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Federal Food, Drug, and Cosmetic Act (Continued)

Federal Food, Drug, and Cosmetic Act (Continued). GRAS, Food, and Color Additives. See handouts. 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. Filth.

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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

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