Tag Archives: Canada-United States Regulatory Cooperation Council (RCC) Nanotechnology Initiative

Everything old is new again: Canadian Parliament holds first reading of another bill to regulate nanotechnlogy

Back in March 2010, Canadian New Democratic Party (NDP) Member of Parliament (MP) Peter Julian introduced a bill to regulate nanotechnology (Bill C-494) in Canada. The Conservative government was in power at the time. I can’t remember how many readings it received but it never did get passed into legislation. Now, Mr. Julian is trying again and, coincidentally or not, the Liberals are in power this time. A July 26, 2016 post by Lynn L. Bergeson and Carla N. Hutton for the National Law Review (Note: Links have been removed),

On June 8, 2016, the Canadian House of Commons held its first reading of an Act to amend the Canadian Environmental Protection Act, 1999 (CEPA) (nanotechnology) (C-287).  The bill would add Part 6.1 to CEPA primarily to implement procedures for the investigation and assessment of nanomaterials. …

The bill would define nanomaterial as any manufactured substance or product or any component material, ingredient, device or structure that:  (a) is within the nanoscale (one nanometer (nm) up to and including 100 nm), in at least one external dimension; or (b) if it is not within the nanoscale, exhibits one or more properties that are attributable to the size of a substance and size effects.  The bill mandates a risk assessment process to identify the potential benefits and possible risks of nanotechnologies before nanoproducts enter the market.  It would also create a national inventory regarding nanotechnology, including nanomaterials and nanoparticles, using information collected under CEPA Sections 46 and 71 and “any other information to which the Ministers have access.” On July 25, 2015, Canada published a notice announcing a mandatory survey under CEPA Section 71(1)(b) with respect to certain nanomaterials in Canadian commerce.  …

I do have a few observations about the proposed bill. First, it’s more specific than what we have in place now. As I understand current CEPA regulations, they do not cover materials at the nanoscale which are already imported and/or produced at the macroscale and are considered safe, e.g. titanium dioxide. It is assumed that if they’re safe at the macroscale, they will be safe at the nanoscale. I gather this bill is designed to change that status.

Second, there is no mention in Julian’s press release (text to follow) of the joint Canada-United States Regulatory Cooperation Council (RCC) Nanotechnology Initiative which was designed to harmonize US and Canadian regulatory approaches to nanotechnology. Would bill C-287 introduce less harmony or was it designed to harmonize our approaches?

Third, I don’t see a big problem with the idea of an inventory, the issue is always implementation.

Finally, it appears that this bill means more bureaucrats or computerized systems and I’m not sure it addresses the problem that I believe it is trying to address: how to deal with uncertainty about the risks and hazards of an emerging technology while meeting demands for economic progress.

Very finally, here’s Peter Julian’s June 8, 2016 press release,

Julian’s bill to include Nanotechnology under Environmental Protection Act

You can watch the video here: https://peterjulian.ca/Introduction_of_Private_Member_Bill_C287_An_Act_t…

OTTAWA – Today [June 8, 2016], Peter Julian, MP (New Westminster-Burnaby) re-introduced Bill C-287 in the House of Commons, which aims to include a framework that would regulate nanotechnology in the Canadian Environmental Protection Act.

“I first introduced this Bill in 2010. I am pleased to see that some of the aspects of this Bill are being considered by Health Canada and Environment Canada, such as the development of a registry for nanomaterials in commerce and use in Canada. However, there is much more that needs to be done to ensure the responsible use of nanotechnologies in Canada”, said Julian.

Nanotechnology is the application of science and technology to manipulate matter at the atomic or molecular level. Nanomaterials are any ingredient, device, or structure that is between 1 and 100 nm. These materials are present in more than 1000 consumer products, including food and cosmetics. The increasing proliferation of nanoproducts has not been met with an adequate regulatory framework.

