GAO-06-157R FDA Feed Testing Program 

October 11, 2005 

The Honorable Saxby Chambliss 

Chairman 

The Honorable Tom Harkin 

Ranking Democratic Member 

Committee on Agriculture, Nutrition, and Forestry 

United States Senate 

The Honorable Thad Cochran 

United States Senate 

The Honorable Richard J. Durbin 

United States Senate 

Subject: Mad Cow Disease: An Evaluation of a Small Feed Testing Program FDA 

Implemented in 2003 With Recommendations for Making the Program a Better 

Oversight Tool 

In 1997, the Food and Drug Administration (FDA) banned the use of most proteins 

derived from mammals (referred to as prohibited material) in feed intended for cattle 

and other ruminants.1

 The feed-ban rule is one of the primary actions taken by the 

federal government to protect U.S. cattle from bovine spongiform encephalopathy 

(BSE),2 commonly known as mad cow disease, which is believed to be spread through 

feed that contains malformed protein found in certain tissue—particularly brain and 

central nervous system tissue—of BSE-infected animals.3 Earlier this year, mad cow 

disease was found for the first time in a 12-year old animal born and raised in the United 

States. 

In January 2002, we reported on the effectiveness of federal actions to prevent the 

introduction and spread of BSE in the United States and identified a number of areas 

where improvements were needed to strengthen FDA’s oversight of firms in the feed 

 

1

Ruminants are animals with four-chambered stomachs, including, but not limited to, cattle, buffalo, sheep, 

goats, deer, elk, and antelope. For the purpose of this report, “cattle” refers to cattle and all other 

ruminant animals and “cattle feed” refers to feed for cattle and other ruminant animals. 

2

21 C.F.R. §589.2000. 

3

Adding protein (derived from animals or plants) to feed is a common nutritional practice used to speed 

animal growth. 

United States Government Accountability Office

Washington, DC 20548 
2 GAO-06-157R FDA Feed Testing Program 

industry.4 In February 2005, we issued a follow-up report that examined the 

effectiveness of FDA’s actions since the 2002 report to ensure industry compliance with 

the feed-ban rule and protect U.S. cattle from BSE.5 Our report concluded that while 

FDA has taken a number of positive steps, its processes still have room for improvement. 

Our February 2005 report also noted that FDA had begun a small, discrete feed testing 

program in August 2003. We reported that we would provide information on this new 

feed testing program, which FDA described as a unique effort, once FDA provided us 

with data on the feed tests. FDA later gave us the information we required to examine 

those feed testing activities. Accordingly, this report assesses FDA’s small feed testing 

program and examines the extent to which this feed testing program helps FDA better 

assure industry compliance with the feed-ban rule. This report is the final component of 

our follow-up work on FDA’s BSE prevention efforts. 

 

FDA established the feed testing program in an assignment memorandum issued in 

August 2003, entitled Assignment Memorandum—Sample Assignment for Domestic 

Products, which contained instructions for implementing the program. The purpose of 

the feed testing program was to collect and analyze cattle and other types of animal feed 

and feed ingredients to determine whether feed that could be fed to cattle might contain 

material prohibited by FDA’s feed-ban rule. Under the program, FDA collected 641 feed 

samples through the end of fiscal year 2004 and planned to collect 900 feed samples 

during fiscal year 2005. 

The 2003 guidance gave FDA’s district offices responsibility for collecting samples and 

submitting them to an FDA laboratory where analysts test the samples using a procedure 

called feed microscopy—a visual (microscopic) examination for potentially prohibited 

material, such as particles of bone, hair, or muscle fiber from certain animals. If an 

analyst detects what appears to be prohibited material, the findings are confirmed by a 

second analyst. According to FDA officials, some samples were tested using a more 

specialized method called polymerase chain reaction (PCR), a test that FDA has been 

piloting, which can differentiate ruminant DNA from other animal DNA.6

 

The guidance noted that because FDA had designated a number of cattle-derived 

exemptions to the feed-ban rule, including blood, milk protein, and plate waste, the 

laboratory tests could not definitively determine violations but, rather, could identify 

potential violations. The guidance directs the districts to conduct follow-up reviews on 

each potential violation to determine whether the facility represented by the sample 

actually violates the feed ban. On the basis of the follow-up reviews, the districts assign 

final compliance determinations—that the facility where the sample was collected has 

complied with or has violated the feed-ban rule. 

In June 2005, FDA issued a directive that all feed sample analysis and follow-up actions 

 

4

GAO, Mad Cow Disease: Improvements in the Animal Feed Ban and Other Regulatory Areas Would 

Strengthen U.S. Prevention Efforts, GAO-02-183 (Washington, D.C.: Jan. 25, 2002).

5

GAO, Mad Cow Disease: FDA’s Management of the Feed Ban Has Improved, but Oversight Weaknesses 

Continue to Limit Program Effectiveness, GAO-05-101, (Washington, D.C.: Feb. 25, 2005). 6

The PCR test works by aiding in the differentiation of mitochondrial DNA between animal species. 
3 GAO-06-157R FDA Feed Testing Program 

be recorded in FDA’s central data system—the Field Accomplishments and Compliance 

Tracking System (FACTS)—and that districts complete follow-up reviews of potential 

violations within 30 working days. In July 2005, FDA issued a revised assignment 

memorandum that, among other things, enhances the testing protocol by adopting the 

PCR test for sample retesting and directs districts to provide sufficient narrative 

explanation in FACTS to explain their final determination on samples that laboratories 

identify as potential violations. 

