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 Gao ID: GAO-06-157R October 11, 2005In 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.
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, 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.
RecommendationsOur recommendations from this work are listed below with a Contact for more information. Status will change from "In process" to "Open," "Closed - implemented," or "Closed - not implemented" based on our follow up work.
Director: Team: Phone:GAO-06-157R, 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
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Washington, DC 20548:
United States Government Accountability Office:
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.[Footnote 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),[Footnote 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.[Footnote 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 industry.[Footnote 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.[Footnote 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.[Footnote 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 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,
* 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 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.[Footnote 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 animal-derived
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.[Footnote 8] In addition, poultry
litter (composed of poultry waste material, bedding, and spilled feed
that is used as a protein source) is allowed in cattle feed.[Footnote
9] Consequently, the presence of animal protein in a feed sample may or
may not indicate a violation of the feed-ban rule.[Footnote 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 in the feed chain revealed a high level of
compliance with the feed-ban rule.[Footnote 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).
Table 1: Classification of 989 Feed Samples by FDA Laboratories and
Districts, by Feed Type, August 2003 through June 2005:
[See PDF for image]
Source: GAO analysis of FDA data.
[End of table]
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:
[See PDF for image]
Source: GAO analysis of FDA data.
[End of table]
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:
[See PDF for image]
Source: GAO analysis of FDA data.
[End of table]
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:
[See PDF for image]
Source: GAO Analysis of FDA Data.
[End of figure]
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 their activities and programs.[Footnote 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.[Footnote 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.
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 follow-up 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.
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 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 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.
Signed by:
Robert A. Robinson:
Managing Director, Natural Resources and Environment:
Enclosures:
Number of Feed Samples Assigned and Collected and Analyzed, as of June
7, 2005, by FDA District:
[See PDF for image]
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.
[End of table]
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.
DEPARTMENT OF HEALTH & HUMAN SERVICES:
Public Health Service:
Food and Drug Administration:
Rockville MD 20857:
Robert A. Robinson:
Managing Director, Natural Resources and Environment:
Natural Resources and Environment Team:
United States Government Accountability Office:
441 G Street, NW:
Washington, DC 20548:
Dear Mr. Robinson:
Please find enclosed the general comments in response to the General
Accountability Office's correspondence entitled, "Mad Cow Disease: FDA
Needs to Fully Implement New Procedures and Correct Other Design Flaws
for the Feed Testing Program to Help Assure Industry Compliance with
the Feed Ban."
We appreciate the opportunity to review and comment on this draft
correspondence before it is published, as well as the opportunity to
work with your staff in its development.
Sincerely,
Signed by:
Lester M. Crawford, D.V.M., Ph. D.,
Commissioner of Food and Drugs:
Enclosure:
FDA General Comments on the Government Accountability Office's Draft
Letter on Mad Cow Disease Follow-up: Feed Testing (GAO-05-904R):
FDA values the opportunity to review and comment on the Government
Accountability Office's (GAO) draft document. Even though we understand
based on our exit conference discussion that some changes will be made
in the draft document, our comments are based on our review of the
draft provided on August 17, 2005, including the draft recommendations
for executive action. We are concerned that GAO's issuance of a
document that focuses on a small component of the overall BSE control
program places an undue emphasis on that component's impact on the
program. For that reason, FDA will present an overview of the BSE
program operating in the United States, and attempt to place into
perspective the role feed testing contributes to the overall program.
FDA will also offer comments on GAO's three recommendations.
Additionally, it is important to note that FDA spent nearly 600 (ORA
and CVM) hours providing information to GAO on this supplemental study.
This includes time accounted for when GAO conducted interviews with
every FDA District office, as well as time spent by Headquarters' staff
compiling information and responding to the 33 questions that GAO asked
in order to assess if feed testing helped FDA better assure industry
compliance with the feed ban.
