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Chemical Substances in Batch 1 of the Challenge

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Risk Management Action Milestones

The Risk Management Action Milestones table outlines the risk management actions that were proposed for each chemical substance in Batch 1 of the Challenge that has met the criteria of section 64 of the Canadian Environmental Protection Act, 1999. These proposed risk management actions were published in the risk management approach documents for these substances. For the complete wording of these proposed actions, please refer to the risk management approach documents listed on the relevant Batch pages.

Draft Screening Assessment Report for One Batch 1 Substance

(Public comment period July 3, 2010 to September 1, 2010)

On July 3, 2010, a Notice relating to the release of the draft screening assessment report for CHPD, a substance in Batch 1 of the Challenge, was published in the Canada Gazette, Part I, Vol. 144, No. 27 and the draft screening assessment report was released on this Web site (see below).

New evidence in the form of data on bioaccumulation has led to the re-evaluation of the risks, conclusions and final decision previously published regarding CHPD.

There is a 60-day public comment period associated with this publication. Public comments may be submitted (from July 3, 2010 to September 1, 2010) on (a) the draft screening assessment report and (b) the proposal to pursue one of the measures as specified under subsection 77(2) of the Canadian Environmental Protection Act, 1999 (CEPA 1999). Details on how to submit public comments can be found within the applicable Canada Gazette Notice for the substance in the table below.

Notice of Intent to Amend the Domestic Substances List to Apply the Significant New Activity provisions of the Canadian Environmental Protection Act, 1999 to Four Batch 1 Substances

(Public comment period July 3, 2010 to September 1, 2010)

For four substances in Batch 1 (CAS No. 75-56-9, 106-88-7, 120-80-9, and 123-31-9), the conclusion of the final screening assessment is that these substances do not meet the criteria in paragraph 64a and 64b of the Canadian Environmental Protection Act, 1999 (CEPA 1999), but they do meet the criteria in paragraph 64(c) of the Act. These substances were added to the List of Toxic Substances in Schedule 1 of CEPA 1999 on May 12, 2010.

In Canada, exposure to these substances from non-naturally occurring sources is low. However, given the hazardous properties of these substances, there is concern that new activities for the substances which have not been identified or assessed under CEPA 1999 could lead to an increase of risk to human health. Health Canada and Environment Canada recommended that the substances be subject to the Significant New Activity provisions specified under subsection 81(3) of the Act, to ensure that any new manufacture, import or use of any of these substances in quantities greater than 100 kg/year is notified and will undergo ecological and human health risk assessments as specified in section 83 of the Act prior to the initiation of the new activity in Canada.

A Notice of intent to amend the Domestic Substances List (DSL) under subsection 87(3) of CEPA 1999 to indicate that subsection 81(3) of the Act applies to four of the substances in Batch 1 [Methyloxirane, Ethyloxirane, 1,2-Benzenediol (catechol) and 1,4-Benzenediol (hydroquinone)] was published in the Canada Gazette, Part I, on July 3, 2010.

There is a 60-day public comment period (from July 3, 2010 to September 1, 2010) associated with this Canada Gazette Notice. Details on how to submit public comments can be found within the Notice.

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 (CEPA 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. As a result, 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.

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 section 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 Web site. 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 B and C below. 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 approaches for these substances.

Final Screening Assessment 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 Web site (see tables below). Please note that two closely related substances (CAS No. 91-08-7 and 584-84-9) are addressed within one Notice.

For eight substances in Batch 1 (CAS No. 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.

For one substance in Batch 1 (CAS No. 54079-53-7), the conclusion of the final screening assessment was that the substance met one or more of the criteria in section 64 of CEPA 1999, and the Government proposed to add this substance to Schedule 1 of the Act. In addition, that substance 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. New evidence in the form of data on bioaccumulation has led to the re-evaluation of the risks, conclusions and final decision previously published regarding CHPD. A Notice relating to the release of the draft screening assessment report for this substance was published in the Canada Gazette, Part I, on July 3, 2010. There is a 60-day public comment period associated with this publication, from July 3, 2010 to September 1, 2010.

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. Links to summaries of the public comments received for specific substances in Batch 1 are provided in Table D below. Some comments were received relating to more general themes, and are summarized in the following table:

Proposed Order to Add Certain Batch 1 Substances to Schedule 1 of the Canadian Environmental Protection Act, 1999

On September 20, 2008, a proposed Order adding toxic substances to Schedule 1 to the Canadian Environmental Protection Act, 1999 (CEPA 1999) was published in the Canada Gazette Part I, 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 (from September 20, 2008 to November 19, 2008) associated with this Canada Gazette Notice.

Final Order Adding Five Substances and One Group of Three Substances in Batch 1 to Schedule 1 to the Canadian Environmental Protection Act, 1999

On May 12, 2010, an Order adding toxic substances to Schedule 1 to the Canadian Environmental Protection Act, 1999 (CEPA 1999) was published in the Canada Gazette Part II, Vol. 144 No. 10, for five substances and one group of three substances in Batch 1 of the Challenge that were determined to meet one or more of the criteria in section 64 of the Act.

