Consultation with Stakeholders on Perfluorooctanoic Acid (PFOA) and Long-Chain Perfluorocarboxylic Acids (PFCAs) Presented by the New Brunswick Lung Association in partnership with Health Canada

Brief Background and Process NBLA contract to engage CSOs on the assessment and management of nine chemical groupings Goals are to increase awareness of the CMP, to engage Canadians, and to provide input to the Government of Canada from CSOs Today’s Webinar Agenda: PFOAs and PFCAs – the process for these was begun before this engagement contract. They are not part of the 9 chemical groupings. High level overview of chemicals, Screening Assessment including sources, risks, and proposed Risk Management Plan Input from participants and dialogue Identification of recommendations to forward to Health Canada Discussion of “process” for future consultations

Is an industrial synthetic substance in a class of chemicals called perfluorocarboxylic acids which are in turn within a group known as perfluoroalkyl compounds (PFA) or perfluorinated chemicals (PFCs) May be found as a salt or formed from the breakdown of precursor chemicals Used in the production of fluoropolymers in the manufacture of non-stick coatings, stain-resistant textiles and clothing, and used in gaskets, hoses and personal care products Used in the past in many industrial processes and consumer products Not manufactured in Canada but the ammonium salt is imported Perfluorooctanoic Acid (PFOA)- What is it?

Perfluorooctanoic Acid (PFOA)- How is it released and how are Canadians exposed?. Released during manufacturing of fluoropolymers, throughout the service life of the articles, during disposal, in waste water effluent or landfill leaching Exposure through air, water, food and the use of certain consumer products (cookware, carpets, clothes) Possible in utero exposure and through breast feeding

Perfluorooctanoic Acid (PFOA) - Potential Harm Assessment PFOA exhibits moderate to low acute toxicities in pelagic organisms, (including fish). PFOA exhibits low chronic toxicities in benthic organisms. There is one study on the toxicity of PFOA in avian wildlife. There is potential for PFOA to affect endocrine function, hepatotoxicity, immunotoxicity, and chemosensitivity. In humans, PFOA is well absorbed by all routes of exposure; it has not been demonstrated to be metabolized and has a relatively long half-life. Low concentrations of PFOA have been identified in blood samples from non-occupationally exposed Canadians, including newborns.

Perfluorooctanoic Acid (PFOA) - Potential Harm Assessment Epidemiological studies have not identified a causal relationship between PFOA exposure and adverse health effects in humans. Therefore, toxicity studies in laboratory animals were used to determine the critical effects and associated serum levels of PFOA. Following oral dosing, PFOA increased liver weight in mice and altered lipid parameters in rats. Increased liver weight was noted in a 26-week toxicity study in monkeys. In mice PFOAs increased liver weight in females, altered fetal bone development and was related to early puberty in male pups. In rats, high doses in the diet of males had significantly higher incidences of adenomas of the liver hepatocytes, Leydig cells in the testes and pancreatic acinar cells. No evidence of carcinogenic activity was seen in the female rats. As primates do not have the same susceptibilities in toxicity pathways present in rodents, the PFOA-induced tumours in male rats are considered to have little or no relevance for humans. Although there is some evidence to suggest that PFOA may be capable of causing indirect oxidative DNA damage, the genotoxicity database indicates that PFOA is not mutagenic.

Perfluorooctanoic Acid (PFOA) - Potential Harm Assessment Summary: This chemical has the potential to remain in the environment for a long time, accumulate in some organisms and cause harm to some organisms (note that “organism” in this context does not include humans). It has been concluded that PFOAs are entering the environment in a quantity or under conditions that may present a danger to the environment. It has been concluded that PFOAs are not harmful to the health of Canadians at the current levels of exposure.

Perfluorooctanoic Acid (PFOA) - Proposed Risk Management For all of the chemicals screened under the Chemicals Management Plan, if a substance is found to meet any of the risk criteria set out in section 64 of the Act, the Ministers can propose to: take no further action with respect to the substance, add the substance to the Priority Substances List (PSL) for further assessment, or recommend the addition of the substance to the List of Toxic Substances in Schedule 1 of the Act. Note: in certain circumstances, the Ministers must make a specific proposal either to recommend addition to the List of Toxic Substances and to recommend the implementation of virtual elimination.

