Evaluation of FSIS Management Controls Over Pre-Slaughter Activities (Audit Report 24601-7-KC)
Results in Brief
On January 30, 2008, the Humane Society of the United States (HSUS) released videos to the public that documented the egregious abuse of cattle awaiting slaughter at the Hallmark-Westland Meat Packing Company (hereafter referred to as Hallmark) in Chino, California. These abuses, which took place in the fall of 2007, included electric shocks, spray from high-pressure water hoses, and the ramming of cattle with a forklift. The abuses were committed by employees of the establishment in an apparent attempt to force non-ambulatory cattle to rise for slaughter. On February 1, 2008, Hallmark voluntarily ceased operations pending investigation by the U.S. Department of Agriculture (USDA), Food Safety and Inspection Service (FSIS) into the alleged abuses. FSIS determined, as part of its own investigation, that Hallmark employees violated the ban1 on slaughter of non-ambulatory disabled (?downer?) cattle by failing to notify the FSIS Public Health Veterinarian (PHV) when animals became non-ambulatory after having passed ante-mortem inspection. ?Downer? animals are known to be at high risk for bovine spongiform encephalopathy (BSE).2 Therefore, it is critical that they be carefully examined before slaughter (ante-mortem) and then, if appropriate, condemned. Currently, an animal that becomes non-ambulatory after ante-mortem inspection may only be slaughtered if the PHV determines through re-examination that its condition is due to an acute injury, such as a broken leg.3 On February 4, 2008, FSIS issued a Notice of Suspension to Hallmark for its failure to maintain and implement controls to prevent the inhumane handling and slaughter of animals. On February 17, 2008, Hallmark announced that it was voluntarily recalling approximately 143 million pounds of raw and frozen beef products. This recall, the largest recall to date, was designated as Class II due to the establishment’s noncompliance with regulatory requirements and the remote possibility that the beef being recalled could cause adverse health effects if consumed.4 In public testimony USDA officials reinforced their determination that the recall occurred because the establishment did not comply with regulatory inspection requirements, not due to food safety concerns. To mitigate public concerns that downers may have entered the 1 Title 9 Code of Federal Regulation (C.F.R.) 309.3 (e). 2 BSE, widely referred to as ?mad cow disease,? is a chronic degenerative disease of the central nervous system of cattle. BSE belongs to the family of diseases known as transmissible spongiform encephalapathies (TSE), which include scrapie in sheep and goats, chronic wasting disease (CWD) in deer and elk, and Cruetzfeldt-Jakob disease (CJD) in humans. 3 In May 2008, the Secretary announced plans for a total ban on the slaughter of cows too sick or weak to stand. A proposed rule to implement such a ban was published for public comment on August 27, 2008. 4 Class I recall involves a health hazard situation where there is a reasonable probability that eating the food will cause health problems or death.
food supply, USDA officials cited three other interlocking safeguards that protect the public even if other safeguards, such as ante-mortem inspection, should fail; these safeguards are the removal of Specified Risk Materials (SRM),5 BSE surveillance testing, and the feed ban.6 Under the Federal Meat Inspection Act (FMIA),7 if an establishment does not present animals for ante-mortem inspection, FSIS is unable to determine that animals are fit for slaughter as human food, and therefore cannot permit the carcasses to be marked as ?inspected and passed.?8 The release of the videos by HSUS led Congress, USDA, and the public to question how such events could have occurred at a slaughter establishment that was under inspection by FSIS. FSIS inspection personnel are charged with enforcing the requirements of the Humane Methods of Slaughter Act, the FMIA, and the Poultry Products Inspection Act. FSIS inspects all meat, poultry, and processed egg products sold in interstate commerce to ensure that they meet U.S. food safety standards. At the request of the Secretary of Agriculture, the Office of Inspector General (OIG) is leading the Department's criminal investigation into potential violations of the FMIA. The investigation is ongoing, and OIG Investigations is working cooperatively with FSIS’ Office of Program Evaluation, Enforcement, and Review (OPEER) and other law enforcement agencies, as well as coordinating these efforts with the U.S. Department of Justice. At the conclusion of the investigation, a report of investigative findings will be issued to the appropriate USDA officials. This audit was conducted to determine what inspection controls and/or processes may have broken down at Hallmark, and whether the events that took place there are isolated or systemic. To make that assessment, we evaluated the adequacy of FSIS’ pre-slaughter controls at 10 other slaughter establishments which, like Hallmark, slaughter cull cows.9 We also evaluated the effectiveness of FSIS’ controls over the removal of SRMs from cattle, as well as inspector-generated samples for residue testing.10 Because of the ongoing investigation, our assessment of what happened at Hallmark is limited by the information we have to date. Also, since Hallmark has ceased operations, we could not observe and validate FSIS’ oversight and verification of that establishment’s food safety systems. Therefore, we made 5 Title 9 C.F.R. 310.22(a) defines SRMs as: 1) the brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral column, and dorsal root ganglia of cattle 30 months of age or older, and 2) the tonsils and distal ileum of all cattle. 6 In 1997, the Food and Drug Administration implemented a mandatory feed ban that prohibits feeding most mammalian protein to ruminants, including cattle. This rule was strengthened in a final rule published April 25, 2008. 7 21 U.S.C. 603 and Title 9 C.F.R. 309.1. 8 FSIS Directive 6100.1, dated September 13, 2007. 9 Cows are culled from a herd for reasons such as unsatisfactory milk production or reproductive failure, a weak condition or old age, or when the cost to feed does not guarantee a profit from feeding. 10 Although all cows may be subject to residue testing, culled dairy cows are particularly likely to have been administered antibiotics and other drugs because of their age and physical condition.
our assessment as to what happened at Hallmark through interviews and review of available records, where possible. We determined that there were deliberate actions11 by Hallmark personnel12 to bypass required inspections, as well as noncompliance with required inspection procedures by FSIS in-plant staff. Supervisory and other management controls did not detect and/or prevent these incidents. Although we found varying degrees of noncompliance and/or inconsistent implementation of required inspection procedures by FSIS inspectors in the other cull establishments reviewed during the audit, nothing came to our attention to indicate that unsuitable animals were passed for slaughter at these establishments. In addition, there was no single underlying reason why the noncompliances occurred. Therefore, we concluded that the events that occurred at Hallmark were not a systemic failure of the inspection processes/system as designed by FSIS. However, we did determine that management controls designed to provide oversight of the inspection processes, as well as organizational controls to demonstrate the sufficiency and competency of its personnel resources, can be strengthened to minimize the chance that events such as those at Hallmark could happen in the future. The observations made during this audit and conclusions reached are limited to cull slaughter operations, which are inherently higher risk due to the health and age of the animals slaughtered. We did not observe any systemic inhumane handling incidents at the 10 establishments visited during this audit, nor did anything come to our attention that would lead us to believe any were occurring when we were not there. However, we concluded that there is an inherent vulnerability that humane handling violations can occur and not be detected by FSIS inspectors because FSIS does not provide continuous surveillance of all operating areas within a slaughter establishment at all times. Further, animals slaughtered at cull slaughter establishments, like Hallmark, are in a generally weak physical condition, which increases the risk that humane handling violations can occur as establishment employees attempt to move the animals from the unloading areas to the holding pens to slaughter. At Hallmark, egregious humane handling violations occurred when its employees attempted to move non-ambulatory cattle. In response to the events at Hallmark, on August 27, 2008, USDA announced a proposed rule to ban the slaughter of all cattle that become non-ambulatory disabled after passing ante-mortem inspection; these animals would be condemned and properly disposed of rather than slaughtered. In addition to implementing the proposed ban on non-ambulatory cattle, and establishing appropriate oversight to ensure compliance at slaughter establishments, FSIS can also strengthen management controls and improve 11 Because of the ongoing criminal investigation, no further information can be provided in this report. 12 The San Bernardino County District Attorney in California filed animal cruelty charges against two former Hallmark employees; both were convicted.
