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From: TSS ()
Date: February 6, 2008 at 12:55 pm PST


Audit Report

Animal and Plant Health Inspection Service

Bovine Spongiform Encephalopathy (BSE) Surveillance Program – Phase II


Food Safety and Inspection Service

Controls Over BSE Sampling, Specified Risk Materials, and Advanced Meat
Recovery Products - Phase III

Report No. 50601-10-KC January 2006

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.

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.


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."

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

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

Downers and Cattle that Died on the Farm 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."

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’

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.

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

"…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."


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

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


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