Registration

SOR/2008-192 June 10, 2008

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Order 2008-87-01-01 Amending the Domestic Substances List

Whereas the substances set out in this Order are on the Domestic Substances List;

Whereas the Ministers of the Environment and of Health have conducted a screening assessment on those substances under section 74 of the Canadian Environmental Protection Act, 1999 (see footnote a) and are satisfied that these substances are persistent and bioaccumulative in accordance with the Persistance and Bioaccumulation Regulations and are inherently toxic to non-human organisms;

And whereas the Ministers have identified no manufacture or importation activity by any person for the substances above 100 kg per calendar year;

Therefore, the Minister of the Environment, pursuant to subsection 87(3) of the Canadian Environmental Protection Act, 1999 (see footnote b), hereby makes the annexed Order 2008-87-01-01 Amending the Domestic Substances List.

Ottawa, May 28, 2008

JOHN BAIRD
Minister of the Environment

ORDER 2008-87-01-01 AMENDING
THE DOMESTIC SUBSTANCES LIST

AMENDMENTS

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

Domestic Substances List	Domestic Substances List	Domestic Substances List	Domestic Substances List	Domestic Substances List
58-38-8	6257-39-2	52591-25-0	68938-51-2	83721-47-5
76-60-8	6368-72-5	52671-38-2	69695-75-6	83721-48-6
77-52-1	6371-23-9	53184-75-1	69898-66-4	83968-86-9
87-10-5	6373-31-5	54079-60-6	69898-67-5	85005-63-6
92-72-8	6408-50-0	54243-60-6	70210-08-1	85186-47-6
92-76-2	6409-68-3	55252-53-4	70660-55-8	85392-21-8
93-46-9	6417-38-5	56307-70-1	71720-89-3	85702-64-3
96-66-2	6420-06-0	56532-53-7	72102-56-8	86551-61-3
132-61-6	6465-02-7	58019-27-5	72102-64-8	90218-20-5
133-49-3	12789-03-6	59583-77-6	72318-87-7	90268-98-7
135-63-7	15958-27-7	59709-10-3	72749-91-8	90459-02-2
145-39-1	15958-61-9	61799-13-1	72812-39-6	90729-40-1
440-17-5	16834-13-2	63133-84-6	72828-63-8	91696-90-1
603-48-5	19163-98-5	63134-15-6	72828-64-9	93384-84-0
608-71-9	19745-44-9	63281-10-7	72828-93-4	93918-79-7
1000-05-1	23077-61-4	63467-15-2	73003-64-2	94199-57-2
1325-85-5	24169-02-6	63467-19-6	73398-86-4	94248-26-7
1326-49-4	24610-00-2	63833-78-3	73398-87-5	103331-97-1
1871-22-3	25150-28-1	64086-95-9	73398-96-6	103331-98-2
2062-78-4	25857-05-0	64086-96-0	73528-78-6	104376-69-4
2379-75-1	27341-33-9	64742-66-1	75908-83-7	108004-27-9
2537-62-4	28118-10-7	67219-55-0	78952-70-2	113089-51-3
2538-84-3	28824-41-1	68214-66-4	79542-46-4	113163-36-3
2653-64-7	31030-27-0	68227-79-2	83027-51-4	114910-04-2
2746-81-8	33979-43-0	68400-36-2	83027-52-5	117310-64-2
3271-22-5	36294-24-3	68512-30-1	83249-47-2	119209-64-2
3687-67-0	41362-82-7	68516-64-3	83249-49-4	127126-02-7
3701-40-4	42479-88-9	68877-63-4	83249-53-0	128683-35-2
3767-68-8	42852-92-6	68910-11-2	83249-54-1	223777-68-2

2. Part 2 of the List is amended by adding the following before the first substance:

Column 1 Substance	Column 2 Significant New Activity for which substance is subject to subsection 81(3) of the Act
Group A*	Any activity involving, in a calendar year, more than 100 kg of any Group A substance.
	The following information must be provided to the Minister at least 90 days before the commencement of the proposed new activity: (a) a description of the proposed significant new activity in relation to the substance; (b) the information specified in Schedule 4 to the New Substances Notification Regulations (Chemicals and Polymers); (c) the information specified in items 6, 7 and 8 of Schedule 5 of those Regulations; and (d) the information specified in items 4 to 11 of Schedule 6 of those Regulations. The above information will be assessed within 90 days after it is received by the Minister.

