Canada Gazette, Part I, Volume 146, Number 45: GOVERNMENT NOTICES
November 10, 2012
DEPARTMENT OF THE ENVIRONMENT
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
Order 2012-66-09-02 Amending the Non-domestic Substances List
Whereas, pursuant to subsections 66(1) and (3) of the Canadian Environmental Protection Act, 1999 (see footnote a), the Minister of the Environment has added the substances referred to in the annexed Order to the Domestic Substances List (see footnote b);
Therefore, the Minister of the Environment, pursuant to subsection 66(3) of the Canadian Environmental Protection Act, 1999 (see footnote c), makes the annexed Order 2012-66-09-02 Amending the Non-domestic Substances List.
Gatineau, October 31, 2012
PETER KENT
Minister of the Environment
ORDER 2012-66-09-02 AMENDING THE NON-DOMESTIC SUBSTANCES LIST
AMENDMENT
1. Part Ⅰ of the Non-domestic Substances List (see footnote 1) is amended by deleting the following:
- 67-20-9
- 37242-45-8
COMING INTO FORCE
2. This Order comes into force on the day on which Order 2012-66-09-01 Amending the Domestic Substances List comes into force.
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DEPARTMENT OF THE ENVIRONMENT
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
Order 2012-87-09-02 Amending the Non-domestic Substances List
Whereas, pursuant to subsections 87(1) and (5) of the Canadian Environmental Protection Act, 1999 (see footnote d), the Minister of the Environment has added the substances referred to in the annexed Order to the Domestic Substances List (see footnote e);
Therefore, the Minister of the Environment, pursuant to subsections 87(1) and (5) of the Canadian Environmental Protection Act, 1999 (see footnote f), makes the annexed Order 2012-87-09-02 Amending the Non-domestic Substances List.
Gatineau, October 31, 2012
PETER KENT
Minister of the Environment
ORDER 2012-87-09-02 AMENDING THE NON-DOMESTIC SUBSTANCES LIST
AMENDMENTS
1. Part Ⅰ of the Non-domestic Substances List (see footnote 2) is amended by deleting the following:
- 67674-67-3
- 129898-01-7
- 1007848-63-6
- 1195978-93-8
2. Part Ⅱ of the List is amended by deleting the following:
- 18304-7
- Fatty acids, reaction products with alkanolamine and alkyloxide
- Acides gras, produits de réaction avec une alcanolamine et un oxyde d’alkyle
COMING INTO FORCE
3. This Order comes into force on the day on which Order 2012-87-09-01 Amending the Domestic Substances List comes into force.
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DEPARTMENT OF THE ENVIRONMENT
DEPARTMENT OF HEALTH
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
Publication after screening assessment of substances — Phenol, 4,4′-(1-methylethylidene) bis[2,6-dibromo- (tetrabromobisphenol A, CAS No. 79-94-7) and two derivative substances, Ethanol, 2,2′-[(1-methylethylidene)bis[(2,6-dibromo-4,1-phenylene)oxy]]bis (tetrabromobisphenol A bis(2-hydroxyethyl ether), CAS No. 4162-45-2) and Benzene, 1,1′-(1-methylethylidene)bis [3,5-dibromo-4-(2-propenyloxy)- (tetrabromobisphenol A bis(allyl ether), CAS No. 25327-89-3) — specified on the Domestic Substances List (subsection 77(1) of the Canadian Environmental Protection Act, 1999)
Whereas tetrabromobisphenol A, tetrabromobisphenol A bis(2-hydroxyethyl ether) and tetrabromobisphenol A bis(allyl ether) are substances on the Domestic Substances List identified under subsection 73(1) of the Canadian Environmental Protection Act, 1999;
Whereas a summary of the draft Screening Assessment Report conducted on tetrabromobisphenol A, tetrabromobisphenol A bis(2-hydroxyethyl ether) and tetrabromobisphenol A bis(allyl ether) pursuant to section 74 of the Act is annexed hereby;
Whereas it is proposed to conclude that tetrabromobisphenol A meets one or more of the criteria set out in section 64 of the Act;
And whereas it is proposed to conclude that tetrabromobisphenol A bis(2-hydroxyethyl ether) and tetrabromobisphenol A bis(allyl ether) 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 (the Ministers) intend to recommend to His Excellency the Governor in Council that tetrabromobisphenol A be added to Schedule 1 to the Act;
Notice therefore is hereby given that the Ministers propose to take no further action on tetrabromobisphenol A bis(2-hydroxyethyl ether) and tetrabromobisphenol A bis(allyl ether) at this time;
And notice is also hereby given that the Ministers have released a risk management scope document for tetrabromobisphenol A to initiate discussions with stakeholders on the development of a risk management approach.
