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From: TSS ()
Date: July 20, 2006 at 7:05 am PST

In Reply to: JOHANNS USDA ET AL WILL STAND UP AND LIE ABOUT USA BSE IN 4 MINUTES posted by TSS on July 20, 2006 at 6:55 am:

Finding 2 Inherent Challenges in Identifying and Testing High-Risk Cattle
Still Remain Our prior report identified a number of inherent problems in
identifying and testing high-risk cattle. We reported that the challenges in
identifying the universe of high-risk cattle, as well as the need to design
procedures to obtain an appropriate representation of samples, was critical
to the success of the BSE surveillance program. The surveillance program was
designed to target nonambulatory cattle, cattle showing signs of CNS disease
(including cattle testing negative for rabies), cattle showing signs not
inconsistent with BSE, and dead cattle. Although APHIS designed procedures
to ensure FSIS condemned cattle were sampled and made a concerted effort for
outreach to obtain targeted samples, industry practices not considered in
the design of the surveillance program reduced assurance that targeted
animals were tested for BSE. In our prior report, we recommended that APHIS
work with public health and State diagnostic laboratories to develop and
test rabies-negative samples for BSE. This target group is important for
determining the prevalence of BSE in the United States because rabies cases
exhibit clinical signs not inconsistent with BSE; a negative rabies test
means the cause of the clinical signs has not been diagnosed. Rabies
Negative Samples APHIS agreed with our recommendation and initiated an
outreach program with the American Association of Veterinary Laboratory
Diagnosticians, as well as State laboratories. APHIS also agreed to do
ongoing monitoring to ensure samples were obtained from this target
population. Although APHIS increased the samples tested from this target
group as compared to prior years, we found that conflicting APHIS
instructions on the ages of cattle to test resulted in inconsistencies in
what samples were submitted for BSE testing. Therefore, some laboratories
did not refer their rabies negative samples to APHIS in order to maximize
the number tested for this critical target population. In addition, APHIS
did not monitor the number of submissions of rabies negative samples for BSE
testing from specific laboratories. According to the Procedure Manual for
BSE Surveillance, dated October 2004, the target population includes:
Central nervous system (CNS) signs and/or rabies negative - sample animals
of any age (emphasis added): a. Diagnostic laboratories –samples submitted
due to evidence of CNS clinical signs.
USDA/OIG-A/50601-10-KC Page 19
USDA/OIG-A/50601-10-KC Page 20
b. Public health laboratories – rabies negative cases. c. Slaughter
facilities – CNS ante mortem condemned at slaughter, sampled by FSIS. d.
On-the-farm – CNS cattle that do not meet the criteria for a foreign animal
disease investigation. For FYs 2002, 2003, and 2004 (through February 2004),
NVSL received 170, 133, and 45 rabies-negative samples, respectively.
Between June 1, 2004, and May 29, 2005, the number of samples received for
testing increased to 226 rabies suspect samples. The collection sites
submitting these samples follow. Collection Site Number of Rabies Suspect
Submissions * Slaughter Plant 0 Renderer 2 On-Farm 11 Public Health Lab 94
Diagnostic Lab 81 3D-4D 8 Other 4 Total 200 * 26 were tested but not counted
by APHIS towards meeting the target goals because the obex was not
submitted. We obtained a copy of a memorandum, dated July 13, 2004, that
APHIS sent to diagnostic and public health laboratories providing them
instructions on submitting samples for cattle showing signs of CNS diseases,
but testing negative for rabies. The letter was sent to about 170 State
veterinary diagnostic and public health laboratories and discussed the need
to submit specimens to NVSL of all adult cattle (emphasis added) that showed
signs of CNS diseases, but tested negative for rabies. This directive did
not specify the age of the cattle. The Procedure Manual for BSE
Surveillance, dated October 2004, specified samples of cattle of any age
should be submitted. We contacted laboratories in six States to determine if
it was standard procedure to submit all negative rabies samples to NVSL. We
found that, because of the lack of specificity in the APHIS letter and
inadequate followup by APHIS, there were inconsistencies in the age of
cattle samples submitted for BSE testing. For those States contacted, the
following samples were submitted versus tested as negative for rabies.
USDA/OIG-A/50601-10-KC Page 21
Rabies Negative Tests Not Sent for BSE Testing Since June 1, 2004 State
Negative Rabies Tests Sent for BSE Testing Not Sent for BSE Testing
Pennsylvania a/ 33 15 18 Kansas b/ 85 69 16 Wisconsin c/ 12 1 11 South
Dakota d/ 7 0 7 Arizona e/ 5 5 0 Mississippi e/ 4 4 0 Total 146 94 52 a/ A
Pennsylvania laboratory official said only rabies negative cattle over 20
months of age were submitted for BSE testing. The laboratory did not submit
18 samples for BSE testing because the animals were less than 20 months of
age. b/ Kansas laboratory officials said early in the expanded surveillance
program, there was confusion as to the cattle ages that should be submitted
for BSE testing. They did not know if cattle should be submitted that were
above 20 months or 30 months of age. Of the 16 animals not submitted for BSE
testing, 14 were under 20 months of age from early in the expanded
surveillance program. The other two animals were not tested due to internal
laboratory issues. The Kansas and Nebraska area office officials contacted
the laboratory and told the officials to submit rabies negative cattle of
any age for BSE testing. The laboratory now submits all rabies negative
cattle for BSE testing. c/ A Wisconsin laboratory official said only rabies
negative cattle samples 30 months of age or older are submitted for BSE
testing. Of the 11 animals not submitted for BSE testing, 8 were less than
30 months of age. Wisconsin laboratory officials were not certain why the
other three samples were not submitted. d/ Laboratory officials from South
Dakota said they did not receive notification from APHIS regarding the
submission of rabies negative cases for BSE testing. The section supervisor
and laboratory director were not aware of any letter sent to the laboratory.
The section supervisor said most bovine rabies tests at the laboratory are
performed on calves. We confirmed the laboratory’s address matched the
address on APHIS’ letter distribution list. However, there was no evidence
that the South Dakota area office contacted the laboratory. The laboratory
was not listed on the documentation from the APHIS regional office detailing
the area office contacts with laboratory personnel. We contacted the South
Dakota area office and were advised that while some contact had been made
with the laboratory, the contact may have involved Brucellosis rather than
BSE. On May 4, 2005, the area office
advised us they recently contacted the laboratory regarding the submission
of rabies negative samples for BSE testing. e/ Arizona and Mississippi
laboratory officials said they submitted all rabies negative samples for BSE
