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Strategies and Agencies

This page introduces the basic strategies used to encourage practices to reduce the risk of adulterated or misbranded foods; it also introduces government agencies and other entities that address food safety concerns.

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Sectors and Strategies

During the 20th century and probably without an overall design, U.S. law categorized the food system into five sectors and developed a regulatory policy for each sector.  These sectors and the regulatory policies are introduced here.

  • The agricultural production sector includes farms, ranches, vineyards, orchards, feedlots and any other businesses that produce agricultural commodities.  The fundamental policy for food safety concerns in the past has been to do little in terms of forcing agricultural producers to think about the safety of the final food product.  This practice has changed since the late 1990s when food safety concerns were traced to production agriculture, especially vegetables and fruits that were not processed, but instead sold as raw commodities to consumers.  In response to these situations, producers were provided opportunity to learn about their role in minimizing the risk that the final food product may not be safe (i.e., producer education).  More recently, government has begun to regulate some production practices, and commodity buyers are imposing expectations on producers (i.e., market forces).
    • The Food Safety Modernization Act (late 2010/early 2011) directs the federal Food and Drug Administration (FDA) to regulate the on-farm handling and packaging of fresh fruits, vegetables, nuts and other agricultural commodities intended to be sold to the consumer as raw commodities.  This directive from Congress is considered by some commentators as being aggressive in that regulation of farms have generally fallen to the USDA in the past and that production agriculture was influenced more by educating producers than by regulating them.  Other commentators would argue that it is reasonable for FDA to have oversight of food products that are being prepared for sale to consumers.
  • The agricultural input sector [e.g., suppliers of livestock feed, veterinary medicines, crop seed (e.g., bio-technology), crop pesticides] also are recognized as part of the food industry.  Increasingly, attention is focused on how these inputs (e.g., their manufacturing process and their use) can impact the safety of the final food product. Agricultural input suppliers, agricultural producers, and food processors must not overlook the possible impact of these production inputs.
    • The food processing sector encompasses the numerous firms that process agricultural commodities into food products.  This broad sector also includes businesses that combine food products into other food products (my favorite example is a business that assembles frozen pizza from sausage, cheese, flour, tomato sauce, and other foods), as well as businesses that store and transport food.  This broad sector is extensively regulated by federal law.
      • Meat and poultry processing businesses are regulated by the Food Safety and Inspection Service (FSIS) of the USDA.
      • All other food processing businesses are regulated the Food and Drug Administration (FDA) in the U.S. Department of Health and Human Services.
      • For some requirements, USDA FSIS and FDA follow similar practices, such as food ingredients/food additives; for other practices, USDA FSIS and FDA follow distinctly different practices, such as inspections.
        • Following enactment of the Food Safety Modernization Act (signed by the President in January 2011), all food processors are now required to develop and implement either a Hazardous Analysis Critical Control Point (HACCP) Plan or a Food Safety Plan.
      • Although federal law dominates the regulation of the food processing sector, state law also has a role.  The relationship between federal and state law, in terms of the food processing sector, may be best described as "state law collaborates with and supports the dominant federal law".
    • The retail and food service sector is extensively regulated by state government, but the states have been given significance guidance from FDA via the Food Code since the late 1990s.
      • The retail component of the sector includes grocery stores, vending machines, etc.
      • The food service component of the sector includes restaurants, cafeterias (e.g., retirement homes, hospitals, universities, shelters/charities), street vendor push carts, etc.
      • The FDA Food Code is offered as assistance to state, tribal and local government by providing a scientifically sound technical and legal basis for regulating the retail and food service sector of the food industry.  The FDA Food Code is used as a model for state, tribal and local food safety rules and to facilitate a consistent national food regulatory policy.  See http://www.fda.gov/Food/GuidanceRegulation/RetailFoodProtection/FoodCode/ucm2006808.htm, visited November 22, 2015.
      • In many states, the Food Code also underpins the state's regulation of the food processing sector.
      • North Dakota's version of the Food Code has been adopted as a regulation by the North Dakota Department of Health; see N.D.A.C. chap. 33-33-04, visited November 22, 2015.
    • Consumers:  consumers will be educated and informed, but they will not be regulated.
      • Consumers will decide what they want to eat, but they need to be educated so they have the skills to make decisions and they need information about specific products so they can make informed decisions.
      • Examples of education programs
      • Note that these programs emphasize nutrition as much as they emphasize safe food handling.  It is at this point in the food industry where the distinction between food safety and nutrition begins to blur.
      • Food product labeling is the dominant method by which consumers are informed about specific food products.  Food labeling is addressed in more detail on the page titled "Food Processing Sector".

