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Proposed Regulations Amending theProhibition of Certain Toxic Substances Regulations, 2005 (Four New Fluorotelomer-based Substances) and Proposed Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999
Canada Gazette, Part I Summary of Comments / EC Response
As part of the ongoing consultations with stakeholders on risk management actions for four new fluorotelomer-based substances, Environment Canada and Health Canada have collected and assessed comments on the proposed Regulations Amending the Prohibition of Certain Toxic Substances Regulations, 2005 (Four New Fluorotelomer-based Substances) and the proposed Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999.
This document has been prepared to present the comments and issues raised by stakeholders on the proposed Order and the proposed Regulations with responses from Environment Canada and Health Canada. All comments have been noted and considered: however, they may not be reported verbatim as similar comments have been combined and paraphrased for brevity.
The proposed Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999 and the proposed Regulations Amending the Prohibition of Certain Toxic Substances Regulations, 2005 (Four New Fluorotelomer-based Substances) were published in Part I of the Canada Gazette on June 17, 2006. The 60-day comment period for the proposed Order and Regulations closed on August 17, 2006. A total of five (5) comments were received, three (3) from industry, one (1) from an environmental non-governmental organization (ENGO) and one (1) from a private citizen.
A notice of objection was also filed under section 333 of the Canadian Environmental Protection Act, 1999 by industry on the proposed Order and proposed Regulations. The basis for the notice of objection and Environment Canada’s response is included in this summary of comments. Given that the party who submitted the notice of objection provided no new information with respect to the nature and extent of the danger posed by the four new fluorotelomer-based substances, the request for a Board of Review was declined by the Minister of Environment and the Minister of Health. The notice of objection is available on the CEPA Environment Registry website at: www.ec.gc.ca/CEPARegistry/participation/object.cfm
Comment: One of the notified substances is unique when compared to other perfluorinated alkyl substances and is the least likely of the four new substances to degrade to perfluorinated carboxylic acids (PFCAs); therefore, it is believed that this substance should not be part of the prohibition.
This comment has been noted in the Government response to comments on the assessments, copies of which can be requested at www.ec.gc.ca/subsnouvelles-newsubs/Default.asp?lang=En&n=7BC7614A-1. The mechanism of forming PFCAs from this substance is different than for the other three substances, as noted in the assessment report; however, Environment Canada and Health Canada have concluded that the notified substance is a source of PFCAs.
Comment: There is no sound or rational scientific basis for the proposals. There is an absence of evidence demonstrating a specific danger which justifies the proposal to prohibit the substances. There are significant uncertainties in the analyses supporting the regulatory proposals.
Assessments of new substances undertaken by Environment Canada and Health Canada consider all available scientific information, including information supplied by the notifier, publications in the peer-reviewed scientific literature and information otherwise available to the departments.
In the case of the assessment of the four polyfluorinated telomer-based polymers, an extensive peer review process was undertaken to validate the assessment conclusions. A total of twenty-two (22) individuals, consisting of academics, industry representatives, non-governmental organizations and regulatory agencies were invited to provide comments focusing on their given areas of expertise addressing the adequacy of the scientific information contained in the reports. The information gathered and shared during the peer review process validated the findings of the assessment. A copy of the summary of the comments received and the Government response is publicly available at: www.ec.gc.ca/subsnouvelles-newsubs/Default.asp?lang=En&n=7BC7614A-1.
Many comments from the peer review process indicated that new information had become available and needed to be considered. The New Substances Programs of Environment Canada and Health Canada have examined all of the scientific comments along with the findings from recent available scientific studies in peer-reviewed literature and elsewhere. This analysis is documented in An Update to Environmental and Human Health Assessments – NSN Nos. 12763, 12798, 12863, 13211 and 13395 (dated April 2006). The conclusions support those of the original assessment reports. These reports cite over 200 sources of information, the majority from the peer-reviewed scientific literature.
Copies of the Updates to the Assessments can be requested at: www.ec.gc.ca/substances/nsb/eng/cp_telomer_e.shtml
Substances Already in Canadian Commerce
Comment: Similar substances, that are prone to degradation into PFCA precursors and PFCAs,are already in Canadian commerce.These are not subject to any restrictions under CEPA 1999 and the new substances have been singled out in the regulatory approach.
