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

My new Nanotechnology Law & Business article -- "An Industry Driven Approach to EHS Issues: 'The NanoSafety Consortium for Carbon'" -- can be found here.  The abstract follows.

The NanoSafety Consortium for Carbon (NCC) is an industry-driven group formed to proactively address potential environmental, health, safety, and regulatory concerns related to the commercia-lization of its members’ nanoscale carbon products. NCC was formed to take advantage of an offer by the EPA for a consortium of companies to providing testing regarding carbon nanotube toxicity. This article provides background on NCC’s activities, purpose, and goals.

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Congress returned to DC on Monday 11/15/2010 to begin a "lame duck" session . Congress, in particular the Senate, will find their agendas crowed with debate on several bills that need to be voted on before adjourning sine die sometime in December. Therefore, it seemed a good time to review the status of the bills that would affect the nanotech field.

H.R. 554, the "National Nanotechnology Initiative Amendments Act of 2009" was introduced by Rep. Bart Gordon on 01/15/2009 and was passed without amendment by the House on 02/11/2009. After being received in the Senate, H.R. 554 was assigned to the Senate Committee on Commerce, Science & Technology. It hasnot been reported out for debate by the full Senate.

H.R. 554, among various provisions, would have amended the reporting requirements of the 21st Century Nanotechnology Research and Development Act, directed the National Nanotechnology Coordination Office to create a publicly accessible database, created the National Nanotechnology Advisory Panel as a distinct entity with a subpanel that would consider the social, ethical, legal, environmental and workplace impact of nanotechnolgy, required the Director of the Office of Science and Technology Policy to designate an associate director of that office as the Coordinator for Societal Dimensions of Nanotechnology with various duties, and would have defined nanotechnology and nanoscale as

   NANOTECHNOLOGY- The term `nanotechnology' means the science and technology that will enable one to understand, measure, manipulate, and manufacture at the nanoscale, aimed at creating materials, devices, and systems with fundamentally new properties or functions.'; and

 

(B) by adding at the end the following new paragraph:

 

`(7) NANOSCALE- The term `nanoscale' means one or more dimensions of between approximately 1 and 100 nanometers.'.

 

H.R. 820, the "Nanotechnology Advancement and New Opportunities Act", was introduced by Rep. Michael Honda on 02/03/2009 and was referred to the House Committee on Science and Technology. Parts of the bill were also referred to the House Committees on Energy & Commerce, Ways and Means, and Homeland Security. H.R. 820 has not been reported out by any of these committees.

H.R. 820 would have had several significant impacts:

1) The Secretary of Commerce would have been directed to establish a "Nanomanufacturing Investment Program", using $100 million in private sector funds

2) Amended the Internal Revenue Code to allow tax credits for purchases of qualified nanotech developer stock and nanotech education and training programs

and 3) would have included commercial nanotech training providers as eligible educational institutions.

H.R. 2769 , the "Commercializing Small Business Research and Development Act", introduced by Rep, Bobby Bright on 06/09/2009, was referred to the House Committee on Small Business and the House Committee on Science and Technology. It was further referred to the Small Business Subcommittee on Contracting and Technology, which held a mark-up session on 06/11/2009. The Subcommittee forwarded the bill on to the full Committee. No further action has occured. H.R. 2769 would have included nanotechnology related topics within federal small business programs.

H.R. 4502 , the "Nanotechnology Education Act", introduced by Rep. David Wu on 01/26/2010, would require the Director of the National Science Foundation to establish a program to award grants to eligible secondary schools and colleges and informal educational centers

i) to acquire qualified nanotechnology equipment and software designed for teaching students about nanotechnology in the classroom;

 

(ii) to develop and provide educational services, including carrying out faculty development, to prepare students or faculty seeking a degree or certificate that is approved by the State, or a regional accrediting body recognized by the Secretary of Education; and

 

(iii) to provide teacher education and certification to individuals who seek to acquire or enhance technology skills in order to use nanotechnology in the classroom or instructional process.

 

H.R. 4502 was referred to the House Committee on Science and Technology and further referred to the Subcommittee on Research and Science Education. It has not been reported out of committee.

H.R. 5116, the "America COMPETES Reauthorization Act of 2010", was introduced by Rep. Bart Gordon on 04/22/2010, was perhaps the most important bill introduced in the 111th Congress (at least to the nanotech community) and produced unexpectedly contentious House debate, discussed on this site earlier this year. Title I, "The National Nanotechnology Initiatives Amendment Act of 2010", is a duplicate of HR 554, discussed above. H.R. 5116 was passed by the House on 05/28/2010. Received in the Senate, the bill was referred to the Senate Committee on Commerce, Science and Transportation. The Senate version of the America COMPETES Act, S. 3605, was introduced by Senator Jay Rockefeller on 07/15/2010 and was assigned to the Senate Committee on Commerce, Science and Transportation, which reported it favourably with an amendment in the nature of a substitute. The bill has not come up for debate by the full Senate. S. 3605 differs from H.R. 5116 by not having the "National Nanotechnology Initiatives Amendment Act" as part of its language. Should the bill come up for debate, it is possible that the Senate may add that language as a further amendment.

H.R. 5786, the "Safe Cosmetics Act of 2010", was introduced by Rep. Janice Schakowsky on 07/20/2010 and was referred to the House Committee on Energy and Commerce and the House Committee on Education and Labor. H.R. 5786 would affect nanotech by requiring

`(e) Labeling of Nanomaterials in Cosmetics- The Secretary may require that--

 

`(1) minerals and other particulate ingredients be labeled as `nano-scale' on a cosmetic ingredient label or list if not less than 1 dimension is 100 nanometers or smaller for not less than 1 percent of the ingredient particles in the cosmetic; and

 

`(2) other ingredients in a cosmetic be designated with scale-specific information on a cosmetic ingredient label or list if such ingredients possess scale-specific hazard properties.

 

H.R. 5786 remains in committee.

S. 596, the "Nanotechnology Innovation and Prize Competition Actr of 2009", was introduced by Senator Ron Wyden on 03/ 16/2009 and was referred to the Senate Committee on Commerce, Science and Transportation, where it remains. S. 596 would have directed the National Institutes of Standards and Technology to award cash prizes and/or public recognition to eligible persons for achievement in applying nanotechnology in four areas:

1) Improvement of the environment

2) Alternative Energy Sources

3) Improvement of Human Health

4) Development of Consumer Products

S. 1482, the "National Nanotechnology Initiatives Amendments Act of 2009", was introduced by Senator John Kerry on 07/21/2009 and subsequently referred to the Senate Committee on Commerce, Science and Transportation. S. 1482 would have directed the National Nanotechnology Program to involve the nanoindustry community to promote more rapid commercialization of nanotech reseach  and would have required the development of a

1) DATABASE-

 

`(A) IN GENERAL- The Director of the National Nanotechnology Coordination Office shall develop and maintain a searchable keyword database of all projects funded by the Nanoscale Science, Engineering, and Technology Subcommittee of the National Science and Technology Council.

 

`(B) DATABASE CONTENTS- The database required by subparagraph (A) shall include the following, with respect to each project in the database:

 

`(i) A description of the project.

 

`(ii) The source of funding of the project, set forth by agency.

 

`(iii) The funding history of the project.

 

Many of the provisions of S. 1482 are similiar to provisions in bills discussed above.

S. 2942, the "Nanotechnology Safety Act of 2010", introduced by Senator Mark Pryor on 01/21/2010 and referred to the Senate Committee on Health, Education, Labor and Pensions, would have required the Secretary of HHS to establish within the FDA a program to investigate the possible toxicity of nanoscale materials and such material's affect on and interaction with biological systems. The bill remains in committee.

S. 3117, the "Promote Nanotechnology in Schools Act", introduced by Senator Ron Wyden on 03/15/2010 and referred to the Senate Committee on Health, Education, Labor and Pensions, is essentially the Senate companion bill to H.R. 4502 discussed above. It too remains in committee.

Other House and Senate bills which focused on other subjests, have included sections relating to nanotechnology.

H.R. 2647, the "National Defense Authorization Act for FY 2010", introduced by Rep. Ike Skelton on 06/22/2010, was passed in the House and Senate and signed into law as P.L. 111-84; section 242 modified the reporting requirements for nanotech defense related research and development.

H.R. 2965 and S. 1233, "The SBIR/STTR Reauthorization Act of 2009", introduced by Rep. Jason Altmire on 06/19/2009 and Senator Mary Landrieu on 06/10/2009 respectively, would have reauthorized the Small Business Inovation Research and Small Business Technology Transfer programs. H.R. 2965 was passed by the House with amendments on 07/08/2009 and forwarded on to the Senate. The Senate further amended H.R. 2965 by substituting the language of S. 1233 as amended and passed in the Senate for the language of H.R. 2965, a procedure known as an amendment in the nature of a substitute. H.R. 2965 was returned to the Senate calendar for further action. Section 206 of the bill reads as follows:

SEC. 206. NANOTECHNOLOGY INITIATIVE.

 

(a) In General- Section 9 of the Small Business Act (15 U.S.C. 638), as amended by this Act, is amended by adding at the end the following:

 

`(ff) Nanotechnology Initiative- Each Federal agency participating in the SBIR or STTR program shall encourage the submission of applications for support of nanotechnology related projects to such program.'.

 

(b) Sunset- Effective October 1, 2014, subsection (ff) of the Small Business Act, as added by subsection (a) of this section, is repealed.

Two other bills that would potentially impact nanotechnology, H.R. 5820, the "Toxic Chemicals Safety Act of 2010", introduced by Rep. Bobby Rush on 07/22/2010 and referred to the House Committee on Energy and Commerce, and S. 3209, the "Safe Chemicals Act of 2010" introduced by Senator Frank Lautenberg and referred to the Senate Committee on Environment and Public Works", remain in committee. Both bills would amend the Toxic Substances Control Act.

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Monday's Federal Register carried a notice from the White House Office of Science and Technology Policy and the Nanoscience, Engineering and Technology Subcommittee of the National Science and Technology Council inviting the public to comment on the 2010 National Nanotechnology Initiative Strategic Plan.

The NNI Strategic Plan

 is the framework that underpins the nanotechnology work of the NNI
member agencies. It aims to ensure that advances in nanotechnology
research and development (R&D) and their applications to agency
missions and the broader national interest continue unabated in this
still-young field. Its purpose is to facilitate achievement of the NNI
vision by laying out targeted guidance for agency leaders, program
managers, and the research community regarding planning and
implementation of nanotechnology R&D investments and activities.
 

The NNI Strategic Plan represents the consensus of the
participating agencies as to the high-level goals and priorities of the
NNI and specific objectives for at least the next three years. It
describes the four overarching goals of the NNI, the major Program
Component Areas established in 2004 to broadly track the categories of
investments needed to ensure the success of the initiative, and the
near-term objectives that will be the concrete steps taken toward
collectively achieving the NNI vision and goals. Finally, the plan
describes collaborative interagency activities, including three
Nanotechnology Signature Initiatives that are a new model of
specifically targeted and closely coordinated interagency, cross-sector
collaboration designed to accelerate innovation in areas of national
priority.
 

The 2010 Strategic Plan is the result of reviews by the President's Council of Advisors on Science & Technology, the National Research Council, a stakeholders workshop held earlier in July 2010 and comments filed in response to a Federal Register notice published in the issue of July 6, 2010.

The four overarching goals of the NNI refered to above are

1) Advance a world class nanotechnology research and development program

2) Foster the transfer of new technologies into products for commercial and public (non-commercial) benefit

3) Develop and sustain educational resources, a skilled workforce, and the supporting infrastructure and tools to further advance nanotechnology

4) Support responsible development of nanotechnology

Each of these goals is further broken down into four objectives and in some case these objectives are further broken down, with a short paragraph describing the objective and how that objective is to be accomplished.

Other sections of the NNI Strategic Plan examine "The Path Forward", discussing future initiatives and activities, and "Program Component Areas", which includes a chart showing where each federal agency taking part in the NNI fits in.

Members of the public who want to file comments on the 2010 Draft NNI Strategic Plan are encouraged to register online at http://stategy.nano.gov. Comments should be only one page or less and should be filed by November 30, 2010. More details on filing comments may be found at the website.

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This article originally appeared on the National Nanomanufacturing Network's InterNano website. It is licensed under Creative Commons Attribution-NonCommercial-NoDerivs 3.0 Unported.

