Plenary session 3

1. National Institute for Nanotechnology• Institut national de nanotechnologie
Governance of Nanomaterials and
Nanotechnologies:
A Canadian perspective
Lori Sheremeta, LL.M.
Counsel, Strategy & Stakeholder Relations
National Institute for Nanotechnology, Edmonton, Alberta, CANADA
NE3LS Network International Conference 2012
November 1-2, 2012, Montreal, Canada

2. Nanotechnology
Lux Research Inc., Nanomaterials State of the Market Q3 2008: Stealth Success, Broad Impact,
July 2008 at p 13

3. What is governance?
• Governance is the act of governing; it is typically
executed by a government.
• The word governance derives from the Greek verb
κυβερνάω [kubernáo] which means to steer
• It includes the body of ethical norms, rules, codes and
laws that apply across the R&D continuum to ensure
science and technologies are developed in a way that
accords with societal values.

4. Why nanotechnology and governance?
• Because of the belief that it can have an enormous
economic impact.
• Plus, the science tells us that:
– Materials, known to us in their bulk form, can behave differently at
the nanoscale
– Physico-chemical properties are mutable as size changes
» Size leads to  Surface Area
» Potential for increased chemical and biological reactivity and a
loss of predictability
• And, we do not fully understand the broader environmental
health and safety implications

5. Governance of Science and Technology
• Questions around the governance of nanoscience and
nanotechnologies are simply a subset of the larger
questions about how science and technology ought to be
governed.
• Who are the players and what are the roles of the players
in the overall S&T system?
• How are governance tools are selected and
implemented?
• Are appropriate governance mechanisms in place in
Canada now?
• What is Canada’s role in the international arena?

6. Rules of Engagement in Canada
• Laws, regulations (and codes of conduct) are
promulgated by government (professional organizations)
to protect the public; they are not put in place without
evidence supporting need
• General Principle: treat similar things similarly
• Strict application of the Precautionary Principle is not
embraced in Canadian law and policy
• Where laws, regulations and contracts do not clearly
specify legal rights and obligations, the common law
applies and can be used to rectify damages done by one
party to another (either through tort law or equity).

7. Who are the stakeholders?
GOVERNMENT INDUSTRY
Legislator/Regulator Innovator
Research Funder Employer
Employer Information receiver and provider
Research Performer Follower of rules
Research Performer Provider of advice
Owner of public lab systems
ACADEMIA PUBLICS
Knowledge creator Consumer base (wants, needs
(research, teaching, information to inform choices)
dissemination) Activist base
Recipient of funding Electorate
Follower of rules
Arbiter of ethical norms
Provider of advice

9. Canada’s Approach Generally
• Nanomaterials and products that contain them are
regulated in Canada; there are no nano-specific
requirements
• Wait and see if nanomaterials and products containing
them warrant special regulatory treatment
• Participate in international activities to generate data that
will inform regulatory decision making

10. Regulatory Challenges
• Canada’s New Substances Notification Regulations (NSNR) were
not designed for nanomaterials
– Issues with notification triggers, information requirements
– This is being worked out on a case by case basis
– Recent example of NCC
• Ideally, all nanomaterials that exhibit nanoscale properties should
be assessed as new substances. BUT, how deep do we go down
this particular rabbit hole? Nanoparticle X, 30nm, 10nm, 5nm?
• Knowledge gaps on material properties, fate, and effects have
been narrowed by the international community with Canada’s
participation
• Information on nanomaterials currently in the Canadian market is
incomplete
• There is a need to engage manufacturers and importers about
current and future requirements; industry wants and needs
certainty

11. Canada’s Approach
• Inform companies of their obligations under CEPA
• Gather information on materials already in commerce
through a CEPA, section 71 survey and a voluntary
challenge (this has not happened)
• Consider whether changes to CEPA (and NSNR) are
needed (this is still being contemplated; insufficient
evidence to inform regulation)
– consider OECD data on nanomaterials of interest once
available
• Use Significant New Activity (SNAc) provisions under
CEPA, 1999 for new nanomaterials, where applicable

