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Covid-19 Limited FSMA Regulation Ending

Worthy goal: Prevent contamination of human and animal food, not just respond to it.

That’s how the Food Safety Modernization Act, signed into law in 2011, refocused food and feed safety regulation under the U.S. Food and Drug Administration. The American Feed Industry Association and other industry groups have collaborated with training efforts since 2015.

However, during 2020-21, Covid-19 and the coronavirus pandemic slowed full-scale FDA inspections for FSMA compliance, including feed mill inspections.

“For the past two years,” says Gary Huddleston, AFIA Director of Feed Manufacturing & Regulatory Affairs, “the FDA has concentrated mainly on ‘for cause’ or ‘mission critical’ inspections of facilities, which for example typically occurs following a product recall.

“FDA is now renewing its focus on routine inspections. So we’re going to see increasing inspection activity, not just for high-tonnage, interstate manufacturers but for smaller, local operations, too.

“The FDA is now moving toward a more comprehensive inspection model since FSMA covers every facility that holds, manufactures, processes, or packs food for animals.”

What does FSMA require?

Huddleston notes that facilities, including retail outlets, that only hold animal food still must:
• Comply with requirements of Current Good Manufacturing Practices
• Train qualified individuals

In addition, facilities that manufacture, process, or pack animal food also must:
• Designate and train a Preventive Controls Qualified Individual
• Conduct a Hazard Analysis
• Develop a written Food Safety Plan covering identified hazards

If you’re starting from “ground zero,” Huddleston says, basic training is the best way to understand responsibilities under FSMA. Training helps prevent confusion in case of an unannounced FDA or state feed control inspection. See AFIA educational resources.

One of the most challenging parts of FSMA compliance is the Hazard Analysis, which varies by facility, considers ingredients and processes, and identifies hazards to animals as well as humans.

A facility’s written Food Safety Plan can have a flexible format, Huddleston says, but it should describe the facility’s risk-based approach to managing the identified hazards.

Beyond preventive controls, CGMP requirements, a Hazard Analysis, and a Food Safety Plan, there may be other applicable FSMA requirements. For guidance, you’re welcome to email Gary Huddleston.

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