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    Agencies Directly Regulating the Food Industry

    Before proceeding further, it may be helpful to be aware of 1) the "food safety" role of various agencies and 2) which sectors of the food industry the agency works with.

    • Environmental Protection Agency (EPA):  in terms of food safety, the role of the EPA is to establish tolerances for pesticide residues on food products.  This regulatory authority impacts both the production and processing sectors, especially if the agricultural commodity is sold to consumers as raw product (such as fruits and vegetables).  See Setting Tolerances for Pesticide Residues in Foods, visited November 22, 2015
    • Food Safety Inspection Service (FSIS) of the USDA:  the FSIS is responsible for overseeing meat and poultry processing firms. See About FSIS, visited November 22, 2015.
    • Food and Drug Administration (FDA):  as one of its numerous responsibilities, the FDA oversees all other food processing businesses, including food transportation and storage.
    • State health or agricultural departments:  the retail and food service sector is most directly regulated by state government.  Many states delegate this oversight responsibility to either the state department of health or the state department of agriculture. The decision as to the responsibilities or regulatory role of state agencies is made by each state legislature.  In some states, the responsibility for the food industry is divided between the two agencies.  See State Departments of Public Health & Agriculture  (visited November 22, 2015) for a list of state departments of health and agriculture.

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    Other Agencies and Entities Influencing the Food Industry

    • Centers for Disease Control and Prevention (CDC) Food Safety Office, see http://www.cdc.gov/foodsafety/, visited November 22, 2015.
      • "The Food Safety Office (FSO) helps lead CDC in the prevention of illness, disability, and death due to foodborne diseases. To achieve this mission, FSO conducts many activities within CDC, across the country, and in international settings."  For example,
        • "Foodborne Diseases Active Surveillance Network, referred to as FoodNet, is the principal foodborne disease component of CDC's Emerging Infections Program. It is a sentinel surveillance system that collects information from sites in 10 states—covering 15% of the US population, or 46 million Americans—about diseases that are caused by any of seven bacteria and two parasites commonly transmitted through food." See http://www.cdc.gov/foodnet/, visited November 22, 2015.
        • "CDC collects reports of foodborne outbreaks due to enteric bacterial, viral, parasitic, and chemical agents. State, local, and territorial public health agencies report these outbreaks to Foodborne Disease Outbreak Surveillance System through the National Outbreak Reporting System (NORS)."  See http://www.cdc.gov/nors/, visited November 22, 2015.
        • "PulseNet is a national network of public health laboratories that performs DNA "fingerprinting" on bacteria that may be foodborne. The network permits rapid comparison of these "fingerprint" patterns through an electronic database at CDC."  The results of these tests help the food industry and regulators identify a relationship among suspected food illnesses over a dispersed area. See http://www.cdc.gov/pulsenet/, visited November 22, 2015.
    • Department of Homeland Security:
      • See the "National Infrastructure Protection Plan -- Agriculture and Food Sector" at http://www.dhs.gov/xlibrary/assets/nipp_snapshot_agriculture.pdf, visited November 22, 2015.
      • Also, U.S. Customs and Border Protection:  "CBP has been entrusted with enforcing hundreds of laws for 40 other government agencies, such as the U.S. Fish and Wildlife Service, the U.S. Department of Agriculture and the Centers for Disease Control and Prevention. These agencies require that unsafe items are not allowed to enter the United States. CBP officers are always at ports of entry and assume the responsibility of protecting America from all threats."  Source no longer available on web site.
    • Department of Commerce:  "NOAA Seafood Inspection Program provides inspection services for fish, shellfish, and fishery products to the industry"; see http://www.seafood.nmfs.noaa.gov/,visited November 22, 2015 . Commercial fishing activities are overseen by the Dept. of Commerce; processing of fish products is overseen by the FDA.
    • Federal Trade Commission: "The FTC, FDA, and USDA share jurisdiction over [advertising] claims made by manufacturers of food products... [T]he Federal Trade Commission Act ... prohibits "unfair or deceptive acts or practices," and, in the case of food products, ... prohibit "any false advertisement" that is "misleading in a material respect." ... Since 1954, the FTC and the FDA have operated under a Memorandum of Understanding, under which the [FTC] has assumed primary responsibility for regulating food advertising, while FDA has taken primary responsibility for regulating food labeling";  see http://www.ftc.gov/bcp/policystmt/ad-food.shtm, visited November 22, 2015.
    • Alcohol and Tobacco Tax and Trade Bureau (TTB) "ensure[s] that [alcohol] products are labeled, advertised, and marketed in accordance with the law; and to administer the laws and regulations in a manner that protects the consumer ..."  See http://www.ttb.gov/about/index.shtml, visited November 22, 2015.
    • USDA Agricultural Marketing Service (AMS): 
      • AMS regulates organic food production; see http://www.ams.usda.gov/AMSv1.0/nop (visited November 22, 2015):  "The National Organic Program (NOP) develops, implements, and administers national production, handling, and labeling standards."
      • USDA AMS:  operates agricultural commodity grading; see http://www.ams.usda.gov/AMSv1.0/standards (visited November 22, 2015)
        • "AMS’ quality grade standards, grading, certification, auditing, inspection, and laboratory analysis are voluntary tools that industry can use to help promote and communicate quality and wholesomeness to consumers."  Commodity grading, over the decades however, has primarily been a tool for firms that buy and market ag commodities.  The grades have not become an informational tool to consumers.
    • USDA Animal and Plant Health Inspection Service (APHIS):  "[P]rotect agricultural health ... [by defending] America’s animal and plant resources from agricultural pests and diseases. livestock and plant diseases."  See http://www.aphis.usda.gov/wps/portal/footer/home/aboutaphis, visited November 22, 2015.  The focus is on limiting the risk of plant and animal diseases that could impact (devastate) production; the focus is not on the safety of the final food product.
    • FDA, USDA APHIS, and EPA:  regulate biotechnology; see http://usbiotechreg.epa.gov/usbiotechreg/ (visited November 22, 2015)
      • "The Federal Government of the United States of America has a coordinated, risk-based system to ensure new biotechnology products are safe for the environment and human and animal health."
      • For current information please visit USDA’s website at: http://www.aphis.usda.gov/biotechnology/petitions_table_pending.shtml, FDA’s website at: http://www.fda.gov/bioconinventory, and EPA’s website at: http://www.epa.gov/oppbppd1/biopesticides/pips/pip_list.htm.
    • Extension Service, etc:  common sources of consumer education programs and materials.

