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

A National Nanotechnology Innovation Summit to mark the 10th anniversary of the National Nanotechnology Initiative (NNI) will be held December 8-10, 2010 at the Gaylord National Hotel & Convention Center in National Harbor, MD. The Nano Science and Technology Institute (NTSI) will join with the White House Office of Science & Technology (OSTP), the Nanotechnology Coordination Office (NNCO) and the National Venture Capital Association (NCVA) to organize the event. Launched in 2001, the NNI is a federal program which serves as the coordinating body for 25 federal agencies which conduct nanotechnology research and development. The Summit will be a forum for the nation’s top nanotechnology researchers, investors, policy makers, and developers to join in recognition of the NNI’s efforts in the field over the past ten years. More information and registration details are available at: http://www.nsti.org/events/NNI  

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Following California's lead, Wisconsin's legislature recently formed a special committee to study the potential regulation of nanomaterials from an environmental, health, and safety perspective.   Our readers will be interested in the committee's membership and focus:

Special Committee on Nanotechnology
Chair: Rep. Chuck Benedict
Vice Chair: Sen. Mark Miller
Legislative Council Staff: Mary Matthias, Pam Shannon, and Larry Konopacki
Member List

The Special Committee is directed to examine the human health and environmental concerns related to the manufacture, use, and disposal of nanomaterials and develop legislation to address these concerns. In particular, the Special Committee shall consider the establishment of methods to monitor nanomaterials by use of a nanotechnology registry system or the imposition of other disclosure requirements. The Special Committee shall also develop strategies to facilitate the development of nanotechnology to create and retain jobs in Wisconsin, including ways in which government can help nanotechnology researchers, small firms, and start-ups address potential risks and meet regulatory requirements.
 

You can find prior articles about Wisconsin's prior efforts here and here.  The committee's first meeting appears to be scheduled for September 2010.

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Here is a bit of shameless self-promotion.  The 2010 edition of my book -- "Nanotechnology Law" -- has just been published by West/Thomson/Reuters.  You can find it here.  Please pass the word.

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Rep. Janice Schakowsky, with Reps. Ed Markey and Tammy Baldwin among the co-sponsors, introduced H.R. 5786, the "Safe Cosmetics Act of 2010" on 07/20/2010. The act would amend Chapter VI of the Federal Food, Drug & Cosmetic Act by adding new language regarding the marketing, labelling, testing and regulation of cosmetic manufacturers, packagers and distributors.

Two sections of the bill would affect the use of nanotechnology and nanoparticles in cosmetics:

`SEC. 614. COSMETIC AND INGREDIENT TESTING AND SAFETY.

`(d) Nanomaterials in Cosmetics- The Secretary shall--

 

`(1) monitor developments in the scientific understanding of any adverse health effects related to the use of nanotechnology in the formulation of cosmetics; and

 

`(2) consider scale specific hazard properties of ingredients when conducting or reviewing safety substantiation of cosmetic ingredients.

 

SEC. 618. COSMETIC AND INGREDIENT STATEMENTS.

`(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.

Other sections of the bill would require:

Domestic manufacturers, packagers and distributors and foreign manufacturers, packagers and distributors who export to the United States to register annually with the Secretary of Health and Human Services (HHS); registration would include information about locations of facilities and trade names, numbers of employees at each location, gross receipts of sales and names and addresses of materials suppliers

Labels on each package of cosmetics would need to name each ingredient in descending order of dominance in the cosmetic. Internet vendors would need to post this information on their websites.

Within one year of the bill's enactment into law

manufacturers and distributors of cosmetics and ingredients shall submit to the Secretary (in an electronic format that the Secretary shall determine) all reasonably available information in the possession or control of the manufacturer or distributor that has not previously been submitted to the Secretary regarding the physical, chemical, and toxicological properties of single or multiple chemicals listed on the cosmetic labels under section 613, including--

 

`(i) functions and uses;

 

`(ii) exposure and fate information;

 

`(iii) tests of finished cosmetics; and

 

`(iv) any other information used to substantiate the safety of such cosmetics or ingredients.

 

The Secretary would, not later than 1 year following enactment, create a publicly accessible database of non-confidential information submitted by manufacturers and distributors.

Within two years of enactment, the Secretary would publish and periodically update lists of prohibited, restricted and safe ingredients

Manufacturers, packagers and distributors would be required to submit reports "containing information received concerning any serious adverse event associated with the use of the cosmetic". These reports would be available to the public via the HHS website.

Other provisions would require to the Secretary of Labor to

promulgate an occupational safety and health standard under section 6 of the Occupational Safety and Health Act of 1970 (29 U.S.C. 655) that requires the following:

 

(1) MANUFACTURERS AND IMPORTERS-

 

(A) IN GENERAL- Each manufacturer or importer selling any cosmetic for professional use shall--

 

(i) obtain or develop an expanded material safety data sheet described in subsection (b) for each such cosmetic or personal care product that--

 

(I) the manufacturer or importer produces or imports; and

 

(II) includes a hazardous chemical, or product ingredient associated with any chemical hazard, that has been indicated by authoritative bodies or scientific studies to be linked to health hazards including mutation, reproductive or developmental toxicity, neurotoxicity, endocrine disruption, asthma, or other immunological toxicity; and

 

(ii) make the expanded material safety data sheet available to distributors and employers, including salon owners, in English and, upon request, in other languages, including Spanish and Vietnamese.

 

(B) PROFESSIONAL USE DEFINED- In this paragraph, the term `professional use' has the meaning given such term in section 611 of the Federal Food, Drug, and Cosmetic Act.

 

(2) DISTRIBUTORS- Each distributor of a cosmetic or personal care product for professional use shall distribute and provide expanded material safety data sheets described in subsection (b) in the same manner as a distributor of a chemical hazard is required to distribute and provide material safety data sheets under section 1910.1200(g) of title 29, Code of Federal Regulations, or any successor regulations.

 

(3) EMPLOYERS- Each employer, including any operator of a salon, shall--

 

(A) have an expanded material safety data sheet in the workplace for each cosmetic or personal care product for professional use that is used in the course of the employer's business;

 

(B) make such expanded material safety data sheet available to all employees of the employer who are exposed or use the product to the same extent and in the same manner as material safety data sheets are required to be made available under section 1910.1200(g) of title 29, Code of Federal Regulations, or any successor regulations; and

 

(C) upon request, provide employees with translations of such expanded material safety data sheet in other languages, including Spanish and Vietnamese.

 

(b) Contents of Expanded Material Safety Data Sheet- An expanded material safety data sheet for a cosmetic or personal care product for professional use described in this section shall--

 

(1) contain the information required in a material safety data sheet under section 1910.1200(g) of title 29, Code of Federal Regulations, or any successor regulations, for each hazardous chemical, or product ingredient associated with any chemical hazard, described in subsection (a)(1)(A)(i)(II); and

 

(2) include the following statement: `This expanded material safety data sheet is also available in multiple languages by contacting the manufacturer, using the contact information provided on this sheet.'.

 

H.R. 5786 has been referred to the House Committee on Energy and Commerce and the House Committee on Education and Labor.

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The Senate Committee on Commerce, Science and Transportation, on July 22, favorably reported S. 3605, the Senate version of the America COMPETES Reauthorization Act of 2010, sending it on the the full Senate for debate.

The text of the bill as reported is not yet available from THOMAS, however the text of the bill as introduced by Senator Jay Rockefeller of West Virginia on July 15, 2010, does show differences from H.R. 5116, the version passed in the House. The Senate version contains no provisions concerning the National Nanotechnology Initiative (NNI) or any other nanotechnology related provisions. It is possible that during debate, the bill may be amended to include provisions for NNI. It is also possible that, during debate, the language of H.R. 5116 may be substituted for the language of S. 3605, in the form of an amendment in the nature of a substitute. The Senate may also substitute the language of S. 3605 for that of H.R. 5116 and pass an amended version of H.R. 5116. Should that happen, the bill would be sent back to the House for its concurrence to the Senate amendment. Should the House vote not to concur, a conference committee would be established to produce a version that both the House and Senate could agree on.

