Meat and Poultry Inspection: Background and Selected Issues
Congressional research reportMar 22, 2010
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Meat and Poultry Inspection:
Background and Selected Issues
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Analyst in Agricultural Policy
March 22, 2010
Congressional Research Service
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www.crs.gov
RL32922
CRS Report for Congress
Prepared for Members and Committees of Congress
Meat and Poultry Inspection: Background and Selected Issues
Summary
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
1900s, has kept pace with changes in the food production and marketing industries.
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 certain stateinspected 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
implementation of these provisions is an oversight item for the 111th Congress. Other recent
inspection issues could receive continued attention in the 111th Congress, which currently appears
to be focused on broader legislation to reform food safety programs—notably those of the U.S.
Food and Drug Administration (FDA), which oversees all foods other than meat and poultry.
Issues relevant to FSIS programs include the following.
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, recalls due to pathogen problems continue to occur, and the significant rates of decline
in the incidence of some major foodborne pathogens have not been sustained 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 authority to mandate recalls of 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 effective.
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, with some
user fees authorized to cover plant overtime and holiday inspection costs. Congress has denied
successive Administrations’ proposals for additional user fees. Congress also has used annual
appropriations measures to direct FSIS’s administration of its programs. Examples include
prohibiting implementation of a rule that would allow imports of some Chinese poultry products;
prohibiting the use of funds to inspect horses to be used for food for humans; and slowing the
agency’s implementation of a controversial “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.
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Meat and Poultry Inspection: Background and Selected Issues
Contents
Background on the Programs ......................................................................................................1
Statutory Authorities .............................................................................................................1
Federal Meat Inspection Act of 1906 ...............................................................................1
Poultry Products Inspection Act of 1957..........................................................................1
Agricultural Marketing Act of 1946.................................................................................2
Egg Products Inspection Act............................................................................................2
System Basics .......................................................................................................................2
Coverage ........................................................................................................................2
Plant Sanitation...............................................................................................................2
HACCP ..........................................................................................................................3
Slaughter Inspection........................................................................................................3
Processing Inspection......................................................................................................3
Pathogen Testing.............................................................................................................3
Enforcement ...................................................................................................................3
Funding ..........................................................................................................................4
Staffing ...........................................................................................................................4
State Inspection...............................................................................................................4
Import Inspection............................................................................................................4
Microbiological Contamination and HACCP...............................................................................5
Development of HACCP.......................................................................................................6
Pathogen Performance Standards and Salmonella..................................................................6
E. coli O157:H7 ....................................................................................................................9
Listeria monocytogenes....................................................................................................... 12
Risk-Based Inspection System ............................................................................................ 14
Other Selected Issues ................................................................................................................ 16
Safety of Meats in School Meals Programs.......................................................................... 16
Recall and Enforcement Proposals ...................................................................................... 18
Meat Traceability and Animal Identification........................................................................ 20
Funding and User Fees........................................................................................................ 21
Chinese Poultry Rule .......................................................................................................... 22
State-Inspected Products ..................................................................................................... 24
BSE .................................................................................................................................... 25
North American Cases................................................................................................... 25
BSE Safeguards ............................................................................................................ 25
Humane Slaughter and the Hallmark/Westland Recall ......................................................... 27
Contacts
Author Contact Information ...................................................................................................... 28
Acknowledgments .................................................................................................................... 28
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Meat and Poultry Inspection: Background and Selected Issues
Background on the Programs
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
virtually all other human foods, including seafood, and for animal drugs and feed ingredients.1
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 certain stateinspected 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, 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.
These incidents have fueled interest in a number of bills in the 110th and 111th Congresses to
change other elements of USDA’s authorizing statutes. What, if any, additional changes should
lawmakers consider to improve safety oversight of meat and poultry production?
Statutory Authorities
Federal Meat Inspection Act of 1906
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. As noted, the 2008 farm bill makes catfish an amenable species.
Poultry Products Inspection Act of 1957
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).
1
FSIS 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 (name redacted), and CRS Report R40443,
Food Safety: Selected Issues and Bills in the 111th Congress,
by (name redacted).
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Agricultural Marketing Act of 1946
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.
Egg Products Inspection Act
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
stores.
System Basics
Coverage
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
state inspection.
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.
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).
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HACCP
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
plant’s compliance.
Slaughter Inspection
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.
Processing Inspection
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.
Pathogen Testing
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.
Enforcement
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
them.
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
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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
plant closure.
Funding
Federal appropriations pay for most, but not all, mandatory inspection. For FY2010, FSIS
received an annual appropriation of approximately $1 billion. 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 FY2010, revenue from the fees is
expected to add approximately $150 million in additional program support.
Staffing
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.
State Inspection
Twenty-seven states have their own meat and/or poultry inspection programs covering nearly
1,900 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 $65 million of the
total FSIS budget annually. 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
performed by state personnel. 2
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
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.
Import Inspection
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
2
A new state inspection option authorized by the 2008 farm bill is discussed later in this report.
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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
inspection facilities for final clearance into interstate commerce. 3
Microbiological Contamination and HACCP
The U.S. Centers for Disease Control and Prevention (CDC) observed in April 2009:
Despite numerous activities aimed at preventing foodborne human infections, including the
initiation of new control measures after the identification of new vehicles of transmission (e.g.,
peanut butter-containing products), progress toward the national health objectives has plateaued,
suggesting that fundamental problems with bacterial and parasitic contamination are not being
resolved. Although significant declines in the incidence of certain pathogens have occurred since
establishment of FoodNet, these all occurred before 2004. Of the four pathogens with current
Healthy People 2010 targets, Salmonella, with an incidence rate of 16.2 cases per 100,000 in
2008, is farthest from its target for 2010 (6.8). The lack of recent progress toward the national
health objective targets and the occurrence of large multistate outbreaks point to gaps in the
current food safety system and the need to continue to develop and evaluate food safety practices
as food moves from the farm to the table.4
Not all of these infections are from consumption of meat and poultry products. A more recent
CDC article reported that, among 243 foodborne disease outbreaks attributed to a single
commodity in 2006, the most outbreaks were attributed to fish (47), poultry (35), and beef (25).
