Tag Archives: Environment Canada

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.

Café Scientifique (Vancouver, Canada) and noise on Oct. 27, 2015

On Tuesday, October 27, 2015  Café Scientifique, in the back room of The Railway Club (2nd floor of 579 Dunsmuir St. [at Seymour St.]), will be hosting a talk on the history of noise (from the Oct. 13, 2015 announcement),

Our speaker for the evening will be Dr. Shawn Bullock.  The title of his talk is:

The History of Noise: Perspectives from Physics and Engineering

The word “noise” is often synonymous with “nuisance,” which implies something to be avoided as much as possible. We label blaring sirens, the space between stations on the radio dial and the din of a busy street as “noise.” Is noise simply a sound we don’t like? We will consider the evolution of how scientists and engineers have thought about noise, beginning in the 19th-century and continuing to the present day. We will explore the idea of noise both as a social construction and as a technological necessity. We’ll also touch on critical developments in the study of sound, the history of physics and engineering, and the development of communications technology.

This description is almost identical to the description Bullock gave for a November 2014 talk he titled: Snap, Crackle, Pop!: A Short History of Noise which he summarizes this way after delivering the talk,

I used ideas from the history of physics, the history of music, the discipline of sound studies, and the history of electrical engineering to make the point that understanding “noise” is essential to understanding advancements in physics and engineering in the last century. We began with a discussion of 19th-century attitudes toward noise (and its association with “progress” and industry) before moving on to examine the early history of recorded sound and music, early attempts to measure noise, and the noise abatement movement. I concluded with a brief overview of my recent work on the role of noise in the development of the modem during the early Cold War.

You can find out more about Dr. Bullock who is an assistant professor of science education at Simon Fraser University here at his website.

On the subject of noise, although not directly related to Bullock’s work, there’s some research suggesting that noise may be having a serious impact on marine life. From an Oct. 8, 2015 Elsevier press release on EurekAlert,

Quiet areas should be sectioned off in the oceans to give us a better picture of the impact human generated noise is having on marine animals, according to a new study published in Marine Pollution Bulletin. By assigning zones through which ships cannot travel, researchers will be able to compare the behavior of animals in these quiet zones to those living in noisier areas, helping decide the best way to protect marine life from harmful noise.

The authors of the study, from the University of St Andrews, UK, the Oceans Initiative, Cornell University, USA, and Curtin University, Australia, say focusing on protecting areas that are still quiet will give researchers a better insight into the true impact we are having on the oceans.

Almost all marine organisms, including mammals like whales and dolphins, fish and even invertebrates, use sound to find food, avoid predators, choose mates and navigate. Chronic noise from human activities such as shipping can have a big impact on these animals, since it interferes with their acoustic signaling – increased background noise can mean animals are unable to hear important signals, and they tend to swim away from sources of noise, disrupting their normal behavior.

The number of ships in the oceans has increased fourfold since 1992, increasing marine noise dramatically. Ships are also getting bigger, and therefore noisier: in 2000 the biggest cargo ships could carry 8,000 containers; today’s biggest carry 18,000.

“Marine animals, especially whales, depend on a naturally quiet ocean for survival, but humans are polluting major portions of the ocean with noise,” said Dr. Christopher Clark from the Bioacoustics Research Program, Cornell University. “We must make every effort to protect quiet ocean regions now, before they grow too noisy from the din of our activities.”

For the new study, lead author Dr. Rob Williams and the team mapped out areas of high and low noise pollution in the oceans around Canada. Using shipping route and speed data from Environment Canada, the researchers put together a model of noise based on ships’ location, size and speed, calculating the cumulative sound they produce over the course of a year. They used the maps to predict how noisy they thought a particular area ought to be.

To test their predictions, in partnership with Cornell University, they deployed 12 autonomous hydrophones – devices that can measure noise in water – and found a correlation in terms of how the areas ranked from quietest to noisiest. The quiet areas are potential noise conservation zones.

“We tend to focus on problems in conservation biology. This was a fun study to work on, because we looked for opportunities to protect species by working with existing patterns in noise and animal distribution, and found that British Colombia offers many important habitat for whales that are still quiet,” said Dr. Rob Williams, lead author of the study. “If we think of quiet, wild oceans as a natural resource, we are lucky that Canada is blessed with globally rare pockets of acoustic wilderness. It makes sense to talk about protecting acoustic sanctuaries before we lose them.”

Although it is clear that noise has an impact on marine organisms, the exact effect is still not well understood. By changing their acoustic environment, we could be inadvertently choosing winners and losers in terms of survival; researchers are still at an early stage of predicting who will win or lose under different circumstances. The quiet areas the team identified could serve as experimental control sites for research like the International Quiet Ocean Experiment to see what effects ocean noise is having on marine life.

“Sound is perceived differently by different species, and some are more affected by noise than others,” said Christine Erbe, co-author of the study and Director of the Marine Science Center, Curtin University, Australia.

So far, the researchers have focused on marine mammals – whales, dolphins, porpoises, seals and sea lions. With a Pew Fellowship in Marine Conservation, Dr. Williams now plans to look at the effects of noise on fish, which are less well understood. By starting to quantify that and let people know what the likely economic effect on fisheries or on fish that are culturally important, Dr. Williams hopes to get the attention of the people who make decisions that affect ocean noise.

“When protecting highly mobile and migratory species that are poorly studied, it may make sense to focus on threats rather than the animals themselves. Shipping patterns decided by humans are often more predictable than the movements of whales and dolphins,” said Erin Ashe, co-author of the study and co-founder of the Oceans Initiative from the University of St Andrews.

Keeping areas of the ocean quiet is easier than reducing noise in already busy zones, say the authors of the study. However, if future research that stems from noise protected zones indicates that overall marine noise should be reduced, there are several possible approaches to reducing noise. The first is speed reduction: the faster a ship goes, the noisier it gets, so slowing down would reduce overall noise. The noisiest ships could also be targeted for replacement: by reducing the noise produced by the noisiest 10% of ships in use today, overall marine noise could be reduced by more than half. The third, more long-term, option would be to build quieter ships from the outset.

I can’t help wondering why Canadian scientists aren’t involved in this research taking place off our shores. Regardless, here’s a link to and a citation for the paper,

Quiet(er) marine protected areas by Rob Williams, Christine Erbe, Erin Ashe, & Christopher W. Clark. Marine Pollution Bulletin Available online 16 September 2015 In Press, Corrected Proof doi:10.1016/j.marpolbul.2015.09.012

This is an open access paper.

Updates on a Canadian election science debate and the 2015 Canadian Science Policy Conference (blog session) plus a protest song

I have some good news on a couple of fronts. First, it seems increasingly likely that we will see a 2015 election science debate.

Canadian election 2015 science debate

The debate will be, according to Jim Handman, senior producer, held in early October 2015 on CBC (Canadian Broadcasting Corporation) radio’s Quirks and Quarks program. Here’s what Mr. Handman had to say after I tweeted and contacted them about holding an election science debate,

… Quirks has approached all the parties at the national
level to provide candidates for a radio panel on science to be
broadcast in early October. They have all expressed interest and we are waiting to hear about specific candidates. It is up to the parties to choose the participants.

