Nanotecnologia

1. Agrifood Nanotechnology:Agrifood Nanotechnology:
Upstream Assessment of Risk andUpstream Assessment of Risk and
OversightOversight

2. OutlineOutline
Introduction to Nanotechnology & AgrifoodIntroduction to Nanotechnology & Agrifood
ApplicationsApplications
Risk and Oversight IssuesRisk and Oversight Issues
Research on Nano OversightResearch on Nano Oversight
DiscussionDiscussion

3. Nanotechnology: What is it?Nanotechnology: What is it?
Small, Diverse, Conglomerate of ExistingSmall, Diverse, Conglomerate of Existing
Fields (enabling technology)Fields (enabling technology)
Unified by 3 criteriaUnified by 3 criteria

1) research and development at the atomic,1) research and development at the atomic,
molecularmolecular scale of approximately 1 - 100of approximately 1 - 100
nm range (1 billionth of a meter)nm range (1 billionth of a meter)

2)creating and using structures, devices2)creating and using structures, devices
and systems that haveand systems that have novel propertiesnovel properties
because of their small size, andbecause of their small size, and

3) ability to3) ability to control or manipulatecontrol or manipulate on theon the
atomic scale.atomic scale.
Creation of nanomaterials by “Top Down” orCreation of nanomaterials by “Top Down” or
“Bottom Up” approaches“Bottom Up” approaches

5. Assembling NanomaterialsAssembling Nanomaterials
Bottom up or top downBottom up or top down
Use
biology
(DNA)—self assembly/chemical synthesis
Use tools
(Atomic force microscopy)
Use electron beams/
light/chemistry
(lithography)
Use electricity
(electrospray)

6. State of NanotechnologyState of Nanotechnology
2000 National2000 National
Nanotechnology InitiativeNanotechnology Initiative
(NNI), $270 M for R&D—(NNI), $270 M for R&D—

Unusual, multidisciplinaryUnusual, multidisciplinary

Not really mission-basedNot really mission-based
2008 NNI continues, $1.4 B2008 NNI continues, $1.4 B
for R&D, including 4% of NNIfor R&D, including 4% of NNI
budget devoted to socialbudget devoted to social
and ethical implicationsand ethical implications
Congressional hearings onCongressional hearings on
need for more EHS andneed for more EHS and
societal work (2008)societal work (2008)
Despite this funding, noDespite this funding, no
coordinated U.S.coordinated U.S.
governance or oversightgovernance or oversight
policy for nanotechnologypolicy for nanotechnology
Time for independent studyTime for independent study
of oversight models forof oversight models for
nanotechnologynanotechnology
More talk and acceptance ofMore talk and acceptance of
the need for publicthe need for public
participation and dialogueparticipation and dialogue
early and oftenearly and often

7. NNI organizationNNI organization
White House/OSTPCongress
PCASTOMB
Nanoscale Science, Engineering and
Technology Subcommittee
Independent Agencies
CPSC, EPA, FDA, ITIC,
NASA, NIH, NIOSH, NIST,
NRC, NSF, OMB, PTO
Departments
DHS, DHHS, DOC, DOD,
DOE, DOJ, DOS, DOT.
DOTreas, USDA
Nano Health and Environ.
Impacts (NEHI)
Nano Innovation and
Industry Liaison (NIIL)
Global Issues In
Nanotechnology
(GIN)
Nano Public Engagement
Group (NPEG)
Congress
PCASTOMB
Nanoscale Science, Engineering and
Technology Subcommittee
Independent Agencies
CPSC, EPA, FDA, ITIC,
NASA, NIH, NIOSH, NIST,
NRC, NSF, OMB, PTO
Departments
DHS, DHHS, DOC, DOD,
DOE, DOJ, DOS, DOT.
DOTreas, USDA
Nano Health and Environ.
Impacts (NEHI)
Nano Innovation and
Industry Liaison (NIIL)
Global Issues In
Nanotechnology
(GIN)
Nano Public Engagement
Group (NPEG)
National Nanotechnology Coordinating Office (NNCO)
Courtesy of N. Savage, EPA

8. NNI historical budgetNNI historical budget

9. NNI recent BudgetNNI recent Budget

10. Anticipatory GovernanceAnticipatory Governance
Near Medium Long
EHS:
Health/environmental risk
Technology funding, development, incentives
Worker Safety
Large Societal changes
Social/Ethical
Human rights
Norms, standards
Science, Risk, SocietyScience, Risk, Society

11. Parallels to Ag BiotechnologyParallels to Ag Biotechnology
Oversight Policy ChallengesOversight Policy Challenges

Applications diverseApplications diverse

Agencies and laws broad and diverseAgencies and laws broad and diverse

Product not process issuesProduct not process issues

Wait and see, using existing laws is theWait and see, using existing laws is the
current approachcurrent approach

Perils of moving too fast and over promisingPerils of moving too fast and over promising

Distribution of risks and benefits of firstDistribution of risks and benefits of first
generation productsgeneration products

12. Has agricultural biotechnology suffered?
www.isb.vt.edu
Some companies abandoning pharmaceutical production in food cropsSome companies abandoning pharmaceutical production in food crops
Down swing in approvalsDown swing in approvals
Lost trade to EU and other countries with labeling policiesLost trade to EU and other countries with labeling policies
Lack of approval of GE animals in U.S.Lack of approval of GE animals in U.S.
Has the public suffered as a result? Fewer potential Benefits?Has the public suffered as a result? Fewer potential Benefits?

13. Kuzma, JNR
2007
Selected Categories of Nanotechnology Applied to Food and Agriculture
Smart and precision ag
Agriculture Bio-Energy
or Products
Single molecule detection to determine enzyme/substrate
interactions (e.g. cellulases in production of ethanol).
Materials from biomass
Agrochemical
Delivery
Delivery of pesticides, fertilizers, and other agrichemicals
more efficiently (e.g. only when needed or for better
absorption).
Animal
Production
Delivery of growth hormone in a controlled fashion.
Identity preservation and tracking.
Animal or
Plant Health
Detect animal pathogens, such as foot and mouth disease
virus. Detect plant pathogens early.
Animal
Medicine
Deliver animal vaccines.
Plant
Production
Delivery of DNA to plants towards certain tissues (i.e.
targeted genetic engineering).
Food Sensing Detect chemicals or foodborne pathogens; biodegradable
sensors for temperature, moisture history, etc.
Safety Selectively bind and remove chemicals or pathogens.
Packaging Prevent or respond to spoilage. Sensing features for
contaminants or pathogens.
Healthy Food Better availability and dispersion of nutrients,
nutraceuticals, or additives.

14. Agrifood Nano-Products on MarketAgrifood Nano-Products on Market
Glycerin micelles to remove
pesticides
Micelles for functional food
(phytosterols)
Geohumus Soil wetting agent
PrimoMAXX Syngenta
(plant growth regulator)
Several dietary supplements
Traceability of food and feed
FoodExpert-ID DNA chip—bioMérieux
Nanobarcodes , Nanoplex
Technologies, USA
Project on Emerging Nanotechnologies consumer inventory
www.nanotechproject.org
Storage of food with Ag antimicrobialStorage of food with Ag antimicrobial
Cocoa delivery with little sugarCocoa delivery with little sugar
Cooking Oil Quality--nanoceramicCooking Oil Quality--nanoceramic
Nanoclay barriers to ONanoclay barriers to O22 and COand CO22
Omega-3 bakery productsOmega-3 bakery products
Lycopene BASFLycopene BASF

15. Agrichemicals in developmentAgrichemicals in development
FOE 2008

16. ConvergenceConvergence
Nano-Geo-(Bio)-Info technologyNano-Geo-(Bio)-Info technology
Berry et al. 2008

17. Stages of NanoStages of Nano
2001 2005 2010 2020
Systems of
Nanosystems
Robotics
3D networks
Guided
assemblers
Molecular
Nanosystems
Molecules by
design
Evolutionary
systems
Passive
Nanostructures
Coatings,
polymers,ceramic
s
Active
Nanostructures
Transistors
Targeted drugs
Adaptive
structures
Quantum/classical
physics interface
Self-directed,
emergent behaviors
Nano-Bio
Interface
Adapted from M. Roco NSF
Drexler
Rice University
2001 2005 2010 2020
Agrifood applicatinos currently in
passive to early “active” stage

18. Emerging products for trackingEmerging products for tracking
•FoodExpert-ID DNA chip—bioMérieux, France
•80,000 oligonucleotide probes synthesized
onto a glass surface using photolithography.
•specific vertebrate cytochrome b genes
•identification of animal species in sample
•Traceability of food and feed
•Nanobarcodes , Nanoplex Technologies, USA
•Supply chain tracking

19. Special Features of NanoparticlesSpecial Features of Nanoparticles
A double-edged swordA double-edged sword
Promise Pitfalls
Increased surface area Increased reactivity?
Increased bioavailability and targeted to
certain tissues
Increased toxicity?
Lower doses effective Lower doses toxic?
Penetration ability for remediation Impair subsurface ecosystems
Skin, membrane penetration may speed
onset of action
Toxicity through nontraditional routes
of administration?

