Scope of Regulations
The Food Safety Regulations will require food facilities (i.e., a facility engaged in the manufacturing, processing, packing, or distribution of food) to implement a written plan that:
- Evaluates hazards that can affect food manufactured, processed, packaged, or held by the facility.
- Implements preventive controls to significantly minimize hazards and assure that food is not adulterated.
- Monitors the performance of those controls and maintains records of this monitoring.
- Establishes procedures to ensure that if the preventive controls are not properly implemented or are not effective, action will be taken to prevent recurrence, and that all affected food is evaluated for safety and prevented from entering commerce if the facility cannot ensure that the food is not adulterated.
The written plan must be reanalyzed every three years and whenever there is significant change in the facility's activities.
The Food Safety Regulations will apply to all but the smallest food companies at virtually every level of the supply chain. Retail, restaurants, and many farming operations are exempt, except that retailers' and farms' holding, storage, and distribution facilities will be required to comply.
Congress imposed a 180-day deadline for FDA to enact the Food Safety Regulations. That deadline passed on July 4, 2012. FDA, however, has submitted a draft of the Food Safety Regulations to the Office of Management & Budget for review, having previously held numerous public meetings to gather a wide variety of input from industry and consumer groups.
Although the Food Safety Regulations' specific requirements are not yet known, their impact will be significant. For the first time, there will be uniform safety standards for food manufacturing, processing, packaging, and storage. In the past, some courts have refused to let juries decide the question of negligence in food-contamination cases on the basis that neither FDA nor the industry has established routine inspection or testing procedures. See e.g., In re Shigellosis Litigation, 674 N.W.2d 1, 9-10 (Minn. App. 2002). The Food Safety Regulations are likely to become the minimum standard of care to which food companies are held in negligence cases, as well as a factor in determining whether a food product is defective under all product- liability legal theories.
Standards for Liability
A commonly used standard in food cases is that the plaintiff must prove that the food contained a deleterious substance (i.e., it was defective), that the plaintiff consumed the substance, and that the plaintiff suffered injury as a result of consumption. See e.g., Ard v. Kraft, Inc., 540 So.2d 1172, 1174 (La. App. 1989). In negligence cases, the plaintiff must establish that the food company's conduct fell below the applicable standard of care.
Plaintiffs will benefit from the FDA regulations more than food-company defendants because, in most states, noncompliance is often sufficient to establish a defect or negligence per se,or at least a presumption of defect or negligence. Food companies, on the other hand, may only use compliance with the regulations as one piece of evidence to argue that their products are not defective and/or that they are not negligent. This approach is found in the common law, § 288C of the Restatement (Second) of Torts ("Restatement 2d") and § 4 of the Restatement (Third) of Torts: Products Liability ("Restatement 3d"), although the latter has been expressly adopted in only a small minority of states. A handful of states have enacted statutes stating that regulatory compliance creates a rebuttable presumption that the product at issue is not defective and/or that the company was not negligent.
In all states, however, compliance or noncompliance with the Food Safety Regulations is a relevant evidentiary consideration. Thus, compliance or noncompliance has the potential to become a major issue in product-liability lawsuits that allege damages as a result of contaminated food.
The Majority Rule Regarding Regulatory Compliance
Noncompliance as Determinative of Defect and Negligence Questions
The common law of several states provides that noncompliance with an applicable safety regulation amounts to negligence per se where the regulation was enacted to protect a class of persons, which includes the plaintiff, from injuries of the type he or she suffered. See e.g., Allen v. Delchamps, Inc., 624 So.2d 1065, 1067-68 (Ala. 1993). (The Federal Food Drug and Cosmetic Act can be used to establish a duty or standard of care.) Some states have taken a similar approach by imposing a rule that noncompliance with an applicable regulation creates a rebuttable presumption of negligence that may be rebutted only by evidence establishing a justification for the noncompliance. See e.g., Ramirez v. Plough, Inc., 863 P.2d 167, 172 (Cal. 1994). Section 4 of the Restatement 3d provides that a product's noncompliance with an applicable safety statute or administrative regulation renders the product defective with respect to the risks sought to be reduced by the statute or regulation.
The Food Safety Regulations will seek to protect consumers from the exact type of injury alleged in food product liability cases—namely, illnesses and deaths that food-contamination can cause. Therefore, noncompliance will be all-but-conclusive evidence of negligence and defect against a food-company defendant in most states. Of course, plaintiffs still need to establish causation in order to prevail.
Compliance as a Non-Conclusive Consideration of Defect and Negligence
Courts often cite to the Restatement 2d and, to a lesser degree, the Restatement 3d to address the effect that compliance with an applicable safety regulation has on whether a product was defective or whether the defendant was negligent. Restatement 2d § 288C provides that compliance does not prevent a finding of negligence where a reasonable person would have take additional precautions. Restatement 3d § 4 provides that a product's compliance with applicable safety regulations is a relevant consideration when determining whether the product is defective, but compliance does not preclude, as a matter of law, a finding that the product was defective. Both provisions reflect, in varying degrees, the traditional view that government regulations establish only the minimum requirements. See e.g., Cartwright v. Pfizer, Inc., 369 F.Supp.2d 879, 882 (5th Cir. 2005) ("FDA regulations are generally minimal standards of conduct."); O'Gilvie v. International Playtex, Inc., 821 F.2d 1438, 1443 (10th Cir. 1987) (Plaintiff "presented ample evidence that mere compliance with FDA standards was not adequate under the circumstances.").
Some states have adopted similar approaches through legislation. In Arkansas, for example, compliance with regulatory standards shall be considered evidence that the product was not defective. See Ark. Code. § 16-116-105(a). Regardless of whether the rule is established through case law, express adoption of the Restatement 2d or 3d, or through legislation, the majority of jurisdictions provide that regulatory compliance is just one relevant, non-dispositive consideration regarding the existence of a defect or negligent conduct.
Although regulatory compliance is not a complete defense, many courts have applied Restatement 2d § 288C, Comment a, to rule that regulatory compliance can be considered due care or establish the lack of a defect absent special circumstances requiring extra caution. See e.g. Beatty v. Trailmaster Products, Inc., 525 A.2d 1005, 743-44 (Md. App. 1993). An Arizona appellate court took this even further to rule that regulatory compliance can be used as evidence to show improbability of a defect. Brown v. General Foods Corp., 573P.2d 930, 934 (Az. App. 1978). Federal and state courts in Texas have ruled that compliance with safety standards is "strong and substantial" evidence that the product is not defective. Lorenz v. Celotex Corp., 896 F.2d 148, 15–51 (5th Cir. 1990); Sims v. Washex Mach, Corp., 932 S.W.2d 559, 565 (Tex. App. 1995).
Under the majority rule, compliance with the Food Safety Regulations will be merely one consideration on the questions of negligence and defect. Some states will attach greater weight to food-company defendant's compliance. The FSMA, however, expressly provides that the Food Safety Regulations will be minimum standards only. 21 U.S.C. § 350g(n)(1)(A). This leaves food-company defendants vulnerable to attack for not taking additional, allegedly reasonable, protective measures, even in states where regulatory compliance is given greater deference.
The Rebuttable Presumption Approach
Several states, though a minority, have enacted statutes providing that regulatory compliance creates a rebuttable presumption that the product at issue was not defective and/or that the manufacturer or seller was not negligent. These states include Colorado, Indiana, Michigan, North Dakota, Tennessee, and Utah. Colorado's statute balances this with a comparable rebuttable presumption in favor of the plaintiff (i.e., a defect existed and/or the manufacturer or seller was negligent) in cases of noncompliance. Colo. Rev. Stat. § 13-21-403(2). The Kansas Products Liability Act combines this approach with Restatement 2d 288C by providing that regulatory compliance creates a rebuttable presumption, unless the plaintiff proves that a reasonably prudent manufacturer or seller could and would have taken additional precautions. See Duffee v. Murray Ohio Mfg., 879 F. Supp. 1078, 1084–85 (D. Kan. 1995) (applying Kan. Stat. 60-3304(a)).
These statues apply to all consumer products, not just foods. Still, food-company defendants sued in these states enjoy more protection than those sued in majority rule states. Nevertheless, plaintiffs still have the opportunity to prove that additional precautions were reasonable and necessary.
No Complete Defense for Regulatory Compliance
No state will allow compliance with the Food Safety Regulations to serve as a complete defense. Some states have enacted statutes providing a complete defense for compliance with design or warning regulations. These statutes, however, likely do not apply to regulations addressing testing, inspection, and hazard analysis measures requirements like those that will be covered in the Food Safety Regulations.
The new Food Safety Regulations will establish minimum preventative controls and hazard analysis standards for the manufacturing, processing, packaging, and storage operations for food companies at virtually all levels of the supply chain. In product-liability lawsuits alleging injury, illness, or death due to contaminated food, a company's compliance or noncompliance with these regulations could take on a critical role. Noncompliance could be fatal, virtually eliminating any defense that the food was not defective and/or that the company was not negligent.
Compliance with the Food Safety Regulations will help a food-company defendant establish that its food product is not defective and that the company was not negligent. However, this will be just one factor to consider. States vary in the amount of deference they will give for compliance. In no event, however, will compliance serve as a complete defense. Plaintiffs will have the opportunity to prove that food-company defendants should have taken precautions above and beyond the minimum requirements stated in the Food Safety Regulations.
The lesson for the food industry is that noncompliance with the Food Safety Regulations can be fatal. Compliance is helpful, but not dispositive.
Keywords: litigation, products liability, Food Safety Regulations, compliance, noncompliance, Food Safety and Modernization Act