Tag Archives: Lynn Bergeson

Canada-US Regulatory Cooperation Council’s Nanotechnology Work Plan

Thanks for Lynn L. Bergeson for her Dec. 1, 2012 posting on the Nanotechnology Now website for the information about a Nov. 28, 2012 webinar that was held to discuss a Nanotechnology Work Plan developed by the joint Canada-US Regulatory Cooperation Council (or sometimes it’s called the US-Canada Regulatory Cooperation Council),

The RCC requested that industry provide more information on the commercial distribution of nanomaterials, as well as more transparency by claiming confidentiality of only that information absolutely critical to market advantage.

To compare risk assessment and risk management practices to highlight and identify best practices, data gaps, and differences between the two jurisdictions, the RCC sought nominations of a nanomaterial substance for a case study. Four nanomaterial substances were nominated: multiwall carbon nanotubes, nanocrystalline cellulose, nano silver, and titanium dioxide. The RCC has selected multiwall carbon nanotubes for the case study. The RCC intends to hold in March 2013 a workshop in Washington, D.C., to discuss information collected to date and approaches moving forward. In spring 2013, the RCC will hold one or two conference calls or webinars to discuss information gathered between countries and the path forward. Finally, in fall 2013, the RCC expects to hold a stakeholder consultation/workshop on results to date.

Here’s some background on the RCC. First announced in February 2011, the RCC had its first ‘stakeholder’ session (attended by approximately 240)  in January 2012 in Washington, DC. where a series of initiatives, including nanotechnology, were discussed (from the US International Trade Administration RCC Stakeholder Outreach webpage),

Agriculture and Food, Session A

  • Perimeter approach to plant protection

Agriculture and Food, Session B

  • Crop protection products

Agriculture and Food, Session C

  • Meat/poultry – equivalency
  • Meat/poultry – certification requirements
  • Meat cut nomenclature

Agriculture and Food, Session D

  • Veterinary drugs
  • Zoning for foreign animal disease

Agriculture and Food, Session E

  • Financial protection to produce sellers

Agriculture and Food, Session F

  • Food safety – common approach
  • Food safety – testing

Road Transport – Motor Vehicles

  • Existing motor vehicle safety standards
  • New motor vehicle safety standards

Air Transport

  • Unmanned aircraft

Transportation

  • Intelligent Transportation Systems

Transportation

  • Dangerous goods means of transportation

Marine Transport

  • Safety and security framework & arrangement for the St. Lawrence Seaway & Great Lakes System
  • Marine transportation security regulations
  • Recreational boat manufacturing standards
  • Standard for lifejackets

Rail Transport

  • Locomotive Emissions
  • Rail Safety Standards

Environment

  • Emission standards for light-duty vehicles

Personal Care Products & Pharmaceuticals

  • Electronic submission gateway
  • Over-the-counter products – common monographs
  • Good manufacturing practices

Occupational Safety Issues

  • Classification & labelling of workplace hazardous chemicals

Nanotechnology

  • Nanotechnology

Led jointly by senior officials from Canada and the United States, the purpose of the various technical review sessions was to seek expert advice and technical input from the approximately 240 stakeholders in attendance.

Since the Jan. 2012 meeting, a Nanotechnology Work Plan has been developed and that’s what was recently discussed at the Nov. 28, 2012 webinar. I did find more on a Canadian government website, Canada’s Economic Action Plan Nanotechnology Work Plan webpage,

Nanotechnology Work Plan

 Canada Leads: Karen Dodds, Assistant Deputy Minister, Science and Technology Branch, Environment Canada (EC)

Hilary Geller, Assistant Deputy Minister, Healthy Environments and Consumer Safety Branch, Health Canada (HC)

U.S. Lead: Margaret Malanoski, Office of Information and Regulatory Affairs, Office of Management and Budget

Deliverable Outcome: Share information and develop common approaches, to the extent possible, on foundational regulatory elements, including criteria for determining characteristics of concern/no concern, information gathering, approaches to risk assessment and management, etc. Develop joint initiatives to align regulatory approaches in specific areas such that consistency exists for consumers and industry in Canada and the US.

Principles: Identification of common principles for the regulation of nanomaterials to help ensure consistency for industry and consumers in both countries

3-6 months:

Canada provides initial feedback on US “Policy Principles for the US Decision-Making Concerning Regulation and Oversight of Applications of Nanotechnology and Nanomaterials”.

6-12 months:

Countries complete an initial draft of shared principles for the regulation of nanomaterials.

