Mad Cow Disease
Improvements in the Animal Feed Ban and Other Regulatory Areas Would Strengthen U.S. Prevention Efforts
Gao ID: GAO-02-183 January 25, 2002
Bovine spongiform encephalopathy (BSE), also known as mad cow disease, has been found in cattle in 23 countries. Countries with BSE have suffered large economic losses because of declines in both beef exports and domestic beef sales. The U.S. Department of Agriculture (USDA) and the Food and Drug Administration (FDA) have primary responsibility for preventing the introduction of BSE-contaminated cattle, beef, and cattle-derived products into the United States. GAO found that FDA has not acted promptly to force firms to keep prohibited proteins out of cattle feed and to label animal feed that cannot be fed to cattle. FDA's data on inspections are severely flawed, and FDA is unaware of the full extent of industry compliance. If BSE was discovered in U.S. cattle, many consumers might refuse to buy domestic beef; beef exports could decline dramatically as could sales in related industries, such as hamburger chains and frozen dinner manufacturers. Furthermore, some people might develop mad cow disease if infected cattle were to enter the food supply. The United States acted as many as five years earlier than did other countries to impose controls over imports of animals and animal feed ingredients from countries that had experienced mad cow disease. Similarly, U.S. surveillance efforts to test cattle brains for mad cow disease met internationally recommended testing targets earlier than did other countries. However, the United States' feed ban is more permissive than that of other countries, allowing cattle feed to contain proteins from horses and pigs. FDA is reviewing whether these ingredients should continue to be allowed in cattle feed. Finally, as in most countries that are BSE-free, cattle brains and other central nervous system tissue can be sold as human food.
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GAO-02-183, Mad Cow Disease: Improvements in the Animal Feed Ban and Other Regulatory Areas Would Strengthen U.S. Prevention Efforts
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Report to Congressional Requesters:
United States General Accounting Office:
GAO:
January 2002:
Mad Cow Disease:
Improvements in the Animal Feed Ban and Other Regulatory Areas Would
Strengthen U.S. Prevention Efforts:
GAO-02-183:
Contents:
Letter:
Results in Brief:
Background:
Weaknesses Exist in Federal BSE Prevention and Detection Efforts:
The Economic Impacts of a U.S. Outbreak Could Be Severe, and the Health
Risks Are Uncertain:
The United States Set Controls on Importing Animals and Met BSE Testing
Goals Earlier Than Many Countries, but Its Feed Ban Is More Permissive:
Conclusions:
Recommendations for Executive Action:
Agency Comments and Our Evaluation:
Appendix I: Scope and Methodology:
Appendix II: Comments from the Department of Health and Human Services:
Appendix III: Comments from the Department of Agriculture:
Appendix IV: Comments from the Customs Service:
Appendix V: GAO Contacts and Staff Acknowledgments:
Tables:
Table 1: Cattle Brain Samples USDA Collected and Tested for BSE in Its
Surveillance Program, Fiscal Years 1994-2001:
Table 2: FDA Feed Ban Inspection and Compliance Information:
Table 3: BSE Level of Risk Assessed for 49 Countries by European
Commission Experts:
Figures:
Figure 1: Countries with Confirmed Cases of BSE, as of December 13,
2001:
Figure 2: Examples of Products Derived from Cattle:
Figure 3: Agencies' Implementation of Restrictions to Prevent the
Importation of Animals and Products at Risk for BSE:
Figure 4: Countries Restricted from Exporting Animals and Products at
Risk for BSE to the United States:
Figure 5: Imports of Inedible Meat By-Products, Which Include Meat and
Bone Meal and Other Animal-Derived Meals, Flours, and Residues, from
Countries with BSE, 1980-2000:
Figure 6: Imports of Beef and Edible Cattle Organs from Countries with
BSE, 1980-2000:
Figure 7: Imports of Prepared Beef Products from Countries with BSE,
1980-2000:
Figure 8: Economic Sectors That Would Be Affected if BSE Were Found in
the United States:
Abbreviations:
BSE: bovine spongiform encephalopathy:
FDA: Food and Drug Administration:
FMD: foot and mouth disease:
GAO: General Accounting Office:
HHS: Department of Health and Human Services:
OIE: Office International Des Epizooties:
TSE: transmissible spongiform encephalopathy:
USDA: United States Department of Agriculture:
vCJ: Dvariant Creutzfeldt-Jacob disease:
United States General Accounting Office:
Washington, DC 20548:
January 25, 2002:
The Honorable Tom Harkin:
Chairman:
The Honorable Richard G. Lugar:
Ranking Minority Member:
Committee on Agriculture, Nutrition, and Forestry:
United States Senate:
The Honorable Richard J. Durbin:
United States Senate:
Bovine spongiform encephalopathy (BSE), commonly known as mad cow
disease, is an always fatal, neuro-degenerative disease that has been
found in cattle in 23 countries around the world. Cattle contract the
disease through animal feed that contains protein derived from the
remains of diseased animals. Scientists generally believe an equally
fatal disease in humans--known as variant Creutzfeldt-Jacob Disease
(vCJD)--is linked to eating beef from cattle infected with BSE. Just
over 100 people have died from vCJD, which many scientists believe is
difficult to contract. Both diseases have long incubation periods
during which they are undetectable--2 to 8 years in cattle and possibly
up to 30 years in humans. Countries with BSE have experienced large
economic losses in both their beef exports and domestic beef sales. In
Europe, more than 5 million head of cattle have been destroyed to
thwart the spread of BSE since 1986, when it was first identified in
the United Kingdom.
The U.S. Department of Agriculture (USDA) and the Food and Drug
Administration (FDA) have primary responsibility for preventing the
introduction of BSE-contaminated cattle, beef, and cattle-derived
products (such as some dietary supplements) into the United States and
the spread of the disease if it were to appear. In 1989, USDA began to
identify countries from which cattle and cattle-derived products cannot
be imported because of BSE concerns; since 1992, FDA has identified the
foods, medical products, and other FDA-regulated products derived from
cattle for which imports from those countries pose a potential risk.
USDA and FDA screen imported shipments of such products. In 1997, to
prevent the spread of BSE should it appear in a U.S. herd, FDA
implemented a ban on animal feed. It prohibited the use of proteins
from most mammals in feed for cattle and other ruminants.[Footnote 1]
The prohibited proteins may still be used in other animal feed,
including pet food and feed for swine and horses. In addition, USDA
inspects domestically prepared meat, and FDA oversees the manufacture
of medical and other products to help ensure they do not contain
potentially infective brain and spinal cord (central nervous system)
tissue. To detect BSE in the estimated 97 million dairy and beef cattle
in the United States, USDA implemented a surveillance program to
conduct post mortem tests for BSE on the brains of certain adult
cattle.
No cases of BSE-infected animals have been detected in the United
States, but the continuing discovery of new cases in other countries,
as well as a limited understanding of the disease and its prevention,
have heightened concerns about the adequacy of federal efforts to keep
BSE out of the United States. In light of these concerns, you asked us
to (1) assess the effectiveness of federal actions to prevent BSE and
ensure compliance with the animal feed ban; (2) assess the potential
economic impacts and health risks if BSE were to be found in U.S.
cattle; and (3) compare U.S. actions with actions taken in other
countries to prevent the emergence or spread of BSE. As you also
requested, we considered, to the extent feasible, a study by the
Harvard Center for Risk Analysis and sponsored by USDA to examine the
potential for BSE in the United States.[Footnote 2] That study, issued
in November 2001, concluded that BSE is extremely unlikely to become
established in the United States and that, if introduced here, it would
be eliminated within 20 years.[Footnote 3] The authors acknowledged
that those conclusions, which were based on a probabilistic simulation
model developed for the study, could be influenced by a number of model
assumptions that could not be verified with confidence--including
assumptions about U.S. measures to prevent the introduction and spread
of BSE. The study also states that the most influential sources of
uncertainty regarding the spread of BSE "are related to compliance with
the feed ban." USDA plans to have the study peer-reviewed by a team of
outside experts to validate its scientific integrity. We did not
attempt to validate the model nor the assumptions Harvard made in
applying the model to the United States. Also, we did not conduct an
independent risk analysis of the potential for BSE to occur in the
United States.
Results in Brief:
While BSE has not been found in the United States, federal actions do
not sufficiently ensure that all BSE-infected animals or products are
kept out or that if BSE were found, it would be detected promptly and
not spread to other cattle through animal feed or enter the human food
supply. With regard to imports, the United States had imported about
125 million pounds of beef (0.35 percent of total imported) and about
1,000 cattle (0.003 percent 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. With regard to animal testing to detect BSE, although USDA has
steadily increased the number of animals it tests, it does not include
many animals that die on farms. Experts consider these animals a high-
risk population. Concerning the feed ban, FDA has not acted promptly to
compel firms to keep prohibited proteins out of cattle feed and to
label animal feed that cannot be fed to cattle. We identified some
noncompliant firms that had not been reinspected for 2 or more years
and instances when no enforcement action had occurred even though the
firms had been found noncompliant on multiple inspections. Moreover,
FDA's data on inspections are severely flawed and, as a result, FDA
does not know the full extent of industry compliance. FDA acknowledges
that it has not yet identified and inspected all firms subject to the
ban. In terms of the public health risk, consumers do not always know
when foods and other products they use may contain central nervous
system tissue, which, according to scientific experts, could pose a
health risk if taken from diseased animals.
The economic impacts of a BSE outbreak in the United States could be
severe, according to federal economists. However, scientific experts
believe the health risks are uncertain. In terms of the economic
impacts, if BSE were discovered in U.S. cattle, beef exports and
domestic beef consumption would drop. The severity and duration of the
economic impact would depend largely on the number of animals affected,
the U.S. response, and the public's reaction. We could not extrapolate
the potential impact on the U.S. economy by looking at the experiences
of countries with BSE because perceptions about food safety risks vary
from country to country, and the economic impacts of BSE on one country
might not be applicable to another. Nonetheless, if BSE were found
here, the economic impact on the $56 billion beef industry could be
devastating. Many consumers might refuse to buy domestic beef; beef
exports could decline dramatically and sales in related industries--
such as hamburger chains and soup and frozen dinner manufacturers--
could be similarly affected. Concerning the health risks, if BSE-
infected cattle were to enter the food supply, some people might
develop vCJD. However, experts disagree about the number of people who
would be affected. While many believe that vCJD is very difficult to
contract, so that relatively few people would develop it, some experts
believe that, because of the long incubation period, no one can predict
whether few or many might contract vCJD.
The United States acted as many as 5 years earlier than other countries
to impose controls over imports of animals and animal feed ingredients
from countries that had experienced BSE. Similarly, U.S. surveillance
efforts to test cattle brains for BSE met internationally recommended
testing targets earlier than other countries. However, the United
States has a more permissive feed ban than other countries--one that
allows cattle feed to contain proteins from horses and pigs. FDA is
reviewing whether these ingredients should continue to be allowed in
cattle feed. Finally, as in most countries that are BSE-free, including
the United States, cattle brains and other central nervous system
tissue can be sold as human food.
This report makes recommendations to USDA and FDA to, among other
things, strengthen enforcement of the feed ban, develop a coordinated
strategy to identify resources needed to increase inspections of
imported goods, and alert consumers when products may contain central
nervous system tissue. In commenting on a draft of this report, FDA and
Customs concurred with our recommendations. USDA largely concurred but
said that labeling and warning statements should be reserved for known
hazards.
Background:
BSE and vCJD are among a group of diseases known as transmissible
spongiform encephalopathies (TSE). Currently, there are no therapies or
vaccines to treat TSEs, and a definitive diagnosis can only be made
from a post mortem examination of the brain. The infective agent that
gives rise to TSEs is generally thought to be a malformed protein,
called a prion,[Footnote 4] which causes normal molecules of the same
protein in the brain to become malformed.[Footnote 5] Prions cannot be
killed by conventional heat, irradiation, or chemical disinfection and
sterilization procedures. The precise amount of material needed to
cause disease is unknown but is generally thought to be very
small.[Footnote 6] TSE prions accumulate in central nervous system
tissue--specifically the brain, spinal cord, and eye--but are also
present in other body tissues of infected humans and animals. Other
TSEs include Creutzfeldt-Jacob disease (in humans), scrapie (in sheep),
transmissible mink encephalopathy, and chronic wasting disease (in elk
and deer).
The original source of BSE is not known with certainty. However,
evidence suggests that the practice of recycling the remains of
diseased animals, specifically scrapie-infected sheep, into feed for
livestock, including cattle, was responsible for the emergence and
spread of BSE in the United Kingdom. In 1988, the United Kingdom banned
the practice of feeding ruminant-derived protein to ruminants.
Following this ban, the number of new cases of BSE-infected cattle
declined from a high in 1992 of 32,280 new cases to a total of 1,312
cases in 2000, and to 526 cases as of September 30, 2001. About 2,500
cases of BSE have appeared elsewhere in 18 other European countries, as
well as Oman, Canada, the Falkland Islands, and Japan, as a result of
the exportation of contaminated feed and cattle (see fig. 1). The one
BSE-infected cow found in Canada had been imported and was destroyed
without entering the animal or human food chains. The BSE-infected
cattle found in Oman (two animals) and the Falkland Islands (one
animal) had also been imported.
Figure 1: Countries with Confirmed Cases of BSE, as of December 13,
2001:
[See PDF for image]
[A] BSE found only in imported cattle.
Source: Office International Des Epizooties (world organization for
animal health).
[End of figure]
In 1996, experts in the United Kingdom reported the first cases of
vCJD. They believed the victims contracted it by eating beef
contaminated by central nervous system tissue from BSE-infected cattle.
Although contamination of meat with central nervous system tissue could
occur in many ways during the slaughtering and processing of cattle,
the major suspect in these cases was meat removed by a system that
mechanically recovered (by squeezing under pressure) the remaining meat
left on carcasses after all accessible meat has been removed by knife.
