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E. coli Webinar
25 years after Jack-in-the-
Box - from a lawyer’s
perspective - A Bit(e) of
History
First off – I am Sorry
Post Upton Sinclair “The Jungle”
The “poke and sniff” system was designed to
prevent rotten, blemished, or damaged meat
from entering the food supply.
Cuts of meat with lesions, growths and
abrasions were found by inspectors, who
used their sense of smell and touch to
identify contaminated meat from clean cuts.
The “command and control” approach meant
that the USDA inspectors were in control of
the facility and meat safety was the
responsibility of U.S. Government.
4
A History of Food Safety and Litigation
“In construing both the Wholesome Meat Act and the Wholesome Poultry
Products Act we are mindful that the presence of salmonellae can be
detected only by microscopic examination. No one contends that
Congress meant that inspections should include such examinations. We
think it follows therefore that Congress did not intend the prescribed
official legends to import a finding that meat and poultry products were
free from salmonellae.”
“The American consumer knows that raw meat and poultry are not
sterile and, if handled improperly, perhaps could cause illness.” In other
words, American housewives and cooks normally are not ignorant or
stupid and their methods of preparing and cooking of food do not
ordinarily result in salmonellosis.”
APHA v. Butz, 511 F.2d 331, 334 (1974).
A Warning Ignored
In 1983 the New England Journal of
Medicine reported two outbreaks of an
unusual gastrointestinal illness that
affected at least 47 people in Oregon
and Michigan in February through
March and May through June 1982 in
Oregon and Michigan that affected at
least 47 people. The outbreaks were
associated with eating at restaurants
belonging to the same fast-food
restaurant chain in Oregon and
Michigan.
E. coli O157:H7 was isolated from 9 of
12 stools collected within four days of
onset of illness in both outbreaks and
from a beef patty from a suspected lot
of meat in Michigan.
“The Beef Industry’s 911”
From November 15, 1992, through
February 28, 1993, more than 600
laboratory-confirmed infections with E.
coli O157:H7 and four associated
deaths occurred in four states:
Washington, Idaho, California, and
Nevada. In Washington, as a result of
publicity and case-finding efforts,
during January-February 1993, 602
patients with bloody diarrhea or HUS
were reported to the state health
department. Onsets of illness peaked
from January 17 through January 20.
Of the patients, 30% were
hospitalized; 30 developed HUS, and
three died. The median age of patients
was 7.5 years.
Idaho
In Idaho, following the outbreak report
from Washington, the Division of
Health, Idaho Department of Health
and Welfare, identified 14 persons with
culture-confirmed E. coli O157:H7
infection, with illness onset dates from
December 11, 1992, through February
16, 1993 Four persons were
hospitalized; one developed HUS.
Nevada – Gambling with your Health
In Nevada, after receiving a report of a
child with HUS who had eaten at a
Jack-in-the-Box restaurant, the Clark
County Health District issued a press
release requesting that persons with
recent bloody diarrhea contact the
health department. Of 58 persons
whose illnesses met the case definition
nine were hospitalized; three
developed HUS. The median age was
30.5 years.
California – A Missed Opportunity
In late December, the San Diego
County Department of Health Services
was notified of a child with E. coli
O157:H7 infection who subsequently
died. After the Washington outbreak
was reported, reviews of medical
records at five hospitals revealed an
overall 27% increase in visits or
admissions for diarrhea during
December 1992 and January 1993
compared with the same period 1 year
earlier. Illnesses of 34 patients met the
case definition The outbreak strain was
identified in stool specimens of six
patients. Fourteen persons were
hospitalized, seven developed HUS,
and one child died. The median age of
case-patients was 10 years.
Where is the Beef?
A meat traceback by a CDC team
identified five slaughter plants in the
United States and one in Canada as
the likely sources of carcasses used in
the contaminated lots of meat. The
animals slaughtered in domestic
slaughter plants were traced to farms
and auctions in six western states. No
one slaughter plant or farm was
identified as the source.
Litigation as Incentive – 25 Years Later
Jack in the Box
Worthless Excuse No. 1
If a document contains
damning information, the
jury will assume you
read it, understood it,
and ignored it
“I never read the
memo.”
The Most Historic Shift In USDA Enforcement
Policy for Meat
September 28, 1994
FSIS Administrator,
Michael Taylor, in a
speech to the AMI
“To clarify an important legal
point, we consider raw ground
beef that is contaminated with E.
coli O157:H7 to be adulterated
within the meaning of the [FMIA].
We are prepared to use the Act’s
enforcement tools, as necessary,
to exclude adulterated product
from commerce. Finally, we plan
to conduct targeted sampling and
testing of raw ground beef at
plants and in the marketplace for
possible contamination.”
17
MEAT INDUSTRY REACTION:
“How can FSIS treat E. coli in hamburger meat as an
adulterant subject to enforcement strategies, while not
applying the same standard to salmonella in broilers…Such
gross policy interpretation favoring the poultry industry and
disfavoring the beef industry is a travesty indeed.” —
Rosemary Mucklow
FOOD MARKETING INSTITUTE:
“It is essential that nothing dilute the consumer message that
the proper cooking of meat eliminates foodborne pathogens.”
E. coli O157:H7 as an Adulterant
And so, of course, they sued the
USDA
18
Lawsuit sought to block “interim final rule [that]
mandates that all uncooked and partially cooked
packages of meat and poultry products will be
required to contain new labels relating to the safe
handling and processing of such items, primarily to
combat the disease caused by E. coli O157:H7”
Court granted the injunction, and explained that it was
“in no way attempting to substitute its own judgment
for the collective wisdom of the USDA, the interested
parties, and the general public…”
Texas Food Industry Ass’n, et al. v. USDA
(Round 1)
“It is disingenuous for the USDA to express the urgent
need for an emergency rule and then delay its
effectiveness date for 60 days, when [it] could have
followed the standard procedure for rulemaking under the
APA within such a time period. If there truly was an
epidemic problem, or anywhere close to such a problem,
the USDA would have presumably required a much
shorter period of time for the effective date of the
emergency rule. Further, the USDA has not rebutted the
Plaintiffs’ showing that an emergency does not exist to
require an emergency rule.”
TFIA v. USDA, 842 F. Supp. 254, 258 (W. D. Tex. 1993).
Texas Food Industry Ass’n, et al. v. USDA
(Round 1)
20
Lawsuit sought injunction “to prevent USDA from
conducting its E. coli sampling program” because:
Agency “failed to adhere to notice and comment
procedure required by [APA]”;
Sampling program and adulterant decision are “arbitrary
and capricious exercise of agency authority and that it
exceeds the USDA’s statutory authority under the FMIA.”
Texas Food Industry Ass’n, et al. v. USDA
(Round 2)
21
Court DENIED the Industry motion for an injunction,
ruling:
Neither the sampling program, nor the decision to treat E.
coli O157:H7 as adulterant, required notice-and-comment
There are rational bases for the sampling program, and
treating E. coli O157:H7 differently than other pathogens.
Texas Food Industry Ass’n, et al. v. USDA
(Round 2)
22
“Plaintiffs’ primary argument …is that E. coli contaminated
ground beef is not adulterated because it is only injurious
to health if improperly cooked. However, after reviewing
the evidence, the Court disagrees. …[U]nlike other
pathogens, it is not ‘proper’ cooking but ‘thorough’ cooking
that is necessary to protect consumers from E.
coli…Therefore, E. coli is a substance that renders
‘injurious to health’ what many Americans believe to be
properly cooked ground beef.”
TFIA v. USDA, 870 F. Supp. 143, 148-49 (W. D. Tex.
1994).
Texas Food Industry Ass’n, et al. v. USDA
(Round 2)
MEAT INSPECTION TOTALLY RE-INVENTED:
1. From “Command and Control” Model to HACCP-based
Model
2. HACCP placed the responsibility for meat safety on the
manufacturer
3. Inspectors are there to confirm that the HACCP plan is in
place & working
4. USDA implemented microbiological testing in-plant and
at retail
Public Outrage Caused Change
A Positive Tend Line
Marler Clark
Revenue
E. coli
O157:H7
Something for Before Dinner Reading
"A stunningly researched
work, "Poisoned" reads as
though Clarence Darrow
had written "The Jungle.”
"Just in time for BBQ
season, an investigative
journalist traces the path of
a devastating outbreak of
food-borne illness linked to
hamburger meat.”
