Editor’s note: In part four of this four-part series with SafetyChain Software, Food Safety News is exploring how food firms can become resilient in the face of 2021’s new challenges, and how resilience will be needed in anticipating government oversight.
Dr. David Acheson, CEO and president of The Acheson Group, suggests that food firms will need resilience when anticipating government oversight.
The U.S. Food and Drug Administration suspended inspections at the beginning of the COVID-19 pandemic, but recently these assessments have resumed. The frequency of these inspections is based on the risk of a foodborne outbreak associated with a company’s facility, the type of products they produce and the company’s history.
A number of factors determine how often these inspections occur.
“Domestic facilities deemed to be high risk will be inspected every three years, while low-risk facilities will undergo an inspection every five years,” Acheson said. “Just 2 percent to 5 percent of imported foods are inspected by the FDA, while the USDA inspects 100 percent. Imported food may also be refused at port, and any events may prompt regulators to place a company on an import alert.”
In addition to the regularly scheduled inspections, Acheson says a number of events can trigger a “for cause” inspection, including:
- an illness is linked to a product;
- a product has been tested and revealed to be contaminated;
- there have been customer complaints which prompt investigation;
- follow-up for prior observations is required;
- follow-up to a Reportable Food Registry report for someone else is required; or
- follow-up to a recall the company initiated is required.
Acheson stresses that, especially during these times, it is important to be prepared for audits at all times.
When these inspections uncover violations, the FDA sends firms warning letters. The letters list the violations based on findings from the inspections. The recipients are then given 15 days to respond to the letters and to inform the FDA how they plan to address the violations.
For the first time, on Sept. 15 2020, the FDA issued a consent decree of permanent injunction against a firm and grower for violating public safety standards under the Produce Safety Rule. This action came two years after sending a warning letter to the firm, and nine years after gaining the power to do so.
The action regarding Fortune Food Product Inc., an Illinois-based processor of sprouts and soy products, involves violations of the sprouts portion of the Produce Safety Rule, which is part of the 2011 Food Safety Modernization Act (FSMA).
Examples like this show the changing landscape of regulation, and how important it is for firms to ensure they are following federal guidelines.
Specifically, the impact of FSMA continues to permeate the food industry. Acheson notes the following recent changes taking place:
- The FDA is now using state inspections to assess for compliance with the Produce Rule.
- Imported foods are an increasingly important area of focus and are required to comply with the Foreign Supplier Verification Program.
- Foreign facilities must be fully compliant with FSMA if importing to the U.S.
- Foreign inspections are risk-based and are currently suspended because of COVID-19 risks.
FDA’s New Era of Food Safety
The FDA blueprint for the agency’s “New Era of Smarter Food Safety” represents a new approach to food safety, leveraging technology and other tools to create a safer and more digital, traceable food system.
According to the FDA, the blueprint seeks simpler, more effective and modern approaches and processes. The ultimate goal is to lower the number of foodborne illnesses in this country.
More on the blueprint can be found on The New Era of Smarter Food Safety website.
Acheson points to how the “New Era of Smarter Food Safety” blueprint emphasizes the importance of leveraging technology to establish a safer and more traceable food system.
“TAG and SafetyChain customers are already checking some of the recommended boxes, using tech-enablement and smarter tools and approaches to achieve supply chain control, enhance quality and safety, trend data and manage third-party audits, among other initiatives,” Acheson says.
In short, a food firm’s best chance to deal resiliently with government oversight is to leverage technology effectively.
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