testing regardless of the age of the animal. An NVSL official stated that
APHIS is not concerned with rabies negatives samples from cattle less than
30 months of age. This position, however, is contrary to APHIS’ published
target population. Our prior audit recognized the significant challenge for
APHIS to obtain samples from some high-risk populations because of the
inherent problems with obtaining voluntary compliance and transporting the
carcasses for testing. USDA issued rules to prohibit nonambulatory animals
(downers) from entering the food supply at inspected slaughterhouses. OIG
recommended, and the International Review Subcommittee33 emphasized, that
USDA should take additional steps to assure that facilitated pathways exist
for dead and nonambulatory cattle to allow for the collection of samples and
proper disposal of carcasses. Between June 1, 2004, and May 31, 2005, the
APHIS database documents 27,617 samples were collected showing a reason for
submission of nonambulatory and 325,225 samples were collected with reason
of submission showing “dead.” Downers and Cattle that Died on the Farm APHIS
made extensive outreach efforts to notify producers and private
veterinarians of the need to submit and have tested animals from these
target groups. They also entered into financial arrangements with 123
renderers and other collection sites to reimburse them for costs associated
with storing, transporting, and collecting samples. However, as shown in
exhibit F, APHIS was not always successful in establishing agreements with
non-slaughter collection sites in some States. APHIS stated that agreements
do not necessarily reflect the entire universe of collection sites and that
the presentation in exhibit F was incomplete because there were many
collection sites without a payment involved or without a formal agreement.
We note that over 90 percent of the samples collected were obtained from the
123 collection sites with agreements and; therefore, we believe agreements
offer the best source to increase targeted samples in underrepresented
areas. We found that APHIS did not consider industry practices in the design
of its surveillance effort to provide reasonable assurance that cattle
exhibiting possible clinical signs consistent with BSE were tested.
Slaughter facilities do not always accept all cattle arriving for slaughter
because of their business requirements. We found that, in one State visited,
slaughter facilities pre-screened and rejected cattle (sick/down/dead/others
not meeting business
USDA/OIG-A/50601-10-KC Page 22
33 Report from the Secretary’s Advisory Committee on Foreign Animal and
Poultry Diseases, February 13, 2004.
USDA/OIG-A/50601-10-KC Page 23
standards) before presentation for slaughter in areas immediately adjacent
or contiguous to the official slaughter establishment. These animals were
not inspected and/or observed by either FSIS or APHIS officials located at
the slaughter facilities. FSIS procedures state that they have no authority
to inspect cattle not presented for slaughter. Further, APHIS officials
stated they did not believe that they had the authority to go into these
sorting and/or screening areas and require that the rejected animals be
provided to APHIS for BSE sampling. Neither APHIS nor FSIS had any process
to assure that animals left on transport vehicles and/or rejected for
slaughter arrived at a collection site for BSE testing. FSIS allows
slaughter facilities to designate the area of their establishment where
federal inspection is performed; this is designated as the official
slaughter establishment.34 We observed animals that were down or dead in
pens outside the official premises that were to be picked up by renderers.
Animals that were rejected by plant personnel were transported off the
premises on the same vehicles that brought them to the plant.35 A policy
statement36 regarding BSE sampling of condemned cattle at slaughter plants
provided that effective June 1, 2004, FSIS would collect BSE samples for
testing: 1) from all cattle regardless of age condemned by FSIS upon ante
mortem inspection for CNS impairment, and 2) from all cattle, with the
exception of veal calves, condemned by FSIS upon ante mortem inspection for
any other reason. FSIS Notice 28-04, dated May 20, 2004, informed FSIS
personnel that, “FSIS will be collecting brain samples from cattle at
federally-inspected establishments for the purpose of BSE testing.” The
notice further states that, “Cattle off-loaded from the transport vehicle
onto the premises of the federally-inspected establishment (emphasis added),
whether dead or alive, will be sampled by the FSIS Public Health
Veterinarian (PHV) for BSE after the cattle have been condemned during ante
mortem inspection. In addition, cattle passing ante mortem inspection but
later found dead prior to slaughter will be condemned and be sampled by the
FSIS PHV.” 34 FSIS regulations do not specifically address the designation
of an establishment’s “official” boundaries; however, FSIS Notices 29-04
(dated May 27, 2004) and 40-04 (dated July 29, 2004) make it clear that FSIS
inspection staff are not responsible for sampling dead cattle that are not
part of the “official” premises. 35 APHIS’ area office personnel stated that
it was their understanding that some establishments in the State were not
presenting cattle that died or were down on the transport vehicle to FSIS
for ante mortem inspection. The dead and down cattle were left in the
vehicle, if possible. In rare circumstances, dead cattle may be removed from
the trailer by plant personnel to facilitate the unloading of other animals.
36 A May 20, 2004, Memorandum between the Administrators of APHIS and FSIS.
USDA/OIG-A/50601-10-KC Page 24
APHIS has the responsibility for sampling dead cattle off-loaded onto
plant-owned property that is adjoining to, but not considered part of, the
“official premises.37 FSIS procedures38 provide that “Dead cattle that are
off-loaded to facilitate the off-loading of live animals, but that will be
re-loaded onto the transport vehicle, are not subject to sampling by FSIS.
While performing our review in one State, we reviewed the circumstances at
two slaughter facilities in the State that inspected and rejected unsuitable
cattle before the animals entered the official receiving areas of the
plants. This pre-screening activity was conducted in areas not designated by
the facility as official premises of the establishment and not under the
review or supervision of FSIS inspectors. The plant rejected all
nonambulatory and dead/dying/sick animals delivered to the establishment.
Plant personnel refused to offload any dead or downer animals to facilitate
the offloading of ambulatory animals. Plant personnel said that the driver
was responsible for ensuring nonambulatory animals were humanely euthanized
and disposing of the carcasses of the dead animals. Plant personnel informed
us that they did not want to jeopardize contracts with business partners by
allowing unsuitable animals on their slaughter premises. In the second case,
one family member owned a slaughter facility while another operated a
livestock sale barn adjacent to the slaughter facility. The slaughter
facility was under FSIS’ supervision while the sale barn was not. Cattle
sometimes arrived at the sale barn that were sick/down/dead or would die or
go down while at the sale barn. According to personnel at the sale barn,
these animals were left for the renderer to collect. The healthy ambulatory
animals that remained were marketed to many buyers including the adjacent
slaughter facility. When the slaughter facility was ready to accept the
ambulatory animals for processing, the cattle would be moved from the sale
barn to the slaughter facility where they were subject to FSIS’ inspection.
We requested the slaughter facilities to estimate the number of cattle
rejected on a daily basis (there were no records to confirm the estimates).
We visited a renderer in the area and found that the renderer had a contract
with APHIS to collect samples for BSE testing. In this case, although we
could not obtain assurance that all rejected cattle were sampled, the
renderer processed a significant number of animals, as compared to the
slaughter plants’ estimates of those rejected. Due to the close proximity
(less than 5 miles) of the renderer to the slaughter facilities, and the
premium it paid for dead cattle that were in good condition, there was a
financial incentive for transport drivers to dispose of their dead animals
at this renderer. 37 FSIS Notice 40-04, dated July 29, 2004. 38 FSIS Notice
29-04, dated May 27, 2004.
USDA/OIG-A/50601-10-KC Page 25
In our discussions with APHIS officials in Wisconsin and Iowa, they
confirmed that there were plants in their States that also used
pre-screening practices. On May 27, 2005, we requested APHIS and FSIS to
provide a list of all slaughter facilities that pre-screened cattle for
slaughter in locations away from the area designated as the official
slaughter facility. Along with this request, we asked for information to
demonstrate that either APHIS or FSIS confirmed there was a high likelihood
that high-risk animals were sampled at other collection sites. In response
to our request, the APHIS BSE Program Manager stated that APHIS did not have
information on slaughter plants that pre-screen or screen their animals for
slaughter suitability off their official plant premises. To their knowledge,
every company or producer that submits animals for slaughter pre-sorts or
screens them for suitability at various locations away from the slaughter
facility. For this reason, USDA focused its BSE sample collection efforts at
other types of facilities such as renderers, pet food companies, landfills,
and dead stock haulers. Further, in a letter to OIG on June 14, 2005, the
administrators of APHIS and FSIS noted the following: “…we believe that no
specific actions are necessary or appropriate to obtain reasonable assurance
that animals not presented for slaughter are being tested for BSE. There are
several reasons for our position. First, we do not believe that the practice
is in fact causing us to not test a significant enough number of animals in
our enhanced surveillance program to invalidate the overall results. Second,
OIG has concluded that because of the geographical proximity and business
relationships of the various entities involved in the case investigated,
there is reasonable assurance that a majority of the rejected cattle had
been sampled. Third, it is also important to remember that the goal of the
enhanced surveillance program is to test a sufficient number of animals to
allow us to draw conclusions about the level of BSE (if any) in the American
herd…We believe that the number we may be not testing because of the
“pre-sorting” practice does not rise to a significant level. The number of
animals tested to date has far exceeded expectations, so it is reasonable to
infer that there are few of the animals in question, or that we are testing
them at some other point in the process…APHIS estimated…there were
approximately 446,000 high risk cattle…[and APHIS has]…tested over 375,000
animals in less than 1 year. This indicated that we are missing few animals
in the high-risk population, including those that might be pre-sorted before
entering a slaughter facility’s property.” We obtained 123 APHIS sampling
agreements and contracts with firms and plotted their locations within the
United States (see exhibit F). We also analyzed the samples tested to the
BSE sampling goals allocated to each State under the prior surveillance
program. This analysis showed that there are
USDA/OIG-A/50601-10-KC Page 26
sampling gaps in two large areas of the United States where APHIS did not
have contracts with collection sites. These two areas are shown in the
following chart (Montana, South Dakota, North Dakota and Wyoming – Group 1
and Louisiana, Oklahoma, Arkansas, and Tennessee – Group 2): State Original
Sampling Goal Based on (268,500 sampling goal) Samples collected as of May
31, 2005 Deficit No. of BSE Sampling Agreements/ Contracts39MT 5,076 182
4,894 2 SD 6,938 2,792 4,146 1 ND 3,616 174 3,442 0 WY 2,513 61 2,452 0 AREA
TOTAL 14,934 OK 7,792 2,407 5,385 1 AR 3,672 353 3,319 0 TN 4,938 3,050
1,888 1 LA 2,312 452 1,860 1 AREA TOTAL 12,452 APHIS notes that for the
current surveillance program, it had established regional goals and APHIS
was not trying to meet particular sampling levels in particular States.
However, we believe that it would be advantageous for APHIS to monitor
collection data and increase outreach when large geographical areas such as
the above States do not provide samples in proportion to the numbers and
types of cattle in the population. We also disagree with APHIS/FSIS’
contention that because they have tested over 375,000 of their 446,000
estimate of high risk cattle, few in the high-risk population are being
missed, including those that might be pre-screened before entering a
slaughter facility’s property. In our prior audit, we reported that APHIS
underestimated the high-risk population; we found that this estimate should
have been closer to 1 million animals (see Finding 1). We recognize that BSE
samples are provided on a voluntary basis; however, APHIS should consider
industry practice in any further maintenance surveillance effort. Animals
unsuitable for slaughter exhibiting symptoms not inconsistent with BSE
should be sampled and their clinical signs recorded. However, this cited
industry practice results in rejected animals not being made available to
either APHIS or FSIS veterinarians for their observation and identification
of clinical signs exhibited ante mortem. Although these animals may be
sampled later at other collection sites, the animals are provided post
mortem without information as to relevant clinical signs exhibited ante
mortem. For these reasons, we believe APHIS needs to 39APHIS noted that
sites with agreements do not necessarily reflect the entire universe of
collection sites and at some sites APHIS collects samples with no payment
involved and no agreement in place. OIG agrees that not all collection sites
are reflected in our presentation of the 123 sites with reimbursable
agreements. OIG believes obtaining sampling agreements is one of the primary
methods available to increase sample numbers in areas with sampling gaps.
USDA/OIG-A/50601-10-KC Page 27
observe these animals ante mortem when possible to assure the animals from
the target population are ultimately sampled and the clinical signs
evaluated. Recommendation 3.......

