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Regulation of the U.S. Food Processing Sector

The U.S. food processing sector is extensively regulated by state and federal agencies. Federal agencies dominate the regulatory oversight: USDA FSIS for the meat and poultry processing businesses and FDA for all other food processing businesses. State agencies also have an active role in overseeing food processing businesses within their respective states, but their role is in collaboration with the federal agencies.

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This web page provides numerous links to regulations, statutes, FDA guidance documents, USDA FSIS fact sheets, and other reference materials.  Students and other readers are strongly urged to take the time to visit and study these related sites.  They provide the majority of insights that underpin the introductory explanation offered on this page.

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Regulation of Processing Sector

When Congress first addressed food safety issues, it focused on the food processing sector, such as the meat processing industry (see the Meat Inspection Act of 1906). At that time, Congress defined "adulterated" and "misbranded" food, and prohibited those foods from being sold. Congress also required that meat processing be continuously inspected.  Since that time, Congress has refined government oversight of the food processing sector.  This page introduces a variety of legal topics that pertain to the food processing sector.

Recall  that the U.S. food industry can be described as consisting of five sectors based on U.S. food law.  Those five sectors may have never been intended; that is just the way the law turned out as it evolved since the early 1900s.  The sectors are 1) agricultural production input sector, 2) agricultural production, 3) food processing sector, 4) retail and food service sector, and 5) consumers.  These materials have also introduced that each of these sectors is regulated to a different extent under U.S. law.  This web page focuses on just the food processing sector.

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Selected Principles of U.S. Federal Food Law

U.S. federal food law applies to all food in "interstate commerce"; foods "not in interstate commerce" are regulated only by state law.  Most foods fit the definition of being in interstate commerce, however, because they are moved across a state line, or an ingredient has been moved across a state line.

Adulterated or misbranded food cannot be sold.  Not being able to sell food products often is an adequate penalty because a food business is in business to sell food.  If the business cannot sell its product, it will not remain in business.

  • Adulterated food means any food that 1) contains any substance, food additive, or pesticide chemical residue which may render it injurious to health or unsafe; 2) consists of any filthy, putrid, or decomposed substance; 3) is unfit for food; 4) has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated; 5) is the product of a diseased animal or an animal that died other than by slaughter; 6) its container is composed of any substance which may render the contents injurious to health; or 7) has been intentionally irradiated. 21 U.S.C. 342.
  • Misbranded food means any food that 1) its labeling or advertising is false or misleading; 2) is offered for sale under the name of another food; 3) is an imitation of another food but the label does not bear the word “imitation”; 4) its container is made or filled to be misleading; or 5) its label does not provide i) the name and place of the manufacturer, and ii) an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count. 21 U.S.C. 343.

It is the food business' responsibility/obligation to establish that the food is "not adulterated nor misbranded"; it is not the government's responsibility to prove that the food is "adulterated or misbranded".  If there is a reasonable belief that food is adulterated or misbranded, the response will be to treat the food as adulterated and misbranded; that is, the food will be separated from consumers until it is established that the food is not adulterated nor misbranded.

Restated, the most common practice if food is possibly adulterated or misbranded is to remove the food from consumers. If the food business is not willing to voluntarily remove (recall) suspect food from consumers, the federal agencies will take enforcement actions to remove the food from "the market".

Food is subject to the laws of the jurisdiction where the food is located, whether the food is being processed there, consumed there, or is merely being moved through the jurisdiction to its final destination.

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Two Broad Categories in the Processing Sector

U.S. federal law divides the food processing sector into two broad categories: meat/poultry as overseen by the Food Safety Inspection Service (FSIS) of USDA and "all other food processors" as overseen by the FDA. This categorization is mentioned throughout the discussion. In some situations, FSIS and FDA follow similar practices; in other situations, the practices of these two agencies are quite distinct.

Distinguishing between the roles of USDA and FDA lead to some interesting situations.  For example, FDA regulates macaroni and noodle products (21 CFR 139) whereas USDA regulates spaghetti sauce with meat (9 CFR 319.307).

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Processing Sector includes Storage and Transportation

The food processing sector is not limited to facilities where food is processed or manufactured; it also includes warehouses where food is stored and vehicles in which food is transported. The breadth of the food processing sector is illustrated in part by 21 U.S.C. 342(a)(4) -- adulterated foods includes those "prepared, packed or held under insanitary conditions whereby it may have become contaminated". This statute is one indication of the breadth of the food processing sector.

Subsequent legislation and regulations directly address transportation, for example:

  • See FDA Guidance for Industry: Sanitary Transportation of Food
    • "This guidance is intended for persons engaged in food transport, including persons who transport food (and store it during transport) as well as manufacturers or other persons who arrange for the transportation of food."  The guide lists "problem areas where food may be at risk for physical, chemical, or biological contamination during food transport" and suggests preventive controls.
  • See USDA FSIS 9 CFR 325
    • "No person shall sell, transport, offer for sale or transportation, or receive for transportation, in commerce, any product which is capable of use as human food unless the product and its container, if any, bear the official inspection legend ... or is [exempt from inspection]..."

In summary, as one considers the regulation of the food processing sector, recognize the broad definition of food processing -- it includes storage facilities and transportation vehicles.

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Food Includes Pet Food and Animal Feed

U.S. food law is NOT limited to human food. Congress defined food to encompass not only food and drink for humans and the components of those foods and drinks, but also food, drink and the components of food & drink for "other animals" (21 U.S.C. 321(f)).  Pet food is subject to regulation similar to human food regulations; animal/livestock feed also is subject to sanitary regulations.  U.S. government oversight of "food" is not limited to human food.

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Federal Registration

Since 2003, "domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the U.S. are required to register with the FDA. Domestic facilities are required to register whether or not food from the facility enters interstate commerce. Foreign facilities that manufacture/process, pack, or hold food ... before the food is exported to the United States [must register with the FDA]." (See Registration of Food Facilities).

Registration provides FDA with information on the origin and distribution of food products, and thereby aids in the detection and response to actual or potential threats to the U.S. food supply. Registration information also helps FDA notify firms that may be affected by an actual or potential threat (based on Compliance Policy Guide - Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002

The FDA Food Safety Modernization Act of 2010 requires that all firms re-register every two years.

Food business exempt from FDA registration include farms, retail food establishments, restaurants, nonprofit food establishments, fishing vessels, and [meat and poultry processing] facilities regulated exclusively by the [FSIS] USDA.

It appears that the term "registered facility" is beginning to take on a meaning; it may be used in the future to mean "those food processing firms subject to FDA oversight."

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Meat and poultry processing firms must be continuously inspected either by FSIS or a state agency while the firm is operating. USDA FSIS already knows which firms are processing meat under federal inspection. As specified in 9 CFR part 302, any firm intending to process meat or poultry must apply for and be granted inspection before initiating operations. USDA refers to inspected facilities as "official establishments".

Businesses handling animal products outside "official establishments" must register with the USDA (9 CFR 320.5).

In North Dakota, meat processing firms subject to state inspection must register with state government, see N.D.A.C. 7-13-02-01.   The distinction between federal and state meat inspection is addressed more fully in a subsequent section.

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Between FDA registration and USDA inspection, the U.S. federal government has a relatively complete inventory or list of firms processing and handling food that is located in or intended for consumption in the United States.

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State License

Despite federal oversight by either FDA or FSIS, food processing firms also are subject to state regulation. For example in North Dakota, food establishments must be licensed. Food establishments include food processing, but does not include meat businesses regulated under a meat inspection law. The North Dakota license is administered by the state Department of Health and subjects licensed firms to state inspections. See N.D.C.C. 23-09-11 and -16 and N.D.A.C. chap. 33-33-08.

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Inspection

Government authority to inspect food processing firms is a critical factor in overseeing the food industry and assuring that adulterated or misbranded food is not sold or delivered to consumers.

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Meat/Poultry Inspection

Federal law requires that all meat processing and each meat product be inspected; USDA is responsible for administering the U.S. federal meat inspection laws.

Federal law also allows states to establish their own meat inspection program but a state program must, at a minimum, meet the standards imposed by federal law. About half the states have established state meat inspection programs. A major implication is that meat inspected by a state program can only be used/consumed within that state; state inspected meat cannot cross state line. Accordingly, meat processors intending to sell their product in other states will choose to be federally inspected.

Congress has defined an exception that allows meat processed at state inspected facilities in certain states to be shipped in interstate commerce.  This program is the USDA FSIS Cooperative Interstate Shipment (CIS) Program (9 CFR 321).

All animals are inspected before slaughter and all carcasses are inspected after slaughter. Consequently, animals cannot be slaughtered and meat cannot be processed if an inspector is not present. Any meat that was slaughtered or processed without inspection is considered adulterated and cannot be sold. As the meat product is inspected, the inspector will stamp the product to indicate that the meat was inspected and that it passed the inspection. Animals or products that do not pass inspection must be separated and disposed of outside the food system.

Animals slaughtered for the owner's consumption do not need to be inspected, but that meat cannot be sold and must be labeled accordingly.

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Inspecting the Processing of "All Other Foods"

The FDA and a state agency in each state (such as the North Dakota Department of Health or the Minnesota Department of Agriculture) are both authorized to inspect any food processing firm in the state. These inspections can occur at any time the business is operating and do not have to be announced before the arrival of the inspector. This is a major difference between inspection of meat/poultry processing and processing of other foods: processing of "other foods" does not require continuous inspection and every food item is not required to be inspected.

During the inspection, the FDA or state agency can ask to view any part of the processing facility, to inspect the business' records, and take samples of the business' product for testing by the agency. Any plant that refuses to allow an inspection will be subject to enforcement action, such as securing a court order/warrant permitting an inspection. For example, see FDA's Investigations Operations Manual at http://www.fda.gov/ICECI/Inspections/IOM/default.htm; more specifically, consider subchapter 5.2.5 at http://www.fda.gov/downloads/ICECI/Inspections/IOM/UCM150576.pdf.

Because an inspection can be conducted at any time, the firm must continuously be ready for an inspection. Cleanliness and proper operating practices must be maintained at all times, for example. Likewise, firms are encouraged to have an inspection plan; that is, a plan for how the firm will respond when an inspector arrives. At a minimum, the firm should know which staff member will be expected to accompany the inspector and respond to the inspector's questions and requests. Again, a review of FDA's Investigations Operations Manual at http://www.fda.gov/ICECI/Inspections/IOM/default.htm (especially chapter 5 at http://www.fda.gov/downloads/ICECI/Inspections/IOM/UCM150576.pdf) should help a firm develop an inspection plan.

Example of details relating to an FDA inspection:

  • the inspector must present credentials before the inspection begins
  • the inspector can request a copy of the business records, such as manufacturing practices/HACCP plan, labeling and promotion practices, identification of immediate previous sources and immediate subsequent recipients of food, and records of interstate shipments
  • the inspector should provide a receipt for each sample taken
  • the inspector must provide a written report at the end of the inspection

A state inspection that reveals a problem could be reported to FDA which then could make an effort to conduct its own inspection.

From a practical perspective, the number of food processing firms far exceed the inspection capacity of FDA and state agencies. Accordingly, FDA and state agencies often have an understanding that the state agencies will try to regularly inspect processing firms, and if a problem is identified, the state agency will inform the FDA. Subsequently, FDA could conduct its own inspection and take appropriate enforcement action. See FDA/State Food Inspection Contract Program at http://www.fda.gov/ForFederalStateandLocalOfficials/FundingOpportunities/Contracts/ucm475166.htm.

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Hazard Analysis and Critical Control Point (HACCP)

Food Safety Plan

Federal and state law prohibit adulterated food.  Within the scope of this broad prohibition is the idea that a food processor will conduct the manufacturing process to minimize the risk of adulteration.  In the past, these practices were referred to as Good Manufacturing Practices (GMP) and addressed topics such as personnel, buildings and facilities, plant and grounds, sanitary operations, sanitary facilities and controls, equipment and utensils (contact surfaces), production and process controls, and warehousing and distribution (see 21 CFR part 110).

Since the early 1990s, GMP has been refined by the concept of Hazard Analysis and Critical Control Point (HACCP). HACCP does not replace the concept of GMP; instead, HACCP provides a larger context in which food firms are expected to develop and implement GMP practices. This section introduces the basics of HACCP.

HACCP/Hazard Analysis is founded on the principle that each food business assess the risks associated with its product, and develop and implement practices to reduce the risk of unsafe food. Additional principles include 1) there is no way to guarantee that food is safe; the best that can be accomplished is to reduce or minimize the risk of unsafe food and 2) because every food and food manufacturing processes poses different risks, each business needs to address its own situation; there is no practical way for the government to develop enough regulations to address the full range of situations that comprise the diverse U.S. food industry.

The U.S. Congress in the FDA Food Safety Modernization Act (December 2010) provided a detailed indication of what Congress expects food businesses to accomplish with a Food Safety/HACCP plan.

  • The food business will identify, evaluate and prepare a written analysis of known or reasonably foreseeable hazards that may be associated with the facility, including (A) biological, chemical, physical, and radiological hazards, natural toxins, pesticides, drug residues, decomposition, parasites, allergens, and unapproved food and color additives; (B) hazards that occur naturally or may be unintentionally introduced; and (C) hazards that may be intentionally introduced, including hazards intentionally introduced by acts of terrorism.

Comment: note the explicit mention of intentional attacks on the food business.

Comment: although not stated in the legislation, a Food Safety/HACCP plan must be developed and implemented for each facility, each food product and each manufacturing process because there are different risks associated with each facility, product and manufacturing process.

  • The food business will identify and implement preventive controls at critical control points to provide assurances that (1) hazards identified in the hazard analysis will be significantly minimized or prevented, and (2) any food manufactured, processed, packed, or held by such facility will not be adulterated or misbranded.
  • The food business will monitor the effectiveness of the implemented preventive controls to assure that the described outcomes will be achieved.
  • The food business will verify that (1) the preventive controls implemented are adequate to control the hazards identified; (2) the food business is monitoring the risks and preventive controls; (3) the food business is making appropriate decisions about corrective actions; (4) the implemented preventive controls are effectively and significantly minimizing or preventing the occurrence of identified hazards, through the use of environmental and product testing programs and other appropriate means; and (5) there is documented, periodic re-analysis of the plan to ensure that the plan is still relevant to the raw materials, conditions and processes in the facility, and new and emerging threats.
  • The food business will establish procedures to ensure that, if the implemented preventive controls are not properly implemented or are found to be ineffective, (1) appropriate action is taken to reduce the likelihood of recurrence of the implementation failure; (2) all affected food is evaluated for safety; and (3) all affected food is prevented from entering into commerce if the food business cannot ensure that the affected food is not adulterated or misbranded.
  • The food business will maintain, for not less than two years, records documenting the monitoring of the implemented preventive controls, instances of nonconformance impacting food safety, the results of testing and other appropriate means of verification, instances when corrective actions were implemented, and the efficacy of preventive controls and corrective actions.