20. Percent of Neutrophils in BAL 24 hrs after Instillation of TiO2 in Rats
0 500 1000 1500 2000
0
10
20
30
40
50
ultrafine TiO2 (~20nm)
fine TiO2 (~250nm)
saline
Correlation with Particle Mass
Particle Mass, µg
%Neutrophils
J. Finkelstein, presentation 2005

21. Implications Side: Unique Challenges?Implications Side: Unique Challenges?
Distribution in soils, water, airDistribution in soils, water, air

Transport, transformation and fateTransport, transformation and fate

ReactivityReactivity

Unique challenges?Unique challenges?
Impacts on human health--ToxicologyImpacts on human health--Toxicology

Exposure--Inhalation, ingestion,Exposure--Inhalation, ingestion,
contactcontact

Dose-ResponseDose-Response

Bioaccumulation,Bioaccumulation,
biotransformation, bioavailabilitybiotransformation, bioavailability
Impacts on ecosystems and particularImpacts on ecosystems and particular
speciesspecies

Either direct (toxicity)Either direct (toxicity)

Indirect (changes local conditionsIndirect (changes local conditions
or prey)or prey)
Royal Society 2004
Fullerene Toxicity studies

22. Risk analysisRisk analysis
Many being developedMany being developed
(Morgan, Risk Analysis 2005)
BUT…..Little to no data to fill boxes
Data on product safety not in public domain
--Conflict of interest, transparency and intellectual property rights
About 1% to 5% of NNI budget goes to Environmental Health & Safety Research
Frameworks developing

23. Gaps in Oversight?Gaps in Oversight?
CPSC
EPA
OSHA
FDA
USDA
TODAY 2006 2010
No pre-market
testing
Pre-market
testing possible
Pre-market
testing required
Lack of
guidance
Chemicals/Particles
Manufacturing
Devices
Drugs/biologics
Agricultural products
Food
Cosmetics
Consumer Products
Adapted from E. Michelson,WWIC

24. Oversight CharacteristicsOversight Characteristics
Complex mixture of laws andComplex mixture of laws and
featuresfeatures

Some technology based,Some technology based,
others command and controlothers command and control

Mixed burden of proof inMixed burden of proof in
existing regulationsexisting regulations

Some medium based, someSome medium based, some
intent based, someintent based, some
manufacturing & use basedmanufacturing & use based
Existing regulations arguablyExisting regulations arguably
have adequate authority tohave adequate authority to
regulate nanotechnology if soregulate nanotechnology if so
desireddesired
(American Bar Association 2006)(American Bar Association 2006)
• Current resources inadequateCurrent resources inadequate
for existing regulatory structuresfor existing regulatory structures
to oversee nanotechnologyto oversee nanotechnology
• Current statutes orCurrent statutes or
interpretation of them paralyzeinterpretation of them paralyze
regulatory agencies (TSCA andregulatory agencies (TSCA and
burden of proof)burden of proof)
Nano version of existingNano version of existing
products does not triggerproducts does not trigger
regulationregulation
• New law best solutionNew law best solution
(Davies 2006)(Davies 2006)

25. Coordinated Framework for the Regulation ofCoordinated Framework for the Regulation of
Biotechnology Products circa 1986Biotechnology Products circa 1986
AgencyAgency JurisdictionJurisdiction LawsLaws
US Dept. ofUS Dept. of
Agriculture (USDA)Agriculture (USDA)
Plant pests, plants,Plant pests, plants,
veterinary biologicsveterinary biologics
Federal Plant Pest ActFederal Plant Pest Act
(FPPA)—1957(FPPA)—1957
Food and DrugFood and Drug
AdministrationAdministration
(FDA)(FDA)
Food, feed, food additives,Food, feed, food additives,
vet. Drugs, human drugs,vet. Drugs, human drugs,
medical devicesmedical devices
Federal Food, Drug andFederal Food, Drug and
Cosmetic Act (FFDCA)--Cosmetic Act (FFDCA)--
19581958
EnvironmentalEnvironmental
Protection AgencyProtection Agency
(EPA)(EPA)
Microbial and plantMicrobial and plant
pesticides; novel microbespesticides; novel microbes
Federal Insecticide,Federal Insecticide,
Fungicide, andFungicide, and
Rodenticide Act (FIFRA)--Rodenticide Act (FIFRA)--
1947; Toxic Substances1947; Toxic Substances
Control Act (TSCA)--1976Control Act (TSCA)--1976
No “new risks”, no new laws needed, “product not process”

26. Coordinated Framework ProposalCoordinated Framework Proposal
Kuzma ELR 2006
4 arguments for coordinated oversight of nano4 arguments for coordinated oversight of nano
Regulation is an important part of governance for emerging technologicalRegulation is an important part of governance for emerging technological
applications and productsapplications and products
New laws and institutions are not necessary in the near term, much canNew laws and institutions are not necessary in the near term, much can
be done for nanotechnology—political will is main barrierbe done for nanotechnology—political will is main barrier
Coordinated framework for regulation of nano products is possible basedCoordinated framework for regulation of nano products is possible based
on existing statuteson existing statutes
Law is based on policy can be interpreted broadly. There is precendentLaw is based on policy can be interpreted broadly. There is precendent
for doing so.for doing so.

27. PossiblePossible
FrameworkFramework
Kuzma ELR 2006Kuzma ELR 2006
Several roles forSeveral roles for
USDAUSDA

28. Oversight ProgramsOversight Programs
Industry Standards and Guidelines

ICON, ANSI, ISO, IRGC, Foresight Institute

IRGC—industry report—can’t regulate, too much
uncertainty and little data
ED and DuPont partnership Risk Framework 2007
EPA Nanoscale Voluntary Program under TSCA—
implemented 2008
EPA decision to regulate nano-silver emitted from
washing machines as pesticide under FIFRA—2007
REACH EU—Is nano captured?

29. Risk Assessment of EngineeredRisk Assessment of Engineered
NanomaterialsNanomaterials
Helland et al, EST 42:640 (2008)Helland et al, EST 42:640 (2008)
40 German and Swiss companies working with NMs40 German and Swiss companies working with NMs
65% do not perform any risk assessment of their NMs65% do not perform any risk assessment of their NMs
45% no toxicity tests45% no toxicity tests
Participation in the UK’s voluntary program is minimal (DEFRAParticipation in the UK’s voluntary program is minimal (DEFRA
2006)2006)
U.S. voluntary system—as of May 2008U.S. voluntary system—as of May 2008

DuPont and Office ZPI, while 10 other companies haveDuPont and Office ZPI, while 10 other companies have
committed to reporting.committed to reporting.

