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Responding to a Food Safety Problem

Before discussing the details of additional legal requirements for food processing firms, it may be helpful to introduce the consequences for a firm that fails to meet all the legal expectations.

 

 

The introduction to food law explains that food businesses are subject to numerous requirements and prohibitions.  Before discussing more details about these requirements and prohibitions, it may be helpful to describe possible events following the occurrence of a food safety problem, including the the legal consequences for a food business that fails to remedy the problem.  Note that at least three types of entities may be involved with a food safety concern:  one or more regulatory agencies, the food business, and the affected consumer(s).  This page describes likely responses by each of these parties.

The primary topics on this page are

  • Government efforts to identify a dispersed foodborne illness:  PulseNet, FoodNet and Reportable Food Registry
  • Alternatives when food business recognizes a problem: stock recovery, market withdrawals and voluntary recalls
  • Communication to consumers about the food problem:  business announcement and enforcement notice
  • Ethical considerations as a business responds to a food problem
  • Federal government enforcement when problem is not being resolved:  advisory letters, administrative action, judicial action; do not overlook FDA's relatively new authority to mandate a recall under the Food Safety Modernization Act.
  • Judicial review of government enforcement
  • Role of state government
  • Business' liability to a sickened consumer:  product liability

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    Several initial thoughts

    • The first objective when a food problem arises is to separate the suspect food from the consumer.
    • The response of federal and state agencies will reflect the reaction of the food business, that is, an agency will need to take a more aggressive approach if the food business does not voluntarily lead the effort to resolve the problem.
    • Most food businesses take a leadership role if a problem is suspected, in large part, to preserve their image among consumers.
    • Modern food processing and distribution technologies can exacerbate food safety challenges by commingling food products from a variety of sources and then distributing the food over a large geographic area in a relatively short time.
    • Sometimes a food safety concern will be identified by the food business or a regulatory agency before the food reaches consumers.  In other situations, the food safety concern will not be recognized until it is identified as a result of consumer illnesses.
    • Reminder:  USDA FSIS oversees food businesses that process meat and poultry products; the FDA oversees the businesses that process most other types of food.
      • FDA refers to the businesses it oversees as "registered facilities" (21 CFR 1.225 & 1.226).
      • USDA FSIS refers to the businesses it oversees as "official establishments" (9 CFR 301.2).

    .

    Responding to Consumer Illnesses

    A food safety issue that leads to consumer illnesses raises several challenges.  Frequent questions include whether the consumer can recover (fortunately many do), what medical treatment would help the recovery, and what went wrong in the industry and government oversight that allowed unsafe food to reach consumers.  Related questions often focus on whether consumers recognize that they are not feeling well due to a food issue (or will they pass it off as "I had something for 24 hours"), and if the ill individual seeks medical treatment, will the medical professional recognize the cause as food?  Likewise, how can several medical professionals dispersed across large geographic areas recognize that each is treating a related food illness?  The technology that allows food from a single location to be rapidly distributed over large areas aggravates this concern.

    The Centers for Disease Control and Prevention (CDC) includes a Food Safety Office (FSO) with several programs and activities intended to provide national leadership and coordination among entities with responsibility for responding to food-borne illness.  The CDC programs provide several foodborne illness surveillance systems to provide information about the occurrence of foodborne disease.  For example:

    • PulseNet is a national network of public health and food regulatory agency laboratories that perform standardized molecular subtyping (or “fingerprinting”) of foodborne disease-causing bacteria.  PulseNet helps scientists determine whether an outbreak is occurring, even if the affected persons are geographically far apart.
    • The FoodNet "project consists of active surveillance for foodborne diseases and related epidemiologic studies designed to help public health officials better understand the epidemiology of foodborne diseases in the United States."

    .

      Reportable Food Registry

      If a food safety problem is discovered, an early step is to report the food at the FDA Reportable Food Registry. Congress directed the FDA in 2007 to establish the Reportable Food Registry.  The Registry is an electronic portal where (registered) food businesses regulated by FDA (except infant formula and dietary supplements, but including pet food) MUST submit a report within 24 hours if there is a reasonable probability that the use of, or exposure to, the food will cause serious adverse health consequences or death to humans (or animals).  Public health officials MAY submit such a report. The purpose of the Registry is to help FDA better track patterns of food safety concerns and target inspections.

