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

On December 21, 2011, the International Center for Technology Assessment (ICTA), along with fellow plaintiffs Friends of the Earth (FOE), the Center for Environmental Health, Food and Water Watch, the Institute for Agriculture and Trade Policy, and the Action Group on Erosion, Technology and Concentration filed a complaint in the US District Court for the District of Norther California against Margaret A. Hamburg, Commissioner of the US Food and Drug Administration (FDA), requesting that "this Court enter an Order:

(1) Declaring that the Defendants have violated the Administrative Procedure Act by failing to respond to the 2006 Petition within a reasonable time;

(2) Declaring that the Defendants continue to be in violation of the Administrative Procedure Act by failing to respond to the 2006 Petition;

(3) Ordering Defendants to respond to the 2006 Petition as soon as reasonably practicable"

In May of 2006, ICTA filed a "Petition Requesting FDA Amend Its Regulations for Products Composed of Engineered Nanoparticles Generally and Sunscreen Drug Products Composed of Engineered Nanoparticles Specifically". The petition requested "that the Commissioner undertake the following actions with regards to all nanomaterial products:

1) Amend FDA regulations to include nanotechnology definitions necessary to properly regulate nanomaterial products . . . .

2) Issue a formal advisory opinion explaining FDA's position regarding engineered nanoparticles in products regulated by FDA.

3) Enact new regulations directed at FDA oversight of nanomaterial products establishing and requiring . . .that: nanoparticles be treated as new substances; nanomaterials be subjected to nano-spefic paradigms of health and safety testing; and that nanomaterial products be labeled to delineate all nanoparticle ingredients

4) Any currently existing or future regulatory FDA programs for nanomaterial products must comply with the requirements of the National Environmental Policy Act (NEPA) including . . . that FDA conduct a Programmatic Environmental Impact Statement (PEIS) reviewing the impacts of nanomaterial products on human health and the environment.

Petitioners request that the Commissioner undertake the following actions with regard to nanomaterial sunscreen drug products:

5) Reopen the Administrative Record of the Final Over the Counter (OTC) Sunscreen Drug Product Monograph for the purpose of considering and analyzing information on engineered nanoparticles of zinc oxide and titanium dioxide currently used in sunscreens.

6) Amend the OTC Sunscreen Drug Monograph to address engineered nanoparticles, instructing that sunscreen products containing engineered nanoparticles are not covered under the Mongraph and instead are "new drugs" for which manufacturers must complete a New Drug Application. . . .

7) Declare all currently available sunscreen drug products containing engineered nanoparticles of zinx oxide and titanium dioxide as an imminent hazard to public health and order entities using the nanoparticles in sunscreens regulated by FDA to cease manufacture until FDA's Sunscreen Drug Monograph is finalized and FDA nanotechnology regulations are developed and implemented.

8) Request a recall from manufacturers of all pulically available sunscreen drug products containing engineered nanoparticles of titatium dioxide and/or zinc oxide until the manufacturers . . .complete new drug applications, those applications are approved by the agency, and the manufactureres otherwise comply with FDA's relevant nanomaterial product testing regulations.

FDA held open meetings and established docket FDA -2006-P-0213 (two versions of this docket exist, on Regulations.gov and on the FDA's site). Comments were filed by various stakeholders between 2006 and 2009. Many of these comments, such as those submitted by Purest Colloids Inc and the Cosmetic, Toiletry and Fragrance Association (CFTA) severly criticized the ITCA's petition and urged the FDA not to take the actions requested in the petition.

In an interim response dated Nov. 9, 2006, Randall W. Lutter, then the FDA's Associate Commissioner for Policy and Planning noted that the

. . .FDA has been unable to reach a decision on your petition because it raises complex issues requiring extensive review and analysis by agency officials. . . . We will respond to your petition as soon as we have reached a decision on your requests.

Almost six years later, FDA is still in the process of formulating regulations and policy affecting nanotechnology and nanoindustry.

The parties in the case have been referred by the US Distirct Court to Alternative Dispute Resolution. We will continue to monitor the case and update as warranted.

UPDATE:

The parties in International Center for Technology Assessment et al v Hamburg, in a stipulation filed with the court on January 13, 2012, agreed  to grant the EPA " an extension of time to April 23, 2012 to answer, move, or otherwise respond to the complaint". EPA requested the extension "because defendent is working in good faith to respond to the citizen petition . . .on or before April 23, 2012."

As before, we'll keep monitoring and updating as warranted.

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One June 9, the President's Office of Budget and Management, United States Trade Representative, and Office of Science and Technology Policy issued a joint memorandum directed to all Executive branch departments and agencies entitled "Policy Principles for the U.S. Decision-Making Concerning Regulation and Oversight of Applications ofNanotechnology and Nanomaterials."