Julian’s Bill C-287 would establish a balanced approach ensuring the responsible development of nanotechnology and the safe use off nanomaterials in Canada. The Bill mandates a risk assessment process to identify the potential benefits and possible risks of nanotechnologies before nanoproducts enter the market. It would also require a comprehensive, publicly accessible database that lists existing nanomaterials identified by the Government of Canada.

“While nanotechnology can be very beneficial to people, there are certain risks to it as well. We must identify and mitigate possible risks to better protect the environment and human health before they become an issue. Canada must ensure our regulatory processes ensure nanomaterial safety before the introduction of these substances in Canada”, said Julian.

I’m including links to my 2010 email interview with Peter Julian (published in three parts),

March 24, 2010 (Part one)

March 25, 2010 (Part two)

March 26, 2010 (Part three)

I also covered a hearing on nanomaterials and safety held by the Canadian House of Commons Standing Committee on Health on June 10, 2010 in a June 23, 2010 posting.

The Canadian nano scene as seen by the OECD (Organization for Economic Cooperation and Development)

I’ve grumbled more than once or twice about the seemingly secret society that is Canada’s nanotechnology effort (especially health, safety, and environment issues) and the fact that I get most my information from Organization for Economic Cooperation and Development (OECD) documents. That said, thank you to Lynne Bergeson’s April 8, 2016 post on Nanotechnology Now for directions to the latest OECD nano document,

The Organization for Economic Cooperation and Development recently posted a March 29, 2016, report entitled Developments in Delegations on the Safety of Manufactured Nanomaterials — Tour de Table. … The report compiles information, provided by Working Party on Manufactured Nanomaterials (WPMN) participating delegations, before and after the November 2015 WPMN meeting, on current developments on the safety of manufactured nanomaterials.

It’s an international roundup that includes: Australia, Austria, Belgium, Canada, Germany, Japan, Korea, the Netherlands, Switzerland, Turkey, United Kingdom, U.S., and the European Commission (EC), as well as the Business and Industry Advisory Committee to the OECD (BIAC) and International Council on Animal Protection in OECD Programs (ICAPO).

As usual, I’m focusing on Canada. From the DEVELOPMENTS IN DELEGATIONS ON THE SAFETY OF MANUFACTURED NANOMATERIALS – TOUR DE TABLE Series on the Safety of Manufactured Nanomaterials No. 67,

CANADA
National  developments  on  human  health  and  environmental  safety  including  recommendations, definitions, or discussions related to adapting or applying existing regulatory systems or the drafting of new laws/ regulations/amendments/guidance materials A consultation document on a Proposed Approach to Address Nanoscale Forms of Substances on the Domestic  Substances  List was  published  with  a  public  comment  period  ending on  May  17,  2015. The proposed approach outlines the Government’s plan to address nanomaterials considered in commerce in Canada (on  Canada’s  public inventory).  The  proposal is a stepwise  approach to  acquire  and  evaluate information,  followed  by  any  necessary  action. A  follow-up  stakeholder  workshop  is  being  planned  to discuss  next  steps  and  possible  approaches  to prioritize  future  activities. The  consultation document  is available at: http://www.ec.gc.ca/lcpe-cepa/default.asp?lang=En&n=1D804F45-1

A mandatory information gathering survey was published on July 25, 2015. The purpose of the survey is to collect information to determine the commercialstatus of certain nanomaterials in Canada. The survey targets  206  substances  considered  to  be  potentially  in commerce  at  the  nanoscale. The  list  of  206 substances was developed using outcomes from the Canada-United States Regulatory Cooperation Council (RCC)  Nanotechnology  Initiative  to  identify nanomaterial  types. These  nanomaterial  types  were  cross-referenced  with  the Domestic  Substances  List to  develop  a  preliminary  list  of  substances  which are potentially intentionally manufactured at the nanoscale. The focus of the survey aligns with the Proposed Approach to  Address  Nanoscale  Forms  of  Substances  on  the Domestic  Substances  List (see  above)  and certain  types  of  nanomaterials  were  excluded  during the  development  of  the  list  of  substances. The information  being  requested  by  the  survey  includes substance  identification,  volumes,  and  uses.  This information will feed into the Government’s proposed approach to address nanomaterials on the Domestic Substances List. Available at: http://gazette.gc.ca/rp-pr/p1/2015/2015-07-25/html/notice-avis-eng.php

