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Regulatory Agencies/Registration & License

State law generally requires food processors to be licensed; federal law requires food facilities to be registered.

 

Various federal and state agencies have been assigned the responsibility of overseeing food processing.

 

USDA (Meat and Poultry Industries)

USDA tracks "official establishments" (meat processing facilities) through the mandatory inspection process.  USDA requires an application for inspection (9 CFR 304), SSOPs (9 CFR 416), and HACCP (9 CFR 417).  By submitting an application, the firm has identified itself to the USDA.  From this information, USDA is able to maintain a data base of "official establishments."

USDA also requires businesses that handle animal products to register with the USDA:  21 U.S.C. 643.  Again, the registration process assures that USDA knows which businesses are involved in the meat industry.

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FDA

FDA is responsible for regulating all other food processors whose products are "in interstate commerce."

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Federal Registration of Food Facilities

U.S. food facilities (food businesses) are required to be registered with the USDA (meat & poultry processing firms) or FDA (all other food processing firms). The FDA requirement was enacted in 2002 following the terrorist attack of September 2001 and is one step to protect the U.S. food system; that is, it provides a data base identifying all businesses involved with food that enters the U.S. market. However, this requirement has broader implications for food safety as well; that is, the registration system begins to provide a data base that can be used in response to any food-borne illness or outbreak.

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The statute:

21 U.S.C. 350d(a) Registration  "... any facility [domestic or foreign] engaged in manufacturing, processing, packing, or holding food for consumption in the United States [must] be registered."

21 U.S.C. 350d(c) Facility...includes any factory, warehouse, or establishment (including a factory, warehouse, or establishment of an importer) that manufactures, processes, packs, or holds food. Such term does not include farms; restaurants; other retail food establishments; nonprofit food establishments in which food is prepared for or served directly to the consumer; or fishing vessels...

 

The corresponding regulation:

21 CFR § 1.225 (a) ... [Owners or operators in charge of domestic or foreign facilities] must register your facility ... if your facility is engaged in the manufacturing/processing, packing, or holding of food for consumption in the United States, unless your facility qualifies for [an exemption under 21 CFR 1.226]. (b) ... a domestic facility ... must register ... whether or not the food from the facility enters interstate commerce. 21 CFR § 1.226

Who does not have to register...?

  • (a) A foreign facility, if food from such facility undergoes further manufacturing/processing (including packaging) by another facility outside the United States...
  • (b) Farms;
  • (c) Retail food establishments;
  • (d) Restaurants;
  • (e) Nonprofit food establishments in which food is prepared for, or served directly to, the consumer;
  • (f) Fishing vessels...; and
  • (g) Facilities that are regulated exclusively, throughout the entire facility, by the U.S. Department of Agriculture under the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), or the Egg Products Inspection Act (21 U.S.C. 1031 et seq.).
    • NOTE that the regulation exempting registration for facilities exclusively regulated by USDA is not explicitly stated in the underlying statute....
    • Even though the meat, poultry and egg processing firms fall within the scope of the food processing sector, they are not required to register with the FDA because they are subject to USDA FSIS oversight (rather than FDA oversight).  The requirement that every facility processing meat and poultry be inspected by USDA FSIS on an ongoing basis assures that USDA already has be good understanding of which firms are processing meat and poultry.

 

Re-emphasize:  Registration is required for domestic and foreign food facilities (21 CFR §1.225(a)).

Information to be provided as part of the registration includes contact information, trade names, and food product categories (21 CFR §1.232). This information must be updated if any of the previously provided information changes (21 CFR §1.234).

Note that "failure to register" is defined as a prohibited act, much like adulterated or misbranded food are defined as prohibited acts (21 U.S.C. 331(dd)). For more than 110 years, adulterated and misbranded foods have been the primary prohibited acts; it is not yet clear whether adding "failure to register" as another prohibited act will have significant implications on these two long-standing prohibitions.

For additional information, see Registration of Food Facilities for an FDA explanation of this requirement; see 21 CFR Sec. 1.225 to 1.243 for regulations; see 21 U.S.C. §350d for statutory law.

The Food Safety Modernization Act (2010) now requires that facilities re-register every two years; re-registration was not mandated by the 2002 law.  This new requirement should allow FDA to maintain a more up-to-date data base of U.S. and foreign food facilities operating in the U.S. food industry.

As discussed in other sections, the Food Safety Modernization Act now requires all food processors to develop and implement HACCP/Food Safety plans.  The definition of facilities required to be registered also is being used in part to define which firms are required to have HACCP/Food Safety plans.  Watch for additional applications of the term "registered firms."

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FDA's data base of "registered facilities" and USDA's data base of "official establishments" will go a long way to identifying the location of food in the United States in the case of a food safety emergency.

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State License

The food industry and food products are subject to state regulation.  For example, North Dakota underpins its oversight of the food industry (both the processing and retail/food service sectors) by requiring the businesses to be licensed.

This discussion is similar to the state license discussion under retail/food service sector, only this time the emphasis is on state oversight of the processing sector (rather than state oversight of the retail sector).

Food processing plants and other food establishments are required to be licensed by the state Department of Health; see N.D.C.C. §23-09-01(6) (a state statute).

