Meat and Poultry Inspection: Background and Selected Issues
Prepared for Members and Committees of Congress
The U.S. Department of Agriculture’s (USDA’s) Food Safety and Inspection Service (FSIS) must
inspect most meat, poultry, and processed egg products for safety, wholesomeness, and labeling.
Federal inspectors or their state counterparts are present at all times in virtually all slaughter
plants and for at least part of each day in establishments that further process meat and poultry
products. Debate has ensued for decades over whether this system, first designed in the early
Several significant changes in meat and poultry inspection programs were included in the 2008
farm bill (P.L. 110-246), signed into law in June 2008. These include permitting some state-
inspected meat and poultry products to enter interstate commerce, just like USDA-inspected
products; bringing catfish under mandatory USDA inspection; requiring an inspected
establishment to notify USDA if it believes that an adulterated or misbranded product has entered
commerce; and requiring establishments to prepare and maintain written recall plans. USDA’s th
implementation of these provisions in 2009 is likely to be an oversight item for the 111
Congress. The following are among other recent inspection issues that could received continued th
attention in the 111 Congress, which also could consider broader legislation to reform food
safety programs—including those of the U.S. Food and Drug Administration (FDA), which
oversees all foods other than meat and poultry. (Among the more sweeping options has been a
proposal to consolidate federal food safety responsibilities, including those of FSIS, under a
single, independent food agency.)
Is enough being done to address longstanding concerns about naturally occurring
microbiological contamination? In 1996, FSIS added a sweeping new system known as Hazard
Analysis and Critical Control Point (HACCP)—essentially plant-specific contamination
prevention plans—on top of the traditional “sight-, smell-, and touch-based” inspection system.
However, large recalls due to pathogen problems are still occurring, and significant declines in
the incidence of major foodborne pathogens have not occurred in recent years, according to
government data. Past proposals to delineate pathogen performance standards and/or safe
tolerance levels could again be offered.
Should USDA have new authority to mandate recalls of suspect meat and poultry products, as
advocates have requested? FSIS now relies on the establishments to recall adulterated products
but asserts that this approach, along with other enforcement tools, is sufficient to protect
consumers. Those wanting mandatory recall authority also contend that an improved ability to
trace animals, meat, and poultry products should be built into the system to make recalls more
Does FSIS have adequate funding and resources, and/or should industry pay more for
inspection? FSIS inspection is mainly funded through USDA’s annual appropriation. Congress
has denied successive Administrations’ proposals for new user fees. Separately, Congress slowed
FSIS’s implementation of a controversial new “risk based inspection system” (RBIS, now being
retooled as the “Public Health Based Inspection System”) aimed at shifting some existing FSIS
resources from processing plants and products that pose relatively lower safety risks to others
posing relatively higher risks.
Background on the Programs..........................................................................................................1
Federal Meat Inspection Act of 1906..................................................................................1
Poultry Products Inspection Act of 1957............................................................................2
Agricultural Marketing Act of 1946...................................................................................2
Egg Products Inspection Act...............................................................................................2
Cove rage ....................................................................................................................... ...... 2
HACCP ............................................................................................................................... 3
Enforcement ........................................................................................................................ 3
Funding ........................................................................................................................ ....... 4
St affi ng ....................................................................................................................... ......... 4
Microbiological Contamination and HACCP..................................................................................5
Development of HACCP...........................................................................................................5
Pathogen Performance Standards and Salmonella....................................................................6
E. coli O157:H7........................................................................................................................8
Risk-Based Inspection System................................................................................................12
Other Selected Issues.....................................................................................................................13
Recall and Enforcement Proposals..........................................................................................13
Meat Traceability and Animal Identification..........................................................................15
Funding and User Fees............................................................................................................16
Food Safety Reorganization....................................................................................................18
BSE ......................................................................................................................................... 20
North American Cases......................................................................................................20
Author Contact Information..........................................................................................................23
The U.S. Department of Agriculture’s (USDA’s) Food Safety and Inspection Service (FSIS) is
responsible for inspecting most meat, poultry, and processed egg products for safety,
wholesomeness, and proper labeling. Federal inspectors or their state counterparts are present at
all times in virtually all slaughter plants and for at least part of each day in establishments that
further process meat and poultry products. The Food and Drug Administration (FDA), within the
U.S. Department of Health and Human Services (HHS), is responsible for ensuring the safety of 1
virtually all other human foods, including seafood, and for animal drugs and feed ingredients.
Several significant changes in meat and poultry inspection programs were included in the 2008
farm bill (P.L. 110-246), signed into law in June 2008. These include permitting some state-
inspected meat and poultry products to enter interstate commerce, just like USDA-inspected
products; bringing catfish under mandatory USDA inspection; requiring an inspected
establishment to notify USDA if it believes that an adulterated or misbranded product has entered
commerce; and requiring establishments to prepare and maintain written recall plans.
Recently, the effectiveness of the FSIS inspection system has been compared favorably (by some)
to FDA’s, particularly with regard to its import safety program. At the same time, large recalls of
fresh and processed meat and poultry products, often due to microbiological contamination, and
illness outbreaks caused by such products, continue to challenge the industry and government
regulators. FSIS policies came under renewed scrutiny in early 2008 after the agency announced
the largest meat recall ever, after evidence emerged that a California beef plant had slaughtered
for food a number of nonambulatory cattle, in violation of both a humane slaughter law and food
These incidents fueled interest in a number of bills in the 110th Congress to change other elements
of USDA’s authorizing statutes. What, if any, additional changes should the 111Congress consider
to improve safety oversight of meat and poultry production?
This law as amended (21 U.S.C. 601 et seq.) has long required USDA to inspect all cattle, sheep,
swine, goats, horses, mules, and other equines brought into any plant to be slaughtered and
processed into products for human consumption. Since passage of the FY2006 USDA
appropriation (P.L. 109-97, Section 798), these types of animals are now called “amenable
species.” P.L. 109-97 also gave the Secretary of Agriculture the discretion to add additional
species to the list, but none have been added under this discretionary authority. As noted, the 2008
farm bill makes catfish an amenable species.
1FSIS responsibilities are separately authorized and operate under a considerably different regulatory framework than
those of FDA. These differences could have significance in the longstanding debate over the need, if any, for
reorganizing U.S. food safety authorities and programs. See CRS Report RS22600, The Federal Food Safety System: A
Primer, by Geoffrey S. Becker and Donna V. Porter.
This law as amended (21 U.S.C. 451 et seq.) makes poultry inspection mandatory for any
domesticated birds intended for use as human food. The current list of included species is
chickens, turkeys, ducks, geese, guineas, ratites (ostrich, emu, and rhea), and squabs (pigeons up
to one month old).
Under this law as amended (7 U.S.C. 1621), FSIS also provides voluntary inspection for buffalo,
antelope, reindeer, elk, migratory waterfowl, game birds, and rabbits, which the industry can
request on a fee-for-service basis. These meat and poultry species (which are not specifically
covered by the mandatory inspection statutes) are still within the purview of FDA under the
Federal Food, Drug, and Cosmetic Act (FFDCA, 21 U.S.C. 301 et seq.), whether or not inspected
under the voluntary FSIS program. FDA has jurisdiction over meat products from such species in
interstate commerce, even if they bear the USDA inspection mark.
This law 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 disposition
of damaged and dirty eggs. FDA holds regulatory authority over shell eggs in restaurants and
USDA Meat Grading
USDA meat and poultry grading is distinct and separate from the FSIS safety inspection program. Upon request, firms
may request that inspectors from a separate USDA agency, the Agricultural Marketing Service (AMS), grade their
products for quality attributes, but only after it has been cleared by FSIS for safety and wholesomeness. Unlike safety
inspection, which is mandatory and largely covered by appropriated funds, grading services are voluntary and funded
by industry user fees.
