As we are receiving every day more and more phone calls about the new FDA Facility Registration that will be coming mandatory starting on October 1, 2012 and ending on December 31. 2012, we have decided to put the answers together as it is not easy to find them on one piece of paper on the FDA pages.
GuidanceComplianceRegulatoryIn formation/ RegistrationofFoodFacilities/ default.htm
Who is required to register as food facilities, which farms or Food/Feed handlers are required to register as food facilities with the Food and Drug Administration?
All domestic and foreign facilities that manufacture, process, pack or hold food for human or animal consumption in the U.S. are mandated to register with FDA.
What do I have to do if my facility is already registered?
All facilities that are required to register must renew their registrations during the period beginning on October 1 and ending on December 31 of each even-numbered year.
What is a food/feed facility?
A food facility includes any factory, warehouse (course grain/hay storage, drying or grain cleaning or mixing or conditioning facility) or establishment that manufactures, (mills, or feed grinding/mixing operation) or processes, packs, or holds (bin storage) food or feed. Manufacturing/processing activities include making food (feed or rations) chopping from one or more ingredients, or synthesizing, preparing, treating, modifying, or manipulating food or feed crops or ingredients.
On farm washing, trimming off outer leaves, and cooling produce are considered part of harvesting and would not require classification as a facility if done on the same day as harvesting. If you hold the harvest in a storage/cooler or warehouse you are a facility.
Which farms are required to register as food facilities with FDA?
if you grow it, store it, pack it, ship it
Farms must register as food facilities with the Food and Drug Administration if they:
Manufacture, process, pack, or hold food/feed beyond what is considered harvesting.
Direct market less than 50% of their product. (Tester Amendment)
In this instance, direct marketing means direct farmer-to-consumer sales and does not apply to stores, restaurants and schools.
Manufacturing/processing activities include making food/feed from one or more ingredients, or synthesizing, preparing, treating, shelling, drying, modifying, or manipulating food/ crops or ingredients. Examples of manufacturing/processing include: Grains/Seeds and other Foods/Feeds
- Cutting, Silage, Hay Processing
- Cooking, Grain Roasting
- Baking, Cotton Ginning
- Cooling, Drying, conditioning
- Pasteurizing, Proponic acid treating grain
- Mixing, Commingling
- Formulating, Hulling
- Bottling, sizing, sorting
- Milling, Mixer/grinder TMR / rolling/ flaking
- Grinding, Nut Hulls,
- Extracting juice, Shelling
- Distilling, DDG’s
- Labeling, or
Additional Food Categories for Foods for 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 for Foods for 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;
- 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;
- 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).
Total list in the link below:
GuidanceComplianceRegulatoryIn formation/GuidanceDocuments/ FoodDefenseandEmergencyRespons e/ucm315290.htm#introduction
Here is the link to the registration page: