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Agrifood Nanotechnology:
Science, Technology, and Society
Prof. Jennifer Kuzma
Center for Science, Technology, and Public Policy
Humphrey Institute, University of Minnesota
James Romanchek, Adam Kokotovich, and Peter VerHage
AARI Meeting 3-1-07
Outline
Why agrifood nanotechnology?
Areas and products of agrifood nanotechnology
U.S. Agrifood nanotechnology R&D—an analysis
Case studies of emerging oversight issues
Thoughts on collaborations and initiatives
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
Challenges: Lessons (AgBiotech) :
Little information about R&D, safety, Need for transparency in product
and products in the public domain review and oversight process
(CBI, IPR)
Need for regulatory clarity and holistic
Overlapping or missing jurisdiction for approaches to convergence products
products? (e.g. premarket testing)
EU vs. US position on GEOs in food
Food and humans have a special and agriculture
relationship tied to necessity, culture,
and environment.
First generation of GEOs in food and
Distribution of risks and benefits are agriculture had few benefits to those
often different than for medical who bore any potential risk
applications
Generally more talk and acceptance of
Time for independent study of the need for public information and
oversight models for agrifood dialogue early and often
nanotechnology –how & who?
Selected Categories of Nanotechnology Applied to Food and Agriculture
Agriculture Bio-Energy Single molecule detection to determine enzyme/substrate
or Products interactions (e.g. cellulases in production of ethanol).
Materials from biomass
Agrochemical Delivery of pesticides, fertilizers, and other agrichemicals
Delivery more efficiently (e.g. only when needed or for better
absorption).
Animal Delivery of growth hormone in a controlled fashion.
Production
Identity preservation and tracking.
Animal or Detect animal pathogens, such as foot and mouth disease
Plant Health virus. Detect plant pathogens early.
Animal Deliver animal vaccines.
Medicine
Plant Delivery of DNA to plants towards certain tissues (i.e.
Production 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.
Kuzma, 2006
Food-related Nano-Products on Market
Project on Emerging Nanotechnologies consumer inventory
www.nanotechproject.org
Micelles for functional food
Storage of food with Ag antimicrobial
Refrigerator with antimicrobials
Cocoa delivery with little sugar
Glycerin micelles to remove
Cooking Oil Quality--nanoceramic
pesticides
Nanoclay barriers to O2 and CO2
Several dietary supplements
Emerging 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
Guiding Principles
What Do People Care About?
Focus groups participants
People do not care only about the generally positive about promise
number of deaths and injuries. of nanotechnology and majority
did not support a ban.
They also care about ―Food and Nutrition‖ 5th most
- Equity** frequently named benefit (6%)
- Controllability**
- Voluntary or involuntary exposure** ―Food and Food Chains
Concerns‖ 6th on concern list (7%)
- Time Frame: Immediate or delayed**
- Intergenerational effects
Mandatory oversight and access
- Nature and extent of Knowledge** to information important to the
majority
- (multiple works of social psychologists,
P. Slovic, Decision Research, and B. Macoubrie, J. 2005 (Project on
Fischoff, CMU) Emerging Nanotechnologies)
Anticipatory Governance
Science, Risk, Society
EHS:
Health/environmental risk
Large Societal changes
Worker Safety
Technology funding, development, incentives Human rights
Norms, standards Social/Ethical
Near Medium Long
Bottom Up Methods
Agrifood Nanotechnology Oversight
Phase 1*: Start with individual
products Research Topics
Inventory and assessment of R&D Research Techniques
in nanotechnology as applied to Estimated time to commercialization
food, agriculture, and Part of food or product supply chain
agroecosystems Endpoints of exposure
Qualitative risk/benefit ranking
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
Methodology for inventory
Public databases and websites
Nano and food or agriculture as search terms
USDA-CRIS, PTO, EPA, NIH, DOE, DOD, DHS, NSF
2000-Fall 2005
Adjusted USDA categories for research, techniques, and topics as
specified in 2003 report, Nanoscale Science and Engineering for
Agriculture and Food Systems.
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
160 projects were found
121 entries were sent to PIs for review
Agrifood Nanotechnology Inventory
Limitations
Not focused on industrial or consumer products
Stopped searches in Dec. 2005—needs updating on a regular basis
Publicly available information
No investigative reporting
Categorization based on available information and PI knowledge/experience
Reviewed by PIs positively, but limited response (14%)
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,)
Key Results of Agrifood Inventory
Large focus on food packaging and
sensing for foodborne pathogens
Focus on retail and consumer
applications
More of a focus on health than
environmental benefits. But significant
proportion on environment/ag waste
No ―high risk‖ projects, according to
our criteria of toxic materials under
widespread use
Most projects applied, and projected to
be commercial in 5-15 years.
Database can be mined in various
ways to focus EHS research
Techniques for Projects
Topics for Projects
USDA Research Areas
Stage and Type of Work
Sector of Food Supply Chain
Endpoints of Exposure
Risk and Benefit Qualitative Ranking
Mining the Database to Focus EHS research
Other ways to mine database
Particles of interest Private vs. public
160
140
20 2 5 EPA
120 15 NIH
100 USDA
80 PTO (ind.)
28 90 PTO (univ)
60
NSF
40
20
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Regulatory Unknowns for Food and Agricultural
Products
CPSC Consumer Products
No pre-market
testing
Pre-market
EPA testing possible
Chemicals/Particles
Pre-market
testing required
OSHA Manufacturing
Lack of
Drugs/biologics guidance
Devices
FDA
Cosmetics
USDA Agricultural products
Food
TODAY 2006 2010
Adapted from E. Michelson,WWIC
Bottom Up Methods
Agrifood Nanotechnology Oversight
Phase 1*: Start with individual
products
Inventory and assessment of
research and development in
nanotechnology as applied to
food, agriculture, and
agroecosystems
• Criteria for case selection:
Phase 2:* Select individual products • Frequency of topics and techniques in
database
Selection of case studies and • Sector of supply chain
qualitative risk/benefit issue • Exposure endpoints
identification • Oversight relevance
Phase 3:* Assess individual • Research Methods:
products, extrapolate up • Literature searches—Toxnet, Fed Reg, etc.
• Researcher inquiries
Analysis of oversight systems
• Case study comparison approach
and issues for selected agrifood
applications
Case Study #1
Agroecosystem—Environmental application
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
Case Study #1
Risk & Oversight Issues
Risk Issues Oversight Issues
Capsule Broad range of statutes
Generally non-toxic TSCA, CWA, FIFRA, etc?
PLGA-chitosan used in drug-delivery
Dissolve in water
Lack of certainty about convergence
However, not tested at large scale applications
environmental release
Nano-bio-environment
Fate and transport in environment
Information needed Detection capabilities
PIs are conducting this work in phase II For large scale release?
DNA Societal
Uptake by microbes? Public perception and concern about
large scale release of DNA in the
Persistence and fate in environment? environment
Usually degraded
Case Study #1
Conclusions
Relatively ―easy‖ to find information on nature of particle
and researchers’ plans (transparent)
High degree of uncertainty as to regulatory system &
statutes
Research needs on fate and transport of PLGA and
DNA—project included some of these elements
High potential for public concern in watershed areas—
perception of DNA released into environment
Case study 2: On-farm plant production
Nano-and Micro-encapsulation of Agrochemicals –
SBIR Phase 1, LNK Chemsolutions
1-Naphthalene Acetic acid (NAA, the target agrochemical) in chitosan
Timed release of agrochemicals, lesser amounts
Marie, et al. Biomolecules, 2002, Chitosan nanocapsule
Case Study #2
Risk & Oversight Issues
Risk Issues
Oversight Issues
Capsule--chitosan
Generally non-toxic Clear Statute—FIFRA
Many toxicity studies found Nano-scale formulation evoked?
However, not tested at large scale
environmental release Social Issues
Special attention and concerns related
Fate and transport in environment to nano-scale formulation of commonly
Information needed used substances?
Not clear if it is being funded General perceptions of pesticides in
the environment
NAA—plant growth regulator
Toxicity studies at macro level indicate
human nasal, skin, and severe eye
irritant
Effects on animals include CNS
depression, decreased live births, birth
weight, and infant survival
Data submitted to EPA for registration
Exemption for food tolerance under
FQPA
Case Study #2
Conclusions
Relatively ―easy‖ to find information on nanoparticle as components
are both already used in drugs and agriculture
High degree of uncertainty as to whether regulatory system &
statutes would give attention to the ―nano‖ scale
Research needs on fate and transport of chitosan (and NAA?) in
environment
Research needs on health effects at nanoscale—FQPA exemption?
Public generally concerned about agrochemicals, but what concerns
would the nano-version trigger? (UPE)
Case Study #3—Food additives
Nano-and Micro-encapsulation of Food Additives
SBIR Phase 1, LNK Chemsolutions
Gum arabic/maltodextrin formulation for the shell of citral capsules
Timed release of nutraceuticals that inhibits bacterial growth and imparts lemon flavor
Capsule restricts the diffusion of air and dissolves readily
Case Study #3
Risk & Oversight Issues
Risk Issues
Oversight Issues
Capsule
Clear Statute—FFDCA
GRAS
GRAS or food additive?
Only harmful when animals
overfed—no carcinogenic effects Micro-level citral GRAS
DSHEA if not in food-supplement
No nano encapuslation toxicity
studies, however
Social Issues
Fate and transport in environment Consumer knowledge of risks and
Information needed benefits of encapsulated citral at
nano scale
Not clear if it is being funded Labeling
Post-market monitoring
Citral
Micro encapsulated citral shown Transparency in safety process
to have negative effects for animal
feeding studies Industry does testing
Malignant lymphoma FDA relies on industry ―nano‖
Liver and fore-stomach damage claims
Case Study #3
Conclusions
Relatively ―easy‖ to find information on nanoparticle as components
are both already used in food and dietary supplements
High degree of uncertainty as to whether regulatory system &
statutes would give attention to the ―nano‖ scale
Research needs on health effects at nanoscale—is citral GRAS,
especially at the nanoscale?
Pre and post market safety evaluation given citral effects
Consumer rights to know—labeling of nano-particles in food
Case study #4—biobased consumer and
medical products
Cellulose Nanocrystal Composites (Simonsen, OSU)
Stronger than steel or alumium
AFM image of cellulose nanocrystal film, Simonsen, http://woodscience.oregonstate.edu/faculty/simonsen/
Case Study #4
Risk & Oversight Issues
Risk Issues Oversight Issues
Cellulose nanocomposites Clear Statute for device use
Diffusion out of matrix? FFDCA and medical device
amendments
Microcrystals—no observed effect Will nano composites in devices by
considered as new or under class I or II
PMN and 510k?
Fate and transport in medical product
Diffusion out of filters for
hemodialysis? WHO ―precautionary approach‖ to
crystals under 5 um
Limit content of particles under this size
Blood toxicity ADI not specified
Cross blood-CNS barriers?
Social Issues
For non-medical product Medical community informed
Life cycle issues about nanoscale particles
Environmental pros and cons embedded in matrix?
Patients informed?
Acceptable level of risk versus
medical benefit of improved
dialysis?
Who decides?
Case Study #4
Conclusions
Relatively ―easy‖ to find information on nanoparticle as components used in
materials
Research needs on nanocellulose diffusion out of matrices
Research needs on health effects at nanoscale—is micro and nano scale
cellulose of concern?
FDA might not consider nanocellulose in devices as a novel device—Class I
or II
International harmonization—WHO taking ―precautionary approach‖
Patient/doctors ability to know—enough information to determine what risk
is acceptable for them vs. the medical benefit
Life cycle analyses of production of nanocellulose and environmental
benefits-risks
Case study #5—Animal production & food
safety
Adhesin-specific Nanoparticles for removal of pathogens from livestock
*Latour et al. Clemson University
Block bacterial colonization in 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
Case Study #5
Risk & Oversight Issues
Risk Issues
Oversight Issues
Use of polyethylene glycol for delivery
PEG shown to be safe Difficult to find information on the
No effect on cell death and do not nanoparticle
activate immune response Intellectual property issues
Nano version effects not known
Statutory authority and exercise by
Weigh any potential risk with benefit of agencies unclear
reduction of antibiotics important for CWA and CAFO for animal
human health waste?
FFDCA—NAD?
Targeting molecule FDA--Feed additive or GRAS?
Mannose for E. coli Agency’s Feed Safety System
Effects on other helpful gut flora
USDA (VSTA)
On farm use Social
Effects on environmental flora Risk perception
Animal waste streams to water Trust in ag industry
Antibiotics and/or hormones in
meat?
Case Study #5
Conclusions
Not very easy to find information on nanoparticles, as intellectual
property rights sought
Regulatory uncertainty—convergence-type product
Trust and independence of communicators
Benefits of antibiotic reduction—human health benefits
Perception of ―antibiotics or hormones‖ in food
Research needs on environmental issues with nanoparticles in
animal waste
Case Study #6—Food quality and safety in
retail and consumption
―Nanoclays‖ in food packaging materials—barriers to O2 and CO2
Silica, silicite, clay,organomontmorillonite, calcium carbonate
Picture from CSIRO http://www.cmit.csiro.au/brochures/tech/nanotech /
Case Study #6
Risk & Oversight Issues
Risk Issues Oversight Issues
Clay nanoparticles toxicity Statutory authority clear—FFDCA
Macro versions non-toxic
Food Contact Substances
Nano versions more reactive, and what
does this mean for toxicity? (Food additive or GRAS if there is
a substance in packaging that is
intended to migrate to food)
Nanoparticle migration out of matrices
Lack of research
Migration likely low Most now go through Notification
Process now (FCN)
No data requirements
When composites contain Ag in packaging has gone through
antimicrobials, detection molecules, this process
etc. there will be additional risk issues
Ag in food packaging Social Issues
Transparency &Trust
Life cycle issues with manufacturing Many FCS with nanoparticles on
market,
Public unaware and safety studies
not available
Case Study #6
Conclusions
Many patents, and compositions of marketed products can be found,
but not easily (I.e. no FDA website of nanopackaging materials and
data submitted, and FCN)
Transparency and public trust/consumer knowledge
Regulatory mechanism clear, but questions as to whether FDA
would be likely to invoke the petition and threshold process for
nanocomposites
Research needs on environmental issues with nanoparticles during
manufacturing—high volume application (TSCA, RCRA, etc.)
Key ―attention‖ areas—importance of issue type
a work in progress… ++= 5 to -/+=1?
other issue areas like COI in safety studies?
Case study Data-risk Regulatory Transparency Public Socio- Potential
gaps Unknowns reactions/ economic benefits
attitudes impacts
1)Agroecosystem + ++ -/+ ++ -/+ +
particles
2) Plant ++ + (nano) + ++ + +
production
particles
3) Food ++ + (nano) + + + +/-
enhancement
particles
4) Composites for + + (nano) + -/+ +/- +
non-food product
(e.g. medical)
5) Animal + ++ ++ ++ -/+ ++
husbandry
particles
6) Composites for + +/- + +/- + +
food packaging
Anticipatory Governance
Integrate natural science and
Identify and address regulatory and non- engineering investigations with social
regulatory oversight issues associated science and policy research from the
with new technological products long outset—Guston and Sarewitz, ASU
before they are marketed so that system
is prepared—Kuzma et al., UMN
Upstream Oversight Assessment Real Time Technology Assessment
UOA RTTA
UPE--Upstream Public Engagement
McNaughten, Willis, Wilsdon, Wynne, Marris, et al.
Future Work
Polish case study analysis
Use of case study analysis for
Expert judgment solicitation
Upstream public engagement
Discussions with decision makers
Collaborations with social scientists and
others on this approach
Comprehensive Study of Oversight Policy
Public Policy
Practical Analysts
S&T
Political Other
Scientists Technology Policy Wonks
Scientists Fields?
Developers Risk Regulatory
Assessors Input?
Policy
Makers
Regulatory S&T
Assessors Studies
(CBA focused) Lawyers
Social Historians
Academic And Philosophers
Legal Scientists
of Science
Communication Social Studies
Experts Psychology Ethicists
Who is thinking about oversight in a comprehensive way?
My thoughts
Begin initiatives and collaborations with the end in mind
Delicate balance between basic, applied, and developmental research
Within applied research, balance between ―products that would be nice‖ and
solving societal/national problems (energy, clean water, health, safe food, etc.)
South African model?
Match applications with implications research because…
Desired ends are consumer and stakeholder acceptance and trust
Trust is affected by not only safety, but also transparency and participation
Employ upstream oversight assessment and other anticipatory governance
approaches
Unique, and in the long run, most successful
goals of better and safer products, sustainability, economic and industry growth,
social and environmental well-being, and justice.
Questions & Input?
Prof. Jennifer Kuzma
612-625-6337
kuzma007@umn.edu
http://www.hhh.umn.edu/centers/stpp
Funding sources:
Project on Emerging Nanotechnologies
Consortium on Law and Values in the Health, Environmental, and Life
Sciences—U of MN
NSF NIRT ―Evaluating Oversight Models for the Nano-bio Interface‖
(2006-2010)
Extra slides if needed/desired
If so, How?
Top-Down Approach to Study Oversight for
Nanotechnology
Multiple methods used, multiple criteria assessed, multiple
disciplines and experts involved
Phase 1—Evaluation of 6 historical oversight models, all relevant to
nano-bio interface
Drugs, Devices, Gene Therapy, GEOs in food and agriculture,
Chemicals in the Environment, Chemicals in the Workplace
Phase 2—Mapping lessons to nano-bio
Phase 3—Testing lessons in scenarios for specific nano-bioproducts
Funded by the NSF, $1.2 M NIRT, co-PIs, Wolf, Kuzma, Paradise, Ramachandran, and Kokkoli
Phase 1: Integrated Oversight Assessment (IOA)
for Historical Models
How was the
What are its What are
oversight model
developed? Attributes? the outcomes?
Common Scale and Correlations?
DRAFT criteria for attributes: DRAFT criteria for outcomes:
DRAFT criteria for development:
•Dealing with uncertainty •Expert, developer and consumer
•Impetus--driving force (e.g. public concern)
•Accountability satisfaction or confidence in
•Stakeholder input
•Feedback loops/Post market monitoring system
•Outside Expert input
•Transparency: access to information •Flexibility for different cultures or
•Empirical risk/benefit studies
•Mandatory or voluntary ethical framework
•Reactive or proactive
•Actors involved •Choice of consumers
•Opportunities for ―values‖ discussions
•Ease of navigation for developers •Effects on industry structure
•Etc.?
•Opportunities for public input •Effects on innovation
•Institutional structure and cultures •Adverse event reported
•Data requirements •General perception of product
•Who conducts safety tests? safety
•Etc.? •Number of products approved
•Time and monetary costs to
Multiple Methods to Assess Criteria bring product to market
•Etc?
Techniques
Transport processes—nanomaterials as agents for transporting chemicals,
molecules, etc.
Bio-selective surfaces—nanomaterials with enhanced or reduced ability to bind or
hold specific molecules and/or organisms.
Bio-separation—nano-materials or -processes with ability to separate molecules,
biomolecules, or organisms.
Microfluidics/MEMs—liquid 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-bioprocessing—use 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 bioengineering—use of DNA as building blocks to form nano-particles or
use of nano-particles for genetic engineering.
Drug delivery—use of nanoparticles or nanomethods to deliver drugs to animals.
Modeling—use of nanotechnology to build models of systems, or the modeling of
nanoparticles in systems.
Topics
Biosensors—use of nanotechnology for sensors based upon biological processes or biological
molecules, or for detection of biological molecules, processes, or organisms.
Environmental processing—use of nanotechnology for studying environmental phenomena, removing
contaminants in the environment, or remediating/reducing waste. Study of nanomaterials in the
environment too.
Sustainable agriculture—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 making
products from agriculture in a sustainable way.
Pathogen detection—use of nanotechnology to detect pathogens in surroundings, organisms or food.
Plant/Animal Production—use of nanotechnology to improve the cultivation of plants or animals,
including via transgenics or cloning.
Veterinary medicine[1]—use of nanotechnology to improve animal health and/or the safety of animal
derived foods.
Bioprocessing for food—use of nanotechnology for better food processing or quality.
Nano-bioindustrial products—use of nanotechnology for developing industrial products from agriculture
or its by-products.
[1] Not in USDA Nanoscale Science and Engineering 2003 Report.
USDA Research Areas
Pathogen and Contaminant Detection—pathogen or contaminant detection in agriculture, food, or the
environment.
Identity Preservation and Tracking—systems 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 Systems—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 to
monitor effects of delivery.
Smart System Integration for Agriculture and Food Processing—integration 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 Biology—devices based on or applied to molecular and cellular biology
that separate, identify, study, modify, or sense.
Nanoscale Materials Science and Engineering—development of novel materials through materials science and
engineering. Work to better understand the behavior and properties of nanomaterials.
Environmental Issues and Agricultural Waste—study 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 Workforce—education about nanotechnology and nanoproducts; studies on
ethical and social issues (cited in USDA report, although not reflected in USDA’s short title of this research area);
infrastructure support; technology transfer support; public understanding of risks and benefits.
Type of Research and Time
Categories
Type of Research:
Development—specific product cited, largely experiments or studies to optimize product
Applied—specific application noted, but may also lead to better understanding
Basic—fundamental 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 years—applied research that is in the early stages of concept or development
15-20 years—applied/basic research for which applications are not specified, but they can be
envisioned.
20-50 years—basic research for which few, if any, applications are envisioned, but for which
fundamental knowledge will eventually lead to some.
Food Supply Chain Sector
Agroecosystems—application for or research on agricultural systems, and/or on
surrounding natural systems.
Pre-harvest—application or research on the farm or in the forest, during
agricultural production.
Transportation—application or research dealing with transporting agricultural or
forest raw commodities or products from the farm to the processor or retailer.
Post-harvest—research or application after harvest, at the stage of processing
the commodity or product
Retail—research or application dealing with storage, display, etc. at the place
where the product is sold.
Consumer—research 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-consumption—research or applications for after the product is consumed.
For example, for food safety illness detection.
Possible Exposure Endpoints for
Potential Products
Lab workers—most 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.
Farmers—farmers are exposed if the nanomaterial, particle, or method is being used on the farm.
Ecosystems—ecosystems 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 Workers—industry workers will be exposed during production, manufacture, transport,
processing, or at the retail/distribution stage.
Consumers—if 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.
Others—in some cases, there might be sub-populations that are specifically exposed as a result of the
application or research.
Unknown—this box is checked when the description of the project is too vague, or the applications are
too broad to determine who will be exposed.
Risks and Benefits
Environmental/Ecological Risks or Health Risks Environmental/Ecological or Health Benefits
Low Low
If exposure to humans, animals or the environment Application or research not meant to improve
is minimal and the particles are generally non-toxic, human or animal health, or the environment.
we categorize the risk as low.
Medium
Medium Application or research might improve health, or the
If exposure to humans, animals or the environment environment, but not explicitly developed for that
is minimal OR the particles are generally non-toxic purpose or for addressing a great societal problem.
we categorize risk as medium. In this category,
there are relatively benign particles that are widely High
used in food and agriculture. Likewise, a toxic
particle that is meant to stay in the lab or processing Application or research specifically developed to
plant could also be in this category. In the cases of address an important societal need for improving
nanotechnology applied to biobased products, health or the environment.
―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.
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