Nationally uniform quality grades are used to convey, to buyers and sellers, such traits as tenderness, flavor, and
juiciness, and so forth. For example, AMS now grades beef carcasses as prime, choice, select, standard and
commercial, utility, cutter, and canner; these grades are not usually visible on individual retail cuts but can appear on
the packages. Grades are also available for veal, lamb, and poultry. Legislative authority for quality (and yield) grades
comes through the Agricultural Marketing Act (7 U.S.C. 1621).
FSIS’s legal inspection responsibilities begin when animals arrive at slaughterhouses, and they
generally end once products leave processing plants. Certain custom slaughter and most retail
store and restaurant activities are exempt from federal inspection; however, they may be under
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.
Plants are required to have a Hazard Analysis and Critical Control Point (HACCP) plan for their
slaughter and/or processing operations. Essentially, a plant must identify each point in the process
where contamination could occur, called a “critical control point,” have a plan to control it, and
document and maintain records. Under HACCP regulations, all operations must have site-specific
standard operating procedures (SOPs) for sanitation. USDA inspectors check records to verify a
FSIS inspects all meat and poultry animals to look for signs of disease, contamination, and other
abnormal conditions, both before and after slaughter (“antemortem” and “postmortem,”
respectively), on a continuous basis—meaning that no animal may be slaughtered and dressed
unless an inspector has examined it. One or more federal inspectors are on the line during all
hours the plant is operating.
The inspection statutes appear to be silent on how frequently USDA inspector must visit facilities
that produce processed products like hot dogs, lunch meat, prepared dinners, and soups. Under
current policies, processing plants visited once every day by an FSIS inspector are considered to
be under continuous inspection in keeping with the laws. Inspectors monitor operations, check
sanitary conditions, examine ingredient levels and packaging, review records, verify HACCP
processes, and conduct statistical sampling and testing of products during their on-site visits.
The HACCP rule also mandates two types of microbial testing: for generic E. coli and for
Salmonella. Levels of these two organisms are indicators of conditions that either suppress or
encourage the spread of such potentially dangerous bacteria as Campylobacter and E. coli
O157:H7, as well as Salmonella itself. Test results (plants test for E. coli and FSIS for
Salmonella) help FSIS inspectors verify that plant sanitation procedures are working, and to
identify and assist plants whose process controls may be underperforming.
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. FSIS does not have mandatory recall authority; if potentially dangerous or
mislabeled products do enter commerce, the agency relies on establishments to voluntarily recall
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, which results in
Federal appropriations pay for most, but not all, mandatory inspection. In FY2008, FSIS received
an annual appropriation of $930 million. In addition, FSIS uses revenue from fees paid by the
meat and poultry industries for FSIS inspection that occurs beyond regularly scheduled shifts and
on holidays, and by private laboratories that apply for FSIS certification to perform official meat
testing and sampling. In FY2008, revenue from the fees was expected to amount to approximately
$141 million in additional program support, for a combined funding level of more than $1 billion.
The agency began FY2009 under a continuing resolution (P.L. 110-329), which provides
appropriations through March 6, 2009.
FSIS carries out its duties with about 9,400 total staff (full-time equivalent). Approximately 7,800
of FSIS’s employees, roughly 1,000 of them veterinarians, are in approximately 6,200
establishments and import inspection facilities nationwide.
Twenty-seven states have their own meat and/or poultry inspection programs covering
approximately 2,000 small or very small establishments. The states run the programs
cooperatively with FSIS, which provides up to 50% of the funds for operating them, comprising
about $50 million of the total FSIS budget annually (plus an additional $7.5 million in indirect
costs for FSIS state-related activities). A state program operating under a cooperative agreement
with FSIS must demonstrate that its system is equivalent to federal inspection. However, state-
inspected meat and poultry products are limited to intrastate commerce only. In states that have
discontinued their inspection systems for meat or poultry (or both), FSIS has assumed
responsibility for inspection at the formerly state-inspected plants. However, actual inspection is 2
performed by state personnel.
Approximately 360 meat and poultry establishments in nine states are covered by a separate
federal-state program, the so-called Talmadge-Aiken plants. Under this program, USDA has
signed cooperative agreements with states whereby state employees are used to conduct federal
inspections, and passed products carry the federal mark of inspection. Established by the
2 See page 17 for a discussion of the new state inspection option authorized by the 2008 farm bill.
Talmadge-Aiken Act of 1962 (7 U.S.C. 450), the arrangement was intended to achieve federal
coverage in remote locations to offset the higher cost of assigning federal inspectors there.
FSIS conducts evaluations of foreign meat safety programs and visits establishments to determine
that they are providing a level of safety equivalent to that of U.S. safeguards. No foreign plant can
ship meat or poultry to the United States unless its country has received such an FSIS
determination. Once they reach U.S. ports of entry, meat and poultry import shipments must first
clear Department of Homeland Security (DHS) inspection to assure that only shipments from
countries free of certain animal and human disease hazards are allowed entry. This function was
transferred to DHS from USDA’s Animal and Plant Health Inspection Service (APHIS) when
DHS was established by the Homeland Security Act of 2002 (P.L. 107-296). After DHS
inspection, imported meat and poultry shipments go to one of approximately 150 nearby FSIS 3
inspection facilities for final clearance into interstate commerce.
Large recent recalls of meat and poultry products, often due to microbiological contamination,
have brought closer attention to USDA’s and industry’s record in detecting harmful pathogens and
preventing them from reaching consumers and making them sick. Although government officials
had asserted that the number of both recalls and illnesses had declined over the long term, illness 4
data from the past several years appear to indicate that this overall decline has not continued.
Twenty recalls tied to E. coli O157:H7 in 2007 were more than in any year since the early 2000s.
The largest in 2007 was of nearly 22 million pounds of frozen ground beef products in September
(see below). This recall and others have caused some in Congress to question not only the
effectiveness of USDA’s pathogen prevention programs but also its recall policies. (The record
In the early 1990s, 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 began to add testing for
pathogenic bacteria on various species and products to its inspection system.
3 As of July 2008, meat or poultry products from 33 countries were eligible for import. An August 2008 audit report by
USDA’s Office of Inspector General made a number of recommendations for improving oversight of imports,
including on the methodology for selecting foreign establishments for review and on production reinspections at the
border. Followup Review of Food and Safety Inspection Service’s Controls Over Imported Meat and Poultry Products,
at http://www.usda.gov/oig/webdocs/24601-08-Hy.pdf. See also CRS Report RL34198, U.S. Food and Agricultural
Imports: Safeguards and Selected Issues, by Geoffrey S. Becker.
4 See for example Richard Raymond, Under Secretary of Food Safety, comments at an October 23, 2007, news
conference regarding recent USDA actions on E. coli O157:H7. Some discussion of the more recent data is contained
in the sections of this CRS report on selected pathogens.
In 1995, under existing statutes, FSIS published a proposed rule to systematize these program
changes in a mandatory program called the Hazard Analysis and Critical Control Point (HACCP)
system. In this system, firms must analyze risks in each phase of production, identifying and then
monitoring “critical control points” for preventing such hazards, with corrective actions taken
when necessary. Record keeping and verification are used to ensure that the system is working.
FSIS published the final rule on July 25, 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 5
The U.S. Centers for Disease Control and Prevention (CDC) has noted that poultry is an
important source of human Salmonella infections. It also occasionally has been found in beef.
According to CDC reports, the overall incidence of Salmonella infections through all types of 6
food has not decreased significantly. CDC also reported that Salmonella has been the most
common foodborne pathogen, although exposure to animals also is an important nonfood source.