Comment:  recall that FDA and state inspectors are authorized to inspect business records, especially records that reveal whether the food might be adulterated.

  • The food business will prepare a written plan that documents and describes the procedures used by the facility to comply with these requirements, including analyzing the hazards and identifying the adopted preventive controls to address those hazards. Such written plan, together with the documentation, shall be made promptly available to a duly authorized representative of the FDA upon oral or written request.
  • The food business will conduct a re-analysis whenever a significant change is made in the activities conducted at a facility if the change creates a reasonable potential for a new hazard or a significant increase in a previously identified hazard, but not less frequently than once every three years, whichever is earlier. Such re-analysis shall be completed and additional preventive controls necessary to address any identified hazards must be implemented before the change in activities at the facility is operative. The food business will revise the written plan if such a significant change is made or document the basis for the conclusion that no additional or revised preventive controls are needed. The FDA also may require a re-analysis in response to new hazards and developments in scientific understanding, including results from the Department of Homeland Security biological, chemical, radiological, or other terrorism risk assessment.

Hazard Analysis/Food Safety Plan (i.e., HACCP) reflects the principle that food businesses are in the best position to know their activities, associated risks, and practices to minimize the risks.  Therefore the focus of government is on directing the businesses' assessment and control of risks.

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Prior to the 2010 legislation, HACCP was mandated for meat and poultry processors (under USDA FSIS), and for seafood and juice (under FDA).  The following links provide information about seafood and juice HACCP

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    HACCP for meat and poultry has been mandated since the early 1990s.  When applying for continuous inspection by USDA FSIS or a state agency, the meat/poultry processor must include a HACCP plan.  See USDA FSIS Federal Grant of Inspection Guide at http://www.fsis.usda.gov/wps/portal/fsis/topics/inspection/apply-for-a-federal-grant-of-inspection.

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    Hazard Analysis includes Intentional Attacks (Food Defense Plan)

    As explicitly stated by Congress in the Food Safety Modernization Act, hazard analysis and food safety plans will need to consider the risk of intentional attacks on food businesses.  Although FDA has not yet proposed any regulations on this topic, such a regulation can be anticipated in the future.  Until then, FDA does offer some thoughts on this critical topic; for example, see

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    USDA FSIS also addresses food defense but not as part of the mandated HACCP plans for "official establishments"; instead, FSIS expects meat & poultry processing firms to voluntarily prepare a food defense plan as part of its overall business operation, see "Food Defense -- Plan Security Measures for Food Defense" at http://www.fsis.usda.gov/wps/wcm/connect/99f95182-0c9e-4214-9762-e98197f54ebf/General-Food-Defense-Plan.pdf?MOD=AJPERES

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    Good Manufacturing Practices (GMPs/SSOPs)

    Several decades prior to the development of HACCP/Hazard Analysis, the standards for processing food were encapsulated in Good Manufacturing Practices (GMPs; for example, see 21 CFR 110).  GMPs address personnel, buildings and facilities, plants and grounds, sanitary operations, sanitary facilities and controls, equipment and utensils, processes and controls, and warehousing and distribution. 

    FDA established a new regulation in 2015 (21 CFR 117) to "refresh" the previous GMPs.  The broad topics of the new regulation are similar to the existing topics, but the new regulation provides additional details for GMPs.  Also recall that Congress, in the Food Safety Modernization Act, stated that the preventive controls of a food safety plan will likely incorporate GMPs (21 U.S.C. 350g(o)(3)).

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    USDA FSIS requires "official establishments" to develop, implement, and maintain written standard operating procedures for sanitation (Sanitation SOP's); see 9 CFR 416.11 specifically, or 9 CFR part 416 more generally.

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    Standard of Identity

    An early and enduring goal of U.S. federal food law is to assure consumers have adequate information about food products when they are deciding whether to purchase the food.  Accordingly, federal law prohibits food from being misbranded; restated, federal law requires that food products be appropriately labeled. Similarly, federal law requires that food products contain appropriate components.  The standard of identity for food products is intended to address some of these concerns.

    Congress authorized FDA to set forth regulations establishing a common or usual name for any food, a reasonable definition and standard of identity, a reasonable standard of quality, or reasonable standards of fill of container to promote honesty and fair dealing in the interest of consumers. 9 U.S.C. 341.

    • Example:  FDA standard of identity for Swiss cheese (21 CFR 133.195).  The purpose of the example is to illustrate 1) the level of detail in the regulation and 2) standards of identity seldom address the quality of the food product (only infant formula are subject to quantity specifications).
      • a) Description. (1) Swiss cheese ... has holes or eyes developed throughout the cheese. The minimum milkfat content is 43 percent by weight of the solids and the maximum moisture content is 41 percent by weight... The dairy ingredients used may be pasteurized. Swiss cheese is at least 60 days old.  (2) If pasteurized dairy ingredients are used, the phenol equivalent value of 0.25 gram of swiss cheese is not more than 3 micrograms... (3) One or more of the dairy ingredients ... may be bleached, warmed, or treated with hydrogen peroxide/catalase, and is subjected to the action of lactic acid-producing and propionic acid-producing bacterial cultures. One or more of the clotting enzymes ... is added to set the dairy ingredients to a semisolid mass. The mass is cut into particles similar in size to wheat kernels. For about 30 minutes the particles are alternately stirred and allowed to settle. The temperature is raised to about 126 °F. Stirring is continued until the curd becomes firm. The acidity of the whey at this point, calculated as lactic acid, does not exceed 0.13 percent. The curd is transferred to hoops or forms and pressed until the desired shape and firmness are obtained. The cheese is then salted by immersing it in a saturated salt solution for about 3 days. It is then held at a temperature of about 50° to 60 °F. for a period of 5 to 10 days, after which it is held at a temperature of about 75 °F. until it is approximately 30 days old, or until the so-called eyes form. Salt, or a solution of salt in water, is added to the surface of the cheese at some time during the curing process. The cheese is then stored at a lower temperature for further curing.
      • (b) Optional ingredients: (1) Dairy ingredients. Milk, nonfat milk, or cream... (2) Clotting enzymes. Rennet and/or other clotting enzymes of animal, plant, or microbial origin.(3) Other optional ingredients. (i) Coloring.(ii) Calcium chloride in an amount not more than 0.02 percent ... (iii) Enzymes of animal, plant, or microbial origin, used in curing or flavor development. (iv) Antimycotic agents, the cumulative levels of which shall not exceed good manufacturing practice, may be added to the surface of the cheese. (v) Benzoyl peroxide or a mixture of benzoyl peroxide with potassium alum, calcium sulfate, and magnesium carbonate used to bleach the dairy ingredients. The weight of the benzoyl peroxide is not more than 0.002 percent of the weight of the milk being bleached, and the weight of the potassium alum, calcium sulfate, and magnesium carbonate, singly or combined, is not more than six times the weight of the benzoyl peroxide used. If milk is bleached in this manner, vitamin A is added to the curd in such quantity as to compensate for the vitamin A or its precursors destroyed in the bleaching process, and artificial coloring is not used. (vi) Hydrogen peroxide, followed by a sufficient quantity of catalase preparation to eliminate the hydrogen peroxide. The weight of the hydrogen peroxide shall not exceed 0.05 percent of the weight of the milk and the weight of the catalase shall not exceed 20 parts per million of the weight of the milk treated...
      • (c) Nomenclature. The name of the food is “swiss cheese”, or alternatively, “emmentaler cheese”.
      • (d) Label declaration. Each of the ingredients used in the food shall be declared on the label ... except that: (1) Enzymes of animal, plant, or microbial origin may be declared as “enzymes”; and (2) The dairy ingredients may be declared, in descending order of predominance, by the use of the terms “milkfat and nonfat milk” or “nonfat milk and milkfat”, as appropriate.

