Order Code IB10082
CRS Issue Brief for Congress
Received through the CRS Web
Meat and Poultry Inspection Issues
Updated September 17, 2003
Jean M. Rawson
Resources, Science, and Industry Division
Congressional Research Service ˜ The Library of Congress

CONTENTS
SUMMARY
MOST RECENT DEVELOPMENTS
BACKGROUND AND ANALYSIS
Overview
Standard and HACCP Inspection Authority and Requirements
Coverage
Plant Sanitation
Slaughter Inspection
Processing Inspection
Enforcement Authority
Challenges to the HACCP Rule
HACCP-Related Legal Action
Funding Issues
Legislative and Administrative Actions
Pathogen Performance Standards
E. coli O157:H7
Listeria monocytogenes
Recall and Civil Penalty Proposals
Meat Traceability
FSIS Bioterrorism Preparedness
Other Selected Issues
“Mad Cow” Disease
Humane Slaughter
LEGISLATION


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Meat and Poultry Inspection Issues
SUMMARY
The U.S. Department of Agriculture’s
performance standards for foodborne patho-
(USDA’s) Food Safety and Inspection Service
gens under HACCP, an FSIS activity that was
(FSIS) is responsible for inspecting most
ruled illegal in December 2001 (S. 1103/H.R.
meat, poultry, and processed egg products for
2203); and (3) impose civil penalties for
safety, wholesomeness, and proper labeling.
violations of the inspection laws and regula-
The Food and Drug Administration (FDA) is
tions (H.R. 1003).
responsible for ensuring the safety of all other
foods, including seafood.
Since the discovery of a case of mad cow
disease in western Canada in May 2003, the
In the early 1990s, foodborne illness
Animal and Plant Health Inspection Service
outbreaks and fatalities traced to undercooked
(APHIS), the USDA agency primarily respon-
hamburger patties renewed Congress’s efforts
sible for protecting U.S. livestock from for-
to address the ongoing problem of naturally
eign diseases, has banned the importation of
occurring microbiological contamination in
Canadian ruminants and ruminant products.
meat and poultry products. From 1996 to
During ante-mortem inspection at slaughter-
2000, FSIS developed and implemented, at all
houses, FSIS officials identify animals show-
federally inspected slaughtering and process-
ing central nervous system disorders, prevent
ing plants, the Hazard Analysis and Critical
their being processed for human food, and
Control Point (HACCP) system, over which
contact APHIS so that tissues from those
Congress has exercised close oversight. The
animals can be sent for testing. Some animals
system is intended to prevent meat contamina-
(called “downers”) with suspicious symptoms
tion by microbial pathogens at points along
arrive at slaughtering facilities unable to stand.
the manufacturing chain where it is most
Legislative proposals that would provide for
likely to occur, and to complement, not re-
the humane treatment of such animals by
place, the traditional system of inspection
immediate euthanasia have been considered
under existing statutes.
by previous Congresses. Companion bills to
this effect were introduced in the 108th Con-
Despite data indicating that HACCP is
gress on June 19, 2003 (H.R. 2519/S. 1298).
reducing the presence of pathogens in raw
meat and poultry products, new illness out-
The House-passed (H.R. 2673) and
breaks, deaths, and very large recalls of
Senate-reported (S. 1427) bills making USDA
ground beef and turkey lunch meats in spring
appropriations for FY2004 propose $785
2002 illustrated the difficulty of preventing
million and $784 million, respectively, for
contamination in processed products. Most of
FSIS. Both bills call for FSIS to use part of
the bills that were introduced in the 107th
the roughly $29 million increase over FY2003
Congress in response to the 2002 events have
funding for hiring more inspectors, among
been reintroduced in the 108th. These include
other things.
proposals to give FSIS the authority to (1)
mandate recalls of suspected contaminated
products (H.R. 2273); (2) set and enforce
Congressional Research Service
˜ The Library of Congress

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MOST RECENT DEVELOPMENTS
On September 17, 2003, USDA’s Food Safety and Inspection Service (FSIS) released
data showing a drop in 2003 in the number of ground beef samples testing positive for the
presence of the deadly E. coli O157:H7 bacteria. Through August 31, 2003, 0.32% of
samples tested positive compared with 0.78% in 2002 and 0.84% in 2001. FSIS officials
maintain that the directives FSIS issued in October 2002 to ground beef manufacturers
concerning improved methods of preventing contamination, and increased training of
compliance officers, among other things, are contributing to the decline in positive samples.
On September 9, 2003, FSIS held a public meeting to collect information on how Best
Management Practices might be developed to help livestock producers and feedlot owners
reduce the presence of pathogens in animals before slaughter, thus lowering the occurrence
of post-slaughter contamination of meat and poultry.
In early September, USDA began to permit imports of limited amounts of certain non-
ruminant animal products from Canada. It is expected, however, that full resumption of
Canadian meat trade with the United States will take some time.
BACKGROUND AND ANALYSIS
Overview
FSIS inspects most meat, poultry, and processed egg products sold for human
consumption for safety, wholesomeness, and proper labeling. FSIS carries out its inspection
duties with a total staff of about 10,000, funded in FY2003 by an annual appropriation of
$759.8 million (P.L. 108-7). In addition, the agency can use for program support the user
fees paid by the packing industry for overtime and holiday inspection services (and fees from
certifying laboratories that test meat samples) — estimated at $101 million annually. About
7,700 of FSIS’s employees, roughly 1,000 of them veterinarians, are located at some 6,200
plants and import stations nationwide. Traditional inspection under the original statutes
comprises constant organoleptic inspection (for appearance, odor, and feel) at slaughter
operations and daily inspection of sample products and operations at processing plants.
Following years of debate over how to respond to mounting evidence that invisible,
microbiological contamination on meat and poultry posed greater public health risks than
visible defects (the focus of traditional inspection methods), FSIS in the early 1990s began
to add testing for pathogenic bacteria on various species and products to its inspection
system. In 1995, under existing statutes, FSIS published a proposed rule to systematize these
program changes in a mandatory new inspection system called the Hazard Analysis and
Critical Control Point system — HACCP. In this system, hazards are identified and risks are
analyzed in each phase of production; “critical control points” for preventing such hazards
are identified and monitored; and corrective actions are taken when necessary. Record
keeping and verification are used to ensure the system is working.