12. http://www.ec.gc.ca/subsnouvelles-newsubs/

13. Environment Canada & Health Canada
• Canadian Environmental Protection Act (CEPA, 1999)
– New Substances Notification Regulations
• Nanomaterials that are “new substances” fall under the chemical
risk assessment paradigm
– Which nanomaterials are new substances?
– Those that have a unique CAS number that does not appear
on the Domestic Substances List? (C60)
– Those nanomaterials that have a bulk counterpart but that are
being used to exploit nanoscale properties (SNAc)
• See, 2007 Nanomaterial Advisory Notice
• And see, Health Canada Working Definition of Nanomaterial

14. New Substances Notification Regulations
(Chemical) requirements
• Low Schedule (>100kg/yr)
– Name, MSDS, volumes, uses (and concentrations)
• High Schedule (>10,000kg/yr)
– Molecular and structural formula, M.W, purities, impurities, M.P,
B.P, water sol., density, V.P, Kow, ready biodeg, chemical
characterization
– Acute ecotoxiciology data
– Acute mammalian test, mutagenicity, skin irritation, skin
sensitization, 28-day repeated-dose, in-vivo mutagenicity
– Exposure: mode of transp., container, releases, etc.
• R&D Exemption

15. Information Gathering Tools
• Research by government staff or through works
commissioned by government
• Advisory Bodies and Expert Panels
• Public call for information as part of pre-regulatory
process (voluntary participation)
• Ministerial prerogative under CEPA, FDA – can formally
request additional information of companies and
individuals (mandatory)
• Require specific information in regulation (mandatory)
• Royal Commission/Public Inquiry – usually after
something goes dreadfully wrong

16. September 2008
• At present, it is not possible to
implement a “science-based”
regulatory approach to
nanoproducts.
• As scientific research fills in
the knowledge gaps, the
decisions respecting the
precautionary measures
applied to nanoproducts can
be revised.
http://scienceadvice.ca

18. Health Canada's Working Definition of
Nanomaterial
• Health Canada adopted the “Policy Statement on Health Canada's
Working Definition for Nanomaterial” on October 6, 2011 following
extensive consultation with stakeholders
• Health Canada considers any manufactured substance or product
and any component material, ingredient, device, or structure to be
nanomaterial if:
– It is at or within the nanoscale (1-100nm) in at least one external
dimension, or has internal or surface structure at the nanoscale, or;
– It is smaller or larger than the nanoscale in all dimensions and
exhibits one or more nanoscale properties/phenomena.
http://www.hc-sc.gc.ca/sr-sr/pubs/nano/pol-eng.php

19. Regulatory Complexity
Environment Canada
Canadian Environmental Protection Act
•New Substances Notification Regs
•Persistence and Bioaccumulation Regs
Canadian Environmental Assessment Act
Fisheries Act, Oceans Act
Agricultural Products, Pest Control and Fertilizers Acts
Health Canada
Food & Drugs Act
•Food & Drugs Regs
•Medical Devices Regs
•Cosmetics Regs
•Natural Health Products Regulations
Hazardous Products Act
•Controlled Products Regulations
•Work Hazardous Materials Information System

20. Labelling - “Nano Inside”?
• Absurd or necessary?
• Akin to labeling all consumer products
with “contains chemicals”
• Label products based on particle size
or if nanoscale properties are
exploited?
• Who decides?
• What is the purpose?
• Products that demand ingredient labels
could incorporate designation for
“nano” ingredient - TiO2(n)

21. Looking Ahead
• Gaps exist in our understanding of the health, safety and
environmental impacts ofnanomaterials but the gaps are narrowing.
• It is important to remember that nanomaterial challenges are not
distinct from the general challenges associated with chemicals.
• Coordinated, strategic research is essential to develop the
foundational knowledge that will empower the responsible
development of key technologies.
• Public trust in the scientific enterprise depends on a coherent and
rational approach to stewardship.
• National and international dialogue, cooperation and coordination is
necessary to ensure that risks and benefits nanotechnology
development are equitably shared.

22. Acknowledgements
• National Institute for Nanotechnology/University of Alberta
• Alberta Innovates – Technology Futures
• Environment Canada
• Health Canada