1. Who’s Minding the Store? The Current State of Food Safety
And How It can be Improved
Seattle, Washington
April 12, 2008
Barbara Kowalcyk, M.A.
Director of Food Safety
Center for Foodborne Illness Research & Prevention

2. Current Food Safety System
“Faith Based Food Safety”
“Dearth of Information”
Antiquated, fracturized, ambiguous, overlapping regulatory system
Inconsistent, inadequate surveillance whose function is not well understood
Tort system is the regulatory system
Unstable, uneven, limited resources
Decreasing consumer confidence

3. How Can It Be Improved? Global farm to fork approach
Risk based, science driven approach
Regulatory Reform
Single Food Safety Agency
Product tracing
Enforceable standards
Better Epidemiology and Surveillance
Better Laboratory Detection Methods
Improve knowledge
Dedicated funding for food safety
Prevention is key
Industry should be responsible and accountable

4. Kevin Michael Kowalcyk, age 2 1/2
12/10/98 - 8/11/01

5. Timeline July 24 – Megan and Kevin consume home prepared hamburgers.
July 22 – Art Fair hamburgers consumed by Megan, Kevin and Michael.
July 24 – Megan and Kevin consume home prepared hamburgers.
July 26 – Family consumes home prepared hamburgers.
July 27 – Megan has loose bowel movement.
July 31 – Kevin has onset of symptoms.
August 1 – Emergency room visit and stool sample taken.
August 2 – Kevin is hospitalized, confirmed O157:H7. Local health department contacted.
August 3 – Kevin’s kidneys fail and he is transferred to Children’s Hospital.

6. Timeline
August 6 – Local health department contacted again. Family spends nearly 2 hours being interviewed.
August 8 or August 9 - All family members submit stool specimens for laboratory testing.
August 11 – Kevin dies at 8:20 pm from multi-organ failure.
August 16 – Kevin’s funeral.
September 10 – Family contacts local health department for more information. First learn of Michael and Megan’s positive laboratory results.
September 12 – Family contacts health department with questions about potential exposures.
September 18 – Family contacted the health department and told the investigation was closed.

7. Timeline
September 2001 – Family is frustrated and contacts MarlerClark.
- 25+ record requests
- 9 public agencies
- Investigation lasted over 3 years

8. Records Requests & Responses
First requests out to local and state health departments, September 2001
Local responds October 15, 2001
State health acknowledges October 22, 2001, responds November 15, 2001
State PHL responds November 20, 2001
5 Xba PFGE matches in Wisconsin (5 different counties)

9. Records Requests & Responses
FOIA requests submitted to USDA, CDC in October/November 2001.
No response, lawsuit threatened.
Partial data supplied, lawsuit threatened.
Finally, receive all responses in February 2003.
Newspaper reports of O157 outbreak in Minnesota prompted record requests to local and state health agencies in Florida and Minnesota.
No epidemiologic link to Kevin found.

10. July 16, 2003
The Xba1 and Bln1 Bionumeric pattern designations for 01BC2510 are:
Xba: EXHX Bln1: EXHA
The Xba1 and Bln1 Bionumeric pattern designations for two USDA ground beef samples collected 8/31/01 are:
Xba1: EXHX Bln1: EXHA

11. FSIS Recalls August 2001
August 13, 2001
August 27, 2001

12. FSIS Recall for Ground Beef
July 2001 – O157:H7 outbreak identified in Chicago and Northern Illinois. Traced back to Wisconsin meat plant.
August 2, 2001 – FSIS conducts O157:H7 test in plant which is positive. Matches Kevin’s PFGE pattern.
August 11, 2001 – Kevin dies.
August 27, 2001 – Establishment recalls 530,000 pounds of ground beef.
July 2003 – Match between Kevin’s PFGE pattern and recall recognized.

13. Product Traceback
November Local Grocer asked to provide records.
May 2004 – Grocer declines to provide records.
July Marler Clark files suit to force release of records.
September 2004 – records provided, two kinds of ground beef sold in July 2001.

14. Conclusions
Unable to conclusively establish link between food consumed and producer.
Litigation abandoned in late 2004.
Kevin Kowalcyk
12/10/98 - 8/11/01

15. Current Food Safety System
“Faith Based Food Safety”
“Dearth of Information”
Antiquated, fracturized, ambiguous, overlapping regulatory system
Inconsistent, inadequate surveillance whose function is not well understood
Tort system is the regulatory system
Unstable, uneven, limited resources
Decreasing consumer confidence

16. How Can It Be Improved? State and local health agencies Educators
Government
Industry
Legal system

17. Ultimate goal is to prevent this from happening to others.

18. you want to see in the world.
Be the change
you want to see in the world.
- Ghandi

19. For more information, please contact
Center for Foodborne Illness Research & Prevention
P.O. Box 206
Grove City, PA
(724)

20. Thank You