Order Code IB10082
Issue Brief for Congress
Received through the CRS Web
Meat and Poultry Inspection Issues
Updated March 7, 2003
Jean M. Rawson
Resources, Science, and Industry Division
Congressional Research Service ˜ The Library of Congress

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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
Pathogen Performance Standards
E. coli O157:H7
Listeria monocytogenes
Recall and Civil Penalty Proposals
Consolidated Federal Food Safety Agency
FSIS Bioterrorism Preparedness
Irradiation
Other Selected Issues
“Mad Cow” Disease
State Inspection
LEGISLATION

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Meat and Poultry Inspection Issues
SUMMARY
The U.S. Department of Agriculture’s
under existing statutes.
(USDA’s) Food Safety and Inspection Service
(FSIS) is responsible for inspecting most
Despite data showing that HACCP may
meat, poultry, and processed egg products for
reduce the presence of pathogens in facilities
safety, wholesomeness, and proper labeling.
that produce meat and poultry products, out-
The Food and Drug Administration (FDA) is
breaks of foodborne illness and very large
responsible for ensuring the safety of all other
recalls of ground beef and turkey lunch meats,
foods, including seafood.
starting in spring 2002, indicate the ongoing
difficulty of preventing contamination of the
After September 11, 2001, much of Con-
products themselves. Toward the end of the
gress’ and food inspection agencies’ attention
107th Congress, new legislation to give FSIS
focused on assuring that food and the U.S.
mandatory recall authority was introduced in
agricultural production system are adequately
both chambers (S. 2803/H.R. 5230), and
protected from bioterrorism. On June 12,
debate recommenced on recall proposals
2002, the President signed into law the Public
introduced earlier (H.R. 3127, H.R. 4834).
Health Security and Bioterrorism Prepared-
Legislation also was introduced to counter a
ness and Response Act (P.L. 107-188). The
successful lawsuit by the meat industry chal-
act authorizes such sums as may be necessary
lenging pathogen performance standards. S.
for enhanced FSIS inspection activities in
2013 would have given FSIS statutory author-
FY2003 and beyond. The act contains exten-
ity to use Salmonella bacteria test results as a
sive provisions concerning FDA food inspec-
basis for enforcement actions under HACCP.
tion activities.
The omnibus FY2003 funding bill that
Preceding the concern with bioterrorism,
the President signed on February 20 contains
Congress for years has paid close attention to
$759.8 million for FSIS, which includes $5
the efforts of FSIS and the meat and poultry
million specifically for the agency to hire at
industry to address the ongoing problem of
least 50 additional employees to help enforce
naturally occurring microbiological contami-
the Humane Methods of Slaughter Act. The
nation, which is responsible for outbreaks of
agency’s enforcement of the Act came under
severe and sometimes fatal foodborne illness.
criticism in 2002. The Administration’s
FY2004 budget request proposes $797 million
Since January 2000, all federally in-
for FSIS. Of the $41 million increase over
spected slaughtering and processing plants are
this year’s appropriation (which would come
operating under a system of inspection called
from a proposed increase in user fees), $25.6
HACCP (for Hazard Analysis and Critical
million would support hiring more inspectors
Control Point). The system is intended to
and increasing laboratory capacity for analyz-
prevent meat contamination by microbial
ing food samples for possible acts of
pathogens at points along the manufacturing
bioterrorism, among other things.
chain where it is most likely to occur. The
HACCP system complements, but does not
replace, the traditional system of inspection

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MOST RECENT DEVELOPMENTS
On February 20, 2003, President Bush enacted the omnibus FY2003 appropriations bill
that includes funding for USDA’s meat, poultry, and egg inspection agency, the Food Safety
and Inspection Service (FSIS). P.L. 108-7 provides $759.8 million for FSIS’s FY2003
activities, which is $29 million above last year’s total appropriation including supplemental
funding.
On February 14, 2003, FSIS released for public comment a draft risk assessment for a
major food pathogen, Listeria monocytogenes. The final risk assessment will serve as the
basis upon which FSIS will issue final regulations aimed at reducing the level of Listeria
contamination of ready-to-eat products such as deli meats and hot dogs. The proposed
regulations were published in February 2001.