For the purpose of this report, we use the term “feed testing program” to distinguish the 

samples FDA collected for the feed-testing assignments from samples FDA and states 

collected in conjunction with routine BSE inspections. We included only the samples 

that FDA collected for the assignments. To examine the extent to which FDA’s feed 

testing program provides better assurance of industry compliance with the feed-ban rule, 

we reviewed FDA’s data on 1,206 samples collected through June 2005. We identified 

989 feed samples collected by FDA’s district offices and analyzed by FDA laboratories 

between August 2003 and June 2005, under the feed testing assignment/program 

implemented under the August 2003 guidance document. We compared sample 

collection, analysis, and follow-up with the program instructions in the August 2003 

assignment memorandum. In order to assess FDA’s timeliness in analyzing feed samples 

and to determine results of these analyses, we analyzed data on feed sample collection 

and laboratory analysis maintained in FACTS on the 989 feed samples. In order to assess 

the types of follow-up activities carried out by the districts and the basis for their final 

determinations on potential violations, we obtained and analyzed additional electronic 

files from FDA districts and discussed those activities and determinations with officials 

in the 19 FDA district offices. We also obtained detailed district-specific data and 

information on sample collection, follow-up, and enforcement activities in interviews 

with the officials in the 19 FDA district offices and discussed this information with FDA 

headquarters officials. To assess the reliability of the FACTS data, we analyzed the feed 

sample records in this database as of June 7, 2005. We analyzed the data to identify 

problems with completeness, accuracy, or timeliness of data entry, and reviewed system 

documentation on controls. We determined that the data were sufficiently reliable for 

the purposes of this report. The testing program data assessed for this report, including 

documentation in FACTS, spreadsheets maintained by individual district offices, 

documents describing district follow-up actions for individual samples, and all written 

guidance documents, were provided in response to our specific requests for all such 

documentation and data related to the feed testing program. Finally, we examined the 

feed testing program guidance that FDA provided in the June 2005 field management 

directive and the July 2005 assignment memorandum and compared it with the 

instructions and guidance FDA provided in the August 2003 memorandum. We 

performed our work from February through August 2005 in accordance with generally 

accepted government auditing standards. Our work included an assessment of FDA’s 

feed testing program data reliability and internal controls. 

Results in Brief

The feed testing program is a small part of FDA’s BSE oversight effort and is one of 

several methods FDA uses to monitor for compliance with the feed-ban rule. However, 
4 GAO-06-157R FDA Feed Testing Program 

several weaknesses in the design and implementation of the feed testing program need to 

be addressed to improve its effectiveness. Specifically, under the program guidance, 

• FDA did not require districts to document their follow-up reviews or the basis for 

their final determinations on samples that the laboratories identified as 

potentially containing banned protein products. Although the districts may have 

conducted rigorous follow-up and exercised sound judgment, the basis for their 

decisions cannot be reviewed and confirmed. 

• For nearly half the 989 samples, FDA took longer than 30 days from the date the 

sample was collected until the date the laboratory completed its analysis—

including 21 samples that took longer than 100 days. This extended period does 

not include the time FDA’s districts would have spent following up on samples 

that indicated potential violations. FDA and industry agree that cattle feed is 

consumed very quickly. By the time FDA conducted its follow up to determine 

whether a violation had occurred, the feed may have been consumed. 

• FDA managers in headquarters did not adequately oversee the feed testing 

program. Specifically, FDA managers did not receive periodic reports or have 

other oversight controls in place to assure that the program was implemented 

correctly. Moreover, FDA did not identify intended program goals and, as a 

result, does not know whether or to what extent the feed testing program is 

contributing to the agency’s BSE oversight efforts. 

FDA’s June 2005 directive and July 2005 revised instructions—issued nearly 2 years into 

the program—includes (1) a requirement that follow-up actions and compliance 

determinations be fully documented in FDA’s centralized FACTS compliance tracking 

system with sufficient explanation to allow the reader to understand the basis for the 

decision and (2) a time limit for districts to complete follow-up reviews. 

To ensure that the feed testing program contributes to FDA’s BSE oversight efforts, we 

are recommending that FDA (1) fully implement the June 2005 field management 

directive and July 2005 assignment memorandum, (2) assure that districts and 

laboratories adhere to time limits on collecting samples, completing sample analysis, and 

carrying out follow-up activities to minimize cattle’s exposure to potentially 

contaminated feed, and (3) require sufficient oversight by headquarters managers to 

assure the program is achieving its intended goals. 

In commenting on a draft of this report, FDA expressed concern that GAO was issuing a 

report that focused on one small aspect of FDA’s BSE oversight efforts. We agree that it 

is a small component of FDA’s overall efforts, but it vies for FDA’s limited BSE oversight 

resources. Furthermore, as we pointed out in our more comprehensive February 2005 

report, we looked at this small program separately because FDA did not provide program 

data in time for its inclusion in the broader report. FDA also disagreed with two of our 

recommendations in a draft of this report: that it set a time period for laboratories to 

complete sample analyses and that headquarters managers exercise sufficient oversight 

to assure the program operates as intended. FDA indicated that it had some target 

timeframes for laboratories. Because we could not pinpoint where delays were 

occurring, we revised our recommendation to address the need to minimize overall 
5 GAO-06-157R FDA Feed Testing Program 

time—from sample collection through analysis and follow-up activities—in order to 

minimize cattle’s exposure to potentially dangerous feed. With regard to our 

recommendation for better management oversight, FDA disagreed with our assertion 

that the program was not sufficiently monitored and noted the activities its managers 

have undertaken. We modified that recommendation to clarify what we believe is 

needed in terms of management oversight. 

Background 

BSE is an always fatal neurodegenerative animal disease, first identified in 1986. The 

disease has been found in cattle in 26 countries, including the United States, which 

discovered its first native-born case in a 12-year old cow in June 2005. The agent 

believed to be responsible for BSE is a malformed protein found in certain tissue—

particularly brain and central nervous system tissue—of BSE-infected animals. Cattle 

contract BSE by eating feed derived from the remains of an infected animal. Scientists 

also generally believe that a rare but fatal disease in humans—known as variant 

Creutzfeldt-Jacob Disease—is linked to eating products containing cattle tissue 

contaminated with the malformed protein. 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. 

