food safety forensics: an emerging field

Food Safety Forensics Food Technical Consulting

Food Safety Forensics™: An Emerging

Field

Darrel Suderman, PhD

President/CEO

Rocky Mountain Food Safety Conference June 26, 2014

Denver, Colorado


2

3

4

5

6

Forensic Science

101

Food Safety Forensics, But

Why?

Legal: Food Safety

Forensics

FSF Methodology

Model

Conclusion

1 Introduction

Table of

Contents


Where are we headed?

2012 Trends in Foodborne Illness in the U.S.

0.50

1.00

2.00

Rel

ativ

e R

ate

(lo

g sc

ale)

Campylobacter

STEC O157

Listeria

Salmonella

Vibrio

*Relative rates of laboratory-confirmed infections with Campylobacter, STEC* O157, Listeria, Salmonella, and Vibrio compared with 1996–1998 rates, by year — Foodborne Diseases Active Surveillance Network, United States, 1996–2012Source: CDC.gov


Introduction


Introduction

Presentation Sequence

─What is the Problem we are trying to Solve?

─A consumer became sick eating grilled beef

─What Questions do we need Answers for?

─What organism (type, subtype, etc.) caused the illness.?

─What elements of plant environment proliferated growth?

─What management practices (control systems) failed?

─What was the “Chain of Command “ from CEO down to problem area

─Why do we have this emerging litigation problem?

─One person died. 25 additional people are in hospital.

─Process Plan had a previous contamination 2 yrs ago

─FDA intends to arrest and jail CEO & QA Manager

─Both people will be charged as criminals


Introduction

Presentation Sequence

─What are the Traditional Methodologies & Data Requirements?

─Organism Typing & Enumeration

─What New Knowledge Sets (Data Types) are required?

─Broken Processes &/or Policy Deviations (Next page)

─A Holistic Supply Chain Process Assessment

─What New Problem Solving Methodologies and Reports are

required?

─Database Information

─Policy Violations

─Patterns of Intent


Introduction

Darrel Suderman, PhD if you forgot…

Speaker Background

Education

•Ph.D. Food Science @ Kansas State University

•New Food Product Innovation Champion

Experience

•20 years QSR restaurant experience @ 12 restaurant brands

•10 years of food & beverage manufacturing and supply chain management software systems consulting

Legal

•5 years legal Expert Witness food litigation experience

•Food Science Forensics™ and Food Safety Forensics™ Champion


Forensic Science


Forensic Science

What is Forensic Science?

Forensic Science is the application of scientific principles and

technological practices to the purposes of justice in the study

and resolution of criminal, civil, and regulation issues.

AAFS Board of Directors, 1993 (American Academy of Forensic Sciences)


Forensic Science

What Is Forensic Science

─Other Definitions include:

─ Scientific tests or techniques used in connection with the detection of

crime (noun)

─ Relating to the use of scientific knowledge or methods in solving

crimes (adjective) Merriam-Webster Online Dictionary

─ The application of scientific knowledge to legal problems; especially:

scientific analysis of physical evidence (as from a crime scene)

Merriam-Webster Online Dictionary


Forensic Science

Forensic Sciences Fields

─Toxicology*

─Technology* (Solving crimes with technology)

─Reconstruction (Re-creating the crime scene)

─Odontology

─Nursing

─Mathematics

─Entomology

─Chemistry* (Pathogen growth environment)

─Anthropology

*Relative to Food Safety Forensics

As recognized by the American Academy of Forensic Sciences


Food Safety Forensics™


Food Safety Forensics

What Is Food Safety Forensics?

─Food Safety Forensics is the methodology of using food safety

principles, detection methods and processes to solve crimes, or

to verify and document food poisoning – including both

humans and pets. It is specific to food micro-organism

poisoning.

─Example: The detection and tracking of pathogenic organisms in a fruit

like melons that result in consumer deaths.

─It represents a disciplined methodology for identifying the food

poisoning case and contributing factors, and identifies a

sequential “tracking and tracing” investigative steps,

technologies, and detection tools.


Why Now?

Why Forensic Food Safety™ Now?

─In 2013 Jensen Melons (Colorado) Food Company Owners and

Executives were charged with criminal liability of food safety

conditions.

─The government must demonstrate a “pattern” of food safety

neglect, rules violations, or food contamination.

─ Saying “I’m Sorry” may work in public media, but not in court

anymore.

─At least one US law firm is recognized as an aggressive

“ambulance chaser” and their methods are sharpened.