Public comment period
As specified under subsection 77(5) of the Canadian Environmental Protection Act, 1999, any person may, within 60 days after publication of this notice, file with the Minister of the Environment written comments on the measure the Ministers propose to take and on the scientific considerations on the basis of which the measure is proposed. More information regarding the scientific considerations may be obtained from the Government of Canada’s Chemical Substances Web site (www. chemicalsustances.gc.ca). All comments must cite the Canada Gazette, Part Ⅰ, and the date of publication of this notice and be sent to the Executive Director, Program Development and Engagement Division, Gatineau, Quebec K1A 0H3, 819-953-7155 (fax), substances@ec.gc.ca (email).
In accordance with section 313 of the Canadian Environmental Protection Act, 1999, any person who provides information in response to this notice may submit with the information a request that it be treated as confidential.
DAVID MORIN
Director General
Science and Risk Assessment Directorate
On behalf of the Minister of the Environment
MARGARET KENNY
Director General
Chemicals Sector Directorate
On behalf of the Minister of the Environment
KAREN LLOYD
Director General
Safe Environments Directorate
On behalf of the Minister of Health
ANNEX
Summary of the Draft Screening Assessment Report of Tetrabromobisphenol A, Tetrabromobisphenol A bis(2-hydroxyethyl ether) and Tetrabromobisphenol A bis(allyl ether)
Pursuant to section 74 of the Canadian Environmental Protection Act, 1999 (CEPA 1999), the Ministers of Environment and of Health have conducted a screening assessment of Phenol, 4,4′-(1-methylethylidene) bis[2,6-dibromo-, commonly known as tetrabromobisphenol A (TBBPA, CAS No. 79-94-7), and two derivative substances — Ethanol, 2,2′-[(1-methylethylidene) bis[(2,6-dibromo-4,1-phenylene)oxy]]bis, commonly known as TBBPA bis(2-hydroxyethyl ether) [CAS No. 4162-45-2], and Benzene, 1,1′-(1-methylethylidene)bis[3,5-dibromo-4-(2-propenyl-oxy)-, also called TBBPA bis(allyl ether) [CAS No. 25327-89-3]. These substances were identified in the categorization of the Domestic Substances List as priorities for screening assessment, as they met the criteria for persistence and inherent toxicity to non-human organisms. TBBPA was determined to present an intermediate potential for exposure of individuals in Canada.
Globally, TBBPA is the highest selling brominated flame retardant, with world market production at over 120 000 tonnes in 2001 and over 170 000 tonnes in 2004, and with future production likely to increase further. TBBPA is incorporated in polymers as a reactive or additive flame retardant for use in flame-retarded epoxy and polycarbonate resins and, to a lesser extent, in acrylonitrile-butadiene-styrene (ABS) resins and phenolic resins. A major usage of flame-retarded epoxy resins containing TBBPA is in rigid epoxy-laminated printed circuit boards; other uses include glass-reinforced construction panels and motor housings and terminal boards. Applications of flame-retarded polycarbonate resins include communications and electronics equipment, appliances, transportation devices, sports and recreation equipment, lighting fixtures and signs. ABS resins containing TBBPA are used in automotive parts, pipes and fittings, refrigerators and other appliances, business machines and telephones. TBBPA is also used in the production of derivative substances which are used in specialty or niche applications. TBBPA bis(2-hydroxyethyl ether) is used as an additive flame retardant in engineering polymers, epoxy resins, thermoset and thermoplastic polyesters, polyurethane, laminates for electronic circuit boards, and adhesives and coatings. TBBPA bis(allyl ether) is a reactive and additive flame retardant used in expanded polystyrene foams and adhesives.
