Nanotechnology in Agriculture and Food Production: An Analysis of R

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Nanotechnology in Agriculture and Food
Production An Analysis of RDFPA meeting
Food Nanomaterials Regulatory and Policy
InsightsSeptember 18, 2006

• Jennifer Kuzma and Peter VerHage
• Center for Science, Technology, and Public Policy
• University of Minnesota

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Nanotechnology What is it?

• Its small, its diverse, conglomerate of
  existing fields, perhaps unified by new tools to
  manipulate atoms and molecules
• The National Nanotechnology Initiative listed the
  following three criteria for defining
  nanotechnology
• 1) research and technology development at the
  atomic, molecular or macromolecular levels, in
  the length scale of approximately 1 - 100
  nanometer range, (1 nm is 80,000th thickness of
  human hair)
• 2)creating and using structures, devices and
  systems that have novel properties and functions
  because of their small and/or intermediate size,
  and
• 3) ability to control or manipulate on the atomic
  scale.
• Creation of nanomaterials by Top Down or
  Bottom Up approaches

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Abbreviated History of Nanotechnology

• Year 2000 National Nanotechnology Initiative
  (NNI) was born, 270 M for RD
• Unusual, multidisciplinary federal initiative
• Not really mission-based
• Year 2006 NNI continues, approximately 1.2 B for
  RD, including approximately 4 of NNI budget for
  social and ethical implications
• Despite this funding, no comprehensive U.S.
  oversight policy for nanotechnology
• Applications too diverse? (like biotech)
• Agencies and laws too broad and diverse? (like
  biotech)
• Product not process issues? (like biotech)
• Wait and see, and using existing laws are the
  current approaches
• Dangers of moving too fast and overpromising with
  nanotechnology (like biotech)

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Why Agrifood Nanotechnology?

• Holds promise for more sustainable and safer
  methods of food and fiber production
• Lots of potential applications, a few on the
  market
• But currently, little attention to oversight
  issues
• Little information about RD and products in the
  public domain (CBI, IPR)
• Lessons learned of transparency in product review
  and oversight process from agricultural
  biotechnology
• Safety studies lacking or not in public domain
• Lessons learned of need for independent research
  and safety studies from agricultural
  biotechnology
• Overlapping or missing jurisdiction for products?
  (e.g. premarket testing)
• Lessons learned with emerging products in
  agricultural biotechnology
• Food and humans have a special relationship tied
  to both necessity and culture.
• Lessons from EU vs. US position on GEOs in food
  and agriculture

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What Do People Care About with Regard to Risk?

• People do not care only about the number of
  deaths and injuries.
• They also care about
• Equity
• Controllability
• Voluntary or involuntary exposure
• Time Frame Immediate or delayed
• Intergenerational effects
• Nature and extent of Knowledge
• (multiple works of social psychologists, P.
  Slovic, Decision Research, and B. Fischoff, CMU)

Unknown

Unknown
PVC
PVC
DNA Technology
DNA Technology
Radioactive Waste
Radioactive Waste
Antibiotics
Antibiotics

Dread

Dread
Auto Exhaust
Auto Exhaust
Coal Mining
Coal Mining
Bicycles
Bicycles
Home Swimming
Home Swimming
Pools
Pools
et al, 1980
Slovic
These perception factors affect perception of
food and agricultural risks
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Example Agricultural Applications
J. Kuzma
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Example Food Applications
J. Kuzma
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Food Industry and Nanotechnology

• Helmut Kaiser report (http//www.hkc22.com/nanofoo
  d.html)
• More than 180 applications are in different
  developing stages and a few of them are on the
  market already. The nanofood market is expected
  to surge from 2.6 bn. US dollars today to 7.0 bn.
  US dollars in 2006 and to 20.4 bn. US dollars in
  2010. More than 200 Companies around the world
  are today active in research and development
• KraftNanoteK Consortium 2000 (as reported in
  Small Times, 2002)
• nanocapsules for nutrient and / or additive
  delivery
• smart nano-based product packaging and
  nanodevices to track food origins and freshness.
• 15 Universities/public laboratories (Harvard,
  Connecticut, and Nebraska universities,
  Chicago-based Argonne laboratories and the Los
  Alamos Lab)
• Heinz, Hershey, Nestle, Unilever, Keystonemainly
  research (Forbes 2005).
• Nestle and Unilevernanoemulsions to make foods
  more uniform
• Nestlenutraceutical delivery

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Food and Agriculture Products on Market or Near
to Commercialization

