Mad Cow Disease: FDA's Management of the Feed Ban Has Improved, but Oversight Weaknesses Continue to Limit Program Effectiveness
Published: 2005-02-25T00:00:00

Fast Facts:

Highlights:
section_title: Why GAO Did This Study
paragraphs: More than 5 million cattle across Europe have been killed to stop the spread of bovine spongiform encephalopathy (BSE), commonly called mad cow disease. Found in 26 countries, including Canada and the United States, BSE is believed to spread through animal feed that contains protein from BSE-infected animals. Consuming meat from infected cattle has also been linked to the deaths of about 150 people worldwide. In 1997, the Food and Drug Administration (FDA) issued a feed-ban rule prohibiting certain animal protein (prohibited material) in feed for cattle and other ruminant animals. FDA and 38 states inspect firms in the feed industry to enforce this critical firewall against BSE. In 2002, GAO reported a number of weaknesses in FDA's enforcement of the feed ban and recommended corrective actions. This report looks at FDA's efforts since 2002 to ensure industry compliance with the feed ban and protect U.S. cattle.
section_title: What GAO Found
paragraphs: FDA has made needed improvements to its management and oversight of the feed-ban rule in response to GAO's 2002 report, but program weaknesses continue to limit the effectiveness of the ban and place U.S. cattle at risk of spreading BSE. Improvements made include FDA establishing a uniform method of conducting compliance inspections and training FDA inspectors, as well as state inspectors who carry out inspections under agreements with FDA, on the new method. FDA also implemented new data-entry procedures that are designed to more reliably track feed-ban inspection results. Consequently, FDA has a better management tool for overseeing compliance with the feed-ban rule and a data system that better conforms to standard database management practices. However, various program weaknesses continue to undermine the nation's firewall against BSE. FDA acknowledges that there are more feed manufacturers and transporters, on-farm mixers, and other feed industry businesses that are subject to the feed ban than the approximately 14,800 firms inspected to date; however, it has no uniform approach for identifying additional firms. FDA has not reinspected approximately 2,800, or about 19 percent, of those businesses, in 5 or more years; several hundred are potentially high risk. FDA does not know whether those businesses now use prohibited material in their feed. FDA's feed-ban inspection guidance does not include instructions to routinely sample cattle feed to test for potentially prohibited material as part of the compliance inspection. Instead, it includes guidance for inspectors to visually examine facilities and equipment and review invoices and other documents. Feed intended for export is not required to carry a caution label "Do not feed to cattle or other ruminants," when the label would be required if the feed were sold domestically. Without that statement, feed containing prohibited material could be inadvertently or intentionally diverted back to U.S. cattle or given to foreign cattle. FDA has not always alerted USDA and states when it learned that cattle may have been given feed that contained prohibited material. This lapse has been occurring even though FDA's guidance calls for such communication. Although research suggests that cattle can get BSE from ingesting even a small amount of infected material, inspectors do not routinely inspect or review cleanout procedures for vehicles used to haul cattle feed.

section_title: Letter
paragraphs: Bovine spongiform encephalopathy (BSE), commonly known as mad cow  disease, is an always fatal neurodegenerative animal disease that has been  found in cattle in 26 countries since it was first identified in the United  Kingdom in 1986. In December 2003, the United States discovered its first  case of BSE in a cow in Washington State. The U.S. Department of  Agriculture (USDA) later determined that this cow was imported from  Canada. The agent believed to be responsible for BSE is a malformed type  of protein called a prion, found in certain tissue—particularly brain and  central nervous system tissue—of infected animals. Cattle contract BSE by  eating feed derived from the remains of BSE-infected animals. In Europe,  more than 5 million head of cattle have been killed to thwart the spread of  the disease. Scientists also generally believe that a fatal disease in  humans—knows as variant Creutzfeldt-Jacob Disease (vCJD)—is linked to  eating beef contaminated with the malformed protein. Research suggests  that vCJD is difficult for humans to contract—about 150 people have died  worldwide from vCJD. 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.
USDA is primarily responsible for detecting the disease in cattle, and the  Department of Health and Human Services’ Food and Drug Administration  (FDA) is primarily responsible for preventing its introduction and spread  through animal feed. Both agencies recognize the importance of preventing  BSE from becoming established in the United States—not only to protect  the safety of the U.S. food supply but also to protect the economic viability  of the $70 billion U.S. beef industry. With 95 million head of cattle, the  United States is the world’s largest beef producer, exporting a record 2.6  billion pounds of beef, valued at over $3.1 billion, in 2003. In January 2002,  we reported that the potential impact of even a small outbreak of BSE in  the United States could be economically devastating. Indeed, between  January and September 2004, the industry lost more than 80 percent of its  export trade, or an estimated $2 billion, following the discovery of the one  BSE-infected animal in December 2003. Although most countries stopped  importing U.S. beef for some period of time, domestic consumption did not  drop. In fact, changing dietary trends have led to increased U.S. beef  consumption in the last several years. The United States is in discussions  with its major trading partners about renewing U.S. beef imports.
To protect U.S. cattle and consumers, USDA and FDA have put in place  three primary firewalls. These include the following:   Controls over imports. Since 1989, USDA has prohibited the  importation of live cattle and certain cattle products from countries  where BSE is known to exist. In 1992, FDA began identifying medical  products and other FDA-regulated foods and products derived from  cattle from countries with BSE. USDA and FDA, in cooperation with the  Department of Homeland Security’s Customs and Border Protection,  screen shipments of such products.
Animal surveillance. Since 1990, to detect BSE, USDA has been testing  brain tissue, primarily from cattle that exhibit neurological symptoms  and adult cattle that die from unknown causes, as well as from cattle  slaughtered for meat.
Feed ban. In 1997, FDA banned the use of most proteins derived from  mammals in feed intended for cattle and other ruminants to keep  potentially infectious tissue out of cattle feed.
This report focuses on FDA’s implementation and enforcement of the  animal feed-ban rule, which many industry and consumer groups consider  the most important firewall against the introduction and spread of BSE in  the United States.
Under the feed-ban rule, FDA requires firms to (1) label feed and feed  ingredients that contain or may contain most proteins from most mammals  (referred to hereafter as prohibited material) with a cautionary statement  that reads “Do not feed to cattle or other ruminants,” (2) have procedures  to protect against commingling or cross-contamination if they handle both  prohibited and nonprohibited material for feed and feed ingredients, and  (3) maintain records so that feed and feed ingredients that contain or may  contain prohibited material can be tracked from receipt through  disposition. Firms that transport both types of materials also must have  procedures to prevent commingling.
FDA’s feed-ban rule applies to feed for cattle and other ruminants, such as  sheep and goats. The material prohibited for use in cattle feed may  continue to be used in pet food and in feed for poultry, swine, horses, and  other nonruminant animals.
The feed-ban rule designates a number of cattle- and other animal-derived  items as exempt from the ban, and hence allowable in cattle feed. These  exempt items include blood and blood products, plate waste, gelatin, and  milk and milk proteins. In addition, poultry litter (a protein source  comprised of poultry waste material, bedding, and spilled feed) is allowed  in cattle feed. FDA has published, but not taken action on, several advance  notices of proposed rulemaking for revising the ban to, among other things,  end most of the exemptions and require that feed manufacturers and other  such firms use dedicated equipment for cattle feed.
To oversee compliance with the feed ban, inspectors from FDA and the 38  states that have contracts or agreements with FDA periodically inspect  firms, using FDA guidance and an inspection form that FDA developed to  document inspection results. Since 1997, FDA and states have identified  and inspected about 14,800 firms that are subject to the feed-ban rule. The  types of firms inspected include renderers, protein blenders, feed mills,  farms that mix their own feed, feed transporters, pet food manufacturers,  and other firms subject to the feed-ban rule. In 2002, FDA began using a  risk-based priority approach to determine which firms to inspect annually.  Under this approach, FDA has designated firms that manufacture, blend,  and otherwise directly process with prohibited material as the highest risk  for potentially exposing U.S. cattle to BSE. Firms that do not process with  prohibited material are designated as lower risk. FDA had designated about  570 firms as high risk in fiscal year 2004. FDA assigns a list of high-risk  firms for inspection to each of its district offices and gives the district  offices some discretion in deciding which lower risk firms to inspect. FDA  also negotiates with states over the number of inspections that FDA will  pay for under contract. States conduct about 70 percent of feed-ban  compliance inspections. When FDA determines that firms are out of  compliance, it can issue warning letters, encourage firms to conduct  voluntary recalls, or seek court orders to seize feed or feed ingredients.  FDA district offices review inspection results for accuracy and enter  inspection information into FDA’s central data system—the Field  Accomplishments and Compliance Tracking System (FACTS)—and  periodically post inspection results on FDA’s Web site.
Our January 2002 report identified a number of weaknesses in federal BSE  prevention and detection efforts. Regarding the feed ban, we reported that  FDA had not promptly taken actions, such as issuing warning letters or  reinspecting firms that were out of compliance, to enforce the feed ban and  keep prohibited material out of cattle feed. We also reported that FDA’s  data on inspections were so severely flawed that the agency could not  know the extent of industry compliance. We made a number of  recommendations to strengthen FDA’s enforcement of the feed ban and its  oversight and monitoring of compliance inspections.
As you requested, this report examines the effectiveness of the actions  FDA has taken, since our 2002 report, to ensure industry compliance with  the animal feed ban and protect U.S. cattle from BSE. In addition, appendix  III provides a chronology of FDA’s and USDA’s actions in response to the  two cases of BSE discovered in North America in 2003.
In conducting our work, we examined in detail 404 inspection reports from  fiscal years 2003 and 2004, which we randomly selected from FDA’s 18  district offices responsible for inspections in the 50 states. We interviewed  FDA district officials in the 18 districts and observed FDA and state  investigators conduct 19 inspections in 12 states. The sites were selected to  cover a range of firm types and sizes in various geographic locations with  concentrations of cattle feeding operations, including dairy cattle. We met  with FDA headquarters’ officials responsible for procedures and actions  taken to (1) oversee and enforce the feed ban, (2) maintain the inspection  data system, and (3) propose and analyze regulatory decisions. We also  surveyed state agency officials in the 38 states that had contracts or  agreements with FDA in fiscal year 2004 regarding their inspection  programs, testing of animal feed and feed ingredients, and the training and  guidance they received from FDA. The state survey instrument and  summary of responses appear in appendix IV. Appendix I contains a  detailed description of our scope and methodology. We performed our  work from October 2003 through January 2005, in accordance with  generally accepted government auditing standards, which included an  assessment of FDA’s BSE program data reliability and internal controls.
subsections: section_title: Background
paragraphs: BSE and vCJD belong to a family of diseases known as transmissible  spongiform encephalopathies (TSE). Other TSEs include scrapie in sheep  and goats, chronic wasting disease in deer and elk, feline spongiform  encephalopathy in domestic cats, and mink encephalopathy. Currently, no  therapies or vaccines exist 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 type of  protein, called a prion, which causes normal molecules of the same type of protein in the brain to become malformed and eventually results in death.  Prions are neither viruses nor bacteria and contain no genetic material—no  deoxyribonucleic acid (DNA). Prions cannot be readily destroyed by  conventional heat, irradiation, chemical disinfection, or sterilization  procedures. TSE prions have been found to accumulate in central nervous  system tissue—specifically the brain, spinal cord, and eye—and have been  found in other body tissues, such as the tonsils and small intestines, of  animals and humans. For BSE, the precise amount of infective material  needed to cause disease is unknown, but research suggests that it is very  small. According to scientific experts in the European Commission, in  careful feeding experiments, less than 1 gram of infected brain tissue  induced disease in all the recipient cattle.