* Group A: 58-38-8 S′, 76-60-8 S′, 77-52-1 S′, 87-10-5 S′, 92-72-8 S′, 92-76-2 S′, 93-46-9 S′, 96-66-2 S′, 132-61-6 S′, 133-49-3 S′, 135-63-7 S′, 145-39-1 S′, 440-17-5 S′, 603-48-5 S′, 608-71-9 S′, 1000-05-1 S′, 1325-85-5 S′, 1326-49-4 S′, 1871-22-3 S′, 2062-78-4 S′, 2379-75-1 S′, 2537-62-4 S′, 2538-84-3 S′, 2653-64-7 S′, 2746-81-8 S′, 3271-22-5 S′, 3687-67-0 S′, 3701-40-4 S′, 3767-68-8 S′, 6257-39-2 S′, 6368-72-5 S′, 6371-23-9 S′, 6373-31-5 S′, 6408-50-0 S′, 6409-68-3 S′, 6417-38-5 S′, 6420-06-0 S′, 6465-02-7 S′, 12789-03-6 S′, 15958-27-7 S′, 15958-61-9 S′, 16834-13-2 S′, 19163-98-5 S′, 19745-44-9 S′, 23077-61-4 S′, 24169-02-6 S′, 24610-00-2 S′, 25150-28-1 S′, 25857-05-0 S′, 27341-33-9 S′, 28118-10-7 S′, 28824-41-1 S′, 31030-27-0 S′, 33979-43-0 S′, 36294-24-3 S′, 41362-82-7 S′, 42479-88-9 S′, 42852-92-6 S′, 52591-25-0 S′, 52671-38-2 S′, 53184-75-1 S′, 54079-60-6 S′, 54243-60-6 S′, 55252-53-4 S′, 56307-70-1 S′, 56532-53-7 S′, 58019-27-5 S′, 59583-77-6 S′, 59709-10-3 S′, 61799-13-1 S′, 63133-84-6 S′, 63134-15-6 S′, 63281-10-7 S′, 63467-15-2 S′, 63467-19-6 S′, 63833-78-3 S′, 64086-95-9 S′, 64086-96-0 S′, 64742-66-1 S′, 67219-55-0 S′, 68214-66-4 S′, 68227-79-2 S′, 68400-36-2 S′, 68512-30-1 S′, 68516-64-3 S′, 68877-63-4 S′, 68910-11-2 S′, 68938-51-2 S′, 69695-75-6 S′, 69898-66-4 S′, 69898-67-5 S′, 70210-08-1 S′, 70660-55-8 S′, 71720-89-3 S′, 72102-56-8 S′, 72102-64-8 S′, 72318-87-7 S′, 72749-91-8 S′, 72812-39-6 S′, 72828-63-8 S′, 72828-64-9 S′, 72828-93-4 S′, 73003-64-2 S′, 73398-86-4 S′, 73398-87-5 S′, 73398-96-6 S′, 73528-78-6 S′, 75908-83-7 S′, 78952-70-2 S′, 79542-46-4 S′, 83027-51-4 S′, 83027-52-5 S′, 83249-47-2 S′, 83249-49-4 S′, 83249-53-0 S′, 83249-54-1 S′, 83721-47-5 S′, 83721-48-6 S′, 83968-86-9 S′, 85005-63-6 S′, 85186-47-6 S′, 85392-21-8 S′, 85702-64-3 S′, 86551-61-3 S′, 90218-20-5 S′, 90268-98-7 S′, 90459-02-2 S′, 90729-40-1 S′, 91696-90-1 S′, 93384-84-0 S′, 93918-79-7 S′, 94199-57-2 S′, 94248-26-7 S′, 103331-97-1 S′, 103331-98-2 S′, 104376-69-4 S′, 108004-27-9 S′, 113089-51-3 S′, 113163-36-3 S′, 114910-04-2 S′, 117310-64-2 S′, 119209-64-2 S′, 127126-02-7 S′, 128683-35-2 S′, 223777-68-2 S′.

