Vol. 143, No. 20 — May 16, 2009

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.)

Issue and objectives

Chemical substances can have detrimental effects on the environment and/or human health when released in a certain quantity or concentration in the environment. Scientific assessments of the impact of human and environmental exposure to a number of these substances have determined that these substances are toxic to human health and the environment as per the criteria set out under section 64 of the Canadian Environmental Protection Act, 1999 (CEPA 1999).

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 pursuant to subsection 90(1) of CEPA 1999, is to add

• Thiourea (CAS No. 62-56-6),
• 1,3-Butadiene, 2-methyl- (CAS No. 78-79-5),
• Oxirane, (chloromethyl)- (CAS No. 106-89-8),
• Colour Index Pigment Yellow 34 (CAS No. 1344-37-2),
• Colour Index Pigment Red 104 (CAS No. 12656-85-8),
• Cyclopentasiloxane, decamethyl- (CAS No. 541-02-6),
• Cyclotetrasiloxane, octamethyl- (CAS No. 556-67-2), and
• Phenol, 2,4,6-tris(1,1-dimethylethyl)- (CAS No. 732-26-3)

to the List of Toxic Substances in Schedule 1 of CEPA 1999. This addition would enable the development of measures (which could include regulatory and non-regulatory instruments) under CEPA 1999 to manage human health and/or environmental risks posed by these substances

Description and rationale

Background

As is the case in many other countries, Canada’s laws require that companies submit information on new chemical substances for scientific assessment before they can be manufactured or imported in the country. However, many substances have been in use well before these laws were in place. “Categorization” was required by CEPA 1999 and was a first step to finding out which of these “existing” chemical substances may present the greatest potential for exposure or that are persistent or bioaccumulative and inherently toxic to human beings or non-human organisms and that therefore require further attention in the form of assessment, research and/or measures to control their use or release. In September 2006, the Minister of the Environment and the Minister of Health (the Ministers) completed the categorization of the approximately 23 000 existing chemical substances listed on Canada’s Domestic Substances List (DSL). Categorization identified approximately 4 300 chemical substances needing further attention by the Government, approximately 200 of which were identified as high priorities for action.

As a result of categorization, on December 8, 2006, the Government of Canada launched the Chemicals Management Plan (the Plan) with the objective of improving the degree of protection from hazardous chemicals. The Plan includes a number of new proactive measures to manage chemical substances.

A key element of the Plan is the collection of information on the properties and uses of the approximately 200 priority substances mentioned above. This includes substances

• that were found to meet the categorization criteria for persistence, bioaccumulation potential and inherent toxicity to non-human organisms, and that are known to be in commerce, or of commercial interest, in Canada; they are referred to as “ecological priority substances”; and/or
• that were found either to meet the categorization criteria for greatest potential for exposure or to present an intermediate potential for exposure, and were identified as posing a high hazard to human health based on available evidence on carcinogenicity, mutagenicity, developmental toxicity or reproductive toxicity; they are referred to as “human health priority substances.”

This information is being used to make decisions regarding the best approaches to protect Canadians and their environment from the risks these substances might pose. This information-gathering initiative is known as the “Challenge.”

To facilitate the process, Environment Canada and Health Canada have organized the approximately 200 substances into 12 “batches” of 12 to 20 substances, and every three months a batch is released, and stakeholders are required to report information such as quantities imported, manufactured or used in Canada via a mandatory survey issued under section 71 of CEPA 1999. Stakeholders are required to submit this information to better inform decision-making with regards to determining whether a substance meets one or more of the criteria set out in section 64 of CEPA 1999, that is to say if the substance is entering or may enter the environment in a quantity or concentration or under conditions that

• has or may have an immediate or long-term harmful effect on the environment or its biological diversity;
• constitutes or may constitute a danger to the environment on which life depends; or
• constitutes or may constitute a danger in Canada to human life or health.

