Consultation document for amending prohibition of certain toxic substances: substituted diphenylamine substances
Official title: Proposed approach to regulatory amendments to the Prohibition of Certain Toxic Substances Regulations, 2012 in consideration of the draft screening assessment for substituted diphenylamine (SDPA) substances
Consultation document
1. Purpose
The purpose of this consultation document is to provide interested parties an opportunity to submit comments on the proposed approach described in Section 3 of this document for Benzenamine, N-phenyl-, Reaction Products with Styrene and 2,4,4-Trimethylpentene (BNST), Chemical Abstracts Service Registry Number (CAS RN)Footnote1 68921-45-9. The proposed approach takes into account the findings of the draft screening assessment on substituted diphenylamine (SDPA) substancesFootnote2 and how this may impact regulatory requirements for BNST under the Prohibition of Certain Toxic Substances Regulations, 2012 (the Prohibition Regulations, 2012).
2. Context
The Prohibition Regulations, 2012 are a multi-substance risk management instrument used to prohibit the manufacture, use, sale, offer for sale and import of a number of toxic substances and products containing these substances, with a limited number of exemptions (Canada 2013). BNST was added to the Prohibition Regulations, 2012 in January 2013, thereby prohibiting the manufacture, use, sale, offer for sale and import of BNST and products containing BNST with a limited number of exemptions. For example, the use of BNST in lubricants was temporarily allowed until 2015, with continued use allowed until March 14, 2018 if a permit is granted. Please visit the Prohibition Regulations, 2012 for more information.
On November 5, 2016, the proposed Regulations Amending the Prohibition of Certain Toxic Substances Regulations, 2012 (the proposed Amendments) were published in Canada Gazette, Part I for a 75-day public comment period (Canada 2016a). The proposed Amendments would modify existing controls on BNST. In particular, they would add an exemption which would allow the manufacture, use, sale, offer for sale and import of BNST used as an additive in lubricants found in replacement parts. In addition, they would extend the temporary exemption for BNST used as an additive in lubricants, and would thereby allow the manufacture, use, sale, offer for sale and import of BNST used as an additive in lubricants until March 14, 2025. In 2025, these proposed Amendments would allow manufacturers and importers of BNST and products containing BNST to apply for a permit to continue their activities after the expiry of the temporary exemption for additives in lubricants. Permits would be valid for one year and could be renewed twice for a total of three years ending March 14, 2028. Please visit the Prohibition Regulations, 2012, including the Regulatory Impact Assessment Statement for more information and to provide comments on the proposed Amendments.
Subsequently, on December 10, 2016, a draft screening assessment for SDPAs and a Notice summarizing the scientific considerations of this draft assessment were published for a 60-day public comment period (Canada 2016b, 2016c). The draft screening assessment proposes to conclude that none of the 14 SDPAs considered in the assessment are harmful to the environment or to human health. This proposed conclusion applies to BNST, which is one of the 14 SDPAs assessed. Please visit the draft screening assessment for SDPAs and related notice for more information.
3. Proposed approach
Scenario 1: In accordance with subsection 90(2) of the Canadian Environmental Protection Act, 1999 (CEPA), should the Minister of the Environment and the Minister of Health conclude in the final screening assessment for SDPAs, anticipated in 2017, that BNST is not toxic under section 64 of CEPA, the Department of the Environment would consider changing the current regulatory proposal in order to publish final amendments removing BNST from the Prohibition Regulations, 2012.
Scenario 2: Otherwise, should the Ministers conclude in the final screening assessment for SDPAs, anticipated in 2017, that BNST remains harmful to the environment, or meets any other criteria of section 64 of CEPA, the Ministers would recommend to finalize the proposed amendments to provide flexibility for the use of BNST beyond March 2018, in replacement parts and legacy equipment.
4. Public comment period
Comments on the proposed approach noted in Section 3 of this document must be submitted no later than February 8, 2017, to the attention of:
Mary Ann Spicer
Acting Executive Director, Chemicals Management Division
Environment and Climate Change Canada
351 boulevard Saint-Joseph 10th floor
Gatineau QC K1A 0H3
Email: ec.interdiction-prohibition.ec@canada.ca
5. Next steps
Environment and Climate Change Canada and Health Canada officials will consider comments received on this consultation document, as well as on the consultations referred to in Section 2 of this document.
The final screening assessment and related notice for SDPAs, including BNST, is expected to be published in 2017.
Depending on the final conclusions of this assessment, publication of final amendments to the Prohibition Regulations, 2012, to either finalize the proposed amendments or remove BNST prohibitions, as the case may be, would be published prior to the end of the permitting provisions (March 14, 2018).
6. References
Canada. 2013. Department of the Environment.Canadian Environmental Protection Act, 1999: Prohibition of Certain Toxic Substances Regulations, 2012, 2 January 2013, SOR/2012-285.
Canada. 2016a. Department of the Environment. Canadian Environmental Protection Act, 1999: Proposed Regulations Amending the Prohibition of Certain Toxic Substances Regulations, 2012, vol. 150, no. 45 - November 5, 2016, pp. 3375-3387.
Canada. 2016b. Department of the Environment, Department of Health. Draft Screening Assessment for the Substance Groupings Initiative of the Chemicals Management Plan, Substituted Diphenylamines.
Canada. 2016c. Department of the Environment, Department of Health. Publication after Screening Assessment of 14 Substituted Diphenylamines (SDPA) Specified on the Domestic Substances List. Canada Gazette, Part I, vol. 150, no. 50 - December 10, 2016, pp. 3949-3957.
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