The Coming Food Problem: Is Nanotechnology Part of the Answer?

Transcription

1 The Coming Food Problem: Is Nanotechnology Part of the Answer? September 27, 2012 ATLANTA CHICAGO DELAWARE INDIANA LOS ANGELES MICHIGAN MINNEAPOLIS OHIO WASHINGTON, DC 2012 Barnes & Thornburg LLP. All Rights Reserved. This page, and all information on it, is the property of Barnes & Thornburg LLP which may not be reproduced, disseminated or disclosed without the express written consent of the author or presenter. The information on this page is intended for informational purposes only and shall not be construed as legal advice or a legal opinion of Barnes & Thornburg LLP.

2 Presenters Mangilal Argarwal, PhD Integrated Nanosystems Development Institute, IUPUI Sudhir Shrestha, PhD IUPUI Grady Chism, PhD IUPUI ATLANTA CHICAGO DELAWARE INDIANA LOS ANGELES MICHIGAN MINNEAPOLIS OHIO WASHINGTON, DC 2012 Barnes & Thornburg LLP. All Rights Reserved. This page, and all information on it, is the property ofbarnes & ThornburgLLP which may notbe reproduced, disseminated or disclosed withoutthe express writtenconsent of the authoror presenter. The informationon this page is intended for informational purposes only and shall not be construed as legal advice ora legal opinionofbarnes & Thornburg LLP. Presenters Lynn Tyler Partner Barnes & Thornburg LLP Frank Witzmann, PhD IUPUI ATLANTA CHICAGO DELAWARE INDIANA LOS ANGELES MICHIGAN MINNEAPOLIS OHIO WASHINGTON, DC 2012 Barnes & Thornburg LLP. All Rights Reserved. This page, and all information on it, is the property ofbarnes & ThornburgLLP which may notbe reproduced, disseminated or disclosed withoutthe express writtenconsent of the authoror presenter. The informationon this page is intended for informational purposes only and shall not be construed as legal advice ora legal opinionofbarnes & Thornburg LLP. 1

3 Food-Nanotechnology Food Technology Seminar Integrated Nanosystems Development Institute (INDI) Indiana University Purdue University Indianapolis (IUPUI) INDI INTEGRATED NANOSYSTEMS DEVELOPMENT INSTITUTE What is Nanotechnology An engineered DNA strand prna tiny motor Semiconducting metal junction formed by two carbon nanotubes Nanotechnology is the creation of functional materials, devices and systems, through the understanding and control of matter at dimensions in the nanometer scale length (1-100 nm), where new functionalities and properties of matter are observed and harnessed for a broad range of applications 2

4 Ant, 5 mm What is Nanoscale 50 nm Gate Transistor 38 mm 38 mm (820 million Transistors) Fullerene, C 60 Fly head, 1 mm 60 m Human Red Blood Cells 6-8 m 50 nm 2 nm 0.7 nm 10-2 m 10-3 m 10-4 m 10-5 m 10-6 m 10-7 m 10-8 m 10-9 m m 1 cm 1 mm 100 m 10 m 1 µm 100 nm 10 nm 1 nm 0.1 nm 2 nm 2 nm Fly Head 1000 m (1mm) 60 m Red Blood Cell (6-8 m), Platelet (2-4 m), and White Blood Cell (7-8 m) 5 m 50 nm Gate Transistor DNA Carbon Nanotube Fullerene Nanoscale Size Effects Realization of miniaturized devices and systems while providing more functionality Attainment of high surface area to volume ratio Manifestation of novel phenomena and properties, including changes in: - Physical Properties (e.g. melting point) - Chemical Properties (e.g. reactivity) - Electrical Properties (e.g. conductivity) - Mechanical Properties (e.g. strength) - Optical Properties (e.g. light emission) Smaller Tin nanoparticles have lower melting points - Phys. Rev. Let. 77, 1996 Quantum dots of different size emit different colors - 3

5 Nanoscale Materials Nanoscale materials have feature size less than 100 nm utilized in nanoscale structures, devices and systems - Nanoparticles and Nanostructures - Nanowires and Nanotubes - Fullerenes - Bionanomaterials - Quantum Dots Gold nanoparticles Silicon Nanowieres Carbon Nanotubes Fullerene Porous silicon (PSi) Quantum Dots Food-Nanotechnology Nanotechnology in Food Industry Better Seeds Smart Fertilizers Food Packaging Nanotechnology Smart Herbicides And Pesticides Food Ingredients Pathogens and Pesticide Detection 4

6 Nanotechnology in Food Pre-Harvest Seeds: Increased Germination and Plant Growth Nanoparticles and nanotubes can penetrate seed coat Affect germination and plant growth Eg. Carbon nanotubes (CNT) can penetrate plant seed coat and increase germination and plant growth Fertilizers: Green slow-release fertilizer Sustained release of fertilizers into soil Smart release: Release fertilizers at specific soil conditions, such as ph. Release only at specific plant sites Eg. Commercial fertilizer: Non-uniform release up to 30 days. Urea surface-modified HA nanoparticle fertilizer: Slow-release up to 60 days Herbicides: Smart delivery of nano-encapsulated herbicides Ability to target specific herbs Controlled release Pesticides: Encapsulation of the pesticide at nanoscale Controlled release Extend plant protection Increased solubility Reduce risk to the agricultural workers Reduce environmental impact by reducing run-off rates 5

7 Nanotechnology in Food Post-Harvest Major Barriers Regulatory Economics Consumer acceptance Major Near Term Opportunities Non-contact applications Longer Term Opportunities Nanotechnology in Food Packaging Short term non-contact Coating for paperboard to improve barrier properties Near Term Improved barrier properties of laminates Sensors Antimicrobial Regulatory environment requires proof that it is safe 6

8 Nanotechnology in Food Ingredients/ Processing Nanoemulsions/dispersions to deliver or enhance bioavailability and/or stability of water insoluble components Nanostructures to provide unique physical properties (texture) Coatings of processing equipment to reduce corrosion, increase hardness, etc. Nano-Sensors Contaminant and pathogen detection Freshness/ quality detection Monitoring gases in storage or packages 7

9 Health and Environmental Concerns Humans and the environment may come under exposure to nanomaterials at different stages of the product cycle Nanomaterials have large surface to volume ratio and novel physical as well as chemical properties which may cause them to pose hazards to humans and the environment Health and the environmental impacts associated with the exposure to many of the engineered nanomaterials are still uncertain The environmental fate and associated risk of waste nanomaterials should be assessed e.g. toxic transformation, and interactions with organic and inorganic materials Exposure of human and the environment to nanomaterials at different stages of product life cycle US environmental protection agency, 2007 (epc.gov ) Mission INDI Integrated Nanosystems Development Institute The mission of INDI is 1)to enable, through innovative interdisciplinary research and educational programs, the development of nanotechnology-based systems for biomedical, energy, environmental, information technology and other applications, and 2)to provide solutions which, through translation of research into practice and technology transfer, contribute to social well being and economic growth. Motivation Growing expertise and resources at IUPUI in nanotechnology Bring together synergistic research interests from multiple campus units Desire by existing researchers and centers to develop nanotechnology-oriented research projects Need for integrated nanotechnology interdisciplinary core facilities Need to be competitive in the recruitment of new faculty Need for nanotechnology-oriented faculty proposals becoming more competitive Ability to attract new students seeking nanotechnology-oriented undergraduate and graduate curricula Ability to meet industry needs for nanotechnology trained workforce Ability to form interdisciplinary partnerships among campus units and external collaborators 8

10 Current Participants Faculty School of Engineering and Technology (SET) School of Science (SOS) School of Medicine (IUSM) Centers Lugar Center for Renewable Energy Transportation Active Safety Institute Center for Sensor and Ubiquitous Networking Nanoscale Imaging Center Center for Regenerative Biology and Medicine Electron Microscopy Center Resources: Cleanroom Nanoassembly Micro/Nanofluidics Material Deposition Material Etching Tissue Engineering Nanoscale Imaging Electrical Characterization Wireless Measurements Computational Resources Other FDA Guidance on Food, Food Packaging, and Nanotechnology ATLANTA CHICAGO DELAWARE INDIANA LOS ANGELES MICHIGAN MINNEAPOLIS OHIO WASHINGTON, DC 2012 Barnes & Thornburg LLP. All Rights Reserved. This page, and all information on it, is the property ofbarnes & ThornburgLLP which may notbe reproduced, disseminated or disclosed withoutthe express writtenconsent of the authoror presenter. The informationon this page is intended for informational purposes only and shall not be construed as legal advice ora legal opinionofbarnes & Thornburg LLP. 9

11 FDA Draft Guidance Assessing Effects of Significant Manufacturing Process Changes... On Safety and Regulatory Status of Food and Food Packaging Broader in scope, but includes nanotechnology Requires evidence of safety and appropriate tests to validate safety ATLANTA CHICAGO DELAWARE INDIANA LOS ANGELES MICHIGAN MINNEAPOLIS OHIO WASHINGTON, DC 2012 Barnes & Thornburg LLP. All Rights Reserved. This page, and all information on it, is the property ofbarnes & ThornburgLLP which may notbe reproduced, disseminated or disclosed withoutthe express writtenconsent of the authoror presenter. The informationon this page is intended for informational purposes only and shall not be construed as legal advice ora legal opinionofbarnes & Thornburg LLP. Regulatory Scheme Food additives and packaging Must be pre-approved or Generally recognized as safe (GRAS) Color additives Must be pre-approved & batch certified NO GRAS exception Regulation GRAS Notice Food Contact Notification ATLANTA CHICAGO DELAWARE INDIANA LOS ANGELES MICHIGAN MINNEAPOLIS OHIO WASHINGTON, DC 2012 Barnes & Thornburg LLP. All Rights Reserved. This page, and all information on it, is the property ofbarnes & ThornburgLLP which may notbe reproduced, disseminated or disclosed withoutthe express writtenconsent of the authoror presenter. The informationon this page is intended for informational purposes only and shall not be construed as legal advice ora legal opinionofbarnes & Thornburg LLP. 10

12 Need for new safety assessment Significant change may require new safety assessment If no longer within regulation, GRAS, or FCN, need pre-market approval Unlikely to be GRAS per FDA Likely need pre-market approval Because of potential differences in bioavailability and other properties, safety studies must be validated for nanoscale materials ATLANTA CHICAGO DELAWARE INDIANA LOS ANGELES MICHIGAN MINNEAPOLIS OHIO WASHINGTON, DC 2012 Barnes & Thornburg LLP. All Rights Reserved. This page, and all information on it, is the property ofbarnes & ThornburgLLP which may notbe reproduced, disseminated or disclosed withoutthe express writtenconsent of the authoror presenter. The informationon this page is intended for informational purposes only and shall not be construed as legal advice ora legal opinionofbarnes & Thornburg LLP. Aspects of Safety Assessment Identity Technical effect Self-limiting level Compare level of likely consumption to level at which toxic effects observed Manufacturing process ATLANTA CHICAGO DELAWARE INDIANA LOS ANGELES MICHIGAN MINNEAPOLIS OHIO WASHINGTON, DC 2012 Barnes & Thornburg LLP. All Rights Reserved. This page, and all information on it, is the property ofbarnes & ThornburgLLP which may notbe reproduced, disseminated or disclosed withoutthe express writtenconsent of the authoror presenter. The informationon this page is intended for informational purposes only and shall not be construed as legal advice ora legal opinionofbarnes & Thornburg LLP. 11

13 FDA Recommended Steps Determine changes to physicochemical structures and properties, purities and impurities Conduct safety assessment, including prior slide, bioavailability, and toxicity Is substance within regulation, GRAS (unlikely), or food contact notification Consult with FDA Make regulatory submission if appropriate ATLANTA CHICAGO DELAWARE INDIANA LOS ANGELES MICHIGAN MINNEAPOLIS OHIO WASHINGTON, DC 2012 Barnes & Thornburg LLP. All Rights Reserved. This page, and all information on it, is the property ofbarnes & ThornburgLLP which may notbe reproduced, disseminated or disclosed withoutthe express writtenconsent of the authoror presenter. The informationon this page is intended for informational purposes only and shall not be construed as legal advice ora legal opinionofbarnes & Thornburg LLP. Case-by-Case Approach Scientific studies to date have shown that some nanomaterials can be toxic Others are not Difficult to predict in advance whether any particular material will or will not be toxic Even based on tests for their microscale or macroscale counterparts Aligns with European Food Safety Authority ATLANTA CHICAGO DELAWARE INDIANA LOS ANGELES MICHIGAN MINNEAPOLIS OHIO WASHINGTON, DC 2012 Barnes & Thornburg LLP. All Rights Reserved. This page, and all information on it, is the property ofbarnes & ThornburgLLP which may notbe reproduced, disseminated or disclosed withoutthe express writtenconsent of the authoror presenter. The informationon this page is intended for informational purposes only and shall not be construed as legal advice ora legal opinionofbarnes & Thornburg LLP. 12

14 Some Important Considerations Regarding ENM Toxicology Route and site of exposure Absorption ADME: Distribution (and accumulation) Pharmacokinetics In vivo (LD50 concept) Metabolism & Toxicokinetics Excretion Health effects local remote systemic In vitro (EC50 concept) acute chronic heritable (germ cell genotoxicity) Dose response relationship (hormesis) Human intestinal cell co-culture model used in silver (Ag) NP exposures Apical Media Proteome: secreted or exfoliated proteins, cytokines AgNPs Mucus layer HT29-MTX cell Caco-2 cell Basolateral Media Proteome: secreted or exfoliated proteins; cytokines Cellular Proteome: biological effects 13

15 Co-culture system simulates intestinal barrier AgNP enter & pass through cells, found in organelles 14

16 Cytotoxicity Assays Inflammatory Assays Proteomics: Ag NPs cause differential protein expression 4,112 unique proteins analyzed Bioinformatic Analysis of these proteins will help us to understand nanosilver s functional effects on the intestinal cells. 15

17 Questions? Contact today s speakers directly by ing them at: Dr. Mangilal Argarwal agarwal@iupui.edu Dr. Sudhir Shrestha sudshres@iupui.edu Dr. Frank Witzmann fwitzman@iupui.edu Lynn Tyler lynn.tyler@btlaw.com Dr. Grady Chism - grchism@iupui.edu ATLANTA CHICAGO DELAWARE INDIANA LOS ANGELES MICHIGAN MINNEAPOLIS OHIO WASHINGTON, DC 2012 Barnes & Thornburg LLP. All Rights Reserved. This page, a nd all information on it, is the property of Barnes & Thornburg LLP which may not be reproduced, disseminated or disclosed without the express written consent of the author or presenter. The information on this page is intended for informational purposes only and shall not b e construed as legal advice or a legal opinion of Barnes & Thornburg LLP. Upcoming Food & The Future Webinar Business Planning in Today s Economy: What the Food Industry Needs to Know and Consider Thursday, Oct. 11, :30-1:30ET To register for this upcoming webinar, btrsvp@btlaw.com ATLANTA CHICAGO DELAWARE INDIANA LOS ANGELES MICHIGAN MINNEAPOLIS OHIO WASHINGTON, DC 2012 Barnes & Thornburg LLP. All Rights Reserved. This page, a nd all information on it, is the property of Barnes & Thornburg LLP which may not be reproduced, disseminated or disclosed without the express written consent of the author or presenter. The information on this page is intended for informational purposes only and shall not b e construed as legal advice or a legal opinion of Barnes & Thornburg LLP. 16

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