12-18 months:

Update of draft principles informed from on-going stakeholder and expert consultations.

18th month:

Stakeholder consultation / workshop on results to date and future ongoing engagement.

Beyond 18 months:

Countries complete final draft of shared principles for the regulation of nanomaterials.

Workplan for Industrial Nanomaterials

Priority-Setting: Identify common criteria for determining characteristics of industrial nanomaterials of concern/no-concern

1-3 months:

  1. Define and finalize workplan (1st month)
  2. Develop mechanisms for stakeholder outreach and engagement (1st month)
  3. Conference call with relevant stakeholders to share and discuss workplan and call for Industry to volunteer nanomaterials for joint CAN/US review

3-6 months:

Share available scientific evidence regarding characteristics of industrial nanomaterials including that obtained from existing international fora (e.g. OECD Working Party on Manufactured Nanomaterials [Canada is a lead in the OECD Working Party on Manufactured Nanomaterials]).

8th month:

Stakeholder workshop to discuss information collected to date and approaches moving forward.

6-12 months:

Initiate an analysis of characteristics of select nanomaterials: similarities, differences, reasons for them.

Initiate discussions on approaches to consider for common definitions and terminology.

12th month:

Second conference call with relevant stakeholders to discuss non-CBI information gathered between the Countries and to discuss path forward in terms of development of reports and analyses.

12-18 months:

Develop draft criteria for determining characteristics of industrial nanomaterials of concern/no-concern.

15th month:

Third conference call with relevant stakeholders to discuss progress and to prepare for the upcoming stakeholder consultation/workshop.

Here’s information for the leads should you feel compelled to make contact,

Canada

(Lead) Karen Dodds, Assistant Deputy Minister, Science and Technology, Environment Canada (karen.dodds@ec.gc.ca; ph. 613- 819-934-6851)

Hilary Geller, Assistant Deputy Minister, Healthy Environments and Consumer Safety Branch (hilary.geller@hc-sc.gc.ca; ph. 613-946-6701)

United States

(Lead) Margaret Malanoski, Office of Management and Budget (Margaret_A._Malanoski@omb.eop.gov)

I gather that the ‘stakeholders’ are business people, researchers, and policy analysts/makers as there doesn’t seem to be any mechanism for public consultation or education, for that matter.

US chemists talk nano in a June 27, 2012 Washington, DC briefing

The American Chemical Society (ACS) has a Science & the Congress Project where they provide information about various science and technology issues to policymakers. Their latest briefing will be on nanomaterials and the Toxic Substances Control Act.  From the June 21, 2012 news release on EurekAlert,

The American Chemical Society (ACS) Science & the Congress Project invites news media to attend a luncheon briefing on “Nanomaterial Safety: Do We Have the Right Tools?” It will be held Wednesday, June 27, 12-1:30 p.m., in the Russell Senate Office Building Room 325. To attend, register at http://tinyurl.com/ACSSciCongr-nanoEHS.

This briefing is hosted by the ACS Science & the Congress Project with honorary co-host the Congressional Nanotechnology Caucus.

With nanotechnology, scientists engineer materials on a molecular level; that is, they work with such basic factors as the size, shape and surface properties of substances, in addition to altering the chemical composition, to create materials that exhibit novel properties. While the science to engineer nanomaterials has been developed largely since the 1980s, public laws to regulate the safety of materials and chemicals, such as the Toxic Substances Control Act (TSCA), were crafted in the 1970s. Important questions for our times: Does our understanding of and information about nanotechnology adequately inform the policies designed to ensure safe product development? Likewise, do the current policies address both the possible problems and benefits associated with nanotechnology? This panel will discuss whether policymakers currently have the necessary tools, both scientific and policy mechanisms, to reap the potentials of nanotechnology.

The briefing will feature the following panelists and an open discussion:

Moderator: Kristen Kulinowski, Ph.D., Science and Technology Policy Institute, Institute for Defense Analyses

Panelists:

  • Lynn Bergeson, Bergeson & Campbell P.C.
  • Richard Denison, Ph.D., Environmental Defense Fund
  • Arturo Keller, Ph.D., University of California, Santa Barbara

For those of us who can’t attend, it is possible to find more information the Science &the Congress Project, from the About page (and if you keep reading you’ll find that you may still be able to access the briefing even if you can’t attend the real-time event),

Since 1995, the American Chemical Society (ACS) has operated the Science & the Congress Project to educate and inform Members of Congress and their staffs on the importance of science and technology to solving national challenges. The Science & the Congress Project has conducted well over 100 congressional briefings on important and timely policy topics, relying on panels of knowledgeable and diverse experts to provide comprehensive, balanced presentations about chosen topics, and to increase the level of scientific and technological literacy on Capitol Hill. The goals of the project include:

  • Highlighting the role of S&T in public policy.
  • Helping Members of Congress and their staffs gain a deeper knowledge of the science involved in policy issues.
  • Serving as a neutral and credible source of scientific information.
  • Promoting the responsible use of science in national policymaking.

