UNITED STATES DEPARTMENT OF AGRICULTURE
FOOD SAFETY AND INSPECTION SERVICE
CITIZEN PETITION REQUESTING
)
ADMINISTRATIVE ACTION TO
PREVENT
)
AND WARN CONSUMERS
ABOUT
)
Docket No.: __________
FECAL CONTAMINATION OF
MEAT
)
AND
POULTRY
)
Submitted on August 29, 2001, by:
Physicians Committee for Responsible Medicine
Mindy S. Kursban, Esq., Staff Counsel
5100 Wisconsin Ave., N.W., Suite 400
Washington, DC 20016
202-686-2210
Submitted to:
Thomas J. Billy, Administrator
Food Safety and Inspection Service
U.S. Department of Agriculture
TABLE OF CONTENTS
INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
PETITIONER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
REQUESTS FOR ADMINISTRATIVE ACTION. . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . .
2
STATEMENT OF FACTS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . 3
I.
Foodborne Pathogens and Illness. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . .
. 3
A. Background. . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . 3
B. Major Foodborne
Pathogens. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . 4
1. E. coli O157:H7. . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4
2.
Salmonella. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . .
5
3.
Campylobacter. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . .
.
5
4.
Listeria Monocytogenes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . .
6
II. Federal Laws and
Regulations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . 7
A.
Federal Meat Inspection Act. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . .
7
B.
Poultry Products Inspection Act. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . .
8
C.
USDA Regulations and FSIS Directives. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . .
8
D.
Microbiological Testing Programs. . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . .
10
1. Generic E. coli
Testing Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
10
2. Salmonella Testing
Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
11
3.
Other Mandatory Testing Programs . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
.
.
11
a.
Salmonella in Ready-to-Eat Products. . . . . . . . . . . . . . . . . . . . . . .
.
12
b.
Listeria Monocytogenes in Ready-to-Eat Products. . . . . . . . . . . . .
12
c.
E. coli O157:H7 in Raw Ground Beef. . . . . . . . . . . . . . . . . . . . . . .
12
ARGUMENT. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
I.
FSIS Should Declare Feces, Whether Visible or Not, an Adulterant and
Regulate Feces as an Adulterant. . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
A. Feces on Carcasses
Are the Primary Avenue of Transmission of
Foodborne Pathogens on Meat and Poultry Products. . . . . . . . . . . . . . . . . . . . .
. . . 13
B. Meat and Poultry
Contaminated with Feces Are “Adulterated” under
the FMIA and the PPIA.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. 16
C. Meat and Poultry Sold
Commercially Should Be Free from Fecal
Contamination. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . .
. 17
D. Feces Should Be
Regulated as an Adulterant. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
17
II. FSIS Must Mandate the Application of a Biohazard Warning
Label on Meat
and Poultry to Prevent Misbranding. . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . 18
III. The Authorized Poultry Inspection Legend Should Be Modified to Exclude
the Word “Wholesome” . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
ECONOMIC IMPACT. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . 22
I. The Economic Cost of Declaring and Regulating Feces as an Adulterant
Will
Be Outweighed by the Reduction in Costs Associated with Foodborne Illness. . . . . . . . .
. 22
II. The Economic Cost of Mandating a Biohazard Warning Label on Meat and
Poultry Products Will Be Outweighed by the Reduction in Costs Associated
with Foodborne Illness. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . 23
III. The Economic Cost for Changing the Poultry Inspection Legend Is Minimal. . . . . . .
. . . . 23
CONCLUSION. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
INTRODUCTION
Is it reasonable that the chicken sold in grocery stores is likely contaminated with
feces? Is it reasonable that if a consumer undercooks a hamburger, her
three-year-old could die? Is it reasonable that the consumer, not industry, is
responsible for ensuring that meat and poultry are disease-free?
Under current U.S. Department of Agriculture (“USDA”) regulations, the answer to
each of these questions is yes. Current
regulations allow fecally contaminated poultry and meat to be passed at inspection, as
long as the feces are not “visible” to the
naked eye. Under current regulations, children regularly become severely ill or even
die from consuming meat or poultry that
was not cooked to precisely the right temperature. Because current USDA regulations
are too weak to guarantee that
adulterated poultry and meat will not be sold to consumers, USDA has implemented programs
that place the burden squarely
on consumers to kill foodborne pathogens on their fecally contaminated meat and
poultry—or suffer the potentially deadly
consequences.
Despite having laws in place since 1906 intended to ensure a wholesome meat supply,
foodborne illness has become a major
public health epidemic in this country. The Centers for Disease Control and
Prevention (“CDC”), which reports only what it
believes to be a fraction of foodborne disease incidents, estimates that 76 million
illnesses, 325,000 hospitalizations, and 5,000
deaths are caused by foodborne pathogens annually. That is 200,000 Americans are sickened
by a foodborne disease every
day, of whom 900 are hospitalized and 14 die. The vast majority of these foodborne
illnesses can be traced to the production,
processing, or consumption of items of animal origin—meat, poultry, fish, dairy
products, and eggs.[1]
However, it is not the actual consumption of meat and poultry[2] that causes foodborne
illness, although such consumption
increases the risk of heart disease, hypertension, diabetes, cancer, and other health
conditions. Rather, it is the presence of
feces on meat and poultry that causes humans to ingest foodborne pathogens and, therefore,
get sick from eating these
products. Despite the “official” USDA policy of zero tolerance for fecal
contamination, the extraordinary rates of foodborne
illness in this country are directly caused by eating poultry and meat contaminated with
feces even though they passed
inspection by USDA’s Food Safety and Inspection Service (“FSIS”).
FSIS oversees the inspection of all poultry and meat products. FSIS also implements
the zero-tolerance policy for fecal
contamination—albeit only for visible fecal contamination—through directives
that authorize spraying, washing, trimming, or
steam-vacuuming carcasses to remove visible feces, checking quality control data, and
infrequent fecal spot-checks for process
control. Yet, the prevalence of foodborne illness in this country caused by eating
fecally contaminated meat and poultry
remains staggeringly high, providing clear evidence that current inspection methods and
regulations are insufficient and
misdirected.
PETITIONER
Petitioner Physicians Committee for Responsible Medicine (“PCRM”) is a national,
nonprofit, health advocacy organization
based in Washington, D.C., comprised of approximately 5,000 physician and approximately
100,000 layperson members.
PCRM teaches consumers, educators, and policy-makers about using a plant-based diet as a
tool for preventive medicine and
maintaining good health. PCRM advocates strengthening the reliance on preventive
measures in the production and slaughter
processes for animals used as food to eradicate foodborne illness caused from eating
fecally contaminated poultry and meat.
REQUESTS FOR ADMINISTRATIVE ACTION
The Federal Meat Inspection Act[3] (“FMIA”) and the Poultry Products Inspection
Act[4] (“PPIA”) direct the Secretary of
Agriculture to inspect all meat and poultry. If, upon such inspection, the meat or
poultry is found to be unadulterated, the
product can pass inspection and be labeled as such, indicating that the product is
wholesome and safe to eat.[5] If the meat or
poultry is adulterated, it must be condemned to keep it from reaching consumers.[6]
Inconsistent with this mandate, USDA
regularly passes at inspection poultry and meat that is fecally contaminated, consequently
conveying to consumers a false
promise of wholesomeness.
In order to prevent this ongoing violation of the law and to prevent the continued release
of fecally contaminated poultry and
meat from slaughterhouses and processing plants, PCRM, pursuant to the Administrative
Procedure Act, 5 U.S.C. § 553(e),
and 7 C.F.R. § 1.28, petitions FSIS to take following actions:
1. Declare feces an adulterant and regulate feces as an
adulterant.
2. Amend Title 9 of the Code of Federal Regulations to
mandate that, in addition to the inspection legend and safe-handling
instructions, all meat and poultry products carry a biohazard warning label stating:
“Biohazard: This product may be
contaminated with feces and, therefore, hazardous to your health.”
3. Amend Title 9 of the Code of Federal Regulations Section
381.123 to mandate a poultry inspection legend
that does not include the word “wholesome” or any other descriptive word that
implies that poultry products
are safe to eat.
STATEMENT OF FACTS
I. Foodborne Pathogens
and Illness
A. Background
CDC estimates that 76 million illnesses, 325,000 hospitalizations, and 5,000 deaths are
caused by foodborne pathogens
annually.[7] Known pathogens account for an estimated 14 million illnesses, 60,000
hospitalizations, and 1,800 deaths
annually.[8] The major foodborne pathogens in the United States are Escherichia coli
(“E. coli”) 0157:H7, salmonella,
Campylobacter jejuni (“campylobacter”), and Listeria monocytogenes (“L.
monocytogenes”). CDC estimates that each
year there are approximately 73,000 E. coli 0157:H7 infections and 60 related deaths; 1.4
million salmonella infections and
1,000 related deaths; 2.4 million campylobacter infections and 124 related deaths; and
2,500 L. monocytogenes infections
and 500 related deaths.[9] Because many ill persons do not seek medical attention
and, of those who do, many are not tested,
many cases of foodborne illness go undiagnosed. For example, CDC estimates that 38
cases of salmonellosis actually occur
for every case that is diagnosed and reported to public health authorities.[10]
USDA’s Economic Research Service (“ERS”) estimates that the economic costs
incurred for these major bacterial pathogens
alone—including medical costs, productivity losses from missed work, and an estimate
of the value of premature
deaths—amount to at least $6.9 billion annually.[11]
Animal products such as red meat, poultry, eggs, seafood, and dairy products are the foods
most likely to cause human
illness.[12] Further, because feces are the vehicle for transmission of pathogens to
humans who consume animal flesh,[13] the
true cause of foodborne illness related to the consumption of meat or poultry is the
presence of feces infected with pathogenic
bacteria on that meat or poultry. Thus, if meat or poultry is contaminated with
pathogenic bacteria, it is most likely also
contaminated with feces.
B. Major Foodborne
Pathogens
1. E. coli O157:H7[14]
The species E. coli is comprised of hundreds of strains of bacteria that normally inhabit
the intestines and colons of
warm-blooded animals, including humans. Although most strains of E. coli are harmless, E.
coli O157:H7 is a mutant strain
found specifically in the intestinal tracts of cattle.[15] E. coli O157:H7 produces
a powerful toxin and can cause severe illness,
ranging from mild diarrhea to severe bloody diarrhea, hemolytic uremic syndrome (HUS),[16]
and death.[17] The number of
E. coli 0157:H7 organisms required to cause sickness is suspected to be very small.
The muscle (“meat”) of cattle does not carry the pathogen. Rather, meat
becomes contaminated during slaughter when it
comes into contact with the feces of infected cattle. E. coli O157:H7 was first recognized
as a cause of illness in 1982 during
an outbreak of severe bloody diarrhea traced to contaminated hamburgers. Since then,
most infections have come from eating
ground beef, which is made from the meat of up to 100 different animals. Thus, if one of
those animals is contaminated, the E.
coli 0157:H7 bacteria are thoroughly mixed into the beef when it is ground, and the whole
batch becomes contaminated.
Illness has also been reported from eating other species, such as pigs, as well as other
cuts of meat.[18]
As current inspection standards cannot ensure a meat supply free from contamination of E.
coli 0157:H7, consumers are
advised through FSIS programs such as Fight Bac! and the Thermy Campaign to cook meat to a
minimum temperature of
160°F to kill the pathogen.
2. Salmonella[19]
Salmonella is a genus of 2,300 serotypes of bacteria, most of which can cause human
disease. Although there are many
different kinds of salmonella bacteria, Salmonella typhimurium and Salmonella enteritis
are the most common types causing
illness in the United States. Most persons infected with salmonella develop diarrhea,
fever, and abdominal cramps 12 to 72
hours after infection, and are ill from four to seven days. Although most people
suffering from salmonellosis recover without
treatment, for others, the diarrhea may be so severe that hospitalization is
required. In these patients, the salmonella infection
may spread from the intestines to the bloodstream, and then to other body sites, and can
cause death unless the person receives
prompt treatment with antibiotics.
Foods contaminated with salmonella are usually of animal origin, such as raw poultry,
beef, and pork, though it is most widely
associated with raw poultry.[20] The bacteria live in the intestinal tracts of
infected animals and are usually transmitted to
humans through eating food contaminated with animal feces. Pathogenic salmonella
bacteria may not cause symptoms in
animals but can still make people sick.
Salmonellosis is the costliest foodborne illness in the United States. ERS estimates that
the annual economic costs due to
foodborne salmonella infections are $2.4 billion,[21] and CDC has estimated that 95
percent of salmonellosis are due to
contaminated food products. As few as 15 to 20 salmonella bacteria can cause
illness, depending on the strain and the age and
health of the individual.[22] Moreover, salmonella bacteria multiply quickly if the
food product is not kept refrigerated at the
proper temperature.
As with E. coli 0157:H7, meat and poultry contaminated with salmonella look and smell
normal. Consequently, because
current inspection standards do not ensure a poultry and meat supply free from salmonella
contamination, consumers are
advised to “thoroughly” cook their poultry and meat to kill the pathogen.
3. Campylobacter[23]
The campylobacter genus is a group of bacteria that can cause disease in humans.
Most cases of campylobacteriosis are
caused by one species, Campylobacter jejuni, but about 1 percent of human campylobacter
cases are caused by other
species (all campylobacter bacteria will hereinafter be collectively referred to simply as
“campylobacter”). Campylobacter
grow best at the body temperature of birds, who carry the bacteria in their intestinal
tracts without becoming ill. CDC notes
that many chicken flocks are “silently” infected with campylobacter; that is,
the chickens are infected with the organism but
show no signs of illness.
Campylobacter can be easily spread from bird to bird through contact with infected feces.
Thus, when an infected bird is
slaughtered, campylobacter in the bird’s feces can then be transferred to the meat of
that infected bird, as well as other
uninfected birds, through contact with the feces. As a result, anywhere from 50 to 80
percent of the raw chicken in the U.S.
market is contaminated with campylobacter.[24] Not surprisingly, most cases of
campylobacteriosis are associated with
handling raw poultry or eating raw or undercooked poultry meat. Even one drop of
fluid from contaminated chicken meat can
carry enough campylobacter to infect a person.
Campylobacter infection affects more than 2 million persons, or 1 percent of the
population, every year. Most people who
become ill with campylobacteriosis experience diarrhea, cramping, abdominal pain, and
fever within two to five days after
exposure. The illness typically lasts one week. Although for some persons, infection
with campylobacter causes no symptoms,
when campylobacter has spread to the bloodstream, it causes a serious life-threatening
infection. Campylobacter infection also
can cause Guillain-Barré Syndrome, a disease that affects the nerves of the body leading
to paralysis,[25] and death.[26]
As with E. coli 0157:H7 and salmonella, current industry practices and inspection
regulations fail to eliminate, or even
significantly reduce, campylobacter from the food supply. Thus, the government
places the burden on consumers to kill the
pathogen on meat and poultry.
4. Listeria
Monocytogenes[27]
Listeria monocytogenes (“L. monocytogenes”), the toxic species of listeria, is a
bacterium that has only recently been
recognized as a foodborne pathogen, and is now considered one of the most dangerous
pathogens in our food supply. Most
cases of listeriosis involve foodborne transmission.
Although listeriosis from contaminated food is less common than infections from other
foodborne pathogens, its consequences
are far more severe. A person with listeriosis experiences fever, muscle aches, and
sometimes gastrointestinal symptoms such
as nausea or diarrhea. If infection spreads to the nervous system, symptoms such as
headache, stiff neck, confusion, loss of
balance, or convulsions can occur. Infected pregnant women may experience only a
mild, flu-like illness; however, infections
during pregnancy can lead to premature delivery, infection of the newborn, or even
stillbirth. The most common manifestation
of listeriosis is meningitis, which has symptoms of high fever, severe headache, neck
stiffness, and nausea.[28] Of the
approximately 2,500 persons who become ill with listeriosis each year, 20 percent
die. Moreover, 92 percent of listeriosis
cases require hospitalization—the highest among foodborne pathogens.
Livestock and poultry can carry L. monocytogenes without appearing ill and can spread the
pathogen through their feces.
Thus, raw meat contaminated with feces from an animal harboring L. monocytogenes could
infect a person who consumes that
meat.
L. monocytogenes is unique in its growth capabilities, having a growth range in
temperatures between 25°F to 98°F. Highly
prevalent in raw meat, researchers have detected the pathogen in up to 77 percent of
ground beef and 95 percent of ground
pork.[29] Although occurring less frequently than in raw products, L. monocytogenes
is also commonly found in meat and
poultry products considered “ready-to-eat,” which are usually consumed without
further cooking. Limited data suggest that L.
monocytogenes may be killed by pasteurization and by the heating methods used to prepare
ready-to-eat processed meats,
but evidence supporting this belief is not conclusive.[30]
As with the other pathogenic bacteria discussed herein, current inspection regulations
fail to adequately prevent contamination
of meat and poultry products with L. monocytongenes.
II. Federal Laws and
Regulations
A. Federal Meat
Inspection Act
In 1906, Congress authorized and mandated USDA to conduct inspections of
“livestock” animals (cows, pigs, goats, sheep,
and horses) used for food before (ante-mortem) and after (post-mortem) slaughter and
during the processing operation to
prevent the distribution and sale of meat that was unwholesome, adulterated, unhealthful,
and not properly marked, labeled, and
packaged.[31]
Under this inspection system, Congress mandated that USDA shall ensure that only
unadulterated carcasses be approved for
further distribution to consumers. If meat is found to be unadulterated, USDA is
required to affix an inspection legend
indicating that the meat has been inspected by USDA, passed the inspection, and is safe to
eat.[32] The mandatory inspection
legend for all unadulterated meat products reads: “Inspected and passed.”[33]
All adulterated carcasses are prohibited from being distributed to consumers.[34]
They must be marked as “Inspected and
condemned” and are prohibited from use as food.[35] The underlying principle,
then, of the FMIA—and upon which all the
other provisions rely—is that adulterated meat is unsafe for consumers to eat and,
thus, cannot be passed at inspection by
USDA for sale to the public.[36]
Under the FMIA, meat is adulterated, in relevant part:
“if it bears or contains any poisonous or deleterious substance which may render it
injurious to health; but in case
the substance is not an added substance, such article shall not be considered adulterated
under this clause if the
quantity of such substance in or on such article does not ordinarily render it injurious
to health” or
“if it consists in whole or part of any filthy, putrid, or decomposed substance or is
for any other reason unsound,
unhealthful, unwholesome, or otherwise unfit for human food.”[37]
Further, the FMIA prohibits the misbranding of meat. Meat is misbranded, in relevant
part, “if its labeling is false or misleading
in any particular” or “if it fails to bear...the inspection legend and....such
other information as the USDA may require...to assure
that it will not have false or misleading labeling.”[38]
B. Poultry Products
Inspection Act
Like the FMIA, Congress enacted the PPIA to protect the “health and welfare of
consumers...by assuring that poultry products
distributed to them are wholesome, not adulterated, and properly marked, labeled, and
packaged.”[39] The PPIA is similar in
most respects to the FMIA except that it governs poultry (chickens, turkeys, ducks, geese,
and guineas). Thus, the PPIA
requires ante-mortem and post-mortem inspection,[40] defines “adulterated”
identically as it is defined in the FMIA,[41] and
prohibits the misbranding of poultry, again applying the same definition of
“misbranding” as used in the FMIA.[42] Also, like
the FMIA, the basic principle underlying the PPIA is that adulterated poultry is unsafe
for consumers to eat and, thus, cannot
be passed at inspection by USDA for sale to the public.
