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Chemical Substances in Batch 1 of the Challenge

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Publication of Proposed Order to add certain Batch 1 substances to Schedule 1 of CEPA 1999

(public comment period 20 September 2008 to 19 November 2008)

On September 20, 2008, a proposed Order adding toxic substances to Schedule 1 to the Canadian Environmental Protection Act, 1999 was published in the Canada Gazette Part I, Vol. 142 No. 38, for nine substances in Batch 1 of the Challenge that were determined to meet the criteria in section 64 of the Act.

There was a 60-day public comment period for this proposed order, from 20 September, 2008 to 19 November, 2008.

Background

Launch of Batch 1

On February 3, 2007, the Minister of the Environment and the Minister of Health released a Notice in the Canada Gazette on the first group of substances identified under the Challenge, entitled: Notice of first release of technical information relevant to substances identified in the Challenge. Industry and interested stakeholders were asked to submit information (by responding to a mandatory survey notice, if applicable, and/or a voluntary questionnaire) that could be used to inform risk assessment and to develop and benchmark best practices for risk management and product stewardship.

In order to gather information on these "Batch 1" Challenge substances from industry and interested stakeholders, a mandatory survey Notice was issued under section 71 of the Canadian Environmental Protection Act, 1999. This Notice applied to 13 of the 15 substances in Batch 1 of the Challenge. The remaining two substances (CAS No. 91-20-3 and 54079-53-7) had been surveyed under a previous section 71 Notice, and the Government had obtained sufficient information. Thus they were not included in the February 2007 Notice.

Industry and interested stakeholders were also invited to complete a voluntary questionnaire.

In addition, Environment Canada and Health Canada released "substance profiles" for each of these substances, summarizing the scientific information and any relevant uncertainties and specifying the information necessary for improved decision-making.

Release of draft screening assessment reports and risk management scope documents

New information was received from industry or interested stakeholders for all of the 15 substances in "Batch 1" of the Challenge. All information that was received during the designated public comment period relating to the mandatory S.71 survey Notice, the voluntary questionnaire and the substance profiles for Batch 1 substances was considered by Government officials in the preparation of draft screening assessments and risk management scope documents for these substances.

On January 19, 2008, 14 Notices relating to the release of draft screening assessments for the 15 substances in Batch 1 of the Challenge were published in the Canada Gazette Part I, Vol. 142 No. 3, and the draft screening assessments were released on this website. In addition, risk management scope documents (preliminary outlines of the options being examined for the management of substances, based on the proposed conclusions of the draft screening assessments) were released.

There was a 60-day public comment period associated with these publications. Public comments were submitted (from January 19, 2008 to March 19, 2008) on (a) the draft screening assessments, (b) the proposal to pursue one of the measures as specified under subsection 77(2) of the Canadian Environmental Protection Act, 1999, and c) the risk management scope documents. Links to summaries of the public comments received for specific substances in Batch 1 are provided in Tables A and B above. Some comments were received relating to more general themes, and are summarized in the following table:

Following the close of the public comment period on March 19, 2008, all information that was received relating to the draft screening assessments, proposed measures and risk management scopes for Batch 1 substances was considered by Government officials in the preparation of final screening assessments and proposed risk management approach documents for these substances.

Release of final screening assessments reports and proposed risk management approach documents

On July 5, 2008, 14 Notices relating to the final assessment decisions for the 15 substances in Batch 1 of the Challenge were published in the Canada Gazette Part I, Vol. 142 No. 27 and the final screening assessment reports were released on this website (see below). Please note that one Notice covers two closely related substances (CAS Nos. 91-08-7 and 584-84-9).

For nine substances in Batch 1 (CAS No. 54079-53-7, 75-56-9, 91-08-7, 91-20-3, 106-88-7, 120-80-9, 123-31-9, 584-84-9 and 26471-62-5 ), the conclusion of the final screening assessments is that the substances meet one or more of the criteria in section 64 of the Canadian Environmental Protection Act, 1999 (CEPA 1999), and the Government proposed to add these substances to Schedule 1 of the Act. In addition, one of these substances, (CAS no. 54079-53-7) has been found to meet the criteria for virtual elimination under subsection 77(4) of the Act, and therefore is proposed for addition to the Virtual Elimination List.

For the remaining six substances in Batch 1 (CAS No. 78-63-7, 1068-27-5, 6731-36-8, 12236-64-5, 43035-18-3 and 59487-23-9) the conclusion of the final screening assessments is that the substances do not meet the criteria in section 64 of CEPA 1999, and the Government will take no further action on these substances at this time.