Sun Jul 16, 2006 09:22

a) PRO-LAK, bulk weight, Protein Concentrate for Lactating Dairy Animals,
Recall # V-079-6;
b) ProAmino II, FOR PREFRESH AND LACTATING COWS, net weight 50lb (22.6 kg),
Recall # V-080-6;
FEED, Recall # V-081-6;
d) Feather Meal, Recall # V-082-6
a) Bulk
b) None
c) Bulk
d) Bulk
H. J. Baker & Bro., Inc., Albertville, AL, by telephone on June 15, 2006 and by press release on June 16, 2006. Firm initiated recall is ongoing.
Possible contamination of animal feeds with ruminent derived meat and bone meal.
10,878.06 tons



Date: June 27, 2006 at 7:42 am PST
Public Health Service
Food and Drug Administration

New Orleans District
297 Plus Park Blvd.
Nashville, TN 37217

Telephone: 615-781-5380
Fax: 615-781-5391

May 17, 2006



Mr. William Shirley, Jr., Owner
Louisiana.DBA Riegel By-Products
2621 State Street
Dallas, Texas 75204

Dear Mr. Shirley:

On February 12, 17, 21, and 22, 2006, a U.S. Food & Drug Administration (FDA) investigator inspected your rendering plant, located at 509 Fortson Street, Shreveport, Louisiana. The inspection revealed significant deviations from the requirements set forth in Title 21, Code of Federal Regulations, Part 589.2000 [21 CFR 589.2000], Animal Proteins Prohibited in Ruminant Feed. This regulation is intended to prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE). You failed to follow the requirements of this regulation; products being manufactured and distributed by your facility are misbranded within the meaning of Section 403(a)(1) [21 USC 343(a)(1)] of the Federal Food, Drug, and Cosmetic Act (the Act).

Our investigation found you failed to provide measures, including sufficient written procedures, to prevent commingling or cross-contamination and to maintain sufficient written procedures [21 CFR 589.2000(e)] because:

You failed to use clean-out procedures or other means adequate to prevent carryover of protein derived from mammalian tissues into animal protein or feeds which may be used for ruminants. For example, your facility uses the same equipment to process mammalian and poultry tissues. However, you use only hot water to clean the cookers between processing tissues from each species. You do not clean the auger, hammer mill, grinder, and spouts after processing mammalian tissues.

You failed to maintain written procedures specifying the clean-out procedures or other means to prevent carryover of protein derived from mammalian tissues into feeds which may be used for ruminants.

As a result . the poultry meal you manufacture may contain protein derived from mammalian tissues prohibited in ruminant feed. Pursuant to 21 CFR 589.2000(e)(1)(i), any products containing or may contain protein derived from mammalian tissues must be labeled, "Do not feed to cattle or other ruminants." Since you failed to label a product which may contain protein derived from mammalian tissues with the required cautionary statement. the poultry meal is misbranded under Section 403(a)(1) [21 USC 343(a)(1)] of the Act.

This letter is not intended as an all-inclusive list of violations at your facility. As a manufacturer of materials intended for animal feed use, you are responsible for ensuring your overall operation and the products you manufacture and distribute are in compliance with the law. You should take prompt action to correct these violations, and you should establish a system whereby violations do not recur. Failure to promptly correct these violations may result in regulatory action, such as seizure and/or injunction, without further notice.

You should notify this office in writing within 15 working days of receiving this letter, outlining the specific steps you have taken to bring your firm into compliance with the law. Your response should include an explanation of each step taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within 15 working days, state the reason for the delay and the date by which the corrections will be completed. Include copies of any available documentation demonstrating corrections have been made.

Your reply should be directed to Mark W. Rivero, Compliance Officer, U.S. Food and Drug Administration, 2424 Edenborn Avenue, Suite 410, Metairie, Louisiana 70001. If you have questions regarding any issue in this letter, please contact Mr. Rivero at (504) 219-8818, extension 103.



Carol S. Sanchez
Acting District Director
New Orleans District



For release only by the House Committee on Appropriations Good morning, Mr. Chairman and Members of the Subcommittee. I thank you for inviting me to testify before you today to discuss the activities of the Office of Inspector General (OIG) and to provide information about our oversight of the Department of Agriculture’s (USDA) programs and operations. I would like to introduce the members of the OIG senior management team who are here with me today: Kathy Tighe, our new Deputy Inspector General; Robert Young, Assistant Inspector General for Audit; Mark Woods, Assistant Inspector General for Investigations; and Suzanne Murrin, Assistant Inspector General for Policy Development and Resources Management. I welcome this opportunity to provide the Subcommittee with an overview of the highlights of our audit and investigative activity over the past year. Fiscal Year 2005 presented many difficult challenges for the USDA and our country’s agricultural producers and consumers. In addition to administering programs relied upon by farmers and rural communities and managing the $128 billion in public resources entrusted to the Department, USDA assumed significant responsibilities responding to the hurricanes that ravaged the Gulf Coast in 2005 and addressing the threat of plant and animal disease. To best serve the Department, our Congressional oversight committees, and the general public, OIG has formally prioritized, organized, and planned our work according to three
central objectives. I will present my testimony to the Subcommittee according to the framework of these three objectives: supporting Safety, Security, and Public Health in USDA programs and operations; protecting Program Integrity as USDA provides assistance to individuals and entities; and improving the Department’s Management of Public Resources. I. Safety, Security, and Public Health The BSE Surveillance Program and SRM Controls We recently issued our second report focusing on the Department’s efforts to establish and enforce effective, interlocking safeguards to protect producers and consumers from Bovine Spongiform Encephalopathy (BSE), commonly referred to as “mad cow disease.” Our February 2006 report reviewed the Animal and Plant Health Inspection Service’s (APHIS) implementation of its expanded BSE surveillance program and the Food Safety and Inspection Service’s (FSIS) controls to prevent banned specified risk materials (SRM) from entering our Nation’s food supply. We found that USDA made significant efforts to implement and improve the expanded surveillance program. The Department faced many challenges in a short period of time to establish the necessary processes, controls, and infrastructure needed for this massive effort. In our recent report, we discuss specific areas where we believe corrective actions were not fully effective in addressing our prior findings and recommendations on issues such as obtaining representative samples of the U.S. herd, identifying and obtaining samples from high-risk surveillance streams, and ensuring the completeness/accuracy of data. The Department
has responded to our report with immediate actions. For example, at the Secretary’s direction, APHIS revised its testing protocols to provide for additional confirmatory procedures when inconclusive test results occur. Also, both APHIS and FSIS agreed with all OIG recommendations, and they have corrected, or have developed action plans to correct, the program weaknesses identified. APHIS’ Implementation of the Expanded Surveillance Plan APHIS obtained significantly more samples for testing than it originally anticipated would be needed to achieve its stated level of confidence in estimating the prevalence of BSE in the U.S. herd. The voluntary nature of the surveillance program, however, makes it difficult to determine how successful USDA was in obtaining a representative proportion of high-risk cattle for testing. OIG found that APHIS’ various statistical approaches to determining the prevalence of BSE mitigate some, but not all, of the limitations associated with its data and the agency’s underlying assumptions in the design and implementation of its surveillance program. The accuracy of the underlying data is critical to the development of a future maintenance surveillance program. We recommended that APHIS disclose the limitations in its surveillance program and underlying data when it makes its final assessment of the prevalence of BSE in the U.S. We also found that USDA needed to strengthen its processes to ensure the quality and capability of its BSE testing program, especially when inconclusive test results occur. We recommended that USDA re-evaluate and adjust its testing protocols based on its
evaluation of emerging science and strengthen its proficiency testing and quality assurance reviews at participating laboratories. Evaluation of FSIS Processes Regarding SRMs To examine FSIS’ inspection procedures to enforce regulations to prevent risk materials in meat products, OIG reviewed the SRM plans of several meat processing facilities, observed FSIS inspections, and evaluated the effectiveness of controls during the slaughter process. FSIS technical experts assisted us in these reviews. We did not identify SRMs entering the food supply during our plant visits. However, we could not determine whether required SRM procedures were followed or were adequate due to the lack of specificity in the plans. We found that the plants lacked documentation of compliance with SRM control procedures and FSIS actions to validate such compliance. In addition to the control issues we identified regarding SRM procedures at slaughter and processing establishments, we found that FSIS’ information system could not readily provide FSIS with the data it needed to identify trends in SRM violations. The expanded stage of USDA’s BSE surveillance program is now nearing its end. Accordingly, it is important that the issues we have raised be considered as USDA completes its BSE surveillance program and reports on the prevalence of BSE in the U.S. herd. The Department has responded to our report with immediate action and agreed to address all of our findings and recommendations.
Assessing USDA Controls for Beef Exported to Japan On January 20, 2006, Japanese officials announced that they had banned any further imports of beef products from the United States, based on the discovery that a U.S. plant had shipped a veal product containing vertebral column material that was prohibited by the terms of an agreement with Japan. On the same date, in response to Japan’s decision, the Secretary announced 12 actions USDA would undertake to facilitate resuming trade. These actions include delisting and investigating the plant that exported the ineligible product, requiring a second signature on export certificates, providing training to inspection personnel on export certification, and holding meetings with inspection officials and industry representatives to reaffirm program requirements. Shortly thereafter, the Secretary requested OIG to audit the adequacy of USDA’s coordination and control processes for the Beef Export Verification (BEV) program for Japan. OIG’s report, issued on February 16, 2006, concluded that the Agricultural Marketing Service (AMS) and FSIS could strengthen their controls over the BEV program by improving processes used to communicate BEV program requirements, clearly defining roles and responsibilities, and implementing additional oversight of FSIS inspection personnel. In response to our recommendations, the agencies agreed to an array of actions. AMS agreed to maintain a list of specific, export-eligible products for each facility with an approved BEV program; to systematically notify FSIS when any establishment is approved/delisted from a BEV program; and to review all establishments in the BEV program to ensure that they adhere to program requirements. FSIS agreed to
clarify the roles and responsibilities of FSIS personnel involved at each stage of the export verification process; expedite the development of export certification training; and increase supervisory oversight of the export certification process. OIG believes that the full implementation of these measures will strengthen and improve the Department’s compliance with BEV program requirements. Assessment of the Equivalence of the Canadian Beef Inspection System Last year, my testimony discussed OIG’s findings from our audit of APHIS’ oversight of the importation of beef products from Canada. Our work on that audit led us to conduct an evaluation of FSIS’ assessment of the equivalence of the Canadian food safety inspection system, which we issued in December 2005. The then FSIS Administrator and the Under Secretary for Food Safety had identified concerns with the Canadian inspection system in late 2003. Our audit determined that FSIS did not fully address the issues raised by USDA officials in a timely manner. For example, in July 2003 FSIS found that Canadian inspection officials were not enforcing certain pathogen reduction and HACCP system regulations. These same types of concerns were identified again in June 2005. At the time of our audit, FSIS did not have protocols for evaluating deficiencies in a foreign country’s inspection system which could be used to question the system’s equivalence to U.S. standards. In addition, FSIS had not instituted compensating controls (such as increased port-of-entry testing) to strengthen public health protections while
deficiencies were present. During the period of January 2003–May 2005, 4.4 billion pounds of Canadian processed product entered the U.S., even though FSIS officials questioned the equivalence of the Canadian inspection system. FSIS agreed with OIG’s five recommendations, which included implementing protocols to determine which deficiencies would lead FSIS to question whether a foreign country’s inspection system is equivalent to the U.S. system. In response to the report, FSIS committed to develop these protocols by March 2006 and to implement them immediately thereafter. Oversight of FSIS Recalls For the past several years we have testified about our continuing work regarding adulterated beef product recalls. In July 2004, a Pennsylvania firm initiated a recall of approximately 170,000 pounds of ground beef patties because of mislabeling. Approximately one-fourth of this product was made, in part, from beef trim from Canada which was not eligible for import to the U.S., following the detection of a Canadian cow with BSE. In May 2005, we reported on the adequacy of FSIS’ effectiveness checks and the agency’s oversight of the recall. Overall, we concluded that FSIS had strengthened its procedures regarding the agency’s oversight of recalls. However, we noted that FSIS personnel did not determine the amount of product purchased by firms on 26 of the 58 completed effectiveness checks. This resulted in reduced assurance that mislabeled product was completely retrieved from distribution. Agency officials concurred with the firms’ assertions that the product had been removed from the marketplace. In response to
our recommendations, FSIS agreed to provide more specific direction to its personnel on identifying and evaluating the amount of product purchased. The Subcommittee has been interested in OIG’s investigation of a Pennsylvania company’s recall of meat products. This remains an ongoing civil fraud investigation and we will be pleased to provide information on its resolution to the Subcommittee upon its conclusion.

snip. ...9 of 34 pages. ...tss



CATTLE With CNS Symptoms Were NOT Always Tested


Between FYs 2002 and 2004, FSIS condemned 680 cattle of all ages due to CNS symptoms. About 357 of these could be classified as adult. We could validate that ONLY 162 were tested for BSE (per APHIS records. ...


