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Chemical Substances in Batch 8 of the Challenge
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- The Challenge
News Release - January 30, 2010- Orders Amending the Domestic Substances List to Apply the Significant New Activity Provisions of the Canadian Environmental Protection Act, 1999 to Three Batch 8 Substances
- Final Screening Assessment Reports and Proposed Risk Management Approach Documents for Batch 8 Substances
- Summary of Batch 8 Substances and Publications
- Background
- Timelines
- Stakeholder Information Workshops on the Challenge
Orders Amending the Domestic Substances List to Apply the Significant New Activity Provisions of the Canadian Environmental Protection Act, 1999 to Three Batch 8 Substances
On August 18, 2010, two Orders 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) to three substances in Batch 8 of the Challenge (CAS No. 626-39-1, 944-61-6 and 68551-44-0), were published in the Canada Gazette, Part II.
- Canada Gazette Part II: Vol. 144, No. 17 - Order 2010-87-07-01 amending the Domestic Substances List ( PDF Version - 1625 K)
- Canada Gazette Part II: Vol. 144, No. 17 - Order 2010-87-07-02 amending the Domestic Substances List ( PDF Version - 1625 K)
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 or from other sources, and therefore that they do not meet the criteria set out in section 64 of 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.
Final Screening Assessment Reports and Proposed Risk Management Approach Documents for Batch 8 Substances
On July 31, 2010, 11 Notices relating to the final assessment decisions for 13 of the 14 substances in Batch 8 of the Challenge were published in the Canada Gazette Part I, Vol. 144, No. 31 and the final screening assessments have been released on this web site (see below).
For four of the substances in Batch 8 (CAS No. 79-46-9, 88-72-2, 17540-75-9 and 72102-55-7 ), 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 Ministers are proposing to add these substances to Schedule 1 of the Act.
For nine of the remaining ten substances in Batch 8 (CAS No. 75-52-5, 139-13-9, 626-39-1, 2215-35-2, 25013-16-5, 944-61-6, 68551-44-0, 70331-94-1 and 75768-65-9), 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 (CAS No. 626-39-1, 944-61-6 and 68551-44-0) so that they are reassessed prior to being manufactured in, or brought into Canada. The Government will take no further action on the remaining six substances which do not meet the criteria in section 64 of CEPA 1999.
For the remaining substance in Batch 8 (CAS No. 65140-91-2), new information was received during the public comment period, and further assessment will be conducted on this substance. A draft screening assessment report will be published on October 2, 2010, when the Batch 11 draft screening assessments are published.
Proposed risk management approach documents were also released on July 31, 2010 for the Batch 8 substances for which the screening assessment conclusion is that the substances meet one or more of the criteria in section 64 of CEPA 1999. These proposed risk management approach documents build on the previously released risk management scope documents, and outlines, in more depth, the risk management actions for these substances, including the choice of instruments. There will be a 60-day public comment period on the proposed risk management approach documents, from July 31, 2010 to September 29, 2010. Information on how to submit comments is provided in the proposed risk management approach documents (see below).
Summary of Batch 8 Substances and Publications
| CAS No. | Chemical Substance Public Summary |
Canada Gazette Notice | Public Comments | Final Screening Assessment | Proposed Risk Management Approach |
|---|---|---|---|---|---|
| 79-46-9 | Propane, 2-nitro- | HTML PDF |
HTML |
HTML |
HTML |
| 88-72-2 | Benzene, 1-methyl-2-nitro- | HTML PDF |
HTML |
HTML |
HTML |
| 17540-75-9 | Phenol, 2,6-bis(1,1-dimethylethyl)-4-(1-methylpropyl)- | HTML PDF |
HTML |
HTML |
HTML |
| 72102-55-7 | Methylium, [4-(dimethylamino)phenyl]bis[4-(ethylamino)-3-methylphenyl]-, acetate | HTML PDF |
HTML |
HTML |
HTML |
| CAS No. | Chemical Substance Public Summary |
Canada Gazette Notice | Public Comments | Final Screening Assessment |
|---|---|---|---|---|
| 1 Further assessment is being conducted on this substance, and a revised draft screening assessment report will be published on October 2, 2010. | ||||
| 65140-91-21 | Phosphonic acid, [[3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl]methyl]-, monoethyl ester, calcium salt (2:1) | none | HTML |
none |
Background
Launch of Batch 8
On January 31, 2009, the Minister of the Environment and the Minister of Health released a Notice in the Canada Gazette for the eighth group of substances identified under the Challenge, entitled: Notice of eighth 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 8 Challenge substances from industry and interested stakeholders, a mandatory survey Notice was issued under section 71 of the Canadian Environmental Protection Act, 1999 (CEPA 1999). This Notice applied to the 14 substances in Batch 8 of the Challenge.
- Canadian Environmental Protection Act, 1999 (CEPA 1999) section 71 Notice with respect to certain Batch 8 Challenge substances ( PDF Version - 1057 K)
- Guidance Document for completing the Canadian Environmental Protection Act, 1999 section 71 Notice
- Declaration of Non-Engagement ( eSubmissions)
Industry and interested stakeholders were also invited to complete a voluntary questionnaire or to submit a Declaration of Stakeholder Interest.