However, the most cases were attributed to poultry (1,355), leafy vegetables (1,081) and
fruits/nuts (1,021). Pairing pathogens with commodities, the CDC found that the most outbreakrelated cases were Clostridium perfringens in poultry (902 cases), Salmonella in fruits nuts (776),
norovirus in leafy vegetables (657), shiga-toxin E. coli in leafy vegetables (398), Salmonella in
vine-stalk vegetables (331), and V. parahaemolyticus in mollusks (223).5
Nonetheless, 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 data from the past several years appear to indicate that this
overall decline has not continued.6
3
As of December 2009, 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 (name redacted).
4
“Preliminary FoodNet Data on the Incidence of Infection with Pathogens Transmitted Commonly Through Food—10
States, 2008,” Morbidity and Mortality Weekly Report, April 10, 2009.
5
“Surveillance for Foodborne Disease Outbreaks—United States, 2006,” Morbidity and Mortality Weekly Report, June
12, 2009. A case is a single person; and outbreak is two or more cases.
6
Some discussion of the more recent data is contained in the sections of this CRS report on selected pathogens.
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Development of HACCP
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.
In 1995, under existing statutes, FSIS published a proposed rule to systematize these 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, and taking corrective actions when
necessary. Record-keeping and verification 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 statutes.7
Pathogen Performance Standards and Salmonella
The CDC has noted that poultry is an important source of human Salmonella infections. The
pathogen also periodically has been found in beef, as well as non-animal foods such as fresh
produce. According to CDC reports, the overall incidence of Salmonella infections through all
types of food has not decreased significantly.8 CDC also has reported that Salmonella has been
the most common foodborne pathogen, although exposure to live animals also has been 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 failure to meet Salmonella
standards as the basis for withdrawing inspection. 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 HACCP plans.
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
microbiological standards.
7
The final rule appeared in 61 Federal Register 38805-38855.
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; “ ...—10 States, 2007,” Morbidity
and Mortality Weekly Report, April 11, 2008; and “ ...—10 States, 2008,” Morbidity and Mortality Weekly Report,
April 10, 2009.
8
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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
http://www.fsis.usda.gov/OPHS/nacmcf/rep_stand.htm.)
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 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
factors such as a plant’s regulatory history and its incidence of the pathogen. 9
FSIS on January 28, 2008 issued a notice on new policies and procedures for Salmonella
sampling and testing. 10 One change was to begin posting 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
90% of such establishments were not testing consistently for low Salmonella rates.
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
20%);
9
Food Chemical News, July 3, 2006. A notice and request for comments on this initiative were published in the
February 27, 2006, Federal Register.
10
73 Federal Register pp. 4767-4774.
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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. The December (fourth quarter) 2009 report showed 12 establishments in
category 2 and four in category 3.11
The CDC in 2009 credited the industry’s response to the FSIS Salmonella initiative with a
decrease in the percent-positive rate for Salmonella in raw broiler chicken, from 11.4% in 2006 to
7.3% in 2008.12 The rate was 8.6% in the fourth quarter of 2009.
Another Salmonella initiative developed by FSIS is on a list of Obama Administration food safety
actions announced by the President’s Food Safety Working Group (FSWG) on July 7, 2009. The
group said that FSIS would, by the end of 2009, “develop new standards to reduce the prevalence
of Salmonella in turkeys and poultry” (more specifically, young chickens, or broilers) and
“establish a Salmonella verification program with the goal of having 90 percent of poultry
establishments meeting the new standards by the end of 2010.”13 On December 31, 2009, the
agency announced that it would “issue a Federal Register notice in the very near future that will
provide specific details” on the new standards, and invite public comments on them, with
implementation by July 2010. FSIS also for the first time is developing new standards for the
pathogen Campylobacter in young chickens (broilers) and turkeys, the announcement stated.
Concerns regarding Salmonella contamination are not limited to poultry, as illustrated by recalls
of 825,769 pounds of ground beef products in August 2009 and another 22,723 pounds of ground
beef products in December 2009, both by a California establishment, Beef Packers Inc. The
recalls were associated with investigations of Salmonella illness outbreaks, according to FSIS.14
Media reports in late 2009 on these recalls by the company, a supplier of beef to the federal
school lunch program, and on pathogens found in ground beef produced by another school lunch
supplier, Beef Products Inc., raised questions about the safety of these USDA-purchased
commodities (see discussion later in this report).
(FSIS’s quarterly Salmonella reports also list performance standards and testing results for, in
addition to broilers and turkeys, market hogs, steers and heifers, cows and bulls, and ground
products—chicken, turkey and beef.)
In another recent incident, Danielle International of Rhode Island had, through February 2010,
recalled approximately 30 Italian-style meat products totaling nearly 1.4 million pounds after
reports of a multistate outbreak of Salmonella Montevideo infections in 252 persons in 44 states
and the District of Columbia.15 Samples of black pepper used on the products tested positive for
11
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
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.
12
Morbidity and Mortality Weekly Report, April 10, 2009.
13
“Food Safety Working Group: Key Findings.” FSWG is an interdepartmental effort to advise the President on how to
improve the U.S. food safety system; its website is http://www.foodsafetyworkinggroup.gov/.