On February 3, 2003, the Administration released its FY2004 budget request for the
U.S. Department of Agriculture (USDA), which includes $797 million in appropriated
money for FSIS, plus an estimated $101 million from user fees, for a program level of $898
million. The Administration proposes using $25.6 million of the $41 million increase for
enlarging the inspection force and other activities aimed at enhancing both meat and poultry
product safety and protection from bioterrorism. However, the Administration is proposing
to raise user fees charged for overtime and holiday inspection in order to fund the increase.
Similar proposals from several previous Administrations have met with stiff opposition from
industry and some Members of Congress, and have never been adopted.
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 – 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
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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
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 HACCP is having a measurable beneficial impact on levels of microbiological
contamination in processing plants. Combined FSIS data for the 1998-2001 period show that
despite minor fluctuations, Salmonella prevalence in all classes of products have decreased
to levels below the baseline prevalence estimates determined prior to HACCP
implementation. The latest data indicate that young chickens average 10.7% under HACCP
compared to 20% prior to HACCP; market hogs average 5.4% 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 3.4% compared to 7.5%; ground chicken averages 15.7% compared
to 44.6%; and ground turkey averages 29.2% compared to 49.9%.
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 not much 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.,
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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 is
probably some connection between HACCP implementation in meat and poultry plants and
the 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
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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
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.
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! Both slaughter plants and those that produce raw ground product must 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; (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. Plants with higher levels than the
standard are required to take remedial actions in order to meet the targets;
failure to meet USDA standards by a third testing series can lead to
suspension of inspection, which effectively closes the plant. USDA
inspectors conduct the Salmonella testing.
Processing Inspection. Inspection of processed products like hot dogs, lunch
meat, prepared dinners, and soups does 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 remained
supportive of the HACCP rule, contending, among other things, that the testing program is
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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
needs (these are available on the FSIS website under “Communications to Congress;” see
[http://www.fsis.usda.gov/oa/congress/congress.htm#Annual]).
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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, arguing that the safety of the food supply is a
legitimate responsibility of the government.
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; FY2004
funding bills have not yet been marked up.
FSIS received $759.8 million in the omnibus FY2003 appropriations act, P.L. 108-7,
an amount that fully funds the President’s budget request. Included in that is $5 million
specifically for FSIS to hire 50 additional inspectors to oversee the agency’s compliance with
the Humane Methods of Slaughter Act. FSIS came under criticism last year for reported
lapses in its compliance with this act.
The FY2004 budget request for FSIS is $797 million. Of the $41 million increase,
which would be provided from the Administration’s proposal to raise second and third shift
user fees, $25.6 million would support hiring more inspectors and increasing laboratory
capacity to strengthen quick detection and response to potential acts of bioterrorism.
Legislative and Administrative Actions
Pathogen Performance Standards. In part because of the Supreme Beef case,
Senator Harkin made several attempts in both the106th and 107th Congresses to add language
to the inspection laws to clarify the Secretary’s authority to set enforceable performance
standards. Toward the end of the 107th Congress, Senator Harkin introduced The Meat and
Poultry Pathogen Reduction and Enforcement Act (S. 2013, Harkin; H.R. 3956, Eshoo). This
stronger and more detailed version of the earlier bills would have required 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 have enforced the standards by not permitting violative
products to be labeled “USDA Inspected and Passed,” which would prevent the product from
being sold for human consumption in any form.
In May 2002, Senator Schumer introduced related but more extensive legislation that
would have: (1) established microbiological performance standards; (2) established livestock
and poultry traceback systems; (3) required states to report illnesses from meat and poultry
products to the CDC; (4) protected employees at federally inspected meat and poultry plants
who report food safety problems from intimidation by their employers; (5) listed biological
threats to the food supply and enhance preparedness and response plans; and (6) conducted
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studies on how to improve the recruitment of federal meat and poultry inspectors and on
whether meat and poultry plants should be required to use rapid detection tests for major
pathogens (S. 2532).
