Shawn Steven ens, Food od Industry ry Attorn orney ey and - PowerPoint PPT Presentation

Shawn Steven ens, Food od Industry ry Attorn orney ey and Lawyer, r, Food d Industry ry 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 RECALLS = CRIMINAL 1993 2017

TH THE FO E FOOD OD SA SAFE FETY TY REV REVOLUTION LUTION

TH THE FO E FOOD OD SA SAFE FETY TY REV REVOLUTION LUTION

MANDATORY REPORTING AND PULSENET

ANATOMY OF A FOODBORNE ILLNESS MLV + PFGE A WGS

>1,000,000 HUMAN ISOLATES (MOSTLY UNSOLVED CASES)

NEW RECALL PROFILE

S M A F FDA COMMANDED TO OVERHAUL THE SAFTEY OF THE U.S. FOOD SUPPLY

FOOD SAFETY MODERNIZATION ACT RULES AND REGULATIONS

FOOD SAFETY MODERNIZATION ACT RULES AND REGULATIONS 55

FOOD SAFETY MODERNIZATION ACT NEW ENFORCEMENT POLICY

FOOD SAFETY MODERNIZATION ACT NEW ENFORCEMENT POLICY

FOOD SAFETY MODERNIZATION ACT NEW ENFORCEMENT POLICY

ENHANCED LIABILITY + =

ENHANCED LIABILITY 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 $250,000 MISDEMEANOR 1 YEAR IN PRISON CHARGE

NEW CONSEQUENCES FOR NONCOMPLIANCE CAN IT HAPPEN TO ME?

Recent FDA Facility Inspections

2015 Ice Cream Products 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

2015 Ice Cream Products Failure to perform micro testing to identify contamination Environmental Sampling Program failed to include: 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 •

2015 Ice 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 Packaged Salad Products 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

2016 Packaged Salad Products 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

2016 Packaged 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

2016 Frozen [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

2016 Frozen [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 COOKIE DOUGH 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

2017 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

2017 SoyNut 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

2017 SoyNut Butter 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

2017 Cheese 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)

2017 Cheese 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

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 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”

KNOW FDA LISTERIA CONTROL GUIDANCE 2 1 3 Operational Controls Incoming Ingredients Finished Products Personnel Plant Design, Construction and Operation Equipment Design, Construction and Operation Cleaning and Sanitation Process Controls (Listericidal or Other Controls) Is Lm reasonably foreseeable? Finished Product Testing Storage, Time, Temperature and Transportation Implement Supplier Controls: FDA Recommends Testing: Environmental Monitoring • Supplier Approval Program • Verification Purposes Analysis of Trends and Maintenance of Records • Certificates of Conformance • Periodic Testing Training • Require Raw Material Testing • Sample for Lm • Require Environmental Monitoring • Test and Hold • Conduct Audits and Verification Activities

GETTING IT RIGHT “WHAT WOULD 12 JURORS THINK?”

Shawn Stevens Food Industry Consultant and Lawyer stevens@foodindustrycounsel.com 920.698.2561