Nano Regulatory

A regulatory outlook for “NanoSafety”

Kimberly Begley Jeskie Operations Manager Physical Sciences Directorate

American Chemical Society Fall 2007 National Convention

OAK RIDGE NATIONAL LABORATORY U. S. DEPARTMENT OF ENERGY

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• 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

Numerous government agencies and organizations are exploring options for regulating engineered nanoscale materials


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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_Needs_Engineered_Nanoscale_Materials.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


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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.


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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

• General interpretation that no current changes to RCRA or CERCLA. - Research being funded in treatment, disposal - Agency points to changing characteristics under

RCRA based on particle size • Regulation of silver nanomaterials used in

consumer products as “germ-killing agents. Under FIFRA

• EPA is holding a “Pollution Prevention through Nanotechnology Conference”

• September 25-26, 2007


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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


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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

- Communication initiated by manufacturers


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Miscellaneous examples are arising from Congress and individual states The Berkeley NanoReg

• Asked for letter to be sent to elected officials pushing for percentage of funding set aside for ES&H research

• “require all businesses that manufacture or use nanoparticles to submit a written report of the current toxicology of the nanomaterials reported, and methods for safe handling, monitoring, containing, disposing, and tracking the inventory, thus assisting with prevention and mitigation of releases”

HR 3235, the Nanotechnology Advancement and New Opportunities (NANO) Act

• Introduced July 31, 2007 by Mike Honda (D-San Jose)

• “To ensure the development and responsible stewardship of nanotechnology”

• Tax credits for investment in nanotechnology firms

• $30M to EPA for R&D • $30M to Health and Human

Services for R&D


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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


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Public perception and involvement: how much influence will it have? “Principles for the Oversight of Nanotechnologies and Nanomaterial” • Released July 31, 2007 • Available at http://www.foe.org/

pdf/Nanotech_Principles.pdf • Interest groups from numerous

countries. Among the list are Greenpeace, United Steelworkers and Friends of the Earth.

• Report espouses 8 basic principles

• Precautionary foundation – “no health and safety data, no market”

• Mandatory nano-specific regulations, esp. environmental and retroactive

• Health and safety of the public and workers – employer proactive action and worker involvement in nanosafety without fear of retaliation

• Environmental Sustainability – lifecycle assessment prior to commercialization

• Transparency (to the consumer) – labeling publicly accessible inventory for health and safety information

• Public participation – technology driven by process involving informed public

• Inclusion of broader impacts – social impact, ethical assessment equity

• Manufacturer liability – including distributors of products


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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


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• 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

Numerous government agencies and organizations are exploring options for regulating engineered nanoscale materials

Technology

Nano Regulatory