and Bacillus species 7 18129-3 do not meet the criteria under paragraph 64(a) or (b) of CEPA 1999, as they are not entering 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 or that constitute or may constitute a danger to the environment on which life depends.

Also, based on the information presented in the Screening Assessment, it is concluded that Bacillus amyloliquefaciens 13563-0, Bacillus atrophaeus 18250-7, Bacillus licheniformis ATCC 12713, Bacillus subtilis ATCC 6051A, Bacillus subtilis ATCC 55405, Bacillus subtilis subsp. subtilis ATCC 6051, Bacillus subtilis subsp. inaquosorum ATCC 55406, Bacillus species 16970-5, Bacillus species 2 18118-1, Bacillus species 4 18121-4 and Bacillus species 7 18129-3 do not meet the criterion under paragraph 64(c) of CEPA 1999, as they are not 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.

Conclusion

It is concluded that Bacillus amyloliquefaciens 13563-0, Bacillus atrophaeus 18250-7, Bacillus licheniformis ATCC 12713, Bacillus subtilis ATCC 6051A, Bacillus subtilis ATCC 55405, Bacillus subtilis subsp. subtilis ATCC 6051, Bacillus subtilis subsp. inaquosorum ATCC 55406, Bacillus species 16970-5, Bacillus species 2 18118-1, Bacillus species 4 18121-4 and Bacillus species 7 18129-3 do not meet any of the criteria set out under section 64 of CEPA 1999.

The Screening Assessment for these living organisms is available on the Government of Canada's Chemical Substances Web site (www.chemicalsubstances.gc.ca).

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DEPARTMENT OF THE ENVIRONMENT

DEPARTMENT OF HEALTH

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Publication of final decision after screening assessment of living organisms — Paenibacillus polymyxa (P. polymyxa) ATCC (see footnote 5) 842, ATCC 55407 and 13540-4 (see footnote 6) — specified on the Domestic Substances List (subsection 77(6) of the Canadian Environmental Protection Act, 1999)

Whereas P. polymyxa strains ATCC 842, ATCC 55407 and 13540-4 are living organisms on the Domestic Substances List identified under subsection 105(1) of the Canadian Environmental Protection Act, 1999;

Whereas a summary of the Screening Assessment conducted on these living organisms, pursuant to paragraph 74(b) of the Act, is annexed hereby;

Whereas it is concluded that these living organisms do not meet any of the criteria set out in section 64 of the Act,

Notice therefore is hereby given that the Minister of the Environment and the Minister of Health propose to take no further action on these living organisms at this time under section 77 of the Act.

LEONA AGLUKKAQ
Minister of the Environment
RONA AMBROSE
Minister of Health

ANNEX

Summary of the Screening Assessment of P. polymyxa Strains ATCC 842, ATCC 55407 and 13540-4

Pursuant to paragraph 74(b) of the Canadian Environmental Protection Act, 1999 (CEPA 1999), the Minister of the Environment and the Minister of Health have conducted a screening assessment on Paenibacillus polymyxa strains ATCC 842, ATCC 55407 and 13540-4.

P. polymyxa strains ATCC 842, ATCC 55407 and 13540-4 share characteristics with other P. polymyxa strains that occur in the environment. P. polymyxa is a facultatively anaerobic bacterium that is present in many environments. It has been isolated from soils, the rhizosphere and roots of plants and from marine sediments. P. polymyxa has a broad host range as a plant growth-promoting bacterium. It has characteristics that make it of potential use in biocontrol, plant growth promotion, the production of enzymes and specialty chemicals, water and wastewater treatment, and cleaning and degreasing applications.

P. polymyxa is not known as an animal or plant pathogen. Release of these strains into the environment is not expected to adversely affect ecosystems.

P. polymyxa is not known as a human pathogen. Despite its ubiquity, there have been only two reported cases of P. polymyxa infection in humans, both involving individuals suffering from pre-existing health conditions. Of those cases, only one indicated P. polymyxa as the sole microorganism involved.