its oversight of its inspection staff. FSIS must take action to demonstrate that the various compensating controls it has in place over its pre-slaughter inspection processes are consistently understood and implemented by its inspection and management staff. We noted the following concerns. Sufficiency and Competency of Inspection Resources FSIS cannot demonstrate that the resources assigned to its offline inspection activities are sufficient to adequately perform the tasks assigned. At Hallmark, and at each of the other 10 slaughter establishments we visited, we noted inspection noncompliances of varying types and degree. The reasons for these noncompliances varied, but at three establishments, in addition to Hallmark, the PHVs stated they took shortcuts in ante-mortem inspection activities in order to complete all assigned tasks. Although we observed no adverse impact at the 10 cull slaughter establishments reviewed, such noncompliances can facilitate attempts to bypass inspection processes, as was the case at Hallmark. We cannot assess the reasonableness of the supervisory span of control assigned to frontline supervisors (FLS) because FSIS cannot provide supportable work measurement assumptions. The FLS is assigned a circuit of establishments for supervision and oversight and represents the first level of supervision above the in-plant level. The FLS at Hallmark, as well as the FLSs at 7 of the 10 establishments reviewed, were not aware of common practices used by in-plant inspection staff that did not meet FSIS requirements. Therefore, we concluded that FSIS needs to develop a supportable, risk-based methodology for assigning its inspection staff, and re-assess the adequacy and effectiveness of its supervisory span of control. FSIS does not have a formal, structured developmental program and system in place to ensure that all of its inspection and supervisory staff receive both formal and on-the-job training to demonstrate that they possess the competencies essential for its mission-critical functions. Since FSIS’ inspection staff is directly involved in ensuring the safety of the food supply, we believe a structured program of continuing education, certified each year, would provide the organizational control needed to demonstrate a knowledgeable and qualified workforce. Management Controls FSIS has a management control structure in place that should have identified and/or mitigated the problems disclosed at Hallmark, as well as those we identified at the establishments visited during the
audit. FSIS management, however, did not detect the inconsistent application and/or noncompliance with required inspection procedures that occurred at Hallmark, or at the establishments visited during the audit. FSIS needs to more fully utilize its management information systems to monitor compliance with its inspection requirements, as well as to obtain early alerts of potential problems. We reported limitations with FSIS’ management control systems in a prior audit, Report 24601-07-Hy, Issues Impacting the Development of Risk-Based Inspection at Meat and Poultry Processing Establishments, dated December 2007. FSIS is in the process of re-aligning its systems in a Public Health Information System (PHIS) to better integrate and consolidate numerous applications that collect information to provide mission critical support. In addition, FSIS is continuing to enhance and implement systems designed to provide management oversight of the public health activities of its inspection workforce. We concluded that these control systems should be strengthened to minimize the potential for events such as those that occurred at Hallmark to happen in the future. SRM Verification Activities FSIS cannot effectively demonstrate that its verification of establishment controls and written procedures for the removal, segregation, and disposition of SRMs is adequate to detect noncompliance. FSIS’ information systems do not provide information to document the verification of each establishment’s controls, nor do they readily provide data for analysis to detect trends of noncompliance or to identify areas where more in-plant oversight is needed. During our establishment visits, we observed that FSIS was verifying the removal of SRMs from each carcass that passed through the slaughter process. However, we found that inspectors did not always detect or consistently document noncompliances with SRM control requirements. We believe FSIS needs to strengthen its overall management controls and oversight processes to provide reasonable assurance that the compensating controls FSIS has put in place for pre-slaughter inspection activities and SRM verification activities are consistently and fully implemented by its inspection staff.
Recommendations In Brief FSIS needs to reassess the inhumane handling risks associated with cull slaughter establishments and determine if more frequent or in-depth reviews need to be conducted. Also, FSIS should establish a process to analyze available data for anomalies or variances in both establishment and inspector performance that could require additional followup by district management. FSIS needs to develop a supportable, risk-based methodology for determining the inspection resources needed at each establishment and its appropriate supervisory structure. We also recommend that a structured training and development program, with a continuing education component, be developed for both its inspection and management resources. Further, supervisory and management oversight of in-plant performance needs to be strengthened to ensure that on-site evaluations are thorough and are conducted at the required frequencies. We have also made numerous recommendations for FSIS to strengthen its pre-slaughter inspection processes and compensating controls over the movement and tracking of animals from ante-mortem inspection, to slaughter, and/or through proper disposal, residue testing procedures, and SRM verification activities.
FSIS agreed with the report’s 25 recommendations. We have incorporated the FSIS response in the Findings and Recommendations section of this report, along with the OIG position. FSIS’ response to the draft report is included in its entirety as exhibit D.
Based on FSIS’ response, we were able to reach management decisions on the report’s 25 recommendations.
SRM Verification Activities FSIS cannot effectively demonstrate that its verification of establishment controls and written procedures for the removal, segregation, and disposition of SRMs is adequate to detect noncompliance. FSIS’ information systems do not provide information to document the verification of each establishment’s controls, nor do they readily provide data for analysis to detect trends of noncompliance or to identify areas where more in-plant oversight is needed. During our establishment visits, we observed that FSIS was verifying the removal of SRMs from each carcass that passed through the slaughter process. However, we found that inspectors did not always detect or consistently document noncompliances with SRM control requirements.
We believe FSIS needs to strengthen its overall management controls and oversight processes to provide reasonable assurance that the compensating controls FSIS has put in place for pre-slaughter inspection activities and SRM verification activities are consistently and fully implemented by its inspection staff.
Finding 7 FSIS Inspectors Did Not Always Detect or Document Noncompliance With SRM Regulations Inspectors at 5 of the 10 establishments we reviewed did not detect instances of noncompliance with FSIS requirements for the removal and disposition of SRMs (see exhibit C). The deficiencies we noted included establishment pre-requisite plans that did not contain required SRM procedures, and the failure of establishment employees to follow in-plant intervention procedures or to ensure that SRMs were being removed from products shipped to other processing establishments. This occurred, in part, because FSIS inspectors misinterpreted applicable regulations and directives. In some cases, we noted that FSIS inspectors had not received up-to-date training on SRM requirements. Finally, we noted that inspectors at three of these establishments were reluctant to write NRs even after the noncompliances had been noted by the auditors. If FSIS in-plant inspectors do not detect such noncompliances, or do not document them with NRs, the ability of FSIS to demonstrate the effectiveness of SRM removal and intervention processes is greatly reduced. In August 2007, FSIS issued a notice that directed inspection personnel at slaughter establishments to conduct awareness meetings with establishment management.106 These meetings were to (1) make establishment managers aware of changes to regulatory requirements for handling SRMs, (2) advise management that because changes might affect the establishment hazard analysis or alter the critical control points they should reassess the adequacy of their HACCP plan, and (3) ask them specific questions that their controls and procedures would be expected to address. Beginning October 1, 2007, inspectors were to use FSIS Directive 6100.4, Verification Instructions Related to SRMs to verify that the establishment’s plans had incorporated the appropriate controls and procedures. However, at two establishments, we found that the pre-requisite plans did not address the requirements of 9 CFR 310.22 and Directive 6100.4, which state that any slaughter establishment which ships carcasses containing SRMs to ?downstream? processing establishments must (1) assure that the carcasses are accompanied by documentation stating that the SRMs must be removed, and (2) maintain documentation to show that the downstream establishment has received the carcasses and has certified to the subsequent removal and disposition of the SRMs. In both of these cases, FSIS personnel had documentation that the awareness meetings had been held as required by Notice 56-07. However, in one case the PHV misinterpreted the directive’s requirements, stating that he believed it sufficient that the processing establishment’s own SRM plan required their removal. In the other case, the inspectors stated they understood the requirement but had failed to notice that the pre-requisite plan did not contain the required controls. In both cases, the PHVs had received training on SRMs; however, this training took place before the training modules were updated to reflect the requirements for shipments to downstream processors. At one of these two establishments, an FSA conducted in April 2008 also failed to disclose that the establishment’s pre-requisite plan did not address the requirements for transporting carcasses containing SRMs. The district manager stated that because of the way FSA reports are formatted,107 the district officials who reviewed the report could not determine the extent to which SRM procedures had been covered. She noted that the FSA did not concentrate on SRM-related issues, but rather on HACCP compliance in general. 106 FSIS Notice 56-07, Final Regulations for Non-Ambulatory Disabled Cattle and SRMs, dated August 31, 2007. 107 We reported this in audit 24601-7-Hy, Issues Impacting the Development of Risk-Based Inspection at Meat and Poultry Establishments. Until July 2008, FSAs were presented in an inconsistent, text-based format that did not allow FSIS managers to fully analyze the results of the FSAs.
