UPDATE: FDA Helps Small Businesses Determine Their Size: Will My Facility Be Inspected?

FDA Publishes a Final Guidance Document
That headline is part of the big news here. We are living in the world of draft FDA guidance documents for food safety that are the FDA’s current thinking on a topic. I applaud the FDA for releasing the final guidance document on this topic in June 2019. FDA published the draft guidance Determining the Number of Employees for Purposes of the “Small Business” Definition of Parts 117 and 507: Guidance for Industry in March 2018, and this is an update on my blog post from that month.

Why did FDA publish this guidance?
The purpose of the guidance is to raise awareness of compliance deadlines for Part 117, the human food rule, and Part 507, the animal food rule through the calculation of number of employees. All food facilities are now under enforcement for the human food rule regardless of the number of employees, making the guidance unnecessary for the human food rule. Only very small businesses can qualify for an exemption from Subparts C and G of Part 117 Preventive Controls for Human Food rule and are defined as earning less than $1 million in annual revenue and not by the number of employees.

The guidance is helpful in defining subsidiary, affiliate, facility and full-time equivalent (FTE) employee. There are clear examples to showcase types of facilities and calculations of FTEs. The purpose for calculating FTEs is to determine if a facility is defined as a small business of less than 500 FTE employees.

Wait. What about the Intentional Adulteration rule?
If you are on top of your FSMA rules game, you know that the last FSMA rule to come under enforcement is the Intentional Adulteration rule in July 2019. Guess what food facilities are first to come on board? Yes, facilities with more than 500 FTE employees! Does your facility have a written and implemented food defense plan? I have blog posts here on food defense to get you started; search “food defense.”

Will my facility be inspected with a preventive controls inspection?
FDA prioritizes their inspections, so FDA must know if a facility is exempt from inspection as a very small business. For all other businesses, there are other factors used by FDA to prioritize inspections.

    • FDA inspection goals for the number of domestic and foreign facilities
    • Facilities posting a recall on the FDA Reportable Food Registry
    • Facilities with a current or previous Class I recall or warning letter
    • Facilities in the same product sector as a facility with a Class I recall
    • Facilities making a high-risk ingredient or product

      1. Ready-to-eat foods
      2. Foods identified in FDA’s Listeria risk assessment
      3. Foods otherwise with a history of risk

Most inspections are Good Manufacturing Practices (GMP) inspections. Every year the goal for the number of preventive control inspections increases and more FDA inspectors are trained. Some states have FDA contracts to inspect on behalf of FDA, and state inspectors go through the same training process as FDA inspectors.

While it is not possible to know if your facility will be inspected until the FDA inspectors are at your door, you can determine the likelihood by using the same tools FDA has to prioritize inspections, i.e. the links above. Very small business can qualify for an exemption of a written food safety plan and recall plan, but all other food businesses will be more prepared for an inspection with a current food safety plan and recall plan.

The ConnectFood website has free resources, and the folks at ConnectFood are here to help! Contact us.

About the Author
Kathy Knutson, Ph.D.
Kathy Knutson Food Safety Consulting LLC
Dr. Kathy Knutson works nationwide with food manufacturers on recall investigations, problem-solving, training, and Food and Drug Administration (FDA) compliance. After being trained in 2016 as a Lead Instructor with the FDA-recognized curriculum for Preventive Controls Qualified Individuals, she has delivered over 20 workshops to the food industry. With 35+ years in microbiology and 15 years of full-time teaching, Dr. Knutson is passionate about training and is an active communicator at all levels of an organization. She has taught and consulted with companies on laboratory methods, interpretation of lab results, quality assurance, sanitation, environmental monitoring, Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMPs), Hazard Analysis and Critical Control Points (HACCP) and the FDA’s Food Safety Modernization Act (FSMA). As a life-long learner, Dr. Knutson is trained in the prevention of intentional adulteration, a topic on the horizon for the food industry. Dr. Knutson is a contributing author at CannabisIndustryJournal.com. Dr. Knutson writes a food safety blog and contributes expert services to manufacturers through connectfood.com, an online site for writing HACCP and food safety plans. When Dr. Knutson is not traveling, she works from home in Green Bay, Wisconsin, where she lives with her husband, two sons, and an adorable Bernedoodle. Learn more about her at https://www.linkedin.com/in/kathyknutsonphd.