      • Although FDA is authorized to inspect registered food businesses, it does not have an adequate staff to inspect on a regular basis.  Instead, FDA often targets inspections of situations where a concern has been identified.  The Registry is a method for businesses to self-report a situation and for FDA to direct its resources.
      • Guidance for Industry: ... Regarding the Reportable Food Registry... at http://www.fda.gov/food/guidanceregulation/ucm212793.htm.

      .

        Firm Discovers a Concern

        A food business that recognizes a potential food safety concern is expected to separate the food from consumers (after submitting a report to the Registry).  If the problem is recognized before the food has left the control of the business, the firm is expected to take steps to prevent the food from moving forward in the food system.  If the food has left the control of the business, the firm is expected to take steps to stop the food from moving through the food system.  The following points expand on these expectations.

        If the food product is unsafe or otherwise in violation of U.S. food law, the business is expected to remove the food from the market. There are three types of product removals. Note that situations involving a stock recovery, for example, are considered as posing a low risk to consumers.  Situations involving a recall are considered as posing a higher risk to consumers.

        • Stock recovery means a firm's removal or correction of a product that has not left the direct control of the firm.  The product is located on premises owned by, or under the control of, the firm and no portion of the lot has been released for sale or use.
        • Market withdrawal means a firm's removal or correction of a distributed product which involves a minor violation for which FDA would not initiate legal action, or which involves no violation.
        • Recall is a firm's removal or correction of marketed products that FDA considers to be in violation of the laws it administers.  Recall does not include market withdrawal or a stock recovery.

        See Regulatory Procedures Manual at https://www.fda.gov/ICECI/ComplianceManuals/RegulatoryProceduresManual/default.htm; these definitions are found in the Glossary at http://www.fda.gov/ICECI/ComplianceManuals/RegulatoryProceduresManual/ucm179275.htm.

        .

        Recall

        Even if a food firm determines that a recall is necessary and the firm decides to voluntarily initiate the recall, the FDA (USDA in case of meat and poultry products) still has a role in the recall process.

        Generally, product recalls are voluntary, that is, the firm decides to recall the product.  However, the Food Safety Modernization Act authorizes the FDA to initiate recalls.  The process that the FDA will use to implement this authority is still emerging.  The food industry can expect regulations and guidance in the future. Until then, understanding the rules for voluntary recalls is valuable, especially if members of the food industry continue to voluntarily initiate recalls when necessary, rather than waiting for FDA to take that step.

        A food business that discovers a problem with its product must report the problem to the appropriate (state?) agency.  If a recall is necessary, the FDA or USDA must be notified.  The following paragraphs are offered as examples of some of the thinking and information behind the recall process.

        "Recalling firms are urged to notify the local FDA District Recall Coordinator as soon as a decision is made that a recall is appropriate and prior to the issuance of press or written notification to customers ... It is recommended that you submit the information outlined in this guidance to your local FDA District Recall Coordinator as soon as possible after the decision to recall is made and the coordinator notified. It is recommended that you do not wait to submit this information until ALL applicable information is prepared and assembled prior to FDA notification. This "early" notification will allow FDA the opportunity to review and comment on your written notification and to offer guidance and assistance in your recall process."

        Sprouters Northwest, Inc. Recalls Raw Alfalfa Sprouts Due to Possible Health Risk - June 3, 2004 - The Food and Drug Administration has been alerted that Sprouters Northwest, Inc. of Kent Washington is recalling 2, 3, and 5 lbs. institutional trays of its raw alfalfa sprouts sent to various food institutions because they may be linked to a recent increase in Salmonellosis in Oregon and Washington State. To date, 12 cases of Salmonella Bovismorbificans possibly linked to the consumption of raw alfalfa sprouts have been reported. In light of these outbreaks, FDA is reiterating its previous alerts about eating raw sprouts. Those persons who wish to reduce the risk of foodborne illness from sprouts are advised not to eat raw sprouts. This advice is particularly important for children, the elderly, and persons with weakened immune systems, all of whom are at high risk of developing serious illness due to foodborne disease. People in high-risk categories should not eat raw sprouts.

        "Salmonella Bovismorbificans is an organism rarely seen in the United Stated that can cause serious and sometimes fatal infections in young children, frail or elderly people and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis (swelling of the lining the heart) and arthritis. Most cases resolve without the need for medical attention.

