Lettuce and SpinachLettuce and Spinach

Over 23 E. coli outbreaks since 1995

– Hundreds of reported illnesses

– Several deaths

Fresh or fresh-cut lettuce or spinach

9 outbreaks traced back to produce from Salinas, California

2006 Wendy’s 2006 Wendy’s E. coliE. coli Outbreak Outbreak

Utah - June 2006

E. coli O21:H19 – only 3 culture-positive cases, although over 50 cases probable

3 HUS, 2 adult women,1 with 30 days, the other with 4 months of dialysis

Likely lettuce from California

Dole and Natural Selections – Fall 2006Dole and Natural Selections – Fall 2006

205 persons infected with outbreak strain of E. coli O157:H7 from 26 states.

102 (51%) hospitalized

31 (16%) developed hemolytic-uremic syndrome (HUS)

Three confirmed deaths – likely five

Dole and Natural Selections – Fall 2006Dole and Natural Selections – Fall 2006

E. coli O157:H7

– Isolated from 16 packages of DOLE spinach

– “DNA fingerprints” of all 16 match the outbreak strain

– Supplied by patients living in 10 states

– Eleven packages with lot codes consistent with a single manufacturing facility on a particular day

Taco Taco E. coliE. coli Litigation Status Litigation Status

Multiple lawsuits filed in Courts in a 5 States

Taco Bell and Ready-Pac

Taco John’s and Bix

Lettuce supplier to Bix - Outbreak PFGE found on nearby Farm

Aunt Mid’s E. coli LettuceAunt Mid’s E. coli Lettuce At Least 40 At Least 40

cases in Illinois, cases in Illinois, Michigan, Ohio Michigan, Ohio and Canadaand Canada

Traceback Traceback looking at looking at Salinas, Salinas, Michigan, Michigan, and California and California Central ValleyCentral Valley

What Could Irradiation Prevent?What Could Irradiation Prevent?

FDA Final Rule (73 FR 49593) FDA Final Rule (73 FR 49593) Fresh Iceberg lettuce Fresh Iceberg lettuce

and Spinach – “reduce and Spinach – “reduce the level of potentially the level of potentially dangerous microbial dangerous microbial pathogens….The FDA pathogens….The FDA has assessed the safety has assessed the safety … and has concluded … and has concluded that it will not adversely that it will not adversely affect the safety of affect the safety of these products.”these products.”

However, “Irradiation However, “Irradiation is voluntary.”is voluntary.”

Food Irradiation from a Legal PerspectiveFood Irradiation from a Legal Perspective

Strict Liability – If the food has a pathogen and it makes someone ill – you pay!

So, why Irradiate?

– Reduce risk of illnesses and lawsuits

– Susceptible Populations – the very young and elderly – schools and nursing homes

– Punitive Damages – failure to use may well“constitute a conscious disregard of a known risk”