Time is a factor in the passage of the bills. Congress will soon adjourn for the August recess and is expected to remain adjourned until after the November elections.

As with other House and Senate bills affecting nanotechnology, we will monitor and report the progress of S. 3605.

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Porter Wright attorney John Monica was quoted in a recent article discussing progress and obstacles in the field of nanotechnology. The article is available at http://pubs.acs.org/cen/coverstory/88/8829cover.html.

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On July 20, 2010, David Hwang of Lux Research gave a webinar entitled: "Lux Research Nanomaterials: The Rise of MWNTs: Oversupply Hides Real Opportunities."

Mr. Hwang’s presentation identified the top global producers of multi-walled carbon nanotubes (MWCNTs), explained why commercialization over the past 25 years has been relatively "anemic," and made some predictions for where the market is heading in the next decade. He explained that while total sales of MWCNTs were under $100 million for 2008, the market is predicted to grow to approximately 2389 tons by 2020.

Two major forces slowing past commercialization included (i) a "you first" mentality by which companies wanted to see others take the first successful steps towards commercialization before they joined the trend, and (ii) regulatory risks inherent in the development of any new technology -- a commercialization bottleneck related to the potential environmental, health, and safety (EHS) impacts of certain carbon nanotubes.  (Regular readers will note that this is a recurring theme in our articles).

Mr. Hwang further explained that he believes the market for MWCNTs is currently in a transition phase, and that an oversupply will exist until 2017.  He commented that total sales in 2009 equaled $75 million and would increase to $513 million by 2020.   Mr. Hwang then covered four specific markets that are leading the commercialization for MWCNTs and provided 2009 versus 2020 material usage estimates:

Mr. Hwang closed with some further trends he saw forthcoming in the next decade which included market consolidation and a shakeout of smaller manufacturers, as well as a "crackdown" through EHS regulation of MWCNTs over the next two years.  Regarding the later point, he indicated that companies which proactively addressed EHS issues would have a competitive advantage over the long run.

You can find a link to the webinar here. 

http://bit.ly/dcrrHD.

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Public comments regarding California's Green Chemistry Draft Regulation for Safer Consumer Products were due last week.  My comment /letter on the nanotechnology provisions contained in the draft regulation is set forth below.  Additionally, you can find a copy of the draft regulation here.

July 15, 2010

Heather Jones, MS 22A
California Department of Toxic Substances Control
Office of Legislation & Regulatory Policy
P.O Box 806
Sacramento, CA 95812
Re: Comments regarding draft regulation: Safer Consumer Product Alternatives, Chapter 53 of Division 4.5 of Title 22, California Code of Regulations

Dear Ms. Jones:

Please accept this letter as my personal comments regarding the nanotechnology-related provisions of the above-referenced draft regulation. Many thanks in advance for your consideration of my brief thoughts.

As a general matter, I believe chemical regulations should be drafted to provide the State with all of the power it needs to effectively do its job without unfairly maligning any chemical substance, either directly or by implication. It is a delicate balance that this draft regulation obviously attempts to achieve. I hope that my specific comments further assist in this regard.

Definition of “Chemical:” I do not believe that Part 3 of the definition of “Chemical” on Page 5 of the draft regulation is necessary. As you know, that provision provides an alternative definition of “Chemical” as: “Materials or substances manufactured or engineered at the nanoscale, which contains nanostructures, or is considered to be a nanomaterial.” Simply put, the first two parts of the definition of “Chemical” in their current form are more than broad enough to capture all nanoscale chemical substances. There is no need to single them out in a separate provision. Doing so implies some type of special skepticism or worry which is not necessary to accomplish the purpose or objectives of the draft regulation.

Definition of “Importer:” The definition of “Importer” on Page 7 of the draft regulation should contain a phrase acknowledging that “Importers” are entities physically located or operating in California. Businesses located outside of the State which ship products into the State are covered by the definition of “Make available for use in California” on Page 8. This distinction is important because some out-of-state manufacturers/distributors of carbon nanotubes were considered “importers” under the CDTSC’s January 2009 carbon nanotube data call-in. This issue should be remedied in the proposed regulation.