This addition made pursuant to subsection 90(1) of CEPA 1999 enables the development of regulatory risk management proposals for these substances under CEPA 1999. The Ministers may, however, choose to develop non-regulatory instruments to manage human health and environmental risks posed by these substances.

Summary of Batch 1 Substances and Publications

A. One substance re-assessed following the consideration of information regarding the bioaccumulation potential of the substance that was not available at the time of the final decision that is proposed NOT to meet any of the criteria set out in Section 64 of CEPA 1999
CAS No. Chemical Substance
Public Summary
Canada Gazette Notice Public Comments
54079-53-7 Propanedinitrile, [[4-[[2-(4-cyclohexylphenoxy)ethyl]ethylamino]-2-methylphenyl]methylene]- Next link will take you to another Web site HTML
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The following documents reflect past decisions on this substance and are no longer applicable. These documents are available for information purposes only
CAS No. Chemical Substance
Canada Gazette Notice Public Comments Final Screening Assessment 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]- Next link will take you to another Web site HTML
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B. Eight substances for 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 order1 and RIAS2 Final order3 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.

3 Final Order adding substance to Schedule 1 to CEPA 1999 (published in Canada Gazette 12 May 2010).

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 Next link will take you to another Web site HTML
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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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C. 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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D. Proposed risk management approach documents, public comments on the proposed risk management approach documents and Government responses
CAS No. Chemical Substance Proposed Risk Management Approach Public Comments
75-56-9 Oxirane, methyl- Next link will take you to another Web site HTML Next link will take you to another Web site HTML
91-08-7 Benzene, 1,3-diisocyanato-2-methyl Next link will take you to another Web site HTML Next link will take you to another Web site HTML
91-20-3 Naphthalene Next link will take you to another Web site HTML Next link will take you to another Web site HTML
106-88-7 Oxirane, ethyl- Next link will take you to another Web site HTML Next link will take you to another Web site HTML
120-80-9 1,2-benzenediol Next link will take you to another Web site HTML Next link will take you to another Web site HTML
123-31-9 1,4-benzenediol Next link will take you to another Web site HTML Next link will take you to another Web site HTML
584-84-9 Benzene, 2,4-diisocyanato-1-methyl Next link will take you to another Web site HTML Next link will take you to another Web site HTML
26471-62-5 Benzene, 1,3-diisocyanatomethyl- Next link will take you to another Web site HTML Next link will take you to another Web site HTML
54079-53-7 Propanedinitrile, [[4-[[2-(4-cyclohexylphenoxy)ethyl]ethylamino]-2-methylphenyl]methylene]- No longer applicable.
Available upon request from GR-RM@ec.gc.ca
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Timelines

Date Substances Affected Activity
3 February 2007 All Batch 1 substances Release of Batch 1 of the Challenge and the accompanying technical documents.
5 June 2007 All Batch 1 substances Deadline for submission of information under the s.71 Notice on Batch 1 substances (if no extension granted).
2 August 2007 All Batch 1 substances 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 All Batch 1 substances 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.
19 March 2008 All Batch 1 substances End of 60-day public comment period.
5 July 2008 All Batch 1 substances 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.
3 September 2008 All Batch 1 substances End of 60-day public comment period.
20 September 2008 CAS No. 54079-53-7, 75-56-9, 106-88-7, 91-20-3, 26471-62-5, 584-84-9, 91-08-7, 120-80-9, and 123-31-9 Publication in Canada Gazette of proposed Order adding substances to Schedule 1, and start of 60-day public comment period.
19 November 2008 CAS No. 54079-53-7, 75-56-9, 106-88-7, 91-20-3, 26471-62-5, 584-84-9, 91-08-7, 120-80-9, and 123-31-9 End of 60-day public comment period.
12 May 2010 CAS No. 75-56-9, 106-88-7, 91-20-3, 26471-62-5, 584-84-9, 91-08-7, 120-80-9, and 123-31-9 Publication in Canada Gazette of final Order adding substances to Schedule 1.
3 July 2010 CAS No. 54079-53-7 Publication in Canada Gazette and start of 60-day public comment period on (a) the draft screening assessment and (b) the proposal to pursue one of the measures as specified under subsection 77(2).
3 July 2010 CAS No. 75-56-9, 106-88-7, 120-80-9 and 123-31-9 Publication in Canada Gazette of Notice of intent to amend the DSL to apply the Significant New Activity provisions of CEPA 1999, and start of 60-day public comment period.
3 July 2010 CAS No. 91-08-7, 584-84-9 and 26471-62-5 Publication in Canada Gazette and start of 60-day public comment period on a Pollution Prevention Planning Notice for TDIs.
1 September 2010 CAS No. 54079-53-7; 75-56-9, 106-88-7, 120-80-9, 123-31-9; 91-08-7, 584-84-9 and 26471-62-5. End of 60-day public comment periods.