Order Code RL32199
CRS Report for Congress
Received through the CRS Web
Bovine Spongiform Encephalopathy (BSE, or
“Mad Cow Disease”): Current and Proposed
Safeguards
Updated October 13, 2005
Geoffrey S. Becker
Specialist in Agricultural Policy
Resources, Science and Industry Division
Sarah A. Lister
Specialist in Public Health and Epidemiology
Domestic Social Policy Division
Congressional Research Service ˜ The Library of Congress

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Bovine Spongiform Encephalopathy (BSE, or “Mad Cow
Disease”): Current and Proposed Safeguards
Summary
There have been two findings of bovine spongiform encephalopathy (BSE, or
“mad cow disease”) in the United States, one identified in December 2003 in a
Canadian-born cow, and one identified in June 2005 in a Texas-born cow.
Shortly after the first case of BSE was announced, U.S. Department of
Agriculture (USDA) and other officials announced measures to improve existing
safeguards against the introduction and spread of BSE. Previously, the major
safeguards were: (1) USDA restrictions on imports of ruminants and their products
from countries with BSE; (2) a ban on feeding most mammalian proteins to cattle and
other ruminants, issued by the Food and Drug Administration (FDA); and (3) a
targeted domestic surveillance program by USDA’s Animal and Plant Health
Inspection Service (APHIS), the agency responsible for animal health monitoring and
disease control.
Some argued that these safeguards were inadequate, as evidenced by the finding
of the first U.S. BSE case and subsequent federal efforts to bolster protections. Most
new actions announced by USDA on December 30, 2003, were under the purview
of USDA’s Food Safety and Inspection Service (FSIS), responsible for the safety of
most U.S. meat and poultry. These actions took effect in January 2004 and included
(1) holding tested carcasses until BSE-negative results are obtained; (2) banning
nonambulatory (“downer”) cattle from human food; and (3) banning certain
additional animal parts from human food. USDA also increased work and spending
on a national animal identification and tracking system, and undertook an enhanced
BSE surveillance program, among other activities. On January 26, 2004, FDA
announced planned changes to its safeguards, including additional bovine materials
banned from the human foods and cosmetics it regulates; a ban on poultry litter,
restaurant waste, and ruminant blood products from ruminant feed; and stricter
oversight of feed manufacturing. In lieu of these changes, FDA on October 6, 2005,
proposed a ban, in all types of animal feed, of some higher-risk cattle parts.
Many Members of Congress have closely followed these BSE developments.
Hearings have been held on various aspects of the issue, and several legislative
proposals have been introduced. Among the policy questions have been whether the
expanded agency actions will protect further against BSE, whether they are
scientifically sound, and what cost they will impose on consumers, taxpayers and
industry. Also at issue have been whether USDA and FDA have effectively
implemented and enforced the current safeguards; whether these safeguards will be
sufficient to rebuild foreign markets’ confidence in the safety of U.S. beef; and
whether other types of actions should be considered, among other questions.
Additional U.S. BSE cases could affect these policy deliberations.
This report will be updated if significant developments occur. For regular
updates on the BSE issue see CRS Issue Brief IB10127, Mad Cow Disease:
Agricultural Issues for Congress, by Geoffrey S. Becker.

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Contents
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Safeguards in Place Prior to December 2003 . . . . . . . . . . . . . . . . . . . . . . . . . 5
Additional Safeguards After December 2003 . . . . . . . . . . . . . . . . . . . . . . . . 5
International Review Team Findings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Trade Restrictions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
International BSE Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Canadian Beef and Cattle Imports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Japan Beef Trade Issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Assessments of Import Safeguards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Harvard Risk Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Government Accountability Office . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Office of Inspector General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
2003 Interagency Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
International Review Team . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Congressional Role . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
The Livestock “Feed Ban” . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
The Feed Ban Prior to December 2003 . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
The Feed Ban After the First U.S. BSE Case . . . . . . . . . . . . . . . . . . . . . . . 18
Stakeholder Response . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Environmental and Economic Impacts of an SRM Ban in Feed . . . . . . . . . 22
FDA Impact Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
NRA/APPI Impact Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
NGFA Impact Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Kansas State Impact Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Enforcement of the Feed Ban . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Congressional Role . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
BSE Surveillance and Testing in Cattle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
BSE Surveillance in the United States Prior to December 2003 . . . . . . . . . 27
Enhanced Surveillance Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
The “Downer” Ban and Impact on Surveillance . . . . . . . . . . . . . . . . . 28
Initial Proposals for Expanded BSE Testing . . . . . . . . . . . . . . . . . . . . 28
One-Time BSE “Enhanced Surveillance Program” . . . . . . . . . . . . . . . 29
Surveillance Program Criticisms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
“Inconclusive” Test Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Confirmatory Testing Methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Private BSE Testing: The Creekstone Decision . . . . . . . . . . . . . . . . . . . . . 35
BSE Testing Costs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Congressional Role . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
BSE Prevention in Slaughter and Processing: The “Fourth Firewall” . . . . . . . . . 37
Ban on “Downer” Cattle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

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Other New Slaughter and Processing Protections . . . . . . . . . . . . . . . . . . . . 39
Congressional Role . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Related Issues and Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Federal Spending on BSE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Animal Identification and Meat Traceability . . . . . . . . . . . . . . . . . . . . . . . . 42
Country of Origin Labeling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Beef Labeled “Organic” . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Chronic Wasting Disease . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Feline Spongiform Encephalopathy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48

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Bovine Spongiform Encephalopathy (BSE,
or “Mad Cow Disease”): Current and
Proposed Safeguards
Introduction
Overview
Bovine spongiform encephalopathy (BSE or “mad cow disease”) is a fatal
degenerative neurological disease of cattle. It is believed to be caused by an
abnormal protein, called a prion. It is in the family of related diseases referred to as
transmissible spongiform encephalopathies, or TSEs. TSEs include scrapie in sheep
and goats, chronic wasting disease (CWD) in deer and elk, and Creutzfeldt-Jakob
disease, or CJD, in humans. BSE is believed to be spread to cattle in feed, but not
transmitted directly from one animal to another in a herd.
Worldwide, BSE has been found in more than 187,000 animals, approximately
183,000 of them in the United Kingdom (UK), where the disease was first detected
in 1986. Most of the rest occurred elsewhere in Europe. Twenty-six countries have
reported cases of BSE, but the total number of annual cases has declined steeply
since their peak in 1992 in the UK.
BSE is thought to be transmissible to humans who eat contaminated beef,
causing a variant form of CJD (variant or vCJD) that was first recognized in 1996
during the BSE outbreak in the UK. About 160 people have been diagnosed with
vCJD since 1986, most of them in the UK. As of September 2005, no persons have
been reported to have contracted vCJD in the United States.1
As of October 2005, BSE had been reported in six cattle in North America, one
in an imported animal and the other five in native-born animals:
! In December 1993, Canada reported BSE in a cow imported from
the UK in 1987, around the height of the outbreak there;
1 By contrast, the U.S. Centers for Disease Control and Prevention (CDC) has estimated that
foodborne diseases cause approximately 5,000 deaths each year in the United States. Many
are caused by such bacteria as Campylobacter, Cryptosporidium parvum, Escherichia coli
O157, Listeria, Salmonella, and Yersinia enterocolitica. For more information and sources,
see CRS Report RL31853, Food Safety Issues in the 109th Congress, by Donna U. Vogt.

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CRS-2
! On May 20, 2003, Canada announced the first native case, found in
a Black Angus beef cow that was born in Saskatchewan in March
1997 and presented for slaughter in Alberta in January 2003;
! On December 23, 2003, USDA announced the first U.S. case, in a
Holstein dairy cow born in Washington state that was born in
Alberta in April 1997;
! On January 2, 2005, Canada confirmed BSE in an Alberta dairy
cow born in October 1996;
! On January 11, 2005, Canada confirmed BSE in an Alberta beef
cow born in March 1998;
! On June 24, 2005, USDA confirmed the first native-born U.S. case,
in a 12-year-old Brahma cross cow from a Texas ranch. This animal
had first been killed and tested in November 2004, when BSE was
initially ruled out, but subsequent retesting of brain tissue in June
2005 determined the presence of BSE.

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CRS-3
Beef Recalls
First U.S. Case: On December 23, 2003, upon the announcement of a BSE-
positive cow in Washington state, FSIS requested a voluntary recall of 10,410
pounds of meat traced to the affected animal and 19 others slaughtered and
processed along with it.2 The agency announced that upon reviewing slaughter
records for the BSE-positive cow, it had determined that high-risk materials — the
animal’s brain, spinal cord and lower intestine (“distal ileum”) — had been
removed at slaughter, and that the muscle meats that passed inspection posed an
“extremely low likelihood that the beef contained the infectious agent that causes
BSE.” Further, the agency stated:
According to scientific evidence, the tissues of highest infectivity are the
brain, spinal cord, and distal ileum. All were removed from the rest of the
carcass at slaughter. Therefore, the meat produced were cuts that would not
be expected to be infected or have an adverse public health impact. The recall
is being conducted out of an abundance of caution.3
Most of the recalled product was distributed to stores in the West, and
primarily in Oregon and Washington, according to various news reports. These
reports indicated that some individuals already had consumed meat from the
affected production lot, consisting of the positive cow and others slaughtered with
it on December 9, 2003. USDA’s February 9, 2004, release observed that
additional beef was mixed in with the originally recalled beef products at several
points in the distribution network. This caused the Department to expand the
recall to approximately 38,000 pounds.

Second U.S. Case: Material from the second U.S. BSE cow — first
suspected of the disease in November of 2004 but not confirmed until June of
2005 — did not enter the food or feed supply, according to USDA. The cow had
been delivered to a Texas plant where its remains would have been processed into
pet food, according to USDA officials. However, these remains were held during
testing for BSE and ultimately were incinerated. So no beef recall was necessary.
In the first U.S. case, USDA stated that virtually no risk to public health existed.
However, the Department announced a voluntary recall of thousands of pounds of
beef that had entered the food supply as a precautionary measure, and also conducted
an extensive epidemiological investigation into how the cow likely contracted BSE
2 USDA, “FSIS Update Of Recall Activities,” release, Feb. 9, 2004, on the Internet at
[http://www.fsis.usda.gov/OA/recalls/prelease/update067-2003.htm]. A Class II recall “is
a health hazard situation where there is a remote probability of adverse health consequences
from the use of the product,” according to the release. USDA does not have explicit
statutory authority to mandate meat recalls or to initiate recalls on its own. However, some
believe that because USDA has the power to withdraw inspection, effectively keeping meat
from the food supply, such mandatory authority is implied. For more information about
meat inspection and slaughter practices, see CRS Report RL32922, Meat and Poultry
Inspection: Background and Selected Issues, by Geoffrey S. Becker.
3 “FSIS Update Of Recall Activities.”

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CRS-4
and whether other animals also might have the disease. During this investigation,
which was officially concluded on February 9, 2004, more than 700 cattle at 11
facilities were destroyed and 255 of those were tested for BSE, all with negative
results. The 255 were deemed “of interest” because they could have been from the
source herd in Alberta, Canada.4
In the second U.S. case, USDA said that no material from the animal entered the
food or feed supply. The epidemiological investigation, completed in late August
2005, attempted to trace all adult animals that left the index farm (the Texas ranch)
after 1990 and all progeny born within two years of the BSE cow’s death. Sixty-
seven animals still on the index farm were killed and tested, all negative for BSE.
USDA determined that 200 animals of interest had left the farm, 143 of which were
slaughtered. Only two others were found alive; one was not tested because its age
ruled it out as a suspicious animal, and the other tested negative. Of the rest, 34 were
presumed dead, one was known dead, and 20 were untraceable. USDA also was
interested in two calves born to the BSE cow, but due to recordkeeping gaps, it had
to trace a total of 213 calves to try to eliminate the calves of interest. None were
found alive to test (most were fed and slaughtered for beef).5
Officials also conducted investigations into the source of the feed consumed by
the infected animals, because feed containing infective ruminant material (i.e., meat
and bone meal from rendered cattle) was considered the most likely source in all of
the cases. All but one of the North American BSE animals were born before both the
United States and Canada in 1997 instituted similar but separate bans on the use of
most mammalian proteins in cattle feed; the other animal was born in Canada more
than six months after the ban was implemented there.
The North American BSE reports prompted widespread debate over the
effectiveness of U.S. (and Canadian) safeguards against BSE. These safeguards
generally have been implemented incrementally over a number of years, not only as
a response to its emergence in Great Britain and spread to other countries, but also
to evolving scientific evidence about this relatively new disease, its causes, and
means of transmission. Many animal health experts inside and outside of
government assert that these regulatory developments do not constitute a “piecemeal”
approach to addressing the BSE threat but rather an increasingly unified system of
overlapping and complementary safeguards.
4 USDA, Final BSE Update — Monday, February 9, 2004. Included in the 255 were 28 of
the 80 cattle that had entered the United States with the cow that tested positive for BSE.
Because of a lack of records, only 28 of these 80 other imports were positively identified,
contributing to the need for the wider investigation and destruction of more animals. For
an overview of the current BSE situation, see CRS Issue Brief IB10127, Mad Cow Disease:
Agricultural Issues for Congress, by Geoffrey S. Becker. For a timeline, see CRS Report
RL32932, Bovine Spongiform Encephalopathy (BSE, or “Mad Cow Disease”) in North
America: A Chronology of Selected Events, by Geoffrey S. Becker.
5 USDA officials had reported, on July 27, 2005, another possible case of BSE, but on
August 3, 2005, they announced that confirmatory tests were negative for the disease. For
the most recent information on this animal and for other USDA statements on BSE issues,
see [http://www.aphis.usda.gov/lpa/issues/bse/bse.html].

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CRS-5
Some critics, nonetheless, have questioned whether these safeguards are
providing adequate protection against BSE. Also at issue have been whether their
costs to taxpayers and industry are justified; whether such steps are defensible
scientifically and will restore foreign markets’ confidence in the safety of U.S. cattle
and beef; and whether other types of regulatory and/or legislative actions should be
considered, among other questions.
Safeguards in Place Prior to December 2003
In the wake of the far more extensive BSE outbreaks in the United Kingdom
starting in 1986, U.S. officials had, by the late 1980s, begun erecting what they and
beef industry leaders had termed the “three firewalls” to keep the disease out of the
United States and to contain it immediately if it should occur here:
! Restrictions on imports of ruminants and their products from
countries with BSE;
! A ban on feeding most mammalian proteins to cattle and other
ruminants; and
! A targeted domestic surveillance program.
A number of critics argued that this system was inadequate. Government
officials acknowledged that the system was not fail-safe, but asserted that it was
scientifically defensible and kept the risks of BSE — to both U.S. agriculture and
human health — at extremely minimal levels. Among other evidence, they cited
reviews they commissioned by the Harvard School of Public Health’s Center for Risk
Analysis (the “Harvard study”) concluding that the safeguards were sound and would
reinforce each other in preventing the spread of isolated BSE cases, should they
arise.6 It should be noted that the Harvard study was a mathematical model that used
assumptions based on existing evidence whenever possible. The study did, however,
consider protections provided by each of the firewalls and a variety of scenarios in
which they could be challenged.
Additional Safeguards After December 2003
Despite official reassurances that the U.S. beef supply and cattle herds were
safe, the first appearance of BSE in the United States ignited a more vigorous debate
on the U.S. safeguards. It also spurred USDA officials to announce, on December
30, 2003, a number of major new actions aimed at strengthening BSE protections.
These additional actions, the Secretary of Agriculture stated, had been under
consideration for some time prior to confirmation of the U.S. BSE case. They are
discussed at greater length later in this CRS report. The new actions included:
! Holding carcasses of tested animals until BSE-negative results are
obtained (notice, January 12, 2004, Federal Register);
6 Joshua Cohen et al., Evaluation of the Potential for Bovine Spongiform Encephalopathy
in the United States, Nov. 2001, revised Oct., 2003, Harvard Center for Risk Analysis,
School of Public Health, at [http://www.aphis.usda.gov/lpa/issues/bse/bse_initiatives.html].
(Hereafter cited as Cohen, Harvard study.)