Under FDA’s 1997 feed-ban rule, firms in the feed industry must (1) label feed and feed 

ingredients that contain or may contain most proteins from most mammals (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 firms handle cattle feed and feed ingredients (in the same facility) as well as material 

intended for other animal species that is prohibited in cattle feed, and (3) maintain 

records for 1 year so that feed and feed ingredients that contain or may contain 

prohibited material can be tracked from receipt through disposition.7

 Firms that 

transport both types of materials also must have procedures to prevent commingling. 

 

The feed ban prohibits the use of certain mammalian proteins in the feed for cattle and 

other ruminants, such as sheep and goats; however, the material prohibited for use in 

cattle feed can be used in pet food and in feed for poultry, swine, horses, and other 

nonruminant animals. In addition, FDA designated a number of cattle- and other animalderived items as exempt from the feed-ban rule and, hence, allowed in cattle feed. The 

exempt items include blood and blood products, plate waste, gelatin, and milk and milk 

proteins.8

 In addition, poultry litter (composed of poultry waste material, bedding, and 

 

7

The feed-ban rule is based on FDA’s authority to regulate food additives, 21 U.S.C. §§ 321(s), 348, as well 

as other authorities. 

8

Plate waste is discarded meat and other food offered for human consumption from institutions, 

restaurants, and other dining facilities, which are collected by processors, recooked to eliminate bacteria, 

and used in animal feed as a protein source. Gelatin is made from boiling animal bones, cartilage, tendons, 

and skin. 
6 GAO-06-157R FDA Feed Testing Program 

spilled feed that is used as a protein source) is allowed in cattle feed.9 Consequently, the 

presence of animal protein in a feed sample may or may not indicate a violation of the 

feed-ban rule.10

Under the risk-based inspection approach that FDA adopted in 2002, FDA has designated 

firms that manufacture, blend, and otherwise directly process with prohibited material as 

posing the highest risk for potentially exposing U.S. cattle to BSE. Firms that do not 

process with prohibited material are designated as posing a lower risk. FDA documents 

the results of BSE inspections in the FACTS compliance data system and periodically 

posts inspection results on the FDA Web site. 

According to the August 2003 assignment memorandum implementing the feed testing 

program, the program objective was to “collect and analyze domestic feed, feed 

ingredients and other animal feed products for the presence of animal tissue using the 

feed microscopy method to monitor for compliance with [the feed-ban rule.]” The 

memorandum instructed districts to (1) select samples from animal feed, feed 

ingredients, and other animal feed products, such as medicated feed; (2) collect at least 

50 percent of samples from products intended for ruminants; (3) select products that are 

labeled as containing animal protein but do not have a caution statement that they not be 

fed to cattle, which is required by the feed-ban rule; (4) include samples from feed that 

does not list mammalian protein in their name or ingredients; and (5) select each sample 

from a different source, processor, or manufacturer, if possible. In addition, FDA 

officials told us samples were being taken from “finished” feed—sold in bags or bulk—

and that the testing program would give FDA an additional way to review products in the 

marketplace. 

The August 2003 assignment memorandum assigned the district offices responsibility for 

regulatory and administrative follow-up of laboratory findings. It directs districts to 

obtain additional information on samples that the laboratories classify as identifying 

potential violations through reviews of firms’ records, trace-back inspections to 

suppliers, and interviews with individuals in the chain of receipt and use of materials in 

the sampled feed. When districts confirm a violation, the guidance directs districts to 

remove the feed or feed ingredients from distribution, either by voluntary recalls or by 

seizure. According to the guidance, decisions to take additional enforcement actions, 

such as issuing warning letters, depend on the history of the firms, the scope of the 

violations, and the source of the prohibited material. 

In May 2004, FDA headquarters conducted an internal evaluation of the feed testing 

program based on a review of sample collection and laboratory analysis information on 

samples collected and testing in the first 8 months of the program. That evaluation did 

not include information on follow-up reviews by the districts. In May 2005, FDA’s Center 

for Veterinary Medicine reported that FDA follow-up reviews at feed mills and elsewhere 

 

9

FDA has published two advance notices of proposed rulemaking requesting comments and information 

revising the ban to, among other things, end most of the exemptions. 

10In September 2005, FDA announced that it would propose regulations that parallel regulations that 

Canada recently announced, banning at-risk tissue—brains, spinal cords, and other parts that may carry 

mad cow disease—from feed for all animals including chicken, pigs, and pets. 
7 GAO-06-157R FDA Feed Testing Program 

in the feed chain revealed a high level of compliance with the feed-ban rule.11

The August 2003 assignment memorandum instructed the districts to collect a total of 

600 samples through the end of fiscal year 2004; in fact, FDA collected 641 feed samples 

in that period. Enclosure I shows the number of feed samples assigned to each district 

and the number collected and analyzed through the end of fiscal year 2004 and for fiscal 

year 2005. 

The Feed Testing Program Has Not Provided FDA Additional Assurance of 

Compliance with the Feed-Ban Rule Because of Weaknesses in Its Design and 

Implementation 

The effectiveness of FDA’s feed testing program has been limited by three design and 

implementation weaknesses. First, in designing the program FDA did not require 

districts to document their follow-up activities on samples that potentially violated the 

feed-ban rule or the basis for their final compliance determinations of those samples. 

Second, it was designed and implemented without time frames for promptly collecting 

and analyzing samples and following up on test results. Finally, FDA headquarters 

managers did not maintain adequate oversight responsibility for ensuring the program 

met the intended goals. FDA’s June 2005 directive and July 2005 revised guidance 

address some of these concerns but will be useful only when fully implemented. 

FDA’s Districts Have Not Documented Follow-up Activities or the Basis for Their 

Determinations on Feed Samples

FDA’s districts may have conducted rigorous follow-up and exercised sound judgment. 

However, they did not document their follow-up actions and the basis for their 

compliance determinations on whether firms violated the feed-ban rule because FDA did 

not require districts to clearly document those activities and decisions. As a result, the 

basis for their decisions cannot be reviewed and confirmed. Without this 

documentation, FDA has no assurance that the districts’ actions were thorough and 

correct. FDA laboratories identified 215 of the 989 samples we examined as identifying 

potential violations. Based on their follow-up reviews, however, the districts determined 

that 214 samples did not show violations—that only one of the firms chosen for 

obtaining a surveillance sample violated the feed-ban rule (see table 1). 

 

11FDA Center for Veterinary Medicine Using the Science and Law to Protect Public and Animal Health,

Annual Report Fiscal Year 2004, October 1, 2003 – September 30, 2004. Rockville, MD: May 2005. 
8 GAO-06-157R FDA Feed Testing Program 

Table 1: Classification of 989 Feed Samples by FDA Laboratories and Districts, by Feed Type, August 2003 

through June 2005 

Type of feed or ingredient 

sampled 

Number of 

samples 

Number of 

samples 

laboratories 

classified as 

identifying 

potential 

violations 

Number of 

samples districts 

classified as 

demonstrating 

violations of the 

feed-ban rule 

Enforcement 

action taken 

Feed or ingredients intended 

for cattle 662 141 1 1 warning letter 

Feed or ingredients that could 

be fed to cattle or other 

animals (no indication that 

feed should not be fed to 

cattle) 242 44 0 None 

Feed or ingredients intended 

for animals other than cattle 85 30 0 None 

Total 989 215 1 1 

Source: GAO analysis of FDA data. 

The one sample FDA determined demonstrated a violation of the feed-ban rule was from 

cattle feed collected at a feed mill. The laboratory classified the sample as identifying a 

potential violation because it contained cattle hair. The label indicated that the feed 

contained poultry meal. The district’s follow-up review determined that the renderer 

that supplied the poultry meal to the feed mill had previously processed prohibited 

material and failed to use adequate clean-out procedures to prevent commingling or 

cross-contamination with the ingredients intended for cattle feed. FDA issued a warning 

letter to the renderer for not maintaining adequate procedures or labeling the product 

with the required cautionary statement that the ingredients not be fed to cattle or other 

ruminants. 

We were unable to independently verify the follow-up reviews on other potential 

violations or confirm the districts’ final compliance determinations of samples, because 

the documentation supporting the districts’ determinations was lacking or incomplete. 

When we asked FDA for this information, FDA acknowledged that it did not require the 

districts to document their follow-up activities. FDA headquarters contacted its districts 

and told them to reconstruct an accounting of their follow-up actions and final 

compliance determinations. Thus, FDA compiled this information several months after 

the fact for most samples. The information we received was unclear and did not contain 

sufficient sample-specific information. Table 2 summarizes the type of district follow-up 

activities compiled by FDA. 
9 GAO-06-157R FDA Feed Testing Program 

Table 2: District Follow-up Action on Samples Identifying Potential Violations by the Laboratories 

District follow-up action 

Number of 

samples Percent 

No inspection or regulatory follow-up for this sample 82 38 

An investigation or follow-up inspection occurred to resolve findings 13 6 

A routine inspection was either scheduled or has occurred since the analysis of 

the sample 71 33 

A warning letter was recommended by the district for at least one firm associated 

with the sample 4 2 

Other action taken or action is still pending 15 7 

There was no indication as to the type of follow-up conducted 30 14 

Total 215 100 

Source: GAO analysis of FDA data. 

Likewise, the narrative information that FDA compiled from the districts on their final 

compliance determinations, which we summarize in table 3, does not give sufficient 

information to verify the basis for those determinations. 

Table 3: District Compliance Determinations on Samples Identifying Potential Violations by the Laboratories 

District compliance determination 

Number of 

samples Percent 

Classified as in compliance through a review of lab results and previous 

inspection records of the firm 77 36 

Classified as in compliance through a review of lab results and accompanying 

ingredient statements 74 34 

Classified as in compliance through a review of lab results and at least one 

inspection conducted after analysis of this sample was completed 29 13 

Classified as in compliance, but no indication given by FDA as to how this 

decision was made 10 5 

Possible mislabeling or adulteration involving nonexempt material—official action 

is possible. 8 4 

Follow-up is still pending 12 6 

Classification was not indicated by FDA 4 2 

Not a BSE-related finding 1 0 

Total 215 100 

Source: GAO analysis of FDA data. 

In order to verify the basis for their determinations, districts must be able to provide 

clear and sufficient information for a reviewer to understand the decisions made and the 

reason for making those decisions. That is, when a district follows up on a sample that a 

laboratory has classified as evidencing a potential violation, the district would describe 

the specific evidence it uses to reach a determination that a firm has not violated the 

feed-ban rule. FDA’s July 2005 guidance recognizes the importance of this critical step 

and directs the districts to provide sufficient narrative explanation in FACTS to allow an 

FDA manager to understand the basis for those decisions. If, for example, the analyst 

observes particles of bone, tissue, or hair in cattle feed, and the district is relying on 
10 GAO-06-157R FDA Feed Testing Program 

records from a recent BSE inspection, we would expect the district to provide a detailed 

description of the animal material the firm used and the date it used that material to 

manufacture the feed. This description would have to fully explain what the laboratory 

observed. If information from a recent inspection is not available, we would expect FDA 

to conduct a follow-up inspection at the firm and describe the documents, such as dated 

invoices, that verify the type of animal material used that fully explains what the 

laboratory observed. 

When we met with FDA officials in September 2005, they acknowledged that 

headquarters and field managers did not have an easily accessible, uniform method for 

tracking districts’ follow-up actions and compliance determinations that would enable 

them to perform thorough oversight and analyze trends in the program. Officials stated 

that the new June 2005 directive should alleviate these shortcomings and that FDA will 

make further changes if managers determine that the directive does not address all of the 

weaknesses. 