The Policy Statement is important because it confirms a "best-science" approach to potential nano-EHS issues, rather than a reactionary approach.  While this has been the stated approach of various federal agencies in the past, it is nice to see it reaffirmed across the entire federal government at the highest levels. The memorandum also reaffirms the importance of nanotechnology to the US economy, and recognizes the potential adverse economic consequences that knee-jerk regulation might have. 

Perhaps most interesting is that the memorandum repeatedly refers to the sufficiency of existing regulations to deal with potential nano-related EHS risks.  Some advocacy groups may have been holding out hope that the Obama administration would enact new nano-specific regulations. That is very doubtful given the tenor of the memorandum, which should provide industry with a measure of reassurance in this regard.

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

Maxine Savitz[1] and Ed Penhoe[2] provided a recent presentation summarizing the highlights of the President’s Council of Advisors on Science and Technology (PCAST)[3] report on the status of the US National Nanotechnology Initiative (NNI) at a public meeting held at the National Academics on March 12, 2010.

Ms. Savitz provided a brief review at the beginning of the presentation regarding how, when, and why NNI was formed; its history from 2000 - 2010; and some of the participants in the PCAST review process. Participants included representatives from DuPont, IBM, A123 Systems, Nanocomp Technologies, Rice, Harvard, Caltech, Sandia National Labs, and the Woodrow Wilson Institute. Ms Savitz also explained that the group held two prior working meetings to solicit input from government agencies, the legislative and executive branches, as well as outside stakeholders. Finally, she explained that PCAST’s report has three major thematic areas: NNI program management; NNI output and work product; and NNI environmental, health, and safety programs and strategies.

Ed Penhoet then provided an update regarding NNI’s continued successes. He noted that the US is currently the world leader in nanotechnology and commercialization, but that other nations are gaining fast -- particularly in Asia and Europe. He further noted that NNI has had a substantial impact on the US nanotechnology industry over the past ten years, which can be seen in the larger number of nanotechnology patents filed, nano-related publications, and nano-related products hitting the commercial market during that period.

Mr. Penhoet further explained that while NNI is being effectively managed, there is still room for some improvement and greater coordination.

For an example, Mr. Penhoet pointed out that there is a lack of basic underlying data from which to analyze the economics of nano-related research, development, and commercialization in the US. Thus, it is difficult to precisely quantify the economic effectiveness of the NNI in measurable terms.

As another example, Mr. Penhoet also mentioned the need to identify and understand potential nano-related risks -- both for purposes of fundamental science, and also to provide a clear regulatory environment and path for commercialization. While undoubtedly a significant portion of PCAST’s written report touches on these issues, the topic was only briefly mentioned in passing during the presentation.

Mr. Penhoet then spent the majority of his presentation explaining the five major recommendations embodied in PCAST’s written report:

• Increase NNI funding for manufacturing research while maintaining support for basic research.
• Strengthen the NNCO, the NNI coordinating entity, with additional funds and a broader mandate.
• Require that metrics be developed to track benefits of nanotechnology such as job creation.
• Develop a cross agency strategy that links EHS research and knowledge gaps and decision making needs.
• Expedite the citizenship review process for those receiving advanced degrees in science and engineering.

The presentation closed with comments by several PCAST members regarding (i) potential methods for developing the underlying economic data needed to properly evaluate nano-related job creation and return on investment; and (ii) potential methods for increasing retention rates of foreign students obtaining advanced nano-related degrees in the US by reducing and/or streamlining citizenship restrictions.

PCAST voted to accept and approve the report after it is amended to reflect the comments discussed during the presentation.

References
[1] Director of the Washington Advisory Group, an LECG Company. Ms. Savitz is the former Deputy Assistant Secretary for Conservation, US Department of Energy. Prior to her DOE service, she was program manager for Research Applied to National Needs at the National Science Foundation. Following her government service, she served in executive positions in the private sector, including: President of Lighting Research Institute, assistant to the vice president for engineering at The Garrett Corporation, and General Manager of Allied Signal Ceramic Components. She recently retired from the position of General Manager for Technology Partnerships at Honeywell.

[2]President of the Gordon and Betty Moore Foundation. Mr. Penhoet is the former dean of the School of Public Health at the University of California, Berkeley, prior to which he cofounded and managed the Chiron Corporation. Prior that he was a faculty member of the Biochemistry Department of U.C. Berkeley. Mr. Penhot currently serves as the vice chairman of the Independent Citizen’s Oversight Committee which oversees the California Institute for Regenerative Medicine created by the passage of Proposition 71, the stem cell initiative.

[3] http://www.whitehouse.gov/administration/eop/ostp/pcast.

