Chemical name: Final regulatory action has been taken for the category: Industrial Final regulatory action: The chemical is Banned Use or uses prohibited by the final regulatory action: N/A The Regulations prohibit the manufacture, use, sale, offer for sale or import of PBDEs unless the substance is incidentally present or contained in a manufactured item, with a limited number of exemptions listed below. The Regulations do not apply to a PBDE that is: a) contained in a hazardous waste, hazardous recyclable material or non-hazardous waste to which Division 8 of Part 7 of CEPA applies; b) contained in a pest control product as defined in subsection 2(1) of the Pest Control Products Act; c) present as a contaminant in a chemical feedstock that is used in a process from which there are no releases of the toxic substance and on the condition that the toxic substance is destroyed or completely converted in that process to a substance that is not a toxic substance set out in either Schedule 1 or 2 of the regulations; or d) to be used in a laboratory for analysis, in scientific research or as a laboratory analytical standard. The Regulations do not prohibit: -The import, manufacture, use, sale and offer for sale of PBDEs or a product containing them, if PBDEs are incidentally present [subsection 4(1) of the Regulations] -The import, manufacture, use, sale or offer for sale of manufactured items containing PBDEs [subsection 4(2) of the Regulations] -The use, sale or offer for sale of: oProducts containing decaBDE that were manufactured or imported before the Regulations come into force [subsection 5(2) of the Regulations] oDecaBDE that was imported in accordance with a permit (section 8 of the Regulations) oProducts that contain decaBDE that were manufactured or imported in accordance with a permit (section 8 of the Regulations) REFERENCES Prohibition of Certain Toxic Substances Regulations, 2012 (SOR/2012-285) under CEPA, as amended 2016 (SOR/2016-252). http://www.gazette.gc.ca/rp-pr/p2/2016/2016-10-05/html/sor-dors252-eng.html Substance Prohibition Summary for Polybrominated Diphenyl Ethers. Environment and Climate Change Canada. July 2017. http://ec.gc.ca/lcpe-cepa/default.asp?lang=En&xml=57E10F1D-FBBB-46DE-93DA-E8E17D6F975D Use or uses that remain allowed: N/A Pesticide use or uses that remain allowed: N/A The final regulatory action was based on a risk or hazard evaluation: Yes Summary of the final regulatory action: Polybrominated diphenyl ethers that have the molecular formula C12H(10-n)BrnO in which 4 ? n ? 10 (tetraBDE, pentaBDE, hexaBDE, heptaBDE, octaBDE, nonaBDE and decaBDE, collectively known as PBDEs), and products containing them are subject to the Prohibition of Certain Toxic Substances Regulations, 2012 (the Regulations) as amended in 2016, under the Canadian Environmental Protection Act, 1999 (CEPA). The Prohibition of Certain Toxic Substances Regulations, 2012 prohibit the manufacture, use, sale, offer for sale, and import of PBDEs, including decaBDE, and all products that contain PBDEs except for manufactured items. The Regulations replace the former Polybrominated Diphenyl Ethers Regulations, which were the subject of a previous Notification of final Regulatory Action from Canada. The regulatory controls pertaining to PBDEs that already existed under CEPA prior to this regulatory action were maintained. The Regulations expand the scope of the existing prohibition for PBDEs to cover all PBDE substances (including decaBDE) and products containing them, except manufactured items. The reasons for the final regulatory action were relevant to: Environment Summary of known hazards and risks to human health: N/A Expected effect of the final regulatory action in relation to human health: N/A Summary of known hazards and risks to the environment: A screening assessment involves an analysis of a substance using conservative assumptions to determine whether the substance meets the criteria as defined in section 64 of CEPA. This ecological screening assessment examines various supporting information and develops conclusions based on a weight of evidence approach as required under Section 76.1 of CEPA. The screening assessment does not represent an exhaustive review of all available data; rather, it presents the most critical studies and lines of evidence supporting the conclusions. One line of evidence includes consideration of risk quotients to identify potential for ecological effects. However, other concerns that affect current or potential risk, such as persistence, bioaccumulation, chemical transformation and trends in ambient concentrations, are also examined in this report. Data relevant to the ecological screening assessment of PBDEs were identified in original literature, review documents, and commercial and government databases and indices. In addition to retrieving the references from a literature database search, direct contacts were made with researchers, academics, industry and other government agencies to obtain relevant information on PBDEs. Ongoing scans were conducted of the open literature, conference proceedings and the Internet for relevant PBDE information. Information obtained as of October 2004 was considered for inclusion into Environment Canada's Ecological Screening Assessment Report, while that received between November 2004 and October 2005 was reviewed, but not generally added. The information obtained between November 2004 and October 2005 was found to support the conclusions of Environment Canada's Ecological Screening Assessment Report determined with information received up to October 2004. In addition, an industry survey on PBDEs was conducted for the year 2000 through a Canada Gazette Notice issued pursuant to Section 71 of CEPA. This survey collected data on the Canadian manufacture, import, uses and releases of PBDEs (Environment Canada 2003). Toxicological studies were also submitted by industry under Section 70 of CEPA. Environment Canada's Ecological Screening Assessment Report indicated that the greatest potential risks from PBDEs in the Canadian environment are the secondary poisoning of wildlife from the consumption of prey containing elevated concentrations of PBDEs, and effects on benthic organisms, which may result from elevated concentrations of certain PBDE congeners in sediments. PBDEs have been detected in remote sites around the world; including the Canadian Arctic (in air, lakes and biota) suggesting PBDEs undergo long-range transport. The 2006 screening assessment report also concluded that PBDEs are 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. More specifically, it concluded that tetraBDE, pentaBDE and hexaBDE congeners meet the criteria for persistence and bioaccumulation, as defined by the Persistence and Bioaccumulation Regulations of CEPA. The screening assessment also concluded that their presence in the environment results primarily from human activity (that is, releases from product manufacturing and processing, and throughout the product life cycle). As a result, tetraBDE, pentaBDE and hexaBDE congeners meet the conditions for virtual elimination, as set out in subsection 77(3) of CEPA. The review conducted in the Ecological State of the Science Report on Decabromodiphenyl Ether (decaBDE) confirms that, based on the reviewed materials published up to August 25, 2009, decaBDE is not shown to meet bioaccumulation criteria as defined under the Persistence and Bioaccumulation Regulations under CEPA. However, some studies show that levels of decaBDE are steadily rising in some biota, and in some cases, measured concentrations are considered high. In addition, some equivocal evidence suggests potential biomagnification in food chains. Although uncertainties remain, it is reasonable to conclude that decaBDE may also contribute to the formation of bioaccumulative and/or potentially bioaccumulative transformation products, such as lower brominated BDEs, in organisms and the environment. The findings of the ecological state of the science report provided justification for the development of additional regulatory controls for decaBDE. Expected effect of the final regulatory action in relation to the environment: The final regulatory action protects the Canadian environment from risks associated with the manufacture, use, sale, offer for sale or import of PBDEs and certain products containing PBDEs. Streamline regulations under CEPA pertaining to the control of toxic substances and add new regulatory controls for PBDEs and decaBDE. Date of entry into force of the final regulatory action: 23/12/2016 |