FDA Did Not Ensure That Samples Were Promptly Sent to Laboratories and Analyzed 

and That Potential Violations Were Quickly Followed Up

FDA’s program guidance did not include timeframes for ensuring that laboratories 

analyzed samples and districts follow up on test results promptly; as a result, FDA had 

no assurance that these activities were carried out expeditiously to minimize the risk 

that cattle would be fed potentially contaminated feed. After FDA received the draft 

report for comment, it informed us that laboratories are to complete their analysis of 

samples taken under the feed testing program within 20 working days, although this 

timeframe is not in the August 2003 program guidance for laboratories. FDA could not 

provide data we requested to determine the amount of time that samples were 

undergoing analysis or the time districts spent in following up on potential violations and 

reaching a final determination because it does not track this information. 

However, FDA did provide the date each sample was collected and the date the 

laboratory reported the results of its analysis to the district because the districts and 

laboratories were entering that information into the FACTS compliance tracking system. 

In analyzing these data, we found that for nearly half of the samples we examined (473 of 

989), more than 30 days elapsed before the laboratories reported sample findings to the 

districts. That included 38 samples for which more than 60 days—and in some cases 

more than 100 days—elapsed before the laboratory findings were reported to the 

districts (see fig. 1). 
11 GAO-06-157R FDA Feed Testing Program 

Figure 1: Number of Days for FDA Laboratories to Analyze Feed Samples and Report to Districts from Date 

of Collection, August 2003 through June 2005 

Source: GAO Analysis of FDA Data. 

The districts initiated follow-up activities on potential violations of the feed-ban rule 

after the laboratories reported their analyses. However, FDA did not provide consistent 

information on the timeliness of district follow up actions because they were not 

tracking this information. Therefore, we could not determine how much more time 

passed before districts took follow-up actions on the 215 samples that the laboratories 

identified as potentially demonstrating violations of the feed-ban rule. 

According to FDA and industry officials, however, cattle feed is consumed very quickly. 

Because FDA did not include timeframes in the August 2003 guidance for laboratories to 

analyze samples and for districts to follow up on samples identifying potential violations, 

by the time inspectors determined that cattle feed was contaminated, all the feed in 

question could have been consumed by cattle. In commenting on a draft of this report, 

FDA indicated that it plans to evaluate the number of days that laboratories are spending 

on analyzing feed samples as those data are compiled. 

FDA Headquarters Managers Did Not Exercise Adequate Oversight of the Feed Testing 

Program

FDA’s managers in headquarters designed the feed testing program and issued the 

August 2003 assignment memorandum. However, those managers did not exercise 

oversight once the program was implemented. Specifically, FDA managers had no 

controls in place to ensure that the August 2003 guidance was consistently followed, that 

516

435

17 21

0

100

200

300

400

500

600

0 to 30 days 31 to 60 days 61 to 100 days More than 100 days

Days to analyze samples and document findings

Number of samples
12 GAO-06-157R FDA Feed Testing Program 

results were carefully tracked, and that the program was operating as intended and 

achieving its intended goals. FDA did not identify program goals and, as a result, does 

not know whether or to what extent the feed testing program is contributing to the 

agency’s BSE oversight efforts. In past reports, we have stressed the importance of 

performance measures as critical internal control standards that enable federal agencies 

to compare and analyze actual performance data against expected or planned goals for 

their activities and programs.12 However, FDA had no such controls in place to compare 

and analyze feed testing activities carried out by its laboratories and districts. Under the 

Government Performance and Results Act of 1993, agencies must use outcome-oriented 

goals and performance measures that assess results, effects, or impacts of a program or 

activity compared with its intended purpose.13 Without such measures, FDA cannot 

assess whether its feed testing efforts achieved the intended results or how well districts 

and laboratories collected and analyzed samples and followed up on samples that 

potentially violated the feed-ban rule. 

Following are some examples where laboratories and districts did not implement the 

2003 assignment consistently and FDA headquarters managers did not have oversight in 

place to discover these inconsistencies: 

• FDA laboratories classified 29 samples as “in compliance” that analysts described 

as containing mammalian protein from an unidentifiable source. Based on the 

August 2003 guidance, however, analysts should have classified these samples as 

identifying potential violations, thus flagging them for district follow-up. 

• One of the six FDA laboratories continued to misclassify samples as 

demonstrating definite violations—a classification that current testing technology 

does not support—after the May 2004 evaluation revealed that this type of 

misclassification was occurring. 

• Eighteen districts collected nearly all samples from firms that had previously 

undergone a BSE inspection, while one district collected samples at retail stores 

that did not manufacture feed and typically had not undergone a BSE inspection. 

FDA’s risk-based inspections target firms that manufacture, blend, and otherwise 

directly process with prohibited material; however, the 2003 assignment 

instructions appear to focus on feed samples collected at the retail level and FDA 

officials told us that samples collected for the feed testing program were to be 

taken from finished feed sold in bags or in bulk, which would give FDA an 

additional way to review products in the marketplace. 

• Laboratories reported that labels and ingredient lists were missing for 28 of the 

215 samples with potential violations, although the August 2003 assignment 

instructed districts to submit these items with samples. The July 2005 assignment 

continues to instruct districts to submit labels with samples. 

 

12See GAO, Results-Oriented Government: GPRA Has Established a Solid Foundation for 

Achieving Greater Results, GAO-04-38, (Washington, D.C.: March 10, 2004); Managing for Results: Strengthening 

Regulatory Agencies’ Performance Management Practices, GAO/GGD-00-10 (Washington, D.C.: Oct. 28, 1999); 

Standards for Internal Controls in the Federal Government, GAO/AIMD-00-21.3.1, (Washington, D.C.: Nov.

1999). 

13Pub. L. No. 103-62, 107 Stat. 285 (1993). 
13 GAO-06-157R FDA Feed Testing Program 

FDA headquarters did not have oversight mechanisms in place to monitor the feed 

testing program nor performance indicators to compare program results across 

laboratories and districts to detect these implementation differences. 

In addition, headquarters had no controls in place to discern that districts were not 

recording or tracking sample follow-up actions and compliance determinations. 

