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Chemical Substances in Batch 4 of the Challenge

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• Risk Management Action Milestones
• Adding Substances to Schedule 1 of the Canadian Environmental Protection Act
• Applying Significant New Activity (SNAc) Provisions
• Summary of Batch 4 Substances and Publications
• Timelines
• Final Screening Assessments and Risk Management Approaches
• Draft Screening Assessments and Risk Management Scopes
• Launch of Batch 4 and Submissions Received

Risk Management Action Milestones

The Risk Management Action Milestones table outlines the risk management actions that were proposed for each chemical substance in this batch of the Challenge that 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.

Adding Substances to Schedule 1 of the Canadian Environmental Protection Act

Three substances in this batch have been included in final Orders to add to Schedule 1.

• Final Order adding three substances:  Canada Gazette, Part II: Vol. 145, No. 5 - March 2, 2011 ( PDF Version - 2326 K)
  • Corresponding proposed Order:  Canada Gazette, Part I: Vol. 143, No. 40 - October 3, 2009 ( PDF Version - 1057 K)

Applying Significant New Activity (SNAc) Provisions

View the Comprehensive Listing of Substances that are Subject to a Significant New Activity Notice.

Seven substances in this batch have been addressed through the application of Significant New Activity (SNAc) provisions. Two Orders have been published. For additional guidance on submitting information required as part of SNAc notifications, please see the Guidelines for the Notification and Testing of New Substances: Chemicals and Polymers.

• Order amending the Domestic Substances List that applies to two substances: Canada Gazette, Part II: Vol. 147, No. 3 - January 30, 2013 ( PDF Version - 1,270 K)
  • Corresponding Notice of intent: Canada Gazette, Part I: Vol. 145, No. 31 - July 30, 2011 ( PDF Version - 1006 K)
• Order amending the Domestic Substances List that applies to five substances:  Canada Gazette, Part II: Vol. 143, No. 17 - August 19, 2009 ( PDF Version - 2350 K)
  • Corresponding Notice of intent:  Canada Gazette, Part I: Vol. 143, No. 4 - January 24, 2009 ( PDF Version - 1121 K)

Summary of Batch 4 Substances and Publications

Substances that meet one or more criteria in section 64 of the Canadian Environmental Protection Act, 1999

CAS No.	Chemical Substance	Final Order and RIAS	Public Comments on the Proposed Risk Management Approach	Final Screening Assessment	Proposed Risk Management Approach	Public Comments on the Draft Screening Assessment and Risk Management Scope
64-67-5	Diethyl sulfate	HTML  PDF	HTML	HTML  PDF	HTML	HTML
77-78-1	Dimethyl sulfate	HTML  PDF	HTML	HTML  PDF	HTML	HTML
68921-45-9	BNST	HTML  PDF	HTML	HTML  PDF	HTML	HTML

Substances that do not meet any of the criteria in section 64 of the Canadian Environmental Protection Act, 1999

CAS No.	Chemical Substance	Public Comments	Final Screening Assessment
115-39-9	Bromophenol Blue	HTML	HTML  PDF
115-40-2	Bromcresol Purple	HTML	HTML  PDF
125-31-5	Xylenol Blue	HTML	HTML  PDF
1154-59-2	Benzamide, 3,5-dichloro-N-(3,4-dichlorophenyl)-2-hydroxy-(3,3',4',5-tetrachlorosalicylanilide)	None	HTML  PDF
1176-74-5	Benzoic acid, 2-[(3,5-dibromo-4-hydroxyphenyl)(3,5-dibromo-4-oxo-2,5-cyclohexadien-1-ylidene)methyl]-, ethyl ester	None	HTML  PDF
17321-77-6	Clomipramine Hydrochloride	HTML	HTML  PDF
62625-32-5	PBTBO	HTML	HTML  PDF
64325-78-6	Adenosine, N-benzoyl-5 -O-[bis(4-methoxyphenyl)phenylmethyl]-2 -deoxy-	None	HTML  PDF
68308-48-5	ATAEP	HTML	HTML  PDF
68443-10-7	Amines, C18-22-tert-alkyl, ethoxylated	None	HTML  PDF
70776-86-2	2-Butanone, 4-[[[1,2,3,4,4a,9,10,10a-octahydro-1,4a-dimethyl-7-(1-methylethyl)-1-phenanthrenyl]methyl](3-oxo-3-phenylpropyl)amino]-, [1R-(1α,4aβ,10aα)]-	None	HTML  PDF
79357-73-6	ATACP	HTML	HTML  PDF
110-54-3	Hexane	HTML	HTML  PDF

Substances for which the Government of Canada concluded that the exposures to 1,3-butadiene (a substance on Schedule 1 to the Act) identified in the assessment should be considered in relation to ongoing risk management activities undertaken for 1,3-butadiene under CEPA 1999

