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TAG May 15, 2019 0 Comments

In April’s FSMA Friday webinar, Clarifying the State’s Role in FSMA Inspections, TAG Senior Director – Food Safety Ben Miller discussed the partnership between FDA and the states in the conducting of FSMA Preventive Controls for Human Food (PCHF) inspections. As the former director of Minnesota’s Food and Feed Safety Division, responsible for the program management and planning of the state’s food inspection and outbreak responses, Miller has first-hand experience with PCHF inspections. Minnesota is one of 23 states that currently conduct PCHF inspections on behalf of FDA. Some states also are conducting Preventive Controls for Animal Foods (PCAF) inspections and Produce Safety Rule (PSR) inspections are being conducted primarily by the states with grant support from FDA. The grant support for inspections and outreach was determined to be the best route for PSR because the state departments of agriculture had pre-existing relationships with growers who had not had to undergo federal food inspections in the past. Currently 44 states have applied for and received the PSR grant; inspections in the other six states will be conducted by FDA itself. While the PCHF partnership with the states is helping FDA meet its required number of annual inspections, there is variability among states that is causing some challenge, particularly for the facilities being inspection. Among the variations are: In the states that are partnering with FDA, inspectors may conduct inspections under state regulatory authority or on behalf of FDA (i.e., under FDA contract). If on behalf of FDA, it means that FDA has identified the facility as one for a PCHF inspection to be performed by the state. FDA pays the state to do so, and the state inspector shares all information gathered with FDA. If under state regulatory authority, the inspection may be PCHF- or GMP-based. Because PCHF-based inspections are multi-day events, state inspections that are not FDA contracted inspections, are more likely to be GMP-based. While many of the states have adopted the FSMA rules (21 CFR 117) as state regulation, some have not. Those that haven’t conduct inspections under state auth inspect to 21 CFR 110. But, even if the state has not adopted the newest federal regulations at the state level, an inspection can still be conducted under FDA authority by a “credentialed” state inspector who will present an FDA ID. With all these options and variations, it is important that the facility know exactly what type of inspection is to be conducted, and under whose auspices, when a state inspector shows up at the door. Not only will the inspection itself vary, but the type of enforcement action can also be different. That is, if there is any enforcement action, the authority under which the inspection was conducted will determine the action, as the states and federal authorities have different tools for enforcement. For example, a state inspector could write corrective action orders on site, requiring 10- or 30-day action, etc. States also have administrative, criminal and civil penalty authorities; they can assess monetary penalty, such as for repeat violations. If, on the other hand, the inspection is being conducted on behalf of FDA, the inspector will write up the report with recommendations. But the FDA will determine the enforcement action (warning letter, injunction, seizure, etc.), based on different classifications, e.g., Official Action Indicated (OAI), Voluntary Action Indicated (VAI) or No Action Indicated (NAI). Thus, the importance of knowing what your state requires (e.g., PCHF or GMP) and understanding the basis and authority of each individual inspection. If you don’t know, ask upon start of the inspection. As we move into the future, it is expected that this federal-state partnership will continue, and even build, to enable FDA to meet its workplan obligations, which require that high-risk facilities be inspected at least once every three years and non-high-risk at least once every five years. Click here for a recorded version of this and other FSMA Friday webinars. Hosted by SafetyChain Software, FSMA Fridays is a monthly live webinar with The Acheson Group (TAG), providing the industry with the latest news and insights on FSMA.  Have a question about FSMA? Need assistance with FSMA compliance or gap assessments? Contact TAG today About The Acheson Group (TAG) Led by Former FDA Associate Commissioner for Foods Dr. David Acheson, TAG is a food safety consulting group that provides guidance and expertise worldwide for companies throughout the food supply chain.  With in-depth industry knowledge combined with real-world experience, TAG’s team of food safety experts help companies more effectively mitigate risk, improve operational efficiencies, and ensure regulatory and standards compliance. Learn more at:


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