Prior to December 1995, when the United Kingdom banned the practice,
mechanically recovered meat, which was included in many cooked meat
products such as sausages, could legally have contained spinal cords.
While scientists believe that at least several hundred thousand people
may have eaten BSE-infective tissue, many believe vCJD is difficult to
contract.[Footnote 7] As of November 2001, 112 people have had vCJD, of
whom just over 100 had died, nearly all in the United Kingdom.[Footnote
8] Most vCJD victims have been young--the average age at death was 28-
-and half died within 13 months from the time they first showed
symptoms.
As figure 2 shows, cattle provide meat and a wide array of consumer
products. Many of these products may pose at least a theoretical risk
for BSE infection. For example, dietary supplements, vaccines,
cosmetics, and surgical replacement tissue, as well as gelatin, are
produced from bovine carcasses, central nervous system tissue, and
blood. The rendering industry in the United States and elsewhere
recycles animals and animal tissues considered unfit for human
consumption into, among other things, animal feed; diseased animals are
routinely part of such recycling. The United States trades extensively
in animals and the full range of animal products.
No test for BSE or TSE infectivity has been proven adequate for
diagnosis in humans or animals before symptoms appear or for screening
blood and other products. Tests to detect proteins from cattle in
animal feed do not distinguish between milk and blood proteins that are
allowed and meat and bone proteins that are not. Furthermore, methods
to test animal feeds are based on the analysis of genetic material,
bone, and protein, all of which are degraded or destroyed in the
rendering process. The lack of unique genetic material associated with
BSE prions has led scientists to look for other biological markers for
the disease, such as accumulations of abnormal forms of the prion
protein in various tissues. Development of valid, sensitive, rapid, and
reliable tests for live animals is difficult because the specific agent
has not been fully identified and elicits no detectable immune
response. Furthermore, efforts are hampered by the limited scientific
understanding of BSE and other TSEs, including when during the
incubation period infectivity appears, what mechanism causes infection,
and whether infectivity is ever present in blood.
Figure 2: Examples of Products Derived from Cattle:
[See PDF for image]
[End of figure]
Four federal agencies are primarily responsible for overseeing the many
imported and domestic products that could pose a risk of BSE and for
surveillance programs designed to detect and monitor animal and human
diseases:
* The U.S. Customs Service screens all goods entering the country to
enforce Customs laws and laws for 40 other agencies.
* USDA's Animal and Plant Health Inspection Service monitors the health
of domestic animals and screens imported animals and other products to
protect animal health.
* USDA's Food Safety Inspection Service monitors the safety of imported
and domestically produced meat, poultry, and some egg products.
* FDA, within the Department of Health and Human Services (HHS),
monitors the safety of all other foreign and domestic food products
(including dietary supplements and animal feed), as well as vaccines
for humans, drugs, cosmetics, medical devices, and the human blood
supply.
In addition, two other HHS agencies--the Centers for Disease Control
and Prevention and the National Institutes of Health--monitor human
health to detect vCJD should it appear and conduct research to better
understand TSEs and the prions thought to cause them.
In August 1997, FDA banned potentially BSE-infective animal proteins in
feed for cattle and other ruminants. Proteins are added to feed to
promote animal growth and can be derived from a number of sources,
including animal meat and bone meal, fishmeal, and plant products. The
feed ban prohibits the use of most animal-derived proteins in cattle
feed.[Footnote 9] It also requires that, among other things, feed and
feed ingredients that contain the prohibited proteins be labeled "Do
not feed to cattle or other ruminants;" firms that handle both
prohibited and nonprohibited feed and feed ingredients have procedures
to ensure that the two are not commingled; and firms maintain records
sufficient to track feed materials through their receipt and
disposition for certain periods. The ban excludes animal blood and
blood products, gelatin, plate waste,[Footnote 10] milk and milk
protein, and protein derived from pigs and horses (and other equines).
Renderers, feed manufacturers and blenders, and feed distributors are
subject to the ban.
Recent research on the ability of animals to be "silent" carriers of
TSEs from another species raises questions about the advisability of
including in feed for cattle, or other ruminants, proteins from animals
such as pigs and horses that are currently not thought to be
susceptible to BSE and other TSEs, according to researchers at the
National Institutes of Health. Specifically, in November 2001 these
researchers reported that even though mice experimentally infected with
hamster scrapie did not develop clinical disease, infectivity persisted
in the brains and spleens of the mice throughout their life
spans.[Footnote 11] Although available laboratory methods were not
sufficiently sensitive to detect the infectivity in these mice, the
researchers could infect other mice and hamsters with tissue from the
original asymptomatic mice.
The European Commission--the executive and legislative body of the
European Union[Footnote 12]--has had its Scientific Steering
Committee[Footnote 13]conduct assessments of the geographical risk of
BSE for countries that requested an assessment. Between July 2000 and
November 2001 these scientific experts issued assessments for 49
countries, including the United States, which the experts stated was
unlikely to have BSE, but they also stated that the possibility could
not be excluded.
BSE differs greatly from foot and mouth disease (FMD). FMD is a highly
contagious viral disease that primarily affects cloven-hoofed animals,
including cattle, sheep, swine, and goats, and last appeared in the
United States in 1929. In contrast to BSE, FMD does not threaten
humans, rarely causes death in afflicted animals, and has an incubation
period of 24 hours to 21 days. In addition, the virus that causes FMD
can be killed using standard sterilization procedures. This report
deals only with BSE. We also have a study underway, to be issued later
in 2002, of federal measures to control the threat FMD may pose to U.S.
livestock.
Weaknesses Exist in Federal BSE Prevention and Detection Efforts:
The continuing absence of BSE in the United States today cannot be
sufficiently ensured by current federal prevention efforts. The
introduction and spread of BSE in the United States could stem from
cattle and cattle-derived products imported from countries that
subsequently developed BSE and from gaps in import controls, animal
testing, and feed ban enforcement. As a result of these problems,
consumers may unknowingly eat foods that contain central nervous system
tissue from a diseased animal.
BSE-Risk Products May Have Entered the Country before BSE Emerged in
the Exporting Countries or through Gaps in Import Controls:
Since 1989 and as recently as 2001, USDA and FDA have identified
countries with BSE or at risk for BSE and issued import restrictions on
cattle and other ruminants, and on products containing cattle-and
ruminant-derived material from those countries. Figure 3 presents a
timeline of the actions taken by USDA and FDA during that period.
Figure 3: Agencies' Implementation of Restrictions to Prevent the
Importation of Animals and Products at Risk for BSE:
[See PDF for image]
Source: GAO analysis of USDA and FDA import restrictions.
[End of figure]
Figure 4 shows the countries on which the United States currently
imposes trade restrictions for BSE-risk items.
Figure 4: Countries Restricted from Exporting Animals and Products at
Risk for BSE to the United States:
[See PDF for image]
Source: USDA regulations.
[End of figure]
Although federal agencies have acted to reduce the possible ways that
BSE-infected animals or products could enter the country, the United
States has imported about 1,000 cattle; about 23 million pounds of
inedible meat by-products, including meat and bone meal; about 101
million pounds of beef; and about 24 million pounds of prepared beef
products during the past 20 years from countries where BSE was later
found. These numbers represent a fraction of total imports in each
category--0.003 percent of cattle, 0.665 percent of meat by-products,
0.314 percent of beef, and 0.728 percent of prepared beef products. In
light of the long incubation period for BSE (up to 8 years), the
possibility that some contaminated animals or products have entered the
United States cannot be ruled out.
The United States imported 334 breeding and dairy cattle from the
United Kingdom between 1980 and 1989.[Footnote 14] According to USDA,
173 of these animals could have been used in animal feed or entered the
human food supply. In addition, the United States imported 443 breeding
and dairy cattle from continental Europe between 1983 and 1997, some of
which may also have been used in animal feed or in the human food
supply. Since 1996, USDA has placed under quarantine any of these
imported cattle it has found still alive. These animals are monitored
and, when they die, USDA obtains brain samples to test for BSE. Thus
far, all tests on these animals have been negative. As of November 16,
2001, three head of cattle from the United Kingdom and five from
continental Europe were still alive and being monitored.
The United States also imported 242 cattle from Japan between 1993 and
1999. Japan reported its first case of BSE in September 2001. As of
November 28, 2001, USDA had located 214 of these cattle. According to
USDA, 24 of these cattle had gone to slaughter or to
rendering,[Footnote 15] 40 had been exported, and 150 were still alive.
USDA has begun monitoring those animals and is attempting to locate the
remaining 28 cattle.
In its evaluation of the potential for BSE in the United States, the
Harvard study considered the ban on imports of cattle from the United
Kingdom as one of the United States' key prevention measures. The study
assumed that remains from some of the cattle imported from the United
Kingdom could have been used in animal feed, food for human
consumption, or both. Although more than 95 percent of the study's
simulations, based on exposure to a low infective dose, resulted in no
BSE cases in cattle, a few resulted in substantial numbers of cases.
The study also assumed that cattle imported from continental Europe
after 1996 had been traced and their movements controlled; it states
that these cattle present virtually no risk for introducing BSE to the
United States. However, the Harvard study did not take into account the
242 cattle imported from Japan between 1993 and 1999. The discovery of
BSE in Japan occurred just before Harvard issued the results of its
study.
The United States also imported about 23 million pounds of inedible
meat by-products--which would include meat and bone meal and other
animal-derived meals, flours, and residues--between 1980 and 2000 from
countries later found to have BSE (see fig 5.). However, the amount of
meat by-products derived from cattle is uncertain because the code
Customs uses to classify such shipments includes by-products from
cattle or other animals. Likewise, any meat and bone meal imported
under that code could be from cattle or other animals. While experts,
including the Harvard researchers, see the risk of exposure posed by
these shipments as extremely low, if any cattle feed contained BSE-
infected meat and bone meal, it could create an opportunity to
contaminate U.S. cattle.
Figure 5: Imports of Inedible Meat By-Products, Which Include Meat and
Bone Meal and Other Animal-Derived Meals, Flours, and Residues, from
Countries with BSE, 1980-2000:
[See PDF for image]
Source: GAO analysis of data from the International Trade Commission
and the Departments of Commerce and Treasury.
[End of figure]
The beef and prepared beef products that the United States imported
from countries that later found BSE, were for human consumption.
According to scientific experts, meat products could represent a risk
to people who ate them if the meat came from a BSE-infected animal (see
figs. 6 and 7). Until February 2001, USDA regulations allowed the
import of beef and beef products from countries with BSE or at risk of
BSE if the facility that processed the meat did not receive, store, or
process ruminant material from a country with BSE or at risk for BSE.
Figure 6: Imports of Beef and Edible Cattle Organs from Countries with
BSE, 1980-2000:
[See PDF for image]
Note: These trade data include beef only for the years 1980-1988; the
data may include meat and organs from other bovines, such as bison,
oxen, and buffalo, for the years 1989-2000.
Source: GAO analysis of data from the International Trade Commission
and the Departments of Commerce and Treasury.
[End of figure]
Figure 7: Imports of Prepared Beef Products from Countries with BSE,
1980-2000:
[See PDF for image]
Note: Prepared products include, among other things, processed meat,
such as sausage, and cured or pickled meat, such as corned beef. These
trade data may include products from other bovines, such as bison,
oxen, and buffalo.
Source: GAO analysis of data from the International Trade Commission
and the Departments of Commerce and Treasury.
[End of figure]
In addition to the BSE risk posed by past imports, a small but steady
stream of BSE-risk material may still be entering the United States
through international bulk mail. USDA inspectors at a New Jersey
international bulk mail facility have begun using new x-ray technology
that clearly distinguishes organic from inorganic matter to screen
packages for products that pose a risk of animal and plant diseases. At
this facility, we saw USDA inspectors seize one package that contained
beef soup mix from Germany, one of the countries from which the United
States restricts trade in beef products. Inspectors also showed us a
package from Ireland that was labeled "cutlery," but contained corned
beef. From May through October 2001, USDA inspectors, using the new x-
ray technology, screened about 7 percent (about 116,000) of the over
1.5 million packages that passed through the New Jersey facility. Of
the screened packages, 570 contained one or more at-risk beef or beef-
derived products. However, USDA does not screen packages at the New
Jersey facility during the 24 hours each week when inspectors are not
on duty. According to the inspectors, the screening rate was low
because only one or two inspectors are on duty at any time, and each
has only seconds to visually inspect packages as they pass by on a
conveyor belt. While all 14 international bulk mail facilities in the
United States have some sort of x-ray technology that can distinguish
organic from inorganic material, the new technology--used only at the
New Jersey facility--provides greater accuracy and clearer imagery. The
new technology is also compatible with the conveyor system and can be
placed over the conveyor belt. USDA officials told us that the new x-
ray technology would facilitate the inspection of international bulk
mail arriving in the United States.
At-risk items may also slip through federal inspections at ports of
entry. Customs often finds discrepancies with the accuracy of importer-
provided information during its annual reviews of trade compliance and,
as a result, BSE-risk products may not be flagged for further
inspection. For example, Customs found a shipment of animal feed
ingredients incorrectly classified as pet food by the importer. It also
found a shipment of animal feed identified by the importer as
originating in Canada that inspectors discovered originated in
Switzerland. For fiscal year 1999, Customs reported that importer-
provided information on shipments of live bovine animals (e.g., cattle,
bison, and buffalo) was inaccurate in over 24 percent of samples taken.
Information on shipments of fresh or frozen beef was inaccurate in over
21 percent of samples and on shipments of animal feed in over 24
percent of samples.
