The September 3, 2012 issue of C&EN discusses what it calls an “onslaught of nanotech drugs coming down the pike” for FDA review. See article entitled “Mapping Nanotech Drugs’ Landscape,” pp. 46, 48.
The FDA is generating a database for nanotech drugs and currently has 158 entries according to the article. The leading application area is cancer treatment (38%). Most are developed to be administered intravenously (56%). The leading types of formulation are liposomes (39%) and nanoparticles (27%).
The FDA will hold a public workshop in the coming months to get input from stakeholders for how to improve the review process.
The US patent literature confirms the role of nanotechnology innovation in cancer treatment. Of the currently published nanotechnology class 977 patent filings (there are 13,814 of them), 1.9% of them refer to cancer in the title or abstract. Considering the breadth of nanotechnology and bio nanotechnology, this is a significant fraction. Also, 4.3% of them refer to cancer in the title, abstract, or claim. Finally, 14.3% of them mention cancer in the patent somewhere.
Interesting example yesterday for how nanotechnology is presented to the public and forming part of our educational systems, including EHS aspects. We visited Virginia Tech for the day as part of my daughter’s evaluation of prospective colleges. Our interests included their engineering departments. In their visitor building, where the tours start, Virginia Tech includes presentation material for several nanotechnology-related issues the university is working on. One was for how nanoparticles can be transported in the environment over long distances. The lead professor is in Geosciences, and collaboration is present with civil and environmental engineering professors. Virginia Tech promotes a “hands-on, minds-on” approach to training its undergrads in engineering, and they indicate that undergraduate research will be part of the project.
Below has more information about the NSF grant on the subject:
Researchers from geosciences and civil and environmental engineering at Virginia Tech are part of a consortium of four principal universities and five other schools awarded a multimillion dollar grant to study nanotechnology and the environment. This is one of only two such consortiums funded by the National Science Foundation (NSF) to form a national Center for the Environmental Implications of Nanotechnology (CEIN). Total funding for the project is $14 million over five years with an opportunity to renew for another five years. Virginia Tech’s portion of the grant is $1.75 million.
EPA and FDA both started 2012 by receiving criticism for their lack of management of nanomaterials in products the agencies regulate. EPA’s inspector general published a report released on December 29, 2011, entitled EPA Needs to Manage Nanomaterial Risks More Effectively in which the inspector general strongly criticizes the effectiveness of EPA’s management of nanomaterials. The report notes EPA’s failure to have in place a formal process to coordinate the distribution and use of information that companies are required to submit under existing regulations. One of the report conclusions is a recommendation that EPA should develop a way to gather and share nanomaterial information throughout the agency and with the public. A possible mechanism to achieve this would be to create a nanomaterials specific website. Although EPA’s response to the report lauded the “significant steps” the agency has taken to provide information regarding nanomaterials to the public, EPA has reportedly agreed to take additional steps to expand its existing procedures for sharing nanomaterial information between its various offices.
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NNI’s Website, www.nano.gov, is showing some additional activity that may indicate the site is finally awake and active for good. NNI posted four reports today that are the products of a series of workshops the government hosted in 2009 and 2010.
According to NNI, the workshops that were the basis for these reports, in conjunction with advice from National Academies and the President’s Council of Advisors on Science and Technology (PCAST), were used to develop an updated EHS Research Strategy for the NNI, which is intended to guide the responsible development of nanotechnology.
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By Sarah Slack, Michael Flanagan, and J. Steven Rutt
In June 2011, several federal agencies issued policy guidance documents regarding the regulation of nanomaterials. Although the guidance documents were issued by several different agencies, including the Office of Management and Budget, the Food and Drug Administration (FDA), and the Environmental Protection Agency (EPA), they all convey the need to strike a careful balance between protecting human health, welfare, and the environment while fostering regulatory certainty for businesses on the forefront of innovation of nanomaterials and nanotechnology. The guidance documents issued by FDA and EPA were published in draft form, and public comments must be submitted by August 15, 2011, and July 18, 2011, respectively.
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Nanotech made headlines on June 9, 2011. Tom Kalil from the Office of Science & Technology Policy (OSTP) wrote about nanotechnology, informing readers about regulatory updates in nanotechnology. A series of government agencies including the OSTP, EPA, FDA, USTR, and OMB issued guidance on nanotechnology regulation. Goals include:
- consistent approaches across different emerging technologies
- protection of public health and environment
- avoid unjustifiably inhibiting innovation
- avoid stigmatizing new technologies
- avoid creating trade barriers
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The importance of standard setting for nanotechnology development has long been recognized. One important organization for standard setting is ASTM International. May 15, 2011 will kick-off ASTM’s Committee Week in Anaheim, California. On May 16 – 17, 2011, the ASTM nanotech committee, E56, will meet. I will be presenting to the group on recent developments in patent issues.