One report on pathogen performance standards relative to the safety of the food supply
was released in late 2002, and another is expected in March 2003. 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 its report that “performance
standards that meet the 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].) The second review of
microbiological performance standards is being conducted by the Institute of Medicine in
collaboration with the National Research Council of the National Academy of Sciences, and
is due out shortly.

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
54,700 samples since the program began; to date, 228 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 will verify that corrective
steps have been taken and conduct random testing of all beef processing plants, including all
grinders (some previously had been exempted). The agency is preparing to issue guidelines
to grinding plants also advising increased pathogen testing by plant employees, and avoidance
of mixing products from different suppliers.
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
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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 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, and hiring an independent third party to assess the plant’s condition after 60
days.
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 it arguably shows
that the original statutes are 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, a pathogen in ready-to-eat foods. The
proposed rule covered more than 100 different types of dried, salt-cured, fermented, and
cooked or processed meat and poultry products. Listeria 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 Listeria
should not be labeled “ready-to-eat” because they would still require cooking to be 100% safe.
To date, FSIS has not published a final rule setting performance standards for Listeria in
ready-to-eat meats.
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
meats for possible Listeria 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 with new and
specific instructions for monitoring processing plants that produce hot dogs and deli meats.
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The guidelines can be found at [http://www.fsis.usda.gov/OPPDE/rdad/FSISDir7000.htm].
On February 14, 2003, FSIS released a draft risk assessment on Listeria for public comment,
saying that it will base its next proposals for controlling the pathogen on the final risk
assessment.
Both the poultry meat and ground beef recalls prompted renewed demands from a
variety of consumer and environmental groups for more federal enforcement and oversight
of inspection, and for an end to large-scale livestock operations, which environmental groups
argue increase the spread of harmful microorganisms.

Recall and Civil Penalty Proposals. In response to the foodborne illness
outbreaks in the summer of 2002 , Senator Harkin and Representative Rivers introduced
companion bills on July 26 and August 7, respectively, to not only give recall, civil penalty,
and withdrawal of inspection authorities to FSIS, but also to give recall and civil penalty
authority to the FDA (S. 2803/H.R. 5230). Similar bills were introduced earlier in the 107th
Congress: H.R. 1276, to give FSIS authority to levy civil penalties on packers that violate
inspection laws, and H.R. 3127, to 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.) In May 2002, a bill
similar to H.R. 3127 was introduced, except that it also would have clarified FSIS’s authority
to withdraw inspection if a company willfully or repeatedly violated meat and poultry
inspection laws and regulations, and would have authorize civil penalties of up to $100,000
per day against problem firms (H.R. 4834).
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 the
agencies’ efforts in making sure 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 compiles 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
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.
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.
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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.
Consolidated Federal Food Safety Agency
Concerns about bioterrorism preparedness after September 11, 2001, brought renewed
attention to a decades-long debate over whether the 12 federal agencies and roughly 35 laws
governing food safety should be consolidated into a single food safety entity. In the 107th
Congress, Senator Durbin, a long-standing proponent of the single agency concept,
reintroduced consolidation legislation shortly after the terrorist attacks, stating that such
reform was necessary to protect the food supply from terrorist threats (S. 1501, the Safe Food
Act of 2001/H.R. 1671). An October 2001 Senate Government Affairs Subcommittee hearing
on food safety preparedness included testimony on the single entity concept proposed in S.
1501. In speeches at a major food industry conferences in March and June 2002, Homeland
Security Secretary Tom Ridge stated that the Bush Administration is considering reorganizing
or consolidating federal food safety agencies at some point in the future.
Consumer groups are in favor of provisions that make federal regulatory oversight of
food safety more consistent across all types of food products, however that might be achieved.
Food processors argue that: (1) increased regulation will not result in increased food safety
until scientifically valid microbiological standards can be determined; (2) reorganization by
itself will not necessarily improve public health; and (3) reorganization or physical
restructuring of agencies would create huge logistical problems that could actually interfere
with the efficacy of the current system.