N. Savage and J. Kuzma
 n1FYI-dietary supplements Website contains
disclaimer (if you look hard enough!) that
products and claims are not FDA approved because
they are marketed as dietary supplements, not
food or drugs.  n2FYIFDA pre-market review
would be required under the Food Drug and
Cosmetic Act if used in bottled water.  n3It
would be appropriate to indicate source of this
information. FDA is precluded by law from
providing information on drugs under
consideration. One could come to the conclusion
in this table that FDA provided the
information.  n4Same comment as for
StarPharma.  n5Company marketing as FDA
authorized but it is not authorized by FDA.
True statement is that FDA provided that material
is not expected to migrate into food so no FDA
pre-market review was required. The use of the
term authorized is not appropriate.  n6  n7
 n8  n9  n10 FDA has not reviewed any
claims so it is not appropriate to state that
product complies with FDA.
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PI Interest in Agrifood Nanotechnology

• Still time with agrifood nanotechnology to do a
  better job of engaging the public, stakeholders,
  farmers, consumers, and researchers before
  technologies are widely adopted, in order to
  ensure that the benefits are maximized and the
  risks minimized, and that other issues
  (socioeconomic, ethical, consumer rights) are
  discussed or addressed.
• Time for independent study of oversight models
  for agrifood nanotechnology
• Generally more talk and acceptance of the need
  for public information and dialogue early and
  often

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Forward looking approaches
EHS Health/environmental risk
Large Societal changes
Worker Safety
Technology funding, development, incentives
Human rights
Norms, standards
Social/Ethical
Near Medium Long
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Bottom Up Method for StudyingAgrifood
Nanotechnology Oversight

• Phase 1 Start with RD database
• Assessment of research and development in
  nanotechnology as applied to food, agriculture,
  and agroecosystems
• Phase 2 Select individual products
• Selection of case studies and qualitative
  risk/benefit issue identification
• Phase 3 Assess individual products, extrapolate
  up
• Analysis of regulatory or non-regulatory
  governance systems for agrifood applications

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Inventory phase
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Methodology for inventory

• Search publicly available databases and websites
• Nano and food or agriculture as search terms
• USDA-CRIS, PTO, EPA, NIH, DOE, DOD, DHS, NSF
• 2000-Fall 2005
• Used or adjusted USDA categories for research,
  techniques, and topics as specified in 2003
  report, Nanoscale Science and Engineering for
  Agriculture and Food Systems.
• Formed own criteria for other categories, such as
  type of research, time to commercialization,
  qualitative risk/benefit ranking, exposure
  endpoints, sectors in the food supply continuum,
  etc.
• 160 projects were found using the search terms
• 121 entries were sent to PIs for review

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Agrifood Nanotechnology Inventory

• Limitations
• Not focused on industrial or consumer products
  (maybe next round should be?)
• Stopped searches in Fall 2005
• Publicly available information
• No investigative reporting
• Reviewed by PIs positively, but limited response
• Categorization based on available information and
  PI knowledge/experience
• Strengths
• Good start to getting compiled information,
  analysis, and dialogue in public domain
• Independent analysis (e.g. PIs have no vested
  interest in this topic, such as stock holdings,
  products being developed, ties to agencies, etc,)

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Agrifood Criteria

• Does this fit nanotech?
• After reading the project abstract, objectives,
  and additional information, we are using the
  three criteria of the NNI definition to determine
  whether the project fits the definition of
  nanotechnology. If so, the box is checked. In
  some cases, there is not enough information to
  determine, and we note this in the comment box.
• Does this fit agrifood?
• Nanotechnology should be applied to or used to
  study agriculture, food, forestry, or
  agroecosystems for this box to be checked.
  Sometimes the project description is vague, or
  the work is broad to determine whether it fits.
  This is noted in the comment box.
• 14 of 160 projects were questionable, but left
  in for this first round in the database.