Although its FACTS compliance tracking system contains data fields for documenting a 

narrative explanation of what action was taken, the rationale for the action, the final 

district classification, and the date of the decision, the 2003 assignment did not direct the 

districts to use FACTS and FDA’s oversight did not detect and correct this until the June 

2005 directive and July 2005 revised assignment. The FACTS compliance tracking 

system is the centralized database that FDA implemented agency wide for the expressed 

purpose of capturing this information. 

Furthermore, after FDA headquarters conducted the internal evaluation in May 2004, it 

did not act to implement internal controls to ensure that the testing program would 

achieve its intended goals and correct the problems identified in that review. The 

internal review looked at 370 samples taken during the first 8 months of the program. 

The report identified 70 samples classified by the laboratories as potentially in violation 

of the feed ban, including 42 samples of feed intended for cattle. FDA based its 

evaluation on the laboratories’ descriptions and any label or ingredient information 

submitted with the samples, but did not consider any district follow up on laboratory 

findings. The evaluation “encouraged” the districts to follow up on 14 of the 42 cattle 

feed samples and 26 samples from feed intended for other species that could include 

prohibited material. FDA headquarters did not question how the districts addressed the 

review findings. 

The feed testing program cannot provide FDA with additional assurance of compliance 

with the feed ban unless headquarters exercises adequate oversight and implements 

internal controls to address these program weaknesses. 

New Procedures Address Some Feed Testing Program Weaknesses 

FDA officials have acknowledged weaknesses in the August 2003 memorandum and told 

us that the June 2005 directive and July 2005 revised assignment memorandum are 

intended to address those problems. 

FDA’s June 2005 directive requires, among other things, that 

• all feed sample analysis and follow-up actions are documented accurately and in a 

timely fashion in the agencywide FACTS compliance tracking system; 

• program managers at headquarters, regions, districts, and laboratories implement 

internal audit procedures and controls to verify that sample analysis and followup actions are timely and accurately documented in FACTS; and 

• districts complete and document follow-up actions within 30 working days 

following receipt of sample results from the laboratory. 
14 GAO-06-157R FDA Feed Testing Program 

The July 2005 revised program instructions clarify sample selection criteria and require, 

among other things, that 

• laboratories use PCR to verify samples that indicate the possible presence of 

mammalian bone or hair, and 

• districts document their assessments of samples found to be in potential violation 

of the feed ban and their final determinations with sufficient narrative 

explanation to allow a reviewer to understand the basis for their decisions. 

The new directive and instructions went into effect immediately. FDA officials told us 

that the districts are entering the required information in FACTS for all samples followed 

up in fiscal year 2005. However, if districts enter the same type of information that they 

provided to us without, for example, citing the specific documentation used and actions 

conducted to reconcile laboratory findings, then these additions to FACTS may not be 

useful for oversight. 

Conclusions 

FDA’s June 2005 directive and the July 2005 revised assignment include important new 

controls that address many of the weaknesses we found in the feed testing program. 

However, the new directive and guidance will be useful only when FDA ensures their full 

implementation. One important requirement in the directive and guidance—for districts 

to document their follow-up activities and compliance decisions—will allow FDA to use 

the program results to supplement the agency’s other BSE oversight activities. FDA’s 

districts and laboratories believe they have implemented the feed testing program 

diligently and thoroughly, using their best professional judgment. That notwithstanding, 

until the districts’ actions are documented in a fashion that fully explains the basis for 

their compliance determinations, FDA cannot verify and hence cannot confidently rely 

on the testing program results. 

Another important requirement in the new directive is the addition of a 30-day time limit 

for districts to complete their follow-up actions and make final compliance 

determinations for feed samples that identify potential violations of the feed-ban rule. 

That new guidance notwithstanding, we remain concerned about the overall time frame. 

We found that more than 30 days elapsed between the date samples were collected and 

the date laboratories completed their analysis for nearly half the samples, and that these 

two steps took more than 100 days in some instances. Only then would districts have 

begun their follow-up activities. However, both FDA and industry agree that cattle feed 

is consumed very quickly. Consequently, by the time FDA completes its follow up 

activities and determines that a violation has occurred, the feed may have been 

consumed. We believe that both the districts and the laboratories need to carry out their 

feed testing program responsibilities promptly to minimize cattle’s exposure to 

potentially contaminated feed. 

While FDA’s new assignment instructions recognize the importance of management 

accountability, they do not include specific oversight requirements that will address the 
15 GAO-06-157R FDA Feed Testing Program 

deficiencies we identified. Even though the feed testing program is small, adequate 

management oversight of the program is critical, because the resources FDA spent on 

the program since August 2003 came directly from the agency’s limited BSE oversight 

funding. If they exercise appropriate oversight, FDA headquarters managers can help 

ensure that future results of the feed testing program will be reliable, and that BSE 

resources will be carefully spent. In this regard, we believe that periodic reports using 

FACTS data would be useful. Other internal controls may also provide useful 

management oversight, and FDA would benefit if it developed performance indicators 

and set goals for its managers to use to determine whether and to what extent the feed 

testing program is contributing to the agency’s BSE oversight efforts. 

Finally, feed testing has the potential to be an important tool in FDA’s feed-ban oversight 

arsenal as technology improves, and we believe FDA would benefit by encouraging the 

development, testing, and implementation of new feed testing technologies. PCR is a 

better tool than feed microscopy, and the capabilities of PCR are being refined and 

improved. As more accurate and effective PCR and other feed testing technologies 

emerge, the value of feed testing to FDA’s BSE oversight will increase. 

Recommendations for Executive Action 

To ensure that the feed testing program is a useful tool for helping FDA oversee industry 

compliance with the feed-ban rule, we are recommending that the Commissioner of FDA 

take the following three actions: 

• Fully implement the June 2005 field management directive and July 2005 

assignment memorandum revising the feed testing program. 

• Assure that districts and laboratories adhere to time limits on collecting samples 

and completing sample analysis and follow-up activities to minimize cattle’s 

exposure to potentially contaminated feed. 

• Require FDA headquarters managers to exercise sufficient oversight, with 

periodic reports from FACTS or other management controls, and identify 

appropriate performance indicators for the feed testing program, to assure that 

the program operates as intended and achieves its intended goals. 