Additionally, the ever-increasing volume of imported shipments strains
inspection resources for both FDA and USDA. In October 2001, we
reported that during fiscal year 2000, FDA inspected about 1 percent of
the over 4 million imported food entries under its
jurisdiction.[Footnote 16] Additionally, FDA inspected less than one
percent of the more than 146,000 entries of imported animal drugs and
feeds. FDA has acknowledged that the increased volume of imports has
severely hampered its ability to inspect a sufficient portion of
imports. Specifically, while imported shipments under FDA's
jurisdiction have risen dramatically in recent years, the agency's
inspection staff has remained almost static since 1992. Prompted by
bioterrorism concerns, the Secretary of Health and Human Services
requested $61 million in October 2001 to hire 410 additional inspectors
and other personnel to allow increased inspections of imported food
products. In 1997 we reported that USDA's inspection workload had
increased dramatically since 1990; we concluded that USDA had little
assurance that it was deploying its limited inspection resources at the
ports of entry that are most vulnerable to the introduction of pests
and diseases.[Footnote 17] USDA has acknowledged the lack of inspection
coverage and, in the wake of foot and mouth disease outbreaks in Europe
and other countries, authorized $32 million in fiscal year 2001 to hire
350 new inspection personnel and additional canine inspection teams at
U.S. borders and ports of entry.
USDA Tests Many Cattle Brains for BSE in Its Surveillance Program but
Does Not Test Many from Cattle That Die on Farms:
USDA began testing animal brains to detect BSE in domestic cattle in
1990. This surveillance program consists primarily of collecting and
analyzing brain samples from adult cattle with neurological symptoms
and adult animals that were nonambulatory at slaughter.[Footnote 18]
Testing animal brains is a key measure to detect BSE, and USDA's
surveillance program should build on current efforts to increase the
number of brain samples tested each year, according to officials from
organizations representing the beef and grain industries, state
officials, and consumers, as well as federal officials. As table 1
shows, the number of samples collected and tested by USDA in its
surveillance program has generally increased each year.[Footnote 19]
The table also shows that a substantial portion of those samples have
been taken from nonambulatory cattle since 1994, when USDA first began
to collect this information. USDA has increased the portion of
nonambulatory cattle because research has shown that this population
includes animals that might have subtle neurological symptoms or
injuries resulting from neurological impairment. In fiscal year 2001
these animals accounted for more than 90 percent of the 4,870 brains
collected and tested by USDA. The remainder includes brain samples from
animals rejected at slaughter for signs of neurological disease.
Table 1: Cattle Brain Samples USDA Collected and Tested for BSE in Its
Surveillance Program, Fiscal Years 1994-2001:
Brain samples tested: Number from nonambulatory cattle[A]; Fiscal year:
1994: 199; Fiscal year: 1995: 223; Fiscal year: 1996: 266; Fiscal year:
1997: 219; Fiscal year: 1998: 344; Fiscal year: 1999: 651; Fiscal year:
2000: 1,895; Fiscal year: 2001: 4,464.
Brain samples tested: Number from ambulatory cattle; Fiscal year: 1994:
296; Fiscal year: 1995: 242; Fiscal year: 1996: 318; Fiscal year: 1997:
636; Fiscal year: 1998: 387; Fiscal year: 1999: 342; Fiscal year: 2000:
414; Fiscal year: 2001: 406.
Brain samples tested: Total brain samples collected and tested; Fiscal
year: 1994: 495; Fiscal year: 1995: 465; Fiscal year: 1996: 584; Fiscal
year: 1997: 855; Fiscal year: 1998: 731; Fiscal year: 1999: 993; Fiscal
year: 2000: 2,309; Fiscal year: 2001: 4,870.
[A] According to USDA, it did not track brain samples from cattle that
had died on farms; the few that were taken would have been counted in
with the nonambulatory cattle.
Source: GAO presentation of USDA data.
[End of table]
In addition to increasing the sample size and the number of
nonambulatory cattle tested, USDA has broadened its testing efforts.
USDA tests samples using two complementary laboratory methods and
conducts surveillance for two TSEs--scrapie in sheep and chronic
wasting disease in deer and elk--that already exist in the United
States. USDA officials and many scientific experts believe surveillance
and eradication of scrapie and chronic wasting disease is important, in
part, because of the suspected link between scrapie in the United
Kingdom and the appearance of BSE, and because both have been
experimentally transferred to other species.
Although USDA has strengthened its surveillance efforts, the program
does not include many samples from cattle that die on farms. Scientific
experts consider these animals a high-risk population because they are
generally older and the reasons for their death are often
unknown.[Footnote 20] USDA told us that efforts to obtain samples more
systematically from such animals are limited largely by the dispersed
nature of the domestic livestock industry, the lack of adequate
laboratory capacity to conduct the tests, and the lack of sufficient
staff and time to collect the samples. When animals die on farms they
may be buried on the farm, taken to landfills, or collected by
renderers who recycle animals and other animal tissues into, among
other things, animal feed. In 1998 USDA implemented a cooperative
program with the rendering industry to ensure that carcasses of animals
condemned at slaughter for signs of neurological disease are held until
test results are completed. Under this program, USDA may share the
expenses to store or dispose of carcasses during the testing period.
USDA was not able to provide us with information on how frequently the
program has been used, but it has been used only sporadically,
according to USDA officials and the USDA veterinarians and renderers we
spoke with in nine states and Puerto Rico.
In its evaluation of the potential for BSE in the United States, the
Harvard Center for Risk Analysis included animals that die on farms as
a potential source of BSE exposure. According to their simulation
model, excluding from the rendering process those animals that die on
farms significantly reduces the potential for cattle to be exposed to
BSE through animal feed. Harvard's report also notes that farmers may
not be willing to send animals displaying neurological symptoms to
slaughter, thereby reducing the likelihood that infected animals would
be inspected by USDA at slaughterhouses. Once dead, these animals might
be rendered, as assumed in the simulation model, or disposed of on
farms. According to USDA officials, when the Harvard study was issued
to the public, the Secretary of Agriculture announced plans to more
than double the number of BSE tests conducted in FY 2002 to more than
12,000.
FDA's Enforcement of the Feed Ban Is Limited and Inspection Data Are
Flawed:
Federal and state officials and the scientific community agree that if
BSE were to be found in a U.S. herd, a well-enforced feed ban would
prevent its spread to other herds. State inspectors (who conduct about
80 percent of inspections) and FDA inspectors document their feed ban
inspections on inspection forms. FDA headquarters compiles and
maintains this information in a database, and it provided to us the
information in that database through October 26, 2001. According to
FDA's data, more than 12,000 inspections have been conducted since 1997
at more than 10,000 firms,[Footnote 21] including renderers, feed
manufacturers, feed haulers, and distributors, as well as at on-farm
feed operations. According to FDA's October 2001 quarterly update that
summarized results of feed ban inspections, 364 firms were out of
compliance. In addition, FDA believes that not all firms that should be
subject to the ban have been identified and inspected, at least 1,200
or more based on industry estimates (see table 2). However, we could
not verify these data because we found significant flaws in FDA's
database, which we discuss later in this report.
Table 2: FDA Feed Ban Inspection and Compliance Information:
Type of firm: Renderers; FDA's estimate of the universe of this type of
firm: 264; Number of firms inspected: 264; Number of firms out of
compliance: 13.
Type of firm: FDA-licensed feed mills[A]; FDA's estimate of the
universe of this type of firm: 1,240; Number of firms inspected: 1,240;
Number of firms out of compliance: 42.
Type of firm: Other feed mills; FDA's estimate of the universe of this
type of firm: 6,000-8,000; Number of firms inspected: 4,835; Number of
firms out of compliance: 228.
Type of firm: Other firms[B]; FDA's estimate of the universe of this
type of firm: At least 4,237 (universe unknown); Number of firms
inspected: 4,237; Number of firms out of compliance: 81.
Type of firm: Total; FDA's estimate of the universe of this type of
firm: At least 11,741; Number of firms inspected: 10,576; Number of
firms out of compliance: 364.
Note: Because of the severe flaws in FDA's inspection database, we were
unable to verify these data or use the database for analysis of
oversight and enforcement.
[A] Feed mills that must be licensed by FDA because they handle
restricted medicines.
[B] Other firms include feed blenders, on-farm mills, and feed haulers.
Source: FDA's Center for Veterinary Medicine Update, Oct. 30, 2001.
[End of table]
FDA did not take prompt enforcement action to compel firms to comply
with the feed ban. When we began this study, in April 2001, the only
enforcement action FDA had taken was to issue two warning letters in
1999.[Footnote 22] The first letter was issued in May 1999--21 months
after inspections began.[Footnote 23] However, since inspections began
in 1997, FDA has reported hundreds of firms out of compliance--most
often for failure to meet requirements to label feed that contained
prohibited proteins or for including prohibited proteins in cattle
feed. In our analysis of individual inspection forms, we found several
instances in which firms were out of compliance in repeated
inspections, yet FDA had not issued a warning letter. We also found
instances in which firms were out of compliance but had not been
reinspected for a year or more--and in some cases for more than 2
years.
Between February and November 2001, FDA issued warning letters to
another 48 firms. In addition, 17 firms voluntarily recalled feed,
including 9 that had been issued a warning letter. As of November 30,
2001, FDA or states had reinspected 33 of the total of 50 firms that
had been issued warning letters (2 in 1999 and 48 in 2001). Six of the
firms were still out of compliance on reinspection. FDA has no
enforcement strategy for feed ban compliance that includes a hierarchy
of enforcement actions, criteria for actions to be taken, time frames
for firms to correct violations, and time frames for follow-up
inspections to confirm that violations have been corrected.
According to FDA, rather than taking enforcement actions, it has
emphasized educating firms subject to the feed ban about the ban's
requirements and working with those firms to establish cooperative
relationships. FDA reported that some states might have taken
enforcement actions, including requiring firms to recall noncompliant
feed. However, FDA does not track enforcement actions taken by states;
therefore, it does not know the extent of such actions.
Even if FDA were to actively enforce the feed ban, its inspection
database is so severely flawed that--until corrected--it should not be
used to assess compliance. Nonetheless, FDA uses the database to manage
and oversee compliance, respond to congressional inquiries about
compliance, and keep industry and the public informed.
From our review of FDA's database of 12,046 feed ban inspection records
(as of October 26, 2001), we found records lacked unique identifiers,
were incomplete, contained inconsistent or inaccurate information, and
were not entered into the database in a timely manner. Examples of the
severe flaws we found include:
* Entries for 5,446 inspections--or about 45 percent of all
inspections--lack information to uniquely identify individual firms. As
a result, the data cannot be used to reliably determine the number of
firms inspected, compliance trends over time, or the inspection history
of an individual firm. In at least one case, the same unique identifier
had been applied to six different firms and, in another case, a firm
had two unique identifiers. In addition, we found 232 cases in which
one or more inspections of the same firm lacked the unique identifier.
* Entries for 301 inspections of firms that handle prohibited proteins
contain no response to whether feed was properly labeled; entries for
438 inspections of firms that handled both prohibited and non-
prohibited proteins had no response to whether prohibited proteins were
included in feed intended for cattle.
* Entries where responses to questions about feed labeling or whether
prohibited proteins were included in feed intended for cattle indicated
that the firms were in compliance; however, inspectors' notes contained
in other sections of the database contradicted the responses and
indicated the firms were not in compliance.
* Inspections were not entered into the database. In assessing the
warning letters, we discovered references to inspections that do not
appear in the database. In fact, the inspection record for the firm
that received the first warning letter--in May 1999--does not appear in
the database.
* Inspections were not entered into the database in a timely fashion.
We found several instances where inspections dating back to 1998 and
1999 were not entered into the database until mid to late 2001--too
late for FDA to reinspect in a timely fashion if violations existed.
Also, too much time had passed for FDA to reliably clarify inconsistent
or conflicting information or obtain answers to questions left blank on
the inspection forms. Moreover, any compliance information FDA reported
to congressional overseers and others would not have been reliable.
* Several states did not use FDA's inspection form, but instead used
their own state-developed forms. Because the questions were different,
certain assumptions had to be made when these data were entered into
FDA's database. The HHS Office of Inspector General noted, in a June
2000 report, that many FDA agreements with states, whose inspectors
conducted about 80 percent of feed ban inspections, do not ensure that
states routinely provide FDA with standardized information on the
inspections they conduct.[Footnote 24] In September 2001 FDA revised
the inspection form and asked states to use the revised form. States
are free to ask other questions during the inspections, but FDA has
also asked them to include FDA's questions in FDA's format.
* The database is incomplete. It does not include all firms subject to
the feed ban. FDA officials relied on the personal knowledge of state
and FDA field staff and on membership lists from industry groups to
identify and locate firms. However, our review of membership records
for the National Renderers Association--for the years 1998 to 2001--
disclosed 21 rendering firms that were not in FDA's database. According
to association records, those firms process meat and bone meal and
other products that could contain proteins subject to the feed ban.
FDA did not count data entries with blanks--no responses--in the
selected data fields it uses when it reports on compliance. Therefore,
when FDA provided compliance information to the Congress--and when it
publishes that information electronically--the data are misleading and
the number of firms identified as out of compliance are undercounted.
For example, for the 364 firms identified as out of compliance in FDA's
October 2001 update--the source for information in table 1 above--FDA
assumed that all entries with blanks in the compliance fields were in
compliance. However, we found entries where firms had blanks in the
data fields FDA used, yet contained inspector comments in other fields
showing that the firms were not in compliance. FDA also did not include
these firms on published lists of noncompliant firms. About half of the
inspection records contain inspector comments. On those entries where
blanks also existed, the inspector comments showed that firms were in
compliance in some instances and out of compliance in others.
An FDA official told us that the database was not originally intended
to track compliance of individual firms, but rather to guide the
agency's efforts to educate firms subject to the ban by illustrating
particular states or practices that needed more intensive focus.
However, FDA has no information system other than the inspection
database to track compliance with the feed ban.
FDA has not placed a priority on oversight of the feed ban. From the
implementation of the feed ban in August 1997 until early 2001, one
person in FDA's Center for Veterinary Medicine was responsible for feed
ban management. Although state and FDA District Office inspectors
conducted the inspections, this individual designed the inspection
form, compiled inspection data, and made enforcement decisions--in
addition to that individual's other duties. Furthermore, the inspection
form had not been pretested--a standard practice to ensure that
questions are interpreted and answered consistently.
