Nano Regulatory

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Nano Regulatory

  1. 1. A regulatory outlook for “NanoSafety” Kimberly Begley Jeskie Operations Manager Physical Sciences Directorate American Chemical Society Fall 2007 National Convention
  2. 2. Numerous government agencies and organizations are exploring options for regulating engineered nanoscale materials •  National Nanotechnology Initiative •  Occupational Safety and Health Administration •  National Institute of Occupational Safety and Health (later talk) •  Environmental Protection Agency •  ANSI •  Food and Drug Administration •  Congress and Individual States •  European Union •  Department of Energy OAK RIDGE NATIONAL LABORATORY U. S. DEPARTMENT OF ENERGY 2
  3. 3. The National Nanotechnology Initiative “federal R&D program established to coordinate the multiagency efforts in nanoscale science, engineering, and technology” •  Interim document for priorities in EH&S research needs currently out for comment through September 17, 2007 •  http://www.nano.gov/ Prioritization_EHS_Research_Nee ds_Engineered_Nanoscale_Materi als.pdf •  Lists 25 priorities -  Instrumentation, metrology analytical methods -  Nanomaterials in human health -  Nanomaterials in the environment -  Health and environmental exposure assessment -  Risk management methods •  The initiative, as a whole is guiding Federal investments in R&D for basic research, applied research, safety and health and to some degree the regulatory framework OAK RIDGE NATIONAL LABORATORY U. S. DEPARTMENT OF ENERGY 3
  4. 4. Occupational Safety and Health Administration •  NanoSafety highlighted as early as 2004 in OSHA planning sessions •  In February 2007 Inside OSHA reported that OSHA plans no regulatory action in 2008 and is working with NIOSH •  Highlighted in the Department of Labor 2006-2011 Strategic Plan -  “knowledge workers” with specialized skills and training •  The administration is taking public criticism for what is perceived as not taking action…more later on this. OAK RIDGE NATIONAL LABORATORY U. S. DEPARTMENT OF ENERGY 4
  5. 5. Environmental Protection Agency “supporting research while evaluating its regulatory responsibility to protect environment and human health” •  Nanoscale Materials Stewardship Program -  Developed under TSCA framework -  Intended to establish scientific foundation for regulatory decisions -  Would include voluntary inventory collection -  New chemical determination on a case-by-case basis -  http://epa.gov/oppt/nano/nmspfr.htm -  Public comments accepted through September 10, 2007 •  Working with Organization for Economic Cooperation and Development (OECD) -  International -  Safe testing and testing guidelines -  Voluntary and regulatory schemes •  EPA is holding a •  General interpretation that no current changes “Pollution to RCRA or CERCLA. Prevention through -  Research being funded in treatment, disposal Nanotechnology -  Agency points to changing characteristics under RCRA based on particle size Conference” •  Regulation of silver nanomaterials used in •  September 25-26, consumer products as “germ-killing agents. 2007 Under FIFRA OAK RIDGE NATIONAL LABORATORY U. S. DEPARTMENT OF ENERGY 5
  6. 6. American National Standards Institute Nanotechnology Standards Panel “development of standards in the area of nanotechnology” •  Has been in place since 2004 •  Focus areas -  Nomenclature/ terminology -  Materials properties -  Testing, measurement and characterization •  Appears to have been lots of activity in the nomenclature and morphology areas. Additional progress unclear •  Established TAG to ISO TC 229 •  http://www.ansi.org/ standards_activities/ standards_boards_panels/ nsp/overview.aspx?menuid=3 OAK RIDGE NATIONAL LABORATORY U. S. DEPARTMENT OF ENERGY 6
