Mad Cow Disease: Improvements in the Animal Feed Ban and Other Regulatory Areas Would Strengthen U.S. Prevention Efforts
Published: 2002-01-25T00:00:00

Fast Facts:

Highlights:
section_title: Why GAO Did This Study
paragraphs: 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.
section_title: What GAO Found
paragraphs: 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.

section_title: Letter
paragraphs: 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.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. 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. 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.
subsections: section_title: Background
paragraphs: 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,which causes normal molecules of the same protein in the brain to  become malformed. 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. 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.
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. As of November 2001, 112 people have had vCJD, of whom just  over 100 had died, nearly all in the United Kingdom. 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.
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. 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, 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. 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— has had its Scientific Steering Committeeconduct  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.
section_title: Weaknesses Exist in Federal BSE Prevention and Detection Efforts
paragraphs: 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.
subsections: section_title: BSE-Risk Products May Have Entered the Country before BSE Emerged in the cattle and other ruminants, and on products containing cattle- and Exporting Countries or through Gaps in Import Controls
paragraphs: 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  ruminant-derived material from those countries. Figure 3 presents a timeline of the actions taken by USDA and FDA during that period.
Figure 4 shows the countries on which the United States currently  imposes trade restrictions for BSE-risk items.
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. 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, 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.
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.
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. 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. 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.
section_title: USDA Tests Many Cattle Brains for BSE in Its Surveillance Program but Does Not Test Many from Cattle That Die on Farms
paragraphs: 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. 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. 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.
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. 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.
section_title: FDA’s Enforcement of the Feed Ban Is Limited and Inspection Data Are Flawed
paragraphs: 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, 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.
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. The first letter was issued in May 1999—21 months after  inspections began. 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. 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.
section_title: Consumers Cannot Tell Which Beef Products May Contain Central Nervous System Tissue
paragraphs: 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. 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.
section_title: The Economic Impacts of a U.S. Outbreak Could Be Severe, and the Health Risks Are Uncertain
paragraphs: 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. 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.
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. 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. Any health  implications would translate into medical treatment and related financial  and economic costs, such as lost productivity.
section_title: The United States Set Controls on Importing Animals and Met BSE Testing Goals Earlier Than Many Countries, but Its Feed Ban Is More Permissive
paragraphs: 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.
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. 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. 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, had started  or planned to start targeting cattle that die on farms in their surveillance  testing. 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. 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.
section_title: Conclusions
paragraphs: 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.
section_title: Recommendations for Executive Action
paragraphs: 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.
section_title: Agency Comments and Our Evaluation
paragraphs: 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.
section_title: Appendix I: Scope and Methodology
paragraphs: 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.
section_title: Appendix II: Comments from the Department of Health and Human Services
paragraphs: The following are GAO’s comments on the Department of Health and  Human Services’ letter dated January 9, 2002.
subsections: section_title: GAO Comments
paragraphs: 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.
section_title: Appendix III: Comments from the Department of Agriculture
paragraphs: The following are GAO’s comments on the Department of Agriculture’s  comments received January 11, 2002.
subsections: section_title: GAO Comments
paragraphs: 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.
section_title: Appendix V: GAO Contacts and Staff Acknowledgments
subsections: section_title: GAO Contacts
section_title: Acknowledgments
paragraphs: 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.