Tag Archives: EPA

Inaugural workshop using *nanomaterials for environmental remediation being held in Louisiana

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Participants at the Nano-4-Rem (nanomaterials for environmental remediation) aNsseRS workshop will be visiting the Southeastern Louisiana University in Hammond in early June 2013. From the Nov.  6, 2012 news item on Nanowerk,

An inaugural workshop on the safe use of nanomaterials in environmental remediation will be held at Southeastern Louisiana University June 5-7, 2013.

With increased use of nanotechnology and nanomaterials in the cleanup of hazardous sites, there is now a growing body of evidence that exposure to these materials may have adverse health effects, said conference organizer Ephraim Massawe, assistant professor of occupational safety, health and environment.

“The applications and results of nano-enabled strategies and methods for environmental remediation are increasingly promising,” Massawe said. “The challenge is ensuring that such applications are both safe and sustainable.”

There is more information on Southeastern Louisiana University’s Nano-4-Rem aNsseRS webpage,

Background: Groundwater or soil contamination is present at most Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) and Resource Conservation and Recovery Act (RCRA) corrective action sites. Traditional technologies, such as pump-and-treat (P&T) and permeable reactive barriers (PRBs), have been used for decades to remediate such sites. In recent years, remediation strategies involving engineered nanoparticles (ENPs) such as zero-valent iron and titanium dioxide have been demonstrated as viable time-saving and cost-effective alternatives to traditional remediation. In addition, advances in nanotechnology-enabled assessment and monitoring methods such as nano-sensors may support more extensive, reliable, and cost effective assessment and management of remediation activities.

At the same time that applications of nano-enabled strategies and methods for environmental remediation are increasingly promising, there is a growing body of evidence linking exposure to certain nanomaterials with adverse health effects in animals at the laboratory scale. The challenge is to ensure that such applications are both safe and sustainable. …

Workshop Objectives: This is the first national workshop that provides an opportunity for representatives from the environmental remediation community, industry, academia, and government to:

  • Share their perspectives, pose questions, and develop ideas for design of good guidelines, selection criteria, and work practices to support safe and sustainable nano-enabled environmental remediation;
  • Become acquainted with other U.S. nanotechnology stakeholders, including vendors, transporters, and contractors of the remediation sites and communities; and
  • Share case studies of nano-enhanced clean up technologies, including selection criteria for alternative remediation strategies and methods, job planning, job tasks, and nanomaterial handling practices.

Furthermore, in the context of nanoinformatics (Nanoinformatics 2020 Roadmap), the workshop will present:

  • Occupational and environmental regulatory issues as they relate to remediation, synthesis and characterization, and application of nanoinformatics for safe and sustainable use of nanomaterials during remediation;
  • Fate and transport of nanomaterials during and after remediation;
  • Risks, including contributions from both toxicological properties of nanomaterials (hazard) and potentials for occupational and environmental exposure, where hazard x exposure = risk;
  • Results of the recent nanoinformatics survey of state agencies and programs described on the workshop website; and
  • Opportunities for developing and sustaining continuing advances and collaborations.

Call for Presenters and Deadlines: Participants are invited from the industry; site contractors, nanomaterial vendors; laboratories that synthesize and characterize ENPs for environmental remediation; regulatory authorities (local, state, and federal government) and academia (faculty and students). Presenters should submit titles and abstracts for podium or poster presentations by December 14, 2012. The workshop or program schedule will be finalized by February 20, 2013. Event date: June 5-7, 2013. Students are encouraged to submit proposals for podium or poster presentations. “Best student” poster and presentation awards will be given. Information about this workshop can also be found at http://cluin.org [a US Environmental Protection Agency ‘office’].

The Nov. 7, 2012 news release from Southeastern Louisiana University which originated the news item (Nanowerk seems to have posted the item before the release was posted on the university website) provides more detail,

The event, “Nano-4-Rem-Anssers 2013: Applications of Nanotechnology for Safe and Sustainable Environmental Remediations,” is one of the first of its kind in the Southeast which has been designed to provide an opportunity for involved parties to share perspectives, pose questions and develop ideas for generating solid guidelines for best work practices that support safe and sustainable nano-enabled environmental remediation.

Southeastern is sponsoring the event with other agencies and institutions, including the U.S. Environmental Protection Agency (EPA), the National Institute of Safety and Health (NIOSH), the Occupational Safety and Health Administration (OSHA) and in conjunction with the National Nanotechnology Coordination Office (NNCO).

The program will include case studies of nano-enhanced clean up technologies, including selection criteria for alternative remediation strategies and methods, job planning and tasks, and safe material handling practices. Other issues to be discussed are updates of toxicity studies, fate and transport of nanoparticules [the French word for nanoparticles is nanoparticules ..  this seems an unusual choice for a news release from a US university but Louisiana was French at one time, so perhaps there’s a desire to retain a linguistic link?]  in soils and groundwater, and nanoinformatics.

I have written about nanoremediation before. Here are a few of the latest,

Nanoremediation techniques from Iran and from South Carolina

Canadian soil remediation expert in Australia

Phyto and nano soil remediation (part 2: nano)

* ‘nanotechnolmaterials corrected to ‘nanomaterials’ on Sept. 23, 2013.

Soybeans and nanoparticles

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They seem ubiquitous today but there was a time when hardly anyone living in Canada  knew much about soybeans.  There’s a good essay about soybeans and their cultivation in Canada by Erik Dorff for Statistics Canada, from Dorff’s soybean essay,

Until the mid-1970s, soybeans were restricted by climate primarily to southern Ontario. Intensive breeding programs have since opened up more widespread growing possibilities across Canada for this incredibly versatile crop: The 1.2 million hectares of soybeans reported on the Census of Agriculture in 2006 marked a near eightfold increase in area since 1976, the year the ground-breaking varieties that perform well in Canada’s shorter growing season were introduced.

Soybeans have earned their popularity, with the high-protein, high-oil beans finding use as food for human consumption, animal rations and edible oils as well as many industrial products. Moreover, soybeans, like all legumes, are able to “fix” the nitrogen the plants need from the air. This process of nitrogen fixation is a result of a symbiotic interaction between bacteria microbes that colonize the roots of the soy plant and are fed by the plant. In return, the microbes take nitrogen from the air and convert it into a form the plant can use to grow.

This means legumes require little in the way of purchased nitrogen fertilizers produced from expensive natural gas-a valuable property indeed.