CAS No.	Chemical Substance	Public Comments	Final Screening Assessment
75-28-5	Isobutane containing 1,3-butadiene	HTML	HTML  PDF
106-97-8	Butane containing 1,3-butadiene	HTML	HTML  PDF

Timelines

Date	Substances Affected	Activity
January 30, 2013	CAS Nos. 64-67-5 and 77-78-1	Publication in Canada Gazette of Order amending the DSL to apply the Significant New Activity provisions of CEPA 1999.
July 30, 2011	CAS Nos. 64-67-5 and 77-78-1	Publication in Canada Gazette of Notice of intent to amend the Domestic Substances List to apply the Significant New Activity provisions of CEPA 1999, and start of 60-day public comment period.
March 2, 2011	CAS Nos. 64-67-5, 77-78-1 and 68921-45-9	Publication in Canada Gazette of final Order adding three substances to Schedule 1.
October 3, 2009	CAS Nos. 64-67-5, 77-78-1 and 68921-45-9	Publication in Canada Gazette of proposed Order adding substances to Schedule 1, and start of 60-day public comment period.
August 19, 2009	CAS Nos. 1154-59-2, 1176-74-5, 64325-78-6, 68443-10-7 and 70776-86-2	Publication in Canada Gazette of Order amending the DSL to apply the Significant New Activity provisions of CEPA 1999.
August 1, 2009	All Batch 4 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.
January 24, 2009	All Batch 4 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.
January 24, 2009	CAS Nos. 1154-59-2, 1176-74-5, 64325-78-6, 68443-10-7 and 70776-86-2	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.
May 16, 2008	All Batch 4 substances	Deadline for submission of additional information by interested stakeholders, including on the extent and nature of the management/stewardship of Batch 4 substances.
March 18, 2008	All Batch 4 substances	Deadline for submission of information under the section 71 Notice on Batch 4 substances (if no extension granted).
November 17, 2007	All Batch 4 substances	Release of Batch 4 of the Challenge and the accompanying technical documents.

Final Screening Assessments and Risk Management Approaches

In August 2009, the final screening assessment reports for this batch were released. Notices relating to this release were published in the  Canada Gazette, Part I: Vol. 143, No. 31 - August 1, 2009 ( PDF Version - 1153 K).

The final screening assessments concluded that three substances in this batch meet one or more criteria in section 64 of the Canadian Environmental Protection Act, 1999 (CEPA 1999). The Government proposed to add these substances to Schedule 1 of the Act. Proposed risk management approach documents were also released on this date for the substances in this batch which met the criteria in section 64 of CEPA 1999. Comments, and the Government's response, relating to general themes are summarized in the Summary of Overarching Public Comments Received on the Proposed Risk Management Approach Documents for Batch 4.

For the remaining two substances in this batch (CAS Nos. 75-28-5 and 106-97-8), the assessment that was conducted evaluated the exposure to and potential risk from 1,3-butadiene in butane containing 1,3-butadiene and isobutane containing 1,3-butadiene. A screening assessment of the chemical substances butane and isobutane will be conducted at a later stage in the Chemicals Management Plan to see if additional action is needed.  For information on ongoing risk management activities for 1,3-butadiene, please refer to the following document: Ongoing Risk Management Activities for 1,3-Butadiene.

Draft Screening Assessment Reports and Risk Management Scopes

New information was received from industry or interested stakeholders for each of the 18 substances in this batch. In January 2009, the draft screening assessment reports were released and the related Notices were published in the  Canada Gazette, Part I: Vol. 143, No. 4 - January 24, 2009 ( PDF Version - 1121 K). Risk management scope documents were also released in conjunction with these publications.

Comments and the Government's response relating to general themes on the draft screening assessment reports and risk management scope documents are summarized in the  Summary of Overarching Public Comments Received on the Government of Canada's Draft Screening Assessment Reports for Batch 4.

Launch of Batch 4 and Submissions Received

Information on substances in this batch was gathered from industry and interested stakeholders through a mandatory survey Notice issued under section 71 of CEPA 1999. They were also invited to complete a voluntary questionnaire.

A Notice related to the launch of Batch 4 was published in November 2007 in the Canada Gazette. The section 71 Notice applied to all 18 substances in this batch.

• Technical information:  Canada Gazette, Part I: Vol. 141, No. 46 - November 17, 2007 ( PDF Version - 541 K)
• Section 71 Notice:  Canada Gazette, Part I: Vol. 141, No. 46 - November 17, 2007 ( PDF Version - 541 K)

Number of Submissions Received for this Batch

Approximate Number	Type of Information Submitted
140	Responses to mandatory section 71 Notice (responses were received relating to 10 substances in the batch)
45	Requests for extension of the deadline for section 71 Notice responses granted
25	Voluntary submissions of Questionnaires (Questionnaires were received relating to six substances in the batch)
85	Expressions of "Stakeholder Interest" (responses were received relating to all substances in the batch)
15	Other submissions (e.g. studies, additional information) (submissions were received relating to all substances in the batch)