The GAO restated its long-standing criticism of the current fragmented food inspection
system at the October 2001 hearing, and reemphasized the National Academy of Sciences’s
(NAS) report calling for greater coordination and statutory reform, Ensuring Safe Food from
Production to Consumption, which Director Ridge also mentioned in his speech. In the 2002
farm act (Section 10807 of P.L. 107-171, the Farm Security and Rural Investment Act),
Congress created a 15-member Food Safety Commission and charged it with making specific
recommendations to enhance the U.S. food safety system, including a description of how each
recommendation would improve food safety. The report is due one year from the
Commissions’s first meeting; however, the law authorizes commission members to be
appointed only after authorized funds are appropriated. Since the government currently is
operating on a continuing resolution providing 2002 level funding, the Commission awaits
i m p l e m e n t a t i o n . ( T h e N A S r e p o r t i s a v a i l a b l e a t
[http://books.nap.edu/books/0309065593/html/index.html]; also see the GAO website
[http://www.gao.gov/] for links to the October 10 testimony).
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
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allocated the remaining $20 billion from the September 11,2001, disaster relief act (P.L. 107-
38).
Several bills introduced in the Senate in fall 2001 contained provisions affecting the
anti-terrorism activities of FSIS and/or its two primary cooperating USDA agencies, the
Animal and Plant Health Inspection Service (APHIS) (which inspects cargo and passengers
at U.S. ports of entry for animal and plant pests, and responds to animal disease outbreaks,
among other duties) and the Agricultural Research Service (ARS) (which conducts research
on animal diseases and food safety to support FSIS’s regulatory activities, among other
subjects). The USDA-related provisions in these bills were incorporated into S. 1765, the
Bioterrorism Preparedness Act of 2001, which the Senate adopted in toto as an amendment
in the nature of a substitute to H.R. 3448 in December 2001. The House-passed version
(passed the same month) did not contain any USDA-related authorities. The conference
report was passed by both chambers in May and the President signed the bill into law in June
2002 (P.L. 107-188, the Public Health Security and Bioterrorism Preparedness and Response
Act (H.Rept. 107-481)).
The Act authorizes an additional $15 million in FY2002 and such sums as necessary
in subsequent years to strengthen FSIS’s inspection force. The measure also authorizes $30
million to increase APHIS’s border inspection activities, create closer working relationships
with state and private veterinarians, and to establish an integrated FSIS/APHIS computer
tracking and record-keeping system for livestock and meat imports. (Note: The newly enacted
Homeland Security Act of 2002, P.L. 107-296, transfers APHIS’s border inspection activities
to the Department of Homeland Security. It is unclear how the transfer might affect the
implementation of activities specified in P.L. 107-188.) The Bioterrorism Act also contains
a provision making it a federal criminal offense intentionally to damage the property or
employees of public or private animal enterprises (e.g., a livestock or poultry slaughtering
operation, or an animal research laboratory) and authorizes restitution for economic loss
resulting from the damage.
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.
Irradiation
Food irradiation is the process of exposing food to ionizing radiation (e.g., from cobalt-
60, cesium-137, x-ray machines, or electron accelerators) that penetrates food and kills insect
pests and microorganisms without raising the temperature of the food significantly. In
December 1997, FDA approved irradiation for the control of pathogenic microorganisms in
red meats (FDA approval was necessary because irradiation is considered a food additive).
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In December1999, USDA published a final rule in the Federal Register (64 FR 72167) that
guides the meat industry in the use of the technology and in labeling irradiated red meat
products. The rule also permits poultry processors to irradiate unpackaged as well as
packaged poultry (irradiation of packaged poultry has been permitted since 1992). According
to FSIS officials, this change gives processors greater flexibility to use irradiation in the
context of their overall HACCP plans. Only about 1% of poultry is irradiated currently,
according to FSIS.
