Nanotechnology Work Plan

Nanotechnology Work Plan

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Canada Lead: Karen Dodds, Assistant Deputy Minister, Science and Technology Branch, Environment Canada

Hilary Geller, Assistant Deputy Minister, Healthy Environments and Consumer Safety Branch, Health Canada

U.S. Lead: Margaret Malanoski, Office of Information and Regulatory Affairs, Office of Management and Budget

Deliverable Outcome:

Share information and develop common approaches, to the extent possible, on foundational regulatory elements, including criteria for determining characteristics of concern/no concern, information gathering, approaches to risk assessment and management, etc. Develop joint initiatives to align regulatory approaches in specific areas such that consistency exists for consumers and industry in Canada and the U.S.

Principles:

Identification of common principles for the regulation of nanomaterials to help ensure consistency for industry and consumers in both countries

Three to six months:

  • Canada provides initial feedback on U.S."Policy Principles for the U.S. Decision-Making Concerning Regulation and Oversight of Applications of Nanotechnology and Nanomaterials".

Six to 12 months:

  • Countries complete an initial draft of shared principles for the regulation of nanomaterials.

12 to 18 months:

  • Update of draft principles informed from on-going stakeholder and expert consultations.

18th month:

Stakeholder consultation / workshop on results to date and future ongoing engagement.

Beyond 18 months:

  • Countries complete final draft of shared principles for the regulation of nanomaterials.

Workplan for Industrial Nanomaterials

Priority-Setting:

Identify common criteria for determining characteristics of industrial nanomaterials of concern/no-concern

1-3 months:

  1. Define and finalize workplan (1st month)
  2. Develop mechanisms for stakeholder outreach and engagement (1st month)
  3. Conference call with relevant stakeholders to share and discuss workplan and call for Industry to volunteer nanomaterials for joint CAN/U.S. review

3-6 months:

Share available scientific evidence regarding characteristics of industrial nanomaterials including that obtained from existing international fora (e.g. OECD Working Party on Manufactured Nanomaterials).

8th month:

Stakeholder workshop to discuss information collected to date and approaches moving forward.

6-12 months:

Initiate an analysis of characteristics of select nanomaterials: similarities, differences, reasons for them.

Initiate discussions on approaches to consider for common definitions and terminology.

12th month:

Second conference call with relevant stakeholders to discuss non-CBI information gathered between the Countries and to discuss path forward in terms of development of reports and analyses.

12-18 months:

Develop draft criteria for determining characteristics of industrial nanomaterials of concern/no-concern.

15th month:

Third conference call with relevant stakeholders to discuss progress and to prepare for the upcoming stakeholder consultation/workshop.

18th month:

Stakeholder consultation / workshop on results to date and future ongoing engagement.

Beyond 18 months:

Draft technical language providing common descriptions and criteria of classes of industrial nanomaterials, and incorporate into summary report (see column at right).

Draft document on common CAN/U.S. approach to definition, characteristics and test methods for assessing industrial nanomaterials.

Risk Assessment/Management: 

Share best practices for assessing and managing the risks of industrial nanomaterials

1-3 months:

  1. Define and finalize workplan (1st month)
  2. Develop mechanisms for stakeholder outreach and engagement (1st month)
  3. Conference call with relevant stakeholders to share and discuss workplan and call for Industry to volunteer nanomaterials for joint CAN/U.S. review

3-6 months:

Share current experiences and approaches associated with Risk Assessment (RA) & Risk Management (RM) of industrial nanomaterials in Canada and the U.S. (i.e. those under Canadian Environmental Protection Act and Toxic Substances Control Act) including that obtained from existing international fora (e.g. OECD Working Party on Manufactured Nanomaterials).

8th month:

Stakeholder workshop to discuss information collected to date and approaches moving forward.

6-12 months:

Draft data gaps to reduce uncertainties for conducting RA and RM on industrial nanomaterials.

Initiate pilot project on comparing risk assessments through case studies of nano substances, including those put forth by industry.

12th month:

Second conference call with relevant stakeholders to discuss non-CBI information gathered between the Countries and to discuss path forward in terms of development of reports and analyses.

12-18 months:

Initiate an assessment of current RA and RM approaches, for industrial nanomaterials in Canada and the United States, identifying, where possible, best practices.

Finalize pilot project risk assessments of selected industrial nanomaterials.

15th month:

Third conference call with relevant stakeholders to discuss progress and to prepare for the upcoming stakeholder consultation/workshop.

18th month:

Stakeholder consultation / workshop on results to date and future ongoing engagement.

Beyond 18 months:

Complete assessment of current RA and RM approaches and best practices for risk assessment and risk management of industrial nanomaterials, and incorporate into summary report.

Identify opportunities for and barriers to ongoing collaborations and regulatory alignment.

Commercial Information: 

Characterize existing commercial activities and identify gaps and priorities for future knowledge gathering for industrial nanomaterials

1-3 months:

  1. Define and finalize workplan (1st month)
  2. Develop mechanisms for stakeholder outreach and engagement (1st month)
  3. Conference call with relevant stakeholders to share and discuss workplan and call for Industry to volunteer nanomaterials for joint CAN/U.S. review

3-6 months:

Share lessons learned from previous commercial data gathering activities.

8th month:

Stakeholder workshop to discuss information collected to date and approaches moving forward.

6-12 months:

  1. Countries share non-Confidential Business Information (CBI) information concerning industrial nanomaterials in the marketplace.
  2. Identify areas where information is limited.
  3. Invite stakeholder comment and input to help address these gaps.

12th month:

Second conference call with relevant stakeholders to discuss non-CBI information gathered between the Countries and to discuss path forward in terms of development of reports and analyses.

12-18 months:

Initiate an assessment of industrial nanomaterial uses in Canada and the United States.

15th month:

Third conference call with relevant stakeholders to discuss progress and to prepare for the upcoming stakeholder consultation/workshop.

18th month:

Stakeholder consultation / workshop on results to date and future ongoing engagement.

Beyond 18 months:

Complete assessment of industrial nanomaterial uses in Canada and the United States, and incorporate into summary report (see column at right).

Identify opportunities for and barriers to ongoing collaborations and regulatory alignment.

Regulatory Cooperation in Areas of Emerging Technologies: 

Develop a model framework providing key elements and approaches to regulating products and applications of emerging technologies with respect to potential impacts on the environment, human health, food or agriculture

3-6 months:

Initial scoping of study; examination of current or theoretical models, frameworks and approaches that support international regulatory cooperation related to emerging areas (e.g. defining the issue or concern, identifying relevant regulatory authorities, considering approaches for RA).

6-12 months:

Discussion on whether and how CBI can be shared across jurisdictions.

12-18 months:

Complete initial draft report for review / validation.

Apply lessons learned on regulatory cooperation based on results to date from nanotechnology working group.

Recommend what, if any, options are available and specify conditions for sharing CBI across jurisdictions of similar programs.

18th month:

Stakeholder consultation / workshop on results to date and future ongoing engagement.

Beyond 18 months:

Complete final summary report on approaches and points to consider for regulatory alignment in emerging technologies, including nanotechnology, incorporating information gathered on criteria for determining characteristics, RA and RM approaches, and industrial nanomaterial uses.

Contact Information:

Canada: (Lead) Karen Dodds, Assistant Deputy Minister, Science and Technology, Environment Canada (karen.dodds@ec.gc.ca; ph. 613- 819-934-6851)

Hilary Geller, Assistant Deputy Minister, Healthy Environments and Consumer Safety Branch (hilary.geller@hc-sc.gc.ca; ph. 613-946-6701)

United States: Margaret Malanoski, Office of Management and Budget (Margaret_A._Malanoski@omb.eop.gov)

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Contact Information

Regulatory Cooperation Council
700-66 Slater Street
Ottawa, Ontario K1A 0A3
Email: rcc-ccr@pco-bcp.gc.ca
Fax: 613-992-2366