Questions

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2018 Royal Society for Public Health Speech

  • 1. E. coli Webinar 25 years after Jack-in-the- Box - from a lawyer’s perspective - A Bit(e) of History
  • 2. First off – I am Sorry
  • 3. Post Upton Sinclair “The Jungle” The “poke and sniff” system was designed to prevent rotten, blemished, or damaged meat from entering the food supply. Cuts of meat with lesions, growths and abrasions were found by inspectors, who used their sense of smell and touch to identify contaminated meat from clean cuts. The “command and control” approach meant that the USDA inspectors were in control of the facility and meat safety was the responsibility of U.S. Government.
  • 4. 4 A History of Food Safety and Litigation “In construing both the Wholesome Meat Act and the Wholesome Poultry Products Act we are mindful that the presence of salmonellae can be detected only by microscopic examination. No one contends that Congress meant that inspections should include such examinations. We think it follows therefore that Congress did not intend the prescribed official legends to import a finding that meat and poultry products were free from salmonellae.” “The American consumer knows that raw meat and poultry are not sterile and, if handled improperly, perhaps could cause illness.” In other words, American housewives and cooks normally are not ignorant or stupid and their methods of preparing and cooking of food do not ordinarily result in salmonellosis.” APHA v. Butz, 511 F.2d 331, 334 (1974).
  • 5. A Warning Ignored In 1983 the New England Journal of Medicine reported two outbreaks of an unusual gastrointestinal illness that affected at least 47 people in Oregon and Michigan in February through March and May through June 1982 in Oregon and Michigan that affected at least 47 people. The outbreaks were associated with eating at restaurants belonging to the same fast-food restaurant chain in Oregon and Michigan. E. coli O157:H7 was isolated from 9 of 12 stools collected within four days of onset of illness in both outbreaks and from a beef patty from a suspected lot of meat in Michigan.
  • 6. “The Beef Industry’s 911” From November 15, 1992, through February 28, 1993, more than 600 laboratory-confirmed infections with E. coli O157:H7 and four associated deaths occurred in four states: Washington, Idaho, California, and Nevada. In Washington, as a result of publicity and case-finding efforts, during January-February 1993, 602 patients with bloody diarrhea or HUS were reported to the state health department. Onsets of illness peaked from January 17 through January 20. Of the patients, 30% were hospitalized; 30 developed HUS, and three died. The median age of patients was 7.5 years.
  • 7. Idaho In Idaho, following the outbreak report from Washington, the Division of Health, Idaho Department of Health and Welfare, identified 14 persons with culture-confirmed E. coli O157:H7 infection, with illness onset dates from December 11, 1992, through February 16, 1993 Four persons were hospitalized; one developed HUS.
  • 8. Nevada – Gambling with your Health In Nevada, after receiving a report of a child with HUS who had eaten at a Jack-in-the-Box restaurant, the Clark County Health District issued a press release requesting that persons with recent bloody diarrhea contact the health department. Of 58 persons whose illnesses met the case definition nine were hospitalized; three developed HUS. The median age was 30.5 years.
  • 9. California – A Missed Opportunity In late December, the San Diego County Department of Health Services was notified of a child with E. coli O157:H7 infection who subsequently died. After the Washington outbreak was reported, reviews of medical records at five hospitals revealed an overall 27% increase in visits or admissions for diarrhea during December 1992 and January 1993 compared with the same period 1 year earlier. Illnesses of 34 patients met the case definition The outbreak strain was identified in stool specimens of six patients. Fourteen persons were hospitalized, seven developed HUS, and one child died. The median age of case-patients was 10 years.
  • 10. Where is the Beef? A meat traceback by a CDC team identified five slaughter plants in the United States and one in Canada as the likely sources of carcasses used in the contaminated lots of meat. The animals slaughtered in domestic slaughter plants were traced to farms and auctions in six western states. No one slaughter plant or farm was identified as the source.
  • 11. Litigation as Incentive – 25 Years Later Jack in the Box
  • 12. Worthless Excuse No. 1 If a document contains damning information, the jury will assume you read it, understood it, and ignored it “I never read the memo.”
  • 13.
  • 14.
  • 15.
