FSMA Draft Guidance on Supply Chain Program Preventative Control for Animal Food Released by FDA

Animal food facilities without a supply chain program have gotten a potential helping hand through a draft guidance issued by the FDA on June 14, 2018, entitled “Guidance for Industry #246: Hazard Analysis, and Risk-Based Preventative Controls for Food for Animals: Supply-Chain Program.”

The Food Safety Modernization Act (FSMA) requires animal food facilities to have a food safety plan in place that includes an analysis of hazards to determine which ones need control and risk-based preventive controls to minimize or prevent those hazards. 

The draft guidance brings to light in section V.C.1, an important exception for importers that exists in 21 CFR 507.105(a)(2):  A receiving facility that is an importer, is in compliance with the foreign supplier verification requirements under part 1, subpart L of this chapter, and has documentation of verification activities conducted under § 1.506(e) of this chapter (which provides assurance that the hazards requiring a supply-chain-applied control for the raw material or other ingredient have been significantly minimized or prevented) need not conduct supplier verification activities for that raw material or other ingredient. We encourage you to look at the notice to ensure you are (or are exempt from) complying with this set of rules. 

Meanwhile, the draft guidance also assists animal food importers that are subject to program requirements under the Foreign Supplier Verification Program (FSVP). The public comment period for this draft guidance goes through December 13, 2018. Compliance dates are staggered by size of company:  larger animal food facilities had to comply with preventive controls requirements mandated by FSMA by September 18, 2017. These facilities also had to meet Current Good Manufacturing Practice (CGMP) requirements by September 2016.

Small animal food facilities – those with fewer than 500 full-time equivalent employees – were also required to meet the CGMPs by the September 2017 deadline, but they have until September 18, 2018 to meet the preventive controls requirements. Compliance dates for Very Small Businesses are offset further, with CGMP compliance scheduled for September 17, 2018 and preventative controls requirements scheduled for September 17, 2019.   

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