According to public statements from the US Food and Drug Administration (FDA), United States Department of Agriculture (USDA), US Center for Disease Control (CDC), and similarly situated international bodies, there is no current indication based on information to date that the food supply is at risk of infection, and all such authorities have taken the position that the coronavirus is not known to live on, nor is the virus transmitted by, food. There is similarly no indication at this point that the virus is transmitted through imported goods nor are there any reported cases of coronavirus disease 2019 (COVID-19) in the US associated with imported goods. Given the novel nature of COVID-19, this remains subject to change pending further research and information. For the FDA’s current position regarding food safety risk, please see the FDA’s COVID-19 Frequently Asked Questions.
In considering the potentially impacted touch points, consider the following implications based on the FDA’s current guidance:
- From the manufacturing perspective, at present the FDA has not issued any formal legal or regulatory requirements or special actions to be taken by food manufacturers. Rather, manufacturers are encouraged to continue operating under their existing food safety policies and procedures consistent with FSMA preventive controls, sanitation requirements, cGMPs, and/or other quality and safety controls to ensure the safety of the US food supply. CDC further recommends routine cleaning of all frequently touched surfaces in the workplace, such as workstations, countertops, and doorknobs. With increasing travel advisories and restrictions that may impact the ability of receiving facilities and importers to conduct on-site audits of suppliers, the FDA has issued a guidance regarding a temporary policy not to enforce requirements to conduct on-site audits of food suppliers if other supplier verification methods, such as sampling and testing food or reviewing relevant food safety records, are used instead to ensure hazards are being controlled. As such, impacted firms may need to update their food safety plan or FSVP to incorporate the alternative activities. Some cities and states that have implemented local quarantines may restrict manufacturing operations, separate and apart from the FDA’s guidance for those food facilities that continue in operation. We also note that to date, there have been no recalls related to food products handled by allegedly sick employees. FDA has further advised that it does not anticipate that food products would need to be placed on hold, recalled, or withdrawn from the market because of COVID-19 or due to an employee infected with COVID-19, as there is currently no evidence to support the transmission of COVID-19 associated with food or food packaging.
- From the restaurant/retail/food delivery standpoint, and to the extent cities and states permit retail food operations at this time (e.g., certain states may restrict restaurants to delivery or carry-out only), all retail establishments are expected to continue to operate under state food code requirements regarding cleaning, sanitizing, and overall food safety. The FDA does reiterate that surfaces should be frequently cleaned and that employees should follow safe food handling procedures. The FDA also takes a consistent position regarding transmission via food as to whether it’s possible to get COVID-19 from a food worker handling a consumer’s food. As such, the FDA reiterates the importance of cleaning and properly cooking all foods as a matter of food safety, which should mitigate risk of any surface contamination.
- From the consumer standpoint, the FDA advises consumers to practice safe food handling, including the four key steps of food safety: clean, separate, cook and chill. While there is no indication that coronavirus is transmitted through food, there remains a risk of surface contamination (particularly on fresh foods and packaging). Proper handling can help mitigate potential surface contamination.
Regarding FDA food facility inspections, the FDA has announced that for inspections of domestic manufacturing facilities, FDA is postponing routine surveillance inspections planned for this fiscal year, but will continue to conduct for-cause or “mission critical” domestic inspections, so long as such inspections would not put anyone at risk. Based on guidance provided by FDA’s March 18, 2020 stakeholder call, mission-critical inspections may include, for example, inspections relating to a Class I recall.,. The FDA will also take into account geographical restrictions adopted by states, such as those states with a shelter in place. In addition, whereas FDA inspections are typically unannounced, the FDA will now pre-announce the majority of domestic inspections for the foreseeable future.
As it relates to international facility inspections, given the international spread of COVID-19, the FDA has postponed inspecting foreign food manufacturing facilities through April, effective immediately. While some inspections outside the U.S. deemed “mission-critical” will be considered on a case by case basis, foreign inspections are otherwise on hold.
Foreign inspections of facilities manufacturing products intended for the U.S. are important for ensuring safety from the point of manufacturing. By not being able to physically inspect foreign-produced products, the FDA may likely employ interim measures that result in more scrutiny of imported goods. For example, these interim measures may include denying entry of unsafe products into the U.S., physical examinations and/or product sampling at our borders, reviewing a firm’s previous compliance history, using information sharing from foreign governments as part of mutual recognition and confidentiality agreements and requesting records “in advance of or in lieu of” on-site drug inspections.
The FDA utilizes a risk-based import screening tool Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting (PREDICT) to focus its examinations and sample collections based on heightened concerns regarding specific products entering U.S. commerce. The FDA has indicated that it will continue to adjust as necessary risk scores within PREDICT throughout the COVID-19 outbreak. The FDA is also watching for indications of port shopping or cargo diversion and will continue oversight of shipments through potentially higher-risk venues such as International Mail Facilities. As a result, there may be an uptick in product import detentions and higher risk products may face more scrutiny upon import.
As the COVID-19 situation is dynamic, the above guidelines are subject to change. Please contact the authors with any questions or for more information.