  • 16. The Most Historic Shift In USDA Enforcement Policy for Meat September 28, 1994 FSIS Administrator, Michael Taylor, in a speech to the AMI “To clarify an important legal point, we consider raw ground beef that is contaminated with E. coli O157:H7 to be adulterated within the meaning of the [FMIA]. We are prepared to use the Act’s enforcement tools, as necessary, to exclude adulterated product from commerce. Finally, we plan to conduct targeted sampling and testing of raw ground beef at plants and in the marketplace for possible contamination.”
  • 17. 17 MEAT INDUSTRY REACTION: “How can FSIS treat E. coli in hamburger meat as an adulterant subject to enforcement strategies, while not applying the same standard to salmonella in broilers…Such gross policy interpretation favoring the poultry industry and disfavoring the beef industry is a travesty indeed.” — Rosemary Mucklow FOOD MARKETING INSTITUTE: “It is essential that nothing dilute the consumer message that the proper cooking of meat eliminates foodborne pathogens.” E. coli O157:H7 as an Adulterant And so, of course, they sued the USDA
  • 18. 18 Lawsuit sought to block “interim final rule [that] mandates that all uncooked and partially cooked packages of meat and poultry products will be required to contain new labels relating to the safe handling and processing of such items, primarily to combat the disease caused by E. coli O157:H7” Court granted the injunction, and explained that it was “in no way attempting to substitute its own judgment for the collective wisdom of the USDA, the interested parties, and the general public…” Texas Food Industry Ass’n, et al. v. USDA (Round 1)
  • 19. “It is disingenuous for the USDA to express the urgent need for an emergency rule and then delay its effectiveness date for 60 days, when [it] could have followed the standard procedure for rulemaking under the APA within such a time period. If there truly was an epidemic problem, or anywhere close to such a problem, the USDA would have presumably required a much shorter period of time for the effective date of the emergency rule. Further, the USDA has not rebutted the Plaintiffs’ showing that an emergency does not exist to require an emergency rule.” TFIA v. USDA, 842 F. Supp. 254, 258 (W. D. Tex. 1993). Texas Food Industry Ass’n, et al. v. USDA (Round 1)
  • 20. 20 Lawsuit sought injunction “to prevent USDA from conducting its E. coli sampling program” because: Agency “failed to adhere to notice and comment procedure required by [APA]”; Sampling program and adulterant decision are “arbitrary and capricious exercise of agency authority and that it exceeds the USDA’s statutory authority under the FMIA.” Texas Food Industry Ass’n, et al. v. USDA (Round 2)
  • 21. 21 Court DENIED the Industry motion for an injunction, ruling: Neither the sampling program, nor the decision to treat E. coli O157:H7 as adulterant, required notice-and-comment There are rational bases for the sampling program, and treating E. coli O157:H7 differently than other pathogens. Texas Food Industry Ass’n, et al. v. USDA (Round 2)
  • 22. 22 “Plaintiffs’ primary argument …is that E. coli contaminated ground beef is not adulterated because it is only injurious to health if improperly cooked. However, after reviewing the evidence, the Court disagrees. …[U]nlike other pathogens, it is not ‘proper’ cooking but ‘thorough’ cooking that is necessary to protect consumers from E. coli…Therefore, E. coli is a substance that renders ‘injurious to health’ what many Americans believe to be properly cooked ground beef.” TFIA v. USDA, 870 F. Supp. 143, 148-49 (W. D. Tex. 1994). Texas Food Industry Ass’n, et al. v. USDA (Round 2)
  • 23. MEAT INSPECTION TOTALLY RE-INVENTED: 1. From “Command and Control” Model to HACCP-based Model 2. HACCP placed the responsibility for meat safety on the manufacturer 3. Inspectors are there to confirm that the HACCP plan is in place & working 4. USDA implemented microbiological testing in-plant and at retail Public Outrage Caused Change
  • 24. A Positive Tend Line Marler Clark Revenue E. coli O157:H7
  • 25. Something for Before Dinner Reading "A stunningly researched work, "Poisoned" reads as though Clarence Darrow had written "The Jungle.” "Just in time for BBQ season, an investigative journalist traces the path of a devastating outbreak of food-borne illness linked to hamburger meat.”