30. Public InterfacePublic Interface
Focal Groups & ConsensusFocal Groups & Consensus
ConferencesConferences
Studies indicate little knowledge butStudies indicate little knowledge but
general support forgeneral support for
nanotechnology—public seesnanotechnology—public sees
benefits.benefits.
However,However, labeling, mandatorylabeling, mandatory
safety testing and bettersafety testing and better
access to informationaccess to information aboutabout
which nanotechnologies arewhich nanotechnologies are
being publicly funded arebeing publicly funded are
important to publicimportant to public Hart Res. Assoc. 2007

31. What Do People Care About withWhat Do People Care About with
Regard to Risk?Regard to Risk?
People do not care only aboutPeople do not care only about
the number of deaths andthe number of deaths and
injuries.injuries.
They also care aboutThey also care about
- EquityEquity
- ControllabilityControllability
- Voluntary or involuntary exposureVoluntary or involuntary exposure
- Time Frame: Immediate or delayedTime Frame: Immediate or delayed
- Intergenerational effectsIntergenerational effects
- Nature and extent of KnowledgeNature and extent of Knowledge
- (multiple works of social psychologists,(multiple works of social psychologists,
P. Slovic, Decision Research, and B.P. Slovic, Decision Research, and B.
Fischoff, CMU)Fischoff, CMU)
‘Unknown’
‘Dread’
Auto Exhaust
DNA Technology
Radioactive Waste
Bicycles
Home Swimming
Pools
PVC
Coal Mining
Antibiotics
Slovicet al, 1980
‘Unknown’
‘Dread’
Auto Exhaust
DNA Technology
Radioactive Waste
Bicycles
Home Swimming
Pools
PVC
Coal Mining
Antibiotics
Slovicet al, 1980

32. Siegrist, et al 2007
Food packaging
“outside”
Better accepted than food particles
“inside”
Public views dependent onPublic views dependent on
productproduct && trusttrust

33. Looming regulatory policy questions…Looming regulatory policy questions…
1) Should benefits be considered in the regulatory process?1) Should benefits be considered in the regulatory process?

Most agencies do not have authority to do soMost agencies do not have authority to do so

Harm from NOT approving new technologies?Harm from NOT approving new technologies?

Delicate balance—assuring safety and public confidence and allowing technology toDelicate balance—assuring safety and public confidence and allowing technology to
flourish and do good in societyflourish and do good in society
2) How much weight should be placed on potential, but not demonstrated,2) How much weight should be placed on potential, but not demonstrated,
risks?risks?

Cultural differences—EU vs. US on GEOsCultural differences—EU vs. US on GEOs
3) Who should be engaged in setting boundaries and standards?3) Who should be engaged in setting boundaries and standards?

Who should be involved in setting “acceptable” levels of risk?Who should be involved in setting “acceptable” levels of risk?

What risk information is available and generated by independent sources?What risk information is available and generated by independent sources?

Should the public be engaged?Should the public be engaged?
4) What about other factors (e.g. social, cultural, and ethical) should they be4) What about other factors (e.g. social, cultural, and ethical) should they be
considered in oversight processes? If so, how?considered in oversight processes? If so, how?

34. Social & Ethical IssuesSocial & Ethical Issues
Utilitarian, Intrinsic, Structural,Utilitarian, Intrinsic, Structural,
Rights-basedRights-based

Distribution of risks and benefits?Distribution of risks and benefits?
(GEOs parallels)(GEOs parallels)

How far should we go with humanHow far should we go with human
enhancement? (NBIC, Roco 2005)enhancement? (NBIC, Roco 2005)

Technology have and have-nots?Technology have and have-nots?

IPR and ownership impacts?IPR and ownership impacts?

Technology drawing attention awayTechnology drawing attention away
from more sustainable low-techfrom more sustainable low-tech
solutions?solutions?

Privacy issues with surveillance &Privacy issues with surveillance &
detection?detection?
Held together by principles ofHeld together by principles of
justice, equity and fairnessjustice, equity and fairness
Not a distinct separation betweenNot a distinct separation between
risk or technical issues and otherrisk or technical issues and other
onesones
Power relationships within safetyPower relationships within safety
evaluationsevaluations

(Lewenstein 2005; Kuzma in(Lewenstein 2005; Kuzma in
press, Nanoethics)press, Nanoethics)

35. Comprehensive Study of Oversight PolicyComprehensive Study of Oversight Policy
Scientists Technology
Developers Risk
Assessors
Regulatory
Policy
Makers
Practical
S&T
Policy Wonks
Regulatory
Assessors
(CBA focused)
Social
Scientists
S&T
Studies
Political
Scientists
Public Policy
Analysts
Historians
And Philosophers
of Science
Lawyers
Academic
Legal
Studies
Other
Fields?
Input?
Social
Psychology
Who is thinking about oversight in a comprehensive way?
Ethicists
Communication
Experts
Economists

36. Two ApproachesTwo Approaches
Top-Down & Botton UpTop-Down & Botton Up
Anticipatory Oversight PolicyAnticipatory Oversight Policy
Agrifood nano
Lessons from
GEOs
Oversight

37. Why Agrifood Nanotechnology?Why Agrifood Nanotechnology?
Little information about R&D, safety,Little information about R&D, safety,
and products in the public domainand products in the public domain
(CBI, IPR)(CBI, IPR)
Overlapping or missing jurisdiction forOverlapping or missing jurisdiction for
products (e.g. premarket testing)products (e.g. premarket testing)
Food and humans have a specialFood and humans have a special
relationship tied to necessity, culture,relationship tied to necessity, culture,
and environment.and environment.
Distribution of risks and benefits areDistribution of risks and benefits are
often different than for medicaloften different than for medical
applicationsapplications
Need for transparency in productNeed for transparency in product
review and oversight processreview and oversight process
Need for regulatory clarity and holisticNeed for regulatory clarity and holistic
approaches to convergence productsapproaches to convergence products
EU vs. US position on GEOs in foodEU vs. US position on GEOs in food
and agriculture (internationaland agriculture (international
harmonization)harmonization)
Initially, few benefits to those who boreInitially, few benefits to those who bore
any potential riskany potential risk
Need for public information andNeed for public information and
dialogue early and oftendialogue early and often
Holds promise for moreHolds promise for more sustainablesustainable and safer methods of food and fiber productionand safer methods of food and fiber production
Lots of potential applications, a few on the market, but currently, little attention to oversight issuesLots of potential applications, a few on the market, but currently, little attention to oversight issues
Potential Challenges: Lessons (AgBiotech) :
Time for independent study of oversight models for agrifood nanotechnologyTime for independent study of oversight models for agrifood nanotechnology

38. Bottom Up MethodsBottom Up Methods
Agrifood Nanotechnology OversightAgrifood Nanotechnology Oversight
Phase 1*: Start with individual productsPhase 1*: Start with individual products

Inventory, survey, and assessment ofInventory, survey, and assessment of
research and development inresearch and development in
nanotechnology as applied to food,nanotechnology as applied to food,
agriculture, and agroecosystemsagriculture, and agroecosystems
Phase 2:* Select individual productsPhase 2:* Select individual products

Selection of case studies andSelection of case studies and
qualitative risk/benefit issuequalitative risk/benefit issue
identificationidentification
Phase 3: Assess individual products,Phase 3: Assess individual products,
extrapolate upextrapolate up

Analysis of regulatory or non-regulatoryAnalysis of regulatory or non-regulatory
governance systems for agrifoodgovernance systems for agrifood
applicationsapplications
**
Research TopicsResearch Topics
Research TechniquesResearch Techniques
Estimated time to commercializationEstimated time to commercialization
Part of food or product supply chainPart of food or product supply chain
Endpoints of exposureEndpoints of exposure
Qualitative risk/benefit rankingQualitative risk/benefit ranking

39. Methodology for inventoryMethodology for inventory
Public databases and websitesPublic databases and websites

Nano and food or agriculture as search termsNano and food or agriculture as search terms

