The Impact of the COVID-19 Pandemic on Food Safety in the US
Israel Juarbe, Jr
Consumer Safety Officer/Auditor, U.S. Food and Drug Administration
Abstract
The effects of the COVID-19 pandemic on food safety in the United States at facilities regulated by the Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA) are unknown. The U.S. had not faced a pandemic in more than 100 years, and addressing the issues that may impact food safety during a pandemic is something that is crucial in protecting the food supply. Inspectional, recall, and foodborne illness outbreak data from the FDA, USDA, and Centers for Disease Control and Prevention (CDC) was collected. An equal number of days was used to evaluate and compare the days prior to and during the COVID-19 pandemic. The number of inspections conducted by FDA and USDA varied during the pandemic, however, the inspectional impact to the FDA was greater. Furthermore, foodborne illness outbreak investigations conducted by USDA, FDA, and CDC decreased during the pandemic. New ways to conduct inspections and investigations, as well as guidance for regulatory partners for conducting inspections during a pandemic, are highlighted as important for regulatory agencies to consider. Additionally, manufacturing facilities should adopt a food safety culture within its facilities thus decreasing reliance on regulatory inspections to drive motivation to assure food safety.
Key words: Food safety, Pandemic, Inspections, Outbreak Investigations, Recalls
The Impact of the COVID-19 Pandemic on Food Safety in the US
Background
The demand for food keeps increasing every day, (Elferink and Schierhorn, 2016) and during a pandemic the demand for food is not expected to slow down as people still need to eat. How foods are manufactured and processed is a crucial aspect of food safety. However, during a pandemic, food safety may be disrupted due to negative impacts on manufacturing or regulatory personnel. In the United States, the Food and Drug Administration (FDA), the U.S. Department of Agriculture (USDA), the Centers for Disease Control and Prevention (CDC), state agencies, and local municipalities along with tribal and territorial officials have the main responsibility for overseeing food safety. In 2018 and 2019, the FDA averaged about 900 food safety inspections of manufactured food facilities per month, which led to approximately 600 citations per month. During the COVID-19 pandemic in 2020, the numbers fell to 307 inspections and 167 citations in March 2020. In April 2020, just eight inspections took place, leading to two citations (Bagenstose, 2020). In-person routine surveillance inspections of farms and food facilities in the U.S. and others that export foods to the U.S. eventually ceased during the COVID-19 pandemic, according to the Frank Yiannas, FDA’s Deputy Commissioner for Food Policy and Response (Sjerven, 2020). State and local agencies also drastically reduced the number of, or ceased entirely to conduct inspections at retail and manufacturing locations. Surveillance samples also were not conducted during this time. The reduction of inspections was to protect the investigators and inspectors from exposure to the virus.
Food safety responsibility is shared between suppliers, manufacturers, restaurants, retail establishments, and regulatory agencies. Removing the oversight of the regulatory agencies—an extremely important safeguard in the food supply—may put the food system in jeopardy. The absence of regulatory agencies in commercial food facilities removes a checks-and-balances, or verification step in the food safety system. The CDC estimates 48 million people get sick, 128,000 are hospitalized, and 3,000 die from foodborne diseases each year in the United States (Center for Disease Control and Prevention, 2020). The CDC estimates were based on a system whereby manufacturing and retail facilities receive regulatory inspections. A concern exists that consumers are solely relying on food facilities to ensure foods are safe to consume during the COVID-19 pandemic. Many manufacturers modified their facilities and operations to limit the spread of the virus to employees, however, even with the modifications, many manufacturers saw a reduction in their workforce due to COVID-19.
The reduction in workforce occurred while the demand for food never slowed down—as was evident by the empty shelves in grocery stores (Johansson, 2020), putting pressure on manufacturers to maintain or increase production. If manufacturers do not have a well-established food safety program in place to handle unexpected issues during a pandemic event, consumers may be put at risk. For example, would manufacturers be able to continue following safety and quality assurance protocols if the employees responsible for food safety fell ill due to the pandemic? The lack of personnel to monitor food safety or shifting employee responsibilities from food safety tasks to other priorities which emerge could potentially cause the number of foodborne illnesses or outbreaks to increase in the U.S.
An important component of the U.S. food safety system—in addition to regulatory oversight and industry’s role in food safety—is the surveillance of foodborne pathogens and illnesses. Surveillance activities are conducted by the FDA, USDA, CDC, and state & local agencies. These agencies rely on information provided by local doctors and hospitals regarding foodborne illnesses. During the COVID-19 pandemic, many medical facilities were understandably consumed with caring for sick patients infected with COVID-19. Many Americans may have opted to stay home and not seek treatment for gastrointestinal ailments to avoid the risk of contracting COVID-19 from a doctor’s office or hospital (Bagenstose, 2020). As a result, stool samples may not have been taken and may result in lower numbers of reported foodborne illnesses for that period of time. Furthermore, on a national call with consumer groups, CDC officials stated several state health departments reported having trouble keeping up with stool sample testing and had asked for federal support (Bagenstose, 2020).