  7. 7. Food and Drug Administration Nanotechnology Task Force “established to determine adequacy and application of regulatory authorities” •  Established in August of 2006. •  Task force report issued July 2007 -  http://www.fda.gov/ nanotechnology/ •  Cites need to pay attention to emerging science to predict and prepare for types of products •  Calls for timely development of a transparent, consistent, and predictable regulatory pathway -  No immediate need for additional labeling -  Products that normally do not require pre-market authorization requirements -  Public input on adequacy of FDA’s policies for certain products containing nanoparticles OAK RIDGE NATIONAL LABORATORY -  Communication initiated by U. S. DEPARTMENT OF ENERGY manufacturers 7
  8. 8. Miscellaneous examples are arising from Congress and individual states The Berkeley NanoReg HR 3235, the Nanotechnology Advancement and New Opportunities (NANO) Act •  Asked for letter to be sent to •  Introduced July 31, 2007 by elected officials pushing for Mike Honda (D-San Jose) percentage of funding set aside for ES&H research •  “To ensure the development and responsible stewardship •  “require all businesses that of nanotechnology” manufacture or use nanoparticles to submit a •  Tax credits for investment in written report of the current nanotechnology firms toxicology of the nanomaterials reported, and •  $30M to EPA for R&D methods for safe handling, monitoring, containing, •  $30M to Health and Human disposing, and tracking the Services for R&D inventory, thus assisting with prevention and mitigation of releases” OAK RIDGE NATIONAL LABORATORY U. S. DEPARTMENT OF ENERGY 8
  9. 9. International Focus on NanoSafety •  International Organization for Standardization -  ISO/TC 229 commissioned in 2005 with strong delegation from ANSI -  Development of “science- based health, safety and environmental practices” ANSI has lead on this subcommittee •  United Nations -  Environmental Program has expressed concern for ES&H implications of nanoparticals -  Has called for treaties to establish mutually agreed upon standards •  European Union -  Performing a regulatory inventory OAK RIDGE NATIONAL LABORATORY U. S. DEPARTMENT OF ENERGY 9
  10. 10. Public perception and involvement: how much influence will it have? “Principles for the Oversight of Nanotechnologies and Nanomaterial” •  Released July 31, 2007 •  Health and safety of the public and workers – employer proactive •  Available at http://www.foe.org/ action and worker involvement in pdf/Nanotech_Principles.pdf nanosafety without fear of retaliation •  Interest groups from numerous countries. Among the list are •  Environmental Sustainability – Greenpeace, United Steelworkers lifecycle assessment prior to and Friends of the Earth. commercialization •  Report espouses 8 basic •  Transparency (to the consumer) – principles labeling publicly accessible inventory for health and safety •  Precautionary foundation – “no information health and safety data, no market” •  Public participation – technology •  Mandatory nano-specific driven by process involving regulations, esp. environmental informed public and retroactive •  Inclusion of broader impacts – social impact, ethical assessment equity •  Manufacturer liability – including distributors of products OAK RIDGE NATIONAL LABORATORY U. S. DEPARTMENT OF ENERGY 10
  11. 11. Department of Energy Nanoscience Centers “Providing the Nation with resources unmatched anywhere else in the world” •  Issued Policy Statement 456.1 in 2005 -  Adopt emerging consensus standards -  Identify and manage potential health and safety hazards and potential environmental impacts -  Stay informed -  Support ES&H research in the area •  February 2007, 10 CFR 851 issued with a placeholder called “NanoSafety” •  Talk of a “Nano Order” currently on hold supporting use of guidelines document established by working group OAK RIDGE NATIONAL LABORATORY U. S. DEPARTMENT OF ENERGY 11
  12. 12. Numerous government agencies and organizations are exploring options for regulating engineered nanoscale materials •  National Nanotechnology Initiative •  Occupational Safety and Health Administration •  National Institute of Occupational Safety and Health (later talk) •  Environmental Protection Agency •  ANSI •  Food and Drug Administration •  Congress and Individual States •  European Union •  Department of Energy OAK RIDGE NATIONAL LABORATORY U. S. DEPARTMENT OF ENERGY 12

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