food safety and inspection service ~~ update

United States Department of Agriculture

Food Safety and Inspection Service

Food Safety and Inspection Service ~~ Update ~~

7th Annual OutbreakNet ConferencePulseNet and OutbreakNet: Evolving Connectivity in Food Safety

Kristin G. Holt, D.V.M., M.P.H.

FSIS Liaison to CDC

September 21, 2011

Protecting Public Health through Food Safety and Food Defense

FarmFarm--ToTo--Fork ContinuumFork Continuum



Presentation Outline

• FSIS – brief overview

• FSIS – Primary prevention

– PR/HACCP– PR/HACCP

– L. monocytogenes in Ready-to-Eat products

– Non-O157 STEC policy development

• FSIS – Secondary prevention

– Consumer outreach

– Foodborne illness investigations



FSIS Mission

The Food Safety and Inspection

Service (FSIS) is the public health

agency in the U.S. Department of

Agriculture responsible for ensuring Agriculture responsible for ensuring

that the nation's commercial supply

of meat, poultry, and egg products

is safe, wholesome, and correctly

labeled and packaged.

Protecting Public Health through Food Safety and Food Defense



FSIS Workforce

• ~ 10,000 total personnel - of that number 7,500

are inspection and veterinary personnel

• The largest single employer of veterinarians

• 6,100 plants have FSIS personnel present in

them every day, as required by Acts

• Oversee 100 billion pounds of food - about 40%

of all domestic food production



FSIS Laboratory System

Laboratories accredited under ISO 17025

In calendar year 2010, FSIS personnel analyzed– For presence of E. coli O157:H7

• 12,550 raw ground beef samples

• 3,331 raw beef trim and components samples

– For presence of Salmonella

5

– For presence of Salmonella• 29,734 raw product samples

• 1,517 pasteurized egg products samples

– For presence of Listeria monocytogenes• 11,854 ready-to-eat product samples

PulseNet member

Food Emergency Response Network • Network of 157 local, state, and federal food-testing labs

• Jointly directed by the FSIS and FDA

• Testing for threat/select agents (chemical, biological, radiological)



FSIS Organizational Structure



Food Safety – People and Priorities

Secretary of Agriculture Tom Vilsack:

“There is no more fundamental function of government than protecting consumers from harm. “

“USDA and our partners are working together, more than ever before, to improve and modernize the food safety system based on prevention. ”

Dr. Elisabeth Hagen is sworn in to her

new position as Under Secretary for

Food Safety, August 20, 2010

Under Secretary for Food Safety Elisabeth Hagen, M.D.1) Prevention - prevent foodborne illness2) Tools - have the right tools and data to do the job3) People - remember the people we are here to protect

and empower our people to do the best job possible



Primary prevention

• The Pathogen Reduction/Hazard Analysis and Critical Control Point (HACCP) Systems Final Rule Systems Final Rule

• Listeria monocytogenes and ready-to-eat (RTE) meat and poultry

• Non-O157 STEC policy development



• Published in July 1996

• Moved FSIS toward a preventive, science-based inspection system

The Pathogen Reduction/Hazard Analysis and Critical Control Point (HACCP) Systems Final Rule

• Empowered the industry to look for and address food safety hazards

– Sanitation Standard Operating Procedures (SSOP)

– Pathogen reduction – held to performance standards

– HACCP plan(s)

• Required that government verify industry’s efforts to reduce food safety hazards

• Food safety and food defense verification procedures daily



FSIS Public Health Information System (PHIS)

• Enhanced FSIS data warehouse – 2011 launch

• Integrate FSIS separate and disparate data systems into

one comprehensive data-driven, easy-to-use data-analytics one comprehensive data-driven, easy-to-use data-analytics

system

• Powerful decision-making tool that will enable FSIS to

protect public health more efficiently, effectively and rapidly

• On-going efforts to incorporate data along the farm-to-table

continuum

• human data into a predictive analytics module



Performance Standards for Young Chicken and

Turkey Slaughter Establishments

• Tougher performance standards for Salmonella

• New performance standards for Campylobacter

• Effective starting with FSIS July 2011 verification sample sets

• Sample set criteria for Salmonella

– Young chickens – 5/51 samples positive

– Performance standard: original 20%, current 7.5%

– Turkeys – 4/56 positive

• Performance standard for Campylobacter

– Young chickens – 10.4%

– Turkeys – 0.79%

• Sample set criteria for Campylobacter

– Young chickens – 8/51 samples positive

– Turkeys – 3/56 positive



Performance Standards for Young Chicken and

Turkey Slaughter Establishments

• Establishments that fail to meet our new standards will

have their names published and undergo a more

intensified inspection by FSIS. intensified inspection by FSIS.

• FSIS estimates these new

standards will prevent a total

of about 25,000 illnesses

each year.

FRN posted at: http://www.fsis.usda.gov/OPPDE/rdad/FRPubs/2010-0029.pdf



Assessment(Reassessment)

Assurance

FSIS Application of Public Health Model

Quantitative risk assessments

Other scientific assessments

Policy Development

Evaluation• Food data

• Human data

• Animal data

• Environmental data

• Consumer practices



4.61%

4.03%

3.61%

3.44%

2.90%3.02%

2.91%

2.54%

3.0%

3.5%

4.0%

4.5%

5.0%

Perc

en

t P

osit

ive

FSIS Regulatory Testing for Lm in RTE Products by Calendar Year 1990-2009

(All Years All Random/Risk-based Projects)

2.25%

2.54%

1.91%

1.45%1.32%

1.03%

0.76%

0.55%0.64% 0.61%

0.43% 0.42% 0.38%

0.0%

0.5%

1.0%

1.5%

2.0%

2.5%

1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009

Perc

en

t P

osit

ive

Calendar Year



Listeria monocytogenes - Attribution

• Lm prevalence and Lm levels are higher for in‐store packaged than for manufacturer‐packaged RTE food

Assessment(Reassessment)

Quantitative risk assessments

Other scientific assessments

‐

‐

food

– Gombas et al., 2003

– NAFSS, 2008

• > 80% of all listeriosis cases attributed to deli meat are from deli meat sliced and packaged at retail

– Endrikat et al., 2010

• Food data

• Human data

• Animal data

• Environmental data

• Consumer practices



Interagency Listeria monocytogenes in

Retail Risk Assessment

• New risk assessment - initiated in 2009

• Multi-agency risk assessment - FSIS, FDA, and CDC

• Collaborators - ARS, UMD, VA Tech, Cornell, EHS-Net• Collaborators - ARS, UMD, VA Tech, Cornell, EHS-Net

• Stakeholder participation early in the process and call for

additional data on cross-contamination at retail

• Focus:

– FDA & FSIS regulated RTE foods

– Foods that are sliced, prepared and/or packaged in

the retail deli environment and consumed in the home

(e.g., deli meats, cheeses, deli‐type salads)



Lm in retail Risk Assessment -

Data Collection Considerations



Six additional STEC - adulterants in

non-intact raw beef

• STEC O26, O45, O103, O111, O121, and O145

• Raw, non-intact beef products (e.g., ground beef, • Raw, non-intact beef products (e.g., ground beef,

hamburger, beef patty products, tenderized steaks)

• Raw intact components used to manufacture these

products (e.g., manufacturing trim)

• Adulteration within the meaning of 21 U.S.C. 601(m)(1)

• Unhealthful and unwholesome under 21 U.S.C. 601(m)(3)

• Federal Register, September 20, 2011

• http://www.fsis.usda.gov/Frame/FrameRedirect.asp?main=http://www.fsis.usda.gov/OPPDE/rdad/FRPubs/2010-0023.htm



Six additional STEC - adulterants in

non-intact raw beef – next steps• Launch testing program March 5, 2012

• Test raw intact components used to manufacture raw, ground beef

– Testing is in support of FSIS in-plant verification procedures

– Test ground beef at a later date

• Survey by FSIS personnel to capture how establishments

are addressing STEC

• Conduct nationwide microbiological baseline survey

• Review comments to federal register notice – 60 day period

• Review comments to guidance validating commercial test

kits

• Conduct outreach to small and very small establishments



Presentation Outline

• FSIS – brief overview

• FSIS – Primary prevention

– PR/HACCP– PR/HACCP

– L. monocytogenes in Ready-to-Eat products

– Non-O157 STEC policy development

• FSIS – Secondary prevention

– Consumer outreach

– Foodborne illness investigations



Initiatives Targeting ConsumersFood Safe Families

• In June 2011 USDA, FDA, CDC, and the Ad Council debuted

Food Safe Families, the first joint public service campaign to

help families prevent foodborne illnesses in the home

• Links to the video ads are on www.foodsafety.gov• Links to the video ads are on www.foodsafety.gov

• This campaign used simple messaging, humor, TV air time, and

YouTube to remind Americans to

– clean kitchen surfaces, utensils, hands while preparing food,

– separate raw meats from other foods by using different cutting boards,

– cook foods to the correct temperatures, and

– chill raw and prepared foods promptly.

Ask Karen - FSIS 24/7 virtual food safety advisor

• Launch of smart phone “app” m.askkaren.gov | En Español



Alerting consumers – during foodborne

illness investigations



FSIS - Foodborne Illness Investigations (FY10)

• 25 foodborne illness investigations possibly associated with FSIS-regulated products

– STEC: O157:H7 - 8, O157:NM - 1, O26 - 1

– Salmonella - 11, L. monocytogenes - 3 , C. perfringens - 1

10 food recalls• 10 food recalls

• Multiple investigations involving multiple agencies

12/2009 Multistate Salmonella Montevideo ClusterReady-To-Eat Italian Sausage Recall

06/2010 Multistate Salmonella Chester ClusterCheesy Chicken and Rice Frozen Meals Recall



CDC-FDA-FSIS

Outbreak Investigation Team Orientation Sessions

• Objective - gain a better understanding of each federal

agency and its outbreak response procedures and build

relationships to facilitate teamwork

• Goal – improved communication and collaboration during • Goal – improved communication and collaboration during

investigations resulting in more successful investigations

• Participants – epidemiologists, investigative and regulatory

personnel, and liaisons

• CDC session - November 2010

• FSIS session - Late January – early February 2011

• FDA session – May 2011



Chain of custody

• FSIS Directive 10,000.1 guides FSIS personnel in the evaluation of lab results

from non-FSIS labs, defined as State and local government laboratories,

academic laboratories, and private sector laboratories.

• Follows a sample through a continuum starting with how the sample was

stored and handled prior to collection, how the chain od custody was

maintained, through lab result

• Directive 10,000.1 is referenced in the investigations directive (8080.3).

• (http://www.fsis.usda.gov/OPPDE/rdad/FSISDirectives/10000.1.pdf)



FSIS Directive 10,000.1 - section V. Decision Criteria

for Accepted NON-FSIS Laboratory Results

A. To decide whether to rely on non-FSIS laboratory results, FSIS will consider the following questions:

1. Was the sample handled and stored properly prior to collection?

2. Did the party responsible for the sample collection maintain the sample’s 2. Did the party responsible for the sample collection maintain the sample’s identity and integrity properly (e.g., through handling and storage) before submitting for testing? Did the party responsible for the sample properly ship it to the laboratory? FSIS will determine whether and how those responsible for maintaining the identity and integrity of the sample did so (e.g., there was an appropriate chain of custody, the sample was not subject to temperature abuse).

3. Did the non-FSIS laboratory use a methodology appropriate for the analysis in question?

4. Did the non-FSIS laboratory ensure that the results of its analysis are reliable and accurate?

•



Sample collection - caveats

• Appreciate efforts to collect and test products during outbreak investigations

• Feel free to call and ask about standards we are • Feel free to call and ask about standards we are looking at regarding sample identity, integrity, and lab methods

• Backdrop is decisions can be based on lab results with regulatory actions that follow



Foodborne Illness Investigations

FSIS needs:

• Continued success of FoodCORE

• Data shared as close to real-time as possible

• Chain of custody maintained

• Alerting state officials

• Move implication of food vehicle up on the timeline

Your needs: Please share them with us ☺



Thank you!

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