Public comments received on the proposed regulations amending the toxic substances regulations
The proposed Regulations Amending the Prohibition of Certain Toxic Substances Regulations, 2012 were published on April 4, 2015 in the Canada Gazette, Part I for a 75-day public comment period. Approximately 20 organizations provided comments : Boeing Canada Operations Ltd, Canadian Environmental Law Association, Canadian Network for Human Health and the Environment, Canadian Vehicle Manufacturers Association, Chemical Sensitivities Manitoba, David Suzuki Foundation, Dow Chemical Canada, EcoJustice, Environmental Defense, Fire Fighting Foam Coalition, FluoroCouncil, Global Automakers Canada, Hewlett-Packard Company, Imperial Oil Limited, KAN Centre for Environment and Development, Learning Disabilities Association of Canada, Nekxemia Petrochemical Inc, Donald Spady, Superior Electroplating, Toshiba of Canada Limited, Helen White.
A number of stakeholders submitted comments supporting the proposed regulatory approach for Hexabromocyclododecane (HBCD), Perfluorooctanoic Acid (PFOA), Long-Chain Perfluorocarboxylic Acids (LC-PFCAs), Polybrominated Diphenyl Ethers (PBDEs) and Perfluorooctane Sulfonate (PFOS). In addition, a number of specific comments were submitted relating to the proposed amendments on various topics. A summary of comments and responses is included below, organized by topic.
Please note that responses to some of the comments received following the publication of the proposed Amendments in Canada Gazette, Part I are included in the Regulatory Impact Analysis Statement (RIAS) for the Regulations Amending the Prohibition of Certain Toxic Substances Regulations, 2012. Please see section 7.2 of the RIAS for additional information.
|Support||A number of stakeholders submitted comments supporting the proposed regulatory approach for HBCD, PFOA, LC-PFCAs, PBDEs and PFOS.||The Government of Canada acknowledges the comments submitted and notes that the regulatory approach for these substances is aligned with a phased approach to the risk management of toxic substances.|
|Exemptions||A number of stakeholders questioned the need for exemptions outlined in the proposed amendments for HBCD, PFOA, LC-PFCAs, PBDEs and PFOS and requested additional information regarding the rationale for exemptions.||
The risk management objective for HBCD, PFOA, LC-PFCAs, PBDEs and PFOS is to achieve the lowest level of releases into the Canadian environment which is technically or economically feasible.
Based on feedback from stakeholders, alternatives to HBCD, PFOA, LC-PFCAs, PBDEs and PFOS are available in many but not all applications. Thus the amendments have included exemptions that reflect this information.
Even though the amendments include exemptions it is important to note that the Government of Canada often takes a phased approach to the risk management of toxic substances. For example, earlier actions have been taken to risk manage PFOA, LC-PFCAs, PBDEs and PFOS, therefore the amendments represent the next phase in the risk management of these substances.
The Department also considered current global action in the determination of the domestic risk management measures, such as those under the Stockholm Convention.
In addition, monitoring of these substances is occurring under a comprehensive monitoring and surveillance strategy under the Chemicals Management Plan. This monitoring will be used to help inform further restrictions, as warranted.
|Changes proposed by the Standing Joint Committee on the Scrutiny of Regulations (SJCSR)||One stakeholder requested that more information should be provided regarding the changes recommended by the SJCSR.||The changes recommended by the SJCSR aim to improve the clarity and consistency of the regulatory text. These include minor editorial changes to subsection 3(2) and subsection 10(3) and the addition of a new sub-section 10(4) in the Prohibition of Certain Toxic Substances Regulations, 2012 (the Prohibition Regulations).|
|Record keeping||Two stakeholders were not supportive of the record keeping changes proposed and indicated that the requirement for a 30 day notice for moving records was unwarranted.||These provisions have been added to improve enforceability of the Prohibition Regulations. Under the Regulations, every person that submits information to the Minister must keep a record containing a copy of that information, a copy of the certification and any documents supporting the information, including test data if applicable for a period of at least 5 years from the date of submission of the information. If records are moved, the amendments require regulatees to notify the Minister in writing, with the civic address of the new location, within 30 days after the day of the move. Records must be kept at the principal place of business in Canada or, on notification to the Minister, at any place in Canada where records can be inspected. It is important for the Department to have up-to-date information on the location of records to undertake enforcement activities such as inspections of records when verifying compliance with the Prohibition Regulations. This change is also consistent with the provisions of other regulations under CEPA such as the Products Containing Mercury Regulations and the Ozone-depleting Substances Regulations, 1998.|
|Reporting||One stakeholder asked for a justification for the annual reporting requirement associated with laboratories.||Information gathered through these reports will provide the Government of Canada with data on the use of toxic substances for scientific research and in laboratories, and aid in determining whether additional controls are required for these uses.|
