Vol. 140, No. 26 — July 1, 2006

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

Statutory authority

Canadian Environmental Protection Act, 1999

Sponsoring departments

Department of the Environment and Department of Health

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Order.)

Description

The purpose of this initiative is to propose the addition of polybrominated diphenyl ethers to Schedule 1 to the Canadian Environmental Protection Act, 1999 (CEPA 1999).

Seven polybrominated diphenyl ethers (PBDEs) were identified in a pilot project list of 123 substances for screening assessment under CEPA 1999, on the basis of their potential persistence and/or bioaccumulation in the environment and inherent toxicity to non-human organisms. The seven PBDE homologues include tetra–, penta–, hexa–, hepta–, octa–, nona– and decaBDE.

A scientific assessment conducted indicates that these substances are entering the environment in a quantity or concentration or under conditions that constitute or may have an immediate or long-term harmful effect on the environment or its biological diversity and thus satisfy the criterion set out under paragraph 64(a) of CEPA 1999. Therefore, these substances are proposed for addition to Schedule 1 of CEPA 1999. The available data regarding persistence and bioaccumulation also indicates that tetraBDE, pentaBDE and hexaBDE satisfy the criteria outlined in the Persistence and Bioaccumulation Regulations, made under CEPA 1999, and as such, meet the statutory criteria for virtual elimination of releases to the environment.

The full screening assessment reports may be obtained from the CEPA Registry Web site at www.ec.gc.ca/CEPARegistry/subs_ list/assessments.cfm or from the Existing Substances Division, Environment Canada, Gatineau, Quebec K1A 0H3, (819) 953-4936 (fax), ESB.DSE@ec.gc.ca (email).

Authority

Subsection 73(1) of CEPA 1999 requires that "the Ministers shall, within seven years from the giving of Royal Assent to this Act, categorize the substances that are on the Domestic Substances List by virtue of section 66, for the purpose of identifying the substances on the List that, in their opinion and on the basis of available information,

(a) may present, to individuals in Canada, the greatest potential for exposure; or

(b) are persistent or bioaccumulative in accordance with the regulations, and inherently toxic to human beings or to non-human organisms, as determined by laboratory or other studies."

Section 74 of CEPA 1999 requires the Minister of the Environment and the Minister of Health to conduct a screening assessment of a substance in order to determine whether the substance satisfies the criteria set out in section 64 of CEPA 1999 and, if it meets any of the criteria, to propose one of the measures described in subsection 77(2) if

(a) the Ministers identify a substance on the Domestic Substances List to be a substance described in paragraph 73(1)(a) or (b); or

(b) the substance has been added to the Domestic Substances List under section 105.

A substance is determined to meet the criteria under section 64 of CEPA 1999 if it is 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;
• constitute or may constitute a danger to the environment on which life depends; or
• constitute or may constitute a danger in Canada to human life or health.

Screening assessments under CEPA 1999

CEPA 1999 requires the Minister of the Environment and the Minister of Health to conduct screening assessments of substances that meet the categorization criteria set out in the Act to determine, in an expeditious manner, whether substances present or may present a risk to the environment or to human health. The responsibility for assessing substances is shared by Environment Canada and Health Canada. The assessment process includes examining potential effects on humans and other organisms, as well as determining the entry of the substance into the environment, the environmental fate of the substance and the resulting exposure.

A draft screening assessment report was prepared and made available to the public. In addition, the Ministers must publish the following in the Canada Gazette:

• a summary of the scientific results of the assessment; and
• a statement as to whether they propose to recommend that the substance be added to Schedule 1 of CEPA 1999; added to the Priority Substances List for further assessment; or that no further action be taken in respect of the substance.

The notice in the Canada Gazette provides for a 60-day public comment period, during which interested parties can file written comments on the recommendations the Ministers propose to take and their scientific basis.

After taking into consideration any comments received, the Ministers may, if they deem it appropriate, make revisions to the draft screening assessment report. The Ministers must then publish in the Canada Gazette their final decision as to whether they propose to recommend that the substance be added to Schedule 1, added to the Priority Substances List for further assessment, or whether they recommend that no further action be taken in respect of the substance. A copy of the final report of the assessment is also made available to the public. If the Ministers' final decision is to propose that the substance be added to Schedule 1 of the Act, they must also recommend to the Governor in Council that the substance be added to the List.

Once the Ministers' final decision is made public, the Government must publish within two years, in the Canada Gazette, Part I, a proposed regulation or instrument respecting preventive or control actions. Once a substance is added to Schedule 1 of CEPA 1999, the Government can regulate it or propose other instruments respecting preventive or control actions (for example, a pollution prevention plan or an environmental emergency plan).

Polybrominated diphenyl ethers (PBDEs)

PBDEs are not manufactured in Canada but are imported in finished articles, or are used in making a variety of commercial and consumer products, such as computer housings, household appliances, furniture, automotive/aircraft seating and interiors, and a variety of electrical and electronic components. Releases of PBDEs to the environment can occur during manufacturing and processing operations, throughout the service life of articles containing PBDEs, and when articles that contain PBDEs are disposed of. Studies indicate that PBDE levels in Canadian biota are rising, with increases in tissue concentrations evident over the last two decades. The highest levels in biota are associated with industrialized regions; however, the increasing incidence of PBDEs in Arctic biota provides evidence for long-range atmospheric transport of these compounds.

Empirical and predicted data indicate that all PBDEs subject to this screening assessment are highly persistent, and each satisfies the requirements for persistence as defined by the Persistence and Bioaccumulation Regulations under CEPA 1999. Specifically, tetra–, penta–, hexa– and heptaBDEs have been measured in the Arctic environment, providing evidence that they are subject to long-range atmospheric transport. DecaBDE in natural sediments has been shown to be stable and resistant to biodegradation under anaerobic conditions for up to two years.

Measured data indicate that tetra–, penta– and hexaBDE are highly bioaccumulative and satisfy the criteria for bioaccumulation in the CEPA 1999 regulations. There is a weight of evidence showing that highly brominated PBDEs are precursors of bioaccumulative and persistent PBDEs. While it is not known the degree to which this phenomenon adds to the overall risk presented to organisms from the tetra– to hexaBDE congeners, there is sufficient evidence for concern.

Available data indicate the potential for exposure of organisms to PBDEs at concentrations of concern. Although concentrations of homologues from commercial decabromodiphenyl ether may not currently exceed known effect thresholds, those homologues are persistent and may contribute to the overall loadings of lower brominated PBDEs over the long term. The long-range transport of PBDEs has resulted in their widespread occurrence, including in remote regions.

Conclusions

Based on the available data, it is concluded that PBDEs, including tetraBDE, pentaBDE, hexaBDE, heptaBDE, octaBDE, nonaBDE and decaBDE, meet the criterion set out in paragraph 64(a) of CEPA 1999. Therefore, these substances are proposed for addition to Schedule 1 of CEPA 1999.

The available data regarding persistence and bioaccumulation for tetraBDE, pentaBDE and hexaBDE indicate that they satisfy the criteria outlined in the Persistence and Bioaccumulation Regulations of CEPA 1999. Their presence in the environment results primarily from human activity, and they are not naturally occurring radionuclides or naturally occurring inorganic substances. It is proposed that tetraBDE, pentaBDE, and hexaBDE be added to the Virtual Elimination List under CEPA 1999.

Alternatives

The screening assessment report concludes that PBDEs are considered to meet the criterion set out under paragraph 64(a) of CEPA 1999. Additionally, three of the seven substances under consideration may have a long-term harmful effect on the environment, are persistent, bioaccumulative, inherently toxic and present in the environment primarily as a result of human activity. Consequently, the Ministers have determined that the alternative of taking no further action is not acceptable for PBDEs.

After the Ministers publish the screening assessment reports and indicate that they propose to recommend a substance for addition to Schedule 1, they must publish, within two years, proposed regulations or an instrument respecting preventive or control actions for the substance.

Benefits and costs

The addition of PBDEs to Schedule 1 of CEPA 1999 will enable the taking of preventive or control actions to ensure the protection of human health and the environment.

The decision to amend Schedule 1 of CEPA 1999 is based primarily on a scientific assessment. It would be premature to proceed, at this point, with an assessment of costs to the public, industry or governments. The Government will undertake an appropriate assessment of the potential impacts of a range of possible instruments during the risk management phase.

Consultation

A notice concerning the screening assessment under CEPA 1999 was published in the Canada Gazette, Part I, as follows:

The notice was posted on Environment Canada's CEPA Registry Web site.

During the 60-day public comment period, comments, which were mostly technical in nature, were received from non-governmental organizations (NGOs), from academics, and from the industry.

Comments provided by NGOs and academia reflected similar positions and opinions that where predominantly based on human health issues and that supported formal and strong action on all PBDEs.

Comments provided by industry stakeholders focused on decaBDE and reflected the chemical industry's strong position on maintaining the manufacture and use of this product. They noted that any possible harmful risk relating to the use of decaBDE are far outweighed by the benefits derived from the reduction in fire risk. The industry also suggested that because decaBDE has properties different from the other congeners, it should not be associated with this group.

In relation to the human health screening assessment, the industry noted that each of the commercial products should have been evaluated separately due to their differences in toxicity and human exposure. Thus, the use of data on the pentaBDE commercial product is not applicable to make inference on the risk to human health from the decaBDE commercial product.

The technical comments submitted by stakeholders were carefully considered, and the text of the screening assessment report was revised as documented in the response to comments. The final revisions did not impact on the proposed conclusion that the substances meet the criteria under section 64 of CEPA 1999. A summary of public comments and government responses on the draft screening assessment report may be obtained from Environment Canada's Web site at www.ec.gc.ca/substances/ese/.

The CEPA National Advisory Committee has been given an opportunity to advise the Ministers on the scientific evidence supporting the declaration of these substances as toxic and their proposal to have them added to Schedule 1 of CEPA 1999. There were no concerns raised with respect to the addition of these substances to Schedule 1 of CEPA 1999.

Compliance and enforcement

There are no compliance or enforcement requirements associated with Schedule 1 of CEPA 1999 itself.

Contacts

Ms. Danie Dubé, Existing Substances Division, Environment Canada, Gatineau, Quebec K1A 0H3, (819) 953-0356 (telephone), (819) 953-4936 (fax), danie.dube@ec.gc.ca (email); or Ms. Bette Meek, Existing Substances Division, Health Canada, Ottawa, Ontario K1A 0K9, (613) 957-3129 (telephone), (613) 954-2486 (fax), bette_meek@hc-sc.gc.ca (email).

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 proposes, pursuant to subsection 90(1) of that Act, 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 to Ms. Danie Dubé, Existing Substances Division, Department of the Environment, Ottawa, Ontario K1A 0H3.

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, June 22, 2006

DIANE LABELLE
Acting Assistant Clerk of the Privy Council

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:

Polybrominated diphenyl ethers that have the molecular formula C₁₂H_(10-n)Br_nO in which 4<n<10

COMING INTO FORCE

2. This Order comes into force on the day on which it is registered.

[26-1-o]

Footnote a

S.C. 2004, c. 15, s. 31

Footnote b

S.C. 1999, c. 33

Footnote 1

S.C. 1999, c. 33

NOTICE:
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