The U.S. had not faced a pandemic in more than 100 years. No historical data is available to show how safe our foods are when a pandemic impacts supply chains and manufacturing and processing of foods. Addressing the issues that may impact food safety during a pandemic is something that is crucial in protecting the food supply.
Problem Statement
The effects that the COVID-19 pandemic have had on food safety in the US at facilities regulated by the FDA and USDA are unknown.
Research Questions
1. How were the food safety inspections conducted by FDA and USDA affected during the pandemic?
2. What were the FDA and USDA doing to ensure food safety during the pandemic?
3. How were the number of recalls, foodborne illness outbreaks, and food safety violations affected during the pandemic?
Methodology
To compare food safety data prior to and during the COVID-19 pandemic, inspectional, recall, and foodborne illness outbreak data was obtained from the FDA, USDA, and CDC websites. Comparable timeframes were used to evaluate and compare the days prior to and during the COVID-19 pandemic. FDA data was collected from March to December 2019 and March to December 2020 and the USDA’s data was collected from January to September 2019 and January to September 2020. The difference in collection periods between FDA and USDA is based on how each respective agency reports its data. CDC data was collected from January to December 2020. The above federal agencies were chosen since they are responsible for food safety at the federal level in the U.S.
Results
Figure 1 compares the number of FDA inspections that were conducted from March to December in 2019 and 2020. Approximately 7,700 inspections were conducted in 2019 and approximately 1,600 inspections in 2020, a reduction of approximately 6,100 inspections during 2020. The inspections during 2019 included domestic and foreign inspections, routine, mission critical, and for-cause inspections such as compliance follow-up, complaints, or outbreak investigations during the pandemic. However, during 2020 only mission critical and for-cause inspections were conducted. In addition, no foreign inspections were conducted during 2020.
Figure 1
FDA Inspections from March to December in 2019 and 2020
Figure 2 shows the number of inspections that were conducted by USDA for the second (January-March), third (April-June), and fourth (July-September) quarters in 2019 and 2020. Approximately 5,257,000 inspections were conducted in 2019 and approximately 5,313,300 inspections were conducted in 2020.
Figure 2
USDA Inspections for 2019 and 2020
Figure 3 demonstrates the FDA classification outcomes of the inspections that occurred in 2019 and 2020. FDA classifies inspection outcomes as: Official Action Indicated (OAI) which means regulatory and/or administrative actions were recommended; Voluntary Action Indicated (VAI) which means objectionable conditions or practices were found but agency did not take or recommend any administrative or regulatory action; or, No Action Indicated (NAI) which means no objectionable conditions or practices were found during the inspection (or the objectionable conditions found do not justify further regulatory action). In 2019, the FDA classified approximately 200 inspections as OAI and approximately 3,000 inspections as VAI with the remainder as NAI. In 2020, the FDA only classified approximately 40 inspections as OAI and approximately 720 inspections as VAI with the remainder as NAI.
Figure 3
FDA Inspection Classification for 2019 and 2020
Figure 4 shows the noncompliance reports documented for the inspections performed during 2019 and 2020. In 2019, the USDA had approximately 80,500 non-compliances and in 2020 there were approximately 72,600 noncompliances documented.
Figure 4
USDA Noncompliances Documented in 2019 and 2020
Figure 5 shows the number of recalls that were handled by the FDA and USDA in 2019 and 2020. In 2019, the FDA reported approximately 260 recalls and the USDA reported approximately 126 recalls. In 2020, the FDA reported approximately 383 recalls and the USDA reported 31 recalls.
Figure 5
FDA and USDA Recalls in 2019 and 2020
Figure 6 demonstrates the outbreaks that were investigated by the CDC and FDA and/or USDA. In 2019, there were a total of 17 investigations and in 2020 there were a total of 10 investigations.
