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

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Vol. 144, No. 21 — October 13, 2010

Registration

SOR/2010-210 September 30, 2010

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

P.C. 2010-1181 September 30, 2010

Whereas, pursuant to subsection 332(1) (see footnote a) of the Canadian En- vironmental Protection Act, 1999 (see footnote b), the Minister of the Environment published in the Canada Gazette, Part I, on June 17, 2006, a copy of the proposed Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999, substantially in the form set out in the annexed Order, 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, Her 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), hereby 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:

92. Hexane, 1,6-diisocyanato-, homopolymer, reaction products with alpha-fluoro-omega-2-hydroxyethyl-poly(difluoro- methylene), C16-20-branched alcohols and 1-octadecanol

93. 2-propenoic acid, 2-methyl-, hexadecyl ester, polymers with 2-hydroxyethyl methacrylate, gamma-omega-perfluoro-C10-16-alkyl acrylate and stearyl methacrylate

94. 2-propenoic acid, 2-methyl-, 2-methylpropyl ester, polymer with butyl 2-propenoate and 2,5-furandione, gamma-omega-perfluoro-C8-14-alkyl esters, tert-Bu benzenecarboperoxoate-initiated

95. 2-propen-1-ol reaction products with pentafluoroiodoethane tetrafluoroethylene telomer, dehydroiodinated, reaction products with epichlorohydrin and triethylenetetramine

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 and objectives

Canadians depend on chemical substances that are used in hundreds of goods, from medicines to computers, fabrics and fuels. However, some chemical substances can negatively affect our health and environment when released in a certain quantity or concentration in the environment. Scientific assessments of the impact of human and environmental exposure have determined that a number of these substances constitute or may constitute a danger to human health and/or the environment as per criteria set out under section 64 of the Canadian Environmental Protection Act, 1999 (CEPA 1999).

The objective of the Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999 (hereinafter referred to as the Order) made under subsection 90(1) of CEPA 1999, is to add the following substances to the List of Toxic Substances in Schedule 1 of CEPA 1999:

  • Hexane, 1,6-diisocyanato-, homopolymer, reaction products with alpha-fluoro-omega-2-hydroxyethyl-poly(difluoromethylene), C16-20-branched alcohols and 1-octadecanol
  • 2-propenoic acid, 2-methyl-, hexadecyl ester, polymers with 2-hydroxyethyl methacrylate, gamma-omega-perfluoro-C10-16-alkyl acrylate and stearyl methacrylate
  • 2-propenoic acid, 2-methyl-, 2-methylpropyl ester, polymer with butyl 2-propenoate and 2,5-furandione, gamma-omega-perfluoro-C8-14-alkyl esters, tert-Bu benzenecarboperoxoate-initiated
  • 2-propen-1-ol, reaction products with pentafluoroiodoethane tetrafluoroethylene telomer, dehydroiodinated, reaction products with epichlorohydrin and triethylenetetramine

These substances are collectively referred to as the “four new fluorotelomer-based substances” and their addition to Schedule 1 enables the development of measures under CEPA 1999 to manage human health as well as environmental risks the substances pose.

Description and rationale

Background

In 2004 four companies notified Environment Canada and Health Canada of their intention to market the four new fluorotelomer-based substances in Canada. Internationally, these substances are primarily used in applications involving water-, oil-, soil- and grease-repellents for paper, fabric, leather, packaging, rugs and carpets, as well as tiles and grouts. They are also used as a levelling agent in coatings.

The Canadian Environmental Protection Act, 1999 requires, under the new substances notification and assessment regime established under sections 80 to 89, that no new substance be introduced into Canadian commerce without first being assessed to determine if it could pose a risk to Canadians or the environment. Consequently, in 2004, the four new fluorotelomerbased substances were assessed by Environment Canada and Health Canada. (see footnote 2) The assessments indicated that the four new fluorotelomer-based substances are ultimately sources of long chain perfluorinated carboxylic acids (PFCAs), a class of toxic substances, through the release of precursors. (see footnote 3)

Evidence indicates certain precursors to PFCAs are volatile and subject to long-range transport in the atmosphere as some PFCAs have been found in very remote locations. PFCAs themselves may be subject to long-range transport via oceanic currents. These substances are considered to be very persistent in the environment as they may degrade in the environment at extremely slow rates and certain PFCAs can accumulate in tissues of living beings. Studies report levels of PFCAs in a variety of environmental media that directly impact human exposure, such as indoor air, dust, food and drinking water.

Based on this evidence, the Minister of the Environment and the Minister of Health concluded, in 2004, that the four new fluorotelomer-based substances 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 and may constitute a danger in Canada to human life or health. Therefore, the Ministers concluded that these substances meet the toxicity criteria set out in paragraphs 64(a) and 64(c) of CEPA 1999.

