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Shawn Stevens, Food Industry Attorney and Lawyer, Food Industry Counsel
INCREASING CIVIL, REGULATORY AND CRIMINAL
EXPOSURE FOR FOOD SAFETY FAILURES
WHAT EVERY FOOD EXECUTIVE MUST KNOW
THE FOOD SAFETY
WHAT IS THE RISK THAT YOUR COMPANY WILL BE
INVOLVED IN A RECALL IN THE NEXT 24 MONTHS?
HIGH
MEDIUM
LOW
THE THEME OF EVOLVING INDUSTRY EXPOSURE
CIVIL
REGULATORY
CRIMINALRECALLS =1993 2017
THE FOOD SAFETY REVOLUTION
THE FOOD SAFETY REVOLUTION
MANDATORY REPORTING AND PULSENET
ANATOMY OF A FOODBORNE ILLNESS
+PFGE MLV
A
WGS
>1,000,000 HUMAN ISOLATES (MOSTLY UNSOLVED CASES)
NEW RECALL PROFILE
FDA COMMANDED TO OVERHAUL
THE SAFTEY OF THE U.S. FOOD SUPPLY
S MF A
FOOD SAFETY MODERNIZATION ACTRULES AND REGULATIONS
FOOD SAFETY MODERNIZATION ACTRULES AND REGULATIONS
55
FOOD SAFETY MODERNIZATION ACTNEW ENFORCEMENT POLICY
FOOD SAFETY MODERNIZATION ACTNEW ENFORCEMENT POLICY
FOOD SAFETY MODERNIZATION ACTNEW ENFORCEMENT POLICY
+ =
ENHANCED LIABILITY
MISDEMEANOR
CHARGE
$250,000
1 YEAR IN PRISON
You are aware of a condition that
could lead to product contamination
You are in a position to eliminate the condition
You fail to eliminate the condition
ENHANCED LIABILITY
CAN IT HAPPEN TO ME?
NEW CONSEQUENCES FOR NONCOMPLIANCE
Recent FDA Facility Inspections
2015
Suitable outer garments not worn by employees
Employees’ soiled shirts (with holes) touching FCS
Employees not washing hands after becoming soiled
Pieces of filling equipment stored in hand washing sink
Cracked gaskets and peeling paint on equipment
Exposed food not protected from condensation
Ice Cream Products
2015
Failure to perform micro testing to identify contamination
Environmental Sampling Program failed to include:
Ice Cream Products
• Sampling of food contact surfaces (FCS)
• Determination of corrective actions for positives
• Determination of the impact of positives on product
• Determination of the Listeria spp. for positives
2015Ice Cream Products
THE INFAMOUS FDA “SWAB-A-THON”
Multiple environmental samples were + for Lm
Environmental samples matched
9 illnesses in PulseNet database from previous 5 years
THE FINDINGS TRIGGERED
A MASSIVE RECALL OF ALL PRODUCTS PRODUCED
CRIMINAL INVESTIGATION INITIATED
2016
Food residue observed on multiple pieces of equipment
Cutting boards observed to have deep groves
Facility floors contained deep cracks, ruts and groves
No caulk between stainless steel curbs and walls
Peeling paint and rust on walls
Gaps along dock plates allowing pest access
Packaged Salad Products
2016
Failure to perform micro testing to identify contamination
Positive sites recleaned, resanitized and retested
Total of 9 positive Lm environmental samples had been
collected by the company over previous 2 years
Packaged Salad Products
2016Packaged Salad Products
THE INFAMOUS FDA “SWAB-A-THON”
Finished Product and in-process samples were + for Lm
Samples collected matched 19 illnesses
in PulseNet database from previous 6 months
FINDINGS TRIGGERED
A RECALL OF ALL PRODUCTS AT ISSUE
2016Frozen [IQF] Vegetables
Failure to have smoothly bonded food contact surfaces
Multiple rough welds observed on FCS
Food residues observed on processing equipment
Failure to protect food from drip condensation
Non-FCS observed with grime after preop
2016Frozen [IQF] Vegetables
THE INFAMOUS FDA “SWAB-A-THON”
19 of 106 environmental samples were + for Lm[18% of all environmental samples]
[6% were collected from FCS]
Environmental samples matched
8 illnesses in PulseNet database from previous 3 years
FINDINGS TRIGGERED
RECALL OF AFFECTED PRODUCTS
2017
Floors covered with flour, shortening and liquid egg
Carrying trash to a dumpster while wearing aprons
Equipment was rusty and missing bolts
Using pressure hoses to clean floors near exposed food
Overspray from pressure hoses contaminating equipment
COOKIE DOUGH
THE INFAMOUS FDA “SWAB-A-THON”
4 environmental samples were + for LM
WGS was performed on 11 company samples
Matched other ice cream and cookie dough samples
RECALL OF ALL PRODUCTS
PRODUCED DURING 6 MONTH PERIOD
2017COOKIE DOUGH
2017SoyNut Butter
Liquid substance dripping from a hole in the ceiling
Product and black filth on processing room floor
Restroom cleaning equipment intermingled with
production floor cleaning equipment
Mixing kettle lid and maintenance tools stored on floor
Had not disassembled processing equipment since 2015
Did not routinely sanitize pipes, fittings, gaskets and seals
Fly infestation in firm’s quality control laboratory
THE INFAMOUS FDA “SWAB-A-THON”
A Swab-A-Thon was NOT NEEDED
Product was already linked to an E. coli O157:H7
outbreak involving 32 persons
6 consumer and 2 retail samples were positive
RECALL OF ALL PRODUCTS
2017SoyNut Butter
2017Cheese
Employee with multiple cuts and abrasions was observed
dipping arms up to elbows in cheese vats
Using wooden boards that are not easily sanitized
Condensation dripping onto food contact surfaces
Floors were cracked and pitted
Over 20 months, 54 out of 198 samples positive
10 positives were from FCS from 2014 – 2015
(Corrective Action - stopped sampling FCS)
2017Cheese
THE INFAMOUS FDA “SWAB-A-THON”
A Swab-A-Thon was NOT NEEDED
PRODUCTS WERE ALREAFDY LINKED TO A LISTERIA OUTBREAK
September 2016 through March 2017
Finished products collected and tested [+]
8 Illnesses (which included 2 deaths)
WHAT CAN COMPANIES DO TO BETTER
PROTECT THEMSELVES?
REVIEW THE FDA INSPECTION CHECKLIST
REVIEW THE FDA INSPECTION CHECKLIST
REVIEW THE FDA INSPECTION CHECKLIST
REVIEW THE FDA INSPECTION CHECKLIST
“PLAY FDA FOR A DAY”CONDUCT YOUR OWN MICROBIOLOGICAL PROFILING
OF ZONE 3 AND ZONE 4 AREAS
REVIEW THE FDA INSPECTION CHECKLIST
REVIEW THE FDA INSPECTION CHECKLIST
REVIEW THE FDA INSPECTION CHECKLIST
HOLD ANY PRODUCT FDA SAMPLES
REVIEW THE FDA INSPECTION CHECKLIST
CLEAN AND SANITIZE ALL AREAS FDA SAMPLES
REVIEW THE FDA INSPECTION CHECKLIST
PROTECT YOUR RECORDS
REVIEW THE FDA INSPECTION CHECKLIST
AFTER THE INSPECTION
DON’T ALWAYS AGREE TO RECALL
AFTER THE INSPECTION
AFTER THE INSPECTION
KNOW YOURSELF
HOW ARE YOU SAMPLING?
WHEN ARE YOU SAMPLING?
WHERE ARE YOU SAMPLING?
KNOW YOURSELF
“ROOT CAUSE” v. “ROOT SOURCE”
Operational ControlsIncoming Ingredients
1 2 3
Is Lm reasonably foreseeable?
• Supplier Approval Program
• Certificates of Conformance
• Require Raw Material Testing
• Require Environmental Monitoring
• Conduct Audits and Verification
Activities
Finished Product Testing
FDA Recommends Testing:
Finished ProductsPersonnel
Plant Design, Construction and Operation
Equipment Design, Construction and Operation
Process Controls (Listericidal or Other Controls)
Storage, Time, Temperature and Transportation
Environmental Monitoring
Analysis of Trends and Maintenance of Records
Training
• Verification Purposes
• Periodic Testing
• Sample for Lm
• Test and Hold
Implement Supplier Controls:
Cleaning and Sanitation
KNOW FDA LISTERIA CONTROL GUIDANCE
GETTING IT RIGHT
“WHAT WOULD 12 JURORS THINK?”
Shawn Stevens
Food Industry Consultant and Lawyer
stevens@foodindustrycounsel.com
920.698.2561
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