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Pre-Harvest example from database

• Adhesin-specific Nanoparticles for removal of
  Camplyobacter from poultry Latour et al.
  Clemson University
• Block bacterial colonization in poultry guts and
  remove these important human pathogens on the farm

Nanoparticles bind and block this interaction
    . Photo from Dr. Gary E. Kaiser,
http//student.ccbcmd.edu/gkaiser/goshp.html
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Agroecosystem example from database

• Using Nanotechnology to identify and characterize
  hydrological flowpaths in agricultural landscapes
  (Walter, et al. Cornell University)
• Encapsulated DNA and PCR detection--use the vast
  diversity of DNA sequences for finer resolution
  of flows in order to address non-point source
  pollution

    . Photo from Quinn et al. http//www.ncl.ac.uk
/wrgi/TOPCAT/TCTheory.html
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Post-Harvest example from database

• Application of nanotechnolgy, antimicrobial, and
  polymer films in food safety and quality (Dawson,
  Clemson University)
• Antibodies attached to nanoparticles to target
  and detect bacterial pathogens
• Nanoparticles luminesce for detection and films
  contain biocides (EDTA, lysozyme)

Picture from CSIRO http//www.cmit.csiro.au/brochu
res/tech/nanotech/
Picture from Particle Engineering and Research
Center, UFL http//www.erc.ufl.edu/research/signif
icant.asp
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Consumer product example from database

• Cellulose Nanocrystal Composites (Simonsen, OSU)
• Stronger than steel or alumium

AFM image of cellulose nanocrystal film,
Simonsen, http//woodscience.oregonstate.edu/facul
ty/simonsen/
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Multi-sector example

• Nano-and Micro-encapsulation of Food Additives
  and Agrochemicals
• SBIR Phase 1, LNK Chemsolutions
• Timed release of drugs, agrochemicals,
  nutraceuticals, and probiotics
• Bioerodible capsules-
• 1-Naphthalene Acetic acid (NAA, the target
  agrochemical) in chitosan
• Gum arabic/maltodextrin formulation for the shell
  of citral capsules

Marie, et al. Biomolecules, 2002, Chitosan
nanocapsule
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Techniques and Topics for Projects
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USDA Research Areas for Agrifood Nanotechnology
Projects
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Estimated Time to Commercialization and
Types of Research in Agrifood Nanotechnology
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55
17
25
Sector of Food Supply Chain
Possible Exposure Endpoints
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Risks and Benefits

• Environmental/Ecological Risks or Health Risks
• Low
• If exposure to humans, animals or the environment
  is minimal and the particles are generally
  non-toxic, we categorize the risk as low.
• Medium
• If exposure to humans, animals or the environment
  is minimal OR the particles are generally
  non-toxic we categorize risk as medium. In this
  category, there are relatively benign particles
  that are widely used in food and agriculture.
  Likewise, a toxic particle that is meant to stay
  in the lab or processing plant could also be in
  this category. In the cases of nanotechnology
  applied to biobased products, medium was used
  for environmental or ecological risks with the
  question of whether harvesting and processing are
  done in a sustainable way (i.e. life cycle
  issues).
• High
• Exposure to humans, animals or the environment is
  widespread and particles show toxicity or are
  expected to be toxic.

• Environmental/Ecological or Health Benefits
• Low
• Application or research not meant to improve
  human or animal health, or the environment.
• Medium
• Application or research might improve health, or
  the environment, but not explicitly developed for
  that purpose or for addressing a great societal
  problem.
• High
• Application or research specifically developed to
  address an important societal need for improving
  health or the environment.

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Health Risks and Benefit Qualitative Ranking
Risk
Benefit
45
14
25
55
61
Environmental Risks and Benefit Qualitative
Ranking
25
14
49
Low
Medium
High
75
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Health Risks and Benefits for Projects including
Consumers as Exposure Endpoints (n77)
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Key Results of Agrifood Inventory

• Large focus on food packaging and sensing for
  foodborne pathogens
• Focus on retail and consumer applications
• Generally, more of a focus on health benefits,
  than on environmental benefits.
• No high risk projects, according to our
  criteria of toxic materials under widespread use
• Most projects are applied, and projected to be
  commercial in 5-15 years.
• Database can be mined in various ways to focus
  EHS research

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Other ways to mine database

• Particles of interest

• Private vs. public

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Bottom Up Method for StudyingAgrifood
NanotechnologyOversight

• Phase 1 Start with RD database
• Assessment of research and development in
  nanotechnology as applied to food, agriculture,
  and agroecosystems
• Phase 2 Select individual products
• Selection of case studies and qualitative
  risk/benefit issue identification
• Phase 3 Assess individual products, extrapolate
  up
• Analysis of regulatory or non-regulatory
  governance systems for agrifood applications

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Phase 2

• Case studies chosen on basis of frequency, sector
  distribution, and risk/benefit issues
• Encapsulation/delivery of food additives
• Encapsulation/delivery of agrochemicals
• Remove pathogens during meat and poultry
  processing
• Biosensors in food packaging material
• Biomolecules in agricultural landscapes as
  tracers
• Nanocrystals for bio-based products
• Both specific nano-materials and general
  application are of interest.
• Nearing completion

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Support for Our Work

• Agrifood Nanotechnology Inventory (phase 1)
• Supported by WWIC-Project on Emerging
  Nanotechnologies and Center for Science,
  Technology, and Public Policy
• Assessment and Governance of Agrifood
  Nanotechnology (phase 2) through October
• Supported by Consortium on Law and Values in
  Health, Environment, and the Life Sciences
• Assessing Oversight Mechanisms for Active
  Nanostructures and Nanosystems Learning from
  Past Technologies in a Social Context.
• NSF-NIRT. 1.2 million over 4 years. (2006-2010)

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Comments, Additions, and Edits Welcome

• Prof. Jennifer Kuzma
• 612-625-6337
• kuzma007_at_umn.edu

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Extra slides if needed for questions
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Techniques

• Transport processesnanomaterials as agents for
  transporting chemicals, molecules, etc.
• Bio-selective surfacesnanomaterials with
  enhanced or reduced ability to bind or hold
  specific molecules and/or organisms.
• Bio-separationnano-materials or -processes with
  ability to separate molecules, biomolecules, or
  organisms.
• Microfluidics/MEMsliquid streams used to
  separate, control, or analyze at the nanoscale.
  They might have special flow properties at this
  scale. Microelectromechanical systems (MEMs) are
  also included here. They are devices with
  channels and wells, electrodes for detection,
  connectors, and fluidic input/output ports.
• Nano-bioprocessinguse of nanoscale technology
  and/or biological processes to create a desired
  compound or material from a defined stock. The
  product itself may be bulk or nanoscale.
• Nucleic acid bioengineeringuse of DNA as
  building blocks to form nano-particles or use of
  nano-particles for genetic engineering.
• Drug deliveryuse of nanoparticles or nanomethods
  to deliver drugs to animals.
• Modelinguse of nanotechnology to build models of
  systems, or the modeling of nanoparticles in
  systems.

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Topics

• Biosensorsuse of nanotechnology for sensors
  based upon biological processes or biological
  molecules, or for detection of biological
  molecules, processes, or organisms.
• Environmental processinguse of nanotechnology
  for studying environmental phenomena, removing
  contaminants in the environment, or
  remediating/reducing waste. Study of
  nanomaterials in the environment too.
• Sustainable agricultureuse of nanotechnology for
  reducing agricultural inputs or outputs that can
  harm the environment or human health (e.g.
  pesticides) or are in short supply (e.g. water)
  or for making products from agriculture in a
  sustainable way.
• Pathogen detectionuse of nanotechnology to
  detect pathogens in surroundings, organisms or
  food.
• Plant/Animal Productionuse of nanotechnology to
  improve the cultivation of plants or animals,
  including via transgenics or cloning.
• Veterinary medicine1use of nanotechnology to
  improve animal health and/or the safety of animal
  derived foods.
• Bioprocessing for fooduse of nanotechnology for
  better food processing or quality.
• Nano-bioindustrial productsuse of nanotechnology
  for developing industrial products from
  agriculture or its by-products.
• 1 Not in USDA Nanoscale Science and
  Engineering 2003 Report.

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USDA Research Areas

• Pathogen and Contaminant Detectionpathogen or
  contaminant detection in agriculture, food, or
  the environment.
• Identity Preservation and Trackingsystems that
  provide producers, processors, and customers with
  information about the practices and activities
  used to produce a particular crop or agricultural
  product. Also, provide information on the origin
  and movement of crops, animals, or products.
• Smart Treatment Delivery Systemsdelivery of
  molecules in agricultural production or
  processing in time-controlled, spatially
  targeted, regulated, responsive, or other precise
  ways. Also, systems could have the ability to
  monitor effects of delivery.
• Smart System Integration for Agriculture and Food
  Processingintegration of a working system with
  sensing, reporting, localization, and control.
  System could be used anywhere along farm to table
  continuum, or at multiple points.
• Nanodevices for Molecular and Cell
  Biologydevices based on or applied to molecular
  and cellular biology that separate, identify,
  study, modify, or sense.
• Nanoscale Materials Science and
  Engineeringdevelopment of novel materials
  through materials science and engineering.
  Work to better understand the behavior and
  properties of nanomaterials.
• Environmental Issues and Agricultural Wastestudy
  of nanoparticles in the environment, such as in
  the transport and bioavailability of nutrients
  and pollutants. Understand transport and
  toxicity of nanoparticles in agricultural
  pollutants. Nanotechnology applied to
  environmental or waste issues.
• Educating the Public and Future
  Workforceeducation about nanotechnology and
  nanoproducts studies on ethical and social
  issues (cited in USDA report, although not
  reflected in USDAs short title of this research
  area) infrastructure support technology
  transfer support public understanding of risks
  and benefits.