Not realizing something was in the works at Quirks and Quarks and following on a suggestion from David Bruggeman at Pasco Phronesis (noted in my Aug. 17, 2015 posting), I contacted Lynne Quarmby (Green shadow science minister), Ted Hsu (Liberal shadow science minister), Kennedy Stewart (NDP [New Democratic Party] shadow science minister), and Ed Holder (Conservative science minister) about their willingness to participate in a debate. As of this writing, both Lynne Quarmby and Ted Hsu have shown interest.

While I was busy tweeting, this was brought to my attention,

UVic2015electonScienceDebate

You can see, if you look carefully at the bottom of the poster, the Evidence for Democracy logo. Those folks kicked off a proposal for science debate for this election in an Aug. 12, 2015 opinion piece for the Toronto Star.

Plus, CBC is reporting a new call for a science debate in a Sept. 3, 2015 news item by Julie Ireton,

Members of Canada’s long-silent scientific research community are increasingly speaking out during this year’s federal campaign as they desperately try to make science an election issue.

Jules  Blais, a biology professor at the University of Ottawa, calls cuts to science-related jobs “targeted strikes.”

Like many Canadian scientists, Blais considers himself non-partisan and said he’s not campaigning for any particular party, but that he and others are speaking out for the need to protect independent scientific research.

“Science has always been apolitical by its nature, but in recent years because of the dramatic changes that we’re seeing in the way science is being done, and science is being conducted, it’s increasingly a political issue,” said Blais.

To sum it up, it all looks quite promising for 2015 although I hope any national debate will be more broad-ranging and nuanced than a simple Conservative science policy bashing.

For anyone interested in ancient history, there’s my Aug. 17, 2015 posting which provides a view of previous efforts to get a science debate during an election in English-speaking Canada and notes like efforts have taken place in French-speaking Canada. Happily for anyone wanting a more complete history, Pascal Lapointe and Josh Silberg have written an Aug. 31, 2015 posting on Science Borealis detailing efforts in Québec.

Canadian Science Policy Conference blogging session

In an Aug. 18, 2015 posting, I highlighted and critiqued the blogging session offered at the upcoming 2015 Canadian Science Policy Conference. One of the blog panel members, Chris Buddle kindly contacted me via Twitter to answer a few of the questions I’d posed and to tell me that he’d contacted the organizers and suggested some changes be made to the descriptions based on my comments. You can find the changed descriptions here.

They’ve added one person to the panel, Lisa Willemse, who’s billed as Senior Communications Advisor, Ontario Institute for Regenerative Medicine.

One final comment about the science blogging panel descriptions, I wish they’d added links to the blogs. Perhaps that wasn’t technical feasible?

Protest song

Part of what has mobilized scientists and a discussion of science in Canada has been the Conservative government’s policy of ‘muzzling scientists’. Glyn Moody in a Sept. 1, 2015 posting on Techdirt profiles an incident where Environment Canada scientist, Tony Turner, has been put on leave while charges that he violated conflict-of-interest rules are being investigated. His sin: he wrote a protest song, got a group of friends and supporters to sing it with him, and then posted it to Youtube. From Moody’s posting (Note: A link has been removed),

Turner’s song, with its opening lines “Who controls our parliament? Harperman, Harperman. Who squashes all dissent? Harperman, Harperman,” and a refrain of “It’s time for you to go,” is pretty mild stuff. …

Of course, the great thing about the Canadian government’s absurd overreaction to this gentlest of private protests is that many more people will now learn that Turner is an environmental scientist who is being muzzled by a bunch of desperate control freaks who are frightened that the Canadian people might be told the truth about important scientific issues. Thank goodness for the Streisand Effect…. [As I understand it, Barbra Streisand once responded to criticism or commentary about herself that she found offensive. Her response, given her star power, drew a great of attention to the commentary. Techdirt folks have dubbed this the ‘Streisand’ effect, i.e. drawing attention to something no one would have noticed otherwise.]

An Aug. 28, 2015 article by Madeline Smith for the Globe and Mail provides details about the protest song and government response,

An Environment Canada scientist is under investigation for allegedly breaching the public service code of ethics by writing and performing a political song that criticizes the Harper government.

Andrew Hall, who filmed the Harperman video – a singalong with a backup choir that had almost 60,000 views as of Friday [Aug. 28, 2015] evening – said the song is a “joyful” expression of protest. [emphasis mine] He said Mr. Turner wasn’t acting as a public servant, so there should be a reasonable expectation “to be able to engage in democracy.”

As of Thurs., Sept. 3, 2015 at 10 am PDT the number of views is 525,823. So, from June 2015 when it was first posted to Aug. 28, 2015, there were almost 60,000 views. The Streisand effect in operation!

According to Smith’s article, Turner, after working for the government for 20 years, is months from retirement.

Finally, the song,

Rousing, isn’t it? That said, there is a fine line to be tread here. Civil servants are required to be neutral and, assuming you’re not dealing with noxious forces, you need to be respectful of the agreements you’ve made. As a civil servant for a number of years, that freedom of speech vs. neutrality ethics divide always bothered me. I believe that people are entitled to speak their opinions in private but I do see the point of insisting on neutrality professionally and privately. Most times, neutrality is the way to go for civil servants. However, there are times when one must speak out. The question is: what is the tipping point?

ETA Sept. 4, 2015: In the US they’re having their own civil servant neutrality issues. As evidenced by this story of the Kentucky clerk who refuses to issue marriage licences to same sex couples, civil service neutrality is not an open and shut discussion. Note: Slate has adopted a policy of urging readers to subscribe with popup ads.

Frogs: monitoring them, finding new species, and research about the golden ones in Panama

I have three frog-oriented items and while they’re not strictly speaking in my usual range of topics, given this blog’s name and the fact I haven’t posted a frog piece in quite a while, it seems this is a good moment to address that lack.

Monitoring frogs and amphibians at Trent University (Ontario, Canada)

From a March 23, 2015 Trent University news release,

With the decline of amphibian populations around the world, a team of researchers led by Trent University’s Dr. Dennis Murray will seek to establish environmental DNA (eDNA) monitoring of amphibian occupancy and aquatic ecosystem risk assessment with the help of a significant grant of over $596,000 from the Natural Sciences and Engineering Research Council of Canada (NSERC).

Awarded to Professor Murray, a Canada research chair in integrative wildlife conservation, bioinformatics, and ecological modelling and professor at Trent University along with colleagues Dr. Craig Brunetti of the Biology department, and Dr. Chris Kyle of the Forensic Science program, and partners at Laurentian University, University of Toronto, McGill University, Ontario Ministry of Natural Resources and Forestry and Environment Canada, the grant will support the development of tools that will promote a cleaner aquatic environment.

The project will use amphibian DNA found in natural breeding habitats to determine the presence and abundance of amphibians as well as their pathogens. This new technology capitalizes on Trent University’s expertise and infrastructure in the areas of wildlife DNA and water quality.

“We’re honoured to have received the grant to help us drive the project forward,” said Prof. Murray. “Our plan is to place Canada, and Trent, in a leadership position with respect to aquatic wildlife monitoring and amphibian conservation.”