Until reading Dorff’s essay, I hadn’t early soybeans had been introduced to the Canadian agricultural sector,

While soybeans arrived in Canada in the mid 1800s-with growing trials recorded in 1893 at the Ontario Agricultural College-they didn’t become a commercial oilseed crop in Canada until a crushing plant was built in southern Ontario in the 1920s, about the same time that the Department of Agriculture (now Agriculture and Agri-Food Canada) began evaluating soybean varieties suited for the region. For years, soybeans were being grown in Canada but it wasn’t until the Second World War that Statistics Canada began to collect data showing the significance of the soybean crop, with 4,400 hectares being reported in 1941. In fact, one year later the area had jumped nearly fourfold, to 17,000 hectares…

As fascinating as I find this history, this bit about soybeans and their international importance explain why research about soyboans and nanoparticles is of wide interest (from Dorff’s essay),

The soybean’s valuable characteristics have propelled it into the agricultural mix in many parts of the world. In 2004, soybeans accounted for approximately 35% of the total harvested area worldwide of annual and perennial oil crops according to the Food and Agriculture Organization of the United Nations (FAO) but only four countries accounted for nearly 90% of the production with Canada in seventh place at 1.3% (Table 2). Soymeal-the solid, high-protein material remaining after the oil has been extracted during crushing-accounts for over 60% of world vegetable and animal meal production, while soybean oil accounts for 20% of global vegetable oil production.

There’s been a recent study on the impact of nanoparticles on soybeans at the University of California at Santa Barbara (UC Santa Barbara) according to an Aug. 20, 2012 posting by Alan on the Science Business website, (h/t to Cientifica),

Researchers from University of California in Santa Barbara found manufactured nanoparticles disposed after manufacturing or customer use can end up in agricultural soil and eventually affect soybean crops. Findings of the team that includes academic, government, and corporate researchers from elsewhere in California, Texas, Iowa, New York, and Korea appear online today in the Proceedings of the National Academy of Sciences.

The research aimed to discover potential environmental implications of new industries that produce nanomaterials. Soybeans were chosen as test crops because their prominence in American agriculture — it is the second largest crop in the U.S. and the fifth largest crop worldwide — and its vulnerability to manufactured nanomaterials. The soybeans tested in this study were grown in greenhouses.

The Aug. 20, 2012 UC Santa Barbara press release has additional detail abut why the research was undertaken,

“Our society has become more environmentally aware in the last few decades, and that results in our government and scientists asking questions about the safety of new types of chemical ingredients,” said senior author Patricia Holden, a professor with the Bren School [UC Santa Barbara’s Bren School of Environmental Science & Management]. “That’s reflected by this type of research.”

Soybean was chosen for the study due to its importance as a food crop –– it is the fifth largest crop in global agricultural production and second in the U.S. –– and because it is vulnerable to MNMs [manufactured nanomaterials]. The findings showed that crop yield and quality are affected by the addition of MNMs to the soil.

The scientists studied the effects of two common nanoparticles, zinc oxide and cerium oxide, on soybeans grown in soil in greenhouses. Zinc oxide is used in cosmetics, lotions, and sunscreens. Cerium oxide is used as an ingredient in catalytic converters to minimize carbon monoxide production, and in fuel to increase fuel combustion. Cerium can enter soil through the atmosphere when fuel additives are released with diesel fuel combustion.

The zinc oxide nanoparticles may dissolve, or they may remain as a particle, or re-form as a particle, as they are processed through wastewater treatment. At the final stage of wastewater treatment there is a solid material, called biosolids, which is applied to soils in many parts of the U.S. This solid material fertilizes the soil, returning nitrogen and phosphorus that are captured during wastewater treatment. This is also a point at which zinc oxide and cerium oxide can enter the soil.

The scientists noted that the EPA requires pretreatment programs to limit direct industrial metal discharge into publicly owned wastewater treatment plants. However, the research team conveyed that “MNMs –– while measurable in the wastewater treatment plant systems –– are neither monitored nor regulated, have a high affinity for activated sludge bacteria, and thus concentrate in biosolids.”

The authors pointed out that soybean crops are farmed with equipment powered by fossil fuels, and thus MNMs can also be deposited into the soil through exhaust.

The study showed that soybean plants grown in soil that contained zinc oxide bioaccumulated zinc; they absorbed it into the stems, leaves, and beans. Food quality was affected, although it may not be harmful to humans to eat the soybeans if the zinc is in the form of ions or salts, in the plants, according to Holden.

In the case of cerium oxide, the nanoparticles did not bioaccumulate, but plant growth was stunted. Changes occurred in the root nodules, where symbiotic bacteria normally accumulate and convert atmospheric nitrogen into ammonium, which fertilizes the plant. The changes in the root nodules indicate that greater use of synthetic fertilizers might be necessary with the buildup of MNMs in the soil.

At this point, the researchers don’t know how zinc oxide nanoparticles and cerium oxide nanoparticles currently used in consumer products and elsewhere are likely to affect agricultural lands. The only certainty is that these nanoparticles are used in consumer goods and, according to Holden, they are entering agricultural soil.

The citation for the article,

Soybean susceptibility to manufactured nanomaterials with evidence for food quality and soil fertility interruption by John H. Priester, Yuan Ge, Randall E. Mielke, Allison M. Horst Shelly Cole Moritz, Katherine Espinosa, Jeff Gelb, Sharon L. Walker, Roger M. Nisbet, Youn-Joo An, Joshua P. Schimel, Reid G. Palmer, Jose A. Hernandez-Viezcas, Lijuan Zhao, Jorge L. Gardea-Torresdey, Patricia A. Holden. Published online [Proceedings of the National Academy of Sciences {PNAS}] before print August 20, 2012, doi: 10.1073/pnas.1205431109

The article is open access and available here.

 

Nanosilver disinfectant spray: final report from the US Environmental Protection Agency

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The Aug.5, 2012 news item on Nanowerk is an announcement of the final report from the US Environmental Protection Agency’s (EPA) National Center for Environmental Assessment on nanosilver  (nano Ag) disinfectant spray,

This report presents a case study of engineered nanoscale silver (nano-Ag), focusing on the specific example of nano-Ag as possibly used in disinfectant sprays.
This case study is organized around the comprehensive environmental assessment (CEA) framework, which structures available information pertaining to the product life cycle, environmental transport and fate, exposure-dose in receptors (i.e., humans, ecological populations, and the environment), and potential impacts in these receptors. The document does not draw conclusions about potential risks. Instead, it is intended to be used as part of a process to identify what is known and unknown about nano-Ag in a selected application. In turn, the external review draft of the document provided a starting point to identify and prioritize possible research directions to support future assessments of nanomaterials.

The Nanomaterial Case Study: Nanoscale Silver in Disinfectant Spray (Final Report) is approximately 423 pages and the comprehensive environmental assessment framework mentioned seems to be an analytical tool used to establish directions for future research. In a July 5, 2012 posting (Toxicology convo heats up: OECD releases report on inhalation toxicity testing and Nature Nanotechnology publishes severe critique of silver toxicity overanalysis) I made note of some comments on inhalation testing and reports about nanosilver toxicity issued by international institutions that seem à propos in this context. (I first wrote about this study in an Aug. 17, 2010 posting when the EPA had released a draft version for comments.)

The relationship of silver ions & nanoparticles, Nietzsche, and Rice University

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My hat’s off to Mike Williams for introducing Nietzsche into a news item about silver nanoparticles and toxicity. Here’s the line from his July 11, 2012 Rice University news release (Note: I have removed some links),

Their work comes with a Nietzsche-esque warning: Use enough. If you don’t kill them, you make them stronger.

Scientists have long known that silver ions, which flow from nanoparticles when oxidized, are deadly to bacteria. Silver nanoparticles are used just about everywhere, including in cosmetics, socks, food containers, detergents, sprays and a wide range of other products to stop the spread of germs.

But scientists have also suspected silver nanoparticles themselves may be toxic to bacteria, particularly the smallest of them at about 3 nanometers. Not so, according to the Rice team that reported its results this month in the American Chemical Society journal Nano Letters.

This next bit describing the research is an example of what I find so compelling (curiosity and persistence) about science,

To figure that out, the researchers had to strip the particles of their powers. “Our original expectation was that the smaller a particle is, the greater the toxicity,” said Zongming Xiu, a Rice postdoctoral researcher and lead author of the paper. Xiu set out to test nanoparticles, both commercially available and custom-synthesized from 3 to 11 nanometers, to see whether there was a correlation between size and toxicity.

“We could not get consistent results,” he said. “It was very frustrating and really weird.”

Here’s what they did next, what they found, and the implications of their findings,

Xiu decided to test nanoparticle toxicity in an anaerobic environment – that is, sealed inside a chamber with no exposure to oxygen — to control the silver ions’ release. He found that the filtered particles were a lot less toxic to microbes than silver ions.

Working with the lab of Rice chemist Vicki Colvin, the team then synthesized silver nanoparticles inside the anaerobic chamber to eliminate any chance of oxidation. “We found the particles, even up to a concentration of 195 parts per million, were still not toxic to bacteria,” Xiu said. “But for the ionic silver, a concentration of about 15 parts per billion would kill all the bacteria present. That told us the particle is 7,665 times less toxic than the silver ions, indicating a negligible toxicity.”

“The point of that experiment,” Alvarez [Pedro Alvarez, George R. Brown Professor and chair of Rice’s Civil and Environmental Engineering Department] said, “was to show that a lot of people were obtaining data that was confounded by a release of ions, which was occurring during exposure they perhaps weren’t aware of.”

Alvarez suggested the team’s anaerobic method may be used to test many other kinds of metallic nanoparticles for toxicity and could help fine-tune the antibacterial qualities of silver particles. In their tests, the Rice researchers also found evidence of homesis; [e.g..,] E. coli became stimulated by silver ions when they encountered doses too small to kill them.

“Ultimately, we want to control the rate of (ion) release to obtain the desired concentrations that just do the job,” Alvarez said. “You don’t want to overshoot and overload the environment with toxic ions while depleting silver, which is a noble metal, a valuable resource – and a somewhat expensive disinfectant. But you don’t want to undershoot, either.”

He said the finding should shift the debate over the size, shape and coating of silver nanoparticles. [emphasis mine] “Of course they matter,” Alvarez said, “but only indirectly, as far as these variables affect the dissolution rate of the ions. The key determinant of toxicity is the silver ions. So the focus should be on mass-transfer processes and controlled-release mechanisms.”

Interestingly, this is a joint US-UK effort (US Environmental Protection Agency and the U.K. Natural Environment Research Council). H/T to Will Soutter’s July 12, 2012 news item on Azonano for the information about this latest silver nanoparticle research from Rice University. The July 11, 2012 news item on Nanowerk also features information about the silver nanoparticles, ions, and Rice University.

I have mentioned Vicki Colvin’s work previously including this Jan. 28, 2011 posting about a UK/US joint environmental research effort. I have also mentioned Pedro Alvarez a few times including this Aug. 2, 2010 posting about nanomaterials and the construction industry.

Nanomaterials and toxicology (US Environmental Protection Agency and National Institute of Occupational Health and Safety)

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It seems to be ‘toxicology and nanomaterials’ season right now. In addition to the ISO (International Standards Organization) technical report on nanomaterials and toxicology which was released in early June (mentioned in my June 4, 2012 posting), the US Environmental Protection Agency (EPA) and the US National Institute of Occupational Safety and Health (NIOSH) have released new reports.

Yesterday (July 2, 2012), the EPA posted a notice on the US Federal Register about a report, a commenting period, and a public information exchange meeting for “Nanomaterial Case Study: A Comparison of Multiwalled Carbon Nanotubes and Decabromodiphenyl Ether Flame-Retardant Coatings Applied to Upholstery Textiles.”

As I noted in an Aug. 27, 2010 posting, the EPA has adopted a very interesting approach to studying possible toxicological effects due to nanomaterials (and other materials),

Such case studies do not represent completed or even preliminary assessments; rather, they are intended as a starting point in a process to identify and prioritize possible research directions to support future assessments of nanomaterials.

Part of the rationale for focusing on a series of nanomaterial case studies is that such materials and applications can have highly varied and complex properties that make considering them in the abstract or in generalities quite difficult. Different materials and different applications of a given material could raise unique questions or issues as well as some issues that are common to various applications of a given nanomaterial or even to different nanomaterials. After several individual case studies have been examined, refining a strategy for nanomaterials research to support long-term assessment efforts should be possible. (p. 19 PDF, p. 1-1 in print version of a  US EPA silver nanomaterials draft report)

The July 3, 2012 news item on Nanowerk offers more detail about this latest case study (Note: I have removed a link),

EPA announces the release of the draft report, Nanomaterial Case Study: A Comparison of Multiwalled Carbon Nanotube and Decabromodiphenyl Ether Flame-Retardant Coatings Applied to Upholstery Textiles (External Review Draft), for public viewing and comment. This was announced in a July 2, 2012 Federal Register Notice  along with information about the upcoming public Information Exchange Meeting scheduled for October 29, 2012. The purpose of this meeting is to receive comments and questions on the draft document, as well as provide information on the draft document and a workshop process that it will be used in, which is being conducted independently by RTI International, a contractor for EPA. The deadline for comments on the draft document is August 31, 2012. [emphases mine]

The notice on the EPA website offers details and extensive links to satisfy your information needs on this matter,

The draft document is intended to be used as part of a process to identify what is known and, more importantly, what is not yet known that could be of value in assessing the broad implications of specific nanomaterials. Like previous case studies (see History/ Chronology below [on the EPA website]), this draft case study on multiwalled carbon nanotubes (MWCNTs) is based on the comprehensive environmental assessment (CEA) approach, which consists of both a framework and a process. Unlike previous case studies this case study incorporates information about a traditional (i.e., “non-nano-enabled”) product, against which the MWCNT flame-retardant coating applied to upholstery textiles (i.e., the “nano-enabled” product) can be compared. The comparative element serves dual-purposes: 1) to provide a more robust database that facilitates identification of data gaps related to the nano-enabled product and 2) to provide a context for identifying key factors and data gaps for future efforts to evaluate risk-related trade-offs between a nano-enabled and non-nano-enabled product.

This draft case study does not represent a completed or even a preliminary assessment of MWCNTs; rather, it uses the CEA framework to structure information from available literature and other resources (e.g., government reports) on the product life cycle, fate and transport processes in various environmental media, exposure-dose characterization, and impacts in human, ecological, and environmental receptors. Importantly, information on other direct and indirect ramifications of both primary and secondary substances or stressors associated with the nanomaterial is also included when available. The draft case study provides a basis for the next step of the CEA process, whereby collective judgment is used to identify and prioritize research gaps to support future assessment efforts that inform near-term risk management goals.

Meanwhile, NIOSH has released a safety guide (from the June 29, 2012 news item on Nanowerk),

The National Institute for Occupational Safety and Health (NIOSH) has published “General Safe Practices for Working with Engineered Nanomaterials in Research Laboratories” (pdf).
…

With the publication of this document, NIOSH hopes to raise awareness of the occupational safety and health practices that should be followed during the synthesis, characterization, and experimentation with engineered nanomaterials in a laboratory setting. The document contains recommendations on engineering controls and safe practices for handling engineered nanomaterials in laboratories and some pilot scale operations. This guidance was designed to be used in tandem with well-established practices and the laboratory’s chemical hygiene plan. As our knowledge of nanotechnology increases, so too will our efforts to provide additional guidance materials for working safely with engineered nanomaterials.

Here is more information  from the executive summary of the General Safe Practices for Working with Engineered Nanomaterials in Research Laboratories,

Risk Management

Risk management is an integral part of occupational health and safety. Potential expo­sures to nanomaterials can be controlled in research laboratories through a flexible and adaptive risk management program. An effective program provides the framework to anticipate the emergence of this technology into laboratory settings, recognize the po­tential hazards, evaluate the exposure to the nanomaterial, develop controls to prevent or minimize exposure, and confirm the effectiveness of those controls.

Hazard Identification

Experimental animal studies indicate that potentially adverse health effects may result from exposure to nanomaterials. Experimental studies in rodents and cell cultures have shown that the toxicity of ultrafine particles or nanoparticles is greater than the toxicity of the same mass of larger particles of similar chemical composition.

Research demonstrates that inhalation is a significant route of exposure for nanoma­terials. Evidence from animal studies indicates that inhaled nanoparticles may deposit deep in lung tissue, possibly interfering with lung function. It is also theorized that nanoparticles may enter the bloodstream through the lungs and transfer to other or­gans. Dermal exposure and subsequent penetration of nanomaterials may cause local or systemic effects. Ingestion is a third potential route of exposure. Little is known about the possible adverse effects of ingestion of nanomaterials, although some evidence sug­gests that nanosized particles can be transferred across the intestinal wall.

Exposure Assessment

Exposure assessment is a key element of an effective risk management program. The ex­posure assessment should identify tasks that contribute to nanomaterial exposure and the workers conducting those tasks. An inventory of tasks should be developed that in­cludes information on the duration and frequency of tasks that may result in exposure, along with the quantity of the material being handled, dustiness of the nanomaterial, and its physical form. A thorough understanding of the exposure potential will guide exposure assessment measurements, which will help determine the type of controls re­quired for exposure mitigation.

Exposure Control

Exposure control is the use of a set of tools or strategies for decreasing or eliminating worker exposure to a particular agent. Exposure control consists of a standardized hi­erarchy to include (in priority order): elimination, substitution, isolation, engineering controls, administrative controls, or if no other option is available, personal protective equipment (PPE).

Substitution or elimination is not often feasible for workers performing research with nanomaterials; however, it may be possible to change some aspects of the physical form of the nanomaterial or the process in a way that reduces nanomaterial release.

Isolation includes the physical separation and containment of a process or piece of equipment, either by placing it in an area separate from the worker or by putting it within an enclosure that contains any nanomaterials that might be released.

Engineering controls include any physical change to the process that reduces emissions or exposure to the material being contained or controlled. Ventilation is a form of engi­neering control that can be used to reduce occupational exposures to airborne particu­lates. General exhaust ventilation (GEV), also known as dilution ventilation, permits the release of the contaminant into the workplace air and then dilutes the concentration to an acceptable level. GEV alone is not an appropriate control for engineered nano­materials or any other uncharacterized new chemical entity. Local exhaust ventilation (LEV), such as the standard laboratory chemical hood (formerly known as a laboratory fume hood), captures emissions at the source and thereby removes contaminants from the immediate occupational environment. Using selected forms of LEV properly is ap­propriate for control of engineered nanomaterials.

Administrative controls can limit workers’ exposures through techniques such as us­ing job-rotation schedules that reduce the time an individual is exposed to a substance. Administrative controls may consist of standard operating procedures, general or spe­cialized housekeeping procedures, spill prevention and control, and proper labeling and storage of nanomaterials. Employee training on the appropriate use and handling of nanomaterials is also an important administrative function.

PPE creates a barrier between the worker and nanomaterials in order to reduce expo­sures. PPE may include laboratory coats, impervious clothing, closed-toe shoes, long pants, safety glasses, face shields, impervious gloves, and respirators.

Other Considerations

Control verification or confirmation is essential to ensure that the implemented tools or strategies are performing as specified. Control verification can be performed with traditional industrial hygiene sampling methods, including area sampling, personal sampling, and real-time measurements. Control verification may also be achieved by monitoring the performance parameters of the control device to ensure that design and performance criteria are met.

Other important considerations for effective risk management of nanomaterial expo­sure include fire and explosion control. Some studies indicate that nanomaterials may be more prone to explosion and combustion than an equivalent mass concentration of larger particles.

Occupational health surveillance is used to identify possible injuries and illnesses and is recommended as a key element in an effective risk management program. Basic medical screening is prudent and should be conducted under the oversight of a qualified health-care professional. (pp. 9 – 11 PDF or pp. vii – ix in print)

The guidance as per the executive summary seems to rely heavily on what I imagine are industrial hygiene practices that should be followed whether or not laboratories are researching nanomaterials.

Two (Denmark & US) contrasting documents about nanomaterials and risk

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The Danes released their NanoRiskCat (NRC) document in early December 2011 while the US National Research Council released its report on the US research strategy on environmental and health impact of engineered nanomaterials today, Jan. 25, 2012.

(BTW, There”s going to be an alphabet soup situation in this posting with two different NRCs [the catalogue] and the US National Research Council for starters. I’ll do my best to keep these entities distinct from each other.)

The documents represent an interesting contrast regarding approaches to nanomaterials and their risks. From the Jan. 25, 2012 Nanowerk Spotlight article about Denmark’s NanoRiskCat,

The project’s aim was to identify, categorize and rank the possible exposure and hazards associated with a nanomaterial in a product. NanoRiskCat is using a stepwise approach based on existing data on the conventional form of the chemical as well as the data that may exist on the nanoform. However, the tool still needs to be further validated and tested on a series of various nano products in order to adjust and optimize the concept and thereby to achieve a screening tool as informative and practical as possible.

Meanwhile, here’s the description of the US NRC’s latest report, from the Jan. 25, 2012 news item on Nanowerk,

Despite extensive investment in nanotechnology and increasing commercialization over the last decade, insufficient understanding remains about the environmental, health, and safety aspects of nanomaterials. Without a coordinated research plan to help guide efforts to manage and avoid potential risks, the future of safe and sustainable nanotechnology is uncertain, says a new report (“A Research Strategy for Environmental, Health, and Safety Aspects of Engineered Nanomaterials“)from the National Research Council. The report presents a strategic approach for developing research and a scientific infrastructure needed to address potential health and environmental risks of nanomaterials. Its effective implementation would require sufficient management and budgetary authority to direct research across federal agencies.

I find it interesting that the US government which has poured billions into its National Nanotechnology Initiative (NNI) is still trying to develop a research strategy for environmental and health impacts while the Danish (who have likely spent far less and, to be fair, likely have less bureaucracy) have created an assessment tool designed to evaluate the exposure to and hazards posed by nanomaterials found in consumer and industrial use.

One other interesting tidbit, both the Danish and the US Environmental Protection Agencies (EPAs) were instigators of their country’s respective documents. The Danish EPA was one of the three funders (the other two were the Danish Technical University and the National Research Centre for the Working Environment) for their NanoRiskCat. The US EPA was one of the sponsors  for the strategy report. The other sponsors include the The National Academy of Sciences, National Academy of Engineering, Institute of Medicine, and National Research Council.

I have to admit I’m getting a little tired of strategy documents and I’m please to see an attempt to evaluate the situation. I’m not sure which version (alpha or beta) of the tool they’ve released but there’s definitely some tweaking to be done as the Danes themselves admit,

It is the view of the Danish EPA that the traffic light ranking [I’m assuming they assign a colour [red, amber, yellow] as a means of quickly identifying a risk level in their documentation of specific nanomaterials) of the health effects may be further modified to obtain a better ranking in the various categories. Thus titanium dioxide in sunscreen is ranked as red due to lung effects of titanium dioxide, because the tool in its present form does not sufficiently take account of which type of health effects that are most relevant for the most relevant exposure route of the product. In this case the inhalational exposure of titanium dioxide from a sun screen seems less relevant.

Yes, I agree that exposure to nanoscale titanium dioxide via inhalation is an unlikely when you’re using a nanosunscreen. Although given some folks I’ve known, it’s not entirely out of the question. (It’s been my experience that people will inhale anything if they think they can get high from it.)

US Environmental Protection Agency needs to do more about possible nanomaterial risks

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The US Environmental Protection Agency (EPA) has its own watchdog, the EPA Office of Inspector General. According to a Jan. 5, 2012 news item on Nanowerk that watchdog has published a report suggesting the EPA should do more to manage nanomaterials risks,

EPA has the statutory authority to regulate nanomaterials but currently lacks the environmental and human health exposure and toxicological data to do so effectively. The Agency proposed a policy under the Federal Insecticide, Fungicide, and Rodenticide Act [FIFRA] to identify new pesticides being registered with nanoscale materials. After minimal industry participation in a voluntary data collection program, the Agency has proposed mandatory reporting rules for nanomaterials under the Federal Insecticide, Fungicide, and Rodenticide Act, and is also developing proposed rules under the Toxic Substances Control Act [TSCA]. However, even if mandatory reporting rules are approved, the effectiveness of EPA’s management of nanomaterials remains in question for a number of reasons:

  • Program offices do not have a formal process to coordinate the dissemination and utilization of the potentially mandated information.
  • EPA is not communicating an overall message to external stakeholders regarding policy changes and the risks of nanomaterials.
  • EPA proposes to regulate nanomaterials as chemicals and its success in managing nanomaterials will be linked to the existing limitations of those applicable statutes.
  • EPA’s management of nanomaterials is limited by lack of risk information and reliance on industry-submitted data.

The full report is titled EPA Needs to Manage Nanomaterial Risks More Effectively, Report No. 12-P-0162.

 

US Environmental Protection Agency funding opportunities

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The US Environmental Protection Agency (EPA) has announced a couple of funding opportunities for some new centers. The first one I’m going to mention is the call for Centers for Material Life Cycle Safety. From the Jan. 3, 2012 news item on Nanowerk,

The U.S. Environmental Protection Agency (EPA), as part of its Science to Achieve Results (STAR) program, is seeking applications for an interdisciplinary center focused on the application of a life cycle perspective towards the development of materials (Centers for Material Life Cycle Safety). Funding Opportunity Number: EPA-G2012-STAR-B1. Solicitation Closing Date: April 25, 2012, 11:59:59 pm Eastern Time. [emphasis mine]

Note: The term “materials” broadly refers to any and all types of chemicals, including individual chemicals, compounds, mixtures of compounds, or products. Such examples of materials include a discreet molecule, a polymer, a nanomaterial or a biochemical. [emphasis mine]

The aim of the center will be to develop methodologies and practices for materials design which applies a holistic perspective. This holistic approach to design, which considers all the stages of a material’s life cycle, provides an opportunity to produce materials which minimize, and preferably eliminate, any associated potential environmental and human health impacts that may occur during the life cycle.

You can read more about funding opportunity EPA-G2012-STAR-B1  here where, amongst other things, you’ll find out that requests for amounts exceeding $5M will not be considered. There’s a total of $10M to be awarded for the centers and the EPA anticipates awarding two grants.

The second funding opportunity announced by the US EPA is for  Centers for Sustainable Molecular Design. From the Jan. 3, 2012 news item on Nanowerk,

The U.S. Environmental Protection Agency (EPA), as part of its Science to Achieve Results (STAR) program, is seeking applications for an interdisciplinary center focusing on the sustainable molecular design of chemicals (Centers for Sustainable Molecular Design). Funding Opportunity Number: EPA-G2012-STAR-C1. Solicitation Closing Date: April 25, 2012, 11:59:59 pm Eastern Time. [emphasis mine]

Note: The term “chemicals” broadly refers to any and all types of materials, including individual chemicals, compounds or mixtures of compounds, endocrine disrupting chemicals (EDCs), and nanomaterials. [emphasis mine]

The aim of the center will be to develop a set of parameters and strategies that will establish design criteria regarding the properties of chemicals that will lead to the development of intrinsically less hazardous substances when compared to those currently used in society. These newly acquired criteria and design principles will direct researchers towards the generation of novel chemicals that will minimize, and preferably eliminate, associated potential environmental and human health impacts that may occur during the life cycle of that chemical. The advent of these novel chemicals and their respective discovery of correlations between a chemical’s inherent properties and their adverse impacts require the development of improved methods for the design of next generation chemicals.

You can read more about funding opportunity EPA-G2012-STAR-C1 here. Just like the Centers for Material Life Cycle Safety awards, you’ll find that requests for Centers for Sustainable Molecular Design in amounts exceeding $5M will not be considered. There’s a total of $10M to be awarded for the centers and the EPA anticipates awarding two grants.

I find it quite interesting that the study of nanomaterial life cycles in various forms is being classified as a subset of a larger topic, e.g. Material Life Cycle Safety and Sustainable Molecular Design.

First lawsuit on risks of nanotechnology?

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I got this Dec. 21, 2011 news release this morning,
 

Consumer Safety Groups File First Lawsuit on Risks of Nanotechnology

San Francisco, CA – Concerned by the growing body of scientific reports cautioning against the unregulated use of nanotechnology in consumer products, a coalition of nonprofit consumer safety and environmental groups sued the Food and Drug Administration (FDA) today.  The case is the first lawsuit over the health and environmental risks of nanotechnology and nanomaterials.

Nanotechnology is a powerful platform technology for taking apart and reconstructing nature at the atomic and molecular level.  Just as the size and chemical characteristics of manufactured nanomaterials give them unique properties, those same properties – tiny size, vastly increased surface area to volume ratio, and high reactivity – can also create unique and unpredictable health and environmental risks.

The lawsuit demands FDA respond to a petition the public interest organizations filed with the agency in 2006, nearly six years ago.  The coalition is led by the International Center for Technology Assessment (CTA), on behalf of fellow plaintiffs Friends of the Earth, Food and Water Watch, the Center for Environmental Health, the ETC Group, and the Institute for Agricultural and Trade Policy.

“Nano means more than tiny; it means materials that have the capacity to be fundamentally different.  Yet more and more novel nanomaterials are being sold infused into new consumer products every day, while FDA sits idly by,” said George Kimbrell, ICTA Attorney.  “The agency’s unlawful delay unnecessarily places consumers and the environment at risk.”

The eighty-page petition documents the scientific evidence of nanomaterial risks stemming from their unpredictable toxicity and seemingly unlimited mobility.  The 2006 petition [http://www.icta.org/doc/Nano%20FDA%20petition%20final.pdf] requested FDA take several regulatory actions, including requiring nano-specific product labeling and health and safety testing, and undertaking an analysis of the environmental and health impacts of nanomaterials in products approved by the agency.

Nanomaterials in sunscreens, one of the largest sectors of the nano-consumer product market, were also a focus of the action.  The petitioners called on the agency to regulate nano-sunscreens to account for their novel ingredients rather than assume their safety, and to pull such sunscreens from the market until and unless the agency approves them as new drug products.

“Year after year goes by but we have yet to see the FDA do the bare minimum and require nanosunscreens to be labeled as such. This is a basic consumer right,” said Ian Illuminato of Friends of the Earth.  “We’re well past the 1800s — nobody likes or should be forced to use mystery chemicals anymore.”

Since 2006, numerous studies and reports, including agency publications by the Environmental Protection Agency, the Office of the Inspector General, and the U.S. Government Accountability Office, acknowledge significant data gaps concerning nanomaterials’ potential effects on human health and the environment.  Most troubling are studies using mice that show that nano-titanium dioxide when inhaled and when eaten can cause changes in DNA that affect the brain function and may cause tumors and developmental problems in offspring.  One study found titanium dioxide nanoparticles were found in the placenta, fetal liver and fetal brain.

“It is unacceptable that the FDA continues to allow unregulated and unlabeled nanomaterials to be used in products consumers use every day,” said Wenonah Hauter, executive director of Food & Water Watch. “It is past time for this agency to live up to its mission and protect public health by assessing the health and environmental risks of nanomaterials, and to require labeling so that consumers know where these new materials are being used.”

“The scientific consensus is that nanomaterials require specific testing to account for their novel capacities and potential risks.  The FDA must do such testing as part of a pre-market safety assessment in a broader regulatory initiative to protect public health,” said Steve Suppan of the Institute for Agriculture and Trade Policy.

For more, see generally (http://www.icta.org/about/).

Despite the headline ICTA gave this news release, I found a 2008 news release for another nanotechnology law suit where they were suing the US Environmental Protection Agency,  GROUPS DEMAND EPA STOP SALE OF 200+ POTENTIALLY DANGEROUS NANO-SILVER PRODUCTS; Nanotech Watchdog Launches First-Ever Legal Challenge To EPA Over Unregulated Nanotech Pesticide Pollution.

If I understand this rightly, the ICTA along with its coalition partners is suing the FDA for not responding to its petition, which would have made for a much less compelling headline. I didn’t have much luck accessing the 2006 petition (clicking on the link brought up an error page) but will try again later.

I notice that sunscreens with with nanoscale titanium dioxide are used as an example of the use of dangerous nanomaterials in consumer products. It seems the general consensus is that nanoscale titanium dioxide and/or zinc oxide used in nanosunscreens are relatively safe. You can read more about this on the Cancer Council of Australia or the Environmental Working Group (EWG) websites. From the EWG,

EWG reviewed the scientific literature on hazards and efficacy (UVB and UVA protection) for all active ingredients approved in the U.S. Though no ingredient is without hazard or perfectly effective, on balance our ratings tend to favor mineral sunscreens because of their low capacity to penetrate the skin and the superior UVA protection they offer.

I really wish they would stop using the nanosunscreens as their ‘go to’ concern as I think it damages these groups’ credibility.

Still, the FDA should respond to a petition and six years seems like a long time to wait.

Nano regulatory frameworks are everywhere!

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The scene around nanotechnology regulatory frameworks has been frantic (by comparison with any other time period during the 3 years I’ve been blogging about nano) in the last month or so. This is my second attempt this month at pulling together information about nanotechnology regulatory frameworks (my June 9, 2011 posting).

I’ll start off slow and easy with this roundup of sorts with a brief look at the international scene, move on to US initiatives, offer a brief comment on the Canadian situation, and wrap up with Europe.

International

Dr. Andrew Maynard at the University of Michigan Risk Science Center (UMRSC) blog has written a commentary about the ISO’s (*International Organization for Standardization) latest set of nanotechnology guidelines in his May 27, 2011 posting.  From the posting,

ISO/TR 31321:2011: Nanotechnologies – Nanomaterial risk evaluation is unashamedly based on the Environmental Defense Fund/DuPont Nano Risk Framework. Much of the structure and content reflects that of the original – a testament to the thought and effort that went into the first document. …The ISO report is written in a much tighter style than that of the original document, and loses some of the occasionally long-winded expositions on what should be done and why. And the ISO document is more compact – 66 pages as opposed to 104. But from a comparative reading, surprisingly little has been changed from the 2007 document.

It’s build around a framework of six steps:

  1. describe materials and applications
  2. material profiles
  3. evaluate risks
  4. assess risk management options
  5. decide, document, and act
  6. review and adapt

From the posting,

Inherent to this framework is the need to make situation-specific decisions that are guided by the Technical Report but not necessarily prescribed by it, and the need to constantly review and revise procedures and decisions. This built-in flexibility and adaptability makes ISO/TR 31321 a powerful tool for developing tailored nanomaterial management strategies that are responsive to new information as it becomes available. It also presents an integrative approach to using materials safely, that deals with the need to make decisions under considerable uncertainty by blurring the line between risk assessment and risk management.

Andrew’s view of these guidelines is largely positive and you can get more details and history by viewing his original commentary. (I first mentioned these new ISO guidelines in my May 18, 2011 posting.)

Sticking with the international scene (in this case, ISO), there was a June 13, 2011 news item on Nanowerk about a new ISO general liability classification for nanotechnology and alternative energy (from the news item),

The new classifications to address the growing use of nanotechnology are Nanomaterial Distributors and Nanomaterial Manufacturing. The once-limited use of nanotechnology in electronics and information technology industries is now swiftly permeating the consumer marketplace, from cosmetics to clothing and more. The Nanomaterial Distributors classification applies to risks that sell nanomaterials to others, and the Nanomaterial Manufacturing classification applies to risks that manufacture or engineer nanomaterials for others.

“With heightened interest to reduce the carbon footprint, establish energy independence, and increase the use of renewable resources, alternative power is a priority for many,” said Beth Fitzgerald, vice president of commercial lines and modeling at ISO. “In response to the growing demand for alternative energy, ISO introduced classifications for risks in three main areas: biofuels, solar energy, and wind energy. The new classifications will allow for future evaluation of the loss experience of those emerging markets.”

The biofuels classifications consist of Biofuels Manufacturing and Biofuels Distributors. Since ethanol already has a widespread and accepted use, a further distinction is made between “ethanol” and “biofuels other than ethanol.”

The solar energy classifications include Solar Energy Farms, Solar Energy Equipment Dealers or Distributors, and Solar Energy Equipment Manufacturing. The wind energy classifications include Wind Turbine Contractors – Installation, Service, or Repair and onshore and offshore Wind Farms.

* I have for many years understood that ISO is the International Standards Organization and I see from a note on the UMRSC blog that these days it is the International Organization for Standardization.

US

On the US front, three different agencies have made announcements that in one way or another will have an impact on the nanotechnology regulatory frameworks in that country.

The White House Emerging Technologies Interagency Policy Coordination Committee (ETIPC) recently released a set of principles for the regulation and oversight of nanotechnology applications and guidance for the development and implementation of policies at the agency level. From the June 9, 2011 news item on Nanowerk,

The realization of nanotechnology’s full potential will require continued research and flexible, science-based approaches to regulation that protect public health and the environment while promoting economic growth, innovation, competitiveness, exports, and job creation.

In furtherance of those goals, the White House Emerging Technologies Interagency Policy Coordination Committee (ETIPC) has developed a set of principles (pdf) specific to the regulation and oversight of applications of nanotechnology, to guide the development and implementation of policies at the agency level.

These principles reinforce a set of overarching principles (pdf) for the regulation and oversight of emerging technologies released on March 11, 2011. They also reflect recommendations from a report on nanotechnology (pdf) by the President’s Council of Advisors on Science and Technology. The report encourages Federal support for the commercialization of nanotech products and calls for the development of rational, science- and risk-based regulatory approaches that would be based on the full array of a material’s properties and their plausible risks and not simply on the basis of size alone.

You can read more about the guidelines at Nanowerk or on the Environemental Expert website here.

Back over on the UMRSC blog, Dr. Andrew Maynard had these comments in his June 13, 2011 posting,

In a joint memorandum, the Office of Science and Technology Policy, the Office of Management and Budget and the Office of the United States Trade Representative laid out Policy Principles for the U.S. Decision Making Concerning Regulations and Oversight of Applications of Nanotechnology and Nanomaterials.

…

Reading through it, a number of themes emerge, including:

  • Existing regulatory frameworks provide a firm foundation for the oversight of nanomaterials, but there is a need to respond to new scientific evidence on potential risks, and to consider administrative and legal modifications to the regulatory landscape should the need arise.
  • Regulatory action on nanomaterials should be based on scientific evidence of risk, and not on definitions of materials that do not necessarily reflect the evidence-based likelihood of a material causing harm.
  • There should be no prior judgement on whether nanomaterials are intrinsically benign or harmful, in the absence of supporting scientific evidence.
  • Transparency and communication are important to ensuring effective evidence-based regulation.

Overall, this is a strong set of policy principles that lays the groundwork for developing regulation that is grounded in science and not swayed by speculative whims, and yet is responsive and adaptive to emerging challenges. Gratifyingly, the memorandum begins to touch on some of the concerns I have expressed previously about approaches to nanomaterial regulation that seem not to be evidence-based. There is a reasonable chance that they will help move away from the dogma that engineered nanomaterials should be regulated separately because they are new, to a more nuanced and evidence-based approach to ensuring the safe use of increasingly sophisticated materials. Where it perhaps lacks is in recognizing the importance of other factors in addition to science in crafting effective regulation, and in handling uncertainty in decision making.

June 9, 2011 was quite the day as in addition to the White House documents, the US Environmental Protection Agency (EPA) and the US Food and Drug Administration (FDA) both announced public consultations on nanotechnology regulation.

From the June 9, 2011 news item on Nanowerk about the US EPA public consultation,

The U.S. Environmental Protection Agency announced today it plans to obtain information on nanoscale materials in pesticide products. Under the requirements of the law, EPA will gather information on what nanoscale materials are present in pesticide products to determine whether the registration of a pesticide may cause unreasonable adverse effects on the environment and human health. The proposed policy will be open for public comment.

“We want to obtain timely and accurate information on what nanoscale materials may be in pesticide products, “said Steve Owens assistant administrator for EPA’s Office of Chemical Safety and Pollution Prevention. “This information is needed for EPA to meet its requirement under the law to protect public health and the environment.”

…

Comments on the Federal Register notice will be accepted until 30 days after publication. The notice will be available at www.regulations.gov in docket number EPA–HQ–OPP–2010-0197. More information or to read the proposed notice: http://www.epa.gov/pesticides/regulating/nanotechnology.html [Pesticides; Policies Concerning Products Containing Nanoscale Materials; Opportunity for Public Comment]

The US FDA has taken a more complicated approach to its public consultation with two notices being issued about the same consultation. The June 9, 2011 news item on Nanowerk had this to say,

The U.S. Food and Drug Administration today released draft guidance to provide regulated industries with greater certainty about the use of nanotechnology, which generally involves materials made up of particles that are at least one billionth of a meter in size. The guidance outlines the agency’s view on whether regulated products contain nanomaterials or involve the application of nanotechnology.

…

The draft guidance, “Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology”, is available online and open for public comment. It represents the first step toward providing regulatory clarity on the FDA’s approach to nanotechnology.

Specifically, the agency named certain characteristics – such as the size of nanomaterials used and the exhibited properties of those materials – that may be considered when attempting to identify applications of nanotechnology in regulated products.

“With this guidance, we are not announcing a regulatory definition of nanotechnology,” said Margaret A. Hamburg, MD, Commissioner of Food and Drugs. “However, as a first step, we want to narrow the discussion to these points and work with industry to determine if this focus is an appropriate starting place.”

Then there was a June 15, 2011 news item on Nanowerk offering more details about the draft guidance announcement of June 9, 2011,

The guidelines list things that might be considered when deciding if nanotechnology was used on a product regulated by FDA—including the size of the nanomaterials that were used, and what their properties are.

And FDA wants industry leaders and the public to weigh-in.

Nanotechnology—the science of manipulating materials on a scale so small that it can’t be seen with a regular microscope—could have a broad range of applications, such as increasing the effectiveness of a particular drug or improving the packaging of food or cosmetics. “Nanotechnology is an emerging technology that has the potential to be used in a broad array of FDA-regulated medical products, foods, and cosmetics,” says Carlos Peña, director of FDA’s emerging technology programs. “But because materials in the nanoscale dimension may have different chemical, physical, or biological properties from their larger counterparts, FDA is monitoring the technology to assure such use is beneficial.”

In other words, using nanotechnology can change the way a product looks or operates, Peña says.

Although the technology is still evolving, it’s already in use as display technology for laptop computers, cell phones, and digital cameras. In the medical community, a number of manufacturers have used nanotechnology in:

  • Drugs
  • Medical imaging
  • Antimicrobial materials
  • Medical devices
  • Sunscreens

Andrew Maynard in his previously noted June 13, 2011 posting on on the UMRSC blog had this to say  about the EPA’s draft document,

This is a long and somewhat convoluted document, that spends some time outlining what the agency considers is an engineered nanomaterial, and reviewing nanomaterial hazard data.

Reading the document, EPA still seems somewhat tangled up with definitions of engineered nanomaterials. After outlining conventional attributes associated with engineered nanomaterials, including structures between ~1 – 100 nm and unique or novel properties, the document states,

“These elements do not readily work in a regulatory context because of the high degree of subjectivity involved with interpreting such phrases as “unique or novel properties” or “manufactured or engineered to take advantage of these properties” Moreover the contribution of these subjective elements to risk has not been established.”

This aligns with where my own thinking has been moving in recent years. Yet following this statement, the document reverts back to considering nanoparticles between 1 – 100 nm as the archetypal nanomaterial, and intimates “novel” properties such as “larger surface area per unit volume and/or quantum effects” as raising new risk concerns.

Canadian segue

I’ll point out here that Health Canada’s Interim Policy definition also adheres to the 1 to 100 nm definition for a nanomaterial, a concern I expressed in my submission to the public consultation held last year. Interestingly, since 29 submissions does seem particularly daunting to read there has yet to be any public response to these submissions. Not even a list of which agencies and individuals made submissions.

Back to US

Andrew also comments on the FDA document,

The FDA Guidance for Industry: Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology is a very different kettle of fish to the EPA document. It is overtly responsive to the White House memo; it demonstrates a deep understanding of the issues surrounding nanotechnology and regulation; and it is mercifully concise.

To be fair, the scope of the draft guidance is limited to helping manufacturers understand how the agency is approaching nanotechnology-enabled products under their purview. But this is something it does well.

One of the more significant aspects of the guidance is the discussion on regulatory definitions of nanomaterials. Following a line of reasoning established some years ago, the agency focuses on material properties rather than rigid definitions:

“FDA has not to date established regulatory definitions of “nanotechnology,” “nanoscale” or related terms… Based on FDA’s current scientific and technical understanding of nanomaterials and their characteristics, FDA believes that evaluations of safety, effectiveness or public health impact of such products should consider the unique properties and behaviors that nanomaterials may exhibit”

I recommend reading the full text of Andrew’s comments.

Europe

Meanwhile, there was a June 10, 2011 news item on Nanowerk about the availability of  28 presentations from a May 10-12, 2011 joint European workshop hosted by the Engineered NanoParticle Risk Assessment (ENPRA) FP (Framework Programme) 7 project and the European Commission’s Joint Research Centre. From the news item about the Challenges of Regulation and Risk Assessment of Nanomaterials workshop,

Twenty-eight presentations delivered at the Joint JRC Nano event and 2nd ENPRA Stakeholders Workshop are now available on-line: ENPRA Workshop 2011 – Programme with Presentations.

…

The workshop (by invitation only) involved about 90 participants, from industry, government, NGOs, and academia. …

During two days and a half, 34 experts from 26 different organisations informed the participants on the latest scientific progress in the field of nanoparticles risk assessment produced within national and European projects, and first results of ENPRA FP7 project were presented in detail. In addition, recent developments concerning legislation in the EU and beyond were discussed.

Amongst other participants, you can include representatives of EU Associate and Candidate Countries, environment and workers’ protection organisations, CAIQ (Chinese Academy of Inspection and Quarantine), US-EPA, ECHA, and EFSA.

To close this piece (and I want to do that very badly), I’m going to give Tim Harper at his TNT blog (on the Cientifica website) the final word from his June 10, 2011 posting,

The White House Emerging Technologies Interagency Policy Coordination Committee (ETIPC) has developed a set of principles (pdf) specific to the regulation and oversight of applications of nanotechnology, to guide the development and implementation of policies at the agency level.

I’m glad to see that it addresses those two old bugbears, the confusion between risk and hazard and the prejudging of issues without reference to scientific evidence …

It is an approach which appears to diverge slightly from the European adoption of the precautionary principle …

As with any regulation, the problems will arise not from the the original wording, but through its (mis)interpretation and inconsistent application.