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Type of Research and Time Categories

• Type of Research
• Developmentspecific product cited, largely
  experiments or studies to optimize product
• Appliedspecific application noted, but may also
  lead to better understanding
• Basicfundamental understanding is goal, specific
  application not stated (although there could be
  one in the future)
• Time to Commercialization
• 0-5 years applied/development projects which
  directly address regulatory or product
  optimization issues. The applications of the
  work appear to be very near- term with minimal
  regulatory concerns, or they are already in the
  marketplace and properties are being studied or
  optimized.
• 5-10 years applied/development research that is
  based upon proven technology and for which there
  are not serious safety concerns
• 10-15 yearsapplied research that is in the early
  stages of concept or development
• 15-20 yearsapplied/basic research for which
  applications are not specified, but they can be
  envisioned.
• 20-50 yearsbasic research for which few, if any,
  applications are envisioned, but for which
  fundamental knowledge will eventually lead to
  some.

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Food Supply Chain Sector

• Agroecosystemsapplication for or research on
  agricultural systems, and/or on surrounding
  natural systems.
• Pre-harvestapplication or research on the farm
  or in the forest, during agricultural production.
• Transportationapplication or research dealing
  with transporting agricultural or forest raw
  commodities or products from the farm to the
  processor or retailer.
• Post-harvestresearch or application after
  harvest, at the stage of processing the commodity
  or product
• Retailresearch or application dealing with
  storage, display, etc. at the place where the
  product is sold.
• Consumerresearch or application dealing with the
  consumer end, such as storage and use of
  agricultural products in the home. Also, this
  category is used for research which primarily
  improves the quality of the end product (e.g.
  better taste).
• Post-consumptionresearch or applications for
  after the product is consumed. For example, for
  food safety illness detection.

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Possible Exposure Endpoints for Potential
Products

• Lab workersmost nanomaterial or particles are
  made or studied in the lab at some point. In
  most cases, lab workers will be exposed. The
  study of naturally-occurring nanoparticles would
  be a case in which this box would not be checked.
  
• Farmersfarmers are exposed if the nanomaterial,
  particle, or method is being used on the farm.
• Ecosystemsecosystems are exposed if the
  nanomaterial is used 1) on the farm (animals and
  plants on the farm, or the farm agroecosystem) or
  2) for wide environmental applications, or 3) if
  it is not disposed of properly. We assume that
  material used in manufacturing or the lab is
  disposed of properly. So, if this box is checked,
  it is because the material is intended at some
  point for environmental release.
• Industry Workersindustry workers will be exposed
  during production, manufacture, transport,
  processing, or at the retail/distribution stage.
• Consumersif consumers will likely come in
  contact with the material, this box is checked.
  The applications are either intended for consumer
  products or are left in the material as a result
  of production or processing.
• Othersin some cases, there might be
  sub-populations that are specifically exposed as
  a result of the application or research.
• Unknownthis box is checked when the description
  of the project is too vague, or the applications
  are too broad to determine who will be exposed.

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World-wide investment
Roco, M. Journal Nano Research 7 707 (2005)
43
Global Production
Royal Society report 2004
44
(No Transcript)
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Special Features of NanoparticlesBenefit and
Risk Context
46
Gaps in Oversight?
No pre-market testing Pre-market testing
possible Pre-market testing required
CPSC EPA OSHA FDA USDA
Consumer Products
Chemicals/Particles
Manufacturing
Lack of guidance
Drugs/biologics
Devices
Cosmetics
Agricultural products
Food
TODAY 2006 2010
Adapted from E. Michelson,WWIC
47
Relevant organizations
NNI
National Nanotechnology Coordinating Office (NNCO)
Courtesy of N. Savage, EPA
48
Assembling Nanomaterials
Use biology (DNA)
Use electricity (electrospray)
Use electron beams/ light/chemistry (lithography)
Use tools (AFM)
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NNI funding for FY 2007

• Cut total by 2
• But, bigger share going to EPA for Environmental
  Health and Safety research
• 9 million of 1.275 billion, but 80 increase
• 21 less for DOD (345 million)
• 25 more for DOE (258 million)