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Enforcement Reports for Class II and Class III Recalls Offer Help to the Food Industry

I subscribe to alerts for Class I recalls from the Food and Drug Administration (FDA). The message goes to my email with a link to the press release. It’s a great automated system, and the number of alerts is small enough to manage daily in email. The FDA recalls more than just food – their recalls include biologics (medical products), animal health products (pet food), medical devices, drugs, cosmetics and tobacco. I didn’t sign up for everything, and the subject of the emails I receive helps me decide which ones I can delete without opening… efficient.

Class I recalls are announced when there is a large possibility a consumer will become ill or be injured from a food they have ingested; think of glass shards or pathogens in food. This is where the food industry spends research dollars and companies take measures to prevent biological, chemical, and physical hazards. Class I recalls are the ones we see in social media, which are heavily communicated on the news and posted about on the FDA website. Class I recalls must be entered into the Reportable Food Registry. Do you know what hazard is the number one cause of Class I recalls? The answer is… allergens: a chemical hazard. You cannot put too many resources into allergen management if your product contains an allergen.

I was recently reminded by a colleague to keep up with the Class I notices (done!) and enforcement reports. Hmmm, enforcement reports? In FDA’s words:

    “All recalls monitored by FDA are included in the Enforcement Report once they are classified and may be listed prior to classification when FDA determines the firm’s removal or correction of a marketed product(s) meets the definition of a recall. Once FDA completes the hazard assessment, the Enforcement Report entry will be updated with the recall classification.”

“Classified” does not mean the recall is top secret! There are three classes; Class I is discussed above as the most serious among the classes. A Class II recall is a situation where the probability of illness or injury is remote. Only the manufacturer can make the call on if the recall will be classified as Class I or II based upon the specifics of what went wrong. The situation has a possibility of illness or injury, but the chances are so small that the conditions for illness or injury are unusual or unlikely. A Class III recall is not likely to cause any illness or injury. Period. It absolutely will not happen. The fourth option in an enforcement report is “pending.” This means the FDA is still considering the class for the recall. You would think this is pretty straight forward, but recalls are one big bell curve. Class I and Class III extremes are easy to get right, but there is a huge bump in the middle for Class II. This leads me to the FDA website.

Enforcement reports are posted weekly. When you go to the previous link, click on the week of interest, then sort with the ‘Product Type’ dropdown menu for ‘Food’ or another category. Dietary supplements are posted under ‘Food,’ even though they are not food and are separately regulated. If you really want a scare, choose the category of ‘Drugs’ to see all the problems in that industry, or see pending recalls of drugs. In addition to the Class I recalls, the other classes are of interest as well.

We use enforcement reports to keep up with our industry. What problems do others in your commodity experience? When we read the Class II and Class III recalls, we see what problems are occurring in our industry. Are you in dairy, flour, nuts, or produce? Look for companies with similar commodities as both your ingredients and your products. As part of reviewing your written food safety plan, the food safety team is required to keep up with current science and potential hazards. One way to know what is going on in your commodity is to keep up with enforcement reports.

Have you heard all the recalls of pet food? These are not coming to my email, so I need to update my alerts. The ConnectFood website has free resources, including the ability to create a recall plan for your facility and products using the online software. The folks at ConnectFood are here to help! Contact us.

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