Bovine Spongiform Encephalopathy (BSE, or "Mad Cow Disease"): Current and Proposed Safeguards

Bovine Spongiform Encephalopathy
(BSE, or “Mad Cow Disease”):
Current and Proposed Safeguards
Updated May 18, 2007
Sarah A. Lister
Specialist in Public Health and Epidemiology
Domestic Social Policy Division
Geoffrey S. Becker
Specialist in Agricultural Policy
Resources, Science, and Industry Division

Bovine Spongiform Encephalopathy
(BSE, or “Mad Cow Disease”):
Current and Proposed Safeguards
Through mid-May 2007, the United States had confirmed three cases of bovine
spongiform encephalopathy (BSE, or “mad cow disease”): the first in December
2003 in a Canadian-born cow found in Washington state, the second in June 2005 in
cow in Texas, and the third in March 2006 in a cow in Alabama.
Shortly after the first case, 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 findings
of BSE here 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 manufact-
uring. 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. A final rule is pending.
Many Members of the 110th Congress continue to closely follow these BSE
developments; hearings and legislative proposals on various aspects of the issue are
possible. Among the policy questions have been whether expanded agency actions
have provided further protections against BSE, whether they are scientifically sound,
and what costs they may have imposed 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.

In troduction ......................................................1
Overview ....................................................1
U.S. Cases of BSE.............................................4
Safeguards in Place Prior to December 2003.........................5
Additional Safeguards After December 2003........................6
International Review Team Findings...............................7
Trade Restrictions.................................................8
International BSE Standards.....................................9
Canadian Beef and Cattle Imports................................11
Japan and Korea Beef Trade Issues...............................14
Assessments of Import Safeguards...............................15
Harvard Risk Analysis.....................................15
International Review Team.................................16
Government Accountability Office...........................17
Office of Inspector General.................................17
2003 Interagency Report...................................18
Congressional Role...........................................19
The Livestock “Feed Ban”..........................................20
Overview ...................................................20
The Feed Ban Prior to December 2003............................21
Proposed Changes to the Feed Ban...............................22
Environmental and Economic Impacts of an SRM Ban in Feed.........25
FDA Impact Analysis......................................26
Industry Comments.......................................27
Earlier NRA/APPI Impact Analysis...........................28
NGFA Impact Analysis....................................28
Kansas State Impact Analysis...............................28
Enforcement of the Feed Ban....................................29
FDA Reports............................................29
GAO Evaluations.........................................30
Feed Testing Program.....................................30
The Feed Ban in Canada.......................................31
Congressional Role...........................................31
BSE Surveillance and Testing in Cattle................................32
Overview ...................................................32
BSE Surveillance in the United States Prior to December 2003.........33
Enhanced Surveillance Program.................................33
The “Downer” Ban and Impact on Surveillance.................33
Initial Proposals for Expanded Surveillance....................34
One-Time BSE Enhanced Surveillance Program................34
Ongoing Surveillance Plan.................................36
Critiques of the Enhanced Surveillance Program................36
“Inconclusive” Test Results.................................38
Confirmatory Testing Methods..............................38

BSE Surveillance Costs........................................41
Congressional Role...........................................42
BSE Prevention in Slaughter and Processing: the “Fourth Firewall”.........43
Ban on “Downer” Cattle.......................................44
Other New Slaughter and Processing Protections....................45
Congressional Role...........................................47
Related Issues and Options.........................................48
Federal Spending on BSE......................................48
Animal Identification and Meat Traceability........................49
Country of Origin Labeling.....................................51
Beef Labeled “Organic”........................................52
Chronic Wasting Disease.......................................52
Feline Spongiform Encephalopathy...............................55

Bovine Spongiform Encephalopathy
(BSE, or “Mad Cow Disease”):
Current and Proposed Safeguards
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 in
approximately two dozen countries. However, the majority of cases, approximately
183,000, have been in the United Kingdom (UK), where the disease was first
detected in 1986. Most of the rest occurred elsewhere in Europe, although Japan and
North America have reported multiple cases. 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. Almost 200 people have been diagnosed with
vCJD since 1986, most of them in the UK. As of mid-May 2007, no persons had
been reported to have contracted vCJD in the United States.1
As of mid-May 2007, BSE had been reported in 14 cattle in North America.
One animal, found in Canada in 1993, had been imported from the UK. The rest
were born in North America and were detected in 2003 or afterward. They include
10 native-born cases in Canada, one case in the United States (U.S.) which was born
in Canada, and two native-born U.S. cases. Because the first Canadian case in 1993
is not relevant to an understanding of recent North American BSE risk or control
measures, it is often excluded from official case counts. While both native-born U.S.

1 Three cases of vCJD diagnosed in the United States to date are felt to have been contracted
in other countries. 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, E. coli, Listeria,
Salmonella, and Yersinia.

cases were born prior to the institution of feed controls (the “feed ban”) in 1997, at
least six of the 11 Canadian-born animals (including the one discovered in the United
States) were born after similar controls were implemented in Canada, also in 1997.
This has raised concerns about the effectiveness of the feed ban in general, and the
speed and thoroughness of its implementation, particularly in Canada. A list of
North American BSE cases follows:
!December 1993, Canada reported BSE in a cow imported from the
UK in 1987, around the height of the outbreak there;
!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;

!January 2, 2005, Canada confirmed BSE in an Alberta dairy cow
born in October 1996;
!January 11, 2005, Canada confirmed BSE in an Alberta beef cow
born in March 1998;
!January 22, 2006, Canada confirmed BSE in an approximately six-
year-old crossbred cow born and raised in Alberta;
!April 16, 2006, Canada confirmed BSE in a six-year-old dairy cow
in British Columbia;
!July 4, 2006, Canada confirmed BSE in a crossbred beef cow of at
least 15 years of age in Manitoba;
!July 13, 2006, Canada confirmed BSE in a 50-month-old dairy cow
from Alberta;
!August 23, 2006, Canada confirmed BSE in a “mature” (likely 8- to

10-year-old) crossbred beef cow from Alberta.

!February 7, 2007, Canada confirmed BSE in a “mature” bull from
Alberta. Preliminary investigation suggested that the animal was
born in 2000.
!May 2, 2007, Canada confirmed BSE in a mature (likely 66-month-
old) dairy cow from British Columbia.
United States:
!December 23, 2003, USDA announced the first U.S. case of BSE,
a Holstein dairy cow in Washington state that was born in Alberta,
Canada in April 1997;

!June 24, 2005, USDA confirmed the second (first native-born) U.S.
BSE case, a 12-year-old Brahma cross cow from a Texas ranch.
This animal had been killed and tested in November 2004, when
BSE was initially ruled out, but subsequent retesting of brain tissue
in June 2005 confirmed BSE;
!March 13, 2006, USDA confirmed the third (second native-born)
U.S. BSE case, a nonambulatory, red crossbred cow in Alabama that
was more than 10 years old.
U.S. Beef Recall
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 meat2
traced to the affected animal and 19 others slaughtered and processed along with it. 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.” The agency stated that the tissues of highest infectivity are the brain,
spinal cord, and distal ileum, and 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 of3
an abundance of caution.”
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 and Third U.S. Cases: Material from the second and third U.S. cases did
not enter the food or feed supply, according to USDA. The Texas 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. The Alabama cow was buried on the farm. So no beef
recall was necessary in either case.

2 USDA, “FSIS Update Of Recall Activities,” release, February 9, 2004, on the Internet at
[]. 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.”