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. However, a federal court ruled in 2000 that the meat and
poultry inspection statutes do not give USDA the authority to use Salmonella standards as the
basis for withdrawing inspection from a plant that has not met them. An appeals court upheld this
decision in 2001. Subsequently, USDA has adopted the position that the court decision did not
affect the agency’s ability to use the standards as part of the verification of plants’ sanitation and
Nonetheless, the appeals court ruling supports 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 and a number of other meat and poultry
products. 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 amending the meat and poultry inspection statutes to expressly require
FSIS had reported its concern about increases in Salmonella rates observed over a three-year
period (2003-2005) among the three poultry product categories, broiler carcasses, ground
chicken, and ground turkey. To address the problem, in early 2006 the agency launched an
initiative to reduce the pathogen in raw meat and poultry products, including the concentration of
more inspection resources at establishments with higher levels, and quarterly rather than annual
reporting of Salmonella test results. Sampling frequency was to be based on a combination of 7
factors such as a plant’s regulatory history and its incidence of the pathogen.
5 The final rule appeared in 61 Federal Register 38805-38855.
6 CDC, “Preliminary FoodNet Data on the Incidence of Infection with Pathogens Transmitted Commonly Through
Food—10 States, 2006,” Morbidity and Mortality Weekly Report, April 13, 2007; and “ ... —10 States,
2007,”Morbidity and Mortality Weekly Report, April 11, 2008.
7 Food Chemical News, July 3, 2006. A notice and request for comments on this initiative were published in the
February 27, 2006, Federal Register.
Scientific Advice on Performance Standards
National Advisory Committee on Microbiological Criteria for Foods. The committee, established in 1988 to
provide scientific advice to the Secretaries of Agriculture and of Health and Human Services on public health issues,
concluded in a report issued in October 2002 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 at
Institute of Medicine-NRC. A second review of microbiological performance standards, Scientific Criteria to Ensure
Safe Food, was released in 2003 by the Institute in collaboration with the National Research Council (NRC). Among
many recommendations, this 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 Institute report also makes specific recommendations for FSIS to improve meat and poultry safety, including (1)
to conduct surveys to evaluate changes over time in the microbiological status of certain components of processed
meats and poultry; (2) to 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; and (3) to greatly expand generic E. coli criteria, and Salmonella performance standards, for beef trim
intended for grinding. (This report may be accessed at http://www.nap.edu/catalog/10690.html.)
FSIS on January 28, 2008 issued a notice on new policies and procedures for Salmonella 8
sampling and testing. One change has been to post on its website sampling test results from
establishments, with their names and locations—beginning with young chicken slaughter
establishments—that have substandard or variable records in meeting Salmonella performance
standards. The agency stated that it was taking this unprecedented action in part because at least
The FSIS performance standard for Salmonella in young chickens is 20%, i.e., 12 positive
samples out of 51 taken. Tested plants are placed in one of three categories, as follows:
Category 1 establishments have results from their two most recent completed sample sets
that are at or below half of the standard (i.e., at or below 10%);
Category 2 establishments have results from their most recent completed sample set that are
higher than half of the standard but do not exceed the standard (i.e., above 10% but below
Category 3 establishments have results from their most recent completed sample set that
exceed the standard (i.e., above 20%).
Twenty-one category 2 or category 3 plants, out of 195 tested, were named in the first report,
accessed in April 2008. In the agency’s June 2008 posting, a total of 17 plants—15 in category 2
and two in category 3—were listed. In the September 2008 posting, 13 category 2 and no
category 3 plants were posted. The December 2008 report showed 15 establishments in category 9
8 73 Federal Register pp. 4767-4774.
9 The testing results are posted monthly. A description of the testing and the most recent results can be accessed at
http://www.fsis.usda.gov/science/Salmonella_Verification_Testing_Program/index.asp. Another description of, and
more critical look at, the Salmonella testing program is in More Foul Fowl: An Updated Analysis of Salmonella
Another recent change is a “Salmonella Initiative Program,” under which poultry slaughter plants
with relatively low Salmonella positives could effectively increase line speeds—i.e., process their
chickens faster—in exchange for providing more microbial data to help study the links between
FSIS-regulated products and human illness.
CDC noted that “E. coli O157:H7 is one of hundreds of strains of the bacterium Escherichia coli.
Although most strains are harmless and live in the intestines of healthy humans and animals, this
strain produces a powerful toxin and can cause severe illness. E. coli O157:H7 was first
recognized as a cause of illness in 1982 during an outbreak of severe bloody diarrhea; the
outbreak was traced to contaminated hamburgers. Since then, most infections have come from
eating undercooked ground beef.” CDC also noted that “... people have also become ill from
eating contaminated bean sprouts or fresh leafy vegetables such as lettuce and spinach. Person-to-
person contact in families and child care centers is also a known mode of transmission. In
addition, infection can occur after drinking raw milk and after swimming in or drinking sewage-10
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 tens of thousands of samples since the program
began; to date, hundreds of samples have tested positive.
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 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. FSIS inspectors are to 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 announced
guidelines for grinding plants advising them to increase the level of pathogen testing by plant 11
employees, and to avoid mixing products from different suppliers.
Contamination in Broiler Chickens, March 2008, by the advocacy group Food and Water Watch. It was accessed in
July 2008 at http://www.foodandwaterwatch.org/food/pubs/reports/more-foul-fowl.
10 Background information on this pathogen may be viewed at the following CDC website: http://www.cdc.gov/nczved/
11 67 Federal Register 62325.
On September 25, 2007, USDA announced that Topps Meat Company, LLC, an Elizabeth, N.J., establishment, was
voluntarily recalling approximately 331,582 pounds of frozen ground beef products because they might be
contaminated with E. coli O157:H7. On September 29, the recall was expanded to 21.7 million pounds, making it one
of the largest in history. By October 6, the Centers for Disease Control (CDC) had cited 32 illnesses apparently
related to the recall.
According to trade press reports, the initial (September 25) recall covered three days of ground beef production (on
June 22, July 12, and July 23, 2007). The expansion to 21.7 million pounds covered one year of production (back to
September 25, 2006), because the plant was carrying over each day’s production to the next, rather than processing
the ground meat in separate batches, which would create a clean break in production, as industry experts have 12
stressed should be done. In addition, the plant had not followed its own HACCP plan, according to the reports.
More specifically, for example, reports indicated that the plant appeared to be grinding meat that did not carry the
necessary documentation showing that it had been tested by the supplier for contamination. At the same time, the
USDA inspector who visited the plant daily (but was not there continuously) reportedly did not uncover the problem,
either. The plant has since ceased operations.
By early November 2007, the Topps recall was linked to beef trim supplied by an Alberta, Canada, packer, Ranchers
Beef Ltd.,13 which had closed in August 2007. On November 9, 2007, FSIS began to hold Canadian beef products at
the border until they could be tested for E. coli; by December 2007 it had eased this policy but continued heightened
testing of these products destined for ground beef.
FSIS reported that, of an average of nearly 10,000 ground beef samples tested annually in 2004,
2005, and 2006, a total of 43 (less than 0.2%) tested positive for E. coli O157:H7, part of a
significant decline in the percentage of positive samples since 2000, when it was 0.86%. FSIS
asserted that the reduction reflected the success of its HACCP-based and related regulatory
policies. However, increases were recorded in 2007, when 29 or 0.24% of 12,200 ground beef
samples tested positive, and in 2008, when 54 or 0.47% of 11,535 were positive.
