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From: TSS ()
Subject: Mad Cow Disease: An Evaluation of a Small Feed Testing Program FDA Implemented in 2003 GAO-06-157R, October 11
Date: November 9, 2005 at 12:22 pm PST

GAO


GAO-06-157R FDA Feed Testing Program

October 11, 2005

The Honorable Saxby Chambliss

Chairman

The Honorable Tom Harkin

Ranking Democratic Member

Committee on Agriculture, Nutrition, and Forestry

United States Senate

The Honorable Thad Cochran

United States Senate

The Honorable Richard J. Durbin

United States Senate

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

Implemented in 2003 With Recommendations for Making the Program a Better

Oversight Tool

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

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

and other ruminants.1 The feed-ban rule is one of the primary actions taken by the

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

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

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

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

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

States.

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

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

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

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.

2

21 C.F.R. §589.2000.

3

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

animal growth.

United States Government Accountability Office

Washington, DC 20548

2 GAO-06-157R FDA Feed Testing Program

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

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

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

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

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

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

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

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

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

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

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

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

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

August 2003, entitled Assignment Memorandum—Sample Assignment for Domestic

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

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

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

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

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

during fiscal year 2005.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

complied with or has violated the feed-ban rule.

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

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).

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).

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

3 GAO-06-157R FDA Feed Testing Program

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

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

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

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

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

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

identify as potential violations.

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

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

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

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

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

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

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

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

implemented under the August 2003 guidance document. We compared sample

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

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

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

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

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

determinations on potential violations, we obtained and analyzed additional electronic

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

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

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

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

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

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

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

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

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

documentation in FACTS, spreadsheets maintained by individual district offices,

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

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

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

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

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

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

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

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

feed testing program data reliability and internal controls.

Results in Brief

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

several methods FDA uses to monitor for compliance with the feed-ban rule. However,

4 GAO-06-157R FDA Feed Testing Program

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

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

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

their final determinations on samples that the laboratories identified as

potentially containing banned protein products. Although the districts may have

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

decisions cannot be reviewed and confirmed.

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

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

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

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

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

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

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

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

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

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

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

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

contributing to the agency’s BSE oversight efforts.

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

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

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

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

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

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

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

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

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

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

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

assure the program is achieving its intended goals.

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

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

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

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

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

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

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

complete sample analyses and that headquarters managers exercise sufficient oversight

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

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

occurring, we revised our recommendation to address the need to minimize overall

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.

SNIP...FULL TEXT 29 PAGES ;

http://www.gao.gov/new.items/d06157r.pdf


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-06-157R, October 11
http://www.gao.gov/cgi-bin/getrpt?GAO-06-157R


Docket No, 04-047-l Regulatory Identification No. (RIN) 091O-AF46 NEW BSE SAFEGUARDS (comment submission)

https://web01.aphis.usda.gov/regpublic.nsf/0/eff9eff1f7c5cf2b87256ecf000df08d?OpenDocument

Docket No. 03-080-1 -- USDA ISSUES PROPOSED RULE TO ALLOW LIVE ANIMAL
IMPORTS FROM CANADA


https://web01.aphis.usda.gov/BSEcom.nsf/0/b78ba677e2b0c12185256dd300649f9d?OpenDocument&AutoFramed


Docket No. 2003N-0312 Animal Feed Safety System [TSS SUBMISSION]

http://www.fda.gov/ohrms/dockets/dockets/03n0312/03N-0312_emc-000001.txt

Docket Management Docket: 02N-0273 - Substances Prohibited From Use in

Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed

Comment Number: EC -10

Accepted - Volume 2


http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004be07.html

PART 2


http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004be09.html

PDF]Freas, William TSS SUBMISSION

File Format: PDF/Adobe Acrobat -

Page 1. J Freas, William From: Sent: To: Subject: Terry S. Singeltary

Sr. [flounder@wt.net] Monday, January 08,200l 3:03 PM freas ...

http://www.fda.gov/ohrms/dockets/ac/01/slides/3681s2_09.pdf

Asante/Collinge et al, that BSE transmission to the 129-methionine

genotype can lead to an alternate phenotype that is indistinguishable

from type 2 PrPSc, the commonest _sporadic_ CJD;

http://www.fda.gov/ohrms/dockets/ac/03/slides/3923s1_OPH.htm

Docket No, 04-047-l Regulatory Identification No. (RIN) 091O-AF46 NEW BSE SAFEGUARDS (comment submission)https://web01.aphis.usda.gov/regpublic.nsf/0/eff9eff1f7c5cf2b87256ecf000df08d?OpenDocument[Docket No. 03-025IFA] FSIS Prohibition of the Use of Specified Risk Materials for Human Food and Requirement for the Disposition of Non-Ambulatory Disabled Cattle03-025IFA03-025IFA-2Terry S. SingeltaryPage 1 of 17From: Terry S. Singeltary Sr. [flounder9@verizon.net]Sent: Thursday, September 08, 2005 6:17 PMTo: fsis.regulationscomments@fsis.usda.govSubject: [Docket No. 03-025IFA] FSIS Prohibition of the Use of Specified Risk Materials for Human Food and Requirementsfor the Disposition of Non-Ambulatory Disabled CattleGreetings FSIS,I would kindly like to submit the following to [Docket No. 03-025IFA] FSIS Prohibition of the Use of Specified Risk Materials for Human Food andRequirements for the Disposition of Non-Ambulatory Disabled CattleTHE BSE/TSE SUB CLINICAL Non-Ambulatory Disabled CattleBroken bones and such may be the first signs of a sub clinical BSE/TSE Non-Ambulatory Disabled Cattle ;SUB CLINICAL PRION INFECTIONMRC-43-00Issued: Monday, 28 August 2000NEW EVIDENCE OF SUB-CLINICAL PRION INFECTION: IMPORTANT RESEARCHFINDINGS RELEVANT TO CJD AND BSEA team of researchers led by Professor John Collinge at the MedicalResearch Council Prion Unit1 report today in the Proceedings of theNational Academy of Sciences, on new evidence for the existence of a?sub-clinical? form of BSE in mice which was unknown until now.
snip...full text;

9/13/2005
http://www.fsis.usda.gov/OPPDE/Comments/03-025IFA/03-025IFA-2.pdf


TSS





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