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Chemical Substances in Batch 3 of the Challenge
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- The Challenge
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Publication of Proposed Order to add certain Batch 3 substances to Schedule 1 of CEPA 1999
- Background
- Timelines
- Contact Information
Publication of Proposed Order to add certain Batch 3 substances to Schedule 1 of CEPA 1999
(public comment period May 16, 2009 to July 15, 2009)
On May 16, 2009, 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. 143 No. 20, for four substances in Batch 3 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 May 16, 2009 to July 15, 2009.
Background
Launch of Batch 3
On August 18, 2007, the Minister of the Environment and the Minister of Health released a Notice in the Canada Gazette on the third group of substances identified under the Challenge, entitled: Notice of third 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 3" 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 3 of the Challenge.
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CEPA 1999 section 71 Notice with respect to certain Batch 3 Challenge substances
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Guidance Document for completing the CEPA section 71 Notice ( PDF, Word)
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Declaration of Non-Engagement ( PDF, Word)
Industry and interested stakeholders were also invited to complete a voluntary questionnaire or to submit a Declaration of Stakeholder Interest.
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Declaration of Stakeholder Interest ( PDF, Word)
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Challenge Questionnaire ( PDF, Word)
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Guidance Document for completing the Challenge Questionnaire ( PDF)
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 19 substances in "Batch 3" 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 3 substances was considered by Government officials in the preparation of draft screening assessments and risk management scope documents for these substances.
On August 23, 2008, 17 Notices relating to the release of draft screening assessments for the 19 substances in Batch 3 of the Challenge were published in the Canada Gazette Part I, Vol. 142 No. 34 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 3 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 periods, all information that was received relating to the draft screening assessments, proposed measures and risk management scopes for Batch 3 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 DSL to apply the SNAc provisions of CEPA 1999 to three Batch 3 substances
On August 23, 2008, a Notice of intent to amend the DSL to apply the Significant New Activity (SNAc) provisions specified under subsection 81(3) of CEPA 1999 to three of the substances in Batch 3 (CAS No. 4395-65-7, 60352-98-9 and 74336-60-0), was published in the Canada Gazette, Part I. There was a 60-day public comment period associated with this publication.
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Canada Gazette: Vol. 142, No. 34 - Notice of intent to amend the Domestic Substances List under subsection 87(3) of the Canadian Environmental Protection Act, 1999 to indicate that subsection 81(3) of the Act applies to 9,10-Anthracenedione, 1-amino-4-(phenylamino)- , 1-Propanaminium, 3-[[4-[(2,4-dimethylphenyl)amino]-9,10-dihydro-9,10-dioxo-1-anthracenyl]amino]-N,N,N-trimethyl-, methylsulfate and 9,10-Anthracenedione, 1-[(5,7-dichloro-1,9-dihydro-2-methyl-9-oxopyrazolo[5,1-b]quinazolin-3-yl)azo] - ( PDF)
The conclusion of the final screening assessment is that these three substances are currently not entering, or likely to enter, the environment as a result of commercial activity, and therefore that they do not meet the criteria set out in section 64 of the CEPA 1999.
However, given the hazardous properties of these "PBiT" (persistent, bioaccumulative and inherently toxic to non-human organisms) substances, there is concern that new activities for the three substances which have not been identified or assessed under CEPA 1999 could lead to the substances meeting the criteria set out in section 64 of the Act. Therefore it was recommended that the three substances be subject to the SNAc 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 substance being introduced into Canada.
Publication of Notice of intent to amend the DSL to apply the SNAc provisions of CEPA 1999 to an additional Batch 3 substance
For one additional substance in Batch 3 (CAS No. 111-15-9), the proposed conclusion of the draft screening assessment is that the substance does not meet the criteria set out in section 64 of CEPA 1999.
However, given this substance has been classified by the European Commission on the basis of reproductive and developmental toxicity, 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 assessment 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 Ethanol, 2-ethoxy-, acetate (2-ethoxyethanol acetate, 2-EEA) was published in the Canada Gazette Vol. 143, No. 10 on March 7, 2009.
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Canada Gazette: Vol. 143, No. 10 - Notice of intent to amend the Domestic Substances Listunder subsection 87(3) of the Canadian Environmental Protection Act, 1999 to indicate that subsection 81(3) of the Act applies to Ethanol, 2-ethoxy-, acetate (2-ethoxyethanol acetate, 2-EEA) ( PDF)
There was a 60-day public comment period (from March 7, 2009 to May 6, 2009) associated with this Canada Gazette Notice.
Release of Final Screening Assessment Reports and Proposed Risk Management Approach Documents for Batch 3 Substances
On March 7, 2009, Notices relating to the final assessment decisions for the 19 substances in Batch 3 of the Challenge were published in the Canada Gazette Part I, Vol. 143 No. 10 and the final screening assessment reports were released on this web site (see below).
