Vol. 140, No. 25 — December 13, 2006

Registration
SOR/2006-298 November 24, 2006

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Virtual Elimination List

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 August 16, 2003 a copy of the proposed Virtual Elimination List, substantially in the form set out in the annexed List, and persons were given an opportunity to file comments with respect to the proposed List or to file a notice of objection requesting that a board of review be established and stating the reasons for the objection;

Therefore, the Minister of the Environment and the Minister of Health, pursuant to subsection 65(2) of the Canadian Environmental Protection Act, 1999 (see footnote c), hereby compile the annexed Virtual Elimination List, effective on the date on which it is registered.

signature	signature
Ottawa, August 21, 2006	Ottawa, November 22, 2006
Rona Ambrose Minister of the Environment	Tony Clement Minister of Health

VIRTUAL ELIMINATION LIST

VIRTUAL ELIMINATION LIST

Item	Column 1 Substances	Column 2 Level of Quantification
1.	Hexachlorobutadiene, which has the molecular formula C4Cl6	0.06 ng/mL, in a chlorinated solvent

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the List.)

Description

This initiative adds Hexachlorobutadiene (HCBD) to the Virtual Elimination List (the "VE List") with a level of quantification in chlorinated solvents of 0.06 ng/mL.

Subsection 65(2) of the Canadian Environmental Protection Act, 1999 (CEPA 1999) mandates the establishment of the VE List by the Ministers of the Environment and Health (the "Ministers"). The addition of HCBD marks the establishment of the VE List.

Virtual Elimination under CEPA 1999

Virtual elimination is the reduction of releases of a toxic substance into the environment to a concentration level below that which can be accurately measured using sensitive but routine sampling and analytical methods. CEPA 1999 refers to this concentration level as the "level of quantification". More specifically, subsection 65(1) of CEPA 1999 defines virtual elimination as the ultimate reduction of the quantity or concentration of the substance in a release below the level of quantification specified by the ministers in the VE List.

There are four key elements in the implementation of virtual elimination under the Act:

I. The addition of a substance to the List of Toxic Substances in Schedule 1 of CEPA 1999 and the proposed implementation of virtual elimination

To be added to the VE List, a substance must be toxic according to section 64 of CEPA 1999. In addition, a substance that, as a result of an assessment conducted under section 77 of CEPA 1999 is determined to be persistent and bioaccumulative, entering the environment primarily as a result of human activity, and not a naturally occurring radionuclide or a naturally occurring inorganic substance, shall be proposed for virtual elimination under subsection 65(3) of CEPA 1999. These latter three criteria are set out in subsection 77(4) of CEPA 1999.

II. The preparation and submission of Virtual Elimination Plans

The Minister of the Environment has the authority under subsection 79(1) of CEPA 1999 to request those parties who use or release a substance identified for virtual elimination to prepare and submit a Virtual Elimination Plan. Virtual Elimination Plans are an information gathering tool and a request to prepare one may be judged necessary by the Minister of the Environment to document progress already made in preventing or controlling the use or release of the substance, and/or to help identify what additional measures may be required for the virtual elimination of releases associated with the substance. When appropriate, the request for such plans will accompany the publication of the final science assessment for a substance in the Canada Gazette. Only those parties identified in the Canada Gazette Notice would be required to prepare and submit a plan.

III. The addition of the substance and its level of quantification to the VE List

CEPA 1999 requires the ministers to add substances for virtual elimination to the VE List with a level of quantification by way of publication in the Canada Gazette. This is the focus of the current initiative – the addition of HCBD to the VE List with a level of quantification in chlorinated solvents.

The level of quantification is a scientific determination. It is defined as the lowest concentration of a substance that can be accurately measured using sensitive but routine sampling and analytical methods. A sampling and analytical method can be considered "routine" if the equipment and knowledge required to carry out the method is common in commercial laboratories involved in micro-pollutant analysis, recognizing that minor adjustments may be required.

IV. The development of a regulation prescribing a release limit and other preventive or control instruments

Following the addition of the substance and its level of quantification to the VE List, subsection 65(3) of CEPA 1999 requires the development of a regulation that sets the quantity or concentration of a substance that may be released (referred to as a release limit) into the environment.