By June 2007, after FSIS had identified an increased number of positive E. coli O157:H7 beef
samples, along with a larger number of recalls and illnesses linked to the pathogen than in recent
years, it increased the number of tests on ground beef by more than 75%, the agency stated. It
also began or accelerated implementation of several other E. coli prevention initiatives that had
been under development. Among the actions it cited in October 2007 were the testing (starting in
March 2007) of beef trim, which is used in ground beef; requiring beef plants to verify that they
are effectively controlling E. coli O157:H7 during slaughter and processing; directing its
inspectors to use a new checklist to review establishment control procedures; beginning testing
other types of materials used in ground beef in addition to beef trim and requiring importing
countries to conduct equivalent sampling; better targeting its routine E. coli testing; and working 14
to speed up recalls.
Nonetheless, as noted, E. coli positives climbed in 2008. As the year was ending, FSIS and other
food safety experts were speculating as to whether the increase was due to a higher prevalence of
12 See for example, Cattle Buyers Weekly, October 8, 2007; Feedstuffs, October 8, 2007.
13 Source: Cattle Buyers Weekly, various 2007 issues.
14 USDA, FSIS. “FSIS Takes Aggressive Actions To Combat E. coli O157:H7,” October 23, 2007, at
http://www.fsis.usda.gov/News_&_Events/NR_102307_01/index.asp. FSIS has published an August 2008 report on its
findings in Results of Checklist and Reassessment of Control for Escherichia coli O157:H7 in Beef Operations, at
the bacteria, or simply to the fact that the agency had changed its testing method earlier in the 15
year. It is possible, for example, that the new method is more sensitive to the presence of E. coli.
The CDC foodborne illness reports for 2006 and 2007 indicated that the incidence of all
foodborne infections caused by E. coli O157:H7 had declined significantly from the 1996-1998
baseline through 2004, but not since then. The CDC reported that it did not know why reductions
had not been maintained, but it did point out that the 2006 outbreaks caused by contaminated
spinach and lettuce highlighted the need for more effective prevention. The earlier CDC report
(on 2006) stated that the frequency of E. coli O157:H7 in ground beef samples taken in 2005 and 16
2006 had remained about the same as in 2004. The report on 2007 concluded that “additional
efforts are needed” to control the pathogen in cattle “and to prevent its spread to other food 17
animals and food products, such as produce.”
During calendar 2006, FSIS announced eight recalls due to E. coli O157:H7 contamination,
mostly of ground beef products, and none were related to human illness. In 2005, the agency
announced five recalls. In 2007 FSIS announced 20 recalls, totaling more than 33 million pounds,
mostly ground beef products, due to E. coli concerns. At least nine of the 2007 recalls were
related to human illnesses (the rest came about after routine testing). Although many of the recalls
were relatively small, a June recall involved nearly 6 million pounds of beef, and the Topps recall 18
In 2008, 17 E. coli-related recalls were listed on the FSIS website. The largest was by Nebraska
Beef, of Omaha, of approximately 5.3 million pounds of beef manufacturing trimmings and other
products intended for use in raw ground beef produced between May 16 and June 26. Nebraska
Beef was involved in another large recall, of 1.36 million pounds of primal cuts, subprimal cuts,
and boxed beef, produced on June 24 and on July 8, 2008. Dozens of illnesses were linked to
products in the two Nebraska Beef recalls. Nebraska-processed products sold under the Coleman 19
Natural Beef brand were also recalled by the Whole Foods Market chain.
In February 2001, FSIS published a proposed rule to set 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 foods (e.g., cold cuts and hot dogs). The proposal covered over
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
has been a major reason for meat and poultry product recalls.
The proposed rule raised controversy among 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
15 “Explanation to higher number of E. coli positives may be in broth,” Food Chemical News, October 20, 2008.
16 Morbidity and Mortality Weekly Report, April 13, 2007.
17 Morbidity and Mortality Weekly Report, April 11, 2008.
18 Some information is from the October 23, 2007, Raymond press conference. Recall updates are at the FSIS website,
19 “Nebraska Beef E. coli recall gets a sequel,” Food Chemical News, August 18, 2008.
categories of foods too broadly and heavily, while not covering some other high-risk foods at all
(such as milk, which is under FDA jurisdiction). Consumer groups said the proposed rule would
not require enough testing in small processing plants and that products not tested for Lm should
not be labeled “ready-to-eat” because they would still require cooking to be 100% safe.
Interest in the Listeria issue had grown in 1998 and 1999, following reports of foodborne 20
illnesses and deaths linked to ready-to-eat meats produced by a Sara Lee subsidiary. Interest
increased significantly after October 2002, when Pilgrim’s Pride Corporation recalled a record-
breaking 27.5 million pounds of poultry lunch meats for possible Lm contamination after a July
2002 outbreak of listeriosis in New England. CDC confirmed 46 cases of the disease, with 7
deaths and 3 stillbirths or miscarriages. The recall covered products made as early 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 21
specific instructions for monitoring processing plants that produce hot dogs and deli meats. In
June 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. The rule directs FSIS inspectors to conduct random tests to verify
establishments’ programs. Plants are subject to different degrees of FSIS verification testing 22
depending upon what type of control steps they adopt in their HACCP and sanitation plans.
On January 4, 2005, the Consumer Federation of America (CFA) issued a report sharply
criticizing USDA’s Listeria rulemaking. CFA asserted that the Department essentially adopted
meat industry positions in weakening the final rule, such as by deleting proposed plant testing
requirements and by not explicitly requiring that HACCP plans include Listeria controls. In 2003, 23
Listeria illnesses increased by 22%, CFA contended, citing CDC data.
USDA and meat industry officials countered that the number of product recalls related to Listeria
had declined from 40 in 2002 to 14 in 2003, that the rise in Listeriosis cases was quite small in
2003 after four years of declines, and that the interim rule provides more incentives for plants to
improve safety. The CDC’s 2006 and 2007 FoodNet reports indicated that the incidence of
foodborne illness caused by Listeria, which had reached its lowest level in 2002 compared with a 24
Recalls of FSIS-regulated products continue. In 2005, the largest was a December 2005 recall of
2.8 million pounds of various bologna, ham, and turkey lunchmeat products by ConAgra. Another
28 Listeria-related recalls were announced during 2005, involving approximately 649,000 pounds
of processed meat and poultry products, according to the agency’s website. The website had
posted six Listeria recalls in 2006 and another 11 in 2007, including, in January and February
20 Source: Food Chemical News, various issues.
21 The guidelines can be found on the FSIS website at http://www.fsis.usda.gov.
22 See the FSIS website for more details on the rule.
23 CFA website: http://www.consumerfed.org/.
24 Morbidity and Mortality Weekly Report, April 13, 2007, and April 11, 2008.
2007, 2.8 million pounds of Oscar Mayer/Louis Rich chicken breast cuts and strips.25 Fifteen
Listeria-related recalls were posted in 2008.
Congress in 2007 ordered a halt to FSIS’s work on what the agency was calling a more robust
“risk-based inspection system” (RBIS), aimed at enabling the agency to rebalance existing 26
inspection resources. The objective of this initiative was “to improve public health by placing
greater inspection and verification emphasis on federally inspected meat and poultry
establishments that pose greater risks. In a more robust RBIS, each establishment’s risk could be 27
categorized, and the type and intensity of inspection could be based primarily on that risk.”
More specifically, the initiative was to enable FSIS to shift some processing inspection resources
from lower-risk products and plants to relatively higher-risk products (for example, ground
poultry), and to plants with relatively poor safety records. USDA in February 2007 had
announced a timetable for introducing RBIS, beginning in April 2007 at 30 locations representing
about 254 processing (but not yet slaughter) establishments. About a fourth of these plants would
come under closer scrutiny, about a fourth less scrutiny, and about half would receive
approximately the same level of attention as currently, a USDA official said. He added that all
plants will still be under “daily inspection,” and full-time employees would not be reduced under 28
Public comments to FSIS on RBIS, and hearings by a House appropriations subcommittee,
indicated that many agreed in concept with risk-based inspection but were concerned that the
agency had provided too few specifics on how it would be implemented, lacked the data it needed
to implement it, and should consider doing it through formal rulemaking. A few warned that it
could undermine rather than strengthen safety oversight, and wondered whether the agency has 29
the statutory authority to change inspection frequency.
