Vol. 147, No. 23 — November 6, 2013

Registration

SOR/2013-188 October 25, 2013

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999

P.C. 2013-1109 October 24, 2013

Whereas, pursuant to subsection 332(1) (see footnote a) of the Canadian Environmental Protection Act, 1999 (see footnote b), the Minister of the Environment published in the Canada Gazette, Part I, on September 29, 2012, a copy of the proposed Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999, substantially in the annexed form, and persons were given an opportunity to file comments with respect to the proposed Order or to file a notice of objection requesting that a board of review be established and stating the reasons for the objection;

And whereas, pursuant to subsection 90(1) of that Act, the Governor in Council is satisfied that the substances set out in the annexed Order are toxic substances;

Therefore, His Excellency the Governor General in Council, on the recommendation of the Minister of the Environment and the Minister of Health, pursuant to subsection 90(1) of the Canadian Environmental Protection Act, 1999 (see footnote c), makes the annexed Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999.

ORDER ADDING TOXIC SUBSTANCES TO SCHEDULE 1 TO THE CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

AMENDMENT

1. Schedule 1 to the Canadian Environmental Protection Act, 1999 (see footnote 1) is amended by adding the following in numerical order:

• 129. Perfluorooctanoic acid, which has the molecular formula C₇F₁₅CO₂H, and its salts
• 130. Compounds that consist of a perfluorinated alkyl group that has the molecular formula C_nF_2n+1 in which n = 7 or 8 and that is directly bonded to any chemical moiety other than a fluorine, chlorine or bromine atom
• 131. Perfluorocarboxylic acids that have the molecular formula C_nF_2n+1CO₂H in which 8 ≤ n ≤ 20 and their salts
• 132. Compounds that consist of a perfluorinated alkyl group that has the molecular formula C_nF_2n+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.

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Order.)

Issue

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 at a certain quantity or concentration in the environment.

Screening assessments of the following substances have concluded that they are harmful to the environment or its biological diversity as defined under paragraph 64(a) of the Canadian Environmental Protection Act, 1999 (CEPA 1999 or the Act):

• Perfluorooctanoic acid, which has the molecular formula C₇F₁₅CO₂H (PFOA), and its salts;
• Compounds that consist of a perfluorinated alkyl group thathas the molecular formula C_nF_2n+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 formulaC_nF_2n+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 C_nF_2n+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).

Background

The Chemicals Management Plan builds on Canada’s position as a global leader in the safe management of chemical substances and products, to reduce risks to Canadians and our environment. Conducted under the Chemicals Management Plan, screening assessments for PFOA, its salts and precursors and long-chain PFCAs, their salts and precursors also fulfill the Government’s commitment to assess PFCAs in accordance with the action plan entitled Action Plan forthe Assessment and Management ofPerfluorinated Carboxylic Acids and their Precursors, as published in the Canada Gazette, Part I, on June 17, 2006. (see footnote 2)^, (see footnote 3) The screening assessments were conducted in order to assess whether these substances meet one or more of the criteria set out in section 64 of CEPA 1999, that is, whether they are entering or may enter the environment in a quantity or concentration or under conditions that

• (a) have or may have an immediate or long-term harmful effect on the environment or its biological diversity;
• (b) constitute or may constitute a danger to the environment on which life depends; or
• (c) constitute or may constitute a danger in Canada to human life or health. (see footnote 4)

The draft screening assessments and a risk management scope document were published on the Chemical Substances Web site along with a notice published in the Canada Gazette, Part I, on October 30, 2010. (see footnote 5) These publications signalled the intent of the Minister of the Environment and the Minister of Health (the Ministers) in regard to further risk management activities.

After public comments were considered, the final screening assessments and a risk management approach document were published on the Chemical Substances Web site along with a notice published in the Canada Gazette, Part I, on August 25, 2012. (see footnote 6) In addition, a proposed order adding these substances to Schedule 1 to CEPA 1999 was published in the Canada Gazette, Part I, on September 29, 2012. (see footnote 7)

Substance descriptions and assessment conclusions

PFOA, its salts and its precursors

PFOA is a synthetic substance belonging to the PFCA class of chemicals. The ammonium salt of PFOA is 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, and non-stick cookware, and in personal care products. PFOA, its salts and precursors (compounds that degrade to become PFOA) have also been used in the past in many industrial processes as well as in commercial and consumer products.

