Canada Gazette, Part I, Volume 146, Number 39: Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999
September 29, 2012
Canadian Environmental Protection Act, 1999
Department of the Environment and Department of Health
REGULATORY IMPACT ANALYSIS STATEMENT
(This statement is not part of the Order.)
Issue and objectives
Canadians depend on chemical substances that are used in hundreds of goods, such as medicines, computers, fabrics and fuels. Unfortunately, some chemical substances can negatively affect human health or the environment when released above a certain quantity or concentration in the environment.
Scientific screening assessments of the following substances have concluded that these substances are entering or may enter the environment in a quantity or concentration or under conditions that have or may have an immediate or long-term harmful effect on the environment or its biological diversity, as defined under paragraph 64(a) of the Canadian Environmental Protection Act, 1999 (CEPA 1999, also referred to hereafter as the “Act”):
- Perfluorooctanoic acid, which has the molecular formula C7F15CO2H (PFOA), and its salts;
- Compounds that consist of a perfluorinated alkyl group that has the molecular formula CnF2n+1 in which n = 7 or 8 and that is directly bonded to any chemical moiety other than a fluorine, chlorine or bromine atom (precursors of PFOA);
- Perfluorocarboxylic acids that have the molecular formula CnF2n+1CO2H in which 8 ≤ n ≤ 20 (long-chain PFCA) and their salts; and
- Compounds that consist of a perfluorinated alkyl group that has the molecular formula CnF2n+1 in which 8 ≤ n ≤ 20 and that is directly bonded to any chemical moiety other than a fluorine, chlorine or bromine atom (long-chain PFCA precursors).
The objective of the proposed Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999 (hereinafter referred to as the “proposed Order”), made under subsection 90(1) of CEPA 1999, is to add PFOA, its salts and precursors and long-chain PFCAs, their salts and precursors to the List of Toxic Substances in Schedule 1 of CEPA 1999.
This addition enables the Minister of the Environment and the Minister of Health (the “Ministers”) to propose regulations or other risk management instruments to manage environmental risks posed by these substances under CEPA 1999. The Ministers may, however, choose to develop instruments outside of the purview of CEPA 1999 in order to manage these risks.
Description and rationale
The screening assessments for PFOA, its salts and precursors and long-chain PFCAs, theirs salts and precursors were completed to fulfill the Government’s commitment to assess PFCAs in accordance with the action plan titled Perfluorinated Carboxylic Acids (PFCAs) and Precursors: An Action Plan for Assessment and Management, as published in the Canada Gazette, Part Ⅰ, on June 17, 2006. They were conducted in order to assess whether the substances met the criteria set out in section 64 of CEPA 1999. When a substance is found to meet one or more of the criteria set out in section 64 of the Act, a recommendation can be made that the substance be added to Schedule 1 of CEPA 1999.
The addition of a substance to Schedule 1 of CEPA 1999 allows the Ministers to develop risk management instruments in order to meet their obligations under section 91 of CEPA 1999 to protect the health of Canadians and their environment. This requires the Ministers to propose a regulation or other risk management instrument within two years of publication of the final assessment decision, and to finalize the instrument 18 months later.
The Act enables the development of risk management instruments, such as regulations, guidelines or codes of practice, in order to protect the environment and human health. These instruments can be developed for any aspect of the substance’s life cycle, from the research and development stage through manufacture, use, storage, transport and ultimate disposal or recycling. A proposed risk management approach document, which provides an indication of where the Government will focus its risk management activities, has been prepared for PFOA and PFCAs and is available on the Chemical Substances Web site. (see footnote 1)
The draft screening assessments for PFOA, its salts and precursors, and PFCAs, their salts and precursors, were published on the Chemical Substances Web site, (see footnote 2) and the statement recommending addition to Schedule 1 was published in the Canada Gazette, Part Ⅰ, on October 30, 2010, for a 60-day public comment period. The assessment summaries, conclusions and overviews of the public comments received during the public comment period are presented below.
Substance description, assessment summary and conclusions
Perfluorocarboxylic acids are synthetic chemicals that belong to the broader class of chemicals known as perfluoroalkyls (PFAs). The ecological assessment focused on PFCAs that contain carbon chains of 9–20 carbon atoms in length, as well as their salts and precursors.
Only one PFCA substance, which contains a 9-carbon chain, is known to be used for surfactant applications and in the production of fluoropolymers. Other long-chain PFCAs, containing carbon chains of 10–20 atoms, are rarely used intentionally in products. However, some substances, such as fluorotelomers, are PFCA precursors and can degrade to form long-chain PFCAs. These substances are commonly used and found in commercial products to provide oil-, grease-, water- and stain-repellent properties to products.