This assessment considers the aforementioned characteristics of P. polymyxa ATCC 842, ATCC 55407 and 13540-4 with respect to environmental and human health effects associated with product use and industrial processes subject to CEPA 1999, including releases to the environment through waste streams and incidental human exposure through environmental media. To update information about current uses, the Government launched a mandatory information-gathering survey under section 71 of CEPA 1999, published in the Canada Gazette, Part I, on October 3, 2009. Information submitted in response to the notice indicates that P. polymyxa ATCC 55407 was not imported into or manufactured in Canada in 2008, but that P. polymyxa ATCC 842 and 13540-4 are used in consumer and commercial products.

Considering all available lines of evidence presented in the Screening Assessment, there is a low risk of harm to organisms and the broader integrity of the environment from P. polymyxa ATCC 842, ATCC 55407 and 13540-4. It is concluded that P. polymyxa ATCC 842, ATCC 55407 and 13540-4 do not meet the criteria under paragraph 64(a) or (b) of CEPA 1999 as they are not entering 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 or that constitute or may constitute a danger to the environment on which life depends.

Also, based on the information presented in the Screening Assessment, it is concluded that P. polymyxa ATCC 842, ATCC 55407 and 13540-4 do not meet the criterion under paragraph 64(c) of CEPA 1999, as they are not 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.

Conclusion

It is concluded that P. polymyxa ATCC 842, ATCC 55407 and 13540-4 do not meet any of the criteria as set out in section 64 of CEPA 1999.

The Screening Assessment for these living organisms is available on the Government of Canada's Chemical Substances Web site (www.chemicalsubstances.gc.ca).

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DEPARTMENT OF HEALTH

CANADA CONSUMER PRODUCT SAFETY ACT

Notice to interested parties — Risk of strangulation posed by corded window covering products

This is to notify interested parties that Health Canada is considering further risk management actions, including proposing amendments to the Corded Window Covering Products Regulations to help reduce the risk of strangulation posed by corded window covering products (see footnote 7) to children in Canada.

Accessible cords in corded window covering (CWC) products pose safety risks primarily to young children. Since 1986, Health Canada has received reports of 39 deaths and 27 near-miss incidents related to strangulation from corded window covering products. One-year-old children, in particular, appear to be the most vulnerable (see “Summary of Risk Assessment of Corded Window Covering Products”). From 1986 to 2009, the annual fatality rate averaged one to two deaths per year.

In 2009, the Corded Window Covering Products Regulations (the Regulations) came into force. The Regulations incorporate by reference safety standards and labelling requirements (the Canadian National Standard) developed by the Canadian Standards Association working through a consensus-based standards committee. A corded window covering product may not be manufactured, imported, advertised or sold if it does not meet the requirements for safety and labelling set out in the Canadian National Standard (CNS). Health Canada has also issued many warnings to the public about the risk corded window covering products pose to children and promoted the replacement of corded window coverings with cordless products through consumer education campaigns. In several instances, the Department has taken preventive action by negotiating voluntary recalls of products that were known to pose a danger to children. Despite these efforts, there has been no reduction in the overall annual rate of fatalities in Canada. The incident rate has not significantly declined from the average rate of one or two deaths per year despite the introduction of the Regulations in 2009.

In 2012, Health Canada, along with regulators in the United States, Australia, and the European Union, issued a consensus document under the Pilot Alignment Initiative (PAI) that recognized the strangulation hazard posed by corded window covering products, and identified a common goal of developing requirements for product designs to eliminate exposure to, or eliminate, this hazard entirely.

Health Canada has undertaken a comprehensive risk assessment regarding corded window covering products (summarized below) and has found that products compliant with the CNS continue to pose preventable risks of strangulation to young children. As well, numerous incidents in Canada and the United States have shown that a single cord or multiple long cords can easily form a loop that can fatally strangle a child. Consequently, Health Canada is considering further risk mitigation measures, including regulatory amendments to the Corded Window Covering Products Regulations.

The Department acknowledges the recent work of industry and other stakeholders on the standards development committee to revise the CNS. While the revision includes some additional mitigation measures for some of the risk (e.g. requirement for cord cleats), Health Canada is of the opinion that the requirements published in this revision (CAN/CSA-Z600-14) [and those in the corresponding American voluntary standard] will likely not significantly reduce the risk posed by accessible cords.