The original source of BSE is not known with certainty. However, based on  available evidence, experts generally agree 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 1986, BSE was first identified in  the United Kingdom; and in 1988, that government banned the practice of  feeding ruminant-derived protein to ruminants to thwart its spread. The  number of new cases of BSE has declined from a high in 1992 of 37,316 to a  total of 764 new cases in 2004. BSE has been found in about 189,000  animals worldwide, most of which (about 184,000) were discovered in the  United Kingdom. The remaining cases were discovered in 26 countries,  including Canada and the United States. Three nations—the United States,  Oman, and the Falkland Islands—have only detected the disease in  imported animals. The following are the number of reported cases, by  region and/or country:   Europe. United Kingdom—184,045; the rest of Europe—5,107;  North America. Canada—4; United States—1;  Asia-Pacific. Japan—14; and  South America. Falkland Islands—1.
In 1996, the United Kingdom reported the first case of the human disease,  vCJD. Scientists believe vCJD is linked to exposure to the BSE prion, most  likely through consuming beef and beef products infected with BSE.  While scientists and regulatory officials believe that millions of people in  the United Kingdom may have ingested BSE-infected tissue, many also  believe vCJD is difficult to contract. As of December 1, 2003, 153 cases of  vCJD had been reported worldwide, with 143 of these cases in the United  Kingdom. The Department of Health and Human Services’ Centers for  Disease Control and Prevention, which is responsible for surveillance of  vCJD, reported that almost all of the vCJD victims had multiple-year  exposures in the United Kingdom during the height of the outbreak of  BSE-infected cattle—between 1980 and 1996. 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.
The first indigenous case of BSE in North America was discovered in  Canada in May 2003. (Canada’s first infected cow, discovered in 1993, had  been imported from the United Kingdom.) A Canadian government  investigation concluded that the infected cow discovered in 2003 most  likely contracted the disease by consuming feed containing  BSE-contaminated ruminant material, probably before Canada imposed its  feed ban in 1997. Canadian authorities believe that BSE entered the feed  chain through slaughtered and rendered cattle imported from the United  Kingdom. In December 2003, an animal infected with BSE was discovered  in the United States. According to U.S. authorities, that animal—a dairy  cow in Washington State—had been part of a herd of 81 cattle imported  from Canada in September 2001. Appendix III describes FDA’s and USDA’s  actions in response to the 2003 discoveries. In January 2005, Canada  discovered two more cases of BSE.
Following the discovery of the infected cow in the United States, U.S. beef  exports dropped precipitously. The United States is currently engaged in  discussions with its major trade partners to reestablish beef exports. In  October 2004, Japan, previously the largest importer of U.S. beef, agreed in  principle to resume imports of certain beef products from cattle  slaughtered at 20 months or younger; as of February 11, 2005, the two  countries were working out the details of this agreement.
To detect potentially prohibited material in feed, FDA uses a test called  “feed microscopy,” which is a visual examination of a sample under a  microscope for the presence of animal tissue, such as hair and bone  particles. According to FDA officials, when performed by an experienced  analyst, the species can sometimes be identified. FDA is evaluating a more  sensitive test called “polymerase chain reaction” (PCR), which detects  animal DNA and can distinguish ruminant DNA. However, feed containing  exempt items (e.g., milk and blood proteins) derived from ruminants would  test positive for ruminant DNA using PCR.
When inspectors find violations of the feed-ban rule, FDA can issue  warning letters, and firms may conduct voluntary feed recalls. FDA has the  authority to take immediate enforcement action, including seeking a court  order to seize feed products that violate the feed ban or obtaining a  court-ordered injunction ordering a firm to cease operations. Of the 38  states we surveyed, 37 told us they have authority to take action for  violations of the feed ban. FDA directs its districts to issue warning letters  within 30 workdays—approximately 45 calendar days after the inspection.  Warning letters give firms the opportunity to voluntarily take corrective  action before FDA initiates enforcement actions.
Under the risk-based priority inspection system that FDA adopted in 2002,  FDA and states have focused inspection resources on the following types  of firms, which FDA has designated as high-risk for potentially exposing  cattle to BSE:  renderers that accept dead ruminant animals and/or the waste materials  from beef slaughter facilities;  feed mills that use prohibited material, which can include FDA-licensed  mills that handle certain new animal drugs for use in animal feeds and  nonlicensed mills that do not handle such animal drugs; and   protein blenders that use prohibited material.
Other firms subject to the feed ban include the following:  firms that manufacture only pet food;  firms that transport or distribute animal feed;  firms that salvage animal feed or pet food; and  other firms that handle animal feed, including retailers, grocery  warehouses, and specialty food companies.
In addition to inspections of high-risk firms, FDA asks states to perform a  number of inspections at the lower risk firms under their contracts or  agreements with FDA. FDA also performs inspections of some lower risk  firms. Table 1 shows the number of firms inspected during fiscal year 2004.
Our 2002 report found that  FDA was not acting promptly to compel firms to keep prohibited  materials out of cattle feed and to label animal feed that cannot be fed to  cattle;   FDA’s data on feed inspections was so severely flawed that FDA did not  know the full extent of industry compliance;  FDA had no clear enforcement strategy for firms that do not obey the  feed ban and did not know what enforcement actions states had taken;  and  FDA had been using inaccurate, incomplete, and unreliable data to track  and oversee feed-ban compliance.
A 2001 study by the Harvard Center for Risk Analysis noted that the  greatest risk of BSE exposure to cattle in the United States is through  mishandling, mislabeling, or contaminating cattle feed. The study  developed a simulation model for predicting the number of infected  animals that would result from the introduction of BSE into the United  States. Using this model, the Harvard study concluded that, if 10 cattle  infected with BSE were imported into the United States, only three new  cases of BSE would likely occur, on average, and that BSE is virtually  certain to be eliminated from the United States within 20 years following its  introduction. According to the study, any new cases of BSE would come  primarily from industry’s failure to comply with the feed ban. A subsequent  2003 Harvard reassessment—following the discovery of the BSE-infected  cow in Canada that year—arrived at a similar conclusion.
section_title: FDA Has Taken Important Steps to Improve Implementation of the Feed Ban
paragraphs: Since our January 2002 report, FDA has changed the way it collects, tracks,  and reports inspection data. In April 2002, FDA implemented a uniform  inspection form for federal and state inspectors to document inspection  results. Although FDA had an inspection form earlier, inspectors were not  always completing the required information, and several states did not use  FDA’s form.
FDA has also issued feed-ban inspection guidance and appointed BSE  coordinators in each of its district offices to review inspection forms for  completeness. The district BSE coordinators told us that FDA has trained  inspectors on using the inspection form and carrying out inspections.  Although most states reported that this training was sufficient, a few told  us that they had not received training since the late 1990s or were not able  to attend training because of state budget constraints. However, in  commenting on a draft of the report, FDA officials said that the agency  always offers to provide training to states, when requested.
Regarding the data deficiencies we reported in 2002, FDA implemented a  newly designed feed-ban database and data entry procedures in its Field  Accomplishment and Compliance Tracking System (FACTS) in April 2002.  According to our analysis, this new approach and data system are designed  to more reliably track feed-ban inspection results. As a result, FDA has a  better management tool for overseeing compliance with the feed-ban rule  and a data system that better conforms to standard database management  practices. Specifically, FDA’s new approach makes the following  improvements:  All firms have unique identifiers. Inspection records in FDA’s data  system—including those that were previously missing unique  identifiers—now have them, according to our data reliability analysis.  Before the new approach, about 45 percent of FDA’s feed inspection  records lacked information to identify individual firms. As a result, the  earlier data could not be used to reliably determine the number of firms  inspected, compliance trends over time, or the inspection history of an  individual firm. These problems should not occur with FDA’s new  system.
Information is substantially complete and accurate. FDA has  corrected information problems we had identified in our 2002 report,  according to our data reliability analysis of the inspections conducted  since April 15, 2002. The new FACTS database contains edit checks to  detect any incomplete or inaccurate data. Furthermore, FDA’s current  feed-ban inspection guidance directs district BSE coordinators or their  designees to review BSE inspection forms for completeness and  accuracy. Previously, headquarters staff had entered the data received  from district offices and did not have sufficient knowledge to detect  irregularities in the data they were entering. In addition, states that have  contracts or agreements with FDA are now using the same inspection  forms as FDA. Previously, several states used state-developed forms,  which did not always provide comparable information.
Data are more timely. Since April 15, 2002, about 95 percent of  inspections with serious violations have been entered into the FACTS  database within 45 days of the inspection date, according to our  analysis. This rate of entry is a significant improvement over the  timeliness of entry rates we reported in 2002. At that time, we found that  some inspections were entered into FDA’s database 2 or more years  after the date of inspection. For such inspections, FDA could not  accurately report on firms’ compliance with the feed ban and could not  clarify inconsistent or conflicting information, or obtain answers to  missing information—situations that FDA’s new approach should help  avoid.
As a result of these improvements, FDA is able to present more reliable  feed ban inspection information on its Web site for the approximately  10,000 firms inspected since April 15, 2002, or about two-thirds of the  approximately 14,800 firms inspected since 1997. Appendix II provides a  detailed description of actions FDA has taken on the recommendations in  our 2002 report.
section_title: Program Weaknesses Continue to Limit the Effectiveness of FDA’s Animal Feed Ban
paragraphs: While FDA has made many improvements to its oversight and enforcement  of the feed ban in response to our 2002 report recommendations, we found  a number of oversight weaknesses that limit the effectiveness of the ban  and could place U.S. cattle at risk for BSE. Specifically, we found that FDA  does not  have a uniform procedure to identify all firms subject to the feed ban,  require firms to notify FDA if they process with prohibited material,  routinely use tests to verify compliance with the feed ban,  alert USDA or states when cattle may have been fed with feed  containing prohibited material, and  adequately overseeing the procedures for cleaning vehicles that haul  cattle feed.
Furthermore, we found that cautionary statements are not required on feed  or feed ingredients intended for export that contain prohibited materials. In  addition, FDA has not been reporting BSE inspection results to Congress  and the public in a full and complete context.
subsections: section_title: FDA Does Not Have Uniform Procedures to Identify Additional Firms Subject to the Feed- Ban Rule
paragraphs: When the feed ban took effect in 1997, FDA first focused on identifying as  many firms as possible that were subject to the ban. As of September 30,  2004, FDA officials had identified approximately 14,800 firms that are  subject to the feed ban (see table 2). That is about 4,200 more firms than  the 10,576 firms FDA had identified approximately 3 years earlier. FDA  officials acknowledge that the agency has not identified all firms subject to  the feed-ban rule.
FDA has identified firms by reviewing  its list of firms that manufacture feed that contains certain new animal  drugs; FDA knew about these firms because it requires them to be  licensed and because it has certain regulatory responsibility over these  firms.  a list of the firms or individuals that USDA has identified as violating  USDA’s and FDA’s requirements with respect to chemical and drug  residues in animals slaughtered for human consumption.   lists of firms that states identified. For example, 27 of the 38 states we  surveyed register renderers, 28 register protein blenders, and 34 register  feed mills that FDA has not licensed, and provide this information to  FDA during meetings to set up annual inspection plans.  membership lists of industry associations, such as the National  Renderers Association.
In addition, FDA officials told us that FDA districts have used multiple  approaches, including looking through telephone books to identify the  names of additional firms. However, FDA has not developed a systematic  approach for identifying additional firms subject to the feed ban. For  example, FDA does not have an approach for identifying additional  nonlicensed feed mills in states that do not provide that information. FDA  also acknowledged that it has identified only a small percentage of the  thousands of transportation firms that may haul cattle feed. Moreover, in  commenting on a draft of this report, FDA told us that there are an  estimated 1 million businesses (e.g., dairy farms feedlots, and other  facilities) that feed cattle and other animals. FDA also told us that it does  not consider farms that mix their own feed or feed cattle as well as other  animals as low risk. However, FDA does not have a strategy for ensuring  that this industry sector is in compliance with the feed-ban rule.