    Even though few consumers will ever read the standard of identity for Swiss cheese, they can be confident that each package of Swiss cheese will generally have the same characteristics due to the regulated standard of identity.

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    Additional standards of identity are specified in FDA and USDA regulations.

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    Even though the underlying statute authorizes the standard of identity to include standards for quality, standard of identity regulations primarily address content, not quality.

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    Firms that want to produce a food product that does not have a standard of identity may request (petition) the agency to set forth a standard of identity (see 21 CFR 130.5 and 10.30).

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    Other entities also are defining food standards:

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    Food Additives and GRAS

    Most food processing involves directly adding ingredients or substances to the food product.  Likewise, packaging as well as contacting the surface of processing equipment can indirectly impact the food.  Federal law states that adding ANYTHING (directly or indirectly) to food will render the food adulterated, EXCEPT if the substance is allowed to be added according to an FDA or USDA FSIS regulation.  The discussion of this subsection focuses on several broad categories of substances that can be added to food as indicated in federal regulations.

    For additional information, see

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    When considering substances that are directly or indirectly added to food, the assessment does not focus solely on the substance; the assessment also focuses on how the substance is used.  Accordingly, a regulation that allows substance X to be used for purpose A in processing food does not allow substance X to be used for purpose B.  When reviewing a regulation for directly or indirectly adding a substance to food, be certain to investigate what the regulations has to say about both the substance and its use.

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    Substances that can be directly or indirectly added to food are placed in several broad categories.

    • Category 1. Prior-sanctioned substance is a substance and its use that was explicitly approved by FDA or USDA prior to September 1958 (21 CFR 181).  The September 1958 date reflects a major revision in the law addressing food additives.  Accordingly, that date continues to be significant for this particular topic.
    • Category 2. Generally Recognized as Safe (GRAS) is a substance that has a long history of safe use in food, such as salt (21 CFR 182).  Since the early 1970s, FDA has been reviewing GRAS substances and affirming them as GRAS or defining them as a food additive.
      • Direct food substances affirmed as GRAS (21 CFR 184)
      • Indirect food substances (e.g., packaging or contact surfaces) affirmed as GRAS (21 CFR 186)
    • Category 3. Substances that are food additives -- general (21 CFR 170)
      • Substances identified as direct food additives (21 CFR 172 & 173)
      • Substances identified as indirect food additives (21 CFR 174, 175, 176, 177 & 178)
    • Category 4.  GRAS Notification Program and GRAS Notice Inventory
      • A program followed by FDA that allows food firms to inform the FDA that a substance is safe and that the firm intends to use the substance in a food product; the FDA then has an opportunity to accept the firm's assessment or to pose questions about the firm's assessment of the substance.  This approval process is used by FDA to shorten the time it takes to have a substance approved for use in food processing.  However ...
      • FDA is under pressure to formalize the GRAS Notification Program because the FDA has been using the program for several decades without finalizing the rules for how this program is implemented; the concern is that is program is not reviewing food additives at the level of review intended by the underlying Congressional statutes.
    • Prohibited substances (21 CFR 189)

    Unless there is a regulation placing a substance in one of the three categories listed above, the substance cannot be directly or indirectly added to food, even if the substance is not listed as prohibited.

    A food business can petition for a regulation to allow a substance to be recognized as a food additive (21 CFR 171).

    It is the responsibility of the firm to prove the substance is safe to use as the firm wants to use it.  It is not the responsibility of government to prove the substance or its intended use is safe or unsafe.

    The primary differences between a substance that would be considered GRAS or a food additive is "GRAS substances are distinguished from food additives by the type of information that supports the GRAS determination, that it is publicly available and generally accepted by the scientific community, but should be the same quantity and quality of information that would support the safety of a food additive."  See Food Ingredients and Packaging Terms at http://www.fda.gov/Food/IngredientsPackagingLabeling/Definitions/ucm064228.htm.

    • Information about food additives may not be as publicly available as information about GRAS substances.

    A substance that does not reach the level of GRAS will be treated as a food additive.

    Food additives are expected to be used according to good manufacturing practices (GMP) and the quantity used should be no more than is needed to accomplish the purpose of the substance, such as adding flavor, preserving the food product, or changing the characteristic of the food.

    The GRAS Notification Program was proposed in April 1997 and has not been finalized but is being used.  The consequence of this program is that 1) the GRAS review effort is not being completed (but that review process was moving slowly anyway and may have been a reason for this 1997 proposal) and 2) petitions for food additive regulations are not being pursued by food businesses if the notification program moves more quickly.  A concern, however, is that agency oversight of the substances is not as strict; see http://cspinet.org/new/201504151.html

    In summary -- any food that contains an unsafe (unapproved) food additive is adulterated and thus prohibited.  Source: http://www.fda.gov/Food/IngredientsPackagingLabeling/FoodAdditivesIngredients/ucm228269.htm.  Substances can be directly or indirectly added to food if there is a regulation identifying the use of the substance as prior-sanctioned, GRAS or a food additive.  See subsequent sections titled Contact Surfaces and Packaging for more discussion of indirect food additives.

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    Color Additives

    Color additives also are subject to FDA approval before they may be used in food.  Source:  http://www.fda.gov/ForIndustry/ColorAdditives/default.htm.  Many color additives must be batch certified by FDA; that is, as each batch of color additive is manufactured, the batch of color additive must be certified as complying with regulatory standards.  Certifying each batch of color additive is different than the oversight process used for food additives.  Source:  http://www.fda.gov/ForIndustry/ColorAdditives/ColorCertification/default.htm.  Also see 21 CFR parts 70-82.

    Color additives are used for products other than food; for example, they are added to drugs, cosmetics, etc.  Accordingly, the regulations for color additives address concerns that arise outside the food industry.

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    Supplier Verification

    Congress, in the Food Safety Modernization Act, imposed greater expectations on food processors in terms of assessing the safety of the raw ingredients using in food manufacturing.  The question is "food processors, have you assessed the safety of the ingredients your firm is receiving and using in food processing?"

    The law requires that any food facility receiving raw materials and other ingredients must establish and implement a risk-based supply-chain program for materials and ingredients for which the food facility has identified a hazard.  The strategy then is to implement a supply-chain-applied control.

    The law also requires that if a receiving facility determines that the supplier is not controlling hazards, the receiving facility must take prompt action and document its prompt action to ensure the ingredients from the supplier do not cause food the receiving firm is processed to be adulterated.

    The law allows the receiving facility to rely on audits conducted by third-party auditors.

    The FDA regulation lists numerous documents the receiving firm must maintain, for example:

    • a written supply-chain program
    • approval of a supplier
    • written procedures for receiving raw materials
    • documentation demonstrating use of the written procedures for receiving raw materials
    • documentation of appropriate supplier verification activities
    • written results of appropriate inspection of the supplier
    • actions taken if supplier is not conforming
    • document of the receiving facility's review of other firms' documentation

    See 21 CFR 117.405 et seq.

    .

    Contact Surfaces, Water and Air

    U.S. law recognizes that other substances contact food during processing and that these contacts can adulterate the food.  For example, materials used in constructing food-contact surfaces of food-processing equipment can migrate into food (21 CFR 174.6).  Accordingly, all plant equipment and utensils must be designed and made of material to be cleanable. The design, construction, and use of equipment and utensils also must prevent lubricants, fuel, metal fragments, contaminated water, or other contaminants from adulterating the food. Food-contact surfaces should be corrosion-resistant and made of nontoxic materials and designed to withstand the environment of their intended use and the action of food, cleaning compounds and sanitizing agents.  Holding, conveying, and manufacturing systems are required to be designed and constructed so they can be maintained in appropriate sanitary condition (21 CFR 110.40).

    Compressed air or other gases mechanically introduced into food or used to clean food-contact surfaces or equipment shall be treated in such a way that food is not contaminated with unlawful indirect food additives. See 21 CFR 110.40(g)

    Any water that contacts food or food-contact surfaces shall be safe and of adequate sanitary quality. See 21 CFR 110.37(a)

    FDA regulation 21 CFR 117 includes the following points

    • 117.40(a)(1) All plant equipment and utensils must be so designed and of such material and workmanship as to be adequately cleanable, and must be properly maintained.
    • 117.35 All food-contact surfaces, including utensils and food-contact surfaces of equipment, must be cleaned as frequently as necessary to protect against cross-contact and contamination of food.
    • 117.37(a) ... Any water that contacts food, food-contact surfaces, or food-packaging materials must be safe and of adequate sanitary quality...
    • 117.80(c)(16) When ice is used in contact with food, it must be made from water that is safe and of adequate sanitary quality, and must be used only if it has been manufactured in accordance with current good manufacturing practice as outlined in this part.
    • 117.40(g) Compressed air or other gases mechanically introduced into food or used to clean food-contact surfaces or equipment must be treated in such a way that food is not contaminated with unlawful indirect food additives.

    .

    Packaging

    Food packaging also raises the question of indirect food additives.  If the substance (e.g., the packaging material) has not been pre-approved in a federal regulation, the packaged food would be considered adulterated.  See 21 CFR 175, 176 and 177.

    The other broad prohibition in U.S. food law -- misbranding -- also can arise from food packaging.  An early concern was that food was packaged in a way to mislead the consumer, such as disguising the quantity in the container or not filling the container.  Appropriate fill is necessary to prevent the food from being considered "misbranded."  See 21 CFR 100.100.

    The next section addresses product labeling which is primarily directed at assuring the food product is not misbranded.

    .

    Labeling

    Food products must be labeled so consumers have the information they need to make decisions based on nutrition and safety, such as allergens.  This information is to be available to the consumer at time of purchase so the consumer can consider the information in deciding which food to purchase and consume.  This section introduces the basics of food labeling.

    USDA pre-approves labels, FDA does not.  For products regulated by FDA, the food business does its best to develop a label but it is only after it has begun to use the label that the business will learn whether FDA considers the label adequate.  FSIS, as part of its continuous inspection, must approve a label before it can be used.

    .

    USDA FSIS labeling of meat and poultry products

    USDA labeling regulations:  see 9 CFR part 317

    USDA FSIS labeling requirements from A GUIDE TO FEDERAL FOOD LABELING REQUIREMENTS FOR MEAT AND POULTRY PRODUCTS at http://www.fsis.usda.gov/PDF/Labeling_Requirements_Guide.pdf.

    • "There are up to eight specific requirements for each product label: (1) product name, (2) inspection legend and establishment number, (3) handling statement, (4) net weight statement, (5) ingredients statement, (6) address line, (7) nutrition facts, and (8) safe handling instructions."
    • "The principal display panel, or "PDP," is the part of the label most likely to be displayed, presented, shown, or examined under customary conditions to the consumer. The PDP must include the name of the product, net quantity of contents, the official inspection legend, number of the official establishment, and, if necessary, a handling statement."
    • "The information panel typically is that part of the label immediately contiguous and to the right of the PDP... All information required to appear on the label of a package must appear either on the PDP or the information panel unless otherwise specified by regulation. Other label information that may be placed on the information panel (unless on the PDP) includes an ingredients statement, name and address of the manufacturer or distributor, and nutrition labeling, if required. The safe handling instructions may be placed anywhere on the label."
    • "Foods subject to a standard of identity must be labeled with the name specified in the standard."
    • "FSIS requires imported meat and poultry products to bear the name of the country of origin, preceded by the words "Product of." ... The "country of origin" statement must be immediately under the name of the product."

    .

    FDA labeling of "other foods"

    FDA's Food Labeling Guide is a good source of information about labeling requirements; see Food Labeling Guide at http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/LabelingNutrition/ucm2006828.htm.

    • The Principal Display Panel (PDP):  side of package that the consumer is expected to see first; the PDP must provide the product name (based on standard of identity) and quantity in the package
    • The Information panel is located to the right of the PDP  It must provide nutrition facts in a specific format, serving size, required nutrition information, and optional nutrition information.
    • The Information panel also must list the ingredients and indicate whether any of the ingredients are recognized food allergens.
    • The Information panel must provide the firm's name and contact information.
    • The remainder of the package can be used for other information, such as preparation steps and promotion (as long as the promotion is not misleading)

    .

    Additional points

    Food businesses most likely include a product code so the firm can identify the product, if necessary, such as a recall.

    As a general rule, food products do not need to be dated; any dating is at the option of the manufacturer.  See http://www.fsis.usda.gov/wps/portal/fsis/topics/food-safety-education/get-answers/food-safety-fact-sheets/food-labeling/food-product-dating/food-product-dating.

    • "[I]f a calendar date is used, it must express both the month and day of the month (and the year, in the case of shelf-stable and frozen products). If a calendar date is shown, immediately adjacent to the date must be a phrase explaining the meaning of that date such as "sell-by" or "use before.""

    An expired date does not indicate the product is unsafe; an expired date means that the product may not be at its peak quality.

    .

    Nutrient Content and Health Claims

    Food businesses, like any business, seek opportunities to promote their product, such as "the benefit of eating our product is ???".  Society, however, has some concern about such message.  Accordingly, Congress has included misleading statements in the definition of "misbranded"; that is, a food promotion or advertisement that misleads consumers will render the food misbranded (and thus prohibit the food from being sold).  This section introduces regulations that have evolved over several decades to guide food businesses in the promotion or claims about their product.  The discussion introduces "nutrient content claims" and "health claims".  This brief discussion does NOT introduce "qualified health claims" or "structure/function claims".

    .

