Long-Chain (C9-C20) Perfluorocarboxylic Acids (LC-PFCAs), their Salts, and their Precursors and Perfluorooctanoic Acid (PFOA) Its Salts, and Its Precursors - Response to Comments on Consultation Document

The Consultation Document on the Proposed Risk Management Measure for Perfluorooctanoic Acid (PFOA), its salts and its precursors and Long-chain Perfluorocarboxylic Acids (LC-PFCAs), their salts and their precursors was published on January 2, 2014 for a 30-day electronic public consultation period.  Six organizations provided comments: Canadian Vehicle Manufacturers’ Association (CVMA), Hewlett-Packard Company, FluoroCouncil, German Federal Environment Agency, Department of National Defence (DND), and Canadian Armed Forces (CAF).

A summary of comments and responses is included below, organized by topic:

Ecological Assessment

Comment:
PFOA and LC-PFCAs do not meet the bioaccumulation criteria, as set out in the Persistence and Bioaccumulation Regulations, 2000, therefore these chemicals should not be subject to virtual elimination under the Canadian Environmental Protection Act , 1999 (CEPA).
Response:
The Screening Assessments did not conclude that PFOA and LC-PFCAs met the numeric bioaccumulation criteria under the Persistence and Bioaccumulation Regulations under CEPA 1999.  Thus, the provisions for mandatory virtual elimination were not triggered.   However, based on the weight of evidence, the assessments concluded that PFOA and LC-PFCAs are bioaccumulative as the mechanism of accumulation for perfluorinated substances is different from that associated with substances that have typically met the numeric bioaccumulation criteria. Risk management measures are, therefore, implemented to address the nature and extent of harm that may be posed by PFOA and LC PFCAs in the Canadian environment. The addition of PFOA and LC-PFCAs to the Prohibition of Certain Toxic Substances Regulations, 2012, is consistent with the risk management actions for substances that are found to be toxic to the environment, and are persistent as well as bioaccumulative.

Uses

Comment:
A fluoropolymer is a polymer made by (co)polymerization of olefinic monomers, at least one of which contains fluorine bound to one or both of the olefinic carbons, to form a carbon-only polymer backbone with fluorine atoms directly attached to it.
Response:
The Government of Canada acknowledges the clarification.

Comment:
Use information gathered through the Section 71 Notice conducted in 2000 should be updated.
Response:
More recent information has been gathered from industry through the preparation of a socio-economic study, participation in the Global PFC Group, and during consultations on the proposed prohibition through regulation. This new information was considered in the regulatory proposal.

Proposed Prohibition Through Regulation

Comment:
The global phase out of PFOA and long-chain PFCAs is supported.
Response:
The Government of Canada acknowledges the comment and this will be taken into consideration moving forward with risk management.

Comment:
The term “manufactured items” should be defined and the intent of the regulatory action as it relates to manufactured items should be clarified.
Response:
The proposed amendments would prohibit the manufacture, use, sale, offer for sale, or import of PFOA and LC-PFCAs, unless present in manufactured items, from the coming into force of the proposed Amendments. The on-going use, sale, offer for sale, and import of these substances in aqueous film-forming foams (AFFF) used in fire protection applications would be allowed. In addition, a temporary permitted use would be allowed for these substances in water-based inks and photo media coatings until the end of 2016.

Manufactured items (subsection 4(2) of the Prohibition of Certain Toxic Substances Regulations, 2012) are defined as an item that is formed into a specific physical shape or design during its manufacture and that has for its final use, a function or functions dependent in whole or in part on its shape or design.

Examples of manufactured items include semi-conductors and frying pans, but would not include liquids such as fire-fighting foams, inks, or coatings.

Comment:
A list of Chemical Abstract Services (CAS) Registry Numbers for all substances covered under this risk management initiative should be provided.
Response:
The Schedule 1 listing describes the moiety of concern for PFOA and LC PFCAs.   A list of CAS RNs for PFOA and LC PFCAs have been identified, however, this should be viewed as non-exhaustive - a list of CASRNs for substances covered under this risk management initiative is available in the final risk assessment reports.

Please consult Appendix 1 of the Final Ecological Screening Assessment report for Long-Chain (C9–C20) Perfluorocarboxylic Acids, their Salts and their Precursors (August 2012).

Please also consult Table 2 of the Final Screening Assessment Report for Perfluorooctanoic Acid, its Salts, and its Precursors (August 2012).

The Organization for Economic Co-operation and Development (OECD) has also prepared a document entitled, Preliminary Lists of PFOS, PFAS, PFOA and Related Compounds that may Degrade to PFCA (OECD 2007), which combined information from various member countries, including Canada, to assist the OECD in its risk management activities for perfluorinated compounds.

