FDA Outlines Inspection and Assessment Activities During Pandemic, Roadmap for Future Operations

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The Food and Drug Administration (FDA or the agency) recently released a report entitled Resiliency Roadmap for FDA Inspectional Oversight (Report) recapping the inspectional activities across all parts of the agency during the COVID-19 pandemic and detailing its plan to resume more “normal” operations. [1]/ The Report is not limited to inspections and plans for only the food industry, but the impacts for the food industry are the focus of this memorandum. FDA explains that it experienced unprecedented and unique challenges during the pandemic, but recognizes the importance of getting back to “normal” operations/inspections.

At a high level, FDA explains that it will not able to meet inspection frequencies for food facilities as mandated under the FDA Food Safety Modernization Act (FSMA). The Report outlines FDA’s priority scheme for approaching inspections going forward based on various scenarios relating to how quickly the agency can access its full resources. Notably, FDA affirmatively states it is looking for alternative ways to increase remote inspection opportunities.

Background

FDA announced in March 2020 that due to the pandemic it was temporarily postponing all domestic and foreign routine surveillance facility inspections. [1]/ Importantly, FDA continued to conduct mission-critical inspections [2]/ when possible and engaged in alternative forms of review where legally permitted (e.g., remote inspections for the Foreign Supplier Verification Program).

In early July 2020, FDA announced that it would begin to work toward resuming prioritized domestic inspections using its COVID-19 Advisory Rating (AR) system. [3]/ The AR system system was based upon three metrics: (1) the Covid-19 phase of the state; (2) statistics measured at the county level to gauge current trends; and (3) statistics measured at the county level to gauge the intensity of infection. Based on the AR system, FDA would identify the appropriate regulatory activities that could occur within the given geographic region.

Summary of Inspectional Activities for Food Establishments

The report provides general statistics for completed mission critical and prioritized domestic human and animal food facility inspections during the pandemic. While these were FDA’s focus, the agency was also able to complete 1,183 (remote) FSVP inspections due to broader authority to conduct remote inspections and collect electronic records under the FSVP regulations. Further, FDA took advantage of other tools and authorities to help monitor and provide oversight, including:

  • Applying remote assessments for individual program areas to evaluate facility records;
  • Leveraging information shared by state, local, tribal, and territorial regulatory partners;
  • Leveraging information shared by foreign regulatory partners through Systems Recognition Agreements with New Zealand, Canada, and Australia;
  • Conducting sampling and analytical testing of FDA-regulated products both domestically and at international borders; and
  • Refusing entry of unsafe imported products into the US.

FDA Inspectional Targets and Approach to Moving Forward

Approach to Inspections Going Forward

FDA recognizes that it will be unable to meet the high-volume of remaining inspections it intended to conduct, and that given the large number, prioritization will need to occur. Plans for how FDA may tackle this workload are outlined in the report and are largely dependent on the future course of the COVID-19 pandemic.

Statutory inspection frequency mandates play a significant role in the type and number of routine surveillance inspections that remain to be conducted. [4]/ Over 15,500 (nearly 67%) of the 23,297 surveillance inspections still to be conducted in FY21 represent human food facilities that are required to be inspected according to the statutorily-mandated frequency.

The uncertainty created by the COVID-19 pandemic means that FDA will continue to conduct most mission-critical inspections and prioritized surveillance inspections; however, inspections that do not meet these criteria may be postponed. FDA identifies in the report the following inspectional priority/tiers for human and animal food:

  • Tier 1: Mission Critical – Agency crisis or emergency response For-cause work; Other mission-critical special assignment
  • Tier 2: Higher Priority – For-cause but not considered mission critical; High-priority and high-risk* inspection and sampling
  • Tier 3: Lower Priority – Routine-surveillance, including non-high-risk* inspection and sampling assignment

* inspection frequency is mandated by statute

Routine surveillance inspections will continue to be conducted; however, FDA states it will prioritize higher-tiered needs. Thus, a longer interval between inspections will occur for lower-tiered inspection assignments as the agency adjusts for the impact of the COVID-19 pandemic. This means that postponed inspections will be prioritized based on risk and conducted over a longer period, ultimately increasing the amount of time between inspections of certain lower-risk facilities.

Scenarios Driving Inspection Numbers Going Forward

As noted, the future approach to inspections largely depends on how pandemic recovery unfolds. FDA identifies three possible near-term scenarios for inspectional operations:

  • Best-case scenario (immediate transition to standard operations): FDA assumes standard operations in May 2021, no travel prohibitions or restrictions on access to regulated establishments, and the COVID-19 AR System is not being used. FDA estimates that 2,579 (21%) of all domestic surveillance inspections still to be conducted in FY21 are achievable under this scenario.
  • Best-case scenario (gradual transition to standard operations): FDA continues using the COVID-19 AR System to focus on mission-critical and prioritized domestic inspections from May through July 2021 and resumes standard operations in July 2021. FDA estimates that 1,272 (10%) of all domestic surveillance inspections still to be conducted in FY21 are achievable under this scenario.
  • Worst-case scenario (resurgence or appearance of variants): FDA focuses on oversight work most critical to its mission and limit inspection activities accordingly. FDA would increase focus and reliance on alternative oversight tools as non-mission-critical surveillance work could not be accomplished.

Potential Expansion of Inspection Authorities and Tools

FDA states that the agency will continue to use remote regulatory assessments and may seek statutory authority for remote inspections. The report states the following:

The agency has developed a process to conduct voluntary remote regulatory assessments of domestic human and animal food establishments during the pandemic because, as noted above, the regulatory authority under 704(a)(4) does not apply to FDA oversight of food. FDA will continue to utilize these assessments in the future, which provide an opportunity for increased oversight of the food supply. However, these remote assessments do not count towards the FSMA surveillance inspection requirement.

Consistent with FDA’s New Era of Smarter Food Safety vision, we plan to further leverage new and emerging technologies and data-driven, predictive analytical approaches to strengthen our compliance oversight work. This could involve working with Congress to make the policy changes needed to modernize and allow greater flexibility to achieve FSMA goals, which would include deploying tools that may not have been contemplated when FSMA was passed over a decade ago.

Thus, regardless of which scenario plays out, FDA will continue to look to other tools to help maintain regulatory oversight.

 

Next steps

We will continue to monitor FDA’s inspectional activities and approaches as the pandemic recovery unfolds. Please contact us if you have any questions.

[1]/ Resiliency Roadmap for FDA Inspectional Oversight (May 2021) (hereinafter “Report), https://www.fda.gov/media/148197/download.

[1]/ FDA Statement: Coronavirus Disease 2019 (COVID-19) Update: Foreign Inspections (March 10, 2020) https://www.fda.gov/news-events/press-announcements/coronavirus-disease-2019-covid-19-update-foreign-inspections; see also Hogan Lovells COVID-19 Update : FDA Temporarily Postpones Routine Domestic Inspections (March 19, 2020), https://www.hlfoodlaw.com/2020/03/covid-19-update-fda-temporarily-postpones-routine-domestic-inspections/.

[2]/ An example of a mission critical inspection is when a product requires follow-up due to recall, or if there is evidence of serious adverse events or outbreaks of foodborne illness.

[3]/ FDA Statement: Coronavirus (COVID-19) Update: FDA prepares for resumption of domestic inspections with new risk assessment system (July 10, 2020), https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-prepares-resumption-domestic-inspections-new-risk-assessment-system; see also Hogan Lovells 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.

[4]/ The frequency of human and animal surveillance inspections for registered food facilities is governed by FSMA and requires FDA to inspect domestic food facilities (such as manufacturers/processors) at specified frequencies based on two broad categories of risk. High-risk food facilities in the U.S. are to be inspected at least once every three years, while non-high-risk food facilities are to be inspected at least once every five years. 21 USC § 350j.

[View source.]

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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