    Nutrient content claim

    A nutrient content claim is a statement about a food product that directly or by implication characterizes the level of a nutrient in the food (e.g., "fat free," "low fat," "high in oat bran," or "contains 100 calories").  The question than is "what standard must be met to claim that a food is calorie-free or low-calorie or reduced calorie?  Likewise, what standards must be met to describe a food as free, low or reduced in total fat, saturated fat, cholesterol, sodium or sugars?"  Similarly, what standards must be met to claim "light, reduced, more, less, rich in, fortified, excellent source of, good source of, lean, extra lean, high potency, fiber or antioxidant"?

    Note that some claims are relevant to a base food, such as "reduced"; whereas other claims are absolute, such as "fat-free".  Accordingly, the standards set forth the expectations in terms of either a comparison or in absolute terms.  Continuing these examples, "reduced fat" means there is at least 25% less fat per serving than an appropriate reference/base food, whereas "fat free" means there is less than 0.5 grams in a serving.

    This web page will not repeat these standards; for more information about these standards, visit

    If these standards are not met, the product will be considered "misbranded" and prohibited from being sold.

    .

    Health claim

    Health claim is any claim made on the label that expressly or by implication characterizes the relationship of any substance to a disease or health-related condition.  For example,

    • "Development of cancer depends on many factors. A diet low in total fat may reduce the risk of some cancers."   See http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/LabelingNutrition/ucm064919.htm
    • "Diets low in sodium may reduce the risk of high blood pressure, a disease associated with many factors."
    • "While many factors affect heart disease, diets low in saturated fat and cholesterol may reduce the risk of this disease."
    • "Diets low in saturated fat and cholesterol and rich in fruits, vegetables, and grain products that contain some types of dietary fiber, particularly soluble fiber, may reduce the risk of heart disease, a disease associated with many factors."
    • "Health claims are limited to claims about disease risk reduction, and cannot be claims about the diagnosis, cure, mitigation, or treatment of disease. Health claims are required to be reviewed and evaluated by FDA prior to use."

    .

    FSIS Nutrition Labeling (including nutrient content claims) regulations at 9 CFR 317 Subpart B at http://www.ecfr.gov/cgi-bin/text-idx?SID=e681f9e76b3f275a680cb4b5ff1067eb&mc=true&node=sp9.2.317.b&rgn=div6

    .

    Misleading advertising (as well as misleading product labels) will render the food "misbranded".  For more information about food advertising, see Federal Trade Commission's Enforcement Policy Statement on Food Advertising at http://www.ftc.gov/bcp/policystmt/ad-food.shtm.

    .

    Product Recall & Recall Plan

    The strategy when food is adulterated or misbranded is to separate the food from consumers.  Often the food business is willing to do this by announcing a recall with hopes that a recall will be viewed as showing "the firm is a concerned and caring business and deserves continued customer loyalty".  The following list sets forth a few points about product recall.

    See FDA Regulatory Procedures Manual, Chapter 7 Recall Procedures at http://www.fda.gov/ICECI/ComplianceManuals/RegulatoryProceduresManual/ucm177304.htm

    Prior to the Food Safety Modernization Act, the FDA and USDA had limited authority to mandate a recall.  FDA now has authority to mandate a recall (see 21 U.S.C. 305l(b)); the industry should anticipate regulations describing how FDA will administer this new authority.

    .

    The purpose of a recall is to separate the product from consumers.

    In nearly all situations, the food firm initiates a recall.  An early step is to inform the appropriate agency (either the USDA FSIS or FDA).

    For example, 21 CFR 7.46 lists the information a firm needs to provide FDA when the firm initiates a recall.

    • 1) Identity of the product involved. 2) Reason for the removal or correction and the date and circumstances under which the product deficiency or possible deficiency was discovered. 3) Evaluation of the risk associated with the deficiency or possible deficiency. 4) Total amount of such products produced and/or the timespan of the production. 5) Total amount of such products estimated to be in distribution channels. 6) Distribution information, including the number of direct accounts and, where necessary, the identity of the direct accounts. 7) A copy of the firm's recall communication if any has been issued, or a proposed communication if none has issued. 8) Proposed strategy for conducting the recall. 9) Name and telephone number of the firm official who should be contacted concerning the recall.

    .

    Another early step in the recall process is assess the risk associated with the product being recalled.  The classes of recall are

    • Class I: Dangerous products that predictably could cause serious health problems or death.
    • Class II: Products that might cause a temporary health problem, or pose only a slight threat of a serious nature.
    • Class III: Products that are unlikely to cause any adverse health reaction, but that violate FDA labeling or manufacturing laws.

    The classification of the recall is determined by the overseeing agency.

    .

    Role of firm in conducting recall

    Elements of the firm's recall strategy include depth of recall; need for public warning; effectiveness check level; and disposition of recalled products.

    21 CFR 7.49 Recall communications

    • "A recalling firm is to promptly notify each of its affected direct accounts.  The recall communication should indicate (1) That the product in question is subject to a recall. (2) That further distribution or use of any remaining product should cease immediately. (3) Where appropriate, that the direct account should in turn notify its customers who received the product about the recall. (4) Instructions regarding what to do with the product."
    • 21 CFR 7.50 Public notification of recall
    • "The FDA will promptly make available to the public in the weekly FDA Enforcement Report a descriptive listing of each new recall according to its classification, whether it was FDA-requested or firm-initiated, and the specific action being taken by the recalling firm."
    • "It is the recalling firm’s responsibility to determine whether its recall is progressing satisfactorily. The firm has an obligation to conduct effectiveness checks as part of its recall strategy. Effectiveness checks assist in the verifying that all known, affected consignees have received notification about a recall and have taken appropriate action."

    .

    21 CFR 7.53 Recall status reports

    "The recalling firm must submit periodic recall status reports to the FDA so the agency may assess the progress of the recall. The recall status report should contain (1) Number of consignees notified of the recall, and date and method of notification. (2) Number of consignees responding to the recall communication and quantity of products on hand at the time the communication was received. (3) Number of consignees that did not respond (if needed, the identity of non-responding consignees may be requested by the Food and Drug Administration). (4) Number of products returned or corrected by each consignee contacted and the quantity of products accounted for. (5) Number and results of effectiveness checks that were made. (6) Estimated time frames for completing the recall.

    .

    The agency lists the recall and other enforcement actions; see

    .

    FDA or FSIS will monitor the recall process, but perhaps most significantly, decide whether the recall has been effective and whether the recall can be terminated.

    21 CFR 7.55 Termination of a recall

    • "FDA will terminate a recall when the monitoring district office determines that the recalling firm has completed all recall activity, including monitoring and final product disposition."

    .

    Each firm needs a recall plan; there is not time to assemble all this information and prepare a recall strategy once a problem is identified.

    • Based on the Food Safety Modernization Act, a recall plan is now a required component of a Food Safety plan (see 21 U.S.C. 350g(o)(3)).
    • FDA now has regulations in place for developing a recall plan as a mandatory component of a Food Safety Plan, see 21 CFR 117.139.  The written recall plan must describe the steps to be taken, and assign responsibility for taking those steps, to perform the following actions:  (1) directly notify the direct consignees of the food being recalled, including how to return or dispose of the affected food; (2) notify the public about any hazard presented by the food when appropriate to protect public health; (3) conduct effectiveness checks to verify that the recall is carried out; and (4) appropriately dispose of recalled food—e.g., through reprocessing, reworking, diverting to a use that does not present a safety concern, or destroying the food.

