Sweating the small stuff: Canada's emerging regulatory approach to nanomaterials

This article was written by Gatlin Smeijers, Megan Strachan and Liane Langstaff*

How do you regulate something so small that 100 million of its particles can fit on the head of pin? Canada's approach has been to regulate nanomaterials in the same way as their meso-scale counterparts, under the Canadian Environmental Protection Act, 1999 (CEPA). Regulating nanomaterials has been identified as critical given their prevalence in everyday consumer products and the industry's rapid growth. The Nanotechnology Consumer Products Inventory now contains over 1,600 consumer products that have been introduced to the market since 2005; a 24%  increase since 2010.¹ The global market for nanotechnology is expected to exceed three trillion USD by 2015.²

Canada and other countries, like the United States, appear to be continuously assessing their approach to nanomaterials; however, this has not resulted in the development of regulations specific to nanomaterials. Canada's approach has been precautionary, focussing on encouraging and gathering research, leaving nanomaterials to be regulated under Canada's general environmental and new substances legislation.

Defining Nanomaterials

There is no definition of nanomaterials enshrined in Canadian law. Health Canada uses a working definition that is based on the physical, rather than chemical, properties of nanomaterials. A manufactured product or substance is considered a nanomaterial if it is at or within the nanoscale in at least one external dimension, or has internal or surface structure at the nanoscale; nanoscale means one to 100 nanometers. A manufactured product or substance is also considered a nanomaterial if it is smaller or larger than the nanoscale in all directions and exhibits one or more nanoscale properties/phenomena. A nanoscale property/phenomenon refers to a properties that are attributable to size and their effect and are therefore different from the  properties of individual atoms, molecules or the bulk material.

Nanomaterials can be inorganic (such as metal-based compounds) and organic (covalently bonded carbon-based compounds). Although there are naturally-occurring nanomaterials, Canada does not include naturally-occurring nanomaterials in its working definition. Canada has focused its attention on "manufactured" nanomaterials, which includes nanomaterials produced through engineering processes. Engineered nanomaterials are intentionally produced via chemical and physical processes, such as self-assembly from atoms and molecules, or milling nanomaterials from their corresponding macro-scale substances.³

Nanomaterials – Small but Mighty

Nanomaterials are not chemically or physically equivalent to their meso-scale counterparts. They have a greatly increased surface-to-volume ratio (ie. a high specific surface area) and may also exhibit electrical, mechanical and optical changes not found in bulk substances of the same kind.⁴ This means that they may have unique health and environmental impacts.

Their almost inconceivably small size means that they can enter the human body through unusual routes, pass through cell membranes, or cross the blood-brain barrier. They can also interact with environmental media and pollutants to produce unique by-products, which then have the potential to cause adverse health impacts.

There has been at least one report of an occupational workplace injury as a result of nanomaterials. When a chemist was unknowingly exposed to nickel nanoparticle powder she experienced throat congestion and nose drippings. ⁵ Her skin even began reacting to her earrings and belt buckle. After she stopped working with the material, the symptoms continued until she left the building. It is anticipated that she can never work in the building again.⁶

Canadian regulators are in the process of trying to understand these unanticipated and unexpected effects, collaborating with the United States Environmental Protection Agency (EPA) and the Organisation for Economic Co-operation and Development (OECD). OECD members have pooled resources to test nanomaterials for their physical and chemical properties, environmental toxicology and mammalian toxicology, among other parameters.⁷ The work focuses on some of the most commercially relevant nanomaterials including multi-walled carbon nanotubes, iron and gold nanoparticles, and nanoclays.

Nanomaterial Regulation in Canada – a Moving and Miniscule Target

Since 2007, Health Canada and Environment Canada have regulated nanomaterials primarily through the regulatory controls on "new substances" established under CEPA, treating them like any other chemical or biological substance. While CEPA is the main regulatory statute, numerous other federal and provincial regulations may have direct application to certain nonmaterial-based products.⁸