Supporters of irradiation as a food safety technology claim that it will significantly
reduce the public health threat, particularly from ground beef that may be contaminated with
E. coli O157:H7 (the process also can reduce the levels of Salmonella and other major
foodborne pathogens). Some consumer groups support irradiation for food safety purposes,
but state that it is not a panacea — good sanitary conditions through final preparation still will
be necessary — and that it raises other issues concerning worker and environmental safety.
Other interest groups remain concerned that it may alter the nutrient content of meat. An
August 2000 GAO report to Congress concluded that the cumulative evidence from more than
40 years of research in U.S., European and other laboratories indicates that irradiated food is
safe to eat. Retailers of meat products, especially ground beef, increasingly are offering
irradiated products for sale. Some research studies show potential consumer acceptance of
irradiated ground beef could be as high as 50%, but observers still expect the technology to
be adopted slowly.
In the 2002 farm act (P.L. 107-171, Sections 10808-09), Congress passed a provision
that requires the FDA to permit the use of the term “pasteurized” on food labels to indicate
that products (including meat products) have undergone a treatment process, including
irradiation, that reduces pathogen levels and remains effective even if the products are stored
improperly. FDA would have to publish proposed regulations to being complying with the
law, but it has not done so to date.
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.
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, and in 1991, the agency banned the importation of
rendered by-products from ruminants. As of December 2000, the importation of all rendered
animal protein products (whether from ruminants or not) is prohibited. The Food and Drug
Administration, which regulates animal feed ingredients domestically, banned the feeding of
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virtually all mammalian proteins to ruminants in August 1997. Periodic surveys show,
however, that full compliance has been difficult to achieve. A June 2001 FDA survey showed
that 22% of renderers, feed mills, and other facilities that handle ruminant material were out
of compliance with FDA’s labeling, recordkeeping, and commingling requirements. A
February 2002 GAO study reports that 364 out of 10,576 firms inspected by FDA (out of at
least 11,741 total firms potentially handling ruminant material) are still out of compliance.
Furthermore, according to GAO, FDA’s database for ensuring compliance is so flawed as to
be useless [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.”
FSIS’s responsibility regarding BSE requires the agency’s inspectors to divert from
processing any cattle showing suspicious clinical symptoms and send their brains to an APHIS
laboratory in Ames, Iowa, for testing. More than 11,000 cattle brains have been tested since
1990, and no BSE has been found. 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 criticizes USDA for not testing the brains
of cattle that die on farms, since they may be at higher risk of carrying BSE, and 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. (For additional information on BSE, see
CRS Report RS20839, Mad Cow Disease: Agriculture Issues).
State Inspection
For more than a decade, Members of Congress have introduced bills that would permit
state-inspected meat and poultry plants to ship their products across state lines (the most
recent was introduced in the 106th Congress). Currently, plants under state inspection, which
must be at least “equal to” (but not necessarily identical to) the federal program, can only
market their products intrastate. At past hearings on legislative proposals, representatives of
state departments of agriculture, state meat processing associations, the American Farm
Bureau Federation, the National Cattlemen’s Beef Association, and several major consumer
and food safety organizations have testified in support of the measure. The American Meat
Institute (AMI), which represents the manufacturers of about 70% of U.S. meat products, has
always testified in opposition to such bills, stating that for economic equity and other reasons,
state-inspected plants that want to ship interstate should be required to meet the same
standards that federally inspected plants must meet. None of the proposals ever progressed
to a vote.
The 2002 farm act (P.L. 107-171) contains a provision that requires FSIS to conduct
a survey of state inspection programs to determine how they currently compare to the federal
program, and to offer guidance on the changes state inspections systems might expect if the
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statutory prohibition against interstate shipment were removed (Title X, Subtitle B(65)). The
survey and guidelines are to be included in FSIS’s next annual report to Congress.
LEGISLATION
107th Congress
P.L. 107-171, H.R. 2646/S. 1731
Farm Security and Rural Investment Act of 2002. Provides for the continuation of
agricultural programs through FY2007. Contains provisions on bioterrorism preparedness,
country-of-origin labeling of meats, irradiation labeling, and humane treatment of livestock,
among other things. Conference agreement passed by the House on May 2 and by the Senate
on May 8, 2002. Signed into law May 13, 2002.