Information on:

a.risk  assessment  decisions, including  the  type  of:  (a)  nanomaterials  assessed; (b) testing recommended; and (c) outcomes of the assessment;

Four substances were notified to the program since the WPMN14 – three surface modified substances and  one  inorganic  substance.  No  actions,  including  additional  data requests,  were  taken  due  to  low expected  exposures  in  accordance  with  the New  Substances  Notifications  Regulations  (Chemicals and Polymers) (NSNR) for two of the substances.  Two of the substances notified were subject to a Significant New Activity Notice. A Significant New Activity notice is an information gathering tool used to require submission  of  additional  information  if  it  is suspected  that  a  significant  new  activity  may  result in  the substance becoming toxic under the Canadian Environmental Protection Act, 1999.

b.Proposals, or modifications to previous regulatory decisions

As  part  of  the  Government’s  Chemicals  Management Plan,  a  review  is  being  undertaken  for  all substances  which  have  been  controlled through  Significant  New  Activity  (SNAc)  notices (see  above).  As part  of  this  activity,  the  Government  is  reviewing past  nanomaterials  SNAc  notices  to  see  if  new information  is  available  to  refine  the  scope  and information  requirements.    As  a  result  of  this  review, 9 SNAc  notices  previously  in  place  for  nanomaterials have  been  rescinded.    This  work  is  ongoing,  and  a complete review of all nanomaterial SNAcs is currently planned to be completed in 2016.

Information related to good practice documents

The Canada-led,  ISO  standards project, ISO/DTR  19716 Nanotechnologies — Characterization  of cellulose  nanocrystals, [emphasis mine] initiated  in  April 2014, is  now at Committee  Draft  (CD)  3-month  ISO ballot, closing    Aug 31, 2015. Ballot comments will be addressed during JWG2 Measurement and Characterization working  group meetings  at  the 18th Plenary  of  ISO/TC229, Nanotechnologies,  being held in Edmonton, Alberta, Sep. 28 – Oct. 2, 2015.

Research   programmes   or   strategies   designed   to  address   human   health   and/   or environmental safety aspects of nanomaterials

Scientific research

Environment Canada continues to support various academic and departmental research projects. This research has to date included studying fate and effects of nanomaterials in the aquatic, sediment, soil, and air  compartments. Funding  in  fiscal  2015-16  continues  to  support  such  projects,  including  sub-surface transportation, determining key physical-chemical parameters to predict ecotoxicity, and impacts of nano-silver [silver nanoparticles]  addition  to  a  whole  lake  ecosystem [Experimental Lakes Area?]. Environment  Canada  has  also  partnered  with  the National Research  Council  of  Canada  recently  to  initiate  a project  on  the  development  of  test  methods  to identify surfaces of nanomaterials for the purposes of regulatory identification and to support risk assessments. In addition,  Environment  Canada  is  working  with  academic laboratories in  Canada  and  Germany  to  prepare guidance to support testing of nanoparticles using the OECD Test Guideline for soil column leaching.

Health  Canada  continues  its  research  efforts  to  investigate  the  effects  of  surface-modified  silica nanoparticles. The   aims   of   these   projects   are  to:   (1) study the importance of size and surface functionalization;  and  (2)  provide a genotoxic profile and  to  identify  mechanistic  relationships  of  particle properties  to  elicited  toxic  responses.  A manuscript reporting  the in  vitro genotoxic,  cytotoxic and transcriptomic  responses  following  exposure  to  silica  nanoparticles  has  recently  been  submitted to  a  peer reviewed journal and is currently undergoing review. Additional manuscripts reporting the toxicity results obtained to date are in preparation.