CEPA and the associated New Substances Notification Regulations (Chemicals and Polymers)⁸  establish the regulatory regime for the assessment and management of new substances, including reporting and testing obligations.¹⁰ Generally speaking, any "new" chemical or polymer is subject to review by Environment and Health Canada prior to prescribed annual quantity limits on import and/or manufacture being reached. A substance is considered "new" when it is not already listed on the Domestic Substances List ("DSL"), meaning the substance in question was in regular commerce during the years 1984 to 1986 or has not subsequently been added to the DSL.   Substances listed on the DSL are listed by both chemical name and would Chemical Abstract Service Registry (CAS) number.¹¹ The entity wishing to manufacture or import a new substance into Canada above the prescribed quantity limit must submit a "new substances notification package"¹², containing sufficient administrative and technical data for Environment and Health Canada to determine whether or not the substance has the potential to adversely affect human and/or environmental health.¹³

Therefore, any nanomaterial with a unique CAS number not listed on the Domestic Substances List is considered a "new substance" just as would be the case with any meso-scale material. However, a nanomaterial may be considered "new" even where it has an identical CAS number to its meso-scale counterpart already included on the DSL (eg. nanoscale nickel powder). If the nanoscale form of a substance has unique nanoscale properties, it will be considered a "new" substance despite the regulatory status of its bulk form.¹⁴ Thus, companies engaging in the manufacture and/or import of nanomaterials or products containing nanomaterials should be cognizant of  Canada's working definition and how it is used in respect of the federal controls on new substances (ie.  the CAS number may not tell all).

Nanomaterials may also be subject to Environment and Health Canada's Significant New Activities (SNAcs) under CEPA. When it is suspected that an activity is resulting in a substance potentially becoming toxic,¹⁵ a SNAc notice is issued requiring the provision of additional informational to Health and Environment Canada.¹⁶ This information is required prior to the commencement of the new activity.

Some activities involving nanomaterials have already been identified as presenting potential issues and  SNAcs have been issued. Specifically, in August 2013, Environment Canada issued a SNAc for multi-walled carbon nanotubes where it is manufactured or imported in a quantity greater than 100 kilograms in a calendar year and used for consumer products or products for children.¹⁷ Multi-walled carbon nanotubes would also require notification in all other cases where the substance is manufactured or imported in a quantity greater than 10,000 kilograms per year.

Nanomaterial Regulation – the Bigger Picture

Canada has sought harmonization with its major trading partners in many areas of environmental regulation. Nanotechnology is no exception. Looking to relevant international efforts in this area, it appears that nanomaterials will not spark the creation of a unique regulatory regime in the near future. Instead, nanomaterials are being slotted into existing regimes – as is the case with Canada's regulatory approach.¹⁸

The approach of the US is of particular importance, as Canada  has "committed to considering the US document 'Policy Principles for the US Decision-Making Concerning Regulation and Oversight of Applications of Nanotechnology and Nanomaterials'...and subsequently, wherever appropriate, develop shared and/or common principles to guide Departments and Agencies in their oversight of nanomaterials".¹⁹ The US Food and Drug Administration (FDA) has released three final guidance documents and one draft guidance document on the topic of nanotechnology regulations.²⁰ All support the proposition of regulating nanomaterials under existing regimes, but point to a possible future trend of introducing additional or varied testing parameters for nanotechnology.

For instance, one US FDA publication recommends a framework for assessing the safety of nanomaterials in cosmetics. While the FDA does not have the authority to require that safety data be approved prior to marketing a product, manufacturers and distributors are responsible for "obtaining all data and information needed to substantiate the safety of their products before putting them on the market" to avoid misbranding cosmetics contrary to s 301(a) of the Federal Food, Drug and Cosmetic Act.²¹ Therefore, the FDA suggests testing nanomaterials used in cosmetics to address several factors, including:

• the physicochemical characteristics;
• agglomeration and size distribution of nanomaterials under the conditions of toxicity testing and as expected in the final product;
• impurities;
• potential routes of exposure to the nanomaterials;
• potential for aggregation and agglomeration of nanoparticles in the final product;
• dosimetry for in vitro and in vivo toxicology studies; and
•  in vitro and in vivo toxicological data on nanomaterial ingredients and their impurities, dermal penetration, potential inhalation, irritation (skin and eye) and sensitization studies, mutagenicity/genotoxicity studies.²²

Other US FDA publications also the flag the need for more specific testing for nanomaterials. The draft guidance document on the use of nanomaterials in animal feed suggests that since there is no generally available safety data sufficient to establish nanomaterials as a food substance "Generally Recognized as Safe" under the Food, Drug and Cosmetics Act, evidence will be needed for approval of a Food Additive Petition.²³ The data submitted in the Food Additive Petition should include information regarding the identity of the nanomaterial, manufacturing methods and controls, intended uses and labelling of the material, analytical methods, safety evaluation and proposed tolerances for the food additive, proposed regulations, and an environmental assessment of the material.²⁴

Conclusion

Nanotechnology has the potential to harness the power of the very small to massive effect, from more targeted drug delivery to enhanced waste-water treatment processes. Nevertheless, like many other substances, they can pose unique risks to human health and the environment. A survey of some international policy approaches to nanotechnology that are most relevant to Canada suggest that separate regimes specific to nanomaterials are not currently under development. However, different testing methods, relevant to the scale and properties of nanomaterials, may be increasingly recommended or required.