    .

    For more information about USDA FSIS recall procedures, see "FSIS Food Recalls" at http://www.fsis.usda.gov/wps/portal/fsis/topics/food-safety-education/get-answers/food-safety-fact-sheets/production-and-inspection/fsis-food-recalls/fsis-food-recalls; also see "How to Develop A Meat and Poultry Product Recall Plan" at http://www.fsis.usda.gov/shared/PDF/RecallPlanBooklet_0513.pdf

    • USDA FSIS regulations at 9 CFR 418.3 (but it does not say much; rely on "How to Develop a Meat and Poultry Recall Plan" listed above.

    .

    Records

    Another legal requirement is that food firms maintain records relating to the manufacture, processing, packing, distribution, receipt, holding, or importation of food products. The purpose is to assist in determining whether anything has happened to the food or been done to the food that would render it unsafe (i.e., adulterated). Accordingly, firms must maintain records and government authorities may access the records.

    Maintenance and inspection of records 21 U.S.C. 350c

    • The focus of this statute is not to specify which records need to be maintained, but to indicate that the regulatory agencies can access any records that the firm decides to maintain (certain financial records are not accessible and the agencies must take steps to protect the firm's confidential information).
    • It may be appropriate to describe the purpose of maintaining records as "to help determine the source and scope/magnitude of a food safety problem." If that is an appropriate statement of purpose, what records would you recommend a food business maintain? Why those records?
    • Does the firm need to maintain records to document whether GMPs were followed or the HACCP plan was implemented?
    • Remember: it is the food firm's responsibility to establish that the food is not adulterated or misbranded.  If this cannot be established, the food cannot be sold.  The firm needs to maintain adequate records to establish that its food is not adulterated or misbranded.  This expectation should guide the firm in its decisions about what records to maintain.

    .

    Examples of laws mandating records

    Traceability – “(b) The Secretary ... may by regulation establish requirements regarding the establishment and maintenance, for not longer than two years, of records by persons (excluding farms and restaurants) who manufacture, process, pack, transport, distribute, receive, hold, or import food ... needed ... to identify the immediate previous sources and the immediate subsequent recipients of food, including its packaging, in order to address credible threats of serious adverse health consequences or death to humans or animals ...“ 21 USC §350c(b)

    Subsection (b) was added by the Bioterrorism Act of 2002 and took effect in late 2003. This requirement is sometimes referred to as "traceability;" that is, these records are intended to document the path the food followed based on the "source" and "recipient" information maintained by food businesses.

    .

    Infant formula 21 U.S.C. §350a(b)(4); 21 CFR 106.100

    • "the retention of all records necessary to demonstrate compliance with the good manufacturing practices and quality control procedures "

    .

    Meat 21 U.S.C. §642; 9 CFR 320.1

    • records of transactions of meat products

    .

    Poultry 21 U.S.C. §460(b); 9 CFR 381.175

    • (1) Records of each transaction in which any poultry or poultry carcass, or part or product of a poultry carcass, is purchased, sold, shipped, received, transported, or otherwise handled; (2) Guaranties provided by suppliers of packaging materials; (3) Records of canning; (4) Records of irradiation; (5) Records of nutrition labeling; and (6) Records of all labeling.

    .

    Egg 21 U.S.C. §1040; 9 CFR 590.200

    .

    Records of interstate shipments 21 U.S.C. §373

    • "carriers engaged in interstate commerce, and persons receiving food ... in interstate commerce or holding such articles ... [must maintain and provide, when requested,] ... records showing the movement ... of food ... or the holding thereof ... and the quantity, shipper, and consignee thereof;"

    .

    FDA regulation at  21 CFR 117.190 identifies records that must be maintained as part of a Hazard Analysis/Food Safety Plan.

    The owner, operator, or agent in charge of a facility must establish and maintain the following records:
    (1) The written food safety plan, including the written hazard analysis, preventive controls, monitoring procedures, corrective action procedures, verification procedures, and recall plan.
    (2) Records that document the monitoring of preventive controls;
    (3) Records that document corrective actions;
    (4) Records that document verification, including, as applicable, those related to:

    (i) Validation,
    (ii) Monitoring,
    (iii) Corrective actions,
    (iv) Calibration of process monitoring and verification instruments,
    (v) Records review, and
    (vi) Reanalysis; and

    (5) Records that document applicable training for the qualified individual.

    .

    Additional FDA regulations on recordkeeping21 CFR 117 Subpart F (Requirements Applying to Records) & 21 CFR 117.475 (records for Supply-Chain Program); also see 21 CFR part 1 Subpart J (Establishment, Maintenance, and Availability of Records).

    .

    Records be kept and be accessible 21 U.S.C. §331(e)

    .

    Employee Training

    Achieving the practices necessary to meet legal requirements requires that employees understand their responsibilities.  Accordingly, management should recognize its responsibility in providing adequate training for new employees (orientation sessions) and regular review sessions to reinforce necessary practices and implement new practices as appropriate.  Despite the cost, employee training and retraining are critical if the business is to succeed in meeting its legal requirements

    Examples of topics to address in employee training could include

    • Employee's specific tasks/responsibilities
    • Maintaining a safe work environment and practicing safe work habits
    • Recognizing and practicing environmental stewardship
    • Practices to assure a quality product
    • Practices to assure a safe product (e.g., observe all ingredients, practices and products; accurately document, etc)
    • Ethical business practices (e.g., incur a cost to assure a safe product)

    See FDA regulation Qualifications of Individuals who handle food at 21 CFR 117.4

    • Personnel responsible for identifying sanitation failures or food contamination should have a background of education or experience, or a combination thereof, to provide a level of competency necessary for production of clean and safe food.
    • Food handlers and supervisors should receive appropriate training in proper food handling techniques and food-protection principles and should be informed of the danger of poor personal hygiene and insanitary practices.

      Employee training and leaders' example will establish the culture of the business.

      .

      Exporting Food from the United States

      Food must meet the regulations of the jurisdiction where it is located.  For example, food produced in the United States and then exported to another nation for consumption must first meet U.S. standards and then the standards of the importing nation.  If the standards of the two nations are quite different, the food company could have a challenge in meeting the requirements of both nations.

      Many nations realize that substantially different standards could interfere with food trade.  Accordingly, nations are willing to negotiate trade agreements.  Nations also realize that negotiating a trade agreement with each other nation in the world would mean that each nation would need to enter into more than 190 bi-lateral trade agreements.  An alternative is for nations to negotiate a multi-lateral (multi-national) trade agreement that many or all nations are willing to abide by.  Such trade agreements are based on the idea that if the standards of both trading nations are identical, a food company that is meeting the standards of the first nation would also be meeting the standards of the second nation.

      Efforts to establish a multi-lateral trade agreement have not been without challenges.  To ease the negotiating process, many nations recognize that their national standards will not be identical to the agreed-upon standards, but at least the standards might be similar.  The effort to achieve a multi-lateral trade agreement often is described as attempting to "harmonize" product standards.

      If two trading nations have harmonized their food product standards, it is envisioned that the importing nation will be confident in the food it is importing if the exporting nation "certifies" that the food meets the standards of the exporting nations. Accordingly, U.S. agencies are willing to provide a certificate, when asked, to indicate that the food being exported from the United States was produced in compliance with U.S. law.  It will then be up to the importing nation to decide whether that certification is enough to address any concerns the importing nation may have about the food.

      See

      .

      Importing Food into the United States

      Importing food into the United States is more complex than exporting from the United States (but do not interpret this statement to mean that importing into the United States is any more difficult than importing into other nations -- as a general practice, most nations impose more rules on imports than they impose on exports).  Importing into the United States will likely involve several U.S. federal agencies.

      .

      An import agent is a firm or individual who helps coordinate the import activity.

      .

      This section focused on the importation of food; it does not address the issues of importing animals or plants (which are regulated by USDA APHIS, see http://www.aphis.usda.gov/import_export/index.shtml).

      .

      Reportable Food Registry

      The Reportable Food Registry is a web site where food businesses report a food problem they have encountered. 

      • Food facilities that manufacture, process, pack or hold food and are required to register with the FDA must file a report within 24 hours through the Reportable Food Registry when there is a reasonable probability that an item of food will cause serious adverse health consequences to humans or animals.

      Government agencies also may use the site to report a food problem. 

      • Federal, state, and local public health officials also may use the portal to voluntarily report information that may come to them about reportable foods.

      The filed reports are received by FDA which then investigates and responds to the reported incident.  The FDA reviews and assesses the submitted information to identify whether "there is a reasonable probability that the use of, or exposure to, an article of food will cause serious adverse health consequences or death to humans or animals."  The FDA will then issue an alert or notification as the FDA deems necessary, and exercise other food safety authorities to protect the public health.

      For more information, see

       

      Identifying a Food Safety Problem

      The modern food industry distributes significant quantities of food over large geographically dispersed areas.  As a result if a food is a source of illness, the stricken people could be hundreds or thousands of miles apart.  Members of the medical community and government staff may not recognize that they are observing one part of a larger problem.  The Center for Disease Control (CDC) established a network wherein medical professionals can report food-related illnesses.  See The National Outbreak Reporting System (NORS)

      NORS is a web-based program that allows local, state, and territorial health departments in the United States to report outbreaks to the CDC.  See NORS is related to Foodborne Outbreak Tracking and Reporting

      In addition, the CDC developed FoodNet and PulseNet as information networks to help identify whether a local incident is one part of larger situation.

       

      Enforcement

      With all the rules that food processing firms must comply with, there will be violations.  Perhaps many of the violations will be unintentional or the result of an oversight, but occasionally there may be a violation because the firm's manager decides to "stretch the rules".

      FDA enforcement relies on inspections, whether the inspection was initiated by FDA, conducted by FDA after being contacted by a state agency, or conducted by FDA after a suspected food safety issue is traced to the food business.  FDA's Regulatory Procedures Manual at http://www.fda.gov/ICECI/ComplianceManuals/RegulatoryProceduresManual/default.htm outlines FDA's enforcement practices.

      .

      Advisory Actions at http://www.fda.gov/downloads/ICECI/ComplianceManuals/RegulatoryProceduresManual/UCM074330.pdf

      • untitled letter -- a letter from FDA to a food business indicating that there are violations but they are not of regulatory significance.  The use of an Untitled Letter is based on the expectation that most firms will voluntarily comply with the law
      • warning letter -- A letter from FDA to a food business indicating there are violations of regulatory significance and that the violations may lead to enforcement action if not promptly and adequately corrected. Like an untitled letter, the use of a Warning Letter is based on the expectation that most firms will voluntarily comply with the law.

      .

      Administrative Action at http://www.fda.gov/downloads/ICECI/ComplianceManuals/RegulatoryProceduresManual/UCM074324.pdf

      • section 305 meeting -- FDA believes there is a violation of the law but will meet with the firm before contacting the U.S. attorney about initiating legal action against the firm.
      • administrative detention -- the authority of FDA official to detain any food that is found during an inspection, examination, or investigation if the official has credible evidence or information indicating that the food presents a threat of serious adverse health consequences or death to humans.  The food may be detained for 20 to 30 days during which time it cannot be moved.  During that time FDA may pursue judicial actions.

      .

      Judicial Actions at http://www.fda.gov/downloads/ICECI/ComplianceManuals/RegulatoryProceduresManual/UCM074317.pdf.  Seizing food, from a legal perspective, is government taking private property.  Accordingly, the law requires FDA to convince a court that FDA must seize the food in order to protect consumers from unsafe products.  The following actions identify several judicial proceedings FDA may pursue when calling on the courts to authorize FDA to take control of the business' property (food).

      • seizure -- FDA should pursue judicial authority to seize (take control of) food only after considering whether alternatives could achieve the public protection.
      • injunction -- an injuction is a court ordering the food business to not move the food, but FDA does not take control of the food.  FDA, however, does monitor the food to assure that it is not moved.
      • inspection warrants -- a court order requested by FDA after a food business has refused access to the facility or records during an inspection; the warrant instructs the firm to allow the FDA inspection to proceed.
      • search warrants -- FDA will request a search warrant as authorization to enter the plant without permission.  Search warrants are granting if there is evidence that a crime is being committed.  The Office of the U.S. Attorney often will be involved in the execution of a search warrant.

      .

      Recall Procedures at http://www.fda.gov/downloads/ICECI/ComplianceManuals/RegulatoryProceduresManual/UCM074312.pdf.  Most firms, however, cooperate based on the idea that not solving a problem could become a public affairs nightmare that the firm may not be able to survive; that is, the firm risks losing customers who choose to consumer alternative food products, rather than continuing to buy product from this firm.

      • voluntary recall -- most firms will take steps to remove the food from the food system and thereby not allow consumers access to the suspected food.  As a general rule, most firms voluntary initiate the food recall.
      • mandatory recall -- prior to the 2010 FDA Food Safety Modernization Act, the federal government had limited authority to mandate a food recall.  The 2010 legislation now empowers FDA to mandate food product recalls, but because the authority is still relatively new, there is no details yet as to how this authority will be implemented.
        • Apparently, mandatory recalls will be conducted by the firm; that is, in case of FDA mandating a recall, the FDA will direct the firm to initiate the recall.  The FDA will not conduct the recall.  If a firm refuses to initiate a recall when mandated by FDA to do so, the FDA will respond by taking enforcement actions.

      .

      FSIS/USDA enforcement practices, see 9 CFR part 500; for example

      A “regulatory control action” is the retention of product, rejection of equipment or facilities, slowing or stopping of lines, or refusal to allow the processing of specifically identified product.

      (b) A “withholding action” is the refusal to allow the marks of inspection to be applied to products. A withholding action may affect all product in the establishment or product produced by a particular process.

      (c) A “suspension” is an interruption in the assignment of program employees to all or part of an establishment.

      For USDA FSIS, perhaps the easiest enforcement step is for the inspector(s) to walk out of the plant which means any product produced without inspection would be considered adulterated.  If a concern cannot be resolved, the inspectors can leave the plant thereby stopping its operation.

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      Summary

      The food processing sector is extensively regulated by the FDA or USDA FSIS, depending on the food product.  Each of the regulated topics is based on the goal of wanting to prevent adulterated or misbranded food from reaching the consumer.  It is the food business' burden to establish that the food is not adulterated or misbranded.  Until that burden is met, a reasonable belief that the food is adulterated or misbranded authorizes the FDA or FSIS to take appropriate enforcement actions.

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      Email David.Saxowsky@ndsu.edu

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