Under the Food Safety Modernization Act (FSMA), employers who manufacture, process, pack, transport, distribute, receive, hold, or import food are prohibited from discharging or “discriminat[ing] against any employee with respect to his or her compensation, terms, conditions, or other privileges of employment” for raising food safety concerns. 21 U.S.C. § 399d(a)(1)–(4). On April 18, 2016, the Occupational Safety and Health Administration (OSHA) published its “Final Rule,” titled Procedures for Handling Retaliation Complaints Under Section 402 of the U.S. Food and Drug Administration Food Safety Modernization Act. 29 C.F.R. § 1987, et seq.
In this rule, OSHA lays out an ambitious plan to resolve FSMA whistleblower complaints. Employees must file their FSMA complaints within 180 days of the alleged retaliatory activity. Following receipt of the complaint and follow-up interviews, OSHA is required to engage in a “gatekeeping function” and to dismiss complaints where the employee has not alleged that (1) the employee participated in protected activity under FSMA; (2) the employer either knew of or suspected the existence of protected activity; (3) the employee suffered an adverse action; and (4) the protected activity was a contributing factor in the adverse action. 29 CFR § 1987.104(e)(2). If OSHA fails to issue a final decision within 210 days of receiving a complaint, an employee may sue in a U.S. District Court. § 1987.114(a)(2). An employee may also file suit within 90 days of an unfavorable written determination. § 1987.114(a)(1).
As more FSMA Final Rules go into effect, the number of whistleblower complaints is likely to increase. Since FSMA’s enactment, the number of FSMA whistleblower complaints filed with OSHA has increased each year. In 2011, 17 whistleblower complaints were brought under FSMA. In 2016, that number had ballooned to 66. Due to the increasing volume of whistleblower complaints relative to OSHA’s resources, it is likely that more and more FSMA whistleblower claims will be brought in federal court as OSHA’s 210-day limit expires.
On June 6, 2013, the first FSMA whistleblower complaint was filed in federal court. Chase v. Brothers Int’l Food Corp., Case No. 6:13-cv-06297 (W.D.N.Y.). Colin Chase sued Brothers International Food for allegedly terminating him after raising “safety and health concerns” regarding the re-dating and sale of expired food products, including foods marketed to toddlers. Mr. Chase also claimed he was fired for raising questions about potential bacterial contamination during the rehydration of apple crisps. The parties entered a stipulation and order of dismissal on August 9, 2016. The terms of any settlement were not disclosed.
On February 9, 2017, the second FSMA whistleblower complaint was filed in the Northern District of Illinois against Mead Johnson Nutrition Company. (Case No. 17-cv-01046). Linda O’Risky, the former Global Product Compliance Director for Mead Johnson, alleges she was fired after she “began raising and escalating concerns about serious safety issues related to defects in the manufacture of Mead Johnson’s ready-to-use infant formula.” According to the lawsuit, Ms. O’Risky learned that Mead Johnson planned to reject more than 1 million units of formula due to leaking seals. Combined with what she claims were an increased number of consumer complaints about spoiled product, Ms. O’Risky became concerned that there was a larger systemic problem. She alleges that after speaking up, she was excluded from relevant meetings and eventually terminated.
Ms. O’Risky originally filed her claim with OSHA, which failed to issue a timely decision. Mead Johnson’s response to the complaint is due April 17, 2017, but it has publicly denied Ms. O’Risky’s allegations. In a statement to the Chicago Tribune, a Mead Johnson representative said, “The company’s main focus is—and has been for more than a century—the quality and safety of our products . . . The packaging matter cited in the suit was thoroughly reviewed by the U.S. Food and Drug Administration, and no action was required.”
In addition to increased litigation, a surge in FSMA whistleblower actions has other implications for the food industry. Whistleblower information will likely be shared with the FDA. This could lead to more FDA inspections and enforcement actions. Companies must keep in mind this new category of business risk and ensure that their internal procedures and training programs are updated appropriately.