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FSMA Conversation, AAFCO Annual Meeting 2019

This was not a training session. Rather, this all day session discussed industry and regulatory perspectives over the file0001865744985last 18 months of FSMA inspections. There were essentially four sessions: the NC State regulatory experience, an industry perspective, the FDA’s view, and a panel of state regulators. Synopsis below:

From NC State, extension:

  • If you don’t know where to start in creating your food safety plan (FSP), then it’s a great idea to start with standard operating procedures (SOPs).
  • Once all of those are documented, from there you can build your hazard analysis and critical control point (HACCP) plan.
  • In developing your HACCP, if there is a hazard that doesn’t need a preventive control (PC), document it. Otherwise, there’s opportunity for “discussion“ with inspector who may see a need for a PC.
  • Reminder that there continues to be courses available for training.
  • A “blended“ curriculum to deliver preventive controls qualified individual (PCQI) training is in development. The goal is to deliver most of the training on-line with only need for a one-day in-person session, of the current three day session.

The speaker lead a discussion regarding

  • dilated cardiomyopathy (DCM),
  • phenobarbital,
  • pathogens,
  • “risk to humans”,
  • vitamin d excesses,
  • diverting food to swine (esp concerning African swine fever),
  • aflatoxins,
  • and pest control.

The key is that if there has been a major public health issue, like DCM, or a recall issue, like phenobarbital, manufacturers need to discuss these items in their HACCP. Even if you don’t see it as a potential risk – state it as such and why. The topics need to be specified as they will be on the inspector’s radar.

One final point from the regulator’s perspective: the major deficiencies that they have seen have been

  • insufficient PCQI training and documentation of such,
  • and pest control problems.

Rodents and roaches. Ew.

Industry perspective

A great discussion was lead by Dave Fairfield, of National Grain and Feed Association (NGFA), regarding what the FSMA inspections have been like for the large companies.

In a nutshell: “Be prepared to expend significant resources during inspections”

There’s no inspection checklist, although Industry has been asking. (Apparently the checklist is all of the pertinent regulations.)

Investigators want you to talk , explain, justify, and tell your story. Whoever signs off on the FSP at the local level should be able to talk about it.

Inspectors are authorized to come whenever the FDA decides, no warrant is needed.


Several critical business actions will help facilitate a more favorable FSMA inspection. These recommendations are available to Next Gen PFMA members upon request. (support@ngpfma.org)


Many statistics were presented

  • 400 cGMP inspections were conducted in FY 2018
    • 60% by FDA
    • 40% by state officials
    • 6% of facilities received written FDA Form 483s – warning letter explaining the inspectional deficit(s)
    • 1 warning letter issued
  • The findings were principally
    • Pests
    • Housekeeping
  • 2018 was mostly feed mills

Routine inspections for “small” manufacturers start this fall. Some “small” sized companies were inspected in FY 2019; these were “for cause”. “For cause” means a company has had a reportable food report (RFR) or complaint filed.

The FDA has planned for 330 routine and “for cause” inspections to commence October 2019 (FY 2020).

Routine FSMA inspections for “very small” firms will begin in October 2020. Sooner of there is a complaint.

In general, the FDA representative stated they do not yet have enough data to provide the public with general overall impression to help guide future inspections. Some, more specific comments, will be provided to members of Next Gen PFMA upon request, as mentioned above.

State Officials

Re-iterated what was already mentioned previously.


In Summary

I attend these meetings so you don’t have to. Some of our members have attended and continue to attend the AAFCO meetings. It’s my pleasure to be your representative; I sit on many committees representing our industry’s needs.  However, these meeting are not without cost – both from a time and financial perspective. If you benefit from this information and are not already a member, please join.



About Cathy Alinovi

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