FSMA: The Sanitary Transport Rule
All food plants in the US perform distribution and penetration studies by utilizing a Process Authority (PA), who then files the results with the FDA and/or the USDA.
Distribution testing can be needed for many reasons that include, but are not limited to:
- New retorts/autoclaves
- New loading schemes
- New container
- New racking/holding system for container
- Change in utility supply and/or exhaust
- Valves
- Boilers
- Compressors
- Drain routing
- Cooling Water Handling
- Retort mechanical changes
- More/fewer plates in heat exchangers
- Orifice plate change (flow determination)
- System cleaning (mainly water spray retorts)
Not all the above require distribution retests, but most do, and in general, are rare. However, 1. And 2. happen regularly at co-packing facilities (facilities which do not have their own labels, but run products for other brands).
The reasons for doing penetration testing include but are not limited to:
- New product formulation, container, or loading pattern
- Change in product formulation
- Change in meat
- Change in particle size
- Change in starch
- Others
- Change in container dimensions or shape
- Change in retort process, i.e. water immersion process vs. water spray process
- Change in loading pattern
- Process deviation clearance
The specific testing requirements at each site depend on the PA. The frequency of the items in the list above depend on the plant itself. If a plant runs the same thing or a few of the same things (containers and/or products) all the time, they’re less likely to run distribution a lot and they might only run penetration testing if they have a very rare, unclearable deviation. Co-packers might run distribution, penetration, or both multiple times every day for multiple reasons from the list above.
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