Transcript Slide 1

United States Department of Agriculture
Food Safety and Inspection Service
The FSIS Role in
Food Safety
Who’s Minding the Store? The Current State of
Food Safety and How It Can Be Improved
David Goldman, MD, MPH
Assistant Administrator
Office of Public Health Science
Food Safety and Inspection Service
April 11, 2008
United States Department of Agriculture
Food Safety and Inspection Service
FSIS Mission
•Protect consumers by ensuring that
meat, poultry, and egg products are safe,
wholesome, and accurately labeled.
•With FDA, responsible for ensuring the
Healthy People 2010 food safety goals
•Incorporate food safety objectives into
agency strategic plan and OMB reporting
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
• 6,300 plants have FSIS inspectors present in
them every day, as required by our acts
• 100 billion pounds of meat, poultry and liquid
egg products are verified safe by FSIS each yr
• Inspects product that represents more than
one-third of all consumer spending on food in
the U.S. and about 40% of all domestic food
production
United States Department of Agriculture
Food Safety and Inspection Service
FSIS Profile
• Forerunner organization established in
1906 with passage of the Federal Meat
Inspection Act
• Agency has historically been focused on
inspection activities
• Public health mission has evolved more
recently
United States Department of Agriculture
Food Safety and Inspection Service
FSIS Profile
• HACCP Rule passed in 1996
• Focus on verification of establishment
pathogen control
– Increased product testing
– Collaboration with PH partners in foodborne
illness investigations
• Founding partner of FoodNet in 1996
• Member of PulseNet
United States Department of Agriculture
Food Safety and Inspection Service
FSIS Application of
Public Health Model
Assessment
(Reassessment)
Assurance
Quantitative risk
assessments
Other scientific
assessments
Evaluation
• Food data
• Human data
• Animal data
• Environmental
data
Policy Development
United States Department of Agriculture
Food Safety and Inspection Service
HP2010 Food Safety Goals
• Reduce infections caused by key
foodborne pathogens; targets were
set at 50% of the illness rate in
1997
United States Department of Agriculture
Food Safety and Inspection Service
FSIS Initiatives for E. coli O157:H7
• FSIS target = 0.2% prevalence in ground beef (20042006 rates each 0.17%; preliminary 2007 rate=0.24%)
• Recent baseline in beef trim (major component of GB)
• Routine trim testing
• More aggressive follow-up testing of positive tests
• Risk-based sampling based on testing history and
volume
• New micro testing methodology
• Update to E. coli O157 risk assessment:
– model both the contribution of all ground beef
components; and,
– effect of industry interventions
• Consideration of primal cuts and non-O157 STEC
United States Department of Agriculture
Food Safety and Inspection Service
FSIS Initiatives for Salmonella
• February 2006 announced new sampling/testing strategy
• Focus initially on broilers, having increasing
contamination rates and known vehicle for human illness
• More agency testing would be done in plants with higher
rates of contamination or harboring serotypes of human
health concern
• Agency goal: move plants to lower contamination rates
• This new approach resulted in a change in our
performance measure as reported to OMB
– From: overall percent of samples positive for
Salmonella
– To: percent of plants performing at desired level
United States Department of Agriculture
Food Safety and Inspection Service
FSIS Initiatives for
Listeria monocytogenes
• FSIS target: 0.70% contamination rate (preliminary 2007
rate=0.37%)
• Risk assessments revealed that deli meat and hot dogs
were greatest risk among FSIS-regulated products
• Risk assessments also showed the benefits of industry
mitigations, adding growth inhibitors, antimicrobials or
other post-lethality treatment to ready-to-eat products
that may be exposed to Listeria in the environment
• Pathogen testing became risk-based, factoring past
testing, volume of production, use of interventions, and
product risk
• Recent study suggests that cross-contamination in retail
delis may be a significant source of Lm contamination
United States Department of Agriculture
Food Safety and Inspection Service
FSIS Initiatives for
Campylobacter
• Lab methodological problems delayed our ability to
establish a performance standard or begin a regulatory
program
• Baseline testing in broiler chickens currently underway—
Campy historically associated with chicken exposure
• Once complete the agency will establish performance
standards or guidelines for industry to meet
• Industry interventions for Salmonella expected to be
effective against Campylobacter