14
FSIS, “Constituent Update,” December 31, 2009.
15
U.S. Centers for Disease Control (CDC) and Prevention, “Investigation Update: Multistate Outbreak of Human
(continued...)
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Salmonella, indicating that outside ingredients can be a source of concern. FDA, which oversees
pepper and other spices, has been coordinating with FSIS regarding the recall.
E. coli O157:H7
Illness outbreaks continue to be linked to the pathogen E. coli O157:H7 in beef products. This has
led to calls from critics for improvements in testing for E. coli and for minimizing its presence.
Some consumer groups have argued that more tests should be mandated; meat industry
representatives counter that while an effective sampling and testing program is important to help
determine whether a plant’s pathogen control measures are working, testing itself cannot assure
safety.
CDC noted that “E. coli O157:H7 is one of hundreds of strains of the bacterium Escherichia coli.
Although most strains are considered 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 sewagecontaminated water.”16
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
2006 had remained about the same as in 2004.17
The CDC report on 2007 concluded that “additional efforts are needed” to control the pathogen in
cattle “and to prevent its spread to other food animals and food products, such as produce.”18 The
CDC reported an increase in the percentage of ground beef samples yielding O157:H7—from
0.24% in 2007 to 0.47% in 2008—but said it was unknown whether this was related to focused
sampling of higher-risk facilities, improved laboratory detection, or an actually higher microbial
load.19
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.20 In 2005, the agency
(...continued)
Salmonella Montevideo Infections,” update for March 17, 2010.
16
Background information on this pathogen may be viewed at the following CDC website: http://www.cdc.gov/nczved/
dfbmd/disease_listing/stec_gi.html.
17
Morbidity and Mortality Weekly Report, April 13, 2007.
18
Morbidity and Mortality Weekly Report, April 11, 2008.
19
Morbidity and Mortality Weekly Report, April 10, 2009.
20
Source: FSIS press releases on recalls posted at http://www.fsis.usda.gov/Fsis_Recalls/index.asp.
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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
21.7 million pounds (see box, “Topps Recall”). 21
Topps Recall
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
stressed should be done. In addition, the plant had not followed its own HACCP plan, according to the reports.22
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.,23 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.
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
Natural Beef brand were also recalled by the Whole Foods Market chain. 24
For 2009, a total of 15 E. coli-related recalls were announced by FSIS, four of which were linked
to an illness outbreak investigation. The others generally were the result of routine testing. Two
large recalls late in the year included 545,699 pounds of fresh ground beef products from a New
York State establishment in October, following an investigation of 26 E. coli-related illnesses
21
Recall updates are at the FSIS website, http://www.fsis.usda.gov/Fsis_Recalls/index.asp. Also, CRS has tallied
recalls, by product type and reason, for 1994 through 2009; see the appendix in CRS Report RL34313, The USDA’s
Authority to Recall Meat and Poultry Products, by Cynthia Brougher and (name redacted).
22
See for example, Cattle Buyers Weekly, October 8, 2007; Feedstuffs, October 8, 2007.
23
Source: Cattle Buyers Weekly, various 2007 issues.
24
“Nebraska Beef E. coli recall gets a sequel,” Food Chemical News, August 18, 2008.
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among 26 persons from eight states;25 and 248,000 pounds of primarily whole beef cuts from an
Oklahoma establishment in December, linked to 21 illnesses in 16 states.26
FSIS had begun testing samples of raw ground beef for E. coli O157:H7 in October 1994,
declaring 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
employees, and to avoid mixing products from different suppliers.27
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
to speed up recalls.28
Additional FSIS E. coli initiatives were announced as one of the items on the FSWG list of
actions on July 7, 2009. The working group stated that FSIS is increasing its sampling, focusing
25
CDC, “Multistate Outbreak of E. coli O157:H7 Infections Associated with Beef from Fairbank Farms Final Update,”
November 24, 2009; at http://www.cdc.gov/ecoli/2009/.
26
The December recall was of products that had been mechanically tenderized. Consumer advocates argue that this
process can transfer surface pathogens into the center of the meat, which, if not cooked thoroughly, can sicken those
who eat it. FSIS also stated in its December 24, 2009, recall announcement “that there is an association between nonintact steaks (blade tenderized prior to further processing) and illnesses” in a number of states. See also “E. coli-Tainted
Beef Infects 21 in 16 States,” Washington Post, December 30, 2009.
27
67 Federal Register 62325.
28
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
http://www.fsis.usda.gov/PDF/Ecoli_Reassement_&_Checklist.pdf.
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on the components that go into ground beef, and also improving its instructions to field staff on
how to verify beef establishment controls over the pathogen. These beef components are typically
are referred to as “bench trim” and are the trimmings from larger cuts of primal and sub-primal
cuts of beef. A notice on sampling bench trim and a directive on E. coli verification activities
were issued on July 31, 2009.29 Meanwhile, FSIS reportedly was considering whether to define
all cuts of beef as adulterated if they test positive for E. coli O157:H7, something a number of
groups requested after a recent recall of 421,000 pounds of such “muscle cuts.”30
The agency also is planning or contemplating a number of other efforts aimed at addressing E.
coli O157:H7, including directing its enforcement investigators to gather more information within
48 hours of a presumed positive test for the pathogen (to improve ability to trace contaminated
products back to their source); proposing rules requiring products to be held until testing results
are completed; requiring labels on whole meat cuts that have been mechanically tenderized; and
possibly instituting new record-keeping requirements aimed at enhancing traceback capabilities. 31
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. FSIS and other
food safety experts were speculating as to whether the increase was due to a higher prevalence of
the bacteria, or simply to the fact that the agency had changed its testing method in 2008. It is
possible, for example, that the newer method is more sensitive to the presence of E. coli.32 In
2009, through December 27, a total of 41 or 0.32% out of 12,685 ground beef samples tested
positive. In 2009 testing of ground beef components, FSIS reported that 30 or 0.86% out of 3,496
samples tested positive.
