Agrifood Nanotechnology: Upstream Assessment of Risk and Oversight

1. 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

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

3. 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

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

6. 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 State of Nanotechnology

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

8. NNI historical budget

9. NNI recent Budget

10. 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

11. 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

12. 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?

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

14. 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 Agrifood Nano-Products on Market 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 [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.

15. Agrichemicals in development FOE 2008

16. ConvergenceNano-Geo-(Bio)-Info technology Berry et al. 2008

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

18. 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

19. Special Features of NanoparticlesA double-edged sword

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

21. 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) Implications Side: Unique Challenges? Royal Society 2004 Fullerene Toxicity studies

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

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

24. 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) Oversight Characteristics

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

26. 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.

27. Possible Framework Kuzma ELR 2006Several roles for USDA

28. 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?

29. 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.

30. 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 Public Interface Hart Res. Assoc. 2007

31. ‘ ‘ Unknown’ Unknown’ PVC PVC DNA Technology DNA Technology Radioactive Waste Radioactive Waste Antibiotics Antibiotics ‘ ‘ Dread’ Dread’ Auto Exhaust Auto Exhaust Coal Mining Coal Mining Bicycles Bicycles Home Swimming Home Swimming Pools Pools Slovic Slovic et al, 1980 et al, 1980 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)

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

33. 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?

34. 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) Social & Ethical Issues

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

36. Two ApproachesTop-Down & Botton Up Lessons from GEOs Oversight Agrifood nano

37. 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 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 Lessons (AgBiotech) : Potential Challenges: Time for independent study of oversight models for agrifood nanotechnology

38. 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 Bottom Up Methods Agrifood Nanotechnology Oversight

39. 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

40. 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,)

41. Inventory phase

42. Techniques for Projects

43. Topics for Projects

44. USDA Research Areas

45. Stage and Type of Work

46. Sector of Food Supply Chain

47. Endpoints of Exposure Kuzma & Verhage PEN 2006

48. Risk and Benefit Qualitative Ranking

49. Mining the Database to Focus EHS research

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