To capitalize on the boom in nanotechnology in the near future, researchers, manufacturers and importers of nanomaterials must ensure they are in compliance with CEPA and applicable SNAcs. There are a host of other regulatory instruments that could also be relevant, depending on the specific product. In the longer-term, testing methods which are more specific to the scale and properties of nanomaterials are also likely to be incorporated into the Canadian regulatory regime. It is therefore important to stay abreast of new regulatory developments, as well as new technological ones.

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¹ The Project on Emerging Nanotechnologies,  Consumer Products Inventory (2014), online: The Project on Emerging Nanotechnologies <http://www.nanotechproject.org/cpi/>.The Project on Emerging Nanotechnologies was established in 2005 to help ensure that possible risks of nanotechnology are minimized, public and consumer engagement remains strong, and that the potential benefits of nanotechnology are realized. The Project collaborates with researchers, government, industry, NGOs, policymakers, and other to provide objective knowledge that can inform decisions affecting the development and commercialization of nanotechnology.

² National Research Council, Research Progress on Environmental, Health, and Safety Aspects of Engineered Nanomaterials (2013), online: The National Academies Press <http://www.nap.edu/catalog.php?record_id=18475>.

³ United States Environmental Protection Agency (EPA), Engineered nanomaterials in the environment (10 January 2013), online: US EPA < http://www.epa.gov/athens/research/nano.html>.

⁴ Health Canada, Policy Statement on Health Canada's Working Definition for Nanomaterials (26 May 2011), online: Health Canada <http://www.hc-sc.gc.ca/sr-sr/pubs/nano/pol-eng.php> at s.5.1.

⁵ Stephen Leahy, Exotic Nanomaterials Claimed Their First Major Workplace Injury (May 20, 2014), online: http://motherboard.vice.com/en_ca/read/exotic-nanomaterials-
claimed-their-first-major-workplace-injury

⁶ Exotic Nanomaterials Claimed Their First Major Workplace Injury, (May 20, 2014) available online: Vice Media <http://motherboard.vice.com/en_ca/read/exotic-nanomaterials-
claimed-their-first-major-workplace-injury>.

⁷ Organisation for Economic Co-operation and Development (OECD), "Flyer on nanomaterials at the OECD", Safety of manufactured nanomaterials, online: <http://www.oecd.org/science/nanosafety/45910212.pdf>.

⁸ Along with the New Substances Notification Regulations (Chemicals and Polymers), under CEPA, there is the Food and Drugs Act (along with associated regulations: Cosmetic Regulations, Food and Drug Regulations; Medical Devices Regulations; Natural Health Products Regulations; Safety of Human Cells, Tissues and Organs for Transplant Regulations), the Canadian Consumer Product Safety Act, the Hazardous Products Act (and the Controlled Products Regulations), the Pest Control Products Act (and some associated regulations – List of Pest Control Product Formulants and Contaminants of Health or Environmental Concern, and Pest Control Products Regulations).

⁹

¹⁰ SC 1999, c 33, Part 5.

¹¹ A Chemical Abstract Service Registry (CAS) number is "a confidential accession number assigned by Environment Canada or an Enzyme Commission (EC) Number assigned by the International Union of Biochemistry and Molecular Biology (IUBMB)". See Environment Canada, Search Engine for Chemicals and Polymers (2013), online: Environment Canada <http://www.ec.gc.ca/lcpe-cepa/eng/substance/chemicals_polymers.cfm>.

¹² Environment Canada, New Substances Program Advisory Note 2007-06: Requirements for nanomaterials under the New Substance Notification Regulations (Chemicals and Polymers) (June 2007), online: Environment Canada <http://www.ec.gc.ca/subsnouvelles-newsubs/3C32F773-FA09-420E-9941-
A41F02CE0C7A/Advisory%20Note%20%282007-06%29%20-%20EN.pdf>.

¹³ Government of Canada, Evaluating New Substances Assessment and Management of New Substances in Canada (11 October 2013), online: Environment Canada <http://www.ec.gc.ca/subsnouvelles-newsu
bs/default.asp?lang=En&n=AB189605-1>.

¹⁴ Environment Canada, New Substances Program Advisory Note 2007-06: Requirements for nanomaterials under the New Substance Notification Regulations (Chemicals and Polymers) (June 2007), online: Environment Canada <http://www.ec.gc.ca/subsnouvelles-newsubs/3C32F773-FA09-420
E-9941-A41F02CE0C7A/Advisory%20Note%20%282007-06%29%20-%20EN.pdf> at 2.

¹⁵ A substance would become toxic within the meaning of s. 64 of CEPA where it appears a substance is "entering or may enter the environment in a quantity or concentration or under conditions that

(a) have or may have an immediate or longterm harmful effect on the environment or its biological diversity;

(b) constitute or may constitute a danger to the environment on which life depends; or

(c) constitute or may constitute a danger in Canada to human life or health."

¹⁶ Environment Canada, Significant New Activity Notices (Chemicals and Polymers) (4 April 2014), online: Environment Canada <https://www.ec.gc.ca/subsnouvelles-newsubs/default.asp?lang=en&n=21ADF98D-1#a2>.

¹⁷ Environment Canada, "Significant New Activity Notice No. 17192" Canada Gazette (24 August 2014), online: Government of Canada <http://www.gazette.gc.ca/rp-pr/p1/2013/2013-08-24/html/notice-avis-eng.html#d104>.

¹⁸ For instance, Canada has been working with the OECD on nanotechnology regulation since 2006. In 2013, the OCED issued a Council Recommendation advising that existing frameworks be used to regulate nanomaterials. OECD, Safety of Manufactured Nanomaterials, online: OECD< http://www.oecd.org/science/nanosafety/>. OECD, "Recommendation of the Council on the Safety Testing and Assessment of Manufactured Nanomaterials" Decisions, Recommendations and other Instruments of the OECD (19 September 2013), online: OECD <http://acts.oecd.org/Instruments/ShowInstrumentView.aspxInstrumentID
=298&InstrumentPID=314&Lang=en&Book=False>.

¹⁹ Under the RCC nanotechnology workplan, Canada has "committed to considering the US document 'Policy Principles for the US Decision-Making Concerning Regulation and Oversight of Applications of Nanotechnology and Nanomaterials' ...and subsequently, wherever appropriate, develop shared and/or common principles to guide Departments and Agencies in their oversight of nanomaterials". See the following link for more details: Government of Canada, "RCC Nanotechnology Policy Principles for Decision-Making Concerning Regulation and Oversight of Nanotechnology and Nanomaterials" Government of Canada Nanoportal, online: Government of Canada <http://nanoportal.gc.ca/6AEDAEBA-759A-4C21-A3C0-52CAA61783AE/RCCenglish2.pdf>.

²⁰ US Food and Drug Administration (FDA), "FDA issues guidance to support the responsible development of nanotechnology products" US FDA Press Announcements, online: US FDA <http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm402499.htm>.

²¹ US FDA, Guidance for Industry: Safety of Nanomaterials in Cosmetic Products (June 2014), online: US FDA <http://www.fda.gov/Cosmetics/GuidanceRegulation/GuidanceDocuments/ucm300886.htm>.

²² US FDA, Guidance for Industry: Safety of Nanomaterials in Cosmetic Products (June 2014), online: US FDA <http://www.fda.gov/Cosmetics/GuidanceRegulation/GuidanceDocuments/ucm300886.htm> at 13.

²³ US FDA, Guidance for Industry: Use of Nanomaterials in Food for Animals (Draft) (June 2014), online: US FDA <http://www.regulations.gov/#!documentDetail;D=FDA-2013-D-1009-0002> at 5.

²⁴ US FDA, Guidance for Industry: Use of Nanomaterials in Food for Animals (Draft) (June 2014), online: US FDA <http://www.regulations.gov/#!documentDetail;D=FDA-2013-D-1009-0002> at 8-10.

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* Liane Langstaff​ was a summer student at Gowlings' Toronto office in the Gowlings 2014 Summer Program.