On June 17, 2006, Environment Canada and Health Canada published a Notice of Action Plan for PFCAs and their precursors. In this Notice, Environment Canada and Health Canada committed to pursue further assessment of PFCA precursors and PFCAs currently in commerce in order to guide further risk management actions.
In addition, the Action Plan recognizes the presence of residual levels of PFCAs in certain substances already in commerce, and committed to seek action from industry to significantly reduce the levels of these residuals. A proposed voluntary agreement was published for public comment on January 30, 2009. Under the agreement, participating companies would voluntarily commit to:
- Reduce by 95% the product content levels of residual perfluorooctanoic acid (PFOA), long chainPFCAsand their precursors in their perfluorochemical products sold in Canada by December 31, 2010;
- Work towards eliminating the remaining 5% of these substances by 2015; and
- Report annual information on the residual and non-residual (i.e., active ingredient) content of their perfluorochemical products sold in Canada.
This approach is consistent with other regulatory initiatives in the United States and the European Union.
Environment Canada and Health Canada continue to strive toward advancing the understanding of PFCAs and precursor substances, and solutions to issues surrounding these substances that are already in Canadian commerce. This work is ongoing domestically as well as in cooperation with other international partners. Additionally, this will be accomplished through the promotion of scientific research, to foster a better understanding of the impacts of these chemicals in the environment, and through the promotion of the development of alternatives.
CEPA 1999 Instrument
Comment: The decision for prohibition of the four new substances versus other available regulatory mechanisms, including less extreme actions, is questioned.
After a detailed analysis of the regulatory instruments available to manage the four new fluorotelomer-based substances, it was concluded that a prohibition through regulations is the most appropriate instrument.
Additionally, not proposing regulations that prohibit the four substances would have permitted the possible introduction of the four new fluorotelomer-based substances into Canada upon expiry of the two-year ministerial prohibitions imposed on these substances under section 84 of CEPA 1999. This would have resulted in new sources of PFCAs in the Canadian environment. The persistent and bioaccumulative nature of long chain PFCAs warrants taking action to prevent new sources of PFCAs from entering Canada.
Information supporting the instrument choice for the four new fluorotelomer-based substances is included in the Regulatory Impact Analysis Statement that accompanied the proposed Regulations. The Regulatory Impact Analysis Statement is available at: www.ec.gc.ca/ceparegistry/
Comment: The proposed prohibition creates the opportunity for ongoing production of products containing these toxic substances in Canada and sends a signal to the public that products with toxic substances are acceptable and is contrary to the objective of preventing further increases of PFCAs. The Government should commit to working with stakeholders to discuss how toxic substances in manufactured items can be managed through the regulatory process.
The prohibition of the four fluorotelomer-based substances is part of a comprehensive risk management strategy for PFCAs and their precursors, detailed in the Action Plan, mentioned above.
The purpose of the proposed Regulations is to uphold Ministerial Prohibitions placed on the four new substances that prohibit the manufacture, import, use, sale and offer for sale of the substances, except when present in manufactured items. The proposed Regulations prevent the introduction of the four new substances into the Canadian marketplace, thereby preventing their application to manufactured items.
Environment Canada and Health Canada agree that the presence of toxic substances in products is an important aspect to consider and an emerging issue in relation to many toxic substances.
Also, as described above, Environment Canada and Health Canada are working with industry through a voluntary agreement to reduce the concentration of PFCA and precursor substances in perfluorochemical products sold in Canada. The voluntary agreement was published for public comment in January 2009 and is available at: www.ec.gc.ca/epe-epa/default.asp?lang=Fr&n=10551A08-1
As well, research and information gathering, domestically and internationally, is currently under way and will guide the risk management actions related to imported manufactured items treated with substances containing PFCAs and their precursors.
Interested and affected parties will have the opportunity to take part in consultations on any proposed regulatory actions on managing toxic substances in manufactured items.
Comment: The government should require importers to label the substances found in products entering the Canadian market.
The Government of Canada uses labelling as a risk management measure to inform consumers of the potential risks of food constituents, or to provide them with tools to protect and improve their health. Mandatory labelling for these substances is not being considered as a risk management approach at this time. However labelling may be considered as part of future risk management actions on PFCAs and precursors that are outlined in the PFCA Action Plan.
Comment: Environment Canada should commit to a timeline for the control of imported manufactured items containing the prohibited fluorotelomer-based substances.