One Establishment Did Not Properly Carry Out SRM Removal
At one establishment we visited, an investigation by FSIS OPEER disclosed that the establishment had not been properly removing the tonsils from market heads that it began shipping in 2003. Establishment personnel stated that at that time, the PHV instructed them in the method for tonsil removal. They continued using that method until a State inspector in Iowa discovered tonsil material during a routine inspection of cattle heads shipped by the establishment in 2008. Continuous review by FSIS inspection personnel during the previous 4 years, however, failed to identify this deficiency. The establishment issued a voluntary recall of over 400,000 pounds of product - about half of the cattle heads it shipped since 2003. Because the PHV who initially instructed establishment employees in tonsil removal was no longer with the agency, we could not validate that incorrect instructions were given to the establishment. The current PHV and FLS stated that they had not monitored tonsil removal sufficiently to have discovered that the establishment failed to remove all SRMs. We noted that both the CSI and the FLS received training in SRM tonsil removal after this noncompliance at this establishment had been disclosed.
Establishments Did Not Use Dedicated or Properly-Cleaned Equipment When Cutting Products That Contained SRMs
Title 9 C.F.R. 310.22 and FSIS Directive 6100.4 require that precautions be taken when establishments slaughter cattle of mixed ages (over-and-under 30 months of age) to prevent cross-contamination by SRMs. If establishments do not segregate the carcasses and parts from the older and younger cattle, FSIS inspectors are required to verify that the establishment is either using dedicated equipment for each age group to cut through the SRMs, or cleaning and sanitizing the equipment before it is again used on carcasses or parts from cattle under 30 months old. However, at two establishments we found that these requirements were not being followed. Establishment 1’s pre-requisite plan called for cattle, following the initial splitting of the carcass in the slaughter area,108 to be processed in order of their age with all cattle under 30 months of age being processed on any given day before any of the over-30-month cattle. Under this plan, it would have been unnecessary to either use dedicated equipment or to break down and clean the saws and other equipment until the next day’s slaughter operations began. However, we found that by the time the carcasses reached the processing area, they had been graded by USDA Agriculture Marketing Service; and from that point forward, the establishment first grouped the carcasses by USDA grade (e.g., USDA Prime, Choice, or Select) for further processing, and only then by age. Under this system, an over-30-month old carcass of one grade would be sawed before an under-30-month carcass in the next grade-grouping. Because it was not specified in the pre-requisite plan, the establishment did not break down and clean the equipment during this process (although each saw had a low-pressure ?sanitizer? spray installed). 108 In the slaughter area, the establishment’s pre-requisite plan called for the use of dedicated equipment for sawing under-and-over 30-month-old carcasses, and we found the establishment to be in compliance with that requirement.
The FLS was not aware that this had been occurring, while the Supervisory Public Health Veterinarian stated that this would not warrant writing an NR because there were no ?visible SRMs? on the equipment.109 During the audit, establishment management agreed to change their pre-requisite plan to ?rinse and sanitize? the equipment. Although we observed establishment employees actually breaking down the equipment for cleaning during our visit, the FLS stated that the pre-requisite plan – even as revised – did not specifically require anything beyond the ?continuous sanitation? provided by the sanitation sprayers attached to the saws. FSIS Headquarters officials also agreed that an NR was unnecessary because they believed the sanitizer spray was sufficient to address the problem. We do not agree with this position because the establishment was not following its own pre-requisite plan, and this alone should have generated an NR. We observed a similar situation at Establishment 10 where its employees used a single set of knives for removing the heads from carcasses of mixed ages. In addition, the establishment was using a single split saw to cut through the vertebral columns of these carcasses; and although establishment employees sprayed off the saw when switching from older carcasses back to under-30-month old carcasses, they did not break down the equipment and remove all visible debris as required by their pre-requisite plan. FSIS had not been aware that this was occurring, and agreed that the establishment was out of compliance. The PHV immediately dealt with the issue and the FLS stated a meeting would be held with establishment management to address the issue regarding the knives. The establishment took immediate corrective actions. However, FSIS again determined that an NR would not be written for the noncompliance. We also observed that at Establishment 1, the automatic denaturant system did not disperse denaturant in sufficient amounts to ensure that inedible materials – including SRMs – were clearly identified as being inedible. This system should spread denaturant evenly across the inedible material and be readily visible. However, during our visit, the denaturant was barely visible. FSIS agreed that the system malfunctioned, but stated that the system appeared to be functioning properly the last time they had checked. Title 9 C.F.R. part 314.3 states that denaturant must be deposited in all portions of the carcass or product to the extent necessary to preclude its use for food purposes. The PHV agreed with this following our discussion, and wrote an NR to document the noncompliance. 109 We noted – as we found at Establishment 10 – that there was a buildup of material inside the closed saw casing. Unlike at Establishment 10, however, the PHV and FLS did not believe this qualified as "visible SRMs."
FSIS Did Not Take Consistent Enforcement Actions on SRM Violations
During the audit, when we pointed out apparent SRM noncompliances, FSIS inconsistently issued regulatory citations (NRs). We attributed this to an inadequate understanding of SRM requirements, which in turn indicates a need for additional training. For instance, Establishment 3 and 4 both had deficiencies in their pre-requisite plans that resulted in similar noncompliances regarding the shipping and tracking of carcasses that contained SRMs. At Establishment 4, the PHV agreed with our assessment and immediately wrote an NR. At Establishment 3, however, the CSI stated that he believed the establishment had ?met the intent? of Directive 6100.4 and refused to write an NR. He was subsequently overruled by the district manager, who stated that an NR would be written.110 At Establishment 2, which was located in another district, we found that although the establishment’s pre-requisite plan was in compliance, it was not being followed. In this case, although the establishment was properly identifying the shipped carcasses as containing SRMs, they were not ensuring that downstream processors provided the required certifications that the SRMs had been removed. FSIS inspectors were not aware of the noncompliance before the audit, but did issue an NR when we notified them as to what we found. However, we were subsequently notified by the district office that the NR had been rescinded. An FSIS Headquarters official stated that the establishment was generally following their written procedure and the OIG finding represented only a ?minor variation,? despite the fact that nearly half of the downstream shipments we reviewed (23 of 43 shipments, involving over 540,000 pounds of product shipped) did not contain the required certification. The FLS for this establishment stated, however, during our visit that any deviation from an establishment’s written plan would justify an NR. Establishment 3 and 4 were both in the same district; and while both ultimately took equivalent enforcement action, in one case this only came about through the intervention of the district office. However, despite the fact that an FSA had recently been performed at Establishment 4, the district office only became aware of the deficiencies in the establishments’ pre-requisite plans as a result of our audit. Establishment 2 was in another district, which took a markedly different position on the enforcement of a situation similar to that found at the other two establishments. We believe that such inconsistencies further highlight the need for more effective management controls and training. 110 FSIS Directive 6100.4 requires, among other provisions, that when an establishment ships meat products containing SRMs to other establishments for additional processing, the shipping establishment must obtain written certifications from the processors that the SRMs have been removed before the products are marketed. Neither of these two establishments reflected this in their pre-requisite plans; therefore, the required procedures were not being followed.