U.S. Cases of BSE
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 (see box), and also
conducted an extensive epidemiological investigation into how the cow likely
contracted BSE 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
Regarding the third U.S. case, in which no material entered the food or feed
supply (the animal had been euthanized and buried on the farm), APHIS and
Alabama State officials investigated 36 farms and five auction houses, and conducted
DNA testing on herds that may have included relatives of the BSE case. However,
they were unable to determine the cow’s herd of origin or to find any related animals
of interest, except for the two most recent calves of the infected animal. One calf
was still on the farm of the infected cow and being held by APHIS for observation;
the other had died the year before.
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) is considered the most likely source of BSE
infection. Of concern to some scientists, however, was that several of the Canadian
BSE cases were born after 1997, when both the United States and Canada instituted
similar but separate bans on the use of most mammalian proteins in cattle feed. This

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
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 Texas BSE Investigation — Final Epidemiology Report, August 2005. For recent
USDA information, see [].

led some to question the effectiveness of such a feed ban in general, and/or the
effectiveness of its implementation in Canada. (Both native-born U.S. cases were
born before 1997.)
In June 2006, a USDA official reported that the two native-born U.S. cattle had
“atypical” BSE, not the type seen in cattle in Europe or in the other North American
cases.6 The implications of this finding, including whether atypical BSE could be
spread by novel means, or whether existing controls are appropriate, are unclear at
this time. The USDA official stated at the time that there were no plans to change
existing controls, and the department was already in the process of ramping down its
domestic BSE surveillance activity.
The North American BSE cases 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 have not constituted a
“piecemeal” approach to addressing the BSE threat but rather an increasingly unified
system of overlapping and complementary safeguards.
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 fully 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 and
other countries 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

6 Bill Tomson, “Much Still Unknown About Two US BSE Cases,” Dow Jones Newswires,
June 8, 2006.

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.7 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);
!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).

7 Joshua Cohen et al., Evaluation of the Potential for Bovine Spongiform Encephalopathy
in the United States, November 2001, revised October, 2003, Harvard Center for Risk
Analysis, School of Public Health, at [
initiatives.html]. (Hereinafter cited as Cohen, Harvard study.) USDA-FSIS announced the
public availability of the most recent (2005) version of the Harvard risk assessment in the
July 12, 2006 Federal Register (pp. 39282-39283).

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.8 However, in the July 14, 2004 Federal Register, FDA published,
jointly with USDA, a somewhat different approach, in 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). A final rule had not been issued as of mid-May 2007. Some have
criticized FDA over both the pace and adequacy of these proposed changes. 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 had released its findings on February 4,
2004.9 The panel (the “International Review Team” or IRT, a subcommittee of a
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 the three-year examination of the U.S. BSE situation by
the Harvard Center for Risk Analysis.

8 U.S. Department of Health and Human Services (HHS), “Expanded ‘Mad Cow’ Safeguards
Announced to Strengthen Existing Firewalls Against BSE Transmission,” press release,
January 26, 2004.
9 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, February 4, 2004, hereafter referred to as the USDA Subcommittee
report or the IRT report.

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.10
The actions taken by USDA and FDA in response to the finding of BSE in
North America were intended not only to reassure consumers and protect livestock
health, but also to calm foreign markets, most of which had banned the entry of U.S.
cattle and beef products after December 23, 2003. Beef exports continue to recover
slowly, although Korea remained effectively closed at the end of 2006 and a number
of major markets still restrict certain types of U.S. beef.11 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
Worldwide, some 24 countries, including the United States, had reported one
or more indigenous cases of BSE, and several others reported only imported cases,
as of early 2007. The United Kingdom (UK), where BSE was first reported, has
experienced 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.12
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).

10 USDA, Report of the Secretary’s Advisory Committee on Foreign Animal and Poultry
Diseases: Measures Relating to Bovine Spongiform Encephalopathy in the United States,
February 23, 2004, hereafter referred to as the USDA Advisory Committee report.
11 For a discussion of economic issues and impacts on 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.
12 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 [
eng/info/en_esb.htm] .

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.)13
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.14
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.15 (Until

2005, 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)
were banning most ruminant products from any country that reported even a single
case of BSE. Many still do.
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

13 Sources for this section: various APHIS backgrounders and briefing materials, available
at []. No establishments
in countries with BSE have been permitted to ship beef to the United States, unless they
have been determined by USDA to have adequate BSE safeguards.
14 OIE standards are at []. See, also, OIE,
15 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-


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
country 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.
APHIS announced in March 2007 that the OIE Scientific Commission had
approved the U.S. request to be classified as a Category 2 “controlled risk” country.16
The recommendation and the same risk designation for Canada were to go to the OIE
General Assembly for final approval in late May 2007. 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. U.S.
officials have stressed on several occasions that they expect other countries to
recognize the OIE designation in opening their markets to more types of U.S. beef.
(See “Japan and Korea Beef Trade Issues,” below.)
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 by
practical developments between the United States and its trading partners. More
specifically, Canada has been gaining continued 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

16 Statement of APHIS Administrator Ron DeHaven, March 9, 2007, accessed May 18,

2007, at [


been trying to rebuild foreign confidence in its own beef supply, and to convince
other countries that U.S. safeguards are scientifically sound, equaling or exceeding
the internationally-recognized standards (also see “Japan and Korea 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.17
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
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
followed appropriate rulemaking procedures.18 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

17 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, November 4, 2003.

18 Ranchers Cattlemen Action Legal Fund USA vs. USDA (CV-04-51-BLG-RFC).

(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....”19
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.”20
July 18, 2005, became the first day that live cattle began to cross the border
from Canada since May 2003. Subsequently, from July 18 through the end of 2005,
approximately 563,000 cattle were imported from Canada. Approximately 1 million
head were imported through all of calendar year 2006.21
Restarting U.S.-Canadian beef and cattle trade has not been error-free. For
example, in early August 2005, 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. USDA officials also
found that more than a dozen of the Canadian cattle during the first month of imports
were pregnant, also in violation of the rule. The incidents fueled criticism among
some opponents that the border reopening was premature.
Despite such mistakes, and despite recent findings that a number of the
Canadian cattle with BSE were born after that country instituted its cattle feeding
restrictions in 1997, the U.S. Secretary of Agriculture and others have generally
expressed confidence in the safety of Canadian beef and cattle. They have continued
to assert that U.S. import safeguards, both generally and as applied to Canada, have
been applied with scientific rigor and careful oversight.

19 Ranchers Cattlemen Action Legal Fund USA vs. USDA (CV-05-06-BLG-RFC).
20 Ranchers Cattlemen Action Legal Fund United Stockgrowers of America 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
21 USDA, Foreign Agricultural Service and Agricultural Marketing Service (AMS) data. For
new import data see the AMS website at [].
Details on import requirements and procedures are posted on the USDA-APHIS website.