Agency Comments and Our Evaluation 

We provided FDA with a draft of this report for review and comment. In its comments 

on the draft report, FDA included an overview of its BSE oversight program to put the 

feed testing effort in context. FDA expressed concern that we were issuing a report that 

focused on one small aspect of that effort. As we explained in our more comprehensive 

February 2005 report, we analyzed and are reporting separately on this small program 

because FDA did not provide program data in time for its inclusion in the broader report. 

With respect to our first recommendation, FDA indicated that it plans to fully implement 

the June directive and July guidance. We have included this as a recommendation to help 

FDA maintain its momentum and attention to a program that commands a portion of its 

limited BSE oversight resources. With respect to our second recommendation, FDA told 
16 GAO-06-157R FDA Feed Testing Program 

us that its laboratories have a time limit of 20 working days to analyze feed samples from 

this program. However, FDA could not provide data to document whether laboratories 

were meeting this time limit and our analysis of the elapsed time for the two steps of 

sample collection and data analysis often showed the time spent to be excessively long—

from 60 to 100 days and longer in some instances. Because the overall time frame is the 

period of concern, we revised our recommendation to address overall timeliness to 

minimize cattle’s exposure to potentially contaminated feed. We believe that when FDA 

implements better tracking under the 2005 directive and guidance, it will have data to 

help determine specifically where timeliness can be improved. This will give FDA data 

to assess laboratory timeframes, which it indicated that it plans to do. Regarding our 

third recommendation for better management oversight, FDA disagreed with our 

assertion that the program has not been adequately monitored. However, FDA did not 

provide evidence that its managers received periodic reports assessing program 

performance or that they had other adequate management oversight controls in place. 

We believe that our revised recommendation, if implemented, will put FDA in a position 

to determine whether and to what extent the feed testing program is contributing to its 

BSE oversight efforts. 

_ _ _ _ _

As agreed with your offices, unless you publicly announce the contents of this report 

earlier, we plan no further distribution until 30 days from the date of this letter. At that 

time, we will send copies of this report to the congressional committees with jurisdiction 

over FDA and its activities; the Secretary of Health and Human Services; the Secretary of 

Agriculture; and the Director, Office of Management and Budget. In addition, this report 

will be available at no charge on the GAO Web site at http://www.gao.gov. 

If you or your staff have any questions about this report, please contact me at (202) 512-

3841 or robinsonr@gao.gov. Contact points for our Office of Congressional Relations 

and Public Affairs may be found on the last page of this report. Key contributions to this 

report were made by Erin Lansburgh, Assistant Director; Jeremy Manion; Lynn Musser; 

George Quinn; Carol Herrnstadt Shulman; John C. Smith; and Amy Webbink. 

Robert A. Robinson 

Managing Director, Natural Resources 

 and Environment 

Enclosures
Enclosure I 

17 GAO-06-157R FDA Feed Testing Program 

Number of Feed Samples Assigned and Collected and Analyzed, 

as of June 7, 2005, by FDA District 

District Number of samples 

 First sample assignment Second sample assignment 

 Assigned 

Collected and 

analyzeda

Assigned 

Collected and 

analyzed, as of 

June 7, 2005 

Atlanta 20 22 20 0 

Baltimore 18 18 17 13 

Chicago 58 56 29 21 

Cincinnati 70 72 61 27 

Dallas 58 52 94 48 

Denver 20 20 26 13 

Detroit 58 55 60 31 

Florida 5 3 20 0 

Kansas City 88 89 171 42 

Los Angeles 8 38 35 3 

Minneapolis 70 84 181 81 

New England 5 5 9 11 

New Jersey 0 0 2 0 

New Orleans 20 15 18 8 

New York 20 27 18 16 

Philadelphia 20 20 51 15 

San Francisco 20 20 60 0 

San Juan 16 19 5 2 

Seattle 26 26 23 17 

Total 600 641 900 348 

Source: GAO analysis of FDA data. 

a

We excluded samples that were collected by the districts when the analysis was not also included in the files provided 

by FDA. 
Enclosure II 

18 GAO-06-157R FDA Feed Testing Program 

Comments from the Food and Drug Administration 

Note: GAO 

comments 

supplementing those 

in the report text 

appear at the end of 

this enclosure.
Enclosure II 

19 GAO-06-157R FDA Feed Testing Program 

See comment 1. 

See comment 2. 

See comment 3. 

See comment 4. 

See comment 5. 
Enclosure II 

20 GAO-06-157R FDA Feed Testing Program 
Enclosure II 

21 GAO-06-157R FDA Feed Testing Program 

See comment 6. 

See comment 7. 
Enclosure II 

22 GAO-06-157R FDA Feed Testing Program 

See comment 8. 
Enclosure II 

23 GAO-06-157R FDA Feed Testing Program 

See comment 9. 

See comment 10. 

See comment 11. 
Enclosure II 

24 GAO-06-157R FDA Feed Testing Program 

See comment 12. 

See comment 13. 
Enclosure II 

25 GAO-06-157R FDA Feed Testing Program 

The following are GAO’s comments on the Food and Drug Administration’s letter 

received on Monday, September 19, 2005. 

