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 (11-OCT-05, GAO-06-157R).	 
                                                                 
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. 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), 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. 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 industry. 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. 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. 		 
-------------------------Indexing Terms------------------------- 
REPORTNUM:   GAO-06-157R					        
    ACCNO:   A39477						        
  TITLE:     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				 
     DATE:   10/11/2005 
  SUBJECT:   Animal diseases					 
	     Cattle						 
	     Federal regulations				 
	     Feed additives					 
	     Feed industry					 
	     Infectious diseases				 
	     Inspection 					 
	     Livestock products 				 
	     Program evaluation 				 
	     Bovine Spongiform Encephalopathy			 
	     FDA Field Accomplishments and Compliance		 
	     Tracking System					 
                                                                 

******************************************************************
** This file contains an ASCII representation of the text of a  **
** GAO Product.                                                 **
**                                                              **
** No attempt has been made to display graphic images, although **
** figure captions are reproduced.  Tables are included, but    **
** may not resemble those in the printed version.               **
**                                                              **
** Please see the PDF (Portable Document Format) file, when     **
** available, for a complete electronic file of the printed     **
** document's contents.                                         **
**                                                              **
******************************************************************
GAO-06-157R

United States Government Accountability Office Washington, DC 20548

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

1

and other ruminants. 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

1Ruminants 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.

221 C.F.R. S:589.2000.

3Adding protein (derived from animals or plants) to feed is a common
nutritional practice used to speed animal growth.

                      GAO-06-157R FDA Feed Testing Program

4

industry. 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

4GAO, 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).

5GAO, 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). 6The PCR test works by aiding in the
differentiation of mitochondrial DNA between animal species.

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,

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,

o  	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.

o  	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.

o  	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

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

7

prohibited material can be tracked from receipt through disposition. 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

8

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

7The feed-ban rule is based on FDA's authority to regulate food additives,
21 U.S.C. S:S: 321(s), 348, as well as other authorities.

8Plate 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.

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

9FDA 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.

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.

Table 1: Classification of 989 Feed Samples by FDA Laboratories and
Districts, by Feed Type, August 2003 through June 2005

                                         Number of Number of                  
                                           samples samples                    
                                      laboratories districts     
                                     classified as classified as 
                                       identifying demonstrating 
                                         potential violations of 
       Type of feed or     Number of    violations the feed-ban   Enforcement
     ingredient sampled      samples               rule          action taken
     Feed or ingredients                                            1 warning 
     intended for cattle         662           141             1       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.

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

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).

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

Number of samples

600

500

400

300

200

100

0

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

Days to analyze samples and document findings

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

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

12

their activities and programs. 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

                                       13

activity compared with its intended purpose. 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:

o  	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.

o  	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.

o  	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.

o  	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).

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

o  	all feed sample analysis and follow-up actions are documented
accurately and in a timely fashion in the agencywide FACTS compliance
tracking system;

o  	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

o  	districts complete and document follow-up actions within 30 working
days following receipt of sample results from the laboratory.

The July 2005 revised program instructions clarify sample selection
criteria and require, among other things, that

o  	laboratories use PCR to verify samples that indicate the possible
presence of mammalian bone or hair, and

o  	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

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:

o  	Fully implement the June 2005 field management directive and July 2005
assignment memorandum revising the feed testing program.

o  	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.

o  	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

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 [email protected]. 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

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
                           Collected and           Collected and analyzed, as 
                  Assigned     analyzeda Assigned             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.

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

Enclosure II

Comments from the Food and Drug Administration

Note: GAO comments supplementing those in the report text appear at the
end of this enclosure.

18 GAO-06-157R FDA Feed Testing Program

                                  Enclosure II

                                 See comment 1.

                                 See comment 2.

                                 See comment 3.

                                 See comment 4.

                                 See comment 5.

                    19 GAO-06-157R FDA Feed Testing Program

                                  Enclosure II

                    20 GAO-06-157R FDA Feed Testing Program

                                  Enclosure II

                                 See comment 6.

                                 See comment 7.

                    21 GAO-06-157R FDA Feed Testing Program

                                  Enclosure II

                                 See comment 8.

                    22 GAO-06-157R FDA Feed Testing Program

                                  Enclosure II

                                 See comment 9.

                                See comment 10.

                                See comment 11.

                    23 GAO-06-157R FDA Feed Testing Program

                                  Enclosure II

                                See comment 12.

                                See comment 13.

                    24 GAO-06-157R FDA Feed Testing Program

Enclosure II 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.

                    25 GAO-06-157R FDA Feed Testing Program

                                  Enclosure II

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

                    26 GAO-06-157R FDA Feed Testing Program

Enclosure II 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)

                    27 GAO-06-157R FDA Feed Testing Program

This is a work of the U.S. government and is not subject to copyright
protection in the United States. It may be reproduced and distributed in
its entirety without further permission from GAO. However, because this
work may contain copyrighted images or other material, permission from the
copyright holder may be necessary if you wish to reproduce this material
separately.

                                 GAO's Mission

Obtaining Copies of GAO Reports and Testimony

The Government Accountability Office, the audit, evaluation and
investigative arm of Congress, exists to support Congress in meeting its
constitutional responsibilities and to help improve the performance and
accountability of the federal government for the American people. GAO
examines the use of public funds; evaluates federal programs and policies;
and provides analyses, recommendations, and other assistance to help
Congress make informed oversight, policy, and funding decisions. GAO's
commitment to good government is reflected in its core values of
accountability, integrity, and reliability.

The fastest and easiest way to obtain copies of GAO documents at no cost
is through GAO's Web site (www.gao.gov). Each weekday, GAO posts newly
released reports, testimony, and correspondence on its Web site. To have
GAO e-mail you a list of newly posted products every afternoon, go to
www.gao.gov and select "Subscribe to Updates."

Order by Mail or Phone 	The first copy of each printed report is free.
Additional copies are $2 each. A check or money order should be made out
to the Superintendent of Documents. GAO also accepts VISA and Mastercard.
Orders for 100 or more copies mailed to a single address are discounted 25
percent. Orders should be sent to:

U.S. Government Accountability Office 441 G Street NW, Room LM Washington,
D.C. 20548

To order by Phone: 	Voice: (202) 512-6000 TDD: (202) 512-2537 Fax: (202)
512-6061

                           To Report Fraud, Contact:

Waste, and Abuse in Web site: www.gao.gov/fraudnet/fraudnet.htm

E-mail: [email protected] Programs Automated answering system: (800)
424-5454 or (202) 512-7470

Gloria Jarmon, Managing Director, [email protected] (202)
512-4400Congressional U.S. Government Accountability Office, 441 G Street
NW, Room 7125 Relations Washington, D.C. 20548

Public Affairs 	Paul Anderson, Managing Director, [email protected] (202)
512-4800 U.S. Government Accountability Office, 441 G Street NW, Room 7149
Washington, D.C. 20548

                           PRINTED ON RECYCLED PAPER
*** End of document. ***