        "FDA is working closely with state officials and the company to determine the cause of this problem and what steps can be taken to combat it. The agency will provide additional information as it becomes available."

        • If the problem is discovered by a government agency, the agency must notify the food processor of action required (correction and/or recall).
        • Prior to the Food Safety Modernization Act in December 2010, FDA was not authorized to mandate a recall but worked in conjunction with state agencies that may have recall authority. FDA also works with firms that voluntarily recall a product.
          • Exception -- even prior to 2011, FDA was authorized to recall infant formula (21 CFR 107.200 et. seq.).

        .

        USDA FSIS Recall

        USDA FSIS specifies its expectations for a food product recall in an FSIS Directive:  RECALL OF MEAT AND POULTRY PRODUCTS at http://www.fsis.usda.gov/OPPDE/rdad/FSISDirectives/8080.1.pdf

        More specifically, see PRODUCT RECALL GUIDELINES FOR FIRMS, pp. 22-31 of the Directive.  Topics within the Guidelines are

        • Recall Plan
          • Personnel
          • Procedures
          • Evaluation of Hazard
          • Scope of Recall
          • Records
          • Depth of Recall
          • Recall Communication
          • Responsibility of other firms
          • Public Notification
          • Effectiveness Checks
          • Control of Recalled Product
          • Recall Simulations
        • Notifying the FSIS
        • Recall Assessment
        • Recall Termination
        • Recall Follow-up

        .

        FDA Food Recall

        FDA also describes the steps it expects food firms to follow in implementing a product recall. 

          • "This guidance is intended to assist those members of industry regulated by the Food and Drug Administration (FDA) in handling all aspects of a product recall, including all corrections and removals. The guidance includes a checklist of documentation and information that FDA utilizes to evaluate, classify, monitor and audit product recalls."
        • The outline for this guidance is listed here.

        A. Recall Submission to FDA

        Product Information: codes (production identification numbers); recalling firm; manufacturer; firm responsible for the violation/problem; reason for the recall; health hazard assessment; volume of recalled product; distribution pattern; and recall strategy 

        B. Public Notification 

        Press release; guidance for written recall notification letters; product identification; description of the problem; depth of the recall; instructions to customers 

        C. Evaluation of the Recall

        Effectiveness of the recall; recall status reports; root cause of the problem that resulted in the recall; corrective actions to prevent future occurrences of the problem; termination of the recall

        .

        FDA Recall Regulations 21 CFR 7.40 to 7.59

        • Recall policy (21 CFR 7.40)
        • Evaluation of class for the recall (21 CFR 7.41)
        • When a recall is initiated, the scope of the problem needs to be assessed and based on the assessment, the recall will be classified.  Classes of Full Recalls(21 CFR 7.41(b))
          • Class I - use of the food will cause serious adverse health consequences
          • Class II - use of the food may cause temporary or medically reversible health effects
          • Class III - use of the food not likely to cause any health problems, this is usually a product quality issue
        • Recall strategy (21 CFR 7.42)
        • Role of the firm involved -- report progress of recall to the agencies (21 CFR 7.53)
        • Only FDA or USDA can terminate a recall (21 CFR 7.55)

        .

        • General Industry Guidance for Recalls(21 CFR 7.59)
          • Have a written recall plan /strategy
          • To facilitate the recall, the food business should have a product code system that can be used to trace all products
            • Establish a code system to identify date and time when the product was manufactured, the line on which it was manufactured, and where and how the product was distributed
          • Maintain records of all products distributed and sold

        .

        Public Notice of Enforcement Actions

          • FDA Enforcement Report --weekly FDA publication containing "information on actions taken in connection with agency regulatory activities."
          • FSIS Recalls Current recall news -- "Look here first for current [FSIS] recall news."

        .

        Communication

        An important strategy when unsafe food -- or the potential for unsafe food -- is discovered is to communicate that information to the public and other agencies.

        One aspect of resolving a food problem is providing effective communication with causing unnecessary panic.  The challenge is how to communicate the appropriate level of urgency without raising undue fears or concerns?  The business firm does not want “a public relations disaster,” nor do the agencies want unwarranted public fear.

        • With respect to the public, public announcements via the mass media are a common technique; e.g., 21 CFR §7.50 Public notification of recall.

        .