Proposed risk management approach documents were also released on July 5, 2008 for those Batch 1 substances for which the screening assessment conclusion is that the substances meet the criteria in section 64 of CEPA 1999. These proposed risk management approach documents build on the previously released risk management scope documents, and outline, in more depth, the risk management actions for these substances, including the choice of risk management instruments. There was a 60-day public comment period on these proposed risk management approach documents, from July 5, 2008 to September 3, 2008.

A. Nine substances which the Government of Canada has concluded meet one or more criteria in Section 64 of CEPA 1999
CAS No. Chemical Substance
Public Summary
Canada
Gazette

Notice
Public Comments Final
Screening
Assessment
Proposed Risk
Management Approach
Proposed
order1 and
RIAS2

1 Proposed order adding substances to Schedule 1 to CEPA 1999 (published in Canada Gazette 20 September 2008).

2 RIAS stands for regulatory impact analysis statement. The RIAS provides information to Canadians and decision-makers on regulatory decisions and their impacts to protect and advance the public interest in health, safety and security, the quality of the environment, and the social and economic well-being of Canadians.

54079-53-7 Propanedinitrile, [[4-[[2-(4-cyclohexylphenoxy)
ethyl]ethylamino]-2-
methylphenyl]
methylene]-
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75-56-9 Oxirane, methyl- Next link will take you to another Web site HTML
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91-08-7 Benzene, 1,3-
diisocyanato-2-methyl
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91-20-3 Naphthalene Next link will take you to another Web site HTML
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106-88-7 Oxirane, ethyl- Next link will take you to another Web site HTML
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120-80-9 1,2-benzenediol Next link will take you to another Web site HTML
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123-31-9 1,4-benzenediol Next link will take you to another Web site HTML
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584-84-9 Benzene, 2,4-
diisocyanato-1-methyl
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26471-62-5 Benzene, 1,3-diisocyanatomethyl- Next link will take you to another Web site HTML
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B. Six substances which the Government of Canada has concluded DO NOT meet any of the criteria in Section 64 of CEPA 1999
CAS No. Chemical Substance
Public Summary
Canada Gazette Notice Public Comments Final Screening Assessment
78-63-7 Peroxide, (1,1,4,4-tetramethyl-1,4-butanediyl)bis[(1,1-dimethylethyl) Next link will take you to another Web site HTML
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1068-27-5 Peroxide, (1,1,4,4-tetramethyl-2-butyne-1,4-diyl)bis[(1,1-dimethylethyl) Next link will take you to another Web site HTML
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6731-36-8 Peroxide, (3,3,5-trimethylcyclohexylidene)bis[(1,1-dimethylethyl) Next link will take you to another Web site HTML
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12236-64-5 2-Naphthalenecarboxamide, N-[4-(acetylamino)phenyl]-4-[[5-(aminocarbonyl)-2-chlorophenyl]azo]-3-hydroxy- Next link will take you to another Web site HTML
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43035-18-3 Benzenesulfonic acid, 4-[[3-[[2-hydroxy-3-[[(4-methoxyphenyl)amino]carbonyl]-1-naphthalenyl]azo]-4-methylbenzoyl]amino]-, calcium salt (2:1) Next link will take you to another Web site HTML
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59487-23-9 2-Naphthalenecarboxamide, 4-[[5-[[[4-(aminocarbonyl)phenyl]amino]carbonyl]-2-methoxyphenyl]azo]-N-(5-chloro-2,4-dimethoxyphenyl)-3-hydroxy- Next link will take you to another Web site HTML
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Timelines

Date Activity
3 February 2007 Release of "batch 1" of the Challenge and the accompanying technical documents
5 June 2007 Deadline for submission of information under the s.71 notice on "batch 1" substances (if no extension granted)
2 August 2007 Deadline for submission of additional information by interested stakeholders, including on the extent and nature of the management/stewardship of batch 1 substances
19 January 2008 Publication in Canada Gazette and start of 60-day public comment period on (a) the draft screening assessments, (b) the proposal to pursue one of the measures as specified under subsection 77(2) and (c) the risk management scope documents.
5 July 2008 Publication in Canada Gazette of final assessment decisions under subsection 77(6), release of the proposed risk management approach documents, and start of 60-day public comment period on the proposed risk management approach documents.
20 September 2008 For substances concluded to meet the criteria in section 64 of CEPA 1999
Publication in Canada Gazette of proposed order adding substances to Schedule 1, and start of 60-day public comment period
19 November 2008 End of 60-day public comment period

Contact Information

Comments or questions should be sent to:

Existing Substances Program
Gatineau (QC) K1A 0H3

Telephone: 1-888-228-0530 (in Canada) or 819-956-9313
Fax: 1-800-410-4314 (in Canada) or 819-953-4936
E-mail: DSL.surveyco@ec.gc.ca