The final rule was
published in 1996, and since January 2000 all slaughter and processing operations are
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required to have HACCP plans in place. HACCP is intended to operate as an adjunct to the
traditional methods of inspection, which still are mandatory under the original statutes.
The packing industry was generally receptive to HACCP at the outset. Numerous
plants, particularly the ones with 500 or more employees (which account for 75% of all U.S.
slaughter production and 45% of all processed product output), already were using HACCP-
type processes in their operations. However, since full implementation, the mandatory
HACCP system has proved to be controversial. Although records show that packing plants
for the most part have been abiding by the mandatory standards for pathogen levels, major
players in the industry argue that the regulations exceed the HACCP concept by establishing
what they view as impractical, expensive testing regimes and unrealistic standards.
A lawsuit brought against FSIS at the end of 1999 and reaffirmed on appeal in
December 2001 challenges the agency’s authority to carry out HACCP reforms and pathogen
testing under existing statutes. These events raise the question of whether the original laws
sufficiently undergird FSIS’s stated intention to move to a more science-based inspection
system.
Performance data on HACCP gradually are becoming available and generally indicate
that it is having a measurable beneficial impact on microbiological contamination of raw
meat and poultry. Combined FSIS data for the 1998-2002 period show that Salmonella
prevalence in all classes of products have decreased to levels below the baseline prevalence
estimates determined prior to HACCP implementation. The data indicate that young
chickens average 10.9% under HACCP compared to 20% prior to HACCP; market hogs
average 4.7% compared to 8.7%; cows and bulls average 2.2% compared to 2.7%; steers and
heifers average 0.4% compared to 1%; ground beef averages 3.2% compared to 7.5%;
ground chicken averages 19.8% compared to 44.6%; and ground turkey averages 26.6%
compared to 49.9%. The most significant improvement between 2001 and 2002 was in
market hogs, which had a 5.4% prevalence level in the 1998-2001 dataset.
Reductions in Salmonella levels mean reductions in the presence of other foodborne
pathogens as well, according to FSIS. Data that the Centers for Disease Control and
Prevention (CDC) released in April 2002, showing a 23% overall drop in bacterial foodborne
illnesses since 1996, would appear to substantiate this. According to the new CDC data, the
four major bacterial foodborne illnesses — Campylobacter, Salmonella, Listeria, and E. coli
O157:H7 — posted a 21% decline in the past 6 years. However, despite the decline in the
incidence of those four illnesses, the rate of positive tests for E. Coli O157:H7 bacteria in the
raw product has been increasing steadily since FSIS began testing in 1994. This suggests
that such factors as testing and more widespread knowledge among restaurant chefs and
household consumers about proper cooking methods may be preventing people from
becoming ill, but that insufficient progress is being made in reducing the presence of the
bacteria in meat products themselves.
CDC officials emphasize that several food safety improvements — in addition to
HACCP in meat and poultry plants — have been implemented over the same period (e.g.,
HACCP regulation of fruit and vegetable juices and seafood, and industry adoption of FDA
guidelines on Salmonella prevention in egg production), and that the data collected have
limitations and do not reflect the entire U.S. population. FDA officials state that there may
be some connection between HACCP implementation in meat and poultry plants and the
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decline in foodborne illness, but it likely never will be possible to say how exactly how
much.
Standard and HACCP Inspection Authority
and Requirements
The Federal Meat Inspection Act of 1906, as amended [21 U.S.C. 601 et seq.], requires
USDA to inspect all cattle, sheep, swine, goats, and horses brought into any plant to be
slaughtered and processed into products for human consumption. The original Meat
Inspection Act did not cover the poultry industry, which at the time was mainly small-scale
production by independent farmers. The 1957 Poultry Products Inspection Act, as amended
[21 U.S.C. 451 et seq.], made poultry inspection mandatory. In May 1995, the authority for
processed egg inspection was transferred from USDA’s Agricultural Marketing Service to
FSIS. The Egg Products Inspection Act, as amended [21 U.S.C. 1031 et seq.], is the
authority under which FSIS assures the safety of liquid, frozen, and dried egg products,
domestic and imported, and the safe use or disposition of damaged and dirty eggs.
The primary goals of the FSIS inspection program are to prevent adulterated or
misbranded animals and products from being sold as food, and to ensure that meat and
poultry are slaughtered and processed under sanitary conditions.
Uninspected and
condemned products cannot be sold for human consumption in domestic or foreign
commerce. Requirements also apply to intrastate commerce (for which either USDA
programs or federally approved state programs must be in place). FSIS conducts overseas
evaluations to determine that imports from foreign countries are processed under equivalent
inspection systems; agency officials also verify equivalency by visiting various foreign
slaughtering and processing operations. All firms seeking to export meat or poultry to the
United States must first receive FSIS certification. After passing through Customs and
inspection by USDA’s Animal and Plant Health Inspection Service (APHIS) for possible
animal or human disease hazards, all imports go to FSIS inspection facilities for final
clearance.
The following are the basic requirements of FSIS standard and HACCP inspection
systems:
Coverage. FSIS’s legal inspection responsibilities do not begin until animals arrive
at slaughterhouses, and they generally end once products leave processing plants. The
agency has no regulatory jurisdiction at the farm level. Also, certain custom slaughter and
most retail store and restaurant activities are exempt from federal inspection; however, they
may be under state inspection. Most exotic meats — including venison, rabbit, and buffalo
— are under the Food and Drug Administration’s (FDA) regulatory oversight and not
subject to mandatory inspection under the meat and poultry acts, although producers of these
meats may request USDA inspection on a fee-for-service basis. FDA also is responsible for
seafood (even those fish and shellfish raised through aquaculture), milk, and for the safety
of shell eggs in retail stores and restaurants. Beginning April 26, 2001, FSIS inspection is
mandatory for meat from ratites (ostrich, emu, rhea) and quail. A provision in the USDA
appropriations act for FY2001 (P.L. 106-387) amended the Poultry Products Inspection Act
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to include these animals, and the interim final rule was published in the Federal Register
May 1, 2001 (66 FR 21631).
