Nanotechnology Lawyer & Attorney : Porter Wright Morris & Arthur : Nanotechnology Law Report - Germanium nanobead image provided by UT-Battelle, which manages Oak Ridge National Laboratory for the Department of Energy

On February 17 2011, the EPA, in conjunction with the Consumer Product Safety Commission (CPSC) and the UK's Natural Environmental Research Council (NERC), announced the awarding of $12 million ($5.5 million from the EPA, $500,000 from CPSC, and $6 million from NERC) to three consortia to fund research aimed at providing a greater understanding of potential risks to human health and the environment posed by engineered nanomaterials and their increasing use in a wider variety of products.

The three consortia, the "Consortium for Manufactured Nanomaterial Bioavailability and Environmental Exposure", "Risk Assessment for Manufctured Nanoparticles Used in Consumer Products (RAMNUC)", and "The Transatlantic Initiative for Technology and the Environment", are composed of leading US and UK Universities and research centers, such as Duke University, Carnegie-Mellon University, and Lancaster University. NERC's $6 million is limited to participating universities and research centers in the UK.  The table below provides more information.

The results of the grant supported research "will help researchers determine whether certain nanomaterials can leach out of products . . . when they are used or disposed of and whether they could become toxic to people and the environment. The results could also be used by nanoindustries to create better and safer products.

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Here is the Summer 2009 edition of Nanotechnology Law Report.  The newsletter contains the below-listed articles (and more):

• EPA Issues Significant New Use Rules for Carbon Nanotubes
• Are Nanoparticles Released by Cutting or Compounding Nano-Composites?
• Annual Nano TiO2 Production Estimated at 44,000 Metric Tons
• Are Nano Consumer Products Headed Underground?
• Oversight of Next Generation Nanotechnology
• Regulating Nanotechnologies
• More Interesting Nano-Regulatory Developments
• Nano Tug of War
• Pumpkins & Nanoparticles
• Green Nano
• NanoBiotech 2009
• Take two silver nanoparticles and call me in the morning
• International Approaches to the Regulatory Governance of Nanotechnology
• ETUC Resolution on Nanotechnologies and Nanomaterials
• Private Spending on Nano Exceeds Government Spending
• EMERGNANO Released

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Late last month, the Woodrow Wilson International Center for Scholar's Project on Emerging Nanotechnologies (PEN) published a paper on the ability of the U.S. Consumer Product Safety Commission (CPSC) to deal with possible environmental, health, and safety risks potentially posed by the use of some nanoscale materials in certain consumer products.

 E. Marla Felcher, "The Consumer Product Safety Commission and Nanotechnology," Project on Emerging Nanotechnologies, PEN 14, August 2008.

 The article begins with an analysis of PEN’s online consumer nanoproduct inventory which is used to support the author’s claims that "nanotechnology-enabled products" have made their way into every category of product under the CPSC's jurisdiction. Of the 60 products on PEN’s website, the author claims that "all of them are available for purchase by consumers," and approximately "half of nanotechnology consumer products currently on the market would fall under CPSC's jurisdiction." She notes that "[e]very day, new nanoengineered products make their way into stores’ shelves, among them kids’ pants, teddy bears, baby bottles, pacifiers, teething rings, plastic food storage containers, socks, chopsticks, humidifiers, mobile phones, computer processors and tennis rackets."

In a loaded rhetorical follow-up question the author asks: "Is it safe for an infant to spend hours each day sucking on a nano-enhanced pacifier?" The question does more to cement the author’s predilection against the use of nanoscale materials in consumer products than it does to present readers with a true quandary. Moreover, while PEN’s online inventory is a great tool, the author fails to take into account that many of the products on the site have never been commercialized, or have long been taken off the market. Such an analysis would provide a helpful balance to the article’s "pending emergency" tone.

Getting beyond initial issues, the author’s key concerns appear to have less to do with potential nano-specific product risks than with CPSC foundational issues. The author’s primary complaint appears to be that the CPSC has no premarket testing authority. She also believes that there is "[a]mple evidence" that companies do not do premarket testing or self-report hazards and defects -- a conclusion many dispute.

In keeping with her general approach, the author lists "Five Generic Weaknesses in CPSC's Product Oversight Capacity:" 1. "CPSC's Data Collection System is Not Nano Ready;" 2. "CPSC has Limited Ability to Tell the Public About Health Hazards Associated with Nanoproducts;" 3. "CPSC Has Limited Ability to Get Recalled Nanoproducts Out of Use;" 4. "CPSC Lacks Sufficient Enforcement Staff to Identify Manufacturers That Fail to Report Nanoproduct Hazards;" and 5. "CPSC Does Not Have Sufficient Authority to Promulgate Mandatory Safety Standards for Nanoproducts."

While some of these points are valid, they are not nano-specific. In fact, this section of the article would suffer little if the prefix "nano" and the term "nanotechnology" were eliminated from the text. (Try it.) The same could be said for several of the prior papers published by PEN in which the authors’ complaints and cautions appear more related to broader governance issues than to nano-specific difficulties.

To get to the heart of the paper, most readers will want to flip to the last section where the author lists several recommendations to correct the problems she perceives with the CPSC.

The author recommends that the CPSC should: 1. "Build the agency’s nanotechnology base and expertise;" 2. Identify companies making "nanoproducts and request that they submit research studies, risk assessment data and any information they hold that will enable CPSC scientists to assess the safety of nanoproducts;" (Although she notes that the Consumer Product Safety Act provides sufficient authority to accomplish this recommendation); 3. "Coordinate with other health and safety agencies, and combine efforts to evaluate the risks associated with nanoproducts;" and 4. "Convene a CHAP to evaluate the health and safety risks associated with nanoproducts currently on the market that are intended for use by children."

The author’s second CPSC recommendation is the most interesting and could benefit from further development. If the Consumer Product Safety Act provides sufficient authority to allow the CPSC to ask companies making nanoproducts to submit safety and risk assessment data (as the author suggest), that should go a long way to satisfying the author’s nano-information gathering concerns. The potential civil liability facing companies marketing nanoproducts without first collecting such data after it has been specifically requested by the CPSC would act as a hefty deterrent to the potential misconduct she fears.

The author also recommends two Congressional remedies:

1. "Amend the Consumer Product Safety Act to give CPSC the authority to require manufacturers to identify the presence of nanomaterials in their products;" and 2. "Adopt Section II of the Consumer Products Safety Act Bill recommended to Congress by the NCPS in its 1970 Field Report." This would give the CPSC the ability to promulgate "safety standards for any 'new' consumer products" . . . "where there exists a lack of information adequate to determine the safety of such product in use by consumers."

It is hard to argue against the author’s first Congressional recommendation. Collecting more information is a good thing as long as the requirements are not onerous and the CPSC actually has the ability to process and use the data productively. Although mentioned in the "Foreword," left out of the author’s Congressional "should do" list is more CPSC funding specifically dedicated to nanotechnology safety issues. Arguably, many of the author’s issues with the CPSC could be diminished with additional funding, staff, and resources to more fully address nanotechnology issues.

All in all, the paper is well worth reading as long as PEN’s and the author’s predispositions are kept in mind.

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