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

The Risk Management Approach for Perfluorooctanoic Acid (PFOA), its salts and its precursors and long-chain Perfluorocarboxylic Acids (PFCAs), their salts and their precursors was published on August 25, 2012 for a 60-day electronic public consultation period.

Six organizations provided comments: Canadian Vehicle Manufacturers’ Association (CVMA), New Brunswick Lung Association (NBLA) on behalf of the Canadian Network for Human Health and the Environment, Assembly of First Nations (AFN), FluoroCouncil, Rohm and Haas Canada LP (a subsidiary of The Dow Chemical Company), and Taft Stettinius & Hollister LLP. 

A summary of comments is organized below by topic:

Human Health Effects and Exposure

Comment:
Do assessments consider exposure to specific populations such as children, the human fetus and First Nations people?
Response:
The screening assessment for PFOA, its salts and its precursors took into consideration both exposure and potential health effects to vulnerable populations, specifically children and the developing fetus.  The assessment included biomonitoring data from infants and children, which incorporates exposure from all sources (including breast milk, food, water, air, products and precursors).  The exposure estimates are based on current use patterns in Canada and the health endpoints considered include, but are not limited to, developmental and reproductive, and short-term and long-term effects. For PFOA, one of the critical health effects in risk characterization was from a developmental study.  The resulting margins of exposure were considered to be adequately protective of human health and to address the uncertainties in the health effects and exposure databases.

The screening assessment for PFOA, its salts and precursors incorporates biomonitoring data for Inuit children.   Biomonitoring data in First Nation people were not available at the time of the assessment.   In June 2013, the Assembly of First Nations released biomonitoring results of a national health survey for First Nation peoples’ living on reserve south of 60°.  Levels of PFOA were found to be lower than those found in the general Canadian population.

Comment:
What assumptions were made in the scientific studies and were they considered?
Response:
Internationally accepted testing methods for assessing hazard from chronic exposure to chemicals are used by government, industry and independent laboratories to identify and characterize potential hazards of chemicals.  Studies adhering to these guidelines provide the data necessary to characterize chronic hazard potential.  The toxicity studies for the screening assessment were comprised of studies in peer-reviewed journal articles and unpublished studies submitted to other government agencies.  When reviewing toxicity studies consideration is given to how the studies were conducted and if they were conducted according to internationally accepted methods.  If needed, expert advice was sought in data analysis and interpretation.

Comment:
Who funded the various studies and was this considered?
Response:
Typically funding sources include industry, government and academia.  The assessment reports have undergone internal and external peer review and public comments.  

Comment:
The Government of Canada should consider additional studies for the evaluation of human health effects, specifically the C8 Science Panel Reports.
Response:
All available and relevant data on the potential human health effects related to PFOA from studies published before the literature cut-off date of April 2011 for the human health sections of the assessment (February 2011 for the ecological assessment) were reviewed and incorporated, as appropriate, into the final screening assessment. 

The final C8 Science Panel Reports published in 2012 were not available prior to the publication of the final PFOA screening assessment.

Comment:
What is assessed related to long term human health effects, which end-points are considered and were low exposure levels considered when assessing endocrine disruption?
Response:
Acute and chronic (long-term) human health effects associated with low and high levels of exposure were assessed for the following endpoints:  carcinogenicity, acute toxicity, reproductive and developmental toxicity (endocrine disruption), immunotoxicity, organ toxicity and sensitivity.

Ecological Assessment

Comment:
The federal government should describe the regulatory framework that defines the “weight of evidence” approach used in the bioaccumulation assessment.
Response:
A summary table of public comments received on the draft screening assessment report of PFOA, its Salts and its Precursors and the Government of Canada’s responses is available on the Environment Canada website.

The section titled “Bioaccumulation” of the screening assessment for PFOA, its salts and its precursors provides a detailed explanation on the “weight of evidence” approach to ecological bioaccumulation.