While the PPIA also mandates application of an inspection legend to all unadulterated
poultry indicating that it has passed
inspection as required by law, it does not specify the exact language that must be
included on the legend, leaving discretion of
this matter to USDA.[43]
C. USDA Regulations and
FSIS Directives
USDA regulations implementing the FMIA and PPIA are found in Title 9 of the Code of
Federal Regulations at Chapter III, 9
C.F.R. pt. 300, et. seq. USDA has delegated the responsibility for enforcing the
FMIA and PPIA to the FSIS.[44] To
implement and enforce the inspection laws, FSIS developed directives that provide detailed
instructions for FSIS inspectors.
Pursuant to the authority granted under the FMIA, USDA permits the use of several
inspection legends for meat, including
“Inspected and passed,” “U.S. Inspected and Passed,” or “U.S.
Inspected and Passed by Department of Agriculture,” all of
which contain the required phrase, “inspected and passed.”[45] For
poultry, USDA authorizes only one inspection legend:
“Inspected for wholesomeness by U.S. Department of Agriculture.”[46] All
poultry that has passed inspection must bear the
“Inspected for wholesomeness” label.[47] Each livestock or poultry carcass
that is found on final inspection to be “unsound,
unhealthful, unwholesome, or otherwise adulterated” must be marked as “U.S.
Inspected and Condemned.”[48]
In addition to the official inspection legend, USDA requires that safe-handling labels be
placed on all raw meat and poultry
products.[49] The safe-handling label advises that the meat or poultry product was
prepared from inspected-and-passed meat
or poultry. Then, in contradiction to this implied assurance of wholesomeness, the
safe-handling label advises that “[s]ome food
products may contain bacteria that could cause illness.”[50] It then advises
the consumer on handling and cooking procedures
to prevent illness associated with foodborne pathogens.[51]
FSIS has been directed to enforce a zero-tolerance standard for visible fecal
material. This standard is reflected in USDA
regulations, which require, inter alia, that establishments handle livestock carcasses and
carcass parts to prevent contamination
with fecal material and promptly remove contamination if it occurs,[52] and that
establishments prevent poultry carcasses
contaminated with visible fecal material from entering the “chilling
tank.”[53] When inspection program personnel observe
feces at post-mortem livestock inspection or thereafter under the FMIA or when poultry
carcasses are about to enter the
chilling tank or thereafter (i.e., at any point after the final pre-chiller wash) under
the PPIA, they are supposed to condemn the
affected product unless the visible feces are removed by reprocessing.[54]
Reprocessing includes trimming, vacuuming, or
washing a carcass where it has been contaminated.[55]
In 1996, FSIS began implementation of its Pathogen Reduction and Hazard Analysis and
Critical Control Point Systems
(“HACCP”).[56] HACCP is intended to identify hazards that may arise at
“critical points” in the production process of meat
and poultry and devise measures to minimize the risks associated with these hazards.
Under HACCP, (1) all meat and poultry
plants must develop and implement a system of preventive controls, (2) slaughter plants
and plants producing raw ground
products must meet established pathogen reduction performance standards for salmonella,
verified through microbial
spot-checking by FSIS, (3) meat and poultry plants must develop and implement written
standard operating procedures for
sanitation, and (4) meat and poultry slaughter plants must conduct a microbial spot-check
for generic E. coli.[57] HACCP’s E.
coli and salmonella spot-checking systems are meant to verify whether the plant’s
systems are working as intended to prevent
fecal contamination.[58]
A plant is deemed to be operating in compliance with HACCP if it meets the established
performance standards (pre-HACCP
prevalence levels of the particular pathogen). Test results that indicate the
presence of what the FSIS has deemed to be
unacceptable levels of the pathogen are an indication that the establishment needs to
review process controls and take
corrective actions as determined by the plant.
D. Microbiological
Testing Programs
1. Generic E. coli
Testing Program[59]
Slaughter and process plants that produce poultry and meat are required to meet pathogen
reduction performance standards
for generic E. coli (not E. coli 0157:H7) as a process control indicator for fecal
contamination. The plant operates the generic
E. coli testing program by testing carcasses for the non-pathogenic bacteria on a per
volume basis. That is, the plant is only
required to test 1 out of every 22,000 chicken carcasses, 1 out of every 300 cattle
carcasses, and one 1 of every 1,000 pig
carcasses. The plant collects the bacteria samples, tests the samples, and records the
results. The data relating to the testing
program are maintained by the plant.
Thereafter, to evaluate whether the plant is complying with the generic E. coli testing
program procedures, FSIS inspectors
spot-check the test results as recorded by the industry. Test results that do not
meet the performance standard for generic E.
coli indicate an establishment may not be maintaining process controls sufficient to
minimize fecal contamination. In such case,
the FSIS inspector should complete a non-compliance record and “take further action
as appropriate to ensure that applicable
provisions of the law are met.” FSIS explicitly states that generic E. coli
performance standards are not regulatory standards;
thus, FSIS does not use the test results to determine whether products are adulterated or
whether they can be sold to the
public.
2. Salmonella Testing
Program[60]
The pathogen reduction performance standards for salmonella apply to livestock and poultry
slaughterhouses and to plants that
produce raw ground poultry and meat products. The performance standards are based on
industry averages, rather than an
estimate of how much salmonella it takes to make someone sick. Separate performance
standards apply to each species
slaughtered and the class of the product produced. The performance standards are
expressed in terms of the maximum number
of positive samples that are allowed per sample set (a “test” consists of a full
sample set). Sample sets are statistically
determined and range from 51 samples for broiler chickens to 82 samples for steers and
heifers. For example, in steers and
heifers, 1 out of 82 samples is permitted to be positive. For broiler chickens, 12 out of
51 samples are permitted to be positive.
Tests are either positive or negative—the results are not expressed in terms of
number of organisms found in a sample.
In contrast to the generic E. coli spot-check system, in which industry collects and tests
samples based on how many animals it
slaughters, FSIS inspectors collect the samples and perform the tests to detect the
presence of salmonella. Further, the
frequency of the salmonella checks is not based on the number of animals slaughtered;
rather the frequency of testing is done
randomly at the discretion of FSIS, based on an establishment’s performance history.
When the first set of test results are non-compliant with the salmonella performance
standard, the FSIS inspector is to complete
a non-compliance record.[61] The plant is then put in line for a second salmonella
test, which only has to be performed
sometime during the ensuing two months.[62] When repeat violations occur, the
inspector may deem the non-compliance a
failure to maintain an adequate HACCP plan or order inspection services
withheld.[63] A positive result for salmonella in raw
product generally does not result in an adulteration determination.[64]
3. Other Mandatory
Testing Programs
In addition to the microbial testing spot-checks for process control verification, FSIS
also mandates other testing programs
meant to prevent the distribution of adulterated products.[65]
a. Salmonella in
Ready-to-Eat Products
FSIS has a zero-tolerance policy for salmonella in ready-to-eat products.
Under FSIS’s Microbiology Monitoring Program,
ready-to-eat poultry and meat products are subject to random sampling and testing
requirements for the presence of
salmonella.[66] The presence of salmonella in a ready-to-eat meat or poultry product
renders it adulterated and subject to a
voluntary recall.[67]
b. L. monocytogenes in
Ready-to-Eat Products
FSIS has a zero-tolerance policy for L. monocytogenes in ready-to-eat products.
Under FSIS’s Microbiology Monitoring
Program, ready-to-eat meat and poultry products are subject to random sampling and testing
requirements for the presence of
L. monocytogenes.[68] Further, processing plants must set forth in their HACCP plans
how they will control for L.
monocytogenes in ready-to-eat meat and poultry products.[69] Any amount of L.
monocytogenes found in a ready-to-eat
meat or poultry product renders it adulterated and subject to a voluntary recall,[70] and
is evidence that a HACCP plan may
be inadequate and, therefore, should be reassessed.[71] Currently under this
program, FSIS inspectors annually test only
about 7,000 samples of domestic and imported products for the presence of L.
monocytogenes.[72]
c. E. coli 0157:H7 in
Raw Ground Beef[73]
In 1994, USDA declared that ground beef contaminated with E. coli O157:H7 is adulterated
under the FMIA, creating
accountability for the presence of this pathogen in ground beef.[74] Tied to this
new definition of E. coli 0157:H7 is a limited
microbiological testing program for the pathogen in raw ground beef conducted either by
FSIS or the regulated
establishment.[75] If the establishment conducts its own in-house testing, which
most do, FSIS is responsible for verifying that
the sampling program is being implemented. As long as the establishment uses
“validated pathogen reduction interventions,”
which all are required to do under HACCP, the plant is not required to test for E. coli
0157:H7 on any predetermined
frequency, just “routinely.”
