Notice of objection filed by MCPP France and Minister’s response to the Notice of objection
Notice of objection
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The Honourable Steven Guilbeault Minister of the Environment
c/o Christina Paradiso Executive Director Chemicals Management
Environmental Protection Branch
Department of the Environment
351 Saint-Joseph Boulevard, Gatineau, Quebec K1A 0H3
Email: ec.interdiction-prohibition.ec@ec.gc.ca
Tiffauges, July 07, 2022
Re: Notice of Objection and Request for Board of Review in relation to proposed regulations prohibiting the manufacture, use, sale and import of decabromodiphenyl ethane (DBDPE, CAS Registry Number 84852-53-9) and polybrominated diphenyl ethers (PBDEs) while providing exemptions to the prohibitions, Canada Gazette, Part I, Volume 156, Number 20 —May 14, 2022: Prohibition of Certain Toxic Substances Regulations, 2022.
Dear Minister Guilbeault:
Our company/organization writes to express our formal objection to the above-referenced regulatory proposal. We, MCPP FRANCE, are producer of TPE compounds for automotive application cables. This project of regulation for prohibition of DBDPE would impact 90% of our cable business. DBDPE is used in our formulation as flame retardant. It can not be substituted by another substance without degrading final product properties and performances.
As provided for by section 332(2) of CEPA 1999, MCPP FRANCE is filing this Notice of Objection and respectfully request that a Board of Review be established, pursuant to section 333 of CEPA 1999, to "inquire into the nature and extent of danger" posed by DBDPE and PBDEs for the reasons set out below.
Proposed Risk Management Measures May Lead to Severe Risk to Public Health and Safety
DBDPE performs a valuable function by reducing the flammability of the products where it is used. Those products include not just consumer devices and appliances, but also include airplanes and motor vehicles. In the absence of alternatives, the prohibitions pose a genuine risk of increasing flammability of those products therefore creating a severe risk to public health and safety. DBDPE enables us to pass the international flammability tests and standards for automotive wires, in order to protect public again all fire issues in vehicles.
Proposed Risk Management Measures May Lead to Supply Chain Disruptions
Product manufacturers operate in a global regulatory environment and must take into account a broad range of product safety and design factors. This includes considerations related to product certification, performance, use and end of life, and even chemical registration. These regulatory, design, and performance requirements are addressed through a complex global supply chain for components and subcomponents.
A 2020 socioeconomic study commissioned by ECCC on DBDPE in the Canadian market noted that "at this time, effective fully tested alternatives are not currently known for many critical applications." ECCC suggests that its consultations with industry stakeholders have helped it develop permits and exemptions to address the lack of available alternatives to DBDPE. However, these permits and exemptions are insufficient in addressing the lack of available alternatives for DBDPE. ECCC notes several times during the draft Regulation that there is a lack of data and certainty regarding cost and availability of alternatives to DBDPE for some critical applications, and consequently that compliance costs have not been estimated for proposed risk management measures affecting wire and cable, automotive products, and other applications.
The engineering and certification of products is a time-consuming process that can take years, and there are considerable financial costs involved in this effort. MCPP FRANCE design products to meet relevant safety standards and to be safe when used as intended. Given the lack of available alternatives for DBDPE and unknown costs of compliance with the regulatory proposal, ECCC must revise its approach in regulating DBDPE to avoid disruptions to an already overburdened supply chain. For our company, it takes at least two years in order to get the final approval from car maker's.
Proposed Risk Management Measures for PBDEs do not Align with Global Regulations and Restrictions
As mentioned earlier for DBDPE, it is also important that risk management measures for other substances align with global agreements and regulations. That is true for PBDEs, a group of flame retardants which have largely been phased out in Canada and around the world and are no longer being produced. At present, Canada already prohibits the manufacture, use, sale, offer for sale, and import of PBDEs, including decaBDE, and all products that contain PBDEs except for manufactured items. Canada's current regulations for PBDEs are largely consistent with international regulations for PBDEs.
