FDA published the draft guidance Determining the Number of Employees for Purposes of the “Small Business” Definition of Parts 117 and 507: Guidance for Industry on March 19, 2018. The comment period is through May 20, 2018. The purpose of the guidance is to raise awareness of exemptions for Part 117, the human food rule, and Part 507, the animal food rule. There is also a later compliance date for small businesses under the animal food rule of September 17, 2018, than originally set. I am addressing human food within this blog.

Why did FDA publish this draft guidance?
I’m having a difficult time understanding the publication of this Food Safety Modernization Act (FSMA) draft guidance at this time. It 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 of calculating FTEs is to determine if a facility is defined as a small business of less than 500 FTE employees. This is a concern when multiple facilities are related and if there are part-time or seasonal employees. This is a question I have tried my best to address in PCQI workshops for my participants. It’s nice to have the draft guidance. The reason I am having a difficult time is that it is a moot point for industry now. All small businesses came under enforcement in September 2017 for human food. Small businesses must meet the same requirements their larger competitors met in September 2016.

    I believe the reason for the publication of the draft guidance
    is not as much for industry as it is for the FDA.

Will my facility be inspected?*
FDA prioritizes their inspections, so FDA must know if a facility is a small business or larger. In fiscal year 2016-2017 when businesses with more than 500 employees came under enforcement, FDA’s goal was to complete 300 FSMA inspections. Facilities with more than 500 employees were under inspection first, because of the potential public health impact to a larger number of consumers. A total of 165 domestic and foreign FSMA inspections were completed. All other inspections-the majority-were Good Manufacturing Practices (GMP) inspections. That trend will continue with most inspections being GMP inspections. The FDA continues to train its inspectors on FSMA, and FDA inspectors are primarily in a FSMA educator mode with industry. In fiscal year 2017-2018 the goal is higher at 500 FSMA inspections; the pace is faster.

In addition to the number of FTEs, there are other factors used by FDA to prioritize inspections.

    • Domestic and foreign facilities goals are 400 and 100 inspections, respectively.
    • Facilities with a current or previous Class I recall or warning letter
    • Facilities in the same market 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

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.

*The author participated in a Food Safety Preventive Controls Alliance quarterly webinar for Lead Instructors on February 8, 2018, in which FDA inspection data was shared.

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About the Author
Kathy Knutson, Ph.D.
Kathy Knutson Food Safety Consulting
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 delivered over 20 workshops to industry. With over 35 years in microbiology and 15 years of full-time teaching, Dr. Knutson is passionate about training and is an effective communicator at all levels in 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 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