Agrifood Nanotechnology PowerPoint Presentation

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Agrifood Nanotechnology: Upstream Assessment of Risk and Oversight Prof. Jennifer Kuzma Center for Science, Technology, and Public Policy Humphrey Institute, University of Minnesota USDA Risk Forum May 13, 2008

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Outline Introduction to Nanotechnology & Agrifood Applications Risk and Oversight Issues Research on Nano Oversight Discussion

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

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Assembling Nanomaterials Bottom 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)

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State of Nanotechnology 2000 National Nanotechnology Initiative (NNI), $270 M for R&D— Unusual, multidisciplinary Not really mission-based 2008 NNI continues, $1.4 B for R&D, including 4% of NNI budget devoted to social and ethical implications Congressional hearings on need for more EHS and societal work (2008) Despite this funding, no coordinated U.S. governance or oversight policy for nanotechnology Time for independent study of oversight models for nanotechnology More talk and acceptance of the need for public participation and dialogue early and often

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NNI organization National Nanotechnology Coordinating Office (NNCO) Courtesy of N. Savage, EPA

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NNI historical budget

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NNI recent Budget

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Anticipatory 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, Society

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Parallels to Ag Biotechnology Oversight Policy Challenges Applications diverse Agencies and laws broad and diverse Product not process issues Wait and see, using existing laws is the current approach Perils of moving too fast and over promising Distribution of risks and benefits of first generation products

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

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Kuzma, JNR 2007 Selected Categories of Nanotechnology Applied to Food and Agriculture Smart and precision ag

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Agrifood 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  [n1]FYI-dietary supplements Website contains disclaimer (if you look hard enough!) that products and claims are not FDA approved because they are marketed as dietary supplements, not food or drugs.  [n2]FYI—FDA pre-market review would be required under the Food Drug and Cosmetic Act if used in bottled water.  [n3]It would be appropriate to indicate source of this information. FDA is precluded by law from providing information on drugs under consideration. One could come to the conclusion in this table that FDA provided the information.  [n4]Same comment as for StarPharma.  [n5]Company marketing as FDA “authorized” but it is not authorized by FDA. True statement is that FDA provided that material is not expected to migrate into food so no FDA pre-market review was required. The use of the term “authorized” is not appropriate.  [n6]  [n7]  [n8]  [n9]  [n10] FDA has not reviewed any claims so it is not appropriate to state that product “complies” with FDA. Project on Emerging Nanotechnologies consumer inventory www.nanotechproject.org Storage of food with Ag antimicrobial Cocoa delivery with little sugar Cooking Oil Quality--nanoceramic Nanoclay barriers to O2 and CO2 Omega-3 bakery products Lycopene BASF

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Agrichemicals in development FOE 2008

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Convergence Nano-Geo-(Bio)-Info technology Berry et al. 2008

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Stages of Nano Adapted from M. Roco NSF Drexler Rice University 2001 2005 2010 2020 Agrifood applicatinos currently in passive to early “active” stage

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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

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Special Features of Nanoparticles A double-edged sword

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Percent of Neutrophils in BAL 24 hrs after Instillation of TiO 2 in Rats 0 500 1000 1500 2000 0 10 20 30 40 50 ultrafine TiO 2 (~20nm) fine TiO 2 (~250nm) saline Correlation with Particle Mass Particle Mass, m g % Neutrophils J. Finkelstein, presentation 2005

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Implications Side: Unique Challenges? Distribution in soils, water, air Transport, transformation and fate Reactivity Unique challenges? Impacts on human health--Toxicology Exposure--Inhalation, ingestion, contact Dose-Response Bioaccumulation, biotransformation, bioavailability Impacts on ecosystems and particular species Either direct (toxicity) Indirect (changes local conditions or prey) Royal Society 2004 Fullerene Toxicity studies

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Risk analysis Many 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

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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

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Oversight Characteristics Complex mixture of laws and features Some technology based, others command and control Mixed burden of proof in existing regulations Some medium based, some intent based, some manufacturing & use based Existing regulations arguably have adequate authority to regulate nanotechnology if so desired (American Bar Association 2006) Current resources inadequate for existing regulatory structures to oversee nanotechnology Current statutes or interpretation of them paralyze regulatory agencies (TSCA and burden of proof) Nano version of existing products does not trigger regulation New law best solution (Davies 2006)

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Coordinated Framework for the Regulation of Biotechnology Products circa 1986 No “new risks”, no new laws needed, “product not process”

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

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Possible Framework Kuzma ELR 2006 Several roles for USDA

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Oversight 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?

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

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Public Interface Focal Groups & Consensus Conferences Studies indicate little knowledge but general support for nanotechnology—public sees benefits. However, labeling, mandatory safety testing and better access to information about which nanotechnologies are being publicly funded are important to public Hart Res. Assoc. 2007

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

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Siegrist, et al 2007 Food packaging “outside” Better accepted than food particles “inside” Public views dependent on product & trust

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

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

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Comprehensive Study of Oversight Policy Scientists Technology Developers Risk Assessors Regulatory Policy Makers Practical S&T Policy Wonks Regulatory Assessors (CBA focused) Political Scientists Lawyers Academic Legal Studies Other Fields? Input? Who is thinking about oversight in a comprehensive way?

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Two Approaches Top-Down & Botton Up Agrifood nano Lessons from GEOs Oversight

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Why Agrifood Nanotechnology? Little information about R&D, safety, and products in the public domain (CBI, IPR) Overlapping or missing jurisdiction for products (e.g. premarket testing) Food and humans have a special relationship tied to necessity, culture, and environment. Distribution of risks and benefits are often different than for medical applications Need for transparency in product review and oversight process Need for regulatory clarity and holistic approaches to convergence products EU vs. US position on GEOs in food and agriculture (international harmonization) Initially, few benefits to those who bore any potential risk Need for public information and dialogue early and often 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 Potential Challenges: Lessons (AgBiotech) : Time for independent study of oversight models for agrifood nanotechnology

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Bottom Up Methods Agrifood Nanotechnology Oversight Phase 1*: Start with individual products Inventory, survey, and assessment of research and development in nanotechnology as applied to food, agriculture, and agroecosystems Phase 2:* Select individual products Selection of case studies and qualitative risk/benefit issue identification Phase 3: Assess individual products, extrapolate up Analysis of regulatory or non-regulatory governance systems for agrifood applications * Research Topics Research Techniques Estimated time to commercialization Part of food or product supply chain Endpoints of exposure Qualitative risk/benefit ranking

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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

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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,)

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Inventory phase

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Techniques for Projects

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Topics for Projects

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USDA Research Areas

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Stage and Type of Work

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Sector of Food Supply Chain

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Endpoints of Exposure Kuzma & Verhage PEN 2006

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Risk and Benefit Qualitative Ranking

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Mining the Database to Focus EHS research

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Other ways to mine database Particles of interest Private vs. public

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Key Results of Agrifood Inventory Large focus on food packaging and sensing for foodborne pathogens Focus on retail and consumer applications 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

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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 Phase 2:* Select individual products Selection of case studies and qualitative risk/benefit issue identification Phase 3:* Assess individual products, extrapolate up Analysis of oversight systems and issues for selected agrifood applications * Criteria for case selection: Frequency of topics and techniques in database Sector of supply chain Exposure endpoints Oversight relevance Research Methods: Literature searches—Toxnet, Fed Reg, etc. Researcher inquiries Case study comparison approach

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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

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Case Study #1 Risk & Oversight Issues Risk Issues Capsule Generally non-toxic PLGA-chitosan used in drug-delivery Dissolve in water However, not tested at large scale environmental release Fate and transport in environment Information needed PIs are conducting this work in phase II DNA Uptake by microbes? Persistence and fate in environment? Usually degraded Oversight Issues Broad range of statutes TSCA, CWA, FIFRA, etc? Lack of certainty about convergence applications Nano-bio-environment Detection capabilities For large scale release? Societal Public perception and concern about large scale release of DNA in the environment

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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

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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

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Case Study #2 Risk & Oversight Issues Risk Issues Capsule--chitosan Generally non-toxic Many toxicity studies found However, not tested at large scale environmental release Fate and transport in environment Information needed Not clear if it is being funded 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 Oversight Issues Clear Statute—FIFRA Nano-scale formulation evoked? Social Issues Special attention and concerns related to nano-scale formulation of commonly used substances? General perceptions of pesticides in the environment

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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)

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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

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Case Study #3 Risk & Oversight Issues Risk Issues Capsule GRAS Only harmful when animals overfed—no carcinogenic effects No nano encapuslation toxicity studies, however Fate and transport in environment Information needed Not clear if it is being funded Citral Micro encapsulated citral shown to have negative effects for animal feeding studies Malignant lymphoma Liver and fore-stomach damage Oversight Issues Clear Statute—FFDCA GRAS or food additive? Micro-level citral GRAS DSHEA if not in food-supplement Social Issues Consumer knowledge of risks and benefits of encapsulated citral at nano scale Labeling Post-market monitoring Transparency in safety process Industry does testing FDA relies on industry “nano” claims

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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

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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/

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Case Study #4 Risk & Oversight Issues Risk Issues Cellulose nanocomposites Diffusion out of matrix? Microcrystals—no observed effect Fate and transport in medical product Diffusion out of filters for hemodialysis? Blood toxicity Cross blood-CNS barriers? For non-medical product Life cycle issues Environmental pros and cons Oversight Issues Clear Statute for device use FFDCA and medical device amendments Will nano composites in devices by considered as new or under class I or II PMN and 510k? WHO “precautionary approach” to crystals under 5 um Limit content of particles under this size ADI not specified Social Issues Medical community informed about nanoscale particles embedded in matrix? Patients informed? Acceptable level of risk versus medical benefit of improved dialysis? Who decides?

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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

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

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Case Study #5 Risk & Oversight Issues Risk Issues Use of polyethylene glycol for delivery PEG shown to be safe No effect on cell death and do not activate immune response Nano version effects not known Weigh any potential risk with benefit of reduction of antibiotics important for human health Targeting molecule Mannose for E. coli Effects on other helpful gut flora On farm use Effects on environmental flora Animal waste streams to water Oversight Issues Difficult to find information on the nanoparticle Intellectual property issues Statutory authority and exercise by agencies unclear CWA and CAFO for animal waste? FFDCA—NAD? FDA--Feed additive or GRAS? Agency’s Feed Safety System USDA (VSTA) Social Risk perception Trust in ag industry Antibiotics and/or hormones in meat?

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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

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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/

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

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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.)

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Upstream Oversight Assessment Kuzma, Romanchek, Kokotovich Risk Analysis, in press

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Agrifood Future Work Update database and select additional cases Use of case study analysis for Expert judgment solicitation Upstream public engagement Discussions with decision maker First year USDA has included ELSI component in RFP (Lindquist, Verdlitz, and Kuzma USDA proposal)

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Anticipatory 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.

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Top-Down Approach to Study Oversight for Nanotechnology Wolf, Kokolli, Kuzma, Paradise, Ramachandran Multiple methods criteria, disciplines, stakeholders, and experts involved Rooted in historical analysis, expert elicitation, stakeholder input, and multi-criteria decision analysis Quantitative & Qualitative, Normative and Empirical 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 NSF-NIRT grant 2006-2010, $1.2M

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Developing Hypotheses : Integrated Oversight Assessment Approach Kuzma et al. 2008, Risk Analysis, in press

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“Consensus” criteria Kuzma et al. 2008, forthcoming in Risk Analysis

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GEOs Expert Elicitation

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Generating Hypotheses Kuzma, Najmaie, Larson. In prep Correlation coefficients R>0.7, p<0.0016

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Public Confidence p<0.05

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Hypotheses generated Evidence-based lessons for nano

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Conclusions Information gaps in agrifood nanotechnology Need to be filled by trusted sources Need for transparency Need for upstream analysis of products, oversight systems, potential risks, and societal issues Time is ripe Data needs Engagement needs Tie ELSI work with policy making Convergent applications of agrifood nano Will present oversight challenges Public input into risk analysis process and oversight decisions (key variable in positive outcomes)

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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) NSF NIRT “Intuitive Toxicology for Nanotechnology” (2007-2011) Questions & Input? Prof. Jennifer Kuzma 612-625-6337 kuzma007@umn.edu http://www.hhh.umn.edu/centers/stpp

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Extra slides if needed/desired

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

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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.

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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.

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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.

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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.

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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.

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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.

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In memory of Prof. Ed Schuh 1930-2008 National Order of Scientific Merit, Gra Cruz, the equivalent of the U.S. Presidential Medal of Freedom Director of agriculture and rural development for the World Bank Deputy Under Secretary for International Affairs and Commodity Programs at the US Department of Agriculture Member Board on Agriculture and Natural Resources, U.S. National Academy of Sciences and National Research Council (1998-2004) U.S. Council of Economic Advisors U of MN HHH Dean U of MN Regents Professor Kind and Attentive Mentor to many junior faculty and students.