|Service standards||One stakeholder suggested that the Government of Canada establish a 30 day service standard for delivering a permit following submission of an application.||The Government of Canada understands the importance of providing a reliable and prompt service. The existing permit application processes have been evaluated and as per the current process for the Prohibition Regulations, the Government of Canada will endeavor to respond to permit applications within 60 working days or less. Permit applications are assessed to determine whether the conditions of issuance outlined in Section 10 of the Prohibition Regulations have been met. If the information provided in the application is complete, then the Government of Canada can undertake this assessment more rapidly. However, if the application is incomplete then the Government of Canada will require additional time to undertake the assessment. The Government of Canada has developed guidance materials which are intended to assist regulatee when preparing their applications (please refer to the Fact sheet for the Prohibition of Certain Toxic Substances Regulations, 2012).|
|Clarification of regulatory provisions||Several stakeholders stated that the proposed amendments were complex and suggested that the provisions be simplified.||
When possible, modifications have been made to improve clarity of the regulatory provisions. For example, the provisions for HBCD have been modified to align with the existing provisions of the Prohibition Regulations. In addition, titles have been added to the Schedules in order to clarify the linkages between Schedules and regulatory provisions. With respect to products, section 4 has been updated in order to make it clearer that the existing controls continue to apply.
The Government of Canada published guidance materials to support regulatee awareness and understanding of their obligations under the Prohibition Regulations.
|Chemical Abstracts Service Registry (CAS RN)||Two stakeholders requested that the Department identify CAS RNs for each substance covered by the amendments. Furthermore, some stakeholders stated that there was a lack of information on which products would be covered by the proposed amendments and whether certain substances were present in their products||The Department provided, to known stakeholders, guidance materials on the proposed amendments when they were published in the Canada Gazette, Part I, including a fact sheet describing the proposed regulatory provisions and the products covered by the proposed provisions, and a non-exhaustive lists of applicable CAS RNs for HBCD, PFOA, LC-PFCAs, PBDEs and PFOS. These non-exhaustive lists represent a consolidation of CAS RNs that have been identified in a variety of Government of Canada sources and are intended to assist stakeholders with understanding the applicability of the Prohibition Regulations. Exhaustive CAS RNs lists are not available given the numerous daily additions to the Registry which make it difficult to track and update. The Department published on the CEPA Registry updated versions of these materials as part of an information package associated to the publication of the final Regulations in Canada Gazette Part II, and circulate these materials to known stakeholders.|
|Compliance promotion||Two stakeholders suggested that compliance promotion activities with respect to the final amendments be undertaken by the Government of Canada and that compliance promotion materials be made available to stakeholders upon the publication of the final amendments.||Compliance promotion activities with respect to the amendments are planned and the materials have been made available to the public after the publication of the amendments (please refer to Management of Toxic Substances website).|
|Enforcement||One stakeholder sought clarification on how Canada will ensure that no EPS containing HBCD is imported into Canada upon the expiry of the temporary exemption for EPS and XPS foam and their intermediary products in building and construction applications.||Potential violations of the Regulations, including those that relate to EPS containing HBCD, will be referred to the Enforcement Branch. Enforcement officers may carry out inspections for the purpose of verifying compliance with the Prohibition Regulations, as described in the Compliance and Enforcement Policy for CEPA. Whenever an alleged violation is discovered, enforcement officers will take action consistent with the criteria described in the Policy|
|Cost benefit analysis||For the substance HBCD, one stakeholder indicated that the amendments would likely not result in an improvement in environmental quality and requested that the Government of Canada accurately portray the benefits, costs and impacts of regulatory actions.||The Government of Canada recognizes that the phase-out of HBCD has already started, and that in most applications, the use of HBCD will be phased out by 2015 in most applications. The Amendments will provide certainty that the substances will not be re-introduced in the future, and reduce the use of HBCD in the remaining applications, leading to an improvement in environmental quality by contributing to a reduction of HBCD use and ultimately its release to the environment over time.|
