CDC and FSMA: Implications for

State Public Health Laboratories

Dale Morse, MD, MS

APHL Annual Meeting

Seattle, Washington

May 20, 2012

National Center for Emerging and Zoonotic Infectious Diseases

Division of Foodborne, Waterborne, and Environmental Diseases

Topics Covered

Food Safety Modernization Act

Integrated Food Safety Centers of Excellence

CDC support of State Health Departments

Emerging Emphasis on Metrics

Enacted January

2011

Primarily effects

FDA

Authorization, but

not appropriation

4 provisions

directed at CDC

Multiple other

provisions for

which CDC has a

role

Main Themes of the Legislation

Informed by strong evidence base

The Food Safety Modernization Act

(FSMA)

“The act requires CDC to

strengthen the capacity of

state and local health

departments to respond

to foodborne outbreaks

and improve the

coordination and

integration of surveillance

systems and laboratory

networks.”

-Thomas R. Frieden, MD, MPH, Director, CDC

The Food Safety Modernization Act: CDC’s task

CDC FSMA

Lead Activities

CDC FSMA

Supporting activities

(FDA lead)

205(b)1 Surveillance Systems

205(b)2; 210, 399V-5:

Working Group Development

210: Centers of Excellence

112(b): Food Allergies

At a Glance: CDC and FSMA

103: Processing Sector Study

104: Performance Standards, Contaminants

105(a): Produce Safety Regulation

110(a): Report on Domestic Capacity

110 (g): Food Safety Research Plan

202(b): FERN Report (DPEI)

203: ICLN (DPEI)

204(d)(2): High Risk Foods

205(c)(1): Enhance S&L Capacity

205(c)(2): Review S&L Capacity

CDC FSMA Enhanced Surveillance Responsibilities

Coordinating and integrating Federal, State and

local foodborne illness surveillance systems

Increasing participation in national networks

Facilitating timely sharing of information

Developing improved epi and lab tools

Improving attribution of illness to specific foods

CDC’s Foodborne Disease Surveillance Systems:

‘Challenges’

Surveillance systems are underfunded, understaffed,

often backlogged and suffer incomplete participation

Critical partners at state and local health departments

are on life support

Between 2008-2011

• 52,000 job losses

FSMA came with no appropriation

Progress on Creating FSMA Working Group(s)

Combined working groups on surveillance and

Centers of Excellence

Established under the CDC Board of Scientific

Counselors (BSC) FACA

Members were named by July 1

Members include representatives from

Federal, state, and local government

Academia

Industry

Consumers

Meetings held Nov 7-8, 2011 & Apr 24-25, 2012

BSC presentations on Nov 9, 2011 May 2, 2012

FSMA Integrated Food Safety Centers of Excellence Background

Public/private/academic partnerships

• State Health Department lead

• Partnership with 1 or more academic institution

Specified activities are related to surveillance*

• Training

• Education

• Program evaluation/research

Existing networks can serve as building blocks*

• FoodNet PulseNet EHS-Net

• FoodCORE FDA RRTs etc.

*Examples are not limited to these activities

FSMA Integrated Food Safety Centers of Excellence Status Update

Nov 2011 BSC FSMA WG recommended

criteria

Feb 2012 FOA developed

May 17, 2012 CoE FOA posted

July 17, 2012 Applications due

Sept 2012 CoEs designated

FY 13 CoEs funded dependent on the

availability of funds

Bridging the Gap: CDC funded State programs supporting Food Safety and FSMA*

EIP FoodNet 10 states ~$5 M

ELC programs all states ~$9-10 M

PulseNet ~4 M

OutbreakNet ~3 M

CaliciNet ~$350 K

NARMS ~$200 K

FoodCORE 7 states ~$2 M

NCEH EHS-Net 6 states ~$1 M

ACA Food Activities ~$3.5 M

Partners (ASTHO, CSTE, APHL, NACCHO, NEHA) &

affiliated programs (CIFOR, Epi Ready, etc.) ~$.5 M

PHEP, OSTLTS and OSELS capacity building funding

that can be applied to food activities

*Approximate current annual value

Increasing importance of Foodborne Illness Performance Measures (Metrics)

FoodNet has metrics

FoodCORE has metrics

CIFOR has metrics – chapter 8

ELC has been adding metrics

For PulseNet

For OutbreakNet

For CaliciNet

For NARMS

PHEP and OSTLTS have PFGE metrics

Examples of FoodNet Lab Metrics

Isolates received from clinical labs >85-95%

Salmonella, E. coli O157:H7, listeria, vibrio

Isolates with serotype >95%

Salmonella, shigella, vibrio, yersinia

NARMS isolates received at CDC 5%

Salmonella, E.coli O157:H7, shigella

PulseNet patterns submitted to CDC 100%

E. coli O157:H7, Salmonella typhi, Listeria

Foodborne Disease Reporting EIP vs Non-EIP Counties, NYS, 2007

Lab Data EIP non-EIP

Isolates received by state lab 98% 82%

Salmonella cases serotyped 99% 84%

STEC E. coli cases typed 99% 75%

Lab Timeliness

Specimen collection to confirmation 5 days 6 days

Confirmation to epi report – median 2 days 9 days

Time from lab to epi report – mean 5 days 17 days

FoodCORE Sites, 2012

The seven fully funded sites cover about 13% of the U.S. population, or 41 million

individuals.

