The Trump Administration or Whistleblowers: Which Might Have More Impact on FSMA Compliance?

Posted by TraceGains on February 22, 2017 at 4:58 PM

Trump or Whistleblowers?

For small businesses, defined by the FDA as a business that employs fewer than 500 persons, there are fewer than 200 days left to become compliant with FSMA’s Preventive Controls for Human/Animal Food rules (the actual compliance deadline is September 18, 2017).

Additionally, the next rule in line for implementation and compliance deadlines for businesses that do not meet the “small” or “very small” definition is the Sanitary Transportation rule (April 6, 2017), followed closely by the Foreign Supplier Verification Program rule (May 27, 2017).

But with the uncertainty around the new administration with regards to actual FSMA regulation, many are wondering if the looming deadlines still count, especially with the current hiring/regulatory freezes that have occurred in the past few of weeks.

To top it all off, one of President Donald Trump’s numerous executive orders calls upon agencies to cut two existing regulations for every new one between January 20 and September 30 of this year. The actual order reads:

“Sec. 2.  Regulatory Cap for Fiscal Year 2017.  (a)  Unless prohibited by law, whenever an executive department or agency (agency) publicly proposes for notice and comment or otherwise promulgates a new regulation, it shall identify at least two existing regulations to be repealed.”

Talk about confusing for the food and beverage industry!

It’s important to note, however, that this executive order and the freezes will have no impact on FSMA deadlines. And as we mentioned in our previous blog post (FSMA and the New Congress: What’s Likely and Unlikely to Happen), the likeliness of repealing a final rule—like the seven core rules of FSMA—is rare. So, yes, compliance and implementation deadlines are still a go.

Blowing the Whistle

The greatest vulnerability to non-compliance of FSMA may not be Trump’s executive orders, however, but rather disgruntled employees who are aware of the September 2017 deadline. These employees are now protected under the new FSMA whistleblower provision.

FSMA whistleblower protections extend to employees who uncover food safety problems at their workplace. This is the first time such protection has applied to food safety issues, per an analysis by the national law firm, Thompson Coburn LLP.

The whistleblower provisions took effect immediately upon FSMA’s passage in 2011. The rules cover companies in food manufacturing, processing, packing, distribution, holding, importation, and transportation. (Whistleblower complaints are managed for the FDA by the Occupational Health & Safety Administration (OSHA), which manages whistleblower actions for more than twenty federal departments.) Protected activity under this provision of FSMA protects employees of covered entities from retaliation for:

  • Providing information relating to any violation of the FD&C or any act that he or she reasonably believed to be a violation of the FD&C to:
    • The employer
    • The Federal Government
    • The attorney general of a state
  • Testifying, assisting, or participating in a proceeding concerning a violation of the FD&C
  • Objecting to or refusing to participate in any activity that he or she reasonably believed to be in violation of the FD&C

The protections afforded to whistleblowers are straightforward: employers are prohibited from firing or discriminating against any employee who speaks up about potential or ongoing safety issues, whether publicly or privately. FSMA’s Section 402 specifically prohibits employer actions such as termination or demotion, while protecting workers from any form of reprisal that might dissuade other employees from engaging in similar activity. 

From an employer’s perspective, however, whistleblower claims can be difficult to defend against since the claims are founded on an employee’s “belief” that the employer violated the applicable law. 

Since the whistleblower protections were first established under FSMA, there have been 280 complaints filed with OSHA, but many complaints are withdrawn for various reasons. 

To better understand how the rules protect food industry workers, TraceGains is teaming up with regulatory attorney Marc Sanchez to explore the whistleblower protections and procedures in an upcoming webinar: Blowing the Whistle - How & When to Do the Right Thing.

Specifically, this webinar will outline:

  • Who is covered
  • What is the whistleblower's burden of proof?
  • What remedies can be taken if an employer retaliates against a whistleblower
  • The statute of limitations
  • The "whistleblowing" requirements of third-party auditors under FSMA

Date: March 22, 2017
Time: 12:00pm EDT
Duration: 1 Hour
Cost: Free 

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With the clock ticking towards compliance, and employees empowered to call out employers for non-compliance, the need to have access to fact-based data is not only wise, but increasingly necessary.

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Tags: FSMA, Regulations