• The Acheson Group

Ensuring Food Safety Despite Reduced Regulatory and Standards OversighT


As discussed in a previous TAG Insights article, FDA postponed most foreign and all routine domestic inspections at least through April, due to the COVID-19 pandemic. Similarly, GFSI has set contingencies to enable businesses to continue or establish certification, while still conforming to government recommendations to “flatten the curve.” The primary impact of both is a significant, or complete, reduction in site visits for inspections or audits. Because that will somewhat diminish the effectiveness of government regulatory programs and GFSI certification programs, food facilities need to ensure that their internal food safety controls remain strong during this reduced external oversight. This will have particular impact when these third-party inspections are part of your supply chain risk control program.


In addition to areas covered in last week’s article, Maintaining Food Safety in the COVID-19 Era, which focused on those that are likely being impacted by the pandemic, other key areas on which food facilities should focus to continue to mitigate operational, reputational, and regulatory risk during this time are:


Regulatory and Standards Compliance. Even if inspectors and auditors are not showing up at your site, you are still responsible for complying with all applicable regulations and certificated standards. FDA and USDA are providing regular updates on their websites (USDA, FDA). To provide information and advice to food manufacturers who are wondering about their GFSI status, TAG compiled current responses from the main GFSI standard owners, available at GFSI COVID-19 Contingencies on our FAQ page.


Environmental Controls and Monitoring. Environmental contaminants have proven to be the cause of food contamination leading to numerous recalls. Not only is controlling environmental risks in the food facility and being able to demonstrate effective control through a robust environmental monitoring program (EMP) a critical part of a food safety program — it is a regulatory requirement under the FDA and USDA/FSIS, as well as Canada’s CFIA. While sampling your environment (in place of FDA “swab-a-thons) is important, it is essential to remember that you can't test food safety into a product, so it is critical to not simply monitor your manufacturing environment through testing, but to ensure your preventive controls continue to be in place and your Food Safety Plan be followed. This includes conducting root-cause analysis and corrective action when needed to help ensure a pathogenic contamination doesn’t add to the already challenging era of COVID-19.


Recall and Crisis Management. An efficient and effective recall management plan is predicated on having a good product tracking system and knowing “at the click of a mouse” who got which products, and when, at any given time. But a good plan also has a written recall strategy and initiation procedures, well-trained personnel, cohesive communication – and a well-developed, quick-response crisis management plan. With the potentially reduced workforce caused by COVID-19 absenteeisms, it becomes even more critical to have a quick-action plan in place with back-up and cross-trained personnel. It also is advisable to contact your customers and suppliers – at least one forward and one back – to determine alternate contacts and contingency plans should your primary contact be out.


Intentional Adulteration/Food Defense. With FSMA’s Intentional Adulteration (IA) Rule, food defense became increasingly important for all food facilities. A unique aspect of the IA Rule is the requirement to assess your facility and processes for vulnerabilities, and to implement mitigation strategies preventing potential “insider attacks” and “acts of terrorism” against the food supply. This Rule not only works to protect the public, it also benefits food businesses by protecting your brand. The IA Rule also requires general awareness and specific training to employees and supervisors based on their roles, and the development of a Food Defense Plan that addresses significant vulnerabilities identified through a risk or vulnerability assessment, focused mitigation strategies, and monitoring, verification and corrective action procedures


Should your food business need support, assistance or training in any of these areas, contact TAG. We have virtual training programs and new remote technology applications by which we are continuing the support we have always provided.



About The Acheson Group (TAG)

Led by former FDA Associate Commissioner for Foods Dr. David Acheson, TAG is a food safety and public health consulting group that provides guidance and expertise worldwide for companies throughout the food supply chain. With the advent of the COVID-19 pandemic, TAG’s public health and infectious disease expertise has been brought to the forefront to assist food businesses weather the increased challenges of employee protection, food safety, and business continuity. With in-depth industry knowledge combined with real-world experience and advanced virtual technologies, TAG’s team of experts helps companies assess their unique situation, address gaps, and deploy best practices to more effectively mitigate risks, improve operational efficiencies, and protect their brand. www.AchesonGroup.com


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