USDA-APHIS officials also had long been working on a proposed rule to permit
older (i.e., over 30-month-old) cattle to enter from Canada as well. This rule in July
2006 had been at the White House Office of Management and Budget (OMB) for
clearance, generally considered one of the final steps prior to publication in the
Federal Register. However, the department reportedly withdrew the proposed rule
from OMB to await more information from Canada about a BSE case announced
earlier in July in an approximately four-year-old cow. Some critics outside of the
department had asserted that because the cow was born long after the Canadian feed
ban was instituted, the effectiveness of the ban and its enforcement should be
scrutinized more closely before further relaxing import restrictions.22
On January 4, 2007, APHIS announced the proposed rule to permit older cattle
from Canada.23 Under the proposal, the following would be added to the list of
permitted imports:
!Any live cattle and other bovines for any use so long as they were
born on or after March 1, 1999. This effectively would enable
Canada to ship cattle over 30 months of age, including those, like
breeding animals, which are not ready or nearly ready for immediate
slaughter (as under the current final rule);
!Blood and blood products from bovines if collected under prescribed
!Casings and part of the small intestine derived from bovines.
APHIS officials observed that the proposed expansion does not cover deer,
sheep, and goats. Also, although this proposal does not explicitly address the import
eligibility of additional meat and meat products (as long as SRMs are removed).
However, such products were to be permitted under the January 2005 final Canada
rule, but their eligibility was postponed. If this January 2007 proposal is finalized,
USDA also will allow the importation of these meat products as well, APHIS stated,
adding that any such meats would be permitted — even those from animals born
before March 1, 1999.
APHIS stated that it had chosen the March 1, 1999, cutoff for live cattle
shipment because this was what it had determined to be the date of effective
enforcement of the Canada feed rule. An agency official explained that its assessment
allowed for six months beyond the formal implementation of the ban in August 1997,
and also for an additional year “for the normal marketing period where you would
expect feed to be cycled through in the cattle in that system.”24

22 Various trade publication reports, including “USDA Withdraws Rule to Allow Imports
of Older Canadian Cattle,” Food Chemical News, July 31, 2006; and “USDA Will Likely
Delay OTM Rule,” Cattle Buyers Weekly, September 4, 2006.
23 Unless noted, sources for the following section are materials and remarks provided by
APHIS on January 4, 2007. The proposed rule was published at 72 Federal Register 1582-

1619, January 9, 2007; public comments are due by March 12, 2007.

24 Dr. John Clifford, USDA Chief Veterinary Officer, January 4, 2007, audioconference.

Some U.S. cattle groups, among others, have expressed discomfort about the
proposal. Fueling their concern were Canada’s announcements on February 7, 2007,
of BSE in a “mature bull” in Alberta, and on May 2, 2007, of BSE in a likely
66-month-old dairy cow from British Columbia.25 Some critics cited the cases as
more evidence that Canada had not yet effectively implemented its BSE safeguards.
U.S. and Canadian authorities acknowledged that three of the earlier Canadian BSE
cases were found in cattle born after March 1, 1999, but have continued to argue that
the entirety of Canadian and U.S. safeguards ensured that any additional risk would
remain extremely low. Nonetheless, some analysts were speculating that the latest
Canadian case might delay publication of a final rule.26
An accompanying economic impact statement, also in the January 9, 2007
Federal Register, would result in higher imports of cull cattle from Canada, but
declines in feeder cattle, fed cattle, and fed beef. Cull cattle primarily are used for
processing beef, and so price declines in processing beef are anticipated, ranging
from $5 per 100 pounds in 2007 to $3 in 2009.
Japan and Korea 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 had stated that the two countries would evaluate this interim
system by July 2005 and modify it if appropriate. However, Japan, which reported
28 cases of BSE in its own cattle herd through mid-September 2006, moved much
more slowly to open its market than U.S. interests had hoped for, not accepting any
U.S. beef until December 2005. Then, on January 20, 2006, the Japanese again
halted all U.S. beef imports after finding vertebral column bones (a prohibited
material) in several boxes of veal shipped by a New York processor. Despite U.S.
apologies and promises of stronger oversight measures, Japan did not reopen its
market again until July 27, 2006. Japanese safety inspections of U.S.-certified beef
plants were among a number of new concessions made by the United States.

25 See, for example, R-CALF United Stockgrowers of America, “Latest Alberta BSE Case
Leaves Little Doubt: Canada Has a Problem,” February 9, 2007. A larger U.S. cattle group,
the National Cattlemen’s Beef Association, had earlier expressed some reservations about
the proposed rule at their recent annual convention, urging USDA to require permanent
identification of all live Canadian cattle imports through slaughter. Source: Cattle Buyers
Weekly, February 12, 2007.
26 Cattle Buyers Weekly, May 7, 2007.

Despite these concessions, the Japanese market has remained difficult to rebuild
for a number of reasons. For example, Japan has continued to inspect 100% of the
boxes of U.S. beef shipments. Announcing another possible step forward, Agriculture
Secretary Johanns said in April 2007 that the Japanese had promised to ease the
100% testing after conducting another series of audits of U.S. processing plants. He
also reminded the Japanese and other countries that he expected them to observe
OIE’s anticipated recognition of the United States as a “controlled risk” country.
That presumably means Japan should begin accepting beef from animals from under
30 months of age, not just under 21 months old. 27 Meanwhile, Japanese consumers
were substituting other proteins and other beef sources (notably, Australia and New
Zealand) for U.S. beef, which had once accounted for 25% to 30% of beef consumed
in Japan.
U.S. rules to permit the importation of Japanese beef are already in place.
USDA published, in the December 14, 2005, Federal Register, a rule to permit the
importation of whole cuts of boneless beef from Japan, under specified conditions.
USDA said the rule was in accord with OIE guidelines and was based on a risk
analysis indicating that such cuts could be safely imported.28 Prior to imposition of
a U.S. ban on Japanese beef imports due to animal disease (including BSE) outbreaks
there, Japan exported an annual average of less than 9 tons of primarily specialty beef
(Kobe and other Wagyu), according to department data. Some in Congress had
expressed frustration that the United States appeared to be favoring Japanese beef
producers at a time when authorities in Japan, where the BSE problem has been more
pronounced, were blocking U.S. imports.
The United States has encountered even more difficulty in regaining the South
Korean market, once the second-largest U.S. beef buyer. Although Korea ostensibly
lifted its ban on certain U.S. beef products on September 11, 2006, extremely strict
import inspection requirements and procedures have continued to effectively block
most of them. The South Koreans were rejecting U.S. beef first because they found
bone fragments, albeit very small ones that are typically acceptable in commercial
trade, in boneless beef (bone-in has not yet been made eligible), and, later, for what
they claimed were unacceptable levels of dioxin. In late April 2007, the Koreans
reportedly passed a 6.4-ton beef shipment, raising expectations that additional
clearances would soon follow.29
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

27 Statement of Agriculture Secretary Mike Johanns, April 23, 2007, accessed on May 18,

2007, on the USDA website. Also, “USDA gives on inspections and ‘expects’ science-

based import requirements ahead,” accessed April 4, 2007, at [].
28 70 Federal Register 48494 and 73905.
29 “Korea’s acceptance of Creekstone beef draws praise,” Food Chemical News, May 7,


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.
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 over30

1.2 million cattle and 185,000 tons of feed annually from Canada.

International Review Team. 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 for31
further propagation of BSE within the USA.
In another section of its report, the 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

30 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. [].
31 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
[ h t t p : / / www.aphi l p a/ i ssues/ b se/ US_BSE_Repor t .pdf ] .

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.”32
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
as inspection capacity that has not kept pace with the growth in imports, may33
allow BSE-infected products to enter the country.
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

32 Report on Measures Relating to Bovine Spongiform Encephalopathy (BSE) in the United
States, p. 11.
33 Government Accountability 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, January 2002; hereafter cited as GAO Mad Cow Disease report. At the time, the
agency was called the General Accounting Office.

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, entered34
U.S. commerce.
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
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 of35
entry. 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.36

34 USDA, OIG, Animal and Plant Health Inspection Service Oversight of the Importation
of Beef Products from Canada, at [].
35 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, January


36 Ibid.

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, with hearings held and several legislative proposals introduced
(but not passed) in the 109th Congress. Attention to this issue is likely to persist in
the 110th Congress, particularly with the release of the new Canada import proposal,
and also if any lingering problems with Japan and South Korea are not soon resolved.
On March 3, 2005, the Senate had approved, 52-46, a resolution (S.J.Res. 4) to
disapprove USDA’s January 4, 2005 Canada import rule, but the measure did not
advance in the House. The Administration opposed the resolution. Other pending
bills addressing the Canada rule included 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. S. 294 would have
prohibited 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.” These bills also did not advance, but several
COOL-related bills (H.R. 357; S. 404; S. 1308) have re-emerged in the 110th
The sluggish pace of the Japanese negotiations frustrated the beef industry and
many Members of Congress, who believed opening the Japanese market would
convince other importing nations, particularly in Asia, to follow suit. This frustration
was evident in the Senate’s passage on September 19, 2005, of a floor amendment
which would have prohibited implementation of USDA’s August 18, 2005 Japan rule
unless Japan opened 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 lacked the amendment, which was
deleted in conference on the final measure (P.L. 109-97).
Other proposals included a House resolution introduced earlier in 2005 (H.Res.

137) calling for economic sanctions against Japan if it did not permit U.S. beef;

several bills (S. 3364; S. 3538; H.R. 5675) introduced in June 2006 that would have
required trade sanctions against Japan if the market was not opened; and the pending
Senate version of the FY2007 USDA appropriation (H.R. 5384), which included a
committee-approved, nonbinding amendment recommending such sanctions if
necessary. The final appropriation did not pass, and USDA and most other agencies
operated since the start of the fiscal year through at least early 2007 under a
continuing resolution.
A more comprehensive proposal, the “BSE and Other Prion Disease Prevention
and Public Health Protection Act” (S. 2002), included a section prohibiting the
importation of any human food, animal feed, or other article intended for human or

37 For details, see “Country-of-Origin Labeling,” later in this report.

animal use that contains animal-derived material but does not include information
stating in English the common name of the animal. If the source animal is a
ruminant, the item must also include text stating in English the country of origin and
whether it contains any prohibited material (i.e., SRM). Also, no ruminant-derived
imports could be imported from a country with BSE risk unless that country met OIE
guidelines. This proposal also did not advance in the 109th Congress.
The Livestock “Feed Ban”
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
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.”38
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 noted that, relative to other countries,
U.S. surveillance and import controls were stronger, but the feed ban was more
permissive.39 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.

38 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.
39 GAO, Improvements in the Animal Feed Ban and Other Regulatory Areas Would
Strengthen U.S. Prevention Efforts, (GAO-02-183), January 2002.

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.40
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 U.S. BSE case, the FDA in January 2004 announced
imminent plans to expand feed ban restrictions. The agency published an advance
notice of proposed rulemaking (ANPR) in 2004 and a proposed rule in 2005, each
with provisions that varied from the other and from the 2004 announcement. The
regulation had yet to be altered as of mid-May 2007. An analysis of these rulemaking
proposals follows.
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 have 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.41

40 Cohen, Harvard study, p. 111.
41 FDA, Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk

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.42
Proposed Changes to the Feed Ban
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.43
On February 3, 2004, the IRT recommended additional steps, including more
stringent animal feed restrictions than those just announced by FDA. The panel
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.”44 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.45 The report stressed 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.

41 (...continued)
of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease
(vCJD) by Blood and Blood Products, January 2002, at [
gdlns/cj dvcj d.htm] .
42 FDA, “Substances Prohibited From Use in Animal Food or Feed; Animal Proteins
Prohibited in Ruminant Feed,” 67 Federal Register 67572, November 6, 2002.
43 U.S. Department of Health and Human Services, “Expanded ‘Mad Cow’ Safeguards
Announced To Strengthen Existing Firewalls Against BSE Transmission,” press release,
January 26, 2004.
44 USDA Subcommittee report, pp. 8-9.
45 USDA Advisory Committee report, p. 2.

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.”46 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.
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.47 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.48 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 proposed rule to modify the feed ban on October 6,
2005.49 Comments were accepted until December 20, 2005, after which they were
to be evaluated prior to publication of a final rule. The proposal would ban, from all
types of animal feeds (including pet food), the following materials that would be
considered higher-risk (i.e., SRM):

46 USDA/HHS, “Federal Measures to Mitigate BSE Risks: Considerations for Further
Action,” Federal Register, July 14, 2004.
47 OIE Terrestrial Animal Health Code 2005, Chapter 2.3.13, Bovine Spongiform
Encephalopathy, at []. 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.
48 U.S. Senate Committee on Agriculture, Nutrition and Forestry, hearing on Mad Cow
Disease, January 27, 2004, 108th Cong., 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.
49 70 Federal Register 58570-58601.

!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 in Slaughter 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.
Each of the remaining SRMs covered by the USDA-FSIS human food ban contain
much smaller percentages of total infectivity, FDA said.50
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 verify51
compliance on over 1 million farms where cattle are being fed.
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.

50 70 Federal Register 58578.
51 70 Federal Register 58576.

In its accompanying economic analysis, FDA stated that it had considered 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 to be prohibited in all
feeds. It generally concluded that such additional measures are not necessary because
the partial SRM ban being proposed would remove an estimated 90% of BSE
infectivity. However, it again asked for further comments on these options.
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.”52 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.53 Members of the rendering industry expressed concerns about the
cost of the proposed measures to their industry. These concerns are discussed further
in a section on environmental and economic impacts.
Consumer advocacy groups argued that the proposal was too weak because,
among other things, it didn’t prohibit SRMs from all animal feed, and because it
continued to allow exemptions for bovine blood, poultry litter, and plate waste in
cattle feed. For example, comments from Consumers Union argued, among other
things, that the proposed list of SRMs was too narrow to adequately protect the feed
supply, and is more narrow than the SRM definition used by FSIS to protect the
supply of beef for human consumption.54
As of mid-May 2007, FDA had not finalized any proposed changes to the feed
ban. An FDA official was quoted in September 2006 as saying that the agency may
have underestimated the impacts that the ban of SRM in all feeds could have on the
rendering industry. He said that FDA continued to review the proposal, and that
publication of a final rule would be pushed back to “later this year” or beyond.55
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 in all feeds
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),

52 Hodges, Jim, American Meat Institute Foundation, October 6, 2005, letter in the Atlanta
53 McAdams, Jim, NCBA President, statement on October 4, 2005.
54 Consumers Union, “Consumers Union’s Comments on FDA Docket Number 2002N-0273:
Substances Prohibited from Use in Animal Food and Feed,” December 20, 2005, at
[ h t t p : / / www.f d a.go v/ ohr ms / docke t s / docke t s / 02n0273/ 02n-0273-EC248-At t a ch-1.pdf ] .
55 Tomson, Bill, “U.S. Feed Ban May Be Too Costly to Industry - FDA Official,” Dow Jones
Newswires, September 12, 2006.

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.56
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.57 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.
FDA Impact Analysis.58 In its October 2005 proposed rule, 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

56 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, April 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.
57 See FDA, TSE Regulatory Options Cost Analysis, June 1997, at [
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.
58 FDA’s Analysis of Economic Impacts begins on page 58584 of 70 Federal Register. See,
also, Eastern Research Group, “Economic Impacts of Proposed Regulatory Changes,” and
“Economic Impacts of Alternative Changes to the FDA Regulation,” both viewed on July

25, 2005; studies commissioned by FDA, at [].

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.59
Industry Comments. The National Renderers Association (NRA), which
commissioned its own economic analysis of the proposal, commented that by
prohibiting most if not all cattle brains and spinal cords from all livestock feed
markets, the rule would “have immediate and profound impacts on the livestock
sector, particularly on the rendering industry and livestock producers.” The analysis,
based in part on a survey of rendering plants, “conservatively” estimated the direct
economic losses faced by the rendering industry and livestock producers at more than
$127.7 million annually, substantially higher than FDA’s estimate. When slaughter
plants’ costs of handling and disposing of newly prohibited materials are added, the
aggregate impact would exceed $150 million annually, the NRA argued.
The NRA sponsored analysis concludes that FDA significantly underestimated
the proportion of dead cattle and calves that are currently rendered in the United
States; that the proposed rule severely reduces the number to be rendered; that
reduced collections by renderers and higher fees would create more potential for
environmental problems; and that livestock producers’ disposal costs could increase
by $112 million per year. Reduced MBM and tallow sales from the loss of deadstock
for rendering could exceed $15.7 million yearly, or more than 15 times the level
suggested by FDA, among other NRA assertions.60

59 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.
60 National Renderers Association, comments on FDA Docket No. 2002N-0273, Substances
Prohibited From Use in Animal Food or Feed, December 20, 2005. The analysis, Economic
Impacts of Proposed Changes to Livestock Feed Recommendations, was conducted for NRA
by Informa Economics, an agribusiness consulting firm. Its report provides much more
detail on how it arrived at its findings than is described here. NRA’s comments are at
[ h t t p : / / www. f d a . go v/ohrms /dockets/dockets/02n0273/ 02n-0273-c000461-01-vol39.pdf].
The Informa economic analysis can be viewed on the NRA website at [http://www. economic_impact/index.htm] .

Earlier NRA/APPI Impact Analysis. In its earlier (2004) ANPR, FDA also
had sought information about the economic and environmental impacts of prohibiting
SRM in all animal feeds. Joint comments on the earlier ANPR by 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 the61
industry would be $166.3 million annually.
The NRA/APPI response also 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 states
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, in 2004 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.62
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 per63
ton, or $3.17 per steer, the study reported. Banning animal consumption of all SRM

61 National Renders Association and Animal Protein Producers Industry, Response to FDA
Docket No. 2004N-0264, Federal Measures to Mitigate BSE Risks: Considerations for
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.
62 National Grain and Feed Association, Response to FDA Docket No. 2004N-0264, August

13, 2004.

63 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

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.)
Enforcement of the Feed Ban
FDA Reports. The FDA Center for Veterinary Medicine has since 200164
provided periodic updates of its feed ban enforcement activity on a public website.
Its January 12, 2007 update reported that it had received more than 50,000 inspection
reports since the program began, on 19,492 renderers, feed mills, protein blenders,
and related establishments. The agency noted that 5,905 of them (30%) handled
materials prohibited for use in ruminant feeds.
Of this subset, FDA reported that the vast majority were within compliance.
More specifically, the January 2007 update found that seven of the firms that handled
prohibited material (0.1%) were classified as so-called “Official Action Indicated,”
or OAI, meaning that significant problems were found that warranted regulatory
sanctions. For example, one OAI might be that the manufacturer lacked the
procedures to ensure that ruminant feed is not contaminated with nonruminant feed.
Another 188 firms (3.2%) were classified as “Voluntary Action Indicated,” or VAI,
meaning that problems were found but only advisory actions were warranted. A VAI
example might be a minor recordkeeping lapse, FDA explained.
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%).
FDA had asserted on several past occasions that feed industry compliance with
the ban has reached 99%.65 FDA bases its compliance determinations mainly 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

63 (...continued)
Agriculture), April 2005, at [
industry/demand/EconomicImpactofBSEonUSBeefIndustry.pdf], and henceforth called the
Kansas State University study.
64 See the FDA website at [].
65 See, for example, FDA, “FDA Statement on Rendered Products Derived From BSE Cow
in Washington State,” December 27, 2003, at [

material. In its July 2004 ANPR, FDA requested information on potential test
methods for detecting SRM in animal feed.66
GAO Evaluations. GAO issued reports on FDA’s oversight of the feed ban,
in 2002 and 2005, in which it noted a number of problems with administrative
procedures, inspection, and enforcement.67 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 at the time. Among
other concerns, GAO also commented that FDA had not reinspected approximately
2,800 firms for several years and therefore did 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
alerted USDA and the states when it learns that cattle may have been given
prohibited feed.
Feed Testing Program. FDA started a small, discreet feed testing program
in 2003, which GAO evaluated in an October 11, 2005, report to several Senators.68
The purpose of the program, according to GAO, was to collect and study samples of
cattle and other animal feeds and ingredients to determine whether permitted cattle
feed might contain FDA prohibited material. Because some cattle-derived products
are permitted in feeds (blood, milk protein, plate waste), laboratory tests could not
definitively determine violations — only potential violations, leading to follow-up
reviews, it was noted.

66 Such tests would determine only if prohibited materials were present in the feed, not
whether infectious BSE prions were present. For information on a small FDA feed testing
program begun in 2003, see the subsequent section of this report.
67 GAO, FDA’s Management of the Feed Ban Has Been Improved, but Oversight
Weaknesses Continue to Limit Program Effectiveness (GAO-05-101), February 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), January 2002.
68 Mad Cow Disease: An Evaluation of a Small Feed Testing Program FDA Implemented
in 2003 With Recommendations for Making the Program a Better Oversight Tool (GAO-06-

157R). Report for the Hon. Saxby Chambliss, Tom Harkin, Thad Cochran, and Richard J.

Durbin, October 11, 2005.

GAO cited several weaknesses in the testing program, including no FDA
requirement that districts document follow-up reviews or provide the basis for their
final determinations on samples; extended periods to complete nearly half of the 989
samples studied by GAO, making it possible for feed to be consumed before results
were in; and inadequate headquarters oversight of the program.
The Feed Ban in Canada
On June 26, 2006, the Canadian Food Inspection Agency announced a proposal
to strengthen the country’s feed ban, introduced in 1997, with new measures to
become effective on July 12, 2007.69 The expansion would prohibit SRMs in all
animal feeds and in fertilizer. The Canadian ban is somewhat stronger than the FDA
proposal of October 2005: the list of SRMs is somewhat more restrictive, and the
prohibition against SRMs in fertilizer is not included in the FDA proposal. There
may be trade and other concerns if the FDA’s final feed rule is substantially different
from the amended Canadian rule.
Congressional Role
If Congress more closely reviews the feed ban and its role in preventing the
spread of BSE, issues for consideration might include the effects on the safety of the
feed supply of banning “downer” animals from slaughter and thus channeling them
to rendering, and whether current oversight of the feed ban has accommodated 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 that processes to ensure
the safe disposal of animal remains are included in new regulations as they are
implemented. Congress also could scrutinize the anticipated changes in feed ban
restrictions proposed by FDA, particularly regarding their economic implications,
their likely impact in strengthening BSE prevention, and the agency’s strategies for
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, S. 73 would have statutorily defined “SRM,” and
explicitly made it illegal for any person to introduce into interstate or foreign
commerce these and other prohibited materials, among other provisions. Also
introduced was S. 2002, a more comprehensive BSE proposal that included a section
similarly defining and restricting the introduction of “SRM” into
Members of the 110 Congress could reintroduce these or additional measures, and

69 Canadian Food Inspection Agency, “Bovine Spongiform Encephalopathy (BSE) in North
America,” Web page, at [
bseesb/bseesbindexe.shtml ].

are likely to be interested in the substance of the anticipated final rule and its
BSE Surveillance and Testing in Cattle
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
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.
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.70 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 proposed that surveillance should approximate programs in
European countries, where every adult animal was 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

70 Testimony of Elsa Murano, Under Secretary for Food Safety, USDA, before the U.S.
Congress, Senate Committee on Appropriations, Bovine Spongiform Encephalopathy (BSE),thnd
hearing, 108 Cong., 2 sess., February 24, 2004 (Washington: GPO, 2004).

level of one in 1 million adult cattle. (USDA reported a total of approximately 97
million cattle in the United States as of January 1, 2006.)
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
and 2003, out of about 35 million cattle slaughtered each year.71 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.72
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.)

71 Early (May 2004) information on the APHIS BSE cattle surveillance program is available
at [].
72 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.