Several interest groups reiterated their concerns following the earlier, February 22, 2007, USDA
announcement. The American Meat Institute, representing major meat packers, said in a
statement that it was concerned that the “hasty launch” of the initiative could jeopardize
consumer confidence in meat and poultry, and that details of exactly how the program would
work still were unclear. Several consumer groups questioned the validity of the data that USDA 30
was using to rank product risk and plant performance FY2009.
25 FSIS recall website: http://www.fsis.usda.gov/FSIS_Recalls/index.asp.
26 See “In Congress” later in this section of the report.
27 “Measuring Establishment Risk Control for Risk-based Inspection,” paper for May 23-24, 2006, meeting of the
National Advisory Committee on Meat and Poultry Inspection. Information on the meeting (and on other committee
meetings) is posted at http://www.fsis.usda.gov/regulations_&_policies/
28 Comments by Dr. Richard Raymond, USDA Under Secretary for Food Safety, February 22, 2007, press
29 Risk-based inspection comments posted by FSIS, Food Chemical News, November 27, 2006; also, Agriculture,
Rural Development, Food and Drug Administration, and Related Agencies Appropriations for 2007, hearings before a thnd
Subcommittee of the Committee on Appropriations, U.S. House of Representatives, 109 Congress, 2 session.
30 Sources: various statements as reported in Food Chemical News, February 26, 2007, and April 23, 2007.
The Department’s Office of Inspector General (OIG) conducted an audit of FSIS’s work on RBIS,
issuing its report in December 2007. Among other findings, the OIG questioned whether the
agency had the systems in place “to provide reasonable assurance that risk can be timely or fully
assessed, especially since FSIS lacks current, comprehensive assessments of establishments’ food 31
safety systems.” OIG reported that FSIS lacks adequate management control processes or an
integrated IT (computer) system to support a program, and the agency had not resolved all of the
prior recommendations that OIG said were most critical to successful development of risk-based
inspection. The OIG report offered 35 new recommendations around such matters as improving
the use of food safety assessment-related data; determining how assessment results will be used to
estimate risk; and providing clearer documentation and written procedures and guidance for all
The OIG report was the major item discussed at the February 5-6, 2008, meeting of the National
Advisory Committee on Meat and Poultry Inspection. FSIS said it has been retooling RBIS—
which it now calls a “Public Health Based Inspection System” (PHBIS)—to address the OIG
recommendations and those of public commenters. FSIS issued a report outlining the elements of 32
and scientific basis for the evolving PHBIS on April 2008. The agency has been implementing
the OIG recommendations; it also has asked the National Academy of Sciences to evaluate the
data and methodology underlying its PHBIS initiative.
In the 110th Congress, provisions in several appropriations measures (including P.L. 110-28 and
P.L. 110-161, Division A) had directed USDA not to implement its risk-based inspection system
anywhere until the OIG evaluated the data supporting the system, and the FSIS resolved any
issues raised in the evaluation. A number of other bills were offered that contained provisions
clarifying the Secretary’s authority to set enforceable performance standards. New bills could th
emerge in the 111 Congress.
Currently, the Agriculture 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. The GAO has
criticized agencies’ efforts to ensure that companies carry out recalls quickly and efficiently,
particularly of products that may carry severe risk of illness. A 2004 GAO report concluded that
the agencies do not know how well companies are carrying out recalls and are ineffectively
tracking them. As a result, most recalled items are not recovered and thus may be consumed, 33
31 USDA, OIG, Issues Impacting the Development of Risk-Based Inspection at Meat and Poultry Processing
Establishments (Report. No. 24601-07-Hy).
32 The report, Public Health Risk-Based Inspection System for Processing and Slaughter, along with other materials
from the February meeting, are posted on an agency’s web page: http://www.fsis.usda.gov/regulations_&_policies/
33 Food Safety: USDA and FDA Need to Better Ensure Prompt and Complete Recalls of Potentially Unsafe Food,
At past hearings, consumer 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 asserted 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—and more rapid—action against “bad actors,”or those
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 voluntary
recalls moved too slowly or were 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. Furthermore, they say, new
enforcement powers would increase the potential for plants to suffer drastic financial losses from
suspected contamination incidents that could ultimately be proven false. Some observers argue
that much still needs to be done to educate consumers and restaurateurs about safe meat and
poultry handling and cooking practices.
In August 2004, the consumer group Center for Science in the Public Interest (CSPI) began a
national campaign to urge USDA to publicize the names of retail outlets where recalled meat has
been distributed, so that consumers can learn more quickly whether they have purchased
potentially contaminated products. USDA and industry leaders have contended that distribution
records are proprietary, and exempt from provisions of the Federal Freedom of Information Act;
such information, they argue, should be limited mainly to public officials so that they can monitor
recalls. However, in the March 7, 2006, Federal Register, FSIS proposed posting on its website
the names of retailers who have products subject to a voluntary recall. FSIS announced on July
involved in the potentially most serious (Class I) recalls only.
Reviewing FSIS protocols for handling recalls following the Topps case (see page 9), USDA’s
OIG concluded that while the agency has improved its investigative and recall procedures, it still
needed “a science-based sampling protocol to collect and analyze a representative sample of 35
product at an establishment to conclude whether contamination occurred there.”
Provisions of the Food and Drug Administration Amendments Act of 2007 (H.R. 3580; P.L. 110-
85) require the Secretary of HHS both to establish a food registry for the reporting of food
adulteration, and to encourage more coordination and communication when recalls occur, but it
GAO-05-51. Also see CRS Report RL34313, The USDA’s Authority to Recall Meat and Poultry Products, by Cynthia
Brougher and Geoffrey S. Becker.
34 “USDA Will List Retail Stores Receiving Recalled Meat and Poultry Products,” July 11, 2008 press release.
35 Food Safety and Inspection Service Recall Procedures for Adulterated or Contaminated Product, August 2008, at
applies to FDA-regulated foods. In the Senate but not the House version of the omnibus farm bill
(H.R. 2419) was a requirement that USDA establish similar “reportable food registries” for meat
and poultry and their products. The final conference substitute, enacted as P.L. 110-246, amends
the meat and poultry laws to require an establishment to notify USDA if it has reason to believe
that an adulterated or misbranded product has entered commerce. Another conference provision
requires meat and poultry establishments to prepare and maintain written recall plans.
Several other bills to authorize mandatory recalls for meat and poultry products were introduced th
but not enacted in the 110 Congress. Among other bills containing various provisions for
mandatory recall authority and/or notification requirements were H.R. 5762, H.R. 2108/S. 1274,
H.R. 3484, H.R. 3610, H.R. 3624, S. 2081, H.R. 1148/S. 654, and S. 2952.
Recalls imply the ability to quickly trace the movement of products. On September 30, 2003,
USDA’s OIG released an audit report on a 2002 meat recall by Con Agra. The report recommends
“that FSIS reassess its management control process over ... recall operations ... by ensuring that
ground beef is traceable from manufacturing to point-of-sale and that adequate production records
are maintained to facilitate traceback.”
