Order Code RL32199
CRS Report for Congress
Received through the CRS Web
Bovine Spongiform Encephalopathy
(BSE, or “Mad Cow Disease”):
Current and Proposed Safeguards
Updated March 1, 2004
Sarah A. Lister
Specialist in Social Legislation
Domestic Social Policy Division
Geoffrey S. Becker
Specialist in Agricultural Policy
Resources, Science and Industry Division
Congressional Research Service ˜ The Library of Congress
Bovine Spongiform Encephalopathy (BSE, or “Mad Cow
Disease”): Current and Proposed Safeguards
Summary
Shortly after the first case of bovine spongiform encephalopathy (BSE or “mad
cow disease”) in the United States was announced in December 2003, U.S.
Department of Agriculture (USDA) and other officials announced measures to
improve existing safeguards against the introduction and spread of BSE. Previously,
these safeguards, often called the “three firewalls,” were: (1) USDA restrictions on
imports of ruminants and their products from countries with BSE; (2) a ban on
feeding most mammalian proteins to cattle and other ruminants, issued by the Food
and Drug Administration (FDA); and (3) a targeted domestic surveillance program
by USDA’s Animal and Plant Health Inspection Service (APHIS), the agency
responsible for animal health monitoring and disease control.
Some argued that these safeguards were inadequate, as evidenced by the finding
of the BSE case and subsequent federal efforts to bolster protections. Most new
actions announced by USDA on December 30, 2003 are under the purview of the
Food Safety and Inspection Service (FSIS), responsible for the safety of most U.S.
meat and poultry. These actions, which some call the “fourth firewall,” took effect
in January 2004 and include: (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 announced
accelerated work on a national animal identification and tracking system, and sought
increased funding for that system, for expanded BSE surveillance, and other
activities. On January 26, 2004, FDA also 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.
On February 4, 2004, international BSE experts on a USDA-named
subcommittee recommended additional steps, including more stringent animal feed
restrictions and increased testing of cattle, in part because the panel concluded that
BSE might now be resident in North America. Some in industry responded that the
panel had exaggerated the risks based on flawed assumptions, and had contradicted
other findings, such as a study of the U.S. BSE situation by the Harvard Center for
Risk Analysis. Others, including some BSE experts, embraced some or all of the
panel’s recommendations. On February 23, 2004, a full committee of USDA
advisors questioned some of the subcommittee recommendations, and recommended
that the Harvard Center review the subcommittee report in light of its prior work.
As Members of Congress conduct oversight of the BSE issue and consider
possible legislative options, some have asked whether the expanded agency actions
will protect further against BSE, whether they are scientifically sound, and what cost
they will impose on taxpayers and industry. Also at issue is whether they will restore
foreign markets’ confidence in the safety of U.S. beef, and whether other types of
actions should be considered, among other questions. This report will be updated if
events warrant.
Contents
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Safeguards in Place Prior to December 2003 . . . . . . . . . . . . . . . . . . . . . 1
Additional Safeguards Since December 2003 . . . . . . . . . . . . . . . . . . . . 2
Trade Restrictions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Assessment of Import Safeguards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
International BSE Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Congressional Role . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
The Livestock “Feed Ban” . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
The Feed Ban Prior to the Finding of BSE in the United States . . . . . . 8
Measures to Strengthen the Feed Ban After Finding BSE in the
United States . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Compliance with the Feed Ban . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Additional Concerns . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Congressional Role . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
BSE Surveillance and Testing in Cattle . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
The U.S. BSE Surveillance Program . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Proposals for Expanded Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
BSE Surveillance Program Costs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Additional Concerns . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Congressional Role . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Prevention Practices in Slaughter and Processing Instituted After the
Finding of BSE: A “Fourth Firewall”? . . . . . . . . . . . . . . . . . . . . . . . 16
Recall of Beef from the Positive Cow . . . . . . . . . . . . . . . . . . . . . . . . . 16
Ban on “Downer” Cattle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Additional BSE Protections in Slaughter and Processing . . . . . . . . . . 17
Related Issues and Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Animal Identification and Meat Traceability . . . . . . . . . . . . . . . . . . . . 19
Country of Origin Labeling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Beef Labeled “Organic” . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Chronic Wasting Disease . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Feline Spongiform Encephalopathy . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Bovine Spongiform Encephalopathy
(BSE, or “Mad Cow Disease”):
Current and Proposed Safeguards
Introduction
Overview. Bovine spongiform encephalopathy (BSE or “mad cow disease”)
is a fatal degenerative neurological disease of cattle. It is believed to be caused by
an abnormal protein, called a prion. It is in the family of related diseases referred to
as transmissible spongiform encephalopathies, or TSEs. TSEs include scrapie in
sheep and goats, chronic wasting disease (CWD) in deer and elk, and
Creutzfeldt-Jakob disease, or CJD, in humans. BSE is believed to be spread to cattle
in feed, but not transmitted directly from one animal to another in a herd. BSE is
also 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 United Kingdom.
On December 23, 2003, USDA announced the finding of a single case of BSE
in a cow in a Washington state dairy herd — the first U.S. case, and the third in North
America.1 USDA stated that the case posed virtually no risk to public health but
immediately launched an intensive investigation, which, officials announced on
February 9, 2004, is now officially concluded. During the investigation, 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.2
The first finding of BSE in the United States has prompted intense debate on the
effectiveness of existing U.S. safeguards against BSE.
Safeguards in Place Prior to December 2003. In the wake of the far
more extensive BSE outbreaks in the United Kingdom starting in 1986, U.S. officials
had, by the late 1980s, begun erecting what they and beef industry leaders have
1 Canada announced a single case in May 2003, and following intensive investigation, has
not reported any additional cases. A 1993 case in Canada was found to have been imported
from the United Kingdom during the height of the outbreak there.
2 USDA, Final BSE Update — Monday, February 9, 2004. Included in the 255 were 28 of
the 80 cattle that had entered the United States with the cow that tested positive for BSE.
Because of a lack of records, only 28 of these 80 other imports were positively identified,
contributing to the need for the wider investigation and destruction of more animals. For
an overview of the current BSE situation, see CRS Issue Brief IB10127, Mad Cow Disease:
Agricultural Issues for Congress, by Geoffrey S. Becker.
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termed the “three firewalls” to keep the disease out of the United States and to
contain it immediately if it should occur here. These firewalls are: (1) 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; and (3) a targeted
domestic surveillance program. A number of critics have argued that this system has
been inadequate.
Government officials have acknowledged that the system is not fail-safe, but
have asserted that it is scientifically defensible and has kept the risks of BSE — to
both U.S. agriculture and human health — at extremely minimal levels. Among
other evidence, they cite reviews they commissioned by the Harvard School of Public
Health’s Center for Risk Analysis (the “Harvard study”) concluding that the
safeguards are sound and would reinforce each other in preventing the spread of
isolated BSE cases, should they arise.3 It should be noted that the Harvard study was
a mathematical model that used assumptions based on existing evidence whenever
possible. The study does, however, consider protections provided by each of the
firewalls and a variety of scenarios in which they could be challenged.