The Government is currently working towards pursuing further assessment of PFCAs and precursor substances already in commerce as set out in the Action Plan, which will be published for public comment in due course. Depending on the conclusions of any of the final screening assessment reports, the Government could propose risk management measures relating to the control of certain imported manufactured items. Any potential risk management measures would be based on the criteria identified in the Treasury Board document entitled the Cabinet Directive on Streamlining Regulation.
Comment: The government is urged to fund thorough, long-term research into the environmental and health effects not only of the four new fluorotelomer-based substances, but also of any new chemical substances proposed to be developed or imported into Canada in any form.
As outlined in the Action Plan, Environment Canada and Health Canada are working to advance the understanding of PFCAs and precursor substances and related solutions to issues surrounding these substances that are already in Canadian commerce, by promoting scientific research to foster a better understanding of the contribution of PFCAs in the environment.
Monitoring of certain PFCAs and precursors in media that include air, water, sediment, wastewater, biosolids, indoor air, house dust and human blood was initiated in 2006 and is ongoing.
These monitoring results will be used to inform on exposure sources and levels in Canada. This information will provide current baseline and trend data, which further contributes to domestic and international risk assessment and risk management.
In addition, in line with the Action Plan, further assessment of PFCAs and their precursors is being conducted and will be published for public comment in due course.
Comment: Environment Canada and Health Canada should work with the scientific community to develop more reliable and practical tests so that a testing program to control the import of manufactured items containing the four substances may be developed.
The Government agrees that improved testing methods are required in order to control the import of manufactured items containing toxic substances, and is currently working with the scientific community on developing these methods.
Environment Canada and Health Canada are also committed to continuing research with the scientific community on PFCAs and their precursors outlined in the Action Plan. In particular, research and development of alternatives that are preferable for the protection of human health and the environment, such as substances with reduced persistence, bioaccumulation and toxic properties, are key components of the Action Plan.
Also, the Action Plan sets out how Environment Canada and Health Canada are working with industry through voluntary actions to reduce the concentration of PFCAs and precursor substances in perfluorochemical products sold in Canada. The voluntary agreement was published for public comment in January 2009 and is available at: www.ec.gc.ca/epe-epa/default.asp?lang=En&n=10551A08-1
Comment: The government is called on to inform and educate Canadian citizens about the environmental and health benefits when choosing consumer products manufactured or derived from natural materials and to support the domestic industries producing, selling, marketing, importing or exporting these products.
The Government of Canada agrees that there is a need to provide the information consumers need to make knowledgeable choices. Under the Chemicals Management Plan, the Government of Canada is working to reduce risks associated with chemicals and to inform Canadians. Information on the Chemicals Management Plan can be found at: http://www.chemicalsubstanceschimiques.gc.ca/plan/index-eng.php
Additionally, the Government of Canada’s EcoLogoTM provides customers with assurance that the products and services bearing the logo meet stringent standards of environmental leadership, and works to help customers find and trust the world’s most sustainable products.
Impact of Proposals
Comment: The proposal to amend the Prohibition of Certain Toxic Substances Regulations, 2005 will impact CEPA 1999 beyond prohibitions pertaining to the four new fluorotelomer-based substances, particularly if other substances are added to this new part in the future.
All amendments made to the Prohibition of Certain Toxic Substances Regulations, 2005 are carefully assessed, with respect to the impact of the amendment on the parent Regulation as well as subsequent amendments to add new substances.
Comment: The government of Canada did not set deadlines and timetables for the regulatory process, the rules for the consultation process were not determined or disclosed in advance and the process was not open, fair and transparent.
In accordance with the Government of Canada regulatory policy, timely and thorough consultations with stakeholders were conducted. A meeting was held in February 2006 to consult with stakeholders on the Action Plan on Perfluorinated Carboxylic Acids and their Precursors as well as the Risk Management Strategy for the four new fluorotelomer-based substances. Stakeholders were given an opportunity to comment on the assessment report and the Action Plan following the February 2006 consultation meeting.
Further communications with respect to the proposed regulatory initiatives were held between February and June 2006. These communications included the distribution of the consultation meeting report and the Science Update report.
The notifiers were also informed of the proposed regulatory text in advance of the June 17, 2006, publication in the Canada Gazette, Part I; the notifiers were also given a chance to provide comments on the proposed text.
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