If a sample tests positive for E. coli 0157:H7, the sampled lot[76] is supposed to be
condemned unless it is reprocessed to
remove the adulterant and follow-up testing is conducted. Further, if a sample is
confirmed positive, all products from the shift
represented by the positive sample are subject to a voluntary recall. However, FSIS does
not have the authority to mandate a
recall and even when industry institutes a voluntary recall, a majority of the
contaminated product is never recovered. [77] This
is due, in part, to the fact that most recalls are not even issued until at least five to
six days after the product was shipped, and
have even been issued seven months after the date of shipment.[78]
ARGUMENT
The poultry and meat inspection system costs American taxpayers approximately $700 million
annually.[79] FSIS advises the
public that this inspection system, with its various zero-tolerance policies and microbial
testing programs, serves as satisfactory
means for preventing foodborne illness. While on paper it appears that FSIS has the
structure for an effective food safety
program, the facts belie this conclusion. The current inspection system does not
provide adequate protection against foodborne
illness.
Stringent and proactive rules, policies, and enforcement measures must be taken by FSIS to
prevent the continued fecal
contamination of poultry and meat. Further, until such time as foodborne illness
caused by eating fecally contaminated poultry
and meat is stopped, consumers must be vigilantly warned, and no longer misled, about the
inherent risk involved with
consuming meat or poultry products that have passed inspection.
I. FSIS Should Declare Feces,
Whether Visible or Not, an Adulterant and Regulate
Feces as an Adulterant.
A. Feces on Carcasses
Are the Primary Avenue of Transmission of
Foodborne Pathogens on Meat and Poultry Products.
Feces are the major source of bacterial contamination in livestock and poultry
slaughterhouses,[80] and the consumption of
meat and poultry contaminated with feces is the primary vehicle for transmitting foodborne
pathogens to humans.[81] One-third
of U.S. cattle harbor E. coli 0157:H7.[82] Consumer Reports magazine reported that
virtually every chicken on the market is
contaminated with feces.[83] Preventing poultry and meat carcasses contaminated with
feces, whether visible or not, from
leaving the slaughterhouse is integral to efforts to eradicate foodborne
illness.[84] Yet, current policy regarding fecal
contamination on meat and poultry only addresses feces that are “visible” to the
naked eye, permits processes that contribute to
the spread of fecal contamination, and authorizes plants to reprocess contaminated
carcasses with methods that do not provide
adequate safeguards to the consumer.
If neither the plant workers nor the inspectors see the feces in the course of performing
their job, a carcass contaminated with
feces and, therefore, potentially infected with pathogenic bacteria and other health
hazards, passes through the plant for sale to
consumers.[85] Permissible transport, handling, slaughter, and process methods under
current large-scale food-animal
production make it likely that many animals will be contaminated and cross-contaminated
with feces, and that “visible” feces
will not be seen on a carcass or, if it is seen, that it will not be removed
completely.
To begin with, pathogenic bacteria are transferred from infected animals to uninfected
ones as a result of mass transportation of
animals to slaughterhouses and their maintenance in communal holding pens not amenable to
thorough sanitizing. Thus, feces
enter the slaughterhouse via an animal who has been soiled with feces during transport,
which, in turn, results in the
contamination of other animals.
Slaughter production lines are fertile grounds for the spread of hazardous bacteria.
Poultry plants collectively slaughter 21
million birds every day, typically on high-speed automated production lines.
High-speed lines make it “simply impossible to
adequately inspect every animal.”[86] Thousands of birds are eviscerated every
hour on the same machine, without intervening
decontamination. The guts of individual animals are aligned differently, and
mechanized evisceration frequently tears the
intestines, thus spreading fecal contamination on the exterior of the carcass and the
muscle tissue. Since the same machine
eviscerates thousands of birds an hour, it only takes one pathogen-infected bird to infect
hundreds or thousands of other
birds.[87] Further, at this line speed and with the minimal number of federal
poultry inspectors required, an inspector generally
has less than two seconds to thoroughly check each chicken’s chest, cavity, interior,
and flesh for nearly a dozen diseases,
bruises, cancers, lesions, or other defects, and fecal contamination.[88]
The standard process for defeathering and chilling poultry contributes to the spread of
pathogens. USDA allows poultry
carcasses to be placed in hot water baths, called scalders, to loosen feathers.
Contaminated birds are put in the same water
with all other birds, potentially passing along infective bacteria.[89]
Slaughter of cattle and pigs is executed by plant workers, not machines. At more than 300
cattle slaughtered per hour, and
more than 1,000 pigs slaughtered every hour, the spread of feces is unavoidable.[90]
Organs are torn and their contents
spilled. Feces are smeared and splattered. Because feces may have already
spread from one cow to another during transport,
when cattle undergo the dehiding process, additional fecal contamination can result.
Further, because pigs’ hides are not
removed during the slaughter process, they are put through a communal scalding tank,
similar to the defeathering tank for
chickens. Thus, contaminated carcasses are put in the same water with all other
carcasses, potentially infecting the
uncontaminated ones.
Until 1978, USDA required the condemnation of any carcass with visible fecal
contamination. Thereafter, USDA began
allowing carcasses contaminated with visible feces to be “reprocessed,” rather
than condemned.[91] As long as feces are no
longer visible after the corrective reprocessing action, the carcass may continue to be
processed. However, attempts to
remove visible fecal contamination do not ensure the absence of harmful bacteria.
For example, trimming where feces are visible cannot ensure the removal of all
pathogens. Livestock carcasses can be steam
vacuumed (hot water is sprayed on a carcass and then vacuumed off), washed with an acid
rinse, or trimmed to remove fecal
contamination. Steam vacuuming to remove fecal contamination from meat carcasses
only removes “incidental visible
contamination” and only reduces (not eliminates) bacterial counts.[92] Chemical
rinses may wash off visible traces of feces, but
feces not visible to the naked eye (and associated pathogens), may remain on the
carcass.[93] As reported by USDA’s
Agricultural Research Service (“ARS”), ARS chemical engineer Arthur I. Morgan
states:
Industry has a hard time removing surface contaminants from meat because microorganisms
hang on
tenaciously. Many escape hot-water washes or sprays containing bactericide and
surfactants....This is true
even when exposure time and bactericide content are more than enough to sterilize a smooth
surface. We’ve
seen contaminants remain on meat even after we’ve used organic acid solutions and
trisodium phosphate. One
of the reasons that existing methods aren’t very effective in killing the harmful
microorganisms is because of the
liquid nature of water. Water can’t reach all the contaminated surfaces. Feather,
hair, or scale follicles are large
enough to hide bacteria, but too small to admit a liquid wash or spray. An impossibly high
water pressure
would be needed to overcome the capillary pressure in a pore just large enough to house a
bacterium.[94]
While condemnation rates obviously dropped dramatically after this rule went into
effect—because condemnation was no
longer required by USDA for meat and poultry with fecal contamination—the actual
outcome is that consumers are consuming
more meat and poultry that once was, and potentially still is, contaminated when eaten.
A policy that only addresses visible fecal contamination is sorely inadequate. Not
only can otherwise visible feces not be seen
because of the speed involved in slaughtering and processing the animals, but traces of
feces too small to be seen by the naked
eye can carry pathogens and other potential health hazards.[95] Since feces are the
carrier for pathogenic bacteria, a more
comprehensive policy that addresses all fecal contamination is necessary.
B. Meat and Poultry
Contaminated with Feces Are “Adulterated” under the FMIA and the PPIA.
As set forth above, under the FMIA and the PPIA, meat or poultry is
“adulterated” if
i) it bears or contains any poisonous or deleterious
substance which may render it injurious to health; OR
ii) if a substance is not an added substance, the meat or
poultry is adulterated if the quantity of such substance
in or on the product would ordinarily render it injurious to health, OR
iii) if it consists in whole or part of any filthy, putrid,
or decomposed substance, OR
iv) is for any other reason unsound, unhealthful,
unwholesome, or otherwise unfit for human food.
Meat or poultry contaminated with feces clearly meets each of these criteria. Feces
are a filthy, putrid substance, and food
contaminated with feces is “unsound,” “unhealthful,”
“unwholesome,” and “unfit for human food.”
In U.S. v. Pilgrim Market Corporation,[96] the government brought criminal charges against
a slaughterhouse for distributing
meat and poultry products that were adulterated because they were contaminated with rodent
feces. The government asserted
that the presence of rat feces caused the product to be adulterated because it consisted
of a “filthy, putrid and decomposed
substance” and “was unsound, unhealthful, unwholesome and otherwise unfit for
human food.” As rodent feces are no more of
a health hazard than livestock or poultry feces, there is no logical basis for
distinguishing between the two substances in treating
one as an adulterant and the other not.
Accordingly, meat or poultry contaminated with feces falls within the definition of
“adulterated” under both the FMIA and the
PPIA and should be treated as such.
C. Meat and Poultry Sold
Commercially Should Be Free from Fecal Contamination.