Food Safety Forensics™ Expert Witness

─The skill set of a Food Safety Forensic Expert Witness:

─Food Science & Chemistry

─Food Microbiology

─HACCP Program Requirements

─FDA and USDA Regulatory Requirements

─Working Knowledge of Tracking, Tracing, GS1 Bar Coding, and

Pedigree Technology Systems

─Food Plant Experience

─HACCP & Food Safety Systems

─Manufacturing Software Systems

─Supply Chain Software Systems

─Product Recall Experience

Food Safety Forensics™ Expert Witness Skill Set

What Do You Look for in an Expert?


Old vs. New Data Evidence Search


Organism Typing &

Enumeration – i.e.

Organism

Documentation

VS

.

Deviation to

Specifications,

Process Controls

Checks & Training

Adherence – i.e.

Broken Compliance

Patterns



Investigative Troubleshooting

─LMS Lab Management System – Sample submission,

sequencing, and reporting Process.

─Temperatures throughout processing of product

─Distribution Cold Chain Temperatures

─Air Quality

─Swab checks


Food Safety Forensics Data

Food Software Systems used for Data

Tracking

─Quality Assurance and HACCP Data

─LMS – Laboratory (Sample)Management System

─PLM – Product Life Cycle Management System – check

Specification & Certification accuracy

─SPC – Statistical Process Control Program

─Supply Chain Tracking & Tracing Systems


Food Safety Forensics Data

PLM Business Functions

─Document Management – Data Mining

─Ingredient Tracking and Tracing

─Specification Management & Version Control

─Certification Process Workflow & Doc Management

─Synchronization with Marketing Calendar

─Connectivity to Nutritional Database

─Connectivity to statistical process control QA data

─Integration with customer PLM or databases

─Strong New Product Development & Commercialization

Workflow Management



How Does FSF Differ From Other Forensic

Sciences?

Food Safety Forensics™ (FSF) differs from the other 9 forensic

sciences:

─Food, like pharmaceutical drugs, is ingested into the human body.

─Food is a matter of life and death.

─Food is perishable with a short shelf-life–and its fingerprints vanish.

─Food Safety Forensics™ uses multiple methodologies from the other

forensic sciences

─Food Safety Forensics™ methodology must track through the entire

“farm-to-fork” supply chain



Potential Food Safety Forensic™ Food

Applications

─Fresh Fruit

─Fresh Vegetables

─Raw Meat

─Raw Poultry

─Organic Foods

─Natural Foods

─Restaurants

─Grocery Deli’s



Benefits Of Food Safety Forensic™

Methodology

─In Addition to Traditional Food pathogen Information, you also

have:

─Location Mapping Of Food Pathogen Throughout The Supply

Chain

─Food Pathogen Genealogy Mapping

─Location Mapping of the Food Pathogen throughout the Food

Processing Plant

─Data Documentation of Food Pathogen Life Cycle


Legal: Food Safety

Forensics™


Legal: Food Safety Forensics

Traditional Legal Approaches

─What pathogen caused the sickness outbreak?

─Were other pathogen strains present?

─What was pathogen population?

─Where was the pathogen located?

─Was an approved HACCP Plan Followed?

─Was an Incident Management Plan executed?

─What were the food processing plant environmental

conditions?

─How well was Recall Managed?



New Legal Approaches

─New Methodology Approaches must be Holistic across the

entire Supply Chain

─Food Contamination Tracked & Traced both Upstream and

Downstream in the Supply Chain

─Did Executive Negligence Occur (like Jensen melon case in

Colorado?

─Did Temperature Abuse Occur Upstream or Downstream –

based on data capture?



Benefits To Food Safety Court Cases

─Increases Court Success Rate because justification data is more

accurately detailed

─Incident Data is Mapped to FDA and USDA regulations

─Protection from hint of criminality

─Training and Safety Programs Meetings are documented


Jensen Farms Cantaloupes

Legal: Case Study

Organism: Listeria monocytogenes

Location: Holly, Colorado

Date: July 31, 2011 – December 8, 2011

Deaths: 30 confirmed

Non-Fatal Injuries: 146 cases confirmed

Food Technical Consulting

The recent Jensen Farms listeria food

contamination case in Colorado has brought

food safety to the forefront in the United

States, and its outcome speaks to the need

for more effective methodologies for

tracking and tracing deadly pathogens

throughout the food supply chain – because

food plant owners and executives are now

being prosecuted as criminals – they must

defend themselves against criminal “intent

“ charges.


