Tag Archive for: human food

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 You can check the FDA Hazards and Controls draft guidance, or you can go to Canada!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.

In June 2016 I started teaching a workshop with FDA-recognized curriculum. Everyone was there to get a certificate as a Preventive Controls Qualified Individual (PCQI). After a day of training, someone asked, “What is FSMA?” Much to my own surprise I could not succinctly articulate the extent of FSMA nor did the curriculum do a great job of summarizing FSMA. After much research on the FDA and Federal Register websites, I have this summary for you.

FSMA is the federal Food Safety Modernization Act, signed by President Obama in January of 2011. The purpose is to ensure the U.S. food supply is safe by shifting the focus from responding to hazards to preventing them (https://www.fda.gov/Food/GuidanceRegulation/FSMA/). I now understand there are seven foundation rules with FSMA, all under the jurisdiction of the FDA. All seven rules were published from September 2015 to May 2016 with unique compliance dates. Most of you reading this are going to want information on the rule for the manufacture of human food. The preventive controls for human food final rule requires a written food safety plan, record-keeping, a recall plan, and oversight by a PCQI. A future blog will detail the role of a PCQI.

Final rule: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food
Who? Human food manufacturers and their ingredient suppliers

When? Initial compliance date of September 2016 for large businesses

FDA actually calls large businesses “other businesses.” That is because the large businesses by definition are not small, very small, qualified facilities, or subject to the Pasteurized Milk Ordinance. All of these have compliance dates beyond September 2016.

Small businesses have a compliance date of September 2017 and are defined as having fewer than 500 employees. Therefore, “other businesses” have more than 500 employees. Very small businesses have a compliance date of September 2018 and are defined as having less than $1,000,000 in annual sales and holdings. By default, very small businesses have fewer than 500 employees. With only $1,000,000 in revenue, that makes sense that the business employs fewer than 500.

Very small businesses are qualified facilities. Having a designation as a qualified facility exempts the facility from the hazard analysis, preventive controls and supply chain requirements. This is a big deal. The business is still required to follow Good Manufacturing Practices, provide attestations in support of their status, provide evidence of oversight and compliance in their location, maintain records, and provide evidence of status annually. Even though a qualified facility is not required to conduct a hazard analysis and identify preventive controls for those hazards, the qualified facility is required to state how they are controlling hazards in their process. In other words, what is the qualified facility doing to make their product safe for the consumer? If a very small business believes they are a qualified facility, their status records must already now be in place.

Businesses subject to the Pasteurized Milk Ordinance (PMO) have a compliance date of September 2018. These grade A milk processors come into compliance after the next revision of the PMO is published. The PMO will include elements of preventive control requirements.

What are the foundation rules of FSMA? Here is a summary of them:

Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
This is the animal food rule.
Who? Animal food manufacturers and their ingredient suppliers
When? Initial compliance date of September 2016
In the same way that food for human consumption must be made in a safe manner, the diverting of human food to animal food and the production of animal food must be done safely.

Foreign Supplier Verification Programs for Importers of Food for Humans and Animals
This is the import rule.
Who? Importers of ingredients or food for humans or animals
When? Initial compliance date of May 30, 2017
To see descriptions of who has later dates, go to this FDA document at https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm517545.htm.

Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption
This is the produce rule.
Who? Raw agricultural commodity farmers
When? Produce growers with more than $500,000 in annual sales must be compliant starting in November 2017. Small businesses with annual sales between $250,000 and $500,000 must be compliant November 2018. Very small businesses with annual sales between $25,000 and $250,000 must be compliant November 2019. Due to high risk, sprout growers must be compliant in November 2016, with small and very small sprout growers compliant in November 2017 and 2018, respectively.
Growers may have modified compliance dates for parts of the rule including water quality standards, testing and recordkeeping; labeling; or retention of records supporting eligibility for a qualified exemption. Many commodities are exempt from parts of the rule due to the nature of the crop.

Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications
This is the audit rule.
Who? Third-party auditors
When? The rule was published November 2015. The Model Accreditation Standards when published will include FDA’s final recommendations on third-party auditor/certification body qualifications and incorporate requirements. Thereafter, auditors will be able to apply for FDA recognition. See the draft guidance for the Model Accreditation Standards at https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm455328.htm.

Sanitary Transportation of Human and Animal Food
This is the transportation rule.
Who? Motor carriers, shippers, and receivers of human or animal food
When? Initial compliance date of April 2017
Motor carriers employing fewer than 500 persons and having less than $27.5 million in annual receipts must be compliant in April 2018.

Mitigation Strategies to Protect Food Against Intentional Adulteration
This is the intentional adulteration rule.
Who? Human food manufacturers
When? This being the last of the rules was published in May 2016. The first compliance date is May 2019. Small businesses employing fewer than 500 employees must be compliant in May 2020.
The definition of the very small business is annual sales and holdings less than $10,000,000 and not $1,000,000 as defined in the preventive controls for human foods rule. The very small business must be compliant in May 2021.