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FSMA Compliance Update

Important reminders now that FSMA inspections are under way


During the AFIA Feed Production Education Program at IPPE on Wednesday morning, Gary Huddleston, American Feed Industry Association’s director of feed manufacturing and regulatory affairs, reminded attendees that as far as FSMA is concerned, “everything is required now.”

FDA Food Safety Modernization Act (FSMA), which was signed into law in 2011, is the most sweeping reform of food safety laws in more than 70 years.

“FSMA is on everyone’s mind,” says Huddleston. “It’s come through all its stages and everyone should be in compliance.”

Huddleston said that small businesses – those with less than 500 employees – can expect inspections to start in the fall. These inspections will combine CGMPs, medicated feed, BSE and more together, so expect the inspectors to be at the facility for several days, he says.

Huddleston had some other reminders:

  • A qualified individual training should be in place
  • A designated PCQI (Preventive Controls Qualified Individual) should also be in place
  • Hazard Analysis and Food Safety Plans required
  • Sanitary transportation rule compliance required
  • FSVP rule compliance required

Huddleston also said AFIA has learned some from feed facilities that have gone through the inspection process what to expect.

“Most of the inspection have been CGMP inspections,” he says. “Not many have been preventive controls inspections.”

  • Inspector will do a walk-through of the plant
  • Pest control seems to be a major focus. “It’s best to get an outside pest control firm that understands FSMA rules,” says Huddleston.
  • Unlabeled containers and trash cans are frequent observations
  • Will ask to see QI training documentation
  • Will ask about PCQI and training, including who is it and how were they trained
  • Frequently, they are asking to see records for which they may not be entitled to see. “The FDA may ask to see your complaints,” he says. “Food safety complaints should be separate from other types. They only need to see food safety focused complaints.”
  • Will ask to see hazard analysis and food safety plan. “Have this ready to go – it’s required now,” says Huddleston.
  • Best preparation – know the rule!

Huddleston says there are several FDA FSMA guidance documents available. The best, he says, is #235 Current Good Manufacturing Practice Requirements for Food for Animals. There is a self-assessment tool (inspection checklist).

“As a facility manager, take this list and walk your plant with it,” he says. “It’s the best way to see through the eyes of an inspector.”

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