The Occupational Safety and Health Administration (OSHA) has published an interim final rule implementing the whistleblower provision of the Food Safety Modernization Act (FSMA or the "Act"). The interim final rule became effective Thursday, February 13, 2014. Comments on the rule are due by April 14, 2014.

In 2010, the FSMA amended the Federal Food, Drug and Cosmetic Act to protect whistleblowers from retaliation when they engage in protected activity. The Act defines whistleblowers to include current and former employees, individuals applying for work, and any individual "whose employment could be affected by a covered entity." The statue applies to any entity that engages in the manufacture, processing, packing, transporting, distribution, reception, holding or importation of food. Food, as defined in the Food, Drug and Cosmetic Act, includes food or drink for man or animal, confectionary, condiments, and articles used for components of any such articles.

Under the FSMA and the new implementing regulations, whistleblowers are protected from retaliation when they provide, or are about to provide, to their employer, the Federal Government or a State attorney general, information relating to any act they reasonably believe violates the Food, Drug and Cosmetic Act. They are also protected if they testify, assist or participate in proceedings concerning such violations or if they object to or refuse to participate in an activity they reasonably believe is a violation. Whistleblowers are protected even if they are acting in the normal course of their duties and even if another person is acting pursuant to their request.

Consistent with other whistleblower statutes administered by OSHA, the FSMA requires that the whistleblower have a "reasonable belief" that a violation of the Food, Drug, and Cosmetic Act will occur, is occurring or has occurred. A reasonable belief requires both a subjective, good faith belief and an objectively reasonable belief that the complained of conduct constitutes a violation. The whistleblower need not show that the conduct complained of was, in fact, a violation of law. A whistleblower is protected if he has a reasonable, but mistaken, belief that a violation occurred.

Under the statute, complaints must be filed with OSHA within 180 days of the alleged retaliation. The regulations specify that the complaint may be filed orally or in writing, in any language. Once the complaint is filed, the FSMA requires the Assistant Secretary to determine if the complaint states a prima facie allegation that a protected activity was a contributing factor in the adverse action alleged in the complaint. This means the whistleblower need only show that the protected activity, alone or in combination with other factors, affected in some way the outcome of the employer's decision. The regulations note that the Assistant Secretary may supplement the complaint through interviews of the whistleblower if necessary to make the required showing. If this showing is not made, an investigation will not be undertaken.

If a prima facie showing is made, the statute prevents OSHA from initiating an investigation if the employer can show, to a reasonable certainty, that it would have taken the same action in the absence of the alleged protected activity. If the employer does not meet this burden, OSHA will undertake an investigation. Neither OSHA's decision to investigate, nor its decision to dismiss a complaint without investigation, are subject to review on appeal.

Within 60 days of the filing of the complaint, the Assistant Secretary must issue written findings as to whether there is reasonable cause to believe the employer committed the unlawful retaliation. If the Assistant Secretary finds reasonable cause to believe retaliation occurred, he or she can order various remedies on a preliminary basis: the Assistant Secretary can require the employer to take affirmative action to abate the violation, require the employer to reinstate the whistleblower, order back pay and/or compensatory damages, and require the employer to pay the whistleblower's attorneys' fees and expert witness fees. The statute allows the whistleblower to file a de novo action in district court if the Assistant Secretary issues written findings against him.

Pursuant to the statute and regulations, both sides have 30 days to file objections to the Assistant Secretary's preliminary findings and request a hearing before an Administrative Law Judge (ALJ). Filing objections will stay any remedy in the preliminary order other than preliminary reinstatement. A stay of preliminary reinstatement will be granted only in exceptional circumstances. If timely objections are not filed, the Assistant Secretary's findings become final and will not be subject to judicial review.

OSHA's new rule specifies that a de novo hearing on objections will be held before an ALJ. The whistleblower must show by a preponderance of the evidence that protected activity was a contributing factor in the challenged adverse employment action. The employer will prevail if it can show, to a reasonable certainty, that it would have taken the same adverse action in the absence of any protected activity. If the ALJ finds in favor of the whistleblower, it may order the same remedies discussed above. A decision requiring reinstatement or lifting an order of reinstatement is effective immediately. All other relief will be effective 14 days after the date of decision unless an appeal is filed with the Administrative Review Board (ARB). If no appeal is filed, the ALJ's decision becomes final and is not subject to judicial review.

Under the regulations, an appeal to the ARB must be made within 14 days of the ALJ's decision. The ARB has discretion in deciding whether to hear the appeal. If ARB decides to hear the appeal, the ALJ's decision is stayed, except for any order requiring reinstatement. Once again, if the ARB finds for the whistleblower, it may issue the same remedies discussed above. By statute, either party may appeal the final order of the ARB, or the ALJ if the ARB elects not to hear the appeal, to the Court of Appeals within 60 days of the date the final order is issued.

In certain circumstances, if OSHA does not act within the prescribed time limits, the FSMA allows the whistleblower to seek de novo review of his complaint in district court. The case will be tried by jury at the request of either party. The same burdens of proof and remedies discussed above will apply to the district court proceeding.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.