Information on public/stakeholder consultations;

A consultation document on a Proposed Approach to Address Nanoscale Forms of Substances on the Domestic  Substances  List was  published  with a  public  comment  period ending  on May  17,  2015  (see Question  1).  Comments  were  received  from approximately  20  stakeholders  representing  industry and industry  associations,  as  well  as  non-governmental  organizations. These  comments  will  inform  decision making to address nanomaterials in commerce in Canada.

Information on research or strategies on life cycle aspects of nanomaterials

Canada, along with Government agencies in the United States, Non-Governmental Organizations and Industry,  is  engaged  in  a  project  to  look  at releases  of  nanomaterials  from  industrial  consumer  matrices (e.g., coatings). The objectives of the NanoRelease Consumer Products project are to develop protocols or
methods (validated  through  interlaboratory  testing) to  measure  releases  of  nanomaterials  from  solid matrices as a result of expected uses along the material life cycle for consumer products that contain the nanomaterials. The  project  is  currently  in  the  advanced  stages  of Phase  3  (Interlaboratory  Studies).  The objectives of Phase 3 of the project are to develop robust methods for producing and collecting samples of CNT-epoxy  and  CNT-rubber  materials  under  abrasion  and  weathering scenarios,  and  to  detect  and quantify, to the extent possible, CNT release fractions. Selected laboratories in the US, Canada, Korea and the European Community are finalising the generation and analysis of sanding and weathering samples and the    results    are    being    collected    in    a   data    hub    for    further    interpretation    and    analysis.

Additional details about the project can be found at the project website: http://www.ilsi.org/ResearchFoundation/RSIA/Pages/NanoRelease1.aspx

Under the OECD Working Party on Resource Productivity and Waste (WPRPW), the expert group on waste containing nanomaterials has developed four reflection papers on the fate of nanomaterials in waste treatment  operations.  Canada  prepared the  paper  on  the  fate  of  nanomaterials in  landfills;  Switzerland on the  recycling  of  waste  containing  nanomaterials;  Germany  on  the  incineration  of  waste  containing nanomaterials;  and  France  on  nanomaterials  in wastewater  treatment.  The  purpose  of  these  papers is to provide  an  overview  of  the  existing  knowledge  on the  behaviour  of  nanomaterials  during  disposal operations and identify the information gaps. At the fourth meeting of the WPRPW that took place on 12-14 November 2013, three of the four reflection papers were considered by members. Canada’s paper was presented and discussed at the fifth meeting of the WPRPRW that took place on 8-10 December 2014. The four  papers  were  declassified  by  EPOC  in  June  2015, and  an  introductory  chapter  was  prepared  to  draw these  papers  together. The introductory  chapter  and accompanying  papers  will  be  published in  Fall  2015. At  the sixth  meeting  of  the  WPRPW  in  June – July  2015,  the  Secretariat  presented  a  proposal  for an information-sharing  platform  that  would  allow  delegates  to  share research  and  documents  related  to nanomaterials. During a trial phase, delegates will be asked to use the platform and provide feedback on its use at the next meeting of the WPRPW in December 2015. This information-sharing platform will also be accessible to delegates of the WPMN.

Information related to exposure measurement and exposure mitigation.

Canada and the Netherlands are co-leading a project on metal impurities in carbon nanotubes. A final version  of  the  report  is  expected  to  be ready for WPMN16. All  research has  been completed (e.g. all components are published or in press and there was a presentation by Pat Rasmussen to SG-08 at the Face-to-Face Meeting in Seoul June 2015). The first draft will be submitted to the SG-08 secretariat in autumn 2015. Revisions  will  be  based  on  early  feedback  from  SG-08  participants.  The  next  steps  depend  on  this feedback and amount of revision required.

Information on past, current or future activities on nanotechnologies that are being done in co-operation with non-OECD countries.

A webinar between ECHA [European Chemicals Agency], the US EPA [Environmental Protection Agency] and Canada was hosted by Canada on April 16, 2015. These are  regularly  scheduled  trilateral  discussions  to keep  each  other  informed  of  activities  in  respective jurisdictions.