WE interviewed officials at five laboratories that test for rabies. Those officials CONFIRMED THEY ARE NOT REQUIRED TO SUBMIT RABIES-NEGATIVE SAMPLES TO APHIS FOR BSE TESTING. A South Dakota laboratory official said they were not aware they could submit rabies-negative samples to APHIS for BSE testing. A laboratory official in another State said all rabies-negative cases were not submitted to APHIS because BSE was ''NOT ON THEIR RADAR SCREEN." Officials from New York, Wisconsin, TEXAS, and Iowa advised they would NOT submit samples from animals they consider too young. Four of the five States contacted defined this age as 24 months; Wisconsin defined it as 30 months. TEXAS officials also advised that they do not always have sufficient tissue remaining to submit a BSE sample. ...




The U.S. Department of Agriculture was quick to assure the public earlier
this week that the third case of mad cow disease did not pose a risk to
them, but what federal officials have not acknowledged is that this latest
case indicates the deadly disease has been circulating in U.S. herds for at
least a decade.

The second case, which was detected last year in a Texas cow and which USDA
officials were reluctant to verify, was approximately 12 years old.

These two cases (the latest was detected in an Alabama cow) present a
picture of the disease having been here for 10 years or so, since it is
thought that cows usually contract the disease from contaminated feed they
consume as calves. The concern is that humans can contract a fatal,
incurable, brain-wasting illness from consuming beef products contaminated
with the mad cow pathogen.

"The fact the Texas cow showed up fairly clearly implied the existence of
other undetected cases," Dr. Paul Brown, former medical director of the
National Institutes of Health's Laboratory for Central Nervous System
Studies and an expert on mad cow-like diseases, told United Press
International. "The question was, 'How many?' and we still can't answer

Brown, who is preparing a scientific paper based on the latest two mad cow
cases to estimate the maximum number of infected cows that occurred in the
United States, said he has "absolutely no confidence in USDA tests before
one year ago" because of the agency's reluctance to retest the Texas cow
that initially tested positive.

USDA officials finally retested the cow and confirmed it was infected seven
months later, but only at the insistence of the agency's inspector general.

"Everything they did on the Texas cow makes everything USDA did before 2005
suspect," Brown said. ...snip...end

CDC - Bovine Spongiform Encephalopathy and Variant Creutzfeldt ...
Dr. Paul Brown is Senior Research Scientist in the Laboratory of Central
Nervous System ... Address for correspondence: Paul Brown, Building 36, Room
4A-05, ...

CDC - Afterthoughts about Bovine Spongiform Encephalopathy and ...
Afterthoughts about Bovine Spongiform Encephalopathy and Variant
Creutzfeldt-Jakob Disease. Paul Brown Senior Investigator, National
Institutes of Health, ...

BASE in cattle in Italy of Identification of a
second bovine amyloidotic spongiform encephalopathy: Molecular
similarities with sporadic Creutzfeldt-Jakob disease

Dr. Detwiler, former top vet at the USDA and TSE aka mad cow expert tried to
tell the bush administration this in more ways than one at a BSE ROUNTABLE
event on Wednesday, December 11, 2003, in Denver, Colorado. shortly after
this Dr. Detwiler was put out to pasture along with Dr. Miller and a few
others that knew what was going on and spoke out about it;

USDA 2003

We have to be careful that we don't get so set in the way we do things that
forget to look for different emerging variations of disease. We've gotten
away from collecting the whole brain in our systems. We're using the brain
stem and we're looking in only one area. In Norway, they were doing a
project and looking at cases of Scrapie, and they found this where they did
not find lesions or PRP in the area of the obex. They found it in the
cerebellum and the cerebrum. It's a good lesson for us. Ames had to go
back and change the procedure for looking at Scrapie samples. In the USDA,
we had routinely looked at all the sections of the brain, and then we got
away from it. They've recently gone back.
Dr. Keller: Tissues are routinely tested, based on which tissue provides an
'official' test result as recognized by APHIS

Dr. Detwiler: That's on the slaughter. But on the clinical cases, aren't
they still asking for the brain? But even on the slaughter, they're looking
only at the brainstem. We may be missing certain things if we confine
ourselves to one area.


Dr. Detwiler: It seems a good idea, but I'm not aware of it.
Another important thing to get across to the public is that the negatives
do not guarantee absence of infectivity. The animal could be early in the
disease and the incubation period. Even sample collection is so important.
If you're not collecting the right area of the brain in sheep, or if
collecting lymphoreticular tissue, and you don't get a good biopsy, you
could miss the area with the PRP in it and come up with a negative test.
There's a new, unusual form of Scrapie that's been detected in Norway. We
have to be careful that we don't get so set in the way we do things that we
forget to look for different emerging variations of disease. We've gotten
away from collecting the whole brain in our systems. We're using the brain
stem and we're looking in only one area. In Norway, they were doing a
project and looking at cases of Scrapie, and they found this where they did
not find lesions or PRP in the area of the obex. They found it in the
cerebellum and the cerebrum. It's a good lesson for us. Ames had to go
back and change the procedure for looking at Scrapie samples. In the USDA,
we had routinely looked at all the sections of the brain, and then we got
away from it. They've recently gone back.

Dr. Keller: Tissues are routinely tested, based on which tissue provides an
'official' test result as recognized by APHIS

Dr. Detwiler: That's on the slaughter. But on the clinical cases, aren't
they still asking for the brain? But even on the slaughter, they're looking
only at the brainstem. We may be missing certain things if we confine
ourselves to one area.


