| Comment (source) | Response |
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| Interest expressed on a substance not currently manufactured or imported over the threshold of 100kg per year. 1 |
No information was submitted to the effect that uses that would be covered under the proposed Significant New Activity description exist. The government will proceed as planned.
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| Information submitted for substance with CAS No. 71832-83-2 supporting the conclusion that the substance should not be classified as inherent toxic to aquatic organisms or bioaccumulative 2
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The Government is conducting a separate screening assessment with respect to that substance due to the change in categorization decision. The final assessment report will be released later this year.
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| Substance with CAS No. 13080-86-9 should not be included in the SNAC list. Activities covered by the SNAc description exist. 3
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In light of the new information received, the substance is recommended for addition to the Challenge program.
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| Substance with CAS No. 71032-95-6 should not be included in the SNAC list. Activities covered by the SNAc description exist. 5
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In light of the new information received, the substance is recommended for addition to the Challenge program.
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| Since the review of CEPA 1999 is underway, the government should seek an amendment which would allow substances to be deleted from the DSL in these and other appropriate circumstances (substances with SNAc proposal). 4
Recommendation: The Government of Canada should seek an amendment to CEPA'99 which would allow substances that are no longer in Canadian commerce to be deleted from the DSL. 4
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Such a provision does not exit under current legislation.
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| Limitations of the survey: Creates the possibility that substances manufactured or imported in some year other than 2005, or in amounts smaller than 100 kg, continue to pose a hazard in Canada. 4
Recommendation: Any existing or ongoing uses of the 148 substances which were not captured by the 2006 survey should be considered "new" and subject to the New Substances Notification Regulations (Chemicals and polymers) (NSNR) requirements. Before and until such time as they have received approval under the NSNR, government should impose mandatory risk management measures to eliminate these uses from the Canadian market. 4
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All substances subject to the current proposal had no report of import or manufacture for the year 2005. Users of the substance are also targeted by the Significant New Activity provisions and will also have to provide information in order to start a new activity.
Stakeholders had the opportunity to express interest in a substance if a substance was imported, manufactured or used in years other than 2005. Substances with no report under the survey but that have been flagged as of interest have been included in the Challenge program.
The 100kg per year threshold was used because it is the same threshold that generally triggers notifications under the New Substances Program.
Appropriate risk management activities will apply where necessary based on future notification and assessment conclusion.
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| More transparency in the NSNR assessment process. The public is not informed of new notifications, nor is the public typically given the opportunity to comment on draft risk assessment reports before final decisions are made. 4
Recommendation: The Government of Canada should establish a process to enhance public transparency and participation in any notification to the NSNR involving these 148 substances. The public should be informed of any notifications and have the opportunity to comment on draft assessments before final decisions are made regarding the use of these substances at any quantity. 4
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The New Substances Program has initiated the development of a process for a pilot project for periodic review of its assessment reports by groups outside the New Substances Program. This pilot project will involve the review of New Substances Notification assessments by a panel of stakeholders (i.e. industry, NGO and government).
The New Substances Program will consider publication of assessment report summaries if any Significant New Activity is notified for any of these 145 substances. This will provide an opportunity to stakeholders to comment on assessment conclusions and associated control actions.
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| The SNAc notice goes on to indicate that, prior to the commencement of the proposed new activity, notifiers should submit the NSNR information requirements contained in Schedule 4, Item 8 of Schedule 5 and Item 11 of Schedule 6. Accordingly, should industry seek to (re)introduce the substances onto the market at quantities above 100 kg, they could be allowed to do so without submitting any test data whatsoever. 4
Recommendation: Given the Hazardous properties of these substances, the SNAc notice should define any activity involving these substances to be new, not merely those activities in excess of 100 kg/year. 4
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The 100 kg per year threshold is the same threshold used to determine whether a substance is imported, manufactured or used in Canada in the Section 71 notice under CEPA 1999. It is also the same threshold that generally triggers notifications under the New Substances Program.
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| Government has indicated that "considering the hazardous profile of these substances, there is limited possibility that they would be reintroduced". However, given the fact that 1) government conducted its categorization and screening assessment without requiring any new test data, and 2) these substances are already believed to be highly hazardous, there should be no opportunity for continued use without industry demonstrating through scientific testing that the substances are safe. 4
Recommendation: These 148 substances should not be approved for import, manufacture, or use unless industry can demonstrate their safety through scientific testing. At a minimum, industry should be required to submit testing data equivalent to the highest schedule for non-NDSL substances under the NSNR. Additionally, notifiers should be required to submit data on chronic toxicity, endocrine toxicity, neurodevelopmental toxicity, as well as information regarding safer alternatives. 4
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The requirement for information to be submitted as part of a Significant New Activity Notification has been modified to include all testing data pertaining to human health as specified in Schedule 6 to the New Substances Notification Regulations (Chemicals and Polymers).
Testing data for environmental endpoint are not requested in the SNAc Order, since information available to the New Substances Program allows assessment of the 145 substances as Persistent, bioaccumulative and inherently toxic (PBiT).
If the PBiT profile of these substances is not changed during the risk assessment process and there are anticipated releases, appropriate control measures will be recommended, however, each SNAN or notice will be considered in a case by case basis.
The New Substances Program operates under the information requirements specified in the SNAc. If the information in the Significant New Activity Notification is insufficient, Section 84 (c) of CEPA (1999) enables the New Substances Program to request additional information to determine whether the substance is "toxic" or capable of becoming "toxic" under the Act. After a submission of a new information, the assessment process is resumed and risk management measures can be taken, if necessary.
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