Tag Archives: David Berube

Special issue on nanotechnology and regulations from EJLT

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The European Journal of Law and Technology (EJLT) is featuring 15 articles on the theme of nanotechnology and regulations in a special issue. From the Dec. 12, 2011 news item on Nanowerk,

The issue contains 15 contributions that canvass some of the most pressing philosophical, ethical and regulatory questions currently being debated around the world in relation to nanotechnologies and more specifically nanomaterials.

The EJLT is an open access journal so you can view these articles or any others that may interest you. Here’s the Table of Contents for the special issue,

Table of Contents

Editorial

Editorial
Philip Leith, Abdul Paliwala

Introduction to the Special Issue

Why the elephant in the room appears to be more than a nano-sized challenge
Joel D’Silva, Diana Meagan Bowman

Nano Technology Special Edition

Decision Ethics and Emergent Technologies: The Case of Nanotechnology
David Berube
Justice or Beneficence: What Regulatory Virtue for Nano-Governance?
Hailemichael Teshome Demissie
Regulating Nanoparticles: the Problem of Uncertainty
Roger Strand, Kamilla Lein Kjølberg
Complexities of labelling of nanoproducts on the consumer markets
Harald Throne-Holst, Arie Rip
Soft regulation and responsible nanotechnological development in the European Union: Regulating occupational health and safety in the Netherlands
Bärbel Dorbeck-Jung
Nanomaterials and the European Water Framework Directive
Steffen Foss Hansen, Anders Baun, Catherine Ganzleben
The Proposed Ban on Certain Nanomaterials for Electrical and Electronic Equipment in Europe and Its Global Security Implications: A Search for an Alternative Regulatory Approach
Hitoshi Nasu, Thomas Faunce
The Regulation of Nano-particles under the European Biocidal Products Directive: Challenges for Effective Civil Society Participation
Michael T Reinsborough, Gavin Sullivan
Value chains as a linking-pin framework for exploring governance and innovation in nano-involved sectors: illustrated for nanotechnologies and the food packaging sector
Douglas Robinson
Food and nano-food within the Chinese regulatory system: no need to have overregulation.Less physicality can produce more power.
Margherita Poto
Regulation and Governance of Nanotechnology in China: Regulatory Challenges and Effectiveness
Darryl Stuart Jarvis, Noah Richmond
How Resilient is India to Nanotechnology Risks? Examining Current Developments, Capacities and an Approach for Effective Risk Governance and Regulation
Shilpanjali Deshpande Sarma
Toward Safe and Sustainable Nanomaterials: Chemical Information Call-in to Manufacturers of Nanomaterials by California as a Case Study
William Ryan, Sho Takatori, Thomas Booze, Hai-Yong Kang
De minimis curat lex: New Zealand law and the challenge of the very small
Colin Gavaghan, Jennifer Moore

I notice that the last article was authored by the same people who produced a review of New Zealand’s nanotechnology regulatory framework in Sept. 2011. The Science Media Centre of New Zealand noted this in a Sept. 6, 2011 article about the review,

The “Review of the Adequacy of New Zealand’s Regulatory Systems to Manage the Possible Impacts of Manufactured Nanomaterials” by Colin Gavaghan (in Dunedin) and Jennifer Moore (in Wellington) lists three possible levels of regulatory gaps, but points to a lack of consensus on just what constitutes a “gap”.

The authors note where such nanomaterials are not covered by existing regulation, and where these regulations are triggered by the presence of the nanomaterials. They focus on first and second generation products and say that as nanomaterials evolve, more work will need to be done on regulation.

“Some reviews of this topic have suggested that subsequent generations of nanotechnologies are likely to present a much more significant challenge to existing regulatory structures,” the authors say.

The EJLT special issue looks like it has a pretty interesting range of articles representing nanotechnology and regulations in various jurisdictions. I’m thrilled to see a couple of articles on China, one on India, and, of course, the piece on New Zealand as I don’t often find material on those countries. Thank you EJLT!

US National Nanotechnology Initiative holding EHS webinar

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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).

Public indifferent to nanotechnology risks?

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According to a recent study the public isn’t concerned about nanotechnology risks, from the April 12, 2011 news item on Nanowerk,

A new study (“Comparing nanoparticle risk perceptions to other known EHS risks” [published online in the Journal of Nanoparticle Research, DOI: 10.1007/s11051-011-0325, behind a paywall]) finds that the general public thinks getting a suntan poses a greater public health risk than nanotechnology or other nanoparticle applications. The study, from North Carolina State University, compared survey respondents’ perceived risk of nanoparticles with 23 other public-health risks.
…

“For example, 19 of the other public-health risks were perceived as more hazardous, including suntanning and drinking alcohol,” says Dr. Andrew Binder, an assistant professor of communication at NC State and co-author of a paper describing the study. “The only things viewed as less risky were cell-phone use, blood transfusions, commercial air travel and medical X-rays.”

In fact, 60 percent of respondents felt that nanoparticles posed either no health risk or only a slight health risk.

In reading this news item I noticed that they mentioned suntans as being perceived as more high risk than nanoparticles. It seems to me that there’s been a great deal more work done to convince people that getting a suntan is a risky proposition compared to warning people about nanoparticles. Huge, huge amounts of money have been spent on public education and publicity about the risks posed by exposure to sunlight. Of course, it took a lot of work and money to determine that exposure to sunlight can pose risks in the first place. At this point, we don’t know very much about nanoparticles at all.

When is a nano-enabled product not nano-enabled?

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Dietram Scheufele over at nanopublic has highlighted some research that David Berube (author of Nanohype—book and blog and professor at the University of North Carolina) and colleagues have published in Nanotechnology Law & Business (research article is behind a paywall). From Dietram’s July 3, 2010 blog posting (I’m unable to link to the specific post, so please scroll to or hunt for the date) about Berube’s research into the Project on Emerging Nanotechnologies’ (PEN) Consumer Products Inventory (CPI),

The article takes a critical look at the Project on Emerging Nanotechnologies (PEN) consumer product inventory. The inventory has been used widely as a gauge of the number and types of nano consumer products currently on the U.S. market.

… [the authors concluded]

“that the CPI is not wholly reliable, and does not have sufficient validity to justify its prominence as evidence for claims associated with the pervasiveness of nanotechnology on the U.S. and global markets. In addition, we caution researchers to approach the CPI with care and due consideration because using the CPI as a rhetorical flourish to amplify concerns about market intrusions seems unjustified.”

In other words, use the CPI with care. Unfortunately, I haven’t been able to read Berube’s paper but I did go to the Project on Emerging Nanotechnologies website and looked at the criteria for inclusion in the CPI where PEN clearly states the inventory’s limitations,

Selection of products

Most products in this inventory satisfy three criteria:

1. They can be readily purchased by consumers, and

2. They are identified as nano-based by the manufacturer OR another source, and

3. The nano-based claims for the product appear reasonable.

In every instance, we have tried to identify specific products from specific producers. However, since nanotechnology has broad applications in a variety of fields, we have included a number of “generic” products that you can find in many places on the market such as computer processor chips. These are clearly labeled in the inventory. In some cases, companies offer several similar nanotechnology-based products and product lines. To reduce redundancy, we have just included a few samples in this inventory and hope that they will provide an initial baseline for understanding how nanotechnology is being commercialized.

There are probably some products in the inventory which producers allege are “nano,” but which may not be. We have made no attempt to verify manufacturer claims about the use of nanotechnology in these products, nor have we conducted any independent testing of the products. We have tried to avoid including products that clearly do not use nanotechnology, but some have undoubtedly slipped through.

Finally, some products are marked “Archive” to indicate that their availability can no longer be ascertained. When these products were added to the inventory we included live links, but since then the company may have discontinued the product, gone out of business, removed a self-identifying “nano” claim or simply changed their web address. In these instances we have attempted to locate a cached version of the product website using The Internet Archive.

I imagine that despite PEN’s clearly statements some folks have referenced it carelessly hence the concern about using it as hype from Berube and his colleagues.

The bit about manufacturers removing the ‘nano’ claim hit home since I did some research into washers that use nanosilver. A friend was disturbed by a recent article about them and I remembered that the US EPA (Environmental Protection Agency) had made a special designation for these types of washers. As it turns out, I got it 1/2 right. From the December 4, 2006 article by Susan Morissey in Chemical and Engineering News,

Silver—claimed to be nanoparticles—employed to kill bacteria in washing machines will now be regulated as a pesticide, EPA announced late last month. Currently, washers that generate silver ions are classified as devices and are not required to be registered with EPA.

The products at issue are Samsung washing machines that are advertised as using silver ions to kill 99.9% of odor-causing bacteria. This technology, called SilverCare, generates ions by applying current to two silver plates housed next to the machine’s tub. The ions are then directed into the tub during the wash cycle.

“EPA has determined that the Samsung silver ion-generating washing machine is subject to registration requirements under the Federal Insecticide, Fungicide & Rodenticide Act,” according to an EPA statement. The agency decided to change the classification of the washer because it releases silver ions into the laundry “for the purpose of killing microbial pests,” the statement explains.

For its part, Samsung has pledged to comply with the change of policy. “Samsung has and will continue to work with EPA and state regulators regarding regulation of the silver washing machine,” the company says.

Several groups concerned about the environmental impact of nanoparticles of silver had asked EPA to reevaluate the way products containing such materials are regulated. For example, environmental group Natural Resources Defense Council (NRDC) noted in a letter to EPA that there are currently more than 40 products on the market in addition to Samsung’s washing machine that have made or implied claims of using nanoparticles of silver to kill bacteria.

NRDC praised EPA for taking what it called a “step in the right direction” by reclassifying nanosilver generated in a washer as a pesticide. The group also said this revised policy should lead to EPA reassessing other products that use nanoparticles of silver for their biocidal qualities.

A pesticide is not exactly a special designation but it certainly is unique as applied to clothes washers. The EPA announcement was made around the US Thanksgiving period (late November) according to a December 6, 2006 article by Scott E. Rickert in Industry Week. From Rickert’s article,

First, let’s backtrack and get the facts behind the headline. The trigger for the EPA decision was a Samsung washing machine. The “SilverWash” contains silver nanoparticles and claims that it helps to kill bacteria in clothes by releasing silver ions into the water during the wash.

Various U.S water authorities became concerned that discharged nanosilver might accumulate in the water system, particularly in wastewater treatment plants where beneficial bacteria are used to purify water of its toxins. This opinion means that nanosilver could be viewed as an environmental pesticide, requiring the product to be registered and tested under the Federal Insecticide, Fungicide and Rodenticide Act. In the words of EPA spokesperson Jennifer Wood, “The release of silver ions in the washing machines is a pesticide, because it is a substance released into the laundry for the purpose of killing pests.”

So what does this really mean to nano-industry? Specifically, we’re not sure yet. It will take several months for the final rules to be detailed in the Federal Register. But some of the early responses have me scratching my head.

One company has removed any reference to nanosilver from their marketing information for antimicrobial devices. Apparently, in the short run, that excludes them from any ruling. As Jim Jones, director of the EPA’s Office of Pesticide Programs, said, “Unless you’re making a claim to kill a pest, you’re not a pesticide.”

This is not a simple ‘good guy vs. bad guy’ situation. Defining nanotechnology, nanoparticles, nanomaterials, etc. is a work in progress which makes attempts to regulate products and production in this area an even earlier work in progress. This situation is not confined to the US or to Canada. In fact, it doesn’t seem to be confined to any one country, which makes the situation applicable globally.

There is work being done and changes instituted, for example, the EPA has announced (from the PEN website),

At an April 29 presentation to the Pesticide Programs Dialogue Committee in Washington, D.C. EPA’s William Jordan announced a new working definition of nanomaterials as “an ingredient that contains particles that have been intentionally produced to have at least one dimension that measures between approximately 1 and 100 nanometers.” In addition EPA is preparing a Federal Register Announcement due out in June which announces a new interpretation of FIFRA/regulations and proposes a new policy stating that the presence of a nanoscale material in a pesticide product is reportable under FIFRA section 6(a)(2) and applies to already registered products as well as products pending registration.

As well, statements from the NanoBusiness Alliance suggest (in a previous posting on this blog) that there is some support within the business community for thoughtful regulation. As to what thoughtful means in this context, I think that’s something we, as a a society, need to work out.