P.L. 107-188, H.R. 3448/S. 1765
Public Health Security and Bioterrorism Preparedness and Response Act. Improves
the ability of the United States to prevent, prepare for, and respond to bioterrorism and other
public health emergencies. Introduced December 11, 2001; passed the House on December
12, 2001, under a suspension of the rules. Senate substituted text of S. 1765 as an amendment
to H.R. 3448 on December 20, 2001. Conference agreement filed May 21; passed by House
on May 22 and by the Senate on May 23, 2002 (H.Rept. 107-481). Signed into law June 12,
2002.
H.R. 1276 (Lowey)
Expands enforcement options under the Federal Meat Inspection Act and Poultry
Products Inspection Act to include the imposition of civil money penalties against violators.
Introduced March 28, 2001, and referred to the Committee on Agriculture.
H.R. 3127 (Udall)
Unsafe Meat and Poultry Recall Act of 2001. Amends the Federal Meat Inspection Act
and the Poultry Products Inspection Act to authorize the Secretary of Agriculture to order the
recall of meat and poultry that is adulterated, misbranded, or otherwise unsafe. Introduced
October 12, 2001, and referred to the Committee on Agriculture.
H.R. 4834 (Baldacci)
Safe and Fair Enforcement and Recall for Meat and Poultry Act of 2002. Amends the
Federal Meat Inspection Act and the Poultry Products Inspection Act to give USDA the
authority to recall suspected contaminated meat and poultry if a firm does not comply with
a USDA request for a voluntary recall; also gives authority for civil penalties and withdrawal
of inspection. Introduced May 23, 2002, and referred to the Committee on Agriculture.
S. 2803/H.R. 5230 (Harkin/Rivers)
Safe and Fair Enforcement and Recall for Meat, Poultry, and Food Act of 2002.
Amends the Federal Meat Inspection Act, the Poultry Products Inspection Act, and the Federal
Food, Drug, and Cosmetic Act to provide for improved public health through enhanced
enforcement. S. 2803 was introduced July 26, 2002, and referred to the Committee on
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Agriculture, Nutrition, and Forestry. H.R. 5230 was introduced August 7, 2002, and referred
to the Subcommittee on Livestock and Horticulture of the Agriculture Committee, and to the
Subcommittee on Health of the Energy and Commerce Committee.
H.R. 1671 (DeLauro)/ S. 1501 (Durbin)
Safe Food Act of 2001. To consolidate into a single independent agency within the
executive branch responsibilities regarding food safety, labeling, and inspection currently
divided among several federal agencies. H.R. 1671 was introduced May 1, 2001; referred to
Committee on Agriculture, Subcommittee on Department Operations, Oversight, Nutrition,
and Forestry, and Subcommittee on Livestock and Horticulture, May 14, 2001. Referred to
Committee on Energy and Commerce, May 1, 2001, and referred to Subcommittee on Health,
May 15, 2001. S. 1501 was introduced October 4, 2001; referred to the Committee on
Governmental Affairs. Testimony was given on the measure at a hearing held on bioterrorism
preparedness on October 10, 2001, before the Subcommittee on Oversight of Government
Management, Restructuring, and the District of Columbia.
S. 2013 (Harkin)/H.R. 3956 (Eshoo)
The Meat and Poultry Pathogen Reduction and Enforcement Act of 2002. To clarify
the authority of the Secretary to prescribe performance standards for the reduction of
pathogens in meat and poultry produced under federal inspection. Introduced March 14,
2002, and referred to the Senate Committee on Agriculture, Forestry and Human Nutrition
and the House Committee on Agriculture.
S. 2532 (Schumer)
The Meat and Poultry Products Safety Improvement Act of 2002. To amend the
Federal Meat Inspection Act and the Poultry Products Inspection Act to improve the safety
of meat and poultry products by establishing microbiological standards and traceback systems,
among other things. Introduced May 17, 2002, and referred to the Senate Committee on
Agriculture, Forestry, and Human Nutrition.
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