FDA Resumes Inspections, Plans 2022 Guidance
FDA is back on the road and planning new focus areas for 2022. Two recent FDA announcements provided information on the agency’s resumption of domestic inspections and intended guidances.
Inspections. During the pandemic, FDA had temporarily halted in-person inspections, then, in late January, extended the pause on domestic surveillance inspections through Feb. 4 “with the goal of restarting these activities as soon as safely possible.” With COVID cases now declining across much of the U.S., FDA determined that inspections can be safely resumed. So, in the agency’s February 4th Roundup, FDA announced that on February 7, it would “resume conducting domestic surveillance inspections across all commodities given the decline in COVID-19 cases across the country” and “state inspections under the FDA contract have the discretion to make inspection decisions based on their local information.” The agency expects to begin conducting foreign prioritized inspections starting in April.
Meanwhile, FDA will continue foreign and domestic mission-critical inspections and move forward with planned foreign surveillance that have received country clearance and are within CDC’s Level 1 or 2 COVID-19 travel recommendation. However, it will maintain remote foreign supplier verification program activities for now.
2022 Focus. In a January 31 update, FDA provided a list of guidance topics for which it expects to publish drafts or finals by the end of December 2022. The list included eight key areas of focus, six of which relate to foods:
- Allergens: Public Health Importance of non-Big 9, Q&A on labeling and Consumer Protection Act of 2004
- Food Additives: GRAS panels, culture animal cell food premarket consultation
- Food Safety: Genome edited foods from plants; action levels for lead in juice and food for babies/young children, and inorganic arsenic in apple juice; Detention without Physical Examination (DWPE) of certain products; prevention of Salmonella enteritidis in shell eggs; microbial hazards in seed; fish/fishery product reconditioning; FDA staff guidance on Listeria monocytogenes
- FSMA: Enforcement policies for certain provision of the PC, FSVP, and IA rules; PC Rule Appendix 1, and Chapters 11, 16, 17, and 18; Q&A on accredited third-party certification program; refusal of inspection by foreign facility/government; FSVP rule; produce safety for sprouts.
- Labeling: Plant-based alternatives for milk and animal-derived foods, Q&A on dietary guidance statements
- Nutrition: Protein Efficiency Ratios (PER) for new infant formulas
What does this mean for you? With the pandemic having lingered on (and on and on), most food facilities will have not had an FDA on-site inspection for at least two years. While it will undoubtedly take the agency a while to get back up to speed to inspect to its FSMA-mandated quota, your facility could appear on its list at any time. Are you ready? In announcing its restart of “domestic surveillance inspections,” FDA did not make it clear if these would include unannounced inspections (which were not conducted during COVID). Either way, however, we anticipate that the agency will be doing so in the near future, so facilities should prepare for an unexpected knock on the door.
With FDA having delayed the implementation of preventive controls inspections, while adding Food Defense Quick Checks during this time, it is likely that today’s inspection may be very different than the last one to which your facility was subjected prior to the pandemic. As we discussed in our November 2021 newsletter (Would Your Preventive Controls Stand Up to an FDA Inspection?), facilities are being inspected for preventive controls compliance – and being written up for inadequacies.
Having stated that the list of guidance topics is published “to help inform [stakeholders and partners] of agency priorities,” it also is likely that those are areas in which FDA will focus at least some of its attention during on-site inspections, to determine what guidance is needed as well as assessing compliance. So, we would see these as being areas in which facilities should be placing focus. Besides the specialized guidance on plant-based alternatives, fish, shell eggs, acidified foods, etc., FDA’s planned guidance includes some general areas of focus that we would expect inspectors to be taking a close look at this year, including:
- Allergen controls. The list includes both a focus on labeling and (finally) developing the Preventive Controls draft guidance for Food Allergen Controls (Chapter 11). With sesame being added as a major food allergen last year and FDA announcing a goal to evaluate other food allergens, this seems to be a very strong area of concern for the agency. As such, we would expect allergen practices and controls to also be strong areas of attention during on-site inspections.
- Heavy metals. Heavy metals in juices and foods for babies and young children garnered a great deal of media attention in 2021, which led to a great deal of regulatory attention, and they are the subject area of three planned guidance documents for 2022. If this doesn’t tell the industry to hype its game and check its practices, I’m not sure what will.
- Environmental monitoring/controls. With plans to draft guidance for FDA staff on Listeria monocytogenes (Lm) and for industry on RTE classification (PC Chapter 17), the agency is all but saying that environmental monitoring and control is taking a front seat, as both are directly related to this. And if FDA staff is being provided guidance regarding Lm, the goal is undoubtedly to have them apply their new learnings in the field – e.g., in your facility.
- Hazard analysis/control. In addition to producing guidance documents for Preventive Controls chapters listed above, FDA will be drafting guidance for Potential Hazards for Foods and Processes (Appendix 1) and Validation of Process Controls (chapter 16). Given this, it would be a good idea to take a fresh look at your Food Safety Plan; review your hazard analysis, ensuring it is thorough and up to date; and assess your controls and their validation. Even if all is deemed accurate as is, you will have updated yourself so you are ready to discuss any points that FDA may question.
- FSMA compliance. Perhaps the most portentous of FDA’s planned guidance is its intent to publish guidance on enforcement policies for three rules of FSMA: Preventive Controls, Intentional Adulteration, and the Foreign Supplier Verification Program (FSVP). So not only will inspectors be looking closely at these, they – and you – will know exactly what can be done if you are not in compliance.
None of this is to say that these are the only areas of focus in FDA inspections, nor that a facility should figure that if these are good, their food safety is good. But we would suggest that these be included in your list of priorities. And, if you’ve not had an on-site inspection in some time, we recommend that you do an inspection of your own to be sure you are ready, and, moreover, to be sure your food is safe for your consumers.
Interested in an inspection simulation or exercise? Give TAG a call today!