Health Canada would therefore like to invite comments and feedback from the industry and other interested parties on the risk of strangulation posed by corded window covering products. Interested parties are encouraged to send comments related to the “Summary of Risk Assessment of Corded Window Covering Products” (full document available upon request); information regarding technical changes to make corded window covering products safer for children, including changes to make cords inaccessible to children; and any evidence of economic impacts of such changes.

Information on the following questions is particularly of interest to Health Canada:

  1. Are there other considerations or data Health Canada should include in the Risk Assessment?
  2. What action(s) could be taken to reduce the strangulation risk posed by corded window covering (CWC) products?
  3. Is technology to reduce the strangulation risk posed by CWC products available to the industry in Canada?
  4. What window covering products (e.g. products used in commercial settings, large-sized products and products used with skylight windows) should be in or out of the scope of any risk reduction actions and why?
  5. What are the technical barriers to reducing the strangulation risk posed by CWC products?
  6. Would other product features be affected by design changes that aim to reduce the strangulation risk posed by CWC products?
  7. Are there types of windows in Canada that cannot be effectively covered except by window coverings with accessible operating cords?
  8. How would a requirement to reduce the strangulation risk posed by CWC products affect your business operations: (a) financially? (b) in other ways?
  9. If a requirement to reduce the strangulation risk is implemented, are there any particular considerations that should be taken into account with respect to subpopulations, such as those with mental or physical disabilities, the elderly or children?
  10. If a requirement to reduce the risk of strangulation posed by corded window covering products is implemented, do you anticipate that all products currently in use will be replaced by consumers over time? On average, how long do consumers use CWC products?
  11. What percent of the window covering market, as measured by sales, do corded window coverings represent? Please provide your information by corded window covering type.

Comments should be sent by email or by mail to the address below.

All comments should include the sender's full name and organization (if applicable), mailing address, phone number, and email address and must be received no later than 45 calendar days from the date of publication of this notice or September 15, 2015, whichever is later. Comments sent by email must also ensure “corded window covering NOI” is included in the subject line.

Email (include “corded window covering NOI” in subject line): cps-spc@hc-sc.gc.ca

Mail:
Corded Window Coverings NOI
Risk Management Strategies Division
Consumer Product Safety Directorate
269 Laurier Avenue West, 7th Floor
Address Locator: 4907A
Ottawa, Ontario
K1A 0K9

TINA GREEN
Director General
Consumer Product Safety Directorate
Healthy Environment and Consumer Safety Branch

Summary of Risk Assessment of Corded Window Covering Products

Corded window covering (CWC) products have been regulated in Canada since 2009, under the Corded Window Covering Products Regulations. Health Canada has also been informing consumers about the dangers of CWC products since 1998. Even with these measures in place, fatalities continue to occur in Canada at an average rate of slightly more than one child fatality per year (all ages).

CWC products have a long useful life and some incidents that are occurring now may involve older units that do not meet the requirements of the current Regulations. However, some of the fatalities may involve units covered by the Regulations, because the Regulations do not currently require complete elimination of the strangulation hazard. The most significant issues with the current Regulations are the following:

The majority of fatalities recorded in Health Canada's database involved children from the ages of one to three. Within this age group, one-year-old children make up the majority of fatalities. For the period ranging from 2010 to 2013 (inclusive), there were three recorded deaths involving one-year-old children who were strangled to death on CWC product cords. Based on these data, and using the Risk Assessment Bureau's risk characterization methodology, the risk of strangulation posed by CWC products was characterized as follows:

For comparison purposes, the fatal strangulation risk was also characterized for children ages one to three using the same years, dataset, methodology and assumptions. The resulting user and population risks, although slightly lower, were in the same ranges (i.e. “high” to “serious” for users, and “high” for the general population).

