Polybrominated Diphenyl Ethers (PBDEs) risk assessment

Mandatory survey - section 71 notice

In April 2017, a notice was issued in the Canada Gazette, Part I: Vol. 151, No. 13 – April 1, 2017 under section 71 of the Canadian Environmental Protection Act, 1999 (CEPA 1999). The notice applied to DecaBDE (CAS RN 1163-19-5) and approximately 30 other substances that are toxic or proposed to be toxic as defined under section 64 of CEPA 1999. More information is available on the certain substances requiring information for risk management web page.

Risk management action milestones

In December 2018, Environment and Climate Change Canada and Health Canada published the Consultation Document on Proposed Amendments to the Prohibition of Certain Toxic Substances Regulations, 2012 for PFOS, PFOA, LC-PFCAs, HBCD, PBDEs, DP and DBDPE .

The objective of this consultation document is to inform stakeholders of the proposed amendments to the Prohibition of Certain Toxic Substances Regulations, 2012, solicit comments and request information. Comments and information are requested by February 18, 2019.

Comments and information received in response to the consultation document will be considered in the development of the proposed Regulations to Amend the Prohibition of Certain Toxic Substances Regulations, 2012.

In October 2018, a notice of intent was issued in the Canada Gazette, Part I: Vol. 152, No. 41 – October 13, 2018  indicating that the Department of the Environment and the Department of Health were initiating the development of amendments to the Prohibition of Certain Toxic Substances Regulations, 2012. These amendments would seek to further restrict the manufacture, use, sale, offer for sale and import of certain toxic substances, including PBDEs. There was a 30-day consultation period associated with this publication. Comments received on this publication will be considered in the development of the proposed Regulations to Amend the Prohibition of Certain Toxic Substances Regulations, 2012.

In October 2016, the Regulations Amending the Prohibition of Certain Toxic Substances Regulations, 2012 were published in the Canada Gazette, Part II: Vol. 150, No. 20 - October 5, 2016 and came into force in December 2016. These amendments include controls on PBDEs and expand the scope of the previous prohibition for PBDEs to cover all PBDE substances (including decaBDE) with the exception of manufactured items. The Polybrominated Diphenyl Ethers Regulations were repealed when these amendments came into force.

In April 2015, proposed Regulations Amending the Prohibition of Certain Toxic Substances Regulations, 2012 were published in the Canada Gazette, Part I: Vol. 149, No. 14 - April 4, 2015, for a 75-day public comment period. Comments received during this period were considered in the final development of these regulations. Comments and the Government's response are provided in the summary of public comments received on the Proposed Regulations Amending the Prohibition of Certain Toxic Substances Regulations, 2012.

In February 2013, the Government of Canada's Consultation Document on the Proposed Risk Management Measure for Instrument for Products Containing Polybrominated Diphenyl Ethers (PBDEs) for a 60-day public comment period. Comments and the Government's response are provided in the summary of public comments on the consultation document on the proposed risk management measure for PBDEs. Comments received were considered during the development of the proposed risk management action.

In July 2008, the Government of Canada published the Polybrominated Diphenyl Ethers Regulations to protect Canada's environment from the risks associated with PBDEs by preventing their manufacture and restricting their use in Canada, thereby minimizing their release into the environment.

Final Human Health State of the Science Report on Decabromodiphenyl Ether

In December 2012, the final Human Health State of the Science Report on Decabromodiphenyl Ether (decaBDE) was released and the related Notice was published in the Canada Gazette, Part I: Vol. 146 No. 48 - December 1, 2012.

The final human health state of the science report on decaBDE builds on the health screening assessment of PBDEs (including decaBDE) conducted in 2006, and summarizes human health information on decaBDE that became available since the 2006 assessment. The final human health state of the science report reaffirms that decaBDE is not harmful to human health at current levels of exposure.

Draft human health state of the science report

In February 2012, based on new information that was not considered in the original report, a draft human health state of the science report on decaBDE updating the original state of the science report for a health assessment on the class of substances PBDEs, which includes decaBDE, was released and the notice was published in the Canada Gazette, Part I: Vol. 146, No. 6 - February 11, 2012 for a 60-day public comment period.

The comments received from stakeholders were considered and addressed within the final human health state of the science report, and responses to the comments received are provided in the summary of public comments received on the draft human health state of the science report on decaBDE.

