New Biannual Registration Requirement
On January 4, 2011, 21 U.S.C.§ 350d was amended by the Food Safety Modernization Act (FSMA), adding the requirement that all food facilities, foreign and domestic, must register with the Food and Drug Administration (FDA). This requirement expanded the registration mandate first enacted under the Bioterrorism Act in 2003. The law defines food facilities to mean those “engaged in manufacturing, processing, packing, or holding food for consumption in the United States.” Whether a domestic or foreign facility, “the owner, operator, or agent in charge of the facility” is expected to submit the registration. For facilities that were already registered, no new registration was required, until now. Section 102 of FSMA requires all food facilities to register every (2) two years between the dates October 1 and December 31. That said, however, the FDA held back opening registration while it was redesigning some application requirements. On Saturday, October 20, the FDA released a guidance document – http://www.fda.gov/Food/GuidanceCompliance – opening registration on October 22, 2012.
What does the FDA’s new guidance policy state? First, it says that it is binding and not just a guidance or recommendation. The basis for making the guidance binding is a provision in the FSMA. When the Bioterrorism Act took effect, general food categories were identified at 21 C.F.R. § 170.3. That list is now being expanded through this latest guidance, and designating your products as they appear in these expanded categories will be a mandatory part of the new registration process. (New categories appear below.)
Companies are reminded that the failure to timely renew a registration means you have committed a prohibited act and are subject to criminal prosecution. While the law is not totally clear that goods imported without a valid facility registration being on file are also barred from importation as adulterated products, the FDA is expected to interpret the law that way, in which case the courts may have to settle this issue. Even if importing your product is done seasonally, perhaps during the U.S. summer months, you will want to register between now and December 31, 2012. If you wait until your season starts, the FDA is currently saying your existing registration number will have become invalid due to lack of timely renewal, and you will have to obtain a new registration number prior to the first seasonal shipment. You may be happy to have a new registration number every two years, but if not, you will want to act starting now.
If you registered many years ago, perhaps when the Bioterrorism Act initially took effect, the first step is to find your PIN and password. If you cannot find them, the FDA recommends you simply file a new registration. While all the necessary mechanisms are not yet in place, the FDA expects to declare any existing registrations not timely renewed as invalid and to do so shortly after the registration period closes. Once that happens, you will no longer be able to use the old registration number.
New Fees For Reinspections
One area causing a lot of concern is who is willing to act as U.S. agent. When the Bioterrorism Act took effect, a number of entities agreed to act as U.S. agents for foreign facilities. At that time, there was no responsibility put on the U.S. agent except to timely convey information and documents between the FDA and the foreign facility. Under FSMA, user fees for reinspections will be imposed. As a result, many entities that were originally willing to act as U.S. agent are now declining to do so. When you file a registration, your U.S. agent will receive an email notifying it of its designation as such. At that point, the U.S. agent may decline to act on your behalf, and your registration will be invalid. Make sure the entity you designate as your U.S. agent is willing to act in that capacity.
The FDA has stated that, if it reinspects a domestic facility, it will bill its charges to that domestic facility. To date, the FDA admits all reinspections have been of domestic facilities. However, if reinspection of a foreign facility occurs, the U.S. agent will be billed. Many entities are declining to act as U.S. agent out of concern for potential financial responsibility for those reinspection fees. The FDA is also mandated to inspect foreign facilities. The number of such inspections currently required by the FSMA could go as high as 19,200 (600 in year one and doubling annually thereafter). The FDA admits it is inspecting about 1,200 foreign facilities yearly and does not anticipate increasing much beyond that number. However, foreign facilities should expect that their record keeping, processes, and products will be subject to review, just by other means, including cooperation between the FDA and foreign governments.
New Food Categories
By way of the newly issued guidance, FDA is adding categories for food for human and animal consumption. If any below food category includes an *, that means it was already listed:
For Human Consumption:
Acidified Food (see 21 C.F.R 114.3(b));
Baby (Infant and Junior) Food Products Including Infant Formula*;
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;
Fishery/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 C.F.R 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
If none of the human food categories listed in the registration form apply, print the applicable food category or categories.
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*;
Fats or Oils*;
Minerals or Mineral Products*;
Miscellaneous or Special Purpose Products*;
Molasses or Molasses Products*;
Non-protein Nitrogen Products*;
Recycled Animal Waste Products*;
Vitamins or Vitamin Products*;Yeast Products*;
Mixed Feed (e.g., poultry, livestock, equine)*;
Pet Treats or Pet Chews;
Pet Nutritional 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).
Update Your Registration
Start now. To register, go to: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/ucm324778.htm?source=govdelivery
Step 1: Find your PIN and password. If you cannot find them, file a new registration.
Step 2: Make sure the entity you designate as U.S. agent is willing and agreeable to serve.
Step 3: Classify all human and animal food products correctly using the expanded categories.