The new version of the Canadian Standards Association (CSA) standard has been declared a Canadian national standard and is mandatory in Canada as it has been incorporated by reference in the Corded Window Covering Products Regulations. This updated standard provides a substantial improvement in risk mitigation for inner cords, especially for roman and roll-up shades, which were not specifically addressed in the previous version of the standard. However, the standard does not design the hazard out of the product, and continues to rely on active safety devices that require consumer intervention. Fatalities may continue to occur, even for products that meet those additional requirements.

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DEPARTMENT OF HEALTH

CONTROLLED DRUGS AND SUBSTANCES ACT

Notice to interested parties — Proposal regarding the scheduling of AH-7921 and MT-45 under the Controlled Drugs and Substances Act and the Narcotic Control Regulations

This notice provides interested stakeholders with the opportunity to provide comments on Health Canada's proposal to add AH-7921 (1-(3,4-dichlorobenzamidomethyl)cyclohexyldimethyamine), its salts, isomers and salts of isomers and MT-45 (1-cyclohexyl-4-(1,2-diphenylethyl)piperazine), its salts, derivatives, isomers and analogues and salts of derivatives, isomers and analogues to Schedule I to the Controlled Drugs and Substances Act (CDSA) and to the Schedule to the Narcotic Control Regulations (NCR).

AH-7921 is a synthetic opioid developed in 1974 as a potential analgesic by Allen & Hanburys, a pharmaceutical company based in the United Kingdom, but it was never marketed commercially. AH-7921 does not have any recorded therapeutic applications or industrial use. In 2012, AH-7921 began to be marketed by internet retailers as a “research chemical.” In March 2015, the United Nations Commission on Narcotic Drugs voted in favour of controlling AH-7921 under Schedule I of the Single Convention on Narcotic Drugs, 1961 (1961 Convention). As a signatory, Canada has an obligation to adopt the controls required by the 1961 Convention. The CDSA is the statutory instrument through which the Government of Canada fulfills its international obligations under the UN drug control conventions. As substances that are structurally related to AH-7921 are also known to have abuse potential and are included in the Convention, the salts, isomers and salts of isomers of AH-7921 will also be scheduled along with the parent substance.

MT-45 is a synthetic opioid with potential health risks similar to those of other controlled opioids. Although MT-45 is not currently controlled under the UN drug control conventions, the European Union (EU) Council adopted the decision to control MT-45 across the EU in December 2014, in part as a result of 28 deaths associated with MT-45 in Sweden. To date, there is no known evidence demonstrating that MT-45 has actual or potential uses apart from scientific research. In order to capture substances that are structurally related to MT-45 and have psychoactive effects, it is also proposed that the salts, derivatives, isomers and analogues of MT-45 and the salts of these substances be scheduled along with the parent substance.

These proposed amendments would prohibit, among other activities, the possession, trafficking, possession for the purpose of trafficking, importation, exportation, possession for the purpose of exportation, and production of the above substances, except as authorized under the NCR or via an exemption under section 56 of the CDSA.

The publication of this notice in the Canada Gazette, Part I, initiates a 30-day comment period. Interest in this process or comments on this notice should be expressed to the Regulatory Policy Division, Controlled Substances and Tobacco Directorate, Healthy Environments and Consumer Safety Branch, Health Canada by mail at Address Locator: 0302A, 150 Tunney's Pasture Driveway, Ottawa, Ontario K1A 0K9, or by email at ocs_regulatorypolicy-bsc_politiquereglementaire@hc-sc.gc.ca.

August 1, 2015

JACQUELINE GONÇALVES
Director General
Controlled Substances and Tobacco Directorate
Healthy Environments and Consumer Safety Branch

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DEPARTMENT OF HEALTH

CONTROLLED DRUGS AND SUBSTANCES ACT

Notice to interested parties — Proposed order amending Schedule III to the Controlled Drugs and Substances Act and regulations amending the schedule to Part J of the Food and Drug Regulations to add 2C-phenethylamines and their salts, derivatives, and isomers and the salts of their derivatives and isomers

In March 2015, the Commission on Narcotic Drugs voted in favour of scheduling three 2C-phenethylamine derivatives, 25B-NBOMe, 25C-NBOMe, and 25I-NBOMe, under Schedule I to the United Nations Convention on Psychotropic Substances, 1971 (1971 Convention). As a signatory to the 1971 Convention, Canada has an obligation to impose controls on these substances and their salts.

