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Food Recalls: Lessons Learned, Avoidance & Management Strategies

Oregon Dairy Industry Annual MeetingApril 12, 2016 Salem, Oregon

Allen R. SaylerManaging Partner CFSRS

asayler@cfsrs.com571-931-6763

Background:• 33 years serving the US Dairy Industry

as government regulator & industry advocate

• 12 years w/International Dairy Foods Association (IDFA) serving as primary 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

WinnerEducation: BSc Biology & Human

Physiology, University of Mary - Additional Course Work in Civil Engineering

AllenR.SaylerManagingPartner,

CenterforFood Safety&

Regulatory Solutions(CFSRS)

2016 CFSRS Workshop Schedule1. Official FSMA Preventive Controls Qualified Individual Workshops

• Western Dairy Research Center (sponsor), Utah State University, Logan, UT; March 

7th, 8th,8:30 am‐‐5:00 pm, March 9th, 8:30 am ‐

noon• Western New York Sanitarians (sponsor), Protocol Banquet Facilities Buffalo 

Airport, Buffalo, New York; March 22nd, 23rd, 8:30 am – 5:00 pm, March 24th,8:30 

am ‐

noon• Franklin Grand Isle Workforce Investment Board (sponsor), Swanton, Vermont, 

March 28th

8:30 am – 5:00 pm, March 29th, 8:30 am –

noon & March 30th, 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 21st, 8:30‐4:30 pm and April 22nd, 8:30 ‐

1:00 pm• American Dairy Products Institute (sponsor), Madison, Wisconsin,

May 10th, 11th, 

8:30 am – 4:30 pm, May 12th, 8:30 am ‐

noon• Fresno, CA ‐

May 17th,

18th @ 8:30 am ‐

4:30 pm and May 19th, 8:30 a.m. ‐

noon• Western Dairy Research Center, Utah State University (sponsor), Logan, UT ‐

June 

7th, 8th 8:30 am ‐‐5:00 pm, June 9th, 8:30 am ‐

noon

2. CFSRS Advanced HACCP/HARPC WorkshopMay 23rd & 24, 8:30 am – 5:00 pm, MDT, Utah State, Logan, Utah

3. Implementing SQF 7.2 Systems WorkshopMay 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 Milk5. Overview of Changes: 2013 Grade A Pasteurization Milk Ordinance6. HTST & VAT Pasteurization Technology for Fluid Processors7. Food Processing Instrumentation: Improving Control, Data Capture

and Cost Management8. Computerized Solutions for Food Processing Quality Assurance Programs9. Industry Rights & Responsibilities During an FDA Investigation 10. SQF Practical Implementation Strategies 11. Survival Strategies on Managing a Recall

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• 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

Food Safety Food Safety Modernization ActModernization Act

(FSMA)(FSMA)PL 111PL 111--353, 124 Stat. 353, 124 Stat.

38853885

Seven (7) Foundation FSMA Rules1.Human Food preventive controls2.Animal Feed preventative controls3.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 rules7.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

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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

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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

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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

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The first lawsuit stemming from the Listeriaoutbreak 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.

May 19, 2015 Pritzker Olsen Files First Blue Bell Listeria Lawsuit

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FDA Findings - Blue Bell Oklahoma, Texas & Alabama

Violation Ala. Texa

sOkla.

Product positive for Listeria monocytogenes X X

Inadequate follow‐up after positive product results X

Environmental positive results without adequate  follow‐up

X X

Inadequate environmental monitoring program X X

Condensate dripping into product or processing  equipment

X X X

Processing equipment not clean, not taken apart to  adequately clean or improperly storedX X X

Employee hygiene problems  X X X

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FDA Findings - Blue Bell Oklahoma, Texas & Alabama

Violation Ala. Texa

sOkla.

Inadequate hot water for proper cleaning of  equipment

X

Facility maintenance inadequate XFacility cleaning inadequate XImproper equipment design or repair X XImproper management of temperatures of in‐

process product X

FDA Food Recall ClassificationsClass 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

Market Withdrawals ‐

Generally does not require notification  of regulatory authorities.   Minor violation that would not be 

subject to legal action by the FDA or which involves no violation.•Type A ‐

None of the product has left direct control of manufacturer or 

primary distributor. No reporting required to FDA’s Reportable Food 

Registry.1.Withdrawal

 to same degree as in recall.

2.No

 placement on recall list.3.No press release.  Instead Plant X will prepare an electronic 

communication to customers and respond to inquiries from customer’s  questions.

•Type B  ‐

Regulatory violations are absent or they are minor and  finish goods do not violate any federal or state laws or 

regulations.  Requires no Regulatory action.Stock Recovery ‐

A situation where none of the product has left 

the direct control of the manufacturer or primary distributor. This  type of action would be a recall or market withdrawal if the 

product was in the distribution channels.  Requires no regulatory  action.