Irrespective of the foodborne pathogen health risks posed to consumers who eat meat or
poultry contaminated with feces,
consumers expect and deserve to be able to purchase products free of fecal
contamination. If consumers knew that the source
of foodborne pathogens on poultry and meat is feces, many would choose not to purchase
such products. But a disconnect has
been created between the presence of feces on poultry and meat and the high rates of
foodborne illness. In fact, a July 26,
2001, survey conducted by the Opinion Research Corporation International at the request of
PCRM, found that 84 percent of
Americans do not know that feces are the originating source for foodborne
pathogens.[97] Thus, most consumers do not
realize that when they get sick from eating meat or poultry, it is most likely because
they ate fecally contaminated product.
Consumers are taught that pathogens are unavoidably part of meat and poultry products, as
if no preventive action can be
taken before the products reach their grocery cart. This is false and
misleading. Consumers should be informed of the link
between feces and foodborne illness in order to empower them to make educated purchasing
decisions. The government
should proactively inform consumers of this fact, just as it educates consumers about the
dangers of foodborne pathogens.
Declaring feces an adulterant and regulating it as such is an appropriate step in this
education process.
D. Feces Should Be
Regulated as an Adulterant.
Both the FMIA and the PPIA authorize FSIS to declare feces an adulterant and to regulate
it as such.[98] FSIS relied upon
these provisions when it declared E. coli 0157:H7 on raw ground beef an adulterant,
declared salmonella and L.
monocytogenes on ready-to-eat products adulterants, and when it promulgated its HACCP
Rule. These provisions are
equally applicable here. If infected feces were not on poultry and meat carcasses sold for
consumption, the rates of food
poisoning would drastically decrease. By not declaring feces an adulterant and by failing
to impose stringent regulations to
prevent its spread, FSIS is derelict in its duty to provide a pathogen-free meat and
poultry supply.
A poultry and meat supply contaminated with feces should not be accepted by the American
consumer nor considered
inevitable by the federal government. FSIS should implement reforms that prevent
fecal contamination. For example, FSIS
could mandate less crowded and less stressful living conditions for animals raised for
food; prohibit growth-promoting
antibiotics; require fewer animals on trucks bound for slaughterhouses; mandate shorter
distances to transport animals to
slaughter; require the proper disposal of animal feces at all times; prohibit immersion
tanks for poultry carcasses; prohibit
scalding tanks for pig carcasses; mandate a reduction in permitted slaughter-line speeds;
and implement and enforce a
comprehensive testing program for coliform bacteria.
Further, FSIS’s reliance on educating consumers about proper handling and cooking
techniques clearly violates the FMIA and
the PPIA. The meat and poultry inspection statutes prohibit passing any adulterated
products at inspection, yet FSIS places
the burden of decontaminating adulterated products on consumers. Doing so means that
FSIS approves adulterated meat at
inspection in violation of the law. PCRM is not advocating the discontinuation of
safe-handling labels or consumer education
programs, as there are some instances when pathogenic bacteria may contaminate a product
through means other than fecal
contact in a plant. Nevertheless, demanding the consumer “cook away the
problem” or otherwise adhere to burdensome
measures to perhaps prevent illness[99] should not be the course of action followed by the
government to protect public health.
An additional important benefit of declaring and regulating feces as an adulterant is that
it would encourage the meat and poultry
industries to develop and implement effective production, slaughter, and processing
interventions specifically aimed at
preventing fecal contamination. Because regulating feces as an adulterant would
increase the likelihood of detecting
contamination—resulting in more frequent recalls and associated costs—companies
would have a strong incentive to apply
effective interventions.
Accordingly, to provide mandatory, and meaningful, protection to consumers, FSIS should
declare feces an adulterant and
regulate it as such.
II. FSIS Must Mandate the Application of a
Biohazard Warning Label on Meat and Poultry Products to
Prevent Misbranding.
Feces are a biohazard capable of transmitting infective agents to humans. Under most
institutional circumstances, feces are
treated as a biohazard because they are capable of causing disease in humans and “may
pose a health risk to either individuals,
the community, or both, if not handled or treated properly.”[100] For
instance, potentially contaminated animal carcasses
must be packaged, labeled, and shipped as a biohazard.[101] In a medical setting,
feces per se and animal carcasses which
may be contaminated with pathogenic bacteria and, therefore, contaminated with feces, are
considered biohazards and
regulated as “medical waste” consistent with specific restrictions to minimize
human exposure—mandatory incineration or
disposal in a biohazard container.[102] In particular, fecally contaminated animal
carcasses would be sealed in special
leakproof, puncture-resistant bags labeled “biohazard” and disposed of in a
manner that will prevent human health
hazards.[103]
The FMIA and the PPIA require USDA to protect consumers from adulterated and misbranded
poultry and meat, not only
through inspections at the plants, but also through officially-approved labels affixed to
such poultry and meat. Under these
statutes, meat or poultry is misbranded if it does not bear, in addition to the official
inspection legends, “such other information
as the Secretary [of Agriculture] may require...to assure that [the products] will not
have false or misleading labeling and that
the public will be informed of the manner of handling required to maintain the product in
a wholesome condition.”[104] Current
regulations require the application of the official inspection legend on all poultry and
meat products, and safe-handling
instructions on all raw poultry and meat products. These labels are false and
misleading and unduly confusing to the consumer,
constituting misbranding.
The USDA inspection legend, which has been applied to meat for almost a century and to
poultry since 1957, is intended to
convey to the consumer that meat and poultry products are safe to eat. Consumers
have predictably become accustomed to
this guarantee of safety from their government. However, it is now widely recognized
that eating meat and poultry is not safe
from the standpoint of microbial contamination unless the consumer takes specific
delineated actions to kill foodborne
pathogens. USDA conservatively estimates that salmonella are present in10 percent of
chickens, 7 percent of pigs, 4 percent
of ground beef, 14 percent of ground chicken, and 30 percent of ground turkey;[105] that
between 60 to 80 percent of chilled
whole birds at processing facilities are contaminated with campylobacter;[106] and, that,
at slaughter, 17 percent of pig
carcasses are contaminated with campylobacter.[107] Microbiological tests conducted on
behalf of Consumer Reports
revealed that 63 percent of store-bought chickens are contaminated with campylobacter and
16 percent contaminated with
salmonella.[108] A current FSIS training video for inspectors states, “We
expect [salmonella] contamination to be on raw
product.”[109] As evidenced by FSIS’s food-safety programs, consumers are
advised to treat every piece of raw meat or
poultry as if it is contaminated with pathogenic bacteria.
Thus, application of the inspection legends on poultry and meat lulls consumers into a
false sense of security about the poultry
and meat they purchase and consume. Trying to address the false and misleading
nature of the inspection legends, the
government authorized the affixing of safe-handling instructions. However, the
language of the safe-handling label is confusing
and contradictory. It starts by advising that the product passed USDA
inspection—which means to a consumer that the
product is unadulterated and safe to eat—then indicates the necessity for the
consumer to “properly” handle and cook the
product because the product is not safe to eat.
As presented throughout this Petition, the fact that meat and poultry are not safe to eat
from a microbiological perspective is
most likely due to fecal contamination. Consumers deserve truthful, unambiguous
labels. The labels should make clear that the
government has not, and cannot, guarantee any meat or poultry product as safe to
eat. In order to do so honestly and
effectively, FSIS should mandate the application of a biohazard label on all poultry and
meat products. The text of the
biohazard warning label should unequivocally warn of the likely presence of feces and the
concomitant health hazard, stating:
“Biohazard: This product may be contaminated with feces and, therefore, hazardous to
your health.”
FSIS is not only authorized to require warning labels on poultry and meat products, but,
in this case, it is required to do so,
contrary to the 1974 case American Public Health Association v. Butz.[110] In Butz,
a case decided 27 years ago, the court
held that USDA inspection labels on meat and poultry that had been inspected and passed
were not false and misleading so as
to constitute misbranding, despite the fact that they did not contain a warning about
foodborne pathogens and instructions for
safe handling. Rather, the court noted, a consumer education campaign was sufficient
to address the problems associated with
foodborne illness caused from eating contaminated meat and poultry. In support of
its decision, the court presumed that the
presence of salmonella did not make meat or poultry adulterated,[111] that microscopic
examination of poultry and meat was
unrealistic, and that “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.”[112] Thus, although
the application of warning labels was not
precluded, the court determined that, at that time and under those circumstances, they
were not required. Present
circumstances make the Butz ruling inapplicable today.
Since 1974, FSIS has conducted a massive and targeted food safety campaign to inform
consumers about safe handling and
cooking of meat and poultry products. FSIS instituted a toll-free, nationwide
food-safety hotline and conducts myriad
food-safety campaigns directed at such specialized audiences as food handlers,
institutions, health professionals, and at-risk
populations, as well as food handlers in the home.[113] Moreover, despite
FSIS’s previous protestations that safe-handling
instructions were unnecessary, it began mandating their application on all raw poultry and
meat products in 1994.[114] FSIS
has even imposed microbial testing programs for various pathogens. Salmonella, which USDA
argued in 1974 was not an
adulterant, has since been declared an adulterant if found on some meat and poultry
products.[115]
These efforts, while important, have not sufficiently stopped the spread of foodborne
pathogens. In fact, since the Butz case,
several new pathogens have emerged and inflicted further harm to our nation’s
health. The first E. coli 0157:H7 outbreak
occurred in 1982, and, since that time, this pathogen has caused hundreds of deaths and
thousands of illnesses.[116] L.
monocytogenes was just recently recognized, but is now considered one of the most
dangerous pathogens in our food supply.