The Organization of International Epizootics (OIE), the international animal
disease control organization, recommends that disease risk assessments be carried out
to promote consistent, science-based practices and transparency in international trade.
OIE provides guidance and standards for countries managing BSE within their
borders, and BSE-free countries wanting to maintain their status.4
Additional Safeguards Since December 2003. Despite assurances, the
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.
The new USDA actions include: (1) holding carcasses of tested animals until
BSE-negative results are obtained; (2) banning nonambulatory (“downer”) cattle
from entering facilities that slaughter them for human food; (3) 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; (4) moving
more quickly to implement a national system to identify and track individual animals
from their place of birth to slaughter; and (5) naming an international scientific panel
to review the government’s BSE response and recommend any needed
improvements.
The Administration’s FY2005 budget proposal includes a request for a total of
$60 million for USDA’s BSE-related activities, or $47 million more than in FY2004.
3 Joshua Cohen et al., Evaluation of the Potential for Bovine Spongiform Encephalopathy
in the United States, Nov. 2001, revised Oct., 2003, Harvard Center for Risk Analysis,
School of Public Health, at [http://www.aphis.usda.gov/lpa/issues/bse/bse_initiatives.html].
(Hereafter cited as Cohen, Harvard study.)
4 For more information about OIE activities, see [http://www.oie.int/eng/oie/en_oie.htm].
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Of the total, $33 million would be used to accelerate development of an animal ID
system; $17 million would go to APHIS to collect and test more BSE samples at
rendering plants and on farms; $5 million would go for the research and development
of BSE testing technologies; $4 million would fund FSIS monitoring of compliance
with its BSE-related rules; and $1 million would be used by the Grain Inspection,
Packers and Stockyards Administration to ensure that markets are operating fairly in
the wake of the BSE case. The Secretary of Agriculture earlier had announced that
the Department intended to commit $178 million to complete renovations at the
Ames, Iowa, lab that conducts tests for BSE and other animal diseases.
On January 26, 2004, FDA announced it will publish changes to its own BSE
safeguards, such as banning a number of bovine materials from the human foods and
cosmetics it regulates; banning poultry litter, restaurant plate waste, and ruminant
blood products from ruminant feed; and tightening feed manufacturing procedures
and oversight. As of late February, these changes had not yet been published.
The international panel of BSE experts released its findings on February 4,
2004.5 The panel (a subcommittee of a USDA advisory committee) 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 include further tightening animal
feeding rules by FDA, and increasing cattle testing, at least until USDA has a better
understanding of the extent of the prevalence of BSE here.
Some BSE experts and consumer groups welcomed findings from the report.
Others in the beef, feed, and related industries responded that the panel 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. The panel’s findings contradicted other scientific findings,
such as a three-year examination of the U.S. BSE situation by the Harvard Center for
Risk Analysis, these critics asserted. An FDA official commented that, as a
regulator, he was now “confronted with two very different scientific opinions.”6
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, and report back to the Secretary.7
5 USDA, The Secretary’s Foreign Animal and Poultry Disease Advisory Committee’s
Subcommittee Report on Measures Relating to Bovine Spongiform Encephalopathy (BSE)
in the United States, Feb. 4, 2004, at [http://www.aphis.usda.gov/lpa/issues/bse/bse.html].
6 Denise Grady, “Mad Cow Quandary: Making Animal Feed,” The New York Times, Feb.
6, 2004, p. 22.
7 USDA, Report of the Secretary’s Advisory Committee on Foreign Animal and Poultry
Diseases: Measures Relating to Bovine Spongiform Encephalopathy in the United States,
Feb. 23, 2004, at [http://www.aphis.usda.gov/lpa/issues/bse/bse.html].
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The regulatory and other actions being taken by USDA and FDA are intended
not only to reassure consumers and protect livestock health, but also to calm foreign
markets, most of which have banned the entry of U.S. cattle and beef products. At
issue is whether these steps are needed to protect further against BSE, whether their
cost to taxpayers and industry is justified; whether such steps are defensible
scientifically and will restore foreign markets’ confidence in the safety of U.S. cattle
and beef; and whether other types of regulatory and/or legislative actions should be
considered, among other questions.
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, import
controls to prevent BSE are examined. For a discussion of economic issues and
impacts on the U.S. beef trade following the discovery of BSE, see CRS Report
RS21709, Mad Cow Disease and U.S. Beef Trade.
Since 1989, USDA’s Animal and Plant Health Inspection Service (APHIS), the
lead agency for controlling animal diseases, has banned the importation of live
ruminants (i.e., cattle, sheep, goats, deer, elk, buffalo) and most ruminant products
from the United Kingdom and other countries where BSE has been diagnosed.8 In
1991, APHIS published formal rules banning the import of ruminant meat and meat
products from BSE countries. In 1997, USDA instituted a ban on importing
ruminants and most ruminant products from all of Europe. In December 2000,
USDA prohibited imports of all rendered animal protein products, regardless of
species, from Europe out of concern that feed of nonruminant origin was potentially
cross-contaminated with the BSE agent.9 (These prohibitions on imports, while
similar to the domestic feed controls imposed by FDA, are nonetheless a distinct
federal program.)
The exception to the import ban is Canada, which announced its first indigenous
case of BSE in May, 2003. (Prior to the findings of BSE in the United States and
Canada, the two countries had similar systems of import and feed controls in place.)
The United States immediately banned imports of live cattle and most meat and cattle
products from Canada. On August 8, 2003, USDA announced that it would accept
applications for permits to import selected ruminant products from Canada, including
boneless beef from cattle under 30 months old, boneless veal from calves no older
than 36 weeks at slaughter; and boneless sheep and goat meat from animals under 12
months old. USDA’s decision was based on what it said was a “thorough scientific
analysis” that found minimal risk from these imports. These Canadian imports are
again entering the United States.
8 As of February 23, 2004, 23 countries had reported indigenous cases of BSE, and another
three, including the United States., reported only imported cases. OIE provides updated
information on countries with BSE at [http://www.oie.int/eng/info/en_esb.htm].
9 Source for this section: various APHIS backgrounders and briefing materials, available
at: [http://www.aphis.usda.gov/lpa/issues/bse/bse.html]. Under FSIS’s foreign inspection
program, no establishments in countries with BSE have been permitted to ship beef to the
United States.
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On October 31, 2003, USDA announced proposed changes to its standing BSE
rules that would allow the importation of certain live ruminants and ruminant
products from proposed “minimal risk” regions, including Canada.10 The proposed
rules would permit imports of cattle for slaughter before 30 months of age; sheep and
goats for slaughter before 12 months of age; cervids (e.g., deer and elk) for
immediate slaughter; and various products from these animals. The future of these
proposals, for which the comment period ended January 5, 2004, is unclear at this
time. USDA officials recently said they are again reviewing them in light of the U.S.
