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

Yesterday, the Government Accountability Office (GAO) published a statement indicating that the National Nanotechnology Initiative (NNI) previously overestimated FY 2006 federal funding of nano-related EHS research by about 18%: "Nanotechnology: Accuracy of Data on Federally Funded Environmental, Health, and Safety Research Could be Improved."

NNI reported that federal agencies spent a total of $37 million in FY 2006 researching the potential EHS risks of nanotechnology.  GAO found that this figure was off by about 18%, and that 22 of the 119 projects identified by NNI had little to do with how nanotechnology may pose EHS risks.  Rather, GAO found the studies were primarily related to detecting or remedying environmental hazards unrelated to nanotechnology.  For those keeping score, 20 of the mislabeled projects were sponsored by NSF, two were sponsored by NIOSH, and funding totaled approximately $6.5 million.  On the other side of the coin, GAO also found that NNI failed to capture some ongoing federal nano-related EHS research in its estimate "because the agencies that conduct this research do not systematically track it as EHS-related."  GAO could not value this research.

GAO attributed any mistakes to a federal reporting structure that does not allow easy categorization of research projects, and also to a lack of guidance to agencies regarding how to correctly apportion funding across multiple topics for reporting purposes.

GAO's statement concludes:

Federal Funding for studying the potential EHS risks of nanotechnology is critical to enhancing our understanding of these new materials and we must have consistent, accurate, and complete information on the amount of agency funding that is being dedicated to this effort.  However, this information is not currently available because the totals reported by the NNI include research that is more focused on uses for nanotechnology, rather than the risks it may pose. . . [T]he inventory of projects designed to address these risks is inaccurate and cannot ensure that the highest-priority research needs are met.

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The President's Council of Advisors on Science and Technology (PCAST) recently published "The National Nanotechnology Initiative: Second Assessment and Recommendations of the National Nanotechnology Advisory Panel," April 2008.   For those interested, The 21st Century Nanotechnology Research and Development Act of 2003 requires the National Nanotechnology Advisory Panel (NNAP) to review the National Nanotechnology Initiative's (NNI) performance every two years.  The President prevsiously designated PCAST to serve as the NNAP.  PCAST published its first NNI assessment in 2005.

In its second assessment, PCAST states that the NNI is by-in-large a "model program" and is "highly successful," "well organized," and "well managed" -- although it also has some specific recommendations for improvement.  To improve, PCAST believes NNI should increase its emphasis on (i) public communication and outreach regarding the perceived benefits and risks of nanotechnology; (ii) developing unified standards for nanomaterial identification, characterization, and risk assessment; and (iii) coordinating strategic EHS research which should "include balanced assessments of risks and benefits in the context of specific, real world applications."

Regarding this last issue, PCAST believes the current "approach for addressing EHS research under the NNI is sound," and that "calls for a separate agency or office devoted to nanotechnology EHS research or to set aside a fixed percentage of the budget for EHS research are misguided and may have the unintended consequence of reducing the research on beneficial applications and on risk."  Further countering NNI critics, PCAST believes that "while there is much to learn, the process is certainly not broken." 

Finally, despite expressing its support for the NNI, PCAST is also "concerned that nanoscience is losing a public relations contest. The value of nanotechnology to the U.S. economy and the contribution of nanotechnology to actually improve EHS conditions in our country and is being drowned out by the emphasis on uncertainties and by speculation that is unconstrained by examination of actual exposure and hazard in realistic use settings."    

NNAP also intends to publish an addendum to its report after reviewing NNI's EHS strategy document published in February 2008.

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The Woodrow Wilson International Center for Scholars’ Project on Emerging Nanotechnologies (PEN) recently published S. Keiner’s, "Room at the Bottom? Potential State and Local Strategies for Managing the Risks and Benefits of Nanotechnology," March 2008. Readers can see some of our prior posts regarding local nano-regulation in Berkeley here, here, here, here, here, here, and here; Cambridge here and here; and Wisconsin here.

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The House Science and Technology Committee will hear testimony on the NNI Amendments Act of 2008 on April 16, 2008.  Those scheduled to speak before the committee include:

• Floyd Kvamme, co-chairman of the President's Council of Advisors on Science and Technology;
• Sean Murdock, executive director of the NanoBusiness Alliance;
• Joseph Krajcik, associate dean for research and professor of education at the University of Michigan;
• Andrew Maynard, chief science advisor for the Woodrow Wilson Center's Project on Emerging Nanotechnologies;
• Raymond David, manager of toxicology for the BASF Corporation;
• Robert Doering, senior fellow and research strategy manager at Texas Instruments

This full-committee hearing will begin at 10:00 AM in 2318 Rayburn House Office Building.

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Risk Policy Report indicates an unlikely group of 17 industry and environmental associations has recently come together and asked EPA to begin working with the NAS to develop a federal nano-specific EHS research roadmap -- as requested by Congress back in January 2008.  We previously commented on Congress's strange work of bureaucratic overkill here.  Not only have EPA and NNI already recently published their own nano-EHS research roadmaps, NAS recently began reviewing NNI's efforts in early April, and EPA's roadmap is scheduled for peer-review starting next week.  Coupled with all of this are two upcoming bills which should begin winding their way through Congress later this month which seek to more than double the funds coordinated by NNI for nano-related EHS research.  Stay tuned.