        Ethical Consideration

        For industry personnel – how to respond after discovering a potential problem in a facility or product?

        Example: Ethical issues in food and agriculture
        When do I disclose a possible food safety issue, especially one that would be no more than a class III recall? Is the risk of penalty enough to offset the risk of loss due to bad publicity, especially if the risk of harm to consumers and the chance of detection by others (such as FDA) are low?

        .

        FDA's Response if the Firm Does not Lead the Effort to Resolve the Problem

        Prior to 2011, the FDA could not mandate a recall. Following the Food Safety Modernization Act of 2010, FDA is authorized to recall food as well as take any of the following steps it deems appropriate.

        "The Regulatory Procedures Manual ... provides ... information on agency procedures used in processing domestic and import regulatory and enforcement matters."

        Regulatory Procedures Manual

        • Ch. 2 - FDA AUTHORITY
          • This chapter briefly introduces the federal court system and overviews major legislation amending the FDCA.

        .

        • Ch. 4 - ADVISORY ACTIONS - Procedures for Warning Letters
          • An Untitled Letter is an initial correspondence with regulated industry that cites violations that do not meet the threshold of a Warning Letter... Untitled Letters are intended to cover those circumstances where the Agency has a need to communicate with regulated industry about violations that do not meet the threshold of regulatory significance as described above ...
          • A Warning Letter... is a correspondence that notifies regulated industry about violations that FDA has documented during its inspections or investigations. Typically, a Warning Letter notifies a responsible individual or firm that the Agency considers one or more products, practices, processes, or other activities to be in violation of the Federal Food, Drug, and Cosmetic Act ... Warning Letters should only be issued for violations of regulatory significance, i.e., those that may actually lead to an enforcement action if the documented violations are not promptly and adequately corrected. A Warning Letter is one of the Agency's principal means of achieving prompt voluntary compliance with the Act.
          • Business needs to respond to letter or the agency can take further action as described below.

        If a serious problem is found, FDA will take steps to stop the business operations. Often this step is taken in collaboration with appropriate state agencies.

        .

        Enforcement Steps Beyond Recall

        Ch. 5 - ADMINISTRATIVE ACTIONS - Procedures for: Citation; ... Detentions of Foods

        • See 21 U.S.C. 335 (also referred to as Section 305 Notice); opportunity to meet before a criminal proceeding is initiated (a section 305 meeting). Also see 21 CFR 7.84 to 7.87.
        • FDA is authorized "to detain meat, poultry and egg products as delegated to FDA under the provisions of the Federal Meat Inspection Act (MIA), the Poultry Products Inspection Act (PPIA) and the Egg Products Inspection Act (EPIA)."
        • FDA also was granted authority to administratively detain foods under Subtitle A of the Bioterrorism Act.
          • "The detention process is another regulatory tool to achieve compliance with the Act. It should be considered when such products are encountered during regular District operations, on assignment, or as a follow-up to complaints. This procedure becomes most appropriate when no immediate arrangements can be made for local or state authority to take control of the product, and/or it appears that the product will not be held voluntarily."
          • "WASHINGTON, DC - July 15, 2004 - The Food Safety and Inspection Service (FSIS) today began to detain an undetermined amount of fried pork fat that was produced in a federal establishment without the presence of USDA inspectors. These products are considered to be adulterated and FSIS encourages consumers to avoid eating them and discard them.
            ". FSIS has also withheld the marks of inspection and suspended the assignment of inspectors from the establishment. Without federal inspection, products cannot legally be distributed into commerce.
            "On July 13, FSIS program employees were refused entry to examine the facilities, inventory and records at this establishment. This is a violation of the Federal Meat Inspection Act. When an establishment applies for a grant of inspection, it is understood that every applicant will be held responsible for adhering to this law and other applicable regulations if inspection is granted.
            "FSIS' detention of these products is underway in multiple states. FSIS wants to caution consumers that despite the mark of inspection printed on the packaging, these products were not produced under USDA inspection and are considered to be adulterated. FSIS continues to investigate the incident and is taking the necessary action to remove the products from commerce."

         

        Ch. 6 - JUDICIAL ACTIONS - Procedures for: Seizures; Injunctions; etc

        • Penalties (21 U.S.C. §333) -- first violation - imprisoned for not more than one year or fined not more than $1,000, or both; subsequent violation or committed with intent to defraud or mislead - imprisoned for not more than three years or fined not more than $10,000, or both.
        • Seizure (21 U.S.C. §334)
          • "The [FDA files in court] a Complaint for Forfeiture [requesting] a warrant for arrest, [that is, a court order] directing the United States Marshal to seize (take possession or [control]) the article. The theory in a Complaint for Forfeiture is that the article seized is the defendant, and [the legal action is against the article, not against a person or business. However, any] interested party, owner, or agent may appear to claim the article by filing a verified claim stating the nature of his/her interest in the article."

        "FDA Seizes Adulterated Crabmeat in Louisiana - July 7, 2004 - At the request of the Food and Drug Administration (FDA), U.S. Marshals seized approximately 1,144 cases of Bernard's brand frozen crabmeat, while it was being held for sale at Southern Cold Storage Company, Baton Rouge, La, on July 2, 2004 because it was adulterated with an unapproved food additive, chloramphenicol.

        "The U.S. Marshals seized approximately 304 cases of pasteurized special white crabmeat; 200 cases of pasteurized special claw crabmeat; and 640 cases pasteurized jumbo lump crabmeat. Imported from China, the frozen crabmeat can be identified by lot number 1302 with the sell by date of January 18, 2007. The seized crabmeat has an estimated value of $86,944.

        "In accordance with the Federal Food, Drug and Cosmetic Act, food products that contain chloramphenicol are adulterated and are not permitted to be sold in or imported into this country. "

        • Also see Chapter 6 for discussion of 1) the firm's responses, 2) disposal, 3) consent decree, 4) bond, and 5) reconditioning.
          • FDA pursues a court order requiring the business to not distribute product that is in violation of the law and to correct the underlying problem, such as manufacturing or storing product in conditions that may result in contamination.
          • "An injunction is a civil process initiated to stop or prevent violation of the law, such as, to halt the flow of violative products in interstate commerce, and to correct the conditions that caused the violation to occur. It is not mandatory to demonstrate that the law has been violated to seek an injunction, only that there is likelihood that it may be violated if an injunction is not entered."
          • See http://www.cfsan.fda.gov/~comm/cdfish.html
        • FDA prefers that the firm voluntarily complies by correcting the situation (even recalling product), rather than forcing FDA to pursue judicial action. For example, see 9 CFR §7.40.

        .

          Judicial Review of Agency Action

          Is there a limit to what an inspector can do?  Can a business appeal an inspector’s determination?  Is there an administrative review process?  Is there a judicial review process?

          • For example, see 21 CFR Part 10; 10.25, 10.33, part 16, and 10.45
          • Talk to agency; request hearing; then commence lawsuit (appeal to the judicial system).  Cite a court case?

          .

          Role of state agencies

          Inspections, etc; whatever is authorized by the state law.  Some (many?) states are able to conduct more inspections of food businesses than the FDA (due to staffing numbers relative to the number of food businesses).

          • State agencies may have more legal authority under their respective state law than a federal agency may have under federal law.  For example, state agencies may have more inspection authority under their state law than a federal agency has under federal law; or state agencies may more enforcement authority under their state law than a federal agency has under federal law.  To continue this second example, do not forget that most state laws require food businesses to be licensed (there is no license required by federal law).  Could a state agency use the state-mandated license as a tool to control a food business (such as withdrawing the license to operate) more quickly than a federal agency can control a food business?
          • State agencies may monitor the effectiveness of the recall, for example, with FDA or USDA advising and auditing the recall process.

          State agencies collaborate with the federal agencies, such as FDA and CDC

          • For example, if a problem is recognized by the state, the state agency informs the FDA which then responds with its own inspection of the food business.

          CDC guide for local governments; see http://www.bt.cdc.gov/planning/pdf/cdcresponseguide.pdf

          .

          The Food Business' Responsibility to a Sickened Consumer

          This section considers the potential for a commodity producer, food processor or food preparer to be liable for injuries suffered by a consumer due to a food safety problem. The basic premise is that an injured consumer is entitled to be compensated by the entity that caused the injury. For example, If my product caused your injury, I am responsible for having to compensate you. This area of the law is generally referred to as product liability.

