Thursday, August 3, 2006

On Supplement to the President's FY 2007 budget - READ WHAT INTERESTS YOU

The National Nanotechnology Initiative: Research and Development Leading to a Revolution in Technology and Industry, Supplement to the President’s FY 2007 Budget, 2006.

This was a lot of work. I hope it clarifies a few things for my readers.

We’re in year 6 and 13 agencies (joining NSET this year were the USDA Forest Service, Dept. of Labor, Dept. of Education, and DOD’s Defense Threat Reduction Agency) are now involved.

Nanotechnology is a priority element of the American Competitiveness Initiative (to enhance manufacturing infrastructure as well) which calls for increased spending in the physical science, improved math and science education and training for a skilled workforce. Efforts toward technology transfer and commercialization involve SBIR and STTR funds and tables 7 and 8 (40) evidence some modest growth and the NNI is committed “to promote commercialization” (41) through these program. To bad we can’t get the ATP (Advanced Technology Program) up and running again as well.

The commercial orientation couldn’t be much clearer. Quote: “Acquiring best-in-the-world or state-of-the-art instrumentation for nanoscale imaging, measurements, and manipulation at university and Federal Government laboratories (21).”

The strategic plan in the budget request involves seven PCAs (program component areas). I want to observe that the 7th item in societal dimensions. Ordinal ranking is telling. Under PCA7 – $44m is slated for EHS and $38m for educational related activities and implications for society.

The tabular data at the end is interesting, esp. (39) the tables separating EHS from education and other societal issues. Both areas seem to be getting a modest increase.

It is heartening to see EHS and other societal interests separated so we can have a better sense of the commitments involved. It would be desirable to do the same between education and societal implications; they are not the same while there is some cross-over. If one of the goals of this request is to cultivate public trust (25) and another “acceptance of and knowledge about nanotechnology” (25), one begins to ponder how this is accomplished: education, you say?

For info on the NEHI roadmap check http://commdocs.house.gov/committees/science/hsy24464.000/hsy24464_0.HTM

Another priority includes “efforts to ensure that stakeholders who wish to participate in public debate and decision-making have access to relevant information and education” (25). First, many who wish to participate may not be able to do so and that may have nothing to do with access to information. It may have more to do with time and real opportunities (not intellectual ones). Second, who decides “relevant” information and education? The deficit model is dead, move on.

With all the programs and missions scattered across seven different areas, it is difficult to figure out what it anticipated so I reorganized it below highlighting what I thought was important.

THEMES

There is a clean interest in accelerating the transition of scientific discoveries into practical technologies (10) and research into self-assembly on many levels (18).

INTERESTS

Heavily highlighted technologies included medicine devices and systems to diagnose, prevent and treat disease, esp. cancer (11) as well as energy (see DOE).

NANO-GEEKS

Some fascinating areas FOR ME listed included: nanobarcodes (12) and personal sampling devices of airborne nanoparticles exposure (14).

I am looking forward to material coming out of the Global Issues in Nanotechnology (GIN) informal working group (31) and the National Academies’ evaluation of the NNI to be released in 2006 (iii).

BY AGENCY

DHS is primarily interested in sensor technologies (12). Other areas include: fire resistant construction materials (7) and surfaces to deactivate biological agents and decompose hazardous chemicals (7).

DOC (NIST) wants to improve information dissemination to the business community (4), advance tools, two of which are AFAM [atomic force acoustic microscopy) and variable pressure SEM (17), and new dimensional test standards (19), intrinsic calibration systems (19), and nano-manipulation of soft materials (19), and fabrication platforms for testing functionality (20). They seem intent to increase channel for public comment, etc. (30) which might mean we need a functional “public” clearinghouse. While the NSF is committed to developing an online clearinghouse (32), it needs to be a public clearinghouse and not a web-based library.

DOD has made it clean that its investment is to enhance war-fighter and battle systems capabilities (13) and wants to find ways to guide and monitor the process (20). For more, visit https://www.dodmantech.com/. They reference chemical and biological agent scavengers, taggants, and sensors (4), advance solid state power generation, cooling, and thermal management (4, 13), radiation-hard RAM (11), and the use of viruses as templates for nanowires (20).

