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S. 3187, “Food and Drug Administration Safety and Innovation Act” passes in Senate

Prior to adjourning for the Memorial Say recess, the Senate, on 05/24/2012, by a vote of 96-1, passed  S. 3187, the "Food and Drug Administration Safety and Innovation Act", " To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and medical devices, to establish user-fee programs for generic drugs and biosimilars, and for other purposes", after previously adopting an amendment in the nature of a substitute-  an amendment in the nature of a substitute strips all of the language of a bill following the enacting clause and replaces it with new language – offered by Senator Tom Harkin (D-Iowa). Included as part of the language of the amendment was Title XI – Other Provisions, Subtitle C- Misc. Provisions, Section 1133, "Nanotechnology Regulatory Science Program":

SEC. 1133. NANOTECHNOLOGY REGULATORY SCIENCE PROGRAM.

    (a) In General- Chapter X (21 U.S.C. 391 et seq.) is amended by adding at the end the following:

`SEC. 1013. NANOTECHNOLOGY REGULATORY SCIENCE PROGRAM.

    `(a) In General- Not later than 180 days after the date of enactment of the Food and Drug Administration Safety and Innovation Act, the Secretary, in consultation as appropriate with the Secretary of Agriculture, shall establish within the Food and Drug Administration a Nanotechnology Regulatory Science Program (referred to in this section as the `program’) to enhance scientific knowledge regarding nanomaterials included or intended for inclusion in products regulated under this Act or other statutes administered by the Food and Drug Administration, to address

International Center for Technology Assessment et al v. Hamburg

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 …

White House Issues Nanotechnology EHS Policy Statement

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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Request for Public Comments on the 2010 NNI Strategic Plan

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 …

Wisconsin Legislature to Study Potential Regulation of Nanomaterials

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.…

President’s Council Evaluates National Nanotechnology Initiative

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 …

Australia Considers Proposal for Nano-Regulatory Reform

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 …

Private Spending on Nano Exceeds Government Spending for First Time

Chemical Business NewsBase recently published an article comparing global private funding to government funding for nanotechnology research, development, and commercialization. The article cites Lux Research figures indicating that private funding for nanotechnology reached $9.6 billion in 2008, while government investment was $8.6 billion. According to the article, this was the first year that private spending exceeded public spending. Lux also estimates that nanotechnology-enabled products will constitute a $3.1 trillion market by 2015.

It is interesting to remember that a decade ago, advocates for dramatically increased federal funding of nanotechnology efforts argued that once nanotechnology is firmly established as a field of commerce, federal investment would be dwarfed by private research and development which was estimated would be 10% of ultimate sales revenues. Advocates of the National Nanotechnology Initiative took the position that the federal government should stimulate and support basic nanotechnology research until such time as private commercialization takes root at this level. Annual global government research, development, and commercialization was then estimated at a mere $432 million.

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Nanotechnology Health and Safety Forum — Seattle, June 8 – 9, 2009

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 …

Representative Honda Introduces Nanotechnology Advancement and Opportunities Act

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 …

EPA’s Nanoscale Materials Stewardship Program Receives New Submissions

The first phase of EPA’s voluntary Nanoscale Materials Stewardship Program (NMSP) closes on Monday.  For those keeping track, the most up-to-date NMSP participation statistics as of July 24, 2008 follow.  It is shaping up to be a very respectable list of participants.

Submissions Under Basic Program: (9 submissions – covering 68 nanoscale materials) DuPont; Nanophase Technologies Corporation; Nantero; Office ZPI; Quantum Sphere; Strem Chemicals; Swan Chemicals Inc.; Unidym; and one Confidential Business Information Submission.

Commitments to Submit Information Under Basic Program: (11) Arkema; BASF Corporation; Bayer Material Science; Dow Chemical; Evonik/Degussa; General Electric; International Carbon Black Association; Nanocyl North America; PPG Industries; Sasol North America; and Synthetic Amorphous Silica and Silicate Industry Association.

Commitments to Participate in the In-Depth Program: (2) Swan Chemicals Inc.; and Unidym.…

Nanotechnology Advancement and New Opportunities Act

Nanowerk News is reporting that Representative Mike Honda (D-San Jose) introduced HR 3235, the Nanotechnology Advancement and New Opportunities (NANO) Act.  The legislation is to "promote the development and responsible stewardship of nanotechnology in the United States."  Representative Honda drew on the report, "Thinking Big About Thinking Small"  when drafting the legislation for Congressional consideration.…

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