You thought FDA was the only agency implementing the Food Safety Modernization Act (FSMA), well think again. The Occupational Safety and Health Administration (OSHA) promulgated a final rule that defines whistleblower protections for employees that disclose information about alleged food safety issues in violation of the Federal Food Drug and Cosmetic Act (FDCA).
FSMA § 402 amended the FDCA by adding Section 1012, which protects employees who disclose information about a possible violation of the FDCA from retaliation by employers that manufacture, process, pack, transport, distribute, receive, hold or import food. Although FDA generally administers the FDCA, Congress specifically makes the Secretary of Labor (“Secretary”) responsible for enforcing the employee protection provision set forth in FDCA § 1012. In addition to establishing protections, the Final Rule provides procedures for the handling of such whistleblower complaints.
The Final Rule protects employees of covered entities from retaliation for:
- Providing information relating to any violation of the FDCA or any act that he or she reasonably believed to be a violation of the FDCA to:
- the employer,
- the Federal Government, or
- the attorney general of a state
- Testifying, assisting, or participating in a proceeding concerning a violation of the FDCA; or
- Objecting to or refusing to participate in any activity that he or she reasonably believed to be in violation of the FDCA.
Employees who believe they have been retaliated against in violation of FSMA may file a complaint with OSHA. OSHA further published a fact sheet for workers that defines retaliation and provides instructions on how to file a FSMA complaint (which must be filed 180 days after the alleged retaliatory action).
The Final Rule provides further granular procedural requirements for the burden of proof; timeframes to respond, submit written statements and evidence, and request meetings with OSHA; the agency’s timeframe for an initial decision and proposed order, and requirements to litigate the case before an Administrative Law Judge and for further appeals. If it is determined that the employee was subject to retaliation, the employee may be entitled to a variety of remedies, including reinstatement, back pay and damages for emotional distress and damage to their reputations.
OSHA’s Final Rule does not contain the typical specific FSMA implementation requirements, but this does not mean that industry should not act. Those in the FDA-regulated food industry should review anti-retaliatory policies and ensure employees are trained to comply with the Final Rule. When considering adverse action against an employee, at a minimum, the employer should first determine whether such employee has provided information or made complaints about violations, and/or contact counsel before proceeding.