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

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

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

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

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.

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.

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

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)

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.

July 16, 2003 The Xba1 and Bln1 Bionumeric pattern designations for 01BC2510 are: Xba: EXHX01.0074 Bln1: EXHA26.0014 The Xba1 and Bln1 Bionumeric pattern designations for two USDA ground beef samples collected 8/31/01 are: Xba1: EXHX01.0074 Bln1: EXHA26.0014

FSIS Recalls August 2001 August 13, 2001 August 27, 2001

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.

Product Traceback November 2003 - Local Grocer asked to provide records. May 2004 – Grocer declines to provide records. July 2004 - Marler Clark files suit to force release of records. September 2004 – records provided, two kinds of ground beef sold in July 2001.

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

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

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

Ultimate goal is to prevent this from happening to others.

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

For more information, please contact Center for Foodborne Illness Research & Prevention P.O. Box 206 Grove City, PA 16127 (724) 458-0767 kowalcyk@foodborneillness.org www.foodborneillness.org

Thank You