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Last week the Silicon Valley Toxics Coalition (SVTC) published, "Regulating Emerging Technologies in Silicon Valley and Beyond: Lessons Learned from 1981 Chemical Spills in the Electronics Industry and Implications for Regulating Nanotechnology." Readers may recall that SVTC was one of eight groups filing a May 2006 FDA citizen’s petition asking the agency to take concrete steps to regulate all FDA products containing nanoscale materials. SVTC is back with additional concerns regarding possible community environmental impacts of nanomanufacturing.

SVTC begins by identifying several federal regulatory issues it believes need immediate attention: increased NNI funding for EHS research; collection of EHS data for all nanoscale materials; determining whether mass-based metrics are appropriate for nano-regulatory purposes; developing efficient instruments to detect and monitor nanoparticles; making sure manufacturers issue proper material safety data sheets; closing alleged nano-regulatory gaps in TSCA, RCRA, CWA, CAA, CERCLA, and EPCRA; closing the “loophole” created by TSCA’s small quantities exemption; making sure the CWA and CAA specifically address nanomaterials; and ensuring the success of EPA’s new voluntary NMSP given the failure of similar programs in the United Kingdom and Denmark.

Based on these concerns, SVTC calls for mandatory nanospecific regulations using the precautionary principle; protection of public and worker health and safety; comprehensive environmental protection; transparency for all EHS testing data; continuing research regarding the ethical, legal, and societal impacts of nanotechnology; full manufacturer liability for any injury; treating nanomaterials as “new materials” (rather than as “grandfathered in” under existing laws); subjecting nanomaterials to EPA’s new chemicals program; developing new environmental monitoring and remediation technologies; enacting California chemical policy reform with special provisions for emerging technologies; including nanomaterials in emergency planning and community right-to-know reporting requirements; and using EPA rule-making authority to ensure that regional water and air quality control agencies have adequate authority to regulate nanotechnology.

Finally, SVTC advises that if “companies are unresponsive to community requests for information, the next step is to approach local elected officials and request laws supporting community access to information about what chemicals are being used and the dangers posed by any accidental release into the environment." Further, SVTC recommends that if the surveyed companies do not have answers, or are unwilling to do the fundamental research to provide such answers, "they should not be allowed to operate in the community." To this end, SVTC’s proposed community survey covers the following topics:

• company information, including its name, location, contact person, phone number, and a description of any nano-related activities occurring at each facility;
• all chemicals and nanomaterials currently used at the facility;
• the precautions and cleanup plans the company has made, if any, to protect nearby communities from exposure to harmful substances;
• any empirical studies the company has conducted to determine whether there are any toxicological and epidemiological risks posed by its use of nanoscale materials;
• the company’s ability to detect and monitor nanomaterials, including those in the environment already and those which might be released by their facility;
• standards for permissible levels of exposure to chemicals and nanomaterials used at the facility; 
• performing a life-cycle assessment and creating an end-of-life management plan for all nano-products produced; and
• monitoring worker health at the facility.
  

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The U.S. Chamber of Commerce hosted a "Forum Discussion on EPA's Nanoscale Materials Stewardship Program" yesterday here in Washington, D.C.  The forum was co-sponsored by the NanoBusiness Alliance, American Chemistry Council, United States Council for International Businesses, and the Synthetic Organic Chemical Manufacturers Association.  The purpose of the forum was to reach out to nanomanufacturers and their trade organizations to encourage their participation in EPA's new voluntary NMSP.  Speakers included Tom Myers from the Chamber, Jim Gulliford from EPA, Bill Gulledge from the American Chemistry Council, Sean Murdock from the NanoBusiness Alliance, and Shaun Clancy from Evonik Degussa.  Mr. Gulliford did an excellent job explaining both the structure and importance of EPA's NMSP.  (Previously covered here).  He indicated that two companies have already made NMSP submissions: (i) DuPont and (ii) 2PI, and that ten others have provided letters of intent to participate: (i) BASF; (ii) Bayer; (iii) Dow; (iv) Evonik; (v) GE; (vi) Nanocyl; (vii) Nanophase; (viii) PPG; (ix) Sasol North America; and (x) Strem Chemical.  Arizona State University has also submitted a letter of intent.  Finally, Mr. Gulliford indicated EPA is pleased with the initial response to its NMSP and that the success of the program will be assessed on the quality and breadth of data submitted by participants, not simply the number of submissions filed.

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For those interested, Nanotechnology Law & Business just published my new article: "FDA Labeling of Cosmetics Containing Nanoscale Materials," Volume 5, Issue 1.

The article abstract follows: 

Numerous products are regulated by the U.S. Food & Drug Administration (the “FDA”) that contain nanoscale materials. As more products come to incorporate nanomaterials, the number of products correspondingly regulated will only increase. The FDA does not currently require labels stating that products incorporate nanomaterials. The position of the FDA not to require labels indicating that products contain nanomaterials has been controversial for some advocacy groups. In this article, John Monica examines existing cosmetic labeling requirements in the context of recent calls by advocacy groups for special labels for cosmetics containing nanoscale materials. Mr. Monica concludes that while the FDA has made a serious attempt to address cosmetic nano-labeling issues, a more rigorous analysis of some nano-labeling arguments is necessary.

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