Industry surveys in 2000 and 2004 by Environment Canada found that long-chain PFCAs were not reported to be manufactured in or imported into Canada. However, in both surveys, between 1 000 and 100 000 kg of long chain PFCA precursors were reported to be imported into Canada during the survey years.
Laboratory studies have demonstrated that long-chain PFCAs are toxic to aquatic and terrestrial species; (see footnote 3) for example, they have the potential to cause hepatotoxicity (toxicity to the liver) in polar bears. Furthermore, due to the exceptional strength of the carbon-fluorine bond, long-chain PFCAs are expected to be extremely persistent in the environment. Moreover, long-chain PFCAs have been detected in remote areas, such as the Canadian Arctic. Although mechanisms of transport are not fully understood, certain precursors may undergo long-range transport to remote areas, where subsequent degradation can result in the formation of long-chain PFCAs.
The substance PFOA is a synthetic substance belonging to the PFCA class of chemicals. PFOA and its salts are used as polymerization aids in the production of fluoropolymers and fluoroelastomers. Fluoropolymers are used in the manufacture of coatings that are water- and stain-resistant, and are used on textiles, carpets, hoses, cables, gaskets, non-stick cookware, and in personal care products. PFOA, its salts and precursors have also been used in the past in many industrial processes as well as in commercial and consumer products.
According to industry surveys in 2000 and 2004 under section 71 of CEPA 1999, PFOA was not manufactured in Canada in the survey years. However, 100–100 000 kg of ammonium salt, a precursor to PFOA, were imported for the year 2004.
The substance PFOA may be found in the Canadian environment due to effluent releases from wastewater treatment plants, landfill leachates, and degradation/transformation of PFOA precursors. Once in the environment, PFOA is extremely persistent and not known to undergo degradation. It is expected to end up mostly in the aquatic environment, or, to a lesser extent, in sediments. The presence of PFOA in the Canadian Arctic is likely attributable to long-range transport.
The substance PFOA has been shown to have a number of toxic effects on animals, including hepatotoxicity, immunotoxicity, chemosensitivity and effects on endocrine function. (see footnote 4)
Although experimental evidence indicates that PFOA is not highly bioaccumulative in fish, field studies suggest that PFOA may accumulate and biomagnify in terrestrial and marine mammals. PFOA has been detected in Canadian freshwaters and sediments, as well as a variety of animals, including fish, invertebrates, terrestrial and marine mammals. Polar bears, as the top predator in the Arctic marine food web, have been shown to be the most contaminated with PFOA relative to other Arctic terrestrial organisms.
Low concentrations of PFOA have been identified in blood samples from Canadians in the general population, including newborns. Canadians are exposed to PFOA and its precursors in the environment, including via air, drinking water and food, and from the use of consumer products. Laboratory studies have shown that PFOA may cause developmental effects and liver changes in mice and rats. However, the levels of PFOA in the blood of humans have been found to be so much lower than the levels associated with adverse effects in laboratory animals. These levels are not considered to be a risk to human health.
The final risk assessments have concluded that PFOA, its salts and precursors and long-chain PFCAs, their salts and precursors meet the criteria set out in paragraph 64(a) of CEPA 1999. Therefore, PFOA, its salts and precursors and long-chain PFCAs, their salts and precursors are recommended for addition to Schedule 1 of CEPA 1999.
It is concluded that the substances are extremely persistent and meet the criteria for persistence as set out in the Persistence and Bioaccumulation Regulations, but do not meet the criteria for bioaccumulation as they are not bioaccumulative in freshwater species. However, the weight of evidence is sufficient to conclude that PFOA and its salts, and long-chain PFCAs and their salts, accumulate and biomagnify in terrestrial and marine mammals.
The final screening assessment reports, the proposed risk management approach document and the complete responses to comments received on PFOA and long-chain PFCAs were published on August 11, 2012, and may be obtained through several methods. (see footnote 5)
Measures that can be taken after a screening assessment of a substance is conducted under CEPA 1999 include
- adding the substance to the Priority Substances List for further assessment, when additional information is required to determine if a substance meets the criteria in section 64 of CEPA 1999;
- taking no further action in respect of the substance; or
- recommending that the substance be added to the List of Toxic Substances in Schedule 1 of the Act, and where applicable, the implementation of virtual elimination.
As PFOA, its salts and precursors and long-chain PFCAs, their salts and precursors meet the criteria as defined under paragraph 64(a) of CEPA 1999, adding these substances to Schedule 1, which will enable the development of regulations or other risk management instruments, is therefore the best option.