          Overview of product liability prepared by Legal Information Institute

          • Note the statements about negligence, strict liability, and breach of warranty of fitness.
            • The concepts of negligence and strict liability reflect tort law, whereas breach of warranty more closely aligns with contract law.
          • Introduce and distinguish between contract law and tort law.
            • Contract -- you and I have voluntarily established a legal relationship, such as we agreed that I will store your food in my warehouse and you will pay me a fee for my service. Or our agreement can be more implicit, for example, when you buy a bottle of food from my grocery store. If my service or my product is defective (e.g., the roof of my warehouse leaks which leads to damages to your food, or the bottle of food is defective and you become ill after eating the food), you can bring a legal action against me because I did not complete the agreement as we expected.
            • Tort -- I am responsible if my action injures you, such as losing control of the car I am driving and striking you as you walk on the sidewalk, or the food product is unsafe and you become ill after eating it.
            • In all of these situations, the law states that I have to compensate you for the damages I caused, whether it is your damaged food, your broken leg, or your illness due to eating the food you bought from me.
            • You are entitled to be compensated for the injuries or damages I caused, such as the income you lose because you are not able to work and the medical expenses you incur when you seek medical care after the accident or after you become ill.
          • See AM. UNITED LOGISTICS, INC. v. CATELLUS DEV. CORP.could not pursue $30 million tort claim for faulty warehouse that damaged food; instead had to pursue their claim on the basis of a breached contract (in which the parties had agreed damages would be capped at $1 million).

            Does this case help illustrate the distinction between contract law and tort law?

          North Dakota law defines product liability:

          • N.D.C.C. §28-01.3-01(2) [Product Liability action means] "any [lawsuit] brought against a manufacturer or seller of a product ... on account of personal injury, death, or property damage caused by or resulting from the manufacture, construction, design, formula, installation, preparation, assembly, testing, packaging, labeling, or sale of any product, or the failure to warn or protect against a danger or hazard in the use, misuse, or unintended use of any product, or the failure to provide proper instructions for the use of any product."

          Product Liability and Microbial Foodborne Illness at http://www.ers.usda.gov/publications/aer-agricultural-economic-report/aer799.aspx.

          • By Jean C. Buzby, Paul D. Frenzen, and Barbara Rasco.  ERS Agricultural Economic Report No. 799. 45 pp, April 2001. This report examines how product liability law treats personal injuries attributed to microbially contaminated foods. The risk of lawsuits stemming from microbial foodborne illness and the resulting court-awarded compensation may create economic incentives for firms to produce safer food. It is not known how many consumers seek compensation for damages from contaminated foods because information about complaints and legal claims involving foodborne illness is not readily accessible, especially for cases that are settled out of court. Reviewing the outcomes of 175 jury trials involving foodborne pathogens, the analysis identifies several factors that influence trial outcomes, while noting that the awards won by plaintiffs tend to be modest.
          • Food businesses are interested in minimizing the adverse consequences of having produced or sold a defective or unsafe product. This concern about public image may provide as much motivation for a food business to assure it has a safe product as is provided by regulatory standards.

          Consider the "Product Liability Lawsuits" materials included in the University of Florida publication at http://edis.ifas.ufl.edu/pdffiles/FS/FS10800.pdf (pages 78 and 79 of pdf file).

          • [Compensatory damages] -- a payment from the food manufactuter to the injured party that returns the injury party to the financial position it would have been in had the injury not occurred.
          • Punitive damages -- a payment from the food manufacturer to the injured party to teach the food manufacturer to not ignore product safety concerns that it was aware of. Punitive damages, if warranted, are generally imposed in additionl to compensatory damages

            Note the distinction between compensatory and punitive damages

          • Criminal proceedings -- government bringing an action against a food manufacturer for violating the law; could result in fines being paid to the government or imprisonment of responsible company officials.
            • Such as enforcement action brought by FDA.
          • Civil proceedings -- lawsuit brought by injured party against the food manufacturer seeking a payment to compensate the injured party.
            • Such as a lawsuit brought by an injured consumer.

            Note the distinction between criminal and civil proceedings.

            An unsafe product could lead to both a criminal proceeding brought by a regulatory agency and a civil proceeding brought by an injured consumer.

          • Negligence -- the product causes illness, injury or death because the manufacturer was careless (the business was not as careful as society expects a food manufacturer to be).
          • Strict liability -- business is responsible for damages regardless of how careful it may have been in manufacturing, storing, transporting and marketing the product.