ECCC proposes eliminating the exemption allowing the manufacture, use, sale and import of manufactured items containing PBDEs with a few exceptions. In addition, the presence of each PBDE congener (e.g., decaBDE, octaBDE, etc.) in a substance, mixture, polymer, or resin is proposed to be incidental at a concentration less than or equal to 10 parts per million (ppm). The presence of PBDE congeners in all other products is proposed to be incidental when the total concentration of all congeners is less than or equal to 500 ppm.
In contrast, the European Union's Restriction on Hazardous Substances (RoHS) requires electrical and electronic products to contain less that 1,000 ppm or 0.1% of PBDEs. Further illustrating the complexity in finding alternatives for some substances, although five PBDEs are listed as POPs by the Stockholm Convention, all of them still have some specific exemptions on a time-limited basis. U.S. EPA is also considering additional risk management measures for decaBDE, with a proposal for a new rulemaking expected in Spring 2023.
The proposed risk management measures for PBDEs could put Canada at odds with some of its largest trading partners and consideration should be given to global regulatory alignment, circularity goals, and potential disruptions to critical sectors in the country.
Based upon the facts and arguments set out above we ask the Minister to appoint a Board of Review to "inquire into the nature and extent of danger" posed by DBDPE and PBDEs.
Sincerely,
Evelyne BARRE
Site Director
MCPP FRANCE
Minister's response
Ms. Evelyne Barre
Director General
MCPP France - Mitsubishi Chemical Group
evelyne.barre@m-chem.com
david.gouin@m-chem.com
Dear Ms. Barre:
This letter is in response to your Notice of Objection and request to establish a board of review to the publication of the proposed Prohibition of Certain Toxic Substances Regulations, 2022 (proposed Regulations), which was received by Environment and Climate Change Canada on July 6, 2022. The proposed Regulations were published in the Canada Gazette, Part I, on May 14, 2022.
I have carefully considered all the issues in your Notice of Objection, including those dealing with the nature and extent of the danger posed by decabromodiphenyl ethane (DBDPE) and the other questions and considerations that you brought to my attention. In my opinion, your Notice of Objection does not raise sufficient uncertainty or doubt in the science underlying the proposed Regulations that would warrant the establishment of a board of review under subsection 333(1) of the Canadian Environmental Protection Act, 1999 (CEPA). Therefore, I am denying your request, and I will not establish a board of review. The reasons for my decision are explained below and in the Annex to this letter.
The comments in your Notice of Objection regarding the development of the proposed Regulations have been considered alongside other comments received on these regulations. The specific points you have raised on the proposed Regulations and how they will be addressed are also summarized in the Annex to this letter. Your Notice of Objection raised specific concerns on the proposed exemptions for DBDPE, and to address these concerns, the proposed timeline of the DBDPE exemptions will be extended by an additional 10 years (i.e. extended from 5 years to 15 years for new products and from 20 years to 30 years for replacement parts) and the scope of these exemptions will be broadened to include all manufactured items and additional intermediate materials. This extended timeline will allow all stakeholders additional time for the research and development of alternatives, testing and certification, and transitioning their manufacturing and supply chains. Broadening the scope of the DBDPE exemptions will help to reduce the risk of prohibiting critical components, reduce the need to apply for permits under the proposed Regulations for non-exempted parts, and reduce compliance burden of stakeholders throughout the supply chain.
Please note that the comments on the proposed Regulations will be summarized in the Regulatory Impact Analysis Statement that will be published with the final Prohibition of Certain Toxic Substances Regulations, 2025 (2025 Regulations) in the Canada Gazette, Part II, which describe how these matters have been addressed.
I appreciate your bringing your concerns to my attention. Please accept my best regards.
Sincerely,
The Honourable Julie Dabrusin, P.C., M.P. (elle/she/her)
Annex
1) The following provides a summary of comments related to “Proposed Risk Management Measures May Lead to Severe Risk to Public Health and Safety” as set out in your Notice of Objection and the analysis of the information you have provided:
1A. In your Notice of Objection, you commented that DBDPE is used as a flame retardant to meet international flammability standards and safety requirements in products such as consumer devices, appliances, airplanes and motor vehicles, and specifically in TPE compounds for automotive application wires and cables.