Given that there are many substances related to these three that also have psychoactive effects, Health Canada is seeking input to determine whether scheduling the entire 2C-phenethylamines class is warranted. To this end, this notice provides interested stakeholders with the opportunity to comment on Health Canada's proposal to add 2C-phenethylamines and their salts, derivatives, and isomers, and the salts of their derivatives and isomers to Schedule III to the Controlled Drugs and Substances Act (CDSA) and to the Schedule to Part J of the Food and Drug Regulations (FDR).

As potent synthetic drugs, 2C-phenethylamines have both stimulant and hallucinogenic properties. Considered “designer drugs,” they are emerging in the market at a rapid pace. These designer drugs are readily available for sale on the Internet as “research chemicals” and at raves, nightclubs and head shops.

The majority of the risks to the health and safety of Canadians from 2C-phenethylamines are associated with recreational exposure causing unknown toxicological short-and long-term effects that may cause bodily harm, injury, illness or death. These designer drugs are available in tablet, powder, or liquid form. Their route of administration may be sublingual, buccal, nasal, oral, injection, or rectal and they may be consumed through smoking. Only a small amount of the substance is enough to cause hallucinogenic effects. As use of these substances may lead to paranoia, violent behaviour, intense hallucinations, and impairment of hand-eye coordination, they pose significant risks to the health and safety of not only the user but also the general public. Risks are further heightened by virtue of the fact that users are unlikely to be aware of the exact dose or substance being consumed.

Health Canada is not aware of any legitimate therapeutic or industrial uses and is aware of only limited scientific and research uses of 2C-phenethylamines. In North America and across Europe, their trafficking and recreational abuse have been on the rise over the past decade. Since 2008, Health Canada's Drug Analysis Service (DAS) identified over a thousand exhibits of evidence containing 2C-phenethylamines. Moreover, there is a shifting market of a particular 2C-phenethylamine substance being abused. In 2012, the majority of the exhibits contained 2C-E, whereas since 2013, there has been a growing trend in the use of 25B-NBOMe, 25C-NBOMe, and 25I-NBOMe. The number of 2C-phenethylamine exhibits in 2014 was 88, 70 of which contained 25B-NBOMe, 25C-NBOMe, or 25I-NBOMe.

The publication of this notice in the Canada Gazette, Part I, begins a 30-day comment period. Enquiries or comments on this notice should be directed to the Regulatory Policy Division, Controlled Substances and Tobacco Directorate, Healthy Environments and Consumer Safety Branch, Health Canada, by mail at Address Locator: 0302A, 150 Tunney's Pasture Driveway, Ottawa, Ontario K1A 0K9, or by email at OCS_regulatorypolicy-BSC_ politiquereglementaire@hc-sc.gc.ca.

July 24, 2015

JACQUELINE GONÇALVES
Director General
Controlled Substances and Tobacco Directorate
Healthy Environments and Consumer Safety Branch

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DEPARTMENT OF INDUSTRY

BOARDS OF TRADE ACT

Greater Dufferin Area Chamber of Commerce

Notice is hereby given that His Excellency the Governor General in Council, by Order in Council dated July 16, 2015, has been pleased to change the name of the Greater Dufferin Area Chamber of Commerce to the Dufferin Board of Trade upon petition made therefor under section 39 of the Boards of Trade Act.

July 22, 2015

VIRGINIE ETHIER
Director
For the Minister of Industry

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OFFICE OF THE DIRECTOR OF PUBLIC PROSECUTIONS

DIRECTOR OF PUBLIC PROSECUTIONS ACT

Assignment

Under paragraph 3(3)(g) of the Director of Public Prosecutions Act, I assign to the Director of Public Prosecutions the powers, duties and functions of the Attorney General of Canada as set out on July 20, 2015, in the following Acts:

Ottawa, July 20, 2015

THE HONOURABLE PETER MACKAY
Attorney General of Canada

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