Nanotechnology has often been touted as a new and potentially revolutionary way to improve nearly every aspect of modern life, but has also faced doubt from skeptics who have raised concerns about the downside to incorporating such innovative technology in everyday life. Possible dangers include the unintended consequences of the accumulation of nanoparticles in the human body or the environment. In response, risk management and insurance companies have begun to develop measures to address these concerns, from evaluating and underwriting nanorisks to taking risk management ideas to the nanotechnology community. One company, Zurich, has developed a web-based software product which looks at nanoparticle characteristics to assist nanotechnology users determine potential hazard levels. Another company, Lexington Insurance, has created a integrated coverage insurance policy specifically for nano clients, especially those who may need special assistance in gauging the level of risk management in the field.
America COMPETES Reauthorization Act of 2010: Update
On Friday, May 28, 2010, debate on H.R. 5116, the America COMPETES Reauthorization Act of 2010, discussed here earlier, resumed. As readers may recall, in the earlier debate in the House, a motion to recommit the bill to committee and for it to be reported back with an amendment, had been adopted by the House. On Friday, Rep. Bart Gordon, the sponsor of the bill, reported the bill back to the House, with amendments. In a series of votes, the majority of the proposed amendments, which would have reduced funding and the effectiveness of the bill in supporting innovative technologies and their commercialization, were defeated; only two amendments, adding sections 704, "No salaries for viewing pornography", which would prevent funds authorized under the bill from being used to pay the salaries of Federal employees disciplined for "viewing, downloading, or exchanging pornography, including child pornography, on a Federal government computer or while performing Federal government duties" and section 705, which would prevent colleges and universities that have violated Section 983 of Title X from receiving any funds authorized by the America COMPETES Act for grants or contracts.
Title I, Subtitle A, the National Nanotechnology Initiative Amendments Act was not affected by the proposed amendments and survived intact.
Having been passed in the House, the bill now proceeds to the Senate for debate and hopefully passage in that body. Congress has now adjourned for the Memorial Day Recess and the Senate will not reconvene until June 8. As many observers have noted, the Senate has considerable work ahead of it, ranging from Immigration reform to Climate Change legislation and HR 5116 faces the possibility of not coming up for a vote prior to Congress adjourning for the elections in November.
As always, we will keep track of the bill’s progress and update this site accordingly.
The NNI Strategic Planning Stakeholder Workshop
In a notice in today’s Federal Register the National Nanotechnology Coordination Office announced that it will be holding a public workshop on July 13-14, 2010, for the purpose of giving stakeholders (defined as representatives of the research community, the private sector and NGOs and members of the general public) a forum for presenting their input regarding updating the US National Nanotechnology Initiative Strategic Plan, last updated in 2007. Specifically, the Federal agencies that take part in the NNI are seeking input on the objectives of the strategic plan and on the approaches to achieving those objectives.
Pre-registration is required, since it’s on a "first come, first served" basis. Those planning to attend the workshop, to be held at the Hotel Palomar in Arlington Virginia, may register online at http://www.nano.gov/html/meetings/strategicplan/register.html, via e-mail at strategy@nnco.nano.gov or via regular snail mail at Strategic Planning Workshop, c/o NNCO, 4201 Wilson Blvd., Stafford II, Suite 405, Arlington, VA 22230. Registrations must be received by 4PM July 7, 2010.
The America COMPETES Reauthorization Act of 2010
To retain respect for sausages and laws, one must not watch them in the making
On April 22, 2010, Rep. Bart Gordon of Tennessee introduced HR 5116, the America COMPETES Reauthorization Act of 2010, which was then referred to the House Committee on Science and Technology and the House Committee on Education and Labor.
The bill’s focus, as it’s title implies, is on reauthorizing the America COMPETES Act passed in 2007. Both the original act provided government support for innovation, research and development, increased funding for science, technology, engineering and math (STEM for short) in high schools and colleges, and assistance in getting the results of research and development out to the private sector, ultimately leading to the emergence of new industries and an expansion of the economy. The Reauthorization act would have expanded on this and would have included other areas, such as a reorganization of the National Institutes of Standards and Technology.
