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Summary of Overarching Public Comments received on

the Draft Screening Assessment Reports and Risk Management Scopes on the Challenge substances in Batch 9


(PDF Version - 25 KB)

Overarching comments on the draft screening assessment reports for Batch 9 to be addressed as part of the Chemicals Management Plan Challenge were provided by Chemical Sensitivities Manitoba and the Canadian Environmental Law Association, and Inuit Tapiriit Kanatami (ITK).

A summary of comments and responses is included below, organized by topic:

Summary of comments and responses
TopicCommentResponse
Significant New ActivitiesThe government should reconsider its proposal to apply Significant New Activity provisions (SNAcs) to five substances in Batch 9, CAS Registry Numbers 475-71-8, 1326-05-2, 14295-43-3, 38465-55-3 and 58161-93-6 which are hazardous, but not currently in use in Canada . These substances should be instead designated as meeting the criteria set out in section 64 of CEPA 1999.These five substances had no report of import, use or manufacture for the year 2006; the potential for exposure is already very low, therefore they do not meet the criteria set out in section 64 of CEPA 1999. The application of the Significant New Activity provisions under CEPA 1999 would require that any proposed new manufacture, import or use be subject to further assessment, and would determine if the new activity requires further risk management consideration. The SNAcprovisions will prevent any new activity in relation to these substances that may result in them meeting the criteria set out under section 64.
 With the reporting threshold for the section 71 Notices set at 100 kg/year, the surveys conducted cannot account for the number of possible users that fall below the threshold and who are not required to respond to the survey.Stakeholders not subject to the section 71 Notice (i.e., that fall below the reporting threshold for the reporting year) are strongly encouraged to inform the Government of Canada of their activities relating to substances by responding to the Challenge Questionnaire. When such information is received, it is considered in the screening assessment as well as in the development of the risk management documents. The threshold of 100 kg is consistent with requirements under the new substances notification regulations.
 Toxicity information would be minimal under a Significant New Activity notification as applicants will not be required to submit data for chronic toxicity, endocrine disruption, or neurodevelopmental toxicity. Revisions to the New Substances program are needed for assessment of chemicals that are listed under the Domestic Substances List (DSL) and found to meet the criteria outlined for categorization.If a Significant New Activity notification was submitted, the onus would be on the notifier to submit new reliable/credible information that indicates that it is not harmful to human health or the environment. The New Substances Program operates under the information requirements specified in the Significant New Activity provisions. If the information in the Significant New Activity Notification is insufficient, Section 84 (1)(c) of CEPA 1999enables the Minister of the Environment, under certain conditions, to request additional information to determine whether the substance is not harmful to human health or the environment or capable of becoming harmful. After a submission of new information, the assessment process is resumed and appropriate risk management measures can be taken, if necessary.
 The application of the Significant New Activity provisions on these substances, CAS Registry Numbers 475-71-8, 1326-05-2, 14295-43-3, 38465-55-3 and 58161-93-6, will mean that the public will not have opportunities to engage in the assessment process. It was noted in the Risk Management Workshop held in October 2009 that guidance on how SNAcs are applied in the CMP framework would be released. To date, this document has not been released nor has there been any further development to address the shortfall of the approach.

Although the process is still being developed, it is the Government’s intention for the public to have access to assessment reports when processing Significant New Activity Notifications.

The Government recognizes that stakeholders have been advised of the development of a guidance paper on the use of SNAcs within the CMP framework. The guidance document continues to be in development. It is the stated intention of the Government to make this document available to stakeholders as soon as possible.

AlternativesIdentification and assessment of alternatives in various applications should be included in the assessment report as well as in the risk management scope document.

The Government of Canada welcomes input from stakeholders on alternatives for substances in the Challenge. Consideration of alternatives is done as part of the development of risk management approaches. Where available and relevant to the Canadian context, information on the availability and cost of alternatives to a substance is usually included in public documents related to instrument development.

For alternative substances which are new to Canada , importers and manufacturers are subject to notification and assessment under the New Substances Notification Regulations under the CEPA 1999.

Synergistic / Cumulative EffectsThe potentially synergistic effects of chemical mixtures need to be examined given that exposure to several chemicals occur simultaneously.Consideration of synergistic effects is not precluded from screening assessments. However, to be considered, sufficient information to undertake such analyses would be needed. Under the Challenge, the information typically available for assessing effects is representative only of a substance’s inherent ability to elicit adverse effects.
 Chemicals assessed through the Challenge and found to be toxic under CEPA 1999should be added for reporting under the National Pollutant Release Inventory (NPRI) immediately.Environment Canada is considering the addition of substances found to meet s.64 of CEPA 1999to the NPRI’s substances list based on the importance to be informed of the release levels of these substances of concern. These substances are given high priority in NPRIconsultations. It should be noted that any party (person, government or organization) in Canada may submit a proposal to Environment Canada for changes to the NPRI program. Changes to the substance list result from the NPRI Consultations process and may include the addition, modification or removal of substances as well as changes in the thresholds at which they must be reported.
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