- Challenge Questionnaire
- Guidance Document for responding to the Questionnaire
- Declaration of Stakeholder Interest ( eSubmissions)
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.
| Approximate Number | Type of Response |
|---|---|
| 32 | Responses to the mandatory section 71 Notice on Batch 8 substances (responses were received relating to 11 substances in the batch) |
| 8 | Requests for extension of the deadline for section 71 Notice responses granted |
| 7 | Voluntary submissions of Questionnaires for Batch 8 substances (Questionnaires were received relating to 5 substances in the batch) |
| 44 | Expressions of "Stakeholder Interest"in substances in Batch 8 (responses were received relating to 14 substances in the batch) |
| 24 | Other submissions (e.g. studies, additional information) (submissions were received relating to 10 substances in the batch) |
Notice of Intent to Amend the Domestic Substances List to Apply the Significant New Activity Provisions of the Canadian Environmental Protection Act, 1999 to Four Batch 8 Substances
On January 30, 2010, 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 four of the substances in Batch 8 (CAS No. 626-39-1, 944-61-6, 65140-91-2 and 68551-44-0), was published in the Canada Gazette, Part I. There was a 60-day public comment period associated with this publication.
- Canada Gazette: Vol. 144, No. 5 - 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 this Act applies to four substances ( PDF Version - 1310 K)
Draft Screening Assessment Reports and Risk Management Scope Documents
New information was received from industry or interested stakeholders for all of the 14 substances in Batch 8 of the Challenge. All information that was received further to the publication of the section 71 survey Notice, the voluntary questionnaire and the substance profiles for Batch 8 substances has been considered in the preparation of draft screening assessments and risk management scope documents for these substances.
On January 30, 2010, 11 Notices relating to the release of draft screening assessments for the 14 substances in Batch 8 of the Challenge were published in the Canada Gazette Part I, Vol. 144 No. 5 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 was a 60-day public comment period 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 the Canadian Environmental Protection Act, 1999 (CEPA 1999), and (c) the risk management scope documents. Links to summaries of the public comments received for specific substances in Batch 8 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 period, all information that was received relating to the draft screening assessments, proposed measures and risk management scopes for Batch 8 substances was considered in the preparation of final screening assessments and proposed risk management approach documents for these substances.
Timelines
| Date | Substances Affected | Activity |
|---|---|---|
| 31 January 2009 | All Batch 8 substances | Release of Batch 8 of the Challenge and the accompanying technical documents. |
| 2 June 2009 | All Batch 8 substances | Deadline for submission of information under the section 71 notice on Batch 8 substances (if no extension granted). |
| 31 July 2009 | All Batch 8 substances | Deadline for submission of additional information by interested stakeholders, including on the extent and nature of the management/stewardship of Batch 8 substances. |
| 30 January 2010 | All Batch 8 substances | Publication in Canada Gazette and start of 60-day public comment period on (a) the draft screening assessment, (b) the new information received, (c) the proposal to pursue one of the measures as specified under subsection 77(2) and (d) the risk management scope documents. |
| 30 January 2010 | CAS No. 626-39-1, 944-61-6, 65140-91-2 and 68551-44-0 | Publication in Canada Gazette of Notice of intent to amend the Domestic Substances List to apply the Significant New Activity provisions of the Canadian Environmental Protection Act, 1999 and start of 60-day public comment period. |
| 31 March 2010 | All Batch 8 substances | End of 60-day public comment periods. |
| 31 July 2010 | 13 of 14 substances in Batch 8 | Publication in Canada Gazette of final assessment decision under subsection 77(6), release of Government's proposed risk management approach document, and start of 60-day public comment period on the proposed risk management approach document. |
| 18 August 2010 | CAS No. 626-39-1, 944-61-6 and 68551-44-0 | Publication in Canada Gazette of order amending the DSL to apply the Significant New Activity provisions of CEPA 1999 to three Batch 8 substances. |
| 29 September 2010 | CAS No. 79-46-9, 88-72-2, 17540-75-9 and 72102-55-7 | End of 60-day public comment period on the proposed risk management approach documents. |
| Anticipated in Fall 2010 | CAS No. 79-46-9, 88-72-2, 17540-75-9 and 72102-55-7 | Publication in Canada Gazette of proposed Order adding substances to Schedule 1, and start of 60-day public comment period. |
| Anticipated on 2 October 2010 | CAS No. 65140-91-2 | Publication in Canada Gazette and start of 60-day public comment period on (a) the draft screening assessment, (b) the new information received, (c) the proposal to pursue one of the measures as specified under subsection 77(2) and (d) the risk management scope documents (if applicable). |
Stakeholder Information Workshops on the Challenge
The Government of Canada regularly hosts stakeholder information workshops to help further explain the Challenge, the associated documentation and how to participate.
For information on the latest stakeholder information workshops on the Challenge, please click on the following link:
If you have questions or comments, please contact us.
