Characterization of commercially available nanosilver-polymer composite food packaging
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1 Characterization of commercially available nanosilver-polymer composite food packaging Gregory O. Noonan, Sean Conklin, Laila Ali, Timothy H. Begley Center for Food Safety and Applied Nutrition, US FDA College Park, MD, USA
2 Regulatory Authority 1958 Amendment Food Drug and Cosmetic Act Defines food additive Requires premarket approval of new uses of food additives Provides for a Generally Recognized as Safe (GRAS exemption) 1997 Food and Drug Administration Modernization Act (FDAMA) Established the Notification program for Food Contact Substances (FCS) Establishes proprietary use of FCS to the notifier. Maintains same safety standards as Food Additive Petition. Regulated in Title 21 of the US Code of Federal Regulations (21 CFR)
3 Nanotechnology and Antimicrobials DRAFT Guidance April 2012 Assessing the Effects of Significant Manufacturing Process Changes Including Emerging Technologies FDA does not categorically judge that all nano is inherently benign or harmful. Safety assessments of food substances should be based on data relevant to the physical and chemical properties of the food substance. No regulatory definition of nanomaterial. Antimicrobial US EPA Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) US FDA Federal Food, Drug, and Cosmetic Act (FFDCA) Food Quality Protection Act of 1996 (FQPA), and the Antimicrobial Regulation Technical Corrections Act of 1998 (ARTCA).
4 Research Goals Determine type of polymer and the presence of Ag and determine the form. FTIR ICP-MS Microscopy Measure migration of Ag and determine form. Migration into 3% acetic acid, ICP-MS Microscopy Evaluate antimicrobial claims. ASTM Zone of Inhibition
5 Response (normalized) Polyethylene Thickness Density Ag Conc. Ctrl 91 mm g/cm 3 < 0.5 ng Ag/g PE 63 mm g/cm 3 48 mg Ag/g PE Ag Ctrl-LDPE Ag-LDPE Wavenumber (cm -1 )
6 Response (normalized) Polypropylene Ctrl Thickness Density Ag Conc mm g/cm 3 < 0.5 ng Ag/g PP Ag 1.79 mm g/cm 3 29 mg Ag/g PP Commercial PP Commercial PP with Ag Wavenumber (cm -1 )
7 Repeat Exposure 3 % acetic acid Migration Conditions fresh acid fresh acid 100 C 4 hours Remove acid 100 C 4 hours Remove acid 100 C 4 hours Aliquot 3 + analyze polymer Aliquot 1 Aliquot 2 10 Day Storage 3 % acetic acid fresh acid 100 C 4 hours no acid 40 C 10 days 100 C 4 hours no acid 40 C 10 days Repeat 4 h 100 C Remove acid Aliquot 1 Remove acid Aliquot 2 Aliquot 3
8 Migration Results Sample Silver Concentration (ng/ml) 100% Migration Aliquot 1 Aliquot 2 Aliquot 3 Ag-LDPE Repeat Exposure < Day Storage Underline = <LOQ
9 Migration Results Sample Silver Concentration (ng/ml) 100% Migration Aliquot 1 Aliquot 2 Aliquot 3 Ag-LDPE Repeat Exposure < Day Storage Ag-PP Repeat Exposure Day Storage Underline = <LOQ
10 Migration Results Under these migration conditions would we likely measure diffusion controlled mass transfer from these materials?
11 Extrapolation Migration Estimation/Theory Connolly Volume (Å 3 ) Physicochemical view 2 Log D p 1 1 nm Irganox 1010 D ~ 1.3 x cm 2 /s Assume a nanoparticle with 5 nm radius. 2 nm sphere Connolly Volume ~ 4200 Å 3 D ~ 3 x cm 2 s -1 2 Diffusion Coefficients: A. Simon et al. J Food Nutr. Res (2008) 1 Diffusion Data: A. Reynier et al. Food Addit. Contam.16: (1999)
12 Response (normalized) FDA-Polyethylene Thickness Density Ag Conc. FDA-Ctrl 36 mm g/cm 3 < 0.5 ng Ag/g PE FDA-Ag 43 mm g/cm mg Ag/g PE (Commercial LDPE-Ag = 48 mg/g) FDA-Ctrl FDA-Ag Wavenumber (cm -1 )
13 Migration Results Sample Silver Concentration (ng/ml) 100% Migration Aliquot 1 Aliquot 2 Aliquot 3 FDA Ag-LDPE Repeat Use Ag-LDPE Repeat Use < 0.5 Ag-PP Repeat Use Underline = <LOQ
14 Zone of Inhibition Antimicrobial Properties Inoculate with E. Coli O157:H7 ASTM E : Determining Antimicrobial activity of immobilized Antimicrobial Agents under Dynamic Contact Conditions E. Coli O157:H7 in sterile buffer. + Polymer Sample Shake 1 h Incubate overnight Dilute and Streak Add Polymer Evaluate Cell Growth Incubate Overnight Count colonies
15 Ag-PP Film Zone of Inhibition Positive Control Triclosan (1%) Ag-LDPE Film No Inhibition Inhibition No Inhibition
16 Dynamic Contact Results Polymer Culture Only Control Film (blk) CFU/mL Silver Film Triclosan Film (1%) LDPE 3.5 x x x PP 1.5 x x x 10 4 NA
17 Conclusions Commercial food packaging contained low concentrations (ppm) of silver. Migration (surface desorption) of silver into 3% acetic acid. Extremely small amounts of silver (ng). Repeat exposures showed decreasing migration. None of the polymers exhibited antimicrobial properties (2 different test conditions).
18 Acknowledgements US FDA Laila Ali (Antimicrobial) Timothy Begley (Migration) Sean Conklin (ICP-MS) Tim Duncan (LDPE Films) University of Maryland NISP Lab Dr. Wen-An Chiou Food Environment Research Agency Qasim Chaudhry Emma Bradley Laurence Castle
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