GAO provided three draft recommendations for executive action. For the
first recommendation, FDA appreciates GAO's recognition that the June
2005 field management directive and July 2005 BSE sampling assignment
memorandum provide controls that enhance the agency's ability to
evaluate the utility of this program in the future. Regarding the
second recommendation, FDA disagrees that laboratory testing timeframes
to complete sample analysis for domestic surveillance samples are a
critical element to minimize cattle's exposure to potentially
contaminated feed. Lastly, with regard to the third recommendation, FDA
also disagrees with GAO's assertion that the sampling assignment was
poorly implemented, and that FDA did not adequately oversee the
assignment.
While GAO identifies in its report that feed testing is a small
component of FDA's BSE oversight effort, we believe it is critical to
clarify the current perspective on the utility that feed testing plays
in relation to the overall U.S. BSE control program. The U.S. cattle
BSE control program consists of a multifaceted system to keep the
disease from entering and spreading. The components consist of import
controls on ruminant animals and animal feed, a BSE surveillance cattle
testing program, an effective response to the finding of BSE positive
animals, and a feed ban. This program remains a top priority for FDA,
USDA, and other government agencies. While we focus on the feed ban in
this discussion, we will touch on the other facets to make certain the
overall control program is understood.
Import control is the critical safeguard preventing the BSE agent from
entering the United States. FDA and the USDA's Animal and Plant Health
Inspection Service (APHIS) work in close cooperation with Customs and
Border Protection on controls related to imports of animals and animal-
derived products. Imports were restricted in 1989 from the United
Kingdom, and those restrictions were expanded to imports from countries
where BSE has been reported, and to countries identified to be at high
risk for BSE, as needed. It is important to note that testing imported
feed is a valuable component of our import controls for BSE, yet the
GAO did not include the import testing program in its audit or report.
USDA's active surveillance program to test cattle for BSE is another
element of the prevention efforts to date. USDA has tested more than
460,000 cattle from June 1, 2004 to mid-September 2005 and has found
one BSE-positive cow. Prior to June 1, 2004, USDA's surveillance
program identified an additional BSE-positive cow from Canada. In
addition to its continued testing of the higher risk cattle population,
USDA is planning to test a population of apparently healthy cattle over
30 months of age at slaughter.
An additional control measure is an effective and coordinated response
to the finding of a BSE-positive animal. In response to the December
2003 BSE-positive animal in Washington State, FDA, USDA, and the
Washington State Department of Agriculture coordinated closely in their
epidemiological investigation tracing the positive cow to its farm of
origin in Alberta, Canada, and in the traceforward investigation to
control potentially contaminated product derived from the positive
animal. A similarly coordinated response was seen in the investigation
of the Texas cow that was declared positive for BSE in June 2005.
Although the positive cow posed no risk to the human food or animal
feed supply, FDA, APHIS, the Texas Animal Health Commission, and the
Texas Feed and Fertilizer Control Service conducted an epidemiological
investigation of the herd of origin, as well as a feed investigation.
The feed investigation found that no feed or feed supplements used on
the farm since 1997 were formulated to contain mammalian protein
prohibited under the FDA Ruminant Feed Ban regulation, and that all the
investigated rendering plants were operating in compliance with the
regulation. This high level of coordination came about through
extensive planning, including the sharing of BSE response plans and the
conduct of three joint exercises with our federal and state partners to
test our capabilities to respond.
Another extremely important component in the BSE control program is
FDA's ruminant feed ban, which was put in place in 1997 to prevent the
amplification of BSE through feed in the event that the BSE agent had
been introduced into the United States. The regulation prohibits the
use of most mammalian protein in feeds for ruminant animals. This rule,
found in 21 CFR 589.2000, became effective on August 4, 1997. The
regulation reflected the best epidemiological knowledge at the time.
FDA continues to evaluate the science related to BSE and recognizes the
presence of BSE in the United States. Accordingly, FDA published
jointly with USDA an Advance Notice of Proposed Rulemaking (ANPRM) in
July 2004 to obtain information and comments on additional control
measures being considered to further strengthen the feed ban.
To implement its feed ban regulation, FDA has put into place a Ruminant
Feed Ban compliance program. The key elements of the compliance program
include education of industry on the requirements of the regulation,
inspection of facilities subject to the ban, and appropriate
enforcement of the regulation's requirements. Since a significant
portion of the animal feed industry was impacted by the new regulation,
the initial focus of the compliance program was to educate both the
industry and regulators about the feed ban. FDA sponsored numerous
workshops attended by state veterinarians and feed control officials
from all 50 States and Puerto Rico. In addition, FDA held briefing
sessions with trade associations and consumer groups and has developed
guidance documents to assist industry in complying with the regulation.