BSE case, and are expected to reopen the rule for additional public comment.11
Assessment of Import Safeguards. The adequacy of current import
protections against BSE has been under added scrutiny since the Washington state
case was announced. After discovery of the Canadian BSE case but before the U.S.
case, USDA officials had asked the Harvard Center for Risk Analysis to reassess its
earlier analysis (completed in 2001) of the potential for an outbreak and spread of
BSE in the United States. The reassessment concluded in part that “the possible
introduction of BSE into the United States from Canada cannot be dismissed,” but
that the likelihood is very low, and U.S. protective measures by now would have
contained any possible spread.12 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.13
In its February 4 report, the international panel of BSE experts observed that it
believes:
... 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.
10 U.S. Dept. of Agriculture, “Exportation and importation of animals and animal products:
Bovine spongiform encephalopathy; minimal risk regions and importation of commodities,”
68 Federal Register 62386, Nov. 4, 2003.
11 Testimony of Dr. Ron DeHaven, USDA chief veterinarian, before the Senate Committee
on Appropriations hearing on Bovine Spongiform Encephalopathy, Feb. 24, 2004.
12 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].
13 Ibid.
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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.14
A report by the General Accounting Office (GAO), published more than one
year before the May 2003 Canadian BSE case, stated that federal actions did not
ensure 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.15
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.
A January 2003 federal interagency report on animal disease prevention also
recommended that USDA and HHS should update risk assessments, import
regulations, and guidance on enforcing regulations at ports of entry.16 More
specifically, it was noted that agencies need to develop guidance and plans at ports
of entry to fully implement the recently enacted Animal Health Protection Act (7.
U.S.C. 8301 et seq.). Further, the report recommended revisions to the Virus-Serum-
Toxin Act to help APHIS enforce import rules on animal biologics products. The
interagency report also concluded that the FDA needs additional authority to
strengthen its BSE capabilities at ports of entry. The report said FDA has been
considering a number of additional protective measures for FDA-regulated products,
including: directing importers to use only designated ports for entry of products that
might contain bovine materials; requiring certain importers to be certified in order
14 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].
15 General Accounting Office, Mad Cow Disease: Improvements in the Animal Feed Ban
and Other Regulatory Areas Would Strengthen U.S. Prevention Efforts (GAO-02-183), p.
3, Jan. 2002. (Hereafter cited as GAO Mad Cow Disease report.)
16 Animal Disease Risk Assessment, Prevention, and Control Act of 2001(PL 107-9) Final
Report, pp. 44-45, prepared by the P.L. 107-9 Federal Interagency Working Group, Jan.
2003.
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to import such products into the United States; destroying detained products so that
they cannot be re-imported at another time or port; requiring country-of-origin
documentation of all imports containing mammalian or mammalian sourced
ingredients; and prohibiting imports containing bovine materials from any BSE
country.17
International BSE Standards. In August 2003, U.S. officials said that they,
Canadian and Mexican authorities had entered into discussions with the OIE to
develop new guidance for resuming trade with countries that have reported BSE,
under certain conditions. U.S. officials believe that even under present OIE
standards, certain U.S. beef products could be exported to other countries.18
In a section of its report entitled “Lessons Learned,” the international panel
commended the United States for following a science-based approach to policy
formulation. It further noted that the North American BSE cases “demonstrate again
that exporting countries feel significant national social and financial impacts when
importing countries fail to comply with international rules regarding trade.”
Therefore, the United States “should demonstrate leadership” by following
international standards and by encouraging “the discontinuation of irrational trade
barriers when countries identify their first case of BSE.” At the same time, the panel
concluded, the United States should “continue to act responsibly when considering
export of potentially contaminated materials such as live cattle, MBM [meat and
bone meal] and feed. Risk materials must be destroyed or safely utilized to protect
human health, animal health, and the environment in the USA and worldwide.”19
Congressional Role. USDA and FDA so far have not recommended any
changes in import safeguards since the December 2003 BSE case.20 If Congress
decides to consider ways to strengthen import controls, among the recommendations
that they might examine are those from the Harvard report, the GAO report, the
international panel’s report, and the response of the full USDA advisory committee.
17 Ibid.
18 OIE standards are at: [http://www.oie.int/eng/normes/mcode/A_00068.htm]. See also,
OIE, The OIE standards on BSE: a guide for understanding and proper implementation,
press release, Jan. 9, 2004, at [http://www.oie.int/eng/en_index.htm].
19 Report on Measures Relating to Bovine Spongiform Encephalopathy (BSE) in the United
States, p. 11. For more information on beef trade issues resulting from finding of BSE in
the United States, see CRS Report RS21709, Mad Cow Disease and U.S. Beef Trade, by
Charles E. Hanrahan and Geoffrey S. Becker..
20 However, because foreign countries that import animals and meat products to the United
States must have equivalent safety and inspection measures in place, they will have to
comply with many of the new U.S. rules like the downer ban, for example (see later sections
of this report).
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The Livestock “Feed Ban”
Overview. It is believed that feed is the most common, and perhaps the only,
route of infection for BSE in cattle, and that the emergence of BSE in the U.K.
resulted from the practice of feeding rendered by-products of infected animals,
including highly infectious brain tissue, to other cattle as a protein supplement. The
cause of the first case or cases is unknown; theories include spontaneous emergence
of a single case, or the anomalous transmission of the sheep scrapie agent to cattle.
It is thought that the long incubation period and possibly changes in rendering and
feeding practices led to amplification of the agent in the feed supply and spread of
the disease for years before it was recognized in 1986.
In 1988, the U.K. 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 U.K. 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.”21
FDA registers and inspects renderers, feed mills, pet food manufacturers, animal feed
distributors and others to ensure compliance.
The Harvard study concluded that the feed ban was the dominant protective
firewall, and would protect against spread of the disease even if the other firewalls
failed. On January 26, 2004, FDA announced that it would publish a new interim
final rule to strengthen further the feed ban. One week later, international BSE
experts on a USDA-named panel recommended additional steps, including more
stringent animal feed restrictions than those just announced by FDA. These rules and
recommendations are discussed below.
The Feed Ban Prior to the Finding of BSE in the United States. 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 pose a
minimal risk of transmission. Following the discovery of the U.S. BSE case in
December 2003, FDA reported that prior inspections of renderers and feed mills
found 99% to be in compliance with the ban.22
The GAO noted in 2002 that, relative to other countries, U.S. surveillance and
import controls were stronger, but the feed ban was more permissive. The Harvard
21 21 CFR Part 589.2000, published in the Federal Register on June 5, 1997.
