Nanotechnology Law Report : 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

According to the House Science and Technology Committee: "H.R. 554 requires that the NNI agencies develop a plan for the environmental and safety research component of the program that includes explicit near-term and long-term goals, specifies the funding required to reach those goals, identifies the role of each participating agency and includes a roadmap for implementation.
... H.R. 554 also includes provisions aimed at capturing the economic benefits of nanotechnology. In 2007, $60 billion in nano-enabled products were sold; and it is predicted that the number will rise to $2.6 trillion by 2014. To encourage commercialization in the U.S.—and the corresponding economic benefit—the bill strengthens public-private partnerships by encouraging the creation of industry liaison groups to foster technology transfer and to help guide the NNI research agenda. The bill also promotes the use of nanotechnology research facilities to assist companies in the development of prototypes."

Recall that we've been down this road once before.  In the 110th House also passed the identical reauthorization language, H.R. 5490, only to have it expire at the end of the Senate's term last year.  Hopefully the Senate takes up its version of the bill more quickly this time, and completes the reauthorization process.  The companion bill has not been introduced in the Senate as yet.

It turns out, the NNI re-authorization bill on the Senate side, S.3274, is getting bogged down and is in danger of not passing before the end of the term later this year.  This bill has been slow to be introduced (as in yesterday), and the Commerce, Science, and Transportation Committee may not get to consider it until next week at the earliest.

Some environmentalists are seeing this as an opportunity to try and get the 10% funding increase for EHS research back into the bill, but attempting such an effort may endanger its passage by the full Senate, which is needed to keep the NNI going.  If the full Senate doesn't pass the bill before the end of the session, the whole process will have to be restarted and approved by both chambers.  Given that a markup hasn't happened yet, passage by the end of this Congress is already looking to be tight on the calendar.  We'll have to keep an eye on the progress to see what happens between now and the end of the year. 

On June 5, the House, by a 407-6 vote, passed H.R. 5490: National Nanotechnology Initiative Amendments Act of 2008.  The bill now heads to the Senate for its consideration and vote

As reported earlier in the Committee Stage, "H.R. 5940, does not substantially alter NNI, but makes adjustments to some of the priorities of the program and strengthens one of the core components – environmental and safety research."  There was 40 minutes of debate on the House floor, upon which the motion was called for and passed by a wide margin.

My only question is: Why did the 6 Congressmen and women who voted against it, vote against it?  Unfortunately the Congressional Record for this debate is not yet available.  If you're curious who those people are, the roll-call vote is here.

Key points from the $1.5 billion NNI budget include:

• increased support for research on fundamental nanoscale phenomena and processes, from $481 million in 2007 to $551 million in 2009.
• substantial ongoing growth in funding for instrumentation research, metrology and standards (from $53 million in 2007 to $82 million in 2009) and in nanomanufacturing research (from $48 million in 2007 to $62 million in 2009).
• Environmental, Health, and Safety (EHS) R&D funding in 2009 ($76 million) is more than double the level of actual funding in 2005 ($35 million) - the first year this data was collected.
• The steady growth in EHS R&D spending follows the NNI strategy of expanding the capacity to do high-quality research in this field.

Similarly, EPA's budget also provides funding for nano research and development, and in fact addresses nano in the context of the Resource Conservation Recovery Act (RCRA): "the primary objective is to determine the physicochemical properties controlling the movement of nanomaterials through soil and aquatic ecosystems. Research questions include the identification of system parameters that alter the surface characteristics of nanomaterials through aggregation (e.g. pH effects), complexation (e.g., surface complexation by dissolved organic carbon) or changes in oxidation state (e.g., chemical- or biological-mediated electron transfer)." 

EPA's total budget is $7.1 billion for fiscal year 2009, and nano-specific funding comes in at $14.9 million (or 0.21% of the total budget).  The funding is part of EPA Goal 4 of 5, "Communities and Ecosystems."

The fact that nanotechnology research funding is increasing is an encouraging sign, however, I'm concerned at the length of time it will take to complete the learning curve given the proportionally small amounts of federal investment into this increasingly important area.

What makes this direction curious, included in the 2008 omnibus appropriations bill signed into law in late December, is that is appears on its face to repeat work being conducted by both EPA and the National Nanotechnology Initiative (NNI).  Congress appropriated EPA $1.9 million to contract with NAS to "develop and monitor implementation of a comprehensive, prioritized research roadmap for all federal agencies on environmental, health, and safety issues for nanotechnology."  Congress would like the contract in place by the end of March.

However, the NNI released its general strategic plan on December 31, in which it provides the broad goals and priorities of the multi-agency conglomerate.  Additionally, a second strategic plan is expected from NNI by the end of January that focuses on specifically on health and safety research.  Then, sometime in March, EPA is expected to release its nanotechnology priorities as they relate to health and environmental issues.

Finally, the NAS study was called for by a coalition of industry, trade groups, and nonprofit organizations, including the American Chemistry Council, DuPont, Environmental Defense, Dow, and the Natural Resources Defense Council.  While successfully lobbying Congress for EPA's marching orders, one unnamed coalition member defended the call for NAS involvement by saying that the NNI's work is not as "robust as what we would expect from NAS." 

This last statement may be the most telling--its not exactly a ringing endorsement of NNI's work or efforts.  Clearly the various stakeholders are unhappy with the efforts and answers being provided by NNI and EPA, or they would not have gone directly to Congress for what will be the fourth study released on strategic research priorities since December 31, 2007.  My read is that the stakeholders are getting anxious for direction from federal regulators as the continuing development of nanotechnology in the absence of information is becoming unnerving to them.  And rightfully so.  I'm concerned, however, that NNI was pushed closer to the brink of irrelevance because of the vote of no confidence from the coalition.  Between that, and the duplicative work seemingly being undertaken by no less than three organizations, I'm curious to see where we'll be when the dust all settles.  I hope the four reports do not conflict with each other, thereby adding fuel to the uncertainty fire.

The primary complaint of stakeholders is the speed at which NNI is developing its risk research priorities.  Many complain that the process is taking too long to accomplish while nanotechnology development moves further ahead.  Other comments on the program include the lack of authority over NNI member agency to dictate action, and an observation by Nanotechnology Law Report commenter Dr. Kristen Kulinowski, director of the International Council on Nanotechnology, that government could lean more heavily on non-governmental resources, including industry and research universities, for information.

The speed at which NNI is developing its risk framework is a ponderous given the concerns raised about the potential hazards or risks associated with free nanoparticles in the environment.  And the fact that the concerns over NNI's actions are being voiced by all facets of the nanotechnology community only adds to the confusion.  And, this is not the first time NNI has been questioned in this regard.  Co-author John Monica reported on prior criticism of NNI's work here, and I posted thoughts even earlier here.  Consequently, NNI's deliberate actions cannot be wholly denied.  However, we must keep in mind that NNI is undertaking a huge project in an extremely complex intersection of science, policy, and regulation.  Further NNI is tasked with overseeing the work of 26 federal agencies, none of which it has complete authority over.  Deliberate action is certainly understandable, however, at what point does the deliberateness transform into foot-dragging?  After all, this will be NNI's third appearance in front of Congress.