The House Committee on Science and Technology reported the bill out of committee with an amendment in the nature of a substitute; all of the language after the enacting clause was stripped out and new language substituted. Both the bill as introduced and the bill as reported to the House have the same language for Title I, "Science and Technology Policy", Subtitle A, "The National Nanotechnology Initiatives Amendments Act of 2010", which will be our focus here.
Section 102, "National Nanotechnology Program Amendments" would require, within 12 months of the bill’s enactment into law, of a strategic plan to guide the National Science and Technology Council (NSTC) in achieving activities described in an earlier section and
to guide the activities described under subsection (b) that specifies near-term and long-term objectives for the Program, the anticipated time frame for achieving the near-term objectives, and the metrics to be used for assessing progress toward the objectives, and that describes–
`(A) how the Program will move results out of the laboratory and into applications for the benefit of society, including through cooperation and collaborations with nanotechnology research, development, and technology transition initiatives supported by the States;
`(B) how the Program will encourage and support interdisciplinary research and development in nanotechnology; and
`(C) proposed research in areas of national importance in accordance with the requirements of section 105 of the National Nanotechnology Initiative Amendments Act of 2010;’;
This new language would replace the current version:
(A) how the program will move results out of the laboratory and into application for the benefit of society;
(B) the Program’s support for long-term funding of interdisciplinary research and development in nanotechnology; and
(C) the allocation of funding for interagency nanotechnology projects;
Section 102 would also add new language regarding support for the development of standards for nanotechnology, funding for the National Nanotechnology Coordination Office (NNCO), by directing the NSTC to include descriptions of funding required by the NNCO to perform functions required by earlier sections an the amount of funds provided by each federal agency that participates in the program.
The NNCO would be directed to
develop and maintain a database accessible by the public of projects funded under the Environmental, Health, and Safety, the Education and Societal Dimensions, and the Nanomanufacturing program component areas, or any successor program component areas, including a description of each project, its source of funding by agency, and its funding history. For the Environmental, Health, and Safety program component area, or any successor program component area, projects shall be grouped by major objective as defined by the research plan required under section 103(b) of the National Nanotechnology Initiative Amendments Act of 2010. For the Education and Societal Dimensions program component area, or any successor program component area, the projects shall be grouped in subcategories of–
`(A) education in formal settings;
`(B) education in informal settings;
`(C) public outreach; and
`(D) ethical, legal, and other societal issues.
The requirement for a publicly accessible database has appeared in S. 1482 and H.R. 554, discussed here and here.
Section 5 would retain the requirement for the Director of the NNCO to enter into an agreement with the National Research Council (NRC) to conduct a triennial review. However, the areas covered by the review would be greatly reduced from
(1) an evaluation of the technical accomplishments of the Program, including a review of whether the Program has achieved the goals under the metrics established by the Council;
(2) a review of the Program’s management and coordination across agencies and disciplines;
(3) a review of the funding levels at each agency for the Program’s activities and the ability of each agency to achieve the Program’s stated goals with that funding;
(4) an evaluation of the Program’s success in transferring technology to the private sector;
(5) an evaluation of whether the Program has been successful in fostering interdisciplinary research and development;
(6) an evaluation of the extent to which the Program has adequately considered ethical, legal, environmental, and other appropriate societal concerns;
(7) recommendations for new or revised Program goals;
(8) recommendations for new research areas, partnerships, coordination and management mechanisms, or programs to be established to achieve the Program’s stated goals;
(9) recommendations on policy, program, and budget changes with respect to nanotechnology research and development activities;
(10) recommendations for improved metrics to evaluate the success of the Program in accomplishing its stated goals;
(11) a review of the performance of the National Nanotechnology Coordination Office and its efforts to promote access to and early application of the technologies, innovations, and expertise derived from Program activities to agency missions and systems across the Federal Government and to United States industry;
(12) an analysis of the relative position of the United States compared to other nations with respect to nanotechnology research and development, including the identification of any critical research areas where the United States should be the world leader to best achieve the goals of the Program; and
(13) an analysis of the current impact of nanotechnology on the United States economy and recommendations for increasing its future impact.
