Vol. 144, No. 17 — August 18, 2010

Registration

SOR/2010-169 July 29, 2010

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Order 2010-87-07-01 Amending the Domestic Substances List

Whereas the substances set out in the annexed Order are specified on the Domestic Substances List (see footnote a);

Whereas the Minister of the Environment and the Minister of Health have conducted a screening assessment of each of those substances under section 74 of the Canadian Environmental Protection Act, 1999 (see footnote b);

Whereas the Ministers are satisfied that those substances are not being manufactured in or imported into Canada by any person in a quantity of more than 100 kg in any one calendar year;

And whereas the Ministers suspect that a significant new activity in relation to any of those substances may result in the substance becoming toxic within the meaning of section 64 of the Canadian Environmental Protection Act, 1999 (see footnote c);

Therefore, the Minister of the Environment, pursuant to subsection 87(3) of the Canadian Environmental Protection Act, 1999 (see footnote d), hereby makes the annexed Order 2010-87-07-01 Amending the Domestic Substances List.

Ottawa, July 26, 2010

JIM PRENTICE
Minister of the Environment

ORDER 2010-87-07-01 AMENDING THE
DOMESTIC SUBSTANCES LIST

AMENDMENTS

1. Part 1 of the Domestic Substances List (see footnote 1) is amended by deleting the following:

626-39-1

944-61-6

2. Part 2 of the List is amended by adding the following in numerical order:

Column 1 Substance	Column 2 Significant New Activity for which substance is subject to subsection 81(3) of the Act
626-39-1 S′	1. Any activity involving, in any one calendar year, more than 100 kg of the substance Benzene, 1,3,5-tribromo-. 2. For each significant new activity, the following information must be provided to the Minister at least 90 days before the day on which the quantity of the substance exceeds 100 kg in any one calendar year: (a) a description of the proposed significant new activity in relation to the substance; and (b) the information specified in Schedule 6 to the New Substances Notification Regulations (Chemicals and Polymers). 3. The above information will be assessed within 90 days after the day on which it is received by the Minister.
944-61-6 S′	1. Any activity involving, in any one calendar year, more than 100 kg of the substance Benzene, 1,2,3,4-tetrachloro-5,6-dimethoxy-. 2. For each significant new activity, the following information must be provided to the Minister at least 90 days before the day on which the quantity of the substance exceeds 100 kg in any one calendar year: (a) a description of the proposed significant new activity in relation to the substance; and (b) the information specified in Schedule 6 to the New Substances Notification Regulations (Chemicals and Polymers). 3. The above information will be assessed within 90 days after the day on which it is received by the Minister.

COMING INTO FORCE

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

REGULATORY IMPACT
ANALYSIS STATEMENT

(This statement is not part of the orders.)

Issue and objectives

The purpose of the Order 2010-87-07-01 Amending the Domestic Substances List and the Order 2010-87-07-02 Amending the Domestic Substances List (the orders), made under subsection 87(3) of the Canadian Environmental Protection Act, 1999 (CEPA 1999), is to delete three substances currently listed on Part I of the Domestic Substances List (the List) and add them to Part 2 of the List and to indicate that these substances are subject to the significant new activity requirements under subsection 81(3) of CEPA 1999. The substances subject to the orders are

• Benzene, 1,3,5-tribromo- (Chemical Abstracts Service [CAS] Registry
  No. 626-39-1);
• Benzene, 1,2,3,4-tetrachloro-5,6-dimethoxy (CAS Registry No. 944-61-6); and
• Fatty acids, C_6-19-branched, zinc salts (CAS Registry No. 68551-44-0).

Description and rationale

On January 14, 2010, 11 Notices relating to the release of draft screening assessments for the 14 substances in Batch 8 of the Challenge were published in the Canada Gazette, Part I, Vol. 144, No. 5, for a 60-day public comment period. In addition, the draft screening assessments were also released on Environment Canada’s Chemical Substances Web site. These publications were made in the context of the Chemicals Management Plan announced by the Government of Canada on December 8, 2006. The screening assessments found that four substances met the ecological categorization criteria for persistence, bioaccumulation and inherent toxicity to non-human organisms. Additionally, results from notices issued under paragraph 71(1)(b) of CEPA 1999 in March 2006 and May 2007 revealed no reports of industrial activities (manufacture or import) with respect to these four substances above the reporting threshold of 100 kg per year for the specified reporting year of 2006. These four substances are hence deemed not in commerce.