Listeria monocytogenes
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.
29
FSIS Notice 51-09 and FSIS Directive 10,010.1, Revision 2, respectively.
Source, “USDA Mulls E. coli As Adulterant on Cuts,” Cattle Buyers Weekly, August 24, 2009.
31
The agency’s “current thinking” on E. coli O157:H7 actions was discussed at a public meeting in Washington, D.C.,
on March 10, 2010. See for example: “FSIS surprises attendees with details on new E. coli policies,” Food Chemical
News, March 15, 2010; and “USDA to mandate test and hold, non-intact meat labels,” Meatingplace.com, March 19,
2010.
32
“Explanation to higher number of E. coli positives may be in broth,” Food Chemical News, October 20, 2008. A
March 12, 2009, FSIS Notice (18-09) announced that the agency was “increasing sampling at high volume ground beef
establishments because these establishments produce product that is most widely consumed. The increase in sampling
will allow the Agency to estimate the amount of uncontaminated raw ground beef with a higher degree of certainty.” A
new sampling notice (44-09) dated June 1, 2009, modifies and clarifies some of the provisions in the March notice it
replaced.
30
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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
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
illnesses and deaths linked to ready-to-eat meats produced by a Sara Lee subsidiary.33 Interest
increased significantly after October 2002, when Pilgrim’s Pride Corporation recalled a recordbreaking 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 seven
deaths and three 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
specific instructions for monitoring processing plants that produce hot dogs and deli meats.34 In
June 2003, FSIS announced the publication of an interim final rule to reduce Listeria in ready-toeat 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
depending upon what type of control steps they adopt in their HACCP and sanitation plans.35
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,
Listeria illnesses increased by 22%, CFA contended, citing CDC data.36
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
1996-1998 baseline, has not continued to decline significantly in more recent years.37
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
33
Source: Food Chemical News, various issues.
The guidelines can be found on the FSIS website at http://www.fsis.usda.gov.
35
See the FSIS website for more details on the rule.
36
CFA website: http://www.consumerfed.org/.
37
Morbidity and Mortality Weekly Report, April 13, 2007, and April 11, 2008.
34
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posted six Listeria recalls in 2006 and another 11 in 2007, including, in January and February
2007, 2.8 million pounds of Oscar Mayer/Louis Rich chicken breast cuts and strips.38 Fifteen
Listeria-related recalls were posted in 2008, and eight in 2009.
Risk-Based Inspection System
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
inspection resources.39 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
categorized, and the type and intensity of inspection could be based primarily on that risk.”40
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
RBIS.41
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
the statutory authority to change inspection frequency.42
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
was using to rank product risk and plant performance FY2009.43
38
FSIS recall website: http://www.fsis.usda.gov/FSIS_Recalls/index.asp.
See “In Congress” later in this section of the report.
40
“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/National_Advisory_Committee_on_Meat_&
_Poultry/index.asp.
41
Comments by Dr. Richard Raymond, USDA Under Secretary for Food Safety, February 22, 2007, press
teleconference.
42
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
Subcommittee of the Committee on Appropriations, U.S. House of Representatives, 109th Congress, 2nd session.
43
Sources: various statements as reported in Food Chemical News, February 26, 2007, and April 23, 2007.
39
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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
safety systems.”44 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
stakeholders.
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 Risk-Based Inspection System” (PHRBIS)—to address the
OIG recommendations and those of public commenters. FSIS issued a report outlining the
elements of and scientific basis for the evolving PHRBIS on April 2008.45 The agency has been
implementing the OIG recommendations, and has predicted that implementation will begin in late
FY2010.
The agency also asked the National Academy of Sciences (NAS) to evaluate the data and
methodology underlying its PHRBIS initiative. On March 23, 2009, a committee of the NAS
Institute of Medicine issued its report, commending FSIS for its commitment to develop a riskbased system and agreeing with the “general concept of using process control indicators as part of
an algorithm to rank establishments in different levels of inspection.” However, the committee
also “found it a challenge to evaluate the adequacy of indicators of process control to rank
establishments and allocate agency inspection resources without a clear understanding of the
rationale for the general approach,” which the FSIS technical report did not articulate. For
example, the agency did not clearly define the meaning of “process control indicators,” or provide
in-depth consideration of the underlying statistics for specific microbiological testing protocols,
among other uncertainties or limitations found by the committee. 46
In Congress
Provisions in several successive appropriations measures (including P.L. 110-28 and P.L. 110161, Division A, in the 110th Congress, and P.L. 111-8, Division A, in the 111th Congress) have
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. This prohibition is continued under the FY2010 appropriations measure (P.L. 111-80).
44
USDA, OIG, Issues Impacting the Development of Risk-Based Inspection at Meat and Poultry Processing
Establishments (Report. No. 24601-07-Hy).
45
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/
Public_Health_Based_Inspection/index.asp.
46
Committee on Review of the Use of Process Indicators in the FSIS Public Health Risk-Based Inspection System,
Institute of Medicine. Review of the Use of Process Control Indicators in the FSIS Public Health Risk-Based Inspection
System: Letter Report (National Academies Press, 2009).