Including all sites, 16% of the population, or more than 50 million individuals are covered.

All estimates are from quickfacts.census.gov, 2010. Some sites are not covered by FoodCORE at 100% of their population.

NC

TN

UT

WI

SC

OH

NYC

CT

Fully funded

Partially funded

FoodCORE Goals

Build capacity for laboratory surveillance,

epidemiologic response, and environmental health

assessment

Develop collaborative surveillance and response

programs

Conduct rapid, coordinated, standardized

investigations

Develop measurable performance indicators

FoodCORE Resources in Action

Better, faster investigations

Solved outbreaks utilizing additional resources

More complete investigations led to rapid recall action

Trainings

Multidisciplinary

Development of public health workforce

New tools and technologies

Pilot test data sharing platforms with CDC

Develop routine data analyses

Develop data submission procedures

FoodCORE Summary

Develop best practices and replicable models for

Detection

Investigation

Response

Control

Lab, epi, and environmental health components

Capacity for routine and surge capacity needs

Standing systems for rapid, coordinated response on all fronts

Shorten the time it takes to identify a source of infection and

pinpoint how and why contamination occurred, to

limit additional illnesses and help prevent future outbreaks

Year One Metrics Summary

Critical means to evaluate workload, identify gaps,

and document successes

Lab activities

Received over 9,000 Salmonella, STEC, and Listeria (SSL)

isolates

Many sites serotyping and PFGE subtyping 100% of isolates

Improved timeliness for serotype and PFGE completion

Epi investigations

Notified of nearly 8,000 SSL cases

Identified over 500 clusters

Increased proportion of cases with attempted interview

Improved timeliness and completeness of interviews

Performance Indicators Guidelines Chapter 8

• To evaluate performance of foodborne

disease surveillance and control

• Cover overall foodborne disease program

objectives and program evaluation

• Example: ‒ Indicator: Foodborne pathogens submitted to PHL

‒ Process metric: % of cases with serotyping date

was available

ELC PulseNet Metrics

Total # of isolates received

Total # of isolates run by PFGE

Total # of isolates run with primary enzyme

Total # of isolates run with secondary enzyme

Total # of isolates run using next generation

methods

Isolates = STEC, listeria, salmonella, shigella,

campylobacter, vibrio cholerae and parahaemolyticus

‘What Gets Measured Gets Done’

A Tale of Two Metrics … separated by a common language

For 2011, both the Office for State, Tribal, Local and

Territorial Support (OSTLTS) and the Office of Public

Health Preparedness and Response (OPHPR)

programs ranked states on % of E. coli O157 isolates

submitted to the PulseNet data base within 4 working

days

OSTLTS used existing PFGE testing data reported by

states into the PulseNet national data base between

Oct 1 2009 and Sept 30 2011

OPHPR used self reported state lab survey data on

testing between August 10, 2009 and August 9 2011

Comparison between OSTLTS and OPHPR results on E. coli O157 PFGEs submitted to

PulseNet within 4 days by state

OSTLTS OPHPR

% submitted within 4 days 62% 90%

Correlation coefficient = 0.21

Differences were due to use of different definitions

and audits

For the coming year the metrics are being combined

and improved via mechanisms described next

New PulseNet Measures

for ELC and PHEP

Input by PulseNet Labs

(designed for minimal effort)

Downloaded from national

database

Real-time calculated

measures (using both

grantee inputs and

database downloads)

Old measure: only applies to those

isolates that were tested and

uploaded with a valid receive date

New measures: uses denominator

data to understand impact on

surveillance

New measure: Quality data needed

to interpret turn-around-time

‘What gets measured gets done’

Chinese Symbol for Crisis

Danger (top) + Opportunity (bottom)

Summary

FSMA directs CDC and its partners to enhance the

surveillance of foodborne illness

Metrics are needed to measure performance in

improving surveillance

Good metrics = $$$$

Bad metrics…….well, not so good

http://harajukumatt.deviantart.com/art/We-Are-Not-Alone-146898693

And now that you have your involuntary FSMA upgrade, I and

CDC are not alone either

http://www.phonemag.com/verizon-drops-most-existing-smartphones-to-99-or-less-089999.php

Where do we go from here?

How can we optimize food safety funding to build

state capacity?

If FSMA funding materializes….

Do we fund all states a little or a few a lot?

• Block grant versus Cancer registry model?

• Piecemeal versus FoodCORE like model?

What is the role of metrics?

• Which ones make the most sense?

For more information please contact Centers for Disease Control and

Prevention 1600 Clifton Road NE, Atlanta, GA 30333

Telephone, 1-800-CDC-INFO (232-4636)/TTY: 1-888-232-6348

E-mail: cdcinfo@cdc.gov Web: www.cdc.gov

The findings and conclusions in this report are those of the authors and do not necessarily represent the official

position of the Centers for Disease Control and Prevention.

Questions?

http://www.telegraph.co.uk/news/picturegalleries/howaboutthat

CDC Food Safety Site:

http://www.cdc.gov/foodsafety/

Division of Foodborne, Waterborne, and Environmental Diseases

National Center for Emerging and Zoonotic Infectious Diseases