Example: N.D.C.C. §23-09-16. License - Application. Before any food establishment ... may be operated in this state, it must be licensed by the [state department of health]

The statutory definitions illustrate the breadth of this requirement.

N.D.C.C. §23-09-01. Definitions.

5. "Food establishment" means any fixed restaurant, limited restaurant, coffee shop, cafeteria, short-order cafe, luncheonette, grill, tearoom, sandwich shop, soda fountain, tavern, bar, catering kitchen, delicatessen, bakery, grocery store, meat market, food processing plant, or similar place in which food or drink is prepared for sale or service to the public on the premises or elsewhere with or without charge.
6. "Food processing plant" means a commercial operation that manufactures, packages, labels, or stores food for human consumption and does not provide food directly to a consumer.

Does North Dakota’s definition of food processing plant bear similarities to the breadth of FDA’s authorities discussed previously?

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Several key (no, let's call them CRITICAL) points

  • The state requires the food processing plant to be licensed; e.g., N.D.C.C. §23-09-26.
  • The license subjects the business to state requirements
    • e.g., N.D.C.C. §23-09-09. Sanitation and safety. Every food establishment ... must be operated with strict regard for the health, safety, and comfort of its patrons. The following sanitary and safety regulations must be followed: ...
  • The business also is subject to inspection by a state agency; e.g., N.D.C.C. §23-09-11.
  • The business is subject to state enforcement; e.g., N.D.C.C. §§23-09-18, -19, -21, and -22.
  • Bottom line -- the state has authority to regulate its food industry; not only the processing sector (as discussed here) but also the retail sector (as discussed on another page).

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In Minnesota, the state Department of Agriculture has primary responsibility for regulating that state’s food industry.

  • “The Dairy and Food Inspection Division enforces state laws and regulations related to the production, processing and sale of milk and other dairy products, processed foods, meats, beverages, eggs, poultry and poultry products, and animal feed. The division enforces state laws designed to protect Minnesota’s food supply from accidental or intentional contamination. The division also investigates reports of food contamination, working in tandem with state and local health officials to determine the cause of outbreaks of food-borne illnesses in Minnesota citizens..” Taken from a Minnesota Depart. of Agriculture web page that has since been removed.

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To continue the example, in Wisconsin, the responsibility is divided between the state’s departments of agriculture and health.

  • “Whether you shop for groceries and prepare your family's meals, run a grocery store, process food in a home business or large plant, or warehouse foods, we can provide the how-to's -- of good practices and the law.” Taken from a Wisconsin Department of Agriculture, Trade and Consumer Protection web page that has since been removed.
  • "The Food Safety Division works to ensure a safe, wholesome and secure food supply. The division enforces Wisconsin’s food safety and labeling laws. The division licenses and inspects over 30,000 food establishments, and supervises local government inspection of others."  Taken from Wisconsin Department of Agriculture, Trade and Consumer Protection Food Safety Programs at http://datcp.wi.gov/Programs/Food_Safety/index.aspx
  • Examples of licenses required by the State of Wisconsin
    • Meat establishment license
    • Milk producer license
    • Buttermaker license
    • Cheesemaker license
    • Food processing plants; licensing
    • Food warehouse license
    • Retail food establishments; licensing
    • Dairy plant license
    • Cheese grader license
    • Bulk milk tanker; license
    • Bulk milk weigher and sampler; license
  • "Food safety is everyone's job. It starts at the farm and ends at your table. We license and inspect about 30,000 food-related businesses: dairy farms, plants, and trucks; slaughter plants and meat processors; food processors, wholesalers, retailers, and warehouses. We do not license and inspect restaurants; the Wisconsin Department of Health handles that."  Taken from  Wisconsin Department of Agriculture, Trade and Consumer Protection Food Safety for Consumers at http://datcp.wi.gov/Food/Food_Safety_for_Consumers/index.aspx.
  • “The Food Safety and Recreational Licensing staff are responsible for managing programs that enforce applicable state administrative codes for the inspection and licensure of restaurants, … bed and breakfast establishments … in Wisconsin.” Wisconsin Department of Health and Family Services, Food Safety and Recreational Licensing at http://dhfs.wisconsin.gov/fsrl/.

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The South Dakota Department of Health is responsible for Food Safety and Lodging.  This Department licenses food services to assure health and safety standards are met and the public health protected, as well as it handles complaint investigations involving such facilities.

The South Dakota Department of Public Safety conducts routine food inspections.

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Also see State Departments of Public Health (a USDA web page) for links to many of these state agencies.

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Both federal government and state government have the authority to regulate the processing sector of the food industry.  If there is a conflict between state and federal law, the federal law prevails due to the supremacy clause in  the U.S. Constitution.  Often the state government monitors the food businesses more closely than the federal government, but if the state government detects a problem, the state agency will likely call on the federal agency to help with enforcement.

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Summary

Numerous state and federal agencies have a role in overseeing food processors.  Members of the industry need to take a few moments to identify the agencies that regulate their business and products.

 

 

Email David.Saxowsky@ndsu.edu

This material is intended for educational purposes only. It is not a substitute for competent legal counsel. Seek appropriate professional advice for answers to your specific questions.

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