FDA DELAYS FSMA PREVENTIVE CONTROLS INSPECTIONS UNTIL 2018

On August 10, FDA provided a significant update on its inspection plans for the preventive controls for animal food rule under the FDA Food Safety Modernization Act (FSMA). ASTA members will recall that certain facilities may be affected by FSMA if a small portion of seeds are diverted for animal feed when they are not viable for use in planting. According to draft guidance from FDA, processing and harvesting activities like shelling, hulling and chopping husks are considered “manufacturing” when conducted in a facility. FSMA requirements are to establish Current Good Manufacturing Practices (CGMPs) and to analyze potential hazards and implement Preventive Controls for them.

FDA has announced that as of September 18, 2017, FDA will conduct CGMP inspections for both large and small animal food facilities (those with over $2.5 million in animal food sales) but will not be conducting routine regulatory inspections to ensure compliance with the preventive controls requirements.  The agency will not conduct such inspections until the fall of 2018.  This is part of FDA’s plan to “educate before and while they regulate.”  The agency has heard from animal food producers that they need more time and technical assistance to fully understand the requirements, so they want to give the larger facilities some flexibility to further develop their plans and ensure that their systems are operating correctly. For more information on this announcement, click here.