food safety and inspection service ~~ update
TRANSCRIPT
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
United States Department of Agriculture
Food Safety and Inspection Service
Presentation Outline
⢠FSIS â brief overview
⢠FSIS â Primary prevention
â PR/HACCPâ PR/HACCP
â L. monocytogenes in Ready-to-Eat products
â Non-O157 STEC policy development
⢠FSIS â Secondary prevention
â Consumer outreach
â Foodborne illness investigations
United States Department of Agriculture
Food Safety and Inspection Service
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
United States Department of Agriculture
Food Safety and Inspection Service
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
United States Department of Agriculture
Food Safety and Inspection Service
FSIS Laboratory System
Laboratories accredited under ISO 17025
In calendar year 2010, FSIS personnel analyzedâ For presence of E. coli O157:H7
⢠12,550 raw ground beef samples
⢠3,331 raw beef trim and components samples
â For presence of Salmonella
5
â For presence of Salmonella⢠29,734 raw product samples
⢠1,517 pasteurized egg products samples
â 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)
United States Department of Agriculture
Food Safety and Inspection Service
FSIS Organizational Structure
United States Department of Agriculture
Food Safety and Inspection Service
Food Safety â People and Priorities
Secretary of Agriculture Tom Vilsack:
âThere is no more fundamental function of government than protecting consumers from harm. â
âUSDA and our partners are working together, more than ever before, to improve and modernize the food safety system based on prevention. â
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
United States Department of Agriculture
Food Safety and Inspection Service
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
United States Department of Agriculture
Food Safety and Inspection Service
⢠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
â Sanitation Standard Operating Procedures (SSOP)
â Pathogen reduction â held to performance standards
â HACCP plan(s)
⢠Required that government verify industryâs efforts to reduce food safety hazards
⢠Food safety and food defense verification procedures daily
United States Department of Agriculture
Food Safety and Inspection Service
FSIS Public Health Information System (PHIS)
⢠Enhanced FSIS data warehouse â 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
United States Department of Agriculture
Food Safety and Inspection Service
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
â Young chickens â 5/51 samples positive
â Performance standard: original 20%, current 7.5%
â Turkeys â 4/56 positive
⢠Performance standard for Campylobacter
â Young chickens â 10.4%
â Turkeys â 0.79%
⢠Sample set criteria for Campylobacter
â Young chickens â 8/51 samples positive
â Turkeys â 3/56 positive
United States Department of Agriculture
Food Safety and Inspection Service
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
United States Department of Agriculture
Food Safety and Inspection Service
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
United States Department of Agriculture
Food Safety and Inspection Service
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
United States Department of Agriculture
Food Safety and Inspection Service
Listeria monocytogenes - Attribution
⢠Lm prevalence and Lm levels are higher for inâstore packaged than for manufacturerâpackaged RTE food
Assessment(Reassessment)
Quantitative risk assessments
Other scientific assessments
â
â
food
â Gombas et al., 2003
â NAFSS, 2008
⢠> 80% of all listeriosis cases attributed to deli meat are from deli meat sliced and packaged at retail
â Endrikat et al., 2010
⢠Food data
⢠Human data
⢠Animal data
⢠Environmental data
⢠Consumer practices
United States Department of Agriculture
Food Safety and Inspection Service
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:
â FDA & FSIS regulated RTE foods
â Foods that are sliced, prepared and/or packaged in
the retail deli environment and consumed in the home
(e.g., deli meats, cheeses, deliâtype salads)
United States Department of Agriculture
Food Safety and Inspection Service
Lm in retail Risk Assessment -
Data Collection Considerations
United States Department of Agriculture
Food Safety and Inspection Service
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
United States Department of Agriculture
Food Safety and Inspection Service
Six additional STEC - adulterants in
non-intact raw beef â next steps⢠Launch testing program March 5, 2012
⢠Test raw intact components used to manufacture raw, ground beef
â Testing is in support of FSIS in-plant verification procedures
â 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 â 60 day period
⢠Review comments to guidance validating commercial test
kits
⢠Conduct outreach to small and very small establishments
United States Department of Agriculture
Food Safety and Inspection Service
Presentation Outline
⢠FSIS â brief overview
⢠FSIS â Primary prevention
â PR/HACCPâ PR/HACCP
â L. monocytogenes in Ready-to-Eat products
â Non-O157 STEC policy development
⢠FSIS â Secondary prevention
â Consumer outreach
â Foodborne illness investigations
United States Department of Agriculture
Food Safety and Inspection Service
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
â clean kitchen surfaces, utensils, hands while preparing food,
â separate raw meats from other foods by using different cutting boards,
â cook foods to the correct temperatures, and
â chill raw and prepared foods promptly.
Ask Karen - FSIS 24/7 virtual food safety advisor
⢠Launch of smart phone âappâ m.askkaren.gov | En EspaĂąol
United States Department of Agriculture
Food Safety and Inspection Service
Alerting consumers â during foodborne
illness investigations
United States Department of Agriculture
Food Safety and Inspection Service
FSIS - Foodborne Illness Investigations (FY10)
⢠25 foodborne illness investigations possibly associated with FSIS-regulated products
â STEC: O157:H7 - 8, O157:NM - 1, O26 - 1
â 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
United States Department of Agriculture
Food Safety and Inspection Service
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 â improved communication and collaboration during ⢠Goal â improved communication and collaboration during
investigations resulting in more successful investigations
⢠Participants â epidemiologists, investigative and regulatory
personnel, and liaisons
⢠CDC session - November 2010
⢠FSIS session - Late January â early February 2011
⢠FDA session â May 2011
United States Department of Agriculture
Food Safety and Inspection Service
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)
United States Department of Agriculture
Food Safety and Inspection Service
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 sampleâs 2. Did the party responsible for the sample collection maintain the sampleâs 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?
â˘
United States Department of Agriculture
Food Safety and Inspection Service
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
United States Department of Agriculture
Food Safety and Inspection Service
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 âş
United States Department of Agriculture
Food Safety and Inspection Service
Thank you!