Amphibian populations are declining worldwide, yet in Canada, amphibian numbers are not monitored closely, meaning changes in their distribution or abundance may be unnoticeable. Amphibian monitoring in Canada is conducted by citizen scientists who record frog breeding calls when visiting bodies of water during the spring. However, the lack of formalized amphibian surveys leaves Canada in a vulnerable position regarding the status of its diverse amphibian community.

Prof. Murray believes that the protocols developed from this project could revolutionize how amphibian populations are monitored in Canada and in turn lead to new insights regarding the population trends for several amphibian species across the country.

Here’s more about NSERC and Trent University from the news release,

About NSERC

NSERC is a federal agency that helps make Canada a country of discoverers and innovators. The agency supports almost 30,000 post-secondary students and postdoctoral fellows in their advanced studies. NSERC promotes discovery by funding approximately 12,000 professors every year and fosters innovation by encouraging over 2,400 Canadian companies to participate and invest in post-secondary research projects.

The NSERC Strategic Project Grants aim to increase research and training in areas that could strongly influence Canada’s economy, society or environment in the next 10 years in four target areas: environmental science and technologies; information and communications technologies; manufacturing; and natural resources and energy.

About Trent University

One of Canada’s top universities, Trent University was founded on the ideal of interactive learning that’s personal, purposeful and transformative. Consistently recognized nationally for leadership in teaching, research and student satisfaction, Trent attracts excellent students from across the country and around the world. Here, undergraduate and graduate students connect and collaborate with faculty, staff and their peers through diverse communities that span residential colleges, classrooms, disciplines, hands-on research, co-curricular and community-based activities. Across all disciplines, Trent brings critical, integrative thinking to life every day. As the University celebrates its 50th anniversary in 2014/15, Trent’s unique approach to personal development through supportive, collaborative community engagement is in more demand than ever. Students lead the way by co-creating experiences rooted in dialogue, diverse perspectives and collaboration. In a learning environment that builds life-long passion for inclusion, leadership and social change, Trent’s students, alumni, faculty and staff are engaged global citizens who are catalysts in developing sustainable solutions to complex issues. Trent’s Peterborough campus boasts award-winning architecture in a breathtaking natural setting on the banks of the Otonabee River, just 90 minutes from downtown Toronto, while Trent University Durham delivers a distinct mix of programming in the GTA.

Trent University’s expertise in water quality could be traced to its proximity to Canada’s Experimental Lakes Area (ELA), a much beleaguered research environment due to federal political imperatives. You can read more about the area and the politics in this Wikipedia entry. BTW, I am delighted to learn that it still exists under the auspices of the International Institute for Sustainable Development (IISD),

Taking this post into nanotechnology territory while mentioning the ELA, Trent University published a Dec. 8, 2014 news release about research into silver nanoparticles,

For several years, Trent University’s Dr. Chris Metcalfe and Dr. Maggie Xenopoulos have dedicated countless hours to the study of aquatic contaminants and the threat they pose to our environment.

Now, through the efforts of the International Institute for Sustainable Development (IISD), their research is reaching a wider audience thanks to a new video (Note: A link has been removed).

The video is one of a five-part series being released by the IISD that looks into environmental issues in Canada. The video entitled “Distilling Science at the Experimental Lakes Area: Nanosilver” and featuring Professors Metcalfe and Xenopoulos profiles their research around nanomaterials at the Experimental Lakes Area.

Prof. Xenopolous’ involvement in the project falls in line with other environmental issues she has tackled. In the past, her research has examined how human activities – including climate change, eutrophication and land use – affect ecosystem structure and function in lakes and rivers. She has also taken an interest in how land use affects the material exported and processed in aquatic ecosystems.

Prof. Metcalfe’s ongoing research on the fate and distribution of pharmaceutical and personal care products in the environment has generated considerable attention both nationally and internationally.

Together, their research into nanomaterials is getting some attention. Nanomaterials are submicroscopic particles whose physical and chemical properties make them useful for a variety of everyday applications. They can be found in certain pieces of clothing, home appliances, paint, and kitchenware. Initial laboratory research conducted at Trent University showed that nanosilver could strongly affect aquatic organisms at the bottom of the food chain, such as bacteria, algae and zooplankton.

To further examine these effects in a real ecosystem, a team of researchers from Trent University, Fisheries and Oceans Canada and Environment Canada has been conducting studies at undisclosed lakes in northwestern Ontario. The Lake Ecosystem Nanosilver (LENS) project has been monitoring changes in the lakes’ ecosystem that occur after the addition of nanosilver.

“In our particular case, we will be able to study and understand the effects of only nanosilver because that is the only variable that is going to change,” says Prof. Xenopoulos. “It’s really the only place in the world where we can do that.”

The knowledge gained from the study will help policy-makers make decisions about whether nanomaterials can be a threat to aquatic ecosystems and whether regulatory action is required to control their release into the environment.

You can find the 13 mins. video here: https://www.youtube.com/watch?v=_nJai_B4YH0#action=share

Shapeshifting frogs, a new species in Ecuador

Caption: This image shows skin texture variation in one individual frog (Pristimantis mutabilis) from Reserva Las Gralarias. Note how skin texture shifts from highly tubercular to almost smooth; also note the relative size of the tubercles on the eyelid, lower lip, dorsum and limbs. Credit: Zoological Journal of the Linnean Society

Caption: This image shows skin texture variation in one individual frog (Pristimantis mutabilis) from Reserva Las Gralarias. Note how skin texture shifts from highly tubercular to almost smooth; also note the relative size of the tubercles on the eyelid, lower lip, dorsum and limbs.
Credit: Zoological Journal of the Linnean Society

Here’s more about the shapeshifting and how the scientists figured out what the frogs were doing (from a March 23, 2015 Case Western Research University news release on EurekAlert; Note: A link has been removed),

A frog in Ecuador’s western Andean cloud forest changes skin texture in minutes, appearing to mimic the texture it sits on.

Originally discovered by a Case Western Reserve University PhD student and her husband, a projects manager at Cleveland Metroparks’ Natural Resources Division, the amphibian is believed to be the first known to have this shape-shifting capability.

But the new species, called Pristimantis mutabilis, or mutable rainfrog, has company. Colleagues working with the couple recently found that a known relative of the frog shares the same texture-changing quality–but it was never reported before.

The frogs are found at Reserva Las Gralarias, a nature reserve originally created to protect endangered birds in the Parish of Mindo, in north-central Ecuador.

The researchers, Katherine and Tim Krynak, and colleagues from Universidad Indoamérica and Tropical Herping (Ecuador) co-authored a manuscript describing the new animal and skin texture plasticity in the Zoological Journal of the Linnean Society this week. They believe their findings have broad implications for how species are and have been identified. The process may now require photographs and longer observations in the field to ensure the one species is not mistakenly perceived as two because at least two species of rain frogs can change their appearance.

Katherine Krynak believes the ability to change skin texture to reflect its surroundings may enable P. mutabilis to help camouflage itself from birds and other predators.

The Krynaks originally spotted the small, spiny frog, nearly the width of a marble, sitting on a moss-covered leaf about a yard off the ground on a misty July night in 2009. The Krynaks had never seen this animal before, though Tim had surveyed animals on annual trips to Las Gralarias since 2001, and Katherine since 2005.

They captured the little frog and tucked it into a cup with a lid before resuming their nightly search for wildlife. They nicknamed it “punk rocker” because of the thorn-like spines covering its body.