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 Order.)

Issue and objectives

The purpose of the Order Amending the Domestic Substances List (the Order), made pursuant to subsection 87(3) of the Canadian Environmental Protection Act, 1999 (CEPA 1999) is to move 145 substances currently listed on the Domestic Substances List (DSL) from Part 1 to Part 2 of the DSL and to indicate, by the addition of the letter S’ following the substances identification number, that these substances are subject to the Significant New Activity provisions specified under subsection 81(3) of CEPA 1999. A person who intends to use, manufacture or import any of these substances for a significant new activity in quantities exceeding 100 kg/year must provide the Minister of the Environment the prescribed information prior to the use, manufacture or import.

Description and rationale

On December 9, 2006, a notice entitled Publication after screening assessment of 148 substances on the Domestic Substances List (subsection 77(1) of the Canadian Environmental Protection Act, 1999) was published in the Canada Gazette, Part I, for a 60-day public comment period. This publication was made under the Chemicals Management Plan announced by the Government of Canada on December 8, 2006. The screening assessment found these substances to meet the ecological categorization criteria for persistence, bioaccumulation and inherent toxicity (PBiT) to non-human organisms. Additionally, a survey conducted in 2006 (made under section 71 of CEPA 1999), revealed that there was no use, import or manufacture of these substances above the reporting threshold of 100 kg/year in year 2005. These substances are hence deemed not in commerce. Thus, the proposed conclusion was that the 148 substances did not meet the criteria set out under section 64 of CEPA 1999.

Because of the hazardous PBiT properties of these substances, a Notice of intent to amend the Domestic Substances List to apply the Significant New Activity provisions under Subsection 81(3) of the Canadian Environmental Protection Act, 1999 to 148 substances was also published on December 9, 2006. It was proposed that the Significant New Activity provisions of CEPA 1999 be applied to ensure that re-entry of any of these 148 substances in the marketplace is informed by a scientific review and any applicable control measures.

The ministers of the Environment and of Health have finalized the screening assessment on 145 of the PBiT substances and have published in the Canada Gazette, Part I, on June 7, 2008, the Final Decision on the Screening Assessment of 145 substances on the Domestic Substances List (Subsection 77(6) of the Canadian Environmental Protection Act, 1999). The conclusion of the screening assessment is that the 145 substances are currently not entering, or likely to enter, the environment as a result of commercial activity. Therefore, it is concluded that they do not meet any of the criteria set out in section 64 of CEPA 1999. The final assessment report can be found at www.ec.gc.ca/CEPARegistry/subs_list/assessments.cfm. Three of the substances originally covered by the assessment have been referred for further assessments as new information on their status were received during the public comment period.

Authority

Subsection 81(3) of CEPA 1999 requires persons to provide prescribed information to the Minister of the Environment for significant new activities (SNAc) in relation to a substance listed on the DSL.

The Order requires any person that intends to use, import or manufacture any of the 145 substances in a quantity exceeding 100 kilograms in a calendar year to provide the following information to the Minister, at least 90 days prior to the commencement of the proposed new activity:

• a description of the proposed significant new activity in relation to the substance;
• the information specified in Schedule 4 to the New Substances Notification Regulations (Chemicals and Polymers);
• the information specified in items 6, 7 and 8 of Schedule 5 of those Regulations; and,
• the information specified in items 4 to 11 of Schedule 6 of those Regulations.

The above information will be assessed within 90 days after it is received by the Minister.

In addition, the Order deletes the 145 substances from Part 1 and adds them to Part 2 of the DSL. Part 2 of the DSL contains chemicals substances that are subject to SNAc requirements. In addition, the letter S’ is added to each substance identification number to indicate that subsection 81(3) applies to them.

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

Alternatives

Since the 145 substances are listed on Part 1 of the Domestic Substances List, they could be re-introduced in Canadian market for any activity and in any quantity without the need to report to the Minister of the Environment. The Minister has determined that given the properties of these substances, the alternative of not amending the DSL to indicate that the Significant New Activity provisions of CEPA 1999 apply to the 145 PBiT substances is not acceptable. Therefore, the option of not listing these substances in Part 2 of the DSL to make them subject to the SNAc provisions of CEPA 1999 has been rejected.

