Bovine Spongiform Encephalopathy (BSE, or “Mad Cow Disease”): Current and Proposed Safeguards
Congressional research reportMay 18, 2007
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Bovine Spongiform Encephalopathy (BSE, or
“Mad Cow Disease”): Current and Proposed
Safeguards
(name redacted)
Specialist in Public Health and Epidemiology
(name redacted)
Specialist in Agricultural Policy
May 18, 2007
Congressional Research Service
7-....
www.crs.gov
RL32199
CRS Report for Congress
Prepared for Members and Committees of Congress
Bovine Spongiform Encephalopathy (BSE, or “Mad Cow Disease”)
Summary
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 manufacturing. In lieu of these changes, FDA on October 6, 2005,
proposed a ban, in all types of animal feed, of some higher-risk cattle parts. 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.
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Bovine Spongiform Encephalopathy (BSE, or “Mad Cow Disease”)
Contents
Introduction ................................................................................................................................1
Overview ..............................................................................................................................1
U.S. Cases of BSE ................................................................................................................3
Safeguards in Place Prior to December 2003 .........................................................................4
Additional Safeguards After December 2003.........................................................................5
International Review Team Findings .....................................................................................6
Trade Restrictions .......................................................................................................................7
International BSE Standards..................................................................................................7
Canadian Beef and Cattle Imports .........................................................................................9
Japan and Korea Beef Trade Issues...................................................................................... 12
Assessments of Import Safeguards ...................................................................................... 13
Harvard Risk Analysis................................................................................................... 13
International Review Team............................................................................................ 14
Government Accountability Office................................................................................ 15
Office of Inspector General ........................................................................................... 15
2003 Interagency Report ............................................................................................... 16
Congressional Role ............................................................................................................. 16
The Livestock “Feed Ban” ........................................................................................................ 17
Overview ............................................................................................................................ 17
The Feed Ban Prior to December 2003 ................................................................................ 19
Proposed Changes to the Feed Ban...................................................................................... 19
Environmental and Economic Impacts of an SRM Ban in Feed ........................................... 22
FDA Impact Analysis .................................................................................................... 23
Industry Comments ....................................................................................................... 24
Earlier NRA/APPI Impact Analysis............................................................................... 24
NGFA Impact Analysis.................................................................................................. 25
Kansas State Impact Analysis ........................................................................................ 25
Enforcement of the Feed Ban .............................................................................................. 25
FDA Reports................................................................................................................. 25
GAO Evaluations .......................................................................................................... 26
Feed Testing Program.................................................................................................... 27
The Feed Ban in Canada ..................................................................................................... 27
Congressional Role ............................................................................................................. 27
BSE Surveillance and Testing in Cattle...................................................................................... 28
Overview ............................................................................................................................ 28
BSE Surveillance in the United States Prior to December 2003 ........................................... 29
Enhanced Surveillance Program.......................................................................................... 30
The “Downer” Ban and Impact on Surveillance............................................................. 30
Initial Proposals for Expanded Surveillance................................................................... 30
One-Time BSE Enhanced Surveillance Program ........................................................... 31
Ongoing Surveillance Plan ............................................................................................ 32
Critiques of the Enhanced Surveillance Program ........................................................... 32
“Inconclusive” Test Results........................................................................................... 34
Confirmatory Testing Methods ...................................................................................... 34
Private BSE Testing: the Creekstone Decision ..................................................................... 36
BSE Surveillance Costs....................................................................................................... 37
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Bovine Spongiform Encephalopathy (BSE, or “Mad Cow Disease”)
Congressional Role ............................................................................................................. 38
BSE Prevention in Slaughter and Processing: the “Fourth Firewall” .......................................... 38
Ban on “Downer” Cattle ..................................................................................................... 39
Other New Slaughter and Processing Protections................................................................. 40
Congressional Role ............................................................................................................. 42
Related Issues and Options........................................................................................................ 43
Federal Spending on BSE.................................................................................................... 43
Animal Identification and Meat Traceability........................................................................ 44
Country of Origin Labeling ................................................................................................. 45
Beef Labeled “Organic” ...................................................................................................... 46
Chronic Wasting Disease..................................................................................................... 47
Feline Spongiform Encephalopathy..................................................................................... 49
Contacts
Author Contact Information ...................................................................................................... 49
Congressional Research Service
Bovine Spongiform Encephalopathy (BSE, or “Mad Cow Disease”)
Introduction
Overview
Bovine spongiform encephalopathy (BSE or “mad cow disease”) is a fatal degenerative
neurological disease of cattle. It is believed to be caused by an abnormal protein, called a prion. It
is in the family of related diseases referred to as transmissible spongiform encephalopathies, or
TSEs. TSEs include scrapie in sheep and goats, chronic wasting disease (CWD) in deer and elk,
and Creutzfeldt-Jakob disease, or CJD, in humans. BSE is believed to be spread to cattle in feed,
but not transmitted directly from one animal to another in a herd.
