Procedures for Handling Retaliation Complaints Under Section 402 of the FDA Food Safety Modernization Act

This document provides the final text of regulations governing the employee protection (retaliation or whistleblower) provision found at section 402 of the FDA Food Safety Modernization Act (FSMA), which added section 1012 to the Federal Food, Drug, and Cosmetic Act. An interim final rule governing these provisions and requesting public comment was published in the Federal Register on February 13, 2014. Two comments were received that were responsive to the rule. This rule responds to those comments and establishes the final procedures and time frames for the handling of retaliation complaints under FSMA, including procedures and time frames for employee complaints to the Occupational Safety and Health Administration (OSHA), investigations by OSHA, appeals of OSHA determinations to an administrative law judge (ALJ) for a hearing de novo, hearings by ALJs, review of ALJ decisions by the Administrative Review Board (ARB) (acting on behalf of the Secretary of Labor), and judicial review of the Secretary's final decision.