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

Nanotechnology

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

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.

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

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?

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).

Who are the stakeholders?

GOVERNMENTLegislator/Regulator

Research FunderEmployer

Research PerformerResearch Performer

Owner of public lab systems

INDUSTRYInnovatorEmployerInformation receiver and providerFollower of rulesProvider of advice

ACADEMIAKnowledge creator

(research, teaching, dissemination)

Recipient of fundingFollower of rules

Arbiter of ethical normsProvider of advice

PUBLICSConsumer base (wants, needs information to inform choices)Activist baseElectorate

Media

International Organizations

OECDISOWTO

WIPO

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

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

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

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

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

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

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

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

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

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

Regulatory Complexity

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)

Looking Ahead

• Gaps exist in our understanding of the health, safety and environmental impacts of nanomaterials 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.

Acknowledgements

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