New US Draft Guidance on FSMA Food Facility Registration

PRLog (Press Release) - Sep. 11, 2012 - The FDA Food Safety Modernization Act (FSMA) enables the United States Food and Drug Administration (US FDA) to better protect public health through preventive control standards. Under the FSMA, every registered facility is required to re- register every 2 years in even numbered years from October 1st to December 31st; of which 2012 will be the first year. Additionally, under Section 102 of FSMA there is a requirement that registrants provide to the FDA their general food category information. US FDA has implemented this requirement for additional information which they state will allow rapid communication between the US FDA and facilities that may be impacted by an actual or potential bioterrorist attack, other food-related emergencies or food safety incidents.

On 14 August 2012, the US FDA decided that additional food categories, other than those listed in 21 Code of Federal Regulations (CFR) 170.3 (http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&...), are appropriate for food facility registration. The following food categories are listed:

Additional Food Categories concerning Human Consumption:
   Acidified Food (see 21 CFR 114.3(b));
   Cheese and Cheese Product Categories: Soft, Ripened Cheese; Semi-Soft Cheese; Hard Cheese; Other Cheeses and Cheese Products;
   Dietary Supplement Categories: Proteins, Amino Acids, Fats and Lipid
   Substances; Animal By-Products and Extracts; Herbals and Botanicals;
   Fisher/Seafood Product Categories: Fin Fish, Whole or Filet; Shellfish; Ready to
   Eat (RTE) Fishery Products; Processed and Other Fishery Products;
   Fruit and Fruit Products: Fresh Cut Produce; Raw Agricultural Commodities; Other Fruit and Fruit Products;
   Fruit or Vegetable Juice, Pulp or Concentrate Products;
   Low Acid Canned Food (LACF) Products (see 21 CFR 113.3(n));
   Nuts and Edible Seed Product Categories: Nut and Nut Products; Edible Seed and Edible Seed Products;
   Shell Egg and Egg Product Categories: Chicken Egg and Egg Products; Other
   Egg and Egg Products;
   Vegetable and Vegetable Product Categories: Fresh Cut Products; Raw
   Agricultural Commodities; Other Vegetable and Vegetable Products; and
   Baby (Infant and Junior) Food Products Including Infant Formula.

Additional Food Categories concerning Animal Consumption:
   Grain or Grain Products (i.e., barley, grain sorghums, maize, oat, rice, rye, wheat, other grains or grain products);
   Oilseed or Oilseed Products (i.e., cottonseed, soybeans, other oilseeds or oilseed products);
   Alfalfa Products or Lespedeza Products;
   Amino Acids or Related Products;
   Animal-Derived Products;
   Brewer Products;
   Chemical Preservatives;
   Citrus Products;
   Distillery Products;
   Enzymes;
   Fats or Oils;
   Fermentation Products;
   Marine Products;
   Milk Products;
   Minerals or Mineral Products;
   Miscellaneous or Special Purpose Products;
   Molasses or Molasses Products;
   Non-protein Nitrogen Products;
   Peanut Products;
   Recycled Animal Waste Products;
   Screenings;
   Vitamins or Vitamin Products;
   Yeast Products;
   Mixed Feed (e.g., poultry, livestock, equine);
   Pet Food;
   Pet Treats or Pet Chews;
   Pet Supplements (e.g., vitamins, minerals); and
   If none of the above food categories apply, print the applicable food category or categories (that does not or do not appear above).

The US FDA will include these food categories as mandatory fields for registration when this guidance is finalized.

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