Plant Sanitation. No meat or poultry establishment can slaughter or process products
for human consumption until FSIS approves in advance its plans and specifications for the
premises, equipment, and operating procedures. Once this approval is granted and operations
begin, the plant must continue to follow a detailed set of rules that cover such things as
proper lighting, ventilation, and water supply; cleanliness of equipment and structural
features; and employee sanitation procedures. In addition, under HACCP regulations, all
operations must have site-specific standard operating procedures (SOPs) for sanitation. For
each “critical control point” along the production line, plants must document and maintain
records on all cleaning procedures being used to prevent contamination before, during and
after production. USDA inspectors check the records to verify the plant’s compliance.
Slaughter Inspection. FSIS inspects all meat and poultry animals at slaughter on
a continuous basis; that is, no animal may be slaughtered and dressed unless an inspector has
examined each carcass. One or more federal inspectors are on the line during all hours the
plant is operating. Plants pay user fees to have an inspector on duty on overtime and holiday
shifts. Slaughter inspection under the original statutes consists primarily of organoleptic
detection procedures — sight, touch, and smell — to look for signs of disease,
contamination, and/or other abnormal conditions, both before and after slaughter.
In addition to standard inspection, plants are required under the HACCP rule to have
a HACCP plan for their slaughter and/or processing operations. Simply put, this means that
at each point in the process where contamination could occur, the plant must have a plan to
control it. FSIS’s role is to verify that the plant’s plan effectively maintains sanitation
standards at all the control points.
The HACCP rule also mandates two types of microbial testing to verify that plant safety
procedures are working and to measure plant performance in reducing pathogens:
! All meat and poultry slaughter plants must regularly test carcasses for generic
E. coli in order to verify that their systems are effectively controlling fecal
contamination. The testing is intended as a process verification tool for plants
and inspectors and is not to be used as a standard for enforcement purposes.
However, plants are required to follow approved testing procedures and
methods, and failure to meet specified performance criteria will result in
USDA’s working with the plant to improve sanitation and process controls.
Testing frequency varies, from many tests daily in high volume plants to once
a week in the smallest ones.
USDA states that generic E. coli was chosen because it is the best microbial indicator
of fecal contamination, the primary vehicle for such potentially dangerous bacteria as
Salmonella, Campylobactor, and E. coli O157:H7.
! Both slaughter plants and those that produce raw ground product are
expected to meet or stay below a national standard incidence rate for
Salmonella contamination. USDA states that it chose Salmonella for testing
over other bacteria because: (1) it is the leading cause of foodborne illness;
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(2) it is one of the most common foodborne bacteria; (3) it is easy to test for;
and (4) its reduction also will cause reductions in other foodborne
pathogens. The national standard varies by product. For example, it is set
initially at 1% of samples testing positive for steers and heifers, 7.5% for
ground beef, 20% for broilers, and 49.9% for ground turkey. In the initial
years of HACCP implementation, plants that failed three consecutive
Salmonella tests could have their USDA inspectors withdrawn. This would
effectively shut down the plant until the problem could be remedied. A
court ruling in 2000, upheld on appeal in late 2001, made such enforcement
illegal (see below). Nonetheless, FSIS inspectors still test samples for
Salmonella and use the results as one of a number of indicators of plant
performance.
Processing Inspection. The inspection statutes give the Secretary discretion to
determine how often a USDA inspector must visit facilities that produce processed products
like hot dogs, lunch meat, prepared dinners, and soups. Current regulations do not require
an FSIS inspector to remain constantly on the production line or to inspect each and every
processed item. Instead, inspectors are on site daily to monitor operations, check sanitary
conditions, examine ingredient levels and packaging, review records, and conduct statistical
sampling and testing of products. Such plants also are required to have HACCP plans, which
are verified daily by USDA inspectors. Processing inspectors often have responsibility for
two or more plants that must be visited each day; consequently, these plants are processing
meat or poultry without on-site federal oversight for a large portion of their workday.
Nonetheless, because each plant is visited daily, processing inspection is considered to be
continuous.
Enforcement Authority.
FSIS has a range of enforcement tools to prevent
adulterated or mislabeled meat and poultry from reaching consumers. On a day-to-day basis,
if plant conditions or procedures are found to be unsanitary, an FSIS inspector can, by
refusing to perform inspection, temporarily halt the plant’s operation until the problem is
corrected. FSIS can condemn contaminated, adulterated, and misbranded products, or parts
of them, and detain them so they cannot progress down the marketing chain. Other tools
include warning letters for minor violations; requests that companies voluntarily recall a
potentially unsafe product; a court-ordered product seizure if such a request is denied; and
referral to federal attorneys for criminal prosecution. Prosecutions under certain conditions
may lead to the withdrawal of federal inspection from offending firms or individuals.
Without inspection, plants are prohibited from operating.
Challenges to the HACCP Rule
Reaction to the mandatory HACCP regulations has been mixed. A significant portion
of the packing industry already was using HACCP-type processes and conducting its own
pathogen testing before those activities became mandatory. Nonetheless, after
implementation, several major meat industries have contended that the Salmonella standard,
in particular, oversteps the intent of HACCP and is impractical, expensive, and sets
unrealistic microbiological goals. They also maintain that adding HACCP onto existing
requirements increases the regulatory burden for meat and poultry processors, with no
tangible improvement in public health. On the other hand, consumer advocacy organizations
such as the Center for Science in the Public Interest and Safe Tables Our Priority have
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remained supportive of the HACCP rule, contending, among other things, that the testing
program is effective at reducing pathogens because it forces companies to emphasize
prevention in their operating plans.