month-old animals for one of its buyers. We found that the establishment did not comply with its pre-requisite plan, which required age verification of under-30-month old animals. The inspectors at this establishment disagreed with the need to write an NR, stating that ?the establishment treated all animals as over 30 months of age, so aging is not necessary.? District officials, when they became aware of the situation, instructed the PHV to write an NR. As noted above, we found that Establishment 1 and 10 were not following their pre-requisite plans in that they cut and/or sawed carcasses of mixed ages but did not use dedicated equipment for each group or clean and sanitize the saws when switching from older to younger cattle. However, neither of these noncompliances resulted in inspectors writing an NR. Establishment 10 took corrective actions, including the requirement that the saws be actually broken down and cleaned rather than simply sprayed – a process which had left visible SRMs in the enclosed areas of the saw casings. However, no NR was written. An FSIS official stated that these issues ?did not deal with deviations from critical control points within the HACCP plan.? However, Directive 6100.4 requires that FSIS inspection personnel issue an NR in any instance where the establishment has failed to develop and implement procedures that comply with 9 C.F.R. 310.22. Although Establishment 10’s procedures were in compliance with the regulation, their implementation clearly was not. As a result, we believe an NR should have been issued. Likewise, at Establishment 1, FSIS declined to write an NR on the basis that the low-pressure sprayers on the saws – a measure that the establishment’s revised pre-requisite plan referred to as ?rinsing and sanitizing? – met the requirements of Directive 6100.4. This action appeared inconsistent with the actions taken at Establishment 10, since in both cases a buildup of material was noted inside the closed saw casings. In any case, the presence of the sprayer did not change the fact that Establishment 1 mixed the age groups when sawing carcasses, which clearly violated the controls specified in its pre-requisite plan. We discussed these issues with two of the four EAROs, and asked how, or if, they monitored the effectiveness of SRM verification activities. One stated that SRM controls are primarily monitored through the FSAs, and that they review some – but not all – of these. The other EARO stated that they do not have a large role in monitoring SRM compliance because this is done at the establishment level. Moreover, they do not have major concerns about SRMs because they see relatively few NRs being written on these issues.
The noncompliances we observed at 5 of the 10 establishments visited occurred for various reasons. In some cases, we noted that the PHVs did not have up-to-date training on SRM issues – the training record for the PHV at Establishment 2, for instance, did not list any SRM training at all. However, it is uncertain whether lack of formal training can explain why in-plant personnel were not aware of ongoing noncompliance, or did not recognize them as such. However, we believe that the conditions noted during this audit support the need for greater management control over SRM verification activities. We question how EAROs can effectively use FSAs as the primary tool to monitor compliance with SRM requirements. Also, we believe the EARO’s lack of concern regarding SRM noncompliance because ?relatively few NRs are written? may be questionable because, as disclosed during the audit, there is inconsistent interpretation as to when NRs should be written. Without documentation that there has been noncompliance, FSIS has no means to assess risk and monitor trends in compliance with SRM control and interventions. Thus, under the current management control structure, there is reduced assurance that district offices can become aware of situations that require their intervention; the same would apply to the EAROs who supervise them. Without adequate monitoring tools, FSIS may not become aware of situations that require intervention until these reach a stage that requires a recall or other enforcement action.
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Thursday, April 17, 2008 GAO REPORT ON HUMANE METHODS OF HANDLING AND SLAUGHTER I.E. DOWNER COW SCHOOL LUNCH PROGRAM
What GAO Found
April 17, 2008 HUMANE METHODS OF HANDLING AND SLAUGHTER
Public Reporting on Violations Can Identify Enforcement Challenges and Enhance Transparency
In January 2004, GAO reported that incomplete and inconsistent inspection records made it difficult to determine the frequency and scope of HMSA violations, inspectors did not always document violations of the act, and they did not consistently document the scope and severity of each incident. GAO also reported that enforcement actions to address noncompliance with the act were inconsistent, and that USDA was not using consistent criteria to determine when to suspend plant operations in cases of serious or repeated violations. The Congress has urged USDA to report annually on trends in compliance with humane slaughter methods. Such public reporting can enhance transparency, but USDA’s most recent report was in March 2003 and relied on incomplete data. For example, that report said very few infractions were for inhumane treatment, but GAO found that at least one-fourth of the infractions were for ineffective stunning which fails to meet humane standards. USDA has taken actions to address the recommendations GAO made in 2004 about oversight of HMSA. However, GAO has not evaluated the effectiveness of these actions. USDA faces resource challenges that may make it difficult for it to enforce HMSA and ensure the safety of the food supply. Although USDA’s budget for food safety-related activities has increased since 1988, staffing for these activities has declined from its highest level in 1995. Agency officials noted the overall decline is due, in part, to consolidation in the meat industry, resulting in fewer facilities. In 2004, GAO found that USDA lacked detailed information on how much time its inspectors spend on humane handling and slaughter activities, making it difficult to determine if the number of inspectors is adequate. USDA has taken actions to address most of GAO’s recommendationsfor assessing its resource needs for HMSA, but GAO has not evaluated these actions. Although not directly related to HMSA activities, the quantity of meat and poultry inspected and passed by USDA has grown, and the quantity of meat and poultry recalled has increased. USDA has oversight responsibility for ensuring the safety of meat, poultry, and processed eggs. For example, federal regulations prohibit companies from processing and selling meat from disabled cows—which have a higher probability of being infected with bovine spongiform encephalopathy—without explicit USDA inspector approval. However, USDA is only 1 of 15 agencies that collectively administer at least 30 laws related to food safety. This fragmentation is the key reason GAO added the federal oversight of food safety to its High-Risk Series in 2007 and called for a governmentwide reexamination of the food safety system. GAO has reported on problems with this system—including inconsistent oversight, ineffective coordination, and inefficient use of resources. Going forward, as GAO has recommended, a governmentwide, results-oriented performance plan and a reconvened President’s Council on Food Safety could build a sustained focus on the safety of the nation’s food supply.
Note: Data for 2008 are estimated. Although the number of recalls has declined in recent years, the quantity of meat and poultry recalled has increased sharply. Meat and poultry product recalls declined from 125 in 2002 to 58 in 2007. However, 2 of the 6 biggest meat recalls in U.S. history have occurred in the past 6 months. In October 2007, Topps Meat Company LLC announced the recall of 22 million pounds of ground beef used for frozen hamburgers due to E. coli contamination. At the time, the Topps recall was the fifth largest in U.S. history. The E. coli-contaminated meat sickened at least 32 people in eight states. On February 17, 2008, Westland/Hallmark Meat Company announced the recall of more than 143 million pounds of beef, the largest recall in U.S. history. The quantity of meat and poultry recalled has increased from 5 million pounds in 1994, the first year for which data were readily available, to 145 million in just the first quarter of March 2008.
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To: Majority Members of the Domestic Policy Subcommittee
From: Majority Staff Domestic Policy Subcommittee
Date: April 15, 2008
Re: Severe gaps in USDA oversiqht of WestlandlHallmark plant
In press briefings following the public release of video documenting animal handling abuses at the Westland/Hallmark slaughterhouse in Chino, California, USDA officials have repeatedly affirmed that the incidents at V/estland/Hallmark represented an aberration in the meat industry.1
Prior to the public release of undercover video, however, USDA had judged Westland/Hallmark's practices to be in compliance with federal laws. In its 2007 audit, USDA noted no infractions and gave Westland/Hallmark a faultless report.2 The USDA audit is attached.