The major implementation tool to assure compliance by regulated parties
is a rigorous program of establishment inspections by FDA and state
regulatory counterparts. In collaboration with state feed control
officials, FDA has conducted over 37,000 inspections of renderers, feed
mills, protein blenders, as well as other firms subject to this
regulation such as ruminant feeders, on-farm mixers, pet food
manufacturers, animal feed salvagers, distributors, retailers, and
animal feed transporters. FDA routinely provides reports on its feed
ban enforcement activities. Additionally, FDA posts the results of
every firm inspected under the Ruminant Feed Ban program on the FDA web
site. Compliance with this regulation by renderers, feed mills, and
protein blenders remains very high. Furthermore, FDA has monitored
recalls, issued warning letters, and taken other enforcement actions
when significant violations have been documented during inspections.
The assignment to test domestic feed for the presence of prohibited
material is a relatively small component of FDA's overall domestic
Ruminant Feed Ban efforts. Since no test currently exists for the
detection of the agent that causes BSE in feed, analysis of feed is not
a means of verifying the safety of cattle feed. The substitute for the
infectious agent used in all current tests is the mammalian protein
prohibited under the Ruminant Feed Ban. However, the current tests
used, feed microscopy and/or PCR, are not adequate methods to make
compliance decisions about the presence of prohibited material since
the methods have limitations and the rule has exemptions. Feed
microscopy generally can only detect the presence of mammalian tissue,
either through the identification of bone or hair. The present Ruminant
Feed Ban allows for certain exemptions to the mammalian protein
prohibition. Exempted materials include pure porcine and equine meat
and bone meal, blood (from any animal species, including ruminants),
gelatin, and milk protein. There is no prohibition on the use of non-
mammalian proteins (e.g., poultry meal). Certain tissues, such as bone
or muscle, may be present as a result of the use of exempt ingredients,
such as pure porcine meat and bone meal or poultry meal. While the PCR
method can detect ruminant mitochondrial DNA, it cannot differentiate
between prohibited material and ingredients exempted by the feed ban,
such as ruminant blood and inspected meat products which have been
cooked and offered for human food and further heat processed for feed.
Since neither method can differentiate prohibited material from other
acceptable materials, the analytical results by themselves cannot be
used to verify the presence or absence of prohibited material. The only
way to determine compliance with the Ruminant Feed Ban rule is to
conduct an inspection of the firm.
The FDA assessment of the current weakness of the feed microscopy
method, as a compliance tool, is similar to findings by the Canadian
Food Inspection Agency (CFIA). CFIA conducted a recent trial on the
usefulness of microscopy method for analyzing the composition of feed.
CFIA found that the limitations of the microscopy method outweigh its
usefulness. Further, CFIA found that physical inspection of facilities
and records was necessary to determine compliance with Canada's BSE
feed controls, which are nearly identical to ours. The report is
available at www.inspection.gc.ca.
While CFIA came to its position after a small pilot test, FDA is still
assessing the potential usefulness of feed testing of domestically
produced products in FDA's long-term enforcement of the feed ban.
Further, the sampling assignment is designed to be an additional way to
review products in the marketplace by providing a supplemental piece of
intelligence to help in selecting firms for inspection coverage under
the compliance program. A positive finding from analytical testing
provides information for us to conduct targeted follow-up inspections,
but does not, by itself, prove the presence of prohibited material and
a violation of the Ruminant Feed Ban rule.
On August 18, 2003, FDA/CVM issued the first sampling assignment to the
FDA field staff for the collection of 600 domestic samples, which was
subsequently increased to 900 samples for the current fiscal year. The
fairly recent implementation of this unique sampling assignment has
involved efforts to train laboratory personnel in the techniques of
feed microscopy, to provide reference samples for confirmatory
comparison, and to assess proficiency in the technique by all
laboratories conducting analytical testing. Based on the agency's
experience derived from the initial sampling assignment, FDA issued a
second assignment in July 2005 that refines directions for sample
collection and classification and incorporates PCR for additional
analysis of samples found by the feed microscopy method to contain
animal tissue.