HACCP-Related Legal Action. In December 1999, FSIS attempted to withdraw
inspectors from a processing firm in Texas (Supreme Beef) whose ground beef products had
repeatedly violated Salmonella levels (withdrawing inspectors effectively closes down a
plant). However, the firm obtained a federal court injunction to prevent FSIS’s action. The
firm argued that (1) high Salmonella levels did not indicate the presence of other dangerous
pathogens, (2) that the Salmonella came in with the product from the slaughterhouse and thus
could not be removed, and (3) that the plant had never failed to meet standards for sanitation.
In May 2000, the federal judge ruled that the meat and poultry inspection statutes did not
give FSIS authority to use the Salmonella standard as the basis for withdrawing inspection.
In 2001, USDA asked an appeals court to overturn the ruling, in part because Supreme
Beef had gone of business and the May 2000 decision applied only to meat plants in the
original court’s district. However, on December 11, 2001, the appeals court upheld the
district court’s decision. Shortly afterwards, Secretary Veneman issued a statement saying
that although the decision limited FSIS’s ability to enforce performance standards, it did not
affect the agency’s ability to use the standards as part of the verification of plants’ sanitation
and HACCP plans. In late July 2002, FSIS issued a notice to its employees instituting
detailed procedures for reporting and taking action on failed generic E. coli tests in
slaughtering plants, and on failed Salmonella tests in slaughter and grinding operations. The
notice requires more documentation of test information, faster and more standardized
notification of higher level managers, a procedural schedule for corrective actions, and
instructions on what steps FSIS inspectors are to take if the corrective actions do not result
in a negative test. The notice can be found on the FSIS website [http://www.fsis.usda.gov/].
The appeals court ruling supports the arguments of those who say that pathogen testing
results should not be a basis for enforcement actions until scientists can determine what
constitutes an unsafe level of Salmonella in ground meat. Consumer groups and other
supporters of mandatory testing and microbiological standards, as well as of increased
enforcement powers, have used the case to bolster their argument for moving ahead quickly
with amending the meat and poultry inspection statutes to specify microbiological standards.
Funding Issues
From time to time FSIS has experienced difficulties in having sufficient staff to meet
the agency’s service obligations to the meat and poultry industries. Usually a combination
of factors causes these difficulties, including new technologies that increase plant volume,
insufficient appropriated funds to hire additional inspectors at times of unexpected increases
in demand for inspections, problems in finding people to work in dangerous or unpleasant
environments or at remote locations, etc. These staffing problems have been exacerbated by
the addition of HACCP requirements on top of the traditional carcass-by-carcass inspection
duties. In order to monitor the staffing situation more closely, Congress included language
in the conference report to accompany the FY2000 USDA appropriations law (P.L. 106-78),
requiring FSIS to prepare a quarterly report on budget execution, staffing levels, and staffing
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needs (these are available on the FSIS website under “Communications to Congress”; see
[http://www.fsis.usda.gov/oa/congress/congress.htm#Annual]).
In order to address staffing problems, most administrations over the past 20 years have
included proposals in their annual budget requests to charge the meat packing industry user
fees sufficient to cover the entire cost of federal inspection services. Currently (since 1919),
FSIS charges user fees for overtime (beyond 3 shifts per day) and holiday inspections, which
adds about $100 million annually to the agency’s program level. The primary rationale for
more comprehensive user fees has been that resources would then be adequate to hire new
inspectors as necessary. USDA economists estimate that the cost passed on to consumers
from such a fee would be no more than a one cent per pound. Congressional appropriators
have rejected the user fee proposal every year, stating that the safety of the food supply is a
legitimate responsibility of the government. In addition, some Members have argued that
problems with the HACCP system, which makes plant employees responsible for more food
safety activities than formerly, illustrate why the government should retain taxpayer-funded
regulatory oversight.
The Bush Administration’s FY2003 and FY2004 budget requests included proposals
to increase the industry’s reimbursement for FSIS inspection of second and third shifts,
arguing that the regular working day should be considered standard inspection, and any
services provided beyond that time should be considered additional, hence subject to a higher
fee schedule. Congressional appropriators did not adopt the proposal for FY2003. Neither
the House-passed nor the Senate-reported FY2004 appropriations bill for FSIS adopts the
Administration’s proposal (H.R. 2673/S. 1427). In the current fiscal year, FSIS is operating
on a $759.8 million appropriation, plus roughly an additional $101 million from traditional
user fees. H.R. 2673 would appropriate $785.3 million for FSIS in FY2004, and S. 1427
would provide $783.8 million. Both bills would allocate a portion of the funds specifically
to hire additional inspectors. The Senate bill would also allocate more money to inspection
of meat and poultry safety systems in foreign countries wishing to export products to the
United States; and the House bill would allocate funds specifically for increasing U.S.
laboratory capacity to analyze food samples for acts of bioterrorism, among other things.
Legislative and Administrative Actions
Pathogen Performance Standards. In part because of the Supreme Beef case,
Senator Harkin in recent years has introduced several bills to add language to the inspection
laws clarifying the Secretary’s authority to set enforceable performance standards. On May
22, 2003, he reintroduced the Meat and Poultry Pathogen Reduction and Enforcement Act
(S. 1103; H.R. 2203, Eshoo). These bills would require the Secretary to set performance
standards for the top illness-causing pathogens in raw meat after a 3-year survey and
evaluation period. The bill would enforce the standards by not permitting violative products
to be labeled “USDA Inspected and Passed,” thus preventing them from being sold for
human consumption in any form.
The National Advisory Committee on Microbiological Criteria for Foods, which was
established in 1988 to provide scientific advice and recommendations to the Secretary of
Agriculture and the Secretary of Health and Human Services on public health issues,
concluded in a report issued in October 2002 that “performance standards that meet the
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principles as outlined in this document [i.e., standards that are based on quantitative rather
than qualitative data] are valuable and useful tools to define an expected level of [pathogen]
control in one or more steps in the process.” (The report is available at [http://www.fsis.
usda.gov/OPHS/nacmcf/rep_stand.htm].)
