ARCHIVED — Order 2009-87-03-04 Amending the Domestic Substances List

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Vol. 143, No. 17 — August 19, 2009

Registration

SOR/2009-238 August 4, 2009

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Whereas the substances set out in this Order are 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 those substances under section 74 of the Canadian Environmental Protection Act, 1999 (see footnote b) and suspect that a significant new activity in relation to those substances may result in the substances becoming toxic within the meaning of section 64 of that Act;

And whereas the Ministers have identified no use above 100 kg in any one calendar year other than those regulated under the Pest Control Products Act (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 2009-87-03-04 Amending the Domestic Substances List.

Ottawa, July 22, 2009

JIM PRENTICE
Minister of the Environment

ORDER 2009-87-03-04 AMENDING THE DOMESTIC SUBSTANCES LIST

AMENDMENTS

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

72-43-5

87-86-5

1582-09-8

1897-45-6

1912-24-9

3691-35-8

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

72-43-5 S′

Any activity to which the Pest Control Products Act does not apply and which involves, in any one calendar year, more than 100 kg of benzene, 1,1′-(2,2,2-trichloroethylidene)bis[4-methoxy-.

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 a calendar year:

(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 item 8 of Schedule 5 to those Regulations; and

(d) the information specified in item 11 of Schedule 6 to those Regulations.

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

87-86-5 S′

Any activity to which the Pest Control Products Act does not apply and which involves, in any one calendar year, more than 100 kg of phenol, pentachloro-.

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 a calendar year:

(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 item 8 of Schedule 5 to those Regulations; and

(d) the information specified in item 11 of Schedule 6 to those Regulations.

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

1582-09-8 S′

Any activity to which the Pest Control Products Act does not apply and which involves, in any one calendar year, more than 100 kg of benzenamine, 2,6-dinitro-N,N-dipropyl-4-(trifluoromethyl)-.

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 a calendar year:

(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 item 8 of Schedule 5 to those Regulations; and

(d) the information specified in item 11 of Schedule 6 to those Regulations.

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

1897-45-6 S′

Any activity to which the Pest Control Products Act does not apply and which involves, in any one calendar year, more than 100 kg of 1,3-benzenedicarbonitrile, 2,4,5,6-tetrachloro-.

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 a calendar year:

(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 item 8 of Schedule 5 to those Regulations; and

(d) the information specified in item 11 of Schedule 6 to those Regulations.

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

1912-24-9 S′

Any activity to which the Pest Control Products Act does not apply and which involves, in any one calendar year, more than 100 kg of 1,3,5-triazine-2,4-diamine, 6-chloro-N-ethyl-N′-(1-methylethyl)-.

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 a calendar year:

(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 item 8 of Schedule 5 to those Regulations; and

(d) the information specified in item 11 of Schedule 6 to those Regulations.

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

3691-35-8 S′

Any activity to which the Pest Control Products Act does not apply and which involves, in any one calendar year, more than 100 kg of 1H-indene-1,3(2H)-dione, 2-[(4-chlorophenyl)phenylacetyl]-.

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 a calendar year:

(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 item 8 of Schedule 5 to those Regulations; and

(d) the information specified in item 11 of Schedule 6 to those Regulations.

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 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 is to delete six substances currently listed on the Domestic Substances List from Part 1 and add them to Part 2 of the Domestic Substances List 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 the Canadian Environmental Protection Act, 1999. A person who intends to use, manufacture or import any of these substances for a significant new activity to which the Pest Control Products Act does not apply, and 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 June 23, 2007, a draft screening assessment entitled Summary of the Draft Entry Characterization of Benzenamine,2,6-dinitro-N,N-dipropyl-4-(trifluoromethyl)- (Trifluralin); 1,3,5-Triazine-2,4-diamine, 6-chloro-N-ethyl-N′-(1-methylethyl)- (Atrazine); 1,3-Benzenedicarbonitrile, 2,4,5,6-tetrachloro- (Chlorothalonil); 1H-indene-1,3(2H)-dione, 2-[(4- chlorophenyl)phenylacetyl]- (Chlorophacinone); Benzene, 1,1′-(2,2,2-trichloroethylidene)bis[4-methoxy- (Methoxychlor); and Phenol, pentachloro- (pentachlorophenol) Identified Under Subsection 73(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. All six substances were identified during the categorization exercise conducted under subsection 73(1) of the Canadian Environmental Protection Act, 1999. Specifically, trifluralin met all three criteria (see footnote 2) for categorization, atrazine, chlorothalonil, methoxychlor, and pentachlorophenol were determined to be both persistent (P) and inherently toxic (iT) to non-human organisms, and chlorophacinone was determined to be both bioaccumulative (B) and inherently toxic to non-human organisms. Additionally, four of these substances (atrazine, chlorothalonil, trifluralin, pentachlorophenol) were identified as inherently toxic to humans.

Because of the hazardous 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 benzenamine, 2,6-dinitro-N,N-dipropyl-4-(trifluoromethyl)- (trifluralin); 1,3,5-triazine-2,4-diamine, 6-chloro-N-ethyl-N’- (1-methylethyl)- (atrazine); 1,3-benzenedicarbonitrile, 2,4,5,6-tetrachloro- (chlorothalonil); 1H-indene-1,3(2H)-dione, 2-[(4-chlorophenyl)phenylacetyl]- (chlorophacinone); benzene, 1,1′-(2,2,2-trichloroethylidene)bis[4-methoxy- (methoxychlor); and phenol, pentachloro- (pentachlorophenol) was also published on June 23, 2007. It was proposed that the Significant New Activity provisions of the Canadian Environmental Protection Act, 1999 be applied to ensure that the decision to allow entry of any of these six substances in the marketplace for applications other than those regulated under the Pest Control Products Act 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 six of the substances and have published in the Canada Gazette, Part I, on August 8, 2009, the Final Decision on the Screening Assessment of six substances on the Domestic Substances List [Subsection 77(6) of the Canadian Environmental Protection Act, 1999].