Based on the information received and other available information, “screening assessments” are developed in order to assess whether substances meet the criteria of section 64. These screening assessments are required under section 74 of the Act. They are peer-reviewed and additional advice is also sought, as appropriate, through the Challenge Advisory Panel. The Panel, comprised of experts from various fields such as chemical policy, chemical production, economics and environmental health, was formed to provide advice to Government pertaining to the application of precaution and/or weight of evidence in screening assessments in the Challenge. These screening assessments are then published on the Chemical Substances Web site at www. chemicalsubstances.gc.ca along with notices that are published in the Canada Gazette, Part I, which signal the Ministers’ intent with regards to further risk management.

Pursuant to section 91 of the Act, the Minister of Environment is required to publish in the Canada Gazette a proposed regulation or other instrument establishing preventive or control actions within two years of publishing a statement that the Ministers propose to take further risk management action. Section 92 then requires that the regulation or other instrument be finalized within a further 18 months.

Listing these substances on Schedule 1 of the Act allows the Ministers to develop risk management tools under CEPA 1999 to meet these obligations. The Act provides the Government of Canada with strong risk management instruments (such as regulations, guidelines or codes of practice) to protect the environment and human health that 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. “Risk management approach” documents, which provide an indication of where the Government will focus its risk management activities, have been prepared for Batch 2 substances and are available online.

The draft screening assessments for the second batch of the Challenge comprising 17 substances were published on the Chemical Substances Web site at www.chemicalsubstances.gc.ca, and the notices were published in the Canada Gazette. Bisphenol A, one of these “Batch 2” substances, was published on April 19, 2008. The remaining substances were published on May 17, 2008.

Of the 16 substances assessed in Batch 2 of the Challenge, 8 substances have been concluded to meet the criteria set out in section 64 of CEPA 1999 (the 8 others have not). Of these, 5 substances are human health priority substances and 3 are ecological priority substances. Assessment summaries and conclusions and an overview of the public comments received during the public comment period for the 8 substances are presented below.

Substance descriptions, assessment summaries and conclusions

1. Human health priority substances

Thiourea

Thiourea is used in copper refining, in the manufacture of printed circuit boards, in various types of copy paper, in silver polish/metal cleaners, in black and white photographic chemicals. Thiourea was not reported as being manufactured in Canada in quantities above the 100 kg reporting threshold prescribed in section 71 data gathering notices. (see footnote 1) Imports of the substance into Canada in 2006 was reported in the range of 10 000 kg to 100 000 kg.

Thiourea was assessed as a high priority for human health risk. The assessment has determined that thiourea can cause reproductive or developmental effects and cancer in laboratory animals. These results are based principally on the weight of evidence-based assessments or classifications of several international or national agencies (International Agency for Research on Cancer [IARC], National Toxicology Program [U.S.], Environment Canada, and International Program on Chemical Safety [IPCS]).

1,3-Butadiene, 2-methyl-, (isoprene)

1,3-Butadiene, 2-methyl-, also known as isoprene, is used mainly in the manufacture of rubbers and plastics, such as medical equipment, tires, paints, inner tubes and some rubber adhesives and glues. It is both manufactured in and imported into Canada. The total quantity of isoprene reported as being manufactured in Canada in 2006 exceeded 10 000 000 kg and the total quantity imported ranged from 1 000 000 to 10 000 000 kg.

Isoprene was assessed as a high priority for human health risk. The assessment has determined that isoprene can cause reproductive or developmental effects and cancer in laboratory animals. These results are based principally on the weight of evidence-based assessments or classifications of several international or national agencies (International Agency for Research on Cancer [IARC], National Toxicology Program [U.S.], and the European Commission).

Oxirane, (chloromethyl)-, (epichlorohydrin)

Oxirane, (chloromethyl)-, also known as epichlorohydrin, is used to make other chemical products, such as epoxy resins which are used in paints and protective coatings and adhesives. It is also sometimes used in the production of substances designed to help remove impurities in drinking water and wastewater and of paper products and in the powder coating inside latex gloves. Epichlorohydrin was reported as not being manufactured or imported into Canada above the 100 kg reporting threshold.

Epichlorohydrin was assessed as a high priority for human health risk. The assessment has determined that epichlorohydrin can cause cancer in laboratory animals. These results are based principally on the weight-of-evidence-based assessments or classifications of several international or national agencies (United States Environmental Protection Agency [EPA], International Agency for Research on Cancer [IARC], National Toxicology Program [U.S.], and European Chemical Substances Information System [ESIS]).

Colour Index Pigment Yellow 34 and Colour Index Pigment Red 104

Colour Index Pigment Yellow 34 and Colour Index Pigment Red 104 are used as plastic formulants for commercial applications and export; commercial, non-consumer paints and coatings; and a very limited number of commercial printing inks or coatings used for plastics and certain outdoor applications such as commercial identification decals. Each pigment has been reported to be manufactured and imported in Canada in quantities ranging between 1 000 000 kg and 10 000 000 kg. After exports, quantities remaining for use in Canada range between 1 000 000 kg and 10 000 000 kg for Colour Index Pigment Yellow 34 and between 100 000 kg and 1 000 000 kg for Colour Index Pigment Red 104.

The scientific assessments have determined that the two pigments, which are human health priority substances, can cause cancer and reproductive or developmental effects in laboratory animals. This is based principally on the weight-of-evidence classification of Colour Index Pigment Yellow 34 and Colour Index Pigment Red 104 by the European Commission as a Category 3 carcinogen (possible carcinogenic effects to humans) and the assessments of hexavalent chromium and inorganic lead compounds, which are found in these pigments, by several national and international agencies (U.S. Environmental Protection Agency [EPA], International Agency for Research on Cancer [IARC], Environment Canada/Health Canada, and National Toxicology Program [U.S.]).

Assessment conclusion

On the basis of the carcinogenicity for which there is a possibility of harm at any level of exposure, it is concluded that thiourea, isoprene, epichlorohydrin, Colour Index Pigment Yellow 34 and Colour Index Pigment Red 104 may be entering 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 hence meet the criteria of section 64 of CEPA 1999. These substances are thus proposed for addition to Schedule 1 of CEPA 1999.

2. Ecological priority substances

Cyclotetrasiloxane, octamethyl- (D4) and Cyclopentasiloxane, decamethyl- (D5)

These two substances are used in industrial processes; in lubricants, cleaning products, sealants, adhesives, waxes, polishes and coatings and in personal care products such as hair/skin care products and antiperspirants/deodorants, as well as pharmaceuticals. These substances were not reported as being manufactured in Canada in 2006 in quantities meeting the 100 kg reporting threshold, but it was determined that between 1 000 000 and 10 000 000 kg of both D4 and D5 were imported into Canada in 2006.

The principal sources of release of D4 and D5 to the environment are during the use of personal care products and industrial processes. The substances D4 and D5 have the potential to be persistent and cause adverse effects to aquatic organisms in certain concentrations. Long-term environmental exposure to D4 and D5 may cause adverse effects to aquatic organisms in certain Canadian environments. Based on this evidence, it is concluded that D4 and D5 have the potential to cause ecological harm.

D4 and D5 have significant bioaccumulative potential in organisms, but due to conflicting evidence from experimental and modelled studies, it was impossible to make a conclusion as to whether D4 and D5 meet the bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations. (see footnote 2) There is enough evidence to conclude that D4 and D5 have or may have a harmful effect on the environment or its biological diversity. The Government of Canada is awaiting new information on bioaccumulation for D4 and D5. Should this new information indicate that D4 and D5 are bioaccumulative, virtual elimination of releases to the environment would then be implemented under subsection 77(4) of the Act.