A second review of microbiological performance standards, Scientific Criteria to
Ensure Safe Food, is being conducted by the Institute of Medicine in collaboration with the
National Research Council of the National Academy of Sciences. The report is due out in
hard copy shortly, but can be read online at [http://www.nap.edu/books/030908928X/html/].
Among many recommendations, this newest report calls on Congress to “grant the regulatory
agencies clear authority to establish, implement, and enforce food safety criteria, including
performance standards, and the flexibility needed within the administrative process to update
these criteria.” The report also makes seven specific recommendations for FSIS to take to
improve the safety of meat and poultry products. Among these are: (1) conduct surveys to
evaluate changes over time in the microbiological status of certain components of processed
meats and poultry; (2) expand E. coli O157:H7 testing, identify control points for E. coli
O157:H7 back to the farm level, and inform consumers that even irradiated ground beef must
be cooked to a temperature that kills the pathogen; (3) greatly expand generic E. coli criteria
for, and Salmonella performance standards for, beef trim intended for grinding.
E. coli O157:H7. In October 1994, FSIS began testing samples of raw ground beef
for E. coli O157:H7 and declared that any such product found with this pathogen would be
considered adulterated — the first time a foodborne pathogen on raw product was declared
an adulterant under the meat inspection law. Industry groups immediately asked a Texas
federal court for a preliminary injunction to halt this effort, on the grounds that it was not
promulgated through appropriate rulemaking procedures, was arbitrary and capricious, and
exceeded USDA’s regulatory authority under law. In December 1994, the court denied the
groups’ request, and no appeal was filed, leaving the program in place. FSIS has taken
roughly 58,000 samples since the program began; to date, 237 samples have tested positive.
In June and July 2002, 42 people in 9 states were sickened by eating ground beef
contaminated with E. coli O157:H7, due to delays in tracing the tainted meat back to the
original packer and in having the company issue a recall. The recall was announced July 19,
2002, and applied to about 19 million pounds of beef trim and fresh and frozen ground beef
products produced as far back as April. In September 2002, FSIS issued a press release
stating that “(t)he scientific data show that E. coli O157:H7 is more prevalent than previously
estimated,” and in October 2002, the agency published a notice in the Federal Register (67
FR 62325) requiring manufacturers of all raw beef products (not just ground beef) to reassess
their HACCP plans and add control points for E. coli O157:H7 if the reassessment showed
that the pathogen was a likely hazard in the facility’s operations. The changes at large
operations were required to be complete by December 6, 2002; small plants had until
February 4, 2003, and very small plants until April 7, 2003. FSIS inspectors verify that
corrective steps have been taken and conduct random testing of all beef processing plants,
including all grinders (some previously had been exempted). In addition, the agency is
issuing guidelines to grinding plants advising them to increase the level of pathogen testing
by plant employees, and to avoid mixing products from different suppliers.
In September 2003, FSIS released data indicating that the required changes may be
having a positive effect on the number of ground beef samples testing positive for E. coli
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O157:H7 in 2003. Of the samples collected and analyzed through August 31, 0.32% tested
positive, compared to 0.78% in 2002 and 0.84% in 2001, according to FSIS.
In August 2002, FSIS began investigating a meatpacking plant in Omaha, Nebraska
Beef, for repeated violations of inspection regulations. In mid-January 2003, FSIS attempted
to close down the plant after discovering E. coli O157:H7 in ground beef that the plant had
supplied to another company. Nebraska Beef won a temporary restraining order against
FSIS on the argument that its meat was safe, and a shut-down would destroy the company’s
quality image and cause potentially disastrous economic loss. The U.S. District Court in
Omaha was to review the case on January 24, but FSIS and Nebraska Beef came to an
agreement before the court hearing. On January 25, 2003, the judge issued a consent order,
which will be in effect for 2 years, that commits the company to abiding by certain
obligations, such as putting a full-time employee in charge of overseeing the plant’s
implementation of sanitary standards and its HACCP plan.
USDA officials state that this settlement fully reaffirms FSIS’s authority to enforce
the laws and regulations. Nebraska Beef and other meat industry officials state that the
settlement is a straightforward restatement of existing regulations. Consumer groups and
some Members state that the case shows that FSIS is steadily losing its power to enforce food
safety rules. The case is similar to the Supreme Beef case concerning Salmonella, in that,
arguably, it shows that the original statutes may be insufficient to support actions that FSIS
currently needs to take to assure that meat and poultry products are safe.
Listeria monocytogenes. In February 2001, FSIS published a proposed rule to
establish performance standards that meat and poultry processing firms would have to meet
to reduce the presence of Listeria monocytogenes (Lm), a pathogen in ready-to-eat (RTE)
foods. The proposed rule covered more than 100 different types of dried, salt-cured,
fermented, and cooked or processed meat and poultry products. Lm causes an estimated
2,500 illnesses and 499 deaths each year (from listeriosis), and is still the number one cause
for meat and poultry product recalls. FSIS and FDA jointly prepared the proposed rule in
response to an initiative that the Clinton Administration announced in May 2000 to cut in
half the number of listeriosis cases by 2005. The Federal Register notice (66 FR 5515)
asked the food processing industry for technical comments on a draft risk assessment, and
for comment on a risk management action plan. The action plan was built on a previous set
of performance standards for selected lunch meats and other products that became effective
in March 1999 (64 FR 732).
The proposed regulations raised a controversy among the affected constituencies. The
meat industry argued that the benefits to consumers would not outweigh the cost to packers
of additional testing.
Representatives of food manufacturers criticized the proposed
regulations for covering some categories of foods too broadly and heavily, while not covering
some other, high-risk foods at all (such as milk, which is under FDA’s jurisdiction).
Representatives of major consumer groups said that the proposed rule would not require
enough testing in small processing plants and that products that are not tested for Lm should
not be labeled “ready-to-eat” because they would still require cooking to be 100% safe. No
final rule pursuant to the February 2001 rule was ever published.