Benefits and costs
The proposed Order enables the Ministers to develop proposed regulations or other risk management instruments in order to manage risks posed by PFOA, its salts and precursors and long-chain PFCAs, their salts and precursors, under CEPA 1999. The Ministers may, however, choose to develop instruments outside of the purview of the Act to help protect the environment. The Ministers will assess costs and benefits and consult with the public and other stakeholders during the development of these risk management proposals.
On October 30, 2010, the Ministers published a summary of the scientific assessments for PFOA, its salts and precursors and long-chain PFCAs, their salts and precursors in the Canada Gazette, Part Ⅰ, for a 60-day public comment period. The risk management scope document was also released on the same date, outlining the preliminary options being examined for the management of the two substances above, which were proposed to be toxic under section 64 of CEPA 1999. Prior to this publication, Environment Canada and Health Canada informed the governments of the provinces and territories through the CEPA National Advisory Committee (NAC) of the release of the screening assessment reports, the risk management scope document, and the public comment period noted above. No comments were received from CEPA NAC.
During the 60-day public comment period, submissions were received from two manufacturers’ associations, four non-governmental organizations and one researcher. All comments were considered in developing the final assessments.
Comments were also received on the risk management scope document. They were considered when developing the proposed risk management approach document, which is also subject to a 60-day public comment period.
Below is a summary of some key comments regarding the scientific assessment of PFOA, its salts and precursors and long-chain PFCAs, their salts and precursors, as well as responses to these comments. The complete responses to comments are available on the Government of Canada’s Chemical Substances Web site, or by contacting Environment Canada. (see footnote 6)
- Comment: Four non-governmental organizations and one researcher commented that new biomonitoring data from the Canadian Health Measures Survey (CHMS) are available, and that there are epidemiological data indicating associations between PFOA exposure and reduced birth weight.
Response: The assessment has been updated with new biomonitoring data, including data from the CHMS. The epidemiological data examining reduced birth weight were addressed in the screening assessment. The changes in birth weight are within the normal range of variation. As well, in other epidemiological studies, no associations between PFOA exposure and birth weights were identified, including in studies on highly exposed populations. Additionally, developmental toxicity was selected as one of the endpoints for risk characterization. The margins of exposure are considered adequate to be protective of human health and to address the uncertainties in the health effects and exposure databases.
- Comment: Two non-governmental organizations, two manufacturers’ associations and one researcher commented that the draft screening assessment report does not contain many relevant published studies on immunotoxicity, neurobehavioural effects, and mode of action (i.e. the mechanism by which the substance can produce harmful effects upon a living organism).
Response: The screening assessment does not list or describe each individual study, but highlights key relevant studies that cover the relevant human exposure, epidemiology, toxicology, and mode of action studies. All available and relevant data on the potential human health effects related to PFOA were considered in the draft screening assessment.
- Comment: Two non-governmental organizations expressed concern that the weight of evidence and the emphasis on biomagnification in aquatic species played a significant role in the final decision of bioaccumulation for PFOA despite the availability of evidence of PFOA in higher trophic levels such as mammals and terrestrial animals. They are uncertain whether the low levels of PFOA detected in various species of fish were the primary reasons for concluding that PFOA is not bioaccumulative as prescribed by the bioaccumulation criteria in the Persistence and Bioaccumulation Regulations.
Response: The numeric criteria for bioaccumulation, outlined in the Persistence and Bioaccumulation Regulations, are based on bioaccumulation data for freshwater aquatic species (fish) and for substances that preferentially partition to lipids. The available data on concentrations of PFOA in fish indicated that the numeric criteria in the Regulations were not met. However, given that PFOA preferentially partitions in the proteins of liver, blood and kidney in terrestrial and marine mammals, the numeric criteria in the Regulations are of uncertain relevance as indicators of its bioaccumulation potential. In fact, while it did not lead to concluding that the regulatory criteria for bioaccumulation were met, the evidence for accumulation of PFOA in terrestrial and marine mammals was an important consideration in the assessment conclusion on the potential for PFOA to be harmful to the environment.
- Comment: Two non-governmental organizations asked if the weight-of-evidence approach applied by the assessors was adequate to include careful consideration of all degradation or breakdown products, metabolism, and potential synergistic effects of other substances similar to PFOA, its salts and precursors and long-chain PFCAs, their salts and precursors.
Response: The key issue considered in this assessment is the accumulation potential of PFOA, rather than the accumulation of individual precursors. Although the full range of precursors is less well characterized than PFOA itself, precursors were included as they are expected, over time, to degrade to PFOA, thereby ultimately contributing to the environmental loading for PFOA. As well, the role of precursors in the long-range transport and subsequent degradation to PFOA in remote areas was considered.
- Comment: Two non-governmental organizations commented that the Government should release the human health assessment for long-chain PFCAs, regardless of its finding that the chemicals in the grouping were not considered high priority with respect to risk to human health.
Response: Health Canada has not yet assessed the long-chain PFCAs for risk to human health. Given the environmental impacts of these substances, however, it is considered important to publish the ecological screening assessment report at this time in order to initiate the implementation of risk management measures. Publishing the ecological assessment at this time is also an important step to fulfill the Government’s commitment to assess PFCAs under the action plan Perfluorinated Carboxylic Acids (PFCAs) and Precursors: An Action Plan for Assessment and Management.
- Comment: Two non-governmental organizations commented that all precursors to long-chain PFCAs should be included in the scope of the screening assessment, including those identified by the Organisation for Economic Co-operation and Development (OECD) process.
Response: The screening assessment considered all precursors to long-chain PFCAs that could transform or degrade to long-chain PFCAs given similar use applications and similarities in their chemical structures. The long-chain PFCAs precursors identified in this assessment are also found on the OECD list in Appendix I of the screening assessment, which provides examples of substances in this group. As this list is not considered exhaustive, it is open to including other precursors to long-chain PFCAs as they are identified by other governmental organizations and/or in other literature.
- Comment: Two non-governmental organizations commented that the screening assessment has not used models to determine long-range transport potential as has been applied in screening assessments of other substances under the Chemicals Management Plan. The conclusion of the screening assessment for long-chain PFCAs should confirm that these chemicals have long-range potential, because this information will influence the type of management measures necessary to prevent the formation of long-chain PFCAs.
Response: Measurements of long-chain PFCAs in Canadian Arctic biota and abiotic media are sufficient to confirm the long-range transport potential of precursors to long-chain PFCAs, given that long-chain PFCAs are not manufactured in or imported into Canada. A statement has been added to the conclusion indicating that the precursors to long-chain PFCAs have the potential for long-range transport.
Implementation, enforcement and service standards
The proposed Order would add PFOA, its salts and precursors and long-chain PFCAs, their salts and precursors to Schedule 1 of CEPA 1999, thereby allowing the Ministers to meet their obligation to publish proposed regulations or other management instruments no later than August 25, 2014, and finalize them no later than February 25, 2016. Developing an implementation plan, a compliance strategy or establishing service standards are not considered necessary without any specific risk management proposals. An appropriate assessment of implementation, compliance and enforcement will be undertaken during the development of a proposed regulation or control instrument(s) respecting preventive or control actions for PFOA, its salts and precursors and long-chain PFCAs, their salts and precursors.
Acting Executive Director
Program Development and Engagement Division
Substances Management Information Line
Telephone: 1-800-567-1999 (toll-free in Canada)
Telephone: 819-953-7156 (outside of Canada)
Risk Management Bureau
Safe Environments Directorate
Healthy Environments and Consumer Safety Branch
PROPOSED REGULATORY TEXT
Notice is hereby given, pursuant to subsection 332(1) (see footnote a) of the Canadian Environmental Protection Act, 1999 (see footnote b), that the Governor in Council, on the recommendation of the Minister of the Environment and the Minister of Health, pursuant to subsection 90(1) of that Act, proposes to make the annexed Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999.
Any person may, within 60 days after the date of publication of this notice, file with the Minister of the Environment comments with respect to the proposed Order or a notice of objection requesting that a board of review be established under section 333 of that Act and stating the reasons for the objection. All comments and notices must cite the Canada Gazette, Part Ⅰ, and the date of publication of this notice, and be sent by mail to the Executive Director, Program Development and Engagement Division, Department of the Environment, Gatineau, Quebec K1A 0H3, by fax to 819-953-7155 or by email to email@example.com.
A person who provides information to the Minister of the Environment may submit with the information a request for confidentiality under section 313 of that Act.
Ottawa, September 20, 2012
Assistant Clerk of the Privy Council
ORDER ADDING TOXIC SUBSTANCES TO SCHEDULE 1 TO THE CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
1. Schedule 1 to the Canadian Environmental Protection Act, 1999 (see footnote 7) is amended by adding the following:
Perfluorooctanoic acid, which has the molecular formula C7F15CO2H, and its salts
Compounds that consist of a perfluorinated alkyl group that has the molecular formula CnF2n+1 in which n = 7 or 8 and that is directly bonded to any chemical moiety other than a fluorine, chlorine or bromine atom
Perfluorocarboxylic acids that have the molecular formula CnF2n+1CO2H in which 8 ≤ n ≤ 20 and their salts
Compounds that consist of a perfluorinated alkyl group that has the molecular formula CnF2n+1 in which 8 ≤ n ≤ 20 and that is directly bonded to any chemical moiety other than a fluorine, chlorine or bromine atom
COMING INTO FORCE
2. This Order comes into force on the day on which it is registered.