Due to the hazardous persistence, bioaccumulation and inherent toxicity properties of the four substances, a Notice of intent to amend the Domestic Substances List under subsection 87(3) of CEPA 1999 to indicate that subsection 81(3) of the Act applies to four substances was published in the Canada Gazette, Part I, on January 30, 2010. It was proposed that the Significant New Activity provisions of the Act be applied so that any new use of these four substances is notified and undergoes ecological and human health risk assessments, prior to these substances being introduced into Canada. The four substances were

• Benzene, 1,3,5-tribromo- (Chemical Abstracts Service [CAS] Registry
  No. 626-39-1);
• Benzene, 1,2,3,4-tetrachloro-5,6-dimethoxy (CAS Registry No. 944-61-6);
• Phosphonic acid, [[3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl]methyl]-, monoethyl ester, calcium salt (2:1) (CAS Registry No. 65140-91-2); and
• Fatty acids, C_6-19-branched, zinc salts (CAS Registry No. 68551-44-0).

The Minister of the Environment and the Minister of Health have finalized the screening assessment on three of these substances and have published in the Canada Gazette, Part I, on July 31, 2010, the Final Decision on the Screening Assessment of threesubstances on the Domestic Substances List (subsection 77(6) of the Canadian Environmental Protection Act, 1999). After evaluation of new bioaccumulation and toxicity data that was received on the fourth substance, this substance is not included in the orders.

The screening assessment was conducted to determine whether the substances met the criteria under section 64 of CEPA 1999; pursuant to this provision, a substance is toxic if it is 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.

The conclusion of the screening assessment is that the three substances do not meet any of the criteria set out in section 64 of CEPA 1999. The final screening assessment reports can be found at www.chemicalsubstances.gc.ca.

Authority

The orders are made under subsection 87(3) of CEPA 1999. This modification to the List will trigger the application of subsection 81(3) of the Act with respect to the substances that are the object of the amendment.

Upon the adoption of the orders, subsection 81(3) of the Act will require any person that intends to use any of the three substances in a quantity exceeding 100 kg in a calendar year to provide the following information to the Minister:

• a description of the proposed significant new activity in relation to the substance; and
• the information specified in Schedule 6 to the New Substances Notification Regulations (Chemicals and Polymers).

Subsection 81(3) of CEPA 1999 provides that this information has to be communicated to the minister at least 90 days before the day on which the quantity of the substance used in a new activity or the quantity imported or manufactured for a new activity exceeds 100 kg. The orders also provide that the information will be assessed within 90 days after it is received by the Minister of the Environment.

Alternatives

Since the three substances are listed on Part 1 of the Domestic Substances List, they can currently be introduced in the Canadian market for any activity and in any quantity without any requirement to report to the Minister of the Environment. As these substances have been determined to possess hazardous properties, the option of not listing these substances in Part 2 of the Domestic Substances List to make them subject to the significant new activities provisions of CEPA 1999 has been rejected.

Benefits and costs

Benefits

The amendment of the Domestic Substances List will require notification for risk assessment with respect to any new activity in relation with these substances. This will allow for the making of informed decisions, and appropriately manage the risks associated with any of these three substances prior to the commencement of the new activity.

Costs

For two of the substances (Benzene, 1,3,5-tribromo and Benzene, 1,2,3,4-tetrachloro-5,6-dimethoxy), there is currently no evidence that they are imported or manufactured in quantities of more than 100 kg per calendar year. Therefore, incremental costs to the public, industry or governments associated with these orders are not expected.

In the event, however, that a person wishes to use, import or manufacture any of these two substances in a quantity above the prescribed threshold, the required information specified in Schedule 6 of the New Substances Notification Regulations (Chemicals and Polymers) will need to be provided. That person may incur a one-time cost of up to $179,000 per substance ($ 2004). This amount can be reduced by using surrogate data (test results from a similar substance or obtained from modeling, for example). In addition, the interested party can request a waiver of these requirements under subsection 81(8) of CEPA 1999.