USDA audit findings are at odds with the documented instances of animal cruelty and food safety violations. Following public release of the video evidence, USDA oversaw the largest voluntary beef recall in U.S. history.
In an interview with Subcommittee staff3 the undercover investigator who documented the abuses at Westland/Hallmark revealed instances of collusion by Westland/Hallmark plant management to violate animal handling and food safety laws and to conceal plant practices from USDA auditors. This undercover investigator also recounted the virtual absence of USDA inspectors in the plant, and the inability of USDA inspectors at the Westland/Hallmark to monitor the large plant.
Collusion by Management to evade law
When he began working at Westland/Hallmark, the undercover investigator asserted that he did not receive any formal training. Instead, a plant manager gave him an employee handbook and an informal run through the materials which lasted "about five minutes." On the other hand, the USDA audit notes that "per establishment managers, all employees who handle livestock get humane training at least monthly."4 The Audit goes on to say that employees must sign off on attendance sheets to veriffy their training as well as issues covered in their training.
The investigator described an incident, not depicted in the video, where an animal with untrimmed horns could not get through a chute. Rather than stop operations to pull the animal out and trim its horns, employees electrically stunned the animal in its anus repeatedly to force it to move. The manager present encouraged this practice despite the animal's bellows and obvious discomfort. The investigator noted that the electric prods were used systematically rather than exceptionally on animals while they were on the chute. Despite this practice, the USDA Audit notes that "per establishment managers, a number of changes have been made to address the noncompliance and concerns [regarding excessive prodding] identified during the previous verification visit."5
The investigator also reported that on the eve before a November 13th and 14th audit, management had a meeting with the employees and explained that they should not engage in inhumane animal handling practices in front of the inspectors.
The investigator also reported that plant managers would routinely fail to inform the USDA inspector if local farmers brought cattle to be slaughtered throughout the day i.e., after the conclusion of the 6:30 a.m. inspection and the 12:30 p.m. inspection. The plant manager would not inform the inspector and the inspector, who remained in his office, was never aware of the practice.
The undercover investigator explained that employees did not fear getting caught committing animal handling abuses because the inspector never showed up unannounced. The investigator described how one employee concealed an electric prodder that he used on the animals even while the inspector was present.
The investigator reported that the USDA inspector was rarely present. The investigator commented that "to the USDA inspector, the cattle was invisible unless they were about to be slaughtered."
The investigator explained that had the inspector's offlrce had windows and been located next to the loading pen, "that alone would help curb bad behavior." .......
SNIP...SEE FULL TEXT 12 PAGES ;
this is just another one of the federal gov. broken records they play from time to time. the GAO AND OIG is helpless in oversight of USDA et al. AS you can see from the reports over the past 8 years. same BSe over and over again, and i see no hope with this problem with the new administration coming in, regardless who wins. BIG AG has a stranglehold on the white house. ...TSS
NON-AMBULATORY DOWNER COW SCHOOL LUNCH PROGRAM
Thursday, March 06, 2008 12:15 PM House committee subpoenas Hallmark/Westland CEO - i call for an investigation of the investigators
SRM MAD COW RECALL 406 THOUSAND POUNDS CATTLE HEADS WITH TONSILS KANSAS
SPECIFIED RISK MATERIALS
MAD COW DISEASE terminology UK c-BSE (typical), atypical BSE H or L, and or Italian L-BASE
BSE BASE MAD COW TESTING TEXAS, USA, AND CANADA
Creutzfeldt-Jakob Disease (Variant) and Bovine Spongiform Encephalopathy (Prion Diseases) Description Since 1996, strong evidence has accumulated for a causal relationship between ongoing outbreaks, primarily in Europe, of a disease in cattle called bovine spongiform encephalopathy (BSE, or “mad cow disease”) and a disease in humans called variant Creutzfeldt-Jakob disease (vCJD). Both disorders, which are caused by an unconventional transmissible agent, are invariably fatal brain diseases with incubation periods typically measured in years (1). Transmission of the BSE agent to humans, leading to vCJD, is believed to occur via ingestion of cattle products contaminated with the BSE agent; the specific foods associated with this transmission are unknown. However, a recently published case-control study involving 132 vCJD cases in the United Kingdom (UK) showed evidence of an increased risk for vCJD associated with the frequency of consuming beef products likely to contain mechanically recovered meat and head meat (such as burgers, meat pies, and sausages) (2). Bioassays and molecular tests have enabled identification of what World Health Organization consultants have classified as “high-infectivity” and “lower infectivity” tissues of cattle with BSE (3). The high-infectivity tissues include the brain, spinal cord, retina, optic nerve, and dorsal root and trigeminal ganglia, suggesting that these tissues can pose a relatively high risk of transmission. The lower infectivity tissues include peripheral nerves (e.g., sciatic and facial nerves), tonsils, nictitating membrane (third eye lid), distal ileum, bone marrow, and possibly thigh muscle. The latter tissue from one cow with BSE transmitted disease to highly BSE-sensitive transgenic mice at a rate indicative of trace levels of infectivity.
who’s gonna be following these children over the next decade or so to see if they contract CJD ? the USDA? FSIS? FDA? CDC? NIH? we must not forget, these innocent children were exposed to the most high risk ‘banned’ animals for BSE/TSE mad cow disease. the other firewall they were speaking of protecting these children would have been the feed ban, which we now know was nothing more than ink on paper. 3 suspect CJD cases as we speak in females under 30 in the USA, other young victims in the USA with CJD. who’s going to follow the children from this nationwide long term case study of children to the TSE agent via the most high risk animals i.e. dead stock downer cattle i.e.. non-ambulatory ???
Friday, December 05, 2008
Detection of Prion Infectivity in Fat Tissues of Scrapie-Infected Mice
Evaluation of the Human Transmission Risk of an Atypical Bovine Spongiform Encephalopathy Prion Strain
Qingzhong Kong,1* Mengjie Zheng,1 Cristina Casalone,2 Liuting Qing,1 Shenghai Huang,1? Bikram Chakraborty,1 Ping Wang,1 Fusong Chen,1 Ignazio Cali,1 Cristiano Corona,2 Francesca Martucci,2 Barbara Iulini,2 Pierluigi Acutis,2 Lan Wang,1 Jingjing Liang,1 Meiling Wang,1 Xinyi Li,1 Salvatore Monaco,3 Gianluigi Zanusso,3 Wen-Quan Zou,1 Maria Caramelli,2 and Pierluigi Gambetti1* Department of Pathology, Case Western Reserve University, Cleveland, Ohio 44106,1 CEA, Istituto Zooprofilattico Sperimentale, 10154 Torino, Italy,2 Department of Neurological and Visual Sciences, University of Verona, 37134 Verona, Italy3 *Corresponding author. Mailing address: Department of Pathology, Case Western Reserve University, Cleveland, OH 44106. Phone for Pierluigi Gambetti: (216) 368-0586. Fax: (216) 368-2546. E-mail: email@example.com . Phone for Qingzhong Kong: (216) 368-1756. Fax: (216) 368-2546. E-mail: firstname.lastname@example.org ?Present address: Department of Patient Education and Health Information, Cleveland Clinic Foundation, Cleveland, OH 44195. Received November 30, 2007; Accepted January 16, 2008.
Bovine spongiform encephalopathy (BSE), the prion disease in cattle, was widely believed to be caused by only one strain, BSE-C. BSE-C causes the fatal prion disease named new variant Creutzfeldt-Jacob disease in humans. Two atypical BSE strains, bovine amyloidotic spongiform encephalopathy (BASE, also named BSE-L) and BSE-H, have been discovered in several countries since 2004; their transmissibility and phenotypes in humans are unknown. We investigated the infectivity and human phenotype of BASE strains by inoculating transgenic (Tg) mice expressing the human prion protein with brain homogenates from two BASE strain-infected cattle. Sixty percent of the inoculated Tg mice became infected after 20 to 22 months of incubation, a transmission rate higher than those reported for BSE-C. A quarter of BASE strain-infected Tg mice, but none of the Tg mice infected with prions causing a sporadic human prion disease, showed the presence of pathogenic prion protein isoforms in the spleen, indicating that the BASE prion is intrinsically lymphotropic. The pathological prion protein isoforms in BASE strain-infected humanized Tg mouse brains are different from those from the original cattle BASE or sporadic human prion disease. Minimal brain spongiosis and long incubation times are observed for the BASE strain-infected Tg mice. These results suggest that in humans, the BASE strain is a more virulent BSE strain and likely lymphotropic.
Thursday, December 04, 2008 2:37 PM
"we have found that H-BSE can infect humans."
personal communication with Professor Kong. ...TSS
"the biochemical signature of PrPres in the BASE-inoculated animal was found to have a higher proteinase K sensitivity of the octa-repeat region. We found the same biochemical signature in three of four human patients with sporadic CJD and an MM type 2 PrP genotype who lived in the same country as the infected bovine."
just another one of those sporadic CJD coincidences i suppose $$$
NOT to forget ;
Thursday, June 05, 2008
Review on the epidemiology and dynamics of BSE epidemics
Vet. Res. (2008) 39:15 www.vetres.org DOI: 10.1051/vetres:2007053 c INRA, EDP Sciences, 2008 Review article
And last but not least, similarities of PrPres between Htype BSE and human prion diseases like CJD or GSS have been put forward , as well as between L-type BSE and CJD . These findings raise questions about the origin and inter species transmission of these prion diseases that were discovered through the BSE active surveillance.
Cases of atypical BSE have only been found in countries having implemented large active surveillance programs. As of 1st September 2007, 36 cases (16 H, 20 L) have been described all over the world in cattle: Belgium (1 L) , Canada (1 H)15, Denmark (1 L)16, France (8 H, 6 L)17, Germany (1 H, 1 L) , Italy (3 L)18, Japan (1 L) , Netherlands (1 H, 2 L)19, Poland (1 H, 6 L)20, Sweden (1 H)21, United Kingdom (1 H)22, and USA (2 H)23. Another H-type case has been found in a 19 year old miniature zebu in a zoological park in Switzerland . It is noteworthy that atypical cases have been found in countries that did not experience classical BSE so far, like Sweden, or in which only few cases of classical BSE have been found, like Canada or the USA.
And last but not least, similarities of PrPres between Htype BSE and human prion diseases like CJD or GSS have been put forward , as well as between L-type BSE and CJD . These findings raise questions about the origin and inter species transmission of these prion diseases that were discovered through the BSE active surveillance.
full text 18 pages ;
please see full text ;
***Atypical forms of BSE have emerged which, although rare, appear to be more virulent than the classical BSE that causes vCJD.***
Progress Report from the National Prion Disease Pathology Surveillance Center
An Update from Stephen M. Sergay, MB, BCh & Pierluigi Gambetti, MD
April 3, 2008
Sunday, March 16, 2008
MAD COW DISEASE terminology UK c-BSE (typical), atypical BSE H or L, and or Italian L-BASE
HUMAN and ANIMAL TSE Classifications i.e. mad cow disease and the UKBSEnvCJD only theory JUNE 2008
Tissue infectivity and strain typing of the many variants Manuscript of the human and animal TSEs are paramount in all variants of all TSE. There must be a proper classification that will differentiate between all these human TSE in order to do this. With the CDI and other more sensitive testing coming about, I only hope that my proposal will some day be taken seriously. ...
Plasma & Serum Proteins Receive Continued FDA Approval
4/25/2008 APC, Inc. is pleased to advise our customers and industry partners that as anticipated, the Food and Drug Administration (FDA) will continue to allow the use of bovine blood, plasma and serum proteins in ruminant feeds.
In April 2008 FDA announced the publication of its Final Rule for 21 CFR Part 589.2001 - Substances Prohibited From Use in Animal Food or Feed. FDA specifically stated in their opinion that, "FDA is not prohibiting the use of blood and blood products in animal feed because we believe such a prohibition would do very little to reduce the risk of BSE transmission."
Known as a leader in developing nutritional products for the swine industry, where 95% of pig starter diets in the United States contain functional proteins, APC has more recently developed their line of colostrum replacers, supplements, feed additives and milk replacer ingredients for calves. Products include plasma, serum and immunoglobulin concentrate based Acquire®, Lifeline®, Gammulin® and Nutrapro® used to optimize the health and performance of calves.
To view the full report for Final Rule 21 CFR Part 589.2001 visit:
To view the complete Feed Rule 21 CFR Part 589 visit:
November 25, 2008
Update On Feed Enforcement Activities To Limit The Spread Of BSE
Prion diseases are efficiently transmitted by blood transfusion in sheep
Fiona Houston1, Sandra McCutcheon1, Wilfred Goldmann2, Angela Chong2, James Foster2, Silvia Sisó3, Lorenzo González3, Martin Jeffrey3, and Nora Hunter2 1 Neuropathogenesis Division, Roslin Institute, Compton, United Kingdom; 2 Neuropathogenesis Division, Roslin Institute, University of Edinburgh, Edinburgh, United Kingdom; and 3 Lasswade Laboratory, Veterinary Laboratories Agency, Penicuik, United Kingdom
The emergence of variant Creutzfeld-Jakob disease, following on from the bovine spongiform encephalopathy (BSE) epidemic, led to concerns about the potential risk of iatrogenic transmission of disease by blood transfusion and the introduction of costly control measures to protect blood supplies. We previously reported preliminary data demonstrating the transmission of BSE and natural scrapie by blood transfusion in sheep. The final results of this experiment, reported here, give unexpectedly high transmission rates by transfusion of 36% for BSE and 43% for scrapie. A proportion of BSE-infected tranfusion recipients (3 of 8) survived for up to 7 years without showing clinical signs of disease. The majority of transmissions resulted from blood collected from donors at more than 50% of the estimated incubation period. The high transmission rates and relatively short and consistent incubation periods in clinically positive recipients suggest that infectivity titers in blood were substantial and/or that blood transfusion is an efficient method of transmission. This experiment has established the value of using sheep as a model for studying transmission of variant Creutzfeld-Jakob disease by blood products in humans.
----- Original Message -----
From: Terry S. Singeltary Sr. To: FREAS@CBER.FDA.GOVCc: email@example.com ; firstname.lastname@example.org Sent: Wednesday, November 29, 2006 1:24 PM Subject: TSE advisory committee for the meeting December 15, 2006 [TSSSUBMISSION]
November 29, 2006
Greetings FDA, DHH, Dr. Freas, and Dr. Harvey et al, a kind and warm Holiday Greetings to you all. i kindly wish to submit the following to the TSE advisory committee for the meeting December 15, 2006, about the assessment for potential exposure to vCJD in human plasma-derived antihemophilic factor (FVIII) products manufactured from U.S. plasma donors and related communication material ;
i see the media picked up on this as a 'low risk', from what the gov. agency perceived to be to them;
however, i seem to disagree. from my primitive ciphering, i see it another way. this is a huge catastrophic risk. 3 in 160 is 1.9%. so call that 2% which is 1 in 50 or twenty per thousand or 20,000 per million. also, what about the mixed genotypes/mixed susceptibility? what about the silent carriers that donated tainted blood? what about the sporadic CJDs of UNKNOWN strain or phenotype? this risk assessment is just more BSe to me. just another in a long line of industry fed crap. i pray that my assessment is the one that is wrong. but it is THEY who roll the dice with your life. it is THEY who refuse to regulate an industry that has run amok. just from a recall aspect of potentially tainted blood, and these are just recent recalls ;
PRODUCTSource Plasma, Recall # B-0054-7CODEUnits: 03MMNC5465, 03MMNC6361, 03MMNC6801, 03MMNC7510, 03MMNC7891,03MMNC8252, 03MMNC8801, 03MMNC9144, 03MMND1122, 03MMND1478, 03MMND1969,03MMND2350, 03MMND2825, 03MMND3211, 03MMND3708, 03MMND4072, 03MMND4588,03MMND4831, 03MMND5320, 03MMND5719, 03MMND6268, 03MMND6683, 03MMND7228,03MMND7656, 03MMND8211, 03MMND8652, 03MMND9195, 03MMND9618, 03MMNE0628,03MMNE0884, 03MMNE1597, 03MMNE1979, 03MMNE2644, 03MMNE3064, 03MMNE3707,03MMNE4122, 03MMNE4750, 03MMNE5080, 03MMNE5876, 03MMNE6218, 03MMNE7189,03MMNE7587, 03MMNE8027, 03MMNE8645, 03MMNE9029, 03MMNE9641, 03MMNE9979,03MMNF0491, 03MMNF0685, 03MMNF0937, 03MMNF1260, 04MMNA0351, 04MMNA0707,04MMNA1241, 04MMNA1650, 04MMNA2291, 04MMNA2646, 04MMNA3340, 04MMNA3719,04MMNA4312, 04MMNA4683, 04MMNA5298, 04MMNA5750, 04MMNA6407, 04MMNA6816,04MMNA7482, 04MMNA7915, 04MMNA8632, 04MMNA9076, 04MMNA9723, 04MMNB0063,04MMNB0696, 04MMNB1100, 04MMNB1845, 04MMNB2285, 04MMNB3035, 04MMNB3485,04MMNB4213, 04MMNB4672, 04MMNB5841, 04MMNB6652, 04MMNB7162, 04MMNB7930,04MMNB8453, 04MMNB9239, 04MMNB9747, 04MMNC0456, 04MMNC0931, 04MMNC1578RECALLING FIRM/MANUFACTURERBioLife Plasma Services, L.P., Mankato, MN, by facsimile on June 4, 2004.Firm initiated recall is complete.REASONBlood products, collected from a donor who was at increased risk for newvariant Creutzfeldt-Jakob Disease (nvCJD), were distributed.VOLUME OF PRODUCT IN COMMERCE89 unitsDISTRIBUTIONCA and AustriaEND OF ENFORCEMENT REPORT FOR October 25, 2006###http://www.fda.gov/bbs/topics/enforce/2006/ENF00975.htmlUSA FDA MAD COW BLOOD HUMANS RECALL (these are dime a dozen)RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II______________________________PRODUCTSource Plasma, Recall # B-1708-6CODEUnits: MI180733, MI180927, MI181625, MI181780, MI182337, MI182519, MI183140,MI183311, MI183955, MI185006, MI185278, MI185822, MI186081, MI186855,MI187183, MI187903, MI188273, MI188695, MI189257, MI189553, MI190136,MI190473, MI191073, MI191395, MI191972, MI192303, MI193473, MI194343,04MINA0377, 04MINA0801, 05MINA7147, 05MINA7451, 05MINA8094, 05MINA8504,05MINA9548, 05MINA9883, 05MINB0489, 05MINB0875, 05MINB1469, 05MINB1874,05MINB3116, 05MINB7192, 05MINB7529, 05MINB8246, 05MINB8612, 05MINB9236,05MINB9366, 05MINB9475, 05MINB9641, 05MINC0031, 05MINC0237, 05MINC0336,05MINC0894, 05MINC0964, 05MINC1138, 05MINC1619, 05MINC1750, 05MINC1907,05MINC1977, 05MINC2375, 05MINC2774, 05MINC3113, 05MINC3484, 05MINC4277,05MINC4623, 05MINC5623, 05MINC5914, 05MINC7545, 05MINC7870, 05MINC8355,05MINC8689, 05MINC9437, 05MINC9775, 05MIND0067, 05MIND0393, 05MIND0892,05MIND0951, 05MIND1836, 05MIND2183 and 05MIND2962RECALLING FIRM/MANUFACTURERBioLife Plasma Services L.P., Muncie, IN, by facsimile on November 22, 2005.Firm initiated recall is complete.REASONBlood products, collected from unsuitable donors based on risk factors forCreutzfeldt-Jakob Disease (CJD), were distributed.VOLUME OF PRODUCT IN COMMERCE80 unitsDISTRIBUTIONCA, NC, and MD______________________________PRODUCTa) Red Blood Cells, Leukocytes Reduced, Recall # B-1714-6;b) Fresh Frozen Plasma, Recall # B-1715-6;c) Platelets, Recall # B-1716-6CODEa), b), and c) Unit: 2443732RECALLING FIRM/MANUFACTURERSouth Texas Blood and Tissue Center, San Antonio, TX, by letters datedNovember 11, 2003 and December 18, 2003. Firm initiated recall is complete.REASONBlood products, co cted from a donor who was at increased risk for newvariant Creutzfeldt-Jakob Disease (nvCJD), were distributed.VOLUME OF PRODUCT IN COMMERCE3 unitsDISTRIBUTIONTX and WIEND OF ENFORCEMENT REPORT FOR SEPTEMBER 13, 2006###http://www.fda.gov/bbs/topics/enforce/2006/ENF00969.htmlPRODUCTFresh Frozen Plasma, Recall # B-1751-6CODEUnit: 4936623RECALLING FIRM/MANUFACTURERGulf Coast Regional Blood Center, Houston, TX, by facsimile dated September16, 2005. Firm initiated recall is complete.REASONBlood product, which was collected from an unsuitable donor based on riskfactors for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.VOLUME OF PRODUCT IN COMMERCE1 unitDISTRIBUTIONTXEND OF ENFORCEMENT REPORT FOR SEPTEMBER 6, 2006###http://ww .fda.gov/bbs/topics/enforce/2006/ENF00968.htmlMon Aug 7, 2006 10:24184.108.40.206PRODUCTa) Red Blood Cells, Recall # B-1587-6;b) Cryoprecipitated AHF, Recall # B-1588-6;c) Recovered Plasma, Recal # B-1589-6CODEa), b) and c) Unit: 2016719RECALLING FIRM/MANUFACTURERWalter Shepeard Community Blood Center, Inc., Augusta, GA, by facsimile onMarch 13, 2003. Firm initiated recall is complete.REASONBlood products, which were collected from a donor who may be at increasedrisk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.VOLUME OF PRODUCT IN COMMERCE3 unitsDISTRIBUTIONGA and Germany______________________________PRODUCTa) Red Blood Cells Leukocytes Reduced, Recall # B-1590-6;b) Fresh Frozen Plasma, Recall # B-1591-6CODEa) and b) Unit: 2443595RECALLING FIRM/MANUFACTURERSouth Texas Blood and Tissue Center, San Antonio, TX, by facsimile on June30, 2004. Firm initiated recall is complete.REASONBlood products, which were collected from a donor who may be at increasedrisk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.VOLUME OF PRODUCT IN COMMERCE2 unitsDISTRIBUTIONTX______________________________PRODUCTa) Red Blood Cells Leukocytes Reduced, Recall # B-1592-6;b) Fresh Frozen Plasma, Recall # B-1593-6CODEa) and b) Unit: 2545596RECALLING FIRM/MANUFACTURERSouth Texas Blood and Tissue Center, San Antonio, TX, by facsimile onDecember 14, 2004 and January 3, 2005. Firm initiated recall is complete.REASONBlood products, which were collected from a donor who may be at increasedrisk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.VOLUME OF PRODUCT IN COMMERCE2 unitsDISTRIBUTIONTX______________________________
SNIP...FULL TEXT ;
Friday, October 24, 2008
CBER 2007 Annual Report Assessing the Potential Risk of variant Creutzfeldt-Jakob Disease from Blood Products
Docket APHIS-2006-0041 Docket Title Bovine Spongiform Encephalopathy; Minimal-Risk Regions; Importation of Live Bovines and Products Derived from Bovines Commodities Docket Type Rulemaking Document APHIS-2006-0041-0001 Document Title Bovine Spongiform Encephalopathy; Minimal-Risk Regions; Importation of Live Bovines and Products Derived From Bovines Public Submission APHIS-2006-0041-0006.1 Public Submission Title Attachment to Singletary comment
Tuesday, November 11, 2008
SaBTO Summary of 1st Public Meeting - variant CJD and blood Tuesday 21st October 2008, 2pm-4pm
ONE HUNDRED AND FIRST MEETING OF THE SPONGIFORM ENCEPHALOPATHY ADVISORY COMMITTEE
Oct 23, 2008 at 9:00 AM
Wednesday, June 11, 2008
OIE Recognition of the BSE Status of Members RESOLUTION No. XXI (Adopted by the International Committee of the OIE on 27 May 2008)
snip...SEE FULL TEXT with facts and sources @ ;
Friday, April 25, 2008
Substances Prohibited From Use in Animal Food or Feed [Docket No. 2002N-0273] (Formerly Docket No. 02N-0273) RIN 0910-AF46
USA BSE ACTIVE SURVEILLANCE ???