DOE repeatedly references hydrogen production and storage (4, 7, 9, 11) and solar energy conversion (4, 9, 11) in addition to solid-state lighting (11) and low cost fuel cells (11, 12), lab on a chip systems (14), fossil fuel advances (14). In terms of technologies, the development of transmissions electron aberration-corrected microscopy (TEAM) is on their list (17).

DOS – for some classic bureaucratese, see column 2, p. 30).

EPA ”is developing a voluntary pilot program for reporting of nanomaterials manufacturing under TSCA” (30-31). It also wants to fingerprint characteristics, esp. layer, separation distance, curvature and tortuosity starting with C60 fullerenes (5). It is interested in energy-efficient recovery of biofuels (14), nanoporous filters to remove gaseous pollutants and particulates from air streams (14), reactive coating to destroy or immobilize toxic compounds (20), and all things for greener manufacturing, like solvent free production (20).

FDA
continues to approve devices (iv) and wants to maintain a viable web presence (13).

NASA seems interested in mission special remove sensing (14).

NIOSH seems seriously occupied with exposure instrumentation and methodologies (17) and working on its strategic plan (29). In addition, it is committed to releasing its Nanotechnology Field Teams to begin field studies on occupational health and safety practices (29).

NIH/NCI (DHHS) seems fixed on its Roadmap Initiative (for more see http://nihroadmap.nih.gov/) and its Development Centers (3) and to accelerate transition of basic nanoscale particles and devices to clinical applications (16). And NCI seems intent on making additional awards (29).

It intends to expand NTP (National Toxicology Program) studies on skin uptake, inhalation, and oral routes of exposure (28) esp. for multifunctional engineered nanoscale materials, like dendrimers, liposomes, quantum dots, metals, and carbon-based nanoparticles. There is also interest in immunotoxicity and phototoxicity results (28).

I was puzzled a bit by the following statement. “The time requires to characterize nanomaterials from receipt through the in vivo phase is anticipated to be one year (28).” I am trying to verify this.

Special technologies included: body-friendly implantable materials (7), smart multifunctional particles (7), and cancer therapies (15).

NSF remains committed to its centers of excellence and NSEC system (24). In terms of societal dimensions it repeats its mission of “analyzing, identifying, and quantifying” (32) though I am not sure we are ready to quantify what we have learned so far with any level of confidence.

Presumably, NISE (Nanoscale Informal Science Network) will “conduct a comprehensive review of academic studies, evaluation reports, educational research literature, and public opinion research from the past decade about public understanding of nanotechnology” (32). I guess I should have applied for a grant!

Some of the areas of pre-occupation with the NSF were: quantum computing (5), biosystem exploitation (cellular organelles and biomolecular motors (5), biocompatible structures for implantation (5), and miniature sensors for diagnostics (5),

USDA wants to advance food safety and biosecurity, esp. tracking product identity (6), and nutrition enhancement (15)

USDA – Forest Service wants to capture value in wood-based lignocellulosic materials (6) and wood-plastic composites and engineered biocomposites (10).

Tuesday, August 1, 2006

On ABA Environment, Energy, and Resources Reports - EPA Regulation - MIXED RECOMMENDATIONS

American Bar Aassociation, section of Environment, Energy, and Resources Reports - http://www.abanet.org/environ/nanotech/

As I am writing a web-pased adjunct to a composite publication and a White Paper on regulation for the International Council on Nanotechnology, I found the report interesting and useful. If you are as much as a nano-geek as I am, you will as well.

Before you spend a lot of time reading about regulatory options for the EPA, I recommend you skim the EPA, Nanotechnology White Paper, December 2, 2005 http://www.epa.gov/osa/nanotech.htm/. It remains one of the most useful document on the environmental implications of nanoparticles.

The seven paper ABA SEER report functions on many different levels. For some, it will be very depthful in its analysis of EPA regulatory options. For others, it can be skimmed and perused as a backgrounder. Still for others, it serves as a index of regulation and a research guide.

In general, these reports are useful though I would have liked some discussion on the Pollution Prevention Act of 1990 and the Safe Drinking Water Act of 1996 as two potential regulatory statutes which might apply to nanomaterials.