According to surveys conducted in 2000 and 2004 under section 71 of CEPA 1999, PFOA and its salts were imported but not manufactured in Canada during the survey years. In 2004, between 100 and 100 000 kg of a PFOA ammonium salt were imported into Canada.

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 is not known to undergo further degradation. The presence of PFOA in the Canadian Arctic is likely attributable to long-range transport. PFOA is expected to end up mostly in the aquatic environment, or, to a lesser extent, in sediments.

Although experimental evidence indicates that PFOA is not highly bioaccumulative in fish, field studies suggest that PFOA may accumulate and biomagnify in certain terrestrial and marine mammals. PFOA has been detected in Canadian freshwaters and sediments, as well as a variety of animals, including fish, invertebrates, and 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 organisms. PFOA has been shown to have a number of harmful effects on animals. (see footnote 8)

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 much lower than the levels associated with adverse effects in laboratory animals. Therefore, PFOA is not expected to pose a risk to human health.

Based on all the available information, the screening assessments concluded that PFOA, its salts and its precursors meet the criteria set out in paragraph 64(a) of CEPA 1999. It was also concluded that PFOA and its salts meet the criteria for persistence; however, despite evidence that they may accumulate and biomagnify in certain mammals, they do not meet the criteria for bioaccumulation as set out in the Persistence and Bioaccumulation Regulations.

Long-chain PFCAs, their salts and their precursors

PFCAs are synthetic chemicals that belong to the broader class of chemicals known as perfluoroalkyls (PFAs). The screening 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 in Canada. 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 add oil-, grease-, water- and stain-repellent properties.

According to two industry surveys, conducted by Environment Canada in 2000 and 2004, long-chain PFCAs were not manufactured in or imported into Canada. However, in both surveys, between 1 000 and 100 000 kg of their 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. For example, they have the potential to cause hepatotoxicity (to be harmful 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. Furthermore, 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.

Based on all the available information, the ecological assessment concluded that long-chain PFCAs, their salts and their precursors meet the criteria set out in paragraph 64(a) of CEPA 1999. It was also concluded that long-chain PFCAs and their salts meet the criteria for persistence but despite evidence that they may accumulate and biomagnify in certain mammals, they do not meet the bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations.

Objectives

The objective of the Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999 (hereinafter referred to as the Order)is to enable the Ministers to develop risk management instruments under CEPA 1999 to manage ecological risks posed by these substances.

Description

The Order adds PFOA, its salts and precursors, and long-chain PFCAs, their salts and precursors to Schedule 1 of CEPA 1999 (the List of Toxic Substances).

“One-for-One” Rule

The “One-for-One” Rule does not apply to this Order, as the Order is not expected to have any impact on industry that could result in administrative burden. This Order is an enabling instrument which allows the Ministers to develop risk management measures with respect to the substances.

Small business lens

The small business lens does not apply to this Order, as there are no costs on small businesses. Rather, the Order enables the Ministers to propose risk management measures with respect to the substances, but does not impose any compliance or administrative requirements on businesses.

Consultation

Consultation following publication of the draft screening assessment reports

On October 30, 2010, the Ministers published summaries of the draft screening 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. (see footnote 9) The risk management scope document, also released on the same date, outlined the preliminary options being examined for the management of these substances, which were proposed to be harmful to the environment or its biological diversity under paragraph 64(a) 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 nongovernmental 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.

Below is a summary of some key comments received regarding the screening assessments 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 10)

PFOA, its salts and its precursors

• 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 the studies from 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, neurobehavioral 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 for 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 of PFOA being 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: This assessment considered in particular 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.

Long-chain PFCAs, their salts and their precursors

• 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 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 measure. Publishing the ecological assessment at this time is also an important step to fulfill the Government of Canada’s commitment to assess PFCAs under Perfluorinated Carboxylic Acids and their Precursors: An Action Plan forAssessment 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 known to be 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.

Consultation following prepublication of the Order in the Canada Gazette, Part I

On September 29, 2012, the Government of Canada published a proposed Order to add these substances to Schedule 1 to CEPA 1999 in the Canada Gazette, Part I. During the 60-day comment period, one submission from a non-governmental organization was received supporting the proposed addition of the substances to the List of Toxic Substances.