In the course of our review, FDA attempted to clean up the database so
that it could serve as an accurate management tool. However, in October
2001, FDA turned that effort over to a contractor to (1) review the
completeness of the feed ban inspection database to ensure that
findings have been captured, including written comments by the
inspectors on inspection forms; (2) analyze the data and present the
findings in a report; and (3) review the current enforcement strategy
to determine program strengths and weaknesses and to make
recommendations for improvements that will better support FDA's
compliance goals. FDA expects this work to be completed by February
2002. Also in October 2001, FDA entered into a separate contract to
reconfigure the data so that they can be incorporated into FDA's
primary database for all other inspection activities. Work on the two
contracts is to be carried out concurrently. This work is to be
completed in the spring of 2002.
In evaluating the potential for BSE in the United States, the Harvard
study noted that the feed ban is key to preventing the spread of BSE.
It added, however, that the effectiveness of the feed ban is somewhat
uncertain because compliance rates are not "precisely" known. Harvard's
simulation model assumed the feed ban was compromised to some extent by
on-farm feeding of prohibited proteins to cattle and by some
noncompliance with the requirement that feed containing prohibited
protein carry a warning label. The study's observations underscore the
importance of the problems we found in FDA's oversight and enforcement
of the feed ban.
Consumers Cannot Tell Which Beef Products May Contain Central Nervous
System Tissue:
Some consumers in the United States regularly eat cattle brains and
central nervous system tissue. Brains are a routine part of the diet in
several cultures. Eating such foods would not pose a safety concern
unless they were from a BSE-infected animal. However, most consumers
would not realize that central nervous system tissue could be found on
many beef cuts and in several beef products.[Footnote 25] For example,
bone-in meat cuts, such as T-bone steaks, are stripped directly from
the animal's vertebrae and may contain portions of the spinal cord.
Many other edible products, such as beef stock, beef extract, and beef
flavoring, are frequently made by further processing (e.g., boiling)
the skeletal remains (including the vertebral column) of the carcass
after most of the meat has been removed. USDA officials told us that
they would expect to find central nervous system tissue in these foods.
However, based on food quality--not food safety--concerns, USDA does
prohibit central nervous system tissue in beef products that are
labeled as meat and that are made using technology that mechanically
removes meat from the bones of slaughtered animals in a way that
approximates deboning by hand. Products made from meat using this
technology include sausages and hot dogs. USDA has found central
nervous system tissue in meat that was mechanically removed using a
technology known as advanced meat recovery systems. USDA estimates that
28 beef processing plants use this technology and, in 2000, recovered
257 million pounds of beef. According to a beef industry official, this
technology recovers up to 10 additional pounds of meat per carcass.
Because it is not a food safety issue, USDA has not rigorously enforced
its prohibition against the presence of central nervous system tissue
in meat extracted by using the advanced meat recovery system
technology. Since 1997, USDA has tested a total of 63 beef samples from
18 of the plants that use this technology. Of those samples, 12 tested
positive for central nervous system tissue. USDA has not tested beef
samples from the other plants that use the technology in at least 4
years. When its tests found central nervous system tissue in samples,
USDA did not track to ensure that the processing plants relabeled the
contaminated meat products as something other than meat.
USDA plans to use the Harvard study to help it determine whether the
presence of central nervous system tissue should be a food safety
matter--whether all or some central nervous system tissue should be
considered unsafe for human consumption. The Harvard study notes that a
ban on the use of spinal cords, brains, and vertebral columns in human
food or animal feed significantly reduced the risk of exposure in its
simulation model. As part of its evaluation of the implications of the
study, USDA will issue a Federal Register Notice after January 2002 to
solicit comments on, among other things, the safety of the advanced
meat recovery technology and any meat that comes from the vertebral
column.
In addition, FDA's TSE Advisory Committee--composed of USDA, National
Institutes of Health, Centers for Disease Control and Prevention, and
other federal experts, as well as academic scientists and medical
experts, and consumers--recommended, in October 2001, that FDA consider
taking regulatory action to ban brains and other central nervous system
tissue from human food because of the potential risk of exposure to
BSE-infected tissue. According to FDA, it is considering banning
central nervous system tissue from the foods it regulates as well as
from cosmetics and over-the-counter drugs. FDA told us it is taking
this action to ensure that consumers are protected from consuming BSE-
contaminated products. Representatives of two consumer groups we
interviewed expressed concern that central nervous system tissue
remains a part of food generally and that the use of advanced meat
recovery technology could expose consumers unknowingly to such tissues.
The Economic Impacts of a U.S. Outbreak Could Be Severe, and the Health
Risks Are Uncertain:
If BSE were discovered in U.S. cattle, beef exports and domestic beef
consumption would drop, damaging many sectors of the economy, according
to federal economists. If the infected cattle were to enter the food
supply, some people might develop vCJD.
The economic impacts of a BSE outbreak in the United States would
include the direct impacts on certain sectors, such as the beef and
livestock industries, and indirect impacts on related industries, such
as the animal feed and restaurant industries. In addition, an
assessment of economic impacts would include costs relating to the
public sector, such as farmer compensation payments, increased spending
on research and development, and increased costs to government
agencies.[Footnote 26] While the extent to which economic impacts would
pass from one sector to another is unclear, these effects would
eventually channel through to several sectors of the economy. Figure 8
lists the sectors and some of the likely qualitative impacts within
each sector in the event of a BSE outbreak in the United States.
Figure 8: Economic Sectors That Would Be Affected if BSE Were Found in
the United States:
[See PDF for image]
[A] Beef packers slaughter cattle and other animals and package
carcasses and large cuts for further processing.
[B] Beef processors cut, slice, grind and package beef for consumers
and for other end users, such as grocery stores, restaurants, and
institutions.
Source: GAO analysis.
[End of figure]
To date, however, there are no comprehensive economic studies of the
total direct and indirect economic impacts of a potential BSE crisis in
the United States. A complete assessment of these impacts is difficult
to forecast given the uncertainties surrounding key assumptions, such
as the source of the BSE, the number and timing of cases, and the
public's reaction. For instance, if BSE were to enter the country
through the importation of meat and bone meal rather than live cattle
imports, the economic consequences could be more pervasive, because the
meat and bone meal could potentially contaminate many cattle. Another
difficulty in estimating impacts is the problem of determining how the
increased costs of BSE would be passed on from the farmer to the final
consumer in the beef-marketing channel. Moreover, studies that estimate
losses due to BSE from other countries may not be totally applicable to
the United States.
Food safety experts have noted that perceptions about food safety risks
vary from country to country, and the consumer impacts of BSE in one
country may not be applicable to another country. If BSE were found
here, the economic impact on the $56 billion beef industry and related
industries could be devastating, according to USDA economists. For
instance, consumers in the United States, in response to reports of
BSE-infected cattle, may for a period of time restrict their purchases
of beef and products containing beef. That response would be felt not
only by the cattle and beef industries, but also by peripheral
industries. For example, hamburger chains and soup and frozen dinner
manufacturers could see dramatic declines in business.
Similarly, in international trade, a loss in beef exports may be more
devastating for the United States than for other beef-producing
countries. In particular, since the United States exports nearly 10
percent (by volume) of its total beef production (about 25 percent of
total world beef exports), the trade sector is also critical in
estimating total economic impacts.
As a first approximation, however, FDA officials estimated the direct
effects to the beef and livestock industries based on a 1998 study of
the economic impacts of the first year of the BSE outbreak in the
United Kingdom.[Footnote 27] They estimate that if the United States
were to experience an outbreak as severe as the one in the United
Kingdom, the beef industry could lose as much as $15 billion in sales
revenue. Specifically, these costs were based on the assumption that in
the event of a BSE crisis, U.S. domestic and export demand would
decrease by the same amounts as in the United Kingdom--a 24 percent
decline in domestic beef sales and an 80 percent decline in beef and
live cattle exports. In addition, the FDA estimated the livestock
sector would incur a minimum of $12 billion to slaughter and dispose of
at-risk cattle. This estimate was based on an assumption that the
United States would need to destroy about four times as many cattle as
the United Kingdom. However, the FDA analysis did not include the
offsetting effects of government payments, as occurred in the United
Kingdom, shifts in consumer demand for other types of meat, or the
effects on other related sectors of the economy. Overall, however, FDA
noted that those firms primarily engaged in the production of beef
products would incur severe economic disruption.
In terms of the health risks, if infected cattle were to enter the food
supply, some people might develop vCJD; however, scientific experts
disagree about how many people could develop the disease. Many experts
believe that vCJD is difficult to contract and, therefore, that
relatively few people would develop the disease. However, other
scientific experts believe that, because of the long incubation period,
no one can predict whether few or many might contract vCJD. According
to some scientific experts in the United Kingdom, as many as 100,000
people in Europe may develop vCJD as a result of the BSE outbreak
there. This could include Americans who lived in countries where BSE
occurred. In addition to these direct health implications, an outbreak
of BSE in the United States would carry an emotional toll on consumers
who believe federal regulators will protect them from this devastating
disease. Moreover, according to a National Institutes of Health
scientist, the appearance of vCJD could cast doubt on the safety of
organ donations and the U.S. blood supply.[Footnote 28],[Footnote 29]
Any health implications would translate into medical treatment and
related financial and economic costs, such as lost productivity.
The United States Set Controls on Importing Animals and Met BSE Testing
Goals Earlier Than Many Countries, but Its Feed Ban Is More Permissive:
The United States prohibited the import of cattle and other ruminants 3
to 5 years earlier than many other countries. Its surveillance program
to test cattle brains for BSE also met international targets for the
number of animals tested earlier than many other countries. However,
the United States has a more permissive feed ban than other countries-
-one that allows cattle feed to contain proteins from horses and pigs.
FDA is reviewing whether these ingredients should continue to be
allowed in cattle feed. Finally, as in most countries that are BSE-
free, including the United States, cattle brains and other central
nervous system tissue can be sold as human food.
The European Commission's Scientific Steering Committee has had
scientific experts assess countries, including the United States, for
the risk that BSE could enter the country through imported animals and
feed and be spread through recycled animal proteins in feed. As of
November 30, 2001, risk assessments had been completed for 49
countries. According to the scientific experts, most European countries
are likely to have BSE, even if it has not yet been confirmed by
surveillance testing, or to have BSE at a higher level of incidence
than thought. The scientific experts assessed the United States as
unlikely to get BSE, but indicated that the possibility could not be
excluded. Table 3 presents the results of the 49 BSE risk assessments
completed through November 30, 2001.
Table 3: BSE Level of Risk Assessed for 49 Countries by European
Commission Experts:
BSE risk level: Highly unlikely - Level I; Number of countries (percent
of total assessed): 16 (32.7); European Union countries: [Empty]; Other
countries: Argentina, Australia, Botswana, Brazil, Chile, Costa Rica,
El Salvador, Namibia, Nicaragua, Norway, New Zealand, Panama, Paraguay,
Singapore, Swaziland, Uruguay.
BSE risk level: Unlikely but not excluded - Level II; Number of
countries (percent of total assessed): 12 (24.5); European Union
countries: Austria, Finland, Sweden; Other countries: Canada, Colombia,
India, Kenya, Mauritius, Nigeria, Pakistan, Slovenia, United States.
BSE risk level: Likely but not confirmed or confirmed at a lower level
- Level III; Number of countries (percent of total assessed): 19
(38.8); European Union countries: Belgium, Denmark, Germany, France,
Ireland, Italy, Luxembourg, Netherlands, Spain; Other countries:
Albania, Cyprus, Czech Republic, Estonia, Hungary, Lithuania, Poland,
Romania, Slovakia, Switzerland.
BSE risk level: Confirmed at a higher level - Level IV; Number of
countries (percent of total assessed): 2 (4.1); European Union
countries: United Kingdom, Portugal; Other countries: [Empty].
Notes: Countries with reported cases of BSE as of December 13, 2001,
are in bold type. BSE was found in Austria, Czech Republic, Finland,
Slovakia, and Slovenia after their BSE risk assessments had been
completed. Greece, the only European Union country that did not provide
the data for an assessment, reported its first case of BSE in 2001.
Source: GAO analysis of 49 BSE risk assessments.
[End of table]
Using information on each country's past and present potential exposure
and ability to stop the spread of BSE, the scientific experts
qualitatively assessed the probability that an animal in a country is
infected with BSE. The assessments relied on data voluntarily supplied
by the countries and on discussions with the officials familiar with
BSE prevention efforts from each country on (1) the potential import of
BSE via live cattle or contaminated feed, (2) the adequacy of
surveillance testing to detect the presence of BSE, (3) cattle feeding
and rendering practices, and (4) the use of potentially infective
tissue from cattle. The scientific experts also focused on the import
of infected animals and animal feed as the only initial sources of
infection and on animal feed as the only source of spread. The experts
did not evaluate the risks from consumer products that could contain
BSE-infected tissue. The scientific experts reported using a
conservative, reasonable worst-case approach, whenever data or
information from countries were insufficient. Based on our analyses of
the 49 risk assessments, the United States compared with the other
countries as follows in terms of the potential to import BSE,
surveillance testing, cattle feeding practices, and use of potentially
infective tissue.
* Potential to import BSE. The United States acted earlier than many
countries to ban the import of cattle and meat and bone meal for use in
cattle feed from the United Kingdom and other countries where BSE had
appeared. The United States was one of three countries that banned
trade in cattle from the United Kingdom by 1989; six other countries
did so by 1994. Nine other countries had formal bans in place by 1996,
the year that the United Kingdom stopped all trade in cattle. Actions
to halt trade in cattle with other countries where BSE had appeared has
been variable, and the United States and some other countries phased in
restrictions as cases appeared.[Footnote 30] Also, many of the assessed
countries, particularly those in South America and in Africa, had
little or no trade in cattle with the United Kingdom or other countries
where BSE had appeared. With regard to the import of meat and bone meal
for use in cattle feed, the United States banned imports from the
United Kingdom in 1991 and phased in restrictions from other countries
as cases of BSE appeared. While one country banned such imports from
the United Kingdom as early as 1978, due to concerns about foot and
mouth disease, a few countries imported significant amounts of meat and
bone meal from the United Kingdom and other BSE countries as recently
as 1999.
* Surveillance testing to detect BSE. The United States is one of three
countries that reported meeting Office International Des Epizooties
(OIE)-recommended cattle testing levels by 1994.[Footnote 31] Most
countries either had not met OIE levels at the time of their
assessments or met the levels after 1994. However, nine countries,
including six with BSE,[Footnote 32] had started or planned to start
targeting cattle that die on farms in their surveillance
testing.[Footnote 33] In their assessments of the United States and the
other countries, the scientific experts most often recommended that
countries improve surveillance largely by including tests of high-risk
populations, such as animals that die on farms.
* Cattle feeding practices (feed bans). Of the 49 countries assessed,
41 had some sort of feed ban in place; however, those bans varied on
the extent that they allowed protein from mammals in feed for cattle.
Compared to other countries with a ban, the United States and 16 others
allow at least some mammalian protein in feed for cattle. For example,
the United States and Canada allowed cattle feed to contain protein
from horses and pigs.[Footnote 34] The remaining 24 countries with a
feed ban (including 13 that have BSE) prohibit all mammalian protein in
cattle feed, although 9 allow such protein in feed for pigs and
poultry. Four of the 24 countries have more stringent bans that
prohibit mammalian protein in feed for all farm animals--a practice the
European Commission asked its member countries to adopt on a temporary
basis in 2000. In the assessments, scientific experts found that the
potential for commingling prohibited protein with cattle feed existed
in most countries. Enforcing existing feed bans was the second most
common recommendation made by the scientific experts. In October 2001,
FDA officials held a public hearing to elicit comments on, among other
things, whether the existing feed ban exemptions should be modified. As
of December 17, 2001, FDA had not announced whether it would propose
any changes to the ban.
* Use of potentially infective tissue. Most of the countries assessed
that had not found BSE-infected cattle, including the United States,
generally allowed the sale of brains and other central nervous system
tissue in human food. Nearly half of the countries with BSE prohibited
this high-risk tissue in human food, and at least three countries--the
United Kingdom, Ireland, and Switzerland--banned mechanically
recovered beef, such as that used in meat pies, that may contain
central nervous system tissue and had been linked to vCJD. However, the
Court of Auditors--the investigative agency for the European
Commission--found that efforts by European Union countries to remove
potentially high risk tissue from the human food and animal feed chains
have not been fully implemented and that the countries could not reach
agreement on what constituted high-risk tissue.[Footnote 35]
Conclusions:
BSE and vCJD are devastating, incurable, inevitably fatal diseases. If
they enter the country, they can bring dire economic consequences to
the cattle and beef industries. Therefore, forceful federal prevention
efforts are warranted to keep BSE away from U.S. shores. Nevertheless,
Customs has reported significant error rates in importer-provided
information for BSE-risk shipments, import controls over bulk mail are
weak, and inspection capacity has not kept pace with the growth in
imports. Because of these import weaknesses--and because BSE may have
entered in imports from countries that have since developed the
disease--BSE may be silently incubating somewhere in the United States.
If that is the case, then FDA's failure to enforce the feed ban may
already have placed U.S. herds and, in turn, the human food supply at
risk. FDA has no clear enforcement strategy for dealing with firms that
do not obey the feed ban, and it does not know what, if any,
enforcement actions the states may be taking. Moreover, FDA has been
using inaccurate, incomplete, and unreliable data to track and oversee
feed ban compliance.
Furthermore, if there is even a slight chance that BSE is incubating in
U.S. cattle, consumer groups believe that the American public has the
right to know when food and other consumer products may contain central
nervous system tissue that may pose a risk to the food supply. The
importance of informing consumers is heightened by concerns raised in
the Harvard study and by FDA's TSE Advisory Committee regarding the
potential public health risk posed by consuming such tissue. In
addition, although USDA has been proactive in increasing the number of
cattle brains tested, it does not test many animals that die on farms,
even though it recognizes that older animals and animals that die from
unknown causes are at higher risk for BSE.
Recommendations for Executive Action:
To better ensure that the United States is protected from the emergence
and spread of BSE, we make the following recommendations:
In order to strengthen inspections of imported products that could pose
a risk of BSE, we recommend that the Secretaries of Health and Human
Services and of Agriculture, in consultation with the Commissioner of
Customs, develop a coordinated strategy, including identifying resource
needs.
In order to strengthen oversight and enforcement of the animal feed
ban, we also recommend that the Secretary of Health and Human Services
direct the Commissioner of FDA to take the following actions:
* Develop a strategy, working with states, to ensure that the
information FDA needs to oversee compliance is collected and that all
firms subject to the feed ban are identified and inspected in a timely
fashion.
* Develop an enforcement strategy with criteria for actions to address
firms that violate the ban and time frames for reinspections to confirm
that firms have taken appropriate corrective actions.
* Track enforcement actions taken by states.
* Ensure that, as contractors modify the inspection database, they
incorporate commonly accepted data management and verification
procedures so that the inspection data can be useful as a management
and reporting tool.
In order to help consumers identify foods that may contain central
nervous system tissue, we recommend that, as USDA evaluates whether
such tissue from cattle poses a health risk, the Secretary of
Agriculture:
* consider whether some interim action, such as public service
announcements or caution labels or signs, might be appropriate to
advise consumers that certain beef cuts and beef products may contain
central nervous system tissue; and:
* better enforce the existing labeling requirement for products that
contain beef extracted using advanced meat recovery technology and
contain central nervous system tissue.
Additionally, to further help consumers identify foods and other
products that may contain central nervous system tissue, we recommend
that the Secretary of Health and Human Services consider whether the
products it regulates, including food, cosmetics, and over-the-counter
drugs, should be labeled to advise consumers that the products may
contain central nervous system tissue.
In order to strengthen the BSE surveillance program, we further
recommend that the Secretary of Agriculture increase the number of
tests from cattle that die on farms in the BSE surveillance program.
Agency Comments and Our Evaluation:
We provided HHS, USDA, and Customs with a draft of this report for
review and comment. HHS conveyed comments from FDA. FDA concurred with
our recommendations and said the report highlighted some key areas
where U.S. efforts to prevent BSE could be bolstered. FDA agreed that
further improvements in compliance with the feed ban would reduce the
risk of introducing and spreading BSE in the United States. However,
FDA did not agree that it had misled Congress and the public in
reporting on compliance. It is true, as FDA pointed out, that its June
22, 2001, transmittal of compliance information to the Chairman of the
House Committee on Energy and Commerce "made an effort to identify the
fact that there were reporting problems, including incomplete data,
i.e., blanks." However, we do not believe that caveat conveyed the
extent to which the information could be inaccurate. In fact,
noncompliance could be much higher than FDA reported, because FDA
treated all firms with blanks on compliance questions as if they were
in compliance, even though some of those records contained inspector
comments stating that the firms were not in compliance. FDA's
transmittal to the Chairman did not disclose this. Therefore, we
believe our report is correct in characterizing FDA's data as
misleading. FDA also disagreed with our conclusion that it had not
placed a high priority on oversight of the feed ban. However,
throughout our review, FDA repeatedly pointed out that one individual,
along with that individual's other responsibilities, designed the feed
ban program, the inspection form, and the database to monitor
inspections and, until January 2001, made all decisions regarding
enforcement actions. FDA's comments and our detailed responses are
presented in appendix II.
USDA largely agreed with our recommendations and said that it will
address them as it seeks public comment on any proposed regulatory
changes. USDA stated that a portion of the funding it received to
bolster USDA's homeland security efforts in the January 10, 2002,
Defense Appropriations legislation will be used to increase BSE
surveillance. It plans to more than double the number of animals
sampled and to obtain more samples from animals that die on farms. USDA
also acknowledged its support for providing consumers with information
on product contents and for an open process that allows consumers to
make choices. However, USDA stated that labeling and warning statements
should be reserved for known hazards, which BSE is not in the United
States. In light of the experiences in Japan and other countries that
were thought to be BSE free, we believe that it would be prudent for
USDA to consider taking some action to inform consumers when products
may contain central nervous system or other tissue that could pose a
risk if taken from a BSE-infected animal. This effort would allow
American consumers to make more informed choices about the products
they consume. USDA's comments and our detailed responses are presented
in appendix III.
Customs concurred with the report and the recommendations as they
related to Customs. Its letter is presented in appendix IV. USDA and
FDA also made technical clarifications, which we incorporated as
appropriate.
As agreed with your office, unless you publicly announce its contents
earlier, we plan no further distribution of this report until 30 days
from the date of this letter. At that time, we will send copies to the
Secretaries of Agriculture and HHS, the Commissioner of Customs, and
other interested parties. We will make copies available to others upon
request.
If you have any questions about this report, please contact me or Erin
Lansburgh at (202) 512-3841. Key contributors to this report are listed
in appendix V.
Lawrence J. Dyckman
Director, Natural Resources and Environment:
Signed by Lawrence J. Dyckman:
[End of section]
Appendix I: Scope and Methodology:
To address the effectiveness of federal efforts to prevent BSE or its
spread, we focused on oversight activities in four key areas: import
controls, compliance with feed rules, meat production, and disease
surveillance. This included analysis of import data for calendar years
1980 through 2000 maintained by the U.S. Department of Commerce, the
Treasury Department, and the International Trade Commission; analysis
of FDA data on inspections for compliance with the feed ban for fiscal
years 1997 through 2001; and review of USDA slaughter and meat
processing procedures and BSE surveillance documents. To assess the
effectiveness of compliance with the animal feed ban, we obtained and
analyzed FDA's feed inspection database to determine the accuracy,
completeness, and reasonableness of key data elements, and timeliness
of data entry. We interviewed FDA and feed industry officials and
reviewed various FDA documents, including BSE inspection forms,
assignment memorandums for conducting BSE inspections, and listings of
firms that were out of compliance and firms that received FDA warning
letters. In addition, we reviewed FDA contract information for
evaluating the existing data in the BSE inspection database and for
cleaning up the data and incorporating it into the agency's main
database. We did not independently verify the accuracy of trade data
maintained by the International Trade Commission or inspection data
maintained by FDA. We also visited two large ports of entry to observe
procedures to screen shipments for BSE-risk products, one state to
observe feed ban inspections, and another state to observe slaughter
and advanced meat recovery operations.
To assess the potential health risks and economic impacts of a BSE
outbreak in the United States, we met or spoke with federal and state
officials, as well as academic experts, industry representatives, and
consumer groups, and we reviewed scientific literature. Specifically,
we interviewed USDA officials responsible for oversight of imported
animals and products, meat, animal disease surveillance, and
agricultural statistics; FDA officials responsible for oversight of the
feed ban, vaccines and blood, food regulated by FDA, dietary
supplements, and imported products; officials at the U.S. Customs
Service, International Trade Commission, United States Trade
Representative, Department of State, Centers for Disease Control and
Prevention, and National Institutes of Health. In addition, we attended
public meetings on BSE-related topics sponsored by FDA, HHS, and the
American Meat Institute. We also discussed risks and impacts with
representatives from the National Association of State Departments of
Agriculture, American Association of Feed Control Officials, Center for
Science and the Public Interest, Public Citizen, American Feed Industry
Association, American Meat Institute, National Cattlemen's Beef
Association, National Grain and Feed Association, National Milk
Producers Federation, National Renderers Association, Inc., and the Pet
Food Institute. We interviewed officials at the Harvard Center for Risk
Analysis and reviewed their report, Evaluation of the Potential for
Bovine Spongiform Encephalopathy in the United States, issued in
November 2001.
To compare federal efforts to those taken by other countries, we
reviewed BSE risk assessments of 49 countries, including most major
U.S. trading partners, prepared by the European Commission's Scientific
Steering Committee. We compared the U.S. prevention efforts with those
of countries that have not reported a case of BSE and with countries in
which existing prevention measures did not prevent the emergence of
BSE. We also reviewed evaluations of BSE prevention programs in member
states of the European Union conducted by the European Commission's
Food and Veterinary Office and the European Communities' Court of
Auditors. We conducted our study from April through December 2001 in
accordance with generally accepted government auditing standards.
[End of section]
Appendix II: Comments from the Department of Health and Human Services:
Note: GAO comments supplementing those in the report text appear at the
end of this appendix.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service:
Food and Drug Administration:
Rockville MD 20857:
January 9, 2002:
Mr. Lawrence J. Dyckman:
Director, Resources, Community, and Economic Development Division
United States General Accounting Office
441 G Street, NW:
Washington, DC 20548:
Dear Mr. Dyckman:
Please find the enclosed comments from the Food and Drug Administration
on the GAO draft report entitled, Mad Cow Disease: Improvements in the
Animal Feed Ban and Other Regulatory Areas Would Strengthen U.S.
Prevention Efforts (GAO-02-183).
The Agency also provided extensive technical comments directly to your
staff.
The Agency appreciates the opportunity to comment on this draft report
before its publication.
Sincerely,
Signed by:
Bernard A. Schwetz, D.V.M., Ph.D.
Acting Principal Deputy Commissioner:
Enclosure:
FOOD AND DRUG ADMINISTRATION COMMENTS ON THE GENERAL ACCOUNTING OFFICE
DRAFT REPORT ENTITLED, MAD COW DISEASE: IMPROVEMENTS IN THE FEED BAN
AND OTHER REGULATORY AREAS WOULD STRENGTHEN U.S. PREVENTION EFFORTS
(GAO-02-183):
The Food and Drug Administration (FDA) welcomes the General Accounting
Office's (GAO) draft report on Mad Cow Disease, also referred to as
Bovine Spongiform Encephalopathy (BSE), and appreciates the opportunity
to review and provide comments. In addition to FDA's response to GAO's
specific recommendations, we have some general comments regarding the
draft report.
