Tag Archive for: regulators

Regulators, what are they good for?

When I think about regulators, I think about the wonderful people I met this year while teaching the Preventive Controls for Human Food workshop. I had participants who were state inspectors, and I had FDA inspectors. Some were very knowledgeable and could have taught the workshop. Some were new to their jobs and were learning from the beginning just like many of the industry participants. We all have the same goal of safe food.

When I think about regulators, I think of the ones I have not met, but I know their stories. I know about the state inspector who bullied a company on a Friday afternoon to initiate a recall based on presumptive lab results. I know about the inspector who labeled a control panel swab as a zone 1 sample, and when it came back positive the company had to recall the product. I know about the inspector who chatted up the quality manager about personal matters and wasted a day’s work. There are stories after stories about the demanding, unknowledgeable inspectors who are unreasonable. Just like the news of the world, these are the stories we hear, and we start to believe they represent the whole. They do not.

I am encouraged to know that the inspectors are being trained using the same curriculum as that used to train industry. I am encouraged that FDA inspectors are in the same room with industry participants for the discussion and debate on the material. We are all in this together.

FDA rules and guidance documents are available for free on-line. The much-anticipated Hazards and Controls guidance was published in draft form at the end of August. See the link below. The document is in a six-month comment period. Individuals and organizations can submit comments. After the comment period, the FDA must address every comment, and publish the final guidance document. After working with the FDA, I expect this document to be published around the end of 2017. The Hazards and Controls guidance is critical to inspections. Some inspectors will use it as the bible for inspections. If the guidance identifies a hazard in the food you produce, you better have a preventive control for that hazard or have written justification as to why you do not have a preventive control for that hazard.

So, what do you do in the meantime? You can check the FDA Hazards and Controls draft guidance, or you can go to Canada! The Canadian Food Inspection Agency (CFIA; remember chapter 7 in the PCHF workshop?) has a searchable database; see the link below. This is a technical resource you can cite in your hazard analysis. Check it out!

I know there are many other resources for inspectors, including more training programs. The International Food Protection Training Institute (IFPTI) coordinates training of inspectors with the Association of Food and Drug Officials (AFDO). The IFPTI website provides a link to online courses available free for FDA, State, Local, Territorial & Tribal (SLTT) regulators at:
This summer I asked about these courses being available to industry and the reply was yes, for a fee. Contact the Director of IFPTI, if you are interested in this training for your company.

FDA Hazards and Controls draft guidance
See Download the Draft Guidance.

CFIA searchable database

Dr. Kathy Knutson has food safety expertise in microbiology, hazard analysis, and risk assessment. As a recovering academic, she resides in Green Bay home-of-the-Packers, Wisconsin with her brilliant husband and two handsome sons. Learn more about her consulting services at https://www.linkedin.com/in/kathyknutsonphd.