Canada and a mandatory survey on nanomaterials due February 2016

If memory serves, this is the second nanomaterials reporting survey that the Canadian federal government has requested in the seven years that I’ve *been* blogging on the topic Canadian nanotechnology. (As usual, I’ve gotten my information from a source outside the country.) Thanks to Lynn Bergeson (US lawyer) and her July 27, 2015 posting on Nanotechnology Now where she covers nanotechnology’s regulatory developments (Note: A link has been removed),

The July 25, 2015, Canada Gazette includes a notice announcing that the Minister of the Environment requires, for the purpose of assessing whether the substances described in the notice are toxic or are capable of becoming toxic, or for the purpose of assessing whether to control, or the manner in which to control the listed substances, any person described in the notice who possesses or who may reasonably be expected to have access to the information required to provide that information. See http://www.gazette.gc.ca/rp-pr/p1/2015/2015-07-25/html/notice-avis-eng.php The notice applies to a substance that has a size of between 1 and 100 nanometers in at least one external dimension, or internal or surface structure; and is provided in the list in Schedule 1 of the notice. The list includes over 200 substances. The notice applies to any person who, during the 2014 calendar year, manufactured a total quantity greater than 100 kilograms (kg) of a substance set out in Schedule 1. …

You can find the Canada Gazette notice (Notice with respect to certain nanomaterials in Canadian commerce) here: http://www.gazette.gc.ca/rp-pr/p1/2015/2015-07-25/html/notice-avis-eng.php but you may find the Guidance for responding to the Notice: http://www.ec.gc.ca/ese-ees/default.asp?lang=En&n=AACFB2C0-1 more helpful (Note: Links have been removed),

1.1- Purpose of the Notice

In 2011, the Canada-United States Regulatory Cooperation Council (RCC) Nanotechnology InitiativeFootnote[1] was launched to increase alignment in regulatory approaches for nanomaterials between Canada and the US to reduce risk to human health and the environment; to promote sharing of scientific and regulatory expertise; and to foster innovation. Completed in February 2014, the RCC Nanotechnology Initiative included a work element on Commercial Information.Footnote[2] This work element was aimed at increasing knowledge of commercial uses of nanomaterials in Canada and the US. The primary output from this work element was a Nanomaterials Use Matrix which identified nanomaterials by type and use category based on the most up-to-date information, at the time, on commercially available nanomaterials. The nanomaterial types were cross-referenced with the DSL to identify nanomaterials which could be considered existing in Canada. The result is a preliminary reference list and may not be comprehensive of all nanomaterials. Ongoing engagement with stakeholders through voluntary initiatives and other fora will inform further development of the list of existing nanomaterials in Canada.

The purpose of the Notice is to gather information on 206 nanomaterials identified as potentially in commerce in Canada from the primary reference list. [emphasis mine] The information collected from the Notice will support the development of a list of nanomaterials in commerce in Canada by confirming their commercial status, and subsequent prioritization activities for these substances, which may include risk assessment and risk management activities, if required. This will ensure that future decision making is based on the best available information.

The list of reportable substances is long and not alphabetized but before you check you may want to review this,

2.1- Reporting criteria

To determine whether a company is required to respond, the following factors must be considered:

Type of substance (i.e., nanoscale form)
Type of activity
Calendar year
Quantity
The quantity should be determined based on the quantity of the substance itself at the nanoscale, and not on the quantity of the product or mixture containing the substance.

The purpose of the Notice is to gather information on nanomaterials in commerce in Canada. A response is only required if the conditions set out in Schedule 1 and Schedule 2 of the notice are met.

The Notice applies to any person who, during the 2014 calendar year [emphasis mine], satisfied any of the following criteria:

Manufactured a total quantity greater than 100 kg of a substance listed in Schedule 1 that is at the nanoscale.
Imported a total quantity greater than 100 kg of a substance listed in Schedule 1 that is at the nanoscale, at any concentration, whether alone, in a mixture or in a product.

The reporting threshold of 100 kg is based on activity with the substance in the nanoscale (i.e. you manufacture, or imported a total quantity greater than 100 kg of a substance with a size between 1 and 100 nanometres, inclusive, in at least one external dimension, or internal or surface structure).

Your response to the information requested should also be based on activities with the substance in the nanoscale.

If you are engaged with a substance that is not in the nanoscale (i.e. same CAS RN, but not nanoscale) and would like to identify yourself as a stakeholder for that substance, you may submit a Declaration of Stakeholder Interest (see section 7 of this document).

You may find this flowchart (from the guidance webpage), useful,

Figure 1: Reporting Diagram for Nanomaterials [downloaded from: http://www.ec.gc.ca/ese-ees/default.asp?lang=En&n=AACFB2C0-1]

Figure 1: Reporting Diagram for Nanomaterials [downloaded from: http://www.ec.gc.ca/ese-ees/default.asp?lang=En&n=AACFB2C0-1]

The information you provide needs to cover the 2014 calendar year and is due,

10. Responding to the Notice

Responses to the Notice must be provided no later than February 23, 2016, 5 p.m. Eastern Standard Time using the online reporting system available through Environment Canada’s Single Window available from the Chemical Substances Web site.

Good luck to all those who must report.

*’been’ added on Jan. 13, 2017.

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