Flame retardant substances are generally used to meet performance-based flammability requirements. These requirements do not specify what chemical flame retardants need to be used; rather they may require a product or component to pass a laboratory test such as a cigarette smolder or open flame ignition test (ASTM 2014). Using chemical flame retardants such as DBDPE in products is one of the ways by which companies can meet flammability requirements for their products. Alternate substances as well as non-chemical-based alternatives may also be used to replace the use of DBDPE as a flame retardant in various applications.
In addition to the concerns you have raised in your Notice of Objection, a number of similar comments were received during the public comment period for the proposed Regulations. To address these concerns, the proposed timeline of the DBDPE exemptions will be extended by an additional 10 years (i.e. extended from 5 years to 15 years for new products and from 20 years to 30 years for replacement parts) and the scope of the DBDPE exemptions will be broadened to include all manufactured items and additional intermediate materials. This extended timeline will allow all stakeholders additional time for the research and development of alternatives, testing and certification, and transitioning their manufacturing and supply chains. Broadening the scope of the DBDPE exemptions will help to reduce the risk of prohibiting critical components, reduce the need to apply for permits under the Regulations for non-exempted parts, and reduce compliance burden of stakeholders throughout the supply chain.
1B. In your Notice of Objection, you provided comments that due to the lack of available alternatives for DBDPE in some products such as automotive application cables and that without suitable alternatives, increased flammability of products will create health and safety risks.
Please refer to the response to point 1A (above) respecting the extended timeline for, and broadened scope of the DBDPE exemptions.
2) The following provides a summary of comments related to “Proposed Risk Management Measures May Lead to Supply Chain Disruptions” as provided in your Notice of Objection and the analysis of the information you have provided:
In your Notice of Objection, you provided comments that global product manufacturers take into consideration regulatory, design, performance requirements which are addressed through a complex global supply chain for components and subcomponents and significant time and costs are associated with switching to alternatives which require research and development, prototyping, performance testing, manufacturing retooling, and regulatory compliance certification. Furthermore, you commented that you disagree with the Regulatory Impact Analysis Statement (RIAS) that the proposed permits and exemptions are sufficient for stakeholders due to the lack of available alternatives for DBDPE in some products and unknown costs throughout the global supply chain. You also commented that existing alternatives are not suitable due to impacts on final product properties and performance.
Please refer to the response to point 1A (above) respecting the extended timeline for, and broadened scope of the DBDPE exemptions.
With respect to the estimated cost for transitioning to alternatives, it is acknowledged that the analysis does not monetize the full impact of the 2025 Regulations due to the limited information available on these substances and their possible alternatives. In response to these comments, a sensitivity analysis was done in the RIAS accompanying the 2025 Regulations to consider higher costs based on available information.
3) The following provides a summary of comments related to “Proposed Risk Management Measures for Polybrominated Diphenyl Ethers (PBDEs) do not Align with Global Regulations and Restrictions” as provided in your Notice of Objection and the analysis of the information you have provided:
In your Notice of Objection, you commented that the proposed concentration thresholds for incidental presence of PBDEs could put Canada at odds with some of its largest trading partners and consideration should be given to global regulatory alignment.
The incidental presence concentration threshold values in Schedule 3 of the proposed Regulations endeavored to align with those of other jurisdictions. The concentration thresholds for PBDEs (10 mg/kg (0.001 percent by weight) in a product that is a commercial grade substance, mixture, polymer or resin; and 500 mg/kg (0.05 percent by weight) for all other products) are aligned with the concentration thresholds for PBDEs in Annex I of the European Union's Regulation (EU) 2019/1021 of 20 June 2019 on persistent organic pollutants (EU’s POPs Regulation). However, the EU’s POPs Regulation derogates (or exempts) electrical and electronic equipment (EEE) within the scope of the European Union’s Directive 2011/65/EU of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (EU RoHS Directive) which has a higher incidental presence concentration threshold of 1,000 mg/kg (0.1 percent by weight) for PBDEs.
To support international alignment with the EU RoHS Directive, the proposed incidental presence concentration threshold for PBDEs will be modified to align in specific EEE of 1,000 mg/kg (0.1 percent by weight).