White House Issues Nanotechnology EHS Policy Statement

One June 9, the President's Office of Budget and Management, United States Trade Representative, and Office of Science and Technology Policy issued a joint memorandum directed to all Executive branch departments and agencies entitled "Policy Principles for the U.S. Decision-Making Concerning Regulation and Oversight of Applications ofNanotechnology and Nanomaterials."

The Policy Statement is important because it confirms a "best-science" approach to potential nano-EHS issues, rather than a reactionary approach.  While this has been the stated approach of various federal agencies in the past, it is nice to see it reaffirmed across the entire federal government at the highest levels. The memorandum also reaffirms the importance of nanotechnology to the US economy, and recognizes the potential adverse economic consequences that knee-jerk regulation might have. 

Perhaps most interesting is that the memorandum repeatedly refers to the sufficiency of existing regulations to deal with potential nano-related EHS risks.  Some advocacy groups may have been holding out hope that the Obama administration would enact new nano-specific regulations. That is very doubtful given the tenor of the memorandum, which should provide industry with a measure of reassurance in this regard.

 

Are Major Food Companies Backing Away from Engineered Nanoscale Materials?

A food safety strategist for "As You Sow" recently indicated that the group is conducting a survey "of a wide selection of food manufacturers and retailers regarding their use of nanomaterials in food products."  The group is also creating a "Nanofood Sourcing Framework" designed to guide food-related companies on the issues they should be considering before using engineered nanoscale materials in their products.

Interestingly, the strategist asked some major food-related corporations about their use of engineered nanoscale materials and believes that companies are "taking a precautionary approach."  Evidently, McDonald's, Pepsi, and Kraft all claim to be "nano-free." McDonald's has an interesting post about the issue on its website:

McDonald's Corporation is working to understand the use of nanotechnology and its applications in food and packaging products. Given the current uncertainty related to potential impacts of nano-engineered materials, McDonald's does not currently support the use by supplies of nano-engineered materials in the production of any of our food, packaging or toys.

Regarding Kraft, the strategist wrote that Kraft "first posted a statement on their website in 2009 announcing that they are not using nanotechnology, although they did admit to be exploring nano applications for packaging. Two year later, Food Production Daily reports that ‘Kraft is one company to have taken a deliberate step away from the emerging technology.'"
 

University of California, San Francisco Publishes Nanotechnology Regulatory Policy Recommendations

The Program on Reproductive Health and the Environment (PRHE) at the University of California, San Francisco (UCSF) is part of the Department of Obstetrics, Gynecology & Reproductive Services located in UCSF’s School of Medicine. PRHE just published its "Recommendations for Addressing Potential Health Risks from Nanomaterials in California” which was commissioned by California's Office of Environmental Health Hazard Assessment  (OEHA).  The document is designed to provide the State with an overview of nanotechnology materials and their potential exposures and human health risks, and proposes a selection of policy options for addressing potential hazards and risks from nanotechnology.  We previously provided our comments on the May 2010 draft of this document here.  A year later, many of our same concerns still apply to the final document.

The new document makes a range of recommendations, which are set forth below:

Recommendations to address health risks from nanomaterials for OEHHA that can be achieved under the existing regulatory structure:

1. Develop a definition of nanomaterials that can be used to identify them.

2. Identify and define priority properties for risk characterization and collect information about them for each nanomaterial.

3. Develop characteristics by which to define, describe, and group nanomaterials according to conventional or unique properties.

4. Establish a publicly accessible clearinghouse and inventory of nanomaterial sources and products.

5. Identify and/or develop methods for monitoring nanomaterials in environmental media and through human biomonitoring.

6. Collect information on the fate and transport of nanomaterials, including through monitoring in environmental and biological media.

7. As for other chemicals, focus on identifying and addressing nanomaterials that are persistent, bioaccumulative, and toxic (PBT).

8. Use existing hazard traits from other chemicals and toxicological and environmental-health-related endpoints to assess potential adverse health outcomes from nanomaterial exposure.

9. Evaluate existing risk-assessment guidelines to determine whether they sufficiently cover nanomaterials, adjusting or incorporating nano-specific approaches as needed.

10. Integrate nanomaterials into current efforts to modernize toxicity testing.

11. Develop and maintain relationships with other governments and researchers to share relevant data and information on nanotechnology and nanomaterials’ use, applications, and toxicity.

12. Improve coordination and monitor communication among federal and state agencies, other countries’ governments, businesses, and NGOs.

13. Continue to include opportunities for public input and comment during decision-making processes.
 

Recommendations to support successful approaches to address potential health risks from nanomaterials that are currently outside the scope of OEHHA.

1. Require disclosure of where and what nanomaterials are manufactured, in what quantities, and for what new or existing products.


2. Require reporting of properties that can identify nanomaterials that are persistent,bioaccumulative, and toxic (PBT). Phase out uses consistent with approaches for other PBTs.


3. Develop a framework for making policy and regulatory decisions that balances the uses and benefits of nanomaterials with their toxicity and exposure potential.


4. Require testing of release and exposure potential for nanomaterials in consumer products for both existing and new products.


5. Increase efforts to protect and educate workers, researchers, and downstream users of nanomaterials


6. Require sufficient toxicological testing—preferably pre-market and also post-market as necessary—to assess risks to manufacturing and other workers and to downstream users, including consumers and susceptible subpopulations such as infants.


7. Implement a labeling system that requires labeling of products that contain nanomaterials.
 

8. Increase funding and support for targeted, nano-specific research to fill data gaps.
 

9. Conduct targeted research on the biological fate, transport, and distribution of nanomaterials, including sources, exposure routes, and internal distributions. Integrate this research with information gathered on exposure potential.
 

EPA to Issue New Carbon Nanotube Significant New Use Rule

Here is an advance copy of a new multi-walled carbon nanotube significant new use rule being published tomorrow in the federal register.  It applies only to the specific carbon nanotubes that were the subject of PMN P-08-199, and binds anyone who intends to manufacture, import, or process the specific chemical substance.  It is largely consistent with past SNURs and Consent Orders for other CNTs.  For those wondering, "processors" and "processing" is broadly defined under TSCA.  It has been used in the past to include repackaging for commercial purposes, using the material in the manufacturing of new mixtures, and/or the production of articles using the substance.

Nanoscale Carbon Toxicity Testing Proposal Submitted to EPA

 

 

The NanoSafety Consortium for Carbon just submitted a proposed toxicity testing agreement to EPA under Section 4 of the Toxic Substances Control Act covering a range of nanoscale materials including multi-walled carbon nanotubes, double-walled carbon nanotubes, single-walled carbon nanotubes, and graphene. 

 

Key elements for the curious:

  • The chemical substances to be tested may include representative (i) purified multi-walled carbon nanotubes ranging from 4 to 600 nanometers in diameter and less than 30 micrometers in length; (ii) purified double-walled carbon nanotubes ranging from 1.5 to 4 nanometers in diameter and less than 5 micrometers in length; (iii) purified single-walled carbon nanotubes ranging from .7 to 2 nanometers in diameter and less than 30 micrometers in length; and (iv) purified graphene nanoplatelets in flake/sheet form ranging from .5 nanometers to 100 nanometers thick. All test materials will be purified by the National Institute of Standards and Technology to be at least 99 percent pure. Final test materials will be approved by the EPA and will be selected to adequately represent the constituency of the final signatories to the testing agreement.

 

  • The characteristic for which testing will be conducted is subchronic inhalation toxicity in rodents, or such other toxicity testing as may be approved by EPA to achieve the intent and purpose of the testing agreement. As appropriate, consideration will be given to using in vivo instillation rather than inhalation test methods. Test data will be developed under standards based on TSCA test guidelines in 40 CFR parts 796, 797, and 798, Organization for Economic Cooperation and Development (OECD) test guidelines, or other suitable test methodologies.  Specifically, the signatories will conduct a 90 day inhalation toxicity study in rats with a post exposure observation period of up to 3 months, including broncholaveolar lavage fluid analysis (OPPTS 870.3465 or OECD 413), or such other testing as may be approved by the EPA to achieve the intent and purpose of the testing agreement. Testing guidelines will be modified to account for nanoscale properties of the materials being tested. Such modifications are subject to EPA approval and will be incorporated into the below-referenced study plan.

If EPA decides to pursue the proposed testing agreement, it will initiate a six-month negotiation and comment period which will open to the public pursuant to 40 C.F.R. § 790.28.

Stay tuned.

 

"The New Steel? Enabling the Carbon Nanomaterials Revolution: Markets, Metrology, Safety, and Scale-up"

“The New Steel? Enabling the Carbon Nanomaterials Revolution: Markets, Metrology, Safety, and Scale-up” is a workshop to be held on February 28th and March 1st, 2011, at NIST’s Gaithersburg, Maryland facility. NIST has assembled an outstanding roster of speakers from industry, academia and government to address the full spectrum of issues, including a special panel on EH&S.

If you can join the workshop, please register before the registry is filled! Remember that this will be a true workshop and participants are encouraged to actively share their views and perspectives over the two days, and also to provide if possible before the workshop commences a brief (2-page) white paper on one of the three breakout session topics, listed below, to help seed the discussions. If you prepare a white paper, please send it to TheNewSteel@nist.gov

The three topic areas for the workshop breakout sessions:

• Technology Challenges and Barriers for Carbon-based Nanomaterials
• EH&S – From Regulation to the Marketplace
• Measurement Issues and Grand Challenges

NIST contact information is below if you have any questions or would like to receive more information regarding the workshop.

J. Alexander Liddle, Group Leader
Nanofabrication Research Group
Center for Nanoscale Science and Technology
National Institute of Standards and Technology
Bldg. 216 Rm. B153
100 Bureau Drive, Stop 6203
Gaithersburg, MD 20899-6203
tel: 301 975 6050
fax: 301 975 5314
liddle@nist.gov
http://cnst.nist.gov
 

ABA Program on Nano Governance

Presenting what looks to be a very interesting line-up of top-rate speakers, the American Bar Association's Section of Environment, Energy, and Resources (Pesticides, Chemical Regulation, and Right-to-Know Committee) is presenting a webinar on January 27, 2011:

Nano Governance: The Current State of Federal, State, and International Regulation

Here is a summary of the webinar from ABA's online announcement:

States, federal agencies, and foreign governments are challenged to address the risks and promote the benefits of evolving technologies, including nanotechnology. Companies globally are continuing to harness the properties of nanomaterials for use in products from airplanes to pharmaceuticals and from cosmetics to food packaging. Nano Governance: The Current State of Federal, State, and International Regulation will address these issues in a half-day program. This program will explore the new and creative applications of existing regulatory tools and governance approaches to address the potential risks of nanotechnologies, implement new risk assessment approaches to evolving technologies, and maximize the potential benefits of these materials. Panelists will report on new and emerging federal, State, and international nanomaterials regulations and governance strategies. Attendees will gain insight into potential public health and environmental impacts and the approaches various government agencies and industrial stakeholders are pursuing to address these issues while also promoting nanotechnology. The program is open to attorneys and other professionals with chemical regulatory compliance practices.

Educational Objectives:

  • Develop familiarity with new and emerging federal, State, and international nanomaterials regulations and governance strategies
  • Understand Potential Public Health and Environmental Impacts and the approaches various government agencies are pursuing to promote nanotechnology while also addressing potential public health and environmental risks
  • Appreciate complexities of addressing potential risks with existing governance tools and strategies while also embracing new approaches to accommodate evolving technologies

I hope to attend by telephone and encourage any interested readers to do the same.  It should be a great conference.

 

New Edition of Nanotechnology Law Report

New Edition of Nanotechnology Law Report

Inside you will find:

  • EPA Considering New Approach to Nanoscale Materials Under TSCA
  • EPA May Issue Mandatory Data Collection Rule for Nanoscale Materials Under TSCA
  • EPA Takes Aim at Antimicrobial Products Under FIFRA
  • EPA Unveils New Principles for Chemical Management Reform
  • EPA Report on the Use of Nanoscale TiO2 in Water and Sunscreens
  • EPA Withdraws Carbon Nanotube SNURs
  • Press Release: New Contributing Editor for InterNano
  • Virginia CLE presentation: “Insurance, Nanotechnology, and Risk”
  • Nanoparticles and Deaths in the People’s Republic
  • Sweating the Small Stuff
  • Soil Association Cites China Deaths in Renewed Call for Moratorium on Nanotechnology Commercialization
  • Nanotechnology Legislation in the 111th Congress
  • Mapping Nano
  • Flight of the Nanobees

 

New National Nanomanufacturing Network Newsletter

The National Nanomanufacuring Network (NNN) at the University of Massachusetts, Amherst just published its October newsletter which you can find here.  There is a nice article by Barbara Beck and Chris Long from Gradient regarding the recent Song nanoparticle study from China which was my first contributing editor piece for NNN's InterNano.  Please read the newsletter and follow NNN's valuable work.

Study of Chinese Print Workers Claims to Provide the First Human Evidence of the Clinical Toxicity of Long-term Nanoparticle Exposures

This article was originally published by the National Nanomanufacturing Network's "InterNano" project (www.internano.com).  It is licensed under a Creative Commons Attribution-NonCommercial-NoDerivs 3.0 Unported.

A recent study published in the well-known medical journal, the European Respiratory Journal, has been receiving significant publicity as the authors have claimed their findings support an apparent linkage between workplace exposures to nanoparticles and severe respiratory disease. Specifically, in this study, investigators at China's Capital University of Medical Science related unusual and progressive lung disease in seven Chinese workers, two of whom died, to nanoparticle exposures in a print plant where a polyacrylic ester paste containing nanoparticles was used. This linkage was made by the study investigators despite a general lack of exposure data for the workers. 
 

The complete review is after the jump . . .

Reviewed by Christopher M. Long, Sc.D., and Barbara D. Beck, Ph.D., DABT, FATS, Gradient

While there are cellular and laboratory animal studies that suggest the enhanced toxicity of some engineered nanoparticles (ENP) relative to larger sized particles of the same chemical composition (e.g., carbon nanotubes versus graphite, nano-sized titanium dioxide versus conventional titanium dioxide), there remains no direct human evidence of the health risks posed by ENP. The absence of any epidemiology or medical case studies examining potential ENP exposures and adverse health effects among either workers or consumers is likely a result of several factors. These factors include the fairly recent intensification in ENP manufacturing and commercial application, as well as the fact that relatively small amounts are typically manufactured and handled. The Song et al. (2009) study is a medical case report that claims to provide the first human evidence of "nanomaterial-related disease" following long-term nanoparticle exposure.

This study attributed unusual and progressive lung disease in seven Chinese workers, two of whom died of respiratory failure, to workplace nanoparticle exposures in a print plant where a polyacrylic ester paste containing nanoparticles was sprayed onto a polystyrene substrate, with subsequent heat-curing. For 5 to 13-month durations, all seven employees worked in the same department of the print plant, specifically, in a room with little to no ventilation due to the failure of the mechanical ventilation system. Lacking any measurement data of actual worker exposures, study investigators concluded, based on the detection of 30-nm nanoparticles in the paste material as well as in accumulated dust in the workplace, that these workers were exposed to polyacrylate nanoparticles. Reporting the presence of similarly-sized nanoparticles in the chest fluid and lung cells of the diseased workers, Song et al. highlighted the emerging body of nanotoxicological evidence from animal and in vitro studies to support their conclusion that the observed health effects were due to polyacrylate nanoparticle exposures.

While highly tragic and certain to create a stir among regulators, the media, and the general public, it is important to recognize that this study does more to highlight the critical need to follow well-established industrial hygiene practices than to provide direct evidence in humans of any unique health risks posed by ENPs. This study has several key limitations, including a general lack of information on the exposures experienced by the workers. Given the spraying of a chemical paste and the heating of a plastic material in an enclosed space lacking any mechanical ventilation, it is clear that these workers were exposed to a complex cocktail of chemicals and fumes, in addition to any nanoparticle exposures.

Based on the identification of nanoparticles in the paste, in accumulated dust in the workplace, and in lung tissues and cells of the workers, it is likely that these workers were exposed to nanoparticles in their workplace. However, Song et al. do not provide the necessary materials characterization data to demonstrate that the observed nanoparticles are indeed engineered nanoparticles (i.e., nanoscale particles intentionally created to have nano properties) and to confirm that the nanoparticles observed in the paint paste are the same nanoparticles identified in the workplace dust and in biological samples. Incidental nanoparticles are ubiquitous in indoor and outdoor air from a variety of anthropogenic and natural sources (engine exhaust, metal fumes, secondary organic aerosols), and characterization data are thus needed to confirm that the nanoparticles observed in the dust and in biological samples are indeed polyacrylate nanoparticles.

Given the lack of chemical analysis of the nanoparticles and the workers’ co-exposures to a variety of other toxic substances, it remains highly uncertain to what extent workplace nanoparticle exposures, compared to other workplace exposures, may have contributed to the observed health effects. Further, toxicological evidence cited by the investigators as linking ENP such as carbon nanotubes and zinc oxide with toxic responses in animals and cell cultures is of dubious relevance to polyacrylate nanoparticles, which are unlikely to exhibit similar biological activity due to important differences in toxicologically-relevant properties, in particular chemical composition. Scientific evidence is quite clear that toxicological properties differ greatly among different nanoparticles.

Regardless of the actual role of nanoparticles in the observed health effects, there are important lessons that can be learned from this study. In particular, given the limited knowledge regarding the health and safety risks posed by ENPs, it is imperative that best management practices for workplace exposures be followed to control and minimize potential exposures. It is clear that occasional use of cotton gauze masks, as reported by Song et al. for the Chinese workers, is not an adequate practice for controlling workplace exposures. Fortunately, a number of good resources are available for identifying state-of-the-art nano practices, including the ICON GoodNanoGuide . This study also highlights the critical need for robust exposure assessments to support health effects studies, providing data to characterize key nanoparticle properties and to differentiate ENPs from incidental nanoparticles.