GENERAL COMMENTS:
The overall report highlights some of the key areas where U.S. efforts
to prevent BSE could be bolstered. One such area highlighted is the
enforcement by FDA of its mammalian protein feed ban (21 CFR 589.2000).
While GAO states that federal actions alone cannot provide total
assurance to prevent a BSE outbreak in the U.S., the findings of the
Harvard Risk Assessment suggest that the levels of the feed ban
compliance used in that model, along with the other federal BSE
initiatives, is an effective measure in reducing risk. We agree that,
as both the Harvard and the GAO reports indicate, further improvements
in compliance with the feed ban will further strengthen BSE prevention
efforts in the U.S. and will make the present small risk of
introduction and spread even smaller.
GAO's report asserts that the United States has a more permissive feed
ban than other countries--one that allows cattle feed to contain
proteins from horses and pigs. When the feed ban rule was promulgated
in 1997, FDA realized that U.S. risk factors were not equivalent to
those of many European countries. If the U.S. had similar risk factors
to these countries, mainly importation of similar quantities of
potentially infective meat and bone meal (MBM) and cattle, or confirmed
domestic cases of BSE, then it would follow that the U.S. should have a
comparable feed ban. It should be remembered that the European
temporary total ban was intended to address problems of cross-
contamination in an environment in which BSE was know to exist or be
highly likely to exist. The total ban was not directly related to a
concern about infectivity from porcine or equine origin MBM, or from
feeding MBM to non-ruminants. In October 2001, FDA sponsored a public
hearing in Kansas City on the feed ban to have the opportunity to
discuss with various stakeholders whether changes in the feed ban rule
are needed and the evidence to support any such changes. The agency is
currently evaluating the written and oral comments from that public
meeting.
FDA does not believe Congress or the public was misled when FDA
provided compliance information to the Congress and when information
was published electronically as GAO indicates in the report. In FDA's
June 22, 2001, response to Chairman Tauzin, we stated that, "Although
FDA provided training in completion of the checklist, some reporting
problems have been noted - including failure, in some cases, to
complete all appropriate questions." FDA clearly made an effort to
identify the fact that there were reporting problems, including
incomplete data, i.e., blanks. FDA believes we were forthright in
notifying the Congressional Committee that incomplete data was an issue
in some cases, and, therefore, we do not think that the term
"misleading" is a fair characterization in regards to reporting to
Congress. As the GAO report acknowledges, FDA recognized the need for
significant improvements in its data collection systems for enforcement
of the feed ban rule, initiated those improvements, and is in the
process of implementing them. We discuss further details of these
systems improvements in responses to specific recommendations of this
report.
FDA does not agree with GAO's conclusion that FDA has not placed a high
priority on oversight of the feed ban. FDA began implementing the feed
ban in FY 1998, and this task included training field personnel,
educating the industry, and coordinating with states on inspections.
This required nearly a whole new infrastructure from that which was
previously in place to conduct inspections of manufacturers
engaged in the production of medicated animal feeds. No additional
resources accompanied the development of the animal feed ban regulation
to support the infrastructure to put such a feed ban in place. FDA had
to divert significant resources from other enforcement programs and
activities implement the feed rule and to evaluated whether additional
protections are necessary.
GAO states that one person in FDA's Center for Veterinary Medicine
(CVM) had responsibility for feed ban management. In actuality, FDA had
a number of people involved in the development and management of the
database, overseeing data entry, and preparing reports from the
database. Compliance staff members were and still are available to
answer questions from FDA, state, and industry, as well as
congressional inquiries, and assist in compliance decisions. During FY
1998, CVM reprogrammed one-third of its field inspection resources so
it could determine the extent of compliance with the feed rule. FDA had
additional personnel providing scientific support and input into
inspectional and compliance decisions.
GAO RECOMMENDATIONS FOR EXECUTIVE ACTIONS:
In order to strengthen inspections of imported products that could pose
a risk of BSE, we recommend that the Secretaries of Health and Human
Services and of Agriculture, in conjunction with the Commissioner of
Customs, develop a coordinated strategy, including identifying resource
needs.
FDA Comment:
FDA agrees with GAO's recommendations, and has recognized the need for
close cooperation with both the USDA agencies and the U.S. Customs
Service in order to prevent the importation of products posing the risk
of BSE. FDA's Import Program is the primary tool the Agency has to
"control imports" of products potentially infected with or at high risk
of infection with the agent associated with BSE (i.e., products
"potentially tainted with mad cow disease"). On the issue of protecting
the U.S. from BSE, FDA and the U.S. Department of Agriculture's (USDA)
Animal and Plant Health Inspection Service (APHIS) work together in
close cooperation with the U.S. Customs Service (Customs), the Federal
agency with primary responsibility for administering U.S. laws relating
to imports. There currently exists working groups and a senior
executive interagency steering committee on BSE that includes all three
organizations. FDA is a participating agency on all of these groups,
and, in fact, chairs the Senior Executive Interagency Steering
Committee. A major goal of these groups is to ensure that imports of
products potentially contaminated with the agent associated with BSE do
not get into the U.S. Following is a brief overview of these groups and
specific information on cooperation on imports.
An Interagency Steering Committee of senior officials assures ongoing
coordination between agencies, especially in three main areas:
integrated contingency planning in case BSE or variant Creutzfeldt-
Jakob Disease (vCJD) disease is found in the U.S, identification of and
response to potential vulnerabilities in the U.S. to BSE and vCJD, and
coordination of risk communication plans by the various agencies.
Organizations represented are: the Department of Health and Human
Service's Assistant Secretary for Science Policy, FDA, the Centers for
Disease Control and Prevention (CDC), the National Institutes of Health
(NIH), USDA's APHIS, Foreign Agricultural Service, and Food Safety and
Inspection Service (FSIS), White House Office of Science & Technology
Policy, U.S. Trade Representative, Customs, Department of State,
Department of Defense (DOD), National Association of State Departments
of Agriculture, and the Association of American Feed Control Officials.
An interagency working group on BSE started in 1996 with USDA's APHIS,
FSIS and Agricultural Research Service (ARS), FDA, NIH, CDC, and DOD
represented. The purpose of the group is to share information, evaluate
ideas and issues, and take suggestions back to participating agencies.
Although import issues have long been addressed in the interagency
working group and agencies have coordinated
actions on import issues, to further strengthen coordination of import
issues, an import subgroup to the interagency workgroup was formed to
investigate and make recommendations relating to import issues. This
import subgroup, consisting of representatives from APHIS, FDA and
Customs has been meeting since January 2001, to enhance joint
procedures to prevent the importation of BSE material into the U.S.
FDA, APHIS, and Customs have coordinated their response to the
potential importation of BSE-related products. After APHIS issued their
prohibition on the importation of BSE materials on December 7, 2000,
FDA issued Import Bulletin 71B-02 requesting that FDA's field offices
notify their local APHIS offices of any import suspected of containing
BSE material.
FDA continues to coordinate activities among U.S. Customs, USDA/APHIS
and FDA, and is leading the efforts for developing procedures for
multi-agency operations. FDA has provided FDA product codes (those used
in OASIS entry screening) to APHIS for their review, and has
facilitated APHIS review of Customs HTS codes (used in Customs entry
screening) which resulted in Customs issuing a directive to Customs
field personnel on January 4, 2000, identifying specific HTS codes for
products subject to the APHIS prohibition.
APHIS prohibition of BSE risk products of animal origin is currently
the first line of defense to prevent such products from entering the
U.S. FDA will continue to review entries of FDA-regulated products that
consist of, or may contain, such products and ensure that APHIS has
been notified of and has denied entry of such products as appropriate.
FDA is continuing to review the admissibility of FDA-regulated products
that could pose a BSE-related risk. This tri-agency cooperative effort
has led to a multi-layered review process whereby each agency utilizes
the strengths of their particular entry procedures to produce a
composite system which is considerably more robust than any of the
component.
1) Prior to vessel arrival, USDA examines vessel manifests for products
identified as being of animal origin and takes appropriate action,
based on the origin and the presence of USDA certificates (if any.):
2) When the entry is presented to U.S. Customs, the HTS code is screened
against the list of potential products provided by USDA, and any
suspect products are referred to USDA.
3) Entries subject to FDA regulation are then screened by FDA's entry
review system (OASIS) and subsequent review of importers and brokers
documents (if necessary.) Any products suspected of containing animal
ingredients from a BSE country are referred to USDA for regulatory
follow-up. FDA and USDA have developed a "fax-back" system to rapidly
exchange entry information to facilitate this review.
On November 14, 2001, FDA hosted a satellite broadcast between FDA,
USDA, and U.S. Customs to review this multi-layered system and assess
its effectiveness. Participants included both headquarters and field
personnel. Additional broadcasts will occur as deemed necessary. In
addition FDA, USDA, and Customs staff remain in regular communication
regarding current developments and emerging BSE risks. FDA is currently
developing an import sampling assignment for FDA regulated products to
make sure they are in compliance with 21 CFR 589.2000. This assignment
is being coordinated with the USDA. We will continue development of a
coordinated strategy with USDA and Customs to strengthen controls over
imported products.
Recommendation to develop a strategy, working with states, to ensure
that the information FDA needs to oversee compliance is collected and
that all firms subject to the feed ban are identified and inspected in
a timely fashion.
FDA Comment:
FDA agrees with GAO that the development, coordination, and constant
improvement of a strategy for the oversight of state inspection
activities is critical to the Agency's successful enforcement of 21
C.F.R. 589.2000, and has made extensive progress in implementing this
recommendation. Even before issuing the regulations in 1997, FDA
recognized that the states would play a significant role in
inspections. FDA adopted this compliance strategy because the states
know where these facilities are, have legal authority to gain access to
them, and have enforcement tools that allow immediate control over
violative product.
This strategic alliance with our state partners has produced major
successes in terms of the inspectional coverage of those facilities
covered by 21 C.F.R. 589.2000, with approximately 80% of the over
12,000 inspections conducted by state personnel. One issue raised in
the report is the number of firms that are subject to the FDA
regulation that have not yet been identified and inspected. The number
of 6,000 to 8,000 unlicensed feed mills used by the agency in its
compliance updates was an estimate developed in 1997 by consulting with
a number of trade, industry and state officials and it encompasses a
broad target of potential firms that may be in business. Since 1997,
the feed industry has undergone an intensive consolidation. While there
remains no definitive inventory of unlicensed establishments and there
is no statutory registration requirement, the best estimate of the
number of unlicensed firms on a national basis, is the existing
inventory of firms that have been inspected (4,835). However, the
agency shares the concern expressed in the report that all firms
subject to this regulation should be inspected and in compliance with
the requirements. Therefore, the agency has incorporated into its state
contracts a requirement for each state to inventory all the firms in
the state and reconcile these firms with the FDA's official
establishment inventory of firms. Any new unlicensed feed mills
identified are to be inspected as a priority by the state.
The core ingredient to this strategy is the longstanding relationship
between the agency and the states regarding feed manufacturing and BSE
issues. The agency has steadily increased the number of states working
under contract with it since the regulation became effective. The
regulation became effective in August 1997. In 1998, 15 states entered
into a contractual agreement with the agency followed by 16 in 1999, 18
in 2000, 27 in 2001 and 34 in 2002. Part of this contractual agreement
includes using the Agency's designated information collection forms and
includes requirements for timeliness for data submissions.
In addition, to the states with contracts, the agency has developed
partnership agreements to conduct inspections relating to the BSE
regulations. Nine states entered into partnership agreements in 1998,
12 in 1999, 11 in 2000, 10 in 2001 and 9 in 2002. The partnership
agreements generally provide similar data quality and timeliness as
with contracts, however, the agency has preferred contracts since they
provide the most effective means to oversee the quality and
effectiveness of state inspections. FDA personnel conduct inspections
in states that are not covered by either a contract or partnership
agreement.
The agency works very closely with the states to coordinate their
respective activities in regard to BSE inspections. This includes
providing training, conducting joint inspections, work planning,
sharing of inspection findings, coordination of recall and enforcement
actions and auditing. The agency conducts a 50-state conference call on
a quarterly basis that includes updates on BSE activities. In July 2001
and again in October 2001 specific FDA-State BSE meetings were
conducted to discuss inspection and enforcement strategy. These
meetings are continuing on a quarterly basis with the next meeting
scheduled for February 19, 2002. The agency works closely with the
American Association of Feed Control Officials (AAFCO) and the National
Association of State Departments of Agriculture (NASDA) on BSE issues.
FDA is represented on the AAFCO BSE task force and regularly consults
with its state counterparts.
Recommendation to develop an enforcement strategy with criteria for
actions to address firms that violate the ban and time frames for
reinspections to confirm that firms have taken appropriate corrective
actions.
FDA Comment:
FDA agrees with the need for a comprehensive enforcement strategy for
BSE. FDA made enforcement guidance available on its web-site since
1998, issued specific guidance regarding inspectional assignments in
2001, and FDA's Office of Enforcement provided still more guidance to
the field in early 2001. It should be noted that the agency does not
have a unique enforcement strategy for every regulatory program.
Generally, guidance contained in the Investigators Operations Manual
(IOM) and the Regulatory Procedures Manual (RPM), along with procedures
in place for ad hoc case review, are used to determine the hierarchy of
enforcement action, the criteria for actions to be taken, the
timeframes for firms to correct violations, and the timeframes for
follow up inspections to confirm that violations have been corrected.
However, because of the significance of ensuring industry's compliance
with the BSE regulations, FDA is developing a BSE enforcement strategy
that will be incorporated into a comprehensive BSE compliance program,
the Feed Manufacturing Compliance Program. The compliance program,
which is currently being drafted and is anticipated to be released in
this fiscal year, will add additional detail for inspections, reporting
and enforcement.
