Tuesday, September 24, 2019
 Lessons Learned: Do the Spring 2015 Ice Cream Recalls Identify Potential Operational Weakness in All Dairy Plants?  

By Allen Sayler, ADPI Center of Excellence 

The Spring of 2015 will be remembered in the dairy industry in some ways like September 11th, 2001 is remembered by many in the USA.  Our innocence and confidence were both assaulted by the Blue Bell and shortly thereafter, the Jeni’s Splendid Ice Cream recalls.  At the late April’s National Conference on Interstate Milk Shipments (NCIMS), the recall subject was the first topic of discussion, whether it was in a group of industry, state dairy regulators, FDA headquarters or Regional Milk Specialists or a mixed group of some or all these parts of the US dairy industry. It was clear that both state and FDA regulators intended to increase their sampling of ice cream products for the near future.  


For those of us in the dairy ingredient industry, Listeria is not usually our main biological concern; Salmonella is and in some ways, is more difficult to remove from the dairy plant environment.  Based on news media reports and the FDA Form 483 Inspectional reports for two of the Blue Bell plants and the Jeni’s Splendid Ice Cream plant, it appears that both plants may have had credible written operational programs.  However in one case, apparent failures in equipment and facility cleaning and sanitizing tasks as well as employee food safety training may have contributed to the Listeria problem.  In another case, FDA identified a number of environmental, operational and testing shortcoming  that resulted in an inadequate response to the detection of Listeria and repeated higher levels of coliforms in finished products.


In order to arrive at “Lessons Learned” that all dairy plant can benefit from, below is a cataloging of the various FDA observations and a short comment on how to address or avoid the problem.

FDA Observation Comment
Personnel shortcomings in hand washing, use of beard nets, etc. and a lack of adequate monitoring by supervisory personnel. For example, the Regulatory Manager and the Director of Operations, who were responsible for assuring compliance with current good manufacturing practices by all personnel, demonstrated a lack of competency It is important to periodically send key operational staff to outside food safety training. If the supervisory staff had done any amount of verification, many of the items identified by FDA would like have been found and corrected.
Failure to maintain buildings, fixtures, or other physical facilities in a sanitary condition.  Improper storage on processing equipment and utensils This is dairy plant hygiene 101 and can be related to lack of employee training and oversight.
Failure to perform microbial testing where necessary to identify sanitation failures and possible food contamination.  In another case, the testing was performed, but when positive results were obtained, it appears from FDA’s comments that there was insufficient effort to determine and correct the cause of the positive Listeria or high coliform counts in finished product. It is likely that with the publication of FDA’s FSMA “Preventive Controls for Human Foods” that all food processing plants will be required to have some type of environmental and finished product testing with follow-ups to positive results including a root cause analysis and a preventive as well as a corrective action.
Failure to take apart equipment as necessary to ensure thorough cleaning.  Lack of validation of equipment cleaning and sanitizing program that could have been the cause of the positive Listeria in the finished product. It is common industry practice to use ATP swabbing technology as one tool to ensure the equipment has been properly cleaned and sanitized.  The results are immediate and the response, i.e. re-cleaning the equipment can also be immediate.
In at least two cases, the design and workmanship of equipment did not allow proper cleaning.  In another case, the maintenance of the processing and packaging areas was questioned.  Failure to have smoothly bonded or well-maintained seams on food contact surfaces, to minimize accumulation of food particles and organic matter and the opportunity for growth of microorganisms. These day-to-day efforts by plant engineering and/or maintenance departments needs to be conducted and documented in a more formal manner, then evaluated by senior management at some regular frequency. 
Failure to store raw materials in a manner that protects against contamination.  All reasonable precautions were not taken to ensure that production procedures did not contribute contamination from any source.  Failure to perform filling and packaging in a manner that protects food from becoming contaminated.  In another case, FDA identified condensate from overhead lines dripping into the production line.   These items together point toward a lack of food safety knowledge by production employees and their supervisors.  
Failure to operate fans and other air-blowing equipment in a manner that minimizes the potential for contaminating food and food-contact surfaces.  In another case, ventilation systems were blowing air onto exposed product. Ventilation systems should be located so any incoming air does not blow directly onto raw materials, ingredients, primary packaging, finished products or the product contact surfaces of processing equipment unless said air has been properly Hepa-filtered.


The best “Lessons Learned” from the very damaging dairy product recalls this Spring is pay attention to basic (Dairy Processing 101) as there are no shocking or new causes for the product contaminations. It is important to understand the basic requirements and vulnerabilities of a dairy plant’s equipment, employees and the facility. Such understanding can only come from a robust supervisory and employee training program as well as a strong verification and internal auditing program that is intended to catch potential problems before they become actual problems.  Another weakness with both recalls appeared to be the “rolling” nature of the recall notices.  This might happened in any dairy plant today that does not challenge its recall and lot identification program.  Based on experience, a number of dairy plants today would have a difficult time convincing FDA that contaminated finished product could be isolated to only one lot.  Yet, this type of scrutiny of a plant’s lot identification program is taken for granted and rarely challenged during a mock recall or mock traceability exercise.  

While two dairy companies are suffering from letting basic dairy plant operations degrade, the rest of us need to pay close attention to ensure we are not the next company to host an FDA Recall Team.  

For more information on how to challenge your plant’s food safety operations and the effectiveness of your recall program,  please contact Allen Sayler with the ADPI Center for Excellence (asayler@cfsrs.com), sign up to participate in a webinar on the outcomes of the 2015 NCIMS Conference and their impact on the dairy processing industry (www.cfsrs.com, click on the “Webinar” tab) or call Dan Meyer, Technical Director for ADPI  at (630) 530-8700 x224.                                                    


Posted on Friday, June 26, 2015 (Archive on Friday, July 03, 2015)
Posted by bholcomb@adpi.org  Contributed by bholcomb@adpi.org