Food Recalls: Lessons Learned, Avoidance & Management Strategies Oregon Dairy Industry Annual Meeting April 12, 2016 Salem, Oregon Allen R. Sayler Managing Partner CFSRS asayler@cfsrs.com 1 571-931-6763
Background: Allen R. Sayler • 33 years serving the US Dairy Industry Managing Partner, as government regulator & industry Center for Food advocate Safety & • 12 years w/International Dairy Foods Regulatory Association (IDFA) serving as primary Solutions (CFSRS) HACCP, SQF and food safety trainer, advocating industry views with FDA, USDA and state dairy regulatory agencies • Certified HACCP Trainer • Experienced SQF & BRC Trainer & Consultant • 2009 IAFP Harold Barnum Award Winner Education : BSc Biology & Human Physiology, University of Mary - Additional Course Work in Civil Engineering
2016 CFSRS Workshop Schedule 1. Official FSMA Preventive Controls Qualified Individual Workshops • Western Dairy Research Center (sponsor), Utah State University, Logan, UT; March 7th, 8 th ,8:30 am ‐‐ 5:00 pm, March 9 th , 8:30 am ‐ noon • Western New York Sanitarians (sponsor), Protocol Banquet Facilities Buffalo Airport, Buffalo, New York; March 22 nd , 23 rd , 8:30 am – 5:00 pm, March 24 th ,8:30 am ‐ noon • Franklin Grand Isle Workforce Investment Board (sponsor), Swanton, Vermont, March 28 th 8:30 am – 5:00 pm, March 29 th , 8:30 am – noon & March 30 th , 8:30 am – 4:30 pm • Woodbridge, Virginia (30 miles south of Washington, DC) ‐ April 20th, 1:00 a.m. ‐ 4:30 p.m., April 21 st , 8:30 ‐ 4:30 pm and April 22 nd , 8:30 ‐ 1:00 pm • American Dairy Products Institute (sponsor), Madison, Wisconsin, May 10 th , 11 th , 8:30 am – 4:30 pm, May 12 th , 8:30 am ‐ noon • Fresno, CA ‐ 4:30 pm and May 19 th , 8:30 a.m. ‐ May 17th, 18th @ 8:30 am ‐ noon • Western Dairy Research Center, Utah State University (sponsor), Logan, UT ‐ June 7th, 8th 8:30 am ‐‐ 5:00 pm, June 9 th , 8:30 am ‐ noon 2. CFSRS Advanced HACCP/HARPC Workshop May 23 rd & 24, 8:30 am – 5:00 pm, MDT, Utah State, Logan, Utah 3. Implementing SQF 7.2 Systems Workshop May 25th & 26th @ 8:30 a.m. - 5:00 p.m. MDT, Utah State, Logan, Utah
2015 CFSRS Webinar Schedule (see www.cfsrs.com for current list, & dates): 1. FSMA Preventive Controls, FSV, TPC & Intentional Contamination Update 2. Crisis Readiness: How to Prepare for Operational Failures, Large-Scale Disasters and Everything in Between 3. Food Defense Strategies & FSMA’s Intentional Contamination Reg. 4. The Microbiology of Milk 5. Overview of Changes: 2013 Grade A Pasteurization Milk Ordinance 6. HTST & VAT Pasteurization Technology for Fluid Processors 7. Food Processing Instrumentation: Improving Control, Data Capture and Cost Management 8. Computerized Solutions for Food Processing Quality Assurance Programs 9. Industry Rights & Responsibilities During an FDA Investigation 10. SQF Practical Implementation Strategies 11. Survival Strategies on Managing a Recall
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Food Safety Food Safety Modernization Act Modernization Act (FSMA) (FSMA) PL 111- -353, 124 Stat. 353, 124 Stat. PL 111 3885 3885 • Enacted January 4, 2011 • Sweeping new enforcement authority for FDA • Self-enacting provisions and FDA deadlines on issuing regulations • Lack of targeted funding • FDA Structure for Enforcement
Seven (7) Foundation FSMA Rules 1.Human Food preventive controls 2.Animal Feed preventative controls 3.Produce rules – will set standards for farm growing practices 4.Foreign Supplier Verification Proposed Rule – importer accountability program to ensure imported foods are produced under the same standards/level of protection, as our new preventative control of produce standards. 5.Accredited Third Party Certification of Foreign Suppliers . 6.Safe Food Transport rules 7.Intentional Adulteration provision
FSMA – Mandatory Recall Program • Voluntary Option Available – Usually Class I & II. If industry disagrees with FDA will take action toward a mandatory recall including issuing public notice based on if food product presents a “ serious adverse health consequences or death .“ Effective immediately and only authorized by FDA Commissioner. • Industry responsible in an official recall to notify state regulatory agency, FDA District Recall Coordinator and file report on-line with FDA Reportable Food Registry (Class I & II) • Failure to comply: Possible $50,000 penalty per individual and a $250,000 penalty per company so the total would not exceed $500,000. Note: You do not want FDA to write the public recall notice 8