Phenol, 2,4,6-tris(1,1-dimethylethyl)-, (2,4,6-tri-tert-butylphenol)

Phenol, 2,4,6-tris(1,1-dimethylethyl)-, also known as 2,4,6-tri-tert-butylphenol is used in Canada as a fuel additive. As per the most recent section 71 data-gathering survey, this substance was not reported as being manufactured in Canada in 2000 in quantities meeting the 100 kg reporting threshold, but was imported in the range of 10 000 to 100 000 kg.

The substance 2,4,6-tri-tert-butylphenol may be destroyed through the combustion of fuel and oil, but accidental releases into the Canadian environment could be harmful as the substance is highly hazardous to aquatic organisms.

Assessment conclusion

Based on the information available, it is concluded that D4, D5 and 2,4,6-tri-tert-butylphenol 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 section 64 of CEPA 1999. These substances are thus proposed for addition to Schedule 1 of CEPA 1999.

In addition, 2,4,6-tri-tert-butylphenol is not a naturally occurring substance and is predominantly anthropogenic (the result of human activity), and the available data regarding persistence and bioaccumulation indicate that the substance meets the criteria set out in the Persistence and Bioaccumulation Regulations, made under CEPA 1999. The substance thus meets the criteria for implementation of virtual elimination of releases to the environment as defined under subsection 77(4).

The final screening assessment reports, the proposed risk management approach documents and the complete responses to comments received on both ecological and health priority substances were published on January 31, 2009, and may be obtained from the Chemical Substances Web site at www.chemicalsubstances.gc.ca or from the Program Development and Engagement Division, Gatineau, Quebec K1A 0H3, 819-953-4936 (fax), Existing.Substances.Existantes@ec.gc.ca (email).

Alternatives

The following measures can be applied after an assessment is conducted under CEPA 1999:

• 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 or not);
• 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 and, where applicable, the implementation of virtual elimination.

It has been concluded in the final screening assessment reports that thiourea, isoprene, epichlorohydrin, Colour Index Pigment Yellow 34, and Colour Index Pigment Red 104 are entering, or 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 as defined under section 64 of CEPA 1999.

It has also been concluded that cyclopentasiloxane, decamethyl- (D5), cyclotetrasiloxane, octamethyl- (D4), and 2,4,6-tri-tert-butylphenol 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.

These substances pose a risk to human health or the environment, and they meet one or more of the criteria under section 64 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.

In addition, the presence of 2,4,6-tri-tert-butylphenol in the environment results primarily from human activity. The substance is not a naturally occurring radionuclide or inorganic substance and is persistent and bioaccumulative, as set out in the Persistence and Bioaccumulation Regulations. Consequently, the Ministers must propose to follow the process specified in CEPA 1999 for substances that meet the criteria for virtual elimination.

Benefits and costs

Listing these substances on Schedule 1 enables the Ministers to develop risk management proposals for these substances under CEPA 1999, which may be both regulatory and non-regulatory (such as pollution prevention plans, environmental emergency plans, guidelines, codes of practice or regulations), to help protect human health and the environment. The Government will undertake an assessment of the potential impacts, including an economic analysis, and consult with the public and other stakeholders during the development of these risk management proposals.

Consultation

In accordance with the Act, on May 17, 2008, the Ministers published a summary of the scientific assessments for 16 substances of Batch 2 in the Canada Gazette, Part I, for a 60-day public comment period. Risk management scope documents were also released on the same date for substances proposed to be considered toxic under section 64 of CEPA 1999, outlining the preliminary options being examined for the management of these substances. Prior to this publication, Environment Canada and Health Canada have informed the governments of the provinces and territories through the CEPA National Advisory Committee (NAC) of the release of the Screening Assessment reports on the 16 substances, the risk management scope documents, and the public comment period mentioned above. No comments were received from CEPA NAC. Additionally, the Challenge Advisory Panel provided advice on the approach taken by the two departments related to siloxanes. Advice from the Panel was taken into consideration during the development of the final screening assessment reports.

During the 60-day public comment period, a total of 57 submissions were received from 37 industry stakeholders, 13 industry associations, 5 non-governmental organizations, one research center and one foreign government agency on the scientific assessment and risk management scope documents. All comments were considered in developing the final screening assessments.

Comments received on the risk management scope regarding the substances were considered when developing the proposed risk management approach documents, which are also subject to a 60-day public comment period.

Below is a summary of new comments received for the Batch 2 assessments and responses relevant to the overall process and approach to the assessments. A summary of substance-specific comments and responses is provided in the Human Health and Ecological Priority Substances sections below. In cases where comments have been made concerning whether or not a substance meets the criteria of section 64 of the Act due to lack of information or uncertainty, the Government errs on the side of precaution to protect the health of Canadians and their environment. The complete responses to comments received may be obtained at the Web site, address, fax number or email address listed above.

Summary of general comments

• Both industry associations and chemical manufacturers commented that screening assessments under CEPA 1999 should be “screens” intended for high-level reviews. The results of those screens should direct further evaluation of the hazard and exposure information if new relevant data are available.

 While in other jurisdictions the term “screening assessment” is used to define a cursory first-tier look at the substance to establish its priority for further action, “screening assessments” under CEPA 1999 can cover a range of different issues and complexity. Environment Canada and Health Canada make risk management decisions based on the findings and conclusions of this type of assessment. If additional information is received in the future, assessments can be revisited as appropriate.

• Industry associations and chemical manufacturers encouraged the Government to fully meet the current standards of a peer review process in order to improve transparency and credibility, which includes disclosing the peer process and reviewers, providing a synopsis of comments and providing response to comments in a timely fashion.

 All assessments are subject to a science review. An external science review is undertaken where there are issues or areas of uncertainty identified during the conduct of the assessment. Reviewers may come from academia, industry, consulting firms or government. Comments submitted during this process are considered in modifying the assessment reports. Draft assessments are also subject to a 60-day public comment period, which additionally provides an opportunity to all stakeholders to provide comments. These comments are taken into consideration in finalizing the assessment report.

• A non-government organization commented that volume criteria used in risk assessments should be considered to have a high margin of error because, in most cases, they do not include the volume of imported products.

 The volume of a substance contained in imported products and its contribution to the total load to the Canadian environment are included in the assessment when data are available. In many cases though, information on volumes of a substance contained in imported products is not available. One way that the government can fill these data gaps is to gather this type of information, such as through surveys conducted under section 71 of CEPA 1999 and submission of voluntary questionnaires to industry. Information on products and manufactured items may be provided in these submissions. When no or limited relevant information is obtained and data gaps remain, the assessment recognizes that volumes of substances contained in imported products represent an uncertainty in the assessments.

Summary of comments on Human Health Priority Substances

Thiourea

• A non-governmental organization noted that more information is required for levels of thiourea in paper products and, subsequently, in recycled pulp mill sludge and its application to soil.

 Insufficient information was available to allow for quantification of the potential contribution of sludge to human exposure to thiourea, but based on submissions from industry, this source of exposure is expected to be negligible.

Isoprene

• Chemical manufacturers commented that more analysis and assessment were required for cigarette smoke and its impact on indoor air.

 Although detailed analysis of cigarette smoke is the mandate of the Tobacco Control Programme, information was included to support the indoor air contribution of isoprene from cigarette smoke.

• Chemical manufacturers also commented that it is inappropriate to designate isoprene as CEPA toxic based on its natural sources.

 This comment was considered, and it is noted in the assessment that the contribution of natural versus man-made sources of isoprene to general exposure of the Canadian population is not known. A conclusion of CEPA toxic means that the government can now take action to reduce man-made sources.

Epichlorohydrin

• Chemical manufacturers expressed that in the absence of experimental data, default assumptions used to estimate exposure to epichlorohydrin from migration from food packaging and from the use of consumer products were too precautionary.

 Health Canada considered these comments and text was modified to indicate the conservative nature of the assumptions. However, the estimates were not changed, as exposure from these sources was already considered to be low.

• Chemical manufacturers also commented that the substance should not be concluded as CEPA toxic or placed on Schedule 1 of CEPA 1999, because exposure varies from low to negligible.

 Due to uncertainties associated with the exposure dataset for epichlorohydrin, caused by information gaps, the screening assessment used conservative assumptions, in accordance with the application of a precautionary approach as required by CEPA 1999. Using these conservative estimates, Canadians’ exposure is expected to vary from low to negligible. However, the critical effect for epichlorohydrin is considered not to have a threshold of exposure, and in such cases, it is assumed that there is a probability of harm to human health at any level of exposure.

Colour Index Pigment Yellow 34 and Colour Index Pigment Red 104

• A chemical industry association commented that the conclusion of carcinogenicity was not warranted since chromium compounds are generally carcinogenic by the inhalation route, and inhalation exposure of these two pigments to the general population is negligible. In addition, it was indicated that there are no data on the commercial form of the pigments which would substantiate the claim of carcinogenicity for the two pigments.

 It is acknowledged that the database specific to these two pigments is limited. However, some data on carcinogenicity and genotoxicity are available. In addition, increased lung cancer risk was observed among workers involved in chromate pigment production. The European Commission carcinogenicity classifications were specific to the two pigments. Also, Health Canada’s Priority Substances List (PSL) assessment on chromium included consideration of some of the toxicological information on lead chromate and its derived pigments in its evaluation of chromium. The PSL assessment concluded that chromium VI compounds, as a whole, were carcinogenic to humans. Other international assessments on chromium and lead compounds have also classified hexavalent chromium compounds and lead compounds as carcinogenic.

• Non-governmental organizations did not consider there to be enough experimental evidence to support the rationale that exposure potential would be limited by certain chemical properties of the pigments and encouraged the government to use section 71 of CEPA 1999 to generate more information.

 Health Canada did consider information submitted under a section 71 notice as well as data gathered from the scientific literature. Conclusions reached in the assessment of Challenge substances are based on currently available information. This information, coupled with professional judgment, suggest that exposure to the general population is low to negligible.

• Non-governmental organizations were concerned that although the Hazardous Products Act outlines specific restrictions on lead levels in products, allowed uses in certain sub-populations or misuse of the pigment products in Canada may result in consumer exposure to the lead chromate pigments.

 Health Canada considered this comment; however, data are not available to further quantify these exposures, nor would “misuse” be considered in exposure assessment.

Summary of comments on ecological priority substances

Siloxanes

• Both chemical manufacturers and chemical industry associations raised the fact that there is uncertainty in the findings of persistence and bioaccumulation for the batch two siloxanes. They did not agree on the persistence and bioaccumulation conclusion of the draft screening assessments conclusions. Further testing and field studies are underway and will be available in the next year or two. Screening assessments should be based on the complete science. The Government is urged to consider deferring a final decision on these substances until these new data are available.

 The final assessment recognizes the uncertainties associated with the persistence and bioaccumulation potentials of these substances. The Government of Canada did not conclude on whether D4 and D5 meet the bioaccumulation criterion as defined in the Persistence and Bioaccumulation Regulations, made under CEPA 1999 due to the conflicting evidence between laboratory and modelled bioaccumulation data. The Government of Canada recognizes the ongoing research being conducted to determine whether these substances meet the bioaccumulation criterion. Based on the weight of evidence from laboratory bioconcentration and fish dietary biomagnification data of D4, D5 and D6, D6 has been concluded not to meet the bioaccumulation criterion in the final screening assessment report.

• Chemical manufacturers and chemical industry associations commented that given the fact that D4 and D5 can be transported to remote areas in Canada, the environmental fate of these substances, when they reach northern communities, was not provided in the screening assessment.

 The screening assessments have been modified to reflect that D4 and D5 have the potential to be transported over long distances in the atmosphere. However, these substances lack the potential to be deposited in water or soil in remote regions. It is expected that siloxanes in the air will eventually degrade naturally. New information on the monitoring of a remote area (Lake Opeongo) with limited human activity also supports the low atmospheric deposition potential for these substances. The final assessments have been modified to indicate that these substances lack the potential to be deposited in water or soil in remote regions. It is thus concluded that these substances do not behave like a persistent organic pollutant.