|Cost benefit analysis||One stakeholder suggested that the costs associated with transitioning away from HBCD should not be identified as “minimal”. Also, the stakeholder commented that the assumption that HBCD alternatives would be widely available at the beginning of 2015 is not accurate.||The Government of Canada recognizes that there is significant cost to carry out research, develop alternatives and reformulate products using an alternative. However, for the purposes of this analysis, only costs which are incremental to the proposed Amendments were captured. The impact analysis had identified the cost as “minimal” in the proposed Amendments based on the feedback and information available at the time. The analysis in the RIAS has been updated to reflect comments received from stakeholders on the proposal. Based on publicly available information, the Government of Canada understands that beginning in 2015, the main alternative to HBCD in EPS and XPS applications became more widely available globally as a result of global action to phase out HBCD and as chemical manufacturers initiated production or increased production volumes of the alternative. For applications in which HBCD is still used within the scope of the amendments, the analysis assumes that stakeholders would switch to an alternative before January 1, 2017.|
|Cost benefit analysis||One stakeholder asked how the proposed Amendments would impact Canadian companies that compete with foreign supplies domestically and internationally.||Given that the import and manufacture of the substances are prohibited across Canada, domestic competitiveness is not expected to be impacted based on the Amendments. As indicated in the RIAS, the cost of the Amendments is estimated to be low, and the impact on stakeholders is not expected to be significant.|
|Stockpiles and End of Life Management||One stakeholder asked whether the Regulations allow for stockpiling of HBCD.||The amendments allow for the use, sale and offer for sale of HBCD, and EPS and XPS foam and their intermediary products, that contain HBCD, for use in building and construction applications, which were manufactured or imported before the coming into force date.|
|Stockpiles and End of Life Management||Two stakeholders stated that the regulations should ensure proper disposal and recycling of HBCD, PFOA, LC-PFCAs, PBDEs and PFOS.||The Prohibition Regulations is a multi-substance risk management instrument that is intended to prevent releases of toxic substances and products containing them that could occur during their manufacture, use, sale, offer for sale or import. As such these regulations do not apply to end-of-life disposal. As part of a broader approach to environmental protection, the Government of Canada is strengthening its capacity to manage end-of-life risks with respect to various substances, as well as on the presence and potential releases of toxic substances, and other substances of concern, in waste management facilities in Canada.|
|Export||Two stakeholders stated that the regulations should prohibit the export of HBCD, PFOA, LC-PFCAs, PBDEs and PFOS and products containing these substances.||Regulatory export controls for chemical substances are established by adding a substance to Schedule 3 of the CEPA (the Export Control List) which makes their export subject to the Export of Substances on the Export Control List Regulations which is the Government of Canada’s instrument for export controls. The establishment of regulatory export controls is considered on a case-by-case basis for substances subject to domestic prohibitions or severe restrictions on their use, or substances added to the Rotterdam and/or Stockholm Conventions. Where the substance is known to exist in Canada, regulatory export controls are often necessary to ensure compliance with our international obligations under these treaties. In some cases, no export of a certain chemical is possible because its use has been prohibited in Canada along with manufacture and import, and no stockpiles remain. In these cases, regulatory export controls may not be necessary. PFOS is currently on the Export Control List and its exports (as a substance or contained in a product) are managed accordingly to ensure Canada’s continued compliance with the Rotterdam and Stockholm conventions.|
|Health assessment||One stakeholder stated it was disappointed that none of the substances covered by the proposed amendments met the criterion under subsection 64(c) of CEPA.||The Government of Canada conducted screening environmental and health assessments for HBCD, PBDEs, PFOS and PFOA. At the time these assessments were carried out, it was determined the margins between the exposure to these substances and the health effects endpoints were considered adequately protective. It was therefore concluded that these substances were not a health concern.|
The Government of Canada evaluates the potential environmental impacts of increased trade (including trade in chemicals or products containing chemicals) during the environmental assessments of trade negotiations. Following the estimation of the economic effects of the trade agreement, their likely environmental impacts are approximated - this includes whether the trade negotiations will be consistent with Canada's existing commitments under multilateral environmental agreements (MEAs) such as the Basel, Rotterdam and Stockholm conventions, and whether the trade agreement affect the federal/provincial/ territorial governments' ability to regulate environmental protection or to enhance environmental benefits. The role of the CMP in mitigating the risks posed by harmful chemical substances to the environment and human health is an important consideration of the environmental assessment.
While the CMP is Canada’s initiative to deal with existing chemicals domestically, Canada cooperates with other jurisdictions to share information and work towards the sound management of chemicals globally. This work is done in many fora, through the MEAs as well as through voluntary initiatives such as SAICM, and is informed by the CMP.
||In May 2013, Parties to the Stockholm Convention agreed to list HBCD to Annex A (elimination) of the Convention with an exemption for expanded (EPS) and extruded (XPS) foam applications in buildings. The publication of these amendments is an important step towards the implementation of the domestic phase-out prior to ratification by Canada.|
|Monitoring||Several stakeholders suggested that a comprehensive monitoring and biomonitoring program should be established for the HBCD, PFOA, LC-PFCAs, PBDEs and PFOS||
Health Canada measures a number of chemicals (including HBCD, PFOA, LC-PFCAs, PBDEs, and PFOS) as part of the ongoing national biomonitoring program. Chemicals are measured as part of the human biomonitoring component of the Canadian Health Measures Survey, which is an ongoing national survey that is led by Statistics Canada, in partnership with Health Canada and the Public Health Agency of Canada, which collects information from Canadians about their general health (www.hc-sc.gc.ca/ewh-semt/contaminants/human-humaine/index-eng.php).
At Environment and Climate Change Canada, the national Chemicals Management Plan’s Monitoring and Surveillance Program focuses on monitoring of chemicals in multiple environmental media: air, water, sediment, non-human biota (fish and wildlife); as well as at municipal wastewater treatment plants. This program generates science-based information to support informed decision-making.
HBCD, PFOA, LC-PFCAs, PBDEs and PFOS are chemicals regularly monitored, in appropriate media, under the program. For PFOS and PBDEs information is being used to report under the Canadian Environmental Sustainable Indicators (CESI) program and the Federal Sustainable Development Strategy.
|Alternatives and new substances||Several stakeholders suggested that the assessments of the potential alternatives under the New Substances Program should be made available to the public.||Alternatives may be substances new to Canada, or may already be listed on the Domestic Substances List (DSL). For substances subject to the New Substances Notification Regulation, proponents provide notifications as per the Regulations, and an assessment is conducted by Environment and Climate Change Canada and Health Canada. Assessment summaries are prepared in circumstances where all information required under the regulations has been received and assessed, and/or where a control measure has been imposed and published. The New Substances assessment summaries are found on the Departmental website.|
|Alternatives and new substances||One stakeholder suggested that the use of alternative flame retardant substances should be encouraged.||The Organic Flame Retardant grouping under the second phase of the Chemicals Management Plan (CMP) consists in a number of flame retardants substances, some of which are alternative substances to the controlled substances subject to this amendment. The draft screening assessment reports for these substances are anticipated to be released in 2016 and would contain information which could assist companies in identifying possible alternatives for substances currently subject to the Prohibition Regulations.|
|Virtual Elimination under CEPA||One stakeholder stated that the Canadian Environmental Protection Act, 1999 (CEPA) does not require that preventative or control actions be taken for substances meeting the virtual elimination criteria. This requirement is rather for substances listed on Schedule 1 of CEPA.||The Government of Canada takes note of the correction. Indeed, text in in RIAS for the proposed amendments was not accurate. CEPA requires that substances meeting virtual elimination criteria to be listed on Schedule 1 of CEPA. The requirement for preventative or control actions is for the listed substances. Clarifications were made to the RIAS for the final amendments.|
|Substance-specific comments||Several stakeholders suggested that the Government should address the uncertainty created by the expiration of the Performance Agreement for PFCAs.||
The Performance Agreement was implemented as early risk management action for PFCAs while the Government of Canada pursued further assessment to guide future risk management actions.
The addition of PFOA and LC-PFCAs to the Prohibition Regulations is part of the Government of Canada’s phased approach for the risk management of these substances.
|Substance-specific comments||One stakeholder indicated that EPS and XPS foam insulation products should not be presented as being a dispersive source of HBCD and hence exposure.||The Government of Canada takes note of the information. The RIAS for the final amendments was modified to correctly describe the release profile of HBCD.|
|Substance-specific comments||One stakeholder suggested that information on the use of HBCD in non-building and construction applications be presented in the RIAS.||The Government of Canada takes note of the comment. The RIAS for the final amendments was modified to include information on other uses for HBCD.|
|Substance-specific comments||One stakeholder indicated that RIAS incorrectly states that low releases of HBCD are expected from imported HBCD rather than from imported and domestically manufactured sources.||The Government of Canada takes note of the comment. The RIAS for the final amendments was modified to properly describe the expected releases into the Canadian environment.|
|Substance-specific comments||One stakeholder requested amendments to BNST provisions under the Prohibition Regulations, 2012 be considered for the final amendments.||The Government of Canada takes note of the comment. Proposed amendments to the Prohibition Regulations are being considered to address concerns raised by industry. Please refer to Environment and Climate Change Canada Forward Regulatory Agenda for the CMP for additional information.|
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