For four of the 19 substances in Batch 3 (CAS No. 110-49-6, 111-77-3, 1589-47-5, 2425-85-6), 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 15 substances in Batch 3 (CAS No. 81-68-5, 111-15-9, 1594-08-7, 2814-77-9, 3468-63-1, 4395-65-7, 6410-09-9, 6410-13-5, 6410-41-9, 6471-01-8, 20241-76-3, 25155-25-3, 60352-98-9, 72243-90-4, 74336-60-0), 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 three of these substances (4395-65-7, 60352-98-9 and 74336-60-0) so that they are reassessed prior to being manufactured in, or brought into Canada. The Government will take no further action on the remaining 12 substances which do not meet the criteria in section 64 of CEPA 1999.
Proposed risk management approach documents were also released on March 7, 2009 for the Batch 3 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 March 7, 2009 to May 6, 2009.
| CAS No. |
Chemical Substance Public Summary |
Canada Gazette Notice | Public Comments | Final Screening Assessment | Proposed Risk Management Approach | Proposed order1 and RIAS2 |
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1 Proposed order adding substances to Schedule 1 to CEPA 1999 (published in Canada Gazette May 16, 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. |
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| 110-49-6 | Ethanol, 2-methoxy-, acetate |
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| 111-77-3 | Ethanol, 2-(2-methoxyethoxy)- |
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| 1589-47-5 | 1-Propanol, 2-methoxy- |
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| 2425-85-6 | 2-Naphthalenol, 1-[(4-methyl-2-nitrophenyl)azo]- |
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Publication of Order Amending the DSL to Apply the SNAc Provisions of CEPA 1999 to Three Batch 3 Substances
On March 18, 2009, an Order amending the DSL to apply the SNAc provisions specified under subsection 81(3) of CEPA 1999 to three of the substances in Batch 3 (CAS No. 4395-65-7, 60352-98-9 and 74336-60-0), was published in the Canada Gazette, Part II.
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Canada Gazette Part II: Vol. 143, No. 6 - Order 2009-87-01-01 amending the Domestic Substances List ( PDF)
The conclusion of the final screening assessment is that these three substances are currently not entering, or likely to enter, the environment as a result of commercial activity, and therefore that they do not meet the criteria set out in section 64 of the CEPA 1999.
However, given the hazardous properties of these "PBiT" (persistent, bioaccumulative and inherently toxic to non-human organisms) substances, there is concern that new activities for the three substances which have not been identified or assessed under CEPA 1999 could lead to the substances meeting the criteria set out in section 64 of the Act. Therefore the DSL has been amended, and these three substances are now subject to the SNAc provisions specified under subsection 81(3) of the Act, which require 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 substance being introduced into Canada.
Timelines
| Date | Substances Affected | Activity |
|---|---|---|
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18 August 2007 |
All Batch 3 substances |
Release of "batch 3" of the Challenge and the accompanying technical documents |
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18 December 2007 |
All Batch 3 substances |
Deadline for submission of information under the section 71 notice on "batch 3" substances (if no extension granted) |
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19 February 2008 |
All Batch 3 substances |
Deadline for submission of additional information by interested stakeholders, including on the extent and nature of the management/stewardship of "batch 3" substances. |
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23 August 2008 |
All Batch 3 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. |
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23 August 2008 |
CAS No. 4395-65-7, 60352-98-9 and 74336-60-0 |
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. |
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22 October 2008 |
All Batch 3 substances |
End of 60-day public comment periods |
| 7 March 2009 | All Batch 3 substances | Publication in Canada Gazette of final assessment decision under subsection 77(6), release of proposed risk management approach document, and start of 60-day public comment period on the proposed risk management approach document. |
| 7 March 2009 | CAS No. 111-15-9 | 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. |
| 18 March 2009 | CAS No. 4395-65-7, 60352-98-9 and 74336-60-0 | Publication in Canada Gazette of Order amending the DSL to apply the Significant New Activity provisions of CEPA 1999 |
| 6 May 2009 | CAS No. 110-49-6, 111-77-3, 1589-47-5 and 2425-85-6 | End of 60-day public comment period on the proposed risk management approach document. |
| 6 May 2009 | CAS No. 111-15-9 | End of 60-day public comment period on the Notice of intent to apply the Significant New Activity provisions of CEPA 1999. |
| 16 May 2009 | CAS No. 110-49-6, 111-77-3, 1589-47-5 and 2425-85-6 | Publication in Canada Gazette of proposed order adding substances to Schedule 1, and start of 60-day public comment period. |
| 15 July 2009 | CAS No. 110-49-6, 111-77-3, 1589-47-5 and 2425-85-6 | End of 60-day public comment period. |
| Anticipated in fall, 2009 | CAS No. 111-15-9 | Publication in Canada Gazette of order amending the DSL to apply the Significant New Activity provisions of CEPA 1999. |
Contact Information
Comments or questions should be sent to:
Existing Substances Program
Gatineau, QC K1A 0H3
Email: Existing.Substances.Existantes@ec.gc.ca
Tel: 1-888-228-0530 (in Canada) or 819-956-9313
Fax: 1-800-410-4314 (in Canada) or 819-953-4936
