TEXAS DEPARTMENT OF STATE HEALTH SERVICES 1100 West 49th Street 0 Austin, Texas 78756 PO. Box 149347 I Austin, Texas 78714-9347 KIRK COLE 1-888-963-7111 - WW INTERIM COMMISSIONER Voluntary Regulatory and Public Health Agreement between the Department of State Health Services and Blue Bell Creameries, Inc. I. JURISDICTION The Department of State Health Services (DSHS) has jurisdiction to regulate frozen dessert manufacturers as authorized by Chapters 431 and 440 of the Texas Health and Safety Code (HSC) and the Department rules at 25 Texas Administrative Code Chapter 229 which apply to frozen dessert manufacturers. DSHS is also the state public health agency established to protect and promote the health of the people of Texas. 11. SITUATION 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 (the company), the company voluntarin initiated a national recall of its entire product line and suspended production at the Brenham facilities as well as facilities located in other states. All of the recalled product, except that which has been held for testing and research purposes, has been destroyed or is in the process of being scheduled for destruction. 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. OBJECTIVE As both the regulatory and state public health agency, it is incumbent that, before Blue Bell Creameries re-introduces food products into commerce in Texas from its Brenham facilities, DSHS has con?rmation that the company has: 0 thoroughly cleaned and sanitized the facilities, to include all equipment; Voluntary Agreement Page 1 of4 trained all employees on the subject; deve10ped 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 satuples for Lm; and noti?ed DSHS at least 2 weeks in advance of their intent to re-introduce food products into commerce in Texas from its Brenham facilities. IV. TERMS OF AGREEMENT To achieve confirmation of the steps outlined above, Blue Bell Creameries of Brenham, Texas, voluntarily agrees to: l. Retain an independent sanitation and/or microbiology expert quali?ed 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. Preserve all environmental, product and ingredient testing results and make such results available for DSHS to review upon request. Beginning with the trial run prior to product reintroduction, notify DSHS within 24 hours of receiving a laboratory report of any presumptive positive test result for Listeria monocytogenes found in ingredient or ?nished product samples from the Brenham 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 by DSHS depending on the nature and extent of the test results reported to date. Provide DSHS full access to the Brenham facilities for purposes of collecting ingredient, ?nished product, or environmental samples. It is understood that DSHS would seek to take any presumptive positive test results for Listeria species through to ?nal con?rmation for Lm and maintain any con?rmed Lm isolates in the DSHS laboratory in Austin. Conduct root cause analyses for the purposes of identifying potential or actual sources of contamination and allow DSHS to review the documentation. 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. Make available for DSHS 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; Voluntary Agreement Page 2 of 4 8. c. Plans for plant modi?cations made for the purpose of controlling potentially harm?ll 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. Beginning with the trial run prior to product reintroduction, institute a ?test and hold? program for all ?nished product to be introduced into commerce for a period of one year, or such period as deemed necessary by DSHS 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 re?ection of, the following industry recognized standards for plant performance: 1. Sanitation Standard Operating Procedures 2. Good Manufacturing Practices 3. 4. a Pathogen Monitoring Program (PMP) for Listeria Monocytogenes which includes environmental, ingredient and ?nished product testing; and a Hazard Analysis and Critical Control Points (HACCP) plan and/or a written Food Safety Plan, including sections on: a. veri?able product trace-back procedures and b. suf?cient product recall practices. The Department of State Health Services agrees, to the greatest extent possible, to: l. . 2. Conduct reviews and con?rmatory sampling at the facilities concurrently with company Review items above as they are completed; staff and experts; and Communicate with national and other state regulatory agencies to coordinate activities. Voluntary Agreement Page 3 of 4 So AGREED on this [f?dy of May, 2015. TEXAS DEPARTMENT OF STATE HEALTH SERVICES PERKINS ASSISTANT COMMISSIONER REGULATORY SERVICES So AGREED on this L?E?day of May, 2015. On behalf Of Blue Bell Creameries, Inc., as its President and Responsible Individual in Charge, I hereby acknowledge understanding the terms of this Voluntary Agreement; enter into it freely; and accept and agree to its terms and conditions without reservation. PAUL W. BLUE BELL CREAMERIES, INC. PRESIDENT C.E.O. Voluntary Agreement Page 4 of 4