Information provided on MSDS may not be comprehensive.  Consequently supply chain communication is encouraged to better inform end users of the substances they have in their possession and control.

Comment:
The increased regulatory burden that would result from the addition of these substances to the Prohibition of Certain Toxic Substances Regulations, 2012, needs to be considered.
Response:
The regulatory burden associated with the addition of these substances to the Prohibition of Certain Toxic Substances, 2012 has been assessed and is included in the Regulatory Impact Analysis Statement.

Comment:
The regulatory proposal should focus on the manufacturer rather than the user.
Response:
The addition of these substances to the Prohibition of Certain Toxic Substances Regulations, 2012 is proposed to support the Environmental Performance Agreement Respecting Perfluorinated Carboxylic Acids (PFCAs) and their Precursors in Perfluorochemical Products Sold in Canada (EPA).  This voluntary agreement was made as an early risk management action to encourage manufacturers to work towards eliminating these substances from the Canadian marketplace.  This agreement expires on December 31, 2015, and the 4 signatories are expected to fulfill their obligations. 

It is important to note that not all sellers of perfluorinated chemical substances are signatory to the EPA.  The proposed prohibition through regulation will minimize releases of these substances to the Canadian environment in accordance with the risk management objective. The proposed prohibition will also ensure that these substances are not re-introduced following the completion of the phase-out under the EPA.  Additionally, the proposed amendments would provide regulatory certainty to ensure full industry coverage as the voluntary performance agreement on these substances comes to an end on December 31, 2015.

Comment:
The proposed risk management action should be limited to activities covered in the EPA.
Response:
The goal of the EPA is to eliminate PFCAs from fluoro-chemical products sold in Canada by the end of 2015.  To support the conclusion of the EPA, the prohibition of the manufacture, use, sale, offer for sale and import of these substances, unless present in manufactured items, is proposed.  The prohibition is expected to affect the four companies who are signatories to the EPA and their market competitors who did not sign the EPA.  The prohibition is not expected to affect stakeholders who engage in activities outside of those included in the EPA: specifically the import, use, sale and offer for sale of manufactured items containing these substances.

Comment:
The publication of the Consultation Document (January2014) and future related regulatory action are important steps that build upon the success of the EPA.
Response:
The proposed prohibition through regulation is intended to support the conclusion of the EPA on December 31, 2015 and prevent the re-introduction of these substances into Canadian commerce.

Alternatives, Exemptions and Phase Out

Comment:
Products that are manufactured or imported before the coming-into-force date should be exempt from the regulations.
Response:
The intent of the proposed risk management measure is to prohibit the manufacture, import, use, sale, and offer for sale of PFOA, its salts and its precursors and LC-PFCAs, their salts and their precursors, unless present in a manufactured item, effective from the coming into force of the regulations.  This would not include the use, sale, and offer for sale of products manufactured or imported prior to the coming into force date of the proposed regulations.

Comment:
The regulatory proposal should address the import of articles that contain PFOA and LC-PFCAs, and their precursors.
Response:
Additional risk management measures to prohibit the manufacture and import of manufactured items containing PFOA, its salts and its precursors and LC-PFCAs, their salts and their precursors may be considered in the future.  Separate consultation would be undertaken in the future if regulatory action is considered for manufactured items containing PFOA, its salts and its precursors and LC-PFCAs, their salts and their precursors.

Comment:
Environment Canada should maintain the exclusion of manufactured items/articles from the proposed prohibition through regulation.  The impacts to industry should be considered if any actions for manufactured items are considered.
Response:
Additional risk management measures to prohibit the manufacture and import of manufactured items containing PFOA, its salts and its precursors and LC-PFCAs, their salts and their precursors may be considered in the future.  Separate consultation would be undertaken in the future if regulatory action is considered for manufactured items containing PFOA, its salts and its precursors and LC-PFCAs, their salts and their precursors.

Comment:
The regulatory proposal should prohibit the manufacture, import, use and sale of PFOA and long-chain PFCAs, including manufactured items containing these substances because effective and economically feasible fluoro-technology substitutes are available for nearly all uses of PFOA and long-chain PFCAs.
Response:
At this time, the proposed prohibition through regulation is intended to prevent the re-introduction of these substances into Canadian commerce upon completion of the EPA.  The import of manufactured items containing these substances may be considered at a later date.

Comment:
There are alternatives available to PFOA and long-chain PFCAs for use as fire protection chemicals or processing aids in coatings for photo media.
Response:
The Government of Canada has taken into consideration information submitted by stakeholders on uses requiring phase-out flexibilities.

The proposed prohibition includes time-limited exemptions until the end of 2016, to allow for the use of these substances in:

• water-based inks, and
• photo media coating.

The proposed amendments would also allow the ongoing use of aqueous film forming foams containing these substances used in fire-fighting applications.

The purpose of the exemptions is to accommodate the development and implementation of suitable alternatives and to allow ongoing use where suitable alternatives are not available.

Comment:
The regulations should include exemptions for fire protection and related activities because feasible alternatives are not yet available.
Response:
The Government of Canada has taken into consideration information submitted by stakeholders on uses requiring phase-out flexibilities.

The proposed prohibition includes time-limited exemptions until the end of 2016, to allow for the use of these substances in:

• water-based inks, and
• photo media coating.

The proposed amendments would also allow the ongoing use of aqueous film forming foams containing these substances used in fire-fighting applications.

The purpose of the exemptions is to accommodate the development and implementation of suitable alternatives and to allow ongoing use where suitable alternatives are not available.

Comment:
Alternatives to these substances in fire protection chemicals are currently available and are in use.
Response:
The Government of Canada has taken into consideration information submitted by stakeholders on uses requiring phase-out flexibilities.

The proposed prohibition includes time-limited exemptions until the end of 2016, to allow for the use of these substances in:

• water-based inks, and
• photo media coating.

The proposed amendments would also allow the ongoing use of aqueous film forming foams containing these substances used in fire-fighting applications.

The purpose of the exemptions is to accommodate the development and implementation of suitable alternatives and to allow ongoing use where suitable alternatives are not available.

Comment:
The 30-day comment period is an insufficient amount of time for stakeholders to provide meaningful comments.
Response:
An additional public consultation period of 75-days will take place when the proposed regulations are published in Canada Gazette, Part 1.

Comment:
The proposed regulations should come into force in early 2016.
Response:
The federal government acknowledges the comment and this will be taken into consideration moving forward with risk management.

International Risk Management

Comment:
The proposed risk management approach is aligned with the regulatory approach being discussed in the European Union.
Response:
Efforts will continue to be made to align domestic risk management measures with actions undertaken in other jurisdictions to the extent that is possible in the Canadian context.  Risk management actions have been proposed in the United States, Norway, Germany and the European Union. 

The U.S. EPA announced the Long-Chain Perfluorinated Chemicals (PFCs) Action Plan in December 2009. As part of this Action Plan, the U.S. EPA published a final SNUR on September 30, 2013 that would require manufacturers, importers and processors to notify the U.S. EPA before manufacturing, importing or processing a LC-PFCA chemical substances and products containing these substances for use in carpets, or for treating carpets, except for their use as a surfactant in carpet cleaning products. In addition, the U.S. EPA is considering a comprehensive ban as part of this Action Plan. Prior to this Action Plan, the U.S. EPA established a Stewardship Program where industry committed to reduce global facility emissions and product content of PFOA and related chemicals by 95% by 2010, and to work toward eliminating emissions and product content by 2015.

Norway has banned the use of PFOA in consumer products through regulations which restrict the production, import, export or sale of consumer products that contain PFOA in levels that exceed certain limit values.  The regulations took effect in June 2014.

Comment:
Risk management actions should be aligned with initiatives in the United States.
Response:
Efforts will continue to be made to align domestic risk management measures with actions undertaken in other jurisdictions to the extent that is possible in the Canadian context.  Risk management actions have been proposed in the United States, Norway, Germany and the European Union. 

The U.S. EPA announced the Long-Chain Perfluorinated Chemicals (PFCs) Action Plan in December 2009. As part of this Action Plan, the U.S. EPA published a final SNUR on September 30, 2013 that would require manufacturers, importers and processors to notify the U.S. EPA before manufacturing, importing or processing a LC-PFCA chemical substances and products containing these substances for use in carpets, or for treating carpets, except for their use as a surfactant in carpet cleaning products. In addition, the U.S. EPA is considering a comprehensive ban as part of this Action Plan. Prior to this Action Plan, the U.S. EPA established a Stewardship Program where industry committed to reduce global facility emissions and product content of PFOA and related chemicals by 95% by 2010, and to work toward eliminating emissions and product content by 2015.

Norway has banned the use of PFOA in consumer products through regulations which restrict the production, import, export or sale of consumer products that contain PFOA in levels that exceed certain limit values.  The regulations took effect in June 2014. 

Date modified:

2016-06-28