The screening assessment was conducted to determine whether the substances meet the toxicity criteria under section 64 of the Canadian Environmental Protection Act, 1999; whereas 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.

A survey conducted in 2001 (under section 71 of the Canadian Environmental Protection Act, 1999) revealed that there was no use, import or manufacture of the six substances for applications other than those regulated under the Pest Control Products Act, above the reporting threshold of 100 kg/year in 2000. The conclusion of the screening assessment is that the six substances are currently not entering, or likely to enter, the environment as a result of activities other than those regulated under the Pest Control Products Act. Therefore, it is concluded that they do not meet any of the criteria set out in section 64 of the Canadian Environmental Protection Act, 1999. The final assessment report can be found at: www.chemicalsubstanceschimiques.gc.ca/news-pesticide-nouvelles_e.html.

Authority

Subsection 81(3) of the Canadian Environmental Protection Act,1999 requires persons to provide prescribed information to the Minister of the Environment for significant new activities in relation to a substance listed on the Domestic Substances List.

The Order requires any person that intends to use, import or manufacture any of the six substances for a use that is not regulated under the Pest Control Products Act, and in a quantity exceeding 100 kilograms in a calendar year to provide the following information to the Minister, at least 90 days before quantity of the substance exceeds the 100 kilograms threshold in that calendar year:

  • 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 item 8 of Schedule 5 of those Regulations; and
  • the information specified in item 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 six substances from Part 1 and adds them to Part 2 of the Domestic Substances List. Part 2 of the Domestic Substances List contains chemicals substances that are subject to significant new activities 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 six substances are listed on Part 1 of the Domestic Substances List, they could be re-introduced in the Canadian market for any activity and in any quantity without any requirement to report to the Minister of the Environment. The Minister has determined that these substances possess hazardous properties, therefore, the option of not listing these substances to Part 2 of the Domestic Substances List to make them subject to the significant new activities provisions of the Canadian Environmental Protection Act, 1999 has been rejected.

Benefits and costs

Benefits

The amendment of 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 six substances.

Costs

There is currently no evidence of the presence of these substances in Canadian commerce above an annual threshold of 100 kg, for uses other than those regulated under the Pest Control Products Act. 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 Order and provide the required information specified in Schedule 6 of the New Substances Notification Regulations (Chemicals and Polymers).

As these substances are not in commerce for uses other than those regulated under the Pest Control Products Act, 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 to meet the requirements of section 83 of the Canadian Environmental Protection Act, 1999 and the New Substances Notification Regulations (Chemicals and Polymers) 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 the Canadian Environmental Protection Act, 1999. These costs cannot be estimated at this time.

Consultation

On June 23, 2007, 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 benzenamine, 2,6-dinitro-N,N-dipropyl-4-(trifluoromethyl)- (trifluralin); 1,3,5-triazine-2,4-diamine, 6-chloro-N-ethyl-N’- (1-methylethyl)- (atrazine); 1,3-benzenedicarbonitrile, 2,4,5,6-tetrachloro- (chlorothalonil); 1H-indene-1,3(2H)-dione, 2-[(4-chlorophenyl)phenylacetyl]- (chlorophacinone); benzene, 1,1′-(2,2,2-trichloroethylidene)bis[4-methoxy- (methoxychlor); and phenol, pentachloro- (pentachlorophenol 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 Canadian Environmental Protection Act National Advisory Committee (the 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 the Canadian Environmental Protection Act, 1999. There were no concerns raised by the Committee with respect to this conclusion.

A total of three submissions were received, two from non-governmental organizations and one from industry stakeholders.

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

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

Submissions received from non-governmental organizations fully supported the intent to amend the Domestic Substances List and to apply significant new activities provisions for the six substances but requested that we consider information available in recent re-evaluation by the Pest Management Regulatory Agency.

The final screening assessment has considered recent re-evaluations conducted by the Pest Management Regulatory Agency. The final revisions had no impact on the proposed conclusion that the substances do not meet the definition of toxic set out in section 64 of the Canadian Environmental Protection Act, 1999.

Comments received from the industry stakeholder shared similar views but also provided comments that were technical in nature or requesting clarifications on the contents of the screening assessment.

These comments were carefully considered, and the text of the screening assessment report was revised as a result.

Implementation, enforcement and service standards

Since the Order is made under the Canadian Environmental Protection Act, 1999, enforcement officers will, if and when verifying compliance with the requirements pursuant to section 6 of the New Substances Notification Regulations (Chemicals and Polymers) set out in the Order, 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 Canadian Environmental Protection Act 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.

Since this Order deletes the six substances from Part 1 and adds them to Part 2 of the Domestic Substances List, developing an implementation plan, a compliance strategy or 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
Fax: 819-953-4936
Email: Existing.substances.existantes@ec.gc.ca

Footnote a
SOR/94-311

Footnote b
S.C. 1999, c. 33

Footnote c
S.C. 2002, c. 28

Footnote d
S.C. 1999, c. 33

Footnote 1
SOR/94-311

Footnote 2
Paragraphs 73(1)(a) may present, to individuals in Canada, the greatest potential for exposure; or
(b) are persistent or bioacumulative in accordance with the regulations, and inherently toxic to human beings or to non-human organisms, as determined by laboratory or other studies.