Guidance or Not: Check the List

In mid-August, FDA and OSHA published a joint Employee Health and Food Safety Checklist for FDA-regulated human and animal food operations to use when assessing operations during COVID-19. With businesses still having to temporarily shut down, or just getting back to opening, the checklist remains timely, as it was developed primarily for farms and facilities that are restarting after a shutdown or reassessing operations due to changes made because of the pandemic.

Though rather lengthy at 16 pages, FDA notes that it is “not exhaustive” of all the things that facilities may need to be doing for employee health and food safety during the pandemic, but there also will be items that may not be specifically applicable to your facility. Additionally, it is not considered to be a regulatory document or guidance. Rather, as FDA stated in a September webinar, it should be seen as “a tool to trigger the thinking process.”

As such, FDA investigators “won’t be asking these questions and documenting response or documenting adherence to the checklist as part of the regulatory process.…We won’t be using this information to build cases against firms,” it was stated.

But, I would recommend that all of that be taken with a bit of skepticism, as it also was noted that this “resource document” is based on regulation and links to guidance. In fact, nearly every question includes a reference, footnote, or link to regulation or guidance. So it would seem to me that an investigator certainly could ask any of the questions from the checklist during an inspection, as it also provides a simplified way for them to determine if you have implemented the referenced regulation or guidance.

Divided into two parts, the checklist includes:

• Employee Health and Social Distancing Checklist with considerations for employee health, screening, and operation configuration for social distancing to prevent or minimize the spread of COVID-19.
• Food Safety Checklist. This reiterates that there is no evidence of food or food packaging being associated with transmission of COVID-19, but notes that work environments where workers are in close contact may contribute to worker exposures. So the checklist is intended to focus on potential impacts of pandemic-related changes on the Food Safety Plan, HACCP plan, and CGMPs (e.g., to personnel, suppliers, and incoming ingredients).

While an inspector may not “document” response, adherence, or observations directly related to either checklist, I would highly recommend that all food facilities review the document, determine the items applicable to your facility, and check your activities against it.

And I would recommend that you do this sooner rather than later. Although routine inspections were postponed because of the pandemic, FDA has now restarted these, prioritizing facilities using a risk-based system. Additionally, throughout the pandemic, FDA has conducted foreign and domestic mission-critical inspections (e.g., due to a foodborne outbreak, follow up to a recall, root-cause investigations, serious-injury consumer complaints, etc.).

An investigator may not specifically ask: “Are procedures in place that require symptomatic workers to stay home or go home if they develop symptoms during the work day?”; “Have there been changes to your ingredient suppliers or ingredients that may require you to consider new hazards, or reconsider your evaluation of your hazards, and whether you need to make changes as a result?”; or the exact recitation of any other question in the checklist.

But you can bet on the fact that the employee health questions will be asked in some form ahead of time for the investigator’s own safety; and hazard evaluations relative to changes will be a point on their general inspection checklist.

For “the foreseeable future,” FDA will be pre-announcing inspections — again, for the safety of the investigator and the firm’s employees and to ensure the appropriate staff are on-site. But last-minute reviews, updates, and implementations are rarely a good thing, and often are easy to detect as last-minute — if only because it’s obviously not become a part of the culture — food safety or otherwise. But that is a whole ’nother topic for another column.