The Food Safety Modernization Act’s (FSMA’s) staggered implementation continues with two new compliance events for the animal food industry starting yesterday, September 18, 2017.
- “Large” Facilities (500 or more employees) must comply with the Hazard Analysis and Risk-based Preventive Control Rule (referred to as PCR or HARPC). This regulation requires a facility to conduct a hazard analysis and implement appropriate controls for the significant hazards.
- Small Facilities (fewer than 500 employees) must comply with the Current Good Manufacturing Practices (cGMPs) requirements. This regulation establishes baseline standards for the sanitary manufacturing of animal food – large facilities had to comply with this requirement starting last year.
While the compliance date is September 2017, FDA indicated that they will not start inspecting animal food facilities for compliance with the Preventive Control Rule until fall of 2018 – a year later. Relatedly, that is also when FDA will first start inspecting affected animal food importers for compliance with the Foreign Supplier Verification Program (FSVP) too.
While this gap may be confusing, we believe practical reasons can explain this gap between the compliance date and the inspection dates. Until FSMA, non-medicated animal foods along with cosmetics were the only two primary FDA commodities not subject to a cGMP requirement. By way of context, FDA’s human food cGMPs are over 30 years old with industry and FDA well trained on the requirements. On top of this rich history, FSMA added the Preventive Control Rule, whose root concepts have been explored by FDA in various forms since the mid-1990s. During that time the food industry has become quite familiar with the concepts and conducted independent research into various issues.
Animal foods, on the other hand, over a few short years needed to develop both cGMPs and PCRs regulations (which admittedly mirrors human food regulations closely) and determine how they apply in an animal food context. While FDA refers more heavily to the industry’s desire for more clarity, it is “new terrority for all of us [including FDA].” CVM and their inspectors (the smallest group in FDA) need to additionally train their staff on these issues. This all takes time.
Manufacturers should not take this year-long interlude to do nothing. Rather they need to implement PCR now and be prepared whenever the FDA inspection comes. A firm’s understanding and implementation of the requirement is essential for creating a positive first impression that will set the tone with FDA from then well into the future.
Our staff at FDAImports.com and our affiliated attorneys are here to help you navigate through the maze of PCR implementation and prepare you for the inspections to come. Contact us today!