United States Department of Agriculture
Food Safety and Inspection Service
Other FSIS Initiatives
• Hosted attribution public meeting in April 2007
• Hosted public meeting on non-O157 STEC in October
2007
• Hosted public meeting April 9-10 on STECs
• Will host public meeting May 15 on improving
communications/collaborations during outbreak
investigations
• New investigations directive to be released, regarding
how FSIS investigates foodborne illness linked to
regulated products, the type of evidence collected and
how it is judged
• Strengthened PulseNet and VetNet database linkage
• Development of public health-based performance
measures
United States Department of Agriculture
Food Safety and Inspection Service
Re-assessment—Case Study #1
• Outbreak of E. coli O157:H7 associated
with frozen steaks in 2003
– 7 cases of illness
– Steaks sold door-to-door
– Traceback to producer revealed these steaks
were tenderized/marinated
– Food Safety Assessment conducted; injection
equipment disassembled weekly
– Recall of one week’s production of beef
products
United States Department of Agriculture
Food Safety and Inspection Service
E. Coli case, continued
FSIS Regulatory Policy Response
Federal Register Notice published 5/26/05
• Cited 3 outbreaks in 2000, 2003, 2004 and total of 17 cases
associated with exposure to tenderized beef products
• The FR Notice announced that:
• Plants producing such products should reassess their
HACCP plans during their annual reassessments to consider
whether E. coli O157:H7 is a hazard reasonably likely to
occur
• Plants should consider purchase specifications for source
products treated to minimize E. coli O157:H7
• Plants should consider use of antimicrobial treatments prior
to tenderizing
United States Department of Agriculture
Food Safety and Inspection Service
E. Coli case, continued
• Collaboration with FDA to develop guidance for
retailers for incorporation into the Food Code
• Development of FSIS compliance guidelines
• Consideration of labeling changes and need for
higher temperature for cooking
• FSIS inspection personnel recently surveyed the
industry to determine the extent and nature of
HACCP reassessments
United States Department of Agriculture
Food Safety and Inspection Service
E. Coli case, continued
• Request for FSIS Office of Public Health
Science (OPHS) to consider collecting data on
prevalence of this pathogen in these products (in
collaboration with Agricultural Research Service)
• Request for OPHS to update its risk assessment
on E. coli O157:H7 in non-intact beef products
• There were 3 more outbreaks related to nonintact beef products in 2007
United States Department of Agriculture
Food Safety and Inspection Service
Re-assessment—Case Study #2
• Salmonellosis associated with frozen stuffed raw
poultry products
– Illnesses in 2005 linked to breaded, frozen chicken
entrees
– FSIS issues a public health alert reminding
consumers that these products contain raw poultry,
though the breading has been browned, that
microwave cooking can be inconsistent, and these
products should be cooked to 165o F internal
temperature
– FSIS asked the National Advisory Committee on
Microbiological Criteria for Foods (NACMCF) to
recommend a safe cooking temperature for poultry
United States Department of Agriculture
Food Safety and Inspection Service
Salmonellosis case, continued
• More cases of salmonellosis linked to similar products
reported in early 2006
• Investigations showed that some of the illnesses were
associated with products from one specific producer
– PFGE matches between patients and food products
– Food histories of cases confirmed exposures
• FSIS requested a recall of a lot of frozen stuffed chicken
entrees
• FSIS issued a letter to the industry and then labeling
compliance guidance requiring label changes:
– Wording changes to emphasize that the poultry is raw
– Need to validate cooking instructions
United States Department of Agriculture
Food Safety and Inspection Service
Salmonellosis case, continued
• NACMCF issued report indicating that 165o F
was an effective temperature for consumers to
ensure safe poultry; that microwave preparation
of stuffed poultry products could be used safely
• FSIS learns of new cases of salmonellosis
associated with these products
• FSIS issues another public health alert but no
further recalls
• New labels required by November 1, 2006
United States Department of Agriculture
Food Safety and Inspection Service
Salmonellosis case, continued
WASHINGTON, March 29, 2008 - The
U.S. Department of Agriculture's Food
Safety and Inspection Service (FSIS) is
issuing a public health alert due to
illnesses from Salmonella associated with
frozen, stuffed raw chicken products that
may be contaminated with Salmonella.
United States Department of Agriculture
Food Safety and Inspection Service
Illness Investigation Objectives
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Verify the association
Identify the source of production
Prevent further exposures of consumers
Initiate regulatory action (when indicated)
Identify contributing factors
Prepare an internal summary and lessons
learned
United States Department of Agriculture
Food Safety and Inspection Service
Step 1: Human Health
Surveillance
• Ongoing disease surveillance conducted by
– Local, State and Territorial health departments
– CDC
• Ongoing monitoring of foodborne disease
reports by FSIS
– PHELs in Omaha and Atlanta
– FSIS liaison to CDC in Atlanta
United States Department of Agriculture
Food Safety and Inspection Service
Step 2: Illness Reported; FSIS
Product Suspected
• FSIS receives epidemiologic data from other
public health agencies
• FSIS judges the strength of the association
using recognized criteria
– temporal sequence; biological plausibility; specificity;
dose response; relative risk/odds ratio
• FSIS determines that further action is necessary
United States Department of Agriculture
Food Safety and Inspection Service
Step 3: FSIS Begins
Investigation
• Traceback and Traceforward
• Microbiological Results
– Product
– Clinical
– Environmental
• In-plant Food Safety Assessment
United States Department of Agriculture
Food Safety and Inspection Service
Product Traceback Investigations:
What We Need to Know
• Who?
– Producing establishment
number
• What?
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Name and type
Lot number
Product code
Product weight and units
per case
– Percent lean
• When?
– Production code
– Sell by/use by date
• Where?
– Amount of product
purchased
– Purchase date
– Point of purchase,
including name and
complete address
Is there any left over product held by consumer? Packaging?
Are there other sources of the same product?
United States Department of Agriculture
Food Safety and Inspection Service
Step 4: FSIS Analysis of
Available Data
• Is the epidemiologic evidence consistent with:
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microbiological data?
traceback investigation?
environmental evaluation?
in-plant findings?
United States Department of Agriculture
Food Safety and Inspection Service
EPIDEMIOLOGY
TRACEBACK
MICROBIOLOGY
FOOD SAFETY ASSESSMENT
United States Department of Agriculture
Food Safety and Inspection Service
Step 5: FSIS Regulated
Product Implicated
• Considerations for Agency action:
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the pathogen and severity of illness
population at risk
whether new cases are being reported
strength of the epidemiologic data
strength of laboratory data
investigation at point of purchase and/or
preparation
United States Department of Agriculture
Food Safety and Inspection Service
Step 6: Agency Action
• The Agency considers requesting a recall or
detaining and seizing product in accordance
with the Acts
• The Agency considers a public health alert to
advise about potentially adulterated product
not subject to recall (i.e., not in commerce)
United States Department of Agriculture
Food Safety and Inspection Service
Step 7: FSIS Assessment of the
Investigation & Lessons Learned
• An internal summary documents the investigation,
findings, and recommendations
• Lessons learned generated by those involved in the
investigation
United States Department of Agriculture
Food Safety and Inspection Service
Recall Defined
A firm’s voluntary removal of distributed
meat, poultry, or egg products from
commerce when there is reason to believe
they are adulterated or misbranded under
the FMIA, PPIA or EPIA
United States Department of Agriculture
Food Safety and Inspection Service
Recall Process
• Problem Identification:
– The company finds the problem
– FSIS microbiological sampling
– Information from in-plant inspection
program personnel
– Epidemiological data gathered by Federal
or State Agencies
– Consumer complaints
United States Department of Agriculture
Food Safety and Inspection Service
Why Recall?
A Recall is a fast and effective method
of removing distributed products,
particularly when many lots of product
have been widely distributed.
United States Department of Agriculture
Food Safety and Inspection Service
Who Recalls?
• Manufacturers and distributors of
product
• FSIS does not have, and is not
seeking, mandatory recall authority
United States Department of Agriculture
Food Safety and Inspection Service
However
• FSIS may initiate the recall process by
informing a firm that adulterated
product has been identified in
commerce
• FSIS retains the right to detain or seize
product to protect consumers
United States Department of Agriculture
Food Safety and Inspection Service
Food Safety and Inspection Service
United States Department of Agriculture
www.fsis.usda.gov