Egg Industry News and Commentary

  —  Aug 25

 
FDA to Delay Compliance Inspections for FSMA

Richard Sellers

 

    

According to a posting on the website of the U.S. Food and Drug Administration, the Agency has delayed inspections of feed plants to ensure compliance with the Food Safety Modernization Act. Inspections scheduled for 2017 will be delayed until the Fall of 2018 according to Dr. Steve Solomon, Director of the FDA Center for Veterinary Medicine. This will also delay inspections under the Foreign Supplier Verification Program.

The move was enthusiastically endorsed by the American Feed Industry Association. Richard Sellers, Senior Vice President of Public Policy and Education commented “Producing safe, nutritious food and compliance with the law is the animal food industry’s number one priority.

However, given FSMAs far-reaching and expensive regulatory impact that extends into all areas of our members’ business operations, we have been asking the Administration and Congress to provide a reasonable timeframe so that our members can conduct the necessary action they need and dedicate new resources to come into full compliance with the law.”

  

The action by the FDA is an indication of their deficiencies in planning and execution. The egg industry will recollect the problems associated with introduction of on-farm inspections required under the Salmonella Prevention Rule. There was little coordination among regions carrying out inspections, personnel were totally ill-equipped and untrained to evaluate farms or to appreciate the realities of commercial egg production.

Inspectors who had spent the majority of their careers in pharmaceutical plants were confronted with farms with high-rise houses, six feet of manure and mice. Initially the inspections were time-consuming and laborious since farmers, their Veterinarians and quality assurance personnel had to virtually train and instruct the FDA inspectors. The program only gathered speed when the USDA delegated responsibility for farm inspections in a number of states to respective department of agriculture in major egg-producing states including Ohio, Indiana, Pennsylvania, California and Iowa.

In advance of a FMSA debacle, the FDA would be well advised to step back, ensure that guidance documents are provided for review and comment by the industry. Inspectors must be trained as to what might be considered acceptable and normal and to realistically evaluate deviations from standard procedures. If FSMA degenerates into a paperwork exercise, the value with respect to prevention of food-borne infection will be lost.

The underlying message for FDA is that they should communicate with industry organizations and specialists in both industry and academia to establish standards and to ensure that personnel are appropriately trained before embarking on a national inspection program.

The Salmonella Prevention Program was incubated and hatched entirely in isolation by the FDA without consulting the industry. Within three months of inception of the program, individuals associated with the rule were still trying to obtain information on the efficacy of vaccination which had already been adopted by the U.S. industry as a standard and had proven effective in the E.U. for over a decade prior to 2010. The guidance documents were only available after initiation of the program.