We observed one approach for expanding the number of firms subject to  the feed ban: some FDA and state inspectors we accompanied on firm  inspections wrote down the names of the firm’s suppliers and customers  during the inspection and checked these names against FDA’s inventory of  firms to help identify additional firms. According to officials in one district  where we observed this practice, they inspect these additional firms as  resources allow. However, FDA does not have guidance for inspectors to  do this routinely, and we observed other inspectors who did not record the  names of firms’ suppliers and customers. The approach we observed was  one that may be largely applied with existing resources. Congress provided  FDA with an additional $8.3 million in the fiscal year 2005 budget, which FDA officials told us would be used, in part, to funds states’ efforts to  identify and inspect additional firms.
section_title: FDA Does Not Require Firms to Notify the Agency if They Process with Prohibited Material
paragraphs: Under FDA’s risk-based inspection system, FDA’s goal is to annually inspect  all renderers, feed mills, and protein blenders that process with prohibited  material—about 570 firms—and to inspect a number of other firms that  FDA considers lower risk. The number of other firms varies according to  the inspection resources available. As previously stated, in total, FDA and  states inspected 6,006 firms in fiscal year 2004. However, once FDA has  inspected a firm and determined that it does not process with prohibited  materials, FDA may not reinspect that firm for many years. In the interim,  FDA does not know whether the firm has changed operations and now  processes prohibited materials because it does not require firms that do so  to notify the agency. FDA and state agencies only learn of a change in  operations if they inspect the firms. Without a requirement to notify FDA,  these firms are not annually inspected to monitor for compliance with the  feed ban, as are other high-risk firms.
We found that 2,833 or about 19 percent, of these firms FDA has identified  as subject to the feed-ban rule have not been reinspected in 5 or more  years. These firms include  1,224 farms that fed ruminant animals;  846 farms that mixed their own feed;  377 feed mills; and   386 other types of firms, such as distributors and retailers.
According to FDA officials, of these four types of firms that have not been  reinspected, about 2,100 or two-thirds are farms, which FDA believes are  not likely to change their practices. However, feed mills, which account for  about 400 of the firms, would be classified as high risk if they process with  prohibited material.
FDA officials also believe that the number of firms processing with  prohibited material is declining and that in all likelihood firms that have not  been inspected for a number of years would not change their practices and  start doing so. As FDA pointed out, firms may decrease their use of  prohibited material because of the requirement that they maintain records  sufficient to track all receipt, processing, and distribution of that material.  Nonetheless, some firms that did not use prohibited material when they  were last inspected may begin to use that material in processing their feed.
FDA officials told us that they have considered options for identifying firms  that process feed with prohibited material, including requiring those firms  to be licensed. The officials noted, however, that some firms may not  comply with a notification requirement; thus, FDA would still not know  about all high-risk firms, and it would incur the additional costs of  overseeing the notification requirement.
section_title: FDA Does Not Routinely Sample Feed and Feed Ingredients during Inspections for Analysis to Verify Compliance with the Feed Ban
paragraphs: While FDA inspection procedures include guidance for reviewing firm  documents and procedures, examining their invoices, and inspecting  facilities and equipment, they do not include guidance on when samples  should be taken and tested. For example, the feed-ban inspection guidance  does not instruct inspectors to routinely sample cattle feed to verify firms’  claims that they do not use prohibited materials or exempt ingredients, or  to ensure that firms’ cleanout and flushing procedures to prevent  commingling are followed and are effective.
We recognize that the usefulness of testing is limited at firms that use  exempt items—cattle and other ruminant blood, milk proteins, poultry  litter, and plate waste—as ingredients in cattle feed. FDA officials told us  that they did not want to routinely test samples at firms during inspections  because the tests would likely have many false positives as a result of the  exemptions. Consequently, officials believed testing would not use  resources wisely.
However, in 9 of the 19 inspections we observed, inspectors could have  used tests to verify feed-ban compliance because the firms claimed they did  not use any animal-derived exempt items. Even in these instances, where  tests would be beneficial, inspectors did not sample the feed. For instance,  inspectors did not take samples to confirm the adequacy of cleanout  procedures at firms that use nondedicated production facilities to  manufacture cattle feed but do not use any exempt materials. FDA’s  feed-ban inspection guidance allows inspectors to draw samples at their  discretion, but FDA officials told us that inspectors rely on their judgment  of whether the cleanout procedures appear to be adequate and rarely use  testing to verify their assessment. FDA officials did not give us a clear  reason why they would not advise testing in situations where tests would  be useful to help confirm compliance.
Some states have also done significant testing that FDA could use to verify  compliance with the feed ban but do not provide their test results to FDA,  although that information could give FDA a more complete picture of feed  ban compliance. In response to our survey, 18 of the 38 states that have  agreements with FDA to conduct feed-ban inspections told us they had  collected and tested over 1,500 feed samples during 2003. For example,  according to a North Carolina Department of Agriculture official, the state  collected and tested 738 samples; and, according to a Kansas Department  of Agriculture official, the state collected and tested 94 samples. In these  states, if the tests find what appears to be prohibited material, the states  followed up with the firms to determine what ingredients they used.  According to the officials, no contaminated cattle feed was found. In  California, which collected and tested about 100 samples, officials found  tests to be useful for demonstrating to cattle feed manufacturers the  difficulties of cleaning equipment that has been used for prohibited  material. FDA and state agency officials told us that most California feed  firms have switched to using dedicated equipment for cattle feed. Eleven of  the 18 states share test results with FDA, but FDA does not use these  results to verify industry compliance with the feed ban.
In August 2003, FDA instructed its districts to begin testing finished feed  and feed ingredients, such as bags of feed sold at retail stores and bulk feed  sold to cattle feedlots. These tests were not taken in conjunction with  feed-ban compliance inspections. FDA inspectors took 660 samples  nationwide. The samples were submitted to FDA regional laboratories for  analysis, where analysts used feed microscopy. Although in its instructions  to districts for the collection effort, FDA called the tests “a method to  monitor for compliance with” the feed ban, FDA officials told us that the  test results could not be the sole basis for enforcement action at individual  firms because microscopic analysis cannot distinguish prohibited bone and  tissue from exempted material. Nonetheless, the officials also told us the  testing gives FDA further assurance of industry’s compliance with feed ban.
Because FDA did not use an approach that allows it to generalize the  results, the test results cannot be used as assurance of industry  compliance. In fact, because FDA did not provide instructions on how to  randomly select firms for sampling and how to take a random sample of  feed at the firms, the results cannot even help confirm compliance by the  stores, feedlots, and other firms where the samples were taken. In initiating  this effort without a sampling plan, FDA wasted its already limited  inspection resources. FDA has committed resources to collect and analyze  900 additional samples in fiscal year 2005. With the same resources, FDA  could have developed a sample design that would have allowed it to  generalize the test results to industry.
FDA officials told us the agency would have to conduct an investigation to  determine whether an enforcement action was warranted. FDA provided  us some information on test results for the 660 samples that were taken and  analyzed. The data showed 145 potential violations, including 8 that FDA’s  laboratories originally classified as serious. About one-third of the 145  samples with potential violations were of cattle feed. Several of those  samples had evidence of mammalian matter. Without more information, we  could not determine whether the cattle feed contained exempt items or  prohibited material. As of February 2005, FDA was in the process of  gathering the information we requested from its district offices on the  results of its investigation of the 145 potential violations and what, if any,  enforcement actions were taken based on the tests and follow-up  investigations. We plan to provide our analysis of FDA’s collection, testing,  and follow-up of these samples later this year.
section_title: The Cautionary Statement Is Not Required on Feed Intended for Export
paragraphs: Animal feed and feed ingredients containing prohibited material (including  material from rendered cattle) are not required to be labeled with the  cautionary statement, “Do not feed to cattle or other ruminants,” when that  material is intended for export. Shipping containers for such material,  however, must be labeled that they are for export only; and, if prohibited  material is put back into domestic commerce, the containers must be  relabeled with the cautionary statement.
Not placing the warning label on exported feed poses a potential risk to  U.S. and foreign cattle and consumers from two perspectives. First, feed  with prohibited materials could be intentionally or inadvertently redirected  into feed for U.S. cattle if firms fail to add the cautionary label to the  product that they had initially intended to export. Second, exported feed  containing prohibited material could mistakenly be fed to cattle that are  subsequently imported into the United States or whose meat and other  products are imported into the United States.
We observed one situation where a problem could occur because a  cautionary statement was not on an exported product. One firm we visited  processed fishmeal, which is normally considered a safe ingredient for  cattle feed. However, this plant processed the fishmeal on the same  equipment it used for prohibited materials. If it were sold domestically, the  fishmeal would have to be labeled with the cautionary statement because it  is potentially contaminated with prohibited materials. However, the  product was shipped to overseas customers without the cautionary  statement. Because the fishmeal was not labeled, and fishmeal would not  be expected to contain prohibited material, customers could unwittingly  mix the fishmeal with other ingredients for their cattle. The FDA inspector  did not document in the inspection report which countries were sent the  fishmeal. When we asked FDA officials about this situation, they were  concerned only about whether feed intended for export was actually being  diverted to domestic cattle, a situation that they believed was unlikely to  occur because FDA rules prohibit it. However, according to the report by  the international panel of experts on BSE convened by USDA, the United  States has an obligation to act responsibly toward its global neighbors  when exporting feed and feed ingredients.
FDA officials told us that FDA cannot require the cautionary statement on  feed intended for export without a change to the Federal Food, Drug, and  Cosmetic Act. Under that act, animal feed intended for export only cannot  be deemed to be adulterated or misbranded if it (1) meets the foreign  purchasers specifications, (2) is not in conflict with laws of the country to  which it is intended for export, (3) is labeled on the outside of the shipping  package that it is intended for export, and (4) is not sold or offered for sale  in domestic commerce.
section_title: FDA Did Not Alert USDA or State Regulatory Authorities When It Learned That Cattle Feed Containing Prohibited Material Was Marketed
paragraphs: When an FDA district office learns that ruminant animals may have been  fed contaminated feed, the feed-ban inspection guidance directs the district  office to oversee efforts to appropriately dispose of the contaminated feed  and to ensure that the animals that had consumed this feed are not  slaughtered for human food or other animal feed. The guidance also  advises FDA to consider coordination with USDA and the affected states.
While FDA districts have monitored voluntary recalls of feed that did not  comply with the feed ban, they had not been alerting USDA or state  departments of agriculture when they learned that such feed had been  given to cattle and other ruminants—in some cases for an extensive period  of time. FDA district and headquarters officials responsible for the  feed-ban program were not aware that the guidance instructed FDA to alert  USDA and states.
In our observations at inspections and our review of inspection records, we  found the following instances in which FDA did not alert USDA or state  authorities or take further action.
A producer of cattle, hogs, and goats had inadvertently fed salvaged pet  food containing prohibited materials to goats, which are ruminants. We  observed the mislabeled feed in a March 2004 inspection. The feed mill  that manufactured and sold the feed had not labeled the salvaged pet  food with the required cautionary statement “Do not feed to cattle or  other ruminants.” Shortly after this discovery, the firm recalled the  misbranded feed. In April 2004, a state feed inspector found out about  the misfed animals from the feed mill, not from FDA, and alerted his  state program managers. The state contacted FDA, and after  determining that FDA did not intend to take action beyond issuing a  warning letter, the state seized and destroyed the animals in May 2004  under state authority to prevent the meat from entering the food supply.  FDA did not alert the state or USDA and did not issue the warning letter  to the feed mill until June 2004.