Some argue that improved traceability capabilities would have enabled USDA to determine the
whereabouts of all related cattle of potential interest in the three U.S. case of BSE (bovine
spongiform encephalopathy, or “mad cow disease”). The traceability issue has also been debated
in connection with protecting against agroterrorism; verifying the U.S. origin of live cattle and
meat products for export; and facilitating 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. The U.S. meat industry argued in the past that such a
system would not be based on sound science, and would be technically unworkable. However,
since the domestic BSE case, the industry, USDA, and other professionals have been attempting
to implement a universal, although not mandatory, national animal ID (but not meat traceability)
system, focused on animal disease control rather than food safety per se. However, progress has
been slow; see the discussion of the National Animal Identification System (NAIS) later in this
section. Some Members of Congress are among those who believe the programs should be
mandatory in order to achieve universal participation. Among other issues are cost, need for a
mandatory rather than voluntary system, potential producer liability, and privacy of records.
Animal ID proposals were offered but not enacted in the 110th Congress. For example, H.R. 1018
would have prohibited the establishment of a mandatory ID system. H.R. 2301 would have
created a livestock identification board with members from industry to oversee a national
program. S. 1292 and H.R. 3485, separate bills, were broader traceability proposals. S. 1292
would have required the Secretary of Agriculture to establish a traceability system for all stages
of production, processing, and marketing of meat and poultry, and would have required animal
producers and meat and poultry processors to maintain records sufficient to enable the Secretary
to trace a product forward to the consumer or backward to where the animal originated. H.R.
Both the House and Senate committee reports to accompany USDA’s FY2008 appropriation
(H.Rept. 110-258; S.Rept. 110-134) had questioned USDA’s progress and direction in
implementing NAIS. Over several years through FY2007, about $117.8 million had gone into the
development of such a program. Despite this effort, “the direction of this system remains
unclear,” noted the report on the Senate appropriations bill, which would have designated $17.4
million in additional funds for NAIS. The House committee report noted that its version would
have provided no new funding, and requested that USDA provide “a complete and detailed
strategic plan for the program, including tangible outcomes, measurable goals, specific
milestones, and necessary resources for the entire program.” The final FY2008 appropriation for
USDA—contained in Division A of the Consolidated Appropriations Act, 2008 (P.L. 110-161)—
provided $9.75 million to continue NAIS implementation. Appropriators stated that a USDA
business plan for the program, issued late in 2007, did not provide sufficient information or
justification to grant the entire $33.2 million requested for the year.
Elsewhere, a provision in the Senate-passed farm bill (H.R. 2419) approved in December 2007
would have required USDA to issue regulations addressing “the protection of trade secrets and
other proprietary and/or confidential business information that farmers and ranchers disclose in
the course of participation” in an ID system. The provision was removed during the House-Senate
conference prior to final passage.
From time to time in the past, FSIS has had difficulty in sufficiently staffing its service
obligations to the meat and poultry industries. Usually a combination of factors causes these
shortages, including new technologies that increase plant production speeds and volume,
insufficient appropriated funds to hire additional inspectors at times of unexpected increases in
demand for inspections, and problems in finding qualified people to work in dangerous or
unpleasant environments or at remote locations. These staffing problems were complicated
somewhat by the addition of HACCP requirements on top of the traditional inspection duties.
To ease funding pressures, most administrations over the past 20 years have proposed to charge
the meat-packing industry new user fees sufficient to cover the entire cost, or at least a portion, of
federal inspection services. (FSIS has been authorized since 1919 to charge user fees for holiday
and overtime inspections, and does so). The primary rationale for more extensive 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
one cent per pound. Meat industry and consumer groups have consistently opposed increased
fees, arguing that food safety is a public health concern that merits taxpayer support.
As part of its FY2009 budget submitted to Congress in February 2008, the Bush Administration
again had asked for new user fees. Its FY2009 proposal would raise $92 million by collecting
licensing fees from meat and poultry establishments, and another $4 million by charging plants
that require additional inspections due to performance failures. These fees also were proposed,
unsuccessfully, with the Administration’s FY2008 budget.
FSIS inspection costs are mainly funded through USDA’s annual appropriation. For FY2008, the
Senate-reported bill had recommended $930.6 million for FSIS, or $38.5 million above the
FY2007 level. The House-passed bill and the final version (Division A of P.L. 110-161) provided
$930.1 million in appropriations for FSIS for FY2008, the same as the Administration’s request.
The congressional appropriation was to be supplemented in FY2008 by an estimated $141 million
in existing user fees.
The Administration’s FY2009 budget proposal recommended $952 million in new appropriations
for FSIS, to be supplemented by about $140 million in existing user fees (i.e., not counting the
proposed $96 million in new fees described above). This would bring the FSIS program level to th
approximately $1.1 billion in FY2009. The 110 Congress did not complete action on the
agriculture appropriation measure for the full year. As noted earlier, FSIS and other USDA
agencies were operating under a continuing resolution (P.L. 110-329) through March 6, 2009.
As noted, current federal law long prohibited state-inspected meat and poultry plants from
shipping their products across state lines, a ban that many states and small plants have wanted to
overturn. Limiting state-inspected products to intrastate commerce is unfair, these states and
plants argued, because their programs must be, and are, “at least equal” to the federal system.
While state-inspected plants could not ship interstate, foreign plants operating under USDA-
approved foreign programs, which must be “equivalent” to the U.S. program, have been
permitted to export meat and poultry products into and sell them anywhere in the United States.
Those who have opposed state-inspected products in interstate commerce argued that state
programs have not been required to have the same level of safety oversight as the federal, or even
the foreign, plants. For example, foreign-processed products are subject to U.S. import
reinspection at ports of entry. The opponents of interstate shipment note that a recent FSIS review,
which had found all 28 state programs to be at least equal to the U.S. program, was based largely 36
“At Least Equal to” vs. “Equivalence”
According to FSIS, “at least equal to” means “that the food safety and other consumer protection measures effected
by a State program address the same issues addressed by the Federal (FSIS) program, and the results of the State’s
approach are to be at least as effective as those of the Federal program. The State program need not take exactly the
same action as the Federal program” (FSIS Directive 5720.2, Revision 3, November 16, 2004).
“Equivalence” is a somewhat different concept. “Meat and poultry products exported from another nation must meet
all safety standards applied to foods produced in the United States. However, under international law, food regulatory
systems in exporting countries may employ sanitary measures that differ from those applied domestically by the
importing country. The United States makes determinations of equivalence by evaluating whether foreign food
regulatory systems attain the appropriate level of protection provided by our domestic system. Thus, while foreign
food regulatory systems need not be identical to the U.S. system, they must employ equivalent sanitary measures that
provide the same level of protection against food hazards as is achieved domestically” (FSIS, “Equivalence Process,” at
36 The FSIS Review of State Programs: Summary Report (January 2007) was accessed on April 27, 2007, at
http://www.fsis.usda.gov/PDF/Review_of_State_Programs.pdf. Later in 2007, New Mexico turned its inspection
activities over to FSIS.
In the 110th Congress, Section 11015 of the enacted farm bill (P.L. 110-246) amends the FMIA
and the PPIA to authorize a new opt-in program for state-inspected plants. This program is to
supplement rather than replace the existing federal-state cooperative inspection program. In states
that choose to participate, a federally employed coordinator would supervise state employees in
plants that want to ship across state lines. Eligible plants are limited to those with 25 or fewer
employees—except that plants with between 25 and 35 employees can apply for coverage within
the first three years of enactment. The law sets federal reimbursement for state costs under the
new program at 60%; the current federal-state cooperative inspection program provides
reimbursement at 50% of costs. Products inspected under the new program are to carry the federal
mark of inspection. Other provisions prohibit federally inspected establishments from
participation, establish a new technical assistance division to assist the states, and require periodic
audits by USDA, among other things.