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Several freestanding bills were introduced late in the first session of the 111th Congress that aimed
to address microbiological contamination. They include S. 2792, which would direct USDA to
require beef slaughterhouses, processing establishments, and grinding facilities to meet minimum
testing requirements for E. coli O157:H7. The new provisions would be applied to imported as
well as domestic beef, require positive E. coli O157:H7 test results to be reported to USDA within
24 hours, and exempt facilities that process or grind 25,000 pounds or less per day. Also, S. 2819
would prohibit the marketing of any processed food regulated under the meat and poultry
inspection laws (as well as any processed food regulated by FDA under the Federal Food, Drug,
and Cosmetic Act) that either has not undergone a pathogen reduction treatment or is certified not
to contain verifiable traces of pathogens.
In the second session, H.R. 4750, introduced March 3, 2010, would subject firms and other
entities to up to three years in prison, a $10,000 fine, or both, if they prohibit—whether by
contract or other means—another firm or entity from further examining carcasses, carcass parts,
or the meat or poultry products from them to ensure that they are not adulterated. The measure
follows reports that some firms were prohibiting those who bought their products from testing
them to ensure they were free of pathogens; at issue, among other things, is who might be liable
for such products if they are found to be contaminated.
Other Selected Issues
Safety of Meats in School Meals Programs
As noted earlier, media reports appeared in late 2009 that raised questions about the safety of the
meat being supplied to school meals programs. Meanwhile, several lawmakers also have called
for a review of how USDA screens meat and poultry destined for school meals and/or for
consideration of legislation in the second session of the 111th Congress that would require the
Department to enforce more rigorous testing, recall, and other procedures for products to be used
in the programs.
Although schools use cash to purchase directly most of the foods used in these programs, a
significant amount—by law, at least 12% of the combined value of cash and commodity
assistance—is provided through commodities purchased by USDA and transferred to schools
through the states. This 12% now amounts to about $1 billion annually for all types of
commodities.47 USDA’s Agricultural Marketing Service (AMS) handles purchases for most
commodities, including meat and poultry, and has purchased approximately 133 million pounds
of beef alone in each of the past three years.48
USA Today reported that, during the dates covered by the Beef Packers Inc. recall, USDA
purchased four orders totaling nearly 450,000 pounds of ground beef for the school lunch
program. One order reportedly tested positive for the Salmonella strain that triggered the retail
recall—and was rejected by USDA. However, it would have been prudent for the Department to
reject the other three orders even though they did not produce positive test results, one food safety
47
For an explanation of these programs see CRS Report R40397, Child Nutrition and WIC Programs: A
Brief Overview, by (name redacted).
48
Source: AMS e-mail communication, March 18, 2010.
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expert told the newspaper.49 Such pathogen tests do not guarantee that the pathogen is absent.
“Because Salmonella is seldom distributed evenly in any lot of beef, ‘94% of the time, I won’t
find it even though it’s there,’” the article quoted the expert as saying. On the other hand, the
three lots that were not rejected were produced during production runs on days following those
that the recalled beef was produced; the assembly lines are cleaned each night, making it very
unlikely that the pathogen would have survived, he added. 50
A subsequent USA Today article observed that on the one hand, AMS’s safety rules for schoolbound meat and poultry are more stringent than the Department’s (presumably meaning FSIS’s)
rules are for commercially marketed products. On the other hand, the article asserted, many of the
larger fast food and supermarket chains set testing and safety standards that are far higher than
those required by AMS. For example, McDonald’s, Burger King, and Costco test the ground beef
they buy five to 10 times more frequently than the Department’s tests for a typical production
day. 51
The New York Times reported on a separate case where E. coli and Salmonella have been found
“dozens of times” in meat produced for the school lunch program by Beef Products Inc. The
Times stated that the meat was diverted before it went into the program. Although one of the
company’s facilities reportedly has been suspended from the school lunch buying program three
times in three years, USDA (again, presumably FSIS) has allowed the facility to remain in
production for other customers. 52
The Times article outlines the company’s use of “a product made from beef that included fatty
trimmings the industry once relegated to pet food and cooking oil.” Because the “trimmings were
particularly susceptible to contamination,” the company began treating the product with ammonia
gas, which, it said, proved highly effective in killing pathogens. The challenge, according to the
Times, has been how to keep the ammonia levels high enough to kill the pathogens but not
negatively affect the taste of the product. Furthermore, the government reportedly did not require
that the ammonia-treated meat be so labeled, because the government agreed with Beef Products’
assertion that it was a processing agent and not an additive.53
The food safety expert quoted by USA Today, James Marsden, generally defended the AMS
purchasing program in a recent Internet posting. He observed that ground beef destined for
schools must be tested for both Salmonella and E. coli O157:H7, both of for which AMS has a
“zero-tolerance” policy and thus will not accept any products where it is found. Furthermore,
suppliers must hold the product until tests confirm that samples are negative for the pathogens.
Marsden added that other provisions in the AMS purchasing program require that slaughter plants
include at least two pathogen intervention steps and that carcasses themselves be tested regularly
for E. coli O157:H7. However, he also reiterated the “potential weakness” in the program that he
49
“Why a Recall of Tainted Beef Didn’t Include School Lunches,” USA Today, December 2, 2009. James Marsden, the
food safety expert quoted in the article, is a Kansas State University professor who among other things serves as senior
science advisor for the North American Meat Processors Association, an industry trade association.
50
Ibid.
51
“Fast Food Standards for Meat Top Those for School Lunches,” USA Today, December 9, 2009. An accompanying
article in the newspaper asserted that the Department also buys for the school lunch program “spent hen” meat, from
old egg-laying birds that most private companies no longer use, even for soup and other processed foods, out of quality
concerns.