[117] Campylobacter is one of the most prevalent forms of food poisoning, sickening
at least 1 percent of our population
annually.[118]
Further, eating habits have changed, resulting in reduced personal control over the safety
of the food consumed. For example,
compared to 1974, Americans today eat in restaurants far more often, eat significantly
more “consumer-ready” prepared and
processed poultry and meat, and prepare their own food considerably less often.[119]
Thus, the circumstances relied upon by
the Butz court are notably, and materially, different from the situation today.
Public education efforts and safe-handling
instructions have failed to adequately attack the prevalence of foodborne illness.
Despite implementation of HACCP,
foodborne illness rates remain unacceptably high.
Given the continued health threat posed to consumers from eating fecally contaminated
poultry and meat, FSIS must exercise
its authority under the FMIA and the PPIA to require a biohazard warning label on all
poultry and meat products. Otherwise,
current inspection labels are false and misleading under the FMIA and the PPIA,
constituting misbranding.
III. The Authorized Poultry Inspection Legend Should
Be Modified to Exclude the Word “Wholesome.”
USDA has discretion to regulate the text of the poultry inspection legend.[120]
Using its discretion, the only inspection legend
authorized for poultry reads: “Inspected for wholesomeness by United States
Department of Agriculture.” USDA regulations
advise that the “Inspected for Wholesomeness” seal is intended to inform
consumers that poultry was found to be unadulterated
and, thus, free of disease, not decomposed, and to be otherwise fit for human
consumption.[121] Now, however, as explained
on FSIS’s Web site, the “inspected for wholesomeness” label merely
“insures the chicken is free from visible signs of
disease.”[122] Based on this new and distorted interpretation of the poultry
inspection legend, the presence of feces not visible
to the naked eye, as well as the presence of every pathogenic bacteria known to
contaminate meat and poultry, would not
make the product unwholesome.
As currently evidenced by Fight Bac!, the Thermy Campaign, and other FSIS consumer
education programs, FSIS has
made clear its belief that, under current inspection regulations, it cannot guarantee a
fecal- or foodborne pathogen-free poultry
supply. Since FSIS cannot provide any degree of assurance that the poultry it
inspects is unadulterated, free from fecal
contamination, or wholesome—and, because contamination is, in fact, common and even
expected by FSIS—use of the word
“wholesome” should be discontinued in the official inspection legend. The
government should not, and cannot, affix a seal that
misleads consumers and may increase the incidence of foodborne illness and death.
The misleading “Inspected for Wholesomeness” inspection certificate affixed to
poultry should be modified to protect
consumers.
ECONOMIC IMPACT
I. The Economic Cost of Declaring
and Regulating Feces as an Adulterant Will Be Outweighed by the
Reduction in Costs Associated with Foodborne Illness.
The cost to the taxpayer for declaring and regulating feces as an adulterant is
minimal. No formal administrative procedures are
required to declare meat and poultry products contaminated with feces adulterated or to
regulate feces as an adulterant.[123]
Further, as PCRM is not recommending what specific actions FSIS should take to regulate
fecal contamination, the
determination of the expected economic impact to industry is premature at this time.
Nonetheless, if effective regulations are
imposed that prevent the occurrence of infected feces in animals used for food, the spread
of feces on animals, or the rate of
fecal contamination on meat and poultry products, the rate of foodborne illness in this
country would decrease dramatically.
Given that foodborne illness in this country is estimated to cost, at a minimum, $6.9
billion annually, any cost to industry would
be significantly outweighed by a reduction in public health costs, both financial and
otherwise.
II. The Economic Cost of Mandating a
Biohazard Warning Label on Meat and Poultry Products Will Be
Outweighed by the Reduction in Costs Associated with Foodborne Illness.
The economic analysis for the application of a biohazard warning label is very similar to
the economic analysis for the
application of safe-handling instructions in 1994.[124] Thus, the requirement
that a biohazard warning label be affixed to all
meat and poultry products would affect slaughter and processing facilities and retail
establishments differently. For products
prepackaged by the slaughter or processing establishment, the label would be made part of
the wrapping, as is currently done
for USDA inspection legend and safe-handling instructions. Consequently, as with the
safe-handling labels, slaughter and
processing facilities would only face upfront, one-time costs, but would not experience
recurring costs.
For retail stores, the biohazard label could be incorporated onto the existing
safe-handling label or a store’s weight and price
information label, both of which are currently affixed to poultry and meat products.
Retail stores may need to upgrade
equipment to accommodate a different or larger label, but there would be no additional
labor costs. There will also be
recurring costs in the form of the cost for each label that is applied. Regardless
of the manner in which those labels are
formatted, the recurring costs for the labels will be very low, especially in light of the
net societal benefit.
III. The Economic Cost for Changing the Poultry
Inspection Legend Is Minimal.
Changing the poultry inspection legend would impose a minimal up front, one-time cost to
both processing and retail facilities,
similar to the up-front, one-time costs imposed for the biohazard label. The cost for the
modified label would result in a net
societal benefit.
CONCLUSION
Poultry and meat carry bacteria that make people sick because the products were at some
point contaminated with feces
carrying pathogenic bacteria. The rules requested herein will reduce the risk of
foodborne illness associated with the
consumption of fecally contaminated poultry and meat products. Reduced risk would
lead to public health benefits that are
measured in reduced medical costs, reduced time lost from work, reduced pain and
suffering, and reduced loss of life. In 1972,
USDA fought—and won—a legal battle to prevent the application of safe-handling
instructions on meat and poultry products.
At that time, USDA asserted that a consumer education campaign was sufficient to remedy
the problems associated with
foodborne illness. But consumer education has not been sufficient. Thus, in
1994, USDA agreed that safe-handling
instructions were necessary to prevent foodborne illness and issued regulations regarding
same. Still, that step proved grossly
insufficient. Beginning in 1996, USDA issued final regulations introducing HACCP
into the processing and slaughter operations
of poultry and meat products. As the evidence shows, however, this is still not
enough. The time is ripe to directly attack the
problem—to affect means to prevent fecal contamination and to adequately warn
consumers to protect themselves.
Accordingly, PCRM hereby requests that FSIS:
1. Declare that any meat
or poultry product contaminated with feces is adulterated, and create accountability
for the presence of feces by regulating it as an adulterant;
2. Amend Title 9 of the
Code of Federal Regulations to mandate a biohazard warning label on all meat and
poultry products that states: “Biohazard: This product may be contaminated with feces
and, therefore, hazardous
to your health”; and,
3. Amend Title 9 of the
Code of Federal Regulations to change the authorized poultry inspection legend to
preclude the word “wholesome” or any other descriptive word that implies that
poultry products are safe to eat.
[1] For instance, poultry and meat carcasses can become contaminated during slaughter by
contact with small amounts of intestinal
contents; fresh fruits and vegetables can be contaminated if grown in contaminated manure
as fertilizer or are washed or irrigated with
water contaminated with infected animal manure; some types of salmonella can infect a
hen’s ovary so the internal contents of a
normal-looking egg can be contaminated even before the shell is formed; microbes can be
transferred from one piece of contaminated
food to another via knives, cutting boards, or other utensils; fully cooked meat or
poultry on which all pathogens have been killed can
become recontaminated if it touches other raw meat or poultry or drippings from raw meat
poultry that contains pathogens.
CDC/Division of Bacterial and Mycotic Diseases (“DBMD”), Foodborne Infections
General Information, How does food become
contaminated?, available at
<http://www.cdc.gov/ncidod/dbmd/diseaseinfo/foodborneinfections
_g.htm#howcontaminated>.
[2] Although all foods of animal origin are likely to carry foodborne pathogens, this
Petition is limited to regulations governing meat
and poultry and, therefore, will not discuss fish, dairy products, or eggs any further.
[3] 21 U.S.C. § 601, et seq. (1906).
[4] 21 U.S.C. § 451, et seq. (1957).
[5] 21 U.S.C. §§ 451, 604.
[6] Id.
[7] CDC/DBMD, Foodborne Infections Technical Information, available at
<http://www.cdc.gov/ncidod/
dbmd/diseaseinfo/foodborneinfections_t.htm>.
[8] Id.
[9] CDC/DBMD reports, available at
<http://www.cdc.gov/ncidod/dbmd/diseaseinfo/escherichiacoli
_g.htm>, <http://www.cdc.gov/ncidod/dbmd/diseaseinfo/salmonellosis_g.htm>,
<http://www.cdc.gov/
ncidod/dbmd/diseaseinfo/campylobacter_g.htm>,
<http://www.cdc.gov/ncidod/dbmd/diseaseinfo/
listeriosis_g.htm>.
[10] CDC/DBMD, Foodborne Diseases General Information, How are foodborne diseases
diagnosed?, available at
<http://www.cdc.gov/ncidod/dbmd/diseaseinfo/foodborneinfections_g.htm>.
[11] USDA/ERS, Food Safety, available at
<http://www.ers.usda.gov/Emphases/SafeFood/>.
[12] USDA/ERS, Bacterial Foodborne Disease: Medical Costs and Productivity Losses.
Agricultural Economic Report No. 741
(August 1996); CDC/DBMD, Foodborne Infections General Information, What foods are most
associated with foodborne illness?,
available at <http://www.cdc.gov/ncidod/
dbmd/diseaseinfo/foodborneinfections_g.htm#riskiestfoods>; See also Pathogen Reduction;
Hazard Analysis and Critical Control Point
(HACCP) Systems, 60 Fed. Reg. 6774 (proposed February 3, 1995).