Perfluorooctanoic Acid (PFOA) - Proposed Risk Management Based on the conclusion of the final screening assessment, the Government of Canada will consider options to reduce or eliminate releases to the environment of PFOA, its salts and its precursors. On March 30, 2010, Environment Canada and Health Canada signed a Performance Agreement with participating companies who sell perfluorochemical products that contain perfluorooctanoic acid (PFOA), long chain (C 9 -C 20 ) PFCAs and their precursors in Canada. The purpose of the Agreement is to work towards elimination of residual PFOA, long chain (C 9 -C 20 ) PFCAs and their precursors in those products by December 31, 2015, as well as to collect and report information on the products sold in Canada.perfluorooctanoic acid (PFOA) The final screening assessment report on PFOA, its Salts and its Precursors and the proposed risk management approach document for PFOA, its Salts and its Precursors were published on August 25, The risk management approach document will be followed by a 60-day public comment period (from August 25, 2012 to October 24, 2012).final screening assessment report on PFOA, its Salts and its Precursors proposed risk management approach document for PFOA, its Salts and its Precursors To see public comments go to:

Long-Chain Perfluorocarboxylic Acids (PFCAs) What are they? Fluorocarbon-based chemicals used in industrial processes that may also be formed unintentionally from human activities Also formed from the degradation of PFCA precursors Used in production of large molecules such as polyvinylidene fluoride and as a processing aid in the production of non-stick coating Used to provide oil, grease, water and stain repellants in paper, textiles, carpets and leather These are not manufactured in, or imported into, Canada. However precursors to these are imported into Canada.

Long-Chain Perfluorocarboxylic Acids (PFCAs) - How are they released and how are Canadians exposed? Data is not available on the direct release of these but evidence suggests that their precursors are released and may be transported long distances and may degrade to PFCAs. Degradation may occur during wastewater and sewage treatment and the breakdown of products containing precursor molecules.

Long-Chain Perfluorocarboxylic Acids (PFCAs)- Potential Harm Assessment Summary: The ecological screening assessment indicated that PFCAs, their salts and precursors have the potential to remain in the environment for a long time and accumulate in and cause harm to organisms. It has been concluded that PFOAs are entering the environment in a quantity or under conditions that may present a danger to the environment.

Long-Chain Perfluorocarboxylic Acids (PFCAs) - Proposed Risk Management Based on the conclusion of the final screening assessment, the Government of Canada will consider options to eliminate releases to the environment of these substances. On March 30, 2010, Environment Canada and Health Canada signed a Performance Agreement with participating companies who sell perfluorochemical products. The purpose of the Agreement is to work towards the elimination of residual PFOA, long- chain (C 9 -C 20 ) perfluorocarboxylic acids (PFCAs) and their precursors in those products by December 31, The Agreement also allows for the collection and reporting of information on these products that are sold in Canada.long- chain (C 9 -C 20 ) perfluorocarboxylic acids (PFCAs) The final screening assessment report on long-chain (C9-C20) perfluorocarboxylic acids (PFCAs), their salts, and their precursers and the proposed risk management approach document for long-chain (C9-C20) perfluorocarboxylic acids (PFCAs), their salts, and their precursers were published on August 25, The risk management approach document will be followed by a 60-day public comment period (from August 25, 2012 to October 24, 2012).final screening assessment report on long-chain (C9-C20) perfluorocarboxylic acids (PFCAs), their salts, and their precursersproposed risk management approach document for long-chain (C9-C20) perfluorocarboxylic acids (PFCAs), their salts, and their precursers

Perfluorooctanoic Acid (PFOA) and Long-Chain Perfluorocarboxylic Acids (PFCAs)-- Proposed Risk Management The Ministers proposed to recommend the addition of both PFOA and long-chain PFCAs to the List of Toxic Substances in Schedule 1 of CEPA As a result, the Ministers will develop a regulation or instrument respecting preventive or control actions to protect the environment from the potential effects of exposure to these substances. The final screening assessment reports did not conclude that either PFOA or long-chain PFCAs meet the conditions set out in subsection 77(4) of CEPA As a result, PFOA, and long-chain PFCAs will not be subject to the statutory implementation of virtual elimination.

Perfluorooctanoic Acid (PFOA) and Long-Chain Perfluorocarboxylic Acids (PFCAs) As required by the Government of Canada’s Cabinet Directive on Streamlining Regulation [2], and criteria set out in the Treasury Board document entitled Assessing, Selecting, and Implementing Instruments for Government Action, the proposed risk management instruments were selected using a consistent approach, and took into consideration information available at the time.2 In order to achieve the risk management objective and to work towards achieving the environmental objective, the risk management being considered for PFOA and long-chain PFCAs is prohibition through regulation. A prohibition regulation would prohibit the manufacture, use, sale, offer for sale, import and export of PFOA and long-chain PFCAs and products containing PFOA and long-chain PFCAs. In accordance with the Government of Canada’s Toxic Substances Management Policy, socio- economic factors will be taken into account when determining interim targets, appropriate management approaches and timelines for implementation. To see public comments go to: