Sunday, February 17, 2008

Release No. 0046.08 Statement by Secretary of Agriculture Ed Schafer Regarding Hallmark/Westland Meat Packing Company Two Year Product Recall

Release No. 0046.08
USDA Press Office (202) 720-4623

Statement by Secretary of Agriculture Ed Schafer Regarding Hallmark/Westland
Meat Packing Company Two Year Product Recall

February 17, 2008

"Today, USDA is announcing additional actions as a result of the ongoing
investigation at Hallmark/Westland Meat Packing Company. USDA's Food Safety
and Inspection Service (FSIS) has evidence that Hallmark/Westland did not
consistently contact the FSIS public health veterinarian in situations in
which cattle became non-ambulatory after passing ante-mortem inspection,
which is not compliant with FSIS regulations. Because the cattle did not
receive complete and proper inspection FSIS has determined them to be unfit
for human food and the company is conducting a recall.

The United States enjoys one of the safest food supplies in the world. To
help ensure the safety of the food supply, we implement a series of
safeguards to protect against foodborne disease. These safeguards include
in-plant procedures to reduce dangerous foodborne pathogens such as E. coli
O157:H7 and Salmonella. It also includes the removal of specified risk
materials-those tissues demonstrated to contain the bovine spongiform
encephalopathy agent in infected cattle-from the human food chain, along
with the U.S. Food and Drug Administration's 1997 ruminant to ruminant feed
ban. The prohibition of non-ambulatory cattle from the food supply is an
additional safeguard against bovine spongiform encephalopathy.

Upon notification of possible violations of USDA regulations, we immediately
began an investigation and placed products from this plant destined for the
National School Lunch Program, the Emergency Food Assistance Program and the
Food Distribution Program on Indian Reservations on hold. Since then, we
also suspended all Federal food and nutrition program contracts with
Hallmark/Westland Meat Packing Company. To date, Hallmark/Westland Meat
Packing Company remains suspended by the Food Safety and Inspection Service.
The products destined for the Federal food assistance programs, including
the National School Lunch Program, will now be removed from schools and
other holding facilities and destroyed.

I am dismayed at the in-humane handling of cattle that has resulted in the
violation of food safety regulations at the Hallmark/Westland Meat Packing
Company. It is extremely unlikely that these animals were at risk for BSE
because of the multiple safeguards; however, this action is necessary
because plant procedures violated USDA regulations.

In addition, our Office of the Inspector General and the Food Safety and
Inspection Service continue the investigation. We will respond immediately
if further findings warrant. Details about this recall and USDA actions are
available at . "


>>>It also includes the removal of specified risk materials-those tissues
demonstrated to contain the bovine spongiform encephalopathy agent in
infected cattle-from the human food chain, along with the U.S. Food and Drug
Administration's 1997 ruminant to ruminant feed ban. The prohibition of
non-ambulatory cattle from the food supply is an additional safeguard
against bovine spongiform encephalopathy. <<<

in my opinion, this is a food safety issue.

SOME FACTS BELOW, this 8/4/97 feed ban usda et al are so proud of was/is nothing but ink on paper. it was never enforced. thousands and thousands of tons of mad cow protein in commerce in 2006 and 2007. usda et al forgets to add this to their phony statements ;


Geographical BSE Risk (GBR) assessments covering 2000-2006

Date : 01.08.2006


[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 03-025IFA 03-025IFA-2 Terry S. Singeltary Page 1 of 17 9/13/2005

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

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 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 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’ 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.

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." snip... 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 evaluated.


[Docket No. FSIS-2006-0011] FSIS Harvard Risk Assessment of Bovine Spongiform Encephalopathy (BSE)

APHIS-2006-0041-0006 TSE advisory committee for the meeting December 15, 2006

Attachment to Singeltary comment January 28, 2007

Greetings APHIS, I would kindly like to submit the following to ;

BSE; MRR; IMPORTATION OF LIVE BOVINES AND PRODUCTS DERIVED FROM BOVINES [Docket No. APHIS-2006-0041] RIN 0579-AC01 [Federal Register: January 9, 2007 (Volume 72, Number 5)] [Proposed Rules] [Page 1101-1129] From the Federal Register Online via GPO Access [] [DOCID:fr09ja07-21]


In this context, a word is in order about the US testing program. After the discovery of the first (imported) cow in 2003, the magnitude of testing was much increased, reaching a level of >400,000 tests in 2005 (Figure 4).

Neither of the 2 more recently indigenously infected older animals with
nonspecific clinical features would have been detected without such testing,
and neither would have been identified as atypical without confirmatory
Western blots. Despite these facts, surveillance has now been decimated to
40,000 annual tests (USDA news release no. 0255.06, July 20, 2006) and
invites the accusation that the United States will never know the true
status of its involvement with BSE.



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, ...


Tuesday, September 12, 2006 11:10 AM

"Actually, Terry, I have been critical of the USDA handling of the mad cow
issue for some years, and with Linda Detwiler and others sent lengthy detailed critiques and
recommendations to both the USDA and the Canadian Food Agency."

Volume 12, Number 12–December 2006


On the Question of Sporadic

or Atypical Bovine SpongiformEncephalopathy and

Creutzfeldt-Jakob Disease

Paul Brown,* Lisa M. McShane,† Gianluigi Zanusso,‡ and Linda Detwiler§

A link between BSE and

sporadic CJD has been suggested on the basis of laboratory

studies but is unsupported by epidemiologic observation.

Such a link might yet be established by the discovery

of a specific molecular marker or of particular combinations

of trends over time of typical and atypical BSE and various

subtypes of sporadic CJD, as their numbers are influenced

by a continuation of current public health measures that

exclude high-risk bovine tissues from the animal and

human food chains.


Sporadic CJD

The possibility that at least some cases of apparently sporadic CJD might be
due to infection by sporadic cases of BSE cannot be dismissed outright.
Screening programs needed to identify sporadic BSE have yet to be
implemented, and we know from already extant testing programs that at least
a proportion of infected animals have no symptoms and thus would never be
identified in the absence of systematic testing. Thus, sporadic BSE (or for
that matter, sporadic disease in any mammalian species) might be occurring
on a regular basis at perhaps the same annual frequency as sporadic CJD in
humans, that is, in the range of 1 case per million animals.

Whether humans might be more susceptible to atypical forms of BSE cannot be
answered at this time. Experimentally transmitted BASE shows shorter
incubation periods than BSE in at least 1 breed of cattle, bovinized
transgenic mice, and Cynomolgus monkeys (12,13). In humanized transgenic
mice, BASE transmitted, whereas typical BSE did not transmit (13).
Paradoxically, the other major phenotype (H) showed an unusually long
incubation period in bovinized transgenic mice (12).

The limited experimental evidence bearing on a possible relationship between
BSE and sporadic CJD is difficult to interpret. The original atypical BASE
strain of BSE had a molecular protein signature very similar to that of 1
subtype (type 2 M/V) of sporadic CJD in humans (5). In another study, a
strain of typical BSE injected into humanized mice encoding valine at codon
129 showed a glycopattern indistinguishable from the same subtype of
sporadic CJD (15). In a third study, the glycopatterns of both the H and L
strains of atypical BSE evidently did not resemble any of the known sporadic
CJD subtypes (12).

To these molecular biology observations can be added the epidemiologic data
accumulated during the past 30 years. The hypothesis that at least some
cases of apparently sporadic CJD are due to unrecognized BSE infections
cannot be formally refuted, but if correct, we might expect by now to have
some epidemiologic evidence linking BSE to at least 1 cluster of apparently
sporadic cases of CJD. Although only a few clusters have been found (and
still fewer published), every proposed cluster that has been investigated
has failed to show any common exposure to bovines. For that matter, no
common exposure has been shown to any environmental vehicles of infection,
including the consumption of foodstuffs from bovine, ovine, and porcine
sources, the 3 livestock species known to be susceptible to transmissible
spongiform encephalopathies. Additional negative evidence comes from several
large case-control studies in which no statistically significant dietary
differences were observed between patients with sporadic CJD and controls

On the other hand, the difficulty of establishing a link between BSE and CJD
may be compounded by our ignorance of the infectious parameters of a
sporadic form of BSE (e.g., host range, tissue distribution of infectivity,
route of transmission, minimum infectious dose for humans, whether single or
multiple). Presumably, these parameters would resemble those of variant CJD;
that is, high infectivity central nervous system and lymphoreticular tissues
of an infected cow find their way into products consumed by humans.
Transmissions that might have occurred in the past would be difficult to
detect because meat products are generally not distributed in a way that
results in detectable geographic clusters.

Barring the discovery of a specific molecular signature (as in variant CJD),
the most convincing clue to an association will come from the observation of
trends over time of the incidence of typical and atypical BSE and of
sporadic and variant CJD. With 4 diseases, each of which could have
increasing, unchanging, or decreasing trends, there could be 81 (34)
possible different combinations. However, it is highly likely that the
trends for typical BSE and variant CJD will both decrease in parallel as
feed bans continue to interrupt recycled contamination. The remaining
combinations are thus reduced to 9 (32), and some of them could be highly

For example, if the incidence of atypical BSE declines in parallel with that
of typical BSE, its candidacy as a sporadic form of disease would be
eliminated (because sporadic disease would not be influenced by current
measures to prevent oral infection). If, on the other hand, atypical BSE
continues to occur as typical BSE disappears, this would be a strong
indication that it is indeed sporadic, and if in addition at least 1 form of
what is presently considered as sporadic CJD (such as the type 2 M/V subtype
shown to have a Western blot signature like BASE) were to increase, this
would suggest (although not prove) a causal relationship (Figure 5).

Recognition of the different forms of BSE and CJD depends upon continuing
systematic testing for both bovines and humans, but bovine testing will be
vulnerable to heavy pressure from industry to dismantle the program as the
commercial impact of declining BSE cases ceases to be an issue. Industry
should be aware, however, of the implications of sporadic BSE. Its
occurrence would necessitate the indefinite retention of all of the public
health measures that exclude high-risk bovine tissues from the animal and
human food chains, whereas its nonoccurrence would permit tissues that are
now destroyed to be used as before, once orally acquired BSE has




full text ;

Terry S. Singeltary Sr.
P.O. Box 42
Bacliff, Texas USA 77518

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