Food Law

Accessibility


| Share

Introduction

This page begins the discussion of U.S. regulation of its food processing sector by suggesting a description of the food processing sector, and introducing the general requirements of a state license and federal registration.

U.S. food law has divided the food industry into five sectors:  consumers, retail and food service, food processing, production agriculture, and input suppliers for production agriculture.  Dividing the food industry into these five sectors may have never been intended or planned, but instead, resulted from more than a century of food issues and responses to those issues.  This section of this web site focuses on the food processing sector.  This page begins by offering a description or definition of the food processing sector and introducing government and industry actions intended to motivate food processing to take steps to reduce the risk of unsafe food.

This page addresses the following topics:

  • a description of the food processing sector,
  • the importance of describing the food product(s),
  • the role of the FDA, USDA FSIS, and other U.S. federal agencies in overseeing food processors,
  • the role of state governments in overseeing food processors,
  • the response of other nations and international organizations in directing the practices of food processors, and
  • food industry expectations of one another (often expressed in business-to-business contracts).

 

Topics of subsequent pages include

  • state license and federal registration of food businesses
  • consequences of a violating a food law, including product recalls, other enforcement actions, product liability suits, and enforcing business-to-business contracts
  • product standard of Identity, ingredients, GRAS, indirect food additives (packaging, food contact surfaces), and color additives
  • food safety plans and GMPs, HACCP and SSOPs, and plant security
    • need for flow chart
  • employee training
  • intermediate inspection of processing "other foods" (FDA & state), and ongoing inspection of meat and poultry processing (USDA FSIS & state)
  • food packaging and labeling
  • food transportation and storage
  • records to be kept by food processors
  • food advertising, product claims and consumer education
  • export and import of food
  • rules for specific foods

     

    Focus on the Food Processing Sector

    As stated previously, U.S. food law addresses the food industry as several sectors:  production agriculture input suppliers, agricultural production, food processing, retail sales and food service, and consumers.  These materials focus on the processing sector.

    Food processing was the first sector to be addressed by U.S. federal law beginning in the early 1900s.  State laws and local ordinances addressed a variety of food safety issues prior to that time, but the decision by the U.S. Congress to enact federal law to address food issues could be considered the birth of modern food law.

    U.S. federal law subdivides government oversight of the food processing sector according to the product being processed, such as, meat, poultry, eggs, seafood, infant formula, juice and other foods.  This distinction stems back to the two original U.S. federal food laws; both were enacted in 1906:  the Federal Meat Inspection Act and the Food and Drugs Act.  These categorizations of the food industry most likely were never intended when Congress began to enact food laws, but arose over time as Congress continued to respond to specific food safety concerns.  Accordingly, there are unique statutes and regulations for these categories of food.

     

    Describing The Food Processing Sector

    There probably is no legal definition of the processing sector, but several laws suggest what activities may be 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 U.S.C. §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 U.S.C. §374(a)(1) .

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

    • Recall that the FDA's authority extends to trucks and other vehicles 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? See FDA's Guide to Inspections of Grain Product Manufacturers
    • Does FDA’s authority extend to grocery stores? Generally no, but ... (this topic is discussed in another section of this web site).

    .

    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 retail/food service sectors may not be absolutely clear, one should be able to begin appreciating the wide range of activities, businesses and types of facilities comprising the food processing sector.

    In summary, the broad jurisdictions of these two agencies (FDA and USDA FSIS) suggest the scope of the food processing sector.

    .

    Understanding the Food Product

    In applying food law, it may be helpful to consider the characteristics of the intended food product.  For example, what is the food product, what is the intended container size (e.g., bulk or individual serving), who is the intended customer (e.g., another food business, a food service firm or individual consumers), where will the product be marketed, where will the product be processed, where will the ingredients be sourced or acquired, and what is the manufacturing process. The answer to these questions will help identify relevant laws and the application of those laws to the food product being considered.

    Comment:  food safety and food quality are NOT the same.  Quality refers to the characteristics of the food such as taste and texture.  Food safety focuses on whether the food poses a risk to the health of the consumer.  Although some U.S. food law briefly mentions quality, the focus of food law is on safety.  Quality is generally left for the food business to consider.  Many food businesses, however, do not draw a distinction between quality and safety that emerges from food law.  Remember:  food law primarily focuses on food safety; not food quality.

    As discussed on other pages, food manufacturers are sometimes interested in making claims about their product in an effort to attract customers.  Such claims, however, are regulated to prevent the food from being misbranded.  This is an appropriate time for the food business to begin considering what claims it may want to make as part of promoting the food product.  Refining these claims, based on federal law, is addressed subsequently.