In summary, this study highlights the importance of continued vigilance for any signs of ENP-related illnesses in exposed human populations. However, it lacks the essential materials characterization, exposure, and toxicity data for both the ENP and the other chemicals to which the workers were exposed. Thus, the study is not supportive of the authors' conclusions that ENP exposures underlie the observed health effects among the Chinese workers and that these findings are of relevance to all commercially available ENPs.
 

Another Nano-Silver Sock Study

We have previously reported on a study by Arizona State researchers looking into the potential release of nanosilver particles from odor-killing socks during theoretical wash cycles.  A new study from Switzerland examines the issue in further detail.

L. Geranio, et al., "The Behavior of Silver Nanotextiles during Washing," Environ. Sci. Technol. (Sept. 2009).

Three authors from the Swiss Federal Laboratories for Materials Testing and Research conducted the study with the aim of determining "the amount and the form of Ag released during washing from nine fabrics with different ways of silver incorporation into or onto the fibers."  The study generally found that when washed at low pH levels, there was little dissolution of nanoparticles from the textiles being tested.  However, the researchers theorized that the use of bleach "can greatly accelerate the dissolution of Ag."  The percentage of total silver emitted during one wash cycle for the fabrics varied between 1% and 45%.  Almost 75% of the silver released was greater than 450 nm in diameter. 


 

New Article: Examples of Recent EPA Regulation of Nanoscale Materials Under the Toxic Substances Control Act

Nanotechnology Law & Business just published our new article on the EPA's recent treatment of nanoscale materials under the Toxic Substances Control Act.  An abstract for the article is below and you can find a copy of the article itself here.

Abstract: This article provides a summary of recent (2008-2009) regulatory efforts by the U.S. Environmental Protection Agency under the Toxic Substances Control Act concerning nanoscale materials. These efforts include entering into two consent orders with a manufacturer of carbon nanotubes; issuing four significant new use rules for two siloxane-based nanoparticles and two carbon nanotubes (and then withdrawing the latter two); intimating that new testing and data collection rules will be implemented for certain nanoscale materials; and proposing and/or requiring acute toxicity rat inhalation testing regimes in certain instances. The authors explain these developments in detail and then provide some initial strategic and legal considerations for businesses attempting to navigate this emerging regulatory thicket.

Fantastic Voyage II: Nanotech Motors

When I was growing up, one of the local tv channels in Baltimore, after football season was over, devoted Sunday afternoons to running old movies. One of those films was Fantastic Voyage, a fairly slick 1966 sf film. The plot of the movie revolved around a submarine and its crew being shrunk to the point where they could be injected into a human vein with the mission of finding and dissolving a blood clot lodged in the brain of a scientist defecting from an unnamed Iron Curtain nation.

The plot and acting ranged from the thoroughly absurd to the god awful bad, but the special effects were top of the line for that period of film making (okay, the scene of Donald Pleasance' villain being devoured by a white blood cell that looks more like slowly poured soap bubbles is a hoot and a half, but it worked . . . sort of.) The image that stays in the mind is of the sub just gliding through the blood steam.

Fantastic Voyage leapt up from the depths of my memories while I was reading "How to Build Nanotech Motors" , by Thomas E. Mallouk and Ayusman Sen and published in the May issue of Scientific American briefly reviews nanocar experiments and focuses on two problems with nanocars: (1) how to power them and (2) how to steer them. The article discusses progress made in developing "motors" to power the nanomobile and controlling its direction via the manipulation of magnetic fields.

Mallouk and Sen's vision of the future of the nanocar is more one of nanotrucks, carrying cargoes of drugs to areas of the human body where no ordinary delivery system can reach. For example, anticancer medications could be carried directly to the site of the tumor and delivered without affecting the surrounding healthy cells, much as the crew of the sub reached their blood clot and dissolved it without damaging the other brain cells. This is one area of nanomedicine that I think everyone hopes will reach its full potential.

As for Fantastic Voyage,  the producers and director of Independence Day are working on a remake, scheduled to come out in 2010. If its anything like the remake of Godzilla, do yourself a favour and watch the original.

 

 

Ohio 7th in Nanotech and Microtech Innovation

The Cleveland Plain Dealer recently reported on Ohio's standing in nanotechnology and microtechnology innovation.  According to Small Times Magazine, Ohio is now 7th in the nation, returning to the top 10 after dropping off last year.  This puts Ohio in good company with nanotech heavyweights Massachusetts (#3), New Mexico (#2), and California (#1).