Chemical Substances
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Chemical Substances in Batch 2 of the Challenge
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- The Challenge
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Publication of Order Amending the DSL to Apply the SNAc Provisions of CEPA 1999 to Two Batch 2 Substances
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Publication of Proposed Order to add certain Batch 2 substances to Schedule 1 of CEPA 1999
- Background
- Timelines
- Contact Information
Publication of Order Amending the DSL to Apply the SNAc Provisions of CEPA 1999 to Two Batch 2 Substances
On May 27, 2009 an Order amending the Domestic Substances List (DSL) to apply the Significant New Activity (SNAc) provisions specified under subsection 81(3) of CEPA 1999 to two of the substances in Batch 2 (CAS No. 70161-19-2 and 83006-67-1), was published in the Canada Gazette, Part II.
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Canada Gazette Part II: Vol. 143, No. 10 - Order 2009-87-02-01 amending the Domestic Substances List ( PDF)
The conclusion of the final screening assessment is that these two 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 two 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 two 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.
Publication of Proposed Order to add certain Batch 2 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 Bisphenol A, a substance in Batch 2 of the Challenge, which was determined to meet the criteria in section 64 of the Act.
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 another eight substances in Batch 2 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 each of these proposed orders, from May 16, 2009 to July 15, 2009.
Background
Launch of Batch 2
On May 12, 2007, the Minister of the Environment and the Minister of Health released a Notice in the Canada Gazette Part I on the second group of substances identified under the Challenge, entitled: Notice of second 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 2" Challenge substances from industry and interested stakeholders, a mandatory survey Notice was issued under section 71 of CEPA 1999. This Notice applied to 15 of the 17 substances in Batch 2 of the Challenge. The remaining two substances (CAS No. 732-26-3 and 15086-94-9) had been surveyed under a previous section 71 Notice, and the Government had obtained sufficient information that they were not included in the May 2007 Notice.
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CEPA 1999 section 71 Notice with respect to certain Batch 2 Challenge substances identified in the Challenge ( PDF, Word)
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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 Non-engagement or 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 17 substances in "Batch 2" 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 2 substances was considered by Government officials in the preparation of draft screening assessments and risk management scope documents for these substances.
On April 19, 2008, May 17, 2008 and May 24, 2008, 16 Notices relating to the release of draft screening assessments for the 17 substances in Batch 2 of the Challenge were published in the Canada Gazette Part I, Vol. 142 Nos. 16, 20 and 21, 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 2 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 2 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 CEPA 1999 to two Batch 2 substances
On May 24, 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 two of the substances in Batch 2 (CAS No. 70161-19-2 and 83006-67-1), 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. 21 - 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 Benzenesulfonic acid, [(9,10-dihydro-9,10-dioxo-1,4-anthracenediyl) bis(imino-4,1-phenyleneoxy)]bis-, disodium salt and Benzenesulfonic acid, 2,2' -[(9,10-dihydro-5,8-dihydroxy-9,10-dioxo-1,4-anthracenediyl)diimino]bis[5-(1,1-dimethylethyl)-, disodium salt ( PDF)
The conclusion of the final screening assessment is that these two 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 two 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 two 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 either 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.
Release of final screening assessment reports and proposed risk management approach documents for all Batch 2 substances
There were 17 substances in Batch 2 when it was originally released as part of the Challenge on May 12, 2007. The final screening assessment conclusion for one substance in Batch 2, Bisphenol A, was released on October 18, 2008. The final screening assessment conclusions for the remaining 16 substances were published on January 31, 2009. Please see below for more details.
Bisphenol A
On October 18, 2008, a Notice relating to the release of the final screening assessment for bisphenol A (CAS No. 80-05-7), was published in the Canada Gazette Part I, Vol. 142 No. 42 and the final screening assessment report was released on this web site (see below).
The conclusion of the final screening assessment of bisphenol A is that the substance meets 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 this substance to Schedule 1 of the Act.
Remaining 16 Substances of Batch 2
On January 31, 2009, 15 Notices relating to the final assessment decisions for the remaining 16 substances in Batch 2 of the Challenge were published in the Canada Gazette Part I, Vol. 143 No. 5 and the final screening assessment reports were released on this web site (see below). Please note that one Notice covers two closely related substances (CAS No. 70161-19-2 and 83006-67-1).