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This article was written by John C. Monica, Jr. and Dr. Diana Bowman and originally appeared on the National Nanomanufacturing Network's InterNano website earlier today.  It is licensed under Creative Commons Attribution-NonCommercial-NoDerivs 3.0 Unported.

Dr. Bowman is a Senior Research Fellow in the School for Population Health at the University of Melbourne and a Visiting Research Fellow in the Department of International and European Law, KU Leuven. Dr. Bowman is also a co-editor, along with Matthew Hull, of the book “Nanotechnology Environmental Health and Safety: Risks, Regulation and Management,” (Elsevier, 2010).

In November 2009, the Australian Government’s Department of Health and Aging (DHA) published a public discussion paper —“Proposal for Regulatory Reform of Industrial Nanomaterials”—in relation to the National Industrial Chemicals Notification and Assessment Scheme (NICNAS), which provides a national system of notification and assessment of industrial chemicals. For the purpose of the scheme, “industrial chemicals” include chemical entities found in, for example, many plastics and paints. And, unlike many jurisdictions, those chemicals found in cosmetic products. The paper provides concrete recommendations for the regulation of both “new” nanoscale chemical substances and “existing” chemical substances in nanoscale formulations, while thoughtfully considering legitimate business needs.

Regarding “new” nanoscale chemical substances, the paper notes that—by legal definition—these substances are those which are not already listed on the Australian Inventory of Chemical Substances and as such are subject to existing regulatory requirements. The paper also notes that several permitting exemptions currently exist for certain uses of chemicals already on the Inventory. As an initial nano-regulatory step, the paper recommends excluding “new” nanoscale materials not already on the Inventory from regulatory low volume exemptions, “thereby shifting a post-market audit activity to a pre-market assessment (i.e. new nanomaterials to be assessed under permit or certification categories prior to commercialization).” The suggestion is not unduly punitive, and a similar approach is already in use by the US EPA.

Additionally, the paper recommends modifying the Research and Development exemption for “new” chemical substances to require annual reporting of nanoscale materials produced in quantities exceeding 100 grams per year. While the paper could benefit from some explanation of why this specific threshold was selected, the idea of providing basic information on nanoscale materials used in sufficient quantities for research and development is not onerous.

The main rationale for these modifications is that the “uncertainty surrounding the hazards, exposure, and risk assessment methodologies . . . means that the determination of ‘no unreasonable risk’ or ‘non-hazardous’, both of which are prerequisites to a range of exemptions, is not expected to be straightforward,” and the accompanying need for a case-by-case approach to the responsible development of nanoscale chemical substances.

Regarding “existing” nanoscale chemical substances, the paper recommends that the Australian Government consider following up on their somewhat disappointing voluntary data call-ins under the NICNAS scheme (held in 2006 and 2008) with a study on “the feasibility of a mandatory notification and assessment program.” Such a program would be designed to establish a database of “existing” nanoscale chemicals in use in Australia and increase public confidence in regulatory oversight efforts. U.S. EPA is also considering a mandatory data call-in for nanoscale materials, while California has already issued a mandatory data call-in for carbon nanotubes and is targeting several additional nanoscale materials.

Australia’s DHA’s recommendations are well-balanced. Business and commercialization needs are recognized even though human and environmental, health, and safety regulatory needs are given priority. However, the paper largely ignores the most difficult topic in this space—whether nanoscale versions of “existing” chemicals already on the Australian Inventory of Chemical Substances should be considered “new” chemical substances for regulatory purposes, as suggested by Ludlow, Bowman, and Hodge in their review of Australia’s regulatory framework for nanotechnology, thus triggering pre-market approval requirements prior to commercialization. This issue has been argued back and forth in the US, the EU and other jurisdictions for quite some time, and it is unlikely that Australia will be able to avoid similar strong debate. It is perhaps the biggest issue facing regulators seeking to modify Australia’s industrial chemical legislative framework to fully cover both “new” and “existing” nanoscale materials.

Beyond the substantive regulatory changes noted above, the paper does an excellent job of explaining what “industrial nanomaterials” are, their current regulatory status in Australia, and national and international regulatory activities for nanoscale materials. Moreover, the paper is written in sharp, clear language. It provides lots of key questions for stakeholders to consider when thinking about these issues, as well as surveys and questionnaires encouraging feedback and input. The Australian Government is also sponsoring public consultation activities in most of the country’s larger metropolitan areas to explains the paper to stakeholders first-hand and to solicit additional input.