Based on these conclusions, the Minister of the Environment published three Notices of Ministerial Prohibition in the Canada Gazette, Part I, on July 17, 2004, (see footnote 4) and a fourth one on February 5, 2005, (see footnote 5) which temporarily prohibited the importation and manufacture of the four new fluorotelomer-based substances.

In April 2006, an update to the Environmental and Human Health Assessments Report was published. The Report supported the conclusion made in the previous assessments and confirmed that the notified substances will release PFCA precursors.

Given that the four new fluorotelomer-based substances meet the toxicity criteria under section 64 of CEPA 1999, the Order adds the four substances to the List of Toxic Substances in Schedule 1 of CEPA 1999.

Alternatives

It was concluded in the 2006 Update Report that the four new fluorotelomer-based substances may enter the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health and have or may have an immediate or long-term harmful effect on the environment or its biological diversity as set out in section 64 of CEPA 1999.

Adding these substances to Schedule 1 of CEPA 1999 enables the development of the full range of risk management measures available under the Act, and is therefore the most effective option to prevent new sources of PFCAs from entering Canada.

Benefits and costs

Listing these substances on Schedule 1 enables the Ministers to develop risk management measures, which may be both regulatory and non-regulatory under CEPA 1999, to help protect human health and the environment. Certain non-regulatory measures, such as codes of practice or guidelines, are also available without the addition of these substances to Schedule 1. The Government will assess costs and benefits during the development of these risk management measures.

Consultation

A multi-stakeholder consultation meeting was held in Ottawa, in February 2006, to discuss proposed actions to address PFCAs. The meeting involved representatives from industry, academia, non-governmental organizations (NGOs) and governmental organizations.

One outcome of the consultation was the development of an Action Plan on PFCAs, published by Environment Canada and Health Canada in June 2006. The Action Plan was developed to address the assessment and management of the broad class of PFCAs and substances that are a source of PFCAs, including the four new fluorotelomer-based substances. This Action Plan, in part, also indicates that Environment Canada and Health Canada will pursue further assessment in order to guide further risk management actions.

Overall, stakeholders agreed on the need to take action on the four new fluorotelomer-based substances. However, they expressed concerns regarding the update to the Environmental and Human Health Assessments, (see footnote 6) published in April 2006, as outlined below.

  • Industry stakeholders, representing sectors such as pulp and paper and chemical manufacturing, argued that it is not essential to maintain the prohibition for the four new fluorotelomer-based substances. They suggested that it would be sufficient to include the four new fluorotelomer-based substances in the proposed plan for addressing fluorotelomer-based substances already in Canadian commerce.

Environment Canada maintains that the prohibitions are consistent with the preventive approach that is the basis of CEPA 1999. The intent of the New Substances Program is to ensure that no new substance is introduced into Canada before an assessment is made. If a substance has the potential to pose a risk to the environment or to human health, control measures are put in place before they are introduced into the Canadian marketplace. Risk management actions taken at an early stage of a substance’s life cycle are arguably more cost-effective than actions taken after a substance has become “entrenched” in the economy. The addition of the four fluorotelomer-based substances to Schedule 1 to CEPA 1999 is necessary to enable the taking of management measures in respect of these substances to prevent any new sources of PFCA precursors in Canada. Further assessment of other PFCAs and their precursors is outlined as part of the Action Plan. Consideration of adding additional PFCAs or their precursors to Schedule 1 will be given following the final conclusions of this assessment work.

  • Industry stakeholders were also concerned that adding these substances to Schedule 1 to CEPA 1999 could negatively impact the market perception of the whole class of similar substances.

Environment Canada recognized that there is a potential for public perception of similar substances to be negatively affected. However, given current market conditions, it is not expected that there will be any impact on the demand for products containing such substances.

Comments following publication of the proposed Order in the Canada Gazette, Part I, on June 17, 2006

The proposed Order was published in the Canada Gazette, Part I, on June 17, 2006, for a 60-day comment period. A total of three submissions were received from stakeholders comprising industry, an NGO and a private citizen. In addition, a Notice of Objection was received from an industry stakeholder that questioned the validity and completeness of the science used by Environment Canada and Health Canada to determine that the four substances should be added to Schedule 1 to CEPA 1999.

The Minister of the Environment responded to the industry stakeholder regarding the Notice of Objection in May 2008. Given that the industry stakeholder who submitted the Notice of Objection provided no new information with respect to the nature and extent of the danger posed by the four new fluorotelomer-based substances, the request for a Board of Review was declined by both the Minister of the Environment and the Minister of Health. The Notice of Objection is available at the following Web site : www.ec.gc.ca/CEPARegistry/participation/object.cfm.