For eight of the remaining 16 substances in Batch 2 (CAS No. 62-56-6 , 78-79-5, 106-89-8, 541-02-6, 556-67-2, 732-26-3, 1344-37-2, and 12656-85-8), 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. In addition, one of these substances, (CAS No. 732-26-3) has been found to meet the criteria for virtual elimination under subsection 77(4) of the Act, and therefore is being proposed for addition to the Virtual Elimination List.
For the remaining eight substances in Batch 2 (CAS No. 108-05-4, 540-97-6, 2778-42-9, 4474-24-2, 15086-94-9, 70161-19-2, 83006-67-1 and 125351-99-7) 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 October 18, 2008 (for bisphenol A) and on January 31, 2009 (for the remaining eight Batch 2 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 October 18, 2008 to December 17, 2008 (for bisphenol A) and from January 31, 2009 to April 1, 2009 (for the remaining eight substances that meet the criteria in section 64 of CEPA 1999). Information on how to submit comments is provided in the proposed risk management approach documents.
| 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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| 62-56-6 | Thiourea |
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| 78-79-5 | 1,3-Butadiene, 2-methyl |
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| 80-05-7 | Phenol, 4,4′ -(1-methylethylidene)bis- |
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| 106-89-8 | Oxirane, (chloromethyl) |
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| 541-02-6 | Cyclopentasiloxane, decamethyl |
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| 556-67-2 | Cyclotetrasiloxane, octamethyl |
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| 732-26-3 | Phenol, 2,4,6-tris(1,1-dimethylethyl) |
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| 1344-37-2 | C.I. Pigment Yellow 34 |
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| 12656-85-8 | C.I. Pigment Red 104 |
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Timelines
| Date | Substances Affected | Activity |
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| 12 May 2007 | All Batch 2 substances | Release of "batch 2" of the Challenge and the accompanying technical documents |
| 12 September 2007 | All Batch 2 substances | Deadline for submission of information under the section 71 notice on "batch 2" substances (if no extension granted) |
| 13 November 2007 | All Batch 2 substances | Deadline for submission of additional information by interested stakeholders, including on the extent and nature of the management/stewardship of "batch 2" substances. |
| 19 April 2008 | CAS No. 80-05-7 (bisphenol A) | 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. |
| 17 May 2008 | CAS No. 540-97-6, 541-02-6, 556-67-2, 732-26-3, 4474-24-2, 62-56-6, 78-79-5, 106-89-8, 108-05-4, 1344-37-2, 12656-85-8 | 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. |
| 24 May 2008 | CAS No. 2778-42-9, 15086-94-9, 70161-19-2, 83006-67-1, 125351-99-7 | 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). |
| 24 May 2008 | CAS No. 70161-19-2 and 83006-67-1 | 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 October 2008 | CAS No. 80-05-7 (bisphenol A) | 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. |
| 31 January 2009 | The remaining 16 substances in Batch 2 | 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. |
| 17 December 2008 | CAS No. 80-05-7 (bisphenol A) | End of 60-day public comment period |
| 1 April 2009 | CAS No. 62-56-6 , 78-79-5, 106-89-8, 541-02-6, 556-67-2, 732-26-3, 1344-37-2, and 12656-85-8 | End of 60-day public comment period |
| May 16, 2009 | CAS No. 62-56-6 , 78-79-5, 80-05-7, 106-89-8, 541-02-6, 556-67-2, 732-26-3, 1344-37-2, and 12656-85-8 | Publication in Canada Gazette of proposed order adding substances to Schedule 1, and start of 60-day public comment period |
| July 15, 2009 | CAS No. 62-56-6 , 78-79-5, 80-05-7, 106-89-8, 541-02-6, 556-67-2, 732-26-3, 1344-37-2, and 12656-85-8 | End of 60-day public comment period |
| May 27, 2009 | CAS No. 70161-19-2 and 83006-67-1 | 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
E-mail: DSL.surveyco@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
