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Chemical Substances in Batch 4 of the Challenge
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- The Challenge
- Publication of Proposed Order to add certain Batch 4 substances to Schedule 1 of the Canadian Environmental Protection Act, 1999 (CEPA 1999)
- Publication of Order Amending the Domestic Substances List (DSL) to apply the Significant New Activity (SNAc) Provisions of the Canadian Environmental Protection Act, 1999 (CEPA 1999) to five Batch 4 substances
- Release of Final Screening Assessment Reports and Proposed Risk Management Approach Documents for Batch 4 Substances
- Background
- Timelines
- Contact Information
Publication of Proposed Order to add certain Batch 4 substances to Schedule 1 of the Canadian Environmental Protection Act, 1999 (CEPA 1999)
(public comment period October 3, 2009 to December 2, 2009)
On October 3, 2009, the proposed Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999 (CEPA 1999) was published in the Canada Gazette Part I, Vol. 143 No. 40 for three substances in Batch 4 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 October 3, 2009 to December 2, 2009.
Publication of Order Amending the Domestic Substances List (DSL) to Apply the Significant New Activity (SNAc) Provisions of the Canadian Environmental Protection Act, 1999 (CEPA 1999) to five Batch 4 substances
On August 19, 2009 an Order 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 five of the substances in Batch 4 (CAS No. 1154-59-2, 1176-74-5, 64325-78-6, 68443-10-7 and 70776-86-2), was published in the Canada Gazette, Part II.
Canada Gazette Part II: Vol. 143, No. 17 - Order 2009-87-05-03 amending the Domestic Substances List ( PDF Version - 2345 K)
The conclusion of the final screening assessment is that these five 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 five 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 five 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.
Release of Final Screening Assessment Reports and Proposed Risk Management Approach Documents for Batch 4 Substances
On August 1, 2009, 13 Notices relating to the final assessment decisions for the 18 substances in Batch 4 of the Challenge have been published in the Canada Gazette Part I, Vol. 143 No. 31 and the final screening assessments have been released on this web site (see below).
For three of the 18 substances in Batch 4 (CAS No. 64-67-5, 77-78-1 and 68921-45-9), 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 13 of the 18 substances in Batch 4 (CAS No. 115-39-9, 115-40-2, 125-31-5, 17321-77-6, 62625-32-5, 68308-48-5, 79357-73-6, 1154-59-2, 1176-74-5, 64325-78-6, 68443-10-7, 70776-86-2 and 110-54-3), 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.
For the remaining two substances in Batch 4 (CAS No. 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 propane, 2-methyl- containing 1,3-butadiene. A screening assessment of the chemical substances butane and propane, 2-methyl- will be conducted at a later stage in the Chemicals Management Plan to see if additional action is needed.
Proposed risk management approach documents were also released on August 1, 2009 for the Batch 4 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 will be a 60-day public comment period on these proposed risk management approach documents, from August 1, 2009 to September 30, 2009. Information on how to submit comments is provided in the proposed risk management approach documents.
Background
Launch of Batch 4
On November 17, 2007, the Minister of the Environment and the Minister of Health released a Notice in the Canada Gazette on the fourth group of substances identified under the Challenge, entitled: Notice of fourth 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 4" Challenge substances from industry and interested stakeholders, a mandatory survey Notice was issued under section 71 of CEPA 1999. This Notice applied to the 18 substances in Batch 4 of the Challenge.
- Canadian Environmental Protection Act, 1999 (CEPA 1999) section 71 Notice with respect to certain Batch 4 Challenge substances ( PDF Version - 541 K, Word Version - 313 K), eSubmissions)
Industry and interested stakeholders were also invited to complete a voluntary questionnaire or to submit a Declaration of Non-engagement or Stakeholder Interest.
- Declaration of Non-Engagement ( PDF Version - 26 K, Word Version - 56 K)
- Declaration of Stakeholder Interest ( PDF Version - 26 K, Word Version - 56 K, eSubmissions)
- Challenge Questionnaire ( PDF Version - 134 K, Word Version - 394 K, 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.
Release of draft screening assessment reports and risk management scope documents
New information was received from industry or interested stakeholders for all of the 18 substances in "Batch 4" 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 4 substances was considered by Government officials in the preparation of draft screening assessments and risk management scope documents for these substances.