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Public Recall LetterPublic Recall Letter1. Industry is responsible for drafting & sharing with FDA District

Recall Coordinator2. Content is required to include:

a. Name of company and contact point for consumers, name of product(s) recalled and lot Numbers of product(s)

b. Geographic locations where recalled product might be purchased by consumers

c. Pictures of the product’s principle display panel along with the location where the lot or date identification is located

d. Identifying the reasons for the recall including the name of the suspect pathogen, chemical agent or physical object triggering the recall (Note: it is common to start with “Due to the abundance of caution . . .” in the opening statement of the public recall letter.)

e. Get your ducks in order before calling FDA or the state regulatory organization

Company Recall ElementsCompany Recall Elements1. Update Company Recall program annually based on FDA’s

“Guidance for Industry: Product Recalls, Including Removals and Corrections” with current contact information for the Company Recall Team, FDA District Recall Coordinator & State Dairy Regulatory Contact

2. Identify processing “hard breaks” identified by equipment cleaning, rework disposal, etc. to isolating lots of product.

3. Activate Company Recall Team4. Follow Company Recall “Play Book” including specific

instructions to all customers affected by recall5. Gather all information available applicable to recalled product

including customer contact information6. Draft public recall notice or press release utilizing examples

provided in FDA’s “Guidance for Industry: Product Recalls, Including Removals and Corrections”

Company Recall ElementsCompany Recall Elements

7. Contact FDA same time as team begins formal notification of FDA Recall Coordinator

8. Keep thorough written record of all recall activities9. Build official Company Recall File, which will be evaluated at

the end of the recall by FDA investigators.10.Arrange with FDA for destruction of the recalled product with

FDA investigators as a witness11.Once all product has been identified (or as much as is

practically possible), then initiate the Effectiveness Check.

Recall Information Submission to FDA

1. PRODUCT INFORMATION:•Product name (include brand name and generic name)•Model, catalogue, or product order number(s)•Description of the product•Include if product is powder, liquid, tablet, capsule, etc.•Include the intended use or indications.•Expected product shelf life if perishable.•Include type of packaging (i.e. box, flexible plastic, glass).•Amount of product distribute•Two complete sets of all labeling to your local FDA district recall 

coordinator. Include:Product labeling (including ALL private labels)Individual package labelCase label (photocopy acceptable)Package InsertsDirections for UsePromotional Material (if applicable)

WRAPPING UP AN OFFICIAL RECALLEffectiveness Check ‐

A specific procedure required by FDA and 

designed to verify that anyone who received or purchased a product  being recalled/ withdrawn has received notification about the recall and 

has taken the required notified action.  Plant X shall target 50% of  customers for the effectiveness check and if no suspect finished

goods 

are found, then the withdrawal or recall will be classified as successful.

Level A (Class I Recall) ‐

100% of all accounts receiving product  contacted.

Level B (Class II Recall) ‐

10% ‐

100% of all accounts receiving product  contacted.

Level C (Class III Recall) ‐

A minimum of 10% of all accounts receiving  product contacted.

Level D (Stock Recovery/Market Withdrawal) ‐

A minimum of 2% of all  accounts receiving product contacted.

Level E (Mock Recall) ‐

No effectiveness check necessary.  

Firm’s status reports• The recalling firm will be asked to provide Recall Status 

Reports after initiating a recall (usually on a monthly basis  but more frequently when indicated) to the FDA District 

office monitoring the recall. The reports requested will  usually include the following information:

‐

Dates customers notified‐

Number of customers notified

‐

Number of customers responding‐

Quantity of Realled product returned or accounted for

‐

Details of firm’s recall effectiveness checks

NOTE: FDA may refuse to “end” the recall and require firms to repeat require steps including contacting customers and re- issuing a public recall notice

RIGHTS, RESPONSIBILITIES, DOs & DON’Ts DURING AN FDA  INVESTIGATION/INSPECTION

The 2011 Food Safety Modernization Act (FSMA) has dramatically change the authority of US Food & Drug Administration (US FDA) regarding access to dairy plant processing records and action they can take against dairy plant management, employees and finished dairy products. This is a summary of the dos and don’ts as well as the rights and responsibilities of dairy plant management and employees when an FDA investigator arrives to conduct a formal US FDA investigation (inspection). Any credentialed US FDA investigator has the right to access any part of a food processing plant at any “reasonable” time. Failure to allow access is a federal offense with penalties ranging from a return visit by a large number FDA investigators, a formal warning letter from FDA, product detention to criminal charges against plant management.

Conclusion: Dairy Processing Industry “Best Practice” & Due Diligent Criteria are

Changing Rapidly

Thank You!

asayler@

CFSRS.com

571-931-6763