ARCHIVED — Order 2010-87-03-03 Amending the Domestic Substances List

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Vol. 144, No. 7 — March 31, 2010

Registration

SOR/2010-66 March 22, 2010

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Whereas the substances set out in this 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 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 a 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 2010-87-03-03 Amending the Domestic Substances List.

Ottawa, March 2, 2010

JIM PRENTICE
Minister of the Environment

ORDER 2010-87-03-03 AMENDING THE DOMESTIC SUBSTANCES LIST

AMENDMENTS

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

1325-86-6

6407-74-5

6407-78-9

6786-83-0

29398-96-7

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

1325-86-6 S′

1. Any activity involving, in a calendar year, more than 100 kg of the substance 1-Naphthalenemethanol, α,α-bis[4-(diethylamino)phenyl]-4-(ethylamino)-.

 

2. 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; 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.

6407-74-5 S′

1. Any activity involving, in a calendar year, more than 100 kg of the substance 3H-Pyrazol-3-one, 4-[(2-chlorophenyl)azo]-2,4-dihydro-5-methyl-2-phenyl-.

 

2. 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; 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.

6407-78-9 S′

1. Any activity involving, in a calendar year, more than 100 kg of the substance 3H-Pyrazol-3-one, 4-[(2,4-dimethylphenyl)azo]-2,4-dihydro-5-methyl-2-phenyl-.

 

2. 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; 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.

6786-83-0 S′

1. Any activity involving, in a calendar year, more than 100 kg of the substance 1-Naphthalenemethanol, α,α-bis[4-(dimethylamino)phenyl]-4-(phenylamino)-.

 

2. 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; 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.

29398-96-7 S′

1. Any activity involving, in a calendar year, more than 100 kg of the substance [1, 1′-Biphenyl]-4,4′-diamine, N,N′-bis(2,4-dinitrophenyl)-3,3′-dimethoxy-.

 

2. 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; 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 Order.)

Issue and objectives

The purpose of the Order Amending the Domestic Substances List (the Order), made under subsection 87(3) of the Canadian Environmental Protection Act, 1999 (CEPA, 1999) is to delete five substances currently listed on Part 1 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 subsection 81(3) of CEPA, 1999.

The substances subject to the Order are

  • 3H-Pyrazol-3-one, 4-[(2-chlorophenyl)azo]-2,4-dihydro-5-methyl-2-phenyl-[Chemical Abstracts Service [CAS] Registry Number [RN] 6407-74-5] (Pigment Yellow 60),
  • 3H-Pyrazol-3-one, 4-[(2, 4-dimethylphenyl)azo]-2,4-dihydro-5-methyl-2-phenyl- [CAS RN 6407-78-9] (Solvent Yellow 18),
  • 1-Naphthalenemethanol, α,α-bis[4-(diethylamino)phenyl]-4-(ethylamino)- [CAS RN 1325-86-6 ] (Solvent Blue 5),
  • 1-Naphthalenemethanol, α,α-bis[4-(dimethylamino)phenyl]-4-(phenylamino)- [CAS RN 6786-83-0] (Solvent Blue 4), and
  • [1, 1’-Biphenyl]-4,4’-diamine, N,N’-bis(2,4-dinitrophenyl)-3,3-dimethoxy- [CAS RN 29398-96-7] (Pigment Brown 22).

Description and rationale

On September 5, 2009, nine Notices relating to the release of draft screening assessments for the 14 substances in Batch 7 of the Challenge were published in the Canada Gazette, Part I, Vol. 143, No. 36, for a 60-day public comment period. In addition, the draft screening assessments were released on the Government of 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 five 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 August 2008, revealed no reports of industrial activities (manufacture or import) with respect to these five substances above the reporting threshold of 100 kg per year for the specified reporting year of 2006. These five substances are hence deemed not in commerce.

Because of the hazardous persistence, bioaccumulation and inherent toxicity properties of the five substances, 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 five substances was published in the Canada Gazette, Part I, on September 5, 2009. It was proposed that the Significant New Activity provisions of the Act be applied so that any new use of these five substances is notified and undergoes ecological and human health risk assessments, prior to these substances being introduced into Canada. The five substances are 3H-Pyrazol-3-one, 4-[(2-chlorophenyl)azo]-2,4-dihydro-5-methyl-2-phenyl-[CAS RN 6407-74-5], 3H-Pyrazol-3-one, 4-[(2, 4-dimethylphenyl)azo]-2,4-dihydro-5-methyl-2-phenyl- [CAS RN 6407-78-9], 1-Naphthalenemethanol, α,α-bis[4-(diethylamino)phenyl]-4-(ethylamino)- [CAS RN 1325-86-6 ], 1-Naphthalenemethanol, α,α-bis[4-(dimethylamino)phenyl]-4-(phenylamino)- [CAS RN 6786-83-0] and [1, 1′-Biphenyl]-4,4′-diamine, N,N′-bis(2,4-dinitrophenyl)-3,3′-dimethoxy- [CAS RN 29398-96-7].

The Minister of the Environment and the Minister of Health have finalized the screening assessment of these five substances and have published in the Canada Gazette, Part I, on March 6, 2010, the Final Decision on the Screening Assessment of five 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 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 five substances do not meet any of the criteria set out in section 64 of CEPA, 1999. The final screening assessment report can be found at www.chemicalsubstanceschimiques.gc.ca.

Authority

The Order is 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 Order, subsection 81(3) of the Act will require any person that intends to use, import or manufacture any of the five substances in a quantity exceeding 100 kg 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; and
  • the information specified in Schedule 6 to the New Substances Notification Regulations (Chemicals and Polymers).

The Order provides that this information will be assessed within 90 days after it is received by the Minister of the Environment.

Alternatives

Since the five substances are listed on Part 1 of the 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. As these substances have been determined to possess hazardous properties, the option of not listing these substances to Part 2 of the List to make them subject to the significant new activities provisions of CEPA, 1999 has been rejected.

Benefits and costs

Benefits

The amendments to the List will allow 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 manage appropriately the risks associated with any of these five substances prior to the commencement of the new activity.

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, the required information specified in Schedule 6 to the New Substances Notification Regulations (Chemicals and Polymers) needs 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 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 September 5, 2009, a Notice of intent to amend the Domestic Substances List under subsection 87(3) ofthe Canadian Environmental Protection Act, 1999 toindicate that subsection 81(3) of the Act applies to five substances and a proposed summary of the screening assessment under subsection 77(1) were 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 Order via a letter, with an opportunity to comment.

No comments on the notice of intent were received.

Implementation, enforcement and service standards

Since the Order is made under CEPA, 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 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 this Order deletes the five substances from Part 1 and adds them to Part 2 of the 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, Québec
K1A 0H3
Telephone: 819-956-9313
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