One of the factors that led me to recommend the first four of the papers indicated below is the subject matter of the papers themselves. Undoubtedly, the first deals with some innovative regulatory approaches toward environmental accountability wherefore the regulation is tailored to the specific industry and its waste streams. The second, third, and fourth cover three laws which are most likely to be directly involved in the regulatory process as it involves nanoparticles. As such, the subject matter seems to be most relevant variable in assigning recommendations. Finally, Hester is a colleague of mine and in fairness that needed to be said.

G. Curran et al, EMS/Innovative Regulatory Approaches, June 2006 - RECOMMENDED.

Read this paper to understand the philosophy of this project and to get a general introduction to alternatives to command and control methods of regulation.

This paper argues the regulatory approach should be innovative and suggests corporate stewardship, voluntary programs, performance based standard, tailored monitoring and reporting, and public education and dialogue. In justifying this approach, the authors indicate concerns with the speed of development, competition, limited government resources, problems associated with new legislation, scientific uncertainty, special risks, monitoring challenges, and public confidence.

p. 5 – Authors mention relevant stakeholder dialogues and it concerns me who decides what dialogues are relevant.

The authors mention the Environmental Defense-DuPont Responsible Standards Initiative about which we will hear more in a later blog.

p. 6 – Authors mention a standard nanotechnology management system as a key to providing accountability and transparency to voluntary management though I wish this was detailed.

Under LEADERSHIP INCENTIVES, (p. 6) the authors mention incentives for participating in a voluntary program would include (a) public recognition, (b) improve working relations with government agencies, (c) penalty avoidance through auditing and self-reporting. It will be interesting to see exactly how the Stewardship Program under consideration at the EPA is able to tap into the motivations underlying both (b) and (c).

Not to mislead the reader to believe a voluntary approach is a cure-all, the authors (p.6) mention three criticisms of the voluntary approach: (a) diverting resources away from strengthening inspection and enforcement, (b) focus away from priority environmental problems, and (c) phantom participation despite a poor performance record.

On p. 7 we get the troublesome phrase, “and other relevant stakeholders” and it is repeated twice on the next page. Both these occurrences send me into recoils as I try to determine who are irrelevant and again who makes that determination.

On the same page, the authors suggest liability may be a powerful motivator.

On p. 9 two flexible regulatory models are reviewed but their application to nanotechnology is left hanging.

On p. 10, the authors argue for voluntary first and mandatory and enforceable regulations later, a position wholly consistent with my upcoming liability regulation article (see December NLBJ).

There is a brief discussion of confidentiality issues and public disclosure that is interesting (p. 11). A call for science-law judges (p. 12) which needs more contemplate if we are to take the recommendation seriously.

On the same page they call for a risk assessment model for sharing information with insurers and federally funded liability insurance (both of which are covered in my forthcoming article).

EFNT stands for environmentally friendly nanotechnology or Green Nano (see earlier blog) and it is barked in detail (pp. 12-13) and I am sure we will hear much more about this soon as remediative technologies involving nanotechnology receive more experimentation. For example, there is a zero valent iron pilot study to remove the pesticide Mirex at an EPA Region 5 National Priorities List site in Ohio (p. 14 EPA White Paper and http://www.epa.gov/region5/sites/index.htm#nease).

There is a brief discussion on international cooperation and expanded public education and this is the weakest part of the paper.

Finally, they use Mandel’s system approach to the last few pages and demonstrate a very rudimentary understanding of risk communication. However, since that is what I do I will shy away from any more criticism.

J. Chen et al, The Adequacy of FIFRA to Regulate Nanotechnology-Based Pesticides, May 2006 - HIGHLY RECOMMENDED.

My rationale here is simple. FIFRA has many instrumentalities in the law that might be highly applicable to a regulatory model beyond the subject class of pesticides and the authors offer a thoughtful interpretation. Concluding the EPA has sufficient authority to regulate nano-pesticides, the authors correctly note that the most powerful regulatory weapon the EPA has is the registration requirement in FIFRA.