A feed mill had inadvertently contaminated cattle feed with prohibited  material. The firm had made a mistake in designing and placing  equipment in the manufacturing process, which allowed spilled feed  containing prohibited material to become commingled with ingredients  used to make cattle feed. We observed this problem during an April 2004  inspection. FDA issued a warning letter in June 2004 demanding that the  firm correct the violations; the firm also conducted a voluntary recall of  the feed in June. Because the mill operated with this flawed system for  about 1 year before the discovery, potentially contaminated feed was  marketed and sold for cattle feed for that period of time. FDA did not  contact USDA or state authorities to alert them that cattle had  consumed the feed.
A feed mill did not clean mixing equipment and transportation vehicles  used for processing and transporting feed containing prohibited and  nonprohibited materials. The firm also failed to properly label feed  containing prohibited materials with the required cautionary statement  and did not maintain sufficient records for tracking the sale of cattle  feed to its customers, as FDA requires. We identified these problems  during our review of inspection reports. The inspection occurred in  March 2003. The firm corrected the violations and recalled all cattle feed  that had not yet been consumed in March 2003. FDA issued a warning  letter to the firm in May 2003 and took no further action.
When we discussed these findings with FDA headquarters officials, they  told us they were not familiar with the guidance recommending this  communication. As a result, FDA, USDA, and state authorities had not  assessed the health risk to humans and the animals that may have ingested  that feed and may not have taken sufficient action to prevent those cattle  and other ruminants from entering the human food or animal feed supply.  The FDA officials said they had not considered coordinating with USDA  and state officials but that USDA and the states were notified of the recalls  because the recalls are posted on the FDA Web site. However, we found  that the posted recall notices do not include information on whether, or for  how long, cattle or other ruminants had been given the contaminated feed.  Furthermore, FDA officials asserted that no action was needed beyond a  recall in these incidents because BSE has not been discovered in a cow  born in the United States. According to the officials, the meat would not  make people ill and the feed would not make cattle ill. Before this report  was issued, these same FDA officials told us that in the future, FDA will  alert USDA and states when cattle may have consumed prohibited feed.  USDA officials told us that they were not aware of these three incidents.
They said that, had they known, USDA would have tracked the animals and  tested them for BSE when they were slaughtered.
section_title: FDA Has Limited Assurance That Vehicles Used to Haul Cattle Feed Comply with the Feed Ban
paragraphs: According to FDA’s feed-ban rule, transportation firms that haul prohibited  material and use the vehicles to haul feed or feed ingredients for cattle  must have and use procedures to prevent commingling or  cross-contamination. The procedures must provide for cleaning out the  vehicles or other adequate preventative measures. Research suggests that  cattle can get BSE from ingesting even a small amount of infected  material—an amount that could be introduced in feed that was transported  in a poorly cleaned vehicle. As part of an inspection of transportation firms,  inspectors review the adequacy of these procedures, but the inspection  form does not prompt them to do so during inspections of other types of  firms. The following two problems impede the effectiveness of FDA’s  current procedures:   FDA has not identified and does not inspect many transportation firms.
According to FDA officials and transportation data, thousands of  independent truckers, large and small trucking companies, and rail  companies may carry cattle feed and feed ingredients. FDA officials told  us that it would be virtually impossible to identify and inspect all of  these firms, given its limited resources. However, FDA agrees that  transportation compliance is important. In commenting on a draft of this  report, the agency noted that it is planning to increase oversight of  transportation firms based on FDA’s assessment of compliance and risk  in this industry sector.
Inspecting transportation firms at their home base would not ensure  that the required procedures are being used and that the nearly 200,000  large trucks that haul animal feed would be clean at the time they picked  up cattle feed, in part, because vehicles that carry prohibited material  may also carry cattle feed and other loads in succession before  returning to their home base. For example, at an inspection of one  high-risk protein blender, we observed an FDA inspector talking with an  independent trucker who had dropped off a load of cattle feed  ingredients, was picking up prohibited materials at the protein blender,  and was scheduled later to pick up a load of corn, which could be used  in cattle feed. The trucker explained that if he saw anything in the truck  between loads, he would climb in and sweep the material out with a  broom; if he did not see anything, he did not sweep out the truck  between loads. The trucker also said it would be extremely difficult to  find washout facilities to clean the truck between loads while on the  road.
Consequently, we believe that it would be more effective to require FDA  and state inspectors to review and document procedures that feed mills  and other firms use to ensure that the vehicles they use to haul cattle feed  and feed ingredients are free of prohibited material as part of their  inspections at feed mills and other firms. During our observations of  inspections, we found that some FDA and state inspectors were already  doing so. However, our observations and analysis of inspection reports  showed that the inspectors did not routinely do so and did not uniformly  report on the adequacy of the firms’ procedures for preventing the  introduction of prohibited material. We believe that inspectors were  overlooking the adequacy of firm’s procedures to ensure the safe transport  of cattle feed because the BSE inspection form does not have any questions  to capture that information. Specifically, 82 of the 404 inspection reports  we reviewed were for renderers, protein blenders, feed mills, and other  firms that processed with prohibited material and handled cattle feed and  feed ingredients. We found that inspectors had documented the required  cleanout procedures for transportation equipment at only 11 of these 82  firms. Without requiring inspectors to uniformly review and document  vehicle cleaning procedures, FDA has insufficient assurance that the  vehicles are safe to carry cattle feed and feed ingredients.
section_title: FDA Does Not Fully Report BSE Inspection Results
paragraphs: In January 2004, FDA’s Deputy Commissioner testified that inspectors “at  least annually, targeted BSE inspections of 100 percent of known  renderers, protein blenders, and feed mills processing” with prohibited  material. He testified that compliance by those firms was “estimated to be  better than 99 percent.” Subsequently, some industry officials claimed that  overall compliance with the feed ban is nearly 100 percent and used that  figure to support their claim that the feed ban does not need to be  strengthened. However, as noted earlier, those groups are comprised of  about 570 firms—approximately 4 percent of the firms in FDA’s inventory.
In addition, FDA periodically publishes compliance information on its Web  site for all industry segments. This information has also been used to cite  high industry compliance. However, FDA and industry do not have a basis  for citing a compliance rate for a segment of firms subject to the feed ban  or industrywide because there are too many unknowns. Specifically, FDA  does not know the status of compliance for firms that  have never been inspected,  have not been reinspected in 5 or more years, and   may have started to process with prohibited materials since their last  inspection.
Furthermore, as we previously discussed, because FDA does not routinely  sample feed to confirm compliance, inspection results are largely based on  a review of paper documents and a visual inspection. All these concerns  apply to compliance information FDA reports to Congress and the public  on its Web site.
Additionally, our analysis of inspection reports also disclosed that FDA was  not including all serious violations in its calculation of the compliance rate  because it reclassified firms as “in compliance” once they correct  violations, regardless of how long the problem may have existed.
Finally, we found that FDA has classified 42 firms as having less serious  violations that it counted as “in compliance” with the feed ban. Inspectors  reported that 18 of these firms failed to include a cautionary statement on  feed containing prohibited materials. Although FDA’s feed-ban inspection  guidance designates the lack of a cautionary statement as a serious  violation, and lack of such a statement should result in the feed being  deemed misbranded under the Federal Food, Drug, and Cosmetic Act, FDA  excluded the violations at these firms from its calculation of the  compliance rate. Inspectors also reported that the remaining 24 firms had  procedures for preventing commingling but did not have these procedures  in writing. FDA’s guidance designates the lack of written procedures as a  less serious violation, but we believe these violations should be classified  as serious. Without written procedures, FDA has no assurance that the  firms consistently take the necessary steps to prevent commingling. FDA  officials told us that the guidance is advisory and therefore gives the agency  the discretion to reclassify the violations based on its review.
section_title: Conclusions
paragraphs: Diligent FDA oversight and enforcement of the feed ban is essential, not  only because of the potential threat to public health but also because of the  economic impact on the cattle and beef industry; this impact was clearly  demonstrated by the sharp drop in U.S. beef exports after one infected cow  was discovered in 2003. The ongoing discussions and agreements to reopen  beef export markets could be derailed if more cattle were discovered with  BSE.
FDA has taken positive steps since our 2002 report. Today FDA can say  with greater confidence that it has more timely and reliable inspection  data. Also, the risk-based system FDA has adopted to target inspection  resources on high-risk firms will increase the likelihood that firms  inspected annually will remain in compliance with the feed ban.
FDA’s processes, however, still have considerable room for improvement.  FDA does not have uniform procedures for identifying additional firms that  are subject to the ban but have never been inspected or for learning about  firms that change their practices and begin to handle prohibited material.  Furthermore, because inspectors are not using tests optimally—to help  confirm, when appropriate, that cattle feed, production equipment, and  transportation vehicles are free of prohibited material—FDA is limiting its  ability to assure that firms are in compliance with the feed ban and that  cattle feed is safe. Additionally, FDA is not taking advantage of state test  results to provide greater assurance that industry is adhering to the feed  ban and is not using its own program for sampling finished feed and feed  ingredients in a manner that will allow it to project test results.
Moreover, the lack of a requirement for warning labels on feed and feed  ingredients intended for export that contain prohibited material, creates  opportunities for having the material fed to domestic or foreign cattle,  either intentionally or inadvertently. As the international group of BSE  experts convened by USDA pointed out, the United States has an obligation  to act responsibly toward its global neighbors when exporting feed and  feed ingredients.
Especially troubling was our discovery that FDA did not alert USDA and  state authorities when it became aware that cattle had been given feed that  contained prohibited material. FDA, and its key partner, USDA, together  provide critical firewalls that the federal government has in place to protect  U.S. cattle and consumers. In addition, the lack of notification was contrary  to FDA’s own guidance and FDA’s inaction prevented USDA and states from  being able to make an informed decision on how to respond to the  discovery that cattle had consumed prohibited material.
Given these weaknesses and the fact that FDA does not include all  violations in its estimates, we believe FDA is overstating industry’s  compliance with the animal feed ban and understating the potential risk of  BSE for U.S. cattle in its reports to Congress and the American people.  Despite the problems in FDA’s calculation, some in the feed industry claim  that overall compliance with the feed ban is nearly 100 percent—a claim  that FDA’s compliance information does not support.
section_title: Recommendations for Executive Action
paragraphs: To further strengthen oversight and enforcement of the animal feed ban  and better protect U.S. cattle and American consumers, we recommend  that the Commissioner of FDA take the following nine actions:  Develop uniform procedures for identifying additional firms subject to  the feed ban.
Require firms that process with prohibited material to notify FDA. If  FDA believes it does not have the necessary statutory authority, it  should seek that authority from Congress.
Develop guidance for inspectors to systematically use tests to verify the  safety of cattle feed and to confirm the adequacy of firms’ procedures  for ridding equipment and vehicles of prohibited material before they  are used for processing or transporting cattle feed or feed ingredients.
Collect feed test results from states that sample feed to help verify  compliance with the feed ban.
Develop a sample design for FDA’s inspectors to use for sampling  finished feed and feed ingredients that will allow FDA to more  accurately generalize about compliance with the feed ban from the test  results.
Seek authority from Congress to require the cautionary statement on  feed and feed ingredients that are intended for export and that contain  prohibited material.
Ensure that USDA and states are alerted when inspectors discover that  feed or feed ingredients with prohibited material may have been fed to  cattle.
Modify the BSE inspection form to include questions inspectors can use  to document whether firms that process or handle cattle feed or feed  ingredients have procedures to ensure the cleanliness of vehicles they  use to transport cattle feed and feed ingredients.