Completely Edited Version

Accomplished this day, Wednesday, December 11, 2003, Denver, Colorado


Friday, February 3, 2006 (202) 225-3661

National Veterinary Services Laboratory (NVSL) Immunohistochemistry (IHC) Testing Summary

The BSE enhanced surveillance program involves the use of a rapid screening test, followed by confirmatory testing for any samples that come back "inconclusive." The weekly summary below captures all rapid tests conducted as part of the enhanced surveillance effort. It should be noted that since the enhanced surveillance program began, USDA has also conducted approximately 9,200 routine IHC tests on samples that did not first undergo rapid testing.

DeLauro Questions APHIS Officials over Retesting of Infected Cow

? IG Report finds agency officials overruled advice of field scientists ?

WASHINGTON, D.C. ? Congresswoman Rosa L. DeLauro (Conn.-3) today questioned
the reasoning of officials at the Animal and Plant Health Inspection Service
(APHIS) that overruled the advice of field scientists on the retesting of a
domestic cow found to have the bovine spongiform encephalopathy (BSE)
disease. After the USDA announced that the first case of BSE was identified
in a native-born cow last June, officials at APHIS said no further testing
of the animal was needed. The USDA?s inspector general, however, determined
the testing used proved inconclusive results and said that a sample from the
cow should be sent for further testing.

DeLauro is ranking member of the House Appropriations Agriculture
subcommittee, which has jurisdiction and oversight responsibilities of USDA
and FDA.

?I am concerned that the APHIS officials that reviewed these results seemed
to make decisions based not on science, but on the economic ramifications a
positive BSE finding in a domestic born animal could have on the U.S.
economy,? said DeLauro. ?When consumer safety is in question, APHIS should
not be forced into additional testing of an inconclusive sample by its
inspector general.

?While we are glad that this cow did not enter the human food supply, APHIS
officials had a responsibility to further examine this sample that even our
?gold standard? test proved inconclusive. By refusing to send samples for
further testing, APHIS could have jeopardized consumer health and safety and
put the industry at a disadvantage, drawing into question the safety of our

?Today I am requesting that APHIS disclose which officials made this
decision and further explain their reasoning for not voluntarily testing
this inconclusive sample further.?


Audit Report Animal and Plant Health Inspection Service Bovine Spongiform
Encephalopathy (BSE) Surveillance Program ? Phase II and Food Safety and
Inspection Service Controls Over BSE Sampling, Specified Risk Materials, and
Advanced Meat Recovery Products - Phase III

Washington, D.C. 20250 January 25, 2006 REPLY TO ATTN OF: 50601-10-KC TO: W.
Ron DeHaven Administrator Animal and Plant Health Inspection Service Barbara
Masters Administrator Food Safety and Inspection Service ATTN: William J.
Hudnall Deputy Administrator Marketing Regulatory Program Business Services
William C. Smith Assistant Administrator Office of Program Evaluation,
Enforcement, and Review FROM: Robert W. Young /s/ Assistant Inspector
General for Audit SUBJECT: Animal and Plant Health Inspection Service -
Bovine Spongiform Encephalopathy (BSE) Surveillance Program - Phase II and
Food Safety and Inspection Service - Controls Over BSE Sampling, Specified
Risk Materials, and Advanced Meat Recovery Products - Phase III This report
presents the results of our audit of the enhanced BSE surveillance program
and controls over specified risk materials and advanced meat recovery
products. Your written response to the official draft report, dated January
20, 2006, is included as exhibit G with excerpts of the response and the
Office of Inspector General?s (OIG) position incorporated into the Findings
and Recommendations section of the report, where applicable. We accept the
management decisions for all recommendations. Please follow your agency?s
internal procedures in forwarding documentation for final action to the
Office of the Chief Financial Officer (OCFO). We are providing a separate
memorandum to the agencies and OCFO that provides specific information on
the actions to be completed to achieve final action. We appreciate your
timely response and the cooperation and assistance provided to our staff
during the audit USDA/OIG-A/50601-10-KC/ Page i

Executive Summary

Animal and Plant Health Inspection Service - Bovine Spongiform
Encephalopathy (BSE) Surveillance Program - Phase II and Food Safety and
Inspection Service - Controls Over BSE Sampling, Specified Risk Materials,
and Advanced Meat Recovery Products - Phase III

Results in Brief This report evaluates elements of the interlocking
safeguards in place to protect United States (U.S.) beef from Bovine
Spongiform Encephalopathy, widely known as BSE or "mad cow disease." Since
1990, the U.S. Department of Agriculture (USDA), Animal and Plant Health
Inspection Service (APHIS), has led a multi-agency effort to monitor and
prevent BSE from entering the food supply. After discovering a BSE-positive
cow in December 2003, APHIS expanded its BSE surveillance program. To
further protect the food supply, USDA banned materials identified as being
at risk of carrying BSE (specified risk materials (SRM)), such as central
nervous system tissue. As part of this effort, USDA?s Food Safety and
Inspection Service (FSIS) required beef slaughter and processing facilities
to incorporate controls for handling such materials into their operational
plans. Onsite FSIS inspectors also inspect cattle for clinical signs in
order to prevent diseased animals from being slaughtered for human
consumption. To evaluate the effectiveness of the safeguards, we assessed
APHIS? implementation of the expanded surveillance program, as well as FSIS?
controls to prevent banned SRMs from entering the food supply.

In June 2004, APHIS implemented its expanded surveillance program;
participation by industry in this surveillance program is voluntary. As of
May 2005, over 350,000 animals were sampled and tested for BSE. To date, two
animals tested positive for BSE; one tested positive after implementation of
the expanded surveillance program.

USDA made significant efforts to implement the expanded BSE surveillance
program. Much needed to be done in a short period of time to establish the
necessary processes, controls, infrastructure, and networks to assist in
this effort. In addition, extensive outreach and coordination was undertaken
with other Federal, State, and local entities, private industry, and
laboratory and veterinary networks. This report provides an assessment as to
the progress USDA made in expanding its surveillance effort and the
effectiveness of its controls and processes. This report also discusses the
limitations of its program and data in assessing the prevalence of BSE in
the U.S. herd.


40 ELISA test procedures require two additional (duplicate) tests if the
initial test is reactive, before final interpretation. If either of the
duplicate tests is reactive, the test is deemed inconclusive.

41 Protocol for BSE Contract Laboratories to Receive and Test Bovine Brain
Samples and Report Results for BSE Surveillance Standard Operating Procedure
(SOP), dated October 26, 2004.

