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Chemical Substances in Batch 4 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 this batch of the Challenge that met the criteria of section 64 of the Canadian Environmental Protection Act, 1999 (CEPA 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

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

Applying Significant New Activity Provisions

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

Two Orders have been published addressing seven substances in this batch through the application of Significant New Activity (SNAc) provisions.

In January 2017, a Notice of intent to amend the Domestic Substances List (DSL) to vary the SNAc requirements for diethyl sulfate (CAS RN 64-67-5) and dimethyl sulfate (CAS RN 77-78-1) was published in the Canada Gazette, Part I. The proposed amendments are an outcome of the SNAc Review. The DSL amendments are not in force until the final Order is adopted by the Minister of the Environment pursuant to subsection 87(3) of CEPA 1999. The final Order will be published in the Canada Gazette, Part II. Any current SNAc requirements remain in effect until such time as the final Order is 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.

Summary of Batch 4 Substances and Publications

Substances that meet one or more criteria in section 64 of CEPA 1999
CAS RN 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
Table 1 footnotes
Table 1 footnote 1

BNST has been re-assessed with other substituted diphenylamine substances in the Substance Grouping Initiative based on new information obtained after its original assessment and structural similarity to these substances.

Return to table 1 footnote 1 referrer

64-67-5 Diethyl sulfate
 PDF
77-78-1 Dimethyl sulfate
68921-45-9Table 1 footnote 1 BNST
Substances that do not meet any of the criteria in section 64 of CEPA 1999
CAS RN Chemical Substance Public Comments Final Screening Assessment
115-39-9 Bromophenol Blue
115-40-2 Bromcresol Purple
125-31-5 Xylenol Blue
1154-59-2 Benzamide, 3,5-dichloro-N-(3,4-dichlorophenyl)-2-hydroxy-(3,3',4',5-tetrachlorosalicylanilide) None
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
17321-77-6 Clomipramine Hydrochloride
62625-32-5 PBTBO
64325-78-6 Adenosine, N-benzoyl-5 -O-[bis(4-methoxyphenyl)phenylmethyl]-2 -deoxy- None
68308-48-5 ATAEP
68443-10-7 Amines, C18-22-tert-alkyl, ethoxylated None
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
79357-73-6 ATACP
110-54-3 Hexane  HTML
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 RN Chemical Substance Public Comments Final Screening Assessment
75-28-5 Isobutane containing 1,3-butadiene  HTML
106-97-8 Butane containing 1,3-butadiene
Timelines
Date Substances Affected Activity
January 14, 2017 CAS RNs 64-67-5 and 77-78-1 Publication in the Canada Gazette of a Notice of intent to amend the DSL to vary the SNAc requirements, and start of 60-day public comment period.
December 2017 CAS RN 68921-45-9 Anticipated publication in Canada Gazette of the final screening assessment decision under section 68 and subsection 77(6) of CEPA 1999 on 14 substituted diphenylamine substances.
February 8, 2017 CAS RN 68921-45-9 Deadline for submission of public comments on the draft screening assessment for the 14 substituted diphenylamines (SDPAs) and consultation document on BNST.
December 10, 2016 CAS RN 68921-45-9 Publication in Canada Gazette and start of 60-day public comment period on the draft screening assessment of 14 SDPAs and consultation document on BNST.
January 30, 2013 CAS RNs 64-67-5 and 77-78-1 Publication in Canada Gazette of Order amending the DSL to apply the SNAc provisions of CEPA 1999.
July 30, 2011 CAS RNs 64-67-5 and 77-78-1 Publication in Canada Gazette of Notice of intent to amend the DSL to apply the SNAc provisions of CEPA 1999, and start of 60-day public comment period.
March 2, 2011 CAS RNs 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 RNs 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 RNs 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 SNAc 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 RNs 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 SNAc 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.

Benzenamine, N-phenyl-, reaction products with styrene and 2,4,4-trimethylpentene (BNST): CAS RN 68921-45-9

BNST is a substituted diphenylamine (SDPA) that was assessed in 2009. Subsequent to the publication of that assessment, other SDPAs were identified for assessment based on their potential risks to the environment and their similarity with BNST. Significant new information also became available regarding the inherent toxicity and bioaccumulation potential of these substances, which brought into question the validity of the previous assessment conclusion for BNST. As a result, BNST has been re-assessed with these other SDPAs as part of the Substance Groupings Initiative of the Chemical Management Plan. In December 2016, the draft screening assessment was released and the related Notice was published in the Canada Gazette, Part I: Vol. 150, No. 50 - December 10, 2016 (PDF Version - 3,980 K). The draft screening assessment proposes to conclude that none of the 14 SDPAs assessed poses a risk to the environment or to human health and, therefore, does not meet any of the criteria under section 64 of CEPA 1999. This proposed conclusion applies to BNST, which was considered among the 14 SDPAs, and which had previously been found to meet the criteria set out in section 64 (b) of CEPA 1999 in its 2009 screening assessment. There is a 60-day public comment period associated with this publication. Given the proposed change in conclusion for BNST and potential implications to the regulatory requirements for this substance, the Government of Canada also published a consultation document on the proposed approach regarding future regulatory amendments for BNST. The consultation document on BNST is also subject to the 60-day public comment period. A final screening assessment for SDPAs, including BNST, will be published following the public comment period and further assessment. The Government of Canada will base any modification to existing risk management measures, if needed, on the findings of the final screening assessment and consultations with stakeholders on the proposed approach for BNST in advance of its 2018 regulatory deadline.

Final Screening Assessments and Risk Management Approaches

In August 2009, the final screening assessments 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 - 1,153 K).

The final screening assessments concluded that three substances in this batch meet one or more criteria in section 64 of 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.

For the remaining two substances in this batch (CAS RNs 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 Assessments 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 assessments were released and the related Notices were published in the  Canada Gazette, Part I: Vol. 143, No. 4 - January 24, 2009 (PDF Version - 1,121 K). Risk management scope documents were also released in conjunction with these publications.

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.

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 (for example, studies, additional information)
(submissions were received relating to all substances in the batch)