Terminology Clarifications

Comment:
What is a “parent compound”?
Response:
Parent compounds, in the screening assessments, are considered to be precursors that have the potential to degrade/transform to PFOA and long-chain (C9-C20) PFCAs in the environment.

The screening assessment for long-chain (C9-C20) PFCAs, their salts and their precursors, defines precursors as any substance where the perfluorinated alkyl moiety has the formula C_nF_2n+1 (where 8≤n≤20) and is directly bonded to any chemical moiety other than a fluorine, chlorine or bromine atom.

The screening assessment for PFOA, its salts and its precursors, defines precursors as substances where the perfluorinated alkyl moiety has the formula C_nF_2n+1 (where n= 7 or 8) and is directly bonded to any chemical moiety other than a fluorine, chlorine or bromine atom.

Comment:
Request to distinguish between (a) PFOA and its salts and (b) potential precursors of PFOA in the proposed risk management instrument.
Response:
It is agreed that the term “PFOA” should not be used collectively to refer to PFOA, its salts and its precursors. As stated in the screening assessment, the term “PFOA” can only be used to refer to the acid, its conjugate base or its principal salt forms.  The federal government acknowledges this clarification and it will be taken into consideration moving forward with risk management.

Comment:
Suggestion to change the acronym “PFCAs” for the long-chain (C9-C20) perfluorocarboxylinc acids to “LCPFCAs” .
Response:
The federal government acknowledges these recommendations and will consider the terminology, as appropriate, in future work.

Comment:
Recommendation to adopt the use of harmonized terminology for fluorinated substances (Perfluoroalkyl and polyfluoroalkyl substances in the environment: Terminology, classification, and origins.  Integrated Environmental Assessment and Management 2011, 7(4), 513-541.)
Response:
The federal government acknowledges these recommendations and will consider the terminology, as appropriate, in future work.

Comment:
“Fluorochemicals” is a broad term referring to all organic or inorganic chemicals containing fluorine; more specific terminology would be appropriate in the proposed risk management instrument.
Response:
The federal government acknowledges these recommendations and will consider the terminology, as appropriate, in future work.

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 carbon atoms, to form a carbon-only polymer backbone with fluorine atoms directly attached to it. Fluoropolymers are a subset of fluorinated polymers.

A fluorotelomer-based polymer is one derived from use of a fluorotelomer raw material, typically fluorotelomer alcohol, fluorotelomer methacrylate or fluorotelomer acrylate, in its synthesis.

PFOA is not used as a reactive intermediate. PFOA and its salts are neither used nor added in the manufacture of fluorotelomer-based products.  APFO (the ammonium salt of PFOA) is used as a processing aid in the production of some fluoropolymer materials.
Response:
The federal government acknowledges the clarification and this will be taken into consideration moving forward with risk management.

Comment:
Aqueous fire-fighting foams (AFFF) manufactured in the past approximately 20 years or more have not contained APFO as an intentional active component.  The statement on page 10 related to APFO as a component of AFFF should be removed.
Response:
The additional information provided by the commenter is acknowledged, and will be taken into consideration moving forward with risk management, while noting that aqueous fire-fighting foams may have contained APFO in historical usages.  The following references from the risk management approach document support the historical uses of APFO in aqueous fire-fighting foams: 

[OECD] Organisation for Economic Co-operation and Development. 2006. Results of the 2006 survey on production and use of PFOS, PFAS, PFOA, PFCA, their related substances and products/mixtures containing these substances. ENV/JM/MONO (2006) 36. Paris (FR): Organisation for Economic Co-operation and Development. Environment, Health and Safety Publications, Series on Risk Management No. 22.

Prevedouros K, Cousins IT, Buck RC, Korzeniowski SH. 2006. Sources, fate, and transport of perfluorocarboxylates. Environ Sci Technol 40: 32–44.

