Strike Out! FSMA Whistleblowers Bat Zero in FY11/12

By Will Woodlee, Contributing Editor

As vendors begin hawking peanuts in baseball stadiums across America this week, implementation of the Food Safety Modernization Act (FSMA) has stretched into its third spring. Due to FDAs well-publicized delays in issuing required regulations, many of the laws most demanding requirements have yet to take effect or be enforced. These delays make it difficult to assess the larger impacts of FSMA, which was widely viewed as the first major overhaul of the U.S. food safety laws in more than 70 years.

However, some self-executing FSMA provisions have been in effect long enough that there are initial data to review. These include the "employee protection" provisions added by section 402. Based on the early data, so-called "whistleblowers" have not fared well under the new law. Specifically, U.S. Department of Labor (DOL) statistics indicate that workers who have complained of retaliation for exposing potential food safety issues have struggled mightily to vindicate themselves via a formal determination from the agency. Precisely what these data mean is less clear.

As amended by FSMA, the Federal Food, Drug, and Cosmetic Act (FDCA) now prohibits a food industry employer from discharging or otherwise discriminating against an employee in retaliation for engaging in certain protected activities. These include reporting information about an act or omission that raises an FDCA compliance issue to the employer, the federal government or a state attorney general. Notably, such a report need not correctly identify conduct as a violation in order to qualify the communication as protected." Rather, an employee must have only an objectively reasonable belief that an act or omission violated a provision of the FDCA or any order, rule, regulation, standard or ban issued by FDA. (As a technical matter, the law does not require that the communication relate to a food safety issue. The law would protect, for example, a report about a misleading statement on a food label.)

FSMAs whistleblower protection provisions set forth extensive procedures for the investigation of discrimination complaints by, and litigation of controversies before, DOL. A case begins when a worker files her complaint with the Occupational Safety and Health Administration (OSHA), which is tasked with investigating and making an initial determination on the merits of the complaint. An aggrieved employer or complainant may contest an OSHA determination and seek a de novo hearing before DOLs Office of Administrative Law Judges with opportunities for further administrative appeal and judicial review.

After the close of the governments fiscal year, DOL releases statistics on the various whistleblower protection programs that OSHA administers. During fiscal years 2011 and 2012 (the two fiscal years for which DOL has released data), OSHA received a total of 38 complaints filed under the FSMA provisions. Not one of these cases resulted in a finding that the workers whistleblower complaint had merit, though a number resulted in a settlement or withdrawn complaint. While some complainants have appealed OSHAs no-merit findings, DOLs Office of Administrative Law Judges thus far has not reversed any of these rulings on appeal. It also does not appear that any complainant has successfully appealed an unfavorable ruling from an administrative law judge.

For context, it bears mentioning that, according to recent OSHA statistics, success rates across the various whistleblower protection programs are generally quite low. Nevertheless, no program could have a lower rate than the FSMA programs zero-percent yield. But what should we make of it?

Some might argue the zero-percent rate reflects how FSMA has underscored the importance of addressing food safety issues and that the whistleblower protection provisions have had their intended deterrent effect on employers. They might also assert that workers with even arguably meritorious complaints have settled with employers, which serves the purposes of the program and leaves only frivolous cases to be dismissed or withdrawn. Others could argue that the rate demonstrates how the FSMA whistleblower protection program provides a solution to a problem that never existed. Still others may view the data as indicting the system and highlighting the obstacles faced by brave whistleblowers.

Given the small data set and paucity of dismissals that have received appellate review to date, it is too early to make definitive conclusions about the FSMA whistleblower provisions impact. Like so many well meaning FSMA provisions, especially those FDA has yet to implement, section 402 likely has not thus far had the impact Congress intended. As the agency has no role in the FSMA whistleblower program, however, FDA should not be assessed an error in this particular case.

Will Woodlee is an associate at the law firm of Kleinfeld, Kaplan & Becker LLP. His practice focuses primarily on counseling and advocating on behalf of food, cosmetic, pharmaceutical, medical device, dietary supplement, and tobacco companies on matters involving FDA law, USDA law, and related federal and state laws. Prior to joining the firm, he clerked for two administrative law judges at the United Stated Department of Labor.