Summary of Comments Received on the Interim Policy Statement on Health Canada's Working Definition for Nanomaterials - March to August 2010
Unusual physical, chemical, and biological properties can be seen in some materials at the nanoscale that may differ from the properties of bulk materials and individual atoms or moleculesFootnote 1. These "nanomaterials" are currently present in a wide range of products from electronics, to health and consumer products that Health Canada plays a role in regulating. In their inventory, the Woodrow Wilson Center identifies over 1,000 nanotechnology-based consumer products currently on the marketFootnote 2.
Health Canada Acts and Regulations have no explicit reference to nanomaterial at this time. Health Canada helps protect and promote health by using existing legislative and regulatory frameworks to mitigate the potential health risks of nanomaterials and to help realize their health benefits. Health Canada recognises that the state of science around nanomaterials is evolving as are international norms and consensus on terminology - a flexible approach is warranted.
Adopted in late 2009, the Interim Policy Statement on Health Canada's Working Definition for Nanomaterials was an important first step to establishing a transparent working means of identifying nanomaterials. A broad working definition provides Health Canada with a consistent approach across several diverse regulatory program areas to request information about regulated products and substances that may be or may contain nanomaterials. It allows for the Department to ask for information and to integrate that new knowledge into regulatory decision making. Health Canada's interest is in obtaining information to improve the understanding of nanomaterials for their risk assessment and risk management.
Summary of Comments
The Interim Policy Statement on Health Canada's Working Definition for Nanomaterials (Interim Policy Statement) was posted on the Health Canada website on March 1, 2010 for a six month public comment period. Over 3,000 individuals and organizations, such as industry associations, public interest groups, government bodies, public health associations and regulatory authorities, were also contacted via e-mail to provide an opportunity for stakeholders with a diverse range of interests to comment. The comment period ended August 31, 2010. Health Canada received a total of 29 submissions, with the majority of comments originating from companies or industry groups. Input was also received from governments, academia, public interest groups, a media blog, as well as interested individuals.
- DuPont Canada
- Hogan Lovells International LLP
- Johnson & Johnson Inc
- Johnson & Johnson Medical Products
- Logistik Unicorp
- PerkinElmer Instruments
- Canadian Apparel Federation
- Canadian Association of Chemical Distributors
- Canadian Consumer Specialty Products Association
- Canadian Cosmetic, Toiletry and Fragrance Association
- Canadian Manufacturers & Exporters
- Canada's Medical Technology Companies
- Canada's Research-Based Pharmaceutical Companies
- Food & Consumer Products of Canada
- Industry Coordinating Group for the Canadian Environmental Protection Act
- The Nanotechnology Panel of the American Chemistry Council
- The Society of the Plastics Industry, Inc.
- Ministry of Health, Government of British Columbia
- Peel Public Health
- Centre des Nanomatériaux de l'Université du Québec à Montréal
Public Interest Groups:
- Canadian Cancer Society
- Canadian Environmental Law Association
- Canadian Institute for Environmental Law and Policy
Based on stakeholders' feedback, a number of changes were made to the Interim Policy Statement. These amendments appear in the Policy Statement on Health Canada's Working Definition for Nanomaterial (herein referred to as the Policy Statement) which has been posted on the Health Canada website along with answers to some frequently asked questions. The revisions to the Policy Statement were also informed by developments in international norms, evolving scientific evidence, and regulatory program needs. The Policy Statement will continue to be updated as the body of scientific evidence and international norms progress.
Key comments provided fell into three categories:
- the Process of the creation of the working definition (how it was developed);
- the Content of the working definition (clarity/inclusion of key terms); and,
- the Application or use of the policy statement (clarifying the regulatory context).
Key stakeholder comments and Health Canada's responses are summarized by each category below.
|Comment A-1||Health Canada's Response|
|Health Canada was asked to work with or consider the work of international jurisdictions in generating a definition of nanomaterial||Health Canada considered recent international developments such as those of the International Organization for Standardization, the Organisation for Economic Cooperation and Development, and the European Commission. The Department also considered the approaches of other regulators, such as in the U.S.A., Australia, and the European Union. The Policy Statement will continue to be updated as the body of scientific evidence evolves and as international norms progress; at this time it remains a Departmental Policy on a working definition for nanomaterial in order to maintain flexibility.|
|Comment A-2||Health Canada's Response|
|Health Canada should be more explicit on past or existing collaborations that led to the development of the working definition||Health Canada established an Expert Technical Advisory Committee to address comments received through the web-based consultation process and to promote consistency. These organizations were involved in developing both versions of the Policy Statements. Participating Canadian Federal Departments and Agencies include the:
|Comment A-3||Health Canada's Response|
|Canadian Federal Departments and Agencies (including Environment Canada) should have a common definition for nanomaterial||The Policy Statement Section 4.1 addresses Health Canada's broad regulatory responsibilities and integrates key elements of international definitions. Health Canada will continue to work with Canadian federal organizations in support of a consistent federal approach. For example, Health Canada and Environment Canada regulatory programs who share responsibility under the Canadian Environmental Protection Act, 1999 work together and share a similar focus in its application.|
|Comment B-1||Health Canada's Response|
|Further clarification should be provided for the term "manufactured"||The Policy Statement Section 4.2 - Elaboration now further clarifies the term "manufactured" to include engineering processes and control of matter that lead to the synthesis, generation, fabrication or isolation of nanomaterials. Health Canada may request information for risk assessment purposes regarding a deliberately or incidentally manufactured nanomaterial. The term also includes natural components that have been deliberately used or engineered to have nanoscale properties/phenomena. See also response to Comment B-3.|
|Comment B-2||Health Canada's Response|
|Health Canada should provide further clarification on what is meant by "nanoscale phenomena" and the criteria used to determine it||The Policy Statement Section 4.1, Part b now refers to "nanoscale properties/phenomena" which means properties which are attributable to size and their effects. This term relates to nanomaterial that exhibits different properties attributable to size (for example (e.g.) a substance that acts as a chemical catalyst at the nanoscaleFootnote 3) or demonstrates biological effects due to the size-related properties (e.g. interaction with select immune cellsFootnote 4), when they are distinguishable from those of individual atoms, molecules and their typical form/bulk material. Section 4.2 elaborates further. Risk (and benefit) assessments are conducted within program areas on a case-by-case basis, see Section 7 - General Guidance.|
|Comment B-3||Health Canada's Response|
|The scope should be made more clear and exclusions be listed (such as a proteins, etc)||The Policy Statement now includes Section 3 - Scope which now clarifies the focus as nanomaterial that are manufactured and intended to be sold or represented for use as a regulated product or substance, or fall under the mandate of Health Canada. Section 5.2 - Explanatory Note has been added and explains that materials that naturally exist at the nanoscale or exhibit nanoscale properties/ phenomena in nature will not automatically be re-classified as nanomaterial. As many regulations are implicated (see Appendix A), programs will refine their focus within the broad working definition and/or develop specific exclusion and inclusion criteria based on their respective mandates.|
|Comment B-4||Health Canada's Response|
|Health Canada should explain the size range of 1 to 100 nm in its working definition of nanomaterial; include the concept of "internal structure"; and be consistent with the International Organization for Standardization (ISO)||Terms defined by ISO represent current international consensus. ISO defines nanomaterial as a material with any external dimension in the nanoscale or having internal structure or surface structure in the nanoscale. The Policy Statement Section 4.1; Part a) states that a "manufactured substance or product and any component material, ingredient, device, or structure is 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". This concept correlates with that communicated in the ISO definition: Both describe a nanomaterial as having at least one dimension in the 1 - 100 nm range (e.g. nanoparticle, nanofibre, and nanofilm) or a material that has structure in the 1 - 100 nm range (e.g. porous and fibrous materials). Furthermore, ISO defines the nanoscale as the size range from approximately 1 nm to 100 nm. Application of the term "approximately" or "typically" in a regulatory context is challenging, thus Health Canada elected to define the nanoscale as an absolute range of 1 - 100 nm, inclusive. However, nanomaterial with potential "nanoscale properties/phenomena" of interest to risk assessors may fall outside this size range and is excluded from Part a). Therefore, Section 4.1, Part b) is meant to capture these nanomaterial.
To address a mandate which includes regulation of substances and products, the ISO term "material" has been modified by Health Canada to describe both substances as well as products of interest to Health Canada. The Department wishes to collect information about potential "size-related" risks and benefits (where applicable). By having information regarding material size available, it may be possible to classify materials, indications, applications or other general categories that may require additional analyses, and distinguish them from those that do not pose additional size-related risk, thereby contributing to the oversight of potential nanomaterialFootnote 5. Through the development of accurate internal databases, risk assessors would be well-positioned to increase the knowledge related to the safety of nanomaterial.
|Comment B-5||Health Canada's Response|
|Health Canada should set a single content threshold (e.g. >10% by weight) for particulate substances||Health Canada requests information as part of current risk assessment requirements to determine if a regulated substance or product could be, or could contain a nanomaterial. That information is used to determine if current risk (and benefit) assessments are adequate. The Department has chosen to collect nanomaterial-related information on a program-by-program basis as consistently as possible to determine if more rigid criteria and/or regulatory amendments are necessary. Based on current knowledge, Health Canada is unable to set a single nanomaterial size distribution threshold, a content threshold by weight, or a threshold for volume specific surface area (VSSA) for all nanomaterial that Health Canada regulates. However, as information becomes available, program-areas may establish such threshold values consistent with their regulatory responsibilities and international norms.|
|Comment B-6||Health Canada's Response|
|Health Canada should capture nanomaterial that are aggregated or agglomerated||The Policy Statement Section 4.2 - Elaboration, now explains that internal structures or surface structures at the nanoscale include nanomaterial that are aggregated or agglomerated to form a larger group. The size of aggregates and agglomerates are subject to variation depending upon conditions of formation. Aggregated or agglomerated nanomaterial are captured in the Working Definition (Section 4.1) if any of the following apply:
|Comment C-1||Health Canada's Response|
|Health Canada should use the working definition for information gathering, but not apply it in a regulatory context||Health Canada issued the Policy Statement as a Departmental policy on a working definition. While no longer interim, it will continue to be updated as the science evolves and international norms progress; the working definition is not written in regulations. Its key objective is to identify nanomaterial for information gathering. However, informational requests will be made by specific regulatory programs across the Department for risk (and benefit) assessment, and to provide assistance to manufacturers and other stakeholders to meet their current statutory obligations. The Policy Statement's working definition is not an additional source of authority.|
|Comment C-2||Health Canada's Response|
|More explicit information should be provided on Health Canada's approach to the Working Definition||The Policy Statement now includes more detail on Health Canada's approach including in: Section 3 - Scope; Section 4.2 - Elaboration; Sections 5.1 - Application of the Policy Statement and 5.2 - Explanatory Note; and more detail in the Section 7 - General Guidance.|
|Comment C-3||Health Canada's Response|
|Health Canada should develop program-specific guidance documents||Section 5.1 - Application of the Policy Statement, indicates that Health Canada guidance documents for nanomaterial specific to regulated products, substances or commodity groups will be developed over time. Guidance documents will be developed in a manner that is both consistent with the Policy Statement, and in accordance with the unique parameters of program legislative and regulatory authorities. Manufacturers and other stakeholders are encouraged to communicate with individual program areas with specific questions and can continue to submit comments and questions on the Policy Statement at firstname.lastname@example.org.|
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