NTF Annual ConferenceFebruary 16, 2012

Dr. Regina TanDirector, Applied Epidemiology Division

Office of Public Health ScienceFood Safety and Inspection Service

Regina.Tan@fsis.usda.gov

Potential Changes in Information Sharing

• Special-emphasis Salmonella• As you can imagine, our members will also be

especially interested in Salmonella, but you wouldn’t have to talk policy – Dan E. is speaking the next day so I can make sure those type of questions are directed towards him.

• If you are available, I’m happy to send over a formal invite. The meeting runs from 1-5pm and we can work around your schedule as to which specific time would be best. This slide contains quotes from the original presentation request. It’s

purpose is only to ensure the presentation is written to meet the needs of the audience. The slide will be deleted prior to presentation delivery.

Proposed Agenda• Bottom Line Up Front• Foodborne Illness Investigations

– Directive 8080.3– Anatomy of an investigation– Information-sharing opportunities– Example traceback

• Consumer Complaints– Directive 5610.1– Anatomy of a complaint investigation– Information-sharing opportunities

Bottom Line Up Front

• Partners in prevention• Shared importance in safety of food• Shared importance in consumer trust• Always opportunities to improve• Welcome conversations to do so

ILLNESS INVESTIGATIONS

Directive 8080.3

Key Points :• Factors determining whether to submit a

product sample• Collecting, preparing, and shipping

product samples• Field activities during a foodborne illness

investigation (Environmental assessment)• Procedures for analyzing data• Agency responses to the findings of a

foodborne illness investigation

FSIS Homepage search “8080.3”

Anatomy of an InvestigationNotification

• Local/State Territorial DOH

• CDC or FDA• Internal

Surveillance• Media

reports• Other parts

of FSIS

Evaluation

• Is it FSIS-regulated product?

• Is there a link to illness?

• Are methods scientifically valid?

• Are lab/epi/ environmental findings consistent?

Was the sample intact?Did it suffer temperature abuse?Was it properly stored to avoid

cross-contamination?Are the product labels available

for product identification?

*Initiate Investigation

Anatomy of an Investigation

OPEER: Traceback & Traceforward

• In commerce• Product sampling• Product info• Locate/detain

product• Product

tampering

OFO: Traceback & Traceforward

• Under est. control

• Product sampling• Supplier info• Same- or like-

coded product

OPHS: Analysis and Assessment

• Population-descriptive information

• Common source• Geographic and

temporal distribution w.r.t. product distribution

• Alternative hypotheses

• Biological plausability

Did exposure precede illness?Was illness consistent with known clinical

characteristics?Do Traceback/Forward suggest common

source?Are findings consistent with Agency

experience?Was disease confirmed by laboratory

analysis?

Concurrent activities require constant communication

Example Traceback

Points of Communication

• Directive 8080.3– CDC leads public health coordination– OPHS AED leads internal FSIS coordination– OFO leads coordination with establishment

• Discussion: Potential opportunities for communication

CONSUMER COMPLAINTS

Directive 5610.1: Origins• March 2001 OIG Investigation

Report

• CCMS established in November 2001– Provide centralized mean

of managing consumer complaints.

Directive 5610.1

• FSIS Directive 5610.1 – Procedures to Implement the Consumer Complaint Monitoring System

CCMS The System

• The CCMS System: Electronic database – Records Consumer Complaints for documentation– Triages Complaints for evaluation– Tracks and coordinates investigation

• Purpose: Facilitate detection of potential public health threats in the nation’s food supply and enable rapid response to mitigate such threats.

FNS, ODIFP, OPPD and other USDA Program Areas

Consumer

State/local DOHFDA

Meat & PoultryHotlineOFO or OPEER

CCMS FSIS-OPHS-AED-ZFHSB

FNS,ODIFP,* OPPED/LCPS*

and other USDA Program Areas

* Program Area with employees having direct access to CCMS, but generally use the system for review and not input of complaints.

Anatomy of a Complaint

Investigation

CCMS System

CCMS Team

FSIS OPHS AED

Investigation Information Consumer Contact Information Complaint

Type: Foreign object, Allergy, Illness, Other Description (symptoms, symptom onset time, known

allergies, etc) Food history, medical history, etc.

Product Information Brand Establishment number Lot codes/sell by dates, package size and type

Point of Purchase Information Name & location Purchase date

Issues Not Entered in CCMS

• Whistle-blower• Industry complaints initiated by a competitor• Retail-prepared product• Product tampering• Criminal violations of the FMIA, PPIA or EPIA• National School Lunch Program complaints NOT involving

an FSIS product • Quality issues involving meat cuts and grades• General concerns or comments

CCMS Issues• Initiated by a consumer or

on the consumer’s behalf • Directly related to an FSIS-

inspected product• Imported products re-

inspected by FSIS at the port of entry

• Complaint types:– Illness– Foreign Object– Injury– Allergic Reaction– Improper Labeling– Poor Quality– Economic Adulteration Pictures from the USDA Kitchen Companion

BACK-UP SLIDES

Multiple Locus VNTR Analysis Protocol

http://www.pulsenetinternational.org/SiteCollectionDocuments/mlva/MLVA_overview.pdf

Current State of MLVA

http://www.aphl.org/conferences/proceedings/Documents/2007_11th_Annual_PulseNet_Update_Meeting/MLVA_Protocol%20Update.pdf

Limitations of MLVA Use

To date, several schemes for MLVA subtyping of S. enteritidis have been published. However, the use of:

• Different loci in each protocol (or different promers for the same loci)• Different sequencer platforms• Dye chemistries and size standards used for fragment analysis• Differences in interpretation of loci where incomplete TRs or TRs of heterogeneous

sequence occur, and • Different ways of assigning allele numbers

means comparison of data between laboratories can be problematic.