Hot off the email. I received notice, about 60 mins. ago, that the results of the March – August 2010 public consultation on Health Canada’s Policy Statement on Health Canada’s Working Definition for Nanomaterials. From my Oct. 11, 2011 email,
In March 2010, Health Canada launched a web-based consultation on the Interim Policy Statement on Health Canada’s Working Definition for Nanomaterials. The consultation was open for comment from March 1 to August 31, 2010. During that period, Health Canada received a total of 29 submissions from companies, industry groups, governments, academia, public interest groups and interested citizens.
Health Canada made changes to the Interim Policy Statement based on stakeholders’ feedback. Changes were also informed by developments in international norms, evolving scientific evidence and regulatory program needs. These changes appear in the Policy Statement on Health Canada’s Working Definition for Nanomaterial which will continue to be updated as the body of scientific evidence and international norms progress.
Health Canada’s responses to key stakeholder comments are summarised in the following documents:
· Summary of Comments Received on the Interim Policy Statement on Health Canada’s Working Definition for Nanomaterials – March to August 2010
· Frequently Asked Questions Related to the Policy Statement on Health Canada’s Working Definition for Nanomaterial.
The Policy Statement, the Summary Report, and the Frequently Asked Questions are all now available on Health Canada’s website on the Science and Research webpage at http://www.hc-sc.gc.ca/sr-sr/pubs/nano/index-eng.php
Thank you to Laird Roe, A/Director General, Science Policy Directorate Strategic Policy Branch, and all of the other folks who’ve worked to get this published.
I have taken a very quick look at the updated website which no longer includes the word ‘interim’ with its title: Policy Statement on Health Canada’s Working Definition for Nanomaterial. It was made effective Oct. 6, 2011.
The changes made in response to submissions received as part of the public consultation are noted on the Summary of Comments Received on the Interim Policy Statement on Health Canada’s Working Definition for Nanomaterials – March to August 2010 page. Included is a list of the 29 respondents,
- 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
Not sure I’d ever describe this as a media blog (obsession, maybe?) but to paraphrase the Scotsman Robbie Burns, it’s always interesting to see ourselves as others see us.
I’m sorry they didn’t post the individual submissions as they did for the Review of Federal Support to Research and Development as it would have interesting to see and compare the other submissions.
They did break down the comments in the various submissions,
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).
This description of the categories is followed by a table which summarizes both the comments and Health Canada’s responses (not reproduced here).
One of my key concerns, public engagement/discussion was not addressed either in the summary or on the FAQs (Frequently Asked Questions) page. I suggest looking at the FAQs page as there is some very interesting information there including the answer to this question,
8. Does Health Canada take a precautionary approach to nanomaterials?
Taking a precautionary approach is key to fostering the development and inclusion of new knowledge into decision making. The precautionary approach is part of the Canadian Environmental Protection Act, 1999, the Pest Control Products Act, and is referenced in the Canada Consumer Product Safety Act which will further support existing authorities to collect information regarding nanomaterial for the assessment of potential health risks and benefits.
Over the next few years, Health Canada will take an incremental approach to address regulatory, science and policy needs while allowing for the integration of new scientific evidence as it becomes available. Health Canada’s principle interest is in obtaining information that will improve the understanding of nanomaterials for risk assessment and risk management purposes.
I was much encouraged to see a flexible approach has been adopted as you can see in this example from the elaboration on the policy statement,
“Part a” of the Working Definition relates to current evidence suggesting that nanoscale properties/phenomena are more likely observable at the scale of 1-100 nanometres (more often at the lower end)5 and “Part b” reflects that it is possible for nanoscale properties/ phenomena to be exhibited outside this size range, such as select quantum devices6.
A variety of lexicons and interpretations of “nano-terminology” currently exist, underlining the importance of understanding the context in which these terms are used. In the risk assessment context supporting hazard and exposure assessment for risk characterization and management, the term “nanoscale properties/phenomena” refers to size-related properties which have qualities or characteristics that do not readily extrapolate from those observed in individual atoms, molecules or bulk materials. For example, “bulk” gold is not very reactive, but nanoscale gold can act as a chemical catalyst2. For risk assessment purposes, this term includes observable biological or environmental effects resulting from size-related properties as described above. Examples of such biological or environmental effects could be increased permeability through cell membranes8 or increased reactivity of iron/iron oxides for the purposes of groundwater remediation9, respectively.
So there you have it a few nits to pick and a few roses to give. I trust and hope that there will be more commentary from other sources over the coming days.