FDA Outlines Inspection and Assessment Activities During Pandemic, Roadmap For Future Operations | Hogan Lovells



Background

The FDA announced in March 2020 that due to the pandemic, it was temporarily postponing all routine inspections of domestic and foreign surveillance facilities. [1]/ Importantly, the FDA continued to conduct critical inspections [2]/ where possible and engaged in other forms of review where permitted by law (eg remote inspections for overseas supplier verification program).

In early July 2020, the FDA announced that it would begin work on resuming priority national inspections using its COVID-19 Advisory Assessment (RA) system. [3]/ The AR system was based on three measures: (1) the State’s Covid-19 phase; (2) statistics measured at the county level to assess current trends; and (3) statistics measured at the county level to assess the intensity of infection. Based on the AR system, the FDA would identify the appropriate regulatory activities that could take place in the given geographic region.

Summary of food establishment inspection activities

The report provides general statistics on the carried out and priority inspections of national food and feed facilities during the pandemic. While these have been the focus of the FDA’s attention, the agency has also been able to perform 1,183 (remote) FSVP inspections due to a broader authority to perform remote inspections and collect electronic records under FSVP regulations. In addition, the FDA has leveraged other tools and authorities to help monitor and provide oversight, including:

  • Apply remote assessments for individual program areas to assess facility records;
  • Leverage information shared by state, local, tribal and territorial regulatory partners;
  • Leverage information shared by overseas regulatory partners through system recognition agreements with New Zealand, Canada and Australia;
  • Perform sampling and analytical testing of FDA regulated products both domestically and internationally; and
  • Deny entry of dangerous imported products into the United States.

FDA Inspection Goals and Approach for Moving Forward

Approach to upcoming inspections

The FDA recognizes that it will not be able to respond to the high volume of remaining inspections it intended to conduct, and that given the large number, prioritization will have to take place. Plans for how the FDA can tackle this workload are outlined in the report and largely depend on the future course of the COVID-19 pandemic.

Regulatory inspection frequency mandates play an important role in the type and number of routine surveillance inspections that remain to be performed. [4]/ More than 15,500 (almost 67%) of the 23,297 surveillance inspections still to be carried out in FY21 represent human food facilities that must be inspected at the frequency prescribed by law.

The uncertainty created by the COVID-19 pandemic means that the FDA will continue to perform most critical inspections and priority surveillance inspections; however, inspections that do not meet these criteria may be postponed. The FDA identifies the following food and feed inspection priorities / levels in the report:

  • Level 1: Critical mission – Crisis or emergency intervention of the Agency Motivated work; Other critical special mission
  • Level 2: Higher priority – Due but not considered mission critical; High priority and high risk inspection and sampling *
  • Level 3: Lower priority – Routine surveillance including inspection and sampling without high risk *

* the frequency of inspections is prescribed by law

Routine surveillance inspections will continue to be carried out; However, the FDA says it will prioritize higher-level needs. Thus, a longer interval between inspections will occur for lower level inspection missions as the agency adjusts to the impact of the COVID-19 pandemic. This means that deferred inspections will be prioritized based on risk and conducted over a longer period of time, ultimately increasing the time between inspections of some low risk facilities.

Scenarios for driving inspection numbers in the future

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

  • Best case scenario (immediate transition to standard operations): FDA assumes standard operations in May 2021, no travel bans or restrictions on access to regulated establishments, and the COVID-19 AR system is not in use. The FDA estimates that 2,579 (21%) of all national surveillance inspections that are yet to be completed in FY21 are achievable in this scenario.
  • Best-case scenario (gradual shift to standard operations): FDA continues to use the COVID-19 AR system to focus on critical and priority national inspections from May to July 2021 and resumes standard operations in July 2021. FDA estimates that 1,272 (10%) of all national surveillance inspections still to be carried out in FY21 are achievable in this scenario.
  • Worst case scenario (recurrence or appearance of variants): FDA focuses on the surveillance work most critical to its mission and limits inspection activities accordingly. The FDA would increase attention and reliance on other surveillance tools, as non-mission-critical surveillance work could not be accomplished.

Potential extension of inspection powers and tools

The FDA says the agency will continue to use remote regulatory assessments and may seek legal authorization for remote inspections. The report states the following:

The agency has developed a process to conduct voluntary regulatory assessments remotely of national food and feed establishments during the pandemic because, as noted above, the regulator under 704 (a) ( 4) does not apply to FDA food oversight. The FDA will continue to use these assessments in the future, which provide an opportunity for increased oversight of the food supply. However, these remote assessments are not taken into account for the FSMA’s supervisory inspection obligation.

In line with the FDA’s vision for a New Era of Smarter Food Safety, we plan to further leverage new and emerging technologies and data-driven predictive analytical approaches to strengthen our compliance monitoring work. This could involve working with Congress to make the necessary policy changes to modernize and allow greater flexibility to achieve FSMA goals, which would include the deployment of tools that may not have been considered when the FSMA was adopted over ten years ago.

So, whatever the scenario, the FDA will continue to look to other tools to help maintain regulatory oversight.

Next steps

We will continue to monitor FDA inspection activities and approaches as the pandemic recovery unfolds. Contact us if you have any questions.

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

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



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