Blue Bell Ice Cream Recall - March 2015 March 13, 2015: The public first learned about potential problems with Listeria in Blue Bell products, after the deaths of three people hospitalized in Kansas were linked to single-serve ice cream scoops and milkshakes. March 23, 2015: Blue Bell then announced a second recall of three flavors of 3- ounce ice cream cups with tab lids (chocolate, strawberry and vanilla). April 3, 2015: Operations were suspended at the Oklahoma facility. April 7, 2015: FDA notified Blue Bell that Listeria was also found in samples of Banana Pudding ice cream pints made at the Oklahoma plant. The company then expanded its recall to products made between Feb. 12 and March 27, 2015. April 20, 2015: The company announced that all products from all of its plants were being recalled and the four facilities were being temporarily shut down April 27, 2015: Announced an intensive cleaning & training program at all facilities Epilogue: 6 patients who were sickened from 2010–2014 with listeriosis had the same rare PFGE pattern 10
Blue Bell Ice Cream Recall - March 2015 May 14, 2015; Entered into voluntary agreement with Texas and Oklahoma to rigorously clean, revise testing protocol and production policies upgrade employee training, employ a microbiological expert, immediate notification if plants have any presumptive positive results in ingredients or finished products and upgrade response to environmental positive results. June 1, 2015: Entered into voluntary agreement with Alabama similar to what was agreed to with Texas and Oklahoma June 10, 2015: FDA publically released results of inspections of the Blue Bell plants in Oklahoma, Texas and Alabama 11
Blue Bell Ice Cream Recall - March 2015 July 21, 2015: Blue Bell response on Sylacauga, Alabama improvements and notice of start-up August 28, 2015: Blue Bell response on Broken Arrow, Oklahoma improvements and notice of start-up November 13, 2015: Blue Bell response on Brenham, Texas improvements November 17, 2015: Brenham, Texas restarts production 12
May 19, 2015 Pritzker Olsen Files First Blue Bell Listeria Lawsuit The first lawsuit stemming from the Listeria outbreak linked to Blue Bell ice cream. The suit was filed on behalf of David Philip Shockley, a 33-year-old Maryland man who developed Listeria meningitis that left him with severe neurological impairment. Mr. Shockley lived in Houston, Texas where he worked as the Associate Executive Director and Nursing Facility Administrator at a retirement community. While at work, Mr. Shockley regularly consumed Blue Bell products. He developed a severe headache with nausea and light sensitivity. He was taken by ambulance to the hospital where he was diagnosed with a migraine and sent home. Several hours later he lost consciousness. He was found un-responsive in his home and rushed to the hospital where his temperature was 106˚ to 107˚ F. He was in acute respiratory failure, septic shock and suffering seizures. He did not fully regain consciousness for six days. Mr Shockley was unable to walk, talk, swallow, see properly or move much of his body. He was diagnosed with Listeria meningitis with encephalitis. He requires round-the-clock assistance. 14
FDA Findings - Blue Bell Oklahoma, Texas & Alabama Ala. Texa Okla. Violation s Product positive for Listeria monocytogenes X X Inadequate follow ‐ up after positive product results X Environmental positive results without adequate X X follow ‐ up Inadequate environmental monitoring program X X Condensate dripping into product or processing X X X equipment Processing equipment not clean, not taken apart to X X X adequately clean or improperly stored Employee hygiene problems X X X 16
FDA Findings - Blue Bell Oklahoma, Texas & Alabama Ala. Texa Okla. Violation s Inadequate hot water for proper cleaning of X equipment Facility maintenance inadequate X Facility cleaning inadequate X Improper equipment design or repair X X Improper management of temperatures of in ‐ X process product 17
FDA Food Recall Classifications Class I • Reasonable probability of serious adverse health consequences or death. Examples: Undeclared allergens such as peanuts, eggs, or milk; pathogens such as Salmonella, Listeria monocytogenes and E. coli O157:H7. Public Notice Required! Class II • Temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. Examples: Undeclared wheat, preservatives, FD&C Yellow #5 or #6; foreign objects that pose a physical hazard . Public Notice Sometimes Required Class III • Not likely to cause adverse health consequences. Examples: Net weight mistakes; insect parts; high levels of yeasts and molds, off ‐ flavors or odors, spoilage if determined to not be related to pathogens. Usually No Public Notice Required
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