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CRS-6
! Banning nonambulatory (“downer”) cattle from entering facilities
that slaughter them for human food (interim final rule, January 12,
2004, Federal Register);
! Keeping additional animal parts considered to be at higher risk —
such as central nervous system and several other tissues of older
animals — from the human food supply (interim final rule, January
12, 2004, Federal Register);
! Prohibiting certain meat plant practices such as air injection stunning
and some types of mechanical deboning operations (interim final
rule, January 12, 2004, Federal Register);
! Working on a national system to identify and track individual
animals from their place of birth to slaughter; and
! Naming an international scientific panel to review the government’s
BSE response and recommend any needed improvements (The
panel’s findings are discussed below).
On January 26, 2004, FDA announced it would publish changes to its own BSE
safeguards, such as banning a number of bovine materials from the human foods and
cosmetics it regulates; banning poultry litter, restaurant plate waste, and ruminant
blood products from ruminant feed; and tightening feed manufacturing procedures
and oversight. In the July 14, 2004, Federal Register, FDA published jointly with
USDA an advance notice of proposed rulemaking (ANPR) asking for public input
“on additional measures under consideration to help prevent the spread of BSE.”
Significantly, the FDA stated that it “has reached a preliminary conclusion that it
should propose to remove Specified Risk Material (SRM) from all animal feed and
is currently working on a proposal to accomplish this goal.”
On October 6, 2005, FDA published its long awaited proposed rule to tighten
feed restrictions, by banning, from all animal feeds, some higher-risk cattle parts (i.e.,
some SRM). Some have criticized FDA over both the pace and adequacy of these
proposed changes (a final rule is not anticipated until 2006). FDA officials have
defended their rulemaking, noting that they needed to fully consider the latest
scientific advice, and consider, in addition to the safety aspects, a rule’s impact on
affected industries and on the environment. (For details on these developments, see
later sections of this report).
International Review Team Findings
The international panel of BSE experts released its findings on February 4,
2004.7 The panel (the “International Review Team” or IRT, a subcommittee of a
7 USDA, The Secretary’s Foreign Animal and Poultry Disease Advisory Committee’s
Subcommittee Report on Measures Relating to Bovine Spongiform Encephalopathy (BSE)
(continued...)

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CRS-7
USDA advisory committee on animal diseases) concluded that it is probable that
material from other infected animals imported earlier from Canada and possibly
Europe has been rendered and fed to U.S. cattle, likely causing indigenous infection
here. Although the panel observed that many of the government actions taken so far
had been effective and conformed to international standards, it nonetheless
recommended additional steps. These included further tightening animal feeding
rules by FDA, and more extensive testing of cattle, to gain a better understanding of
the prevalence of any BSE here.
Some BSE experts and consumer groups welcomed findings from the report.
Others in the beef, feed, and related industries responded that the IRT had
exaggerated the risks based on faulty assumptions, and had not properly distinguished
between the BSE situation in North America and the far more extensive problems
experienced in Europe. Some claimed that the panel report contradicted other
scientific findings, such as a three-year examination of the U.S. BSE situation by the
Harvard Center for Risk Analysis.
On February 23, 2004, a full committee of USDA advisors concurred with some
of the subcommittee recommendations, and questioned others. The full committee
recommended that the Harvard Center review the subcommittee’s report in light of
its prior risk analysis.8
The additional actions taken by USDA and FDA in 2004 were intended not only
to reassure consumers and protect livestock health, but also to calm foreign markets,
most of which had quickly banned the entry of U.S. cattle and beef products after
December 23, 2003. (A number of major markets continue to do so as of September
2005.) More actions are possible; a discussion of each major safeguard follows.
Trade Restrictions
With few exceptions, countries with BSE can trace the first case(s) to
importation of affected animals or infected by-products. In this section, U.S. import
controls to prevent BSE are examined, within the context of internationally accepted
standards. For a discussion of economic issues and impacts on the U.S. beef trade
following the discovery of BSE, see CRS Report RS21709, Mad Cow Disease and
U.S. Beef Trade, by Charles E. Hanrahan and Geoffrey S. Becker.
Worldwide, 24 countries, including the United States, had reported one or more
indigenous cases of BSE, and another two reported only imported cases, as of July
2005. The United Kingdom (UK), where BSE was first reported, has experienced
7 (...continued)
in the United States, Feb. 4, 2004, at [http://www.aphis.usda.gov/lpa/issues/bse/bse.html],
hereafter referred to as the USDA Subcommittee report or the IRT report.
8 USDA, Report of the Secretary’s Advisory Committee on Foreign Animal and Poultry
Diseases: Measures Relating to Bovine Spongiform Encephalopathy in the United States,
Feb. 23, 2004, at [http://www.aphis.usda.gov/lpa/issues/bse/bse.html], hereafter referred to
as the USDA Advisory Committee report.

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CRS-8
some 183,000 of the approximately 187,000 cases worldwide, and most of the rest
have been found elsewhere in Europe. Annual BSE cases peaked in the UK in 1992
at more than 37,000, and have been declining there since then.9
As the UK was coping with a then-rising number of BSE discoveries, USDA’s
Animal and Plant Health Inspection Service (APHIS), the lead agency for controlling
animal diseases, began to impose a series of import restrictions here. During 1989,
APHIS first began to ban (by not issuing import permits) the importation of live
ruminants (i.e., cattle, sheep, goats, deer, elk, buffalo) and most ruminant products
from the UK and other countries where BSE has been diagnosed. On December 6,
1991, APHIS published formal rules banning the importation of ruminants, ruminant
meats and related products from BSE countries (these rules essentially superseded
the policy of not issuing import permits).
On December 12, 1997, as BSE cases were emerging in other parts of Europe,
APHIS instituted a ban on importing ruminants and most ruminant products from all
of Europe. On December 7, 2000, USDA began to prohibit imports of all rendered
animal protein products, regardless of species, from Europe out of concern that feed
of nonruminant origin was potentially cross-contaminated with the BSE agent.
(These prohibitions on imports are distinct from the FDA’s domestic feed controls,
described later in this report.)10
International BSE Standards
The Organization of International Epizootics (OIE), the international animal
disease control organization, has recommended that disease risk assessments be
carried out to promote consistent, science-based practices and transparency in
international trade. OIE provides guidance and standards for countries managing
BSE within their borders, and BSE-free countries wanting to maintain their status.
These BSE guidelines are formally published within the OIE Terrestrial Animal
Health Code. As for other animal diseases, the OIE standards for BSE are considered
to be scientifically-based guidelines and recommendations, not hard and fast rules for
trade. Veterinary authorities in individual countries are free to interpret and
implement these guidelines to help prevent the introduction of foreign diseases into
their domestic herds and flocks.11
9 The UK banned the feeding of meat and bone meal (MBM) to ruminants as of July 18,
1989, and imposed a total ban on feeding of MBM to any farm animals in 1996. The OIE
provides regularly updated information on countries with BSE at
[http://www.oie.int/eng/info/en_esb.htm].
10 Sources for this section: various APHIS backgrounders and briefing materials, available
at [http://www.aphis.usda.gov/lpa/issues/bse/bse.html]. Under FSIS’s foreign inspection
program, no establishments in countries with BSE have been permitted to ship beef to the
United States.
11 OIE standards are at [http://www.oie.int/eng/normes/en_norm.htm]. See also OIE,
[http://www.oie.int/eng/info/en_statesb_2003.htm#evaluation].

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CRS-9
The OIE-recommended trade conditions for such countries become increasingly
restrictive as a country’s BSE risk status increases. Under the OIE code, trade in
some ruminant products, even from a highest-risk country, theoretically could occur
so long as the exporting country followed the recommended safeguards.12 (Until
recently the OIE Code described five BSE risk categories for exporting countries,
ranging from BSE free to high BSE risk; there are now three categories. See below).
In practice, however, most countries — including, until August 2003, the United
States — have banned most ruminant products from virtually all countries reporting
even a single case of BSE.
In August 2003, the United States had announced that it, Canada, and Mexico
were entering into discussions at the OIE to develop new guidance for resuming trade
with countries that have reported BSE, under certain conditions. The basis for the
proposal, according to U.S. officials, was that conditions for trade should be based
not simply on the number of “mad cow” cases a country has reported. Rather, trade
conditions should better reflect the adequacy of a country’s safeguards in addressing
whatever level of risk is found through a scientifically valid risk assessment. In other
words, countries with strong safeguards should not be penalized because rigorous
testing has found an acceptably low number of BSE cases, whereas another exporting
with inadequate protections may simply not be testing for and/or reporting the
disease. On May 26, 2005, the OIE agreed to new BSE trade guidelines. Included
is a simplified hierarchy of risk:
! Category 1 countries are those with negligible risk, and thus subject
to the least restrictive conditions for exporting ruminants and
ruminant products;
! Category 2 are those countries with controlled risk; and
! Category 3 are those where the risks are unknown.
In another guideline change, OIE decided that trade in boneless muscle beef
from cattle under 30 months of age should be considered to be safe, regardless of
their exporting country’s BSE risk profile, so long as that country has appropriate
controls in place. For example, one control would be an acceptable method for
determining these animals’ ages and for segregating them from older animals.
The United States and Canada most likely fall within category 2, several
analysts have observed. Again, as under the prior OIE guidelines for BSE, the newly
modified guidelines leave it up to the exporting countries to convince importing
country authorities that their beef and cattle are safe. The importing country, in turn,
might or might not accept these demonstrations of safety — and might not
necessarily agree to observe the OIE guidelines.
12 OIE authorities have explained that importing countries should evaluate the source
country’s risk mitigation measures as a whole, not as separate items on a checklist. See for
example, Declaration of David Wilson, head of the OIE International Trade Department,
February 17, 2005, in the case Ranchers Cattlemen Action Legal Fund USA vs. USDA (CV-
05-06-BLG-RFC).

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CRS-10
If a bilateral trade disagreement over a country’s BSE safeguards were to reach
an international dispute panel, presumably that panel would look to the OIE
guidelines for direction in resolving it. However, a dispute resolution process (such
as under the Uruguay Round agreements administered by the World Trade
Organization) can be lengthy and not always settled to the satisfaction of either party.
The U.S.-supported approach to BSE and trade has been put to the test recently
by practical developments between the United States and its trading partners. More
specifically, Canada has been seeking expansion of its permitted ruminant exports
to the United States. Although the Administration and many in Congress agree with
Canada, several U.S. producer groups and their allies do not (see “Canadian Beef and
Cattle Imports,” below). At the same time, the United States has been trying to
regain access to the Japanese, Korean, and other important export markets, which
have been closed since the United States found its first case of BSE in December
2003. This is despite U.S. efforts to convince them that U.S. safeguards are
scientifically sound, and that they equal or exceed the internationally-recognized
standards (see “Japan Beef Trade Issues” later in this section).
Canadian Beef and Cattle Imports
When Canada announced its first indigenous case of BSE on May 20, 2003, the
United States immediately banned imports of live ruminants, including live cattle,
and ruminant products, including beef and veal, from Canada. On August 8, 2003,
the Secretary of Agriculture announced that the United States would begin to use a
system of permits to import selected ruminant products from Canada, including
boneless beef from cattle under 30 months of age at slaughter. This announcement
was not published in the Federal Register as a formal notice or rule.
USDA did publish, in the November 4, 2003, Federal Register, proposed
changes to its BSE rules that would allow the importation of certain live ruminants
and ruminant products from proposed “minimal risk” regions, including Canada.13
The proposed rules most notably would permit imports of cattle for slaughter before
30 months of age, among other younger ruminants and various products from these
animals.
However, APHIS already had been gradually expanding the types and/or
definitions of eligible Canadian products, by posting these changes on its website but
not widely announcing the changes or publishing them as formal rules. These actions
were challenged in a lawsuit by a group of U.S. cattlemen, Ranchers Cattlemen
Action Legal Fund, United Stockgrowers of America (R-CALF USA).
On April 26, 2004, a federal judge in Montana issued a temporary restraining
order barring USDA from allowing imports of any beef or veal, beyond the types that
the Department had announced as eligible on August 8, 2003. The judge cited
concerns about the safety of animal and human health, and said that USDA had not
13 U.S. Dept. of Agriculture, “Exportation and importation of animals and animal products:
Bovine spongiform encephalopathy; minimal risk regions and importation of commodities,”
68 Federal Register 62386, Nov. 4, 2003.

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CRS-11
followed appropriate rulemaking procedures.14 USDA subsequently reached a May
5, 2004, agreement with plaintiffs that it would no longer allow products beyond
those listed in August 2003 (see above). Any additional Canadian products
(including bone-in beef or live cattle) would not be permitted until after issuance of
the final rule that was first proposed on November 4, 2003, USDA promised.
The final version of the November 4, 2003, proposal was then published in the
January 4, 2005, Federal Register, to take effect March 7, 2005. Specifically, the
rule creates a new category of “minimal risk” BSE regions — those in which
BSE-infected animals have been diagnosed, but where sufficient regulatory measures
have been in place to ensure that the introduction of BSE into the United States is
unlikely. The rule further classifies Canada in this category. The U.S. cattle group
(R-CALF USA) again sued. The same federal judge on March 2, 2005, issued a
preliminary injunction halting implementation of the final rule. The judge stated in
part that R-CALF had “demonstrated the numerous procedural and substantive
shortcomings of the USDA’s decision to allow importation of Canadian cattle and
beef. The serious irreparable harm that will occur when Canadian cattle and meat
enter the U.S. and co-mingle with the U.S. meat supply justifies issuance of a
preliminary injunction ....”15
The Administration appealed. On July 14, 2005, a three-judge panel of the U.S.
Court of Appeals for the Ninth Circuit stayed the district judge’s preliminary
injunction. In its opinion, the three-judge appeals panel rejected each of the major
grounds for the district court’s findings. Among the appeals court’s conclusions were
that “... based on the low incidence of BSE in the Canadian herd, the numerous
safeguards against BSE in this country, the lack of any Canadian cattle under 30
months of age found with BSE, and the lack of any case of vCJD attributable to
Canadian beef, any increased risk to human and animal health created by the Final
Rule is negligible.”16
Subsequently, July 18, 2005, became the first day that live cattle began to cross
the border from Canada since May 2003. From July 18 through October 1, 2005,
approximately 190,000 cattle had been imported from Canada.17 In early August, a
U.S. packer recalled more than 1,800 pounds of beef after authorities discovered that
a 31-month-old Canadian heifer had been imported and processed into meat. The
animal, which was one month older than the 30-month cutoff in the rule, had been
certified as part of a 35-head shipment by veterinarians accredited by Canadian food
safety authorities. In addition, USDA officials have found that more than a dozen of
the Canadian cattle during the first month of imports were pregnant, also in violation
14 Ranchers Cattlemen Action Legal Fund USA vs. USDA (CV-04-51-BLG-RFC).
15 Ranchers Cattlemen Action Legal Fund USA vs. USDA (CV-05-06-BLG-RFC).
16 Ranchers Cattlemen Action Legal Fund USA vs. USDA, (No. 05-35264, DC No. CV05-
006RFC), July 25, 2005. U.S. Court of Appeals for the Ninth Circuit. On September 9,
2005 R-CALF petitioned for a rehearing before the full appellate court.
17 Details on import requirements and procedures are posted on the USDA-APHIS website
at [http://www.aphis.usda.gov/lpa/issues/bse/bse.html]. For the latest import data see the
Agricultural Marketing Service website at [http://www.ams.usda.gov/lsmnpubs/canada.htm].

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CRS-12
of the rule. The incidents fueled criticism among some opponents that the border
reopening was premature.
Japan Beef Trade Issues
On October 23, 2004, U.S. and Japanese negotiators announced that they had
made progress in negotiations to resume two-way beef trade. According to a joint
statement, the United States would certify that only beef from cattle of 20 months or
younger are shipped. (Roughly 70% of the 35 million U.S. cattle each year are
believed by USDA to be 20 months of age or younger, but verifiable age records may
only be available for anywhere from 10% to 25% of cattle, according to various
estimates.) The United States also agreed to, among other things, an expanded SRM
definition, to cover cattle of all ages. USDA’s current SRM list is somewhat
different and generally covers only cattle over 30 months of age.
The announcement stated that the two countries would evaluate this interim
system by July 2005 and modify it if appropriate. However, Japan, which has
reported 20 cases of BSE in its own cattle herd as of mid-October 2005 had not yet
accomplished what it maintains are all the necessary regulatory changes. Although
Japan said that as of August 1, 2005, it had eased its testing rules so that only cattle
over 20 months of age must be tested, additional policy changes to actually allow
imports of U.S. beef are not yet final. These changes have involved many steps and
a number of different agencies, including review by Japan’s independent Food Safety
Commission. Press reports have been conflicting as to how soon the market might
reopen. For example, the Commission again deferred a final decision at a September
26, 2005 meeting, with members stating that they wanted more time to evaluate U.S.
safety measures. Then, by mid-October 2005, Reuters and several other news
sources reported there were signs that the Commission’s concerns about the adequacy
of U.S. safeguards had been eased. Still, most observers do not expect any U.S. beef
to enter Japan before the end of the year at the earliest.
Meanwhile, U.S. rules to permit the importation of Japanese beef are advancing.
USDA published, in the August 18, 2005, Federal Register, a proposed rule that
would permit the importation of whole cuts of boneless beef from Japan, under
specified conditions. USDA said the proposal is in accord with OIE guidelines and
is based on a risk analysis indicating that such cuts could be safety imported. Some
expressed frustration that the United States appeared to be acceding to the Japanese
request without a coinciding move by Japan, where the BSE problem has been more
pronounced.
Assessments of Import Safeguards
Harvard Risk Analysis. After discovery of the first Canadian BSE case in
May 2003, but before the first U.S. case in December 2003, USDA officials had
asked the Harvard Center for Risk Analysis to reassess its earlier analysis (completed
in 2001) of the potential for an outbreak and spread of BSE in the United States. The
reassessment concluded in part that “the possible introduction of BSE into the United
States from Canada cannot be dismissed,” but that the likelihood is very low, and
U.S. protective measures by now would have contained any possible spread.

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CRS-13
However, the reassessment also noted that a group of cattle imported into Canada
from the United Kingdom in 1993 included one that was found to have BSE:
If additional animals in this group harbored the disease and were slaughtered and
rendered, infectivity may have been introduced into the Canadian and U.S. cattle
feed supplies before the 1997 feed ban was implemented in both countries.... If
additional animals were infected, they may have been exported to the U.S. as
well.... [It] appears that any related introduction of BSE into the U.S. from
Canada would have been due to the import of either infected animals or
contaminated feed. Imports are a plausible source of introduction of BSE into
the U.S. from Canada because the American and Canadian beef industries are
closely linked. During the last five years, the U.S. has on average imported over
1.2 million cattle and 185,000 tons of feed annually from Canada.18
In its February 4, 2004, report, the international panel of BSE experts which
examined the first U.S. BSE case and the government’s response (the “International
Review Team,” or IRT) observed:
... the number of cattle actually infected on the farm of origin in Canada was
probably small. Indeed the index case identified in the USA may be the only
infected animal from the Canadian herd of origin that survived to adulthood.
However, it is probable that other infected animals have been imported from
Canada and possibly also from Europe. These animals have not been detected
and therefore infective material has likely been rendered, fed to cattle, and
amplified within the cattle population, so that cattle in the USA have also been
indigenously infected. Therefore, animals that have not been identified from the
birth cohort of the index case do not represent significant additional risk for
further propagation of BSE within the USA.19
Government Accountability Office. A January 2002 report by the
Government Accountability Office (GAO) stated that federal actions had not ensured
that all BSE-infected animals or products are excluded from the United States. GAO
observed that:
[T]he United States had imported about 125 million pounds of beef (0.35% of
total imported) and about 1,000 cattle (0.003% of total imported) from countries
that later discovered BSE — during the period when BSE would have been
incubating. In addition, weaknesses in USDA’s and FDA’s import controls, such
18 Joshua Cohen and George M. Gray, Evaluation of the Potential Spread of BSE in Cattle
and Possible Human Exposure Following Introduction of Infectivity into the United States
from Canada, pp. 1-2 (undated 2003 report). Harvard Center for Risk Analysis, School of
Public Health. [http://www.aphis.usda.gov/lpa/issues/bse/harvard_10-3/text_wrefs.pdf].
19 Report on Measures Relating to Bovine Spongiform Encephalopathy (BSE) in the United
States, p. 3. The expert panel, formally a subcommittee of the Secretary of Agriculture’s
Foreign Animal and Poultry Disease Advisory Committee, included two Swiss experts and
one each from the United Kingdom, New Zealand, and the United States, the latter Dr. Will
Hueston, a veterinarian who is Director of the Center for Animal Health & Food Safety at
the University of Minnesota and a former FSIS official. The report can be viewed at
[http://www.aphis.usda.gov/lpa/issues/bse/US_BSE_Report.pdf].

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CRS-14
as inspection capacity that has not kept pace with the growth in imports, may
allow BSE-infected products to enter the country.20
GAO recommended that the Secretaries of Health and Human Services (HHS)
and of Agriculture develop a coordinated strategy to strengthen import inspections,
in consultation with the Commissioner of Customs. Although the GAO has since re-
examined the Administration’s recent record on the animal feed rules, it has not done
so with regard to U.S. import protections.
Office of Inspector General. USDA’s Office of Inspector General (OIG)
in February 2005 published a critical report on the Department’s actions on opening
the border to cattle and beef products from Canada. The OIG concluded that
USDA’s actions were sometimes arbitrary and undocumented; policy decisions were
poorly communicated to the public and between APHIS and FSIS; and controls over
the regulatory process were inadequate. Explaining that APHIS used a permitting
system (as opposed to formal rulemaking) for reopening the border to some Canadian
products, OIG found that between August 2003 and April 2004:
APHIS issued 1,155 permits for the importation of ruminant products from
Canada without ensuring that the agency had an appropriate system of internal
controls to manage the process. The APHIS permit system was originally
designed to allow for the import of research quantities (generally small amounts)
of material into the United States. According to APHIS officials, this permit
system handled approximately 400 permit requests annually. The procedures
that APHIS had developed for handling permit requests for small amounts of
product were not adequate to deal with the high volume of requests for large
quantities of commercial use beef. The agency did not implement or finalize
standard operating procedures for processing the large volume of permits. For
example, APHIS did not establish controls to ensure that risk mitigation
measures were consistently applied. We found that 8 of the 83 permits issued for
bovine liver did not include the risk mitigation measure that the livers be from
animals slaughtered after August 8, 2003. We also found that APHIS did not
implement requirements to perform onsite monitoring of permit holders,
Canadian facilities, or inspection personnel at U.S. ports of entry. As a result,
there was reduced assurance that Canadian beef entering the United States was
low-risk. Some product with questionable eligibility, as described above, entered
U.S. commerce.21
The OIG recommended that APHIS institute procedures for communicating
changes in policy to all interested parties, e.g., importers and the public, and for
monitoring the consistency between agency practice and publicly stated policy. OIG
also recommended, among other things, that APHIS strengthen its controls and
procedures for issuing and monitoring permits for commercial quantities of products;
that FSIS implement its own controls for communicating changes in the eligibility
of imported products; and that FSIS implement an edit check in its import
20 General Accounting Office, Mad Cow Disease: Improvements in the Animal Feed Ban
and Other Regulatory Areas Would Strengthen U.S. Prevention Efforts (GAO-02-183), p.
3, Jan. 2002. (Hereafter cited as GAO Mad Cow Disease report.).
21 USDA, OIG, Animal and Plant Health Inspection Service Oversight of the Importation
of Beef Products from Canada, at [http://www.usda.gov/oig/webdocs/33601-01-HY.pdf].

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CRS-15
information system to identify ineligible product presented for entry into the United
States. USDA agreed with and promised to implement most of the report’s findings.
2003 Interagency Report. A January 2003 federal interagency report on
animal disease prevention had also recommended that USDA and HHS update risk
assessments, import regulations, and guidance on enforcing regulations at ports of
entry.22 More specifically, it was noted that agencies need to develop guidance and
plans at ports of entry to fully implement the recently enacted Animal Health
Protection Act (7. U.S.C. 8301 et seq.). Further, the report recommended revisions
to the Virus-Serum-Toxin Act to help APHIS enforce import rules on animal
biologics products. The interagency report also concluded that the FDA needs
additional authority to strengthen its BSE capabilities at ports of entry. The report
said FDA has been considering a number of additional protective measures for FDA-
regulated products, including: directing importers to use only designated ports for
entry of products that might contain bovine materials; requiring certain importers to
be certified in order to import such products into the United States; destroying
detained products so that they cannot be re-imported at another time or port;
requiring country-of-origin documentation of all imports containing mammalian or
mammalian sourced ingredients; and prohibiting imports containing bovine materials
from any BSE country.23
International Review Team. In a section of its report entitled “Lessons
Learned,” the international panel (IRT) commended the United States for following
a science-based approach to policy formulation. It further noted that the North
American BSE cases “demonstrate again that exporting countries feel significant
national social and financial impacts when importing countries fail to comply with
international rules regarding trade.” Therefore, the United States “should
demonstrate leadership” by following international standards and by encouraging
“the discontinuation of irrational trade barriers when countries identify their first case
of BSE.” At the same time, the panel concluded, the United States should “continue
to act responsibly when considering export of potentially contaminated materials
such as live cattle, MBM [meat and bone meal] and feed. Risk materials must be
destroyed or safely utilized to protect human health, animal health, and the
environment in the USA and worldwide.”24
Congressional Role
USDA and FDA so far have not recommended any statutory changes in import
safeguards. However, Congress has demonstrated interest in trade-related aspects of
the BSE situation, and several legislative proposals have emerged. In the 109th
Congress, the Senate Agriculture Committee received testimony on February 3, 2005,
22 Animal Disease Risk Assessment, Prevention, and Control Act of 2001(PL 107-9) Final
Report, pp. 44-45, prepared by the P.L. 107-9 Federal Interagency Working Group, Jan.
2003.
23 Ibid.
24 Report on Measures Relating to Bovine Spongiform Encephalopathy (BSE) in the United
States, p. 11.

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CRS-16
from Agriculture Secretary Johanns on the impacts of BSE on U.S. cattle and beef
imports and exports. The House Agriculture Committee held a hearing on March 1,
2005, on USDA’s rulemaking to admit more Canadian beef and live cattle. The
matter also was a major topic at Secretary Johanns’ confirmation hearing and at
USDA’s FY2006 appropriations hearings.
On March 3, 2005, the Senate approved, 52-46, a resolution l (S.J.Res. 4) to
disapprove USDA’s January 4, 2005, Canada import rule. However, House and
Presidential approval have not been anticipated. Other pending bills addressing the
Canada rule include H.R. 187, to prohibit the rule “unless United States access to
major markets for United States exports of cattle and beef products is equivalent or
better than the access status accorded such exports as of January 1, 2003”; and H.R.
384/S. 108, to prohibit the Canada rule unless mandatory retail country of origin
labeling (COOL), is implemented. The current statutorily set deadline for COOL for
fresh meats is September 30, 2006. S. 294 would prohibit imports (from a minimal
risk region like Canada) of meat, meat byproducts, and meat food products from
bovines over 30 months old unless the Secretary reports to Congress that the region
“is in full compliance with a ruminant feed ban and other [BSE] safeguards.”
The sluggish pace of the Japanese negotiations has frustrated the beef industry
and many Members of Congress, who believe opening the Japanese market will
convince other Asian nations, including Korea, to follow suit. This frustration was
evident in the Senate’s passage on September 19, 2005, of a floor amendment which
would prohibit implementation of USDA’s August 18th Japan rule unless Japan opens
its market to U.S. beef. The amendment was attached by a 72-26 vote to H.R. 2744,
the FY2006 appropriation for the Department and related agencies. The
House-passed version of H.R. 2744 lacks the amendment, so the provision awaits
House-Senate conference. Pending in the House is a resolution introduced earlier in
2005 (H.Res. 137) which calls for economic sanctions against Japan if it does not
permit U.S. beef.
The Livestock “Feed Ban”
Overview
Feed is thought to be the most common and perhaps only route of infection for
BSE in cattle. The emergence of BSE in the UK is generally thought to have resulted
from the feeding of rendered by-products of infected animals, including highly
infectious brain tissue, to other cattle as a protein supplement. The cause of the first
cases of BSE is unknown; theories include spontaneous emergence of a single case,
or the anomalous transmission of the sheep scrapie agent to cattle. It is thought that
the long incubation period and possibly changes in rendering and feeding practices
led to amplification of the agent in the feed supply and spread of the disease for years
before it was recognized in 1986.
In 1988, the UK banned the practice of feeding ruminant by-products back to
ruminants. When the purported causal link between BSE and the human disease,
variant Creutzfeld-Jakob disease (vCJD), was announced by the UK in 1996, the

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CRS-17
United States added similar controls over cattle feed, to prevent spread of the disease
should it emerge. 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.”25
FDA registers and inspects renderers, feed mills, pet food manufacturers, animal feed
distributors and others to ensure compliance.
In a 2002 report on the feed ban, the GAO (then called the General Accounting
Office) noted that relative to other countries, U.S. surveillance and import controls
were stronger, but the feed ban was more permissive.26 The Harvard study concluded
that the feed ban was the dominant protective firewall, and would protect against
spread of BSE even if the other firewalls failed. Conversely, the study also showed
that failure of the feed ban led to the greatest increase in number of BSE cases. Many
also noted that certain continuing, permissible practices may nonetheless result in the
feeding of rendered ruminant materials to cattle. One such potential breach is the
feeding of rendered cattle to poultry and the subsequent incorporation of poultry
waste (called “litter”), which may contain spilled feed, into livestock feeds.
Though in 2002 GAO limited its recommendations to improved enforcement
of the existing feed ban, others suggested that the regulation itself be changed to
enhance protection. The Harvard study found that if BSE were present in the United
States, the greatest source of potential feed contamination would be from cattle that
died on the farm and were rendered. By-products from these animals could legally
be fed to non-ruminants, and the Harvard study found that if one such rendered cow
were BSE-positive, the resulting release of infectivity into the feed supply could lead
to new bovine cases from a single subsequent breach in the feed ban.27
Many, including the GAO and the Harvard study, have noted that there are
opportunities for noncompliance at many points in the feed chain, and that some may
be difficult to detect, such as intermittent commingling of feeds on farms that feed
cattle along with poultry and other livestock. Some experts argued that if high-risk
materials were prohibited in all animal feeds, that cross-contamination, breaches at
feeding, and the concurrent regulatory oversight of these activities would become
irrelevant. Livestock industry representatives have expressed concern about potential
lost income if certain beef by-products were to lose their commercial value. Yet
others have voiced concern about potential environmental and other impacts of
converting these by-products from their useful functions and instead designating
them as waste.
Following the first domestic BSE case, the FDA in January 2004 announced
imminent plans to expand feed ban restrictions. The regulation has yet to be altered
25 21 CFR Part 589.2000, published in the Federal Register on June 5, 1997. Canada
adopted a similar but not identical ban at the same time.
26 GAO, Improvements in the Animal Feed Ban and Other Regulatory Areas Would
Strengthen U.S. Prevention Efforts, (GAO-02-183), January 2002.
27 Cohen, Harvard study, p. 111.

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CRS-18
as of October 2005, although FDA did publish, on October 6, 2005, its proposed rule
to ban some higher-risk cattle parts from all types of animal feed.
The Feed Ban Prior to December 2003
The feed ban imposed in 1997 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.
Some also questioned the feed ban exemptions, including the practice of using
rendered bovine blood in milk substitutes for calves. Based on concerns that the
agent linked to the human form of BSE, vCJD, could be present in blood, another
center at FDA had recommended that persons having resided in the UK be barred
from blood donation in the United States, to eliminate the potential for transmission
from blood donors infected in the UK and not yet showing symptoms.28
In 2002, FDA published an advance notice of proposed rule-making (ANPR),
stating that it was considering revising its feed regulation and seeking comments on
five relevant topics: excluding from feed the brain and spinal cord from rendered
animal products; use of poultry litter in cattle feed; use of pet food in ruminant feed;
preventing cross-contamination; and elimination of the plate waste exemption.29
The Feed Ban After the First U.S. BSE Case
On January 26, 2004, after the first U.S. BSE case was found, FDA announced
the imminent publication of a new interim final rule with four provisions to further
strengthen the feed ban. The provisions were to be the elimination of the exemptions
for 1) blood and 2) plate waste, 3) a prohibition on feeding poultry litter to cattle, and
4) expanded measures to prevent cross-contamination of ruminant feeds with non-
ruminant feeds in mills and storage facilities.30
On February 3, 2004, the IRT recommended additional steps, including more
stringent animal feed restrictions than those just announced by FDA. The panel
28 FDA, Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk
of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease
(vCJD) by Blood and Blood Products, Jan. 2002, at [http://www.fda.gov/cber/
gdlns/cjdvcjd.htm].
29 FDA, “Substances Prohibited From Use in Animal Food or Feed; Animal Proteins
Prohibited in Ruminant Feed,” 67 Federal Register 67572, Nov. 6, 2002.
30 U.S. Department of Health and Human Services, “Expanded ‘Mad Cow’ Safeguards
Announced To Strengthen Existing Firewalls Against BSE Transmission,” press release,
Jan. 26, 2004.

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expanded both the proposed list of products that should be banned from ruminant
feed, and also from the feed stream in general, recommending “that the current feed
ban be extended to exclude all mammalian and poultry protein from all ruminant
feeds,” and that “all (specified risk material, or SRM) must be excluded from all
animal feed, including pet food.”31 The panel defined SRM more stringently than
had the USDA in December 2003 in its food safety provisions, recommending the
removal of high-risk tissues from all cattle older than 12 months, rather than 30
months, keeping these SRM out of both the food and feed supplies.
In the subsequent report of the full advisory committee, released on February 24,
2004, concerns were expressed about inconsistencies between the IRT
recommendations and findings from the Harvard study. The Committee noted that
“A major discrepancy exists with the Subcommittee’s conclusions that BSE
continues to circulate, or even amplify, ... when compared with the Harvard risk
assessment,” and stated that this issue of risk must be resolved before the Committee
could complete its recommendations.32 The report explains the importance of
establishing a robust nationwide surveillance system as a means to better understand
the extent of BSE circulation. The Committee endorsed some elements of the IRT’s
proposed feed ban expansions, but was silent on others.
Instead of implementing the measures it had announced in January 2004, FDA,
on July 14, 2004, published an ANPR seeking information and comment about its
“(tentative conclusion) that it should propose removing SRM from all animal feed
to adequately control the risks associated with cross-contamination throughout feed
manufacture and distribution and with intentional or unintentional misfeeding on the
farm.”33 Since this measure would eliminate the need for protections against cross-
contamination or a ban on feeding of poultry litter, FDA said, those proposals would
not be finalized at that time but would be reassessed in light of a possible expanded
SRM ban. But the previously announced bans on feeding bovine blood and plate
waste were also not finalized. FDA instead posed a number of questions to gather
information and relevant scientific evidence, as well as economic, environmental and
other consequences of a variety of proposals, including an SRM ban in feed.
Consumer groups and some Members of Congress criticized the FDA for its
failure to move more quickly on proposed feed ban modifications. They said that
decisions regarding the exemptions for blood and plate waste would not depend on
a decision on SRM prohibitions, and that the blood and plate waste exemptions
should therefore be promptly removed. The blood exemption has been the subject
of considerable discussion. Blood is used to make formula (“milk replacer”) for
newborn calves, which some experts feel may be especially susceptible to infection
from small doses of the BSE agent.
31 USDA Subcommittee report, pp. 8-9.
32 USDA Advisory Committee report, p. 2.
33 USDA/ HHS, “Federal Measures to Mitigate BSE Risks: Considerations for Further
Action,” Federal Register, July 14, 2004.

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The OIE continues to state, as it always has, that bovine blood and blood
products in feed do not present a risk for BSE transmission.34 But in its rationale for
proposing a blood ban in January 2004, FDA noted recent concerns about human
transmission of vCJD by blood transfusion, which suggested that infectious prions
could be present in blood, while also noting that transfusion would likely pose a
greater risk from minute exposures than would feeding.35 In its July 2004 ANPR, the
agency requested comment on the evidence of a transmission risk from blood in feed.
The FDA next published a proposal to modify the feed rule on October 6,
2005.36 Comments are being accepted until December 20, 2005, after which the
comments are to be evaluated and, presumably, the rule can be published in final
form. The proposal would ban, from all types of animal feeds (including pet food),
the following materials that would be considered higher risk (that is, SRM):
! brains and spinal cords of cattle 30 months of age and older;
! brains and spinal cords of any cattle, regardless of age, if they were
not inspected and passed for human consumption;
! the entire carcass of any cattle not so inspected and passed if their
brains and spinal cords have not been removed;
! tallow derived from the above higher-risk materials if it contains
more than 0.15% insoluble impurities;
! mechanically separated beef derived from such higher-risk materials.
The FDA proposed rule thus defines SRM more narrowly for animal feeds than
USDA-FSIS defines it for human food (see a more complete discussion of the FSIS
rule in the section of this report entitled “BSE Prevention and Processing: The
‘Fourth Firewall’”). For example, the FDA proposal appears to permit skull, eyes,
trigeminal ganglia, spinal cord, vertebral columns, and dorsal root ganglia of cattle
30 months of age and older, and the tonsils and part of the small intestine (distal
ileum) of cattle of all ages. The October 6 proposed rule also would not ban — even
from ruminant feed — blood and blood products, plate waste, and poultry litter.
Explaining its proposal, FDA stated that banning the brain and spinal cords of
cattle 30 months and older would remove 90% of BSE infectivity without creating
an undue burden on the rendering and meat industries. It based the 90% claim on a
report by a European Union scientific panel which found that approximately 64% of
the infectivity in an animal with BSE is in the brain, and 26% is in the spinal cord.
34 OIE Terrestrial Animal Health Code 2005, Chapter 2.3.13, Bovine Spongiform
Encephalopathy, at [http://www.oie.int/eng/normes/mcode/en_chapitre_2.3.13.htm]. OIE
notes the caveat that blood and blood products pose no known risk as long as cattle are
slaughtered with a method that does not result in spreading of brain matter into the blood.
35 U.S. Senate Committee on Agriculture, Nutrition and Forestry, hearing on Mad Cow
Disease, Jan. 27, 2004, 108th Congress, 2nd sess., comments of Lester Crawford, then Deputy
Commissioner of FDA. See also CRS Report RL32269, Transmissible Spongiform
Encephalopathies (TSEs), Including “Mad Cow Disease”: Public Health and Scientific
Issues, by Sarah A. Lister and Judith A. Johnson.
36 70 Federal Register pp. 58570-58601.

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CRS-21
Each of the remaining SRMs covered by the USDA-FSIS human food ban contain
much smaller percentages of total infectivity, FDA said.37
Even though the existing feed rule provides “strong control measures” and
compliance “is high by renderers, protein blenders and feed mills,” FDA
acknowledged that concerns about cross-contamination remain:
For example, without fully dedicated equipment, it may not be possible to verify
that there is zero carryover of feed or feed ingredients in equipment, even where
a firm’s cleanout procedures have been judged to be adequate. In addition,
resource constraints limit FDA’s ability to assure full compliance by all segments
of the industry that are subject to the current BSE feed regulation. For example,
resources are not available to the FDA and its state counterparts to fully verify
compliance on over 1 million farms where cattle are being fed.38
The agency also noted concerns not only about unintentional but also intentional
misfeeding of non-ruminant feed to ruminants on the farm. Financial incentives may
exist to do so whenever inexpensive sources of prohibited protein are locally
available, FDA concluded, adding that it believes the proposed rule would protect
cattle by removing the highest risk materials even from non-ruminant feed.
In its accompanying economic analysis, FDA stated that it did consider the
following options: requiring the use of dedicated facilities or equipment to keep
ruminant feed separate from non-ruminant feed; bans on poultry litter, blood products
and/or plate waste in ruminant feeds; and a larger list of SRM unacceptable in all
feeds. It generally concluded that such additional measures are not necessary because
the partial SRM ban being proposed removes so much (i.e., an estimated 90%) of
BSE infectivity. However, it again asked for further comments on these options.
Stakeholder Response. Initial reactions to the proposed rule were mixed.
The American Meat Institute (AMI), representing the major meat packing companies,
described the approach, in part, as “the appropriate science-based policy.”39 The
National Cattlemen’s Beef Association (NCBA) declared that the proposals would
“further enhance stringent BSE safeguards already in place and diligently enforced
in the United States for the past two decades.” But NCBA said it would be analyzing
the rule to ensure that it is science-based.40
Public Citizen, a consumer advocacy organization, argued that the proposal
would leave “gaping holes” in the animal feed ban by continuing to allow the use of
cattle blood, poultry litter, and plate waste in cattle feed. The rule also would still
allow the use of rendered cattle remains, including some nervous system tissues, in
feed for hogs and poultry. Because their remains, in turn, “can be put back into cattle
37 70 Federal Register p. 58578.
38 70 Federal Register p. 58576.
39 Hodges, Jim, American Meat Institute Foundation, October 6, 2005, letter in the Atlanta
Journal-Constitution.
40 McAdams, Jim, NCBA President, October 4, 2005, statement, accessed on the Internet at
[http://hill.beef.org/newview.asp?DocumentID=16518].

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CRS-22
feed, the pathways for the disease to spread will still exist.” The group also
contended that the rule is less restrictive than the “complete ban on SRMs in animal
feed” under development in Canada.41
Environmental and Economic Impacts of an SRM Ban in Feed
The feed ban instituted in 1997 permits rendering of ruminant by-products as
long as they are not re-fed to ruminants. Proposals to ban the use of SRM imply that
alternate disposal routes for these products will be needed. Proper rendering
practices kill most important human and animal disease organisms (including the
Foot and Mouth disease virus, Salmonella, and the anthrax organism), and can reduce
BSE infectivity, while complying with existing clean air and clean water regulations.
Some assert that a broader SRM ban in animal feeds could lead to disposal of these
products in ways that are unsafe, with adverse health, economic and environmental
impacts. Some studies have concluded that there may not at this time be safe, legal,
widely-available alternatives if certain cattle and their by-products cannot enter either
the slaughter-and-food system, or the rendering-and-feed system. Alternative carcass
disposal options, such as burial or burning on the farm, or disposal in a landfill, may
be prohibited by state or federal law, or be unavailable.42
SRM removal from cattle at slaughter is already underway for all cattle over 30
months of age, in accordance with FSIS food safety measures introduced in
December 2003. FDA’s proposal to ban SRM from all animal feed would alter
where these by-products could go, but would not substantially alter slaughter
practices. In contrast, cattle that are dead or condemned at slaughter had gone to
rendering in their entirety. Careful removal of SRM from these animals would
require entirely new carcass-handling arrangements at rendering, with attendant
economic consequences. Economic analyses often were outdated, did not use
comparable assumptions, or did not address FDA’s current proposals.43 Nonetheless,
impacts appeared to be substantial, with ripple effects through the rendering industry,
beef and live cattle markets, and markets for alternative livestock feed ingredients
such as soybeans.
41 Hauter, Wenonah, Director, Public Citizen’s Food Program, “ New Animal Feed Rules
Still Leave Consumers at Risk for Mad Cow Disease,” October 4, 2005 statement, accessed
on the Internet at [http://www.citizen.org/pressroom/release.cfm?ID=2058].
42 See Jean E. Sander et. al., “Selected Methods of Animal Carcass Disposal,” Journal of the
American Veterinary Medical Association, vol. 220, no. 7, pp. 1003-1005, Apr. 1, 2002, and
Sparks Companies Inc., The Rendering Industry: Economic Impact of Future Feeding
Regulations, June 2001. Several comments in response to FDA’s ANPR noted that the
packing and rendering industries are exploring alternative uses for SRM such as biomass-
based energy.
43 See FDA, TSE Regulatory Options Cost Analysis, June 1997, at
[http://www.fda.gov/cvm/index/bse/tse_options.htm], and Sparks Companies, Inc., The
Rendering Industry: Economic Impact of Future Feeding Regulations, June 2001. For a
description of the industry and its role in livestock production also see CRS Report
RS21771, Animal Rendering: Economics and Policy, by Geoffrey S. Becker.

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CRS-23
In its ANPR, FDA had sought information about the economic and
environmental impacts of prohibiting SRM in all animal feeds. There have been
several recent efforts to better describe and/or quantify these environmental and
economic impacts. Some of these observations were reflected in comments
submitted in 2004 in response to FDA’s feed rule ANPR, and are described in more
detail later in this section of the report.
FDA Impact Analysis.44 FDA calculated the total costs of the proposed
changes to rendering and slaughtering firms at between $14.4 million and $23.8
million per year over seven years. These figures include the costs of needed capital
investments in slaughter and rendering facilities, plus their labor and recordkeeping
expenses, lost value of cattle parts no longer eligible for feed, feed substitution costs,
and disposal costs.
Disposal costs account for the single largest expense for slaughterers and
renderers, estimated at $7.7 million to nearly $10 million per year. This expense is
based on the need to dispose of from 64.3 million to 83.1 million pounds of cattle
parts no longer eligible for animal feed use. In addition, cattle producers will incur
additional costs of from $1.02 million to $2.53 million per year for disposing of from
26,000 to 64,000 cattle carcasses that could no longer be rendered, according to
FDA’s economic analysis.
Several analysts argue that under the proposed rule, enough potential remaining
BSE infectivity (i.e. 90%) would be removed from the feed supply, leaving a much
lower cost burden to industry than a broader SRM ban, which would bring only
minimally greater risk reduction, and at far higher cost. For example, as the
economic analysis estimates, banning all SRM plus all dead and downed cattle
carcasses would have cost the industry an estimated $195 million to $240 million.
Such a broader ban also would have had major environmental implications, because
quantities of all SRM, dead and downer animals could total 2.1 billion pounds or
more, and much of this would have to be incinerated, placed in landfills, or otherwise
disposed of.45
NRA/APPI Impact Analysis. Joint comments on the earlier ANPR by the
National Renderers Association (NRA) and the Animal Protein Producers Industry
(APPI) cited an August 2004 study commissioned by NRA. The study estimated that
1.423 billion pounds of raw material (i.e., cattle parts) generated annually by
livestock slaughter facilities would be affected by a broader SRM ban, at a loss in
annual sales value to the industry of $91.6 million. Adding a disposal cost of $74.7
million per year, the total economic loss to the industry would be $166.3 million
annually.46
44 FDA’s Analysis of Economic Impacts begins on page 58584 of 70 Federal Register.
45 This volume estimate is from FDA’s Environmental Assessment for Amendments to 21
CFR 589, Substances Prohibited From Use in Animal Food or Feed Proposed Rule,
September 26, 2005, page 29.
46 National Renders Association and Animal Protein Producers Industry, Response to FDA
Docket No. 2004N-0264, Federal Measures to Mitigate BSE Risks: Considerations for
(continued...)

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CRS-24
The NRA/APPI response claims that extensive SRM restrictions could
discourage pickup of dead animals by renderers. Their study also found that the
rendering industry now processes many dead or condemned animals before they can
be slaughtered for food. It estimated the lost value of this material (1.133 billion
pounds annually) at another $100.8 million per year. The NRA/APPI comment
agrees that limited disposal options as a result of the rule would create a major
environmental impact.
NGFA Impact Analysis. The National Grain and Feed Association (NGFA),
representing grain, feed, processing, and other grain-related companies including
commercial feed mills, has cited one estimate of the per-head cost of removing and
disposing all SRM at $10.70 per animal. This includes removal and segregation of
SRM at the packing plant, lost value of rendered product, and disposal costs.47
Kansas State Impact Analysis. A 2005 study by Kansas State University
estimated that after implementation of the 1997 (current) feed ban, the average price
of ruminant meat and bone meal (MBM) was discounted by $15.78 per ton relative
to porcine MBM, which did not change from January 1998 to December 2003. (As
an example, a 1,275 pound steer, live weight, which yields 108 pounds of MBM,
would be discounted 86 cents per head.) After discovery of the first U.S. cow with
BSE in December 2003, during the first half of 2004, the discount reached $58.56 per
ton, or $3.17 per steer, the study reported.48 Banning animal consumption of all SRM
would represent a further revenue loss of $1.63 for an animal under 30 months of age
and $5.11 for animals over 30 months, the study calculated. Disposal costs would
an additional 53 cents per younger animal and $1.66 per older animal — for a total
combined cost of $2.16 per head for fed slaughter cattle, and $6.77 per head for older
animals. For dead and downer animals, the total cost of such a rule would be $76.50
per head, of which $57.75 is lost MBM revenue, and $18.75 is disposal costs. (The
latter figure may be overestimated, according to the study.)
46 (...continued)
Further Action, August 13, 2004. The study, An Economic and Environmental Assessment
of Eliminating Specified Risk Materials and Cattle Mortalities from Existing Markets,
August 2004, is on the FDA docket website as an attachment to the NRA/APPI comment.
47 National Grain and Feed Association, Response to FDA Docket No. 2004N-0264, August
13, 2004.
48 The Kansas study also examined per-steer costs associated with a number of other feed
policy options: an end only to the exemption in the current feed ban for blood meal; an
expanded definition of SRM to cover younger as well as over 30-month-old cattle; a ban on
feeding any animal protein to ruminants; a ban on feeding ruminant protein to any farmed
animals; and a ban on feeding any animal protein to any farmed animals. Coffey, Brian, et
al., Kansas State University Agricultural Experiment Station and Cooperative Extension
Service, The Economic Impact of BSE on the U.S. Beef Industry: Product Value Losses,
Regulatory Costs, and Consumer Reactions, (prepared for the Kansas Department of
A gr i c u l t u r e ) , A p r i l 2 0 0 5, at [ ht t p: / / www.agmanager .i nf o/ l i ve s t o c k/
marketing/bulletins_2/industry/demand/EconomicImpactofBSEonUSBeefIndustry.pdf], and
henceforth called the Kansas State University study.

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CRS-25
Enforcement of the Feed Ban
The FDA Center for Veterinary Medicine has since 2001 provided periodic
updates of its feed ban enforcement activity on a public website.49 On June 20, 2005,
the agency reported that it had identified and conducted initial inspections on 15,676
renderers, feed mills, protein blenders and related establishments. The agency noted
that 4,093 of them (26%) handled materials prohibited for use in ruminant feeds. Of
this subset, FDA reported that the vast majority were within compliance.
FDA has asserted on several occasions that feed industry compliance with the
ban has reached 99%.50 FDA bases its compliance determinations on inspection of
facilities, practices, and records. At this time there is no certified test that can be
used on actual ruminant feed to determine if it contains prohibited material. In its
July 2004 ANPR, FDA requested information on potential test methods for detecting
SRM in animal feed.51
The Government Accountability Office (GAO) has twice evaluated FDA’s
oversight of the feed ban, in 2002 and 2005, and reported a number of problems with
administrative procedures, inspection, and enforcement.52 In its February 2005
report, GAO commented that FDA’s 99% reported compliance rate may be
misleading because the rate was based on inspections of only about 570 firms. GAO
added that FDA does not include all serious violations in its calculations because it
reclassifies firms as being in compliance once they correct violations, no matter how
long a problem existed. For this and other reasons GAO said that FDA did not have
sufficient information to calculate a compliance rate and recommended instead that
the agency report enforcement information in its complete context.
Also in its 2005 report, GAO concluded that FDA had made improvements in
its management of the feed ban since the 2002 GAO report, but that “various
program weaknesses continue to undermine the nation’s firewall against BSE.” One
of the weaknesses cited was the lack of a uniform approach to identify all the
additional feed manufacturers, on-farm mixers, and other feed industry businesses
beyond the approximately 14,800 firms the agency had identified. Among other
concerns, GAO also commented that FDA had not reinspected approximately 2,800
firms for several years and therefore does not know whether they use prohibited
materials in their feed, that the agency had not required a warning label on feed for
export that is not intended for cattle and other ruminants, and that it had not always
49 See FDA, “BSE — CVM Updates” page at [http://www.fda.gov/cvm/bse_updates.htm].
50 See, for example, FDA, “FDA Statement on Rendered Products Derived From BSE Cow
in Washington State,” Dec. 27, 2003, at [http://www.fda.gov/bbs/topics/NEWS/
2003/NEW01000.html].
51 Such tests would determine only if prohibited materials were present in the feed, not
whether infectious BSE prions were present. No such prion test for feed exists.
52 GAO, FDA’s Management of the Feed Ban Has Been Improved, but Oversight
Weaknesses Continue to Limit Program Effectiveness (GAO-05-101), Feb. 2005. See also
GAO, Mad Cow Disease: Improvements in the Animal Feed Ban and Other Regulatory
Areas Would Strengthen U.S. Prevention Efforts, (GAO-02-183), Jan. 2002.

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alerted USDA and the states when it learns that cattle may have been given
prohibited feed.
The preamble to the October 6, 2005, proposed feed rule provides additional
insights into compliance with the present ban. FDA stated that during FY2004 and
the first half of FY2005, federal and state inspections had identified 41 instances of
cross-contamination or commingling problems in firms that handle feeds containing
prohibited mammalian protein. That number represented 0.4% of inspections.
During the same period these inspectors found 165 instances of mislabeling (1.7%)
and 604 instances of improper recordkeeping (6.3%).
Congressional Role
If Congress reviews the feed ban and its role in preventing the spread of BSE,
issues that it might consider could include: the effects on the safety of the feed supply
of banning “downer” animals from slaughter and thus channeling them to rendering;
whether current oversight of the feed ban can accommodate this shift; the effect of
changing market conditions that may result from the “downer” ban on the safety of
both food and feed in the United States; and, processes to ensure the safe disposal of
animal remains as new regulations are implemented. Congress may also be
interested in any changes in feed ban restrictions proposed by FDA, their economic
implications, their likely impact in strengthening BSE prevention, and the agency’s
strategies for enforcement.
In its July 2004 ANPR, FDA requested comment on the matter of whether its
authorities under the Federal Food, Drug and Cosmetic Act and the Public Health
Service Act provide a legal basis to support an SRM ban. The concern is that SRM
themselves are not harmful unless they were to contain a BSE or other TSE agent.
Since there is not a test to identify the presence of harmful TSE agents in feed, the
agency’s authority to prosecute a violation of an SRM ban may not be clear. In the
109th Congress, pending S. 73 would statutorily define “SRM,” and explicitly make
it illegal for any person to introduce into interstate or foreign commerce these and
other prohibited materials, among other provisions.
BSE Surveillance and Testing in Cattle
Overview
The goals of BSE surveillance are to determine the prevalence of disease in a
country, and to ensure timely detection and response to cases. Surveillance is not
synonymous with testing. Depending on the disease of interest, surveillance may or
may not involve laboratory tests. For BSE, which is clinically similar to other
neurologic diseases, surveillance requires testing, so the two activities are closely
intertwined.
BSE testing is constrained by the unique nature of the disease, and this drives
the design of surveillance programs. Because it evokes no immune or inflammatory
response, BSE cannot be diagnosed from blood, urine, or other noninvasive samples.

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CRS-27
And, because abnormal prions are found in abundance only in the brain and spinal
cord, an animal must die or be killed to be tested. Also, research to date suggests that
existing tests cannot detect the disease in an animal any time sooner than two to three
months before an animal begins to exhibit clinical signs of infection.
Representatives of the USDA and some in industry have repeatedly stressed that
BSE testing serves to support the surveillance program, and is not directly intended
as food safety testing. Dr. Elsa Murano, then the USDA Under Secretary for Food
Safety, testified in 2004 that the consistent removal of certain high-risk tissues from
cattle at slaughter (described in greater detail in a subsequent section of this report)
is the relevant food safety protection.53 For this reason, USDA argues that a BSE
surveillance program does not have to test every animal slaughtered for food, but can
instead use targeted sampling to determine overall prevalence.
After the first report of BSE in a U.S. cow in December 2003, the U.S. BSE
surveillance program came under fire from critics who argued that the program did
not test sufficient numbers of animals or was not properly targeting high-risk
animals, thereby failing to give a true picture of BSE risk in the United States. The
International Review Team, in particular, commented in its report that uncertainty
about domestic BSE prevalence hampered decisions about the scope of other
safeguards such as the feed ban.
Some observers propose that surveillance should approximate programs in
European countries, where every adult animal is being tested, or Japan, which has
claimed to test every animal slaughtered. USDA has argued that it already tested
many more animals than are recommended by the OIE, and that because the program
targeted animals with suspicious signs, it could detect BSE if it were present at a
level of one in 1 million adult cattle. (USDA reported a total of nearly 96 million
cattle in the United States as of January 1, 2005.)
A complicating factor was that Japan — the top foreign customer — had
demanded that all cattle be tested for BSE as a precondition for again accepting U.S.
beef. Some individual firms in 2004 sought, unsuccessfully, to offer such testing in
order to regain access to Japanese markets, even though most U.S. government and
industry officials have asserted that such testing would be unscientific, expensive,
and a bad trade precedent. (Private testing issues are discussed later in this report.)
BSE Surveillance in the United States Prior to December 2003
In 1990 APHIS began surveillance for BSE in cattle, in response to the British
livestock outbreak. The program grew steadily in scope, from a few thousand
animals tested annually in the mid-1990s to about 20,000 animals each year in 2002
53 Testimony of Elsa Murano, Under Secretary for Food Safety, USDA, before the U.S.
Congress, Senate Committee on Appropriations, Bovine Spongiform Encephalopathy (BSE),
hearing, 108th Cong., 2nd sess., Feb. 24, 2004 (Washington: GPO, 2004).

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and 2003, out of about 35 million cattle slaughtered each year.54 The Washington
state cow was the first BSE-positive animal detected by the program.
Three high-risk groups of cattle were targeted for surveillance: animals that die
on the farm, animals exhibiting neurologic signs, and a sample of “downers,” animals
presenting non-ambulatory at slaughter. While the former two groups are considered
high-yield populations for screening, they provided limited numbers for surveillance.
Most of the samples came from downer animals. Although animals can be non-
ambulatory for reasons other than neurologic disease, the sheer numbers of downed
animals available and concentrated at slaughterhouses, once reported by USDA to be
about 200,000 animals per year, offered a ready sample for targeted surveillance.55
Enhanced Surveillance Program
Following the finding of BSE in December, 2003, USDA began revising its
surveillance program. Among other factors, advisory committee recommendations
and negotiations with trading partners affected proposals to expand BSE surveillance.
The “Downer” Ban and Impact on Surveillance. Following the first
finding of a cow with BSE, USDA announced, on December 30, 2003, a ban on
downer cattle in the human food supply. Some Members of Congress and industry
representatives had previously expressed concern that a downer ban, by removing
economic incentives that brought animals into the testing program, could force this
high-yield population “under the radar” and compromise BSE surveillance. (The
rationale for the ban and its potential merits are discussed in a subsequent section on
slaughter and processing practices, the “Fourth Firewall” of food safety protections.)
In House and Senate hearings following this first BSE discovery, USDA
officials were asked how they were finding and testing downed cattle, since they were
no longer being brought to slaughter plants. Officials did not provide concrete
information about downer animals tested since the ban, but acknowledged the
importance of finding and testing these animals at new points of concentration such
as rendering plants.56
Initial Proposals for Expanded BSE Testing. After the discovery of BSE
in Canada in May 2003, but before the finding in the United States in December
2003, USDA had planned to nearly double surveillance to 38,000 animals tested per
year. Initially this was modified only slightly after the discovery of the domestic case
54 Additional information on the APHIS BSE cattle surveillance program is available at
[http://www.aphis.usda.gov/lpa/issues/bse/bse-surveillance.html].
55 USDA (at 9 CFR §309.2(b) defines nonambulatory or “downer” cattle as those “that
cannot rise from a recumbent position or that cannot walk,” More recent USDA surveys also
have estimated that there may be as many as 450,000 or more nonambulatory cattle and
calves on U.S. farms and ranches. See “Ban on ‘Downer’ Cattle” later in this report.
56 See transcripts of U.S. House of Representatives Committee on Agriculture, Hearing on
Mad Cow Disease Response, Jan. 21, 2004, and U.S. Senate Committee on Agriculture
Nutrition and Forestry, Hearing on Mad Cow Disease, Jan. 27, 2004, 108th Congr., 2nd Sess.

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of BSE. The Administration’s FY2005 budget for APHIS proposed the testing of
40,000 animals.
On February 4, 2004, the International Review Team recommended that USDA
continue to focus its surveillance on high-risk animals, but that all such animals over
30 months of age be tested, along with a sample of healthy animals over 30 months
of age. The subcommittee report did not state how many animals this proposal might
encompass, but a USDA official at the time estimated it at 600,000 per year. In its
subsequent report to the Secretary, the full advisory committee also urged expanded
surveillance but fell short of recommending that all animals of any subgroups must
be tested, saying only that USDA should focus its efforts on high risk animals —
cattle showing symptoms of central nervous system disease, non-ambulatory cattle,
and cattle that die on farms.57
One-Time BSE “Enhanced Surveillance Program”. On March 15,
2004, USDA announced a one-time expansion of its BSE surveillance activities. The
Department said it would test as many cattle as possible in the high-risk population,
animals with signs of a central nervous system disorder, animals that are
nonambulatory, or animals that are dead for reasons that are unknown.58 Enhanced
surveillance was to occur over a 12 to 18 month period and was expected to test
between 200,000 and 300,000 animals. USDA did not set a fixed target for the
number of tests. Instead, it stated its intention to test all animals in the high risk
groups (estimated to total 446,000 on an annual basis), and noted that finding and
testing as many of them as possible would increase the certainty that the program
would identify BSE if it was present in the United States. Officials stated that if
268,500 high-risk animals were to be sampled, APHIS could detect BSE at the rate
of 1 positive in 10 million adult cattle with a 99 percent confidence level.
In addition, USDA announced plans to test a sample (about 20,000) of the
apparently healthy older cattle population, including animals that were born prior to
institution of the feed ban.
Enhanced surveillance of the high-risk population began on June 1, 2004, and
has required a number of expansions of USDA activities.59 USDA set sampling goals
for each state, noting that these were estimates based on cattle population data.60 The
57 USDA, Report of the Secretary’s Advisory Committee on Foreign Animal and Poultry
Diseases: Measures Relating to Bovine Spongiform Encephalopathy in the United States,
Feb. 23, 2004, at [http://www.aphis.usda.gov/lpa/issues/bse/bse.html].
58 See USDA, “Veneman Announces Expanded BSE Surveillance Program,” press release,
Mar. 15, 2004, and “Transcript of Technical Briefing with Bill Hawks, Under Secretary for
Marketing and Regulatory Services, Dr. Elsa Murano, Under Secretary for Food Safety, Dr.
Ron DeHaven, Administrator, Animal Plant Health Inspection Service, Dr. Barbara Masters,
Acting Administrator, Food Safety Inspection Service,” May 21, 2004
59 See APHIS, “Bovine Spongiform Encephalopathy (BSE) Surveillance Plan,” March 15,
2004, at [http://www.aphis.usda.gov/lpa/issues/bse/BSE_Surveil_Plan03-15-04.pdf].
60 See APHIS, “Examples of Geographic Distributions of Sample Collections for the BSE
S u r v e i l l a n c e P l a n , ” a t [ h t t p : / / w w w . a p h i s . u s d a . g o v / l p a / i s s u e s / b s e /
(continued...)

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program depends on the use of APHIS-approved “rapid tests” for screening at
geographically dispersed laboratories, so negative results can be obtained in 12-72
hours, minimizing the burden for holding carcasses pending negative test results.
FSIS veterinarians, whose daily presence is already required for ante- and post-
mortem inspections at slaughter plants, have collected brain samples from animals
sampled at slaughter, freeing APHIS staff to collect samples at farms, rendering
plants, and other points of concentration of high-risk animals.61
The approved rapid tests are for screening purposes. The policy is to follow up
any screening test that reacts as positive for BSE — which USDA has termed an
“inconclusive” result — with confirmatory testing at USDA’s National Veterinary
Services Laboratory (NVSL) in Ames, Iowa. The OIE recognizes either the
immunohistochemistry (IHC) test, or a version of the Western blot test, for
confirmatory purposes. However, until recently (see below), most official USDA and
cattle industry statements referred only to the IHC test as being the “gold standard”
confirmatory test.
News reports in 2004, noting the slow pace of the program in its first month,
had mentioned initial delays in setting up the national laboratory network, and
educating farmers, veterinarians, animal haulers and renderers about the new program
and how to submit animals for testing.62 USDA officials and representatives of the
rendering industry now maintain that sufficient numbers of animals have been
obtained through voluntary incentives, particularly at facilities that render and
process animals into non-human food uses (e.g., so called “4D” plants which collect
dead, dying, disabled, and diseased animals). USDA has agreements with such
plants that pay up to $100 per carcass for storage until BSE test results are complete;
up to $40 per sample to cover collection of the brain stem, data processing, and
submission of samples; and up to $10 per sample for removal and presentation of the
head at facilities where a trained collector is not available immediately.63
After 71 weeks through October 9, 2005, USDA reported that it had completed
testing of more than 491,000 animals.64 Three of these animals tested “inconclusive”
on screening; two were subsequently determined to be negative on the IHC test. The
third was determined to be negative in an initial round of confirmatory testing but
later was found to be positive for BSE, becoming the first native-born U.S. case.
(Discussion of the reporting of inconclusive findings follows in subsequent sections.)
60 (...continued)
bse_geo_dist_samples.html].
61 In March 2004, USDA finalized a rule clarifying its authority to enter such establishments
and conduct sampling in furtherance of its animal disease control efforts. USDA, APHIS,
“Blood and Tissue Collection at Slaughtering and Rendering Establishments,” 69 Federal
Register 10137, Mar. 4, 2004.
62 For example, see Andy Dworkin, Testing Protocols for Mad Cow a Complex Process, The
Oregonian, July 7, 2004.
63 Personal communications with National Renderers Association, July 11, 2005, and with
APHIS veterinarians, July 13, 2005.
64 See APHIS BSE testing results at [http://www.aphis.usda.gov/lpa/issues/bse_testing/].

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As of mid-October 2005, it was unclear when USDA would terminate this
special surveillance program, although some observers have speculated it could end
at the close of calendar 2005. The Department already has exceeded both the number
of animals that some observers had once predicted would be tested and its own
estimate of the high-risk population. The single BSE-positive animal from this
testing was found in November 2004 but not announced until June 2005 (see below
for details). Some analysts have speculated that it would be politically awkward for
officials to call an end to the program so soon after this case. Also, USDA did not
announce the start of testing of the 20,000 healthy cattle until late August 2005; this
segment of the program was supposed to get under way in the fall of 2005.
Surveillance Program Criticisms. USDA’s surveillance program has
garnered considerable criticism. On February 17, 2004, the House Committee on
Government Reform held a hearing to question USDA officials and others, following
the Committee’s month-long investigation into the circumstances surrounding testing
of the Washington state cow (December 2003). The Committee Chairman and
Ranking Member released a letter to the Secretary of Agriculture the same day, in
which they questioned whether the cow was in fact non-ambulatory when it was
selected for testing.65 The committee raised questions relevant to the design of an
improved surveillance program. If in fact the animal were not a downer but rather
an apparently healthy cow with BSE, had the surveillance program been targeted
effectively, and could Congress be confident that the disease is very rare in the
United States?
On April 27, 2004, a cow showing signs of a central nervous system disease at
a Texas slaughter plant was condemned for human food use by FSIS, and the FSIS
veterinarian on site recommended that it be tested for BSE. However, a higher-level
APHIS official determined that it should not be tested, so the animal’s carcass was
sent to a rendering plant for processing into inedible byproducts. This led some
critics to charge that the Department had “covered up” a possible case of BSE.
Such testing concerns became subjects of investigations by USDA’s Inspector
General (IG). She presented her preliminary findings at a joint hearing held July 14,
2004, by the House Government Reform and Agriculture Committees. The IG told
the committees that in the case of the Washington state cow, her office had “...found
no instances where USDA personnel knowingly conveyed false or misleading
information, or engaged in intentional misconduct.” The investigation, however,
“...did reveal procedural errors and inconsistent descriptions that gave rise to some
of the public concerns that the identification of the BSE-positive cow may have been
mishandled.”66
65 Letter from Reps. Tom Davis and Henry Waxman to Agriculture Secretary Veneman
concerning “Mad Cow” Disease, Feb. 17, 2004, and related documents, available at
[http://reform.house.gov/GovReform/News/DocumentSingle.aspx?DocumentID=2497].
66 Testimony of Phyllis K. Fong, USDA Inspector General, “A Review of the USDA”s
Expanded BSE Cattle Surveillance Program,” joint hearing of the House Committee on
Government Reform and the House Committee on Agriculture, July 14, 2004.

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The IG testified that her office also found “no substantive evidence” that USDA
officials provided any “false information or engaged in intentional misconduct” in
the Texas case. However, the IG cited inconsistencies in officials’ understanding of
BSE sampling and carcass handling procedures. As a result, FSIS and APHIS on
May 5, 2004, had announced a new joint policy to clarify these procedures and
responsibilities, she observed.67
The IG also presented the preliminary results of an audit of the Department’s
expanded surveillance plan, finding a number of inconsistences. For example, the
IG stated that surveillance findings may be unreliable because the plan: is not truly
random since participation is voluntary; assumes that BSE is confined only to the
high-risk cattle population while other studies show that healthy-looking animals
could have BSE; does not include a process for obtaining animals that die on farms;
cannot obtain a statistically appropriate geographical representation of the cattle
population; and does not allow APHIS to find and test enough cattle in the high-risk
population. The final OIG report, issued in late August 2004, generally paralleled the
preliminary findings.68
The Secretary of Agriculture and other USDA officials at the July 2004 hearing
defended the surveillance program, noting among other things that the OIG
observations were based on the plan before it was implemented and that many of the
report’s recommendations had already been addressed. APHIS was receiving a
representative mix of samples from all locations, reaching deeply into the higher-risk
cattle population, and the statistical basis for the sampling was sound, officials
asserted. They added that adjustments had been made as the result of ongoing
assessments of the program. The OIG has continued to assess the testing program.
It was at the IG’s insistence that APHIS researchers re-tested tissue from a cow that
first was determined to be negative, and then ultimately positive for BSE (see below).
“Inconclusive” Test Results. In June 2004, shortly after the enhanced
surveillance program was begun, USDA announced two inconclusive findings for
BSE which were later determined to be negative. The finding announced on June 25,
2004, was confirmed negative on June 30. The finding announced on June 29, 2004,
was confirmed negative on July 2. USDA reported each inconclusive finding but did
not provide information on the location or any other details about the animals.
According to policy instituted in December 2003, the carcasses of the two affected
animals were held pending test results, and were later destroyed.
Cattle market prices fell in response to news of the inconclusive findings, but
rebounded to varying degrees once the conclusive negative results were announced.
USDA was criticized both for releasing too much and too little information, though
some industry groups said the policy to release partial information struck the right
balance. During the wait for final results, USDA officials repeated the assertion that
rumors generated by withholding information while an inconclusive test were
67 Ibid.
68 USDA, Office of Inspector General Audit Report, Animal and Plant Health Inspection
Service and Food Safety and Inspection Service Bovine (BSE) Surveillance Program —
Phase I, Report No. 50601-9-KC, August 2004.

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pending would be just as damaging to markets as would the release of preliminary
findings. They also reiterated that given the extent of the enhanced surveillance
problem, some false positive screening tests were to be expected and, possibly,
additional true cases of BSE could surface as well.
APHIS’s policy had been to announce an inconclusive result if an initial
screening test were positive. APHIS changed this policy after the controversy and
market uncertainties which followed the first two inconclusive announcements. On
August 4, 2004, the agency stated that it would announce a result as inconclusive
(i.e., testing positive in the screen but not yet confirmed in follow-up testing) only if
a second screening test on the sample were also positive.
Confirmatory Testing Methods. With this newer policy in place, APHIS
announced another inconclusive finding on November 18, 2004. As with the
previous two announcements, the agency did not provide details on the animal’s age
or location, although some unconfirmed press reports speculated that it was a 12-
year-old cow in Texas. Cattle market prices again fell steeply, as did stock prices for
such chains as McDonald’s Corporation and Wendy’s International.69
Five days later, on November 23, APHIS reported that confirmatory testing at
its Ames NVSL facility had found the sample to be negative for BSE. Ames had run
the
immunohistochemistry (IHC) test, an internationally-recognized gold standard
test.... Because the November 18 screening test results were reactive in both the
first and second screens, NVSL scientists made the recommendation to run the
IHC test a second time.... Negative results make us confident that the animal in
question is indeed negative for BSE.70
Following this announcement, live cattle prices rebounded dramatically, enabling
cattle producers to more than recoup their earlier losses at the expense of buyers (i.e.,
meat packers) who paid the higher prices, thus incurring their own operating losses.71
When its November 2004 IHC test came back negative for BSE, USDA did not
run the other OIE-recognized confirmatory test, the Western blot, or send tissue to
the World Reference Laboratory in Weybridge, England, to evaluate the sample. By
contrast, USDA did run the Western blot test and consult with Weybridge to confirm
the BSE-positive result in December 2003.
In the spring of 2005, USDA’s IG asked APHIS to retest the samples from the
three 2004 “inconclusives,” because of its concerns about the original testing. For
example, the November 2004 sample should not have been frozen; and there were
paperwork reporting problems, it was reported. This OIG-requested retesting in early
69 See for example “New mad cow case possible,” The Kansas City Star; and “Mad cow test
news again hits producers; As future prices fall, officials industry promote safety of U.S.
beef,” The Fort Worth Star Telegram, both November 19, 2004.
70 Statement by Clifford, John, APHIS Deputy Administrator, November 23, 2004.
71 “Market Rebounds With a Vengeance,” Cattle Buyers Weekly, November 29, 2004.

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June 2005 was done by USDA scientists (reportedly without the direct knowledge
of the Secretary of Agriculture) using the Western blot method. When this test
showed the presence of BSE in the November 2004 sample, the Secretary of
Agriculture made the result public on June 10, calling it a “weak positive.” USDA
officials delivered a sample from the animal to Weybridge for further testing and also
began their own additional testing.
The Weybridge lab conducted a series of analyses on the sample. All but one
detected BSE, including another IHC test. The Secretary of Agriculture explained
that the positive IHC test by Weybridge used a different procedure than the one used
in November 2004 by USDA at Ames. A Weybridge scientist, Dr. Danny Matthews,
confirmed that “there are no two laboratories around the world that are using
identical IHC methods and not a single test that you can take off the shelf,” so that
tests may not perform comparably.72
USDA officials also revealed on June 24, 2005, that a USDA laboratory had
actually found possible BSE in the animal when it applied an “experimental” version
of the IHC test back in November 2004. However, they asserted that the laboratory
had not reported this result because the test method had not been validated for
regulatory use.73 This information, and the positive BSE confirmation by Weybridge,
provoked strong criticism by consumer groups and several Members of Congress.
They expressed renewed skepticism about the adequacy of USDA’s testing methods
and procedures; about department officials’ efforts to communicate all relevant
information about BSE in the United States; and about earlier assurances that the
IHC was “the gold standard.”
Secretary Johanns, who replaced Ann Veneman as Secretary earlier in 2005,
promised on June 24, 2005, that henceforth the Department would conduct two types
of confirmatory tests — the IHC and the Western blot — if any screening tests were
to yield an “inconclusive” result. If either confirmatory test is positive, a positive
result will be reported, he announced. But Secretary Johanns also defended USDA’s
surveillance program, stating, “Science is ever evolving. It is not static. And as we
learn more we apply the knowledge.” USDA is carefully reviewing its testing to
ensure that it is “in line with the very latest science,” he said, adding, “perhaps the
most important thing to remember is that we’ve only needed this test three times
since our enhanced surveillance began.”74
In all three instances of “inconclusives,” the so-called Bio-Rad ELISA test was
used as the screening test. Bio-Rad Laboratories has previously said that its test
detected a case of BSE in a 23-month old bull in Japan, shown to be positive on a
72 Transcript of media conference, June 24, 2005, at [http://www.usda.gov/wps/
portal/usdahome]. For an explanation of the two OIE-approved tests, see the June 2005
APHIS factsheet at [http://www.aphis.usda.gov/lpa/pubs/fsheet_faq_notice/
faq_BSE_confirmtests.pdf].
73 Ibid.
74 Transcript of media conference, June 24, 2005. The APHIS website also has posted a
series of factsheets explaining in more detail the confirmatory testing methods and how they
were applied in this case.

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Western blot test, but negative on immunohistochemistry (IHC) — a case that Japan
reported to OIE as “atypical BSE.”75 It also has been reported that the Bio-Rad
screening test has been found to be “false positive” (i.e., positive in the screening test
but negative upon confirmatory testing) at a rate of about one in a thousand times.76
The variety of testing schemes for BSE and seemingly conflicting statements about
their accuracy illustrates that laboratory science itself, and international consensus
on it, continue to evolve.
Private BSE Testing: The Creekstone Decision
On January 13, 2004, APHIS requested permit and license applications for rapid
BSE tests to be used to support the surveillance program. Subsequently, APHIS
approved five commercial test kits for use, and has certified 12 laboratories to
conduct these tests, all existing university or state-government based animal
diagnostic labs that are working under contract to USDA. This arrangement
effectively restricts BSE testing to USDA and its contract labs.
Early in 2004, Creekstone Farms Premium Beef, a private specialty producer of
Black Angus beef, applied to USDA to conduct BSE testing (using a USDA-
approved test) on every animal it slaughtered, in hopes of reclaiming Japanese
customers lost following the discovery of BSE. Denying Creekstone’s request,
USDA stated that approved BSE tests had only been licensed for animal health
surveillance purposes and “the test as proposed by Creekstone would have implied
a consumer safety aspect that is not scientifically warranted.”77 The Creekstone
decision prompted a range of reactions. Critics, including consumer advocates,
decried the decision as free-market interference and a lost opportunity for additional
BSE testing at private expense. They also noted that other USDA programs permit
label claims for marketing rather than food safety purposes, including the “organic”
label and a number of certified beef and quality system assessment programs.78
Government officials and many in industry countered that especially because BSE
is a foreign animal disease, there must be strong federal oversight of control
measures, and that allowing private-sector testing of low-risk animals would
undermine negotiations with Japan and other countries aimed at re-opening the entire
U.S. beef market to trade.79
75 For more information, see OIE, Disease Information, “Bovine spongiform encephalopathy
in Japan: atypical case,” Vol. 16, No. 41, Oct. 10 2003, at [http://www.oie.int] and the Bio-
Rad Laboratories website, [http://www.bio-rad.com].
76 “Second US cow tests positive for BSE,” NewScientist.com News Service, June 28, 2004.
77 USDA, “Statement by Bill Hawks, Undersecretary for Marketing and Regulatory
Programs Regarding a Request by Creekstone for Private BSE Testing,” press release, Apr.
9, 2004.
78 For information on these programs, see the website of USDA’s Agricultural Marketing
Service at [http://www.ams.usda.gov/].
79 A legal analysis of the Creekstone decision is available in CRS Report RL32414, The
Private Testing of Mad Cow Disease: Legal Issues, by Stephen R. Vina.

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BSE Testing Costs
The cost of BSE tests and the infrastructure to support a testing program have
been topics of discussion since BSE was first announced in the United States. The
cost of individual rapid BSE test kits has been reported to range from $7 to $25 per
animal.80 An APHIS spokesperson said in 2004 that considering overhead costs, tests
could run $25 to $50 per animal.
A more recent study published by Kansas State University indicates that the
variable cost of testing is approximately $15 to $20 per head. This figure includes
the cost of the test itself ($12 to $15), plus the cost of labor ($3 to $5), but not the
investment needed to establish a testing facility at a plant.81
To fund the enhanced surveillance program, USDA said that it transferred $80.4
million during FY2004 from the Commodity Credit Corporation (CCC) to APHIS
to support testing. On a fiscal year basis, $32 million of this was spent in FY2004,
and $48 million was budgeted for FY2005. When annually appropriated funds are
added to the CCC transfer, the total BSE regulatory, surveillance, and testing budget
was $44 million in FY2004 and $69 million in FY2005.
If one assumed that 500,000 cattle will have been tested by the end of the special
program, and based on a simple mathematical calculation, this total would translate
into approximately $161 per head. However, analysts point out that this has been a
far more extensive and complex program than is the case with routine testing of a
smaller number of samples. For example, as noted, USDA has agreements with
rendering firms to cover such costs as collecting and submitting samples, and storing
carcasses until test results are known.
Using the Kansas State per-head figures, testing 20,000 cattle annually (the
amount tested by USDA in 2003) would cost a total of $300,000 to $400,000 per
year. The Kansas State study observes that the cost of testing, regardless of the actual
dollar figure, will be offset by any economic benefits if one assumes that such testing
would reopen more foreign markets (e.g., Japan, Korea) to U.S. beef.
The House-passed and Senate committee-approved appropriation for BSE
testing for FY2006 is approximately $17 million. (These would be funds used to
resume ongoing testing, after the expected end of the enhanced surveillance program,
probably later in 2005.)
Congressional Role
Congress closely followed the special BSE surveillance effort as it was getting
under way in 2004, when concerns were raised about its basic design and initial
operation. Many Members continue to express keen interest in the impact of testing
80 Dennis Normile, “First U.S. Case of Mad Cow Sharpens Debate Over Testing,” Science,
vol. 303, pp. 156-157, Jan. 9, 2004.
81 Kansas State University study.

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on cattle prices, particularly whenever USDA has reported anything other than a
negative finding of BSE, as has occurred on three occasions over a 13-month period.
There was renewed congressional interest in testing when USDA, at OIG’s
insistence, in June 2005 retested tissues from a cow which initially had been declared
negative for BSE, but were later confirmed to be positive (see above). Despite the
recent controversies, however, the current 109th Congress has not yet held a hearing
or received proposed legislation on these issues. Lawmakers’ major role in
surveillance so far has been in considering and approving funding for some APHIS
testing activities through the annual USDA appropriation.
BSE Prevention in Slaughter and Processing: The
“Fourth Firewall”
USDA (FSIS) is responsible for the safety of meat produced in facilities under
federal inspection. In addition, under Memoranda of Understanding with FSIS, many
states have programs to inspect meat for in-state sale only. State-regulated safety
measures, including all BSE prevention measures, must be equivalent to those in
federally-inspected plants. Therefore, all food safety measures announced by USDA
to control BSE apply to state meat inspection facilities as well as federal facilities.
FSIS earlier had been considering a number of policy options for protecting the
human food supply from possible contamination by BSE agents. These measures
were summarized in a January 15, 2002, “current thinking” paper.82 A number of
these possible options related to designating various types of cattle parts as
“Specified Risk Materials” (SRM, thereby making them unfit for human
consumption), or to restricting the use of certain mechanical systems for recovering
meat from vertebral columns (notably so-called advance meat recovery systems, or
AMR). The agency announced a number of steps to ensure the safety and proper
labeling of AMR products, but major new regulatory actions did not come until after
the discovery of the first U.S. BSE cow.
USDA announced these new preventive measures on December 30, 2003. The
“three firewalls” had been in place, but they primarily were intended to prevent the
emergence of BSE or its spread in cattle. Most of the new measures involved
changes in meat inspection and human food safety protections, interventions that had
been regarded by USDA to be unnecessary before BSE was known to be present in
the United States. Officials and an advisory panel have subsequently noted that these
measures, which remove all designated high-risk material from the food supply,
regardless of test findings on specific animals or measures of BSE prevalence
nationwide, represent the strongest actions to protect public health since the first U.S.
finding of BSE.
82 USDA, FSIS, FSIS Current Thinking on Measures That Could Be Implemented to
Minimize Human Exposure to Materials that Could Potentially Contain the BSE Agent, Jan
15, 2002, at [http://www.fsis.usda.gov/OA/topics/BSE_thinking.htm].

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Ban on “Downer” Cattle
The most sweeping USDA action in response to BSE was the immediate ban on
the use of non-ambulatory or so-called “downer” cattle in the food supply.
USDA/FSIS took this regulatory action as part of the series of rule changes it
announced on December 30, 2003. This action was published on January 12, 2004,
as an interim final rule.83 Under the rule, meat inspectors must condemn all
nonambulatory cattle presented for inspection for human food, regardless of the
reason for their condition. “Downers” are defined as non-ambulatory or disabled
animals that are unable to rise from a recumbent position (i.e., to stand) or are unable
to walk. The action was based on the concern that animals could become non-
ambulatory as a result of BSE.
Proponents of this ban have argued that downer animals pose numerous food
safety hazards, not limited to BSE but including microbial hazards such as
Salmonella; they have noted that some prominent fast-food chains already ban the
use of these animals for the meat they accept. Opponents of the ban have expressed
concern about the integrity of BSE surveillance if these animals are no longer
brought to slaughter, and have questioned the scientific basis of the ban, in light of
its economic impacts. (As noted earlier, USDA says it has taken steps to ensure that
many downed animals can continue to be tested, even if they are diverted from
slaughter for human food.)
USDA has estimated that up to 200,000 “downer” cattle were slaughtered in the
United States annually, and accounted for less than 1% of roughly 35 million animals
slaughtered. Within this total, 25% or perhaps higher were ultimately condemned by
meat inspectors as unfit for human consumption.84 USDA’s statistical agency has
since collected two years of on-farm national data; it estimates there were
approximately 465,000 nonambulatory cattle and calves at U.S. beef and dairy
operations in 2003, and 450,000 in 2004.85
Some within the cattle industry have argued that the downer ban should
distinguish between animals that cannot walk because of BSE or another potentially
dangerous disease, and those that are simply lame (and, presumably, safe for use as
food). Opponents have argued that a cow might have become lame because it was
suffering from a nervous condition like BSE, and that making an accurate diagnosis
would be difficult under the conditions which exist at slaughter.
Nonambulatory disabled cattle generally can be separated into those that display
central nervous system (CNS) disorders (of which BSE is one of several possible
types) and those that do not but simply appear to be lame, USDA has observed.
83 “Prohibition on the Use of Specified Risk Materials for Human Food and Requirements
for the Disposition of Non-Ambulatory Disable Cattle,” 69 Federal Register 1861.
84 USDA, FSIS, Preliminary Analysis of Interim Final Rules and an Interpretative Rule to
Prevent the BSE Agent from Entering the U.S. Food Supply, April 7, 2004.
85 USDA, National Agricultural Statistics Service, Non-Ambulatory Cattle and Calves,
released May 5, 2005.

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However, the Department concluded, no data are available to determine the level of
disease infectivity among non-ambulatory disabled cattle without CNS symptoms.
So, officials decided it would be prudent to prohibit all “downers” from the food
supply.86
Prior to the emergence of the North American BSE cases, downer cattle were
linked with the issue of humane slaughter. Widespread media reports in the 1990s
made claims that nonambulatory cattle were suffering in transport to and after arrival
at slaughter plants. Some in Congress believed that a ban on their inspection
(effectively reducing any higher value as human food) would serve to improve their
treatment.
Other New Slaughter and Processing Protections
Additional measures announced on December 30, 2003, include a policy to
hold meat from any animals tested for BSE until the test results are known; a ban on
air-injection stunning, which is suspected to spread brain matter through the
bloodstream and into meat; a ban on mechanically-separated meat, in which bones
may be crushed to produce meat paste; and several provisions to keep certain high-
risk materials out of the food supply, or out of Advanced Meat Recovery (AMR)
systems, depending on the age of the animal. (AMR, as distinct from mechanically-
separated meat, uses pressure to remove edible tissues from bone without crushing
it. The resulting product can be labeled “meat,” and is typically incorporated into
products such as hot dogs and sausages.) USDA published in the January 12, 2004,
Federal Register three interim final rules and one notice to codify these actions,
effective immediately.87
One of these rules redefines so-called “Specified Risk Materials,” (SRM), those
parts of a carcass where prions are believed to concentrate, and that are deemed
inedible and cannot be inspected and passed as human food. The rule designates as
SRM, among other tissues, brain and spinal cord in cattle older than 30 months, but
continues to permit such materials from younger animals (under 30 months) to be
inspected and passed as human food.
Another of the rules prohibits the inclusion of certain parts in AMR meat.
USDA has prohibited central nervous system tissue (brain, spinal cord and some
86 USDA, FSIS, Preliminary Analysis of Interim Final Rules and an Interpretative Rule to
Prevent the BSE Agent from Entering the U.S. Food Supply, undated document released in
2004, at [http://www.fsis.usda.gov/OPPDE/rdad/FRPubs/03-025N/BSE_Analysis.pdf]. See
also, USDA APHIS, USDA BSE Surveillance Plan: Background on Assumptions and
Statistical Inferences, March 15, 2004, at
[http://www.aphis.usda.gov/lpa/issues/bse/BSEOIG.pdf].
87 “Prohibition on the Use of Specified Risk Materials for Human Food and Requirements
for the Disposition of Non-Ambulatory Disable Cattle,” 69 Federal Register 1861; “Meat
Produced by Advanced Meat/Bone Separation Machinery and Meat Recovery (AMR)
Systems,” 69 Federal Register 1874-1885, “Prohibition on the Use of Certain Stunning
Devices Used to Immobilize Cattle During Slaughter,” 69 Federal Register 1885-1891, and
“Bovine Spongiform Encephalopathy Surveillance Program,” 69 Federal Register1892.

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other nerve tissues) from AMR meat in the past based on quality standards, not for
food safety, but has found in tests of AMR meat that about one-third of it did contain
prohibited material.88 The GAO has asserted that, irrespective of USDA’s
determinations of the safety of AMR meat, the public should be able to identify foods
that may contain nervous system tissue. GAO recommended that USDA continue
evaluating the safety of AMR meat, improve enforcement to keep prohibited nervous
system tissue out, and consider labeling and other education efforts to advise
consumers when they purchase products that may contain this tissue.89
The USDA expert panel (IRT) had commented on February 4, 2004, that until
a more aggressive BSE surveillance were in place, the SRM definition for parts
excluded from food should be expanded, to exclude high-risk tissues from any
animal older than 12 months of age (as they had also recommended for the feed ban).
However, the report also included a seemingly contradictory statement that until a
better understanding of BSE prevalence were established, the 30 month cut-off was
“a reasonable temporary compromise.” The full advisory committee reported that the
USDA action to ban SRM from animals over 30 months removed the highest-risk
tissues from the food supply and was in accordance with international standards. The
Harvard risk assessment concluded that SRM removal would reduce potential human
exposure by 95%.
FDA published in the July 14, 2004, Federal Register, an interim final rule to
prohibit, in the food, drugs, and cosmetics that it regulates, the same materials (i.e.,
SRM) banned in FSIS-regulated products.90 In the same issue, FDA and FSIS issued
a joint advance notice of proposed rulemaking (ANPR) seeking public comments on
additional measures under consideration to mitigate BSE risks. Among the questions
specific to FSIS authorities were:
! What data or scientific information is available to evaluate an IRT
recommendation that the entire intestine from cattle of all ages be
removed, not only the distal ileum as currently required, to prevent
potentially infective material from entering the human and animal
food chains?
! What measures are needed to prevent cross contamination between
cattle carcasses?
! In establishments that mainly slaughter cattle 30 months of age and
older, are additional sanitation requirements necessary to prevent
edible portions of carcasses from being contaminated with SRM?
88 For further information on FSIS AMR standards and testing, see USDA, “Advanced Meat
Recovery (AMR)” Web page at [http://www.fsis.usda.gov/OA/topics/amr.htm].
89 GAO Mad Cow Disease report, p. 38.
90 69 Federal Register 42256-42274.

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! With regard to determining the equivalence of imports, should FSIS
exempt countries with low or no BSE risk from its SRM rule, and if
so, under what conditions?
FSIS and FDA each published an interim rule in the September 7, 2005, Federal
Register altering their separate rules on SRM in meat products, foods and cosmetics.
Both agencies had earlier designated the distal ileum of all cattle, regardless of age,
as SRM, but required companies to remove the entire small intestine, even though
the distal ileum was the only portion where BSE infectivity has been confirmed. The
September 7 interim rules permit companies, beginning on October 7, 2005, to
remove the distal ileum (defined to be at least 80 inches) and to utilize the rest of the
small intestine in food or cosmetics. These actions were in response to industry
comments that technology exists to effectively remove the distal ileum.91
Congressional Role
Although BSE’s potential impact on food safety and public health has been of
interest to many Members of Congress, testimony at most of the recent hearings, and
most BSE-related bills, have addressed the trade-related, animal disease, and
economic aspects of the disease. But a few proposed measures could directly or
indirectly affect FSIS’s oversight of BSE safeguards in meat plants. For example,
as noted earlier, pending S. 73 focuses primarily on keeping higher-risk cattle parts
out of animal feeds, but one section of the bill explicitly makes it illegal for any
person to introduce into interstate or foreign commerce these and other prohibited
materials, among other provisions.
Other measures have focused on the “downer” issue. During action on the
FY2004 agriculture appropriations bill (H.R. 2673) in the 108th Congress, for
example, lawmakers debated amendments that reflected the content of companion
bills in the House and Senate (the Downed Animal Protection Act; H.R. 2519/S.
1298). These would have amended the 2002 farm act to require that downed animals
at stockyards, market agencies, livestock dealer facilities, and slaughter facilities be
euthanized immediately and barred from federal inspection. The Senate adopted the
downed animal provision in its version of the funding bill, but it was dropped in
conference on the final measure, incorporated into the FY2004 Consolidated
Omnibus Appropriations (P.L. 108-199).
In the 109th Congress, during floor consideration of the FY2006 USDA
appropriation (H.R. 2744) on September 20, 2005, the Senate adopted by voice vote
an amendment by Senator Akaka that would prohibit nonambulatory livestock (also
called “downers”) from being used for human food. The House-passed bill lacks
such a ban, so the matter faces House-Senate conference. When the Senate adopted
the provision, there was discussion of its potential to protect against BSE. However,
the amendment would apply not only to cattle, but also to any sheep, swine, goats,
horses, mules or other equines “that are unable to stand or walk unassisted” at the
91 70 Federal Register 53043-53050 (FSIS) and 70 Federal Register 53063-53069 (FDA).
The FDA interim rule also clarifies that milk and milk products, hide and hide-derived
products, and tallow derivatives are not prohibited cattle materials.

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point of antemortem inspection. (Senator Akaka also again introduced the Downed
Animal Protection Act as S. 1779; the House companion bill by Representative
Ackerman is H.R. 3931.)
One bill (H.R. 4121) in the 108th Congress would have amended the Federal
Meat Inspection Act to define “non-ambulatory” as “any cattle that, at the time of
examination and inspection ... is unable to rise from a recumbent position or unable
to walk for any reason, including metabolic conditions or central nervous system
disorders, unless the reason for such inability is fatigue, stress, obdurator nerve
paralysis, obesity, or one or more broken or fractured appendages, severed tendons
or ligaments, or dislocated joints.” Other meat safety-related proposals conceivably
might emerge during the course of the 109th Congress, particularly if more BSE cases
are found in North America and/or Members perceive the need to strengthen any
FSIS regulations.
Related Issues and Options
Federal Spending on BSE
The Administration’s FY2006 budget, released in early 2005, requested a total
of $66 million for USDA’s BSE-related activities, including $33 million to continue
work on an animal identification (ID) program (see next section), $21 million for
BSE testing/surveillance, and $12 million for research. Total USDA spending for
BSE in FY2005 is estimated at $123 million, of which $69 million was for BSE
testing (and most of that for the enhanced surveillance program), $49 million to
launch the animal ID effort, and $3 million for research. Much of the FY2005
funding was through transfers from USDA’s Commodity Credit Corporation (CCC)
account rather than through direct appropriation by Congress. USDA’s BSE
spending in FY2004 was an estimated $51 million.
Additional BSE amounts are spent through FDA and other agencies. The FDA
request for FY2006 is for a total of nearly $30 million, which both the House-passed
and Senate-passed USDA-FDA appropriation measure (H.R. 2744) include. The
House and Senate committee reports (H.Rept. 109-102 and S.Rept. 109-92,
respectively) to accompany the bill state that this funding will be used primarily to
enforce the 1997 feed ban, including yearly inspections of renderers and feed mills
processing products containing prohibited materials; extension of more oversight to
other segments of the industry subject to the rule; validation of test methods for
detecting bovine-derived proteins in animal feed; and research activities. Conference
committee action on the measure was pending on October 12, 2005.
Animal Identification and Meat Traceability
Among the steps announced on December 30, 2003, by the Secretary of
Agriculture was to “begin immediate implementation” of a national animal
identification (ID) system. Many producers already keep records on the identities of
each of their animals, primarily for herd management and marketing purposes.