Worldwide, BSE has been found in more than 187,000 animals 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.
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:
Canada:
•
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;
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.
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Bovine Spongiform Encephalopathy (BSE, or “Mad Cow Disease”)
•
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 meat traced to the affected animal and 19 others slaughtered and
processed along with it.2 The agency announced that upon reviewing slaughter records for the BSE-positive cow, it
had determined that high-risk materials—the animal’s brain, spinal cord and lower intestine (“distal ileum”)—had
been removed at slaughter, and that the muscle meats that passed inspection posed an “extremely low likelihood that
the beef contained the infectious agent that causes BSE.” 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,
2
USDA, “FSIS Update Of Recall Activities,” release, February 9, 2004, on the Internet at http://www.fsis.usda.gov/
OA/recalls/prelease/update067-2003.htm. A Class II recall “is a health hazard situation where there is a remote
probability of adverse health consequences from the use of the product,” according to the release. USDA does not have
explicit statutory authority to mandate meat recalls or to initiate recalls on its own. However, some believe that because
USDA has the power to withdraw inspection, effectively keeping meat from the food supply, such mandatory authority
is implied. For more information about meat inspection and slaughter practices, see CRS Report RL32922, Meat and
Poultry Inspection: Background and Selected Issues, by (name redacted).
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the meat produced were cuts that would not be expected to be infected or have an adverse public health impact. The
recall is being conducted out of an abundance of caution.”3
Most of the recalled product was distributed to stores in the West, and primarily in Oregon and Washington,
according to various news reports. These reports indicated that some individuals already had consumed meat from
the affected production lot, consisting of the positive cow and others slaughtered with it on December 9, 2003.
USDA’s February 9, 2004 release observed that additional beef was mixed in with the originally recalled beef products
at several points in the distribution network. This caused the department to expand the recall to approximately
38,000 pounds.
Second 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.
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
(...continued)
3
“FSIS Update Of Recall Activities.”
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 (name redacted).
5
USDA Texas BSE Investigation—Final Epidemiology Report, August 2005. For recent USDA information, see
http://www.aphis.usda.gov/newsroom/hot_issues/bse/index.shtml.
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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 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
6
Bill Tomson, “Much Still Unknown About Two US BSE Cases,” Dow Jones Newswires,
June 8, 2006.
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•
A targeted domestic surveillance program.
A number of critics argued that this system was inadequate. Government officials acknowledged
that the system was not fail-safe, but asserted that it was scientifically defensible and kept the
risks of BSE—to both U.S. agriculture and human health—at extremely minimal levels. Among
other evidence, they cited reviews they commissioned by the Harvard School of Public Health’s
Center for Risk Analysis (the “Harvard study”) concluding that the safeguards were sound and
would reinforce each other in preventing the spread of isolated BSE cases, should they arise.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).
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;
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
http://www.aphis.usda.gov/lpa/issues/bse/bse_initiatives.html. (Hereinafter cited as Cohen, Harvard study.) USDAFSIS 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).
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Bovine Spongiform Encephalopathy (BSE, or “Mad Cow Disease”)
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.
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
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.
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.
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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 standards.
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).
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 crosscontaminated 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
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 (name redacted) and (name redacted).
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 http://www.oie.int/eng/info/en_esb.htm.
13
Sources for this section: various APHIS backgrounders and briefing materials, available at
http://www.aphis.usda.gov/newsroom/hot_issues/bse/index.shtml. 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.
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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 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.
14
OIE standards are at http://www.oie.int/eng/normes/en_norm.htm. See, also, OIE, http://www.oie.int/eng/info/
en_statesb_2003.htm#evaluation.
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-05-06-BLG-RFC).
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Bovine Spongiform Encephalopathy (BSE, or “Mad Cow Disease”)
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 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 internationallyrecognized 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 animals.
16
Statement of APHIS Administrator Ron DeHaven, March 9, 2007, accessed May 18, 2007, at
http://www.aphis.usda.gov/newsroom/content/2007/03/OIE_statement3-9-07.shtml.
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.
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Bovine Spongiform Encephalopathy (BSE, or “Mad Cow Disease”)
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 (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 RCALF 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 threejudge 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
18
19
Ranchers Cattlemen Action Legal Fund USA vs. USDA (CV-04-51-BLG-RFC).
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. CV05006RFC), July 25, 2005, U.S. Court of Appeals for the Ninth Circuit. On September 9, 2005, R-CALF petitioned for a
rehearing before the full appellate court.
21
USDA, Foreign Agricultural Service and Agricultural Marketing Service (AMS) data. For new import data see the
AMS website at http://www.ams.usda.gov/lsmnpubs/canada.htm. Details on import requirements and procedures are
posted on the USDA-APHIS website.
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Bovine Spongiform Encephalopathy (BSE, or “Mad Cow Disease”)
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.
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 conditions;
•
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.
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.
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Bovine Spongiform Encephalopathy (BSE, or “Mad Cow Disease”)
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
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
24
Dr. John Clifford, USDA Chief Veterinary Officer, January 4, 2007, audioconference.
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.
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Bovine Spongiform Encephalopathy (BSE, or “Mad Cow Disease”)
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.
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 in 2001) of the potential for an outbreak and spread of BSE in the
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
http://agweb.com/.
28
70 Federal Register 48494 and 73905.
29
“Korea’s acceptance of Creekstone beef draws praise,” Food Chemical News, May 7, 2007.
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Bovine Spongiform Encephalopathy (BSE, or “Mad Cow Disease”)
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 over 1.2 million cattle and
185,000 tons of feed annually from Canada.30
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 for further propagation of BSE
within the USA.31
In another section of its report, the IRT commended the United States for following a sciencebased approach to policy formulation. It further noted that the North American BSE cases
“demonstrate again that exporting countries feel significant national social and financial impacts
when importing countries fail to comply with international rules regarding trade.” Therefore, the
United States “should demonstrate leadership” by following international standards and by
encouraging “the discontinuation of irrational trade barriers when countries identify their first
case of BSE.” At the same time, the panel concluded, the United States should “continue to act
responsibly when considering export of potentially contaminated materials such as live cattle,
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. http://www.aphis.usda.gov/lpa/issues/bse/harvard_10-3/
text_wrefs.pdf.
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 http://www.aphis.usda.gov/lpa/issues/
bse/US_BSE_Report.pdf.
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Bovine Spongiform Encephalopathy (BSE, or “Mad Cow Disease”)
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, may allow BSE-infected products to enter the
country. 33
GAO recommended that the Secretaries of Health and Human Services (HHS) and of Agriculture
develop a coordinated strategy to strengthen import inspections, in consultation with the
Commissioner of Customs. Although the GAO has since re-examined the Administration’s recent
record on the animal feed rules, it has not done so with regard to U.S. import protections.
Office of Inspector General
USDA’s Office of Inspector General (OIG) in February 2005 published a critical report on the
department’s actions on opening the border to cattle and beef products from Canada. The OIG
concluded that USDA’s actions were sometimes arbitrary and undocumented; policy decisions
were poorly communicated to the public and between APHIS and FSIS; and controls over the
regulatory process were inadequate. Explaining that APHIS used a permitting system (as opposed
to formal rulemaking) for reopening the border to some Canadian products, OIG found that
between August 2003 and April 2004:
APHIS issued 1,155 permits for the importation of ruminant products from Canada without
ensuring that the agency had an appropriate system of internal controls to manage the
process. The APHIS permit system was originally designed to allow for the import of
research quantities (generally small amounts) of material into the United States. According
to APHIS officials, this permit system handled approximately 400 permit requests annually.
