On September 1, 2020, the Food and Drug Administration (FDA) and Occupational Safety and Health Administration (OSHA) held a joint webinar to discuss the jointly-issued Employee Health and Food Safety Checklist for Human and Animal Food Operations During the COVID-19 Pandemic (Checklist)¹, as well as the status of foreign and domestic food industry inspections.² The Checklist is intended to be used as a reference tool for the food industry to assess operations during the pandemic, particularly if restarting after a shutdown or when reassessing operations because of changes due to COVID-19. FDA has emphasized that the Checklist is not intended to be used by FDA to determine whether regulatory requirements are met. Additionally, FDA explained during the webinar that domestic inspections will continue to be pre-announced to all FDA-regulated businesses. This memorandum discusses the Checklist and FDA’s approach to inspections during the COVID-19 era.

Checklist Overview and Agency Use

Overview

The Checklist does not introduce new information; rather, it assembles existing guidance for food facilities into one reference point. It is broken down into two distinct parts:

• Part 1: Employee Health and Social Distancing – The Checklist provides questions for general oversight, facilities, personnel, persons who are symptomatic or develop symptoms at work, exposure investigation and testing, and work environment configurations.
• Part 2: Food Safety – The Checklist provides questions for operations to consider when re-starting operations after a shut down or when reassessing operations to make changes due to COVID-19. The questions are intended to help facilities consider potential impacts of changes, such as those to personnel, suppliers, and incoming ingredients, on food safety plans or Hazard Analysis and Critical Control Points (“HACCP”) plans, as well as current good manufacturing practices (“CGMPs”).

Notably, the Checklist restates the statement FDA has made consistently throughout the pandemic: “there is no evidence of food or food packaging being associated with transmission of COVID-19.” Rather, the work environment may contribute substantially to potential worker exposure.

Purpose of the Checklist

The checklist is intended as a tool for industry, rather than an inspection tool. Importantly, FDA stated on the webinar that the Checklist will not be used to determine whether regulatory requirements are met. Michael Rogers, Assistant Commissioner for Human and Animal Food Operations in the Office of Regulatory Affairs, stated that FDA will not be asking firms the Checklist questions, documenting the firm’s responses, and/or documenting the firm’s adherence to the Checklist as part of FDA’s regulatory process. Further, FDA (and states conducting inspections under contract) will not be using information from the Checklist to build a regulatory record for or against the inspected facility. FDA emphasized that the agency’s approach to inspections will be educational and collaborative to help address challenges during the pandemic.

Nevertheless, it is important to recognize that the Checklist incorporates many elements that are mandatory under FDA regulations (particularly in Part 2: Food Safety). Thus, while the Checklist itself may not be used as part of an inspection, inspections are likely to address the regulatory provisions identified on the Checklist. Therefore, members of the food industry would be well-served to conduct an internal review of their programs against the items on the Checklist as part of their inspection readiness efforts.

Conducting Inspections

FDA previously announced that it would be resuming domestic inspections in mid-July and that such inspections would be pre-announced.³ During the recent webinar, FDA stated that it will continue to preannounce domestic inspections, using its COVID advisory tool to determine which inspections to prioritize. The agency also is using a standard script to assess the current status of the facility (e.g., whether an outbreak is ongoing). FDA investigators will wear face covering and perform self-health checks before conducting inspections. For purposes of foreign inspections, FDA does not have the benefit of an international COVID advisory tool, but it is continuing to monitor travel warnings and advisories to determine when it can resume routine foreign inspections. Last, the agency will continue conducting mission critical inspections domestically and internationally—e.g., for facilities implicated in foodborne outbreaks, follow-ups to recalls, and root cause investigations for consumer complaints where there are serious injuries.

We will continue to monitor the impacts on the food industry from COVID-19. 

¹ FDA and OSHA Employee Health and Food Safety Checklist for Human and Animal Food Operations During the COVID-19 Pandemic (Aug. 11, 2020), https://www.fda.gov/media/141141/download.

² FDA COVID-19 Update for Food Operations Stakeholders Webinar (Sept. 1, 2020), https://bit.ly/32S7P11.

³ See HL Memorandum - COVID-19 Update: FDA Prepares to Resume Domestic Inspections (July 13, 2020), https://www.engage.hoganlovells.com/knowledgeservices/news/covid-19-update-fda-prepares-to-resume-domestic-inspections.

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