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.73
Initial Proposals for Expanded Surveillance. 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 first U.S. case
(i.e., the Canadian-born cow found in Washington state). 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.74
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.75 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

73 See transcripts of U.S. House of Representatives Committee on Agriculture, Hearing on
Mad Cow Disease Response, January 21, 2004, and U.S. Senate Committee on Agriculture
Nutrition and Forestry, Hearing on Mad Cow Disease, January 27, 2004, 108th Cong., 2nd
74 USDA, Report of the Secretary’s Advisory Committee on Foreign Animal and Poultry
Diseases: Measures Relating to Bovine Spongiform Encephalopathy in the United States,
February 23, 2004, at [].
75 See USDA, “Veneman Announces Expanded BSE Surveillance Program,” press release,
March 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.

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 of the apparently healthy
older cattle population, including animals that were born prior to institution of the
feed ban. APHIS completed this testing of 21,216 clinically normal adult animals on
November 21, 2005. All of these animals tested negative for BSE.
Enhanced surveillance of the high-risk population began on June 1, 2004, which
has required a number of expansions of USDA activities.76 USDA set sampling goals
for each state, noting that these were estimates based on cattle population data.77 The
program has depended 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.78
The approved rapid tests are for screening purposes. The policy has been 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.79 USDA officials and representatives of the
rendering industry later maintained that sufficient numbers of animals were being
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 had agreements with such
plants that pay up to $100 per carcass for storage until BSE test results are complete;

76 See APHIS, “Bovine Spongiform Encephalopathy (BSE) Surveillance Plan,” March 15,

2004, at [].

77 See APHIS, “Examples of Geographic Distributions of Sample Collections for the BSE
Surveillance Plan,” at [
78 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, March 4, 2004.
79 For example, see Andy Dworkin, “Testing Protocols for Mad Cow a Complex Process,”
The Oregonian, July 7, 2004.

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.80
After more than two years of enhanced surveillance through late August 2006,
USDA reported that it had completed testing of about 788,000 animals.81 Four of
these animals tested “inconclusive” on screening; two, which had been tested in the
early weeks of the program, 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. The fourth also proved to be positive on subsequent testing. (A
discussion of the reporting of inconclusive findings follows later.)
Ongoing Surveillance Plan. In April 2006, USDA made public its analysis
of BSE surveillance data, covering not only the period (to date) of the enhanced
surveillance program, but also earlier “routine” testing. The data covered a total of
seven years. “The analysis concluded that the prevalence of BSE in the United States
is less than one case per million adult cattle. The analysis further revealed that the
most likely number of cases is between four and seven infected animals out of 42
million adult cattle,” USDA declared.82 USDA also said that the analysis was
subjected to peer review and that a panel of outside experts had affirmed the
The Secretary of Agriculture released this analysis in announcing that enhanced
surveillance would soon be scaled back to an ongoing level of 40,000 tests per year.
From September 2006 through April 2007, USDA tested a total of 23,818 cattle for83
BSE, with no positive results reported.
Critiques of the Enhanced Surveillance Program. The enhanced
surveillance program garnered considerable criticism, at least in its early stages. 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.84 The committee
raised questions about 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

80 Personal communications with National Renderers Association, July 11, 2005, and with
APHIS veterinarians, July 13, 2005.
81 See APHIS BSE testing results at [].
82 “USDA Announces New BSE Surveillance Program,” May 20, 2006 press release.
83 Monthly test results and related information are at [
hot_issues/bse/surveillance/ongoing_surv_results.shtml ].
84 Letter from Reps. Tom Davis and Henry Waxman to Agriculture Secretary Veneman
concerning “Mad Cow” Disease, February 17, 2004, and related committee documents.

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 concerns became the subject of investigation 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
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.86
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.87
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

85 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.
86 Ibid.
87 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.

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.88 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
generally recovered 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 was 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-

88 A fuller statistical and descriptive picture of the surveillance conducted, such as the types
of sites where samples were taken, their geographical locations, and clinical signs observed,
is available in APHIS documents on the web, i.e., Summary of Enhanced BSE Surveillance
in the United States, prepared by APHIS’ Veterinary Services Centers for Epidemiology and
Animal Health National Surveillance Unit, April 27, 2006 at [
news room/hot_issues/bse/surveillance/bse_disease_surv.shtml ].

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.89
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
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 in90
question is indeed negative for BSE.
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.91
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
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, 2005, 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.92

89 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.
90 Statement by Clifford, John, APHIS Deputy Administrator, November 23, 2004.
91 “Market Rebounds With a Vengeance,” Cattle Buyers Weekly, November 29, 2004.
92 Transcript of media conference, USDA, June 24, 2005.

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.93 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 test 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.”94
In the four instances of “inconclusives,” including the March 2006 test, 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 Western blot test, but negative on immunohistochemistry95
(IHC) — a case that Japan reported to OIE as “atypical BSE.” 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.96 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

93 Ibid.
94 Transcript of media conference, June 24, 2005. The APHIS website also had posted a
series of factsheets explaining in more detail the confirmatory testing methods and how they
were applied in the 2005 case. In the March 2006 case, both types (the Western blot and
IHC) confirmed the presence of the BSE agent.
95 For more information, see OIE, Disease Information, “Bovine spongiform encephalopathy
in Japan: atypical case,” Vol. 16, No. 41, October 10 2003, at [
96 “Second US cow tests positive for BSE,” News Service, June 28, 2004.

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 LLC (“Creekstone”), 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.”97
Creekstone sued USDA in March 2006. The Federal District Court for the
District of Columbia ruled on March 29, 2007, that the department lacks the authority
to prohibit private BSE testing. The ruling is on hold pending an appeal, but takes
effect on June 1, 2007, if USDA does not appeal the decision.
The Creekstone matter has prompted a range of reactions. Critics of USDA’s
actions, 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.98 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.
BSE Surveillance Costs
The cost of BSE surveillance and the infrastructure to support it 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.99 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.100

97 USDA, “Statement by Bill Hawks, Undersecretary for Marketing and Regulatory
Programs Regarding a Request by Creekstone for Private BSE Testing,” press release, April
9, 2004. A legal analysis of USDA’s Creekstone decision is available in CRS Report
RL32414, The Private Testing of Mad Cow Disease: Legal Issues, by Stephen R. Vina.
98 For information on these programs, see the website of USDA’s Agricultural Marketing
Service at [].
99 Dennis Normile, “First U.S. Case of Mad Cow Sharpens Debate Over Testing,” Science,
vol. 303, pp. 156-157, January 9, 2004.
100 Kansas State University study. The study observes that the cost of testing, regardless of

An APHIS spokesperson said in 2004 that, considering overhead costs, tests
could run from $25 to $50 per animal. However, the USDA’s enhanced surveillance
program involved a variety of activities beyond the conduct of tests, including
outreach to farmers and renderers (to identify all animals that should be tested),
transportation of carcasses to sites where sample collection (including removal of the
head) can be performed, sample transport and storage (including refrigeration),
record-keeping, and the costs of investigating inconclusive and positive results,
including indemnity payments. As a result, per-head cost comparisons can be
difficult unless one knows the precise scope of activities that have been included, and
whether the activities are limited to testing or encompass the broader requirements
of a comprehensive surveillance program.
To fund the enhanced surveillance program, USDA in March 2004 transferred
an initial $70 million from its Commodity Credit Corporation (CCC). By the time
enhanced surveillance had ended, a total of $152.4 million in CCC funds had been
used for the program. This amount was in addition to allocations for BSE
surveillance coming out of annual congressional appropriations, which rose from $2
million in FY2001 to $17 million annually in each of FY2005-FY2007 (projected;
this is an expected cost of testing 40,000 animals per year).101 Responding to
questions at an April 2006 briefing on the program, the APHIS administrator
estimated that the weekly cost of testing between 5,000 and 7,000 animals was
approximately $1 million.102
Congressional Role
The 108th and 109th Congresses closely followed the enhanced BSE surveillance
effort as it was getting under way in 2004, when concerns were raised about its basic
design and initial operation. Many Members expressed interest in the impact of
testing on cattle prices, particularly whenever USDA reported anything other than a
negative finding of BSE, as occurred on four occasions during the two years of
enhanced surveillance. 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 was later confirmed to be positive (see
The 109th Congress did not hold hearings or introduce many bills on these
issues, although a section of S. 2002 did propose a relatively extensive prion disease
surveillance program that would have included compensation to industry for animals

100 (...continued)
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.
101 House Appropriations Committee, Agriculture, Rural Development, Food and Drug
Administration, and Related Agencies Appropriations for 2007, Part 3 of hearings. Also,
undated, unpublished APHIS fact sheet on BSE test funding obtained in December 2006.
102 Transcript of Telenews Conference on the Enhanced BSE Surveillance Program with
Agriculture Secretary Mike Johanns and APHIS Administrator Dr. Ron DeHaven, April 28,


tested, and called for a task force on prion diseases to provide recommendations to
Congress on all surveillance and research programs.
Questions about surveillance and testing also have arisen during lawmakers’
consideration of annual funding for APHIS. In the 109th Congress, during House
floor consideration of the pending FY2007 USDA appropriation bill (H.R. 5384),
Representative Kucinich offered but later withdrew an amendment aimed at
maintaining BSE testing at the enhanced surveillance level. During its markup on
May 9, 2006, the House Appropriations Committee defeated, on a voice vote, an
amendment by Representative Tiahrt that would have barred USDA from enforcing
its restriction on the private testing of cattle for BSE. Similar proposals could arise
in the 110th Congress, particularly if one or more additional positive BSE cases is
found in the United States.
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.103 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.
The Secretary of Agriculture 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 these
newer FSIS measures involve changes in meat inspection and human food safety
protections, interventions that had been regarded by USDA and FSIS 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

103 USDA, FSIS, FSIS Current Thinking on Measures That Could Be Implemented to
Minimize Human Exposure to Materials that Could Potentially Contain the BSE Agent,
January 15, 2002, at [].

specific animals or measures of BSE prevalence nationwide, represent the strongest
actions to protect public health since the first U.S. finding of BSE.
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.104 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 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.105 USDA’s statistical agency then
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 2004.106
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.

104 “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.
105 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.
106 USDA, National Agricultural Statistics Service, Non-Ambulatory Cattle and Calves,
released May 5, 2005.

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.
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
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
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
immediat el y.108
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.

107 USDA, FSIS, Preliminary Analysis of Interim Final Rules and an Interpretative Rule to
Prevent the BSE Agent from Entering the U.S. Food Supply, document released in 2004, at
[]. See also,
USDA APHIS, USDA BSE Surveillance Plan: Background on Assumptions and Statistical
Inferences, March 15, 2004, at [].
108 “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.

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
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.109 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.110
The USDA expert panel (IRT) had commented on February 4, 2004, that until
a more aggressive BSE surveillance was 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.111 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 the following:
!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?

109 For further information on FSIS AMR standards and testing, see the agency’s AMR Web
page at [].
110 GAO Mad Cow Disease report, p. 38.
111 69 Federal Register 42256-42274.

!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.112
Congressional Role
Although BSE’s potential impact on food safety and public health has been of
interest to many Members of Congress, the trade-related, animal disease, and
economic aspects of the disease have attracted as much attention. Still, a few
proposed measures in the 109th Congress would have directly or indirectly affected
FSIS’s oversight of BSE safeguards in meat plants. For example, as noted earlier,
S. 73 focused primarily on keeping higher-risk cattle parts out of animal feeds, but
one section of the bill explicitly would have made it illegal for any person to
introduce into interstate or foreign commerce these and other prohibited materials,
among other provisions.
Other measures 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 have prohibited nonambulatory
livestock from being used for human food. The House-passed bill lacked such a ban,
and the amendment was deleted during the House-Senate conference. When the
Senate adopted the provision, there was discussion of its potential to protect against
BSE. However, the amendment would have applied not only to cattle, but also to any
sheep, swine, goats, horses, mules or other equines “that are unable to stand or walk

112 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.

unassisted” at the point of antemortem inspection. (Senator Akaka also again
introduced the Downed Animal Protection Act as S. 1779; the House companion bill
by Representative Ackerman was 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.”
These or other proposals aimed at addressing the food safety and animal welfare
aspects of the BSE issue could re-emerge in the 110th Congress. Senator Akaka and
Representative Ackerman in January 2007 introduced bills (S. 394; H.R. 661) to ban
downed animals in human food and to require that they be humanely euthanized
immediately. Among the possible venues for debating them are the House and
Senate Agriculture Committees, which plan to draft new omnibus legislation to
replace expiring provisions of the 2002 farm bill (P.L. 107-171), and the House
Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug
Administration, and Related Agencies, whose new chairwoman has expressed a
strong desire to review a variety of food safety problems and the effectiveness of
existing federal programs.
Related Issues and Options
Federal Spending on BSE
Federal dollars devoted to BSE-related activities have risen significantly in
recent years, from less than $6 million in appropriated funds in FY2001 to an
estimated $90 million in FY2006, and a requested $98 million in FY2007. These
figures do not include transfers of an additional $157.4 million from the CCC
account (which the Secretary is permitted to do under standing authority). Most of
these CCC funds were used to pay for the enhanced surveillance program.
More specifically, USDA’s BSE spending (exclusive of the CCC money) has
increased from less than $500,000 in FY2000 to $60 million in FY2006 and a
requested $68 million in FY2007. Within these totals, $7 million has been budgeted
for research by USDA’s Agricultural Research Service (which wants an increase to
$15 million for FY2007), $17 million for APHIS ongoing surveillance, and $3
million for FSIS meat safety activities. APHIS also includes another $33 million
annually within this total to continue the establishment of a national animal ID
system, but this program is intended to support efforts to address any animal disease,
not just BSE.
FDA spending for BSE-related work has risen from less than $4 million in
FY2001 (the first year for which figures are available) to nearly $30 million in each
of FY2005-FY2007 (estimated). Within this total, $16 million annually is for federal

feed inspections, more than $3 million for state feed inspections, and about $10
million for a variety of regulatory, educational, and research activities.113
The Administration’s final FY2007 budget for USDA and for FDA was not
cleared by the 109th Congress, so programs for these (and most other federal)
agencies and activities have been funded under a series of continuing resolutions,
including the fourth and final one, H.J.Res. 20 (P.L. 110-5). The 110th Congress in
spring 2007 was beginning to consider the FY2008 USDA and FDA appropriations
requests. Although the Administration’s requests for BSE-related appropriations
generally have not been highly contentious, efforts to constrain the federal budget
deficit, along with the observations of some that BSE is a diminished threat to U.S.
cattle and people, could be factors in future spending decisions.
Animal Identification and Meat Traceability
Following the first U.S. report of a cow with BSE in late December 2003, the
Secretary of Agriculture promised to take the lead in implementing an animal ID
program capable of identifying all animals of interest within 48 hours of a disease
discovery (BSE or other). Many animal producers support establishment of a
nationwide identification (ID) system capable of quickly tracking animals from birth
to slaughter. Many of them already keep records on the identities of each of their
animals, primarily for herd management and marketing purposes.
Still, 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, 2004.114
However, despite years of effort on an animal ID program for disease purposes,
many contentious issues remain unresolved. For example, should it be mandatory