In its ongoing efforts to guard against potential unintended environmental, health, or safety injuries related to possible exposure to certain nanoscale materials, the US Environmental Protection Agency (EPA) plans to issue three new proposed nano-specific regulations in January 2011. While EPA is already actively regulating certain nanoscale materials which it considers new chemical substances (e.g./ carbon nanotubes, fullerenes, etc.), the new proposed rules will provide EPA with greater latitude in regulating both new and existing nanoscale materials. Manufacturers working with nanoscale materials should keep a very close eye on these new proposed regulations to determine whether they will be required to comply with any of EPA's final rulings. Additionally, there will be opportunities for public comment and input.

Significant New Use Rule

Advocacy groups have been asking EPA for years to treat nanoscale versions of existing chemical substances as significant new uses of those substances under the Toxic Substances Control Act (TSCA). These types of substances include nanoscale silver, nanoscale TiO2, and nanoscale zinc oxide. Among other things, treating these materials as significant new uses of existing chemical substances would allow EPA to limit their production, require the use of workplace safety measures, require companies to conduct toxicity testing, and require companies to prevent intentional/purposeful releases of the materials to water.

Although its exact parameters have not been released, it appears that EPA intends to issue a proposed significant new use rule under Section 5 of TSCA in January 2011 addressing these issues. While the contours of the rule are difficult to predict, a likely tactic may be to "grandfather in" nanoscale versions of existing chemical substances, but to treat any new attempts to manufacture or use nanoscale versions of existing chemical substances as significant new uses. While such an approach will likely to draw complaints from “newcomers” because companies already manufacturing in the niche would have a distinct competitive advantage, it might be the only workable approach available to EPA. It is virtually impossible to catalogue all existing uses of each nanoscale material already in the marketplace.

Testing Rule

While EPA is already requiring rigorous 90 day in vivo inhalation toxicity testing for certain new nanoscale materials, it appears that the Agency intends to propose a testing rule under Section 4 of TSCA in January 2011 requiring this same type of testing for certain nanoclays, nanoscale aluminum oxide, and nanotubes. Nanoclays and nanoscale aluminum oxide were apparently considered because no country volunteered to be lead sponsor for their testing under the Organization for Economic Cooperation and Development's comprehensive toxicity testing program. Additionally, no manufacturers have submitted premanufacturing notices for nanoclays un the U.S. which might otherwise provide EPA with the chance to require similar testing.

Conducting a 90 day in vivo inhalation test on a nanoscale material is difficult and can cost between $350,000 to $500,000 for each material tested. It will be interesting to see whether EPA’s proposed testing rule will allow for joint testing by manufacturers in order to reduce cost and increase efficiency. At least one group of manufacturers -- the NanoSafety Consortium for Carbon -- is already preparing to ask EPA to use this approach with their nanoscale carbon materials.

Data Collection Rule

Perhaps the broadest proposed rule EPA intends to issue in January 2011 will require manufacturers of nanoscale substances which have not already made formal detailed submissions to EPA to submit detailed EHS data for EPA’s review and consideration. The new proposed rule will be issued under Section 8(a) of TSCA, and will essentially make EPA's prior voluntary Nanoscale Materials Stewardship Program (NMSP) into a mandatory data collection effort. Readers may recall that the NMSP program received lukewarm industry participation, which is apparently resulting in the new mandatory approach.

Fortunately, the TSCA provision authorizing such data-call-ins allows manufacturers to apply to EPA for exemptions in instances where the subject nanoscale materials are only manufactured in small quantities (less than 500 kgs) or are being made solely for research and development purposes.

Finally, for those who might be interested, Section 8(a) of TSCA allows EPA to request information regarding:

• The common or trade name, the chemical identity, and the molecular structure of each chemical substance or mixture.
• The categories or proposed categories of use of each such substance or mixture.
• The total amount of each such substance and mixture manufactured or processed, reasonable estimates of the total amount to be manufactured or processed, the amount manufactured or processed for each of its categories of use, and reasonable estimates of the amount to be manufactured or processed for each of its categories of use or proposed categories of use.
• A description of the byproducts resulting from the manufacture, processing, use, or disposal of each such substance or mixture.
• All existing data concerning the environmental and health effects of such substance or mixture.
• The number of individuals exposed, and reasonable estimates of the number who will be exposed, to such substance or mixture in their places of employment and the duration of such exposure.
• The manner or method of its disposal, and in any subsequent report on such substance or mixture, any change in such manner or method.

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