  • A chemical industry representative stated that Environment Canada did not set deadlines and timetables for the regulatory process, the rules for the consultation process were not determined or disclosed in advance and the process was not open, fair and transparent.

During the preparation of the risk assessments there was a high level of interaction between Environment Canada and the notifiers, both at the scientific and policy levels. There were also consultations on the science with academics, Government research staff, notifiers’ research and regulatory staff and other regulatory bodies prior to the initial imposition of the prohibitions. In addition, draft risk-assessment reports were released to the notifiers and their comments were taken into consideration in finalizing the reports.

Further consultation took place in February 2006 on the Action Plan for the Assessment and Management of Perfluorin- ated Carboxylic Acids and their Precursors, which also included consultation on the proposed Risk Management Strategy for the four new fluorotelomer-based substances.

Stakeholders had an early opportunity to submit comments on the science assessment and risk management activities following the February 2006 consultation meeting, in addition to the 60-day comment period following pre-publication in June 2006. (see footnote 7)

  • A chemical industry representative stated that there is a lack of evidence demonstrating a specific danger that would justify prohibiting the substances and that there exists significant uncertainty in the analyses supporting the proposals.

In 2004 and 2005, assessments of the new notified substances were conducted under section 83 of CEPA 1999 and considered all available scientific information, including information supplied by the notifier, publications in peer-reviewed scientific literature and information otherwise available to the Government.

The notifying companies were engaged in extensive discussions during the assessments of the four substances, and were provided with the draft assessment reports and the opportunity to submit comments. A total of 22 individuals, consisting of academics, industry representatives, NGOs and regulatory agencies, were invited to provide comments focusing on their given area of expertise addressing the adequacy of the scientific information contained in the assessments. The information gathered and shared during the peer-review process valid- ated the findings of the assessments.

  • A chemical industry representative commented that one of the four substances notified is the least likely of the four new fluorotelomer-based substances to degrade to PFCAs and therefore should not be part of the prohibition.

Environment Canada agrees that the mechanism of forming PFCAs from this substance is different than for the other three substances, as noted in the assessment report. One key difference is that fluorotelomer alcohol is not formed in the case of this polymer. However, the assessment does conclude the notified substance is a source of long chain PFCAs. Therefore, this substance is included in the prohibitions.

In fall 2009, stakeholders were informed by mail of Environment Canada’s intention to finalize the Order Adding Toxic Substances to Schedule 1 to CEPA 1999 by winter 2010. No concerns were received from stakeholders.

Implementation, enforcement and service standards

The Order only adds the four new fluorotelomer-based substances to Schedule 1 of CEPA 1999. Therefore, developing an implementation plan, a compliance strategy or establishing service standards are not considered necessary.

Contacts

Vincenza Galatone
Chemicals Management Division
Environment Canada
351 St. Joseph Boulevard, 17th Floor
Gatineau, Quebec
K1A 0H3
Telephone: 819-934-4533
Fax: 819-997-7121
Email: vincenza.galatone@ec.gc.ca

Arthur Sheffield
Economics and Health Analysis Division
Risk Management Bureau
Healthy Environments and Consumer Safety Branch
Health Canada
269 Laurier Avenue West
Ottawa, Ontario
K1A 0K9
Telephone: 613-957-8166
Fax: 613-952-8857
Email: arthur.sheffield@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
Copies of the Assessments of the four new fluorotelomer-based substances can be requested by contacting the New Substances Notification Information Line by e-mail at nsn-infoline@ec.gc.ca.

Footnote 3
Copies of the New Substances Assessment Reports and Updates on the four fluorotelomer-based substances are available at ec.gc.ca/substances/nsb/eng/cp_telomer_e.shtml.

Footnote 4
Notices under subsection 84(5) of CEPA 1999: gazette.gc.ca/archives/p1/2004/2004-07-17/pdf/g1-13829.pdf

Footnote 5
Notice under subsection 84(5) of CEPA 1999: canadagazette.gc.ca/archives/p1/2005/2005-02-05/pdf/g1-13906.pdf

Footnote 6
Copies of the Update to the Environmental and Human Health Assessments Report can be requested by contacting the New Substances Notification Information Line by e-mail at nsn-infoline@ec.gc.ca.

Footnote 7
A Summary of and Response to Comments on the Action Plan proposed at the February 2006 consultations is available on Environment Canada’s Web site at www.ec.gc.ca/Publications/default.asp?lang=En&xml=92B4CD31-AE80-4B84-8705-3A61C975A41E.