In  March 2015, Health  Canada  hosted  3  nanotechnology knowledge  transfer sessions  targeting Canadian  government  research  and  regulatory  communities  working  in  nanotechnology.  These  sessions were  an  opportunity  to  share  information  and perspectives  on  the  current  state  of  science supporting  the regulatory  oversight  of  nanomaterials with  Government.  Presenters  provided  detailed  outputs  from  the OECD WPMN including: updates on OECD test methods and guidance documents; overviews of physical-chemical properties, as well as their relevance to toxicological testing and risk assessment; ecotoxicity and fate   test   methods;   human   health   risk   assessment   and   alternative   testing   strategies;   and exposure measurement  and  mitigation.  Guest  speakers  included  Dr  Richard  C.  Pleus  Managing  Director  and  Director of Intertox, Inc and Dr. Vladimir Murashov Special Assistant on Nanotechnology to the Director of National Institute for Occupational Safety and Health (NIOSH).

On   March   4-5, 2015, Industry   Canada   and   NanoCanada co-sponsored  “Commercializing Nanotechnology  in  Canada”,  a  national  workshop  that brought  together  representatives  from  industry, academia and government to better align Canada’s efforts in nanotechnology.  This workshop was the first of  its  kind  in  Canada. It  also  marked  the  official  launch  of  NanoCanada (http://nanocanada.com/),  a national  initiative  that  is  bringing  together stakeholders  from  across  Canada  to  bridge  the  innovation  gap and stimulates emerging technology solutions.

It’s nice to get an update about what’s going on. Despite the fact this report was published in 2016 the future tense is used in many of the verbs depicting actions long since accomplished. Maybe this was a cut-and-paste job?

Moving on, I note the mention of the Canada-led,  ISO  standards project, ISO/DTR  19716 Nanotechnologies — Characterization  of cellulose  nanocrystals (CNC). For those not familiar with CNC, the Canadian government has invested hugely in this material derived mainly from trees, in Canada. Other countries and jurisdictions have researched nanocellulose derived from carrots, bananas, pineapples, etc.

Finally, it was interesting to find out about the existence of  NanoCanada. In looking up the Contact Us page, I noticed Marie D’Iorio’s name. D’Iorio, as far as I’m aware, is still the Executive Director for Canada’s National Institute of Nanotechnology (NINT) or here (one of the National Research Council of Canada’s institutes). I have tried many times to interview someone from the NINT (Nils Petersen, the first NINT ED and Martha Piper, a member of the advisory board) and more recently D’Iorio herself only to be be met with a resounding silence. However, there’s a new government in place, so I will try again to find out more about the NINT, and, this time, NanoCanada.

Canada and a mandatory survey on nanomaterials due February 2016

If memory serves, this is the second nanomaterials reporting survey that the Canadian federal government has requested in the seven years that I’ve *been* blogging on the topic Canadian nanotechnology. (As usual, I’ve gotten my information from a source outside the country.) Thanks to Lynn Bergeson (US lawyer) and her July 27, 2015 posting on Nanotechnology Now where she covers nanotechnology’s regulatory developments (Note: A link has been removed),

The July 25, 2015, Canada Gazette includes a notice announcing that the Minister of the Environment requires, for the purpose of assessing whether the substances described in the notice are toxic or are capable of becoming toxic, or for the purpose of assessing whether to control, or the manner in which to control the listed substances, any person described in the notice who possesses or who may reasonably be expected to have access to the information required to provide that information. See http://www.gazette.gc.ca/rp-pr/p1/2015/2015-07-25/html/notice-avis-eng.php The notice applies to a substance that has a size of between 1 and 100 nanometers in at least one external dimension, or internal or surface structure; and is provided in the list in Schedule 1 of the notice. The list includes over 200 substances. The notice applies to any person who, during the 2014 calendar year, manufactured a total quantity greater than 100 kilograms (kg) of a substance set out in Schedule 1. …