As these two substances are currently not in commerce, a reasonable assumption of the magnitude of their use and the size of the industry is not feasible. Hence, a total cost expected to be incurred by the industry in the event of significant new activities cannot be estimated at this time.

For the substance fatty acids, C_6-19-branched, zinc salts, the Ministers are satisfied that there were in 2006 no manufacture or importation activities in relation to those substances in a quantity of more than 100 kg. If a person wishes to use, manufacture or import the substance in a quantity exceeding 100 kg per calendar year, that person would incur a cost corresponding to the amount needed to produce the required information to continue the activities.

There would likely be cost to the government associated with assessing the information provided by the regulatees as per section 83 of CEPA 1999. These costs cannot be estimated at this time.

Consultation

On January 30, 2010, a Notice of intent to amend the Domestic Substances List under subsection 87(3) of the Canadian Environmental Protection Act, 1999 to indicate that subsection 81(3) of the Act applies to four substances was published. A proposed summary of the screening assessment under subsection 77(1) was published for a 60-day public comment period in the Canada Gazette, Part I.

Environment Canada has also informed the governments of the provinces and territories through the CEPA National Advisory Committee (CEPA NAC) about the orders via a letter, with an opportunity to comment. No comments were received from CEPA NAC.

During the public comment period, three submissions were received from two industry stakeholders and one non-governmental organisation (NGO), on the notice of intent to amend the Domestic Substances List.

It was expressed by an NGO that Environment Canada should reconsider its proposal to apply Significant New Activity provisions (SNAcs) to four substances in Batch 8 which are hazardous, but not currently in use in Canada. The application of SNAc provisions as proposed by Environment Canada has limits and could not guarantee that these substances would be prohibited from future use in Canada. These substances should be considered toxic under the Canadian Environmental Protection Act (CEPA) to send a signal to any potential users, importers and manufacturers that these chemicals should not be permitted re-entry into the Canadian market. Environment Canada could use other tools under CEPA to ensure that future uses of these substances are not permitted in Canada, such as adding these substances to the Prohibition of Certain Toxic Substances Regulation, 2005.

• The substances subject to the current proposal had no report of import or manufacture for the year 2006. Use of the SNAc provision will ensure that further assessment of a substance is conducted if a stakeholder is interested in using it in the future in a quantity exceeding the threshold that triggers notifications under the New Substances Program. As specified in section 83 of the Act, a joint assessment process is carried out between Environment Canada and Health Canada to determine whether there is a potential for adverse effects of the substances on the environment and human health. Notification of new activities, and assessment prior to their use, allows the Government to take action on these substances before exposure becomes a concern. CEPA 1999 defines “toxic” in terms of both intrinsic properties and exposure potential. Since there is only a very low exposure potential at the moment, the substances do not meet the toxicity criteria set out in section 64.

There are also concerns from an NGO that toxicity information would be minimal under a Significant New Activity notification as notifiers will not be required to submit data for chronic toxicity, endocrine disruption, or neurodevelopmental toxicity.

• It was decided that this type of data is not necessary at the moment. If, after the beginning of the evaluation, Environment Canada or Health Canada estimates that the information in the Significant New Activity Notification is insufficient, paragraph 84(1)(c) of CEPA 1999 enables the Minister of the Environment, under certain conditions, to request additional information to determine whether the substance is “toxic” or capable of becoming “toxic” under the Act.

An NGO expressed the opinion that, with the reporting threshold for the section 71 survey set at 100 kg/year, the surveys conducted cannot account for the number of possible users that fall below the threshold and who are not required to report to the survey. The lack of consideration on the aggregate use of these chemicals raises significant concerns as to the validity of the conclusion made for a Significant New Activity application. The application of the 100 kg threshold for reporting is viewed as a gap in the government approach.