The procedures that APHIS had developed for handling permit requests for small amounts of
product were not adequate to deal with the high volume of requests for large quantities of
commercial use beef. The agency did not implement or finalize standard operating
procedures for processing the large volume of permits. For example, APHIS did not establish
controls to ensure that risk mitigation measures were consistently applied. We found that 8
of the 83 permits issued for bovine liver did not include the risk mitigation measure that the
livers be from animals slaughtered after August 8, 2003. We also found that APHIS did not
implement requirements to perform onsite monitoring of permit holders, Canadian facilities,
or inspection personnel at U.S. ports of entry. As a result, there was reduced assurance that
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.
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Canadian beef entering the United States was low-risk. Some product with questionable
eligibility, as described above, entered U.S. commerce.34
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 of entry.35 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 VirusSerum-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-oforigin documentation of all imports containing mammalian or mammalian sourced ingredients;
and prohibiting imports containing bovine materials from any BSE country. 36
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
34
USDA, OIG, Animal and Plant Health Inspection Service Oversight of the Importation of Beef Products from
Canada, at http://www.usda.gov/oig/webdocs/33601-01-HY.pdf.
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 2003.
36
Ibid.
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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 Congress.37
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 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”
Overview
Feed is thought to be the most common and perhaps only route of infection for BSE in cattle. The
emergence of BSE in the UK is generally thought to have resulted from the feeding of rendered
by-products of infected animals, including highly infectious brain tissue, to other cattle as a
protein supplement. The cause of the first cases of BSE is unknown; theories include spontaneous
emergence of a single case, or the anomalous transmission of the sheep scrapie agent to cattle. It
37
For details, see “Country of Origin Labeling” later in this report.
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Bovine Spongiform Encephalopathy (BSE, or “Mad Cow Disease”)
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.
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
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.
40
Cohen, Harvard study, p. 111.
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Bovine Spongiform Encephalopathy (BSE, or “Mad Cow Disease”)
(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
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 crosscontamination 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
41
FDA, Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of
Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products,
January 2002, at http://www.fda.gov/cber/gdlns/cjdvcjd.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.
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Bovine Spongiform Encephalopathy (BSE, or “Mad Cow Disease”)
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.
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.
45
USDA Advisory Committee report, p. 2.
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
http://www.oie.int/eng/normes/mcode/en_chapitre_2.3.13.htm. OIE notes the caveat that blood and blood products
pose no known risk as long as cattle are slaughtered with a method that does not result in spreading of brain matter into
the blood.
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
(continued...)
46
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Bovine Spongiform Encephalopathy (BSE, or “Mad Cow Disease”)
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):
•
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 crosscontamination remain:
For example, without fully dedicated equipment, it may not be possible to verify that there is
zero carryover of feed or feed ingredients in equipment, even where a firm’s cleanout
procedures have been judged to be adequate. In addition, resource constraints limit FDA’s
ability to assure full compliance by all segments of the industry that are subject to the current
BSE feed regulation. For example, resources are not available to the FDA and its state
counterparts to fully verify compliance on over 1 million farms where cattle are being fed.51
(...continued)
RL32269, Transmissible Spongiform Encephalopathies (TSEs), Including “Mad Cow Disease”: Public Health and
Scientific Issues, by (name redacted) and (name redacted).
49
70 Federal Register 58570-58601.
50
70 Federal Register 58578.
51
70 Federal Register 58576.
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Bovine Spongiform Encephalopathy (BSE, or “Mad Cow Disease”)
The agency also noted concerns not only about unintentional but also intentional misfeeding of
non-ruminant feed to ruminants on the farm. Financial incentives may exist to do so whenever
inexpensive sources of prohibited protein are locally available, FDA concluded, adding that it
believes the proposed rule would protect cattle by removing the highest risk materials even from
non-ruminant feed.
In its accompanying economic analysis, FDA stated that it had considered the following options:
requiring the use of dedicated facilities or equipment to keep ruminant feed separate from nonruminant 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
52
Hodges, Jim, American Meat Institute Foundation, October 6, 2005, letter in the Atlanta Journal-Constitution.
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 http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n0273-EC248-Attach-1.pdf.
55
Tomson, Bill, “U.S. Feed Ban May Be Too Costly to Industry - FDA Official,” Dow Jones Newswires, September
12, 2006.