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Though animals often may be identified individually as part of an animal disease
program, no nationwide comprehensive U.S. animal ID system is in place.
Some observers have suggested that such a system, for example, would have
enabled USDA to find more of the cows imported from Canada with the December
2003 BSE cow. APHIS officials acknowledged that they had concluded their
investigation of the U.S. outbreak after positively identifying only 28 of the 80 cattle
that were imported with the BSE cow. “The limitations of the cattle identification
system necessitated a more extensive tracing exercise than would otherwise have
been necessary in order to identify the cattle to be culled in accordance with
international standards, thus enabling the identification of some animals only by
process of elimination,” the international panel of experts reported on February 4,
2004.92
More recently, the Center for Science in the Public Interest (CSPI), a consumer
advocacy group, charged that lack of a cattle ID program initially had made it
difficult for USDA to find the herd of origin of what has become the first U.S.-born
cow to test positive for BSE (i.e., the November 2004 Texas cow). CSPI was among
those calling for faster implementation of an ID program.93
Interestingly, while the BSE issue has stimulated much of the current interest
in animal ID, it historically has been regarded as a tool for tracking mainly
contagious diseases — which BSE is not.
While most cattle and beef industry leaders appear to be supportive of an animal
ID program (most major industry groups are represented on the task force), some also
assert that animal ID should be viewed primarily as a potential tool in animal health
and food safety assurance programs — not as another BSE preventive measure itself.
Industry leaders also have pointed to a number of other policy issues that remain
unresolved, including how much such an animal ID program will cost; how much
government might contribute toward this cost; several questions regarding privacy
of industry data and legal liability; and whether animal ID could or should be used
for purposes besides animal disease management (also see Country of Origin
Labeling, below). A growing number of animal industry leaders appears to recognize
that a national system will have mandatory aspects to it.
For several years prior to the Secretary’s announcement, a government-industry
task force had been working to develop the framework for an ID system, aimed at
helping authorities to determine more rapidly the origin of an animal disease
outbreak and to contain it quickly. With the discovery of BSE, USDA attempted to
take the lead in development of a national program. On April 27, 2004, the Secretary
92 USDA, The Secretary’s Foreign Animal and Poultry Disease Advisory Committee’s
Subcommittee Report on Measures Relating to Bovine Spongiform Encephalopathy (BSE)
in the United States, Feb. 4, 2004, at [http://www.aphis.usda.gov/lpa/issues/bse/bse.html],
p. 2. Earlier, the international team examining Canada’s BSE investigation also had
observed that the lack of a mandatory ID system prior to Canada’s adoption of one in 2001,
contributed to the need for “the extensive culling of animals.”
93 Reuters, “Beef-loving U.S. shrugs at finding second mad cow,” June 26, 2005.

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announced what she called “the framework for implementation” of the national ID
plan.
On August 5, 2004, USDA said it was providing nearly $12 million for
cooperative agreements with states and tribal governments, to register premises (i.e.,
sites with animals), collect data, and test ID technologies. On June 21, 2005, USDA
announced that it was accepting applications to disburse another $14.3 million to
continue premises registration efforts. APHIS now projects that all states will have
the capability to register individual premises (but not yet animals) by this year, and
that individual animal numbers will also become available this year. But a national
system may not be fully in place and/or mandatory until 2009.94
Some argue that USDA, which has embarked on an all-farm species approach,
is progressing too slowly. The National Cattlemen’s Beef Association (NCBA), for
example, announced its intention to establish a privately operated system for cattle
and other species, that it has said could be fully operational for cattle by October
2006. Apparently responding to such producer concerns about the pace of
implementation and the need for private sector leadership, Secretary Johanns on
August 30, 2005, announced four “guiding principles” for a national ID system:
! It must be able to allow tracking of animals from point of origin to
processing within 48 hours without unnecessary burden to producers
and other stakeholders;
! Its architecture must be developed without unduly increasing the size
and role of government;
! It must be flexible enough to utilize existing technologies and
incorporate new identification technologies as they are developed;
! Animal movement data should be maintained in a private system
that can be readily accessed when necessary by state and federal
animal health authorities.
Focusing on the last point, Secretary Johanns stated: “We are eager to work
closely with industry as they develop and maintain databases that contain animal
movement information. After hearing the confidentiality concerns of producers, we
envision a system that allows these databases to feed a single, privately held
animal-tracking repository that we can access.”95
Not everyone endorsed this approach. R-CALF United Stockgrowers of
America, representing some cattle producers, issued an August 31, 2005, statement
noting its disappointment with the decision, and asserting that protecting U.S. animal
health has national security and public accountability dimensions that should not be
ceded to the private sector.
94 For updates on USDA’s animal ID activities, including information on its strategic plan
for an ID program, see [http://animalid.aphis.usda.gov/nais/index.shtml].
95 “Johanns Announces Key Component of Animal I.D. System.” August 30, 2005, press
release.

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Conceptually, animal ID follows cattle from place of birth to the point of
slaughter. That is one segment of overall meat traceability, which extends further,
generally through the marketing chain to the final consumer. Some policymakers
have urged the adoption of this broader approach. For example, companion bills
offered in 2003 (S. 1202 and H.R. 3546) would have required USDA to establish a
traceability system for all stages of production, processing, and distribution of both
meat and poultry and their products, essentially from the birth of source animals to
the ultimate consumer. Other bills in the 108th Congress that would have required
some type of animal ID system included H.R. 3961; H.R. 3714; S. 2008; H.R. 3787;
S. 2070, and H.R. 3822.96
In the 109th Congress, several animal identification bills had been introduced
as of mid-September 2005, including H.R. 1254, the National Farm Animal
Identification and Records Act, H.R. 1256, to limit animal ID information disclosure,
and H.R. 3170, creating a private Livestock Identification Board to oversee the
program. The House Agriculture Committee held two hearings in September 2005
on the feasibility of establishing a privately-held system.
Country of Origin Labeling
U.S. law requires most imports, including many food items, to bear labels
informing the “ultimate purchaser” of their country of origin. Various raw
agricultural products have been exempt. The 2002 farm bill (P.L. 107-171) required
many retailers to provide, starting September 30, 2004, country-of-origin labeling
(COOL) on fresh fruits and vegetables, and unprocessed red meats, fish, and peanuts.
The conference report on the omnibus FY2004 appropriation, which included USDA
funding (H.Rept. 108-401; P.L. 108-199) delayed the effective date for mandatory
COOL for two years, until September 30, 2006 (except for fish; that portion is now
in effect).
However, debate over the pros and cons of COOL has continued into the 109th
Congress, where some Members continue to oppose the two-year delay, and others
are working to make COOL a voluntary, not mandatory program for industry.
Among the reasons that COOL is needed, according to supporters, is that consumers
have a right to know where their food is from, particularly in light of recent animal
health and food safety concerns such as the two BSE cases in Canadian-born cows.
COOL critics have countered that it is a thinly-disguised trade barrier intended to
increase the costs of imports, and that it undermines U.S. efforts to reform world
agricultural trade; moreover, they argue that, as designed, the mandatory program for
industry will be extremely expensive to maintain, and might hold them legally
accountable for inadvertent or minor mistakes in records.
Prior to enactment of mandatory COOL in 2002, industry leaders were seeking
from USDA a voluntary program for labeling beef of U.S. origin. Although such
labeling already is permitted so long as existing FSIS conditions are satisfied,
presumably a newer, more specific origin program would have been more attractive
to the industry.
96 See CRS Report RL32012, Animal Identification and Meat Traceability, by Geoffrey S.
Becker.

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Separately, after the May 2003 Canadian BSE discovery, Japanese officials said
they would require proof, effective September 30, 2003, that beef shipped from the
United States was of U.S. origin. Japan’s aim was to ensure that no products came
from Canada. Hoping to satisfy Japanese (and Korean) demands, the Department
unveiled in August 2003 a new “Beef Export Verification” (BEV) program as a
voluntary, user-fee funded service. Exporters desiring to sell beef to Japan (or any
other country that may request similar documentation) were to apply for BEV
certification from USDA after satisfying a list of requirements so that the agency
could verify that their beef is from cattle slaughtered in the United States. As noted,
BEV is considered voluntary, even though at the time it was widely viewed as a
minimum prerequisite for gaining access to the Japanese and perhaps other foreign
markets. After the December 23, 2003, announcement of a U.S. BSE cow, Japan was
among the first countries to halt imports of U.S. beef, clouding the future of BEV.
Bills offered earlier in 2005 (H.R. 384/S. 108) would prohibit the Canada rule
(see “Trade Restrictions”) unless mandatory COOL is implemented. Other pending
bills would make COOL voluntary for meats (H.R. 2068; S. 1333), and for meats and
other commodities (S. 1300). The House-passed USDA appropriation for FY2006
(H.R. 2744) would prohibit use of funds to implement COOL for meats. On the
other hand, S. 1331 would accelerate implementation for mandatory COOL to
January 30, 2006. (See CRS Report 97-508, Country-of-Origin Labeling for Foods,
by Geoffrey S. Becker.)
Beef Labeled “Organic”
A USDA program, the National Organic Program (NOP), prohibits the feeding
of “mammalian or poultry slaughter by-products to mammals or poultry,” if they are
to be labeled “organic.”97 Numerous news reports have suggested a safety benefit
from beef grown using organic or other alternative practices, now that there have
been domestic BSE cases. The NOP was developed to assure that labeling claims
reflect defined and verifiable production and handling practices. USDA endorses no
claims that organically produced food is safer or more nutritious than conventionally
produced food.
Chronic Wasting Disease
Chronic Wasting Disease (CWD), a TSE, is a fatal neurological disease of
farmed and wild deer and elk in North America. CWD is generally similar to BSE,
and is thought to be caused by a similar type of infectious prion protein. CWD
differs from BSE in a number of significant ways, however, including the types of
tissues involved and the fact that it is contagious among animals in a herd. A study
under experimental conditions suggested that CWD may be transmissible through
contaminated environments long after infectious animals were no longer present.98
97 7 CFR 205.237, National Organic Program. For further information, see [http://www.ams.
usda.gov/nop/NOP/NOPhome.html].
98 M.W. Miller, et al., “Environmental Sources of Prion Transmission in Mule Deer,”
Emerging Infectious Diseases, June 2004, at [http://www.cdc.gov/ncidod/EID/
vol10no6/04-0010.htm].

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Since 1997, CWD has been detected in 39 captive cervid herds in nine states:
Colorado, Kansas, Minnesota, Montana, Nebraska, New York, Oklahoma, South
Dakota, and Wisconsin. As of June 1, 2005, there were six known positive captive
herds in the United States: 4 elk herds in Colorado, and two deer herds in Wisconsin.
Federal and state policy is to depopulate (destroy) these herds (see below). CWD has
been detected in wild cervids in nine states: Colorado, Illinois, Nebraska, New
Mexico, New York, South Dakota, Utah, Wisconsin, and Wyoming.99 (It has also
been found in Canada and the Republic of Korea.)
The Centers for Disease Control and Prevention (CDC) says regarding the
potential for CWD transmission to humans:
It is generally prudent to avoid consuming food derived from any animal with
evidence of a TSE (a “transmissible spongiform encephalopathy,” or prion
disease such as BSE and CWD). To date, there is no evidence that CWD has
been transmitted or can be transmitted to humans under natural conditions.
However, there is not yet strong evidence that such transmissions could not
occur. To further assess the possibility that the CWD agent might occasionally
cause disease in humans, additional epidemiologic and laboratory studies could
be helpful. Such studies include molecular characterization and strain typing of
the agents causing CWD in deer and elk and CJD (the human form of prion
disease) in potentially exposed patients. Ongoing national surveillance for CJD
and other neurological cases will remain important for continuing to assess the
risk, if any, of CWD transmission to humans.100
With regard to the potential for CWD transmission to cattle, possibly causing
BSE or a related disease that could pose a food safety hazard, USDA says:
During the approximately two decades of monitoring, researchers have not found
any evidence that CWD can be transmitted to domestic cattle under natural
conditions. Ongoing experiments involving oral exposure and contact exposure
on heavily CWD contaminated sites have not resulted in infection of cattle.
These experiments, however, require additional time before they are completed.
CWD has been experimentally transmitted by artificial means to mice, ferrets,
mink, goats, squirrel monkeys, and calves.101
FDA prohibits the feeding of rendered deer and elk to ruminants. In addition,
FDA prohibits the use of known-CWD positive animals in any animal feeds, and
99 West Virginia state officials announced on September 2, 2005, that a road-killed deer had
tested positive for CWD. A map on CWD in North America by the U.S. Geological Survey
is at [http://www.nwhc.usgs.gov/research/chronic_wasting/chronic_wasting_map.html].
100 Found at USDA APHIS, “Questions and Answers About Chronic Wasting Disease,”
Sept. 2002, at [http://www.aphis.usda.gov/lpa/pubs/fsheet_faq_notice/faq_ahcwd.html]. In
addition, see E.D. Belay, et. al., “Chronic Wasting Disease and Potential Transmission to
Humans,” Emerging Infectious Diseases, June 2004, at [http://www.cdc.gov/ncidod/EID/
vol10no6/ 03-1082.htm].
101 Ibid.

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recommends against the use of rendered deer and elk material considered high-risk
in any animal feeds.102
Activities related to CWD control are also conducted by USDA’s Agricultural
Research Service (ARS) and Cooperative State Research, Education and Extension
Service (CSREES)103 and several agencies in the Department of the Interior (DOI).
In recognition that CWD is being found in more areas, and that resource limitations
and program inconsistencies exist among the states, a national CWD Task Force was
formed in 2002 “to ensure that federal and state agencies cooperate in the
development and implementation of an effective national CWD program.”104 This
task force, initiated between USDA, DOI, and state wildlife and agriculture agencies,
produced the strategic plan (see footnote) which, among other things, states that the
primary federal role will be to provide coordination and assistance with research,
surveillance, disease management, diagnostic testing, technology, communications,
information, education, and funding for state CWD programs. The task force has
working groups with action plans organized around most of these topics, though
there have been concerns about delays in its implementation.
According to the most recent CWD task force’s progress report, total federal
spending for CWD approximates $25 million annually, of which about $20 million
are USDA funds. The most recently published report estimates state spending to be
roughly $15-20 million per year.105 Several bills addressing research, surveillance,
or control of CWD were introduced in the 108th Congress, including H.R. 2057; H.R.
2430; H.R. 2431; H.R. 2636; H.R. 3714, and S. 1036; S. 1366 and S. 2007. A
hearing on CWD was held by the Senate Environment and Public Works Committee,
Fisheries, Wildlife and Water Subcommittee on April 5, 2004. CWD interest in the
109th Congress appears to be centered around the funding levels in the pending
annual appropriation measures, including USDA’s, H.R. 2744.
Feline Spongiform Encephalopathy
Feline Spongiform Encephalopathy (FSE) was first identified in domestic cats
in Britain in 1990, and is believed to result from eating BSE-affected beef. (When
brain tissue from cats with FSE was inoculated into mice, the pattern of incubation
periods and lesions in the mice was indistinguishable from that produced by BSE.)
There have been more than 100 cases of FSE in Europe, mostly in the UK. No cases
have been reported in the United States.
102 FDA, Guidance for Industry #158: Use of Material from Deer and Elk in Animal Feed,
Sept. 15, 2003, at [http://www.fda.gov/cvm/guidance/published.htm].
103 See ARS research website to search for CWD studies at [http://www.ars.usda.gov/
Research/Research.htm] and CSREES CWD website at [http://www.csrees.usda.gov/nea/
animals/in_focus/ health_if_wasting.html].
104 PUSDA/ DOI, Plan for Assisting States, Federal Agencies, and Tribes in Managing
Chronic Wasting Disease in Wild and Captive Cervids, June 26, 2002, at
[http://www.aphis.usda.gov/lpa/issues/cwd/cwd62602.html#intro].
105 Progress Report on the Plan for Assisting States, Federal Agencies and Tribes in
Managing Chronic Wasting Disease in Wild and Captive Herds (October 2002-September
2003), May 2004.

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The FDA feed ban both prior to and since the announcement of enhanced
safeguards in January, 2004, permits beef by-products in U.S. commercial cat food,
which is technically regulated as “feed.” Since the finding of BSE in the United
States, some have expressed concern about the welfare of cats, and others about the
risks faced by people who consume cat food.
The Cornell Feline Health Center comments that “the risk of BSE-contaminated
pet food is very small indeed,” for the following reasons: none of the rendered by-
products from U.S. BSE-positive cows were released into manufacturing channels
for pet food; imports of rendered products prohibited from cattle feed but intended
for pet food must originate from countries free of BSE; and, imported pet foods may
not contain mammalian-derived material.106
106 Cornell Feline Health Center, “Mad Cow Disease and Cats,” accessed Aug. 1, 2005, at
[http://www.vet.cornell.edu/fhc/resources/madcow.htm].

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