# Presentation: 642593

## Shiga Toxin-Producing E. coli: Addressing the Challenges, Moving Forward With Solutions FSIS Public Health Activities related to Illnesses from E. coli O157:H7 in Raw Beef Products, 2007

**David Goldman, MD, MPH**
**Assistant Administrator**
**Office of Public Health Science**
**Food Safety and Inspection Service**
- April 9, 2008

## Objectives

- Describe how FSIS conducts foodborne illness investigations
- Report on 2007 FSIS foodborne illness investigations related to *E. coli* O157:H7
- Discuss areas for improvement

## Foodborne Disease Investigations Branch

- Coordinates FSIS foodborne illness investigations
- Staff in two regional offices collaborate with local, state, and territorial public health partners to investigate foodborne illnesses potentially associated with FSIS-regulated product
- Serves as liaison between local health partners and FSIS Inspection Personnel

## Assist with traceback of FSIS-regulated foods potentially associated with foodborne illness to slaughter and processing establishments 
Work with public health partners to collect and sample foods potentially associated with foodborne illness
Resource for epidemiologic assessments for the Agency, especially during investigations

- Work with public health partners to collect and sample foods potentially associated with foodborne illness
- Resource for epidemiologic assessments for the Agency, especially during investigations

**Public Health and Epidemiology Liaisons: Roles and Responsibilities**** **

**Notes:**
FSIS must be involved so products can be traced back to their source in USDA-inspected slaughter and processing establishments
.
PHELs can assist and ensure samples are taken, and tested and have the ability to trace foods back to their sources
Information about adulterated products may result in USDA recall and in hazard assessments, in order to evaluate processes within production facilities.  Enforcement Officers can be called on to review processes, take samples, and follow-up with the establishment.

## Investigations and Recalls for E. coli O157:H7 in Beef Products, 2004-2007

**Notes:**
Background
OPHS investigations of potential E. coli O157:H7 contamination of beef products have risen.  
Data generally reflects the AED involvement with all agents and product types and may not be suggestive of increasing contamination in beef.
The number of recalls of ground beef significantly increased in 2007 as compared to prior years
The absolute number of recalls identified with human illness increased in 2007

Definitions:
OPHS E. coli Investigations – Investigations undertaken because evidence suggested regulated product as a possible cause.  The relationship may have been disproven or could not be proven. 

Note:  a small number(3) of investigations in various years involved “other than ground products  e.g. steak (needle-tenderized, marinated)  or trim  in addition to ground product
	1)  Quantum Beef, 2004-33 – marinated, tenderized steak
  2)  Dinner Bell Meats, 2006-27 – cubed steak and boneless beef 
  3)  PM Holdings, 2007-22 – fresh beef trimmings

Note: E. coli O103 in ground beef was found in an investigation in 2005.  Product was not recalled due to inadequate supportive evidence. 

Recalls of Beef Products – All agency recalls of ground beef found to be adulterated with E. coli O157:H7.  Most were determined contaminated through micro testing, and were not found to be associated with human illness.  Epidemiological investigation supporting contamination may also provide sufficient evidence to support a recall. 

Recalls of ground beef products, Illness-Associated – Product was recalled due to epi and/or laboratory evidence that contaminated product caused human illness

## E. coli O157:H7 Illness Clusters Associated with Beef Products, 2007

**Applied Epidemiology Division (AED) investigated 36 *****E. coli***** O157:H7 illness clusters associated with beef products  **
**10 voluntary recalls **
**1 public health alert**
**Clusters were linked to regulated product by indistinguishable Pulsed-Field Gel Electrophoresis (PFGE) patterns **
**6 combinations new to the PulseNet database**
**Remainder were either rare (4) or common (1)**

**Notes:**
2007 Public Health Alert
First-ever that IDed the producing establishment to improve the public health impact.  
Recall was not implemented because fresh product was already out of the distribution chain by the time of action.
Remaining 25 investigations-No regulatory action – don’t trust numbers/speculative
No involvement of FSIS product – another source identified (2)
Lack of Epi Information to identify a source of the illnesses  (most)
Insufficient Product Information to traceback product (5)
Product collected and tested Negative for E.coli O157:H7 (5)
Investigation of NEW PFGE patterns is essential 
New and  rare PFGE patterns may have led to more aggressive investigation than if the patterns were common.  
With regard to the investigation around the one pattern
MN DOH investigation resulted in a regulatory action associated with a common PFGE pattern
MN, unlike many other states, proactively interviews all case-patients with foodborne diseases with detailed questionnaires at the time of initial disease report

## E. coli O157:H7 Illnesses Associated with Beef Products, 2007

**170 case-patients (161 culture-confirmed) from 34 states were identified  by epidemiology or PFGE pattern analysis for 11 investigations resulting in agency action. **
**112 were both culture-confirmed  **_**and**_** epidemiologically linked to FSIS product **
**# of Illnesses: 1 to 47; mean 15.5; median 9**
**56 hospitalized**
**12 hemolytic-uremic syndrome (HUS)**
**No deaths reported**

**Notes:**
For the 10 recalls and one PH alert
170 case patients were included in clusters by investigators, either because they were culture-confirmed with outbreak pattern PFGEs (161) or because they were non-confirmed, but presumptive (9)
112 had both outbreak PFGE and were epi-linked to regulated product 

Prior-year comparisons:
2006:  No recalls were associated with illnesses (All recalls  were the result of contaminated product)
2005:  4 recalls associated with illness; 68 total ill (3,3,3,49)
2004: 2 recalls associated with illness, 9 total ill  (4,5)

## State Collaborations

- State health departments directly contacted FSIS AED in 8 of 11 investigations
**AED also contacted via District Office, FSIS CDC Liaison, Food Safety Hotline**
**Average 4.7 states per investigation; range 1-16**
** ****Predominantly CDC FoodNet states**
**FoodNet states participated in 10 of 11 investigations**
**FoodNet states led/co-led 8 of 11 investigations**
- FSIS investigation time from first notification to regulatory action
**Average: 9.9 calendar days  Range: Same day – 37 days**

**Notes:**
AED usually notified by state public health partners.  
Suggests increased outreach efforts improved collaboration with state public health partners.  

FoodNet -- 10 states comprising approximately 15% of the U.S. population
Case-patients from FoodNet states all but one investigation
FoodNet states lead or co-lead 8 investigations.  
Strongly suggests the power of FoodNet’s active surveillance plus the infrastructure, capacity, and capabilities of the involved states.

Agency time to regulatory action
0 to 37 days from HHSD’s initial notification
A result of the agency’s information-gathering process prior to taking appropriate regulatory actions.
Average of 40 days from earliest onset to when FDIB notified by state public health partners, Range 8-65 days

The better question would be time from when state has identified an FSIS product but we really do not have that data

## One Establishment – Distribution, Illnesses

**Notes:**
Implicated products were distributed nationwide from many establishments.
The map above illustrates one recall from a CA establishment.
5.7M lbs of product was distributed to the states in red.
[click 2X to show states with reported illness]
Earliest reported onset- 4/25/07 in Colorado
FDIB notified on May 25, 2007
Illnesses in CA, CO, UT, WY, and ID resulted in the June 3rd recall 
Starred states reported illnesses. 
Illness in AZ contributed the expansion of the recall on June 9th 
Initial recall expanded on June 6th and June 9th  
27 total reported ill (23 culture-confirmed with PFGEs indistinguishable to the product)

After the fact we found out that Arizona had the earliest onset on 4/22/07 did not notify us until June 1, 2007 – Pulse Net

## Characteristics of Implicated Beef Products, 2007 

**Over 29M lbs of ground beef product impacted (11 events)**
**Mean: 2.6M; Median: 129,000**
**Range:  5,920 – 21,700,000**
**Type of ground beef products involved (# of events): **
**Fresh 649,000 lbs (6)**
**Frozen 22.8M lbs (4)**
**Both 5.7M lbs (1)**

**Notes:**
Background for 2007 Recalls and PH Alert
Most Agency actions involved fresh ground beef products, but the recalls associated with frozen product impacted much more product due largely to two recalls of frozen ground beef totaling 27.4 million pounds. This may be due to larger amounts of frozen product in commerce for a longer period of time. (Product from Recall 2007-22, was both fresh/frozen, unable to determine what portion in either state) 
2007 is 97% frozen  - given the limitation of 5.7million lbs as both
 Note:  Per RMS suggestion, a product was considered “Frozen” if so stated in the recall notice.  Absent that information, the product was considered “fresh.”  However RMS cautions that “fresh” product -- esp. if from establishments producing large volumes in chubs, etc. – may be frozen in commerce or homes after leaving the establishment.
Prior Year comparisons:
2006 – 8 recalls; none associated with illness; all fresh product; 
LBS OF PRODUCT mean 22,738 median 3009 range:120- 156,236   (0% frozen)
2005 – 5 recalls; 4 “frozen products” associated with illness  
LBS OF PRODUCT  mean 310,563  median 139,00 range 63,850-900,000
1 “fresh product” recall, (5,238 lbs) of NOT associated with illness; (99.6% frozen)
2004 – 6 recalls; 
3 fresh products, NOT associated with illness  LBS OF PRODUCT mean 68,533  median 59,000 range 45,000 – 101,600 
2 of 3 “frozen products” associated with illness  LBS OF PRODUCT  mean 331,000  median 406,000 range 90,000-497,000 (82.8% frozen)

## Size of Establishments Producing Implicated Beef Products, 2007

- Very Small: None
- Very Small: <10 employees
- Small: 10 of 11 implicated establishments
- Small: 10-499 employees
- Large: 1 of 11 implicated establishments
- Large: 500 or more employees

**Notes:**
Background Info
All FSIS establishments – approx 6,200
FSIS establishments producing raw ground beef – 668 (Per PBIS 4/1/08)
 Large establishments – 33 (4.9%)   
small establishments – 121 (18.1%)  
very small establishments – 514 (76.9%)

??? - It would be interesting to know what percentage of ground beef is produced by the 3 size categories.

[Is there some possibility for sampling bias or other issues? tci]

## Conclusions

- FSIS reported an increase in *E. coli* O157:H7 investigations and recalls associated with beef products in 2007
- Recalls of frozen ground beef products were noteworthy in 2007
- New technology, such as PFGE, has aided outbreak detection and investigation
- FoodNet sites significantly contributed to investigations leading to regulatory action

## Discussion

- Bolstering the public health infrastructure for investigating foodborne illnesses
- Can we address the time between illness diagnosis, FSIS notification, and regulatory action?
- How can we enhance communication and coordination between public health partners?

## Discussion

- Do frozen ground beef products present an elevated public health risk?
- Are better mechanisms needed to investigate illness associated with fresh beef products?