Ensure that inspection results are reported in a complete and accurate  context.
section_title: Agency Comments and Our Evaluation
paragraphs: We provided FDA with a draft of this report for review and comment. FDA  stated that our report was thorough and that it recognized the  enhancements FDA has put in place in its feed-ban program. However, FDA  said the report did not identify material weaknesses to support our position  that oversight weaknesses limit FDA’s program effectiveness and place U.S.  cattle at risk of spreading BSE. FDA believes that its current risk-based  inspection approach is adequate to protect U.S. cattle. According to FDA,  given the wide variety of firms subject to the feed ban and its resource  limitations, it “is obligated to set priorities for inspecting a meaningful  subpopulation of these regulated firms.” We recognize that FDA has made  many improvements, including adopting a risk-based approach for  inspections, that have substantially improved its oversight of the feed-ban  rule. However, our report identifies significant problems in FDA’s oversight  that continue to place cattle at risk for BSE. The importance of a strictly  enforced feed ban is heightened now that BSE has been found in North  American cattle. As Harvard and the international panel of experts pointed  out, the feed ban is the most important fire wall against the spread of BSE.  Given the problems we identified and the significance of a well enforced  feed ban, it is important that FDA improves its feed ban oversight and  optimizes its use of resources.
In addition, FDA does not agree with our criticism of its compliance  reporting. FDA believes that it provides the inspection results in a  transparent, complete, and accurate context. FDA notes that the BSE  inspection data posted on its Web site “allows the user to analyze the data,  in a multitude of ways, to provide their own contextual reference.” Our  concern is precisely that the data are being analyzed and interpreted in an  erroneous context. Specifically, when FDA and industry used those data to  assert a 99 percent compliance rate with the feed ban, they took that  information out of context. While FDA’s calculation of compliance by a  subset of regulated industries may in fact be quite high, FDA’s data are not  sufficient to make that projection to all regulated industries. In addition,  FDA does not know the status of compliance for firms that have never been  inspected or have not been reinspected in years. Nor does it know if  previously inspected firms have started using prohibited material.  Furthermore, because FDA reclassifies firms from “out-of-compliance” to  “in-compliance” on its Web site when the firms correct violations, the  information posted on that Web site does not tell the user when serious  and/or long-standing violations have occurred. Lastly, inspection results are  largely based on a review of paper documents and a visual inspection, with  little or no feed testing. Given these data concerns and compliance  unknowns, FDA’s data should not be used to project industry compliance;  and, anytime those data are cited, they should be reported in a complete  and accurate context.
Regarding the nine recommendations we make in the report, FDA did not  take issue with the need for five and generally disagreed with four.  Although FDA noted implementation concerns, it did not take issue on the  need for (1) developing uniform procedures for identifying firms subject to  the feed ban, (2) collecting test results from the states that sample feed, (3)  including a cautionary statement on feed and feed ingredients intended for  export, (4) notifying USDA and states when feed or feed ingredients  containing prohibited material may have been fed to cattle, and (5)  modifying the inspection form to include questions to better oversee the  cleanliness of vehicles used to transport cattle feed or feed ingredients.
FDA disagreed with our recommendation that it require firms that process  with prohibited material to notify the agency. FDA believes that it is already  getting information on changes to firms’ practices from states and that  requiring an additional notification process would be costly to implement.  However, FDA acknowledged that it has generally not identified high-risk  feed salvagers and farms that mix their own feed or those that feed cattle as  well as other animals. The cost of the notification program will depend on  the requirements FDA puts in place. In developing the program, FDA could  target the notification to firms that pose a potentially high risk for exposing  cattle feed to prohibited material. We believe that FDA should know which  firms are high risk and that industry self-reporting is a mechanism that  would help the agency identify those firms and help it ensure compliance  with the feed ban.
FDA also disagreed with our recommendation to systematically use tests in  conjunction with compliance inspections. While we recognize the  limitations of current test methodologies, we believe that tests are useful.  In fact, states and FDA are currently using these tests on feed. Our  recommendation speaks to systematically using these tests where  appropriate, to augment inspections, which are largely observation and  paperwork reviews. We expanded the recommendation to recognize that  FDA may validate other tests in the future.
With respect to our recommendation that FDA develop a sample design for  testing finished feed and feed ingredients, FDA disagreed with the need for  a sample design that will allow it to more accurately generalize about  compliance. FDA stated that tests alone cannot serve as a basis to  generalize compliance. We agree that tests that indicate potential violations  need to be confirmed, because of the limitations of the current tests.  However, FDA is using the test results to identify potential problems, and it  tested 660 samples in 2003/2004 and plans to test 900 samples this year. The  point of our recommendation is that any testing activity of this magnitude  should have a sampling plan.
Finally, FDA believes that it already reports inspection results in a  complete and accurate context, as we recommend. We disagree. As noted  above, given the data concerns and compliance unknowns raised in this  report, FDA’s data should not be used to project industry compliance.  Anytime those data are cited, they should be reported in a complete and  accurate context. FDA also provided technical comments, which we have  incorporated into this report, as appropriate. FDA’s written comments and  our responses are in appendix VI.
We also provided USDA with a draft of appendix III, which summarizes  FDA’s and USDA’s actions in response to the 2003 discovery of BSE in  North America, for review and comment. USDA had no comments on the  draft appendix.
As agreed with your offices, unless you publicly announce the contents of  this report earlier, we plan no further distribution of it until 30 days from  the date of this letter. We will then send copies to interested congressional  committees; the Secretary of Health and Human Services; the Secretary of  Agriculture; the Director, Office of Management and Budget; and other  interested parties. We will make copies available to others on request. In  addition, the report will be available at no charge on GAO’s Web site at  http://www.gao.gov.
If you or your staffs have any questions about this report, please call me at  (202) 512-3841. Key contributors to this report are listed in appendix VII.
section_title: Scope and Methodology
paragraphs: As discussed below, to assess the effectiveness of the Food and Drug  Administration’s (FDA) actions to ensure industry compliance with the  feed ban and protect U.S. cattle from bovine spongiform encephalopathy  (BSE), we (1) analyzed 404 inspection reports for BSE inspections  performed during fiscal year 2003 and 2004; (2) observed 19 inspections in  12 states that were conducted by either FDA or state inspectors; (3)  assessed the reliability of FDA’s feed-ban inspection database; (4)  interviewed officials at FDA headquarters and district offices, state  agencies, and industry associations, as well as reviewed documents  provided by these officials concerning oversight of the animal feed ban;  and (5) surveyed state agency officials in 38 states.
To assess FDA’s oversight, we analyzed BSE inspection records to identify  types of firms inspected; types of material processed (prohibited,  nonprohibited, or both); oversight of transportation equipment; violations  identified during inspections (if applicable); and final inspection  classifications. We randomly selected 413 inspection reports from the  universe of BSE feed inspections conducted during fiscal year 2003 and  fiscal year 2004 (up to February 7, 2004). For each of the 18 FDA districts,  responsible for inspections in the 50 states, we randomly selected  inspection reports from one state (most FDA district offices cover more  than one state). We included all of the 314 high-risk firms that process  prohibited materials for the 18 selected states. In addition, we randomly  selected 12 other firms that process with prohibited materials; 68 firms that  distribute prohibited materials; and 19 firms that do not process or  distribute prohibited materials. We examined only 404 of the 413 inspection  reports because 9 of the report files that we requested were still open-case  files at the time of our review.
To evaluate the inspection process, we accompanied inspectors on 19 BSE  inspections of firms in 12 states covered by the feed ban. The sites were  selected to cover a range of firm types and sizes in various geographic  locations with concentrations of cattle feeding operations, including dairy  cattle. The 19 inspections included renderers, protein blenders, feed mills,  farms with ruminants and other animals, and pet food manufacturers.  Seven of these firms processed or handled only prohibited material, and  the remaining 12 processed or handled both types of material. On 12 of the  inspections, we accompanied FDA inspectors, and on 7 we accompanied  state inspectors.
To assess the reliability of the data FDA uses when reporting industry  compliance, we analyzed the agency’s database for inspections conducted  on or after April 15, 2002, when FDA implemented its newly designed feed- ban database. Specifically, we analyzed the 9,230 inspection records in this  database, as of February 7, 2004. To complete the reliability assessment, we  (1) reviewed existing documentation related to the data sources; (2)  electronically tested the data to identify obvious problems with  completeness, accuracy, or timeliness of data entry; and (3) interviewed  knowledgeable agency officials about the data. We determined that the  data were sufficiently reliable for purposes of this report.
We interviewed officials or reviewed documents at FDA headquarters and  at the 18 FDA district offices that are responsible for overseeing and  enforcing the feed ban in the 50 states, maintaining the inspection database  system, and proposing and analyzing regulatory decisions. In the 18 district  offices, we used a structured interview to uniformly gather information on  various issues, such as methods used to identify the universe of firms  subject to the feed ban; the process for selecting firms for inspection;  training programs for FDA and state inspectors; feed-ban inspection  guidance and procedures; the processes for reviewing inspection results,  classifying findings, and determining what, if any, enforcement action  should be taken; and oversight of contracts and agreements with state  agencies that perform BSE inspections. We received information and  documentation on FDA’s oversight and enforcement of the feed ban from  the following specific FDA units: Center for Veterinary Medicine, Office of  Management, Office of Surveillance and Compliance; Office of Regulatory  Affair’s Office of Regional Operations; Center for Food Safety and Applied  Nutrition’s Office of the Director; and Office of the Chief Counsel. We  reviewed various FDA program documents, including the BSE/Ruminant  Feed Ban Inspections Compliance Program Guidance; BSE feed inspection  form; advance notices of proposed rulemakings to strengthen the feed ban,  including public comments; and the reports on the feed samples collected  and tested. We also interviewed state agency officials and reviewed  documents from the California Department of Food and Agriculture; the  Departments of Agriculture of Georgia, Illinois, Kansas, Missouri, North  Carolina, and Pennsylvania; and the Texas Feed and Fertilizer Control  Service. Lastly, we interviewed officials and reviewed documents from the  American Feed Industry Association, the Association of American Feed  Control Officials, the National Renderers Association, the Association of  Analytical Communities, and the Harvard Center for Risk Analysis.
To understand the role that states play in the feed inspection program, we  surveyed state officials in the 38 states that have contracts or other  agreements with FDA to perform feed-ban compliance inspections and  report the inspection results to FDA. The survey included questions about  the states’ inspection programs, testing of animal feed ingredients, and  FDA’s training and guidance for feed-ban inspections and enforcement.  Before implementing our survey, we pretested the questionnaire with state  agriculture officials in five states. During these pretests, we interviewed the  respondents to ensure that (1) questions were clear and unambiguous, (2)  terms were precise, and (3) the survey did not place an undue burden on  the staff completing it. We received completed questionnaires from all 38  states surveyed. The state information presented in this report is based on  information obtained from this survey and interviews with state officials.
We performed our work from October 2003 through January 2005, in  accordance with generally accepted government auditing standards, which  included an assessment of data reliability and internal controls.
section_title: GAO’s Analysis of the Status of Actions on Recommendations to FDA in Our January 2002 Report
subsections: section_title: In order to strengthen oversight and enforcement of the animal feed ban, we recommended that the Secretary of Health and Human Services direct the Commissioner of FDA to take the following actions:
paragraphs: Develop a strategy, working with the 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 manner.
FDA (1) developed a new BSE inspection form that provides  guidance to FDA and state feed-ban inspectors on how to  uniformly and completely document firm’s operations and assess  compliance, (2) designated a BSE program coordinator in each  district office who is responsible for ensuring that inspection  reports are accurate and completed timely, and (3) provided  training for FDA and state inspectors on conducting and  documenting BSE inspections.
FDA has not developed a uniform strategy to identify all firms  subject to the feed ban or to ensure that all firms are inspected in  a timely manner.
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.
FDA implemented a newly designed BSE feed-ban database and  data-entry procedures designed to more reliably track feed-ban  inspection results. The new database, a module of FDA’s Field  Accomplishment and Compliance Tracking System, contains  commonly recognized database management and verification  procedures, such as unique identifiers for each inspected firm and  edit checks to help ensure that data entered is complete and  valid.
Develop an enforcement strategy with criteria for actions to address  firms that violate the ban and time frames for reinspections to  confirm that firms have taken appropriate corrective actions.