In many cases, one can only fully understand an invention by understanding the properties or performance in quantitative terms. This leads to the question of measurement. Patent documents, including patent claim strategies, can be improved by resort to standard testing, including ASTM testing. A review of the patent literature through May 5, 2011 shows that only 2.3% of the nanotech 977 granted patents refer to ASTM tests (160 out of 6,880 patents), and only 3.5% of the published nanotech 977 patent applications refer to ASTM tests (298 out of 8529).
Recent developments in the standardization processes from the solar cell and OLED sectors will be discussed. Patent claim construction and the risks of patenting a standard will also be discussed.
For more information about the program or to register, please visit the ASTM Committee Week Web page.
A leading House subcommittee, Research and Science Education, heard testimony on April 14, 2011 on nanotechnology funding. A few brief highlights:
- The testimony was more product oriented compared to past testimony.
- Should EHS funding be increased? One person testified no.
- Some say the Department of Energy funding and ARPA-E could be targets for scrutiny.
- The ongoing debate is how can federal investment in nano strengthen the economy and create jobs without the government "picking winners and losers"?
- Testimony was given by Dr. Clayton Teague (NNCO), Dr. Jeffrey Welser (Semiconductor Research Corporation); Dr. Seth Rudnick (Liquidia Technologies), Dr. James Tour (Rice University), and Mr. William Moffitt (Nanosphere).
The most recent issue of Washington Lawyer featured an extensive cover story on nanotech commercialization and regulation.
The current mood for cost-cutting in the federal government, as well as state governments, will perhaps limit nanotech regulatory developments in 2011 – time will tell. The EPA continues to look at nanotechnology, but does so through the use of other phrases such as particulate matter in air quality and safety of chemical under TSCA.
On the commercialization side, patent reform momentum is gaining in Congress and is now a real possibility in 2011.
Environmental, health, and safety issues are a top priority for nanotech now, as reflected in presentations at the NNI at Ten event in DC last week. Now, we can review and comment at www.nano.gov the draft “National Nanotechnology Initiative 2011 Environmental, Health, and Safety Strategy,” which is only 106 pages.
I could not help but connect this with recent media coverage about air quality, including small particulates, in Western Pennsylvania. In that coverage, the quote “Our particles aren’t as bad as your particles” comes from and reflects the comparison between relative harm for particles emitted from coal-fired power plants and vehicular exhaust.
Particular (no pun intended) issues stem from particles less than 2.5 microns which covers the nanodomain (they are called PM2.5). The EPA webpage refers to studies from the 1990′s about these tiny particles.
So hopefully the NNI EHS document builds on what is already known about particles in the air from cars and coal. The PM2.5 are not nanoengineered per se but in figuring out what to do with nano-EHS, one should not ignore PM2.5. Gritty public health and economic issues apply to both.
The 9th Annual Washington D.C. Roundtable, the official public policy forum of the NanoBusiness Alliance, will take place on March 15 – 17, 2010, with informative legislative meetings as well as networking among nanotechnology industry leaders.
In particular, the March 17th Federal Roundtable session is expected to draw business leaders, investors, venture capitalists, scientists, engineers, government officials and visionaries who are driving the success of nanotechnology. The full day agenda will stimulate dialogue between NanoBusiness Alliance Members and Federal Agencies, explore the latest on regulatory policy/impending regulatory actions and federal research initiatives, and familiarize guests with federal product approval authorities, processes, and innovation strategies, with an emphasis on pending developments.
For those navigating through public policy to advance their nanotechnology, this forum has proved to be a helpful and insightful tool. Also, stay tuned for developments on the annual NanoBusiness Alliance Conference slated for September 27 – 29, 2010 in Chicago, Illinois.
EPA is poised next year to propose a new rule requiring manufacturers of nanomaterials to submit data on production, exposure and available safety information, as the agency moves towards stricter rules in the wake of lackluster results from a voluntary Bush-era initiative.
The agency is developing a rule under Section 8 of the Toxic Substances Control Act to “establish reporting requirements for certain nanoscale materials,” according to the EPA’s recently published unified agenda. Manufacturers would be required to provide EPA with information on “production volume, methods of manufacture and processing, exposure and release information, and available health and safety data” under the rule.
The information “will provide EPA with an opportunity to evaluate the information and consider appropriate action under TSCA to reduce any risk to human health or the environment,” the agenda says. A notice of proposed rulemaking is slated for June 2010.
Graphene has become a new darling in the electronic application. As also noted by ScienceDaily, a team in the Kansas State University has developed 24-carat gold "snowflakes" to improve graphene’s electrical properties.