Interest in the Listeria issue increased significantly after October 2002, when the
Pilgrim’s Pride Corporation recalled a record-breaking 27.5 million pounds of poultry lunch
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meats for possible Lm contamination after a July 2002 outbreak of listeriosis in New
England. The Centers for Disease Control and Prevention confirmed 46 cases of the disease,
with 7 deaths and 3 stillbirths or miscarriages. The recall covered products made as long ago
as May 2002, and officials stated that very little of the meat was still available to be
recovered.
In December 2002, FSIS issued a directive to inspection program personnel giving
new and specific instructions for monitoring processing plants that produce hot dogs and deli
meats. (The guidelines can be found on the FSIS website at [http://www.fsis.usda.gov]). On
February 14, 2003, FSIS released a draft risk assessment on Lm for public comment, saying
that it would base its next proposals for controlling the pathogen on the final risk assessment.
On June 4, 2003, FSIS announced the publication of an interim final rule to reduce
Listeria in ready-to-eat meats. Rather than set performance standards, as the February 2001
proposed rule would have, the new regulation requires plants that process RTE foods to add
control measures specific to Listeria to their HACCP and sanitation plans, and to verify their
effectiveness by testing and disclosing the results to FSIS. FSIS inspectors will conduct
random tests to verify establishments’ programs. Plants will be subject to different degrees
of FSIS verification testing depending upon what type of control steps they adopt in their
HACCP and sanitation plans (see the FSIS website for more details on the rule).
On June 5, 2003, Senator Clinton introduced a bill that would require ready-to-eat
foods that have not been processed under a science-based Lm control plan to bear a label
advising pregnant women and other at-risk consumers how to handle them so as to avoid
contracting listeriosis.
Recall and Civil Penalty Proposals. Following the recall-related problems that
accompanied the foodborne illness outbreaks in the summer of 2002, a number of
enforcement-related bills were introduced in both chambers. Some of these have been
reintroduced in the first session of the 108th Congress. In February 2003, Representative
Lowey reintroduced the Meat and Poultry Inspection Accountability Act (H.R. 1003), which
would give FSIS the authority to impose substantial civil money penalties on slaughtering
and processing operations that violated the meat and poultry inspection laws and regulations.
Representative Udall reintroduced the Unsafe Meat and Poultry Recall Act (H.R. 2273),
which would authorize FSIS to recall suspected contaminated products directly if the product
owner did not comply with the agency’s request for a voluntary recall. Currently, the
Secretary must go to the courts to obtain an order to seize and detain suspected contaminated
products if a firm refuses to issue a recall voluntarily.
An August 2000 GAO study on FSIS and FDA recalls (Food Safety — Actions Needed
by USDA and FDA to Ensure that Companies Promptly Carry Out Recalls) criticized both
the agencies’ efforts to ensure that companies carry out recalls quickly and efficiently,
particularly of products that may carry severe risk of illness. GAO also stated that neither
FDA nor FSIS compiled sufficient information on companies’ recall schedules or methods,
and that determining the need for mandatory recall authority could not be done until such
data were available.
At past hearings, consumer groups and food safety advocacy groups have testified in
favor of obtaining these new enforcement tools to improve food safety in general, and to
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strengthen USDA’s enforcement of the new HACCP system in particular. These groups
have stated that civil fines would serve as an effective deterrent and could be imposed more
quickly than criminal penalties or the withdrawal of inspection. They also have argued that
the authority to assess civil penalties would permit USDA to take stronger action against
“bad actors” — processors who persistently violate food safety standards. Food safety
advocates argue that FSIS should have the authority to mandate product recalls as a backup
guarantee in case the voluntary recall system moved too slowly or was not comprehensive
enough. In a speech at the Food Safety Summit in March 2003, Secretary Veneman said that
USDA is weighing the merits of amending the meat and poultry inspection laws to: (1)
require slaughtering and processing firms to inform the Department if they suspect
adulteration or misbranding of their product; (2) obtain authority to impose civil penalties
on a firm if, after a written warning, it remains out of compliance; and (3) permit FSIS
inspectors to issue cease-and-desist orders or to withdraw inspection on the basis of HACCP
violations at an earlier stage than currently is the practice.
Meat and poultry industry trade associations have testified in opposition to granting
USDA new enforcement powers.
Both producers and processors argue that current
authorities are sufficient and that only once has a plant refused to comply with USDA’s
recommendation to recall a suspected contaminated product. Industry representatives have
testified that USDA’s current authority to withdraw inspection, thereby shutting down a
plant, is a strong enough economic penalty to deter potential violators and punish so-called
bad actors. Furthermore, they say, new enforcement powers would increase the potential for
plants to suffer drastic financial losses from suspected contamination incidents which could
ultimately be proven false. Some observers argue that much still needs to be done in
educating consumers and restaurateurs about safe meat and poultry handling and cooking
practices.
Meat Traceability. On June 5, 2003, Senator Schumer introduced a proposal that
relates to the recall issue: traceability. S. 1202 would require USDA to develop a system for
tracing contaminated meat and poultry products back, step by step, to the animals from which
they came and the farms on which they were raised. Such a system could begin as an animal
registration and record-keeping system, but some observers speculate that a computerized
barcode system, or even implantable microchip technology, could become feasible
eventually. Congress currently is debating the traceability issue in various contexts: (1) to
enhance U.S. agriculture’s protection against foreign animal diseases such as BSE, as well
as against bioterrorism; (2) to verify the U.S. origin of live cattle and meat products for
export; and (3) to facilitate recalls to prevent or contain foodborne illness outbreaks, among
other things. Supporters of animal ID and meat traceability point out that most major meat
exporting countries already have domestic animal ID systems. A major U.S. meat industry
group, on the other hand, argues that such a system would not be based on sound science, and
would be technically unworkable. (For further information, see CRS Report RL32012,
Animal Identification and Meat Traceability.)
Relatedly, Representative Kucinich introduced a bill on July 25, 2003, that, if enacted,
likely would require some system of farm-to-fork identification for enforcement purposes.
