Another FSMA final rule was published last week: The Whistleblower Act (or more precisely: Procedures for Handling Retaliation Complaints Under Section 402 of the FDA Food Safety Modernization Act). If you didn’t realize this was part of FSMA, or are wondering how FDA will enforce it, you’re not alone. And, rest assured, it’s not another thing you have to write into your Food Safety Plan.

The act fulfills the employee protection provision of FSMA’s section 402, which added section 1012 to the Federal Food, Drug, and Cosmetic Act. Section 1012 became effective upon enactment on January 4, 2011, with the finalization of the rule providing the specifications of regulation. And, as the rule notes, although FDA “generally administers the FD&C, the Secretary of Labor is responsible for enforcing the employee protection provision set forth in section 1012 of the FD&C. Thus, it will be enforced by OSHA.

So what is required under this new FSMA rule?

The purpose of the rule is to provide protection to employees against retaliation by a food facility for:

• providing to their employer or federal or state government information on a violation of, or act or omission the employee reasonably believed to be a violation of the FD&C.

• testifying, assisting or participating in a proceeding concerning such violation.

• objecting to, or refusing to participate in, anything the employee reasonably believed to be in violation of the FD&C.

• If an employee believes a retaliation occurred, the process of the rule provides that:

• The employee can file a complaint with the Secretary of Labor within 180 days of the alleged retaliation.

• Upon receipt, the secretary is to provide written notice to those named in the complaint of the allegations, the substance of the evidence supporting the complaint, and the rights afforded the respondent.

• Within 60 days, the secretary is to provide the complainant and respondent an opportunity to submit a response and meet with the investigator to present statements from witnesses, and conduct an investigation.

• The secretary may conduct the investigation only if the complainant has made a prima facie showing that the protected activity was a contributing factor in the adverse action alleged in the complaint and the respondent has not demonstrated, through clear and convincing evidence, that it would have taken the same adverse action in the absence of that activity. (OSHA interprets the prima facie case requirement as allowing the complainant to meet this burden through the complaint as supplemented by interviews of the complainant.)

• After investigating a complaint, the secretary will issue written findings.

• If the secretary found reasonable cause to believe that retaliation occurred, the respondent is notified and a preliminary order is issued to the respondent to, where appropriate, take affirmative action to abate the violation; reinstate the complainant to his or her former position together with the compensation of that position (including back pay) and restore the terms, conditions, and privileges associated with his or her employment; and provide compensatory damages along with all costs and expenses reasonably incurred by the complainant.

• The complainant and the respondent then have 30 days to file objections and request a hearing before an administrative law judge at the Department of Labor. This stays any remedy in the preliminary order except for preliminary reinstatement. If a hearing is not requested within 30 days, the preliminary order becomes final and is not subject to judicial review.

• If a hearing is held, it must be conducted “expeditiously,” after which the secretary has 120 days to issue a final order. Up until a final order issuance, a settlement agreement may be made that terminates the proceeding.

• As appropriate, the secretary will then assess against the respondent a sum equal to the total amount of all costs and expenses, including attorney and expert witness fees, reasonably incurred by the complainant or may award a prevailing employer reasonable attorney fees, not exceeding $1,000, if the complaint is found to be frivolous or brought in bad faith.

• Within 60 days of the final order, any adversely affected or aggrieved person may file an appeal with the United States Court of Appeals.

The regulatory provisions were written to be consistent with other OSHA whistleblower regulations to the extent possible within the bounds of the statutory language of FSMA. Interestingly, the interim final rule that was published in February 2014 elicited only two comments. These resulted in only minor changes in the final rule, both of which were primarily clarifications, including a revision to clarify that OSHA will ensure that each party is provided with an opportunity to respond to the other party’s submissions.

My question on this regulation is: “Is this checking a box or is it a big deal?”  I am not sure I know the answer, but it is clear that food workers have a new level of protection if they decide to be whistleblowers. My sense is that this will not spawn a whole new set of whistleblowing activity. But, when one looks at the consequences from the PCA trial of the head of QA supposedly playing along to poor decisions, then maybe it will cause some to pause, and not play along, but rather blow the whistle with less fear of retribution than in the past.

About The Acheson Group (TAG)

Led by Former FDA Associate Commissioner for Foods Dr. David Acheson, TAG is a food safety consulting group that provides guidance and expertise worldwide for companies throughout the food supply chain. With in-depth industry knowledge combined with real-world experience, TAG's team of food safety experts help companies more effectively mitigate risk, improve operational efficiencies, and ensure regulatory and standards compliance. www.AchesonGroup.com