Now that the FDA is actively conducting FSMA preventive control inspections, it’s time to clarify the interplay between Federal and State inspection programs. Ben Miller, Ph.D., of TAG, explains how Fed/State inspections overlap & differ and outlines the unique authority and regulations some states have.

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WHAT WE WILL COVER
üFSMA Update
üThe States’ Role in FSMA Inspections
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Presenters
Brian Sharp
President
Ben Miller, PhD
Senior Director – Food Safety
• 20+ years industry experience in public health, food
regulation and food safety management
• Division Director of the Food and Feed Safety Division at
the Minnesota Department of Agriculture
• Epidemiologist at the Minnesota Department of Health

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The States’ Role in FSMA Inspections
Ben Miller, Ph.D.
Senior Director – Food Safety

8. • FSMA passed in January 2011
• FDA and a few states starting inspecting under Subpart 21 CFR 117
Subpart C in late 2017 at a few facilities in the US
• Preventive Controls for Human Foods
• Currently about 5 states conducting inspections
• Preventive Controls for Animal Foods
• Produce Safety (done primarily by states with grant support from FDA)
Background

9. • What are the states’ role in conducting and enforcing FSMA
regulations?
• Varies from state to state
• Dependent on how states adopt federal regulations
• Some states haven’t fully adopted the current version of 21 CFR with regards to
FSMA regulations
• States usually inspect more frequently than FDA
States’ Role

10. • State FSMA PCHF Inspections
• Can be conducted solely under state regulatory authority in states that have adopted
FSMA
• Can be conducted under state regulatory authority on behalf (under contract) of FDA
• Can be conducted by the state under FDA authority using “credentialed” state
inspectors
PCHF Inspections

11. • State FSMA PCHF Inspections
• Enforcement authority will depend on how the inspection was conducted
• Under state authority – the state will take enforcement action using its authority
(administrative, civil, or criminal)
• Under state authority for FDA contract inspections – FDA will determine any relevant
enforcement actions
• State inspector under FDA credentials – FDA will determine any relevant enforcement
actions (warning letter, injunction, seizure, etc.).
PCHF Inspections

12. • Inspection times for both state and FDA are significant
• Partnership between FDA and states will continue to meet FDA
workplan obligations
• 3 years for High Risk facilities
• 5 years for non High Risk facilities
• More states will start to inspect as their inspectors are trained
• May need to meet state and FDA requirements (110 & 117)
• Important to understand under what authority the state is
conducting the inspection
• Any possible enforcement will depend on this authority
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