The new program, which reflects language in the Senate version of the farm bill, reportedly was
developed as a compromise by those on both sides of the issue. It appears to be based in concept
on the Talmadge-Aiken program (see page 4). Some proponents of ending the interstate ban on
state-inspected meat have contended that the new language is overly restrictive, while those who
support the change have countered that it provides appropriate safeguards. The farm bill requires
final rules to implement the new state program by December 2009.
U.S. food safety oversight, while concentrated in FSIS and FDA, is spread among 15 agencies
operating under a variety of statutes. This complex system is supplemented by many state food
safety programs. GAO, which has looked at the matter several times, noted in one report that the
federal food safety system “emerged piecemeal, over many decades, typically in response to
particular health threats or economic crises. The result is a fragmented legal and organizational
structure that gives responsibility for specific food commodities to different agencies and 37
provides them with significantly different authorities to enforce food safety laws.”
In its January 2007 annual report, GAO newly designated food safety oversight as one of 29
“high risk” federal program areas. The report, among other things, recommended that “Congress
consider a fundamental reexamination of the system and other improvements to help ensure the
rapid detection of and response to any accidental or deliberate contamination of food before 38
public health and safety is compromised.” Besides GAO, the National Academy of Sciences and
the National Commission on the Public Service have studied the issue and recommended options 39
37 Food Safety: Experiences of Seven Countries in Consolidating Their Food Safety Systems, GAO-05-212, February
38 High Risk Series: An Update (GAO-07-310), January 2007.
39 See National Research Council, Institute of Medicine, Ensuring Safe Food From Production to Consumption,
Washington, DC, National Academy Press, 1998; and National Commission on the Public Service, Urgent Business st
For America: Revitalizing the Federal Government for the 21 Century, Washington, DC, 2003.
In the 110th Congress, “single food agency” bills were introduced in February 2007, as H.R. 1148
by Representative DeLauro and S. 654 by Senator Durbin. The measures would have combined
federal food safety programs, including meat and poultry inspection, under a new, independent
Food Safety Administration, to be headed by an Administrator appointed by the President and
confirmed by the Senate. The new Administrator would have been required to conduct a
comprehensive analysis of food safety hazards and to adopt and implement a national program
that among other things requires registration of all domestic and foreign food establishments
doing business in the United States. The bills would have required the formulation of food safety
performance standards, set out inspection procedures for establishments, provided for research 40
and education programs, and included enforcement and penalty provisions.
The omnibus farm bill (H.R. 2419) that cleared the Senate included a provision establishing a
bipartisan congressional food safety commission to study the federal food safety system and
recommend needed changes. Another provision in the same measure would have required the
President to consider these changes and report to Congress on legislation needed to effect them.
The provision was removed by farm bill conferees.
Interest in reorganizing the agencies and/or enhancing their resources and authorities, particularly
those of FDA, was the topic of numerous 2007 and 2008 congressional hearings, including
hearings before Representative DeLauro’s House Appropriations subcommittee and several
subcommittees of the House Energy and Commerce Committee. Panels on both sides of Congress
held hearings on the safety of imported food products, including meat and poultry, where agency
organization and resources were at issue as well.
If, as is possible, lawmakers in the 111th Congress are asked to consider new proposals that would
either reorganize or consolidate the federal food safety organization, a range of policy options are
likely to be debated, including whether the current regulatory approaches and their authorizing
statutes remain appropriate, given the diversity of food types, health risks, methods of production,
and sources of supply; the continuously evolving science on foodborne illness and how to prevent
future outbreaks; the impacts on industry competitiveness, particularly in a global economy; and
funding constraints. Another uncertainty is whether food safety reform efforts would be limited to
FDA authorities and programs alone, or would be extended further to those of FSIS (and other
agencies). One factor mitigating against the latter approach is that jurisdiction over FDA and
FSIS is split between separate committees in both the House and Senate.
Nearly 105,000 horses were slaughtered in the United States in 2006 for human food, mainly for
European and Asian consumers. Such slaughter was conducted under federal inspection at two
foreign-owned plants in Texas and another foreign-owned plant in Illinois. Debate has focused on
the acceptability of using horses for human food, and the costs of long-term care for such horses
(or of disposing of their carcasses) if they no longer went for human food.
40 A more recent bill (H.R. 7143) introduced by Representative DeLauro on September 26, 2008, also seeks to
reorganize food safety, but it focuses on elevating the food safety functions of FDA by creating a new agency within
the HHS Department.
Although legislation has been debated in Congress to curtail such slaughter (see below), the
plants’ activities became constrained in 2007 by the courts and state law. A federal lawsuit filed
by the owners of the two Texas slaughter plants, Beltex Corporation and Dallas Crown, Inc.,
sought to clarify that a Texas state law, first passed in 1949 to prevent the use of horsemeat for
human food, was not enforceable and that they should not be prosecuted. The U.S. District Court
for the Northern District of Texas in Fort Worth had earlier agreed with the plants’ owners that the
law had been repealed, was preempted by the FMIA, and violated the dormant Commerce Clause
of the U.S. Constitution. However, on January 19, 2007, a panel of the U.S. Court of Appeals for
the Fifth Circuit rejected all three arguments in the lower court’s ruling, declaring the Texas law
to be in force and clearing the way for the state attorney general to prosecute the plant owners if
they continued to operate. Elsewhere, the Illinois legislature passed a law banning horse slaughter
for food. The U.S. Court of Appeals for the Seventh Circuit by fall 2007 ruled against the
argument of the plant (owned by Cavel International) that the Illinois law violates the interstate
and foreign commerce clauses of the U.S. Constitution, bringing Cavel’s operations there to a
close. (The U.S. Supreme Court in 2008 declined to hear the case.)
The 109th Congress had debated whether to ban horse slaughter and (in the FY2006
appropriation) had banned the use of federal funds for ante-mortem inspection of horses at meat
processing plants. Although supporters of the ban had hoped that the lack of federal funds for
such inspection would force an end to horse slaughter, the practice continued, with the three
plants paying user fees for the federal service (until legal and state-level developments challenged th
the plants; see above). Also in the 109 Congress, the full House approved a bill (H.R. 503) to
ban horse slaughter, but no action occurred on a Senate version (S. 1915).
Bills in the 110th Congress to ban the movement or possession of horses for slaughter included
H.R. 503 and S. 311. The Senate Commerce, Science and Transportation Committee approved S.
of the U.S. Code to make it illegal to knowingly possess, ship, transport, purchase, sell, deliver, or
receive any horse, horseflesh, or carcass intended for human consumption. The Judiciary
Committee favorably reported H.R. 6598 on September 23, 2008, but it too was not enacted.
Meanwhile, the omnibus appropriation for FY2008 (P.L. 110-161, in Division A, Section 741)
had both continued the ban on using appropriated funds for inspecting horses and also prohibited
the USDA-FSIS rule that enabled the collection of user fees for such purposes. The continuing
resolution for FY2009 also appears to continue the ban. (See CRS Report RS21842, Horse
Slaughter Prevention Bills and Issues, by Geoffrey S. Becker.)
Through the end of 2008, 19 cases of BSE had been reported in North America. Sixteen of them
were cattle born in Canada, which reported its first native case in May 2003 (one earlier case was
imported from Great Britain) and its latest case in November 2008. The United States reported its
first case in December 2003 (one of the Canadian-born animals, imported into the United States).
The United States also found two additional cases, in U.S.-born cattle. The most recent U.S. case
was in late February 2006.
In epidemiological investigations of the three U.S. cases, the U.S. Department of Agriculture
(USDA) was unable to track down all related animals of interest, but those that were located
tested negative for the disease. Despite a beef recall, some meat from the first U.S. BSE cow may
have been consumed, USDA said, adding, however, that the highest-risk tissues never entered the
food supply. No materials from the other two U.S. cows entered the food supply, USDA also said.
