FDA Retains Regulatory Flexibility to Offset Continued Supply Chain Disruptions

With supply chain issues having been one of the greatest challenges during the COVID-19 pandemic, regulators have made attempts to ease some of the regulatory burden for supply-chain compliance. But even while Omicron begins ebbing in a westward wave across the U.S., the food industry continues to face business disruptions. In addition to the pandemic-related issues such as labor shortages, transportation challenges, packaging shortages, and international import delays, many are dealing with severe weather events that are further impacting supply chains and, ultimately, consumers.

Because of this, FDA reissued a list of temporary guidance that remains in effect to provide regulatory flexibility to help minimize the impact of supply chain disruptions on product availability. Included are the temporary policies related to:

• The qualified exemption from produce safety rule standards. Recognizing that the ability of farms to shift food sales to available buyers can help reduce food shortages and food waste, and to help support affected farms in selling food to all available buyers, FDA does not intend to enforce the requirement in 21 CFR 112.5(a)(1) that a majority of sales be to qualified end-users for a farm to be eligible for the qualified exemption under the Produce Safety Rule. This policy will apply to any calendar year during which the COVID-19 public health emergency is ongoing. When the public health emergency concludes, FDA intends to issue additional guidance regarding the eligibility criteria for the qualified exemption, which depends on the calculation of a three-year average. (See the full guidance document here.)   
• Returning refrigerated vehicles and storage units to food use. In response to questions as to whether refrigerated food transport vehicles and storage units used for the temporary preservation of human remains during the pandemic can be subsequently used to transport and store human and animal food, FDA issued guidance to provide information and resources related to the cleaning and disinfection of such vehicles and storage units to address food safety before they are used again for food. The recommendations are to supplement existing food safety regulations and guidance. (See the full guidance document here.)  
• Accredited third-party certification program onsite observations and certificate duration. To help address the difficulties with conducting onsite observations and examinations, FDA provided temporary flexibility allowing accreditation bodies (ABs) to maintain the accreditations of certification bodies (CBs) and keep already-issued certifications from lapsing. As such, FDA is not enforcing onsite observation and certificate term requirements in certain situations. (See the full guidance document here.)  
• The Egg Safety Rule. Due to the increased consumer demand for eggs in the table egg market (e.g., sold directly to consumers in retail establishments), FDA is providing temporary flexibility to allow producers who currently only sell eggs to facilities for further processing to sell to the table egg market, if shell eggs from a poultry house consisting solely of laying hens up to 45 weeks of age are sold to the table egg market and specific conditions are met to address food safety concerns. (See the full guidance document here.)  
• Packaging and labeling of shell eggs in retail food establishments. To enable industry to meet the increased demand for shell eggs, FDA is allowing the sale by retail food establishments of shell eggs in cartons or flats without labels, if a POS sign is clearly displayed for each supplier with a statement of identity; the name and place of business of the manufacturer, packer, or distributor; and safe handling instructions for shell eggs that have not been processed to destroy all viable Salmonella. Additionally, the shell eggs must be sold by the complete carton or flat and no nutrition claims may be made. (See the full guidance document here.)  
• Preventive controls and FSVP onsite audits. FDA is not enforcing requirements of the preventive controls for human and animal rules and the Foreign Supplier Verification Programs (FSVP) rule to conduct onsite food-supplier audits, if a facility that is due for the audit is in a region or country covered by a government travel restriction or advisory; in light of that, an onsite audit is impracticable; and other supplier verification methods are used instead. (See the full guidance document here.)  

Many of the points above are focused on specific sectors of the food industry, but the relaxation of on-site third-party audit requirements will help some on the regulatory front.  As we emerge from COVID-19, one of the recommended action items is for food companies to closely review their supply-chain risk-control programs. Many suppliers are struggling, and this can lead to a drop in food safety programs thus creating risks. 

Food Defense. In addition to these, FDA is continuing to conduct Food Defense Quick Checks (vs. full Intentional Adulteration Rule inspections). The quick check consists of a series of a few general questions to see if the site is subject to the rule; if it is, the inspector then asks seven questions to determine the extent of the facility’s food defense program. While FDA has not disclosed the specifics of the seven questions, they are based on the requirements of the rule.

In a presentation at a late 2021 FSPCA conference, the FDA spokesperson stated that full food defense assessments will eventually begin, but no timeline had been developed. Additionally, no guidance documents will be finalized until the industry has had full inspections, and the FDA is able to determine, what if anything, needs to be tweaked.

It also was noted that the quick checks were showing that the majority of large facilities are using the KAT-only vulnerability assessment model. However, with this method, every KAT automatically becomes an actionable process step (APS), so it can create unnecessary mitigation step(s) increasing the burden on the facility. When the Three Elements method is used instead, a scoring of each of the three elements (criticality, accessibility, vulnerability) is applied to determine which process step should be identified as a KAT and become an APS. While the identification will take longer, it will often show that not all KATs need an APS or mitigation strategy, thereby reducing that burden.

For more information, or training on Intentional Adulteration Vulnerability Assessments – or assistance on any of the FSMA rules or temporary guidance compliance, contact TAG.