Food Recalls: Lessons Learned, Avoidance & Management Strategies - - PowerPoint PPT Presentation

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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 571-931-6763

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

Winner

Education: BSc Biology & Human

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

Allen R. Sayler Managing Partner, Center for Food Safety & Regulatory Solutions (CFSRS)

2016 CFSRS Workshop Schedule

• 1. 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 Workshop

May 23rd & 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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• 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 Act Modernization Act (FSMA) (FSMA) PL 111 PL 111-

• 353, 124 Stat.

353, 124 Stat. 3885 3885

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

• ur 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

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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-

• unce 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 Listeria

• utbreak 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 s Okla.

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 stored X X X Employee hygiene problems X X X

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FDA Findings - Blue Bell Oklahoma, Texas & Alabama

Violation

Ala. Texa s Okla.

Inadequate hot water for proper cleaning of equipment X Facility maintenance inadequate X Facility cleaning inadequate X Improper equipment design or repair X X Improper management of temperatures of in‐ process product X

FDA Food Recall Classifications

Class I

• Reasonable probability of serious adverse health consequences
• r 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

• f 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 Letter Public Recall Letter

• 1. Industry is responsible for drafting & sharing with FDA District

Recall Coordinator

• 2. Content is required to include:
• a. Name of company and contact point for consumers, name
• f 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 Elements Company Recall Elements

• 1. 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 Team
• 4. Follow Company Recall “Play Book” including specific

instructions to all customers affected by recall

• 5. Gather all information available applicable to recalled product

including customer contact information

• 6. Draft public recall notice or press release utilizing examples

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

Company Recall Elements Company Recall Elements

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

FDA Recall Coordinator

• 8. Keep thorough written record of all recall activities
• 9. 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 witness 11.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 label
• Case label (photocopy acceptable)
• Package Inserts
• Directions for Use
• Promotional Material (if applicable)

WRAPPING UP AN OFFICIAL RECALL

Effectiveness 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

• ffice 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