Results from an industry survey conducted for the year 2000 indicated that although TBBPA was not manufactured in Canada in that year, between 100 to 1 000 tonnes were imported into Canada, including TBBPA in mixtures and products. Recent estimates suggest TBBPA imports into Canada remain in the 100 to 1 000 tonne range, including pure TBBPA, unreacted TBBPA in printed wire boards, and additive TBBPA in acrylonitrile-butadiene-styrene (ABS) and high impact polystyrene (HIPS) products. It is estimated that current import of TBBPA bis(allyl ether) to Canada is now in the range of 100 to 1 000 tonnes. However, there is no recent evidence that pure TBBPA bis(2-hydroxyethyl ether) is imported into Canada.
Environment
The substance TBBPA is characterized by low to moderate water solubility, low vapour pressure, and a moderately high octanol/water partition coefficient which is dependent on ionization state and responsive to pH. When released into the environment, TBBPA will likely distribute into sediment and soil, binding to the organic fraction of particulate matter and to the lipid fraction of biota. Few measured data are available on the two TBBPA derivative substances; however, predictions based on modelled data suggest these substances have properties that can be related to and extrapolated from TBBPA.
The substance TBBPA is considered to be persistent in the environment, and meets the criteria for persistence as defined in the Persistence and Bioaccumulation Regulations under CEPA 1999. Although the substance will degrade by processes of anaerobic and aerobic biodegradation, complete transformation in the environment has not been established. TBBPA is predicted to be persistent in air, and its measured presence in remote Arctic regions suggests that the substance may be capable of being transported from its source to remote areas. TBBPA has been shown to degrade under anaerobic conditions to form bisphenol A. Bisphenol A has been determined to meet the criteria defined in section 64 of CEPA 1999. Similarly, there is evidence that TBBPA bis(allyl ether) and TBBPA bis(2-hydroxyethyl ether) also meet CEPA 1999 persistence criteria (half-lives in soil and water of 182 days or more, and half-life in sediment of 365 days or more).
Empirical and modelled data indicate that TBBPA may accumulate to some degree in the tissues of biota, but does not meet the criteria for bioaccumulation as defined in the Persistence and Bioaccumulation Regulations under CEPA 1999. Modelled data indicate that TBBPA bis(allyl ether) and TBBPA bis(2-hydroxyethyl ether) do not meet the criteria for bioaccumulation as defined in the same Regulations.
The substance TBBPA is hazardous to a variety of aquatic organisms, with significant adverse effects on survival, reproduction and development at very low concentrations. Recent research suggests that TBBPA may be capable of disrupting normal functioning of the thyroid system in amphibians and fish, and enhancing immune system activity in marine bivalves. Exposure to soil organisms significantly inhibited growth of some terrestrial seedling plants and soil nitrifying bacteria, as well as reproduction in two earthworm species. Modelled ecotoxicity endpoint concentrations for TBBPA bis(2-hydroxyethyl ether) are similar to those predicted for TBBPA. For TBBPA bis(allyl ether), although most predicted ecotoxicity endpoints result in no effects at saturation, there is some evidence of chronic value estimates predicted at very low concentrations in the range of TBBPA bis(allyl ether) solubility.
Combustion of TBBPA under certain conditions may lead to the formation of brominated dibenzo-p-dioxins and dibenzofurans. Small amounts of these compounds have been detected as impurities in TBBPA. These products are analogues of polychlorinated dibenzofurans and dibenzo-p-dioxins, two substances listed on Schedule 1 of CEPA 1999.
It is expected that TBBPA and TBBPA bis(allyl ether) may be released to the Canadian environment as a result of industrial processing activities, although there are very few measurements of these substances in the Canadian environment. The database of TBBPA measured in the environment is limited; however, the substance has been measured in all environmental media, with the highest concentrations being found in samples from urban and industrial areas. Generic industrial scenarios for the aquatic environment (which considered any available site information) were developed separately for each substance to provide estimates of exposure. Risk quotient analyses, integrating conservative estimates of exposure with toxicity information, were performed for the aquatic, sediment and terrestrial compartments for TBBPA and TBBPA bis(allyl ether), to determine whether there is potential for ecological harm in Canada. The risk quotient analysis for TBBPA indicates a potential risk from exposure in the Canadian environment to pelagic, sediment (benthic), and soil organisms. The risk quotient analyses indicate that TBBPA bis(allyl ether) concentrations in the Canadian environment are unlikely to cause adverse effects in pelagic organisms, sediment (benthic) organisms, or wildlife in Canada.
A risk quotient analysis for TBBPA bis(2-hydroxyethyl ether) was not conducted given its apparent lack of usage in Canada; the derivative substance may be considered to have low exposure potential and therefore to present a negligible risk to the Canadian environment at the present time.
Based on the information in this screening assessment indicating increasing use, persistence in the environment, toxicological hazard, potential to degrade to form bisphenol A, and potential for some accumulation in biota, as well as estimated risk for pelagic, sediment, and soil organisms, it is proposed to conclude that TBBPA is 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.
Based on the information in this screening assessment, it is proposed to conclude that TBBPA bis(allyl ether) and TBBPA bis(2-hydroxyethyl ether) 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.
Human health
Known sources of general population exposure to TBBPA are anthropogenic and include environmental media (ambient air, water, soil, sediment) and household dust, indoor air, human breast milk, food and products treated with TBBPA for its flame retardant properties. While most TBBPA is covalently bound within products, small quantities of the unreacted substance are available for migration and may be a potential source of exposure. Although the volatilization of TBBPA is low, there exists potential for offgassing from its presence in electronic components that become heated during operation as well as dust accumulated from those products.
In Canada, the highest derived upper-bounding estimate of exposure was for breast-fed infants. Hazard characterization of TBBPA was based primarily upon the assessment of the European Union, with more recent data taken into consideration. The critical effect for the characterization of risk to human health is liver toxicity observed in female offspring of mice following exposure to TBBPA in a reproductive toxicity study.
Based on the comparison of upper-bounding estimated intake of TBBPA for breast-fed infants and the critical effect for the characterization of risk to human health, it is considered that the resulting margins of exposure are adequate to address uncertainties in the health effects and exposure databases.
Sources of exposure for the two derivatives, TBBPA bis(2-hydroxyethyl ether) and TBBPA bis(allyl ether), are also anthropogenic and include the same sources as those of TBBPA since the derivatives are used in the same manner. TBBPA bis(2-hydroxyethyl ether) is an additive flame retardant and TBBPA bis(allyl ether) can be used as a reactive or additive flame retardant. When used in additive form, these substances are more likely to migrate out of the product and become a potential source of exposure. Although data is limited to quantify the potential for migration of the derivatives and upper bounding estimates of intake have not been derived, there is potential for exposure to both TBBPA and the two derivatives.
An upper bounding estimated intake for TBBPA was derived which is expected to take into consideration any additional contribution to intake from the two derivatives. Similarly, the critical effect for the characterization of risk to human health was considered to represent hazard potential for TBBPA and the two derivatives. It is considered that the resulting margins of exposure are adequate to address uncertainties in the health effects and exposure databases for TBBPA and the two derivatives.
Based on the information in this screening assessment, it is proposed to conclude that TBBPA, TBBPA bis(allyl ether), and TBBPA bis(2-hydroxyethyl ether) are not entering the environment in quantities or concentrations or under conditions that constitute or may constitute a danger in Canada to human life or health.
Proposed conclusion
Based on the information available, it is proposed to conclude that TBBPA meets one or more of the criteria set out in section 64 of CEPA 1999.
It is also proposed to conclude that TBBPA bis(2-hydroxyethyl ether) and TBBPA bis(allyl ether) do not meet any of the criteria set out in section 64 of CEPA 1999.
The draft screening assessment report and the proposed risk management scope document for TBBPA are available on the Government of Canada’s Chemical Substances Web site (www. chemicalsubstances.gc.ca).
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DEPARTMENT OF PUBLIC SAFETY AND EMERGENCY PREPAREDNESS
CRIMINAL CODE
Designation as fingerprint examiner
Pursuant to subsection 667(5) of the Criminal Code, I hereby designate the following persons of the Royal Canadian Mounted Police as fingerprint examiners:
Sean David Allen
David Bezanson
Trevor Wade Cook
Keith Allan Stone
Matthew Mader
Ottawa, October 23, 2012
RICHARD WEX
Assistant Deputy Minister
Law Enforcement and Policing Branch
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DEPARTMENT OF PUBLIC SAFETY AND EMERGENCY PREPAREDNESS
CRIMINAL CODE
Designation as fingerprint examiner
Pursuant to subsection 667(5) of the Criminal Code, I hereby designate the following persons of the Royal Canadian Mounted Police as fingerprint examiners:
Christopher William Saunders
Kelly Lee
Ottawa, October 24, 2012
RICHARD WEX
Assistant Deputy Minister
Law Enforcement and Policing Branch
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