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Federal Food, Drug, and Cosmetic Act (Continued) PowerPoint Presentation
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Federal Food, Drug, and Cosmetic Act (Continued)

Federal Food, Drug, and Cosmetic Act (Continued)

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Federal Food, Drug, and Cosmetic Act (Continued)

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  1. Federal Food, Drug, and Cosmetic Act (Continued)

  2. GRAS, Food, and Color Additives • See handouts

  3. Sec. 402 (a) (1, 3, and 4) Examples • Sec 402 (a) (1) • Glass fragments, sharp objects, mycotoxins • Sec 402 (a) (3) • Rodent pellets in wheat • Sec 402 (a) (4) • Unshielded light fixtures

  4. Filth • Repulsive • Examples • Rabbit foot in frozen greens • Mangled mouse in a custard pie • Piece of rodent skin/hair in bread • June beetle in a muffin • Rodent urine stains on burlap bag of corn • Bird feathers/barbs in flour • Pecan weevil in pecans

  5. Unavoidable Based on industry, retail market, and port of entry surveys Aesthetic Filth 1972 Defect Action Levels (DALs) Product-specific 5000 samples analyzed every year Avoidable Health-specific Health hazards Unsanitary conditions Glass in baby food Allergens in food Mold mite in foods Oriental latrine fly and Salmonella Extraneous materials- glass, stones, shells of clams, etc. Filth

  6. Defect Action Levels (DALs) • Maximum levels of natural or unavoidable defects in foods that present no health hazard • DALs not considered if poor manufacturing is the cause • Pest management and DALs are unrelated • Does not allow for blending • FDA will establish a DAL if none exists

  7. DAL - Cornmeal • Insects (AOAC 981.19): Average of 1 or more whole insects (or equivalent) per 50 grams • Insect filth (AOAC 981.19): Average of 25 or more insect fragments per 25 grams • Rodent filth (AOAC 981.19): Average of 1 or more rodent hairs per 25 grams or average of 1 or more rodent excreta fragments per 50 grams

  8. DAL - Wheat • Insect damage (MPM-V15): Average of 32 insect-damaged kernels per 100 grams • Rodent filth (MPM-V15): Average of 9 mg or more rodent excreta pellets and/or pellet fragments per kilogram

  9. DAL – Wheat flour • Insect filth (AOAC 972.32): Average of 75 or more insect fragments per 50 grams • Rodent filth (AOAC 972.32): Average of 1 or more rodent hairs per 50 grams

  10. Factory Inspection • Sec. 704 • Provide written notice • Enter at reasonable times (factory, warehouse, or an establishment where food, drugs, devices or cosmetics are manufactured, processed, packaged, or held) • Inspections extend to vehicles, finished and unfinished materials, records, etc. • Notification given for each inspection, but not each entry • Inspection report of conditions observed for Sec. 402 (a) (1-4) violations • Information on samples obtained is also provided

  11. Imports and Exports • Sec. 801 • Food is not adulterated if it meets the specifications of a foreign buyer, or if it does not violate food laws of the importing country • Food intended for export should be clearly labeled as such • It should not be offered for sale domestically