[13] CDC/ DBMD, Salmonellosis General Information, How do people catch Salmonella?,
available at
<http://www.cdc.gov/ncidod/dbmd/diseaseinfo/salmonellosis_g.htm> and Campylobacter
Infections General Information, How does
food or water get contaminated with Campylobacter?, available at
<http://www.cdc.gov/ncidod/dbmd/diseaseinfo/campylobacter_g.htm>; FSIS Backgrounder,
Escherichia coli Update: E. Coli
0157:H7, (January 1993) at 1.
[14] The information in this section is taken from the information provided by CDC on E.
coli 0157:H7, available at
<http://www.cdc.gov/ncidod/dbmd/diseaseinfo/escherichiacoli_g.htm>.
[15] E. coli 0157:H7 has been found to colonize the ceca (the large pouch forming the
beginning of the large intestine) of chickens and
has been isolated from retail poultry in the United States, FSIS has never found E. coli
0157:H7 in raw or ready-to-eat poultry
samples. Performance Standards for the Production of Processed Meat and Poultry Products,
66 Fed. Reg. 12,590 (proposed
February 27, 2001).
[16] HUS is a severe, life-threatening disease characterized by the destruction of red
blood cells, kidney failure, and neurological
complications such as seizures and strokes. HUS, once considered a rare disease, is
now the leading cause of renal failure in children.
The Center for Public Integrity, Safety Last: The Politics of E. coli and Other Food-Borne
Killers, 1998, at 13.
[17] CDC Editorial Note. Preliminary Report: Foodborne Outbreak of Escherichia coli
0157:H7 Infections From Hamburgers-Western
United States. JAMA 1993;269:1089.
[18] On June 24, 2001 and July 31, 2001, FSIS announced a recall of ground pork products
because of positive tests for E. coli
0157:H7. USDA/FSIS, Meat and Poultry Product Recalls: News Releases and Information for
Consumers, available at
<http://www.fsis.usda.gov/OA/news/xrecalls.htm>; Policy on Beef Products
Contaminated With Escherichia Coli O157:H7, 64 Fed.
Reg. 2803-01 (January 19, 1999) (“The public health risk presented by beef products
contaminated by E. coli 0157:H7 is not limited,
however, to raw ground beef products.”).
[19] The information in this section is taken from the information provided by CDC on
salmonella, available at
<http://www.cdc.gov/ncidod/dbmd/diseaseinfo/salmonellosis_g.htm>, unless otherwise
noted.
[20] Performance Standards for On-line Antimicrobial Reprocessing of Pre-Chill Poultry
Carcasses, 65 Fed. Reg. 75,187-02
(proposed December 1, 2000).
[21] USDA/ERS, Economics of Foodborne Disease—Salmonella, available at
<http://www.ers.usda.gov/
briefing/FoodborneDisease/Salmonella/index.htm>.
[22] U.S. Food and Drug Administration Center for Food Safety & Applied Nutrition,
Foodborne Pathogenic Microorganisms and
Natural Toxins Handbook, Salmonella ssp. (commonly known as the “Bad Bug Book”).
[23] The information in this section is taken from the information provided by CDC on
campylobacter available at
<http://www.cdc.gov/ncidod/dbmd/diseaseinfo/campylobacter_g.htm>, unless otherwise
noted.
[24] 65 Fed. Reg. 75,187-02, supra note 20.
[25] It is estimated that approximately 1 in every 1,000 reported campylobacteriosis cases
leads to Guillain-Barré Syndrome, and as
many as 40 percent of Guillain-Barré Syndrome cases in this country may be triggered by
campylobacteriosis.
[26] Approximately 500 persons with campylobacter infections die each year.
[27] The information in this section is taken from the information provided by CDC on
listeriosis, available at
<http://www.cdc.gov/ncidod/dbmd/diseaseinfo/listeriosis_g.htm>, or from
“About-Listeria” available at
<http://www.about-listeria.com>, unless otherwise noted.
[28] FSIS Backgrounder, FSIS Strategies for Addressing Listeria Monocytogenes (February
1999).
[29] Council for Agricultural Science and Technology, Foodborne Pathogens: Risks and
Consequences, Task Force Report No. 122
(1994), at 45.
[30] Council for Agricultural Science and Technology, Johne’s Disease in Cattle,
Issue Paper No. 17 (May 2001).
[31] 21 U.S.C. §§ 601.
[32] 21 U.S.C. § 601(n)(12).
[33] 21 U.S.C. § 604(a).
[34] Id.
[35] Id.
[36] See 21 U.S.C. § 608.
[37] 21 U.S.C. §§ 601(m)(1), (m)(3).
[38] 21 U.S.C. §§ 601(n)(1), (n)(12).
[39] 21 U.S.C. § 451.
[40] 21 U.S.C. § 455.
[41] 21 U.S.C. §§ 453(g)(1), (g)(3).
[42] 21 U.S.C. § 453(h).
[43] 21 U.S.C. §§ 453(m), 457(a).
[44] 9 C.F.R. § 300.
[45] 9 C.F.R. § 301.2.
[46] 9 C.F.R. §§ 381.1, 381.96.
[47] 9 C.F.R. § 381.123.
[48] 9 C.F.R. §§ 310.5, 381.1.
[49] 9 C.F.R. §§ 317.2(l); 381.125(b)(1)(i).
[50] Id.
[51] Id.
[52] 9 C.F.R. § 310.18.
[53] 9 C.F.R. § 381.65(e). A “chilling tank” is a large vat of water that
serves as a common bath for all poultry carcasses after
inspection.
[54] See Notice on Complying with Food Safety Standards under the HACCP System
Regulations: Livestock Carcasses and Poultry
Carcasses Contaminated With Visible Fecal Material, 62 Fed. Reg. 63,254-01 (November 28,
1997); Poultry Post-Mortem Inspection
and Reinspection—Enforcing the Zero Tolerance for Visible Fecal Material, FSIS
Directive 6150.1 (June 19, 1998).
[55] 9 C.F.R. §§ 310.18, 381.91(b)(1); FSIS Directive 6150.1, supra note 54;
Livestock Post-Mortem Inspection
Activities—Enforcing the Zero Tolerances for Fecal Material, Ingesta, and Milk, FSIS
Directive 6420.1 (December 17, 1998).
[56] Pathogen Reduction; Hazard Analysis and Critical Control Point (HACCP) Systems
(“hereinafter referred to as “HACCP Final Rule”), 61 Fed. Reg. 38,806-01
(July 25, 1996) codified at 9 C.F.R. § 417. HAACP has
been nicknamed by many FSIS inspectors as “Have a Cup of Coffee and Pray.”
Safety Last, supra note 16, at 13.
[57] Generic E. coli is a common bacterium that does not cause disease; rather, it
indicates the presence of feces. FSIS, “Key Facts:
HACCP Final Rule,” July 1996.
[58] HACCP Final Rule, supra note 56; See also 9 C.F.R. §§ 310.25; 381.94.
[59] All information provided in this section can be found at 9 C.F.R. §§ 310.25(a),
381.94(a), and Enforcement of Regulatory
Requirements in Establishments Subject to the HACCP System Regulations, FSIS Directive
5000.1 (November 21, 1997), at Part
Four, paragraph IV.
[60] All information provided in this section can be found at 9 C.F.R. § 310.25(b) and §
381.94(b)(1), unless otherwise noted.
[61] Enforcement for the Salmonella Performance Standards, FSIS Directive 10,011.1
(September 9, 1998).
[62] Id.
[63] See also FSIS Directive 5000.1, supra note 59, at Part I.
[64] 66 Fed. Reg. 12,590, supra note 15.
[65] FSIS has indicated its intent to propose more pathogen reduction performance
standards to eventually cover every processing
category. Irradiation of Meat Food Products, 64 Fed. Reg. 72,150-01, 72,153 (December 23,
1999).
[66] Microbiological Monitoring Program: Sampling, Testing Procedures and Actions for
Listeria Monocytogenes and Salmonella,
FSIS Directive 10,240.1 (June 2, 1997).
[67] Performance Standards for the Production of Processed Meat and Poultry Products, 66
Fed. Reg. 12,589 (proposed February
27, 2001).
[68] FSIS Directive 10,240.1, supra note 66.
[69] Listeria monocytogenes, Contamination of Ready-to-Eat Products, 64 Fed. Reg. 28,351
(May 26, 1999).
[70] Id.
[71] FSIS Directive 5000.1, supra note 59, at Part I, paragraph III.A.
[72] 66 Fed. Reg. 12,589, supra note 67.
[73] All information provided in this section can be found at Microbiological Testing
Program for Escherichia coli 1057:H7 in Raw
Ground Beef, FSIS Directive 10,010.1 (February 1, 1998), unless otherwise noted.
[74] FSIS Notice 50-94, Microbiological Testing Program for Escherichia coli 0157:H7 in
Raw Ground Beef (December 23, 1994);
See also Texas Food Industry Association v. Espy, 870 F.Supp. 143 (W.D. Texas 1994).
[75] “Establishments” subject to this regulation include plants that grind beef
and retail outlets that regularly grind beef.
[76] A sampled lot is all raw ground-beef products produced between performance of
complete cleaning and sanitization procedures
for all equipment used in handling or processing a raw ground-beef product.
[77] Safety Last, supra note 16, at 12.
[78] USDA/FSIS, Meat and Poultry Product Recalls: News Releases and Information for
Consumers, supra note 18.
[79] Statement of Thomas J. Billy, FSIS Administrator, before the Senate Appropriations
Subcommittee on Agriculture, Rural
Development, and Related Agencies, April 26, 2001.