52
“Safety of Beef Processing Method Is Questioned,” The New York Times, December 31, 2009.
53
Ibid.
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described in theUSA Today article, namely what he called “an overreliance on microbiological
test results.”54
Recall and Enforcement Proposals
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,
GAO reported. 55
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. It is also argued that
voluntary procedures encourage cooperation between industry and its regulators, whereas
mandatory recall authority might discourage it. Mandatory authority would foster a more
adversarial system of mistrust and possible litigation, making recalls less rather than more
effective, industry representatives argue.
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
54
James Marsden, “The Safety of Ground Beef at Schools,” at http://www.meatingplace.com/MembersOnly/blog/
BlogDetail.aspx?topicID=5213&BlogID=11&pf=true.
55
Food Safety: USDA and FDA Need to Better Ensure Prompt and Complete Recalls of Potentially Unsafe Food,
GAO-05-51. Also see CRS Report RL34313, The USDA’s Authority to Recall Meat and Poultry Products, by Cynthia
Brougher and (name redacted).
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the names of retailers who have products subject to a voluntary recall. FSIS announced on July
11, 2008, that it would begin to post such names in August 2008. The lists cover retailers
involved in the potentially most serious (Class I) recalls only.56
Reviewing FSIS protocols for handling recalls following the Topps case (see box, “Topps
Recall”), 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 product at an establishment to conclude whether contamination occurred
there.”57
In Congress
Provisions of the Food and Drug Administration Amendments Act of 2007 (H.R. 3580; P.L. 11085) 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
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. The
proposed implementing rules for these two requirements were still in review at USDA in midSeptember 2009.
Several other bills to authorize mandatory recalls for meat and poultry products were introduced
but not enacted in the 110th Congress. In the 111th Congress, bills by Representative DeGette
(H.R. 815) and by Senator Brown (S. 425) would amend both the FMIA and the PPIA to require
“[a] person (other than a household consumer) that has reason to believe” that any carcass,
poultry, meat product, or poultry product “transported, stored, distributed, or otherwise handled
by the person is adulterated or misbranded shall, as soon as practicable, notify the Secretary of the
identity and location of the article.” The bills set forth a series of steps for voluntary recall and
consumer notification and, if they are not taken, require the Secretary to order them. The bills
(which also would mandate similar requirements for FDA-regulated products) provide for hearing
opportunities, among other related language. A bill with similar objectives also was introduced by
Senator Udall (S. 1527).
Mandatory recall provisions have been incorporated into food safety legislation (H.R. 2749) that
cleared the House on July 30, 2009, as well as into a comprehensive bill (S. 510) approved in
November 2009 by a Senate committee, but these bills’ provisions apply to FDA-regulated foods
and not to FSIS-regulated meat and poultry products.
56
“USDA Will List Retail Stores Receiving Recalled Meat and Poultry Products,” July 11, 2008, press release. A link
to retail distribution lists is being posted at the end of FSIS recall press releases; see, for example,
http://www.fsis.usda.gov/Fsis_Recalls/Open_Federal_Cases/index.asp?src_location=Content&src_page=FSISRecalls.
57
Food Safety and Inspection Service Recall Procedures for Adulterated or Contaminated Product, August 2008, at
http://www.usda.gov/oig/webdocs/24601-09-HY.pdf.
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Meat Traceability and Animal Identification
Recalls imply the ability to quickly trace the movement of products. Some argue, for example,
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 had argued in the past that such
a system would not be based on sound science, and would be technically unworkable. However,
following the domestic BSE case, the industry, USDA, and other professionals attempted to
implement a universal, although not mandatory, national animal ID (but not meat traceability)
system. However, this system was focused on animal disease control rather than on food safety
objectives.
Regardless, progress has been slow on this so-called National Animal Identification System
(NAIS). Some Members of Congress are among those who believed the programs should be
mandatory in order to achieve universal participation. Although many producers themselves
appear to be supportive, many also have expressed adamant opposition to the plan. Among other
issues are cost, need for a mandatory rather than voluntary system, potential producer liability,
and privacy of records.
On February 5, 2010, Secretary of Agriculture Vilsack announced that USDA was revising its
approach to achieving a national capability for animal disease traceability. The NAIS is to be
abandoned. In its place USDA proposes a new approach that will allow individual states (and
tribal nations) to chose their own degree of within-state animal identification (ID) and traceability
for livestock populations. Under this revised focus, states may chose to have no mandatory
animal ID and traceability capability, or to rely on existing ID systems already in place to fight
brucellosis, tuberculosis, and other contagious animal diseases, or to develop their own version of
a more detailed birth-to-market ID system as originally proposed under NAIS. The flexibility is
intended to allow each state to respond to its own producer needs and interests. However, under
the proposed revision USDA will require that all animals moving in interstate commerce have a
form of ID that allows traceability back to their originating states.58
In Congress
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. Several other bills establishing broader traceability programs would have applied to
animal ID as well. Also in the 110th Congress, both the House and Senate committee reports to
accompany USDA’s FY2008 appropriation (H.Rept. 110-258; S.Rept. 110-134) had questioned
58
Adapted from CRS Report R40832, Animal Identification and Traceability: Overview and Issues, by (name redacted).
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USDA’s progress and direction in implementing NAIS. Over several years through FY2008,
about $128 million had gone into the development of such a program.
The FY2009 USDA appropriation (P.L. 111-8, Division A), passed near the start of the 111th
Congress, provided another $14.5 million for program, of which $3.5 million was for information
technology, $9.4 million was for field implementation, and $1.6 million was for program
administration. Explanatory language to accompany the appropriation further directed APHIS “to
make demonstrable progress” to implement the program, and to meet a number of specific
objectives (regarding 48-hour traceback ability) that were in the agency’s 2008 traceability
business plan.