FDA issued feed-ban inspection guidance to FDA and state  inspectors and program managers for determining compliance  with the animal feed ban and to help ensure that BSE feed  inspections and enforcement actions are conducted in a uniform  manner and are of high quality.
Track enforcement actions taken by states.
FDA does not plan to track enforcement actions taken by states,  as we had recommended. Officials told us that FDA and state  enforcement actions would not be comparable because state  standards for initiating an action may not be equivalent to FDA  standards. As a result, FDA believed that the information would be  misleading if presented collectively.
In order to strengthen inspections of imported products that  could pose a risk of BSE, we recommended 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.
FDA hired more than 655 additional food security personnel and  increased its port-of-entry food examinations, including imported  animal feed that could pose a risk of BSE.
As part of the prior notice requirement of the Public Health  Security and Bioterrorism Preparedness and Response Act of  2002, FDA and the U.S. Customs and Border Protection  announced that they have integrated their information systems,  which allows FDA staff to more efficiently evaluate and process  each import entry.
FDA and U.S. Customs and Border Protection signed a  memorandum of understanding under which FDA commissions  Customs officers in ports and other locations to conduct, on  FDA’s behalf, investigations and examinations of imported food,  including animal feed. Currently, FDA has commissioned over  8,000 Customs officers.
To further help consumers identify foods and other products  that may contain central nervous system tissue, we  recommended 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.
FDA does not intend to label these products, as we  recommended. Officials told us that that the decision to label  products has to be based on science and if the presence of  central nervous system tissue poses a human risk, then it should  not be allowed as an ingredient in the product.
FDA issued an interim final rule in July 2004 that prohibits the use  of certain cattle material, including central nervous system tissue  from nonambulatory cattle, in human food, including dietary  supplements, and cosmetics.
section_title: GAO’s Summary of FDA’s and USDA’s Actions in Response to the Two Cases of BSE Discovered in North America in 2003
paragraphs: Canadian government reported that a single cow from  Alberta had tested positive for BSE. FDA began working  with USDA, other federal agencies, and Canadian  officials to gather additional information about this cow,  including its location, previous ownership, and records  about its feed.
USDA temporarily halted imports of live ruminant  animals and most ruminant products from Canada.
FDA learned from the Canadian government that  rendered material from the BSE-infected cow may have  been used to manufacture pet food, some of which was  shipped to the United States. FDA notified the U.S. pet  food firm that received the feed ingredients and the firm  requested that customers who may have purchased the  suspect product hold it for pickup by the distributor.
USDA announced it would allow certain ruminant  products from Canada to enter the United States under  permit. These include boneless beef from cattle under  30 months of age and boneless veal from calves that  were 36 weeks of age or younger.
USDA announced a proposed rule, published on  November 2003, to allow the importation of certain  low-risk, live ruminant animals and ruminant products  from Canada.
USDA released the results of the second Harvard BSE  risk assessment. The study found that even if infected  animals or ruminant feed material entered the United  States from Canada, the risk of BSE spreading within  the U.S. herd is low.
USDA collected samples from a nonambulatory cow  and diverted all potentially high-risk material (central  nervous system tissue) from the human food supply  and into the animal rendering process.
USDA laboratory test results are “preliminary positive”  for BSE.
December 23, 2003 USDA’s Animal and Plant Health Inspection Service  (APHIS) notified FDA’s Office of Crisis Management  that a “presumptive positive” finding of BSE in the  Washington cow.
USDA announced a “presumptive positive” finding of  BSE.
USDA sent a sample from the infected animal to a  world reference laboratory in the United Kingdom for  final confirmatory testing.
FDA activated its Emergency Operations Center and  began to implement its BSE Emergency Response  Plan. FDA headquarters and district office staff  participated in a teleconference with APHIS and  Washington State officials to ensure a coordinated  response to the incident.
APHIS quarantined the cattle herd where the BSE- infected cow last resided and began an  epidemiological investigation.
USDA’s Food Safety and Inspection Service (FSIS)  initiated a recall of the over 10,000 pounds of meat  from the group of 20 cattle slaughtered on   December 9.
FDA dispatched several teams of investigators to find  any FDA-regulated products that were or could have  been made from the infected cow, including animal  feed.
The world reference laboratory in the United Kingdom  confirms USDA’s BSE diagnosis.
FDA announced that an estimated 2,000 tons of feed  that could contain potentially infectious material from  the BSE-infected cow was found before any of it was  used to manufacture animal feed. According to FDA, the  feed was disposed of in a landfill in accordance with  federal, state, and local regulations.
USDA’s investigation with Canadian officials indicated  that the BSE-infected cow was likely imported from  Canada in 2001 and was about 6½ years old.
USDA identified 73 other cattle that were imported  from Canada in the same shipment with the BSE- infected cow.
USDA determined that the recalled meat products had  been distributed to Alaska, California, Guam, Hawaii,  Idaho, Montana, Nevada, Oregon and Washington.
USDA appointed an international team of scientific  experts to review its BSE investigation and make  recommendations following the completion of the  epidemiological investigation.
USDA’s and Canada’s chief veterinary officers held a  joint press conference to announce that DNA evidence  indicated—with a high degree of certainty—that the  BSE-positive cow found in Washington State originated  from a dairy farm in Alberta, Canada.
FSIS issued an interim final rule, effective January 12,  2004, that, among other things, prohibited the use of  brain, skull, spinal cord, and other specified tissues of  cattle 30 months or older for human food, and required  that all nonambulatory animals presented for slaughter  be condemned. FSIS also gave notice that it would no  longer pass and give a mark of inspection to carcasses  and cattle parts selected by APHIS until the sample is  determined to be negative.
FDA announced that it would be issuing interim final  rules to strengthen existing BSE firewalls, including  banning a wide range of cattle material from human  food, dietary supplements, and cosmetics, and  strengthening the 1997 feed ban through an extended  list of banned feeding and manufacturing practices.
USDA completed its investigation of the Washington  State BSE case.
Following the international scientific review panel’s  recommendation, USDA began an enhanced BSE  surveillance program targeting cattle from highest-risk  populations, as well as a random sampling of animals  from the aged cattle population.
FDA requested information and public comment on  additional measures that are being considered for  strengthening the 1997 feed ban. FDA requested this  information because the international scientific review  panel convened by the Secretary of Agriculture  recommended broader measures than FDA had  previously announced it would be issuing as part of an  interim final rule, such as banning all mammalian and  poultry protein from ruminant feed.
USDA asks for public comment on additional  preventative actions that are being considered  concerning BSE, such as implementation of a national  animal identification program.
FDA issued an interim final rule that prohibits certain  cattle material from human food, dietary supplements,  and cosmetics.
September 30, 2004 FDA announced the availability of industry guidance  “Use of Material from BSE-Positive Cattle in Animal  Feed.”
section_title: Survey of State Agencies
paragraphs: The U.S. General Accounting Office (GAO), an  agency of the U.S. Congress, is studying FDA’s  Feed Inspection program at the request of the  Senate Committee on Agriculture, Nutrition,  and Forestry.
In order to ensure that your data are entered  accurately, please use blue or black ink to enter  your answers.  Return the original copy of the  completed questionnaire to us.
As part of our study we are surveying states  that have contracts with FDA to conduct BSE  inspections or who have agreements or  arrangements with FDA to share data from  their state inspections.
We suggest you keep a copy of your completed  questionnaire for your records.
Your cooperation is critical to our ability to  provide current and complete information to  the Congress.  You will be notified when the  report is issued and you will be able to request  a free copy of the report at that time.
John Smith  GAO Atlanta Field Office  2635 Century Parkway, Suite 700  Atlanta, GA  30345  Please return your completed  questionnaire to us by June 25, 2004.
Several questions ask for data from 2003 and  for projected data for 2004.  In answering these  questions, please use the year that your state  uses in planning, scheduling, monitoring, and  reporting the BSE inspections in your state.
3.  Does your state have laws and regulations  covering the adulteration and misbranding of animal feed?  (Please check one.)
1.  What is the year you used for planning,  scheduling, monitoring and reporting to  FDA the data from BSE inspections done  in your state in 2003?
Reporting Year Used for  Inspections in 2003: (Please check  one.)
4.  Does your state have laws and regulations  47.4% (1) Federal Fiscal Year  specifically covering labeling of animal  feed for BSE?  (Please check one.) (2) Calendar Year  36.8% (1) Yes  Skip to Question 6  31.6% (3)
Please provide months   and days below.
From:  (Month/Day)
Please provide months  and days below. regulation that would require labeling of  animal feed for BSE?
From:  (Month/Day)
To: (Month/Day):    2.  What is the year you are using for planning,  scheduling, monitoring and reporting to  FDA the data from BSE inspections being  done in your state in 2004?
Reporting Year Used for  Inspections in 2004:  (Please check  one.)
6.  Does your state have laws and regulations  specifically covering BSE animal feed  inspections?  (Please check one.)
17 45.9% 1 2.7% (1) Federal Fiscal Year  (2) Calendar Year  (3)
Please provide months   and days below.
From: (Month/Day)
From: (Month/Day)
Please provide months  and days below.
From: (Month/Day)
To: (Month/Day):    7.  Has your state referenced any of the  9.  Do your state laws or regulations give you  following in your state laws and  regulations?  (Please check all that apply.) authority to inspect transportation firms  for compliance with the BSE feed ban?   (Please check one.)
14.3% (1)  Referenced all of:  American Association of  Feed Control Officials (AAFCO) Model  Regulation.12, Certain Mammalian Proteins  Prohibited in Ruminant Feed  0.0% (2)  Referenced part of:  American Association  (1) Yes 41.7% (2) No of Feed Control Officials (AAFCO) Model  Regulation.12, Certain Mammalian Proteins  Prohibited in Ruminant Feed  10.  Do your state laws or regulations require  85.7% (3)  Referenced all of:  21 CFR § 589.2000  Animal Proteins Prohibited in Ruminant  Feed  firms that handle both prohibited and non- prohibited materials use dedicated  equipment?  (Please check one.)
Of the above.
100.0% (2) No  Skip to Question 12  (Please provide citation.)
11.  Does your state’s requirement for  dedicated equipment for prohibited and  non-prohibited materials apply to  transportation firms?  (Please check one.)
8.  Does your state plan to reference any of  the following in future state laws or  regulations?  (Please check all that apply.) (1) Yes (2) No 36.7% (1) Do not plan to reference any of the  34.5% (2) Plan to reference all of:  American 12.  In developing your BSE Inspection  following.
Association of Feed Control Officials  (AAFCO) Model Regulation.12, Certain  Mammalian Proteins Prohibited in  Ruminant Feed  35 (92.1%) of the respondents  provided an answer.
24.1% (4) Plan to reference all of:  21 CFR § 589.2000  Animal Proteins Prohibited in Ruminant  Feed  6.9% (5) Plan to reference part of:  21 CFR §  589.2000 Animal Proteins Prohibited in  Ruminant Feed 24.1% (6) Plan to reference definitions used in either  of the above. - 13.  During the year, how often does your state  15.  Did your state perform any BSE  discuss your BSE Inspection Workplan  with FDA staff?  (Please check one.) inspections during 2003 that are not reported in your answer to Question 14?   (Please check one.) (1)  Weekly or more frequently  10.5% (2)  Monthly  23.7% (3)  Quarterly (4)  Annually  31.6% (1) Yes How many?
Total: ~700  (N = 10)  16.  What type of arrangement(s) does your  39.5% (5)  As needed, based on changes to the  feed ban, regulations or guidance  7.9% (6)  Other  (Please specify.) state have with FDA for 2004 and what is  the projected number of inspections that  will be completed under each type of  arrangement?  (Remember to use your  state’s reporting year.)
For 2004: (Please check all that apply and fill  in number of inspections where checked.) 94.6% (1) A contract with FDA to perform BSE  inspections and report results to FDA  14.  What type of arrangement(s) did your state  have with FDA during 2003 and how many  inspections were done under each type of  arrangement?  (Remember to use your  state’s reporting year.)
For 2003: (Please check all that apply  and fill in  number of inspections where  checked.)
Number of BSE  inspections done under  agreement or other  arrangement:  inspections during 2004, or do you expect  to perform inspections, that are not reported in your answer to Question 16?   (Please check one.)
21.0% (4)  Other BSE inspections performed by  state inspectors with results reported  to FDA Number of BSE  inspections done by state  and results reported to  FDA::  32.4% (1) Yes How many?    Total: ~900 (N = 9)  67.6% (2) No   - 18.  For each of the firm types listed below, please indicate whether or not:  (a) your state is  authorized to inspect that type of firm, (b) your state conducts routine BSE inspections of that  firm type, (c) your state requires registration or licensing of that firm type, and (d) your state has  identified all possible firms of that type.  (For each firm type, please check yes or no for each  question.)
C.  Does your  state require  best of your  knowledge,  have you or  registration  or licensing  for this type  firm type? type? of firm? of this type?
FDA-licensed feed mills  for commercial feed  Non-FDA licensed feed  mills for commercial feed  Protein blenderFarmers/ranchers who  raise ruminants and non- ruminant animals  Farmers/ranchers who  raise only ruminants  On-farm mixer (on-farm  use only)
Animal food or pet food  salvagerFour states reported that there are no renderers in their state.  Two states reported that there are no protein blenders in their state.  One state reported that there are no pet food manufacturers in their state.  Three states reported that there are no animal food or pet food salvagers in their state. - 19.  What documentation does your state  complete for each BSE inspection it  performs under your state’s authority? (Please check all that apply.)
22.  Who, in your state organization routinely  makes the final inspection decision as to  whether a firm is in compliance with your  state’s regulations?  (Please enter position  title(s) in box.  Do not enter names.) N = 28  (1)  FDA’s BSE Checklist  11.1% (2)   BSE Checklist developed  33.3% (3)  Form FDA 481- Computer 27.8% (4)  Form FDA 483 – Inspectional (5)  Other inspection forms from  27 (96.4%) of the respondents  provided an answer. 23.  Under your state’s authority which, if any,  30.6% (6)  Other   (Please specify.) of the following enforcement actions can  you take against a firm not in compliance  with your state’s laws or regulations?   (Please check all that apply.) (1) Warning letter  20.  What documentation do you submit to  FDA as part of BSE inspections that are  done under your state’s authority?  (Please  check all that apply.)
89.5% (2) Stop sale of product  86.8% (3) Product seizure or confiscation 78.8% (1)  FDA’s BSE Checklist  55.3% (5) Recall of product  71.0% (6) Criminal or civil prosecution 6.1% (2)   BSE Checklist developed  27.3% (3)  Form FDA 481- Computer 24.2% (4)  Form FDA 483 – Inspectional 24.2% (5)  Other inspection forms from 36.4% (6)  Other   (Please specify.) (7) Other (Please specify)  24.  How frequently does your state report to  FDA information about BSE enforcement  actions taken under your state’s authorit y? (Please check one.)
21.  Under your state’s authority, does your  state make compliance decisions  associated with BSE inspections?  (Please  check one.)
67.6% (1) Always   Skip to Question 26. (2)  Almost always  73.7% (1)  Yes 26.3% (2)  No  Skip to Question 23.
5.4% (3) Sometimes  2.7% (4) Occasionally  (5) Never  25.  Please describe (a) the conditions or circumstances, including type of inspection and (b) the type  of violations for BSE enforcement actions not usually reported to FDA.  (Please use the space  below, or, if you prefer, attach a separate sheet with your answer.) N = 12  9 (75.0%) of the respondents provided an answer. 4 states responded that minor technical violations would not be reported to FDA.  4 states responded that violations found under state authority would not be reported  to FDA.  26.  For each of the firm types listed below, what is the level of compliance in your state with the BSE  feed ban?  (Please check one in each row.)
FDA-licensed feed mills  for commercial feed  Non-FDA licensed feed  mills for commercial  feed  Farmers/ranchers who  raise ruminants and  non-ruminant animals  Farmers/ranchers who  raise only ruminants  On-farm mixer (on-farm  use only)
Animal food or pet food  salvagerFour states reported that there are no renderers in their state.  Two states reported that there are no protein blenders in their state.  One state reported that there are no pet food manufacturers in their state.  Three states reported that there are no animal food or pet food salvagers in their state.
Section III:  Testing of Animal Feed  Ingredients 27.  Do you take samples of animal feed to test  32.  Do you routinely share the results of these  for prohibited materials as part of BSE  inspections that are done under your  tests with FDA?  (Please check one.) (1) Yes 38.9% (2) No 52.6% (2)  No  Skip to question 33. state’s authority?  (Please check one.)
33.  Does FDA direct your state to take samples  28.  When did you start collecting animal feed  samples to test for prohibited materials?   (Please enter month and year below.) of animal feed to test for prohibited  materials as part of BSE inspections that  are done for FDA? (Please check one.)
Dates ranged from September, 1997  to June, 2004.  18 states reported  dates.
92.1% (2) No  Skip to question 37.
29.  How many samples did you collect and test  34.  How many samples did you collect and test  in 2003 (as part of a BSE inspection done  under your state’s authority)?  (Please  enter number in box.) in 2003 (as part of a BSE inspection done  for  FDA)?  (Please enter number in box.)
Total: ~100  N = 3.
30.  How many samples do you plan to collect  35.  How many samples did you collect and test  and test in 2004?  (Please enter number in  box.) in 2004 (as part of a BSE inspection done  for  FDA)?  (Please enter number in box.)
Total: ~100  N = 2 31.  What type(s) of test(s) did you use?
36.  What type(s) of test(s) did you use? (Please check all that apply.) (Please check all that apply.) (1) Feed microscopy  22.2% (2) PCR (polymerase chain  33.3% (3) Elisa (enzyme-linked reaction)
0.0% (1) Feed microscopy  0.0% (2) PCR (polymerase chain reaction immunosorbent assay) assay) (4) Other  (Please specify.)
1 50.0% 1 50.0% (3) Elisa (enzyme-linked immunosorbent  (4) Other  (Please specify.)
Section IV:  FDA Training and  Guidance for BSE Inspection and  Enforcement  37.  Does FDA provide sufficient training on  BSE inspection and enforcement?  (Please  check one.)
40.  When your state inspectors or supervisors  have questions on potential violations and  enforcement actions are they answered by  FDA in a timely manner?  (Please check  one.)
47.4% (1)  Definitely yes  (2)  Probably yes  7.9% (3)  Uncertain  73.7% (1) Always or almost always   21.0% (2) More than half of the time 13.2% (4)  Probably no  (5)  Definitely no  (3) About half of the time  0.0% (6)  No basis to judge  0.0% (4) Less than half of the time  0.0% (5) Never or almost never (6) No basis to judge  38.  When your state inspectors or supervisors  have technical questions on performing  inspections, are they answered by FDA in a  timely manner?  (Please check one.)
41.  How satisfactory are the answers that FDA  78.9% (1) Always or almost always   13.2% (2) More than half of the time provides to your state inspectors’ or  supervisors’ questions about potential  violations and enforcement actions  provided by FDA?  (Please check one.) (3) About half of the time  55.3% (1) Very satisfactory  31.6% (2) Somewhat satisfactory 2.6% (4) Less than half of the time  0.0% (5) Never or almost never (6) No basis to judge  5.3% (4) Somewhat unsatisfactory  0.0% (5) Very unsatisfactory 39.  How satisfactory are the answers that FDA  provides to your state inspectors’ or  supervisors’ technical questions on  performing inspections?  (Please check  one.) (6) No basis to judge  71.0% (1) Very satisfactory  28.9% (2) Somewhat satisfactory 0.0% (4) Somewhat unsatisfactory  0.0% (5) Very unsatisfactory (6) No basis to judge  (For the following questions, please use the space here to provide your answers, or, if you   attach  a separate sheet with your answer.) 42.  In your opinion, what areas of FDA’s BSE inspection program seem to be working well and what  areas need to be improved?  N = 38  29 (76.3%) of the respondents provided comments.  18 states responded that the BSE inspection program is working well, especially for  inspections of renderers, protein blenders, and feed mills.   7 states responded that FDA needs to place more emphasis on-farm mixers and  feeding operations.  4 states responded that FDA needs to place more emphasis on transportation of  animal feed.  6 states responded that FDA needs to share inspection results and enforcement  actions with state agencies.  2 states responded that FDA needs to be more decisive in taking enforcement action,  when warranted.  43.  No questionnaire of this type can cover all aspects of a topic.  If you have further concerns or  comments concerning FDA’s BSE inspection program, please comment below.  Or, if you prefer,  mail or email your comments to us separately.  N = 38  13 (34.2%) of the respondents provided comments, however 1 did not attach  comments to questionnaire, resulting in only 12 responses (31.6%).
Food and Drug Administration BSE Inspection Program:  Survey of States with  Contracts and Other Agreements with FDA  Please complete for all individuals providing information for this questionnaire.
Please attach additional sheets if needed.        Thank You!
section_title: Chronology of FDA’s Feed Ban and Proposed Rulemakings
subsections: section_title: August 4, 1997
paragraphs: FDA feed ban took effect, prohibiting certain materials in ruminant feed to  prevent the establishment and spread of BSE if it were to appear in U.S.  cattle herds. FDA took this action because it had been an industry practice  to feed proteins to ruminant animals that could transmit the infective agent  that causes BSE. Additionally, research in the United Kingdom suggested  that variant Creutzfeldt-Jacob Disease (vCJD) in humans is linked to eating  cattle infected with BSE. The feed ban requires that firms, with some  exceptions, take the following actions:  label feed and feed ingredients that contain most proteins from  mammals (prohibited material) with a cautionary statement “Do not  feed to cattle or other ruminants,”  have procedures to protect against commingling or cross-contamination  if they handle both prohibited and nonprohibited feed and feed  ingredients by using either equipment dedicated exclusively to feed or  ingredients intended for cattle or using cleanout procedures or other  adequate means to prevent carryover, and  maintain records so that feed and feed ingredients that contain or may  contain prohibited material can be tracked from receipt through  disposition.
According to FDA’s rules, firms that transport both types of materials must  also follow these procedures. Additionally, prohibited materials may be  used in pet food and in feed for poultry, swine, horses, and other  nonruminant animals. Lastly, FDA designated a number of cattle- and other  animal-derived items as exempt from the ban—and hence, allowable in  cattle feed. These items include blood and blood products, plate waste,  gelatin, milk and milk protein, and any product whose only mammalian  protein consists entirely of protein from pigs and horses. FDA has also not  regulated the use of poultry litter in feed.
section_title: October 30, 2001
paragraphs: FDA held a public hearing to solicit information and views regarding ways  in which the current feed ban and its enforcement might be improved or to  determine if any new objectives should be considered. FDA took this  action because BSE had spread beyond the United Kingdom to most  countries in western and central Europe and Japan. FDA asked for  responses to 17 questions, including the following:  Should FDA require dedicated facilities for the production of animal  feed containing mammalian protein?
Should FDA require dedicated transportation of animal feed containing  mammalian protein?
Should FDA license renderers and other firms engaged in the  production of animal feed containing mammalian proteins?
Should FDA revoke or change any of the current exemptions in the  current rule?
Should FDA require pet food to contain the cautionary statement?
Should FDA extend the recordkeeping requirement beyond 1 year?
Should FDA request authority to assess civil monetary penalties?
section_title: November 6, 2002
paragraphs: FDA published an advanced notice of proposed rulemaking announcing  that it was considering revising the feed ban and asking the public to  comment on certain possible modifications. FDA explained that shortly  after its October 2001 public hearing, USDA released a report by the  Harvard Center for Risk Analysis on the findings of a major, 3-year initiative  to develop a risk assessment model and assess the risk of BSE in the United  States. The model concluded that the risk to U.S. cattle and to consumers  from BSE is very low, but certain new control measures could reduce that  small risk even further. Therefore, based on comments received at the  public hearing and the findings of the Harvard Study, FDA asked for public  comment on various ways that the BSE feed ban could be strengthened,  including the following questions:  Should tissues that are known to be at higher risk for harboring the  infective agent for BSE, such as brain and spinal cord from ruminants 2  years of age or older be excluded from all rendered products?
How extensive is the use of poultry litter in cattle feed, what is the level  of feed spillage in poultry litter, and what would be the impacts resulting  from banning poultry litter in ruminant feed?
Should pet food for retail sale carry the cautionary statement “Do not  feed to cattle or other ruminants?”
Are there practical ways, other than dedicated facilities, for firms to  demonstrate that the level of carryover of prohibited material in a feed  mill could not transmit BSE to cattle or other ruminants? If so, what is  the safe level of carryover of prohibited material and what is the  scientific rationale for establishing this safe level?
To what extent is plate waste used in ruminant feed and what would be  the impacts from excluding this material from ruminant feed?
section_title: January 26, 2004
paragraphs: FDA announced that it would be issuing interim final rules to strengthen  existing BSE firewalls, including banning a wide range of cattle material  from human food, dietary supplements, and cosmetics, and strengthening  the 1997 feed ban through an extended list of banned feeding and  manufacturing practices.
section_title: July 14, 2004
paragraphs: FDA, with USDA, announced that the agencies are considering additional  measures to protect the public from the health risk associated with BSE  and to prevent the spread of the disease in U.S. cattle and are asking for  public comment. The agencies are considering additional safeguards based  on the recommendations of a panel of international experts convened by  the Secretary of Agriculture to review the U.S. regulatory response  following the finding of a BSE-positive cow in Washington State in  December 2003. In addition to some of the measures FDA had planned to  take in an interim final rule, the international panel recommended broader  measures, such as banning all mammalian and poultry protein from  ruminant feed. Since these recommendations would require significant  changes in current feed manufacturing practices and could make some  previously announced proposals unnecessary, FDA requested additional  information and public comment on the panel recommendations and other  measures, including the following:  What information is available to support or refute the assertion that  removing tissues that are known to be at higher risk for harboring the  BSE infective agent, such as brain and spinal cord tissue, from all animal  feed is necessary to effectively reduce the risks of cross-contamination  of ruminant feed or of misfeeding on the farm?
If FDA prohibits high-risk tissues from all animal feed, would there be a  need to require dedicated facilities, equipment, storage, and  transportation?
What information is available to support banning all mammalian and  poultry meat and bone meal from ruminant feed?
If FDA prohibits high-risk tissues from all animal feed, what information  is available to support banning all mammalian and poultry meat and  bone meal from ruminant feed?
Can high-risk tissues be effectively removed from dead stock and  nonambulatory cattle so that the remaining material can be used in  animal feed, or is it necessary to prohibit the entire carcass from use in  all animal feed?
Do FDA’s existing authorities under the Federal Food, Drug, and  Cosmetic Act and under the Public Health Service Act provide a legal  basis to ban the use of high-risk cattle tissues and other cattle material  in nonruminant animal feed, given that such materials have not been  shown to pose a direct risk to these animals?
FDA also issued an interim final rule on July 14, 2004, to prohibit certain  cattle materials in FDA-regulated food, including dietary supplements, and  cosmetics, to minimize potential human exposure to the BSE infective  agent. Specifically, FDA prohibited use of the brain, skull, spinal cord, and  other specified tissues of cattle that are 30 months or older; small intestine  and tonsils of all cattle; material from nonambulatory disabled cattle or  cattle not inspected and passed for human consumption; and beef that is  mechanically separated from bones. FDA took this action in response to  the finding of a BSE-positive cow in Washington State in December 2003  and to conform with an interim final rule issued by USDA in January 2004  declaring these materials unfit for human consumption.
section_title: Comments from the Food and Drug Administration
paragraphs: The following are GAO’s comments on the Food and Drug Administration’s  letter dated January 13, 2005.
subsections: section_title: GAO Comments
paragraphs: 1. We believe the report identifies numerous oversight weaknesses that  continue to limit program effectiveness and place cattle at risk. The  purpose of the feed ban firewall is to prevent the exposure and spread  of BSE. A well enforced feed ban is even more critical now that BSE  has been discovered in cattle in North America. As shown in our report,  FDA does not know the compliance status or risks posed by firms it has  not identified, inspected or reinspected for many years. FDA  acknowledged that many more firms are subject to the feed ban than  have been inspected to date but said the agency must set priorities for  the number and types of firms it can identify and inspect with limited  inspection resources. We agree with FDA’s use of a risk-based  inspection approach; however, FDA acknowledges the need to increase  inspections of certain industry segments, such as transporters and  animal feed salvagers. Moreover, for firms that FDA inspects, it does  not routinely sample feed to verify whether the operating procedures  observed by its inspectors are actually preventing prohibited materials  from contaminating cattle feed. Our recommendations are aimed at  ensuring that FDA has a strategy for maximizing the effectiveness of its  limited inspection resources, targeting inspections, and using feed tests  to minimize the risk of cattle being fed prohibited material.  2. Our concern is precisely that the data are being analyzed and  interpreted in an erroneous context. Specifically, when FDA and  industry used those data to assert a 99 percent compliance rate with the  feed ban, they took that information out of context. While industry  compliance may in fact be quite high for firms FDA has inspected  recently, FDA’s data are not sufficient to project compliance  industrywide. FDA does not know the status of compliance for firms  that have never been inspected or have not been reinspected in years.  In addition, compliance history is lost—firms that had serious and long- standing violations are classified as “in-compliance” once FDA  determines that the problems are corrected. FDA is not reporting that  the firms were ever out of compliance or the length of time that the  feed ban was violated. Lastly, inspection results are largely based on a  review of paper documents and a visual inspection, with little or no  feed testing. Given these data concerns and compliance unknowns, we  believe that FDA’s data should not be used to project industry  compliance and, anytime those data are cited, they should be reported  in a complete and accurate context. 3. FDA agrees that there are industry sectors (such as transporter and  animal feed salvagers) that need to be assessed to determine their  potential risk to U.S. cattle. In fact, FDA acknowledges that there are  millions of firms potentially subject to the feed-ban rule. At the same  time, FDA implies that it has identified all high-risk firms. FDA has no  basis for that assertion. The example we suggest in this report is one  way of identifying additional firms that we observed during our review.  FDA identified other approaches that its districts used to identify other  firms. We believe that any approaches FDA identifies as useful should  be applied uniformly across all FDA districts. We included information  in the report on how FDA plans to use the $8.3 million it received in the  2005 budget. We also revised the report to include FDA’s estimate of the  number of firms that feed cattle and other ruminants and revised the  recommendation in recognition that it may be impossible for FDA to  identify all firms subject to the feed-ban rule.  4. FDA suggests that requiring notification would take significant  resources. The cost of the notification program will depend on the  requirements FDA puts in place. In developing the program, FDA could  target the notification to firms that pose potentially high-risk for  exposing cattle feed to prohibited material. According to FDA, of the  14,800 firms it has inspected, about 570 renderers, protein blenders,  and feed mills comprise the high-risk firms subject to notification  because they manufacture or process prohibited material. While we  believe there may be more firms that fall into this group, it should not  be a significantly larger number. If it is significantly larger, that is  something FDA needs to know. Furthermore, requiring industry to self- report is another mechanism that would help FDA identify firms and  oversee compliance. Finally, FDA has registration requirements in  place for medicated feed firms and for food facilities, and could draw  on its experience with those programs for developing a notification  program for firms subject to the feed-ban rule. Because firms can  change their practices over time, we believe it is important that firms  notify FDA whenever such changes occur.  5. While we agree that the current test methods have certain limitations,  we believe that testing can be a valuable tool for helping FDA oversee  compliance with the feed ban. FDA maintains that, because the current  test methods cannot differentiate prohibited material from exempt  material, they cannot be used to verify the presence or absence of  prohibited material or to confirm the adequacy of cleanout measures.  However, states told us that they are using tests for these purposes.  Moreover, FDA is currently testing finished feed and using the test  results, together with follow-up inspections, to determine whether the  feed ban had been violated. We believe tests would help inspectors who  now rely on only paperwork review and visual examination to  determine the adequacy of cleanout procedures. Tests would also be  useful for vegetable-based cattle feed, where detecting the presence of  animal protein would indicate a violation. We revised the  recommendation to recognize that FDA may elect to use other test  methods in addition to feed microscopy and polymerase chain reaction  (PCR). With respect to FDA’s sampling of finished feed, the 660 samples  FDA tested were not collected during feed-ban compliance inspections.  We plan to report later this year on FDA’s sampling of finished feed. 6. We agree that FDA’s current test methodology will not allow it to use  test results alone to verify feed-ban violations. However, testing  combined with follow-up inspections would allow FDA to be in a better  position to generalize about compliance with the feed-ban rule if FDA  developed a random sample methodology for inspectors to use for  sampling finished feed and feed ingredients. (Also see comment 5.)  7. After clarifying FDA’s comment with an attorney in FDA’s Office of the  Chief Counsel, we revised the report and the recommendation to delete  references that FDA should encourage firms to include a cautionary  statement on feed exports that may contain prohibited material. We  believe that it would be more prudent for FDA to focus its efforts on  obtaining statutory authority to require that the cautionary statement  be used on such exports.  8. We revised the recommendation to clarify that FDA should be alerting  USDA and the affected states whenever inspectors discover that cattle  may have consumed feed with prohibited material.  9. Based on the inspections we observed and the 404 inspection reports  that we reviewed in detail, we believe that inspector activities during  feed-ban compliance inspections are driven by the checklist  items/questions on the BSE inspection form. Therefore, we believe the  checklist should include specific questions to prompt inspectors to  examine vehicles and firms’ cleanout procedures on every inspection.  10. As noted in the report, FDA believes that it provides the inspection  results in a transparent, compete, and accurate context. FDA notes that  the BSE inspection data posted on its Web site “allows the user to  analyze the data, in a multitude of ways, to provide their own  contextual reference.” Our concern is precisely that the data are being  analyzed and interpreted in an erroneous context. Specifically, when  FDA and industry used those data to assert a 99 percent compliance  rate with the feed ban, they took that information out of context. While  FDA’s calculation of compliance by a subset of regulated industries may  in fact be quite high, FDA’s data are not sufficient to make that  projection for all regulated industries because of the many problems  we cite in the report. Specifically, FDA does not know the status of  compliance for firms that have never been inspected or those that have  not been reinspected in years. FDA also does not know if a firm that it  previously inspected and classified as low-risk has started using  prohibited material; and FDA reclassifies a firm in the database from  “out-of-compliance” to “in-compliance” when it corrects a violation— even when the violation was serious and long-standing. Lastly,  inspection results are largely based on a review of paper documents  and a visual inspection, with little or no feed testing. Given these data  concerns and compliance unknowns, FDA’s data should not be used to  project industry compliance and, anytime those data are cited, they  should be reported in a complete and accurate context.
section_title: GAO Contacts and Staff Acknowledgments
subsections: section_title: GAO Contacts
section_title: Staff Acknowledgments
paragraphs: In addition to the individuals named above, Vincent Balloon, Jim Dishmon,  Natalie Herzog, Lynn Musser and John C. Smith made key contributions.  Other contributors included George Quinn, Carol Herrnstadt Shulman,  Joan Vogel and Amy Webbink.