to
`(1) research priorities and technical content of the Program, including whether the allocation of funding among program component areas, as designated according to section 2(c)(2), is appropriate;
`(2) effectiveness of the Program’s management and coordination across agencies and disciplines, including an assessment of the effectiveness of the National Nanotechnology Coordination Office;
`(3) Program’s scientific and technological accomplishments and its success in transferring technology to the private sector; and
`(4) adequacy of the Program’s activities addressing ethical, legal, environmental, and other appropriate societal concerns, including human health concerns.
The report would be transmitted to be submitted to the Director of the NNCO, who in turn would
transmit it to the Advisory Panel, the Committee on Commerce, Science, and Transportation of the Senate, and the Committee on Science and Technology of the House of Representatives not later than September 30 of every third year, with the first report due September 30, 2010.
The definition of "Nanotechnology" would be changed from the current
Nanotechnology
The term “nanotechnology” means the science and technology that will enable one to understand, measure, manipulate, and manufacture at the atomic, molecular, and supramolecular levels, aimed at creating materials, devices, and systems with fundamentally new molecular organization, properties, and functions.
to a more focused
Nanoscale Carbon: In Vivo Tox Bibliography
The NanoSafety Consortium for Carbon has recently posted a bibliography of in vivo tox studies on its website. The bibliography is (obviously) a work in progress. We would greatly appreciate it if our readers would bring to our attention any pertinent articles that are not already on the bibliography. The articles will be used to inform and guide our attempt in crafting a representative toxicity testing regime with US EPA. Many thanks in advance for your input.
HHS Requests Information on TPO Accounting of Disclosures
The Office of Civil Rights for the Department of Health and Human Services (HHS) recently requested comments related to its upcoming rulemaking under the Health Information Technology for Economic and Clinical Health (HITECH) Act, part of the American Recovery and Reinvestment Act of 2009. HITECH expands the current HIPAA Privacy Rule requirement that a covered entity provide individuals with a right to receive an accounting of certain disclosures of the individual’s protected health information to certain parties. Currently, under HIPAA, a covered entity is not obligated to provide an accounting of disclosures if such disclosures were in furtherance of treatment, payment, or health care operations (TPO). HITECH eliminated these exemptions by requiring covered entities to account for TPO disclosures if such disclosures are made through an electronic health record.
European Parliament votes on measure to regulate food nanotechnology
Members of the European Parliament’s environment, public health and food safety committee have voted to control the use of nanotechnologies in foods for humans. The proposed measure entirely excluded entry onto European Union (“EU”) markets of any food derived from cloned animals as well as food produced by nanotechnology processes, unless such food has undergone a specific risk assessment regarding possible impact on health. Those risk assessment methods must also have been approved for use, i.e., not imply the use of vertebrate animals for testing. The measure also required all ingredients containing nanomaterials to be clearly labeled by listing the names of the ingredients followed by the word ‘nano’ in brackets. A definition of nanomaterials was included in the proposed text as: “nanomaterial means an intentionally manufactured material with one or more external dimensions or an internal structure, of order of 100 nm or less.” The new regulation can only be adopted after co-decision by both the European Parliament and Members States and must be endorsed by the whole parliament in July.
Conference: Multifunctional Nanomaterials
The Nano-Network and Wright State University are holding a joint conference on Multifunctional Nanomaterials: Cross-cutting Growth Opportunities in Energy, Environment and Aerospace Applications on May 24, 2010 at Wright State University in Dayton, Ohio.
"The aim of this one-day networking event is to bring together leaders and sponsors from Ohio industry, AFRL, AFOSR and university faculty to discuss possible growth options and collaborative opportunities."
For more info. contact:
Ken Vaughan, Executive Director
Nano-Network
PolymerOhio Inc.
155 Commerce Park Drive, Suite 8
Westerville, Ohio 43082
Phone: (614) 776-5720
Email: kvaughan44@aol.com
URL: http://www.polymerohio.org/
Chapter 163, MD Task Force to Study Nanobiotechnology
The General Assembly of Maryland has concluded its annual 90 day session. Among the bills that were passed during this year’s session was House Bill 795, introduced by Delegate Susan C. Lee.
As introduced, HB 795 was to establish a "Task Force to Study Nanotechnology and Nanobiotechnology", but was amended to focus solely on Nanobiotechnology and was passed by both the MD State Senate and the House of Delegates on April 1, 2010, signed into law by Governor Martin O’Malley on April 13, 2010 and Chapterized as Chapter 163 Acts of 2010.
The Task Force is to be composed of members appointed by the President of the MD State Senate, the Speaker of the House of Delegates – these individuals will serve as co-chairs of the task force – the Secretary of Business and Economic Development, Chair of the MD Technology Development Corporation or their designees. The Governor is empowered to appoint three representatives to the task force from universities and colleges in Maryland that are involved in research in nanobiotechnology and two CEOs of nanobiotech companies. In addition, the Directors of NIH, NIST, FDA and the USPTO or their designees are also to be invited to become part of the task force.
The task force is charged with studying the benefits of the nanobiotech industry, ranging from job creation to "the generation of revenues for the state", the state’s role in supporting nanobiotech, including promoting private-public partnerships, offering financial incentives for nanobiotech companies to establish themselves in Maryland, etc.. The task force is also charged with reporting its recommendations to the Governor on or before 01/11/2011, prior to the beginning of the next General Assembly session.
The State of Maryland has been criticized lately as having an "unfriendly" business environment for existing businesses or for companies that might relocate or expand into Maryland. Such criticism may become one of the themes of the 2010 election season in the state. Forward looking legislation such as Chapter 163, designed to help attract the next generation of nanoindustry, may help to prove that criticism wrong.
Endorsement Guides Create Concerns for More Than Just Bloggers
Bloggers have been buzzing since the Federal Trade Commission (FTC) updated its Guides Concerning Use of Endorsements and Testimonials in Advertising (“Guides”) to cover “consumer generated media” such as blogs and other Internet media forms. (16 C.F.R. Part 255) (.PDF) The changes are the first update since 1980 for the Guides, which are intended to offer guidance to compliance under 15 USC § 45 (“Unfair methods of competition unlawful; prevention by Commission”). While the FTC describes the Guides as providing “the basis for voluntary compliance with the law by advertisers and endorsers”, the Guides could form the basis for an enforcement action by the FTC, and noncompliance may result in a civil penalty of up to $10,000 per violation.
In the interest of providing consumers with full disclosure, the updated Guides require bloggers to disclose any “material connection[s]” they have with producers of any products that they “endorse” on their blogs. A “material connection” includes not only monetary compensation, but also any free good received by the blogger—even if that good was provided unsolicited, with no conditions attached, for the purpose of allowing the blogger to review the product. Under the Guides, “endorsers” and companies must fully disclose any connection between “the endorser and the seller of the advertised product that might materially affect the weight or credibility of the endorsement.” In an effort to further explain the intent behind the Guides, the FTC has provided 35 example fact patterns in the Guides, and even an instructional video.
Much of the recent media attention to the updated Guides has addressed the required disclosure by bloggers who write about products after receiving free samples of the product or other financial benefits from the product manufacturers. Companies, however, should also be aware of the recommendations and examples set forth in the Guides, and how the Guides might apply in at least two modern contexts: (1) with respect to a company’s interactions with bloggers, and (2) with respect to a company’s own social media or other customer-interactive online presence.