From a historical perspective, it should be noted that the 1998
strategy focused initially on education and attempted to establish a
cooperative approach to implementing 21 C.F.R. 589.2000. In fact, the
database, mentioned throughout this report, was not developed as a
compliance tool but was developed to guide the agency's efforts to
evaluate effected firms knowledge of the feed ban. However, as BSE
began to spread throughout Europe, the database began to assume more
functionality as a source of information about general compliance with
the feed rule. Thus, both our own evaluations of our efforts to date
coupled with the increasing demand for data caused us to make some mid-
course changes to the database. In FY 2001, as part of a contingency
fund request, we asked for additional resources both for database
improvements and more expansive inspectional coverage. In addition, in
FY 2002 we requested and received a substantial amount of resources to
help us further improve our systems and inspectional and enforcement
actions.
The agency however, has progressively increased its enforcement
approach starting with the January 2001 assignment to the field that
provided direct reference authority for issuance of warning letters.
This increased emphasis on enforcement not only included giving the
field authority to issue warning letters without prior approval from
headquarters, but also advised the field to begin using seizures,
injunctions and prosecutions to assure industry's compliance with the
21 C.F.R. 589.2000.
The agency's current position is that the federal feed ban regulation
has now been in effect for more than four years. FDA and its state feed
regulatory counterparts have conducted inspections of all known
renderers, protein blenders, and feed manufacturers in the U.S., as
well as a number of ruminant feeders. These inspections, which were
conducted to ensure industry's understanding and compliance with the
regulations, have led to recalls of more than 200 adulterated or
misbranded products. The regulated industry should now be fully aware
of the regulation, its requirements, and the need to comply with the
regulation. The agency will continue to work with industry to enhance
its understanding of the agency's policies and efforts to prevent the
spread of BSE to the United States. The agency is responsible for
ensuring industry's adherence to the regulation; and we are committed
to using enforcement actions, if necessary, to meet this goal.
Recommendation to track enforcement actions taken by states.
FDA Comment:
FDA thanks the GAO for this recommendation. FDA needs to more fully
evaluate the impact of this recommendation. FDA does not have the
authority to require that all states track and report to FDA
enforcement actions taken. Currently, state laws differ on what
inspection and enforcement authorities each state has and the ability
of each state to provide such information to FDA. We do strongly
support the concept of voluntarily sharing inspection and enforcement
actions taken by FDA and our state partners. This was one of the
primary motivators for our quarterly FDA-State regulator BSE meetings
to provide a forum to share such potentially confidential information.
Recommendation that, as contractors modify the inspection database,
they incorporate commonly accepted data management and verification
procedures so that the inspection data can be useful as a management
and reporting tool.
The agency agrees with this recommendation and has issued a statement
of work for the contractor, Booz-Allen and Hamilton Inc., that
incorporates accepted data management and verification procedures into
the inspection database. The origins of this initiative started in May
2001 when the Acting Principal Deputy Commissioner of FDA tasked FDA's
Director, CVM, and the Associate Commissioner for Regulatory Affairs to
develop solutions to upgrade the database to enhance its ability to
collect, analyze, and report out data in regard to inspections for
compliance with 21 CFR 589.2000. A number of workgroups were tasked
with developing short-term solutions to improve data quality and
timeliness in regard to BSE inspections as well as to propose longer
term solutions to incorporate existing data into existing agency
compliance data systems. These workgroups began meetings in May 2001 on
a biweekly basis and have completed their short-term assignment. FDA
anticipates implementation of the longer-term integration with user
acceptance testing of the new system in mid-February and production
implementation in early March 2002. Specific short-term accomplishments
included the designation of BSE coordinators in each district office to
track and review inspection reports submitted by state or federal
investigators for accuracy and completeness, incorporation of specific
instructions for completion of the checklist, defining terminology to
improve comprehension of the inspection form, revising and updating the
questions to improve ease of completion, and reinforcing the need for
quality control of all BSE data. These short-term accomplishments were
completed in September 2001. Longer-term accomplishments included
incorporating the existing database of checklist information into the
existing Field Accomplishment Compliance Tracking System (FACTS) that
includes unique identifiers for each firm. The new process incorporates
edit checks to help ensure that data entered is complete and valid. The
longer term objectives included:
* Providing the FDA with a centralized repository of BSE firms in
support of its activities pertaining to ruminant feed regulations.
* Supporting the FDA in identifying firms under high-risk categories and
by compliance program such as BSE for which a firm may be regulated and
inspected.
* Providing FDA with an integrated and centralized repository of BSE
related data including inspection checklists, inspection results,
sample collections and compliance activities against non-compliant
firms.
* Avoiding duplication of efforts in the tracking of BSE firms in
different data systems.
The requirements of the system are described below:
BSE FUNCTIONAL REQUIREMENTS:
* BSE FIRMS REQUIREMENTS:
The following Table 3-1 describes the requirements for tracking BSE
firms in FACTS.
Table 3-1: BSE Firms Requirements:
1) Requirement Description: The system shall allow OEI Coordinators
and Investigators to identify firms that are subject to BSE
inspections.
2) Requirement Description: The system shall allow a firm to be
identified with multiple associations of Compliance Programs for which
the firm may be inspected such as BSE, Prescription Drug User Fee Act
(PDUFA) , High Risk for HAACP, etc. In addition, firms may be
identified by their level of risk.
3) Requirement Description: The system shall allow users to query BSE
firms based on their inspection violations such as NAI, VAI, and OAI,
their State and Home District.
4) Requirement Description: The system shall display summary
information of the firms identified in the query results. Information
shall include FEI, firm name, address, inspection status, etc.
5) Requirement Description: The system shall provide and display the
counter hits of the query and the date the query is performed.
6) Requirement Description: The system shall provide a link to the
Inspection Results for the firm highlighted on the summary list.
7) Requirement Description: The system shall allow query results for
BSE firms to be generated through an output file or printed report.
8) Requirement Description: The system shall provide access to the CVM
Information Technology team for querying and viewing BSE firms in
FACTS.
[End of table]
BSE INSPECTION CHECKLIST REQUIREMENTS:
The following Table 3-2 describes the requirements for tracking BSE
Inspection Checklist data in FACTS. Table 3-2: BSE Inspection
Checklist Requirements:
1) Requirement Description: The system shall allow Investigators and
BSE District Coordinators to enter, update, search and view BSE
Inspection Checklist data.
2) Requirement Description: The system shall allow BSE Inspection
Checklist data be entered only for inspections performed under BSE
PACs.
3) Requirement Description: The system shall allow users to enter
information into FACTS from the hardcopy BSE Checklist form for
inspections performed by State investigators.
4) Requirement Description: The system shall link the firm inspection
results to the BSE Inspection Checklist data. BSE Inspection Checklist
data shall be accessible from the Inspections Results screen for a
given firm and inspection date.
5) Requirement Description: The system shall allow users entering BSE
inspections results to update the firm name and address information,
and operational status of the firm such as 'Inactive' and 'Out of
Business'.
6) Requirement Description: The system shall allow users to identify
multiple BSE firm types such as Renderer, Feeder of Ruminant, FDA
Licensed Feed Mill, On Farm Feed Mixers, etc.
7) Requirement Description: The system shall automatically flag the
firm as BSE high risk firm when an inspection is reported under a BSE
PAC and the firm was not previously identified as a BSE firm.
8) Requirement Description: The system shall not allow users to set
the Inspection Status to 'Completed' or 'Awaiting Endorsement' if
inspection was performed under a BSE PAC and BSE Inspection Checklist
data has not been entered.
9) Requirement Description: The system shall prompt and warn users if
the inspected firm is identified as high risk for BSE but no BSE PAC
has been reported under the Inspection Results when setting the
Inspection Status to 'Completed' or 'Awaiting Endorsement'.
10) Requirement Description: The system shall allow all FACTS users to
view BSE Inspection Results and the related BSE Inspection Checklist
data.
11) Requirement Description: The system shall provide access to the
CVM Information Technology team for viewing BSE inspection results and
related BSE Inspection Checklist data.
12) Requirement Description: In a future implementation, the system
shall allow State Investigators to enter BSE inspection results and
BSE Inspection Checklist data directly into FACTS through the State
Access to FACTS application (SAF) .
* BSE LEGACY DATA REQUIREMENTS:
The following Table 3-3 describes the requirements for reconciling
CVM- BSE Firms with ORA Firms data. It also describes the requirements
for transferring BSE Checklist data from the CVM Access application
into FACTS.
Table 3-3: BSE Legacy Data Requirements:
1) Requirement Description: BSE firms identified in the CVM legacy
system shall be reconciled with ORA firms and initialized as high risk
BSE firms in the ORA Firms table.
2) Requirement Description: Initial list of ORA firms to be reconciled
with CVM-BSE firms shall be identified based on inspections performed
under BSE PACs.
3) Requirement Description: CVM-BSE firms not found in the ORA Firms
inventory shall be added to the ORA Firms table as Workload
Obligation 'Yes'.
4) Requirement Description: BSE Checklist data from CVM legacy system
shall be transferred to the corresponding BSE inspection related
tables in FACTS.
5) Requirement Description: The CVM Information Technology team shall
have access to generate ad hoc reports for BSE firms and BSE
Inspection Checklist data from the FACTS Reporting database.
The following are GAO's comments on the Department of Health and Human
Services' letter dated January 9, 2002.
GAO Comments:
1. Our report acknowledged FDA's ongoing review but also notes that FDA
has not set a date to announce a decision on the exemptions. The report
also recognizes that recent research suggests the possibility of
"silent" incubation in species not previously thought susceptible to
TSEs. This research argues against waiting until BSE is found to
strengthen measures shown to prevent the spread of the disease. As FDA
notes, other countries strengthened their feed bans due to concerns
about commingling prohibited and non-prohibited proteins. Such
commingling is a common area of noncompliance in the United States.
2. As FDA points out, its June 22, 2001, transmittal of compliance
information to the Chairman of the House Committee on Energy and
Commerce "made an effort to identify the fact that there were reporting
problems, including incomplete data, i.e., blanks." However, we do not
believe that this caveat conveyed the extent to which the information
could be inaccurate. In fact, noncompliance could be much higher than
FDA reported, because FDA treated all firms with blanks on compliance
questions as if they were in compliance. We found that over 700
inspection records for firms that handled prohibited proteins had
blanks on compliance questions. In its response to the Chairman, FDA
did not disclose that some of those records contained inspector
comments stating that the firms were not in compliance. Nor did FDA
disclose that, at the time it responded to the Chairman, it was aware
of the need for "significant improvements in its data collection system
for enforcing the feed ban." As a result, we believe the data were
misleading.
3. We believe that the nature and severity of the problems we found in
FDA's management, oversight, and enforcement of the feed ban point to
insufficient attention by FDA management. Moreover, the fact that FDA
gave all headquarters responsibility to one individual--as an add-on to
that individual's other duties--is further evidence of the relatively
low priority FDA gave to its regulatory responsibility.
4. Although FDA's field inspectors and state inspectors carried out the
inspections, FDA headquarters tracked overall compliance with the feed
ban and brought together data on FDA field and state compliance
inspections. In meetings with FDA officials, we were repeatedly told
that a single person had designed the program and the database to
monitor inspections and, until January 2001, made all enforcement
decisions. While administrative and other support may have been
available for this person, the overall design and direction of feed ban
implementation rested with this individual. Moreover, because FDA had
no other information system, the database that individual developed was
FDA's only mechanism to monitor the program and track feed ban
compliance.
5. Although FDA cites a number of high-level interagency policy and
technical initiatives aimed at ensuring that BSE-risk products do not
enter the United States, our recommendation is grounded in problems we
found at the operational level. First, the high error rates in
importer-provided information found by Customs are unacceptable.
Second, the ever-increasing volume of imported shipments strains
inspection resources at both USDA and FDA. Third, we observed or were
told by federal field personnel about problems affecting USDA and FDA
staff responsible for reviewing import documentation and conducting
inspections of shipments. FDA staff told us that they need integrated
information technologies, dedicated inspection facilities, and
additional staff to effectively address their workload.
6. We do not agree that FDA has made extensive progress implementing
our recommendation, based on the fact that it periodically meets with
states on BSE-related issues and has increased the number of states
under contracts to conduct inspections. With regard to its progress in
identifying the universe of firms subject to the ban, our work shows
that FDA's efforts have not been successful. In reports, FDA states
that the number of on-farm feed mills, feed blenders, and feed haulers
is still unknown. FDA also asserts that the feed industry has undergone
extensive consolidation, but it has not reconciled the number of firms
inspected with industry or state estimates. Although FDA asserts it has
incorporated into state contracts a requirement to identify firms
subject to the ban, the contracts we reviewed did not include such
provisions. Moreover, as recently as May 2001, we found that FDA was
adding to its database information on inspections conducted in 1998 by
states under contract.
7. FDA agrees on the need for a comprehensive strategy for BSE but
points out that it began an enforcement strategy in 1998. However, our
review shows that the strategy did not contain criteria and timeframes
for specific enforcement actions against firms that fail to comply with
the feed ban, as our recommendation envisions. FDA's contention that
its initial approach was to educate firms does not explain its failure
to take action against firms found out of compliance on repeated
inspections. Now that the feed ban has been in effect for more than 4
years, FDA points out that inspections have resulted in more than 200
recalls. However, those recalls consist of actions taken by 22 firms,
one of which accounted for about 150 recalls. By FDA's own estimates,
more than 300 firms are out of compliance.
8. Regardless of variations in state laws, FDA has instructed states to
provide specific information on the feed ban inspections they conduct.
We believe FDA should request these states to also include information
on enforcement actions taken as a result of those feed ban inspections.
