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1

2 CSL/JIFSAN

3 CSL/JIFSAN USDA USDA/CSREES

4 CSL/JIFSAN

5 CSLCentral Science LaboratoryJIFSANJoint Institute for Food Safety and Applied Nutrition (FDA) ) (USDA)National Program LeaderHongda ChenUSDA USDA CSL/JIFSAN DC -1 -

6 ADME: Adsorption, Distribution, Metabolism and ExcretionAbsorptionDistri butionmetabolismexcretion ASTM: American Society for Testing and Materials CFSAN: Center for Food Safety and Applied Nutrition (FDA) FDA CORDIS: Community Research and Development Information Service (EU) CSL: Central Science Laboratory (UK) CSREES; Cooperative State Research, Education, and Extension Service CVM: Center for Veterinary Medicine (FDA)FDA DDS: Drug Delivery System DOE: Department of Energy EFSA: European Food Safety Authority (EU) FDA: Food and Drug Administration HHS (Department of Health and Human Services HELI: Health and Environmental Science InstituteILSI IEC: International Electrotechnical Commission IEEE: The Institute of Electrical and Electronics EngineersIEEE IHCP:, Institute for Health and Consumer Protection (EU)JRC (Joint Research Center) ILSI: International Life Sciences Institute -2 -

7 IRMM: Joint Research Center, Institute for Reference Materials and Measurements (EU) JECFA: FAO/WHO Joint Expert Committee on Food AdditivesFAO/WHO JIFSAN: Joint Institute for Food Safety and Applied Nutrition (USA) NDS: Nutrition Delivery System NIST: National Institute of Standards and TechnologyDOC (United States Department of Commerce) NNI: National Nanotechnology Initiative (USA) NPL: National Program Leader (USDA) NSET: Subcommittee on Nanoscale Science Engineering and Technology (USA) NSTC NSTC: National Science and Technology Council (USA) SCENIHR: Scientific Committee on Emerging and Newly Identified Health Risks (EU) ( ) TGD: Technical Guidance Documents (EU) USDA: United States Department Agriculture -3 -

8 (CSL)(JIFSAN ) 100 EC 1nm 100nm (USDA) USDA USDA (CSREES) USDA DDS (NNI) (EC) (SCENIHR)

9 CSL/JIFSAN CSL JIFSAN 1) EU (114EC5) 1 2) -5 -

10 (2) (2) (3) 1) CSL; Central Science Laboratory Department for Environment, Food and Rural Affairs ) JIFSAN; Joint Institute for Food Safety and Applied Nutrition FDA (Food and Drug AdministrationUniversity of Maryland 3) CSREES; Cooperative State Research, Education, and Extension Service USDA 4) NIST; National Institute of Standards and Technology HELI; Health and Environmental Science Institute ILSI; International Life Sciences Institute IRMM; Joint Research Center, Institute for Reference Materials and Measurements IHCP; Joint Research Center, Institute for Health and Consumer Protection EFSA; European Food Safety Authority FDA EC FDA EC FDA -6-

11 DOEFDA EC EFSA ) FAO/WHO FAO/WHO Expert Meeting for Nanotechnology ) SCENIHR ) USDA USDA EC 2007 FP EU 2004 R&D (poles of excellence) CORDIS 7) 7 CORDIS 8) NIST -7-

12 X X X 167nm 199nm 184nm 9) nm ISO/TC 229 ASTM 2005 IECIEEEOECD Lee Lo Lo NDS ICP-MASS EC IRMM SEM TEMSPM (AFM) DLSXXRD X EDXX AASICP MASS SECCE HDC BET -8 -

13 CSL FDA in vitro 20nm 37nm 20nm 10) 11, 12) CSL ) 300nm nm 70nm 14) 15) 16) EC IHCP in vitro in vivo in vitro -9 -

14 ILSIHESI FDA CFSAN 17) 62 ADME EU EFSA DDS EFSA Microcrystalline Cellulose (MC) PET

15 MC 5m 10% FAO/WHO JECFA ) EFSA OECD ISO EC FDA CVM CVM NNI CSREES CSREES NPLNPL CSREES NPL Hongda Chen USDA NNI 2001 USDA NNI NNI CSREES ) USDA USDA -11-

16 ASAE 2004 USDA/CSREES 2002 GMO DNA CNT DNA CSREES CREES in vitro in vivo Microfluidics / BioNEMS Bio nanoelectromechanical system Drug Delivery/Biochips / Nucleic Acid Bioengineering Nanobioprocessing Biosesors Nanomaterials Bioselective Surfaces (bioseparation technologies)