Benefits and costs

Benefits

The amendment to the Domestic Substances List will allow for risk assessment of any new activity in relation with these substances. This will allow the government to make informed decisions, and manage appropriately the risks associated with any of these 145 substances.

Costs

There is currently no evidence of the presence of these substances in Canadian commerce above an annual threshold of 100 kg. Therefore, incremental costs to the public, industry or governments associated with this Order are not expected.

However, in the event that a person wishes to use, import or manufacture any of these substances in a quantity above the prescribed threshold, they would be required to meet the requirements of section 2 of the proposed Order and provide the required information specified in Schedule 6 of the New Substances Notification Regulations (Chemicals and Polymers). 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 substances are 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.

There would likely be costs 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 December 9, 2006, a Notice of intent to amend the Domestic Substances List to apply the Significant New Activity provisions under subsection 81(3) of the Canadian Environmental Protection Act, 1999 to 148 substances and a draft screening assessment under subsection 77(1) were published for a 60-day public comment period in the Canada Gazette, Part I.

The CEPA National Advisory Committee has also been given an opportunity to advise the Ministers on the scientific evidence supporting the declaration of these substances as not meeting any of the criteria in section 64 of CEPA 1999. There were no concerns raised by CEPA NAC with respect to this conclusion.

A total of five submissions were received from industry stakeholders and a coalition of environmental non-governmental organizations.

A summary of comments received and Environment Canada’s responses on the draft screening assessment report and the notice of intent is available from Environment Canada’s Web site: www. ec.gc.ca/substances/ese/.

Three industry stakeholders submitted information on the current status of three substances used in their operations.

Based on the information received, one substance was determined no longer to be PBiT, but to only meet the criteria for persistence. Hence, this substance is removed from the proposal to apply SNAc provisions of CEPA 1999 and will be assessed separately. The conclusion of the final assessment for this substance is expected to be published later this year.

The remaining two substances were also removed from the proposal to apply SNAc provisions of CEPA 1999 because of potential commercial activity above 100 kg per calendar year. These two substances will be addressed through other activities under the Challenge program.

The coalition of environmental non-governmental organizations made general comments on the SNAc approach. The comments can be summarized as follows:

• CEPA 1999 does not allow for existing substances to be deleted from the DSL when appropriate (such as when a substance is no longer in commerce);
• Need for more transparency in the New Substances Notification Regulation (Chemicals and polymers) (NSNR) assessment process;
• Limited scope of the survey creates the possibility that substances manufactured or imported in some years other than the one specified in the survey, or in amounts smaller than 100 kg, can continue to pose hazard in Canada; and,
• New activities should be defined as any activity involving these substances, not only activities over the 100 kg threshold.

Environment Canada has noted these general comments. Actions have already been undertaken to enhance transparency in the NSNR assessment process. The threshold for reporting under the section 71 survey and the threshold triggering notifications for the proposed SNAc were fixed at 100 kg per year because this is the same threshold that generally triggers notification under the New Substances Program. Companies also had the chance to express interest for substances that were manufactured, imported or used in other years than the one specified in the current survey.

All comments received during the public comment period were considered and taken into account in the Order and final screening assessment report.

Implementation, enforcement and service standards

Since the Order will be made under CEPA 1999, enforcement officers will, if and when verifying compliance with the Order, apply 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 CEPA 1999 violation). 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.

Contacts

Karen Mailhiot
Chief
Notification and Client Services Section
New Substances Division
Environment Canada
Gatineau, Quebec
K1A 0H3
New Substances Information Line:
Telephone: 1-800-567-1999 (toll free in Canada);
819-953-7156 (outside of Canada)

Markes Cormier
Economist
Regulatory Analysis and Instrument Choice Division
Environment Canada
Gatineau, Quebec
K1A 0H3
Telephone: 819-953-5236
Fax: 819-997-2769
Email: Markes.cormier@ec.gc.ca

Footnote a
S.C. 1999, c. 33

Footnote b
S.C. 1999, c. 33

Footnote 1
SOR/94-311

NOTICE:
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