9. While we agree that FDA has initiated efforts to increase the
integrity and usefulness of the BSE inspection data, it has not taken
the steps necessary to ensure that the inspection data are accurate and
complete and recorded in a timely manner. For example, neither the
steps listed in FDA's letter nor the terms of the contracts we reviewed
include periodic assessment of error rates or controls to help ensure
data entered are complete and accurate. Moreover, FDA's response does
not address how the data on past BSE inspections will be merged with
the Field Accomplishment Compliance Tracking System. Many of the firms
have never before been subject to FDA oversight and would not have such
control numbers to effectively merge the old and new data. Also, FDA
has not included steps to capture timeliness of inspections,
enforcement actions, and follow up, especially for past inspections.
[End of section]
Appendix III: Comments from the Department of Agriculture:
United States Department of Agriculture:
Comments on the Draft General Accounting Office Report: Mad Cow
Disease: Improvements in the Animal Feed Ban and Other Regulatory
Areas Would Strengthen U.S. Prevention Efforts:
General Comments:
USDA will address the recommendations as we seek public comment for any
proposed regulatory changes. We believe that GAO's intent in its
recommendations is to strengthen our ongoing efforts to enhance public
and animal health by innovative, science-based programs and activities.
We agree that the USDA should continue to work with other government
agencies and to target methods of adjusting our BSE prevention system
based on new scientific findings and changing world events. The USDA
has worked proactively for well over a decade to exclude BSE from the
United States, and we have been committed to continual improvement all
along the way. Our general responses to the recommendations are as
follows:
1. In order to strengthen inspections of imported products that could
pose a risk of BSE, we recommend that the Secretaries of Health and
Human Services and of Agriculture, in consultation with the
Commissioner of Customs, develop a coordinated strategy including
identifying resource needs.
Response: We agree on the importance of coordination among government
agencies and have been working closely to take a holistic approach to
resource needs associated with BSE prevention and surveillance. The
U.S. Government coordinates and plans ongoing activities and policies
regarding BSE and other TSEs through technical working groups and an
inter-agency policy planning committee.
For policy-level coordination, a strategic planning group, the Inter-
agency BSE Steering Committee, has several responsibilities, including:
* Planning ways to minimize the spread of BSE and identify potential
vulnerabilities in present policies,
* Clarifying jurisdictional issues,
* Improving communication between Federal agencies on TSE -related
matters, * Developing contingency plans and communication strategies for
the public if a case of BSE or vCJD or BSE-contaminated animal feed
were found in the United States.
Policy-level representatives participate from USDA, DHHS, Customs
Service, USTR, DOD, State Department, the Office of Management and
Budget, the White House Office of Science and Technology, the American
Association of Feed Officials, the National Association of State
Departments of Agriculture, and the National Assembly of Chief
Livestock Health Officials.
A great deal of coordination and planning also takes place at the
technical level among scientists working on BSE issues. APHIS, ARS,
CDC, Customs, DOD, FAS, FDA,
FSIS, and NIH participate together on the Inter-agency BSE Working
Group. Technical representatives from each participating agency discuss
prevention activities, new science, and changing world events and
coordinate efforts across agencies. In addition, the group holds annual
meetings with Canadian and Mexican technical experts from counterpart
agencies that cover animal health, public health, diagnostics, and
research in those countries. These annual meetings have contributed to
greater understanding and harmonization of TSE control and prevention
policies among the three countries, which is crucial given the amount
of trade taking place among the North American countries.
2. Consider whether some interim action, such as public announcements
or caution label or signs, might be appropriate to advise consumers
that certain beef cuts and beef products may contain central nervous
system (CNS) tissue.
Response: The Harvard Risk Assessment indicates that the United States
is highly resistant to the introduction and spread of the BSE agent in
United States cattle herds due to existing Federal regulatory programs.
Additional measures will be used to minimize human exposure to the BSE
agent in the unlikely event that it is introduced in the United States.
While the risk of consuming products containing the BSE agent may be
minimal in the United States, providing consumers with information on
product content indicates a transparent, open process that allows
consumers to make choices about the products they consume.
While products may contain CNS tissue, this does not mean such tissue
is infectious for BSE. Labeling and warning statements should be
reserved for known hazards.
3. In order to strengthen the BSE surveillance program, we further
recommend that the Secretary of Agriculture increase the number of
tests from cattle that die on farms in the BSE surveillance program.
Response: On January 10, 2002, President Bush signed into law the
Defense Appropriations bill, which bolstered USDA homeland security
efforts. This bill included $105 million for USDA's Animal and Plant
Health Inspection Service for pest and disease exclusion, detection and
monitoring. A portion of these funds are being expended to increase BSE
surveillance, and indeed USDA is already well on its way to the goal of
testing 12,500 cattle brains this fiscal year, up from 5,200 last year,
as recommended in the Harvard risk assessment. A focus of this
increased surveillance is to obtain more samples from animals that die
on farms.
Modern, properly equipped laboratory facilities are required to support
testing. The Secretary of Agriculture has submitted a plan to Congress
requesting funds to enhance USDA's laboratory infrastructure.
The following are GAO's comments on the Department of Agriculture's
comments received January 11, 2002.
GAO Comments:
1. While USDA states that it agrees with our recommendation, in its
discussion of policy-level coordination and strategic planning among
various agencies, USDA does not fully address the substance of our
recommendation. Our recommendation focuses on actions to strengthen the
inspection of imported products at an operational level, including
identifying resources needed to do so.
2. With regard to our recommendation to consider interim action to
advise consumers when products may contain central nervous system
tissue, USDA acknowledged its support for providing consumers with
information on product content and for an open process that allows
consumers to make choices. However, USDA stated that labeling and
warning statements should be reserved for known hazards. We believe
that it would be prudent for USDA to consider taking some action to
inform consumers when products may contain central nervous system or
other tissue that could pose a risk if taken from an infected animal,
especially in light of the experiences in Japan and other countries
that were believed to be BSE free. This would allow consumers to make
informed choices about the products they consume. Caution labels or
signs, if used, could facilitate more timely removal of products that
could pose a health risk if BSE were to appear.
3. USDA states that it is more than doubling the number of animals
sampled in its BSE surveillance program for 2002 and that it intends to
obtain more samples from animals that die on farms. USDA notes that
properly equipped laboratory facilities will be needed to support the
increased surveillance. Because of this uncertainty, we are keeping the
recommendation.
[End of section]
Appendix IV: Comments from the Customs Service:
U.S. Customs Service:
Memorandum:
DATE: January 14, 2002 FILE: AUD-1-OP CN:
MEMORANDUM FOR LAWRENCE J. DYCKMAN DIRECTOR, NATURAL RESOURCES AND
ENVIRONMENT:
FROM: Director, Office of Planning:
SUBJECT: Comments on GAO Draft Audit Report Mad Cow Disease:
Improvements in the Animal Feed Ban and Other Regulatory Areas Would
Strengthen U.S. Prevention Efforts:
Thank you for providing us with a copy of your draft report entitled
"Mad Cow Disease: Improvements in the Animal Feed Ban and Other
Regulatory Areas Would Strengthen U.S. Prevention Efforts" and the
opportunity to discuss the issues in this report.
We have reviewed this report and concur with the Customs related
recommendation.
We have determined that the information in the audit does not warrant
protection under the Freedom of Information Act.
Thank you for the opportunity to review the draft report. If you have
any questions regarding this report, please contact Ms. Cecelia Neglia
at (202) 927-9369.
Signed by William F. Riley:
[End of section]
Appendix V: GAO Contacts and Staff Acknowledgments:
GAO Contacts:
Lawrence J. Dyckman (202) 512-3841 Erin Lansburgh (202) 512-3017:
Acknowledgments:
In addition to those named above, Cheryl Williams, James Dishmon,
Stuart Ryba, Janice Turner, Jason Holliday, Barbara Johnson, Barbara
El-Osta, and Carol Herrnstadt Shulman made key contributions to this
report.
FOOTNOTES
[1] Ruminants are animals with four-chambered stomachs including, but
not limited to, cattle, buffalo, sheep, goats, deer, elk, and antelope.
[2] Independent of the Harvard study, in May 2001 the Animal Disease
Risk Assessment, Prevention, and Control Act of 2001 (P.L. 107-9)
required USDA to report on the risk to the United States from BSE, the
effectiveness of current interagency BSE prevention efforts, and
recommendations to reduce and manage the risks. USDA expects to issue
its report later this year.
[3] Evaluation of the Potential for Bovine Spongiform Encephalopathy in
the United States, Harvard Center for Risk Analysis, Harvard School of
Public Health and the Center for Computational Epidemiology, College of
Veterinary Medicine, Tuskegee University, Nov. 26, 2001.
[4] Prions are neither viruses nor bacteria and contain no genetic
material.
[5] The prion hypothesis is not universally accepted. Some scientists
believe a virus or other conventional agent, as yet undetected, gives
rise to TSEs.
[6] According to scientific experts at the European Commission, in
careful feeding experiments less than one gram of brain tissue from an
infected animal induced disease in all the recipient cattle. The
infective dose depends heavily on characteristics of the host and the
route of exposure. Consuming infected material is a less efficient
means of inducing disease than injecting the material directly into the
brain.
[7] According to FDA, millions of people in the United Kingdom may have
been exposed to BSE.
[8] This figure includes 12 probable cases where confirmation will
never be possible, according to officials in the Department of Health
in the United Kingdom.
[9] Animal-derived protein may be used in pet food and in feed for
horses, swine, other non-ruminant animals, and poultry.
[10] Plate waste is cooked meat offered for human food that is further
heat processed.
[11] R. Race, A. Raines, G.J. Raymond, B. Caughey, and B. Chesebro,
"Long-term Subclinical Carrier State Precedes Scrapie Replication and
Adaptation in a Resistant Species: Analogies to Bovine Spongiform
Encephalopathy and Variant Creutzfeldt-Jakob Disease in Humans,"
Journal of Virology, Vol. 75, No. 21 (2001), pp. 10106-12
[12] The European Union is composed of Austria, Belgium, Denmark,
Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, the
Netherlands, Portugal, Spain, Sweden, and the United Kingdom.
[13] The Scientific Steering Committee provides scientific advice to
the European Commission on matters related to consumer protection and
health, including food safety.
[14] In 1989, USDA prohibited all imports of cattle and other ruminants
from countries with BSE.
[15] Renderers recycle animals and animal tissues into, among other
things, animal feed; diseased animals, unfit for human consumption, are
routinely part of such recycling.
[16] Food Safety and Security: Fundamental Changes Needed to Ensure
Safe Food (GAO-02-47T; Oct. 10, 2001).
[17] Agricultural Inspection: Improvements Needed to Minimize Threat of
Foreign Pests and Diseases (GAO/RCED-97-102, May 1997).
[18] Nonambulatory or "downer" animals include primarily animals that
are unable to walk for various reasons ranging from broken limbs to
neurological diseases and some animals that died before slaughter.
[19] USDA also tests in its BSE surveillance program about 300 samples
each year submitted by practicing veterinarians and veterinary schools
and hospitals. Some of these samples come from cattle that displayed
neurological symptoms but tested negative for rabies, another
neurological disease.
[20] Older animals are at risk because, if infected, they have lived
long enough for disease symptoms to appear.
[21] FDA carries out feed ban inspections in 12 states and has entered
into partnership and contract arrangements with the other states to
conduct feed ban inspections.
[22] A warning letter generally represents FDA's first official
notification to a firm that FDA has found one or more products,
practices, processes, or other activities violate its regulations.
[23] Five firms also voluntarily recalled mislabeled or potentially
contaminated feed during 1999.
[24] FDA Oversight of State Food Firm Inspections: A Call for Greater
Accountability (HHS-OIG, June 2000, OEI-01-98-00400).
[25] USDA is responsible for overseeing the health of cattle and
ensuring the safety of fresh and processed beef and beef products,
while FDA is responsible for ensuring the safety of many edible
products made from cattle, including bouillon, flavorings, and dietary
supplements.
[26] For the most part, these costs represent transfer payments from
the public sector or taxpayers to farmers and other related industries.
[27] Using an input-output model of the British agricultural economy, a
study prepared by the Ministries of Agriculture, Fisheries, and Food,
commissioned by United Kingdom agricultural departments and Her
Majesty's Treasury, estimates that economic losses for the first year
of the crisis in the United Kingdom were between $1.07 and $1.4
billion. Economic Impact of BSE on the UK Economy, by DTZ Pieda
Consulting, March 1998.
[28] BSE and vCJD: Background, Evolution, and Current Concerns, Brown
et al., Emerging Infectious Diseases Journal. Vol 7, No 1, Jan-Feb
2001.
[29] FDA monitors the BSE-related safety of the blood supply and has
recommended deferring donors of blood and blood products based on
exposure to the BSE agent, for example donations from individuals who
traveled or resided in the United Kingdom for 3 or more months between
1980 and the end of 1996.
[30] In 1997 the United States restricted trade in cattle and cattle-
derived products, among other things, from most European countries,
regardless of whether the countries had BSE.
[31] The OIE recommends minimum testing levels for BSE surveillance in
countries based on the size of the adult cattle population.
[32] The six countries with BSE that have targeted testing animals that
die on farms are Switzerland, Ireland, Portugal, France, the Czech
Republic, and Slovenia.
[33] The three countries that do not have BSE that have targeted
testing animals that die on farms are Estonia, Cyprus, and Singapore.
[34] FDA allowed these exemptions either because scientific evidence
had not shown infectivity in the protein sources or because the species
involved were not known to contract BSE or other TSEs.
[35] Special Report No 14/200/1: Follow up on the Courts' Special
Report No 19/98 on BSE Together with the Commission's Replies, Sept.
30, 2001.
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TDD: (202) 512-2537:
Fax: (202) 512-6061:
To Report Fraud, Waste, and Abuse in Federal Programs:
Contact:
Web site: www.gao.gov/fraudnet/fraudnet.htm E-mail: fraudnet@gao.gov
Automated answering system: (800) 424-5454 or (202) 512-7470:
Public Affairs:
Jeff Nelligan, managing director, NelliganJ@gao.gov (202) 512-4800 U.S.
General Accounting Office, 441 G Street NW, Room 7149 Washington, D.C.
20548: