June 18, 2018

June 18, 2018

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FDA Delays Preventive Controls Inspections for Large Animal Food Facilities

  • The second major compliance dates are coming up for the Preventive Controls for Animal Food Rule under FDA’s Food Safety Modernization Act (FSMA). On September 18, 2017, larger animal food facilities must comply with preventive controls requirements mandated by FSMA. These facilities had to meet Current Good Manufacturing Practice (CGMP) requirements by September 2016.
  • As background, the Final Rule for Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals, 80 Fed. Reg. 56170 (Sept. 17, 2015) under FSMA became effective on November 16, 2015.  The final rule accomplishes the following:
    • It establishes for the first time CGMPs for food for animals, which are akin to the CGMPs that have long applied to human food;
    • It requires animal food facilities to develop a written food safety plan that includes hazard analysis and imposes risk-based preventive controls (HARPC);
    • It requires the establishment of a supply chain program; and
    • It clarifies the facilities that are subject to CGMPs and HARPC requirements, and the exemptions from these requirements, including exemptions for “farms.”
  • For the CGMP requirements, food facilities generally had one year from publication of the final rule (September 19, 2016) to comply.  “Small Businesses” (a business employing fewer than 500 full-time equivalent employees, regardless of sales) and “Qualified Facilities” (which includes “Very Small Businesses,” i.e., businesses averaging less than $2.5 million per year (adjusted for inflation) in sales of animal food plus the market value of animal food manufactured, processed, packed, or held without sale) have until September 18, 2017 and September 17, 2018, respectively, to comply with the CGMPs.
  • For the HARPC requirements, the general compliance date (i.e., for large facilities) is two years from publication of the final rule (September 18, 2017), while small businesses and qualified facilities (including very small businesses) must comply by September 17, 2018 and September 17, 2019, respectively.
  • FDA recently announced in a post by Jenny Murphy of FDA’s Center for Veterinary Medicine (CVM) that the Agency would be delaying preventive controls inspections until the fall of 2018. At the same time, FDA announced that there will be an increased level of oversight of CGMPs with more routine inspections because, as of September 18, 2017, both large and small facilities will be required to meet those requirements.  The Agency’s thinking here is that CGMPs are the foundation that must be in place before you establish preventive controls – “CGMPs establish a base to make sure you don’t contaminate the animal food and the preventive controls take it a step further by making you really concentrate on things that, if they’re found in animal food, could be a public health concern. Once you have CGMPs in place, you can see where you need extra layers of protection.”
  • For additional details concerning FDA’s plan to delay preventive controls inspections see FDA’s post on “What to Expect With the Next Compliance Dates for the FSMA Preventive Controls for Animal Foods Rule” here.
© 2018 Keller and Heckman LLP


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Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...