References

National Industrial Chemical Notification and Assessment Scheme (Department of Health and Aging, Australian Government). Proposal for Regulatory Reform of Industrial Nanomaterials. Public Discussion Paper. November 2009. Available from NICNAS. http://www.nicnas.gov.au/Current_Issues/Nanotechnology/Stakeholder_Consultation.asp

Ludlow K, Bowman DM, and Hodge GA. 2007. A Reveiw of Possible Impacts of Nanotechnology on Australia'a Regulatory Framework. Monash Centre for Regulatory Studies, Monash University, Melbourn.
 

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Battelle Memorial Institute, the University of Washington, and the University of Oregon are co-sponsoring the international Nanotechnology Health and Safety Forum (NHSF) in Seattle, Washington on June 8 - 9, 2009.  The NHSF is coinciding with the first world-wide meeting of the International Organization for Standardization (ISO) TC 229 -- Nanotechnologies being held in the United States, and will take place at the Bell Harbor International Conference Center.

Topics covered at the NHSF will include:

• The EHS Progress Report: today's status and tomorrow's next steps
• International Standards: developing a timeline & milestones
• Navigating Regulations: encouraging dialogue between Europe, Asia, and the U.S.
• Safety Guidelines: state of the science and recommended occupational safety guidelines for working with nanomaterials
• Managing Risk: the insurance industry perspective
• What's New: current activities of innovative nano-manufacturers

I have been invited to speak on the insurance/managing risk panel along with speakers from Riddell Williams, Hunton & Williams, Zurich North America, and Chubb Insurance:

The availability of insurance for entities using nanotechnology is critical to the further development and application of nanomaterials in industry. Yet the widening use of nanotechnology (while toxicology remains to be determined) is a central concern for the global insurance industry. Insurance, Nanotechnology, and Risk addresses the prospects for managing nano risk through the perspectives of a Silicon Valley loss control specialist, a major international underwriter, and liability / coverage counsel.

This should be a great conference with an international focus; plus Seattle in June is going to be a lot of fun. Hope to see you there.

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SPEECH OF
HON. MICHAEL M. HONDA
OF CALIFORNIA
IN THE HOUSE OF REPRESENTATIVES
TUESDAY, FEBRUARY 3, 2009

Mr. HONDA. Madam Speaker, I rise today to discuss the introduction of the Nanotechnology Advancement and New Opportunities (NANO) Act.

The NANO Act is a comprehensive bill to promote the development and responsible stewardship of nanotechnology in the United States. The legislation draws upon the work of the Blue Ribbon Task Force on Nanotechnology, a panel of California nanotechnology experts with backgrounds in established industry, startup companies, consulting groups, non-profits, academia, government, medical research, and venture capital that I convened with during 2005.

Nanotechnology has the potential to create entirely new industries and radically transform the basis of competition in other fields, and I am proud of my work with former Science Committee Chairman Sherry Boehlert on the Nanotechnology Research and Development Act of 2003 to foster research in this area.

But one of the things I have heard from experts in the field is that while the United States is a leader in nanotechnology research, our foreign competitors are focusing more resources and effort on the commercialization of those research results than we are.

In its report Thinking Big About Thinking Small, which can be found on my website, the Blue Ribbon Task Force on Nanotechnology made a series of recommendations for ways that the nation can promote the development and commercialization of nanotechnology. The NANO Act includes a number of these recommendations.

In addition, the bill addresses concerns that have been raised about whether the federal government is doing enough to address potential health and safety risks associated With nanotechnology. The NANO Act requires the development of a nanotechnology research strategy that establishes research priorities for the federal government and industry that will ensure the development and responsible stewardship of nanotechnology. This strategy will help to resolve the uncertainty that is one of the major obstacles to the commercialization of nanotechnology--uncertainty about what the risks might be and uncertainty about how the Federal government might regulate nanotechnology in the future.

The NANO Act also includes a number of provisions to create partnerships, raise awareness, and implement strategic policies to resolve obstacles and promote nanotechnology. It will: create a public-private investment partnership to address the nanotechnology commercialization gap; establish a tax credit for investment in nanotechnology firms; authorize a grant program to support the establishment and development of nanotechnology incubators; establish a Nanoscale Science and Engineering Center for ``nano-CAD'' tools; establish grant programs for nanotechnology research to address specific challenges in the areas of energy, environment, homeland security, and health; establish a tax credit for nanotechnology education and training program expenses; establish a grant program to support the development of curriculum materials for interdisciplinary nanotechnology courses at higher education institutions; direct NSF to establish a program to encourage manufacturing companies to enter into partnerships with occupational training centers for the development of training to support nanotechnology manufacturing; and call for the development of a strategy for increasing interaction on nanotechnology interests between DOE national labs and the informal science education community.

I look forward to working with Science and Technology Committee Chairman Gordon to incorporate these provisions as his committee works to reauthorize the Nation's nanotechnology research and development program.
 

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