    Understanding the food product, its ingredients, how it will be processed, packaged, handled, stored, and transported also contributes to understanding the risks or hazards that may impact the food, which, in turn, provides the foundation for developing and implementing a HACCP plan or a food safety plan, whichever applies to the food product. 

    Businesses that take the time to thoroughly describe their food product and their processing system will be better prepared to comply with their legal mandates.

    .

    Oversight by Various Levels of Government

    The food industry in the United States is regulated by several levels of government.  Even though the federal government often receives the most attention, members of the food industry cannot overlook the role of state and local governments, as well as the impact of international standards for food that is traded among nations.  This section comments on each of these levels of government.

    As introduced above, several federal agencies share responsibility for food safety in the United States.

    • The Food and Drug Administration (FDA) addresses most other foods
      • The Environmental Protection Agency (EPA) has been given responsibility for establishing tolerances for pesticide residue on foods and shares responsibility for overseeing biotechnology with the USDA and FDA.
        • The Centers for Disease Control and Prevention (CDC) Food Safety Office is responsible for coordinating the identification and response to a foodborne illness.
          • The CDC provides the link between illness in people and the food safety systems of government agencies and food producers. The CDC accomplishes this responsibility by monitoring human illness, tracking the occurrence of foodborne diseases, attributing illness to specific foods and settings, investigating outbreaks and sporadic cases, managing the DNA "fingerprinting" network for foodborne illness-causing germs in all states to detect outbreaks, and targeting prevention measures to meet long-term food safety goals.  See http://www.cdc.gov/foodsafety/resources/CDCandFoodSafety_121410.pdf

        • Other federal agencies oversee animal feed and drugs (FDA Center for Veterinary Medicine), and the international trade of plants and animals (to minimize risk of spreading disease) (USDA Animal and Plant Health Inspection Service), etc
          • USDA also has responsibilities that address increasing agricultural production, marketing of agricultural commodities, establishing standards and grades for agricultural commodities, food and nutrition (food stamp) programs, consumer education about food, etc.  Many of these responsibilities arose for reasons unrelated to food safety.  These programs continue to pursue objectives other than food safety, but USDA is modifying some of these efforts by adding a food safety component or a secondary focus on food safety.

              State agencies:  in most states, either the state department of health or the state department of agriculture has been given responsibility of overseeing the food industry in the state.  In North Dakota, for example, the responsibility lies with the Department of Health.  In Minnesota, responsibility for the food industry is assigned to the Department of Agriculture.

              .

              Local government also has a role in food safety (e.g., Fargo, North Dakota Dairy Product Regulation); some cities had food laws (ordinances) before state or federal laws were enacted.

              • Cities were some of the first government entities to address food safety, extending back to the early 1800s and earlier.  Dairy and bread were some of the first foods regulated by local governments.  Despite the extensive role of government oversight by federal and state governments at this time, local governments have not abandoned their interest in doing what they can to assure safe food.
                • Personal experience:  I grew up on a family Grade A dairy farm in southwestern North Dakota.  The North Dakota State Department of Health regularly (monthly) inspected the dairy operation to assure we were following appropriate practices, that the cows were healthy, etc.  In addition, my parents would annually renew the license from the City of Bismarck to assure we could have our milk delivered and sold to the processing plant in Bismarck, and a city inspector occasionally accompanied the state inspector during a farm inspection.  Likewise, a federal inspector would occasionally accompany the state inspector.  Clearly, all three levels of government wanted to know that my family was doing as well as we could to produce safe milk.  By the way, the milk processor who purchased our milk was concerned about both the safety AND quality of the milk produced on our farm.
                • City inspection of food service businesses (e.g., restaurants) is a major function of local governments relative to the food industry.

                  There is no international government, but there are international organizations (e.g., Codex Alimentarius ) that address food standards and harmonization among trading nations.

                  .

                   

                  Summary

                  U.S. law broadly defines the food processing sector to include food storage and transportation.

                  The U.S. food processing sector is regulated by state and federal law, but federal law dominates.

                  A variety of federal agencies have responsibilities relating to the food processing sector but the FDA and USDA FSIS have the primary responsibilities.

                  States generally require food processing businesses to be licensed.  U.S. federal law requires meat processing firms to apply for inspection by USDA FSIS; other food processing businesses (both domestic and foreign) must register with the FDA.

                   

                   

                  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.

                  This material is protected by U.S. copyright laws.

                  Creative Commons License
                  Feel free to use and share this content, but please do so under the conditions of our Creative Commons license and our Rules for Use. Thanks.