53
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Bovine Spongiform Encephalopathy (BSE, or “Mad Cow Disease”)
anthrax organism), and can reduce BSE infectivity, while complying with existing clean air and
clean water regulations. Some assert that a broader SRM ban in animal feeds could lead to
disposal of these products in ways that are unsafe, with adverse health, economic and
environmental impacts. Some studies have concluded that there may not at this time be safe,
legal, widely-available alternatives if certain cattle and their by-products cannot enter either the
slaughter-and-food system, or the rendering-and-feed system. Alternative carcass disposal
options, such as burial or burning on the farm, or disposal in a landfill, may be prohibited by state
or federal law, or be unavailable.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 Analysis58
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 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
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 http://www.fda.gov/cvm/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 (name redacted).
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 http://www.fda.gov/cvm/
bsefrdNotices.htm.
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Bovine Spongiform Encephalopathy (BSE, or “Mad Cow Disease”)
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
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 the industry would be $166.3 million annually.61
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 http://www.fda.gov/
ohrms/dockets/dockets/02n0273/02n-0273-c000461-01-vol39.pdf. The Informa economic analysis can be viewed on
the NRA website at http://www.renderers.org/economic_impact/index.htm.
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.
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Bovine Spongiform Encephalopathy (BSE, or “Mad Cow Disease”)
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 perhead 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 per ton, or $3.17 per
steer, the study reported. 63 Banning animal consumption of all SRM would represent a further
revenue loss of $1.63 for an animal under 30 months of age and $5.11 for animals over 30
months, the study calculated. Disposal costs would an additional 53 cents per younger animal and
$1.66 per older animal—for a total combined cost of $2.16 per head for fed slaughter cattle, and
$6.77 per head for older animals. For dead and downer animals, the total cost of such a rule
would be $76.50 per head, of which $57.75 is lost MBM revenue, and $18.75 is disposal costs.
(The latter figure may be overestimated, according to the study.)
Enforcement of the Feed Ban
FDA Reports
The FDA Center for Veterinary Medicine has since 2001 provided periodic updates of its feed ban
enforcement activity on a public website. 64 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
62
National Grain and Feed Association, Response to FDA Docket No. 2004N-0264, August 13, 2004.
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 Agriculture), April 2005, at http://www.agmanager.info/livestock/marketing/bulletins_2/industry/
demand/EconomicImpactofBSEonUSBeefIndustry.pdf, and henceforth called the Kansas State University study.
64
See the FDA website at http://www.fda.gov/cvm/2007updates.htm.
63
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Bovine Spongiform Encephalopathy (BSE, or “Mad Cow Disease”)
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 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
65
See, for example, FDA, “FDA Statement on Rendered Products Derived From BSE Cow in Washington State,”
December 27, 2003, at http://www.fda.gov/bbs/topics/NEWS/2003/NEW01000.html.
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.
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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.
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
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.
69
Canadian Food Inspection Agency, “Bovine Spongiform Encephalopathy (BSE) in North America,” Web page, at
http://www.inspection.gc.ca/english/anima/heasan/disemala/bseesb/bseesbindexe.shtml.
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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 enforcement.
In its July 2004 ANPR, FDA requested comment on the matter of whether its authorities under
the Federal Food, Drug and Cosmetic Act and the Public Health Service Act provide a legal basis
to support an SRM ban. The concern is that SRM themselves are not harmful unless they were to
contain a BSE or other TSE agent. Since there is not a test to identify the presence of harmful
TSE agents in feed, the agency’s authority to prosecute a violation of an SRM ban may not be
clear.
In the 109th Congress, 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
commerce. Members of the 110th Congress could reintroduce these or additional measures, and
are likely to be interested in the substance of the anticipated final rule and its implementation.
BSE Surveillance and Testing in Cattle
Overview
The goals of BSE surveillance are to determine the prevalence of disease in a country, and to
ensure timely detection and response to cases. Surveillance is not synonymous with testing.
Depending on the disease of interest, surveillance may or may not involve laboratory tests. For
BSE, which is clinically similar to other neurologic diseases, surveillance requires testing, so the
two activities are closely intertwined.
BSE testing is constrained by the unique nature of the disease, and this drives the design of
surveillance programs. Because it evokes no immune or inflammatory response, BSE cannot be
diagnosed from blood, urine, or other noninvasive samples. 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.
70
Testimony of Elsa Murano, Under Secretary for Food Safety, USDA, before the U.S. Congress, Senate Committee
on Appropriations, Bovine Spongiform Encephalopathy (BSE), hearing, 108th Cong., 2nd sess., February 24, 2004
(Washington: GPO, 2004).
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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 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 mid1990s 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 nonambulatory 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
71
Early (May 2004) information on the APHIS BSE cattle surveillance program is available at
http://www.aphis.usda.gov/lpa/issues/bse/bse-surveillance.html.
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.
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Enhanced Surveillance Program
Following the finding of BSE in December, 2003, USDA began revising its surveillance program.
Among other factors, advisory committee recommendations and negotiations with trading
partners affected proposals to expand BSE surveillance.
The “Downer” Ban and Impact on Surveillance
Following the first finding of a cow with BSE, USDA announced, on December 30, 2003, a ban
on downer cattle in the human food supply. Some Members of Congress and industry
representatives had previously expressed concern that a downer ban, by removing economic
incentives that brought animals into the testing program, could force this high-yield population
“under the radar” and compromise BSE surveillance. (The rationale for the ban and its potential
merits are discussed in a subsequent section on slaughter and processing practices, the “Fourth
Firewall” of food safety protections.)
In House and Senate hearings following this first BSE discovery, USDA officials were asked how
they were finding and testing downed cattle, since they were no longer being brought to slaughter
plants. Officials did not provide concrete information about downer animals tested since the ban,
but acknowledged the importance of finding and testing these animals at new points of
concentration such as rendering plants.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
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 Sess.
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 http://www.aphis.usda.gov/lpa/
issues/bse/bse.html.
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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 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.
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.
76
See APHIS, “Bovine Spongiform Encephalopathy (BSE) Surveillance Plan,” March 15, 2004, at
http://www.aphis.usda.gov/lpa/issues/bse/BSE_Surveil_Plan03-15-04.pdf.
77
See APHIS, “Examples of Geographic Distributions of Sample Collections for the BSE Surveillance Plan,” at
http://www.aphis.usda.gov/lpa/issues/bse/bse_geo_dist_samples.html.
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.
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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; 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 conclusions.
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 for BSE, with no positive results
reported.83
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
79
For example, see Andy Dworkin, “Testing Protocols for Mad Cow a Complex Process,” The Oregonian, July 7,
2004.
80
Personal communications with National Renderers Association, July 11, 2005, and with APHIS veterinarians, July
13, 2005.
81
See APHIS BSE testing results at http://www.aphis.usda.gov/lpa/issues/bse_testing/.
82
“USDA Announces New BSE Surveillance Program,” May 20, 2006 press release.
83
Monthly test results and related information are at http://www.aphis.usda.gov/newsroom/hot_issues/bse/surveillance/
ongoing_surv_results.shtml.
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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
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
mishandled.”85
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 inconsistencies. 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
84
Letter from Reps. Tom Davis and Henry Waxman to Agriculture Secretary Veneman concerning “Mad Cow”
Disease, February 17, 2004, and related committee documents.
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.
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The Secretary of Agriculture and other USDA officials at the July 2004 hearing defended the
surveillance program, noting among other things that the OIG observations were based on the
plan before it was implemented and that many of the report’s recommendations had already been
addressed. APHIS was receiving a representative mix of samples from all locations, reaching
deeply into the higher-risk cattle population, and the statistical basis for the sampling was sound,
officials asserted. 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 http://www.aphis.usda.gov/newsroom/
hot_issues/bse/surveillance/bse_disease_surv.shtml.
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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 the
immunohistochemistry (IHC) test, an internationally-recognized gold standard test....
Because the November 18 screening test results were reactive in both the first and second
screens, NVSL scientists made the recommendation to run the IHC test a second time....
Negative results make us confident that the animal in question is indeed negative for BSE.90
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
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
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.
93
Ibid.
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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 immunohistochemistry (IHC)—a case that Japan reported to OIE as
“atypical BSE.”95 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 conduct these tests, all existing university or stategovernment 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
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 http://www.oie.int/eng/en_index.htm.