The FY2010 appropriation (P.L. 111-80) provided $5.3 million for NAIS, $9.1 million less than
FY2009. This was in contrast to no funding under the House bill and was $2 million less than the
Senate bill. The conference report expressed concern that the lack of progress by APHIS in
registering animal premises in the United States would prohibit APHIS from implementing an
effective national animal ID system, and that such a system was needed for animal health and
would benefit livestock markets. As of mid-2009, about 37% of premises were registered under
NAIS, out of an estimated 1.4 million U.S. animal and poultry operations. USDA had stated that
much higher levels of participation were needed to successfully implement NAIS. The conference
report stated further that, “[i]f significant progress is not made, the conferees will consider
eliminating funding for the program.” Since FY2004, approximately $142 million has been
appropriated for NAIS.
With regard to proposed authorizing legislation in the 111th Congress, the broader food
traceability provisions of H.R. 814 (DeGette) and S. 425 (Brown) both include the requirement
that FSIS establish, within one year, a system that can trace each animal to any premises it was
held at any time prior to slaughter, and each carcass, carcass part, or meat/poultry product from
slaughter through processing and distribution to the ultimate consumer. The bills also would
authorize the Secretary to require records to be maintained and to provide access to them for
purposes of traceability.
Traceability provisions have been incorporated into food safety legislation (H.R. 2749) approved
by the House and into a Senate bill (S. 510), but these provisions would apply to FDA-regulated
foods and not to FSIS-regulated meat and poultry products.
Funding and User Fees
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
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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.
For example, as part of its FY2009 budget submitted to Congress in February 2008, the Bush
Administration again had asked for new user fees, beginning after FY2009, of $92 million by
collecting licensing fees from meat and poultry establishments, and of another $4 million by
charging plants that require additional inspections due to performance failures. These fees were
not adopted by Congress, which also had opposed them when they were in the Administration’s
FY2008 budget. The $4 million user fee was again requested by the Obama Administration in its
FY2010 proposal, but neither the House nor Senate Appropriations Committee recommended its
adoption (which would require a change in authorizing legislation).
In Congress
As noted, the enacted omnibus (P.L. 111-8, Division A) provides $971.6 million for FSIS,
approximately $41 million above the FY2008 level and approximately $20 million above the
Administration request. This congressional appropriation is being augmented in FY2009 by
existing (currently authorized) user fees, which FSIS had earlier estimated would total $140
million for the fiscal year. For FY2010, the enacted appropriation (P.L. 111-80) provides $1.019
billion, which is the Administration-requested level and an increase over the enacted FY2009
level. Congressional consideration of the FY2011 budget request was getting underway in March
2010.
Chinese Poultry Rule
The FY2009 omnibus appropriation continued language, which was also in the FY2007 and
FY2008 USDA appropriations measures, prohibiting FSIS from implementing rules to allow the
importation of poultry products from China into the United States. The explanatory statement
accompanying the FY2009 measure expressed “very serious concerns about contaminated foods
from China,” and called on USDA to submit a report to Congress on the safety implications of
such changes and a plan of action to guarantee the safety of Chinese poultry product imports. A
final rule to allow certain processed poultry products to enter from China had been published by
FSIS rule on April 24, 2006.59
The Chinese government in March 2009 strongly criticized the ban as a violation of trade rules
and stated that it would challenge it in the World Trade Organization (WTO). It also pointed out
that China had “imported 580,000 tons of chicken products from the United States last year,
accounting for 73.4% of total chicken imports.”60 On April 17, 2009, China formally requested
formal WTO consultations on the issue, the first step toward referral to a dispute settlement panel
(which subsequently was established in July 2009 and composed in September 2009).61
59
71 Federal Register pp. 20867-20871.
60
See, for example, “China blasts ‘discriminative’ U.S. measure on Chinese poultry imports,” March 13, 2009, on the
Chinese Government’s official web portal at http://www.gov.cn/misc/2009-03/13/content_1258409.htm.
61
The text of the Chinese request and status of the dispute (DS392) can be accessed through the WTO website at
http://www.wto.org/english/tratop_e/dispu_e/cases_e/ds392_e.htm.
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The House-passed FY2010 appropriation for USDA would have continued the Chinese chicken
prohibition; the Senate would have permitted such imports but only under specified conditions.
House-Senate conferees on the final measure (enacted as P.L. 111-80) adopted language that
appears to be closer (but not identical) to the Senate approach. More specifically, Section 743 of
the final measure states that funds cannot be used to implement the rule unless the Secretary of
Agriculture formally notifies Congress that China will not receive any preferential consideration
of any application to export poultry or poultry products to the United States; the Secretary will
conduct audits of inspection systems and on-site reviews of slaughter and processing facilities,
laboratories, and other control operations before any Chinese facilities are certified to ship
products to the United States, and subsequently such audits and reviews will be conducted at least
annually (or more frequently if the Secretary determines it necessary); there will be a
“significantly increased level” of reinspections at U.S. ports of entry; and a “formal and
expeditious” information sharing program will be established with other countries importing
Chinese processed poultry products that have conducted audits and plant inspections.
Furthermore, USDA must provide a report to the House and Senate Appropriations Committees
within 120 days and every 180 days thereafter, indefinitely, that includes both initial and new
actions taken to audit and review the Chinese system to ensure it meets sanitary standards
equivalent to those of the United States, the level of port of entry reinspections being conducted
on Chinese poultry imports, and a work plan incorporating any agreements between FSIS and the
Chinese government regarding a U.S. equivalency assessment. USDA also is to meet specified
requirements (spelled out in Section 743) for notifying the public about audits and site reviews in
China and lists of certified Chinese facilities.
