Oct 25, 2023

FDA evaluates third-party standards for FSMA compliance

The Food and Drug Administration has vetted four third-party food safety audit standards and their alignment with the Food Safety Modernization Act requirements (FSMA).

The FDA’s pilot program to evaluate third-party standards focused on FSMA’s Preventive Controls for Human Foods Rule and the Produce Safety Rule. Produce buyers and other stakeholders in the food supply chains often use third-party audits to assess food safety of products they buy and sell or serve to consumers or distribute further down the supply chain.

Through the pilot program, the FDA selected food safety standards to assess for alignment with the Preventive Controls for Human Foods Rule (PCHR) and the Produce Safety Rule (PSR). According to the FDA, the third-party auditors’ standards aren’t required to be identical to those in the FSMA’s regulations, as long as it agrees with the technical components of the PCHR and PSR.

Third-Party standards

The third-party standards reviewed by the FDA are:

• BRC Global Standard Food Safety and the Global Standard Food Safety, Issue 9, Interpretation Guideline — aligns with the PCHF.
• The FSSC’s (Food Safety System Certification) 22000 Scheme 5.1 for Food Manufacturing and the FSSC 22000 5.1 FSMA PCHF Report Addendum — aligns with the PCHF.
• The Safe Quality Foods (SQF) Food Safety Code: Food Manufacturing, Edition 9 and the SQF Addendum for the Preventive Controls for Human Food — aligns with the PCHF.
• A.P. Integrated Farm Assurance — All Farm Base-Crops Base — Fruit and Vegetables Checklist Version 5.4-GFS and the GLOBALG.A.P. Food Safety Modernization Act Produce Safety Rule Add-On Module Version 1.2 — aligns with the PSR.

The reviews focused on the technical aspects of the standards and not the overall quality of their standards or qualifications of their auditors. Although the FDA said third-party audit standards provide value to the food industry, the agency doesn’t possess the resources to continue evaluating them beyond the pilot project.

New FDA food safety leader

Soon after the FDA released its audit standards review, the agency named a deputy commissioner for human foods, a new position established in the wake of a review of the FDA’s Human Foods Program. The new deputy commissioner for that program, Jim Jones, was a member of the Reagan-Udall Foundation’s Independent Expert Panel for Foods, which released the report.

The report led to a reorganization of the FDA’s Human Foods Program.

“I’m confident that under Jim’s leadership, we will build a stronger organization that will be integrated with other components of the FDA and focused on keeping the foods we regulate safe and nutritious, while ensuring the agency remains on the cutting edge of the latest advancements in food science and nutrition,” Robert Califf, FDA commissioner, said in a statement on Jones’ hiring.

Western Growers released a statement saying that Jones has a proven record of government leadership.

“We look forward to engaging with Jim as we collaborate on the critical need for the agency to deliver on its promises to aid consumers by setting a prevention agenda,” De Ann Davis, Western Growers’ senior vice president of science, said in the statement.

The International Fresh Produce Association’s Natalie Dyenson, chief food safety and regulatory officer, said the association is “thrilled” about Jones’ appointment.

“We have long advocated for the importance of having a unified Human Foods Program with a single point of accountability for food safety and program leader who can and will elevate the importance of foods within FDA,” Dyenson said in the statement.

— Chris Koger, managing editor