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Chemical Substances in Batch 5 of the Challenge

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Publication of Proposed Order to add certain Batch 5 substances to Schedule 1 of the Canadian Environmental Protection Act, 1999 (CEPA 1999)

(public comment period October 3, 2009 to December 2, 2009)

On October 3, 2009, the 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, Vol. 143 No. 40 for two substances in Batch 5 of the Challenge that were determined to meet the criteria in section 64 of the Act.

There is a 60-day public comment period for this proposed order, from October 3, 2009 to December 2, 2009.

Publication of Order amending the Domestic Substances List (DSL) to apply the Significant New Activity (SNAc) Provisions of the Canadian Environmental Protection Act, 1999 (CEPA 1999) to a Batch 5 substance

On September 16, 2009 an Order amending the Domestic Substances List (DSL) to apply the Significant New Activity (SNAc) provisions specified under subsection 81(3) of the Canadian Environmental Protection Act, 1999 (CEPA 1999) for Disperse Orange 5 (CAS No. 6232-56-0), substance in Batch 5 of the Challenge, was published in the Canada Gazette, Part II.

The conclusion of the final screening assessment is that this substance is currently not entering, or likely to enter, the environment as a result of commercial activity or from other sources, and therefore that it does not meet the criteria set out in section 64 of the CEPA 1999.

However, given that the hazardous properties of this "PBiT" (persistent, bioaccumulative and inherently toxic to non-human organisms) substance, there is concern that new activities for the substance which have not been identified or assessed under CEPA 1999 could lead to the substance meeting the criteria set out in section 64 of the Act. Therefore, the DSL has been amended, and this substance is now subject to the SNAc provisions specified under subsection 81(3) of the Act, which require that any new manufacture, import or use of this substance 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 substance being introduced into Canada.

Notice of Intent to amend the Domestic Substances List (DSL) to apply the Significant New Activity (SNAc) provisions of the Canadian Environmental Protection Act, 1999 (CEPA 1999) to a Batch 5 substance

(public comment period August 22, 2009 to October 21, 2009)

For one additional substance in Batch 5 (CAS No. 79-07-2), the proposed conclusion of the draft screening assessment is that the substance does not meet the criteria set out in section 64 of the Canadian Environmental Protection Act, 1999 (CEPA 1999).

However, while the likelihood of exposure to this substance in Canada resulting from non-pesticidal uses is low, there is concern that new activities for the substance which have not been identified or assessed under CEPA 1999 could lead to the substance meeting the criteria set out in section 64 of the Act. Therefore, it was recommended that the substance be subject to the SNAc provisions specified under subsection 81(3) of the Act, to ensure that any new manufacture or use of the substance is notified and will undergo ecological and human health risk assessments as specified in section 83 of the Act prior to the substance being introduced into Canada.

A Notice of intent to amend the DSL under subsection 87(3) of CEPA 1999 to indicate that subsection 81(3) of the Act applies to Acetamide, 2-chloro- was published in the Canada Gazette Vol. 143, No. 34 on August 22, 2009.

There is a 60-day public comment period (from August 22, 2009 to October 21 2009) associated with this Canada Gazette Notice. Details on how to submit public comments can be found within the Notice.

Release of Final Screening Assessment Reports and Proposed Risk Management Approach Documents for Batch 5 Substances

On August 22, 2009, 19 Notices relating to the final assessment decisions for the 19 substances in Batch 5 of the Challenge were published in the Canada Gazette Part I, Vol. 143 No. 34 and the final screening assessment reports were released on this web site (see below).

For two of the 19 substances in Batch 5 (CAS No. 79-06-1 and 115-96-8), 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 is proposing to add these substances to Schedule 1 of the Act.

For the remaining 17 substances in Batch 5 (CAS No. 5261-31-4, 6232-56-0, 12239-34-8, 16421-40-2, 16421-41-3, 17464-91-4, 23355-64-8, 26850-12-4, 29765-00-2, 52697-38-8, 55281-26-0, 55619-18-6, 72927-94-7, 75-12-7, 79-07-2, 126-73-8 and 127-19-5), the conclusion of the final screening assessments is that the substances do not meet the criteria in section 64 of CEPA 1999.  The Government has proposed to apply the Significant New Activity (SNAc) provisions specified under subsection 81(3) of  CEPA 1999 to two of these substances (CAS No. 6232-56-0 and 79-07-2) so that they are reassessed prior to being manufactured in, or brought into Canada.  The Government will take no further action on the remaining 15 substances which do not meet the criteria in section 64 of CEPA 1999.