On January 24, 2009, 13 Notices relating to the release of draft screening assessments for the 18 substances in Batch 4 of the Challenge were published in the Canada Gazette Part I, Vol. 143 No. 4 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 4 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 4 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 the Canadian Environmental Protection Act, 1999 (CEPA 1999) to five Batch 4 substances
On January 24, 2009, 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 five of the substances in Batch 4 (CAS No. 1154-59-2, 1176-74-5, 64325-78-6, 68443-10-7 and 70776-86-2), was published in the Canada Gazette, Part I. There was a 60-day public comment period associated with this publication.
- Canada Gazette: Vol. 143, No. 4 - 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 Benzamide, 3,5-dichloro-N-(3,4-dichlorophenyl)-2-hydroxy-; Benzoic acid, 2-[(3,5-dibromo-4-hydroxyphenyl)(3,5-dibromo-4-oxo-2,5-cyclohexadien-1-ylidene)methyl]-, ethyl ester; Adenosine, N-benzoyl-5'-O-[bis(4-methoxyphenyl)phenylmethyl]-2'-deoxy-; Amines, C18-22-tert-alkyl, ethoxylated; and 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,4αβ,10aα)]- ( PDF Version - 1116 K)
The conclusion of the final screening assessment is that these five 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 five 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 five 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.
| CAS No. | Chemical Substance Public Summary |
Canada Gazette Notice | Public Comments | Final Screening Assessment | Proposed Risk Management Approach | Proposed Order1 and RIAS2 |
|---|---|---|---|---|---|---|
|
1 Proposed Order Adding Substances to Schedule 1 to CEPA 1999 (published in Canada Gazette October 3, 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. | ||||||
| 64-67-5 | Sulfuric acid, diethyl ester | HTML PDF |
HTML PDF |
HTML PDF |
HTML PDF |
HTML PDF |
| 77-78-1 | Sulfuric acid, dimethyl ester | HTML PDF |
HTML PDF |
HTML PDF |
HTML PDF |
HTML PDF |
| 68921-45-9 | Benzenamine, N-phenyl-, reaction products with styrene and 2,4,4-trimethylpentene | HTML PDF |
HTML PDF |
HTML PDF |
HTML PDF |
HTML PDF |
| CAS No. | Chemical Substance Public Summary |
Canada Gazette Notice | Public Comments | Final Screening Assessment |
|---|---|---|---|---|
|
* The screening assessment covers butane containing 1,3-butadiene and propane, 2-methyl- containing 1,3-butadiene. The screening assessment on butane and propane, 2-methyl in the absence of 1,3-butadiene will be conducted with the group of substances that are of medium priority for assessment as a result of categorization. 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 |
||||
| 75-28-5* | Propane, 2-methyl- | HTML PDF |
HTML PDF |
HTML PDF |
| 106-97-8* | Butane | HTML PDF |
HTML PDF |
HTML PDF |
Timelines
| Date | Substances Affected | Activity |
|---|---|---|
| 17 November 2007 | All Batch 4 substances | Release of "batch 4" of the Challenge and the accompanying technical documents |
| 18 March 2008 | All Batch 4 substances | Deadline for submission of information under the section 71 notice on "batch 4" substances (if no extension granted) |
| 16 May 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. |
| 24 January 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. |
| 24 January 2009 | CAS No. 1154-59-2, 1176-74-5, 64325-78-6, 68443-10-7, 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 |
| 25 March 2009 | All Batch 4 substances | End of 60-day public comment periods |
| 1 August 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. |
| 19 August 2009 | CAS No. 1154-59-2, 1176-74-5, 64325-78-6, 68443-10-7, 70776-86-2 | Publication in Canada Gazette of order amending the DSL to apply the Significant New Activity provisions of CEPA 1999 |
| 30 September 2009 | CAS No. 64-67-5, 77-78-1 and 68921-45-9 | End of 60-day public comment period on the proposed risk management approach documents |
| 3 October 2009 | CAS No. 64-67-5, 77-78-1 and 68921-45-9 | Publication in Canada Gazette of proposed order adding substance to Schedule 1, and start of 60-day public comment period |
Contact Information
Comments or questions should be sent to:
DSL Surveys Coordinator
Chemicals Management Plan
Gatineau, QC K1A 0H3
E-mail: DSL.surveyco@ec.gc.ca
Telephone: 1-800-567-1999 (in Canada) or 819-953-7156
Fax: 819-953-7155
