By James L. Curtis, Meagan Newman, and Craig B. Simonsen

OSHA just published its Procedures for Handling Retaliation Complaints Under Section 402 of the U.S. Food and Drug Administration (FDA) Food Safety Modernization Act. 79 Fed. Reg. 8619 (February 13, 2014).

The interim final regulations relate to the whistleblower provisions found at section 402 of the FDA Food Safety Modernization Act (FSMA), which added section 1012 to the Federal Food, Drug, and Cosmetic Act (FD&CA). See 21 U.S.C. 399d. Although the FDA generally administers the FD&CA, the Secretary of Labor is responsible for enforcing the employee protection provision set forth in section 1012 of the FD&CA.

Section 402 of the FSMA provides protection from retaliation to employees engaged in manufacturing, processing, packing, transporting, distribution, reception, holding, or importation of food “who engage in protected activities under FSMA.” Pursuant to the statute, the procedures include remedies and legal burdens of proof provisions, and a “kick-out” provision allowing the complainant to file a complaint in District Court within ninety days after receiving a written determination from OSHA, or if the Secretary has not issued a final determination within 210 days after the filing of the complaint.

The rule establishes procedures and time frames for the handling of retaliation complaints, including procedures and time frames for employee complaints to 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, and judicial review of the Secretary of Labor’s final decision.

The interim rule is effective on February 13, 2014, with comments submitted to Docket No. OSHA–2011–0859 due by April 14, 2014.