It is important to note that the scientific enhancements in this latest
assignment are based on research the agency has conducted on feed
testing methodology. In 2001, FDA published the results of its first
method validation trial using a PCR-based approach to detect bovine
materials in animal feed. This method was successfully validated at a
detection level of 0.125 percent bovine meat and bone meal, on a weight-
to-weight (w/w) basis. While a robust method, it was labor- intensive
to perform, requiring the analyst to prepare all the necessary
reagents. The 24 hours needed to analyze a sample further limited the
number of samples an analyst could process.
Subsequently, efforts were initiated to develop a second-generation PCR-
based assay using a DNA extraction method that was easier to perform
than the one used in the validated, first-generation PCR-based method.
Using a commercially available DNA Forensic Kit, a suitable method was
developed to permit extraction of DNA from animal feed and feed
ingredients. This method significantly shortened the time required to
analyze a single sample to under 8 hours, start-to-finish. In addition,
because the DNA extraction portion is significantly easier to perform,
the total number of samples that a single analyst can examine was
doubled. The second-generation method has been successfully validated
to permit detection of bovine, ovine, and porcine materials in animal
feed and feed ingredients at a level of 0.1 percent (w/w basis). FDA
has implemented this second-generation PCR-based assay in the enhanced
sampling assignment issued in July 2005 following validation work in
our field laboratories.
Both the first and second-generation PCR-based methods are conventional
PCR-based methods that rely on photo documentation followed by visual
interpretation of the results. These methods are at best semi-
quantitative. Currently, FDA scientists are working on a third-
generation PCR-based method that will use an approach called real-time
PCR. Real-time PCR assays measure the amount of product being formed
while the PCR process is still ongoing. There is no post-PCR processing
of the test samples as is required for the first and second-generation
PCR-based methods. Therefore, a real-time PCR based method will result
in a further reduction in time needed to analyze the feed samples. The
process involved in assessing PCR-product formation yields data that
are proportional to the amount of starting DNA in the test sample, and
therefore, these results are proportional to the amount of prohibited
proteins in the original sample. The chemistry involved with real-time
PCR permits direct addition of internal controls to ensure assay
functionality. Lastly, PCR products formed during real-time PCR permit
a determination as to whether or not the final PCR product was derived
from the expected species (e.g., bovine) by performing a melt-curve
analysis. Each PCR product will have a specific temperature at which
the double-stranded DNA molecules will separate.
While feed microscopy and PCR are used by FDA and some state
laboratories, these methods cannot be performed by all facilities and
organizations that need to test for the absence of prohibited proteins.
There are four companies that market various immunochemical test kits
(antibody-based) that are simpler to use than either PCR or feed
microscopy. These kits might also seem useful for FDA's purposes.
However, these test kits are marketed without FDA's review and
approval, as FDA does not have premarket approval authority over
veterinary devices. FDA therefore initiated a research program to
evaluate their performance characteristics. An essential aspect of this
evaluation was the development of acceptance criteria and performance
guidelines against which these tests would be assessed. An important
component of these guidelines was the criteria that these tests be able
to detect prohibited proteins at the same level as PCR and microscopy.
To date, we have completed our initial evaluation of two of these test
kits and are close to completing our evaluation of a third kit. The two
test kits for which we have completed our evaluation did not meet our
acceptance criteria and performance guidelines; one test had an
unacceptable rate of false positives (true negatives that the test
deemed to be positive) and the second test kit did not have the
sensitivity set out in our performance criteria.
FDA remains firmly committed to fostering the development of new
technologies to better understand BSE. Future scientific. research may
uncover a way to definitively test for the presence of prohibited
materials in animal feed or to detect the presence of the agent that
causes BSE in feed. FDA will continue to evaluate and make changes to
the sampling assignment to reflect current validated scientific
methods.