22 Food and Drug Administration, FDA Statement on Rendered Products Derived From BSE
Cow in Washington State, Dec. 27, 2003, at [http://www.fda.gov/bbs/topics/NEWS/
2003/NEW01000.html].
CRS-9
study, while finding that the feed ban was the dominant protective firewall, also
showed in its hypothetical model that failure of the feed ban led to the greatest
increase in number of BSE cases. Many also noted that certain 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, which may contain uneaten feed, into livestock feeds.
Though GAO limited its recommendations for the feed ban to improved
enforcement of the existing regulation, 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 resulting feed contamination would come
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
rendered cow were BSE-positive, the resulting infusion of infectivity into the feed
supply could lead to new bovine cases from a single subsequent breach in the feed
ban.23 Some experts argued that if high-risk materials were absolutely prohibited in
all animal feeds, that cross-contamination, breaches at feeding, and the concurrent
regulatory oversight of these activities, would become irrelevant.
Some also questioned the feed ban exemptions, including the practice of using
rendered bovine blood in milk substitutes for calves. Based on concerns that the
agent linked to the human form of BSE, vCJD, could be present in blood, another
center at FDA had recommended that persons having resided in the U.K. be barred
from blood donation in the United States, to eliminate the potential for transmission
from blood donors infected in the U.K. and not yet showing symptoms.24
In 2002, FDA published an advance notice of proposed rule-making, 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.25
Measures to Strengthen the Feed Ban After Finding BSE in the
United States. On January 26, 2004, FDA announced the imminent publication
of a new interim final rule with four provisions to further strengthen the feed ban,
saying:
First, the rule will eliminate the ... exemption ... that allows mammalian blood
and blood products to be fed to other ruminants as a protein source. Recent
scientific evidence suggests that blood can carry some infectivity for BSE.
23 Cohen, Harvard study, p. 111.
24 FDA, Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk
of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease
(vCJD) by Blood and Blood Products, Jan. 2002, at [http://www.fda.gov/cber/
gdlns/cjdvcjd.htm].
25 Food and Drug Administration, “Substances Prohibited From Use in Animal Food or
Feed; Animal Proteins Prohibited in Ruminant Feed,” 67 Federal Register 67572, Nov. 6,
2002.
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Second, the rule will also ban the use of “poultry litter” (in feed) for ruminant
animals. Poultry litter consists of bedding, spilled feed, feathers, and fecal
matter that are collected from living quarters where poultry is raised. ... Poultry
feed may legally contain protein that is prohibited in ruminant feed, such as
bovine meat and bone meal. The concern is that spillage of poultry feed in the
chicken house occurs and that poultry feed (which may contain protein
prohibited in ruminant feed) is then collected as part of the “poultry litter” and
added to ruminant feed.
Third, the rule will ban the use of “plate waste” (in feed) for ruminants. Plate
waste consists of uneaten meat and other meat scraps that are currently collected
from ... restaurant operations and rendered into meat and bone meal .... The use
of “plate waste” confounds FDA’s ability to analyze ruminant feeds for the
presence of prohibited proteins, compromising the Agency’s ability to fully
enforce the animal feed rule.
Fourth, the rule will further minimize the possibility of cross-contamination of
ruminant and non-ruminant animal feed by requiring equipment, facilities or
production lines to be dedicated to non-ruminant animal feeds if they use protein
that is prohibited in ruminant feed. Currently, some equipment, facilities and
production lines process or handle prohibited and non-prohibited materials and
make both ruminant and non-ruminant feed — a practice which could lead to
cross-contamination.26
On February 3, 2004, international BSE experts on a USDA-named panel (a
subcommittee of an existing advisory committee) 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.”27 The panel defined SRM more stringently
than had the USDA in December, notably by including high-risk tissues from cattle
older than 12 months, rather than 30 months.
In the subsequent report of the full advisory committee, released on February 24,
2004, concerns were expressed about inconsistencies between the subcommittee
recommendations and findings from the Harvard study. The extent of the feed ban,
not explicitly noted in findings of concurrence, is presumably an area of discord
between the expert panel and the full committee.
The FY2005 budget proposal includes an increase of $8 million for FDA’s
Animal Drugs and Feeds program to expand administration of the feed ban.
26 U.S. Department of Health and Human Services, “Expanded ‘Mad Cow’ Safeguards
Announced To Strengthen Existing Firewalls Against BSE Transmission,” press release,
Jan. 26, 2004. As of late February the rules had not yet been published.
27 USDA, The Secretary’s Foreign Animal and Poultry Disease Advisory Committee’s
Subcommittee Report on Measures Relating to Bovine Spongiform Encephalopathy (BSE)
in the United States, Feb. 4, 2004, at [http://www.aphis.usda.gov/lpa/issues/bse/bse.html].
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Compliance with the Feed Ban. FDA bases its compliance determinations
on inspection of facilities, practices, and records. At this time there is no certified
test that can be used on actual ruminant feed to determine if it contains prohibited
material. FDA has commented that test methods are being studied for this purpose.28
The agency also said that it was able to identify and hold all rendered material from
the U.S. BSE-affected cow, and that none of it had gone into distribution as feed,
obviating the need for a recall.29
The GAO evaluated FDA’s oversight of the feed ban, and reported a number of
problems with administrative procedures, inspection, and enforcement. Many,
including the GAO and the Harvard study, previously have noted that there are
opportunities for non-compliance 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 other livestock such as poultry.
Additional Concerns. The ban as originally designed permits rendering of
ruminant by-products as long as they are not re-fed to ruminants. FDA’s announced
revisions would not alter this basic approach, but would merely expand the list of
products that cannot be fed to ruminants. Proposals by others, including the
international expert panel, that certain ruminant by-products should be banned from
rendering up-front do not suggest alternate disposal routes for these products. Proper
rendering practices kill most important human and animal disease organisms
(including the Foot and Mouth disease virus, Salmonella, and the anthrax organism),
and can reduce BSE infectivity, while complying with existing clean air and clean
water regulations. Some assert that if the feed ban were bolstered by prohibiting
additional high-risk materials in rendering, animals and by-products could be
disposed of 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.30
The USDA expert panel (subcommittee) and full advisory committee concurred
in their recommendations in the context of the downer ban (see later sections of this
28 It is worth noting that such a test would determine only if prohibited species were present
in the feed; it would not test for infectious BSE prions. No such prion test for feed exists.
29 Comments of FDA Deputy Commissioner Lester Crawford during USDA, “Technical
Briefing and Webcast with U.S. Government Officials On BSE Case,” Dec. 30, 2003. This
contrasts with the USDA recall of the BSE cow’s meat that was sold for human
consumption, in which it is believed some of the product was consumed — although USDA
asserted that the meat posed an extremely low risk of danger and was being recalled out of
an “abundance of caution.” See also USDA, “FSIS Update Of Recall Activities,” release,
Feb. 9, 2004, at [http://www.fsis.usda.gov/OA/recalls/prelease/update067-2003.htm].