FIFRA (p. 5) can require generation of data and risk assessments to secure registration. It empowers the EPA to prohibit use if determined to present an unreasonable adverse effects or even condition the use, post-registration testing can be required, re-registration is also required…. The tools the EPA has under FIFRA are impressive.

The authors add a set of recommendations (p. 6) including whether new registrations are needed under current requirements, a reconsideration of exemptions, and the identification of an appropriate data set.

Some of the exemptions which are problematic are detailed (p. 7). For example, they tag certain types of R&D activities, such as tests conducted in labs or greenhouses and replicated field trials or other tests to assess efficacy, toxicity, and other properties. Other exemptions follow (pp. 8-9).

The extensive registration procedures seem to evade the new versus existing conundrum associated with TSCA. There is a good coverage of data requirements (pp. 12-13) worth reading as well. While it is unlikely the FIFRA process will develop into a broader regulatory regime for nanotechnology per se, it is a good place to start.

C. Bell et al, Regulation of Nanoscale Materials under the Toxics Substances Control Act, June 2006 - RECOMMENDED.

The authors here cover much traveled territory. TSCA is the focal point for the debate over new vs. existing. Simply put, nanoize a chemical and it becomes a new chemical or not? TSCA requires premanufacture notification and has a list of exemptions for experimental uses, small volumes, etc. TSCA also can regulate nanomaterials under significant new uses rules (SNUR) (pp. 13-15). The hitch is that the “new uses” window of opportunity is closing quickly (p. 17). “…[T]o the extent that nanoscale versions of some chemical substances are already being distributed in commerce for certain uses, it may be difficult for EPA to make the requisite determination that those uses are new.”

The end of the paper is particularly interesting as other sections of TSCA are reviewed in terms of regulating nanotechnology.

T. Hester et al, RCRA (Resource Conservation and Recovery Act) Regulation of Wastes from the Production, Use, and Disposal on Nanomaterials, June 2006 - RECOMMENDED.

This paper addresses the waste issue and attempts to balance the remediation potential against the pollution implications involved with disposal. After demonstrating nanomaterials would need the definition of hazardous wastes under RCRA (p. 4), the authors conclude EPA has sufficient power to regulate nanomaterials under RCRA.

The paper highlights some areas of interests. “…[I]ssues related to recycling of nanomaterials in manufacturing and consumer products have received comparable less attention” (p. 7). The authors warn that a failure to consider comparative environmental benefits “may discourage efforts to harness nanotechnology for green chemistry or other environmentally beneficial uses” (p. 10). The authors also examine exemptions categories (pp. 11-12) before considering the failure of current research to validate “…the efficacy of incineration or combustion as a control strategy” (p. 14).

These observations were worth mulling over.

M. Terned, ABA SEER CAA (Clean Air Act) Nanotechnology Briefing Paper, June 2006 - NOT RECOMMENDED.

While the paper suggests monitoring concerns, a much stronger analysis of this can be found in the EPA White Paper esp. Appendix C2. In general, the relevance of the Clean Air Act remains unclear. We are talking here about byproducts escaping as air pollutant emissions and that modality is highly speculative though we probable need a better understanding of the waste stream of nanoproducts (p. 13). There is an interesting discussion over scrubber and filtration technologies (pp. 14-15) and a equally fascinating one over the HAPs and how nanomaterials may find themselves regulated there (p. 17).

Finally, much like the White Paper, this paper casts some aspersions of Oxonica’s use of cerium oxide as a fuel additive.

C. McCormack, CERCLA (Comprehensive Environmental Response, Compensation and Liability Act) Nanotechnology Issues, June 2006 - NOT RECOMMENDED.

Most of the issues here are covered above (see RCRA). There is simply too much speculation needed to consider serious regulatory potential here.

P. Barker et al, Nanotechnology Briefing Paper Clean Water Act, June 2006 - NOT RECOMMENDED.

When I read the White Paper, I was interested in application of the Safe Drinking Water Act. I wished this paper had gone there to study regulatory potentials associated with water quality regulation. The linkage to effluent release seems a bit problematical for this paper. While I appreciate the discussion over best management practices (p. 10) and the supposition of medical waste as a potential regulatory locus (p. 12), there is simply not enough here.