FDA

FDA on COVID-19 Food Safety Checklist: This is Not a Regulatory Requirement or Enforcement Tool

By Maria Fontanazza
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FDA

During a multi-agency COVID-19 update with FDA, CDC and OSHA, it became clear that further clarification regarding the FDA-OSHA checklist released in August was needed.

In mid-August, FDA and OSHA released a checklist to help food companies that were going through operational changes as a result of the COVID-19 pandemic. Specifically, the “Employee Health and Food Safety Checklist for Human and Animal Food Operations During the COVID-19 Pandemic” document reviews employee health and social distancing (how to deal with employee exposure and testing, the arrangement of work environments, especially considering work breaks and close operations), and food safety and HACCP plans—including suppliers and incoming ingredients—cGMPs, and other operational alterations due to COVID-19.

Today FDA held an “FDA COVID-19 Update for Food Operations Stakeholders” in collaboration with CDC and OSHA to further discuss the checklist, which targets owners, operators or agents in charge of a food operation. The purpose is to help the user assess operations during the COVID-19 pandemic, particularly operations that have restarted after a facility shutdown. Following the initial remarks, it was clear the FDA wanted to emphasize that the food safety checklist is intended to serve as a resource document, not a new guidance document or a new regulation. What was originally envisioned to be a one- to two-page checklist became a 16-page checklist that should be used in conjunction with additional information provided by FDA, CDC and OSHA, said Jenny Scott, senior advisor, office of food safety at CFSAN.

Scott reviewed the outline of the checklist, touching on employee health practices to help minimize the spread of COVID-19 (from basic handwashing practices to deadline with sick and exposed workers), employee testing and potential changes related to personnel requirements (i.e., if you are putting new people into new roles, you must consider whether more training is required), and the cGMP requirements. Among the key questions related to sanitation that Scott advised one must ask include: Are necessary cleaning, sanitizing and disinfecting supplies available? Are changes needed for cleaning, sanitizing and disinfecting procedures for certain areas or the frequency of conducting the procedures? Do the changes result in the need for updating instructions or training workers?

As the understanding of COVID-19 and how it spreads is evolving, Scott stressed that industry should frequently check FDA, CDC and OSHA websites for updates.

(Noteworthy link from CDC: Testing Strategy for Coronavirus (COVID‐19) in High‐Density Critical Infrastructure Workplaces after a COVID‐19 Case is Identified)

Update on FDA Inspections

Michael Rogers, assistant commissioner for human and animal food operations, ORA, FDA also stressed the fact that the food safety checklist is not a new regulatory requirement, commenting that there has been “some anxiety associated” with this misperception. “This is simply an educational tool,” Rogers said. “We recognize that every firm is different, and the checklist should be information to consider…This is not an enforcement tool.” He added that the FDA’s approach during inspections will be collaborative and that the agency will not be holding firms to the specifics of the checklist. During the pandemic, the agency has been conducting mission critical inspections. FDA has also started domestic inspections in certain areas and will be preannouncing inspections as it moves forward, and it continues to assess the situation abroad to determine when foreign inspections can resume.

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Maria Fontanazza, Food Safety Tech

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