USDA-CRIS, PTO, EPA, NIH, DOE, DOD, DHS, NSFUSDA-CRIS, PTO, EPA, NIH, DOE, DOD, DHS, NSF

2000-Fall 20052000-Fall 2005
Adjusted USDA categories for research, techniques, and topics asAdjusted USDA categories for research, techniques, and topics as
specified in 2003 report,specified in 2003 report, Nanoscale Science and Engineering forNanoscale Science and Engineering for
Agriculture and Food Systems.Agriculture and Food Systems.
Own criteria for other categories, such as type of research, time toOwn criteria for other categories, such as type of research, time to
commercialization, qualitative risk/benefit ranking, exposurecommercialization, qualitative risk/benefit ranking, exposure
endpoints, sectors in the food supply continuumendpoints, sectors in the food supply continuum
160 projects were found160 projects were found
121 entries were sent to PIs121 entries were sent to PIs for reviewreview

40. Agrifood Nanotechnology InventoryAgrifood Nanotechnology Inventory
LimitationsLimitations

Not focused on industrial or consumer productsNot focused on industrial or consumer products

Stopped searches in Dec. 2005—needs updating on a regular basisStopped searches in Dec. 2005—needs updating on a regular basis

Publicly available informationPublicly available information
No investigative reportingNo investigative reporting

Categorization based on available information and PI knowledge/experienceCategorization based on available information and PI knowledge/experience
Reviewed by PIs positively, but limited response (14%)Reviewed by PIs positively, but limited response (14%)
StrengthsStrengths

Good start to getting compiled information, analysis, and dialogue in publicGood start to getting compiled information, analysis, and dialogue in public
domaindomain

Independent analysis (e.g. PIs have no vested interest in this topic, such asIndependent analysis (e.g. PIs have no vested interest in this topic, such as
stock holdings, products being developed, ties to agencies, etc,)stock holdings, products being developed, ties to agencies, etc,)

41. Techniques for Projects

42. Topics for Projects

43. USDA Research AreasUSDA Research Areas

44. Stage and Type of WorkStage and Type of Work

45. Sector of Food Supply Chain

46. Endpoints of ExposureEndpoints of Exposure
Kuzma & Verhage
PEN 2006

47. Risk and Benefit Qualitative RankingRisk and Benefit Qualitative Ranking

48. Mining the Database to Focus EHS research

49. Other ways to mine databaseOther ways to mine database
Particles of interestParticles of interest Private vs. publicPrivate vs. public
0
20
40
60
80
100
120
140
160
Silver(4)
TiO
2
(4)
CNT
(5)
Fullerenes
(2)
Total
2 5
9028
15
20 EPA
NIH
USDA
PTO (ind.)
PTO (univ)
NSF

50. Key Results of Agrifood InventoryKey Results of Agrifood Inventory
Large focus on food packaging andLarge focus on food packaging and
sensing for foodborne pathogenssensing for foodborne pathogens
Focus on retail and consumerFocus on retail and consumer
applicationsapplications
More of a focus on health thanMore of a focus on health than
environmental benefits. But significantenvironmental benefits. But significant
proportion on environment/ag wasteproportion on environment/ag waste
No “high risk” projects, according toNo “high risk” projects, according to
our criteria of toxic materials underour criteria of toxic materials under
widespread usewidespread use
Most projects applied, and projected toMost projects applied, and projected to
be commercial in 5-15 years.be commercial in 5-15 years.
Database can be mined in variousDatabase can be mined in various
ways to focus EHS researchways to focus EHS research

51. Bottom Up MethodsBottom Up Methods
Agrifood Nanotechnology OversightAgrifood Nanotechnology Oversight
Phase 1*: Start with individualPhase 1*: Start with individual
productsproducts

Inventory and assessment ofInventory and assessment of
research and development inresearch and development in
nanotechnology as applied tonanotechnology as applied to
food, agriculture, andfood, agriculture, and
agroecosystemsagroecosystems
Phase 2:* Select individual productsPhase 2:* Select individual products

Selection of case studies andSelection of case studies and
qualitative risk/benefit issuequalitative risk/benefit issue
identificationidentification
Phase 3:* Assess individualPhase 3:* Assess individual
products, extrapolate upproducts, extrapolate up

Analysis of oversight systemsAnalysis of oversight systems
and issues for selected agrifoodand issues for selected agrifood
applicationsapplications
• Criteria for case selection:Criteria for case selection:
• Frequency of topics and techniques inFrequency of topics and techniques in
databasedatabase
• Sector of supply chainSector of supply chain
• Exposure endpointsExposure endpoints
• Oversight relevanceOversight relevance
• Research Methods:Research Methods:
• Literature searches—Toxnet, Fed Reg, etc.Literature searches—Toxnet, Fed Reg, etc.
• Researcher inquiriesResearcher inquiries
• Case study comparison approachCase study comparison approach

52. Case Study #1Case Study #1
Agroecosystem—Environmental applicationAgroecosystem—Environmental application
Using Nanotechnology to identify and characterize hydrological flowpaths inUsing Nanotechnology to identify and characterize hydrological flowpaths in
agricultural landscapes (Walter, et al. Cornell University)agricultural landscapes (Walter, et al. Cornell University)
Encapsulated DNA and PCR detection--use the vast diversity of DNA sequences forEncapsulated DNA and PCR detection--use the vast diversity of DNA sequences for
finer resolution of flows in order to address non-point source pollutionfiner 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

53. Case Study #1Case Study #1
Risk & Oversight IssuesRisk & Oversight Issues
Risk IssuesRisk Issues
CapsuleCapsule

Generally non-toxicGenerally non-toxic

PLGA-chitosan used in drug-deliveryPLGA-chitosan used in drug-delivery

Dissolve in waterDissolve in water

However, not tested at large scaleHowever, not tested at large scale
environmental releaseenvironmental release
Fate and transport in environmentFate and transport in environment

Information neededInformation needed

PIs are conducting this work in phase IIPIs are conducting this work in phase II
DNADNA

Uptake by microbes?Uptake by microbes?

Persistence and fate in environment?Persistence and fate in environment?

Usually degradedUsually degraded
Oversight IssuesOversight Issues
Broad range of statutesBroad range of statutes

TSCA, CWA, FIFRA, etc?TSCA, CWA, FIFRA, etc?
Lack of certainty about convergenceLack of certainty about convergence
applicationsapplications

Nano-bio-environmentNano-bio-environment
Detection capabilitiesDetection capabilities

For large scale release?For large scale release?
SocietalSocietal

Public perception and concern aboutPublic perception and concern about
large scale release of DNA in thelarge scale release of DNA in the
environmentenvironment

54. Case Study #1Case Study #1
ConclusionsConclusions
Relatively “easy” to find information on nature of particleRelatively “easy” to find information on nature of particle
and researchers’ plans (transparent)and researchers’ plans (transparent)
High degree of uncertainty as to regulatory system &High degree of uncertainty as to regulatory system &
statutesstatutes
Research needs on fate and transport of PLGA and DNAResearch needs on fate and transport of PLGA and DNA
—project included some of these elements—project included some of these elements
High potential for public concern in watershed areas—High potential for public concern in watershed areas—
perception of DNA released into environmentperception of DNA released into environment

55. Case study 2: On-farm plant productionCase study 2: On-farm plant production
Nano-and Micro-encapsulation of Agrochemicals –Nano-and Micro-encapsulation of Agrochemicals –
SBIR Phase 1, LNK ChemsolutionsSBIR Phase 1, LNK Chemsolutions
1-Naphthalene Acetic acid (NAA, the target agrochemical) in chitosan1-Naphthalene Acetic acid (NAA, the target agrochemical) in chitosan
Timed release of agrochemicals, lesser amountsTimed release of agrochemicals, lesser amounts
Marie, et al. Biomolecules, 2002, Chitosan nanocapsule

56. Case Study #2Case Study #2
Risk & Oversight IssuesRisk & Oversight Issues
Risk IssuesRisk Issues
Capsule--chitosanCapsule--chitosan

Generally non-toxicGenerally non-toxic

Many toxicity studies foundMany toxicity studies found

However, not tested at large scaleHowever, not tested at large scale
environmental releaseenvironmental release
Fate and transport in environmentFate and transport in environment

Information neededInformation needed

Not clear if it is being fundedNot clear if it is being funded
NAA—plant growth regulatorNAA—plant growth regulator

Toxicity studies at macro level indicateToxicity studies at macro level indicate
human nasal, skin, and severe eyehuman nasal, skin, and severe eye
irritantirritant

Effects on animals include CNSEffects on animals include CNS
depression, decreased live births, birthdepression, decreased live births, birth
weight, and infant survivalweight, and infant survival

Data submitted to EPA for registrationData submitted to EPA for registration

Exemption for food tolerance underExemption for food tolerance under
FQPAFQPA
Oversight IssuesOversight Issues
Clear Statute—FIFRAClear Statute—FIFRA

Nano-scale formulation evoked?Nano-scale formulation evoked?
Social IssuesSocial Issues

Special attention and concerns relatedSpecial attention and concerns related
to nano-scale formulation of commonlyto nano-scale formulation of commonly
used substances?used substances?

General perceptions of pesticides inGeneral perceptions of pesticides in
the environmentthe environment

57. Case Study #2Case Study #2
ConclusionsConclusions
Relatively “easy” to find information on nanoparticle as componentsRelatively “easy” to find information on nanoparticle as components
are both already used in drugs and agricultureare both already used in drugs and agriculture
High degree of uncertainty as to whether regulatory system &High degree of uncertainty as to whether regulatory system &
statutes would give attention to the “nano” scalestatutes would give attention to the “nano” scale
Research needs on fate and transport of chitosan (and NAA?) inResearch needs on fate and transport of chitosan (and NAA?) in
environmentenvironment
Research needs on health effects at nanoscale—FQPA exemption?Research needs on health effects at nanoscale—FQPA exemption?
Public generally concerned about agrochemicals, but what concernsPublic generally concerned about agrochemicals, but what concerns
would the nano-version trigger? (UPE)would the nano-version trigger? (UPE)

58. Case Study #3—Food additivesCase Study #3—Food additives
Nano-and Micro-encapsulation of Food AdditivesNano-and Micro-encapsulation of Food Additives
SBIR Phase 1, LNK ChemsolutionsSBIR Phase 1, LNK Chemsolutions
Gum arabic/maltodextrin formulation for the shell of citral capsulesGum arabic/maltodextrin formulation for the shell of citral capsules
Timed release of nutraceuticals that inhibits bacterial growth and imparts lemon flavorTimed release of nutraceuticals that inhibits bacterial growth and imparts lemon flavor
Capsule restricts the diffusion of air and dissolves readilyCapsule restricts the diffusion of air and dissolves readily

59. Case Study #3Case Study #3
Risk & Oversight IssuesRisk & Oversight Issues
Risk IssuesRisk Issues
CapsuleCapsule

GRASGRAS

Only harmful when animalsOnly harmful when animals
overfed—no carcinogenic effectsoverfed—no carcinogenic effects

No nano encapuslation toxicityNo nano encapuslation toxicity
studies, howeverstudies, however
Fate and transport in environmentFate and transport in environment

Information neededInformation needed

Not clear if it is being fundedNot clear if it is being funded
CitralCitral

Micro encapsulated citral shown toMicro encapsulated citral shown to
have negative effects for animalhave negative effects for animal
feeding studiesfeeding studies

Malignant lymphomaMalignant lymphoma

Liver and fore-stomach damageLiver and fore-stomach damage
Oversight IssuesOversight Issues
Clear Statute—FFDCAClear Statute—FFDCA

GRAS or food additive?GRAS or food additive?

Micro-level citral GRASMicro-level citral GRAS

DSHEA if not in food-supplementDSHEA if not in food-supplement
Social IssuesSocial Issues

Consumer knowledge of risks andConsumer knowledge of risks and
benefits of encapsulated citral atbenefits of encapsulated citral at
nano scalenano scale

LabelingLabeling

Post-market monitoringPost-market monitoring
Transparency in safety processTransparency in safety process

Industry does testingIndustry does testing

FDA relies on industry “nano”FDA relies on industry “nano”
claimsclaims

60. Case Study #3Case Study #3
ConclusionsConclusions
Relatively “easy” to find information on nanoparticle as componentsRelatively “easy” to find information on nanoparticle as components
are both already used in food and dietary supplementsare both already used in food and dietary supplements
High degree of uncertainty as to whether regulatory system &High degree of uncertainty as to whether regulatory system &
statutes would give attention to the “nano” scalestatutes would give attention to the “nano” scale
Research needs on health effects at nanoscale—is citral GRAS,Research needs on health effects at nanoscale—is citral GRAS,
especially at the nanoscale?especially at the nanoscale?
Pre and post market safety evaluation given citral effectsPre and post market safety evaluation given citral effects
Consumer rights to know—labeling of nano-particles in foodConsumer rights to know—labeling of nano-particles in food

61. Case study #4—biobased consumer andCase study #4—biobased consumer and
medical productsmedical products
Cellulose Nanocrystal Composites (Simonsen, OSU)Cellulose Nanocrystal Composites (Simonsen, OSU)
Stronger than steel or alumiumStronger than steel or alumium
AFM image of cellulose nanocrystal film, Simonsen, http://woodscience.oregonstate.edu/faculty/simonsen/

62. Case Study #4Case Study #4
Risk & Oversight IssuesRisk & Oversight Issues
Risk IssuesRisk Issues
Cellulose nanocompositesCellulose nanocomposites

Diffusion out of matrix?Diffusion out of matrix?

Microcrystals—no observed effectMicrocrystals—no observed effect
Fate and transport in medical productFate and transport in medical product

Diffusion out of filters forDiffusion out of filters for
hemodialysis?hemodialysis?
Blood toxicityBlood toxicity

Cross blood-CNS barriers?Cross blood-CNS barriers?
For non-medical productFor non-medical product

Life cycle issuesLife cycle issues

Environmental pros and consEnvironmental pros and cons
Oversight IssuesOversight Issues
Clear Statute for device useClear Statute for device use

FFDCA and medical deviceFFDCA and medical device
amendmentsamendments

Will nano composites in devices byWill nano composites in devices by
considered as new or under class I orconsidered as new or under class I or
II PMN and 510k?II PMN and 510k?
WHO “precautionary approach” toWHO “precautionary approach” to
crystals under 5 umcrystals under 5 um

Limit content of particles under thisLimit content of particles under this
sizesize

ADI not specifiedADI not specified
Social IssuesSocial Issues

Medical community informedMedical community informed
about nanoscale particlesabout nanoscale particles
embedded in matrix?embedded in matrix?

Patients informed?Patients informed?

Acceptable level of risk versusAcceptable level of risk versus
medical benefit of improvedmedical benefit of improved
dialysis?dialysis?

63. Case Study #4Case Study #4
ConclusionsConclusions
Relatively “easy” to find information on nanoparticle as components used inRelatively “easy” to find information on nanoparticle as components used in
materialsmaterials
Research needs on nanocellulose diffusion out of matricesResearch needs on nanocellulose diffusion out of matrices
Research needs on health effects at nanoscale—is micro and nano scaleResearch needs on health effects at nanoscale—is micro and nano scale
cellulose of concern?cellulose of concern?
FDA might not consider nanocellulose in devices as a novel device—Class IFDA might not consider nanocellulose in devices as a novel device—Class I
or IIor II
International harmonization—WHO taking “precautionary approach”International harmonization—WHO taking “precautionary approach”
Patient/doctors ability to know—enough information to determine what riskPatient/doctors ability to know—enough information to determine what risk
is acceptable for them vs. the medical benefitis acceptable for them vs. the medical benefit
Life cycle analyses of production of nanocellulose and environmentalLife cycle analyses of production of nanocellulose and environmental
benefits-risksbenefits-risks

