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Food Processing Sector, Registration and License

Introduction to Food Law
Overview of US Food Law
Government "Players" Involved in US Food Law
Requirements for Food Businesses

Production Sector (Pre-harvest)

Processing Sector (Post-harvest)

Food Service and Retail Sector; Final Preparation (Food Code)

Producer/Processor/Preparer Liability
Looking Forward/Future Issues


The previous section addressed food laws that impact the production sector of the food industry. The focus of the laws expanded over time to now include more provisions to help minimize the risk of a food safety issue arising from the production sector.

This section (the next several web pages) addresses the processing sector of the food industry. The materials begin with some thoughts on how to describe this broad sector. Note, that the processing sector lies between the production sector and the preparation (food service and retail) sector.

Describing The Food Processing Sector

This section of the course addresses the processing sector of the food industry, but how do we describe the food processing sector?  There probably is no legal definition but are there some laws (statutes or regulations) that can help us understand what is included in the food processing sector? For example at the federal level, FDA is authorized to inspect the records of

"each person (excluding farms and restaurants) who manufactures, processes, packs, distributes, receives, holds, or imports”  food;

taken from 21 USC 350c(a); note both the breadth of the definition and the exclusions from the definition.

FDA also is authorized

"(A) to enter, at reasonable times, any factory, warehouse, or establishment in which food … are manufactured, processed, packed, or held, for introduction into interstate commerce or after such introduction, or to enter any vehicle being used to transport or hold such food … in interstate commerce; and

(B) to inspect, at reasonable times and within reasonable limits and in a reasonable manner, such factory, warehouse, establishment, or vehicle and all pertinent equipment, finished and unfinished materials, containers, and labeling therein. In the case of any person (excluding farms and restaurants) who manufactures, processes, packs, transports, distributes, holds, or imports foods, the inspection shall extend to all records and other information described in [21 USC] section 350c…”

taken from 21 USC 374(a)(1)

These two authorities, by excluding farms and restaurants but including “every” food business in between, begin to suggest a definition for the food processing sector.

  • Recall that the FDA's authority extends to trucks that transport food and warehouses in which food is stored.
  • Does FDA’s authority extend to grain elevators and train cars that are used to haul wheat?
  • Does FDA’s authority extend to grocery stores?

USDA regulations also define which businesses are subject to its jurisdiction:

"Official establishment. Any slaughtering, cutting, boning, meat canning, curing, smoking, salting, packing, rendering, or similar establishment at which inspection is maintained under the regulations in this subchapter.”  Taken from 9 CFR 301.2.

This definition applies to the Meat Inspection Act (MIA), Poultry Product Inspection Act (PPIA) and Egg Inspection Act (EIA) as administered by USDA FSIS. USDA also provides a directory of establishments inspected by FSIS under the MIA, PPIA and EIA; see the “The Meat, Poultry and Egg Product Inspection Directory.” 

Again, note the breadth of the definition.  Although the boundaries which distinguish the processing sector from the production and preparation sectors may not be absolutely clear, one should be able to begin comprehending the wide range of activities, businesses and types of facilities comprising the food processing sector. 

In summary, the broad jurisdictions of these two agencies suggest a description of the scope of the food processing sector. These businesses and activities are the scope of this section of the course.


Registering Food Facilities

U.S. food facilities (food businesses) are required to be registered with the FDA. This 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.

Food facility includes any factory, warehouse, or establishment "engaged in the manufacturing/processing, packing, or holding of food for consumption in the United States" see 21 CFR 1.225.

Food facility does NOT include

  • Farms;
  • Retail food establishments;
  • Restaurants;
  • Nonprofit food establishments that prepare or serve food directly to the consumer;
  • Fishing vessels that engage in no more processing than to prepare the fish so it can be held on the vessel;
  • Facilities that are regulated exclusively by the USDA under the Federal Meat Inspection Act, the Poultry Products Inspection Act, or the Egg Products Inspection Act; and
  • A foreign facility if the food from that facility undergoes further manufacturing/processing by another facility outside the United States; see 21 CFR §1.226

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 USC 331(dd)). For nearly 100 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.

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 USC §350d for statutory law.


Licenses to operate a food processing facility/establishment

In addition to the federal registration requirement, many states require food businesses to be licensed. For example in North Dakota, 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?

  • 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.

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 http://www.mda.state.mn.us/about/divisions/dairyfood.htm.

For most states, either the state health department or agriculture department has the primary regulatory responsibility, as illustrated by the situations in North Dakota (Department of Health) and Minnesota (Department of Agriculture). Also see State Departments of Public Health (a USDA web page) for links to many of these state agencies. 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.” Wisconsin Department of Agriculture, Trade and Consumer Protection – Food Processing and Safety at http://datcp.state.wi.us/core/food/food.jsp.
  • “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/.


The next web page addresses standards of identity, food ingredients, and food additives.

Last updated March 11, 2010

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