[80] Statement by Mark Rasmussen, microbiologist with Agricultural Research Service at the
National Animal Disease Center in Ames,
Iowa, available at <http://www.ars.usda.gov/is/pr/1998/980317.htm>.
[81] 62 Fed. Reg. 63,254, supra note 54; See also Poultry Inspection: Revision of Finished
Product Standards With Respect to Fecal
Contamination, 62 Fed. Reg. 5139, 5140 (February 4, 1997) (“Fecal contamination is a
food safety hazard because of its direct link to
microbial contamination and foodborne illness.”)
[82] Charlotte Schubert, Busting the Gut Busters: Virulent E. coli are revealing some
weaknesses, Science News, August 4,
2001;160:74-6.
[83] Chicken: What you don’t know can hurt you, Consumer Reports, March 1998.
[84] In addition to the microbial pathogens for which FSIS spot-checks, there are other
pathogens spread through animal feces for
which FSIS does not test. For instance, Johne’s disease (also known as
paratuberculosis) is primarily an intestinal infection of
ruminant animals that has been linked to Crohn’s disease, a chronic, progressive,
debilitating enteric disease in humans. It is caused by
a bacterium in the same genus as the bacteria causing tuberculosis in humans, cattle, and
other species. About 22 percent of dairy and
8 percent of beef herds in the United States are infected with Johne’s disease. The
causative bacteria is excreted in the feces of
infected cows. Johne’s Disease in Cattle, supra note 30.
[85] The generic E. coli spot-check system is not intended to prevent the sale of fecally
contaminated products and is not used as a
means to withhold or recall products from the consumer market. Moreover, the testing
is too infrequent to provide adequate
assurance that fecally contaminated products are not being sold.
[86] Safety Last, supra note 16, at 17, citing, Food Chemical News, Consumer Groups Kick
Off Push for Family Food Protection
Act, February 6, 1995.
[87] Public Citizen, The Jungle 2000, at 13, available at
<http://www.citizen.org/CMEP/rad-food/The%20Jungle%202000.PDF>.
[88] Safety Last, supra note 16, at 17, citing Food Chemical News, FSIS Should Include
Microbial Testing in HACCP, June 6, 1994.
[89] Studies have documented that the percent of poultry carcasses contaminated with
salmonella increases during processing.
William James, et al., Cost Effective Techniques to Control Human Enteropathogens on Fresh
Poultry, Poultry Science,
1993:72;1174-6.
[90] Joby Warrick, An Outbreak Waiting to Happen: Beef Inspection Failures Let In a Deadly
Microbe, The Washington Post, April
9, 2001, at A1.
[91] 9 C.F.R. § 310.18 (livestock); § 381.91 (poultry).
[92] USDA Announces Approval of Trial Tests for Steam Process to Remove Contamination from
Meat Carcasses, Release No.
0262.95, available at <http://www.usda.gov/news/releases/1995/03/0262>.
[93] Sandy Bishop, Quality Assurance Director at Wayne Poultry Division, Continental Grain
Co., Gainsville, GA. Poultry, Processing
Methods: Eliminating Fecal Contamination (October 1998), available at
<http://www.meatingplace.com/articles/p1182.asp>.
[94] Steaming Out the Salmonella Risk, available at
<http://www.ars.usda.gov/is/AR/archive/
oct97/steam1097.htm>.
[95] USDA/ARS, Battling Food-Poisoning Bacteria, available at
<http://www.ars.usda.gov/is/AR/archive/
feb99/food0299.htm>.
[96] 944 F.2d 14 (1st Cir. 1991).
[97] See Survey attached hereto as Exhibit A.
[98] The Secretary of Agriculture has been granted broad authority to promulgate rules and
regulations “necessary to carry out the
Act[s].” 21 U.S.C. §§ 463, 621.
[99] For instance, to prevent E. coli 0157:H7 food poisoning, the government recommends
always testing meat with a thermometer.
If consumers suspect that a product such as ground beef in hamburger has not been cooked
sufficiently, not only should they not eat
that product, but they should also get a new bun and a new plate. The government
also recommends keeping raw meat separate from
all other foods in preparation, thereby necessitating two cutting boards and enough
counter space to keep everything separate; washing
hands, counters, and utensils with hot soapy water after they touch any raw meat; never
placing cooked hamburgers or ground beef
or other products on the unwashed plate that held raw meat; and washing meat thermometers
in between tests of food that require
further cooking. See What can you do to prevent E. coli O157:H7 infection?,
available at <http://www.cdc.gov/ncidod/dbmd/
diseaseinfo/escherichiacoli_g.htm>.
[100] See Walter Reed Army Medical Center’s Regulation No. 40-2, Medical Services
Waste Disposal (August 25, 1999), citing
Environmental Protection Agency regulations.
[101] Interstate Shipment of Etiologic Agents, 42 C.F.R. § 72.3.
[102] For examples, see Duke University’s Medical Waste Management guidelines,
available at
<http://www.safety.duke.edu/SafetyManuals/University/safman73.htm>, and Ohio State
University’s Guidelines for Research and
Biomedical Waste Disposal, available at
<http://www.biosci.ohio-state.edu/~jsmith/guideline.pdf>.
[103] See Walter Reed Army Medical Center’s Regulation No. 40-2, supra note 100.
[104] 21 U.S.C. §§ 453(h)(12), 601(n)(12).
[105] USDA/FSIS, Progress Report on Salmonella Testing of Raw Meat and Poultry Products,
1998-2000, available at <http://www.fsis.usda.gov/ophs/haccp/salmdata2.htm>.
[106] 65 Fed. Reg. 75,187-02, supra note 20.
[107] USDA/ARS, Battling Food-Poisoning Bacteria, available at
<http://www.ars.usda.gov/is/AR/
archive/feb99/food0199.htm>.
[108] Chicken: What you don’t know can hurt you, supra note 83.
[109] USDA/FSIS, Sampling Raw Meat and Poultry for Salmonella.
[110] 511 F.2d 331 (D.C. Cir. 1974).
[111] The conclusion that “the presence of salmonella in meat does not constitute
adulteration within the meaning of the [FMIA] was
plainly dictum which did not reflect consideration of any factual basis or legal analysis
of the adulteration provision of that Act.”
Seabrook International v. Harris, 501 F.Supp. 1086 (D.D.C. 1980).
[112] APHA v. Butz, 511 F.2d at 334.
[113] Mandatory Safe Handling Statements on Labeling of Raw Meat and Poultry Products, 58
Fed. Reg. 43,478 (Interim Rule August
16, 1993).
[114] Mandatory Safe Handling Statements on Labeling of Raw Meat and Poultry Products, 59
Fed. Reg. 14,528 (March 28, 1994).
In fact, USDA reversed its 1974 opinion on safe-handling instructions to settle a
subsequent lawsuit filed to enjoin USDA from affixing
the official inspection legend to poultry and meat unless it was accompanied by a warning
and safe-handling label. 58 Fed. Reg. at
43,482, supra note 113.
[115] Performance Standards for the Production of Processed Meat and Poultry Products, 66
Fed. Reg. 12,589 (proposed February
27, 2001); FSIS Directive 10,240.1, supra note 67.
[116] Mead P, Slutsker L, Dietz V, McCaig L, Bresee J, Shapiro C, Griffin PM, and Tauxe
RV. Food-Related Illness and Death in the
United States, Emerging Infectious Diseases, September/October 1999; 5:5, available at
<http://www.cdc.gov/ncidod/eid/vol5no5/mead.htm>.
[117] CDC/DBMD, Listeriosis, available at <http://www.cdc.gov/ncidod/dbmd/diseaseinfo/
listeriosis_g.htm>.
[118] CDC/DBMD, Campylobacter, available at
<http://www.cdc.gov/ncidod/dbmd/diseaseinfo/
campylobacter_g.htm>.
[119] USDA/ERS, Food Away >From Home: America’s Changing Food Choices, Food
Review, January-April 1999;22:1.
[120] As set forth above, USDA was not granted wide discretion for the language of the
meat inspection legend.
[121] 9 C.F.R. § 381.1.
[122] FSIS Consumer Education and Information. FOCUS ON: Chicken (September 2000),
available at
<http://www.fsis.usda.gov/oa/pubs/chicken.htm>.
[123] See Texas Food Industry Association v. Espy, 870 F.Supp. 143 (W.D. Texas 1994). In
Texas Food Industry, USDA
announced—without prior notice, opportunity for comment, or any anticipated
rulemaking—that ground beef contaminated with E.
coli O157:H7 is adulterated under the FMIA, creating accountability for the presence of
the pathogen in ground beef. Tied to the new
definition of E. coli 0157:H7 was a limited microbiological testing program. Prior to this
declaration, USDA had treated all
pathogen-contaminated meat as unadulterated. When this USDA announcement was challenged by
the meat industry as a violation of
the Administrative Procedure Act (“APA”), the court held in favor of USDA. In
particular, the court found that USDA had the authority to mandate testing for this
pathogen without engaging in notice-and-comment rulemaking because it was a
“procedural rule.”
Further, USDA’s declaration that ground beef contaminated with E. coli 0157:H7 was an
adulterant was held by the court to be an interpretive rule exempt from the
notice-and-comment procedures under the APA. Thus, USDA was not required to “engage
in substantive rule making as a predicate to considering a particular substance an
adulterant.”
[124] 59 Fed. Reg. 14,528, supra note 114.