64. Case study #5—Animal production & foodCase study #5—Animal production & food
safetysafety
Adhesin-specific Nanoparticles for removal of pathogens from livestockAdhesin-specific Nanoparticles for removal of pathogens from livestock
*Latour et al. Clemson University*Latour et al. Clemson University
Block bacterial colonization in guts and remove these important humanBlock bacterial colonization in guts and remove these important human
pathogens on the farmpathogens on the farm
. Photo from Dr. Gary E. Kaiser,
http://student.ccbcmd.edu/~gkaiser/goshp.html
Nanoparticles
bind and block
this interaction

65. Case Study #5Case Study #5
Risk & Oversight IssuesRisk & Oversight Issues
Risk IssuesRisk Issues
Use of polyethylene glycol for deliveryUse of polyethylene glycol for delivery

PEG shown to be safePEG shown to be safe

No effect on cell death and do notNo effect on cell death and do not
activate immune responseactivate immune response

Nano version effects not knownNano version effects not known
Weigh any potential risk with benefit ofWeigh any potential risk with benefit of
reduction of antibiotics important forreduction of antibiotics important for
human healthhuman health
Targeting moleculeTargeting molecule

Mannose for E. coliMannose for E. coli

Effects on other helpful gut floraEffects on other helpful gut flora
On farm useOn farm use

Effects on environmental floraEffects on environmental flora

Animal waste streams to waterAnimal waste streams to water
Oversight IssuesOversight Issues
Difficult to find information on theDifficult to find information on the
nanoparticlenanoparticle

Intellectual property issuesIntellectual property issues
Statutory authority and exercise byStatutory authority and exercise by
agencies unclearagencies unclear

CWA and CAFO for animalCWA and CAFO for animal
waste?waste?

FFDCA—NAD?FFDCA—NAD?

FDA--Feed additive or GRAS?FDA--Feed additive or GRAS?

Agency’s Feed Safety SystemAgency’s Feed Safety System

USDA (VSTA)USDA (VSTA)
SocialSocial

Risk perceptionRisk perception

Trust in ag industryTrust in ag industry

Antibiotics and/or hormones inAntibiotics and/or hormones in
meat?meat?

66. Case Study #5Case Study #5
ConclusionsConclusions
Not very easy to find information on nanoparticles, as intellectualNot very easy to find information on nanoparticles, as intellectual
property rights soughtproperty rights sought
Regulatory uncertainty—convergence-type productRegulatory uncertainty—convergence-type product
Trust and independence of communicatorsTrust and independence of communicators

Benefits of antibiotic reduction—human health benefitsBenefits of antibiotic reduction—human health benefits

Perception of “antibiotics or hormones” in foodPerception of “antibiotics or hormones” in food
Research needs on environmental issues with nanoparticles inResearch needs on environmental issues with nanoparticles in
animal wasteanimal waste

67. Case Study #6—Food quality and safety inCase Study #6—Food quality and safety in
retail and consumptionretail and consumption
““Nanoclays” in food packaging materials—barriers to O2 and CO2Nanoclays” in food packaging materials—barriers to O2 and CO2
Silica, silicite, clay,organomontmorillonite, calcium carbonateSilica, silicite, clay,organomontmorillonite, calcium carbonate
Picture from CSIRO http://www.cmit.csiro.au/brochures/tech/nanotech/

68. Case Study #6Case Study #6
Risk & Oversight IssuesRisk & Oversight Issues
Risk IssuesRisk Issues
Clay nanoparticles toxicityClay nanoparticles toxicity

Macro versions non-toxicMacro versions non-toxic

Nano versions more reactive, and whatNano versions more reactive, and what
does this mean for toxicity?does this mean for toxicity?
Nanoparticle migration out of matricesNanoparticle migration out of matrices

Lack of researchLack of research

Migration likely lowMigration likely low
When composites containWhen composites contain
antimicrobials, detection molecules,antimicrobials, detection molecules,
etc. there will be additional risk issuesetc. there will be additional risk issues

Ag in food packagingAg in food packaging
Life cycle issues with manufacturingLife cycle issues with manufacturing
Oversight IssuesOversight Issues
Statutory authority clear—FFDCAStatutory authority clear—FFDCA

Food Contact SubstancesFood Contact Substances

(Food additive or GRAS if there is(Food additive or GRAS if there is
a substance in packaging that isa substance in packaging that is
intended to migrate to food)intended to migrate to food)
Most now go through NotificationMost now go through Notification
Process now (FCN)Process now (FCN)

Data requirements?Data requirements?

Ag in packaging has gone throughAg in packaging has gone through
this processthis process
Social IssuesSocial Issues

Transparency &Trust—BPA?Transparency &Trust—BPA?

Many FCS with nanoparticles onMany FCS with nanoparticles on
market,market,

Public unaware and safety studiesPublic unaware and safety studies
not availablenot available

69. Case Study #6Case Study #6
ConclusionsConclusions
Many patents, and compositions of marketed products can beMany patents, and compositions of marketed products can be
found, but not easily (I.e. no FDA website of nanopackagingfound, but not easily (I.e. no FDA website of nanopackaging
materials and data submitted, and FCN)materials and data submitted, and FCN)
Transparency and public trust/consumer knowledgeTransparency and public trust/consumer knowledge
Regulatory mechanism clear, but questions as to whether FDARegulatory mechanism clear, but questions as to whether FDA
would be likely to invoke the petition and threshold process forwould be likely to invoke the petition and threshold process for
nanocompositesnanocomposites
Research needs on environmental issues with nanoparticles duringResearch needs on environmental issues with nanoparticles during
manufacturing—high volume application (TSCA, RCRA, etc.)manufacturing—high volume application (TSCA, RCRA, etc.)

70. UpstreamUpstream
Oversight AssessmentOversight AssessmentDatabase of 160 Emerging
R&D
Applications of Agrifood Nanotechnology1
Selection of Case Studies
Case Study Analysis Approach
Identification of Risk and Oversight Policy Issues2
Kuzma, Romanchek, Kokotovich
Risk Analysis, in press

71. Agrifood Future WorkAgrifood Future Work
Update database and select additional casesUpdate database and select additional cases
Use of case study analysis forUse of case study analysis for

Expert judgment solicitationExpert judgment solicitation

Upstream public engagementUpstream public engagement

Discussions with decision makerDiscussions with decision maker
First year USDA has included ELSI componentFirst year USDA has included ELSI component
in RFPin RFP
(Lindquist, Verdlitz, and Kuzma USDA proposal)(Lindquist, Verdlitz, and Kuzma USDA proposal)

72. Anticipatory GovernanceAnticipatory Governance
UOA
UPE--Upstream Public Engagement
RTTA
Upstream Oversight Assessment
(guided by Integrated Oversight Assessment)
Real Time Technology Assessment
Integrate natural science and
engineering investigations with social
science and policy research from the
outset—Guston and Sarewitz, ASU
Identify and address regulatory and non-
regulatory oversight issues associated
with new technological products long
before they are marketed so that system
is prepared—Kuzma et al., UMN
McNaughten, Willis, Wilsdon, Wynne, Marris, et al.

73. Top-Down Approach to Study Oversight forTop-Down Approach to Study Oversight for
NanotechnologyNanotechnology
Wolf, Kokolli, Kuzma, Paradise, RamachandranWolf, Kokolli, Kuzma, Paradise, Ramachandran
Multiple methods criteria, disciplines, stakeholders, and experts involvedMultiple methods criteria, disciplines, stakeholders, and experts involved

Rooted in historical analysis, expert elicitation, stakeholder input, and multi-Rooted in historical analysis, expert elicitation, stakeholder input, and multi-
criteria decision analysiscriteria decision analysis

Quantitative & Qualitative, Normative and EmpiricalQuantitative & Qualitative, Normative and Empirical
Phase 1—Evaluation of 6 historical oversight models, all relevant to nano-bioPhase 1—Evaluation of 6 historical oversight models, all relevant to nano-bio
interfaceinterface

Drugs, Devices, Gene Therapy, GEOs in food and agriculture, Chemicals in theDrugs, Devices, Gene Therapy, GEOs in food and agriculture, Chemicals in the
Environment, Chemicals in the WorkplaceEnvironment, Chemicals in the Workplace
Phase 2—Mapping lessons to nano-bioPhase 2—Mapping lessons to nano-bio
Phase 3—Testing lessons in scenarios for specific nano-bioproductsPhase 3—Testing lessons in scenarios for specific nano-bioproducts
NSF-NIRT grant
2006-2010, $1.2M

74. Developing Hypotheses :Developing Hypotheses :
Integrated Oversight Assessment ApproachIntegrated Oversight Assessment Approach
Kuzma et al. 2008, Risk Analysis, in press
How was the
oversight model
developed ?
What are its
attributes ?
What are its
outcomes ?
How do the
attributes evolve
over time ?
How was the
oversight model
developed ?
What are its
attributes ?
What are its
outcomes ?
How do the
attributes evolve
over time ?
How was the
oversight model
developed ?
What are its
attributes ?
What are its
outcomes ?
How do the
attributes evolve
over time ?

75. ““Consensus” criteriaConsensus” criteria Kuzma et al. 2008,
forthcoming in Risk Analysis
Development: 7 criteria
D1 Impetus
D2 Clarity of technological subject matter
D3 Legal grounding
D4 Public input
D5 Transparency
D6 Financial resources
D7 Empirical basis
Attributes: 14 criteria
A8 Legal grounding
A9 Data requirements;
A10 Post-market monitoring
A11 Treatment of uncertainty
A12 Empirical basis
A13 Compliance and enforcement
A14 Incentives
A15 Treatment of Intellectual Property
A16 Institutional structure
A17 Flexibility
A18 Capacity
A19 Public input
A20 Transparency
A21 Conflicts of interest
A22 Informed consent
Consensus of >70% of experts
who rated the criteria 70 or higher
“How important is it to consider
this criterion in our oversight case
studies?”
On a scale of 0 (least) to 100 (most),
please rate the importance of each
of the criteria to the oversight assessment
we plan for the six models in this project.
Outcomes: 5 criteria
O24 Public confidence
O25 Research & innovation
O26 Health and Safety
O27 Distributional Health Impacts
O28 Environmental Impacts
Step 2: Expert and Stakeholder Elicitation3
Criteria Reduced from 66 to 28
?
?

76. GEOs Expert ElicitationGEOs Expert Elicitation

77. GeneratingGenerating
HypothesesHypotheses
Kuzma, Najmaie, Larson.
In prep
Correlation
coefficients
R>0.7, p<0.0016

78. Public ConfidencePublic Confidence
p<0.05p<0.05
Public Input
D4
Data
requirements
A9
Incentives
A14
Public Input
A19
Public
Confidence
O24

79. Hypotheses generatedHypotheses generated
Evidence-based lessons for nanoEvidence-based lessons for nano
Anticipatory Oversight PolicyAnticipatory Oversight Policy

80. ConclusionsConclusions
Information gaps in agrifood nanotechnologyInformation gaps in agrifood nanotechnology

Need to be filled by trusted sourcesNeed to be filled by trusted sources

Need for transparencyNeed for transparency
Need for upstream analysis of products, oversight systems,Need for upstream analysis of products, oversight systems,
potential risks, and societal issuespotential risks, and societal issues

Time is ripeTime is ripe

Data needsData needs

Engagement needsEngagement needs

Tie ELSI work with policy makingTie ELSI work with policy making
Convergent applications of agrifood nanoConvergent applications of agrifood nano

Will present oversight challengesWill present oversight challenges
Public input into risk analysis process and oversight decisions (keyPublic input into risk analysis process and oversight decisions (key
variable in positive outcomes)variable in positive outcomes)

81. Risks and BenefitsRisks and Benefits
Environmental/Ecological Risks or Health RisksEnvironmental/Ecological Risks or Health Risks
LowLow
If exposure to humans, animals or the environmentIf exposure to humans, animals or the environment
is minimal and the particles are generally non-toxic,is minimal and the particles are generally non-toxic,
we categorize the risk as low.we categorize the risk as low.
MediumMedium
If exposure to humans, animals or the environmentIf exposure to humans, animals or the environment
is minimal OR the particles are generally non-toxicis minimal OR the particles are generally non-toxic
we categorize risk as medium. In this category,we categorize risk as medium. In this category,
there are relatively benign particles that are widelythere are relatively benign particles that are widely
used in food and agriculture. Likewise, a toxicused in food and agriculture. Likewise, a toxic
particle that is meant to stay in the lab orparticle that is meant to stay in the lab or
processing plant could also be in this category. Inprocessing plant could also be in this category. In
the cases of nanotechnology applied to biobasedthe cases of nanotechnology applied to biobased
products, “medium” was used for environmental orproducts, “medium” was used for environmental or
ecological risks with the question of whetherecological risks with the question of whether
harvesting and processing are done in aharvesting and processing are done in a
sustainable way (i.e. life cycle issues).sustainable way (i.e. life cycle issues).
HighHigh
Exposure to humans, animals or the environment isExposure to humans, animals or the environment is
widespread and particles show toxicity or arewidespread and particles show toxicity or are
expected to be toxic.expected to be toxic.
Environmental/Ecological or Health BenefitsEnvironmental/Ecological or Health Benefits
LowLow
Application or research not meant to improveApplication or research not meant to improve
human or animal health, or the environment.human or animal health, or the environment.
MediumMedium
Application or research might improve health, or theApplication or research might improve health, or the
environment, but not explicitly developed for thatenvironment, but not explicitly developed for that
purpose or for addressing a great societal problem.purpose or for addressing a great societal problem.
HighHigh
Application or research specifically developed toApplication or research specifically developed to
address an important societal need for improvingaddress an important societal need for improving
health or the environment.health or the environment.

82. TechniquesTechniques
Transport processesTransport processes—nanomaterials as agents for transporting chemicals,—nanomaterials as agents for transporting chemicals,
molecules, etc.molecules, etc.
Bio-selective surfacesBio-selective surfaces——nanomaterials with enhanced or reduced ability to bind ornanomaterials with enhanced or reduced ability to bind or
hold specific molecules and/or organisms.hold specific molecules and/or organisms.
Bio-separationBio-separation——nano-materials or -processes with ability to separate molecules,nano-materials or -processes with ability to separate molecules,
biomolecules, or organisms.biomolecules, or organisms.
Microfluidics/MEMsMicrofluidics/MEMs——liquid streams used to separate, control, or analyze at theliquid streams used to separate, control, or analyze at the
nanoscale. They might have special flow properties at this scale.nanoscale. They might have special flow properties at this scale.
Microelectromechanical systems (MEMs) are also included here. They are devicesMicroelectromechanical systems (MEMs) are also included here. They are devices
with channels and wells, electrodes for detection, connectors, and fluidic input/outputwith channels and wells, electrodes for detection, connectors, and fluidic input/output
ports.ports.
Nano-bioprocessingNano-bioprocessing—use of nanoscale technology and/or biological processes to—use of nanoscale technology and/or biological processes to
create a desired compound or material from a defined stock. The product itself maycreate a desired compound or material from a defined stock. The product itself may
be bulk or nanoscale.be bulk or nanoscale.
Nucleic acid bioengineeringNucleic acid bioengineering——use of DNA as building blocks to form nano-particles oruse of DNA as building blocks to form nano-particles or
use of nano-particles for genetic engineering.use of nano-particles for genetic engineering.
Drug deliveryDrug delivery—use of nanoparticles or nanomethods to deliver drugs to animals.—use of nanoparticles or nanomethods to deliver drugs to animals.