Serving ACS and Its Members

The ACS Science & the Congress Project provides significant benefits for ACS and its members:

  • Balanced, nonpartisan briefings lend credibility to ACS policy efforts.
  • Initiation of briefings enhances ACS’s leadership role among peer organizations.
  • Collaborations with cosponsors enhance ACS’s ties and foster cooperation within the scientific community.
  • Online availability of briefing materials increases ACS members’ exposure to science policy topics.

Enhancing Relationships

During more than a decade of existence, the ACS Science & the Congress Project has conducted well over 100 briefings and built relationships with:

  • Congressional offices, committees, caucuses and staffers.
  • Experts in academia, non-governmental organizations and all levels of government.
  • Professional organizations with overlapping interests.

They also make their materials available after the briefing,

Serving as an Ongoing Source of Science Policy Information

Individual web pages for each Science & the Congress Project briefing provide a breadth of resources on the briefing’s topic, including:

  • The speakers’ presentations.
  • Speaker biographical and contact information.
  • Supplemental links, documents, and articles.

I checked and it is possible to access the briefings and other information without a subscription. I hope the nanomaterials briefing will be available soon on the website soon. Here’s the page you should check.

US National Nanotechnology Initiative holding EHS webinar

There’s an Oct. 15, 2011 news item on Nanowerk announcing the US National Nanotechnology Initiative’s Environmental, Health, and Safety webinar on research strategies.

Federal Agencies participating in the National Nanotechnology Initiative (NNI) are hosting a webinar to announce the release of the 2011 NNI Environmental, Health, and Safety (EHS) Research Strategy and to the discuss the development of this document and its key focus areas. The webinar will be held October 20, 2011 from 12 noon until 12:45p.m [EDT].

The event will consist of an overview of the strategy’s development followed by comments from industrial, regulatory, and public health perspectives. Dr. John Howard, Nanotechnology Environmental and Health Implications (NEHI) Working Group Co-Chair, will serve as the moderator. Panelists include:

  • Dr. Treye Thomas, NEHI Working Group Co-Chair
  • Dr. Shaun Clancy, Evonik DeGussa Corporation
  • Dr. Janet Carter, Occupational Safety and Health Administration (OSHA)
  • Ms. Lynn Bergeson, Bergeson & Campbell

The webinar will also feature a 20-minute question-and-answer segment following the presentations. Questions may be submitted prior to the webinar to webinar@nnco.nano.gov beginning at noon (EDT) Wednesday, October 19, 2011 and will be accepted until the close of the webinar at 12:45 p.m. Thursday, October 20, 2011. [???]

I’m pretty sure that last bit is an error. I can’t imagine a webinar that lasts for 25 hours, at least not on this topic.

As registration is necessary to watch the webinar, I tried to do so and failed each time. I think the problem is that I don’t have a zip code. Usually I can fill in a Canadian postal code instead but this system rejected every attempt. If you do have a US zip code, you can register here.

In preparation for this webinar about EHS research strategies to be undertaken by US federal agencies, Dr. Andrew Maynard has summarized some of the public comments about the  key recommendations in the draft version, which was published in December 2010. Excerpted from Andrew’s Oct. 15, 2011 posting,

Bill Kojola

An integrated and linked research effort to assess, via epidemiological studies, the impact of exposure to engineered nanomaterials on human health and any necessary resultant risk assessment/management responses seems to be missing from the strategy.