In conclusion, FDA's Ruminant Feed Ban domestic sampling program is
unlike other sampling programs where analytical methods are available
to detect specific pathogens, toxins, or residues that are considered
adulterants in FDA regulated products. For the Ruminant Feed Ban
domestic sampling and analysis assignment evaluated by GAO in this
study, the analytical contribution to assurances of compliance is more
limited due to the constraints of the currently available test
methodologies and existing exemptions for mammalian proteins in the
regulation. For this reason, FDA conducts only limited testing under
this surveillance assignment (in FY'04 this assignment only accounted
for approximately 600 of the over 46,000 samples collected and analyzed
by FDA regulatory laboratories). The domestic sampling and analysis
component of the Ruminant Feed Ban may become a more valuable tool in
the future, or may be discontinued, depending on development of new
technologies or methods, enhancements to strengthen the feed ban that
may be instituted, and/or a better scientific understanding of the
epidemiology and pathogenesis of the BSE agent in animal populations.
GAO 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, GAO recommends
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.
FDA Response:
FDA appreciates GAO's recognition that the June 2005 field management
directive and July 2005 BSE sampling assignment memorandum provide
controls that enhance the agency's ability to evaluate the utility of
this program in the future and intends to implement the current
versions or subsequent versions of these documents that are issued.
* Establish timeframes for laboratories to complete sample analysis to
minimize cattle's exposure to potentially contaminated feed.
FDA Response:
FDA field laboratories currently have timeframes for completing sample
analyses. The timeframes are 10 business days for compliance samples
and 20 business days for surveillance samples. The samples taken under
the BSE feed sampling assignment are surveillance samples, as opposed
to compliance samples. Because import and "for- cause" samples are
given priority, laboratories are sometimes unable to complete analysis
of surveillance samples within 20 days.
FDA will evaluate the number of days it has taken laboratories to
complete their analyses under this program and will set new timeframes,
if needed. This evaluation will be completed as part of management's
oversight of the implementation of the June 2005 field management
directive and July 2005 sampling assignment memorandum.
GAO asserts that expedited laboratory testing will minimize cattle's
exposure to potentially contaminated feed. FDA disagrees that
laboratory testing timeframes to complete sample analysis for domestic
surveillance samples are a critical element to minimize cattle's
exposure to potentially contaminated feed. FDA relies on its overall
inspection program, rather than analytical methods alone, to enforce
the feed ban.
* 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.
FDA Response:
FDA disagrees with GAO's assertion that the sampling assignment was
poorly implemented, and that FDA did not adequately oversee the
assignment. The FACTS database was utilized in fully describing feed
collection and laboratory activities. Feed collection information
includes feed type, a feed description, a feed label summary, and the
identity of the associated feed manufacturer and distributor.
Laboratory information includes a full description of the test
utilized, the observations of the analyst, and the laboratory
classification of the sample results. Spreadsheets containing both
types of information were generated on a weekly basis and distributed
throughout FDA headquarters. These data spreadsheets were constantly
examined and utilized by FDA headquarters' managers in providing
feedback and education to District and laboratory personnel.
Although the spreadsheet did not contain information regarding follow-
up activities, FDA headquarters was in constant communication with
Districts concerning questions and issues related to sample collection
and interpretation of analytical results. This oversight and
communication were reflected in an improved understanding of the
sampling assignment's goals by Districts and laboratories as time
progressed.
The experiences gained through the August 2003 sampling assignment
allowed for significant improvements as represented in the revised
assignment issued in July 2005. The issuance of the revised assignment
was somewhat delayed until all laboratories were fully prepared to
utilize the new PCR method. The recording of follow-up summaries in the
FACTS database and the development of additional database reports have
enhanced the ability of FDA headquarters to more effectively evaluate
all aspects of activities related to feed testing efforts.
FDA notes that the assignment may again be revised based on experiences
involving the incorporation of the new PCR method. FDA will continue to
monitor and evaluate feed testing to determine whether it is a
worthwhile component of FDA's long-term BSE prevention efforts.
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.
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
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.
[End of section]
(360563):
FOOTNOTES
[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.
[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.
[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.
[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.
[10] In 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.
[11] FDA 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.
[12] See 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).
[13] Pub. L. No. 103-62, 107 Stat. 285 (1993).