GAO comments 

1. At our September 7, 2005, exit meeting with FDA, FDA raised concern that 

the draft title could be taken out of context by U.S. trading partners who 

would not read the report and could construe that we were talking about 

weaknesses in FDA’s bovine spongiform encephalopathy (BSE) oversight 

efforts in general. We told FDA officials that we would look at the title in 

that light. We revised the title to better ensure that readers would realize 

by the title alone that the report focused on the small feed testing program 

that FDA started in August 2003. At the exit meeting, FDA also provided us 

with an untitled and undated document that FDA officials identified as a 

list of time frames for laboratories to complete analysis on various testing 

programs, including the feed testing program. The targeted time frame for 

the feed testing program—from receipt of sample to classifying the sample 

in FACTS—was 20 working days. As our report states, the time frames 

from sample collection to documenting the laboratory result in FACTS 

exceeded 30 days for 473 of the 989 samples we assessed. These included 

17 samples that took from 60 to 100 days and 21 that took more than 100 

days. FDA officials agreed that these time frames were unacceptable and 

did not challenge our analysis. FDA did not give us data on whether 

laboratories are meeting the 20-working day target. Also, FDA could not 

provide information on the time it took for districts to follow up and make 

a final determination on the 215 potential violations we report because it 

did not track those time frames. The timeliness of the entire process from 

sample collection to final determination is a factor that directly affects 

cattle’s exposure. The second recommendation in our draft report initially 

recommended that FDA establish time frames for laboratories to complete 

sample analysis to minimize cattle’s exposure to potentially contaminated 

feed. Because FDA did not provide data to assess whether the delays are 

occurring during sample collection, laboratory analysis, or follow-up, we 

revised our recommendation to address the need to minimize the overall 

time frame to protect cattle. 

2. FDA expressed concern that we were issuing a report that focused on one 

small aspect of its BSE oversight efforts. We agree that the feed testing 

program is a small component of FDA’s overall efforts, but it vies for FDA’s 

limited BSE oversight resources. As we pointed out in our more 

comprehensive February 2005 report—Mad Cow Disease: FDA’s 

Management of the Feed Ban Has Improved, but Oversight Weaknesses 

Continue to Limit Program Effectiveness (GAO-05-101; Feb. 25, 2005)—

we looked at this small program separately because FDA did not provide 

program data in time for its inclusion in the broader report. 
Enclosure II 

26 GAO-06-157R FDA Feed Testing Program 

3. FDA stated that its field staff spent nearly 600 hours to provide information 

to us, and headquarters also spent time to compile information and to 

respond to questions about the program. We had to collect follow-up 

information directly from staff because it was not readily available in 

FDA’s FACTS data system or other electronic data systems. We 

specifically asked FDA not to create documents or compile data after the 

fact. While routine interviews are always involved to clarify our 

understanding of agency documents and data, this study was designed and 

intended to be primarily an analysis of FDA data on the program. 

4. As we note in comment 1, we revised our second recommendation to 

address the need to minimize the overall time frame to protect cattle. 

Comments 11 and 13 discuss FDA’s concerns with the other two 

recommendations. 

 

5. FDA points out that it also has a feed testing program for imported feed 

and feed ingredients. Our report focused on the domestic feed testing 

program that FDA identified as a component of its BSE oversight during 

our earlier study, which resulted in the February 2005 report. We did not 

assess the import feed testing program. 

6. We last examined USDA and other federal BSE detection and prevention 

efforts—other than FDA—in 2002 in a report entitled Mad Cow Disease: 

Improvements in the Animal Feed Ban and Other Regulatory Areas 

Would Strengthen U.S. Prevention Efforts (GAO-02-183; Jan. 25, 2002) 

7. We agree with FDA that feed testing alone may not be able to verify the 

presence of prohibited material and that follow-up is necessary to 

determine whether the feed ban has been violated. Thoroughly 

documenting follow-up actions and the rationale for compliance 

determinations is critical to FDA’s effective oversight of the feed ban. Our 

report recommends that FDA fully implement the 2005 directive and 

revised assignment that require its districts to thoroughly document the 

basis for their decisions. 

8. FDA maintains that it is assessing the potential usefulness of feed testing. 

Because feed testing is using FDA’s limited BSE oversight resources, it is 

imperative that FDA properly exercise oversight of the program by 

evaluating the costs and benefits, developing measurable goals, and 

periodically assessing trends to optimize the use of these resources. We 

believe that implementing our recommendations will help FDA in its 

assessment. 

9. FDA describes the refinement of PCR technology in the context of an 

ongoing technology evaluation. FDA officials made similar comments 

during the course of our work. However, FDA did not provide any 
Enclosure II 

27 GAO-06-157R FDA Feed Testing Program 

information on the evaluation criteria it is using to measure performance or 

on the cost of developing and refining PCR technology. 

10. The draft and the final report clearly state that the feed testing program is a 

small part of BSE’s oversight effort and provides FDA with additional 

information about some sample feed. 

11. We are continuing to include a recommendation that FDA fully implement 

the June 2005 directive and the July 2005 revised assignment to help ensure 

that FDA maintains its momentum and commitment to the new 

procedures. Because the feed testing program draws resources from 

FDA’s BSE oversight activities, it is important that FDA avoid 

implementation weaknesses that limited the potential usefulness of testing 

under the 2003 assignment. In conjunction with our other 

recommendations, fully implementing the directive and the revised 

assignment will help FDA better assure the usefulness of the feed testing 

program as a tool in its BSE oversight efforts. 

12. See discussion of the second recommendation in comment 1. 

13. FDA disagreed with our assertion that the sampling assignment was poorly 

implemented and that it did not adequately oversee the program. 

According to FDA, the FACTS database was used to fully describe feed 

collection and laboratory activities and spreadsheets containing collection 

and laboratory information were distributed weekly and reviewed by FDA 

headquarters managers. FDA provided a copy of this spreadsheet that 

contained counts of the number of samples taken and the laboratory 

classification. However, each week’s spreadsheet overrode the week 

before, and FDA's managers did not maintain previous versions. 

Furthermore, they could not provide any report that summarized their 

weekly review. Thus, FDA’s managers could not do any comparative 

analysis, such as examining the type of feed sampled across districts. FDA 

also did not track or have any reports on follow-up activities or 

determinations to assess whether, for example, districts were using the 

same criteria. We envision a more substantive and meaningful oversight 

that might include comparisons of follow-up findings across districts, 

analyses of the number and types of new firms identified, assessments on 

how frequently follow-up involved only a file review or an on-site 

inspection, and decisions about what documents are consistently proving 

the most useful in expediting follow-up. These or other types of analyses 

give managers better information to assess program performance. 

(360563)
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