            Note the distinction between strict liability and negligence. For example, even if a processor did everything possible to assure the safety of its product, if the law states that the firm will be strictly liable for its product, the firm will be responsible for its damages. By comparison, if the law states the firm is liable only if the firm was negligent in its activities, the firm would not be liable if it can prove that it did everything it could to assure the safety of the product.

          • Causation -- the legal system recognizes that the person or entity that caused the problem should bear that responsibility and the loss; establishing cause can be a complex issue; e.g., was the problem caused by it the manufacturer, or the shipper, or the retailer or the consumer?
            • North Dakota begins to address the issue of who is responsible for the injuries resulting from the product; for example, is the seller responsible (such as the grocery story) or is it the food processor?
              • An injured consumer may sue the seller but the seller can then shift the liability to the manufacturer.
                • N.D.C.C. §28-01.3-04 (1). In any products liability action ... against a seller of a product who did not manufacture the product, the seller shall [identify] ... the manufacturer of the product allegedly causing the personal injury, death, or damage to property.
                  • How does this relate to the concept of traceability
          • Class-action -- court proceeding that allows a group of injured persons to pursue a single legal action against a food manufacturer, rather than requiring each person to bring their own lawsuits; it benefits the manufacturer because it only needs to address one court case and it benefits the injured parties because they can pool their resources to bring one lawsuit rather than each one having to pay the cost of bringing a lawsuit.

          .

          Consider the following excerpt from United States Food Safety System PRECAUTION IN U.S. FOOD SAFETY DECISIONMAKING: Annex II to the United States' National Food Safety System Paper -- link is not working

          A.2. Producers' Responsibility for Caution

          This report focuses upon the role of the U.S. regulatory system in assuring food safety. However, the success of this system can be understood only if one first grasps the legal duty of sellers of products in the United States, a legal duty enforceable by injured consumers under contract and tort law under the law of the states, and reinforced by transparency and publicity. [emphasis added]

          ...

          At the foundation of the U.S. food safety system is the responsibility of food processors to exercise caution in marketing their products. Food processors are allowed to offer consumers only food that is safe. They may be held "strictly liable" if they fail to carry out their duty. "Strict liability" means that a processor who sells a food that causes injury to a consumer may be legally responsible even in the absence of actual knowledge of the product's hazard. The legal responsibility includes both the possibility of a private lawsuit by any injured consumers and the possibility of regulatory actions. Also, processors must have a reasonable basis for believing their products to be safe; they cannot simply assume this is so. Factors in the caution exercised by producers are discussed in more detail at the end of the outline, in paragraphs 201-205.

          In sum, the fundamental U.S. legal system genrally places upon processors a duty of care to the public. On top of this fundamental legal system is strong regulatory infrastructure, administered by scientific food safety regulatory agencies at the Federal and State level.

          .

          See EATERIES, INC. v. J. R. SIMPLOT CO.

          "Eateries is the sole shareholder of Fiesta. Fiesta owns and operates several Garcia's Mexican Restaurants. Eateries and Fiesta contracted with Simplot for Simplot to provide the Garcia's restaurants with chile rellenos. Simplot delivered the chile rellenos but some of them were contaminated with salmonella. Customers at four Garcia's locations became sick after eating the contaminated chile rellenos. Newspaper and television stations provided extensive coverage of the salmonella contamination.

          "Seeking to recover the damage they incurred as a result of the salmonella contamination, Eateries and Fiesta filed suit in Oklahoma state court alleging breach of contract and breach of express and implied warranties."

           

          Does traceability complicate or clarify the issue of product liability? Why?

            • Does it help our understanding if the purpose of traceability is described as "to identify the source of the problem; not the source of the product?"
            • What impact will technology have on being able to identify the source of a food safety problem?
            • Does documentation of a food business' activities help the firm prove that it was not the source of a problem that occurred in food that the firm handled?  Restated, documentation will be a defense for a firm that properly handles its product and documents its activities.

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            Summary of Key Points

            Government regulation is one motivator for the food industry. Loss of customers due to a reputation of not providing a safe product is another motivator.  A third motivator is the responsibility of having to compensate an injured consumer. Collectively, these three motivators provide incentive for the food industry to pursue practices that reduce the risk of unsafe food.

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            Email David.Saxowsky@ndsu.edu

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