Mad Cow Disease: Improvements in the Animal Feed Ban and Other Regulatory Areas Would Strengthen U.S. Prevention Efforts
Released: 2002-02-26T00:00:00

Letter

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,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.

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 cattle and other ruminants, and on products containing cattle- and 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 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.

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. 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.

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, 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.

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. 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. 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.

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.

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.

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.

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.

Appendix II: Comments from the Department of Health and Human Services

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.

Appendix III: Comments from the Department of Agriculture

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.

Appendix V: GAO Contacts and Staff Acknowledgments

GAO Contacts

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.