Legal: Case Study

Jensen Farms Cause & Effect

─Brothers Eric and Ryan Jensen admitted to six counts of food

adulteration and other charges. Each faced up to six years in

prison and up to $1.5m in fines.

─Inadequately washed melons sparked the outbreak

─A US Food and Drug Administration inquiry found Jensen

Farms installed a new cantaloupe cleaning system—designed to

clean potatoes—in 2011.

─The system included a chlorine spray meant to sterilize the

melons, which was never used resulted in a deadly tragedy.

─Could the failure to apply peracetic acid to fresh meat & poultry

follow?


The Food Safety Forensics™

Methodology Model


Methodology Explained

Farm–to–Fork Supply Chain Forensic Scope

Process Documentation

Ingredient Supply Chain Documentation

Fingerprinting

Temperature Tracking

Country of Origin Tracking


Food Safety Forensics Methodology

Food Safety Forensics™ Fingerprinting

Food Safety Forensic™ Fingerprinting is the collection of vital

unique data stored in the fingerprint like:

Food ingredient origin (domestic & International

Ingredient processing data

Finished Product Processing data

Work-in-Process (WIP) genealogy

Inventory History

Distribution History



Traditional vs. Future Data Gathering

Blood DNA vs. Microbe DNA


Traceability

Genealogy

Trackback

Food Safety Forensic™ Methodology

Processes




Food Trackback

─ Product Trackback enables food processors to sequentially track process deviations or product variances back to ingredient suppliers or hidden in-plant processing “enemies”.

─For example, bacon quality changes for a pork processor in Europe were traced back to a feed change by the hog farmer that used a ration with a higher concentration of linoleic acid.

─Product Trackback is also critical to identifying the entry points of microbiological contamination, bone and glass fragments, and bioterrorism poisons. But Trackback should not be confused with “process verification” (next slide). Trackback is reinforced by foundational statistical process control (SPC) disciplines.

─Products subject to Trackback are not necessarily a consumer health risk, but an unacceptable “quality” issue.



Process Verification

─Process verification is represents a quality system that follows

standard operating procedures, best management practices, and

HACCP principles.

─Process verification is typically more detailed and more

interdependent that traceability. Under process verification

plans, animals must be raised according to USDA-approved

specifications and guidelines.



Food Trackback Forensic Impact

It maps the manufacturing process.

It measures the manufacturing process performance.

It verifies compliance (Process Verification)



Food Traceability

─Product Traceability is the process of tracking a product’s

history and sharing that data along the entire processing path –

the so-called “farm-to-fork” or “field-to-plate” programs.

Ideally, traceback allows the consumer or processor to track a

cut of meat or a package of food from the grocery store from

which the product was purchased all the way back to the farm,

field, or processing plant where it originated.

─The main traceability benefit for consumers and food

processors is food safety, or more specifically, the assurance of

food safety. Processors can take advantage of traceability

programs to enhance the quality of their products.


Food Safety Forensics Tracking

Integrated Food Tracking & Tracing

Components

─Electronic production, quality, and HACCP data collection

─Centralized “relational” database

─ Integrated RF scanning and bar code tracking system

─Bar Code Information Management (BCIM) system that is integrated

with a centralized relational database within the MES and ERP

environments – a critical component for transparently accessing and

communicating information across disparate business processes –

such as procurement, manufacturing, order management, inventory

management, warehouse management, transportation management

systems, as well as real-time connectivity to 3rd party warehouses.

─Centralized portal for accessing and reporting information to multiple

users across an entire organization from even remote locations.



Process Genealogy

─Genealogy is the tracking of a product’s assembly through the

manufacturing process. It supports the ability to do the

following:

─Track information about components assembled into a finished food

product

─Verify that all required ingredients are assembled at the start of the

product assembly operation

─Place ingredients on hold to prevent quality issues

─Load and replenish ingredients during the production process

─Determine supplier information for failed components

─Produce reports detailing exactly which ingredients were assembled into

a given SKU or Product #



Incoherent Forensic Data

Most product tracking plans used by food processors’ product

recalls fall short during compressed recall timeframes for the

following reasons:

─ Most food safety data is collected, stored, and retrieved manually – Not

Electronically!

─ Most electronic or manual HACCP or Quality management programs are

only “point solutions” – Not Integrated!

─ Most food companies are not capable of feeding information from bar code

scanners directly into their ERP business transaction and data warehouse

systems.

─ Most food companies cannot track finished goods down to the individual

“case level” that is required for thorough product recalls


The End

Food Technical

Consulting Dr. Darrel Suderman

[email protected]

www.foodbevbiz.com

Contact

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