The next day, Katherine Krynak pulled the frog from the cup and set it on a smooth white sheet of plastic for Tim to photograph. It wasn’t “punk “–it was smooth-skinned. They assumed that, much to her dismay, she must have picked up the wrong frog.

“I then put the frog back in the cup and added some moss,” she said. “The spines came back… we simply couldn’t believe our eyes, our frog changed skin texture!

“I put the frog back on the smooth white background. Its skin became smooth.”

“The spines and coloration help them blend into mossy habitats, making it hard for us to see them,” she said. “But whether the texture really helps them elude predators still needs to be tested.”

During the next three years, a team of fellow biologists studied the frogs. They found the animals shift skin texture in a little more than three minutes.

Juan M. Guayasamin, from Universidad Tecnológica Indoamérica, Ecuador, the manuscript’s first author, performed morphological and genetic analyses showing that P. mutabilis was a unique and undescribed species. Carl R. Hutter, from the University of Kansas, studied the frog’s calls, finding three songs the species uses, which differentiate them from relatives. The fifth author of the paper, Jamie Culebras, assisted with fieldwork and was able to locate a second population of the species. Culebras is a member of Tropical Herping, an organization committed to discovering, and studying reptiles and amphibians.

Guayasamin and Hutter discovered that Prismantis sobetes, a relative with similar markings but about twice the size of P. mutabilis, has the same trait when they placed a spiny specimen on a sheet and watched its skin turn smooth. P. sobetes is the only relative that has been tested so far.

Because the appearance of animals has long been one of the keys to identifying them as a certain species, the researchers believe their find challenges the system, particularly for species identified by one or just a few preserved specimens. With those, there was and is no way to know if the appearance is changeable.

The Krynaks, who helped form Las Gralarias Foundation to support the conservation efforts of the reserve, plan to return to continue surveying for mutable rain frogs and to work with fellow researchers to further document their behaviors, lifecycle and texture shifting, and estimate their population, all in effort to improve our knowledge and subsequent ability to conserve this paradigm shifting species.

Further, they hope to discern whether more relatives have the ability to shift skin texture and if that trait comes from a common ancestor. If P. mutabilis and P. sobetes are the only species within this branch of Pristimantis frogs to have this capability, they hope to learn whether they retained it from an ancestor while relatives did not, or whether the trait evolved independently in each species.

Golden frog of Panama and its skin microbiome

Caption: Researchers studied microbial communities on the skin of Panamanian golden frogs to learn more about amphibian disease resistance. Panamanian golden frogs live only in captivity. Continued studies may help restore them back to the wild. Credit: B. Gratwicke/Smithsonian Conservation Biology Institute

Caption: Researchers studied microbial communities on the skin of Panamanian golden frogs to learn more about amphibian disease resistance. Panamanian golden frogs live only in captivity. Continued studies may help restore them back to the wild.
Credit: B. Gratwicke/Smithsonian Conservation Biology Institute

Among many of the pressures on frog populations, there’s a lethal fungus which has affected some 200 species of frogs. A March 23, 2015 news item on ScienceDaily describes some recent research into the bacterial communities present on frog skin,

A team of scientists including Virginia Tech researchers is one step closer to understanding how bacteria on a frog’s skin affects its likelihood of contracting disease.

A frog-killing fungus known as Batrachochytrium dendrobatidis, or Bd, has already led to the decline of more than 200 amphibian species including the now extinct-in-the-wild Panamanian golden frog.

In a recent study, the research team attempted to apply beneficial bacteria found on the skin of various Bd-resistant wild Panamanian frog species to Panamanian golden frogs in captivity, to see if this would stimulate a defense against the disease.

A March 23, 2015 Virginia Tech University news release on EurekAlert, which originated the news item, provides a twist and a turn in the story (Note: Links have been removed),

They found that while the treatment with beneficial bacteria was not successful due to its inability to stick to the skin, there were some frogs that survived exposure to the fungus.

These survivors actually had unique bacterial communities on their skin before the experiments started.

The next step is to explore these new bacterial communities.

“We were disappointed that the treatment didn’t work, but glad to have discovered new information about the relationship between these symbiotic microbial communities and amphibian disease resistance,” said Lisa Belden, an associate professor of biological sciences in the College of Science, a Fralin Life Science Institute affiliate, and a faculty member with the new Global Change Center at Virginia Tech. “Every bit of information gets us closer to getting these frogs back into nature.”

Studying the microbial communities of Panamanian golden frogs was the dissertation focus of Belden’s former graduate student Matthew Becker, who graduated with a Ph.D. in biological sciences from Virginia Tech in 2014 and is now a fellow at the Smithsonian Conservation Biology Institute.

“Anything that can help us predict resistance to this disease is very useful because the ultimate goal of this research is to establish healthy populations of golden frogs in their native habitat,” Becker told Smithsonian Science News. “I think identifying alternative probiotic treatment methods that optimize dosages and exposure times will be key for moving forward with the use of probiotics to mitigate chytridiomycosis.”

Here’s a link to and a citation for the paper,

Composition of symbiotic bacteria predicts survival in Panamanian golden frogs infected with a lethal fungus by Matthew H. Becker , Jenifer B. Walke , Shawna Cikanek , Anna E. Savage , Nichole Mattheus , Celina N. Santiago , Kevin P. C. Minbiole , Reid N. Harris , Lisa K. Belden , Brian Gratwicke. April 2015 Volume: 282 Issue: 1805 DOI: 10.1098/rspb.2014.2881 Published 18 March 2015

This is an open access paper.

For anyone curious about the article in the Smithsonian mentioned in the news release, you can find it here.

 

Government of Canada’s risk assessment for multi-walled carbon nanotubes

Lynn Bergeson’s Jan. 15, 2015 post on the Nanotechnology Now website mentions a newly issued Canadian risk assessment for multi-walled carbon nanotubes (MWCNTs),

Canada announced on January 9, 2015, that the New Substances Program has published six new risk assessment summaries for chemicals and polymers, including a summary for multi-wall carbon nanotubes.

… Environment Canada and Health Canada conduct risk assessments on new substances. These assessments include consideration of information on physical and chemical properties, hazards, uses, and exposure to determine whether a substance is or may become harmful to human health or environment as set out in Section 64 of the Canadian Environmental Protection Act, 1999 (CEPA 1999), and, if harm is suspected, to introduce any appropriate or required control measures. …

Here’s more information from the Summary of Risk Assessment Conducted Pursuant to subsection 83(1) of the Canadian Environmental Protection Act, 1999
Significant New Activity No. 17192: Multi-wall carbon nanotubes webpage,

Substance Identity

The substance is a short tangled multi-walled carbon nanotube that can be classified as a nanomaterial. [emphasis mine]

Notified Activities

The substance is proposed to be manufactured in or imported into Canada in quantities greater than 1000 kg/yr for use as an additive in plastics.

Environmental Fate and Behaviour

Based on its physical and chemical properties, if released to the environment, the substance will tend to partition to water, sediment, soil, and ambient air. The substance is expected to be persistent in these compartments because it is a stable inorganic chemical that will not degrade. Based on the limited understanding of uptake by organisms, more data is required to assess the bioaccumulation potential of this substance at the current schedule notification.