2,4,6-tri-tert-butylphenol

• Chemical manufacturers commented that they believe that the amount of this substance that would be released to the environment, and thus potentially cause adverse effects, is extremely limited. They also requested that more study be undertaken before risk management is developed that would involve virtual elimination of 2,4,6-tri-tert-butylphenol that is only present in Canada as an impurity.

 It is agreed that the releases of 2,4,6-tri-tert-butylphenol to the environment are estimated to be relatively low. The draft screening assessment report presented a reasonable worst case scenario based upon information submitted in the section 71 survey and other sources. The anticipated release of 2,4,6-tri-tert-butylphenol is a combination of small releases to different media (i.e. a 0.1% loss to soil, a 1.6% loss to air and a 0.8% loss to water for a total of 2.5%). These releases are anticipated to occur throughout the life cycle of the substance at different stages of use.

 However, while the estimated releases of 2,4,6-tri-tert-butylphenol are small, the Government of Canada has decided to manage all substances that are concluded to be persistent (P), bioaccumulative (B), inherently toxic (iT) and that exceed a threshold level (100 kg) of importation or manufacture because the long term risk of PBiT substances cannot be reliably predicted. Furthermore, since accumulations of such substances may be widespread and are difficult to reverse, a conservative response to uncertainty is justified.

Implementation, enforcement and service standards

The proposed Order would add the eight above-mentioned substances to Schedule 1 of CEPA 1999. Developing an implementation plan, a compliance strategy or establishing service standards are not considered necessary without any specific risk management proposals. The Government will undertake an appropriate assessment of implementation, compliance and enforcement during the development of a proposed regulation or control instrument(s) respecting preventive or control actions for these substances.

Contacts

Mark Burgham
Acting Executive Director
Program Development and Engagement Division
Environment Canada
Gatineau, Quebec
K1A 0H3
Telephone: 819-956-9313
Fax: 819-953-4936
Email: Existing.substances.existantes@ec.gc.ca

Arthur Sheffield
Acting Director
Risk Management Bureau
Health Canada
Ottawa, Ontario
K1A 0K9
Telephone: 613-957-8166
Fax: 613-952-8857
Email: Arthur_Sheffield@hc-sc.gc.ca

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 to the Executive Director, Program Development and Engagement Division, Department of the Environment, Gatineau, Quebec K1A 0H3 (fax: 1-800-410-4314 or 819-953-4936; e-mail: Existing.Substances. Existantes@ec.gc.ca).

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, May 7, 2009

MARY PICHETTE
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 3) is amended by adding the following:

Thiourea, which has the molecular formula CH₄N₂S

1,3-Butadiene, 2-methyl-, which has the molecular formula C₅H₈

Oxirane, (chloromethyl)-, which has the molecular formula C₃H₅CIO

Colour Index Pigment Yellow 34

Colour Index Pigment Red 104

Cyclopentasiloxane, decamethyl-, which has the molecular formula C₁₀H₃₀O₅Si₅

Cyclotetrasiloxane, octamethyl-, which has the molecular formula C₈H₂₄O₄Si₄

Phenol, 2,4,6-tris(1,1-dimethylethyl)-, which has the molecular formula C₁₈H₃₀O

COMING INTO FORCE

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

[20-1-o]

Footnote 1
Data for all substances in this document on manufacture and imports have been taken from responses to section 71 notices of CEPA 1999.

Footnote 2
 The Persistence and Bioaccumulation Regulations set the criteria which are used to determine if a substance is persistent or bioaccumulative under CEPA 1999.

Footnote a
 S.C. 2004, c. 15, s. 31

Footnote b
 S.C. 1999, c. 33

Footnote 3
 S.C. 1999, c. 33

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