• The 100 kg per year threshold specified in the section 71 notice and used to determine whether a substance is imported into or manufactured in Canada is based on the lowest threshold that triggers notifications under the New Substances Program. The new substances regulatory framework has been subject to extensive multistakeholder consultations where it was recognised that the CEPA definition of toxic is not based on “hazard” assessments. CEPA 1999 defines toxic in terms of both intrinsic properties and exposure potential. The NewSubstances Notification Regulations were therefore structured around a set of volume-triggered tiered testing requirements, thus incorporating the notion of exposure by requiring more extensive assessments for larger exposure potential. Stakeholders not subject to the section 71 Notice (i.e. that fall below the reporting threshold) are strongly encouraged to inform the Government of Canada of their activities relating to substances by responding to the Challenge Questionnaire. When such information is received, it is considered in the risk assessment and, if applicable, in the development of the risk management approach.

An NGO expressed concerns that the application of the Significant New Activity provisions on these substances will mean that the public will not have legal opportunities to engage in the assessment process. The NGO was of the opinion that the public should have access to this process during the subsequent assessment conducted under the Significant New Activity Notifications, particularly as it has now been expanded to address substances that were originally on the Domestic Substances List.

• The New Substances Program has initiated the development of a process for periodic review of its assessment reports by groups outside the New Substances Program. This pilot project will involve the review of New Substances Notification assessments by a panel of stakeholders (i.e. industry, NGO and government). The New Substances Program will consider publication of assessment report summaries if any Significant New Activity is notified for any of these substances. This will provide an opportunity to stakeholders to comment on assessment conclusions and associated control actions.

One industry stakeholder submitted new bioaccumulation and toxicity data on the substance Phosphonic acid, [[3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl]methyl]-, monoethyl ester, calcium salt (2:1) [CAS Registry No. 65140-91-2], originally subject to this significant new activity Notice of Intent.

• After evaluation of this new data, this substance is not included in the orders.

One industry stakeholder stated that significant new activity provisions on one of the four substances would be equivalent to a ban on the substance use.

• Environment Canada has concerns with the hazard characteristics of the substance (persistence, bioaccumulation and inherent toxicity). Since we have limited information and the substance was not in commerce in 2006, it was decided to move forward with the Significant New Activity provisions for this substance. In the case where a person would want to use the substance in the future, this person (notifier) would be subject to notification requirements following the publication of the Significant New Activity orders. This will trigger a full assessment of the substance, and does not constitute a ban.

Implementation, enforcement and service standards

Since the orders are made under CEPA 1999, enforcement officers will, if and when verifying compliance with the requirements set out in the orders, apply the guiding principles set out in the Compliance and Enforcement Policy implemented under the Act. The Policy also sets out the range of possible responses to violations, including warnings, directions, environmental protection compliance orders, ticketing, ministerial orders, injunctions, prosecution, and environmental protection alternative measures (which are an alternative to a court trial after the laying of charges for a contravention to CEPA 1999). In addition, the Policy explains when Environment Canada will resort to civil suits by the Crown for costs recovery.

When, following an inspection or an investigation, an enforcement officer discovers an alleged violation, the officer will choose the appropriate enforcement action based on the following factors:

• Nature of the alleged violation: This includes consideration of the damage, the intent of the alleged violator, whether it is a repeat violation, and whether an attempt has been made to conceal information or otherwise subvert the objectives and requirements of the Act.
• Effectiveness in achieving the desired result with the alleged violator: The desired result is compliance within the shortest possible time and with no further repetition of the violation. Factors to be considered include the violator’s history of compliance with the Act, willingness to co-operate with enforcement officers, and evidence of corrective action already taken.
• Consistency: Enforcement officers will consider how similar situations have been handled in determining the measures to be taken to enforce the Act.

Since these orders delete three substances from Part 1 and add them to Part 2 of the Domestic Substances List, developing an implementation plan and a compliance strategy and establishing a service standard are not considered necessary.

Contact

Mark Burgham
Acting Executive Director
Program Development and Engagement Division
Environment Canada
Gatineau, Quebec
K1A 0H3
Telephone: 819-956-9313 or 1-888-228-0530
Fax: 819-953-7155
Email: existing.substances.existantes@ec.gc.ca

Footnote a
SOR/94-311

Footnote b
S.C. 1999, c. 33

Footnote c
S.C. 1999, c. 33

Footnote d
S.C. 1999, c. 33

Footnote 1
SOR/94-311

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