GAO says US barriers to mad cow disease are full of holes

Robert Roos

Note: This story was updated March 1, 2002, to include additional information about recent federal actions to prevent mad cow disease.

Feb 28, 2002 (CIDRAP News) Congress's General Accounting Office (GAO) concludes in a new report that the United States remains vulnerable to bovine spongiform encephalopathy (BSE), or mad cow disease, because of inadequate import barriers and weak enforcement of rules to contain any BSE-contaminated products that might reach US shores.

"The continuing absence of BSE in the United States today cannot be sufficiently ensured by current federal prevent efforts," states the report, released Feb 26. "The introduction and spread of BSE in the United States could stem from cattle and cattle-derived products 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."

The report says that about 1,000 cattle and 125 million pounds of beef entered the United States from countries that later found cases of BSE. Further, hundreds of firms have violated a ban on putting meat and bone meal in cattle feed, and the Food and Drug Administration (FDA) has done little to enforce the ban, the GAO says.

The GAO investigated the government's BSE prevention efforts at the request of Sens. Tom Harkin, D-Iowa, Richard Lugar, R-Ind., and Dick Durbin, D-Ill. Durbin promised to introduce a bill to strengthen BSE prevention efforts. "We can't have the world's most reliable food supply without an equally reliable system of regulation and oversight," Durbin said in a Feb 26 news release.

Agriculture Secretary Ann Veneman took issue with the report on several counts, saying the GAO didn't fully consider recent actions that federal agencies have taken to strengthen BSE safeguards. She also said the GAO didn't appropriately recognize a Harvard University report issued last year that determined the risk of BSE in the United States to be very low.

Eating meat from animals with BSE is considered a risk factor for variant Creutzfeldt-Jakob disease in humans. BSE prevention steps in the United States began in 1989 with a ban on the importation of live ruminants (cattle, sheep, and goats) and ruminant meat and bone meal from the United Kingdom and other countries with BSE. In 1997 the ban was extended to the rest of Europe, and the FDA banned the use of most mammalian protein in feed for ruminants the same year. In addition, the FDA and the US Department of Agriculture (USDA) screen cattle-derived, FDA-regulated products imported from countries where BSE exists, the GAO report says.

Over the past 20 years, the nation imported about 1,000 cattle, 125 million pounds of beef, and 23 million pounds of inedible meat byproducts from countries where BSE was later found, the GAO determined. Some contaminated animals or products may have entered the country because BSE's incubation period is up to 8 years, the report says.

In particular, the nation imported 242 cattle from Japan between 1993 and 1999. After Japan reported its first BSE cases in September 2001, the USDA managed to locate most of the imported cattle, but 24 animals had already gone to slaughter or rendering.

"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," the GAO says. USDA inspectors at international bulk mail facilities can spot organic matter with special x-ray scanners, but inspectors are not on duty at all times and they can screen only a fraction of the stream of incoming packages, the report states. In a 6-month period last year, 570 of 116,000 packages screened at one facility contained "at-risk beef or beef-derived products."

Risky items also can slip through federal ports of entry when shipments are inaccurately labeled or through lack of inspection, the GAO reported. For example, sampling by the US Customs Service in fiscal 1999 showed that information on beef shipments was wrong in over 21% of cases. Further, in fiscal year 2000 the FDA inspected only 1% of the 4 million imported food entries under its jurisdiction and less than 1% of the 146,000 shipments of animal drugs and feeds.

BSE prevention efforts also include USDA testing of cattle tissue. The GAO says the USDA has increased its testing program but does not test many cattle that die on farms, which are assumed to pose an increased risk because they are usually older and often die of unknown causes. Some cattle that die on farms are collected and rendered into products that include animal feed, the report says.

The GAO finds serious fault with the FDA's enforcement of the ban on mammalian protein in cattle feed. Since 1997, FDA and state personnel have conducted more than 12,000 inspections at more than 10,576 firms (eg, renderers, feed mills) and found 364 firms in violation, the report states. The FDA estimates that at least another 1,200 firms that should be subject to the ban have not been identified.

"FDA did not take prompt enforcement action to compel firms to comply with the feed ban," the GAO says. By April 2001 (when the GAO investigation began), the agency's only enforcement steps had been to issue two warning letters, though the pace picked up after that. Several firms repeatedly violated the rules but did not receive warning letters. Further, the FDA has no overall enforcement strategy that sets penalties and deadlines.

"Even if FDA were to actively enforce the federal ban, its inspection database is so severely flawed thatuntil correctedit should not be used to assess compliance," the report says. It includes a long list of problems with the database; for example, entries for about 45% of all inspections lack information to uniquely identify the firms inspected.

In other findings, the GAO concluded that the United States acted as much as 5 years earlier than other countries to bar imports of animals and animal feed ingredients from countries with BSE cases. However, the nation has a "more permissive" feed ban than other countries in that cattle feed can contain protein from horses and pigs. The FDA is currently reviewing this provision, the report notes.

The report recommends a number of steps to address the problems it describes. Among other things, it suggests that the secretary of agriculture consider using public service announcements or labels to inform consumers that certain beef cuts and products may contain central nervous system (CNS) tissue. The GAO also suggests that the FDA consider requiring labeling of regulated products, including food, cosmetics, and drugs, that contain CNS tissue.

Agriculture Secretary Veneman critiqued the GAO report in a statement released the same day (Feb 26). "The report fails to appropriately recognize the conclusions and recommendations made last year by Harvard University in its comprehensive, 3-year study on BSE," she said. "The Harvard Risk Analysis showed that the risk of BSE occurring in the Untied States is extremely low and that early government protection systems have been largely responsible for keeping BSE out of the United States and would prevent it from spreading if it ever did enter the country."

Veneman also said that despite extensive USDA comments on the draft report, "scientific and technical errors" survived in the final report. Further, the report "does not appropriately consider the additional actions that have been taken by federal agencies to strengthen BSE programs," she added.

The USDA described a number of recent actions related to BSE in a separate news release (see link below). That release says the FDA has "significantly improved" its database on firms' compliance with the animal feed rule. The improved database will be fully operational in April and will allow the FDA to track compliance more effectively, officials said. In addition, the FDA is receiving an extra $15 million for BSE prevention efforts this year, bringing the total to $19 million, and is hiring 115 people this year to help in those efforts.

The USDA also issued a set of responses to the recommendations in the GAO report. The agency rejected the idea of labeling beef and beef products that may contain CNS tissue, stating, "The presence of CNS tissue does not mean that the product is infectious for BSE. Labeling and warning statements should be reserved for known hazards."

In response to another GAO recommendation, the USDA said it is already increasing its testing of tissue samples from animals that die on farms. The agency said that the number of cattle brains tested this year will be more than double last year's total, and that "A focus of this increased surveillance is to obtain more samples from animals that die on farms."

Regarding the Harvard study of BSE risk in the United States, the GAO report says the agency did not try to validate the model or assumptions used by the Harvard researchers. However, the report says the Harvard authors acknowledged that their conclusions "could be influenced by a number of model assumptions that could not be verified with confidenceincluding assumptions about US measures to prevent the introduction and spread of BSE." The Harvard researchers also noted that compliance with the animal feed ban is the leading source of uncertainty in their assessment, the GAO report states.