17 NSTCNSET Roco 21) USDA/CSREES Roco NNI )

18 - 14 -

19 EU NNI EU FP EU EU NNI 1nm 100nm nm FDA/CVM 2 EU

20 Novel foods (Novel foods)novel foods NNI ) FDAEPA EU ECSCENIHR 5) TGD in vitro QSAR NNI TGD

21 1. The Eighth Joint CSL/JIFSAN Symposium on Food Safety and Nutrition 'Nanotechnology in Foods and Cosmetics': 2. Proceedings of the Eighth Joint CSL/JIFSAN Symposium on Food Safety and Nutrition 'Nanotechnology in Foods and Cosmetics': 3. Management Plan of the European Food Safety Authority for the Year 2007, EFSA: Par.0001.File.dat/Management%20Plan%202007%20Adopted.pdf 4. Joint FAO/WHO Food Standards Programme Codex Alimentarius Commission, Agenda Item 16, Thirtieth Session FAO Headquarters, Rome, 2-7 July 2007, Other matters arising from FAO and WHO, Table 2: ftp://ftp.fao.org/codex/cac/cac30/al3009ge.pdf 5. Opinion on the appropriateness of the risk assessment methodology in accordance with the technical guidance documents for new and existing substances for assessing the risks of nanomaterials, The SCENIHR approved this opinion for the public consultation at the 17th plenary on 29 March 2007: The SCENIHR adopted this opinion at the 19th plenary on June 2007 after the public consultation: 6. Towards a European Strategy for Nanotechnology: EC : 7. CORDIS, Community Research & Development Information Service: 8. CORDIS, EuroNanoForum: 9. B. Alexander et al., Comparison of scanning electron microscopy, dynamic light scattering and analytical ultracentrifugation for the sizing of poly(butylcyanoacrylate) nanoparticles, European Journal of Pharmaceutics and Biopharmaceutics, 57, (2004). 10. J.P. Ryman-Rasmussen et al., Penetration of intact skin by quantum dots with diverse physicochemical properties, Tox. Sci., 91, (2006). 11. A. O. Gamer et al., The in vitro absorption of microfine zinc oxide and titanium dioxide through porcine skin, Toxicol. In. Vitro, 20, (2006). 12. S. E. Cross et al., Human Skin Penetration of Sunscreen Nanoparticles: In-vitro Assessment of a Novel Micronized Zinc Oxide Formulation, Skin Pharmacol. Physiol., 20, (2007). 13. The Woodrow Wilson inventory of nanotechnology consumer products: M. Chen, M. and A. von Mikecz, Formation of nucleoplasmic protein aggregates impairs nuclear function in response to SiO2 nanoparticles, Experimental Cell Research 305, 51-62(2005)

22 15. F. Rohner et al., Synthesis, Characterization, and Bioavailability in Rats of Ferric Phosphate Nanoparticles, J Nutr., 137, (2007). FePO4 16. Z. Chen et al., Acute toxicological effects of copper nanoparticles in vivo, Tox. Lett., 163, (2006). 17. T. S. Thurmond, Are there potential safety concerns for the use of nanosized food additives or the use of nanosized food additives or color additives used in foods?, Proceedings of CSL/JIFSAN joint symposium 2007, pdf 18. Evaluation of certain food additives and contaminants : sixty-seventh report of the Joint FAO/WHO Expert Committee on Food Additives.(WHO technical report series ; no. 940), Joint FAO/WHO Expert Committee on Food Additives. Meeting (67th : 2006 :Rome, Italy) ISBN (NLM classification: WA 701), ISBN , ISSN EFSA and the University of Parma organise Scientific Symposium on Food Safety, Nutrition and Nanotechnology -, 4 October 2007, N. R. Scott and H. Chen, Nanoscale science and engineering for agriculture and food systems, M.C. Roco, The future of National Nanotechnology Initiative, p.5, Environmental, Health, and Safety Research Needs for Engineered Nanoscale Materials, NSTC() Prioritization of Environmental, Health, and Safety Research Needs for Engineered Nanoscale Materials USDA/CSREES FSA A (draft) Review for the UK Food Standards Agency: CSL. Chaudhry, et. al., A scoping study to identify gaps in environmental regulation for the products and applications of nanotechnologies (2006),

23 CSL/JIFSAN

24 - 20 -

25

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