Andrew Maynard

…what would it take to craft a federal strategy that enabled agencies to work together more effectively in ensuring the safe use of nanomaterials?  I’m not sure that this is entirely possible – an internal strategy will always be constrained by the system in ways that an externally-crafted strategy isn’t.  But I do think that there are three areas in particular that could be built on here:

  1. Principles. The idea of establishing principles to which agencies sign up to is a powerful one, and could be extended further.  For instance, they could include a commitment to working closely and cooperatively with other agencies, to working toward a common set of aims, and to critically reviewing progress towards these aims on a regular basis.
  2. Accountability. The implementation and coordination framework set out in chapter 8 of the draft strategy contains a number of items that, with a bit of work, some group within the federal government could be held accountable to.  Formally, the NNCO would seem to be the most appropriate organization to be held responsible for progress here.  With accountability for actions that support the implementation and coordination of the strategy, a basis could be built for an actionable strategy, rather than wishful thinking.
  3. Innovation. So often in documents like this, there is a sense of defeatism – “this is the system, and there’s nothing we can do to change it”.  Yet there are always innovative ways to circumvent institutional barriers in order to achieve specific ends.  I would strongly encourage the NEHI to start from the question “where to we want to go, and how are we going to get there”, rather than “what are we allowed to do”, and from this starting point explore innovative ways of making substantive and measurable progress towards the stated mission of the strategy.  Just one possibility here is to use the model of the Signature Initiatives being developed elsewhere within the NNI – which overcome institutional barriers to encourage agencies to focus on a common challenge.  Something similar to a Signature Initiative focused on predictive modeling, or personal exposure measurement, or nanomaterial characterization, could enable highly coordinated and integrated cross-agency programs that accelerate progress toward specific goals.  But this is just one possibility – there are surely many more ways of getting round the system!

John DiLoreto, The Nanotechnology Coalition

A core mission of the NNI is to foster “technological advancements that benefit society” (Draft NNI 2011 Environmental, Health, and Safety Strategy, page 1). The NNI strategy provides valuable help in identifying key research areas and, in some cases, providing the necessary funding to conduct the research itself. The Coalition believes that to fulfill its mission in this regard, the NNI could and should direct its considerable influence and resources to educating regulatory and other officials in positions of influence about nanotechnology so they can better fulfill their responsibilities to protect the safety of consumers. The EHS research strategy should also examine ways that science-based safety information can be shared with regulatory officials and others in leadership positions and provide scientific resources to assist these officials in understanding what a ‘nanomaterial’ is and help create a better understanding of properties that may impact safety.

David Berube

Section 6, p. 56, line 23/25/26/30 – 23 conflates translation with risk communication (they are different). 25 “approaches” is unclear and should reference levels of acceptable caution. 26 high uncertainty may demand whole new algorithms – your assumption whether risk communication and risk management can be integrated is incorrect. 30 is a good point to discuss the conflation of translation which occurs between parties within similar ranges of understanding and public perception (NGOs) as well as perception of public perception (legislators). Each of these subset publics have different needs and interests and standardization of terminology is hardly sufficient to the task at hand.

p. 57 line 4 – see above and consider we might need to develop algorithms appropriate to different levels of certainty. The assumption the answer to uncertainty is more certainty is not necessarily valid for all publics. The simplified version in the document seems more attuned to strategic communication involving response strategies for different risks and certainty values involving variables like plausibility, phenomenon specificity, exigence, salience, etc.

p. 63 lines 34/37 34 (see above). 37 one model does not fit all. 38 link to trust is very complex and complicated by new/digital media sources as well as new credibility (social media) and reliability.

p. 58 lines 1/5/11/27 (see above) and this demands information sharing and transparency as well as answering how data is defined, who decides what is relevant data, how it is generated, how data is compiled and concatenated. how data is vetted and debunked, and how data is revised. 5 two ways is overly simplistic, try interactional. 11 this is a model issue and we do not have a model for high uncertainty. 27 assumes risk communication is a function of data, esp. scientific data and for many publics that is not true.

p. 76 – Explanation SP objective 4.2 re: needs of the stakeholders – it might be prudent to ask them what their needs are.

Samantha Dozier, PETA

A complete, step-wise method for rigorous characterization is imperative so that measurement is not questioned and studies are not repeated. A clear requirement for nanomaterial characterization will help eliminate redundancy and imprecise data-gathering and will aid in reducing animal use for the field.

For human health effects assessment, the NNI should promote the development of a tiered, weight-of-evidence approach that is based on the most relevant methods available and encourages the NNI to support the incorporation of appropriate in vitro human-relevant cell and tissue assays for all endpoints, instead of relying on inadequately modified, non-validated animal assays. This tiered approach should start with an initial characterization of the nanomaterial, followed by in vitro basal cell and portal-of-entry toxicity assessments according to human exposure potential and a full characterization of the toxicokinetic potential.

There’s a lot more in Andrew’s posting. It saddens me even more now that I see Andrew’s posting that Health Canada did not make the submissions to its public consultation on “Policy Statement on Health Canada’s Working Definition for Nanomaterials” available for viewing (my Oct. 11, 2011 posting).