113 Sources for these figures include unpublished figures from the budget offices of USDA
and FDA, as well as hearings to support the agencies’ FY2006 and FY2007 budget requests
before the House Appropriations Committee.
114 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, February 4, 2004, 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

or voluntary? What types of information should be collected, on what animal species
— and who should hold it, government or private entities? How much will it cost,
and who should pay?
USDA has committed through FY2006 about $85 million to a program, with
another $33 million sought for FY2007; all states now have systems for registering
animal premises. In April 2006, USDA had published a new implementation plan
envisioning an “incremental” series of implementation steps leading to full producer
participation by 2009. By November 2006, USDA had further revised its thinking
on how to achieve implementation. It unveiled a draft “user guide,” which stated that
it was “the most current plan for the NAIS and replaces all previously published
program documents, including the 2005 Draft Strategic Plan and Draft Program
Standards and the 2006 Implementation Strategies.”115 The document seeks to
reassure producers that USDA will not require them to participate in the program,
and that it is bound by law to protect individuals’ private and confidential business
information. The draft user guide describes three successively greater steps toward
full participation, if a producer chooses to do so, which include premises registration,
animal identification, and selection of an animal tracking database to report animal
movements (actually a series of privately or state-administered databases rather than
a central USDA system).
Some industry groups and lawmakers have criticized USDA for moving too
slowly and/or not providing a clearer path toward a universal ID program. Others
believe that USDA’s progress to date simply reflects the deep divisions among
producers and other interests over the many unresolved questions. Meanwhile, a
vocal number of livestock producers, many of them smaller-scale, are opposing any
effort to establish broader programs, fearing they will be costly and intrusive.
The 108th and 109th Congresses were asked to address animal ID issues. The
House Agriculture Committee held hearings in 2005 on the feasibility of establishing
a privately held system. A provision in the House-passed USDA appropriation for
FY2007 (H.R. 5384) would have conditioned the use of the next $33 million in
spending for animal ID on publication in the Federal Register of a “complete and
detailed plan” for the program, “including, but not limited to, proposed legislative
changes, cost estimates, and means of program evaluation.” However, a House floor
amendment to prohibit all ID program funding was defeated by a wide margin. The
Senate committee-reported version of H.R. 5384 requested a GAO review of
USDA’s efforts.
Other bills in the 109th Congress included 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. A provision of S. 2002 would have required USDA to establish a ruminant
ID program.

115 APHIS is accepting comments on the draft user guide until January 22, 2007; it is posted
at its NAIS website: [].

Continuing differences over animal ID have propelled the issue into the 110th
Congress. Many observers expect that these differences could be resolved in a part
of the next omnibus farm bill, which the House and Senate Agriculture Committees
hope to complete in 2007. As of mid-May, two animal ID bills had been introduced:
H.R. 1018, to prohibit USDA from implementing a mandatory program; and H.R.

2301, to establish a producer-governed program.116

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.
Past Congresses delayed the implementation deadline several times. 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). The FY2006 appropriation for USDA (H.R. 2744; P.L. 109-97) postpones
COOL for an additional two years, until September 30, 2008.
Meanwhile, debate over the pros and cons of COOL continues into the 110th
Congress, where some Members still oppose the delay, and have expressed their
intention to require implementation sooner.117 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.
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

116 See CRS Report RL32012, Animal Identification and Meat Traceability, by Geoffrey S.
117 For example, Representative Rehberg introduced the first such bill (H.R. 357), to require
COOL by September 30, 2007.

from Canada. Hoping to satisfy Japanese (and Korean) demands, the department
unveiled in August 2003 a “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 it has been widely viewed as a minimum prerequisite for
gaining access to the Japanese and other foreign markets.
Bills offered earlier in the 109th Congress (H.R. 384/S. 108) the Canada rule (see
“Trade Restrictions”) unless mandatory COOL were implemented. Other bills
would have made 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 have prohibited use of funds to implement COOL for
meats. On the other hand, S. 1331 would have accelerated implementation for
mandatory COOL to January 30, 2006.
Although this bill did not pass, new proposals have been offered in the 110th
Congress to accelerate implementation to September 30, 2007: H.R. 357, by
Representative Rehberg, and S. 404, by Senator Thomas.118 Another bill, S. 1308,
would prohibit USDA from allowing the importation of additional types of Canadian
cattle until the implementation of country of origin labeling requirements.
Beef Labeled “Organic”
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.”119 Numerous news reports have implied 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
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

118 See CRS Report 97-508, Country-of-Origin Labeling for Foods, by Geoffrey S. Becker.
119 7 CFR 205.237, National Organic Program. For further information on the program, see
[ h t t p : / / nop/ NOP/ ml ] .

under experimental conditions suggested that CWD may be transmissible through
contaminated environments long after infectious animals were no longer present.120
Since 1997, CWD has been detected in captive cervid herds in nine states:
Colorado, Kansas, Minnesota, Montana, Nebraska, New York, Oklahoma, South
Dakota, and Wisconsin. As of early December 2006, there were five known positive
captive herds in the United States: four elk herds in Colorado, and one deer herd in
Wisconsin. Federal and state policy is to depopulate (destroy) these herds (see
below). CWD has been detected in wild cervids in 11 states: Colorado, Illinois,
Kansas, Nebraska, New Mexico, New York, South Dakota, Utah, West Virginia,
Wisconsin, and Wyoming.121 It has also been found in Canada and the Republic of
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 the122
risk, if any, of CWD transmission to humans.
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.

120 M.W. Miller, et al., “Environmental Sources of Prion Transmission in Mule Deer,”
Emerging Infectious Diseases, June 2004.
121 Maps of U.S. CWD distribution are prepared by USDA, APHIS and are available at
[ h t t p : / / www.aphi vs/ nahps/ c wd/ c wd-d i s t r i but i ml ] .
122 Found at USDA APHIS, “Questions and Answers About Chronic Wasting Disease,”
September 2002, at [
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.

CWD has been experimentally transmitted by artificial means to mice, ferrets,123
mink, goats, squirrel monkeys, and calves.
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
recommends against the use of rendered deer and elk material considered high-risk
in any animal feeds.124
Activities related to CWD control are also conducted by USDA’s Agricultural
Research Service (ARS) and Cooperative State Research, Education and Extension
Service (CSREES)125 and several agencies in the Department of the Interior (DOI).
In recognition that CWD was 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.”126 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.
APHIS, whose regulations govern cooperative programs to control animal
diseases, had published a final rule in the July 21, 2006, Federal Register to establish
a captive herd certification program for CWD, and rules on interstate movement of
cervids.127 The rule was to take effect on October 19, 2006, but APHIS subsequently
announced an indefinite delay in the effective date and an extension of the comment
period through January 3, 2007. The agency had received petitions raising concerns
about the rule, such as whether federal interstate movement regulations should
preempt state requirements for importation, and the scientific basis underlying federal128
interstate movement requirements. A revised rule had not been published as of
mid-May 2007.

123 Ibid.
124 FDA, Guidance for Industry #158: Use of Material from Deer and Elk in Animal Feed,
September 15, 2003, at [].
125 See ARS research website to search for CWD studies at [http://www.ars.usda.
gov/ main/main.htm] .
126 USDA/ DOI, Plan for Assisting States, Federal Agencies, and Tribes in Managing
Chronic Wasting Disease in Wild and Captive Cervids, June 26, 2002.
127 71 Federal Register 41682.
128 Chronic Wasting Disease Alliance, “CWD Update,” September 13, 2006, at
[ h t t p : / / www.cwd-i n f o.or g/ ] .

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.
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.129

129 Cornell Feline Health Center, “Mad Cow Disease and Cats,” at [
edu/fhc/news/madcow.htm] .