Figure 6
Outbreaks Investigated in 2019 and 2020 by CDC and FDA and/or USDA
While FDA inspections were reduced, the FDA did work with the industry to ensure foods were produced safely. For example, the FDA and the Occupational Safety and Health Administration (OSHA) provided a checklist for FDA-regulated human and animal food operations to use when assessing safe operations during the COVID-19 pandemic, especially when re-starting operations after a shut down or when reassessing operations because of changes due to the COVID-19 public health emergency. The FDA also initiated the New Era of Smarter Food Safety Blueprint (Food and Drug Administration, 2021) during the pandemic. The blueprint outlines achievable goals to enhance traceability, improve predictive analytics, respond more rapidly to outbreaks, address new business models, reduce contamination of food, and foster the development of stronger food safety cultures. It outlines a partnership between government, industry, and public health advocates based on a commitment to further modernize the approach to food safety. The New Era of Smarter Food Safety Blueprint is an approach that leverages technology and other modern tools to create a more digital, traceable, and safer food system. The blueprint is centered around four core elements:
1) Tech-enabled Traceability
2) Smarter Tools and Approaches for Prevention and Outbreak Response
3) New Business Models and Retail Modernization
4) Food Safety Culture
Conclusions
During the beginning of the pandemic, USDA inspections decreased, but the USDA was able to resume and increase inspections during the pandemic by increasing workforce and shifting personnel around to handle the increased production demand. The overall number of inspections performed by FDA, as well as investigations conducted by the USDA, FDA, and CDC, decreased during the pandemic until procedures and personal protective equipment were available to staff. No foreign inspections were conducted by FDA likely due to both the safety of personnel and travel bans, therefore, domestic inspections were limited to mission critical or for-cause inspections. When inspections were conducted by the FDA during the pandemic, the inspection classifications were comparable to inspection outcomes prior to the pandemic based on the number of inspections conducted. However, without resuming routine inspections due to the ongoing pandemic, determining if there is a correlation between food safety issues and the lack of inspections during the pandemic is not currently possible. Recalls handled by FDA increased during the pandemic.
Recommendations
Based on the data collected and the conclusions reached through the analyses of that data, the following recommendations are made:
1. The FDA and USDA should consider developing alternative ways of conducting inspections and investigations to regulate food operations during a pandemic, while still protecting employees.
2. The FDA and USDA should develop guidance for regulatory partners for conducting inspections and investigations during a pandemic.
3. The FDA should continue to usher in the New Era of Smarter Food Safety Blueprint so manufacturing facilities may adapt a food safety culture within their facilities, thus decreasing reliance on regulatory inspections to drive motivation to assure food safety.
4. More research is needed to determine if there is a correlation between lack of inspections and an increase in recalls. In addition, more research also is needed to determine if foodborne illnesses were or were not under reported during the pandemic affecting outbreak investigations.
Acknowledgments
I would like to acknowledge and sincerely thank my Director Ellen Buchanan for encouraging me to apply and for providing me the support to be able to participate in the IFPTI Fellowship Program Cohort IX. I also would like to thank Doug Saunders, who was an amazing mentor with a tremendous amount of knowledge. In addition, I would like to acknowledge the other IFPTI mentors and staff for their assistance and commitment to the fellowship program. This acknowledgment would not be complete without recognizing the other fellows for their hard work and dedication to public health. Lastly, I would like to acknowledge IFPTI for providing me with this wonderful opportunity.
References
Bagenstose, K. (2020, May 11). Inspections, citations, recalls slashed: Coronavirus is testing America’s food safety net. USA TODAY. https://www.usatoday.com/story/news/2020/05/11/food-inspections-citations-and-recalls-slashed-amid-coronavirus/3065141001/
Centers for Disease Control and Prevention. (2020, March 18). Foodborne Germs and Illnesses. https://www.cdc.gov/foodsafety/foodborne-germs.html
Elferink, M. & Schierhorn, F. (2016, April 07). Global demand for food is rising. Can we meet it? Harvard Business Review. https://hbr.org/2016/04/global-demand-for-food-is-rising-can-we-meet-it#comment-section
Johansson, R. (2020, April 16). Will covid-19 threaten availability and affordability of our food? U.S. Department of Agriculture. https://www.usda.gov/media/blog/2020/04/16/will-covid-19-threaten-availability-and-affordability-our-food
Sjerven, J. (2020, April 28). FDA addresses food safety during and after pandemic. Food Business News. https://www.foodbusinessnews.net/articles/15918-fda-addresses-food-safety-during-and-after-pandemic
U.S. Food and Drug Administration. (2021, April 29). New Era of Smarter Food Safety. https://www.fda.gov/food/new-era-smarter-food-safety
Author Note
Israel Juarbe, Jr, Consumer Safety Officer/Auditor
U.S. Food and Drug Administration
This research was conducted as part of the International Food Protection Training Institute’s Fellowship in Food Protection, Cohort IX
Correspondence concerning this article should be addressed to:
Israel Juarbe, Jr, U.S. FDA, 555 Winderley Place, Suite 200, Maitland, FL 32751
Israel.Juarbe@fda.hhs.gov
*Funding for this statement, publication, press release, etc., was made possible, in part, by the Food and Drug Administration through grant 5U18FD005964 and the Association of Food and Drug Officials. Views expressed in written materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services; nor does any mention of trade names, commercial practices, or organization imply endorsement by the United States Government.