96
“Second US cow tests positive for BSE,” NewScientist.com News Service, June 28, 2004.
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
(continued...)
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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
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,
(...continued)
available in CRS Report RL32414, The Private Testing of Mad Cow Disease: Legal Issues, by (name redacted).
98
For information on these programs, see the website of USDA’s Agricultural Marketing Service at
http://www.ams.usda.gov/.
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 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.
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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 above).
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 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.
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, 2006.
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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 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 nonambulatory 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
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 http://www.fsis.usda.gov/OA/topics/
BSE_thinking.htm.
104
“Prohibition on the Use of Specified Risk Materials for Human Food and Requirements for the Disposition of NonAmbulatory Disable Cattle,” 69 Federal Register 1861.
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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.
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 supply. 107
Prior to the emergence of the North American BSE cases, downer cattle were linked with the
issue of humane slaughter. Widespread media reports in the 1990s made claims that
nonambulatory cattle were suffering in transport to and after arrival at slaughter plants. Some in
Congress believed that a ban on their inspection (effectively reducing any higher value as human
food) would serve to improve their treatment.
Other New Slaughter and Processing Protections
Additional measures announced on December 30, 2003, include a policy to hold meat from any
animals tested for BSE until the test results are known; a ban on air-injection stunning, which is
suspected to spread brain matter through the bloodstream and into meat; a ban on mechanicallyseparated 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 mechanicallyseparated meat, uses pressure to remove edible tissues from bone without crushing it. The
resulting product can be labeled “meat,” and is typically incorporated into products such as hot
dogs and sausages.) USDA published in the January 12, 2004, Federal Register three interim
final rules and one notice to codify these actions, effective immediately.108
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.
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 http://www.fsis.usda.gov/OPPDE/rdad/FRPubs/03025N/BSE_Analysis.pdf. See also, USDA APHIS, USDA BSE Surveillance Plan: Background on Assumptions and
Statistical Inferences, March 15, 2004, at http://www.aphis.usda.gov/lpa/issues/bse/BSEOIG.pdf.
108
“Prohibition on the Use of Specified Risk Materials for Human Food and Requirements for the Disposition of NonAmbulatory Disable Cattle,” 69 Federal Register 1861; “Meat Produced by Advanced Meat/Bone Separation
Machinery and Meat Recovery (AMR) Systems,” 69 Federal Register 1874-1885, “Prohibition on the Use of Certain
Stunning Devices Used to Immobilize Cattle During Slaughter,” 69 Federal Register 1885-1891, and “Bovine
Spongiform Encephalopathy Surveillance Program,” 69 Federal Register1892.
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One of these rules redefines so-called “Specified Risk Materials,” (SRM), those parts of a carcass
where prions are believed to concentrate, and that are deemed inedible and cannot be inspected
and passed as human food. The rule designates as SRM, among other tissues, brain and spinal
cord in cattle older than 30 months, but continues to permit such materials from younger animals
(under 30 months) to be inspected and passed as human food.
Another of the rules prohibits the inclusion of certain parts in AMR meat. USDA has prohibited
central nervous system tissue (brain, spinal cord and some 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 cutoff 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 FSISregulated 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
http://www.fsis.usda.gov/Fact_Sheets/Advanced_Meat_Recovery/index.asp.
110
GAO Mad Cow Disease report, p. 38.
111
69 Federal Register 42256-42274.
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•
With regard to determining the equivalence of imports, should FSIS exempt
countries with low or no BSE risk from its SRM rule, and if so, under what
conditions?
FSIS and FDA each published an interim rule in the September 7, 2005, Federal Register altering
their separate rules on SRM in meat products, foods and cosmetics. Both agencies had earlier
designated the distal ileum of all cattle, regardless of age, as SRM, but required companies to
remove the entire small intestine, even though the distal ileum was the only portion where BSE
infectivity has been confirmed. The September 7 interim rules permit companies, beginning on
October 7, 2005, to remove the distal ileum (defined to be at least 80 inches) and to utilize the
rest of the small intestine in food or cosmetics. These actions were in response to industry
comments that technology exists to effectively remove the distal ileum. 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 pers
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