Ecological Assessment

Based on the available hazard information on the substance and surrogate data on structurally related nanomaterials, the substance has low to moderate (1-100 mg/L) acute toxicity in aquatic life (fish/daphnia/algae). The predicted no effect concentration was calculated to be less than 1 mg/L using the ErC50 from the most sensitive organism (P. subcapitata), which was used to estimate the environmental risk.

The notified and other potential activities in Canada were assessed to estimate the environmental exposure potential of the substance throughout its life cycle. Environmental exposure from the notified activities was determined through a conservative generic single point-source release blending scenario. The predicted environmental concentration for notified activities is estimated to be 2.1 µg/L.

Based on the current use profile in conjunction with low to moderate ecotoxicity endpoints, the substance is unlikely to cause ecological harm in Canada.

However, based on the current understanding of carbon nanotubes and nanomaterials in general, a change in the use profile of the substance (SNAc No. 17192) may significantly alter the exposure resulting in the substance becoming harmful to the environment.  Consequently, more information is necessary to better characterize potential environmental risks.

Human Health Assessment

Based on the available hazard information on the substance, the substance has a low potential for acute toxicity by the oral, dermal and inhalation routes of exposure (oral and dermal LD50 greater than 2000 mg/kg bw; inhalation LC50 greater than 1.3 mg/m3). It is a severe eye irritant (MAS score = 68), a mild skin irritant (PII = 1.08) and at most a weak sensitizer (because the positive control was tested at a concentration 10X higher than the test substance). It is not an in vitro mutagen (negative in a mammalian cell gene mutation test and in a mammalian chromosome aberration test).  Therefore the substance is unlikely to cause genetic damage.

Hazards related to substances used in the workplace should be classified accordingly under the Workplace Hazardous Materials Information System (WHMIS).

However, based on the available information on structurally related nanomaterials, the substance may cause respiratory toxicity, immunotoxicity, cardiovascular toxicity and carcinogenicity following oral and inhalation exposure.

When used as an additive in plastics, the substance is expected to be manufactured in or imported into Canada encapsulated in a solid polymer matrix. The potential site of exposure to the substance is expected to be within industrial facilities. Therefore, direct exposure of the general population is expected to be low. No significant environmental release is anticipated due to the specialized use under this notification and therefore indirect exposure of the general population from environmental media is also expected to be low. However, if the substance is produced in different forms (e.g. liquid polymer form), applied in different formulations or used in any other potential applications, an increased direct or indirect exposure potential may exist.

Based on the low potential for direct and indirect exposure of the general population under the industrial uses identified in this submission, the substance is not likely to pose a significant health risk to the general population, and is therefore unlikely to be harmful to human health.

However, based on the current understanding of carbon nanotubes and of nanomaterials in general, the risk arising from the use of the substance in consumer products is not known at this time.  The use of the substance in consumer products or in products intended for use by or for children may significantly alter the exposure of the general population resulting in the substance becoming harmful to human health.  Similarly, the import or manufacture of the substance in quantities greater than 10 000 kg/yr may significantly increase the exposure levels of the general population resulting in the substance becoming harmful to human health.  Consequently, more information is necessary to better characterize potential health risks.

I would like to see a definition for the word short as applied, in this risk assessment, to multi-walled carbon nanotubes. That said, this assessment is pretty much in line with current thinking about short, multi-walled carbon nanotubes. In short (wordplay noted), these carbon nanotubes are relatively safe (although some toxicological issues have been noted) as far as can be determined. However, the ‘relatively safe’ assessment may change as more of these carbon nanotubes enter the environment and as people are introduced to more products containing them.

One last comment, I find it surprising I can’t find any mention in the risk assessment of emergency situations such as fire, earthquake, explosions, etc. which could conceivably release short multi-walled carbon nanotubes into the air exposing emergency workers and people caught in a disaster. As well, those airborne materials might subsequently be found in greater quantity in the soil and water.

OECD’s (Organization for Economic Cooperation and Development) latest report on its regulating manufactured nanomaterials questionnaire

As I have commented on several occasions, most of my information about Canada’s activities with regard to risk and nanomaterials comes from outside the country, notably the OECD (Organization for Economic Cooperation and Development).

Thanks* to Lynn Bergeson and her Sept. 17, 2014 posting on Nanotechnology Now for information about the latest publication from the OECD’s Working Party on Manufactured Nanomaterials (Note: a link has been removed),

On September 16, 2014, the Organization for Economic Cooperation and Development (OECD) published a document entitled Report of the Questionnaire on Regulatory Regimes for Manufactured Nanomaterials 2010-2011. … The Report summarizes responses to the Working Party on Manufactured Nanomaterials (WPMN) Questionnaire on Regulated Nanomaterials: 2010-2011, which was issued July 12, 2012. The Questionnaire contained four sections related to the oversight of nanomaterials in various OECD jurisdictions: regulatory updates; definitions and/or legal approaches for nanomaterials by jurisdiction; regulatory challenges; and opportunities for collaboration.

You can find all of the reports from the OECD’s WPMN here, including this latest report, which is no. 42, Report of the questionnaire on regulatory regimes for manufactured nanomaterials 2010-201, ENV/JM/MONO(2014)28. This is the third time there’s been a questionnaire and subsequent report.

I have quickly skimmed through the report and found a few interesting items about Canada’s current activities and collaborations vis à vis manufactured nanomaterials and risk. From the REPORT OF THE QUESTIONNAIRE ON REGULATORY REGIMES FOR MANUFACTURED NANOMATERIALS 2010-2011 which appears to have been published Sept. 4, 2014. I have had an unusually difficult time including excerpts from the report along with page numbers, etc. On the first try, after almost an hour of cutting and pasting, I was unable to get an intelligible version into a preview. To all intents and purposes the text was in place but the preview attempt resulted in a bizarre column of text overwriting the sidebar to the right of the posts.

I tried again and found that extensive reformatting was necessary and that the original table format has been lost. Nonetheless. you will find there are two pieces of legislation being reported on, CEPA (1999), which I believe has something to do with Environment Canada, and F&DA, which seems to be associated with Health Canada. One or both pieces of legislation may be referenced as per the OECD report. Page numbers from the document are included after the excerpted table entries.

Table 12: Hazard identification …

CEPA (1999)

Extrapolation between nanomaterials (i.e., choosing the appropriate surrogate)

Validity of testing methods and analytical tools to detect, characterize and measure nanomaterials

Participating in international forums such as the WPMN [OECD Working Party on Manufactured Nanomaterials], Expert Meetings, and ISO [International Standards Organization] TC/229 to support the generation and synthesis of appropriate science.

Support domestic research to help minimize challenges in hazard identification.

F&DA

Nanomaterial-based products under the F&DA (i.e. nanomedicines) can be associated with a broad spectrum of toxicities that are dependent on the nanoparticle properties (e.g. size, surface charge and solubility). However, there is currently no specific guidance document available for nanomedicines. Nanoparticle properties can significantly impact the PK profile/biodistribution of nanomedicines resulting in safety concerns. The components of the nanomedicines can also interact with the immune system and may trigger unique immunogenicity/immunotoxicity profile. Animals are generally not predictive of immunological responses for biologics (however, it may not be the case if the nanomedicine is a chemical drug), it is likely that immunological studies for nanomedicines should be carried out in human clinical trials. Long term studies may be required for a nanomaterial that persist and accumulated in particular tissues for an extended period of time.  p. 45

Table 13: Health and safety …

F&DA Veterinary Drugs

Due to the lack of a comprehensive understanding of the effects of nanomaterials on human, animal and environmental health, the Veterinary Drugs Directorate has not yet established a comprehensive occupational health and safety policy. Moreover, occupational health and safety is a shared responsibility between the federal and provincial governments in Canada.

At this time, there is no conclusive evidence linking exposure of nanomaterials from veterinary drugs or food sources to negative impact on human health. Additional research is necessary before a definitive policy approach can be taken.

F&DA Veterinary Drugs
Veterinary drugs including those that contain nanomaterials are regulated by the Food and Drugs Act and the Food and Drug Regulations. These provide the Veterinary Drugs Directorate with the authority to regulate the human health and safety aspects of veterinary drug products. The Regulations cover the aspects of the manufacturing, human and animal safety and efficacy assessment, and post-market surveillance of veterinary drug products including those containing nanomaterials. The latter products are subject to the same rigorous assessments as non-nanomaterial-containing veterinary drug products. p. 47

Table 14: Risk Assessment Methodologies

CEPA (1999)

Our understanding of risk assessments of nanomaterials is still evolving. Nanomaterials regulated under the industrial chemicals program employ a precautionary approach (i.e., exposure is typically mitigated), and nano-relevant information is requested whenever appropriate to conduct more informed risk assessments.

Canada also continues to work in international projects, such as the international life sciences institute NanoRelease project aimed at developing methods to quantify releases of nanomaterials from solid matrices.

Canada is also part of the Regulatory Cooperation Council (RCC) Nanotechnology Initiative with the United States. Under this project, Canada and the US are developing a classification scheme for nanomaterials to inform on the utilization of analogue/read- across, developing frameworks and common assumptions to better
inform risk assessments, and mining public and confidential use information to increase marketplace knowledge of nanomaterials. p. 49

Table 15: Risk Management and Nanomaterials in Commerce …

CEPA (1999)

Knowledge of use profiles of industrial nanomaterials; lack of specificity in risk
management measures given the overall lack of information and nomenclature systems for nanomaterials

Under the RCC, Canada and the US are gathering information on the uses of industrial nanomaterials in the two countries.  p. 52

Table 16: Research … (to support regulatory decisions)

CEPA (1999)

– foster domestic and international capacity to generate research on risk assessment priorities and needs
– applying research findings to nanomaterial risk assessments
– using research on nanomaterials to extrapolate to other nanomaterials

– Canada is actively supporting domestic and international research projects to help inform risk assessments.

F&DA

Filling knowledge gaps

HC [Health Canada] is conducting laboratory research to study the effects of lipid nanoparticles on the thermal stability of various recombinant proteins with the aim of identifying determinants of susceptibility to unintended deleterious interactions.  p. 55

Table 17: Impact of Regulatory Actions and Innovations and Economic Growth

CEPA (1999)

How to obtain the necessary information on nanomaterials, and how to regulate them in a manner that does not prevent them from offering their many benefits to society.

Consult with industry on proposed approaches. Focus information requests and requirements.  pp. 56/7

Table 18: Labelling Communication of Nanomaterials …

CEPA (1999)

Labelling of nanomaterials has not been considered under CEPA 1999 to date. p. 58

Table 19: Collaboration with other countries …

CEPA (1999) & F&DA

New Substances Program is involved in various international activities, including:
1) International Organization for Standardization (ISO) Technical Committee (TC) 229 on Nanotechnologies
2) Organisation for Economic Co-operation and Development (OECD) Working Party on
Manufactured Nanomaterials (WPMN) and Working Party on Nanotechnology (WPN)
3) Canada-US Regulatory Cooperation Council (RCC)
4) International Cooperation on Cosmetic Regulation (ICCR) – 2 Reports have been published
a) Criteria and Methods of Detection for Nanomaterials in Cosmetics:
http://www.fda.gov/downloads/InternationalPrograms/HarmonizationInitiatives/UCM235485.pdf
b) Methods for Characterization of Nanomaterials in Cosmetics
http://ec.europa.eu/consumers/sectors/cosmetics/files/pdf/iccr5_char_nano_en.pdf
5) International Regulators Nanotechnology Working Group
6) International Life Sciences Institutes (ILSI) – NanoRelease Food Additive Project
7) NanoLyse

In addition, for veterinary drugs, Health Canada collaborates with other regulatory agencies in USA, Europe, Australia, etc in the regulation of non-nanomaterial products and substances and would do the same for substances that are, or products containing nanomaterials pp. 59/60

Table 19: Expert Workshop Sponsorship [table number repetition noted]

CEPA (1999)

The Workshop on the Human and Environmental Risk Assessment of Nanomaterials convened by Health Canada and Environment Canada (March 24-26, 2010) provided an open forum for detailed dialogue on nanomaterials among science evaluators, research scientists and regulators. The Workshop was attended by 25 experts from Australia, Canada, Europe, Korea and the United States of America. In addition, seven observers attended the Workshop.

Regulatory Cooperation Council with the United States

F&DA Foods

Health Canada will be hosting a Joint NanoLyse/NanoRelease Workshop to discuss methods and safety of nanomaterials and share information from the respective projects. NanoLyse is an EU research consortium to develop methods of analysis for engineered nano-materials in foods and NanoRelease is an International Life Sciences Institute lead initiative to develop of analytical methods, alimentary canal models for uptake of engineered nano-materials and review of regulatory issues. p. 61

In any event, good luck with the reading and you can find out more about NanoLyse here and more about Canadian participation in the NanoRelease Food Additive Steering Committee project here.

* ‘Thank’s’ changed to ‘Thanks’ on April 7, 2015

Deadline extension (travel grants and poster abstracts) for alternate testing strategies (ATS) of nanomaterials workshop

It seems there have been a couple of deadline extensions (to August 1, 2014) for the September 15-16, 2014 ‘Workshop to Explore How a Multiple Models Approach can Advance Risk Analysis of Nanoscale Materials’ in Washington, DC (first mentioned in my July 10, 2014 posting featuring a description of the workshop). You can go here to submit a poster abstract (from any country) and you can go here if you’re a student or young professional (from any country) in search of a $500 travel award.

I managed to speak to one of the organizers, Lorraine Sheremeta, (Assistant Director, Ingenuity Lab, University of Alberta and co-author a July 9, 2014 Nanowerk Spotlight article about the workshop). Lorraine (Lori) kindly spoke to me about the upcoming workshop, which she described as an academic conference,.

As I understand what she told me, the hosts for the September 15-16, 2014 Workshop to Explore How a Multiple Models Approach can Advance Risk Analysis of Nanoscale Materials in Washington, DC want to attract a multidisciplinary group of people to grapple with a few questions. First, they want to establish a framework for establishing which are the best test methods for nanomaterials. Second, they are trying to move away from animal testing and want to establish which methods are equal to or better than animal testing. Thirdly, they want to discuss what they are going to do with the toxicological data  that we have  been collecting on nanomaterials for years now.

Or, as she and her colleague from the Society of Risk Analysis (Jo Anne Shatkin) have put in it in their Nanowerk Spotlight article:

… develop a report on the State of the Science for ATS for nanomaterials, catalogue of existing and emerging ATS [alternate testing strategies] methods in a database; and develop a case study to inform workshop deliberations and expert recommendations

The collaborative team behind this event includes, the University of Alberta’s Ingenuity Lab, the Society for Risk Analysis, Environment Canada, Health Canada, and the Organization for Economic Co-operation and Development (OECD) Working Party on Manufactured Nanomaterials (WPMN) .

The speaker lineup isn’t settled at this time although they have confirmed Vicki Stone of Heriot-Watt University in Scotland (from her university bio page),

Vicki Stone, Professor of Toxicology, studies the effects of nanomaterials on humans and environmentally relevant species.  Current research projects investigate the mechanism of toxicity of a range of nanomaterials in cells of the immune system (macrophages and neutrophils), liver (hepatocytes) , gastrointestinal tract, blood vessels (endothelium) and lung.  She is interested in interactions between nanomaterials, proteins and lipids, and how this influences subsequent toxicity.  Current projects also develop in vitro alternatives using microfluidics as well as high resolution imaging of individual nanomaterials in 3D and over time.  In addition Vicki collaborates with ecotoxicologists to investigate the impacts of nanomaterials on aquatic organisms. Vicki coordinated a European project to identify the research priorities to develop an intelligent testing strategy for nanomaterials (www.its-nano.eu).

Vicki is Director of the Nano Safety Research Group at Heriot-Watt University, Edinburgh, and Director of Toxicology for SAFENANO (www.safenano.org). She has acted as the Editor-in-chief of the journal Nanotoxicology (http://informahealthcare.com/nan) for 6 years (2006-2011). Vicki has also published over 130 publications pertaining to particle toxicology over the last 16 years and has provided evidence for the government commissioned reports published by the Royal Society (2003) and the on Environmental Pollution (2008).  Vicki was previously a member of the UK Government Committee on the Medical Effects of Air Pollution (COMEAP) and an advisory board member for the Center for the Environmental Implications of NanoTechnology (CEINT; funded by the US Environmental Protection Agency)).

A representative from PETA (People for the Ethical Treatment of Animals) will also be speaking. I believe that will be Amy Clippinger (from the PETA website’s Regulatory Testing webpage; scroll down about 70% of the way),

Science adviser Amy Clippinger has a Ph.D. in cellular and molecular biology and genetics and several years of research experience at the University of Pennsylvania.

PETA representatives have been to at least one other conference on the topic of nano, toxicology, and animal testing as per my April 24, 2014 posting about NANOTOX 2014 in Turkey,

Writing about nanotechnology can lead you in many different directions such as the news about PETA (People for the Ethical Treatment of Animals) and its poster presentation at the NanoTox 2014 conference being held in Antalya, Turkey from April 23 – 26, 2014. From the April 22, 2014 PETA news release on EurekAlert,

PETA International Science Consortium Ltd.’s nanotechnology expert will present a poster titled “A tiered-testing strategy for nanomaterial hazard assessment” at the 7th International Nanotoxicology Congress [NanoTox 2014] to be held April 23-26, 2014, in Antalya, Turkey.

Dr. Monita Sharma will outline a strategy consistent with the 2007 report from the US National Academy of Sciences, “Toxicity Testing in the 21st Century: A Vision and a Strategy,” which recommends use of non-animal methods involving human cells and cell lines for mechanistic pathway–based toxicity studies.

There is a lot of interest internationally in improving how we test for toxicity of nanomaterials. As well, the drive to eliminate or minimize as much as possible the use of animals in testing seems to be gaining momentum.

Good luck to everyone submitting a poster abstract and/or an application for a travel grant!

In case you don’t want to scroll up, the SRA nano workshop website is here.

Canada-US joint Regulatory Cooperation Council nanotechnology initiative completed and Canada endorses OECD nanomaterials recommendation

Thanks to Lynn Bergeson’s July 9, 2014 posting on Nanotechnology Now, I learned the Canada-US joint Regulatory Cooperation Council (RCC) nanotechnology initiative has completed its work and will be filing final reports later this summer (2014).

I have featured the RCC here in at least three postings, a Dec. 3, 2012 posting, a June 26, 2013 posting, and a January 21, 2014 posting. Briefly, the RCC was first announced in 2011 and is intended to harmonize Canadian and US regulatory frameworks in a number of areas including, agriculture and food, transportation, personal care products and pharmaceuticals and more. Significantly, nanotechnology was also part of their portfolio.

The latest information about RCC doings was obtained from the Canadian government’s 2014 summer issue of the Chemicals Management Plan (CMP) Progress Report (a second thank you for Bergeson for information about this publication),

The Canada-U.S. Regulatory Cooperation Council Nanotechnology Initiative is now complete. Canada and the U.S. are implementing the new approaches and lessons learned in risk assessments of nanomaterials. An important outcome of the initiative is the development of consistent policy principles on the regulatory oversight of nanomaterials, which have now been endorsed by the Government of Canada. Watch for the publication of the final reports from the Canada-U.S. Regulatory Cooperation Council Nanotechnology Initiative this summer. The reports will include recommendations about ways in which Canada and the U.S. can align their nanomaterial regulatory work, including the application of consistent risk assessment approaches and methodologies and identifying categories of nanomaterials.

The 2014 CMP summer issue offers a second tidbit of information. This time it’s about Canada and the OECD,

Canada has endorsed a recommendation from the Organisation for Economic Co-operation and Development’s Council on the Safety Testing and Assessment of Manufactured Nanomaterials. The recommendation states that countries “apply the existing international and national chemical regulatory frameworks or other management systems, adapted to take into account the specific properties of manufactured nanomaterials.” The recommendation was based on the work of the Organisation for Economic Co-operation and Development’s Working Party on Manufactured Nanomaterials, which is a harmonization effort to inform regulatory programs regarding the environmental and health and safety implications of manufactured nanomaterials.

For enthusiasts, Canada’s Chemicals Management Plan progress report is expected to be published twice/year. There are now two issues available, the first with a Dec. 30, 2013 publication date. Here’s more about the CMP progress reports,

The Chemicals Management Plan Progress Report has been created to keep stakeholders and other interested parties up to date on the activities and programs related to Canada’s Chemicals Management Plan (CMP). The report is produced jointly by Environment Canada and Health Canada and will be published twice a year. It will report on advances in major initiatives and highlight key activities related to the Government of Canada’s recent work under the CMP. It will also inform you about coming events, dates of interest and how to get involved.

We encourage you to share the reports with anyone who may be interested. We also welcome your feedback or suggestions. We can be reached at Substances@ec.gc.ca.

Anyone interested in more information about the RCC (Regulatory Cooperation Council) and its nanotechnology efforts can find it here.

An upcoming alternate testing strategies (ATS) for nanomaterials workshop and the quest to reduce animal testing

It’s too late to announce a call for poster abstracts or travel awards but that still leaves the possibility of attending a September 15-16, 2014 Workshop to Explore How a Multiple Models Approach can Advance Risk Analysis of Nanoscale Materials in Washington, DC. In a July 9, 2014 Nanowerk Spotlight article,, Jo Anne Shatkin (President, Vireo Advisors) and Lorraine Sheremeta (Assistant Director, Ingenuity Lab, University of Alberta) tout the workshop in the context of describing new approaches to nanotoxicology research (Note: A link has been removed),

Engineered nanoscale materials (ENM or ‘nanomaterials’) offer the potential to create safer and more effective products through the use of smaller quantities of improved performance materials. Currently nanomaterials are used to improve the performance of life-saving drugs and medical technologies, to make renewable energy more efficient, to make value added products from industrial waste streams, to improve food, packaging, to lightweight materials used in transportation systems, and to improve many of the personal care products that we use every day. Nanomaterial manufacture and use is expected to increase over the coming years and despite the widespread use of nanomaterials in a variety of consumer products, we are only beginning to understand the impacts of these emerging materials on our health and the environment. To this end, the University of Alberta’s Ingenuity Lab is collaborating with the Society for Risk Analysis to evaluate the potential to use alternative test strategies (ATS) to improve our ability to assess nanomaterial toxicity and environmental impact.

Shatkin and Sheremeta describe toxicology tests and explain the importance of refining and improving these tests (from the article),

Standard in vivo toxicology test methods that depend heavily on the use of animals have long been used to assess chemical safety. [emphasis mine*] Existing and novel in vitro and in silico test methods provide important alternatives to in vivo animal testing for chemicals and potentially for ENM. Genotoxicity tests, for example, are used to assess the mutagenic potential of chemicals or nanomaterials in the replication of DNA in cells. Driven in part by increasing market and regulatory requirements for safer and more sustainable products, large international infrastructure has developed for creating, testing and validating in vitro test methods, and its use is expanding to chemical and nanomaterial assessment (NSF, 2007). The goals of reducing, refining and replacing animal testing (the commonly cited ‘three Rs’) – resonate with key and diverse stakeholders including animal rights groups, the bioethics community, the pharmaceutical industry, regulatory agencies and the broader public. [emphasis mine*]

Despite nearly a decade of effort in the conduct toxicology and exposure research to inform the assessment of health and environmental risks of nanomaterials, major gaps remain in the ability to understand and quantify risks. While there is now a large body of published data on carbon nanotubes and metal oxide nanoparticles, concern has been raised that speculation about nanomaterial risk has hardened into an assumption that there are ‘as-yet-to-be-discovered risks’ that we must identify and manage (Maynard, 2014) that demands extensive testing.

The authors describe ATS (alternative test strategies) in greater detail,

ATS approaches are regarded by many to have the potential for rapid screening of large numbers and types of materials. They can include a breadth of techniques including high throughput screening methods (HTS), high content screening, computational approaches, toxicogenomics, cell-based methods, in vitro assays and non-mammalian whole animal models. The emergence of ATS raises questions about how the results of these methods may be used for assessing the potential risks of ENM. For instance, ATS could be used in combination in a multiple models approach to evaluate new ENM in a number of rapid assays and compare with well-studied substances using in vivo testing; thereby identifying ENM for additional testing in a more strategic fashion than is possible through conventional testing approaches.

They also describe the current state of affairs with ATS,

In the United States, the U.S. ToxCast program has, as part of their 21st century toxicity screening program (NRC, 2007), tested 29 NMs with 62 in vitro test methods (Wang et al. 2013). Many researchers, including several from the University of Alberta, have proposed and developed ATS to include a variety of methods, some which are standardized for chemicals, and others which take advantage of developments including advanced biological mechanistic understanding, genomics, metabolomics, automation and informatics. However, these existing as well as emerging ATS have a short history with nanomaterials, and have not yet proven to be reliable for quantitative estimation of ENM risk. Still, several international efforts have developed ATS that have potential to be used for screening purposes, and to guide further testing priorities for regulatory decision making. The goal of the September [2014] workshop by the Society for Risk Analysis is to explore ways in which distinct ATS may be used for screening and prioritizing the need for more extensive testing of novel ENM.

The parties (including the authors of the article) involved in developing this risk workshop are listed, also mentioned are members of the international testing scene,

Lori Sheremeta, the Assistant Director of Ingenuity Lab in Edmonton Alberta and past Chair of the Society for Risk Analysis (SRA) Emerging Nanoscale Materials Specialty Group (ENMSG), is collaborating with U.S.-based nanomaterials risk expert Jo Anne Shatkin (an SRA Councilor and co-founder of the SRA ENMSG), Environment Canada, Health Canada, the SRA ENMSG and others on a Pilot Project with the Organization for Economic Co-operation and Development (OECD) Working Party on Manufactured Nanomaterials (WPMN) to develop a report on the State of the Science for ATS for nanomaterials, catalogue of existing and emerging ATS methods in a database; and develop a case study to inform workshop deliberations and expert recommendations.

There are many international efforts to develop, as well as to validate and standardize, these methods for chemicals, including organizations such as the US National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (ICCVAM), the European Union Reference Laboratory European Centre for the Validation of Alternative Methods (EURL ECVAM), the Japanese Center for the Validation of Alternative Methods (JacVAM), the Korean Centre for the Validation of Alternative Methods (KoCVAM) and the OECD. There is wide recognition that the diversity of NMs renders it impractical to use traditional animal testing to evaluate safety, hence there is significant interest in assessing the performance of both existing and emerging alternative testing strategies for NMs. Further, the EU directive REACH (Directive 2006/121/EC) requires replacing in vivo testing, and there is widespread popular agreement about the desire to limit animal testing. Finally, there is a need for more biologically informative toxicology methods (Hartung, 2010; Silbergeld et al, 2011; Landsiedel et al, 2009).

A list of the workshop objectives is offered  in the article,

The main objectives of the workshop are to:

assess the state of the science on HTS and ATS from a ‘multiple models’ perspective to identify areas of common findings from differing approaches, areas of greatest uncertainty, and priorities for follow up in applied research toward risk assessment of ENM;
evaluate the ability to use data from ATS/HTS methods for screening purposes – combining suites of assays and comparing well-studied substances to novel ones;

assess the ability to use a suite of ATS methods to amplify the Weight of Evidence;

characterize uncertainty associated with predictive relationships and propose strategies to address uncertainties;

elicit the perspectives of diverse stakeholders about the use of HTS/ATS for screening purposes in risk analysis of ENM; and

develop a set of recommendations for these alternative approaches to become more widely adopted for environmental, health and safety decision making about ENM across the product life cycle. The output of the workshop holds potential for transformation through risk screening approaches that promote safer and more sustainable material and technology development.

You can find more about the September 15-16, 2014 Workshop to Explore How a Multiple Models Approach can Advance Risk Analysis of Nanoscale Materials in Washington, DC here.

The text in the article is a bit rough. Some of the ideas and topics don’t follow each other logically. So, be prepared to spend a little time reading, Happily, there are references included with the article.

I last mentioned Jo Anne Shatkin here in the context of a 2013 paper on alternative test strategies (ATS) in an Aug. 22, 2013 posting. I think the most recent mention of Lorraine Sheremeta here is in a Jan. 11, 2010 posting about Canada, nanotechnology, and food.

Final note, I am hoping to get some more information about the workshop and ATS scene from Lorraine Sheremeta to be published in a subsequent posting.

* I added the emphases at 0830 hours PDT July 10, 2014.