Many food safety advocates were supportive of the House appropriations language banning the
poultry rule, arguing that China—the third leading foreign supplier of food and agricultural
imports into the United States—lacks effective food safety protections, and that the 2006 rule was
rushed into approval without an adequate safety evaluation. Opponents of a ban, particularly
those in the U.S. animal industries, argue that it would undermine U.S. trade commitments, and
believe it already has led to trade retaliation by the Chinese. 62
“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
http://www.fsis.usda.gov/regulations_&_policies/equivalence_process/index.asp).
62
See also CRS Report R40706, China-U.S. Poultry Dispute, by (name redacted) and (name redacted).
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State-Inspected Products
As noted, 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 stateinspected 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 opposing 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 on selfassessments.63
In Congress
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 inspectors 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, and meet all FMIA and PPIA requirements. 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 contended that the new language is overly restrictive, while those who
supported the change countered that it provides appropriate safeguards.
The farm bill required final rules to implement the new state program by December 2009. FSIS
published, on September 16, 2009, the proposed rules, with an initial 60-day comment period.64
The proposal spells out standards for determining the average number employees in a plant;
clarifies that eligibility is limited to those states that already have a cooperative agreement to
operate a meat or poultry inspection program; describes the process for a state to apply for the
interstate version; and specifies that an eligible establishment is to apply for participation through
63
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.
64
74 Federal Register pp. 47648-47669.
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the state-approved program, not FSIS. Among other provisions, the proposed rule would prohibit
a participating establishment from reverting to intrastate inspection if it fails to correct any
violations of federal standards that are found. A final rule had not yet appeared as of mid-March
2010.
BSE
North American Cases
Twenty-one cases of BSE have been reported in North America. Eighteen of them were cattle
born in Canada, which reported its first native case in May 2003 and its latest case in March 2010
(one earlier case was imported into Canada from Great Britain). 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. The most recent Canadian case was announced by Canadian officials
on March 10, 2010, in a six-year-old beef cow in Alberta.
In epidemiological investigations of the three U.S. cases, 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.
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.
BSE Safeguards
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,
effective immediately:
•
Downer (nonambulatory) cattle are no longer allowed into inspected slaughter
and processing facilities. (This interim final rule was published in the July 13,
2007 Federal Register.)
•
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.
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•
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, “The FDA “Feed Ban””).
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).
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. This final rule took effect April 27, 2009, but FDA set a
compliance date of October 26, 2009, for those (notably renderers) who needed additional time to comply.
In Congress
For many Members of Congress, much of the recent interest in BSE has focused on trade rather
than food safety concerns. Japan and Korea, once among the four leading export markets for U.S.
beef, took years to begin accepting U.S. beef products. Exports to Japan, which restarted in 2005,
are still limited to products from younger cattle. Korean inspection procedures kept that market
largely closed to the United States through much of 2007 and again during early 2008.
On 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.
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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 had
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 (name redacted) and (name redacted).)
A recent incident inciting U.S. lawmakers and trade officials was a vote in early January 2010 by
Taiwan’s parliament to effectively reverse provisions in a U.S.-Taiwan agreement that was to
permit U.S. ground beef and offal to enter that country. The agreement, reached in October 2009
after lengthy negotiations, also is to permit U.S. bone-in beef, but the parliament reportedly did
not change that provision. Taiwan’s actions, which U.S. trade officials declared “do not have a
basis in science and constitute a unilateral violation of a bilateral agreement,”65 could again lead
to congressional proposals for some type of sanctions or retaliation.
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 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 and approved—but before they were
actually slaughtered—for food. FSIS regulations explicitly prohibit most nonambulatory cattle
which are presented for ante-mortem inspection, because of their higher risk of BSE.
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.”
FSIS published a final rule in the March 18, 2009, Federal Register that now specifically requires
cattle slaughter establishments to notify government inspectors when cattle become
nonambulatory even if they have already passed ante-mortem inspection. All such cattle must be
condemned—that is, diverted from the human food supply—and properly disposed of.
65
Office of the U.S. Trade Representative (USTR), “Joint Statement from USTR, USDA on Taiwan’s Actions to
Unjustifiably Restrict U.S. Beef Imports in Violation of Our Bilateral Agreement,” January 5, 2010, at
http://www.ustr.gov/.
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In Congress
The 110th Congress had 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.
In the 111th Congress, the Senate-passed version of the American Recovery and Investment Act of
2009 (H.R. 1) included a provision to prohibit permanently the use of federal funds for inspecting
any nonambulatory disabled cattle for use as human food, regardless of the reason for becoming
nonambulatory. However, the provision was removed by House-Senate conferees prior to final
enactment as P.L. 111-5. A freestanding bill (H.R. 4356) to ban such cattle from the food supply
and to ensure that they are humanely euthanized was introduced in December 2009; the measure
was pending at the start of 2010. A subcommittee of the House Oversight and Government
Reform Committee held a hearing on the issue on March 4, 2010, where, among other witnesses,
the Government Accountability Office testified on a new GAO report concluding that FSIS
inspectors may not be taking consistent actions to enforce the HMSA. For background, see CRS
Report RS22819, Nonambulatory Livestock and the Humane Methods of Slaughter Act, by
(name redacted).
Author Contact Information
(name redacted)
Analyst in Agricultural Policy
[redacted]@crs.loc.g
ov, 7-....
Acknowledgments
This report was originally written by (name redacted), Specialist in Agricultural Policy.
Congressional Research Service
28
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