83. TopicsTopics
BiosensorsBiosensors—use of nanotechnology for sensors based upon biological processes or biological—use of nanotechnology for sensors based upon biological processes or biological
molecules, or for detection of biological molecules, processes, or organisms.molecules, or for detection of biological molecules, processes, or organisms.
Environmental processing—Environmental processing—use of nanotechnology for studying environmental phenomena, removinguse of nanotechnology for studying environmental phenomena, removing
contaminants in the environment, or remediating/reducing waste. Study of nanomaterials in thecontaminants in the environment, or remediating/reducing waste. Study of nanomaterials in the
environment too.environment too.
Sustainable agricultureSustainable agriculture—use of nanotechnology for reducing agricultural inputs or outputs that can harm—use 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 makingthe 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.products from agriculture in a sustainable way.
Pathogen detectionPathogen detection—use of nanotechnology to detect pathogens in surroundings, organisms or food.—use of nanotechnology to detect pathogens in surroundings, organisms or food.
Plant/Animal ProductionPlant/Animal Production—use of nanotechnology to improve the cultivation of plants or animals,—use of nanotechnology to improve the cultivation of plants or animals,
including via transgenics or cloning.including via transgenics or cloning.
Veterinary medicine[Veterinary medicine[1]—use of nanotechnology to improve animal health and/or the safety of animal1]—use of nanotechnology to improve animal health and/or the safety of animal
derived foods.derived foods.
Bioprocessing for foodBioprocessing for food—use of nanotechnology for better food processing or quality.—use of nanotechnology for better food processing or quality.
Nano-bioindustrial productsNano-bioindustrial products—use of nanotechnology for developing industrial products from agriculture—use of nanotechnology for developing industrial products from agriculture
or its by-products.or its by-products.
[1] Not in USDA Nanoscale Science and Engineering 2003 Report.[1] Not in USDA Nanoscale Science and Engineering 2003 Report.

84. USDA Research AreasUSDA Research Areas
Pathogen and Contaminant Detection—Pathogen and Contaminant Detection—pathogen or contaminant detection in agriculture, food, or thepathogen or contaminant detection in agriculture, food, or the
environment.environment.
Identity Preservation and TrackingIdentity Preservation and Tracking——systems that provide producers, processors, and customers withsystems that provide producers, processors, and customers with
information about the practices and activities used to produce a particular crop or agricultural product. Also,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.provide information on the origin and movement of crops, animals, or products.
Smart Treatment Delivery SystemsSmart Treatment Delivery Systems——delivery of molecules in agricultural production or processing in time-delivery of molecules in agricultural production or processing in time-
controlled, spatially targeted, regulated, responsive, or other precise ways. Also, systems could have the ability tocontrolled, spatially targeted, regulated, responsive, or other precise ways. Also, systems could have the ability to
monitor effects of delivery.monitor effects of delivery.
Smart System Integration for Agriculture and Food ProcessingSmart System Integration for Agriculture and Food Processing——integration of a working system withintegration of a working system with
sensing, reporting, localization, and control. System could be used anywhere along farm to table continuum, or atsensing, reporting, localization, and control. System could be used anywhere along farm to table continuum, or at
multiple points.multiple points.
Nanodevices for Molecular and Cell BiologyNanodevices for Molecular and Cell Biology——devices based on or applied to molecular and cellular biologydevices based on or applied to molecular and cellular biology
that separate, identify, study, modify, or sense.that separate, identify, study, modify, or sense.
Nanoscale Materials Science and EngineeringNanoscale Materials Science and Engineering——development of novel materials through materials science anddevelopment of novel materials through materials science and
engineering. Work to better understand the behavior and properties of nanomaterials.engineering. Work to better understand the behavior and properties of nanomaterials.
Environmental Issues and Agricultural WasteEnvironmental Issues and Agricultural Waste——study of nanoparticles in the environment, such as in thestudy of nanoparticles in the environment, such as in the
transport and bioavailability of nutrients and pollutants. Understand transport and toxicity of nanoparticles intransport and bioavailability of nutrients and pollutants. Understand transport and toxicity of nanoparticles in
agricultural pollutants. Nanotechnology applied to environmental or waste issues.agricultural pollutants. Nanotechnology applied to environmental or waste issues.

85. Type of Research and TimeType of Research and Time
CategoriesCategories
Type of ResearchType of Research::
DevelopmentDevelopment—specific product cited, largely experiments or studies to optimize product—specific product cited, largely experiments or studies to optimize product
AppliedApplied—specific application noted, but may also lead to better understanding—specific application noted, but may also lead to better understanding
BasicBasic—fundamental understanding is goal, specific application not stated (although there could—fundamental understanding is goal, specific application not stated (although there could
be one in the future)be one in the future)
Time to Commercialization:Time to Commercialization:
0-5 years0-5 years –applied/development projects which directly address regulatory or product–applied/development projects which directly address regulatory or product
optimization issues. The applications of the work appear to be very near- term with minimaloptimization 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 orregulatory concerns, or they are already in the marketplace and properties are being studied or
optimized.optimized.
5-10 years5-10 years –applied/development research that is based upon proven technology and for which–applied/development research that is based upon proven technology and for which
there are not serious safety concernsthere are not serious safety concerns
10-15 years10-15 years——applied research that is in the early stages of concept or developmentapplied research that is in the early stages of concept or development
15-20 years15-20 years—applied/basic research for which applications are not specified, but they can be—applied/basic research for which applications are not specified, but they can be
envisioned.envisioned.
20-50 years20-50 years—basic research for which few, if any, applications are envisioned, but for which—basic research for which few, if any, applications are envisioned, but for which
fundamental knowledge will eventually lead to some.fundamental knowledge will eventually lead to some.

86. Food Supply Chain SectorFood Supply Chain Sector
AgroecosystemsAgroecosystems——application for or research on agricultural systems, and/or onapplication for or research on agricultural systems, and/or on
surrounding natural systems.surrounding natural systems.
Pre-harvestPre-harvest——application or researchapplication or research on the farm or in the forest, duringon the farm or in the forest, during
agricultural production.agricultural production.
TransportationTransportation——application or research dealing with transporting agricultural orapplication or research dealing with transporting agricultural or
forest raw commodities or products from the farm to the processor or retailer.forest raw commodities or products from the farm to the processor or retailer.
Post-harvestPost-harvest——research or application after harvest, at the stage of processingresearch or application after harvest, at the stage of processing
the commodity or productthe commodity or product
RetailRetail——research or application dealing with storage, display, etc. at the placeresearch or application dealing with storage, display, etc. at the place
where the product is sold.where the product is sold.
ConsumerConsumer—research or application dealing with the consumer end, such as—research or application dealing with the consumer end, such as
storage and use of agricultural products in the home. Also, this category is usedstorage 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. betterfor research which primarily improves the quality of the end product (e.g. better
taste).taste).
Post-consumptionPost-consumption—research or applications for after the product is consumed.—research or applications for after the product is consumed.
For example, for food safety illness detection.For example, for food safety illness detection.

87. Possible Exposure Endpoints forPossible Exposure Endpoints for
Potential ProductsPotential Products
Lab workersLab workers——mostmost nanomaterial or particles are made or studied in the lab at some point. In mostnanomaterial 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 incases, lab workers will be exposed. The study of naturally-occurring nanoparticles would be a case in
which this box would not be checked.which this box would not be checked.
FarmersFarmers——farmers are exposed if the nanomaterial, particle, or method is being used on the farm.farmers are exposed if the nanomaterial, particle, or method is being used on the farm.
EcosystemsEcosystems——ecosystems are exposed if the nanomaterial is used 1) on the farm (animals and plants onecosystems 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 disposedthe 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 thisof 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.box is checked, it is because the material is intended at some point for environmental release.
Industry WorkersIndustry Workers——industry workers will be exposed during production, manufacture, transport,industry workers will be exposed during production, manufacture, transport,
processing, or at the retail/distribution stage.processing, or at the retail/distribution stage.
ConsumersConsumers——if consumers will likely come in contact with the material, this box is checked. Theif 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 productionapplications are either intended for consumer products or are left in the material as a result of production
or processing.or processing.
OthersOthers——in some cases, there might be sub-populations that are specifically exposed as a result of thein some cases, there might be sub-populations that are specifically exposed as a result of the
application or research.application or research.
UnknownUnknown——this box is checked when the description of the project is too vague, or the applications arethis box is checked when the description of the project is too vague, or the applications are
too broad to determine who will be exposed.too broad to determine who will be exposed.