When determining release limits, CEPA 1999 requires the ministers to take into account environmental or health risks posed by the release and any other relevant social, economic or technical matters.

In working towards the objective of virtual elimination, the Ministers may set interim release limits. Virtual elimination can thus be achieved through the setting of progressively lower release limits and the implementation of other risk management tools, until the quantity or concentration of the substance released to the environment is below the level of quantification.

In the case of HCBD, the substance occurs as a contaminant in chlorinated solvents at very low levels. Although the concentration of HCBD can be measured in the solvents, measuring the actual release of HCBD as these products are used would be extremely difficult if not impossible. Consequently, the development of release limit regulations is not a feasible option for this substance. Although release limit regulations will not be developed for HCBD, a number of other actions have been taken that are contributing to its virtual elimination. These actions include the following:

• The addition of HCBD to the Prohibition of Certain Toxic Substances Regulations, 2005. This Regulation prevents the manufacture, sale, import or use of HCBD in Canada, thus ensuring the substance is not reintroduced to the Canadian marketplace.
• Passing of the Solvent Degreasing Regulations,which reduce the use and release of two chlorinated solvents: tricholorethylene and tetrachloroethylene, and the Dry Cleaning Regulations,which reduce the use and release of tetrachloroethylene. As HCBD is found as an incidental contaminant in these solvents, the reduction of their use and release also reduces the potential release of HCBD.

Even though the releases of HCBD are expected to decrease due to the regulations noted above, Environment Canada will track the volume of chlorinated solvents imported into Canada and the HCBD concentrations in those solvents to ensure that other appropriate risk management actions can be taken if warranted in the future.

Regulatory background

In December 1995, the Ministers published the second Priority Substances List, which includes Hexachlorobutadiene, under the Canadian Environmental Protection Act, an Act later replaced by CEPA 1999. The scientific assessment of HCBD then followed.

The conclusion of the scientific assessment indicates that HCBD is entering 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. HCBD was therefore concluded toxic as per paragraph 64(a) of CEPA 1999. Summaries of the draft and final Priority Substances Assessment Reports for HCBD were then published in the Canada Gazette on July 1, 2000 and on May 18, 2002, respectively. Subsequently, the Order to add HCBD to Schedule 1 of CEPA 1999was published in the Canada Gazette on June 1, 2002, with the final Order adding HCBD to Schedule 1 being published on July 24, 2003.

Subsection 77(4) of CEPA 1999 requires that the ministers propose the "implementation of virtual elimination" for any substance that meets any of the criteria in section 64 that also meets the criteria for persistence and bioaccumulation according to the Persistence and Bioaccumulation Regulations, is present in the environment primarily as a result of human activity, and is not a naturally occurring radionuclide or a naturally occurring inorganic substance. The published summaries of the draft and final Priority Substances Assessment Reports for HCBD concluded that it meets all of these criteria. Therefore, the ministers proposed the addition of HCBD to the VE List in the Canada Gazette on August 16, 2003.

Properties of HCBD

HCBD has never been commercially produced in Canada. Formerly, the substance was imported into Canada for use as a solvent, but it is no longer imported as a pure chemical. There are no natural sources of HCBD.

HCBD is generated as a by-product during the production of certain chemicals. Most notably, HCBD is found as a contaminant in certain chlorinated solvents. As a result, it may be released upon the use of these chemicals. Other possible releases of HCBD in the Canadian environment could be from hazardous landfill leachate. Long-range transport may also contribute to its presence in the Canadian environment.

When HCBD is released into the environment, it tends to remain mostly in the environmental compartment to which it was released. If HCBD is emitted into air, more than 98 percent would be found in the air, about 1 percent in soil and less than 1 percent in water and sediments. If released into soil, about 99 percent would be found in the soil and about 1 percent in the air. If released into water, about 70 percent would be found in the water, about 15 percent in each of the air and sediments and less than 1 percent in the soil. HCBD is slowly removed from the atmosphere by photo-oxidation.

HCBD biodegrades slowly in aerobic conditions (i.e. in environmental compartments, such as water, sediment or soil that contain oxygen), but it would persist considerably longer under anaerobic conditions (i.e. in environmental compartments in which the oxygen concentration is depleted). HCBD bioaccumulates in the tissues of freshwater organisms, but it is quite easily metabolized and therefore does not biomagnify through the food chain.

The estimated average daily intake by the general population in Canada from environmental sources is less than a Tolerable Intake derived by Health Canada on the basis of a benchmark dose or effect levels for non-cancer effects in the kidney. A Tolerable Intake is the level of intake to which it is believed a person may be exposed daily over a lifetime without deleterious effect.

Alternatives

The assessment report concludes that HCBD is toxic under paragraph 64(a) of CEPA 1999. HCBD also meets the criteria for persistence and bioaccumulation according to the Persistence and Bioaccumulation Regulations of CEPA 1999 and is present in the environment primarily as a result of human activity. Moreover, it is not a naturally occurring radionuclide or a naturally occurring inorganic substance. Consequently, the Ministers are required by CEPA 1999 to propose the addition of HCBD to the VE List. No other alternative is acceptable in this situation.

Benefits and Costs

The addition of HCBD to the VE List signals the Government's intention to virtually eliminate releases of HCBD to the environment. The decision to add HCBD to the VE List is solely based on a scientific assessment. Any subsequent risk management actions that the Government might take to achieve the virtual elimination of this substance must consider environmental or health risks and any other relevant social, economic or technical matters as required under the Act.

Consultation

The public and stakeholders were given opportunity to comment during the 60-day comment period following the pre-publication in the Canada Gazette of the summary draft Priority Substances Assessment Report for HCBD on July 1, 2000. A 60-day comment period also followed the pre-publication in the Canada Gazette of the proposed Order to add HCBD to the List of Toxic Substances in Schedule 1 of CEPA 1999 on June 1, 2002. No comment opposed the proposed implementation of virtual elimination stated in these Canada Gazette notices. No significant new information regarding the toxicity of HCBD has emerged since that time.

The CEPA National Advisory Committee and relevant federal government departments were consulted on the Virtual Elimination Approach, the Addition of HCBD to the VE List, and also the proposed Risk Management Strategy for HCBD. There were no concerns raised.

Stakeholders were consulted on the proposed Risk Management Strategy for HCBD during a consultation meeting held in Ottawa in December 2002. The level of quantification for HCBD as well as the virtual elimination process was also presented at that meeting. Comments received from industry expressed concern about the level of quantification determination for HCBD in chlorinated solvents, proposing that it should be based on more representative samples and possibly a more common analytical method.

In response, Environment Canada conducted an interlab study which confirmed that the measurement of HCBD at the proposed level of quantification is achievable by other commercial and Government laboratories using the same analytical methods regularly used by organic chemistry labs involved in the analysis of micro-pollutants. Environment Canada further concluded that the number and type of samples taken was representative.

Comments Following Pre-Publication in the Canada Gazette , Part I, on August 16, 2003

During the 60-day comment period following the pre-publication of this initiative in the Canada Gazette, Part I, submissions were received from three industry associations and two companies. These submissions motivated the supplementation and reorganization of the Description section, above, to clarify the meaning and implications of virtual elimination.

A number of comments were critical of the consultation process for establishing the VE List. One comment challenged Environment Canada to use scientifically defensible principles in consultation with stakeholders when proposing the addition of a substance. Another indicated there has been a lack of face-to-face consultations in creating the VE List.

Environment Canada believes due process was followed and stakeholders were consulted with regards to the addition of HCBD to the VE List. Environment Canada's intention to propose the addition of HCBD to the VE List was signaled as early as the pre-publication of the summary draft Priority Substances Assessment Report for HCBD in the Canada Gazette, Part I, on July 1, 2000. Stakeholders had opportunity to provide written comments in response to the various Canada Gazette publications identified above. In addition, a multi-stakeholder meeting was held on December 9, 2002, in Ottawa, to discuss the proposed risk management approach and level of quantification for HCBD.

A Notice of Objection was received from an industry association in the United States. There was no basis on which to establish a Board of Review, and on March 10, 2005 the Minister of the Environment responded denying the request.

Two comments suggested that there is a lack of clarity surrounding the addition to and implementation of the VE List. One stakeholder suggested a protocol be developed to ensure transparency of the VE List addition process, including the determining factors for the application of the substance; the scope of control measures; and any other relevant information considered in the analysis.

Subsection 77(4) of CEPA 1999 clearly establishes the criteria that, if met, require the implementation of virtual elimination for a substance found to be toxic through an assessment under section 77. Other than the evidence used to evaluate the criteria listed in the description section above, there is no other information that goes into the decision to add a substance to the VE List. A detailed description of the statutory scheme for virtual elimination is provided above.

Several comments questioned the protocol and methodology for establishing the level of quantification for HCBD and challenged Environment Canada's interpretation of the term "routine" under subsection 65(1) in regards to the setting of the level of quantification. In particular, comments suggest that many stakeholders interpreted "routine" as meaning "off the shelf".

Regarding a protocol, the level of quantification is established by the ministers in accordance with subsection 65(1) of CEPA 1999. Consultation in setting the level of quantification will typically be provided during: (a) the stakeholder consultations prior to pre-publication of a proposal in the Canada Gazette, Part I, to add the substance to the VE List; and (b) the opportunity to provide written feedback during the 60-day comment period following the aforementioned publication.

Regarding the methodology, Environment Canada is of the opinion that an analytical method is routine if the equipment and knowledge required to carry it out is common in commercial laboratories involved in micro-pollutant analysis, recognizing that minor adjustments may be required. In response to the concerns expressed and after further discussion with stakeholders, Environment Canada conducted an inter-lab study that confirmed the analytical method used to determine the level of quantification for HCBD meets that test, i.e. is routine. The method involves sample preparation followed by gas chromatography – mass spectrometry, and is typically used for trace organic analysis.

Two comments were received recommending Environment Canada take into account social, economic, and other considerations as referenced in subsection 65(3) when setting release limits.

This is a legal obligation under CEPA 1999, and Environment Canada will take into account these considerations when setting release limits under section 65 where relevant in the future.

One comment argued that virtual elimination should not be the only recourse where the daily average intake is less than the Tolerable Intake.

Under CEPA 1999, virtual elimination is mandatory where a substance assessed under section 77 meets the criteria of subsection 77(4), regardless of whether the risks posed by a substance are found to relate to health or to the environment. Flexibility is afforded to take into account health risks and other considerations when setting release limits through regulations under subsection 65(3).

Finally, a number of comments questioned whether HCBD still qualifies as toxic under section 64 of CEPA 1999, in particular given that HCBD contamination in the sediments of the St. Clair River has been remediated.

The assessment report acknowledges the remediation of the St. Clair River and the declining levels of HCBD in the environment. It recommends, however, that action preventing the reintroduction of HCBD in Canadian commerce be taken. It also recognizes international collaborative work in the control of long-range transport of airborne pollutants. Authority to make regulations preventing the reintroduction of HCBD in Canada is only available to the ministers if the substance is on the List of Toxic Substances. Finally, Environment Canada remains confident that the conclusion of toxicity and the science on which it was based is sound. Therefore, the delisting of HCBD from the List of Toxic Substances is not being considered at this time.

An electronic version of a document summarizing and responding to comments received during the 60-day comment period is available at http://www.ec.gc.ca/CEPARegistry/participation/.

Compliance and Enforcement

There are no compliance promotion or enforcement requirements associated with the VE List.

Contacts

James Riordan
Executive Director
National Office of Pollution Prevention
Environment Canada
Ottawa, Ontario
K1A 0H3
Telephone: (819) 953-3353
E-mail: james.riordan@ec.gc.ca

Céline Labossière
Policy Manager
Impact Analysis and Instrument Choice Division
Environment Canada
Ottawa, Ontario
K1A 0H3
Telephone: (819) 997-2377
E-mail: celine.labossiere@ec.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

NOTICE:
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