Rationale

As described in the “Background” section, PFOA, its salts and the precursors of long-chain PFCAs were imported into and used in Canada. Screening assessments conducted on these substances found that they are harmful to the environment or its biological diversity. Given these concerns, the screening assessments concluded that these substances meet the criteria set out in paragraph 64(a) of CEPA 1999.

Measures that can be taken after a screening assessment of a substance is conducted under CEPA 1999 include

• adding the substances to the Priority Substances List for further assessment, when additional information is required to determine if the substances meet the criteria in section 64 of CEPA 1999;
• taking no further action in respect of the substances; or
• recommending that the substances be added to the List of Toxic Substances in Schedule 1, and, where applicable, the implementation of virtual elimination.

Given the concerns identified, adding PFOA, its salts and precursors and long-chain PFCAs, their salts and precursors to Schedule 1 to CEPA 1999, enables the Minister to develop risk management instruments under the Act and is, therefore, the preferred option.

The addition of these substances to Schedule 1 to CEPA 1999 does not result in any incremental impacts (benefits or costs) on the public or industry, since there are no compliance requirements. Accordingly, there is no compliance or administrative burden on small business or businesses in general. The Ministers will assess costs and benefits and consult with the public and other stakeholders during the development of risk management instruments for these substances.

Implementation, enforcement and service standards

The Order adds PFOA, its salts and precursors and long-chain PFCAs, their salts and precursors to Schedule 1 to CEPA 1999, thereby allowing the Ministers to meet their obligation to publish 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 proposal. An appropriate assessment of implementation, compliance and enforcement will be undertaken during the development of a regulation or control instrument(s) respecting preventive or control actions for PFOA, its salts and precursors and long-chain PFCAs, their salts and precursors.

Contacts

Greg Carreau
Executive Director
Program Development and Engagement Division
Environment Canada
Gatineau, Quebec
K1A 0H3
Substances Management Information Line:
1-800-567-1999 (toll-free in Canada)
819-953-7156 (outside of Canada)
Fax: 819-953-7155
Email: substances@ec.gc.ca

Michael Donohue
Risk Management Bureau
Health Canada
Ottawa, Ontario
K1A 0K9
Telephone: 613-957-8166
Fax: 613-952-8857
Email: michael.donohue@hc-sc.gc.ca

• Footnote a
  S.C. 2004, c. 15, s. 31
• Footnote b
  S.C. 1999, c. 33
• Footnote c
  S.C. 1999, c. 33
• Footnote 1
  S.C. 1999, c. 33
• Footnote 2
  The screening assessment reports are peer-reviewed. For further details, please refer to the screening assessments.
• Footnote 3
  For more information on the Action Plan, please visit http://publication.gc.ca/ gazette/rp-pr/p1/2006/2006-06-17/pdf/g1-14024.pdf.
• Footnote 4
  The conclusion of long-chain PFCAs, their salts and precursors was based on an ecological screening assessment to determine whether the substances met the criteria set out in paragraphs 64(a) and 64(b) of CEPA 1999.
• Footnote 5
  For more information, please visit http://gazette.gc.ca/rp-pr/p1/2010/2010-10-30/pdf/g1-14444.pdf.
• Footnote 6
  For more information, please visit http://gazette.gc.ca/rp-pr/p1/2012/2012-08-25/pdf/g1-14634.pdf (pages 2506 and 2501).
• Footnote 7
  For more information, please visit http://gazette.gc.ca/rp-pr/p1/2012/2012-09-29/pdf/g1-14639.pdf.
• Footnote 8
  For example hepatotoxicity, immunotoxicity, chemosensitivity and effects on endocrine function.
• Footnote 9
  For more information, please visit http://gazette.gc.ca/rp-pr/p1/2010/2010-10-30/pdf/g1-14444.pdf (pages 2760 and 2754).
• Footnote 10
  The document can be viewed on the Chemical Substances Web siteat www. chemicalsubstances.gc.ca or obtained from Environment Canada’s Program Development and Engagement Division, Gatineau, Quebec K1A 0H3, or by fax from 819-953-7155, or by email from substances@ec.gc.ca.