Definitions of “Nanomaterial,” “Nanoscale,” and “Nanostructure”: The definitions of these three terms on Page 8 of the draft regulation are only necessary if Part 3 of the definition of “Chemical” on Page 5 is retained. Consistent with my above recommendation, I respectfully suggest that they be eliminated along with Part 3 of the definition of “Chemical” which incorporates them by reference. However, in the event these terms are retained, the State should strongly consider changing the definition of “Nanoscale” to follow commonly accepted definitions used throughout the world which rely on a size range of 1 to 100 nanometers. Any deviation from this traditional definition should be thoroughly explained and justified by the State.

If the State is concerned that some companies might claim they are exempt from the regulation because the materials they manufacture are larger than 100 nm and thus are not truly “nanoscale,” the definitions of “Chemical” provided in Parts 1 and 2 on Page 5 are still broad enough to capture these companies’ materials. Additionally, the term “approximately” could be inserted in the definition of “Nanoscale” which would provide CDTSC the latitude it needs to review companies seeking to invoke any arbitrary size limitation. Further, the definitions of “Nanomaterial” and “Nanostructure” on Page 8 of the draft regulation could be amended to include materials made or sold by any company representing that it or its products are “nano,” or nanoenabled, etc. This would further prevent undue reliance on a technical size limitation.

Finally, the terms “nanomaterial,” “nanoscale,” and “nanostructure” are currently the subject of draft technical specifications being prepared by the International Organization for Standardization (ISO) which has 163 country participants. If technical definitions are included in California’s regulation, I believe ISO’s definitions are the best place to start. I am sure that ISO would be happy to provide the State with current drafts of the relevant technical specifications upon request.
Thank you again for taking the time to consider my thoughts. I would be happy to discuss the draft regulation with you or anyone else at any time.

Very truly yours,

John C. Monica, Jr.
JCM:alm
 

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This article originally appeared on the National Nanomanufacturing Network's InterNano website on July 20, 2010.  It is licensed under Creative Commons Attribution-NonCommercial-NoDerivs 3.0 Unported.

On July 9, 2010, the U.S. Technical Advisory Group (TAG) to the International Organization for Standardization’s (ISO) Technical Committee 229 on Nanotechnologies presented a webinar requesting general public input regarding ISO’s draft technical specification (TS) entitled “Labeling of Manufactured Nano-Objects and Products Containing Manufactured Nano-Objects.” The U.S. TAG is accredited by the American National Standards Institute, the leading standards organization in the U.S. ISO has 163 members countries and its standards often become the de facto standard of care for certain industries.

The document discussed during the webinar is a draft technical specification developed jointly by ISO and the European Committee for Standardization. In general, a TS can be thought of as a guidance document which is one step down in authority from an actual standard. However, it may ultimately become a full-fledged standard in a few years if ISO and its members are so inclined. This particular draft TS will be voted on by ISO in late 2010, and any comments will be resolved in early-to-mid 2010. If passed, the draft TS will most likely take effect in late 2011.

The draft TS has four basic purposes: (i) encourage a standardized approach to nano-product labeling; (ii) ensure that companies in the nano supply chain can adequately identify manufactured nano-objects in products in order to make informed decisions regarding purchasing, distribution, handling, use, and disposal; (iii) standardize labeling use of the “nano” prefix and suffix where appropriate; and (iv) “provide guidance on the use of other specific terms in” nano-labeling.

The draft TS is limited to manufactured nano-objects and products containing such objects. Incidental and natural nano-objects are excluded from coverage, as are products containing manufactured nano-objects bound in a matrix which are not subject to release under reasonably foreseeable use or disposal scenarios.

Getting to the heart of the draft TS, the document recommends the use of the prefix or suffix “nano” when products either contain manufactured nano-objects or display nanoscale phenomena. Additionally, the draft TS suggests that products not containing nano-objects but displaying unique characteristics commonly associated with nanoscale materials should bear a negative label: “This product does not contain manufactured nano-objects.”

The draft TS also provides five suggested forms of nano-disclosure for use in the existing ingredient section of product labels:

• “a manufactured nanoscale form of X;”
• “0.1 g of nanoscale X;”
• “X, approximately size range P nm - Q nm, specific surface area R m2 g-1;”
• “a dispersion of manufactured nanoscale X in Y;” and/or
• “[nanoscale shape of] X, with an aspect ratio of 1:20.”

In addition to these suggested ingredient statements, the draft TS also asks manufacturers to consider including the following information in their nanoproduct labels: (i) whether the nano-objects are in free or unbound form; (ii) any special disposal needs; (iii) the source from which the nano-objects were derived; (iv) the intended function or purpose of the nano-objects in the product; (v) instructions for the safe opening of the nanoproduct package; and (vi) any necessary warnings regarding potential product instability.

Finally, the draft TS recommends that business-to-business nanoproduct labels contain sufficient information for the purposes of (i) unambiguous product identification; (ii) “employee training, batch control, and [explaining] contract conditions of purchase;” and (iii) assigning purchasers “responsibility for identification, safety, [and] production control systems.”

Unfortunately, the entire draft TS is not currently publicly available in written form. However, there is a 2007 document published by the British Standards Institute upon which the draft appears to be based. Although it is difficult to fully analyze the draft TS without having a copy in hand, anyone with comments regarding its general approach should e-mail the U.S. ISO Liaison Representative at: marrapese@khlaw.com
 

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The White House Office of Science and Technology Policy (“OSTP”) and STCI VenCorps.org. has established the National Nanotechnology Initiative Strategy Portal (“NNI Strategy Portal” or “Portal”), an online interactive program designed to facilitate public responses to specific questions posed by the National Nanotechnology Initiative (“NNI”), a multi-agency Federal research and development initiative created to promote nanotechnology innovation. The NNI will publish the new Strategic Plan in December 2010, outlining priorities and objectives for the next 5-10 years, and focusing on:

1.      Advancing a world-class nanotechnology research and development plan;

2.      Fostering the transfer of new technologies into products for commercial and public benefit;

3.      Developing and sustaining educational resources, a skilled workforce, and the supporting infrastructure and tools to advance nanotechnology;

4.      Supporting responsible development of nanotechnology.

The NNI believes the Portal may be helpful to its mission to improve the NNI Strategic Plan by providing a mechanism to reach out to the nanotechnology stakeholder community for specific input. The Portal, which is a Web 2.0 application, will allow users to review responses and rate fellow members, network and connect with other members, earn points for participating, and post their responses to questions and indicate one or more of the four overarching NNI goals to which the response applies. The portal will only be open for comment on the Strategic Plan themes from July 13 – August 15 and can be accessed at:  http://strategy.nano.gov/

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Today's issue of the Federal Register carries a request for information  (RFI) from the White House Office of Science and Technology Policy, as part of the effort to gain input from stakeholders in creating a new National Nanotechnology Initiative Strategic Plan, to be issued in December 2010.

The RFI seeks responses from the stakeholder community to sets of questions under six categories:

A. Goals and Objectives

    A1. What specific and measurable objectives should be
established to help achieve the four stated NNI goals?
     A2. Are there other overarching goals that would enable
the NNI to better support the vision of a future in which the ability
to understand and control matter at the nanoscale leads to a revolution
in technology and industry that benefits society?
 

B. Research Priorities

    B1. What are the most important gaps in the NNI R&D
portfolio (i.e., specific underfunded areas ripe for success) that
should be addressed to achieve the NNI goal(s) (please specify 1, 2, 3,
and/or 4)?
     B2. What nanotechnology R&D areas should NNI member
agencies pursue under the Nanotechnology Signature Initiatives model of
close and targeted program-level interagency collaboration to help
accelerate nanotechnology innovation?
B3. What are the most important scientific and technical
challenges that would need to be met to realize the NNI goal(s) (1, 2,
3, and/or 4) and objectives?
 

C. Investment

    C1. What types of research and development investments
(e.g. support for individual investigators, small teams, centers,
research infrastructure, etc.) should the NNI agencies create, sustain,
and/or expand to achieve the NNI goal(s) (please specify 1, 2, 3, and/
or 4)?
C2. What relative distribution of research and development
investment among the PCAs is needed to achieve the NNI goal(s) (1, 2,
3, and/or 4), and why?
C3. What is the appropriate balance for investment in
nanotechnology among US private and public entities (i.e., government,
corporate R&D, and venture capital) to achieve the NNI goal(s) (please
specify 1, 2, 3, and/or 4), and why?
 

D. Coordination and Partnerships

    D1. How could the NNI strengthen interagency coordination
and collaboration towards specific NNI goal(s) (please specify 1, 2, 3,
and/or 4) and objectives?
    D2. What improved mechanisms may be utilized to facilitate
innovative cross-disciplinary research supporting the NNI goal(s)
(please specify 1, 2, 3, and/or 4)?
    D3. What are the most effective roles of the government,
industry, academia, and other stakeholders in achieving this NNI goal
(1, 2, 3, and/or 4)?
    D4. What new forms of collaboration between stakeholders
should be explored to facilitate nanotechnology-based innovation into
applications?
 D5. What existing activities in the public and private
sector could the NNI develop or model to achieve the NNI goal(s)
(please specify 1, 2, 3, and/or 4)?
 D6. What partners or types of partners would need to
collaborate (i.e., government, specific foundations and industry
groups, new ideas for consortia) to accomplish the NNI goal(s) (please
specify 1, 2, 3, and/or 4)?
    D7. What are effective mechanisms to leverage and/or
coordinate US-funded research and development with international
efforts?
    D8. What mechanisms could NNI use to regularly engage
experts in academia and industry and other organizations for input on
its approach to addressing specific NNI goals (please specify 1, 2, 3,
and/or 4)?
    D9. What is the role of public engagement in achieving
specific NNI goals? In what ways can the Federal government best engage
with citizens to ensure the sustainable development of nanotechnology-
based products with the broadest economic and societal benefits?
 

Evaluation

    E1. What specific criteria (e.g., nanotechnology
publications and citations, nanotechnology patent activity,
nanotechnology-related job creation, relative international
nanotechnology investments) should the NNI use to evaluate its progress
towards the NNI goal(s) (please specify 1, 2, 3, and/or 4) and in what
priority order?
    E2. Which organizations (e.g., government committees,
independent organizations, international bodies) should perform the
evaluation of progress towards the NNI goal(s) (please specify 1, 2, 3,
and/or 4)?
    E3. How can NNI best balance fundamental and applied
research and development towards the NNI goal(s) (please specify 1, 2,
3, and/or 4)?
 

Policy

    F1. What new, or existing, specific policies should the
NNI agencies develop or adjust to support the NNI goal(s) (please
specify 1, 2, 3, and/or 4) and to realize the broader economic and
societal benefits associated with advances in nanotechnology?
    Examples: Policies that impact and/or support the NNI goals might
address procurement, incentive prizes, technical documentary standards,
international collaboration, targeted investment, permanent resident
cards for foreign graduates from accredited US academic institutions,
etc.
    F2. What best practices can be drawn from nanotechnology-
and innovation-related policies in other sectors and countries?
 

Responses and/or questions may be sent to either NNISStrategy@ostp.gov  or to

Office of Science and Technology Policy,

ATTN: Nano RFI,

Executive Office of the President,
725 17th Street,

Room 5228,

Washington, DC 20502.

Phone: (202) 456-
7116,

Fax: (202) 456-6021.
 

Responses to the RFI need to be submitted by 11:59PM August 15, 2010.

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The Capital Hill newspaper POLITICO carries an article today discussing how technology related bills awaiting votes in the Senate, including the America COMPETES Reauthorization Act, are stalled due to the Senate's focusing on the financial reform bill, the upcoming confirmation vote on Elena Kagan to be the next Associate Justice on the US Supreme Court, the upcoming July 4 and August recesses, and the elections in November. The fear among researchers is that federal funding for various projects, including those in the nanotech field, may dry up. The potential for the November elections to energize work on these bills is also briefly discussed. What is not discussed in the article is the possibility of the tech bills to be voted on in a potential "Lame Duck" session of Congress, following the elections.

As always, we will continue to monitor the progress - or lack thereof - of nanotech related bills in Congress.

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