Please remember, the last two mad cows documented in the USA i.e. Alabama and Texas, both were of the 'atypical' BSE strain, and immediately after that, the USDA shut down the testing from 470,000 to 40,000 in the U.S. in 2007 out of about 35 million cattle slaughtered. also, science is showing that some of these atypical cases are more virulent to humans than the typical UK BSE strain ;
***Atypical forms of BSE have emerged which, although rare, appear to be more virulent than the classical BSE that causes vCJD.***
Progress Report from the National Prion Disease Pathology Surveillance Center
An Update from Stephen M. Sergay, MB, BCh & Pierluigi Gambetti, MD
April 3, 2008
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.
In short, a great deal of further work will need to be done before the phenotypic features and prevalence of atypical BSE are understood. More than a single strain may have been present from the beginning of the epidemic, but this possibility has been overlooked by virtue of the absence of widespread Western blot confirmatory testing of positive screening test results; or these new phenotypes may be found, at least in part, to result from infections at an older age by a typical BSE agent, rather than neonatal infections with new "strains" of BSE. Neither alternative has yet been investigated.
Friday, August 29, 2008 CREEKSTONE VS USDA COURT OF APPEALS, BUSH SAYS, NO WAY, NO HOW
Tuesday, June 3, 2008
SCRAPIE USA UPDATE JUNE 2008 NOR-98 REPORTED PA
Sunday, September 07, 2008
CWD LIVE TEST, and the political aspects or fallout of live testing for BSE in cattle in the USA
Saturday, October 18, 2008 WYOMING STAR VALLEY MOOSE TESTS POSITIVE FOR CWD
Wednesday, August 20, 2008
Bovine Spongiform Encephalopathy Mad Cow Disease typical and atypical strains, was there a cover-up ?
A New Prionopathy OR more of the same old BSe and sporadic CJD
Communicated by: Terry S. Singeltary Sr.
[In submitting these data, Terry S. Singeltary Sr. draws attention to the steady increase in the "type unknown" category, which, according to their definition, comprises cases in which vCJD could be excluded. The total of 26 cases for the current year (2007) is disturbing, possibly symptomatic of the circulation of novel agents. Characterization of these agents should be given a high priority. - Mod.CP]
There is a growing number of human CJD cases, and they were presented last week in San Francisco by Luigi Gambatti(?) from his CJD surveillance collection.
He estimates that it may be up to 14 or 15 persons which display selectively SPRPSC and practically no detected RPRPSC proteins.
sporadic Fatal Familial Insomnia
JOURNAL OF NEUROLOGY
MARCH 26, 2003
RE-Monitoring the occurrence of emerging forms of Creutzfeldt-Jakob
disease in the United States
Email Terry S. Singeltary:
I lost my mother to hvCJD (Heidenhain Variant CJD). I would like to comment on the CDC's attempts to monitor the occurrence of emerging forms of CJD. Asante, Collinge et al  have reported that BSE transmission to the 129-methionine genotype can lead to an alternate phenotype that is indistinguishable from type 2 PrPSc, the commonest sporadic CJD. However, CJD and all human TSEs are not reportable nationally. CJD and all human TSEs must be made reportable in every state and internationally. I hope that the CDC does not continue to expect us to still believe that the 85%+ of all CJD cases which are sporadic are all spontaneous, without route/source. We have many TSEs in the USA in both animal and man. CWD in deer/elk is spreading rapidly and CWD does transmit to mink, ferret, cattle, and squirrel monkey by intracerebral inoculation. With the known incubation periods in other TSEs, oral transmission studies of CWD may take much longer. Every victim/family of CJD/TSEs should be asked about route and source of this agent. To prolong this will only spread the agent and needlessly expose others. In light of the findings of Asante and Collinge et al, there should be drastic measures to safeguard the medical and surgical arena from sporadic CJDs and all human TSEs. I only ponder how many sporadic CJDs in the USA are type 2 PrPSc?
THE PATHOLOGICAL PROTEIN
Hardcover, 304 pages plus photos and illustrations. ISBN 0-387-95508-9
BY Philip Yam
CHAPTER 14 LAYING ODDS
Answering critics like Terry Singeltary, who feels that the U.S. under- counts CJD, Schonberger conceded that the current surveillance system has errors but stated that most of the errors will be confined to the older population.
Diagnosis and Reporting of Creutzfeldt-Jakob Disease Singeltary, Sr et al. JAMA.2001; 285: 733-734. Vol. 285 No. 6, February 14, 2001 JAMA
Diagnosis and Reporting of Creutzfeldt-Jakob Disease
To the Editor: In their Research Letter, Dr Gibbons and colleagues1 reported that the annual US death rate due to Creutzfeldt-Jakob disease (CJD) has been stable since 1985. These estimates, however, are based only on reported cases, and do not include misdiagnosed or preclinical cases. It seems to me that misdiagnosis alone would drastically change these figures. An unknown number of persons with a diagnosis of Alzheimer disease in fact may have CJD, although only a small number of these patients receive the postmortem examination necessary to make this diagnosis. Furthermore, only a few states have made CJD reportable. Human and animal transmissible spongiform encephalopathies should be reportable nationwide and internationally.
Terry S. Singeltary, Sr Bacliff, Tex
1. Gibbons RV, Holman RC, Belay ED, Schonberger LB. Creutzfeldt-Jakob disease in the United States: 1979-1998. JAMA. 2000;284:2322-2323. FREE FULL TEXT
2 January 2000 British Medical Journal U.S. Scientist should be concerned with a CJD epidemic in the U.S., as well
15 November 1999 British Medical Journal vCJD in the USA * BSE in U.S.
Creutzfeldt Jakob Disease
USA PRION UNIT BLOG
Sunday, April 20, 2008 Progress Report from the National Prion Disease Pathology Surveillance Center April 3, 2008
Atypical forms of BSE have emerged which, although rare, appear to be more virulent than the classical BSE that causes vCJD.
see full text ;
CJD TEXAS (cjd clusters)
USA WRITTEN CJD QUESTIONNAIRE ???
The statistical incidence of CJD cases in the United States has been revised to reflect that there is one case per 9000 in adults age 55 and older. Eighty-five percent of the cases are sporadic, meaning there is no known cause at present.
Terry S. Singeltary Sr.
P.O. Box 42
Bacliff, Texas USA 77518