The Genetically Engineered Food Right to Know Act (H.R. 2916) would amend the major
federal food safety laws, including the meat and poultry inspection laws, to require that food
containing genetically modified (GM) material or produced with GM material, such as
animals feeds manufactured from GM corn, soybeans, or cotton, be labeled accordingly.
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FSIS Bioterrorism Preparedness
Since September 11, 2001, widespread concern has been voiced about the potential
for terrorist attacks on the U.S. agricultural base and food supply through intentional
contamination by organisms or chemicals injurious to crop, animal, or human health. FSIS
received $15 million in funds for increased oversight of meat and poultry safety in the
Defense emergency supplemental act (P.L. 107-117, enacted January 10, 2002) which
allocated the remaining $20 billion from the September 11,2001, disaster relief act (P.L. 107-
38). The Public Health Security and Bioterrorism Preparedness and Response Act (P.L. 107-
188) authorized an additional $15 million in FY2002 and such sums as necessary in
subsequent years to strengthen FSIS’s inspection force.
The FY2004 budget request
proposes a $25.6 million increase for FSIS to hire additional inspectors and laboratory
personnel to enhance readiness for a potential bioterrorism act against meat and poultry
products.
In March 2002, Under Secretary for Food Safety Elsa Murano testified before the
House Agriculture Appropriations subcommittee on the steps FSIS and the Department
currently are taking administratively to address food biosecurity issues. At the Department
level, the USDA Homeland Security Council coordinates anti-terrorism activities across
USDA and with other federal agencies. Within FSIS, the Food Biosecurity Action Team (F-
BAT) has placed the agency’s 7,600 inspectors on high alert to look for ante-mortem and
post-mortem irregularities in meat animals and poultry, and has conducted mock exercises
to improve response time and communication in emergency situations. FSIS made security
guidelines available to food processors in August 2002 (accessible on the FSIS website).
The Food Threat Preparedness Network (PrepNet) is a joint FSIS/FDA group that works on
threat prevention and emergency response.
Other Selected Issues
“Mad Cow” Disease
“Mad cow” disease, or bovine spongiform encephalopathy (BSE), is a slowly
progressive, incurable disease affecting the central nervous system of cattle. It was first
diagnosed in Britain in 1986. In 1997, European scientists determined that there was a likely
link between BSE in cattle and an outbreak in humans of a new type of fatal brain disease
called Creutzfeldt-Jakob disease (nvCJD) that had begun in Europe in the late 1980s. Most
experts now agree that nvCJD is a human form of BSE that is transmitted to humans who
consume meat from BSE-infected cattle.
On May 20, 2003, Canada announced that one cow in a northern Alberta herd had
tested positive for BSE. U.S. officials immediately prohibited any ruminant animals (cattle,
sheep, goats, deer, elk) and ruminant products from entering the United States, and
announced that the ban would remain in effect until the origin of the case was determined
and no further cases found. In early September, APHIS began to allow limited imports of
non-ruminant animal products from Canada on a permit basis. The next step, according to
APHIS officials, is to develop a protocol for allowing imports of live animals. (For
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additional information on the Canadian case and on BSE in general, see CRS Report
RS20839, Mad Cow Disease: Agriculture Issues).
U.S. federal and state agencies have found no BSE in U.S. cattle since they began
surveillance in 1989. That year, APHIS began banning the import of all live ruminants from
countries where BSE is known to exist. In 1991, APHIS banned the importation of rendered
by-products from ruminants, and then banned, as of December 2000, the importation of all
rendered animal protein products (whether from ruminants or not). The Food and Drug
Administration, which regulates animal feed ingredients domestically, banned the feeding
of virtually all mammalian proteins to ruminants in August 1997. Periodic surveys show,
however, that full compliance has been difficult to achieve. A February 2002 GAO study
reported that 364 out of 10,576 firms inspected by FDA (out of at least 11,741 total firms
potentially handling ruminant material) were still out of compliance with FDA’s labeling,
recordkeeping, and commingling requirements. Furthermore, according to GAO, FDA’s
database for ensuring compliance is inadequate (see [http://www.gao.gov]).
Wide differences of opinion on the adequacy of U.S. safeguards against BSE persist.
A study issued in November 2001 by the Harvard Center for Risk Analysis, states that the
steps that USDA and HHS have taken to date to prevent and prepare for possible BSE
introduction are effective, although some improvements could still be made. The February
2002 GAO study states, “Federal actions do not sufficiently ensure that all BSE-infected
animals or products are kept out or that if BSE were found, it would be detected promptly
and not spread to other cattle through animal feed or enter the human food supply.” USDA
has asked scientific experts to recalculate the risk of BSE appearing in the United States now
that a case has been identified in Canada
FSIS’s responsibility regarding BSE requires the agency’s inspectors to divert from
processing any cattle showing suspicious clinical symptoms and to contact an APHIS
inspector to come evaluate the animal and send brain tissue to a federal laboratory in Ames,
Iowa, for testing. In FY2002, USDA tested 19,900 cattle for BSE, focusing particularly on
high risk animals, including downers (animals that cannot walk at slaughter establishments),
animals that die on farms, older animals, and those showing signs of neurological distress.
Under FSIS’s foreign meat inspection program, no establishments in countries where BSE
has been found are approved to ship beef to the United States. However, the February 2002
GAO report questions the adequacy of the inspection procedures for imported meats. FSIS
also recently announced a new regulatory sampling program to test meat that has been
mechanically removed from bones to ensure that no spinal cord tissue is present. This tissue
would carry the risk of BSE if the disease were to be detected in U.S. beef herds.
Humane Slaughter
Under provisions in the Federal Meat Inspection Act (21 U.S.C. 603(b), 610(b),
620(a)), FSIS inspectors are responsible for enforcing the Humane Methods of Slaughter Act
(7 U.S.C. 1901-1906). This act requires that all livestock (but not poultry) be rendered
unconscious before slaughter. FSIS inspectors have the authority to stop slaughter lines and
order plant employees to take corrective actions to ensure compliance with the act.