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    International Considerations

    Most nations recognize the need for a safe food supply and therefore have taken steps to regulate food within their borders or jurisdictions.  Accordingly, numerous nations have established regulatory agencies to address food safety concerns.  For example,

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    The challenge arises when food is exported and imported.  Food must comply with the laws of the jurisdiction where the food is located.  As food moves from one nation to another, it needs to comply with the laws of all jurisdictions in which it is located, even if the food is in a jurisdiction temporarily, such as, being in a nation just long enough to pass through to another nation. If the standards of the nations vary significantly, a food company may find itself struggling to abide by the varying sets of requirements.  To ease the situation, nations have tried to negotiate trade agreements; first bilateral agreements and then multi-lateral agreements.

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    International Standards

    Another strategy has been to establish or suggest standards for all nations to adopt.  For example, the Codex Alimentarius was created in 1963 by the Food & Agriculture Organization (FAO) and the World Health Organization (WHO) of the United Nations to develop food standards and guidelines to protect consumer health and advance fair trade practices by promoting coordination among national food standards.  The Codex standards are not enforceable unless a nation has adopted them as that nation's standards, but having the Codex standards available offers an opportunity for nations to begin establishing common (harmonized) standards.

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    The International Organization for Standardization (ISO) is a non-govenment entity (NGO) that has addressed national standards for decades.  ISO began with a focus on manufactured products, but has begun to emphasize food standards and production practices in recent years.

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    More details about "verification" by the importing nation and "certification" by the exporting nation are discussed in the section titled "Regulation of the U.S. Food Processing Sector".

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    Summary

    U.S. food law, over the past 100 years, has divided the food industry into four (five?) sectors and adopted a general regulatory practice for each sector.  Although FDA and USDA provide significant leadership in administering U.S. food law, they are not the only agencies with regulatory authority over food businesses.  Similarly, many nations have adopted food laws to advance food safety within their jurisdiction.  Variation among national food standards can hinder global food trade, so entities such as Codex and ISO have emerged in an effort to harmonize food standards and thereby facilitate food trade.

     

     

    Email David.Saxowsky@ndsu.edu

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