Proposed risk management approach documents were also released on August 22, 2009, for the Batch 5 substances for which the screening assessment conclusion is that the substance meets 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 instruments. There is a 60-day public comment period on these proposed risk management approach documents, from August 22, 2009 to October 21, 2009. Information on how to submit comments is provided in the proposed risk management approach documents.

Background

Launch of Batch 5

On February 16, 2008, the Minister of the Environment and the Minister of Health released a Notice in the Canada Gazette for the fifth group of substances identified under the Challenge, entitled: Notice of fifth 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 5" Challenge substances from industry and interested stakeholders, a mandatory survey Notice was issued under section 71 of CEPA 1999. This Notice applied to the 19 substances in Batch 5 of the Challenge.

Industry and interested stakeholders were also invited to complete a voluntary questionnaire or to submit a Declaration of Stakeholder Interest.

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.

Summary of Responses Received for Substances in Batch 5
Approximate Number Type of Response
* Some submissions contained information relating to more than one substance in batch 5.
54* Responses to the mandatory S.71 Notice on batch 5 substances (responses were received relating to 13 substances in the batch)
21 Requests for extension of the deadline for S.71 Notice responses (extension requests were received relating to all 19 substances in the batch)
10 Voluntary submissions of completed Questionnaires for batch 5 substances (questionnaires were received relating to 5 substances in the batch)
52 Expressions of "Stakeholder Interest" in substances in batch 5 (responses were received relating to all 19 substances in the batch)
11* Other submissions (e.g. studies, additional information) (submissions were received relating to 11 substances in the batch)

Release of draft screening assessment reports and risk management scope documents

New information was received from industry or interested stakeholders for all of the 19 substances in Batch 5 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 5 substances was considered by Government officials in the preparation of draft screening assessments and risk management scope documents for these substances.

On February 21, 2009, 19 Notices relating to the release of draft screening assessments for the 19 substances in Batch 5 of the Challenge were published in the Canada Gazette Part I, Vol. 143 No. 8, 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 were 60-day public comment periods associated with these publications. Public comments were submitted on (a) the draft screening assessments, (b) the proposal to pursue one of the measures as specified under subsection 77(2) of CEPA 1999, and c) the risk management scope documents. Links to summaries of the public comments received for specific substances in Batch 5 are provided in Tables A and B below. Some comments were received relating to more general themes, and are summarized in the following table:

Following the close of the public comment periods, all information that was received relating to the draft screening assessments, proposed measures and risk management scopes for Batch 5 substances was considered by Government officials in the preparation of final screening assessments and proposed risk management approach documents for these substances.

Publication of Notice of Intent to amend the Domestic Substances List (DSL) to apply the Significant New Activity (SNAc) provisions of the Canadian Environmental Protection Act, 1999 (CEPA 1999) to one Batch 5 substance

On February 21, 2009, a Notice of intent to amend the Domestic Substances List (DSL) to apply the Significant New Activity (SNAc) provisions specified under subsection 81(3) of the Canadian Environmental Protection Act, 1999 (CEPA 1999) to one of the substances in Batch 5 (CAS No. 6232-56-0), was published in the Canada Gazette, Part I. There was a 60-day public comment period associated with this publication.

A. Two 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 October 3, 2009).

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.

79-06-1 2-Propenamide Next link will take you to another Web site HTML
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115-96-8 Ethanol, 2-chloro-, phosphate (3:1) Next link will take you to another Web site HTML
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B. Seventeen substances which the Government of Canada has concluded DO NOT meet any the criteria in section 64 of CEPA 1999
CAS No. Chemical Substance
Public Summary
Canada Gazette Notice Public Comments Final Screening Assessment
5261-31-4 Propanenitrile, 3-[[2-(acetyloxy)ethyl][4-[(2,6-dichloro-4-nitrophenyl)azo]phenyl]amino]- Next link will take you to another Web site HTML
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6232-56-0 Ethanol, 2-[[4-[(2,6-dichloro-4-nitrophenyl)azo]phenyl]methylamino]- Next link will take you to another Web site HTML
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none Next link will take you to another Web site HTML
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12239-34-8 Acetamide, N-[5-[bis[2-(acetyloxy)ethyl]amino]-2-[(2-bromo-4,6-dinitrophenyl)azo]-4-ethoxyphenyl]- Next link will take you to another Web site HTML
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16421-40-2 Acetamide, N-[5-[[2-(acetyloxy)ethyl](phenylmethyl)amino]-2-[(2-chloro-4,6-dinitrophenyl)azo]-4-methoxyphenyl]- Next link will take you to another Web site HTML
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16421-41-3 Acetamide, N-[5-[[2-(acetyloxy)ethyl](phenylmethyl)amino]-2-[(2,4-dinitrophenyl)azo]-4-methoxyphenyl]- Next link will take you to another Web site HTML
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17464-91-4 Ethanol, 2,2'-[[4-[(2-bromo-6-chloro-4-nitrophenyl)azo]-3-chlorophenyl]imino]bis- Next link will take you to another Web site HTML
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23355-64-8 Ethanol, 2,2'-[[3-chloro-4-[(2,6-dichloro-4-nitrophenyl)azo]phenyl]imino]bis- Next link will take you to another Web site HTML
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26850-12-4 Propanamide, N-[5-[bis[2-(acetyloxy)ethyl]amino]-2-[(2-chloro-4-nitrophenyl)azo]phenyl]- Next link will take you to another Web site HTML
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29765-00-2 Benzamide, N-[5-[bis[2-(acetyloxy)ethyl]amino]-2-[(4-nitrophenyl)azo]phenyl]- Next link will take you to another Web site HTML
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52697-38-8 Acetamide, N-[2-[(2-bromo-4,6-dinitrophenyl)azo]-5-(diethylamino)phenyl]- Next link will take you to another Web site HTML
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55281-26-0 Propanenitrile, 3-[[4-[(2,6-dibromo-4-nitrophenyl)azo]phenyl]ethylamino]- Next link will take you to another Web site HTML
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55619-18-6 Ethanol, 2,2'-[[4-[(2,6-dibromo-4-nitrophenyl)azo]phenyl]imino]bis-, diacetate (ester) Next link will take you to another Web site HTML
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72927-94-7 Benzenamine, 4-[(2,6-dichloro-4-nitrophenyl)azo]-N-(4-nitrophenyl)- Next link will take you to another Web site HTML
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75-12-7 Formamide Next link will take you to another Web site HTML
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79-07-2 Acetamide, 2-chloro- Next link will take you to another Web site HTML
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126-73-8 Phosphoric acid tributyl ester Next link will take you to another Web site HTML
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127-19-5 Acetamide, N,N-dimethyl- Next link will take you to another Web site HTML
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Timelines

Date Substances Affected Activity
16 February 2008 All Batch 5 substances Release of "batch 5" of the Challenge and the accompanying technical documents.
17 June 2008 All Batch 5 substances Deadline for submission of information under the section 71 notice on "batch 5" substances (if no extension granted).
15 August 2008 All Batch 5 substances Deadline for submission of additional information by interested stakeholders, including on the extent and nature of the management/stewardship of "batch 5" substances.
21 February 2009 All Batch 5 substances Publication in Canada Gazette and start of 60-day public comment period on (a) the draft screening assessment, (b) the proposal to pursue one of the measures as specified under subsection 77(2) and (c) the risk management scope documents.
21 February 2009 CAS No. 6232-56-0 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.
22 April 2009 All Batch 5 substances End of 60-day public comment periods
22 August 2009 All Batch 5 substances Publication in Canada Gazette of final assessment decision under subsection 77(6), release of proposed risk management approach documents, and start of 60-day public comment period on the proposed risk management approach documents.
22 August 2009 All Batch 5 substances Publication in Canada Gazette of final assessment decision under subsection 77(6), release of proposed risk management approach documents, and start of 60-day public comment period on the proposed risk management approach documents.
October 3, 2009 CAS No. 79-06-1 and 115-96-8 Publication in Canada Gazette of proposed order adding substances to Schedule 1, and start of 60-day public comment period

Contact Information

Comments or questions should be sent to:

Program Development and Engagement Division
Gatineau (QC) K1A 0H3

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