30 See Jean E. Sander et al., “Selected Methods of Animal Carcass Disposal,” Journal of the
American Veterinary Medical Association, vol. 220, no. 7, pp. 1003-1005, Apr. 1, 2002, and
Sparks Companies Inc, The Rendering Industry: Economic Impact of Future Feeding
Regulations, June 2001.
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report), also noting concerns about improper disposal methods. Quoting the report
of the expert panel:
The subcommittee considered both the merits and the unintended consequences
of the ban ... The goals for measures related to these cattle must be to (1) test
them for surveillance purposes and (2) prevent potentially infective tissues from
entering the food and feed chains. Given their exclusion from ... slaughterhouses,
this important subpopulation may no longer be available for the BSE surveillance
(program) at these locations. Therefore it is imperative that the USDA take
additional steps to assure that facilitated pathways exist for dead and
non-ambulatory cattle to allow for collection of samples and proper disposal of
carcasses. This most likely would involve expending resources to assist with
costs associated with sampling, transport and disposal.
In order to decrease the risk of these potentially infected cattle entering the
normal slaughter process, supplemental measures to encourage compliance must
be in place. These may range from financial incentives to a strengthening of
ante-mortem inspections to identify questionable animals. To further prevent
these cattle from being brought into the normal slaughter process, consideration
may have to be given to the random sampling of appropriate subpopulations of
aged cattle that have passed ante-mortem inspection on presentation at slaughter
plant.
Congressional Role. If Congress reviews the feed ban and its role in
preventing the spread of BSE in light of the finding of a BSE-positive cow in the
United States, issues that it might consider could include: the effects of moving
downer animals from slaughter to rendering on the safety of the feed supply; whether
current oversight of the feed ban can accommodate this shift; the effect of changing
market conditions that may result from the “downer” ban on the safety of both food
and feed in the United States; and, processes to assure the safe disposal of animal
remains as new regulations are implemented.
BSE Surveillance and Testing in Cattle
Overview. The goal of BSE surveillance is to ensure timely detection and
response to cases of the disease in the United States. Because the clinical appearance
of BSE is similar to other neurologic diseases, surveillance hinges on laboratory
testing, including the decision of which animals to test and how many tests to
conduct. Testing is hampered by the unique nature of the disease. 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.
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, USDA Under Secretary for Food Safety, has
testified that the consistent removal of certain high-risk tissues from cattle at
slaughter (described in greater detail in a subsequent section) is the relevant food
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safety protection.31 For this reason, a BSE surveillance program does not have to test
every animal slaughtered for food, but can instead use targeted sampling.
The U.S. BSE Surveillance Program. In 1990 APHIS instituted a
surveillance program for BSE in U.S. cattle, in response to the British livestock
outbreak. The program has grown steadily in scope, from a few thousand animals
tested annually in the mid-1990's to about 20,000 animals each year in 2002 and
2003, out of about 35 million cattle slaughtered each year.32 The Washington state
cow was the first BSE-positive animal detected by the program.
APHIS had targeted three high-risk groups of animals for surveillance: animals
that die on the farm, animals exhibiting neurologic signs (including animals on the
farm, at slaughter, sent for rabies testing, and submitted to diagnostic laboratories),
and a sample of “downers,” animals presenting non-ambulatory at slaughter. All the
groups except downers, while providing rich sample populations for screening,
provided limited numbers for surveillance. The bulk of recent surveillance samples
have come from the downer animals. While animals can be non-ambulatory for
reasons other than neurologic disease, the sheer number of non-ambulatory animals
available and concentrated at slaughterhouses, reported by USDA to be about
200,000 animals per year, offered a ready sample for targeted surveillance. USDA
announced that it is weighing options to continue testing this population. These may
include sampling at rendering plants (a likely new point of concentration for some
“downers”), expanding on-farm outreach and testing, and offering economic
incentives to encourage the submission of these animals.
Critics have argued that U.S. surveillance was inadequate to detect BSE in a
timely manner, and that the positive cow found in Washington state may not be an
isolated case. They propose that surveillance should approximate programs in
European countries, where every adult animal is tested, or Japan, which claims to test
every animal slaughtered. USDA argues that it tests many more animals than are
recommended by the OIE, and that because surveillance targets animals with
suspicious signs, it will detect BSE if it is present in the bovine population at a level
of one in 1 million animals. (There are an estimated 96 million cattle in the United
States.)
One complicating factor is that Japan — the top foreign customer — has been
demanding that all cattle be tested for BSE as a precondition for again accepting U.S.
beef. Some individual firms reportedly are considering whether to offer such testing
in order to regain access to Japan, even though most U.S. government and industry
officials believe that would be unscientific, expensive, and a bad trade precedent.
Proposals for Expanded Testing. On February 4, 2004, the Secretary of
Agriculture’s advisory subcommittee of BSE experts recommended that USDA
31 Testimony of Elsa Murano, Under Secretary for Food Safety, USDA, before the U.S.
Congress, Senate Committee on Appropriations, Bovine Spongiform Encephalopathy (BSE),
hearing, 108th Cong., 2nd sess., Feb. 24, 2004 (Washington: GPO, 2004).
32 Additional information on the APHIS BSE cattle surveillance program is available at
[http://www.aphis.usda.gov/lpa/issues/bse/bse-surveillance.html].
CRS-14
continue to focus its surveillance on high-risk animals, but that all such animals over
30 months of age be tested, along with a random sample of healthy animals over 30
months of age at slaughter. The subcommittee report did not state how many
animals, in total, this proposal might encompass, but a USDA official estimates 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 that USDA should:
Immediately develop and implement an enhanced national surveillance program
for BSE to increase testing of high risk animals (cattle showing symptoms of
central nervous system disease, non-ambulatory cattle, and cattle that die on
farms); this action will further the scientific evaluation of risk for BSE in the
U.S. and North America.33
Prior to the finding of BSE in the United States, USDA had planned to nearly
double surveillance to 38,000 animals tested per year, which was modified only
slightly since the finding of BSE. The Administration’s FY2005 budget proposes the
testing of 40,000 animals. Since the budget proposal was released, USDA has
announced that it plans to further expand the program, and will provide details of the
plan in the future.
BSE Surveillance Program Costs. The cost of BSE tests and the
infrastructure to support a testing program have been topics of discussion since BSE
was announced in the United States. USDA currently uses immunohistochemistry
(IHC), which takes at least one week to run but is the international “gold standard,”
or confirmatory test. The European Union has certified several commercial rapid
BSE tests for use in surveillance programs. APHIS does not currently use any rapid
BSE tests or certify any for commercial use, but has invited companies to submit
applications for review of their test kits.34
The cost of individual rapid BSE test kits has been reported to range from $7
to $25 per animal.35 An APHIS spokesperson has said that considering overhead
costs, tests could run $25 to $50 per animal. The USDA FY2005 budget proposal
notes a unit cost per BSE test of $425,36 though this appears to have been derived
merely by dividing the total surveillance program cost of $17 million by the planned
40,000 tests. Given that the per-test cost is scalable (i.e., it depends on the number
of tests performed), this estimate may be moot in light of statements subsequent to
the budget release that BSE surveillance will be expanded.
33 USDA, Report of the Secretary’s Advisory Committee on Foreign Animal and Poultry
Diseases: Measures Relating to Bovine Spongiform Encephalopathy in the United States,
Feb. 23, 2004, at [http://www.aphis.usda.gov/lpa/issues/bse/bse.html].
34 See USDA, “BSE Update,” press release, Jan. 9, 2003.
35 Dennis Normile, “First U.S. Case of Mad Cow Sharpens Debate Over Testing,” Science,
vol. 303, pp. 156-157, Jan. 9, 2004.
36 USDA “FY2005 Budget Explanatory Notes for the House and Senate Committees on
Appropriations,” Feb. 2, 2005.
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The Administration’s proposed FY2005 budget increase for BSE includes $17
million for BSE surveillance.37 To further bolster testing capability for BSE and
other threats, the budget proposal also includes $178 million for completion of
USDA animal health laboratories in Ames, Iowa.38
Additional Concerns. USDA’s announcement on December 30, 2003 of a
ban on the slaughter of downer or non-ambulatory cattle for food is likely to have
considerable impact on the BSE surveillance program. Some Members of Congress
and industry representatives had previously expressed concern that “downer” bans,
by removing economic incentives that brought animals into the testing program,
could force this targeted surveillance population “under the radar” and compromise
the nation’s BSE control efforts. (The rationale for the ban, and its potential merits,
are discussed below.)
On February 17, 2004, the House Committee on Government Reform held a
hearing to question USDA officials and others, following a month-long investigation
into the circumstances surrounding testing of the Washington state cow. 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.39 The investigation raises questions
relevant to the design of an improved surveillance program. If in fact the animal
were not a “downer,” but rather an apparently healthy cow that nonetheless had BSE,
is testing only abnormal animals adequate for surveillance? (Extensive testing in
Europe has demonstrated that some animals can test positive without showing signs
of illness.)
An affidavit from the plant owner indicates that he had initially declined to
participate in USDA’s surveillance program, suggesting that testing is voluntary.
Can USDA conduct robust surveillance for BSE if plants can decline to participate?
In November 2002, citing authority under P.L. 107-171, the Animal Health
Protection Act of 2002, APHIS published a proposed rule allowing for the collection
of blood and tissue samples at slaughter establishments to support disease
surveillance programs, but the rule has not been finalized.40
37 USDA FY2005 Budget Summary, BSE Related Activities, Feb. 2, 2004, proposes $17
million, an increase from $8 million from the amount appropriated in FY2004. This
excludes $10.5 million in emergency funds transferred from the Commodity Credit
Corporation to investigate and respond to the finding of BSE in December, 2003.
38 See USDA, “Bush Administration Proposes Full Funding for Ames Animal Health
Complex,” press release, Jan. 13, 2004.
39 Letter from Reps Tom Davis and Henry Waxman to Agriculture Secretary Veneman
concerning “Mad Cow” Disease, Feb. 17, 2004, and related documents, available at
[http://reform.house.gov/GovReform/News/DocumentSingle.aspx?DocumentID=2497].
40 USDA, APHIS, “Blood and Tissue Collection at Slaughtering Establishments,” proposed
rule, 67 Federal Register 70864, Nov. 27, 2002.
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Congressional Role. If Congress focuses on BSE surveillance efforts, it
might be expected to review USDA proposals for enhanced BSE surveillance,
including expanded outreach on farms and rendering facilities, the possible use of
economic incentives for industry to ensure that targeted animals are not diverted from
testing, and the scope of current USDA authority to conduct testing. Congress might
also decide to consider options redefining the surveillance population, aimed at
capturing other high-risk populations (such as older animals) at slaughter; to examine
USDA’s proposed rule to establish a “test-and-hold” process for animals tested at
slaughter, and to determine how these two measures might interact with each other
and be affected by the availability and cost of different test methods.
Prevention Practices in Slaughter and Processing Instituted
After the Finding of BSE: A “Fourth Firewall”?
USDA (FSIS) is responsible for safety of meat 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.
On December 30, 2003, USDA announced a number of new preventive
measures. Since the “three firewalls” had been in place to prevent the emergence of
BSE, most of the proposed new activities involve changes in meat inspection and
human food safety protections, interventions believed by USDA to be unnecessary
before BSE was known to be present in the United States. Officials and an advisory
panel have subsequently noted that these measures, which remove all designated
high-risk material from the food supply, regardless of test findings on specific
animals or measures of BSE prevalence nationwide, represent the strongest actions
to protect public health since the finding of BSE was announced.
Recall of Beef from the Positive Cow. On December 23, 2003, upon the
announcement of a BSE-positive cow in Washington state, FSIS requested a
voluntary recall of meat traced to the affected animal and others slaughtered and
processed along with it.41 The agency announced that upon reviewing slaughter
records for the BSE-positive cow, it had determined that high-risk materials — the
animal’s brain, spinal cord and lower intestine (“distal ileum”) — had been removed
at slaughter, and that the muscle meats that passed inspection posed an “extremely
low likelihood that the beef contained the infectious agent that causes BSE.” Further,
the agency states:
According to scientific evidence, the tissues of highest infectivity are the brain,
spinal cord, and distal ileum. All were removed from the rest of the carcass at
41 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 Issue
Brief IB10082, Meat and Poultry Inspection Issues, by Jean Rawson.
CRS-17
slaughter. Therefore, the meat produced were cuts that would not be expected
to be infected or have an adverse public health impact. The recall is being
conducted out of an abundance of caution.42
News reports indicate that some individuals already had consumed meat from
the affected production lot, consisting of the positive cow and those slaughtered with
it on December 9, 2003.
Ban on “Downer” Cattle. The most sweeping USDA action in response to
BSE was the immediate ban on the use of non-ambulatory or so-called “downer”
cattle in the food supply. “Downers” are defined as non-ambulatory or disabled
animals that are unable to rise from a recumbent position or are unable to walk.
USDA estimates that up to 200,000 “downer” cattle are slaughtered in the United
States annually, less than 1% of roughly 35 million animals slaughtered. The action
was based on the concern that animals could become non-ambulatory as a result of
BSE.
The issue of whether to exclude downer animals from the food supply has
received considerable attention in Congress. An amendment to the FY2004
agriculture appropriations bill (H.R. 2673), prohibiting USDA from spending any
funds for the inspection of downed animals, narrowly failed in the House, but the
Senate adopted an identical amendment. (Without federal or state equivalent
inspection, meat from such animals could not be used for human food.) Conferees
on the FY2004 agriculture appropriations measure did not adopt the Senate bill
provision, so the bill, P.L. 108-199, FY2004 Consolidated Omnibus Appropriations,
was signed into law without the downer ban.
Proponents of the 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 is exploring options to ensure that
many downed animals will continue to be tested, even if they are diverted from
slaughter for human food.)
Additional BSE Protections in Slaughter and Processing. Additional
measures announced on December 30, 2003, include: a policy to hold meat from any
animals tested for BSE until the test results are known; a ban on air-injection
stunning, which is suspected to spread brain matter through the bloodstream and into
meat; a ban on mechanically-separated meat, in which bones may be crushed to
produce meat paste; and several provisions to keep certain high-risk materials out of
the food supply, or out of Advanced Meat Recovery (AMR) systems, depending on
the age of the animal. (AMR, as distinct from mechanically-separated meat, uses
pressure to remove edible tissues from bone without crushing it. The resulting
42 USDA, “FSIS Update Of Recall Activities,” release, Feb. 9, 2004, at
[http://www.fsis.usda.gov/OA/recalls/prelease/update067-2003.htm].
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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.43
One of the rules re-defines so-called “Specified Risk Materials,” (SRMs), 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
SRMs, 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.44 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.45
The USDA expert panel commented on February 4, 2004, that until a more
aggressive BSE surveillance is in place, the SRM definition for parts excluded from
food should be expanded, to exclude high-risk tissues from any animal older than 12
months of age (as they had also recommended for the feed ban). However, the report
also included a seemingly contradictory statement that until a better understanding
of BSE prevalence were established, the 30 month cut-off was “a reasonable
temporary compromise.” The full advisory committee reported that the USDA action
to ban SRM from animals over 30 months removed the highest-risk tissues from the
food supply and was in accordance with international standards.
As part of its request for increased BSE funds, the Administration wants an
increase of $3 million in FY2005 for FSIS efforts to protect the food supply from
BSE: for verification of slaughter plant designs for controlling SRMs; for testing
animals that become non-ambulatory and disabled after they arrive at slaughter
plants; and for increased testing of meat produced using AMR systems to help assure
that SRMs are not entering the food supply.
43 See also USDA, “USDA Issues New Regulations to Address BSE,” news release and
related documents, Jan. 8, 2004, at [http://www.fsis.usda.gov/oa/news/2004/bseregs.htm].
44 For further information on FSIS AMR standards and testing, see USDA, “Advanced Meat
Recovery (AMR)” Web page at [http://www.fsis.usda.gov/OA/topics/amr.htm].
45 GAO Mad Cow Disease report, p. 38.
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Related Issues and Options
Animal Identification and Meat Traceability. Among the steps
announced on December 30, 2003, by the Secretary of Agriculture was to “begin
immediate implementation” of a national animal identification (ID) system. The
Secretary added that USDA would offer its computer resources to support the system.
A government-industry task force has been working voluntarily to develop the
framework for such a system, which is aimed at helping authorities to determine
more rapidly the origin of an animal disease outbreak and to contain it quickly.
Presumably USDA now intends to expedite such a plan; a December 2003 draft did
not anticipate full implementation for cattle until July 2005.46
As noted, USDA has requested funds for animal ID as part of the President’s
FY2005 budget. The Administration’s budget proposal includes $33 million to be
used to accelerate development of an animal ID system.
Many producers already keep records on the identities of each of their animals,
primarily for herd management and marketing purposes. Though animals often may
be identified individually as part of an animal disease program, no nationwide
comprehensive U.S. animal ID system is in place.
Some observers have suggested that such a system, for example, would have
enabled USDA to find more of the cows imported from Canada with the BSE cow.
APHIS officials acknowledged that they had concluded their investigation of the U.S.
outbreak after positively identifying only 28 of the 80 cattle that were imported with
the BSE cow. “The limitations of the cattle identification system necessitated a more
extensive tracing exercise than would otherwise have been necessary in order to
identify the cattle to be culled in accordance with international standards, thus
enabling the identification of some animals only by process of elimination,” the
international panel of experts reported on February 4, 2004.47
While most cattle and beef industry leaders appear to be supportive of an animal
ID program (most major industry groups are represented on the task force), some
also assert that animal ID should be viewed primarily as a potential tool in animal
health and food safety assurance programs — not as another BSE preventive measure
itself. Industry leaders also have pointed to a number of other policy issues that still
remain unresolved, including: how much such an animal ID program will cost; how
much government might contribute toward this cost; several questions regarding
privacy of industry data and legal liability; and whether animal ID could or should
be used for purposes besides animal disease management (also see Country of Origin
Labeling, below).
46 The U.S. Animal Identification Plan can be viewed at [http://www.usaip.info].
47 USDA, The Secretary’s Foreign Animal and Poultry Disease Advisory Committee’s
Subcommittee Report on Measures Relating to Bovine Spongiform Encephalopathy (BSE)
in the United States, Feb. 4, 2004, at [http://www.aphis.usda.gov/lpa/issues/bse/bse.html],
p. 2. Earlier, the international team examining Canada’s BSE investigation also had
observed that the lack of a mandatory ID system prior to Canada’s adoption of one in 2001,
contributed to the need for “the extensive culling of animals.”
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Conceptually, animal ID follows cattle from place of birth to the point of
slaughter. That is only one segment of overall meat traceability, which extends
further, generally through the marketing chain to the final consumer. Some
policymakers have urged the adoption of this broader approach. For example,
companion bills offered in 2003 (S. 1202 and H.R. 3546) would require USDA to
establish a traceability system for all stages of production, processing, and
distribution of both meat and poultry and their products, essentially from the birth of
source animals to the ultimate consumer. Other pending bills that would require
some type of animal ID system include S. 2007; H.R. 3714; S. 2008; H.R. 3787; S.
2070, and H.R. 3822.48
Country of Origin Labeling. U.S. law requires most imports, including
many food items, to bear labels informing the “ultimate purchaser” of their country
of origin. Various raw agricultural products have been exempt. The 2002 farm bill
(P.L. 107-171) requires many retailers to provide, starting September 30, 2004,
country-of-origin labeling (COOL) on fresh fruits and vegetables, and unprocessed
red meats, fish, and peanuts. The conference report on the omnibus FY2004
appropriation that includes USDA funding (H.R. 2673; H.Rept. 108-401) delays the
effective date for mandatory COOL for two years, until September 30, 2006 (except
for fish). The conference report passed both the House and Senate, and was signed
into law on January 23, 3004 (P.L. 108-199).
Some Members strongly oppose this two-year delay. Among the reasons that
COOL is needed, according to supporters, is that consumers have a right to know
where their food is from, particularly in light of recent animal health and food safety
concerns such as the two BSE cases in Canadian-born cows. COOL critics have
countered that it is a thinly-disguised trade barrier intended to increase the costs of
imports, and that it undermines U.S. efforts to reform world agricultural trade;
moreover, they argue that, as designed, the mandatory program for industry will be
extremely expensive to maintain, and might hold them legally accountable for
inadvertent or minor mistakes in records.
Prior to enactment of mandatory COOL in 2002, industry leaders were seeking
from USDA a voluntary program for labeling beef of U.S. origin. Although such
labeling already is permitted so long as existing FSIS conditions are satisfied,
presumably a newer, more specific origin program would have been more attractive
to the industry.
Separately, after the May 2003 Canadian BSE discovery, Japanese officials said
they would require proof, effective September 30, 2003, that beef shipped from the
United States was of U.S. origin. Japan’s aim was to ensure that no products came
from Canada. Hoping to satisfy Japanese (and Korean) demands, the Department
unveiled in August 2003 a new “Beef Export Verification” (BEV) program as a
voluntary, user-fee funded service. Exporters desiring to sell beef to Japan (or any
other country that may request similar documentation) were to apply for BEV
certification from USDA after satisfying a list of requirements so that the agency
48 See CRS Report RL32012, Animal Identification and Meat Traceability, by Geoffrey S.
Becker.
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could verify that their beef is from cattle slaughtered in the United States. As noted,
BEV is considered voluntary, even though at the time it was widely viewed as a
minimum prerequisite for gaining access to the Japanese and perhaps other foreign
markets. After the December 23, 2003, announcement of a U.S. BSE cow, Japan was
among the first of what are now dozens of countries to suspend some or all imports
of U.S. cattle, beef, and related products, so the future of BEV is clouded.
Observers anticipate that efforts to overturn the COOL delay could continue
during the second session of the 108th Congress. For example, H.R. 3732,
introduced January 27, 2004, would do so. Other proposed bills include H.R. 2270,
to extend COOL to poultry and goat meat, and to exempt from coverage animals born
prior to October 1, 2004; and H.R. 3083, to ease producer recordkeeping
requirements and eliminate third-party audit provisions. (See also CRS Report
97-508, Country-of-Origin Labeling for Foods, by Geoffrey S. Becker.)
Beef Labeled “Organic”. A USDA program, the National Organic Program
(NOP), prohibits the feeding of “mammalian or poultry slaughter by-products to
mammals or poultry,” if they are to be labeled “organic.”49 Numerous news reports
have suggested a safety benefit from beef grown using organic or other alternative
practices, now that there has been a domestic BSE case. The NOP was developed to
assure that labeling claims reflect defined and verifiable production and handling
practices. USDA makes no claims that organically produced food is safer or more
nutritious than conventionally produced food.
Chronic Wasting Disease. Chronic Wasting Disease (CWD), a TSE, is a
fatal neurological disease of farmed and wild deer and elk in North America. CWD
is generally similar to BSE, and is thought to be caused by a similar type of infectious
prion protein, though CWD also differs from BSE in certain ways, including the
types of tissues involved and its potential for transmission between animals in a herd.
The Centers for Disease Control and Prevention (CDC) says regarding the
potential for CWD transmission to humans:
It is generally prudent to avoid consuming food derived from any animal with
evidence of a TSE (a “transmissible spongiform encephalopathy,” or prion
disease such as BSE and CWD). To date, there is no evidence that CWD has
been transmitted or can be transmitted to humans under natural conditions.
However, there is not yet strong evidence that such transmissions could not
occur. To further assess the possibility that the CWD agent might occasionally
cause disease in humans, additional epidemiologic and laboratory studies could
be helpful. Such studies include molecular characterization and strain typing of
the agents causing CWD in deer and elk and CJD (the human form of prion
disease) in potentially exposed patients. Ongoing national surveillance for CJD
and other neurological cases will remain important for continuing to assess the
risk, if any, of CWD transmission to humans.50
49 7 CFR 205.237, National Organic Program. For further information, see [http://www.ams.
usda.gov/nop/NOP/NOPhome.html].
50 Found at USDA APHIS, “Questions and Answers About Chronic Wasting Disease,” Sept.
2002, at [http://www.aphis.usda.gov/lpa/pubs/fsheet_faq_notice/faq_ahcwd.html].
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With regard to the potential for CWD transmission to cattle, possibly causing
BSE or a related disease that could pose a food safety hazard, USDA says:
During the approximately two decades of monitoring, researchers have not found
any evidence that CWD can be transmitted to domestic cattle under natural
conditions. Ongoing experiments involving oral exposure and contact exposure
on heavily CWD contaminated sites have not resulted in infection of cattle.
These experiments, however, require additional time before they are completed.
CWD has been experimentally transmitted by artificial means to mice, ferrets,
mink, goats, squirrel monkeys, and calves.51
FDA prohibits the feeding of rendered deer and elk to ruminants. In addition,
FDA prohibits the use of known-CWD positive animals in any animal feeds, and
recommends against the use of rendered deer and elk material considered high-risk
in any animal feeds.52
The FY2005 budget proposal includes a $1 million increase (to $20 million) for
APHIS BSE control programs. Proposed FDA programs for CWD control, slated to
come from the funding base for its food programs, include research on the risk
factors and mechanism for CWD. Additional FDA activities to strengthen the feed
ban may include CWD control measures as well. Several bills to increase support
for research and surveillance on CWD have been introduced in the 108th Congress,
including H.R. 2057; H.R. 2430; H.R. 2431; H.R. 2636, and S. 1036.
Feline Spongiform Encephalopathy. Feline Spongiform Encephalopathy
(FSE) was first identified in cats in Britain in 1990, and is believed to result from
eating BSE-affected beef. When brain tissue from cats with FSE was inoculated into
mice, the pattern of incubation periods and lesions in the mice was indistinguishable
from that produced by BSE. There have been 87 cases of FSE diagnosed in the U.K.,
and a few in continental Europe.
The FDA feed ban both prior to and since the announcement of enhanced
safeguards in January, 2004, permits beef by-products in U.S. commercial cat food
(which is technically regulated as “feed”). Since the finding of BSE in the United
States, some have expressed concern about the welfare of cats, and others about the
fact that people have been known to eat cat food.
The Cornell Feline Health Center comments that “the risk of BSE-contaminated
pet food is very small indeed,” for the following reasons: none of the rendered by-
products from the BSE-positive cow were released into distribution; imports of
rendered products prohibited from cattle feed but intended for pet food must originate
from countries free of BSE; and, imports of pet food may not contain mammalian-
derived material.53
51 Ibid.
52 FDA, Guidance for Industry #158: Use of Material from Deer and Elk in Animal Feed,
Sept. 15, 2003, at [http://www.fda.gov/cvm/guidance/published.htm].
53 Cornell Feline Health Center, “Mad Cow Disease and Cats,” Feb. 25, 2004, at
[http://web.vet.cornell.edu/Public/FHC/madcow.html].