You can find the Canada Gazette notice (Notice with respect to certain nanomaterials in Canadian commerce) here: http://www.gazette.gc.ca/rp-pr/p1/2015/2015-07-25/html/notice-avis-eng.php but you may find the Guidance for responding to the Notice: http://www.ec.gc.ca/ese-ees/default.asp?lang=En&n=AACFB2C0-1 more helpful (Note: Links have been removed),

1.1- Purpose of the Notice

In 2011, the Canada-United States Regulatory Cooperation Council (RCC) Nanotechnology InitiativeFootnote[1] was launched to increase alignment in regulatory approaches for nanomaterials between Canada and the US to reduce risk to human health and the environment; to promote sharing of scientific and regulatory expertise; and to foster innovation. Completed in February 2014, the RCC Nanotechnology Initiative included a work element on Commercial Information.Footnote[2] This work element was aimed at increasing knowledge of commercial uses of nanomaterials in Canada and the US. The primary output from this work element was a Nanomaterials Use Matrix which identified nanomaterials by type and use category based on the most up-to-date information, at the time, on commercially available nanomaterials. The nanomaterial types were cross-referenced with the DSL to identify nanomaterials which could be considered existing in Canada. The result is a preliminary reference list and may not be comprehensive of all nanomaterials. Ongoing engagement with stakeholders through voluntary initiatives and other fora will inform further development of the list of existing nanomaterials in Canada.

The purpose of the Notice is to gather information on 206 nanomaterials identified as potentially in commerce in Canada from the primary reference list. [emphasis mine] The information collected from the Notice will support the development of a list of nanomaterials in commerce in Canada by confirming their commercial status, and subsequent prioritization activities for these substances, which may include risk assessment and risk management activities, if required. This will ensure that future decision making is based on the best available information.

The list of reportable substances is long and not alphabetized but before you check you may want to review this,

2.1- Reporting criteria

To determine whether a company is required to respond, the following factors must be considered:

Type of substance (i.e., nanoscale form)
Type of activity
Calendar year
Quantity
The quantity should be determined based on the quantity of the substance itself at the nanoscale, and not on the quantity of the product or mixture containing the substance.

The purpose of the Notice is to gather information on nanomaterials in commerce in Canada. A response is only required if the conditions set out in Schedule 1 and Schedule 2 of the notice are met.

The Notice applies to any person who, during the 2014 calendar year [emphasis mine], satisfied any of the following criteria:

Manufactured a total quantity greater than 100 kg of a substance listed in Schedule 1 that is at the nanoscale.
Imported a total quantity greater than 100 kg of a substance listed in Schedule 1 that is at the nanoscale, at any concentration, whether alone, in a mixture or in a product.

The reporting threshold of 100 kg is based on activity with the substance in the nanoscale (i.e. you manufacture, or imported a total quantity greater than 100 kg of a substance with a size between 1 and 100 nanometres, inclusive, in at least one external dimension, or internal or surface structure).

Your response to the information requested should also be based on activities with the substance in the nanoscale.

If you are engaged with a substance that is not in the nanoscale (i.e. same CAS RN, but not nanoscale) and would like to identify yourself as a stakeholder for that substance, you may submit a Declaration of Stakeholder Interest (see section 7 of this document).

You may find this flowchart (from the guidance webpage), useful,

Figure 1: Reporting Diagram for Nanomaterials [downloaded from: http://www.ec.gc.ca/ese-ees/default.asp?lang=En&n=AACFB2C0-1]

Figure 1: Reporting Diagram for Nanomaterials [downloaded from: http://www.ec.gc.ca/ese-ees/default.asp?lang=En&n=AACFB2C0-1]

The information you provide needs to cover the 2014 calendar year and is due,

10. Responding to the Notice

Responses to the Notice must be provided no later than February 23, 2016, 5 p.m. Eastern Standard Time using the online reporting system available through Environment Canada’s Single Window available from the Chemical Substances Web site.

Good luck to all those who must report.

*’been’ added on Jan. 13, 2017.