42 The NVSL conducted an ELISA test on the original material tested at the
contract laboratory and on two new cuts from the sample tissue.

43 A visual examination of brain tissue by a microscope.

44 A localized pathological change in a bodily organ or tissue.



PAGE 43;

Section 2. Testing Protocols and Quality Assurance Controls



[GAO-05-101 ] Mad Cow Disease: FDA's Management of the Feed Ban Has
Improved, but Oversight Weaknesses Continue to Limit Program Effectiveness
Size: 104986 , Score: 1000 , TEXT , PDF , SUMMARY


[GAO-05-101 ] Mad Cow Disease: FDA's Management of the Feed Ban Has
Improved, but Oversight Weaknesses Continue to Limit Program Effectiveness
Size: 104986 , Score: 1000 , TEXT , PDF , SUMMARY

[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 Cattle

Terry S. Singeltary

Subject: Substances Prohibited from Use in Animal Food or Feed, Proposed
Rule, Docket No. 2002N-0273 C-534 VOL 45 (PhRMA) and Entered On February 17,
Date: March 10, 2006 at 5:23 pm PST

Marie A. Vodicka, PhD

Assistant Vice President

Biologics & Blotechnology

Scientlflc & Regulatory Affairs


Division of Dockets Management (HFA-305)

Food and Drug Administration

5630 Fishers Lane, rrn . 1061

Rackville, MD 20862

Re: Substances Prohibited from Use in Animal Food or Feed, Proposed Rule, Docket

No. 2002N-0273

February 14, 2006

Dear Sir or Madam :

The Pharmaceutical Research and Manufacturers of America (PhRMA) is
providing comment to the proposed rules issued. ......


Subject: Docket No: 2002N-0273 (formerly Docket No. 02N-0273) Substances
Prohibited From Use in Animal Food and Feed PAUL BROWN
Date: January 20, 2006 at 9:31 am PST

December 20,2005

Division of Dockets Management (HFA-305)

Food and Drug Administration

5630 Fishers Lane

Room 1061

Rockville, MD 20852

Re: Docket No: 2002N-0273 (formerly Docket No. 02N-0273)

Substances Prohibited From Use in Animal Food and Feed

Dear Sir or Madame:

As scientists and Irecognized experts who have worked in the field of TSEs
for decades, we are deeply concerned by the recent discoveries of indigenous BSE
infected cattle in North America and appreciate the opportunity to submit comments to
this very.........


Given that BSE can be transmitted to cattle via an
oral route with just .OO1 gram of infected tissue, it may not take much
infectivity to contaminate feed and keep the disease recycling. ........

Division of Dockets Management (HFA-305)

Food and Drug Administration

5630 Fishers Lane

Room 1061

Rockville, MD 20852

Re: Docket No: 2002N-0273 (formerly Docket No. 02N-0273)

Substances Prohibited From Use in Animal Food and Feed

Dear Sir or Madame:

The McDonald?s Corporation buys more beef than any other restaurant in the
United States. It is

essential for our customers and our company that the beef has the highest
level of safety.

Concerning BSE, ...........



##################### Bovine Spongiform Encephalopathy #####################

Subject: SCRAPIE and CWD USA UPDATE July 19, 2006
Date: July 19, 2006 at 12:06 pm PST

Infected and Source Flocks

As of May 31, 2006, there were 93 scrapie infected and source flocks (Figure 3). There were 12 new infected and source flocks reported in May (Figure 4) with a total of 67 flocks reported for FY 2006 (Figure 5). The total infected and source flocks that have been released in FY 2006 are 53 (Figure 6), with 7 flocks released in May. The ratio of infected and source flocks released to newly infected and source flocks for FY 2006 = 0.79 : 1. In addition, as of May 31, 2006, 216 scrapie cases have been confirmed and reported by the National Veterinary Services Laboratories (NVSL), of which 33 were RSSS cases (Figure 7). This includes 33 newly confirmed cases in May 2006 (Figure 8). Eighteen cases of scrapie in goats have been reported since 1990 (Figure 9). The last goat case was reported in March 2006. New infected flocks, source flocks, and flocks released for FY 2006 are depicted in Chart 3. New infected and source statuses from 1997 to 2006 are depicted in Chart 4.


Scrapie Testing

In FY 2006, 26,185 animals have been tested for scrapie : 22,634 RSSS*; 2063 regulatory field cases; 61 necropsy validations, 5 rectal biopsy and 1427 regulatory third eyelid biopsies (Chart 9). ...



NOTICE CWD creeping its way to TEXAS, literally to it's border. ...

THEN NOTICE CWD sample along that border in TEXAS, Three Year Summary of Hunter-Kill CWD sampling as of 31 August 2005 of only 191 samples, then compare to the other sample locations ;

THREE NEW CASES OF CWD were announced in this same location this month ;



SANTA FE – Three deer in southern New Mexico have tested positive for chronic wasting disease, bringing the total number of confirmed CWD-infected deer in the state to 15 since the first infected deer was discovered in 2002.

The Department received test results Wednesday from the state Veterinary Diagnostic Services laboratory in Albuquerque that two wild deer captured near the White Sands Missile Range headquarters east of Las Cruces had tested positive for chronic wasting disease. A third wild deer captured in the small community of Timberon in the southern Sacramento Mountains also tested positive for the disease.

The discoveries of the infected deer were part of the Department's ongoing efforts to monitor the disease, which to date has been confined to the southern Sacramento Mountains southeast of Cloudcroft and areas surrounding the Organ Mountains near Las Cruces. Two wild elk from the southern Sacramento Mountains tested positive for the disease in December 2005.

Chronic wasting disease is a fatal neurological illness that afflicts deer, elk and moose. There is no evidence of CWD being transmitted to humans or livestock. The disease causes animals to become emaciated, display abnormal behavior and lose control of bodily functions. To date, it has been found in captive and wild deer, elk and moose in eight states and two Canadian provinces.

For more information about CWD in New Mexico and how hunters can assist in research and prevention, please visit the New Mexico Department of Game and Fish Web site, . More information about CWD also can be found on the Chronic Wasting Disease Alliance site at .





#################### ####################

JOHANNS IS A LIAR. THIS ADMINISTRATION IS A LIAR. all they have done is cover-up mad cow i.e. mission accomplished. ...TSS

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