Legislative proposals to include poultry under the act were introduced in the 102nd through
104th Congresses, but none was acted upon.
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An advertising campaign by animal rights groups in 2001, alleging major dereliction
of duty by FSIS in enforcing the humane slaughter law (later discredited by formal state
investigations), heightened public awareness of the issue. However, to help reassure the
public, FSIS placed 17 veterinarians in its district offices in February 2002, specifically to
monitor humane slaughter and handling procedures and to report to headquarters on
compliance. The conference agreement on H.R. 2646 (P.L. 107-171, the 2002 farm bill)
contains a provision expressing the sense of Congress that FSIS should fully enforce the
Humane Methods of Slaughter Act and report the number of violations to Congress annually.
In the FY2003 omnibus appropriation act, Congress designated $5 million of FSIS funding
specifically for hiring 50 additional inspectors to oversee the agency’s compliance.
Relatedly, public awareness has risen concerning the treatment of nonambulatory
(“downer”) cattle at stockyards.
Both House and Senate versions of the 2002 farm bill
contained provisions amending the Packers and Stockyards Act of 1921 to make it unlawful
to physically move any downed animal unless it had been humanely euthanized first. The
conferees instead adopted language calling for an investigation of the treatment of downers
and giving the Secretary authority to promulgate regulations if the findings warrant.
During House floor debate in July 2003 on the FY2004 agriculture appropriations bill
(H.R. 2673), Representative Ackerman proposed an amendment to prohibit USDA from
spending any funds for the inspection of downed animals. By denying inspection, no meat
from downed animals could be processed for human consumption, even if the reason for their
inability to stand would not affect the wholesomeness and safety of meat products processed
from them.
The amendment narrowly failed (199-202), but debate on the issue could resume if the
House or Senate take up either of the companion bills that Representative Ackerman and
Senator Akaka introduced on June 19, 2003 (H.R. 2519/S. 1298). The Downed Animal
Protection Act would amend the 2002 farm act to require that downed animals at stockyards,
market agencies, livestock dealer facilities, and slaughter facilities be euthanized
immediately and barred from federal inspection. The intent of the proposal is (1) to end the
mistreatment that downed animals have been known to experience at various points along
the marketing chain; and (2) to ensure that such animals are not processed for food.
Congress recently demonstrated its support for enforcing the humane slaughter act and
addressing the treatment of downers through provisions in the 2002 farm act and designated
appropriations in FY2003. The close vote on Representative Ackerman’s amendment to the
FY2004 spending bill, as well as the number of cosponsors of H.R. 2519 (117 to date)
indicate continuing concern about these issues. Nonetheless, some food safety officials have
criticized the proposed Downed Animal Protection Act, arguing that it could be deleterious
both to food safety and to foreign animal disease prevention. Officials are concerned that
euthanizing and removing downed animals before arrival at a federally inspected
slaughterhouse would result in these animals being disposed of before FSIS veterinarians
could see and evaluate them. In turn, they maintain, APHIS’s and FSIS’s protective
oversight of the necessary testing of downed animals and proper disposal of carcasses would
be significantly reduced, raising the possibility that the animal could end up being used for
human consumption, or could spread disease by being sold for other, nonfood purposes.
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LEGISLATION
H.R. 1003 (Lowey)
The Meat and Poultry Inspection Accountability Act would expand the enforcement
options under the federal meat and poultry inspection laws to include the imposition of civil
money penalties; and would amend the Federal Food, Drug, and Cosmetic Act to expand
FDA enforcement options to include such penalties with respect to meat and poultry.
Introduced February 27, 2003; referred to the Committee on Agriculture and to the
Committee on Energy and Commerce.
H.R. 2203 (Eshoo)
The Meat and Poultry Pathogen Reduction and Enforcement Act would clarify the
authority of the USDA Secretary to prescribe performance standards for pathogens and to
enforce the HACCP system.
Introduced May 22, 2003; referred to Committee on
Agriculture.
H.R. 2273 (Udall)
The Unsafe Meat and Poultry Recall Act would amend the federal meat and poultry
inspection laws to authorize USDA to order the recall of suspected adulterated, misbranded,
or otherwise unsafe products. Introduced May 22, 2003; referred to the Committee on
Agriculture.
H.R. 2519/S. 1298 (Ackerman/Akaka)
The Downed Animal Protection Act would amend the 2002 farm act (P.L. 107-171)
to ensure the humane slaughter of nonambulatory livestock and prevent them from being
processed for human consumption. Introduced June 19, 2003; referred to the House and
Senate Agriculture Committees.
H.R. 2916 (Kucinich)
The Genetically Engineered Food Right to Know Act would amend the Federal Food,
Drug, and Cosmetic Act, the Federal Meat Inspection Act, and the Poultry Products
Inspection Act to require that food containing GM material or produced with a GM input be
labeled accordingly. Introduced July 25, 2003; referred to the House Agriculture and Energy
and Commerce Committees.
S. 1103 (Harkin)
The Meat and Poultry Pathogen Reduction and Enforcement Act would clarify the
authority of the USDA Secretary to prescribe performance standards for the reduction of
pathogens in meat and poultry and processed products; and to enforce the existing
regulations for HACCP.
Introduced May 22, 2003; referred to the Committee on
Agriculture, Nutrition, and Forestry.
S. 1187 (Clinton)
The At-Risk Consumer Protection Through Food Safety Labeling Act would amend
the federal meat and poultry inspection laws to require that ready-to-eat meat or poultry
products not produced under a scientifically validated program to address Listeria
monocytogenes
be required to bear a label advising pregnant women and other at-risk
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consumers of the USDA and FDA regulations regarding consumption of those products.
Introduced June 4, 2003; referred to the Committee on Agriculture, Nutrition, and Forestry.
S. 1202 (Schumer)
The bill would amend the federal meat and poultry inspection laws to require the
Secretary to adopt a traceback system for food animals, so that contaminated products could
be traced back to their source. Introduced June 5, 2003; referred to the Committee on
Agriculture, Nutrition, and Forestry.
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