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

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Shawn Steven ens, Food

d Industry

ry Attorn

rney

ey and Lawyer, r, Food d Industry ry Counsel

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INCREASING CIVIL, REGULATORY AND CRIMINAL EXPOSURE FOR FOOD SAFETY FAILURES WHAT EVERY FOOD EXECUTIVE MUST KNOW

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THE FOOD SAFETY

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WHAT IS THE RISK THAT YOUR COMPANY WILL BE INVOLVED IN A RECALL IN THE NEXT 24 MONTHS? HIGH MEDIUM LOW

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THE THEME OF EVOLVING INDUSTRY EXPOSURE

CIVIL

REGULATORY

CRIMINAL RECALLS =

1993 2017

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

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

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MANDATORY REPORTING AND PULSENET

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ANATOMY OF A FOODBORNE ILLNESS

+ PFGE

MLV A

WGS

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>1,000,000 HUMAN ISOLATES

(MOSTLY UNSOLVED CASES)

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NEW RECALL PROFILE

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

S M

F A

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FOOD SAFETY MODERNIZATION ACT

RULES AND REGULATIONS

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FOOD SAFETY MODERNIZATION ACT

RULES AND REGULATIONS

55

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FOOD SAFETY MODERNIZATION ACT

NEW ENFORCEMENT POLICY

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FOOD SAFETY MODERNIZATION ACT

NEW ENFORCEMENT POLICY

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FOOD SAFETY MODERNIZATION ACT

NEW ENFORCEMENT POLICY

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+

= ENHANCED LIABILITY

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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

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CAN IT HAPPEN TO ME? NEW CONSEQUENCES FOR NONCOMPLIANCE

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Recent FDA Facility Inspections

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

COOKIE DOUGH

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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

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THE INFAMOUS FDA “SWAB-A-THON” A Swab-A-Thon was NOT NEEDED

Product was already linked to an E. coli O157:H7

utbreak involving 32 persons

6 consumer and 2 retail samples were positive RECALL OF ALL PRODUCTS

2017

SoyNut Butter

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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)

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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)

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WHAT CAN COMPANIES DO TO BETTER PROTECT THEMSELVES?

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