In the recent Alabama case, authorities were unable to determine the cow’s herd of origin.
Animal health officials initially indicated that all of the North American cases were caused by the
consumption of BSE-contaminated feed. However, USDA reportedly now believes that the two
native-born U.S. cattle had “atypical” BSE, which differs from other cases. If these cases are
determined to be “spontaneous,” that may affect future control strategies.
FSIS is one of the three federal agencies primarily responsible for keeping BSE out of the food
supply. The other two agencies involved in BSE are USDA’s Animal and Plant Health Inspection
Service (APHIS), which handles primarily the animal disease aspects, and FDA, which regulates
feed ingredients. After the first U.S. BSE case, FSIS published, as interim final rules in the
January 12, 2004, Federal Register, several actions to bolster U.S. BSE protection systems,
• Downer (nonambulatory) cattle are no longer allowed into inspected slaughter
and processing facilities. (This interim final rule was published in the July 13,
• Cattle selected for testing cannot be marked as “inspected and passed” until
confirmation is received that they have tested negative for BSE.
• Specified risk materials (SRM), which include the skull, brain, trigeminal
ganglia, eyes, vertebral column, spinal column, and dorsal root ganglia of cattle
over 30 months of age, and the small intestine of cattle of all ages, are now
prohibited from the human food supply.
• Slaughter facilities are required to develop and implement procedures to remove,
segregate, and dispose of SRM and make information readily available for
review by FSIS inspection personnel.
• SRM from cattle 30 months or older cannot be in a product labeled as “meat” if
derived from advanced meat recovery (AMR) technology, which USDA said
would help ensure it does not contain spinal tissue.
• Mechanically separated meat may not be used for human food.
• Air injection stunning is banned, to ensure that portions of the animal brain are
not dislocated into the carcass.
The FSIS actions, which remain in effect, were in addition to other BSE regulatory safeguards
that have been in place for several years. These include import controls and ongoing BSE
surveillance through carcass testing by APHIS, and restrictions on the feeding of certain
mammalian proteins to cattle by FDA (see box on page 23).
Additional USDA actions in the wake of the December 2003 BSE discovery have included more
attention to implementing a nationwide animal identification program that would enable all cattle
and other animal movements to be traced within 48 hours in cases of animal disease (see prior
section on “Meat Traceability and Animal Identification”); and an intensive, one-time BSE testing
program for higher-risk cattle (since completed).
Humane Slaughter and the Hallmark/Westland Recall
On February 17, 2008, USDA announced that Hallmark/Westland Meat Packing Co. of California was voluntarily
recalling 143 million pounds of fresh and frozen beef products dating to February 1, 2006. About 50 million pounds
were distributed to the school lunch and several other federal nutrition programs in at least 45 states. This largest
U.S. meat recall ever came after USDA’s Food Safety and Inpection Service (FSIS) found that for at least two years the
facility had not always notified inspectors about cattle that had become nonambulatory after they had been inspected,
but before they were slaughtered for food. FSIS regulations explicitly prohibit most nonambulatory cattle in human
food, because of their higher risk of bovine spongiform encephalopathy (BSE, or “mad cow disease”).
FSIS also cited evidence that the plant had violated the Humane Methods of Slaughter Act (HMSA), which first came
to light after animal welfare advocates secretly videotaped what they described as employees inhumanely handling
downer cattle before slaughter. The HMSA stipulates, among other things, that “[n]o method of slaughtering or
handling in connection with slaughtering shall be deemed to comply with the public policy of the United States unless
it is humane.”
The recall was so-called Class II, indicating a remote possibility that consumption of the products could cause adverse
health effects. Nonetheless, FSIS suspended operations at the plant, which is not expected to reopen. The 110th
Congress held several hearings in which the effectiveness and USDA implementation of the HMSA, and its BSE rules,
were challenged. Bills to legislatively prohibit the slaughter of nonambulatory livestock for food included H.R. 661, S.
394, and S. 2770. They were not enacted. For additional details, see CRS Report RS22819, Nonambulatory Livestock
and the Humane Methods of Slaughter Act, by Geoffrey S. Becker.
Although BSE remains a priority for many Members of Congress, much of the recent interest has
focused on trade rather than food safety concerns. Japan and Korea, once among the four leading
export markets for U.S. beef, have taken years to begin accepting U.S. beef products. Exports to
Japan, which restarted in 2005, are still limited to products from younger cattle, and sales remain
below previous levels. Korean inspection procedures kept that market largely closed to the United
States through much of 2007 and again during early 2008.
An April 18, 2008, a new U.S.-Korea agreement was announced that was to lead to that country’s
opening to most U.S. beef in accordance with accepted international veterinary guidelines.
However, Korea first delayed implementation and then scaled back the types of products it would
accept, following vigorous anti-government protests that grew from this agreement’s
announcement. By July, and through the end of 2008, U.S. beef again was moving into Korea.
U.S. authorities have been hopeful that such positive developments could help to defuse the
frustration of many Members of Congress, some of whom had been expected to reintroduce
legislation calling for sanctions against trading partners that failed to accept assurances of U.S.
beef safety. U.S. access to Korea’s beef market has been an issue in the debate over
implementation of the U.S.-Korea free trade agreement (FTA). A number of Members signaled
that their support for legislation to implement the FTA was contingent on Korea fully opening its
market for U.S. beef. (See CRS Report RL34528, U.S.-South Korea Beef Dispute: Agreement and
Status, by Remy Jurenas and Mark E. Manyin.)
Also of concern to many Members has been USDA’s gradual reopening of the U.S. border to
more types Canadian cattle. Some Members are sympathetic to the arguments of certain cattle
organizations, primarily from the Upper Plains, that such cattle continue to pose a BSE threat. In th
the 110 Congress resolutions of disapproval (H.J.Res. 55 and S.J.Res. 20) of the most recent
USDA rule to expand the types of eligible Canadian imports were introduced in both chambers
but not enacted. Even if passed, these resolutions would have had no force of law. (For
background see CRS Report RS21709, Mad Cow Disease and U.S. Beef Trade, by Charles E.
Hanrahan and Geoffrey S. Becker.)
The FDA “Feed Ban”
The FDA Center for Veterinary Medicine (CVM), responsible for the safety of animal feeds, began prohibiting the use
of most mammalian protein in feeds for ruminants in August 1997, a restriction commonly called the “feed ban.” This
ban did not prohibit the inclusion of potential bovine risk materials such as brain and spinal cord in all animal feeds,
but only those feeds intended for ruminants. FDA required that feeds containing ruminant material be labeled with a
prohibition against feeding to ruminants, and that firms and farms effectively separate prohibited and non-prohibited
feeds in production, shipping and feeding. The ban exempted certain bovine by-products, such as blood, milk, gelatin
and restaurant plate waste, on the premise that the exempted materials posed a minimal risk of transmission. On
October 6, 2005, FDA published a proposed rule banning some SRM from all animal feeds, including pet food. The
agency said its rule would remove those cattle parts responsible for 90% of potential BSE infectivity.
The final rule appeared in the April 25, 2008, Federal Register (its issuance was tied in part to the April U.S.-Korea beef
agreement). Under the rule, prohibited materials (i.e., SRM) include the brains and spinal cords from cattle 30 months
of age and older, the entire carcasses of BSE-infected cattle, the entire carcass of cattle that has not been inspected
and passed for human consumption that is 30 months of age or older from which brains and spinal cords were not
removed, tallow derived from BSE-infected cattle and from other prohibited cattle materials, and mechanically
separated beef derived from the same prohibited materials.
Canada had finalized a similar but somewhat more extensive amendment to its own feed rules in June 2006.
Geoffrey S. Becker
Specialist in Agricultural Policy