Comment:
Fluorotelomer-based polymers are not used in non-stick coatings for cookware.  FTOHs are not in emissions from non-stick cookware or frying pans, and PFCAs, FTCAs, and FTUCAs are not released from cookware. FTCAs and FTUCAs are potential products from biodegradation of FTOHs in the environment.
Response:
The additional information provided by the commenter is acknowledged, and will be taken into consideration moving forward with risk management.  The following references are cited in the screening assessments related to non-stick coatings for cookware.

Sinclair et al (2007), Washburn et al (2005), Begley et al (2005), Guo et al. (2009), Gewurtz et al. (2009)

Proposed Prohibition Through Regulation

Comment:
The risk management objective proposed by the federal government is supported.
Response:
The federal government acknowledges the comment and this will be taken into consideration moving forward with risk management.

Comment:
A prohibition regulation is not required at this time because the existing Environmental Performance Agreement will eliminate the use of the substances by December 31, 2015.
Response:
It is important to note that not all sellers of perfluorinated chemical substances are signatory to the Canadian Environmental Performance Agreement.  The proposed prohibition through regulation will minimize releases of these substances to the Canadian environment in accordance with the risk management objective. The proposed amendments would also 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 Approach is an important step in the conclusion of the Environmental Performance Agreement and consistent with science-based, practical and predictable regulations that build upon the success of the Agreement.
Response:
It is important to note that not all sellers of perfluorinated chemical substances are signatory to the Canadian Environmental Performance Agreement.  The proposed prohibition through regulation will minimize releases of these substances to the Canadian environment in accordance with the risk management objective. The proposed amendments would also 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 prohibition will not stop the release of these substances to the Canadian environment from long range atmospheric deposition.
Response:
The domestic risk assessment and subsequent risk management is one aspect of the overall approach to PFOA, its salts and its precursors and long-chain PFCAs, their salts and their precursors.  Canada is engaged in international efforts through the Global PFC group whose aim is to reduce emissions and the content of relevant perfluorinated chemicals of concern in products and to support a global transition towards safer alternatives.

Comment:
A control level is not explicitly stated in the risk management approach.
Response:
Specific control levels or concentrations will be evaluated as the prohibition is developed.

Comment:
How effective is regulation for finished products imported into Canada?
Response:
The proposed prohibition through regulation will not apply to manufactured items imported into Canada.

Comment:
There is uncertainty with respect to the presence of these substances in manufactured items contained within a vehicle. 
Response:
The proposed prohibition through regulation will not apply to manufactured items imported into Canada.

Comment:
Will the proposed instrument address intentional use versus incidental (unintentional) presence?
Response:
The proposed prohibition through regulation of PFOA and LC-PFCAs would not apply to its incidental presence.

In general terms, “incidentally present" refers to the presence of the substance in a final product when it is present as a residual, a trace contaminant or impurity and was not added to the formulation intentionally.

Comment:
What is the difference between virtual elimination and prohibition through regulation?
Response:
Under CEPA 1999, virtual elimination is the reduction of the quantity or concentration of a toxic substance in releases to the environment to below a "level of quantification" specified by the Ministers. One way to achieve this is to develop release-limit regulations as specified in section 65(3) of CEPA 1999.  An alternative approach to reducing potential releases associated with the manufacturing, import, use and sale of the toxic substance where warranted is through prohibition.

Alternatives, Exemptions, and Phase Out

Comment:
A prohibition, or phase-out, of the substances should only proceed after suitable alternatives have been identified, tested, vetted for environmental impacts and tested to meet the use performance requirements.  Manufacturing and sales cycles will need to be considered in the phase-out.
Response:
Accommodations, such as time-limited exemptions, permitted uses, use concentration limits, etc., are being considered for uses where chemical alternatives or alternative non-chemical techniques are not commercially available.  Additional information is being sought from stakeholders to identify these uses through the publication of a Consultation Document and corresponding 60-day public comment period.  Through the Consultation Document process, stakeholders are encouraged to submit documentation identifying specific uses where alternatives are not commercially available.

Comment:
Exemptions may be necessary for uses that do not have commercially available alternatives.
Response:
Accommodations, such as time-limited exemptions, permitted uses, use concentration limits, etc., are being considered for uses where chemical alternatives or alternative non-chemical techniques are not commercially available.  Additional information is being sought from stakeholders to identify these uses through the publication of a Consultation Document and corresponding 60-day public comment period.  Through the Consultation Document process, stakeholders are encouraged to submit documentation identifying specific uses where alternatives are not commercially available.

Timing of the Proposed Prohibition Through Regulation

Comment:
Elimination of PFOA, salts and precursors and Long-Chain PFCAs, their salts and their precursors should be immediate.
Response:
Under CEPA 1999, the publication of a final assessment report concluding that a substance poses a risk to the environment (and/or to human health) and recommendation that the substance be added to Schedule 1 triggers an obligation to publish a proposed instrument.

Stakeholders have been provided an additional opportunity to submit comments on the proposed risk management measures for PFOA, its salts and its precursors and long-chain PFCAs, their salts and their precursors following publication of the Consultation Document (January 2014), and as well as following publication of the proposed regulatory measure (Apr. 2015).

Comment:
Expectation that specific proposed risk management instruments will be published for public comment and measures adopted within a timely manner.
Response:
Under CEPA 1999, the publication of a final assessment report concluding that a substance poses a risk to the environment (and/or to human health) and recommendation that the substance be added to Schedule 1 triggers an obligation to publish a proposed instrument.

Stakeholders have been provided an additional opportunity to submit comments on the proposed risk management measures for PFOA, its salts and its precursors and long-chain PFCAs, their salts and their precursors following publication of the Consultation Document (January 2014), and as well as following publication of the proposed regulatory measure (Apr. 2015).

International Risk Management

Comment:
At this time the federal government should not move forward with a prohibition regulation to ban the substances because actions in other jurisdictions are voluntary.
Response:
Efforts will be made to align domestic risk management measures with actions undertaken in other jurisdictions to the extent that is possible in the Canadian context. Under CEPA 1999, the addition of a substance to Schedule 1 triggers an obligation to publish a proposed instrument.

Risk management actions have been proposed in the United States, Norway, Germany and the European Union.  On September 30, 2013, the United States Environmental Protection Agency (EPA) issued a Significant New Use Rule, which requires companies to report their intent to manufacture or import products containing LC-PFCAs intended for use as part of carpets or to treat carpets, as well as their intent to import carpets already containing these chemicals.  Norway has proposed a ban on 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 have taken effect in June 2014. 

Comment:
Risk management should be coordinated with the United States and other countries.
Response:
Efforts will be made to align domestic risk management measures with actions undertaken in other jurisdictions to the extent that is possible in the Canadian context. Under CEPA 1999, the addition of a substance to Schedule 1 triggers an obligation to publish a proposed instrument.

Risk management actions have been proposed in the United States, Norway, Germany and the European Union.  On September 30, 2013, the United States Environmental Protection Agency (EPA) issued a Significant New Use Rule, which requires companies to report their intent to manufacture or import products containing LC-PFCAs intended for use as part of carpets or to treat carpets, as well as their intent to import carpets already containing these chemicals.  Norway has proposed a ban on 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 have taken effect in June 2014. 

Comment:
The US EPA 2010/2015 PFOA Stewardship Program addresses both product content and facility emissions.
Response:
The Government of Canada acknowledges the clarification and this will be taken into consideration moving forward with risk management.

Waste Management

Comment:
Many First Nation communities are not equipped to handle the disposal of toxic substances nor do many have the capacity or infrastructure for safe waste management of consumer products that may release PFOA and PFCAs.
Response:
No new obligations, associated with waste management, will result from the proposed prohibition through regulation.

Date modified:

2016-06-28