Final Ecological State of the Science Report on Decabromodiphenyl Ether

In August 2010, the results of a final Ecological State of the Science Report on Decabromodiphenyl Ether (decaBDE) were published in the Canada Gazette, Part I: Vol. 144 No. 35 - August 28, 2010.

The report provides an updated analysis of bioaccumulation and environmental transformation of decaBDE. The report concluded that decaBDE may accumulate to high and problematic levels in organisms, and may transform into bioaccumulative and/or potentially bioaccumulative substances.

Draft ecological state of the science report

In March 2009, a Draft Ecological State of the Science Report of Decabromodiphenyl Ether (decaBDE), which consists of an updated analysis of bioaccumulation and environmental transformation of decaBDE, was published for a 60-day public comment period.

The comments received from stakeholders were considered and addressed within the final ecological state of the science report, and responses to the comments received are provided in the summary of public comments received on the revised risk management strategy for PBDEs and the draft ecological state of the science report on decaBDE.

Final Revised Risk Management Strategy for Polybrominated Diphenyl Ethers

Since the completion and publication of the screening assessment in 2006, new information was published respecting the accumulation of one form of PBDE, decaBDE, in biota and its potential transformation to persistent and bioaccumulative products. This information was summarized and evaluated in the final Ecological State of Science Report on Decabromodiphenyl Ether (decaBDE), published in August 2010.

The outcome of this review provided justification for the development of additional regulatory controls for this form of PBDEs and in August 2010 the Government published a final revised Risk Management Strategy for Polybrominated Diphenyl Ethers (PBDEs) for a 60-day public comment period.

Following the comments received on the revised strategy, the conclusions of the final state of the science report, and the voluntary phase-out of decaBDE by the industry in the United States, the final revised risk management strategy proposed to further broaden the control measures for decaBDE. The measures would restrict both the substance and all products that contain it (not limited to electrical and electronic equipment as indicated in the March 2009 risk management strategy). The final revised strategy consists of the following main elements:

  1. Expand prohibitions on the manufacture, use, sale and import currently in force for tetra-, hexa- and pentaBDE (as prescribed by the PBDEs regulations) to all PBDEs assessed under CEPA 1999. As such, prohibitions on the use, sale, offer for sale and import would be extended to hepta-, octa-, nona- and decaBDE congeners, and any resin or polymer containing these substances.
  2. Development of control measures under CEPA 1999 to restrict PBDEs in manufactured and imported products. While further information needs to be gathered, the intention is to prohibit the manufacture, use, sale, offer for sale and import of all new products containing tetra- to decaBDE at concentrations greater than 0.1% by weight.
  3. Federal Environmental Quality Guidelines for Polybrominated Diphenyl Ethers (PBDEs).
  4. Development of a risk management strategy for the waste sector (for example, landfills, incinerators and recycling facilities) that will include PBDE-containing products at end-of-life.
  5. Monitoring Canadians' exposure to PBDEs and concentrations in the environment.

For reference, the Risk Management Strategy on Polybrominated Diphenyl Ethers is available.

Background

Notice of objection

In 2007, a notice of objection was filed by 4 environmental non-profit organizations requesting the establishment of a Board of Review under subsection 332(2) and section 333 of CEPA 1999.

Significant new information on bioaccumulation and environmental transformation of decaBDE, which became available since the publication of the screening assessment, was subsequently analyzed, and the results released in an ecological state of the science report on decaBDE. While the request to establish a Board of Review was declined in 2010, the Government released an Ecological State of the Science Report on the Bioaccumulation and Transformation of decaBDE. In response to this report, the risk management strategy was revised to identify additional controls to restrict the use of decaBDE in manufactured and imported products.

Screening Assessment

In 2006, the Ecological Screening Assessment Polybrominated Diphenyl Ethers (PBDEs) and the State of the Science Report for Polybrominated Diphenyl Ethers (PBDEs) were conducted to determine whether PBDEs met the criteria set out in paragraph 64 of CEPA 1999. The final decision on PBDEs was published in the Canada Gazette, Part I: Vol. 140, No. 26 - July 1, 2006. PBDEs have been identified as meeting the criteria under paragraph 64(a) of CEPA 1999.

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