United States: Protecting Food Industry Whistleblowers: FDA, OSHA Team Up Under FSMA

In 2011, when the Food Safety Modernization Act was passed, it sought to revamp food safety in the United States. Since then, the Food and Drug Administration (FDA) has been hard at work passing regulations to implement the FSMA's statutory requirements. To date, these have included revamping the current Good Manufacturing Practices (cGMPs), Hazard Analysis and Risk-Based Preventive Controls (HARPC) for human and animal food, and creating new rules for the Sanitary Transport of Food, and Produce Safety, while also establishing the Foreign Suppler Verification Program and Verified Quality Importer Program. These have been entirely FDA-led and controlled regulatory programs. In April 2016, however, the Occupational Safety and Health Administration (OSHA) finalized its Rule implementing the FSMA's new whistleblower safe harbor provision.

Whistleblower protection provisions are not new to OSHA, which oversees several such provisions as they relate to other administrative agencies. Including the FDA, OSHA's Whistleblower Protection Program enforces the whistleblower provisions of more than 20 whistleblower statutes protecting employees who report violations of various workplace safety and health, airline, commercial motor carrier, consumer product, environmental, financial reform, food safety, health insurance reform, motor vehicle safety, nuclear, pipeline, public transportation agency, railroad, maritime, and securities laws. Rights afforded by these whistleblower protection laws include, but are not limited to, worker participation in safety and health activities, reporting a work-related injury, illness or fatality, or reporting a violation of the statutes therein.

The basis for the new Rule is found in Section 402 of FSMA, codified at 21 U.S.C. § 399d, and applies to any "entity engaged in the manufacture, processing, packing, transporting, distribution, reception, holding, or importation of food." 21 U.S.C. § 399d(a).

The New Rule

On April 18, 2016, OSHA published the Final Rule establishing "Procedures for Handling Retaliation Complaints Under Section 402 of the Food Safety Modernization Act." The purpose of this new Rule, codified in 29 C.F.R. § 1987, is to provide protection for an employee from retaliation because the employee has engaged in "protected activity" pertaining to a violation or alleged violation of the Food, Drug and Cosmetics Act (FDCA). These protected activities, while not explicitly defined by the new Rule, include:

  • Provided, caused to be provided, is about to provide, or cause to be provided to the employer, the federal government, or another state actor, information relating to any violation, or any act or omission the employee reasonably believes to be a violation of the FDCA, or any rule, regulation, standard or ban under the FDCA;
  • Testifying or about to testify in a proceeding concerning an FDCA violation;
  • Assisted or participated or is about to assist or participate in such a proceeding;
  • Objected to or refused to participate in any activity, policy, practice, or assigned task that the employee (or other such person) reasonably believed to be in violation of the FDCA or any rule, order, regulation, standard or ban under the FDCA.

(See 29 C.F.R. § 1987(b); also 21 U.S.C. § 399d(a)(1)-(4).) This means that an employer can take no actions against an employee who participates in identifying a company's participation in activities that the employee "reasonably believes" violate the FDCA. In the Final Rule, OSHA describes the "reasonable belief" standard applied by the new regulations, and explains it is a standard it has successfully applied in other areas, including whistleblower protections under the Sarbanes-Oxley Act. According to OSHA's comments on the new Rule, in order to fulfill this standard, the employee must have a "subjective, good faith belief and an objectively reasonable belief" that his employer's conduct violated the FDCA, or any rule, order, regulation, standard or ban under the FDCA. (Citing to Sylvester v. Parrexel Int'l LLC, ARB No. 07-123, 2011 WL 2165854, at *11-12 (ARB May 25, 2011), discussing the reasonable belief standard under Sarbanes-Oxley Act whistleblower protections.) It is important to note that this standard is based on the "knowledge available to a reasonable person in the same factual circumstances with the same training and experience" as the employee at issue. Id. What this means is that the employee does not have to be correct. Instead, actions taken by an employee that are based on a reasonable – even if mistaken – belief that a violation of the law has occurred are protected.

Implications for employers

For employers in the food industry, which, under FSMA, and later HARPC and cGMP regulations, includes an increasing number of entities, this means that if an employee takes actions as described above regarding company conduct as it relates to food safety and compliance with FDA regulations, the company may not retaliate against the employee for his actions. Retaliation may come in many forms, but under the new regulations, the company may not:

discharge or otherwise retaliate against, including, but not limited to, intimidating, threatening, restraining, coercing, blacklisting or disciplining, any employee with respect to the employee's compensation, terms, conditions, or privileges of employment because the employee, whether at the employee's initiative or in the ordinary course of the employee's duties (or any person acting pursuant to a request of the employee), has engaged in any of the activities specified in paragraphs (b)(1) through (4) of this section.

(29 C.F.R. §1987.02(a).) If an employee participates in one of the protected activities described above and his employer undertakes one of the retaliatory actions in §1987.02(a), the employee is presented with the opportunity to file a Retaliation Complaint with OSHA within 180 days of the retaliatory employer action. This complaint is not like a legal complaint before a court, and does not have to meet federal pleading requirements. Instead, the complaint serves as a method of alerting OSHA to the existence of the alleged retaliation and the employee's desire that OSHA investigate the matter. Once received, OSHA will alert the employer of the receipt of the complaint.

If the complaint "alleges the existence of facts and evidence to make a prima facie showing" that retaliation for protected activities occurred, OSHA will initiate an investigation of the matter. Such an investigation must include facts which focus on whether:

  • The employee engaged in protected activity;
  • The employer knew or suspected that the employee engaged in the protected activity;
  • The employer undertook an adverse action against the employee; and
  • The circumstances were sufficient to raise the inference that the protected activity was a contributing factor for the adverse action.

Copies of all materials can be provided to all parties. The employer is allowed the opportunity to show that the alleged retaliatory actions were not related to the protected activities (and the protected activity did not contribute to the alleged retaliatory actions). If, during the course of the investigation, OSHA discovers, or the employer shows, via clear and convincing evidence that the employer would have taken the same actions in the absence of the protected activities, the complaint must be dismissed under 21 C.F.R. § 1987.104(e)(4). This is a much higher standard than that which is applied to the employee and places the burden of proof squarely on the shoulders of the employer.

Once the investigation has been completed, OSHA will release a report detailing its findings and issuing preliminary orders to award damages where appropriate. If the complaint was found to have been frivolous, OSHA can award up to $1,000 to the employer for attorney's fees. OSHA and the Assistant Secretary assigned to the matter may award the employee a wide range of relief. This includes reinstatement to the employee's position, affirmative actions to abate the violation, back pay with interest and compensatory damages. OSHA may also award to the employee the same pay and benefits that he would have received prior to termination from his job, but not actually require that he go back to work.

Either party may file objections to this report and its orders within 60 days of its issuance and request a hearing before an administrative law judge (ALJ), wherein the matter will be reviewed de novo. The ALJ's decision may also be appealed to an administrative review board. However, in both cases the ALJ and ARB have a limited time to deal with the matter, and if that time elapses, the matter may be brought before an appropriate U.S. District Court.

Ultimately, OSHA views 21 U.S.C. § 399d as analogous to similar whistleblower legislation and regulation used by many other administrative agencies. While the companies subject to the new rule might have some exposure to these protections in other circumstances, this is the first time that an employee receives such protection for issues arising out of food safety. This protection is one more way that the FDA, using FSMA, is strengthening the legal protections for the U.S. food supply.

At Thompson Coburn, our life sciences and food and agribusiness practices work together to represent food, food additive and dietary supplement clients to help them understand all of the new regulations affecting the day-to-day operations of the food industry. We have extensive experience in counseling our food clients not only on regulatory compliance and the development of the now-required HARPC plans, but on risks and liabilities that are now a reality under these new regulations. If you have any questions about the issues raised in this article, please feel free to contact us.

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.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

Authors
Similar Articles
Relevancy Powered by MondaqAI
 
In association with
Related Topics
 
Similar Articles
Relevancy Powered by MondaqAI
Related Articles
 
Related Video
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
Mondaq on Twitter
 
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
 
Email Address
Company Name
Password
Confirm Password
Position
Mondaq Topics -- Select your Interests
 Accounting
 Anti-trust
 Commercial
 Compliance
 Consumer
 Criminal
 Employment
 Energy
 Environment
 Family
 Finance
 Government
 Healthcare
 Immigration
 Insolvency
 Insurance
 International
 IP
 Law Performance
 Law Practice
 Litigation
 Media & IT
 Privacy
 Real Estate
 Strategy
 Tax
 Technology
 Transport
 Wealth Mgt
Regions
Africa
Asia
Asia Pacific
Australasia
Canada
Caribbean
Europe
European Union
Latin America
Middle East
U.K.
United States
Worldwide Updates
Registration (you must scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions

Mondaq.com (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of www.mondaq.com

To Use Mondaq.com you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.

Disclaimer

The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.

General

Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions