Meeting Pandemic Challenges with FSMA

Which FSMA mandated food safety requirements are being followed to remain in compliance during the current COVID-19 demands? Which are not?

Cheese slices on conveyor belt with gloved hands of worker in view.

Implementation of the guidelines of the Food Safety Modernization Act (FSMA) are currently being affected by the SARS-CoV-2 (COVID-19) pandemic. The FSMA which was enacted in 2011, is the most substantial reform of food safety laws in more than seven decades. As such, the FSMA regulates the way our foods are grown, harvested and processed. Especially increased FDA scrutiny has occurred with the ISO-accredited food safety laboratories through FSMA. It is very important to consider how FSMA requirements are related to the potential challenges associated with the COVID-19 pandemic and industry stresses. 

The FDA has recently posted an updated food safety and food supply FAQ (March 17, 2020) which addresses many of the common questions the food industry is currently asking concerning COVID-19 and its effect on food safety. “The purpose of this guidance is to state the current intent of the Food and Drug Administration, in certain circumstances related to the impact of the coronavirus outbreak (COVID-19), not to enforce requirements in three foods regulations to conduct onsite audits of food suppliers if other supplier verification methods are used instead.” (FDA, 2020)

The FDA is emphasizing that there is no evidence that food or food packaging–based transmission of the COVID-19 virus occurs. Additionally, the FDA continues to support their premise that the nation’s food supply remains safe and that food products do not have to be recalled or held if a food-facility employee is diagnosed with COVID-19.  The FDA has temporarily postponed routine domestic and foreign food facility inspections. Currently, inspections are limited to “mission critical” cases as deemed necessary. This would include class I food recalls, foodborne disease illness outbreaks, and independent specific COVID-19-related issues. 

The three regulations which have been modified by the FDA are: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (21 CFR part 117) (“part 117”); Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals (21 CFR part 507) (“part 507”); and Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (21 CFR part 1 subpart L) (“FSVP regulation”). (FDA, 2020) The FDA has offered new guidance to communicate these policy changes. These three regulations which were created to implement FSMA are better known as: The Preventive Controls for Human Food rule, the Preventive Controls for Animal Food rule, and the Foreign Supplier Verification Programs (FSVP) rule. The FSVP is now requiring importers and/or food receiving facilities to conduct their own supplier verification activities. These supplier verifications are completed on the basis of the processors hazard analysis plans (part of their Food Safety Plan). 

The current pandemic-induced surge in consumer food demand for safe products has been overwhelmed by the evolving capacity responses of domestic supply chain needs. Additionally, new industry practices, policies, procedures and actions to prevent the possible interpersonal contamination of COVID-19 from farm to fork, are being challenged and implemented by industry. Standard Operating Procedures (SOPs) and Best Practices (BPs) are the foundation for FSMA action and these have changed as required by consumer purchasing patterns. New procedures and requirements are now demanding exemplary execution while at the same time adapting to flow-through requirements of these new consumer purchasing patterns. The food industry has continued to be at the forefront stepping up to improve and maintain food safety.  Our “new industry normal” is continuously being developed/adapted and utilized by processors and producers. Domestic and global demand is high for food and these newer SOPs must continue to ensure uniformity and transparency, clear and concise internal and external communication and the implementation of changing BP food standards.

Our industry is doing an outstanding job with the adoption of new requirements while still meeting FSMA guidelines. It is important to reflect on how these changes in consumer demands and supply chain issues relate to the potential industry challenges associated with COVID-19 and necessary safety adjustments. Industry needs to ask the important question:  Which FSMA mandated food safety processes, crop production, harvesting and processing requirements are being followed to remain in compliance during the current COVID-19 demands?  Which are not? The food industry is currently maintaining and complying with the required ability, actions and exemplary expertise during these extremely trying and difficult times to meet consumer needs without diluting essential focus on food safety competencies. 

Prior to the current COVID-19 pandemic, the food processing and supply industries met many challenges required in the implementation to full FSMA compliance. Industry continues to meet these needs. Additionally, with the pandemic, inspection, enforcement and compliance requirements have faced inherent challenges. Industry recognizes that more stringent controls need to be implemented especially within the produce industry, to prevent disease outbreaks. Also, industry has made substantial improvements in baseline compliance with FSMA provisions over the past few years and even now as pandemic improvements are required. Substantial industry efforts have been implemented during the pandemic to identify, quantify, qualify and adopt scientifically valid FSMA compliant process management parameters. Additionally, verification programs through "Hazard Analysis and Risk-Based Preventive Controls" (HARPC) compliance has increased to meet the consumer food needs.  

Our food industry is facing disproportionate pandemic challenges to ensure harvest and post-harvest production staff, processing equipment needs, PPE and necessary material requirements are met. Through all of this, FSMA cleaning and sanitation requirements are still a top industry priority to insure food safety standards. Gains are still being made in Environmental Monitoring Programs to prevent and control diseases such as Listeria monocytogenes from establishing populations within processing plants. Preventing disease establishment in post-harvest packing and processing facilities has remained a top priority. However as seen on a daily basis, improved communication between harvest, post-harvest handling, processing operations and packing/packaging does need improvement. Careful evaluation of industry throughput capacity across the entire product flow steps to meet FSMA requirements has been a challenge with massively increased and changed consumer product demands. Managing the supply chain is more surely the most challenging component to adequate domestic safe food production. Pandemic impacts to the mission-critical supply chain components has in many cases been devastating especially at the harvest and post-harvest levels and production supply chains. Our national news has shown the wastage of American crops during these trying times.

Companies should be identifying their minimum required inventories for designated consumer and industry critical products and subsequently determine which products to collaborate with suppliers on. This will allow production to change their Best Practices (BP) to meet FSMA requirements. Retail service companies should also continue identifying their required products, goods and services and increase specific needs based on consumer demand. Production companies must continue to maintain an open dialogue with suppliers as a plan to maintain operations throughout the pandemic. On the other hand, food producers and manufacturers will need to continue to evaluate inventory requirements and make important assessments of what products they can harvest or manufacture safely while meeting FSMA guidelines during the pandemic. Difficult decisions in many cases will have to be made about realistic retail services and consumer expectations. Disrupted supply chains have changed what can be harvested and produced.           

It is extremely important for the U.S. food industry to immediately take any additional necessary steps to mitigate the risk of suffering through the impending negative impacts from the coronavirus. The good news for food industry professionals is that by continual positive adaptions and changes made during this pandemic, the overall final health of our food service and supply industry will be substantially strengthened and moving toward the continued expectations of the FSMA guidelines. The industry commitments across the food and product supply chains to begin protecting employees, customers, producers and consumers from exposure to COVID-19 has been outstanding.


  1. U.S. FDA (2019) Food Safety and Corona Virus
  2. U.S. FDA (2020) Temporary Policy Regarding Preventive Controls and FSVP Food Supplier Verification Onsite Audit Requirements During the COVID-19 Public Health Emergency Guidance for Industry

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