blue-bellQuestion:  What will the Office of Criminal Investigations and the U.S. Attorneys in Texas, Oklahoma and Alabama do?

I really need to get more cynical – why would you risk a 108 year old company – not to mention jail time, fines, recall costs, business loss and customer lawsuits – by failing to follow simple food safety procedures?  Why would our government ignore the problem until at least 10 were sickened with 3 deaths?  Well, at least Texas and Oklahoma did something today.

Following a series of laboratory results indicating that there was Listeria monocytogenes (Lm) present in products and on equipment of the Blue Bell Creameries located in Brenham, Texas and Broken Arrow, Oklahoma (after being linked to 10 illnesses, including 3 deaths) the company “voluntarily” initiated a national recall of its entire product line and suspended production at the Texas, Oklahoma and Alabama facilities.

The company is also “voluntarily” engaged in comprehensive plant sanitation, employee training, and establishment of new or revised policies, procedures, and environmental and product testing programs to ensure that its products, when re-introduced into commerce, do not contain Lm.

As both the regulatory and state public health agency, it is incumbent that, before Blue Bell Creameries re-introduces food products into commerce that the company has:

  • thoroughly cleaned and sanitized the facilities, to include all equipment;
  • trained all employees on the subject;
  • developed and implemented new or revised policies, procedures, and processes to minimize the likelihood of producing any product containing Lm in the future;
  • completed a trial run of manufacturing an acceptable product as evidenced by negative product samples for Lm; and
  • notified state agencies at least 2 weeks in advance of their intent to re-introduce food products into commerce.

To achieve confirmation of the steps outlined above, Blue Bell Creameries, “voluntarily” agrees to:

1.  Retain an independent sanitation and/or microbiology expert qualified by background, education, training and experience to determine that the methods, facilities and controls necessary are in place that will prevent the introduction of contamination. This expert should also, to the extent possible based on the best science available, help the company assure that the plant and the equipment are properly prepared, maintained and operated to safely produce products that do not contain Lm.

2.  Preserve all environmental, product and ingredient testing results and make such results available to review upon request.

3.  Beginning with the trial run prior to product reintroduction, notify state agencies within 24 hours of receiving a laboratory report of any presumptive positive test result for Listeria monocytogenes found in ingredient or finished product samples from its facilities. If such test result is received by the company on a weekend or holiday, the 24- hour period would expire on the next business day. Such reporting shall continue for a period of 2 years from the date of initial market reintroduction, and may be extended as deemed necessary depending on the nature and extent of the test results reported to date.

4.  Provide full access to the facilities for purposes of collecting ingredient, finished product, or environmental samples. It is understood that state agencies would seek to take any presumptive positive test results for Listeria species through to final confirmation for Lm and maintain any confirmed Lm isolates.

5.  Conduct root cause analyses for the purposes of identifying potential or actual sources of contamination and allow state agencies to review the documentation.

6.  Ensure that the company’s Pathogen Monitoring Program (PMP) for Lm, includes plans on how the company will respond to presumptive positive tests for Listeria species when and where found.

7.  Make available for state agencies review upon request:

a.  Plant deep cleaning and on-going sanitation policies, procedures and records;

b.  Company staff training curriculum and records, along with plans for re-training of 
existing staff, new hire orientation, and ongoing training;

c. Plans for plant modifications made for the purpose of controlling potentially harmful bacteria within the plant operating environment and/or food handling machinery; and

d. Start-up procedures prior to initiating production runs for any purpose, up to and including the manufacture of product for entry into commerce.

8.  Beginning with the trial run prior to product reintroduction, institute a “test and hold” program for all finished product to be introduced into commerce for a period of one year, or such period as deemed necessary by state agencies in light of the nature and extent of the test results reported under paragraph 3 of this section.

In addition, the company “voluntarily” agrees that all future food processing and distribution activities will be undertaken pursuant to, or in reflection of, the following industry recognized standards for plant performance:

1.  Sanitation Standard Operating Procedures (SSOPs);

2.  Good Manufacturing Practices (GMPs);

3.  a Pathogen Monitoring Program (PMP) for Listeria Monocytogenes (Lm), which includes 
environmental, ingredient and finished product testing; and

4.  a Hazard Analysis and Critical Control Points (HACCP) plan and/or a written FoodSafety Plan, including sections on:

a.  verifiable product trace-back procedures and

b.  sufficient product recall practices.

Again, as a company in business for 108 years and the third largest ice cream maker in the U.S,, why are they doing all of this, and why is State and Federal health authorities jumping into action now?